40 CFR Part 180 [OPPÄ300308; FRLÄ4649Ä7] RIN No. 2070ÄAC18 Polyethylene Glycol-Polyisobutenyl Anhydride-Tall Oil Fatty Acid Copolymer; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: This document proposes that an exemption from the requirement of a tolerance be established for residues of polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer when used as an inert ingredient (surfactant, dispersing agent, suspending agent, or related adjuvant) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. This proposed regulation was requested by ICI Americas, Inc. DATES: Comments, identified by the document control number [OPP-300308], must be received on or before January 28, 1994. 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, Crystal Mall Bldg. ñ2, 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. The public docket is 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. FOR FURTHER INFORMATION CONTACT: By mail: Connie Welch, Registration Support Branch, Registration Division (7505W), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Westfield Bldg. North, 6th Fl., 2800 Crystal Drive, Arlington, VA 22202, (703)-308-8320. SUPPLEMENTARY INFORMATION: ICI Americas, Inc., Wilmington DE 19897, has submitted pesticide petition (PP) 3E4201 to EPA requesting that the Administrator, pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(e), propose to amend 40 CFR 180.1001(c) by establishing an exemption from the requirement of a tolerance for residues of polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer when used as an inert ingredient (surfactant, dispersing agent, suspending agent, or related adjuvant) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. 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 intended 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 established data requirements which will be used to evaluate the risks posed by the presence of an inert ingredient in a pesticide formulation. Exemptions from some or all of the requirements may be granted if it can be determined that the inert ingredient will present minimal or no risk. The Agency has decided that the data normally required to support the proposed tolerance exemption for polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer will not need to be submitted. The rationale for this decision is described below: In the case of certain chemical substances which 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. Polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer conforms to the definition of a polymer given in 40 CFR 723.250(b)(11) and meets the following criteria which are used to identify low-risk polymers: 1. The minimum number-average molecular weight of the above-mentioned copolymer is 5,000. Substances with molecular weights greater than 400 are generally not readily absorbed through the intact skin, and substances with molecular weights greater than 1,000 are generally not absorbed through the intact gastrointestinal (GI) tract. Chemicals not absorbed through the skin or GI tract are generally incapable of eliciting a toxic response. 2. The above-mentioned copolymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 3. The above-mentioned copolymer does not contain less than 32.0 percent by weight of the atomic element carbon. 4. The above-mentioned copolymer contains as an integral part of its composition the atomic elements carbon, hydrogen, nitrogen, and oxygen. 5. The above-mentioned copolymer 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)(3)(ii). 6. The above-mentioned copolymer is not a biopolymer, a synthetic equivalent of a biopolymer, or a derivative or modification of a biopolymer that is substantially intact. 7. The above-mentioned copolymer is not manufactured from reactants containing, other than as impurities, halogen atoms or cyano groups. 8. The above-mentioned copolymer does not contain reactive functional groups that are intended or reasonably anticipated to undergo further reaction. 9. The above-mentioned copolymer is not designed or reasonably anticipated to substantially degrade, decompose, or depolymerize. Based upon 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, which contains any of the ingredients listed herein, may request within 30 days after 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 Federal Food, Drug, and Cosmetic Act. Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the document control number, [OPP-300308]. 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. The Office of Management and Budget has exempted this rule from the requirements of section 2 of Executive Order 12866. 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 regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic effect 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, Recording and recordkeeping requirements. Dated: December 10, 1993. Stephen L. Johnson, Acting 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. Section 180.1001(c) is amended by adding and alphabetically inserting the inert ingredient, to read as follows:  180.1001 Exemptions from the requirement of a tolerance. * * * * * (c) * * * c3,L2,tp0,s110,r65,r110 [col head 1] Inert ingredients [col head 1] Limits [col head 1] Uses * * * * * * * Polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer (minimum number-average molecular weight 5,000) Surfactant, dispersing agent, suspending agent, or related adjuvant. * * * * * * * * * * * * [FR Doc. 93Ä31476 Filed 12Ä28Ä93; 8:45 am] BILLING CODE 6560Ä50ÄF