[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) *        *        *


------------------------------------------------------------------------
      Inert Ingredients             Limits                 Uses         
------------------------------------------------------------------------
                                                                        
*            *            *            *            *            *      
                                      *                                 
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