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1,1,1,2-Tetrafluoroethane (Whitmire). April 10, 1996.
Tolerance Exemption. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/1996/April/Day-10/pr-642.html

[Federal Register: April 10, 1996 (Volume 61, Number 70)] [Proposed Rules]
[Page 15913-15915]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300417; FRL-5353-5]

RIN 2070-AB18

1,1,1,2-Tetrafluoroethane; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes that residues of 1,1,1,2- tetrafluoroethane be exempted from the requirement of a tolerance when used as an inert ingredient (aerosol propellant) in insecticide aerosol formulations intended to be applied in food handling establishments. This proposed regulation was requested by Whitmire Research Laboratories, Inc.

DATE: Comments, identified by the document control number [OPP-300417], must be received on or before May 10, 1996.

ADDRESS: 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. 1128, Crystal Mall, Building #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). 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 the EPA without prior notice. The public docket is available for public inspection in Room 1128 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-300417]. 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: Amelia M. Acierto 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: 2800 Crystal Drive, North Tower, Arlington, VA 22202, (703) 308-8375, email: acierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Whitmire Research Laboratories, Inc. 3568 Tree Court Industrial Boulevard, Saint Louis, MO 63122-6620 submitted pesticide petition (PP) number 5E4439 to EPA requesting that the Administrator, pursuant to Section 408(e) of the Federal Food, Drug, and Cosmetic Act,

[[Page 15914]]
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 1,1,1,2- tetrafluoroethane (HFC-134a) when used as an aerosol propellant in pesticide formulations intended for application in food handling establishments. 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 1,1,1,2- tetrafluoroethane will need to be submitted. The rationale for this decision is described below:

  1. HFC-134a (1,1,1,2-tetrafluoroethane) exhibits a low degree of both acute and chronic inhalation toxicity in laboratory animals.
  2. Based on the proposed use pattern for the inert ingredient, concentrations of 1,1,1,2-tetrafluoroethane in air resulting from its use as a propellant in pesticide formulations applied in food handling establishments are expected to be well below the environmental exposure level of 1,000 ppm (for short term exposure) recommended by the American Industrial Hygiene Association (AIHA 1991, Workplace Environmental Exposure Level Guide: 1,1,1,2-Tetrafluoroethane) and are not expected to exceed the RfC of 19.2 ppm for lifetime exposures.
  3. HFC-134a has already been listed as one of the acceptable substitutes for ozone depleting substances (ODS) by the EPA's Stratospheric Protection Division, Office of Air and Radiation (OAR) under the Significant New Alternatives Policy (SNAP) program which implements section 612 of the amended Clean Air Act of 1990 (60 FR 3318, January 13, 1995 and 60 FR 31107, June 13, 1995).
  4. The RfC estimate for HFC-134a, with an uncertainty factor of about 10 of a daily inhalation concentration for the human population (including sensitive subgroups), is 80 mg/cubic meter of atmosphere or 19.2 ppm.
  5. HFC-134a is extremely volatile and would dissipate rapidly when applied as aerosol making the potential for residues on foods minimal; consumers are also unlikely to be exposed to concentrations of HFC-134a approaching the AIHA recommended maximum exposure levels based on the use of pesticide products which will contain HFC-134a. Based upon the information above, the toxicological data and physico-chemical properties, and review of its use, and, based on the EPA's Office of Radiation listing as an acceptable substitute for a variety of chlorofluorocarbons which are being banned or phased out under the Clean Air Act, the Agency has found that, when used in accordance with labeling use instructions, 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.
    A record has been established for this rulemaking under docket number OPP-300417 (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 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 address in ``ADDRESSES'' at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB)). Under section 3(f), the order defines ``significant'' as those actions likely to lead to 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 governments or communities (also known 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 entitlement, grants, user fees, or loan programs; 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. The Office of Management and Budget has exempted this rule from the requirements of section 3 of Executive Order 12866. Pursuant to the requirements of the Regulatory Flexibility Act (Pub.L. 96-354 Stat. 1164,5 U.S.C. 601-612), the Administrator has determined that

    [[Page 15915]]
    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

    Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Recording and recordkeeping requirements.

    Dated: March 29, 1996.

    Peter Caulkins,

    Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I, 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 alphabetically the inert ingredient 1,1,1,2-tetrafluoroethane, CAS Reg. No. 811-97-2, to read as follows: Sec. 180.1001 Exemptions from the requirements of a tolerance.
      • * * * *
        (c) * * *
      Inert ingredients Limits Uses 
                                                                              

      1,1,1,2-Tetrafluoroethane (CAS                        Aerosol propellant
 Reg. No. 811-97-2).

      [FR Doc. 96-8941 Filed 4-9-96; 8:45 am] BILLING CODE 6560-50-F