[Federal Register Volume 60, Number 90 (Wednesday, May 10, 1995)]
[Proposed Rules]
[Pages 24815-24817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11386]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 185 and 186

[FAP 9H5587/P614; FRL-4950-6]
RIN 2070-AC18


Tralomethrin; Food and Feed Additive Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish time-limited food and feed additive 
regulations for residues of the synthetic pyrethroid tralomethrin in or 
on the processed commodity tomato puree and the 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.

DATES: Comments, identified by the document control number [PP 9H5587/
P614], must be received on or before June 9, 1995.

ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, Crystal 
Mall Building #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. 
Information submitted as a comment concerning this notice may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR part 2. A copy of the comment that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the address given above, from 8 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [FAP 9H5587/P614]. No CBI should be submitted through 
e-mail. Electronic comments on this proposed 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. 200, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6100; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: On June 13, 1989, Hoechst-Roussel Agri-Vet 
Co. submitted 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)1,2,2,2-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.
    Based on information furnished by AgrEvo USA Co., an experimental 
use [[Page 24816]] permit (EUP) under section 5 of the Federal 
Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 983), 
will be issued concurrently with the establishment of this food/feed 
additive regulation. The permit authorizes the use of 33 gallons of 
tralomethrin for 1 year in California, Florida, Georgia, New Jersey, 
Maryland, Ohio, Pennsylvania, and Texas for the evaluation of insect 
control on tomatoes. Also, a pesticide petition, 9G3774, has been 
submitted pursuant to section 408(d) of the FFDCA to amend 40 CFR 
180.422 to establish temporary tolerances which allow a maximum 
permissible level for residues of tralomethrin in or on certain raw 
agricultural commodities (RAC's): tomato at 0.20 ppm; fat, meat, and 
meat byproducts of cattle, goats, hogs, horses, sheep at 0.10 ppm, 0.01 
ppm, and 0.01 ppm, respectively; and milk at 0.02 ppm. The raw 
agricultural commodities (RAC's) regulation will be established 
concurrently with the food/feed additive regulation.
    The data submitted in support of these tolerances and other 
relevant material have been evaluated. The toxicological and metabolism 
data and analytical methods for enforcement purposes considered in 
support of these tolerances are discussed in detail in related 
documents published in the Federal Register of September 18, 1985 (50 
FR 37581). In addition, mutagenicity studies were submitted and 
considered in support of these tolerances. Based on the studies 
submitted (an unscheduled DNA synthesis study in rat primary 
hepatocytes and a chromosome aberration study in Chinese hamster ovary 
cells), tralomethrin is not considered mutagenic.
    A dietary exposure/risk assessment was performed for tralomethrin 
using a Reference Dose (RfD) of 0.0075 mg/kg bwt/day, based on a no-
observed-effect level (NOEL) of 0.75 mg/kg bwt/day and an uncertainty 
factor of 100. The NOEL was determined in a 2-year rat feeding study. 
The end-point effect of concern was decreased body weight. The 
Theoretical Maximum Residue Contribution (TMRC) from established 
tolerances utilizes less than 1% of the RfD for the U.S. population or 
18% of the RfD if the new tolerances are granted. Established 
tolerances utilize 1% of the RfD for nonnursing infants less than 1-
year old or 26% of the RfD if the new tolerances are granted. 
Established tolerances utilize less than 1% of the RfD for children 
(age 1 to 6 years), the subgroup with the highest estimated exposure to 
tralomethrin residues or 39% of the RfD if the new tolerances are 
granted. Generally speaking, EPA has no cause for concern if total 
residue contribution for published and proposed tolerances is less than 
the RfD.
    The nature of the residue in tomatoes and ruminants is adequately 
understood for the establishment of a time-limited tolerance. An 
adequate analytical method, gas-liquid chromatography, 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 currently no actions pending against the continued 
registration of this chemical.
    Based on the information and data considered, the Agency has 
determined that the time-limited tolerances established by amending 40 
CFR parts 185 and 186 would protect the public health. Therefore, it is 
proposed that the tolerances be 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 proposal be 
referred to an Advisory Committee in accordance with section 409 of the 
FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, PP 9H5587/P614. All written comments filed in 
response to this petition will be available in the Public Response and 
Program Resources Branch, at the address given above from 8 a.m. to 4 
p.m., Monday through Friday, except legal holidays.
     A record has been established for this rulemaking under docket 
number [FAP 9H5587/P614] (including comments and data submitted 
electronically). 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 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 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.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected].


    Electronic comments 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 all comments 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 comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in the ADDRESSES section above 
in 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 [[Page 24817]] 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, Feed additives, Food additives, Pesticides 
and pests, Reporting and recordkeeping requirements.

    Dated: April 28, 1995.

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

    Therefore, it is proposed that 40 CFR parts 185 and 186 be 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. 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    Expiration
                   Commodity                      million        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                   
                  Commodity                      per     Expiration date
                                               million                  
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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]

    1. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348.

    2. 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.


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                                                Parts                   
                    Feed                         per     Expiration date
                                               million                  
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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. 95-11386 Filed 5-9-95; 8:45 am]

BILLING CODE 6560-50-F