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Tralomethrin (Scout) - Pesticide Tolerance 11/97

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 185

[OPP-300584; FRL-5756-2]
RIN 2070-AB78

Deltamethrin and Tralomethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
deltamethrin and tralomethrin in or on: deltamethrin--cottonseed at
0.04 parts per million (ppm) and cottonseed oil at 0.2 ppm; and
tralomethrin--broccoli at 0.50 ppm, cottonseed at 0.02 ppm, lettuce,
head at 1.00 ppm, lettuce, leaf at 3.00 ppm, soybeans at 0.05 ppm,
sunflower seed at 0.05 ppm and cottonseed oil at 0.20 ppm. It also
removes time limitations for tolerances for residues of deltamethrin
and tralomethrin on the same commodities that expire on November 15,
1997. AgrEvo USA Company requested this tolerance under the Federal
Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1966 (Pub. L. 104-170). These tolerances were
established under petition numbers PP 2F4055, PP 6F3436, PP 4F2993, and
PP 6F3309.

DATES: This regulation is effective November 26, 1997. Objections and
requests for hearings must be received by EPA on or before January 26,
1998.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, OPP-300584, must 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 identified by the docket control
number, OPP-300584, must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA.
    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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number OPP-300584. 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.

FOR FURTHER INFORMATION CONTACT: By mail: John Hebert, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 308-3068, e-mail:
hebert.john@epamail.epa.gov.

Supplementary Information: On August 16, 1995 and September 15, 1985,
EPA established time limited tolerances under section 408 of the
Federal Food Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346 a(d) and 348
for residues of deltamethrin (60 FR 42455) (FRL-4966-3) and
tralomethrin (50 FR 37851) respectively, on cottonseed. These
tolerances expire on November 15, 1997. AgrEvo USA Company, on
September 15, 1997, requested that the time limitation for tolerances
established for residues of the insecticides deltamethrin on cottonseed
at 0.04 ppm and cottonseed oil at 0.2 ppm; and tralomethrin on broccoli
at 0.50 ppm, cottonseed at 0.02 ppm, lettuce, head at 1.00 ppm,
lettuce, leaf at 3.00 ppm, soybeans at 0.05 ppm, sunflower seed at 0.05
ppm and cottonseed oil at 0.20 ppm, be removed based on ecological and
environmental effects data that they had submitted as a condition of
the registration and time-limited tolerances. AgrEvo USA Company also
submitted a summary of its petition as required under the FFDCA as
amended by the Food Quality Protection Act (FQPA) of 1996 (Pub. L. 104-
170). In the Federal Register of September 25, 1997 (62 FR 50337) (FRL-
5848-2), EPA, issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) announcing the
filing of a pesticide petition (PP) for a tolerance by AgrEvo USA
Company. This notice included a summary of the petition prepared by
AgrEvo USA Company (acting as registered US agent for Hoechst Schering
AgrEvo, S. A., Little Falls Centre, 2711 Centerville Road, Wilmington,
DE 19808, the registrant. There were no comments received in response
to the notice of filing.
    The basis for time limited tolerances that expire November 15,
1997, was given in the October 20, 1993 Federal Register (58 FR 54094).
These time-limited tolerances were predicated on the expiration of
pesticide product registrations that were made conditional due to lack
of certain ecological and environmental effects data. The rationale for
using time-limited tolerances was to encourage pesticide manufacturers
to comply with the conditions of registration in a timely manner. There
is no regulatory requirement to make tolerances time-limited due to the
conditional status of a product registration under the Federal
Insecticide, Fungicide, Rodenticide Act (FIFRA) as amended. It is
current EPA policy to no longer establish time limitations on
tolerance(s) with expiration dates if none of the conditions of
registration have any bearing on human dietary risk. The current
petition action meets that condition and thus the expiration dates
associated with specific crop tolerances are being deleted.
    Deltamethrin and tralomethrin are being combined for analysis under
FQPA because tralomethrin is rapidly metabolized by animals to
deltamethrin as a result of debromination. Results of the rat
metabolism study supports this action.

List of Subjects

40 CFR Part 180
    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
    Environmental protection, Food additives, Pesticides and pests.
requirements.

    Dated: November 14, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as
follows:

    Authority: 21 U.S.C. 346a and 371.

    b. By revising Sec. 180.422 to read as follows:

Sec. 180.422   Tralomethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined
residues of the pesticide chemical tralomethrin ((S)-alpha-cyano-3-
phenoxybenzyl (1R,3S)-2,2-dimethyl-3-[(RS)-1,2,2,2-tetrabromoethyl]-
cyclopropanecarboxylate) and its metabolites (S)-alpha-cyano-3-
phenoxybenzyl (1R,3R)-3(2,2-dibromovinyl)-2,2-dimethyl-
cyclopropanecarboxylate and (S)-alpha-cyano-3-phenoxybenzyl(1S,3R)-3-
(2,2-dibromovinyl)-2,2-dimethyl-cyclopropanecarboxylate calculated as
the parent in or on the following agricultural commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Broccoli..................................  0.5
Cottonseed................................  0.02
Cottonseed oil............................  0.20
Lettuce, head.............................  1.00
Lettuce, leaf.............................  3.00
Soybeans..................................  0.05
Sunflower seed............................  0.05
------------------------------------------------------------------------

    (2) 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:
    (i) 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.
    (ii) 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:
    (A) 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.
    (B) 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.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
    c. By revising Sec. 180.435 to read as follows:

Sec. 180.435   Deltamethrin, tolerances for residues.

    (a) General. Tolerances are established for the combined residues
of the pesticide chemical deltamethrin [(1R,3R)-3-(2,2-dibromovinyl)-
2,2-dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl
ester and its major metabolites, trans deltamethrin [(S)-alpha-cyano-m-
phenoxybenzyl(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] and alpha-R-deltamethrin [(R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] in or on the following agricultural
commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Cottonseed................................  0.04
Cottonseed oil............................  0.2
Tomatoes..................................  0.2
Tomato (products) concentrated............  1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

PART 185--[AMENDED]

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

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

Sec. 185.1580  [Removed]

    b. By removing Sec. 185.1580.

[[Page 63002]]

Sec. 185.5450 [Removed]

    c. By removing Sec. 185.5450.

[FR Doc. 97-31103 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F