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Tralomethrin (Scout) Food and Feed Additive Regulations--Final Rule 7/95

Date: Wed, 26 Jul 1995 12:37:48 -0400
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 Subject: Tralomethrin; Food and
Feed Additive Regulations X-Comment: U.S. EPA FEDERAL REGISTER PESTICIDE documents Status: O
X-Status:

[Federal Register: July 26, 1995 (Volume 60, Number 143)] [Rules and Regulations]
[Page 38264-38266]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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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: 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 [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: larocca.george@epamail.epa.gov.

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-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 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:

------------------------------------------------------------------------
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
------------------------------------------------------------------------

Tomato pomace, wet.......................	1.50 June 1, 1997
Tomato pomace, dry.......................	4.00 June 1, 1997

------------------------------------------------------------------------

(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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