[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Proposed Rules]
[Pages 28118-28120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13440]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E04443/P659; FRL-5371-5]
RIN 2070-AB18
1,1-Difluoroethane; Proposed Exemption from Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of 1,1-difluoroethane
(CAS Reg. No. 75-37-6) be exempted from the requirement of a tolerance
when used as an inert ingredient (aerosol propellant) in aerosol
pesticide formulations used for insect control in food- and feed-
handling establishments and animals. This proposed regulation was
requested by The Dupont Company, pursuant to the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: Comments, identified by the docket control number [PP 5E04443/
P659], must be received on or before July 5, 1996.
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 #2, 1921 Jefferson Davis Highway, Arlington, VA.
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 4:30 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number, [PP 5E04443/P659]. 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, telephone number, and e-mail
address: 2800 Crystal Drive, North Tower, Arlington, VA, (703) 308-
8375, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: The Dupont Company, 1007 Market Street,
Wilmington, DE 19898 has submitted pesticide petition (PP) 5E04443 to
EPA requesting that the Administrator, pursuant to section 408(e) of
the FFDCA, 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 the residues of 1,1-difluoroethane (CAS Reg. No. 75-37-6) when used
as an inert ingredient (aerosol propellant) in aerosol pesticide
formulations used for insect control in food- and feed-handling
establishments 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
[[Page 28119]]
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-difluoroethane will
need to be submitted. The rationale for this decision is described
below:
1. 1,1-Difluoroethane has been designated by the EPA as a substance
about which it has little concern regarding its ozone-depleting
potential and is listed as an acceptable substitute for certain uses of
currently used ozone-depleting propellants. 1,1-Difluoroethane is now
used in consumer products (e.g., hair sprays, baby oil mousse, spray
bandage, rug shampoos and oven cleaners).
2. An acute rat toxicity study which showed no mortality when
animals were exposed to 1,1-difluoroethane at concentrations up to
200,000 ppm, indicating that the substance is essentially non-toxic
following acute inhalation exposure.
3. A chronic rat inhalation toxicity study with exposures for 6
hours, 5 days/week for 2 years, with a no-observed-effect-level (NOEL)
of 27,000 mg/M3 and LOEL of 67,500 mg/M3 based on mild
reversible renal effects.
4. A rat inhalation developmental toxicity study with pregnant CD
rats exposed to concentrations of 0, 5,000 or 50,000 ppm for 6 hours/
day on gestation days 6 through 15 showing no treatment-related
maternal or fetal effects at any dose level, indicating that 1,1-
difluoroethane is not a developmental toxicant at dose levels of equal
or less than 50,000 ppm.
5. A human (volunteers) study reported no adverse effects except
for reversible analgesia and feelings of impending loss of
consciousness after acute inhalation exposure to 500,000 ppm of 1,1-
difluoroethane.
6. 1,1-Difluoroethane is approved under 21 CFR 178.3010 by the
United States Food and Drug Administration (FDA) as an indirect food
additive (e.g., blowing agent in the production of polystyrene articles
which come in contact with food).
7. 1,1-Difluoroethane is a gas at ambient temperatures. Therefore,
rapid volatilization of the substance and dilution by ambient air is
expected, suggesting that human exposure would be insignificant. It
would not be expected that the Reference Dose (RfD) of 74 ppm (200 mg/
M3) established by the Agency for this chemical would be reached
or exceeded in exposures resulting from its intended use as an aerosol
propellant.
The toxicological profile indicates a lack of chronic, subchronic
or developmental toxicity. Based upon the physico-chemical
characteristics, and review of its use, and the determination that
there is no reasonable expectation of finite residues in food or feed
items as a result of its use as a propellent in pesticide formulations,
the Agency has concluded that the use of 1,1-difluoroethane would
result in negligible risks to human health and the environment.
Accordingly, the Agency has found that, 1,1-difluoroethane, when used
in accordance with good agricultural practice, 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, [PP 5E04443/P659]. 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 [PP 5E04443/P659] (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 Mall2, 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.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 of Executive Order 12866.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
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).
[[Page 28120]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 15, 1991.
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 is amended in paragraphs (c) and (e) in the
table therein by adding and alphabetically inserting the inert
ingredient, 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-difluoroethane (CAS Reg. For aerosol Aerosol propellant
No. 75-37-6). pesticide
formulations
used for insect
control in food-
and feed-
handling
establishments
and animals.
* * * * * *
*
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* * * * *
(e) * * *
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Inert Ingredients Limits Uses
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* * * * * *
*
1,1-difluoroethane (CAS Reg. For aerosol Aerosol propellant
No. 75-37-6). pesticide
formulations
used for insect
control in food-
and feed-
handling
establishments
and animals
* * * * * *
*
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[FR Doc. 96-13440 Filed 6-3-96; 8:45 am]
BILLING CODE 6560-50-F