[Federal Register Volume 59, Number 206 (Wednesday, October 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26549]
[[Page Unknown]]
[Federal Register: October 26, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300296A; FRL-4908-2]
RIN 2070-AB78
Acrylonitrile Butadiene Copolymer; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes an exemption from the requirement of
a tolerance for residues of acrylonitrile-butadiene copolymer when used
as an inert ingredient (component of ear tags and similar slow-release
devices) in pesticide formulations applied to animals. Y-Tex Corp.
requested this regulation.
EFFECTIVE DATE: This regulation becomes effective October 26, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [OPP-300296A], 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.
FOR FURTHER INFORMATION CONTACT: By mail: Kerry Leifer, Registration
Division (7508W), 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)-308-8323.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 27, 1994 (59
FR 38151), EPA issued a proposed rule that gave notice that the Y-Tex
Corp., P.O. Box 1450, 1825 Big Horn Ave., Cody, WY 82414, had requested
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(e) by establishing an exemption from the requirement of a
tolerance for acrylonitrile-butadiene copolymer, FD & C Yelow No. 6
aluminum lake, 2-(2'-hydroxy-5'-methylphenyl)benzotriazole and
octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate when used as
components of ear tags and similar slow-release devices in pesticide
formulations applied to animals. The proposal was a reissuance of the
original proposal that appeared in the Federal Register of February 3,
1989 (54 FR 5502), and responded to a comment by including a revised
calculation of lifetime risk from exposure to monomeric acrylonitrile.
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.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
The data submitted on 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 30
days after publication of this document in the Federal Register, 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).
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations of recipients
thereof; 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.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 20, 1994.
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. Section 180.1001(e) is amended by adding and alphabetically
inserting the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(e) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Acrylonitrile-butadiene .................. Carrier in animal tag and
copolymer (CAS Reg. No. similar slow-release
9003-18-3) conforming to devices.
21 CFR 180.22, minimum
average molecular weight
1,000.
* * * * * * *
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[FR Doc. 94-26549 Filed 10-25-94; 8:45 am]
BILLING CODE 6560-50-F
