[Federal Register Volume 60, Number 21 (Wednesday, February 1, 1995)]
[Rules and Regulations]
[Pages 6032-6034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2441]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300365A; FRL-4932-1]
RIN 2070-AB78


FD & C Yellow No. 6 Aluminum Lake, 2-[(2'-Hydroxy-5'-
Methylphenyl)Benzotriazole and Octadecyl 3,5-Di-Tert-Butyl-4-
Hydroxyhydrocinnamate; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes exemptions from the requirement of a 
tolerance for residues of FD & C Yellow No. 6 Aluminum Lake (CAS Reg. 
No. 15790-07-5), 2-(2'-hydroxy-5'-methylphenyl)-benzotriazole (CAS Reg. 
No. 2440-22-4), and octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate 
(CAS Reg. No. 2082-79-3) when used as inert ingredients (components 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 February 1, 1995.

ADDRESSES: Written objections, identified by the document control 
number, [OPP-300365A], 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 B. Leifer, Registration 
Support Branch, 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 November 10, 1994 
[[Page 6033]] (59 FR 56027), EPA issued a proposed rule that gave 
notice that Y-Tex Corp. P.O. Box 1450, 1825 Big Horn Ave., Cody, WY 
82414, had submitted a pesticide petition 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(d) by establishing exemptions from the requirement of a 
tolerance for residues of FD & C Yellow No. 6 Aluminum Lake (CAS Reg. 
No. 15790-07-5), 2-(2'-hydroxy-5'-methylphenyl)benzotriazole (CAS Reg. 
No. 2440-22-4), and octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate 
(CAS Reg. No 2082-79-3) when used as inert ingredients (components of 
ear tags and similar slow-release devices) in pesticide formulations 
applied to 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 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 exemptions will protect the public health. Therefore, the 
tolerance exemptiona are 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 or 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: January 23, 1995.

Lois Rossi,
Acting Director, Registration Division, 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 in the table therein by adding 
and alphabetically inserting the inert ingredients, to read as follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

*    *    *    *    *
    (e) *  *  *

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    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
FD & C Yellow No. 6        Not more than 2%    Pigment in animal tag and
 Aluminum Lake (CAS Reg.    by weight of        similar slow-release    
 No. 15790-07-5).           pesticide           devices.                
                            formulation.                                
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
2-(2'-Hydroxy-5'-          Not more than 0.5%  Ultraviolet light        
 methylphenyl)-             by weight of        absorber/stabilizer in  
 benzotriazole (CAS Reg.    pesticide           animal tag and similar  
 No. 2440-22-4).            formulation.        slow-release devices.   
                                                                        
[[Page 6034]]                                                           
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
Octadecyl 3,5-di-tert-     Not more than 0.5%  Thermal stabilizer/      
 butyl-4-                   by weight of        antioxidant in animal   
 hydroxyhydrocinnamate      pesticide           tag and similar slow-   
 (CAS Reg. No. 2082-79-3.   formulation.        release devices.        
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
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[FR Doc. 95-2441 Filed 1-31-95; 8:45 am]
BILLING CODE 6560-50-F