Oxo-Alkyl Acetates; Tolerance Exemption

Exxon Chemical Co., Performance Products Group, Linden, NJ 07036, submitted pesticide petition (PP) 3E04267 to EPA requesting that the Administrator, pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), propose to amend 40 CFR 180.1001(d) by establishing an exemption from the requirement of a tolerance for oxo-alkyl acetates [oxo-hexyl acetate (CAS Reg. No. 88230-35-7), oxo-heptyl acetate (CAS Reg. No. 90438-79-2), oxo-octyl acetate (CAS Reg. No. 108419-32-5), oxo-nonyl acetate (CAS Reg. No. 108419-34-7), oxo-decyl acetate (CAS Reg. No. 108419-33-6), and oxo-tridecyl acetate (CAS Reg. No. 108419-35-8)] when used as solvents in pesticide formulations applied to growing crops only. 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 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 data submitted for this petition are primarily for the oxo- octyl acetate and oxo-tridecyl acetate for which the Agency has decided are representative of the entire class of oxo-alkyl acetates having the general structure CH3COOR where R is a branched alkyl group having carbon numbers in the range of C6 through C14 and that no data, in addition to that described below will need to be submitted. The rationale for this decision is described below: 1. A subchronic oral toxicity study using oxo-octyl acetate in rats with a No Observed Effect Level (NOEL) of 100 mg/kg/day and a Lowest Effect Level (LEL) of 500 mg/kg/day based on increased liver weight in both sexes which indicate an overall low degree of systemic toxicity when administered orally to rats for 13 weeks. 2. A subchronic oral toxicity study using oxo-tridecyl acetate in rats with a NOEL of 100 mg/kg and a LEL of 500 mg/kg based on increased incidence of tubular nephropathy in the males and increased kidney and liver weights in both sexes indicating an overall low degree of systemic toxicity following subchronic oral administration of oxo- tridecyl acetate in rats. 3. The microbial mutagenesis study including Salmonella mammalian microsome plate incorporation assays showed no evidence that oxo-octyl acetate or oxo-tridecyl acetate produces any mutagenic effects at any dose tested, either with or without exogenous metabolic activation. 4. An in vivo mammalian bone marrow micronucleus assay oral gavage dosing method did not significantly increase the frequency of micronucleated polychromatic erythrocytes in mouse bone marrow at any dose of oxo-octyl acetate or oxo-tridecyl acetate (625, 1,250 or 2,500 mg/kg body weight) or sampling time (24, 48, and 72 hours post- treatment). 5. A developmental toxicity study with oxo-octyl acetate and oxo- tridecyl acetate in rats with the maternal systemic NOEL of 100 mg/kg/ day and the maternal LOEL of 500 mg/kg based on decreased body weight and the developmental toxicity NOEL of 500 mg/kg/day and the developmental LOEL of 1,000 mg/kg based on increased incidence of various types of vertebral malformations. 6. An acute oral toxicity study with an acute oral LD50 of 5,000 mg/kg in rats indicating that oxo-octyl acetate or oxo-tridecyl acetate has little or no potential for hazard to rats. 7. An acute oral toxicity study with an acute oral LD50 of greater than 2,250 mg/kg in bobwhite quail indicating that oxo-octyl acetate or oxo-tridecyl acetate has little or no potential for hazard to avian species. 8. A dietary study with LC50 of greater than 5,620 ppm in bobwhite quail indicating that oxo-octyl acetate or oxo-tridecyl acetate are practically nontoxic to avian species. Based upon the above evaluation of the toxicological data which shows no evidence of mutagenicity (Ames Test), and no significant acute and subchronic or developmental toxicity of the branched alkyl acetates in this molecular weight range (C8-C13 alkyl acetates), the Agency concludes that this chemical poses no significant risks under the proposed conditions of use and that no further data are required. Based upon the toxicological data evaluated above, the physico- chemical properties of oxo-alkyl acetates and information regarding their use, the Agency has found that, when used in accordance with good agricultural practice, these ingredients are 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 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 control number, [OPP-300412]. 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 proposal under docket number [OPP-300412] (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-docket@epamail.epa.gov

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 proposal, 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 record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document. The Office of Management and Budget has exempted this proposed rule from the requirements of section 3 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 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, Recording and recordkeeping requirements.

Dated: January 31, 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. Section 180.1001(d) is amended by adding and alphabetically inserting the

following inert ingredients, to read as follows:

Sec. 180.1001 Exemptions from the requirement of a tolerance.

* * * * * (d) * * *

------------------------------------------------------------------------ Inert ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * Oxo-decyl acetate (CAS reg. .............. Solvent No. 108419-33-6). Oxo-heptyl acetate (CAS Reg. .............. Solvent No. 90438-79-2). Oxo-hexyl acetate (CAS Reg. .............. Solvent No. 88230-35-7). Oxo-nonyl acetate (CAS Reg. .............. Solvent No. 108419-34-7). Oxo-octyl acetate (CAS Reg. .............. Solvent No. 108419-32-5). Oxo-tridecyl acetate (CAS .............. Solvent Reg. No. 108419-35-8). * * * * * * * ------------------------------------------------------------------------

[FR Doc. 96-3018 Filed 2-13-96; 8:45 am] BILLING CODE 6560-50-F