[Federal Register Volume 61, Number 139 (Thursday, July 18, 1996)] [Proposed Rules] [Pages 37432-37435] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-17925] ----------------------------------------------------------------------- [[Page 37433]] ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-300429; FRL-5376-4] RIN 2070-AC18 Vinyl Alcohol-Vinyl Acetate Copolymer, Benzaldehyde-o-Sodium Sulfonate Condensate; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: This document proposes to establish an exemption from the requirement of a tolerance for residues of vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate when used as an inert ingredient (water soluble resin) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest and when applied to animals. This proposed regulation was requested by Mitsui Plastics, Inc. DATES: Written comments, identified by the docket number [OPP-300429], must be received on or before August 19, 1996. 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, deliver comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., 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). 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 will be included in the public docket 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: [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 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number [OPP-300429]. 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: Bipin Gandhi, Registration Support Branch, Registration Division (7505W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: 2800 Crystal Drive, North Tower, 6th Floor, Arlington, VA 22202, (703) 308-8380, e-mail: [email protected]. SUPPLEMENTARY INFORMATION: Mitsui Plastics, Inc., 11 Martine Ave, White Plains, NY 10606, submitted pesticide petition (PP) 6E4718 to EPA requesting that the Administrator, pursuant to section 408(e) of the Federal Food Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346 a(e)), propose to amend 40 CFR 180.1001(c) and (e) by establishing an exemption from the requirement of a tolerance for residues of vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate when used as an inert ingredient (water soluble resin) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest and applied to animals. Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125, and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ``inert'' is not to imply nontoxicity; the ingredient may or may not be chemically active. The data submitted in the petition and other relevant material have been evaluated. As part of the EPA policy statement on inert ingredients published in the Federal Register of April 22, 1987 (52 FR 13305), the Agency set forth a list of studies which would generally be used to evaluate the risks posed by the presence of an inert ingredient in a pesticide formulation. However, where it can be determined without that data that the inert ingredient will present minimal or no risk, the Agency generally does not require some or all of the listed studies to rule on the proposed tolerance or exemption from the requirement of a tolerance for an inert ingredient. The Agency has decided that no data, in addition to that described below, for vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate will need to be submitted. The rationale for this decision is described below. In the case of certain chemical substances that are defined as ``polymers,'' the Agency has established a set of criteria which identify categories of polymers that present low risk. These criteria (described in 40 CFR 723.250) identify polymers that are relatively unreactive and stable compared to other chemical substances as well as polymers that typically are not readily absorbed. These properties generally limit a polymer's ability to cause adverse effects. In addition, these criteria exclude polymers about which little is known. The Agency believes that polymers meeting the criteria noted above will present minimal or no risk. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low risk polymers: 1. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate is not a cationic polymer, nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate contains as an integral part of its composition the atomic elements carbon, hydrogen, oxygen, sodium and sulfur. 3. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate does not contain as an integral part of its composition, except as impurities, any elements other than those listed in 40 CFR 723.250(d)(2)(ii). 4. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate is not designed, nor is it reasonably anticipated to substantially degrade, decompose or depolymerize. 5. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate is not manufactured or imported from monomers and/ or other reactants that are not already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. [[Page 37434]] 6. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate is not a water absorbing polymer with a number average molecular weight greater than or equal to 10,000 daltons. 7. The minimum number-average molecular weight of vinyl alcohol- vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate is 20,000 daltons. Substances with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact gastrointestinal (GI) tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response. 8. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate has a minimum number average molecular weight of 20,000 and contains less than 2 percent oligomeric material below molecular weight 500 and less than 5 percent oligomeric material below 1,000 molecular weight. 9. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate does contain aliphatic hydroxy groups, aliphatic ester groups, diacetal groups and sodium sulfonate groups as reactive functional groups. However, these reactive groups are not intended or reasonably anticipated to undergo further reactions. Based on the above information and review of its use, EPA has found that, when used in accordance with good agricultural practice, this ingredient is useful and a tolerance is not necessary to protect the public health. Therefore, EPA proposes that the exemption from the requirement of a tolerance 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, that contains any of the ingredients listed herein, may request within 30 days after the publication of this document in the Federal Register that this rulemaking proposal be referred to an Advisory Committee in accordance with section 408(e) of the FFDCA. Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the docket number, [OPP-300429]. A record has been established for this rulemaking under docket number [OPP-300429] (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 4:30 p.m., Monday through Friday, excluding 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 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 be placed in the paper copies of the official rulemaking record which also will include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in the ``ADDRESSES'' at the beginning of this document. The Office of Management and Budget has exempted this rule from the requirements of section 2 of Executive Order 12866. This action does not impose any enforceable duty, or contain any ``unfunded mandates'' as described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), entitled Enhancing the Intergovernmental Partnership, or special consideration as required by Executive Order 12898 (59 FR 7629, February 16, 1994). Pursuant to the requirement of the Regulatory Flexibility Act (5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have an 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 Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 25, 1996. Stephen L. Johnson, Director, Registration 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 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. In Sec. 180.1001, the table in paragraphs (c) and (e), is amended by adding alphabetically the inert ingredient ``Vinyl alcohol- vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate condensate, minimum number average molecular weight (in amu) 20,000,'' to read as follows: Sec. 180.1001 Exemptions from the requirement of a tolerance. * * * * * (c) * * * ------------------------------------------------------------------------ Inert ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * Vinyl alcohol-vinyl acetate Water soluble resin copolymer,benzaldehyde-o- sodium sulfonate condensate, minimum number average molecular weight (in amu) 20,000. * * * * * * * ------------------------------------------------------------------------ * * * * * (e) * * * [[Page 37435]] ------------------------------------------------------------------------ Inert ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * Vinyl alcohol-vinyl acetate Water soluble resin copolymer,benzaldehyde-o- sodium sulfonate condensate, minimum number average molecular weight (in amu) 20,000. * * * * * * * ------------------------------------------------------------------------ [FR Doc. 96-17925 Filed 7-17-96; 8:45 am] BILLING CODE 6560-50-F