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1,1-Difluoroethane (DuPont). July 29, 1996. Tolerance Exemption for INERT ingredient. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/July/Day-29/pr-819DIR/pr-819.html
[Federal Register: July 29, 1996 (Volume 61, Number 146)] [Rules and Regulations]
[Page 39351-39353]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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 feedhandling 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: opp-docket@epamail.epa.gov. 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: acierto.amelia@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov.
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]
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.
(c) * * *
No. 75-37-6). pesticide
formulations
used for insect
control in food-
and feed-
handling
establishments
and animals.
(e) * * *
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