[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)] [Proposed Rules] [Pages 8901-8903] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-5242] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-300414; FRL-5347-7] RIN 2070-AB18 Triphenyltin Hydroxide; Proposed Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: This notice proposes to revoke tolerances for residues of Triphenyltin Hydroxide in or on carrots, peanuts and peanut hulls. All domestic registrations for use on these crops have been cancelled, therefore there is no longer a need to maintain these tolerances. DATES: Written comments should be submitted to EPA by May 6, 1996. ADDRESSES: By mail, submit written comments to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental [[Page 8902]] Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information.'' CBI should not be submitted through e-mail. Information marked as CBI 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 4:30 p.m., Monday through Friday, excluding legal holidays. Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket-epamail.epa.gov 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 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number [OPP-300414]. 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: Jude Andreasen, Special Review and Reregistration Division (7508W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Telephone: (703) 308-8016; e- mail:andreasen.jude-epamail.epa.gov. SUPPLEMENTARY INFORMATION: I. Legal Authorization The Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.) authorizes the establishment of tolerances (maximum legal residue levels) and exemptions from the requirement of a tolerance for residues of pesticide chemicals in or on raw agricultural commodities pursuant to section 408 [21 U.S.C. 346(a)]. Without such tolerances or exemptions, a food containing pesticide residues is considered ``adulterated'' under section 402 of the FFDCA, and hence may not legally be moved in interstate commerce [21 U.S.C. 342]. To establish a tolerance or an exemption under section 408 of the FFDCA, EPA must make a finding that the promulgation of the rule would ``protect the public health'' [21 U.S.C. 346a(b)]. For a pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.). In 1988, Congress amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) and required EPA to review and reassess the potential hazards arising from currently registered uses of pesticides registered prior to November 1, 1984. As part of this process, the Agency must determine whether a pesticide is eligible for reregistration or whether any subsequent actions are required to fully attain reregistration status. EPA has chosen to include in the reregistration process a reassessment of existing tolerances or exemptions from the need for a tolerance. Through this reassessment process, based on more recent data, EPA can determine whether a tolerance must be amended, revoked, or established, or whether an exemption from the requirement of one or more tolerances must be amended or is necessary.The procedure for establishing, amending, or revoking tolerances or exemptions from the requirement of tolerances is set forth in 40 CFR parts 177 through 180. The Administrator or EPA, or any person by petition, may initiate an action proposing to establish, amend, revoke, or exempt a tolerance for a pesticide registered for food uses. Each petition or request for a new tolerance, an amendment to an existing tolerance, or a new exemption from the requirement of a tolerance must be accompanied by a fee. Current Agency policy on tolerance actions identified during the reregistration process is to waive the payment of fees if the tolerance action concerns revision or revocation of an established tolerance, or if the proposed exemption from the requirement of a tolerance requires the concurrent revocation of an approved tolerance. Comments submitted in response to the Agency's published proposals are reviewed; the Agency then publishes its final determination regarding the specific tolerance actions. II. Chemical--Specific Information and Proposed Actions On Triphenyltin hydroxide: Revocation of Tolerances 1. Regulatory background. Triphenyltin hydroxide (TPTH) was first registered under FIFRA in 1971; a Registration Standard was issued in September, 1984. The Standard established the restricted use classification, announced EPA's intent to initiate a Special Review based on developmental toxicity, imposed label warnings, established a 24-hour reentry period, and required data to fill gaps in product chemistry, residue chemistry, environmental fate, ecological effects and toxicology. Data Call-In Notices were issued in 1986, 1988, 1990 and 1993. Worker exposure studies and reentry studies for pecan harvesters were submitted in early 1995 and are under review. The registrants (Griffin Corporation, Elf Atochem and Hoechst, now Agrevo) formed a Task Force and agreed that carrots and peanuts would not be supported uses, but that data for use on sugar beets, potatoes and pecans would be generated jointly by the Task Force. A notice announcing receipt of a request for a voluntary cancellation of the use of TPTH on carrots was published in the Federal Register on March 6, 1991 (56 FR 9358). No comments were received in connection with this notice and the registration was subsequently canceled 60 days later. Earlier, the technical registrant, Griffin Corporation, submitted an application and proposed label amendments which deleted the use of TPTH on peanuts. The Agency approved this action on June 13, 1988. 