[Federal Register Volume 61, Number 70 (Wednesday, April 10, 1996)]
[Proposed Rules]
[Pages 15913-15915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8941]
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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.
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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: [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-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, e-
mail: [email protected].
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:
[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 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) * * *
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Inert ingredients Limits Uses
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* * * * * * *
1,1,1,2-Tetrafluoroethane (CAS Aerosol propellant
Reg. No. 811-97-2).
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[FR Doc. 96-8941 Filed 4-9-96; 8:45 am]
BILLING CODE 6560-50-F