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Tralomethrin (Scout) - Food and Feed Additive Regulations--Final Rule 10/95

[Federal Register: October 25, 1995 (Volume 60, Number 206)]
[Rules and Regulations]
[Page 54607-54610]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 185 and 186
[FAP 3H5678/R2176; FRL-4980-1]
RIN 2070-AB78
Tralomethrin; Food and Feed Additive Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This rule establishes food/feed additive regulations for the
combined residues of the pyrethroid tralomethrin and its metabolites
cis-deltamethrin and trans-deltamethrin in or on food and feed items as
a result of the application of this pesticide in food/feed handling
establishments. The regulation to establish maximum permissible levels
for residues of the pesticide in food/feed as a result of application
of this insecticide in food/feed handling establishments was requested
in a petition submitted by AgrEvo Environmental Health (formerly
Roussel UCLAF Corp.).

EFFECTIVE DATE: This regulation becomes effective October 25, 1995.

ADDRESSES: Written objections and hearing requests, identified by the
document control number, [FAP 3H5678/R2176], 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
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 3H5678/R2176]. 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), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 204, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6100; e-mail:
larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of October 21, 1993 (58 FR 54356), which announced
that AgrEvo Environmental Health had submitted a food/feed additive
petition (FAP) 3H5678 to EPA requesting that the Administrator,
pursuant to section 409(e) of the Federal Food, Drug and Cosmetic Act
(FFDCA), 21 U.S.C. 348(e), amend 40 CFR parts 185 and 186 by
establishing a food/feed additive regulation to permit residues of the
synthetic pyrethroid tralomethrin ((S)-alpha-cyano-3-phenoxybenzyl-
(1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]
cyclopropanecarboxylate) and its metabolites cis-deltamethrin [(S)-
alpha-cyano-3-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] and trans-deltamethrin [(S)-alpha-
cyano-3-phenoxybenzyl (1S,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] in or on food and feed as a result of
use in food/feed-handling establishments at 0.02 part per million
(ppm). Treatments may be made by general surface, spot, and/or crack
and crevice application.
    There were no comments received in response to the notice of
filing. The scientific data submitted in support of the food and feed
additive regulations and other relevant material have been evaluated.
The toxicological data considered in support of these regulations are
discussed in detail in related documents published in the Federal Register of
September 18, 1985 (50 FR 37581).
    A chronic dietary exposure/risk assessment was performed for
tralomethrin using a reference dose (RfD) of 0.0075 mg/kg bwt/day based
on the no-observable-effect level (NOEL) of 0.75 mg/kg bwt/day in the
2-year rat-feeding study with an uncertainty factor of 100. The
endpoint of concern was decreased body weight gain in males and
increase food and water consumption in both sexes. The Theoretical
Maximum Residue Contribution (TMRC) from established tolerances
utilizes less than 1% of the RfD for the U.S. population and nonnursing
infants less than 1 year of age (the subgroup with the highest
estimated exposure to tralomethrin residues). The current action would
increase exposure to 0.000478 mg/kg bwt/day or 6.4% of the RfD for the
U.S. population and increase exposure to 0.001890 mg/kg bwt/day or
25.5% of the RfD for nonnursing infants less than 1 year. Generally
speaking, EPA has no cause for concern if total residue contribution
for published and proposed tolerances is less than the RfD. EPA
concludes that the chronic dietary risk of tralomethrin does not appear
to be of concern.
    The nature of the residues of tralomethrin and metabolism in plants
and animals are adequately understood for the establishment of a
permanent tolerance in food/feed handling establishments. The residues
of concern are tralomethrin and its metabolites. There is no reasonable
expectation of secondary residues in animal commodities, i.e., meat,
milk, poultry, and eggs from this use, pursuant to 40 CFR 180.6(a)(3).
    An adequate analytical method, capillary gas chromatography
equipped with electron capture detector, is available for enforcement
purposes. The enforcement methodology has been submitted to the Food
and Drug Administration for publication in the Pesticide Analytical
Manual, Vol. II (PAM II). Because of the long lead time for publication
of the method in PAM II, the analytical methodology is being made
available in the interim to anyone interested in pesticide enforcement
when requested from: Calvin Furlow, Public Response and Program
Resources Branch, Field Operations Divisions (7506C), Office of
Pesticide Programs, Environmental Protection Agency 401 M St.,
Washington, DC 20460. Office location and telephone number: Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5232.
    There are presently no actions pending against the continued
registration of this chemical.
    The pesticide is considered useful for the purposes for which it is
sought and capable of achieving its intended physical and technical
effect. Based on the information and data considered, the Agency has
determined that the establishment of a food/feed additive regulation by
amending 40 CFR parts 185 and 186 would protect the public health and
that use of the pesticide in accordance with the food/feed additive
regulations would be safe. Therefore, the food/feed additive
regulations are established as set forth below.
    Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking be referred
to an Advisory Committee in accordance with section 409 of the FFDCA.
    Interested persons are invited to submit written objections on this
regulation. Comments must bear a notation indicating the document
control number, [FAP 3H5678/R2176]. All written objections filed in
response to these petitions will be available in the Public Response
and Program Resources Branch, at the address given above from 8 a.m. to
4:30 p.m., Monday through Friday, except legal holidays.
     A record has been established for this rulemaking under docket
number [FAP 3H5678/R2176] (including objections and hearing requests
submitted electronically as described 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 3H5678/R2176], 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 all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines "significant" as
those actions likely to lead to 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 known 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 (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 this 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, or establishing or raising food additive regulations 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, Feed additives, Food additives, Pesticides
and pests, Reporting and recordkeeping requirements.

