2-Bromo-2-Nitro-1,3-Propanediol; Tolerance Exemption

Kennedy Consultants Inc., 13 ``C'' Street, Suite G, Laurel, MD 20707 on behalf of Knoll Pharmaceuticals, Knoll Microcheck has submitted pesticide petition (PP) 0E03904 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) and (e) by establishing an exemption from the requirement of a tolerance for 2-bromo-2-nitro-1,3-propanediol when used as an antimicrobial in-can preservative in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and 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 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 Agency has decided that no data, in addition to that described below, for 2-bromo-2-nitro-1,3- propanediol will need to be submitted. The rationale for this decision is described below: 1. An acute rat oral toxicity study with an acute oral LD50 of 1.138 g/kg (0.146) for male rats and 1.138 g/kg (0.013) for female rats. 2. An acute rat inhalation toxicity study with a 3.5-hour inhalation LC50 of >5.0 mg/L/hr. 3. A rabbit eye irritation study with irritancy score of 0.43 classifying 2-bromo-2-nitro-1,3-propanediol as a moderate eye irritant. 4. A rat dermal developmental toxicity study with maternal no observe effect level (NOEL) >40 mg/kg/day (HDT) considering 2-bromo-2- nitro-1,3-propanediol as a severe dermal irritant in rats. 5. A rabbit primary dermal irritation study indicating that 2- bromo-2-nitro-1,3-propanediol is a moderate skin irritant. 6. An acute rabbit dermal toxicity study with dermal LD50 of >2 g/kg. 7. A guinea pig dermal sensitization study which suggests that 2- bromo-2-nitro-1,3-propanediol is a skin sensitizer for a 13% formulation. 8. A rabbit developmental effects study with a NOEL for maternal toxicity of 40 mg/kg/day and developmental toxicity NOEL of 40 mg/kg/ day; lowest effect level (LEL) for maternal toxicity of 80 mg/kg/day with a LEL for developmental toxicity of 80 mg/kg/day. 9. Mutagenicity studies including in vitro/in vivo in mouse erythrocytes (micronucleus assay), chromosomal abberation test in human lymphocytes, Salmonella typhimurium plate (Ames) tests with and without activation were negative. 10. The two generation rat reproduction study (drinking water) with a systemic NOEL of 25 mg/kg/day and lowest effect level (LEL) of 70 mg/ kg/day; reproduction NOEL of 70 mg/kg/day and LEL of 200 mg/kg/day; developmental NOEL of 25 mg/kg/day and LEL of 70 mg/kg/day. 11. A 2-year rat (drinking water) carcinogenicity study with asystemic NOEL of 10 mg/kg/day and LEL of 40 mg/kg/day finding 2-bromo- 2-nitro-1,3-propanediol to be not carcinogenic. 12. A 13-week rat gavage study with a NOEL of 20 mg/kg/day and LEL of 80 mg/kg/day. 13. A 13-week dog gavage study with NOEL of 8 mg/kg/day and LEL of 20 mg/kg/day. The reference dose (RfD) for 2-bromo-2-nitro-1,3-propanediol based on the 2-year chronic study (drinking water) in rats with a NOEL of 10 mg/kg/day and using an uncertainty factor of 100 is calculated to be 0.1 mg/kg of body weight (bwt)/day. The estimated worst-case theoretical maximum residue contribution (TMRC) resulting from this action will be 0.000024 mg/kg/bwt/day for the overall U.S. population and represents 0.024 percent of the RfD. 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 proposal be referred to an Advisory Committee in accordance with section 408(e) of FFDCA. Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the docket control number, [OPP-300421]. 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 4:30 p.m. Monday through Friday, except legal holidays. A record has been established for this rulemaking under docket number [OPP-300421] (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 MallCM #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 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 Virginia 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. 96-3 54, 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, Reporting and recordkeeping requirements.

Dated: March 29, 1996

Peter Caulkins,

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. In Sec. 180.1001 the table in paragraph (c) and paragraph (e) is amended by adding alphabetically the inert ingredient 2-bromo-2-nitro- 1,3-propanediol (CAS Reg. No. 52-51-7), to read as follows:

Sec. 180.1001 Exemptions from the requirements of a tolerance.

* * * * * (c) * * *

------------------------------------------------------------------------ Inert Ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * 2-Bromo-2-nitro-1,3- Not more than Preservative propanediol (CAS Reg. No. 52- 0.04 percent by 51-7). weight of pesticide formulation. * * * * * * * ------------------------------------------------------------------------

(e) * * *

------------------------------------------------------------------------ Inert Ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * 2-Bromo-2-nitro-1,3- Not more than Preservative propanediol (CAS Reg. No. 52- 0.04 percent by 51-7). weight of pesticide formulation. * * * * * * * ------------------------------------------------------------------------

[FR Doc. 96-8942 Filed 4-9-96; 8:45 am] BILLING CODE 6560-50-F