[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Rules and Regulations]
[Pages 39351-39353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19084]


-----------------------------------------------------------------------


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5E04443/R2258; FRL-5386-8]
RIN 2070-AB78


1,1-Difluoroethane; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This document establishes an exemption from the requirement of 
a tolerance for 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. The Dupont Company requested this 
regulation pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation becomes effective July 29, 1996.

ADDRESSES Written objections, identified by the document control 
number, [PP 5E04443/R2258] may be submitted to: Hearing Clerk (1900), 
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, 
DC 20460. A copy of any objections and hearing requests filed with the 
Hearing Clerk should be identified by the document control number and 
submitted 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, bring copy of objections and hearing request to: Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees 
accompanying objections shall be labeled ``Tolerance Petition Fees'' 
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number [PP 
5E04443/R2258]. No Confidential Business Information (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: Westfield 
Building North, 6th Fl., 2800 Crystal Drive, Arlington, VA 22202, (703) 
308-8375; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 4, 1996 (61 
FR 28118), EPA issued a proposed rule (FRL-5371-5) that gave notice 
that The Dupont Company, 1007 Market Street, Wilmington, DE 19898 had 
submitted pesticide petition (PP) 5E04443 to EPA requesting that the 
Administrator, pursuant to section 408(e) of the Federal Food, Drug, 
and Cosmetic Act (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 residues of 1,1-difluoroethane (CAS Reg. No. 75-37-
6) when used as an inert ingredient (aerosol propellant) in 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

[[Page 39352]]

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.
    There were no comments or requests for referral to an advisory 
committee received in response to the proposed rule.
    The data submitted relevant to the proposal and other relevant 
material have been evaluated and discussed in the proposed rule. Based 
on the data and information considered, the Agency concludes that the 
tolerance exemption will protect the public health. Therefore, the 
tolerance exemption is established as set forth below.
    Any person adversely affected by this regulation may, within August 
28, 1996, file written objections and/or request a hearing with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is a genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issue(s) in the manner sought by the requestor would be 
adequate to justify the action requested (40 CFR 178.32).
    A record has been established for this rulemaking under docket 
number (PP insert0 number) (including objections and hearing requests 
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 public 
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.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:

    [email protected].

    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk 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.
    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.
    Pursuant to the terms of the Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    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 (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 statement 
containing the factual basis for this certification was published in 
the Federal Register of May 4, 1981 (46 FR 24950).
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 18, 1996.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is 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 to paragraph (c) and paragraph (e) is 
amended by adding alphabetically the inert ingredient, to read as 
follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *

[[Page 39353]]

    (c) * * *
      

                                                                        
------------------------------------------------------------------------
      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.                            
         *        *        *        *        *        *        *        
------------------------------------------------------------------------

    (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.                            
                                                                        
         *        *        *        *        *        *        *        
------------------------------------------------------------------------


[FR Doc. 96-19084 Filed 7-26-96; 8:45 am]
BILLING CODE 6560-50-F