2. Current proposal. Revocation of tolerances under 40 CFR 180.236 are proposed. Registrants are not supporting the use of TPTH on peanuts or carrots. Therefore, the Agency is proposing to revoke the tolerances for peanuts, peanut hulls and carrots. III. Public Comment Procedures EPA invites interested parties to submit written comments, information, or data in response to this proposed rule. Comments must be submitted by May 6, 1996. Comments must bear a notation indicating the docket number. Three copies of the comments should be submitted to either location listed under the ``ADDRESSES'' section above. Information submitted as a comment concerning this document may be claimed confidential by marking any or all of that information as ``Confidential Business Information'' (CBI). EPA will not disclose information so marked, except in accordance with procedures set forth in 40 CFR part 2. A second copy of such comments, with the CBI deleted, must also be submitted for inclusion in the public record. EPA may publicly disclose without prior notice information not marked confidential. Any person who has registered or submitted an application for registration of a pesticide, under FIFRA, as [[Page 8903]] amended, that 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 408(e) of the FFDCA. EPA has established a record for this proposed rule under docket number [OPP-300414] (including comments and data submitted electronically as described below). 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 4:00 p.m., Monday through Friday, except legal holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall2, 1921 Jefferson Davis Highway, Arlington, VA. Electronic comments can be sent directly to EPA at: opp-docket-epamail.epa.gov The official record for this proposed rule, 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 proposed rule record which will also include all comments submitted directly in writing. The official proposed rule record is the paper record maintained at the ``ADDRESSES'' listed at the beginning of this document. IV. References 1. U.S. Environmental Protection Agency. 56 FR 9358, TPTH: Deletion of Uses and Directions for Use on Carrots, March 6, 1991. 2. Application and revised label from Griffin Corporation to EPA, October 16, 1987, deleting the use on peanuts for EPA registration number 1812-244. Accepted application, June 13, 1988. V. Regulatory Assessment Requirements To satisfy requirements for analysis specified by Executive Order 12866, the Regulatory Flexibility Act, the Paperwork Reduction Act, and the Unfunded Mandates Reform Act, EPA has considered the impacts of this proposal. A. Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in 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 tribal governments or communities (also referred to 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 entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; 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 a ``significant regulatory action,'' because it does not meet any of the regulatory-significance criteria listed above. The use sites for which tolerance revocation is proposed have been cancelled for some time. Revoking the tolerances is not expected to have any significant impact. B. Regulatory Flexibility Act EPA has reviewed this proposed rule under the Regulatory Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601et seq.], and has determined that it will not have a significant economic impact on any small businesses, governments, or organizations. The proposed rule is not expected to have any significant impact on entities of any size. Accordingly, I certify that this proposed rule does not require a separate regulatory flexibility analysis under the Regulatory Flexibility Act. C. Paperwork Reduction Act This proposed regulatory action does not contain any information collection requirements subject to review by OMB under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. D. Unfunded Mandates This proposed rule contains no Federal mandates under Title II of the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State, local, or tribal governments or the private sector, because it would not impose enforceable duties on them. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 22, 1996. Lois A. Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR part 180 be amended as follows: PART 180--[AMENDED] 1. The authority citation for part 180 would continue to read as follows: Authority: 15 U.S.C. 346a and 371. 2. Section 180.236 is revised to read as follows: Sec. 180.236 Triphenyltin hydroxide; tolerances for residues. Tolerances are established for residues of the fungicide triphenyltin hydroxide in or on raw agricultural commodities as follows: 0.1 part per million in or on sugar beet roots. 0.05 part per million in or on pecans and potatoes. 0.05 part per million in the kidney and liver of cattle, goats, hogs, horses and sheep. [FR Doc. 96-5242 Filed 3-5-96; 8:45 am] BILLING CODE 6560-50-F