[Federal Register Volume 60, Number 143 (Wednesday, July 26, 1995)]
[Rules and Regulations]
[Pages 38264-38266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18002]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 185 and 186

[FAP 9H5587/R2144; FRL-4960-8]
RIN 2070-AB78


Tralomethrin; Food and Feed Additive Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes time-limited food and feed additive 
regulations for residues of the synthetic pyrethroid tralomethrin in or 
on the processed commodity tomato puree and animal feed tomato pomace, 
wet and dry. AgrEvo USA Co. (formerly Hoechst Roussel Agri-Vet Co.) 
requested these regulations pursuant to the Federal Food, Drug and 
Cosmetic Act (FFDCA) that would establish the maximum permissible 
levels for residues of the pesticide in or on the processed food 
commodity and animal feed.

EFFECTIVE DATE: This regulation becomes effective July 26, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 9H5587/R2144], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St. SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests 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 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 
requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202.
    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 
[FAP 9H5587/R2144]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this 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: George T. LaRocca, Product 
Manager (PM) 13, Registration Division (7505C), Environmental 
Protection Agency, 401 M St. SW., Washington, DC 20460. Office location 
and telephone number: Rm. 259, 1921 Jefferson Davis Hwy., Arlington, VA 
22202, (703)-305-6100; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of May 10, 1995 (60 
FR 24815), EPA issued a proposed rule that gave notice that Hoechst-
Roussel Agri-Vet Co. had submitted to EPA pursuant to section 409 of 
the FFDCA, 21 U.S.C. 348, food/feed additive petition (FAP) 9H5587 
proposing to amend 40 CFR 185.5450 and 40 CFR part 186 by establishing 
time-limited food/feed additive regulations to permit residues of the 
insecticide tralomethrin, (S)-alpha-cyano-3-phenoxybenzyl-(1R,3S)-2,2-
dimethyl-3-[(RS)-1,2,2,-tetrabromoethyl]-cyclopropanecarboxylate, and 
its metabolites in or on the processed commodity tomato puree at 1.00 
part per million (ppm) and the animal feed tomato pomace, wet and dry, 
at 1.50 ppm and 4.00 ppm, respectively.
    There were no comments or requests for referral to an advisory 
committee received in response to the proposed rule.
    The data submitted with 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 time-
limited food and feed additive regulations will protect the public 
health. Therefore, the time-limited food and feed additive regulations 
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).
     A record has been established for this rulemaking under docket 
number [FAP 9H5587/R2144] (including any objections and hearing 
requests submitted electronically as described 

[[Page 38265]]
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 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.
    Written objections and hearing requests, identified by the document 
control number [FAP 9H5587/R2144], may be submitted to the Hearing 
Clerk (1900), Environmental Protection Agency, Rm. 3708, 401 M St., 
SW., Washington, DC 20460.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:
    opp-D[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 any objections and hearing requests 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 objections and hearing requests submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ADDRESSES at the beginning of this document.
    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 Parts 185 and 186

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

    Dated: July 6, 1995.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR parts 185 and 186 are amended as as follows:

PART 185--[AMENDED]

    1. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 348.

    b. By revising Sec. 185.5450, to read as follows:


Sec. 185.5450   Tralomethrin.

    (a) A time-limited food additive regulation is established for the 
combined residues of the insecticide tralomethrin ((S)-alpha-cyano-3-
phenoxybenzyl-(1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]-
cyclopropanecarboxylate; CAS Reg. No. 66841-25-6) and its metabolites 
(S)-alpha-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-alpha-cyano-3-
phenoxybenzyl(1S,3R)-3-(2,2-dibromovinly)-2,2-
dimethylcyclopropanecarboxylate calculated as the parent in or on the 
following food commodities when present as a result of application of 
the insecticide to the growing crops:

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                                            Parts per                   
                Commodity                    million     Expiration date
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Cottonseed oil...........................         0.20  Nov. 15, 1997.  
                                                                        
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    (b) A time-limited food additive regulation is established 
permitting residues of the pesticide tralomethrin ((S)-alpha-cyano-3-
phenoxybenzyl-(1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]-
cyclopropanecarboxylate; CAS Reg. No. 66841-25-6) and its metabolites 
(S)-alpha-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-alpha-cyano-3-
phenoxybenzyl(1S,3R)-3-(2,2-dibromovinly)-2,2-
dimethylcyclopropanecarboxylate calculated as the parent in or on the 
following food commodity resulting from application of the insecticide 
to tomatoes in accordance with an experimental program (34147-EUP-2). 
The conditions set forth in this section shall be met.

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                                            Parts per                   
                Commodity                    million     Expiration date
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Tomato puree.............................         1.00  June 1, 1997    
                                                                        
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    (1) Residues in the food not in excess of the established tolerance 
resulting from the use described in paragraph (b) of this section 
remaining after expiration of the experimental program will not be 
considered to be actionable if the insecticide is applied during the 
term of and in accordance with the provisions of the experimental use 
program and feed additive regulation.
    (2) The company concerned shall immediately notify the 
Environmental Protection Agency of any findings from the experimental 
use that have a bearing on safety. The firm shall also keep records of 
production, distribution, and performance, and on request make the 
records available to any authorized officer or employee of the 
Environmental Protection Agency or the Food and Drug Administration.

PART 186--[AMENDED]

    2. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348.


[[Page 38266]]

    b. By adding new Sec. 186.5450, to read as follows:

Sec. 186.5450   Tralomethrin.

    (a) A time-limited feed additive regulation is established 
permitting residues of tralomethrin ((S)-alpha-cyano-3-phenoxybenzyl-
(1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]-
cyclopropanecarboxylate; CAS Reg. No. 66841-25-6) and its metabolites 
(S)-alpha-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-alpha-cyano-3-
phenoxybenzyl(1S,3R)-3-(2,2-dibromovinly)-2,2-
dimethylcyclopropanecarboxylate calculated as the parent in or on the 
following feed resulting from application of the insecticide to 
tomatoes in accordance with an experimental program (34147-EUP-2). The 
conditions set forth in this section shall be met.


------------------------------------------------------------------------
                                            Parts per                   
                   Feed                      million     Expiration date
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Tomato pomace, wet.......................         1.50  June 1, 1997    
Tomato pomace, dry.......................         4.00  June 1, 1997    
                                                                        
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    (b) Residues in the feed not in excess of the established tolerance 
resulting from the use described in paragraph (a) of this section 
remaining after expiration of the experimental program will not be 
considered to be actionable if the insecticide is applied during the 
term of and in accordance with the provisions of the experimental use 
program and feed additive regulation.

    (c) The company concerned shall immediately notify the 
Environmental Protection Agency of any findings from the experimental 
use that have a bearing on safety. The firm shall also keep records of 
production, distribution, and performance, and on request make the 
records available to any authorized officer or employee of the 
Environmental Protection Agency or the Food and Drug Administration.

[FR Doc. 95-18002 Filed 7-25-95; 8:45 am]

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