[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) *  *  * 

------------------------------------------------------------------------
    Inert ingredients            Limits                  Uses           
------------------------------------------------------------------------
                                                                        
                              * * * * * * *                             
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