    Dated: September 28, 1995.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, chapter I of title 40 of the Code of Federal Regulations
is amended 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. In Sec. 185.5450, by adding new paragraph (c) to read as follows:

Sec. 185.5450   Tralomethrin.

* * * * *
    (c) A food additive tolerance of 0.02 part per million 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) and its metabolites cis-
deltamethrin [(S-alpha-cyano-3-phenoxybenzyl-(1R,3R)-3-[2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate] and trans-
deltamethrin [(S)-alpha-cyano-3-phenoxybenzyl (1S,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate] as follows:
    (1) In or on all food items (other than those covered by a higher
tolerance as a result of use on growing crops) in food-handling
establishments.
    (2) The insecticide may be present as a residue from application of
tralomethrin in food-handling establishments, including food service,
manufacturing, and processing establishments, such as restaurants,
cafeterias, supermarkets, bakeries, breweries, dairies, meat
slaughtering and packing plants, and canneries in accordance with the
following prescribed conditions:
    (i) Application shall be limited to a general surface and spot and/
or crack and crevice treatment in food-handling establishments where
food and food products are held, processed, prepared, and served.
General surface application may be used only when the facility is not
in operation provided exposed food has been covered or removed from the
area being treated. All food-contact surfaces and equipment must be
thoroughly cleaned after general surface applications. Spot and/or
crack and crevice application may be used while the facility is in
operation provided exposed food is covered or removed from the area
being treated prior to application. Spray concentration shall be
limited to a maximum of 0.06 percent active ingredient. Contamination
of food and food-contact surfaces shall be avoided.
    (ii) To assure safe use of the insecticide, its label and labelling
shall conform to that registered with the U.S. Environmental Protection
Agency and shall be used in accordance with such label and labelling.

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.

    b. In Sec. 186.5450, by redesignating paragraphs (b) and (c) as
paragraphs (a)(1) and (2), respectively, and by adding new paragraph
(b), to read as follows:

Sec. 186.5450   Tralomethrin.

* * * * *
    (b) A feed additive tolerance of 0.02 part per million 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) and its metabolites cis-
deltamethrin [(S)-alpha-cyano-3-phenoxybenzyl-(1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate] and trans-
deltamethrin [(S)-alpha-cyano-3-phenoxybenzyl (1S,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate as follows:
    (1) In or on all feed items (other than those covered by a higher
tolerance as a result of use on growing crops) in feed-handling
establishments.
    (2) The insecticide may be present as a residue from application of
tralomethrin in feed-handling establishments, including feed
manufacturing and processing establishments in accordance with the
following prescribed conditions:
    (i) Application shall be limited to a general surface and spot and/
or crack and crevice treatment in feed-handling establishments where
feed and feed products are held or processed. General surface
application may be used only when the facility is not in operation
provided exposed feed has been covered or removed from the area being
treated. All feed-contact surfaces and equipment must be thoroughly
cleaned after general surface applications. Spot and/or crack and
crevice application may be used while the facility is in operation
provided exposed feed is covered or removed from the area being treated
prior to application. Spray concentration shall be limited to a maximum
of 0.06 percent active ingredient. Contamination of feed and feed-
contact surfaces shall be avoided.
    (ii) To assure safe use of the insecticide, its label and labelling
shall conform to that registered with the U.S. Environmental Protection
Agency and shall be used in accordance with such label and labelling.