[Federal Register Volume 59, Number 231 (Friday, December 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29689]


[[Page Unknown]]

[Federal Register: December 2, 1994]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300363; FRL-4912-6]
RIN 2070-AC18

 

Revocation of Folpet Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revoke the tolerances for residues 
of the fungicide folpet (N-(trichloromethylthio)phthalimide) in or on 
the following raw agricultural commodities: apples, blackberries, 
blueberries, boysenberries, celery, cherries, citrus fruits, 
crabapples, cranberries, cucumbers, currants, dewberries, garlic, 
gooseberries, grapes, huckleberries, leeks, lettuce, loganberries, 
melons, onions (dry bulb), onions (green), pumpkins, raspberries, 
shallots, strawberries, summer squash, tomatoes, and winter squash. EPA 
is revoking the tolerances because it does not have adequate data to 
make a finding that the tolerances will protect the public health.

DATES: Written comments, identified by the OPP document control number 
[OPP-300363], must be received on or before January 3, 1995.

ADDRESSES: By mail, submit comments to Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person, 
deliver comments to Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis 
Hwy., Arlington, VA.

FOR FURTHER INFORMATION CONTACT: By mail: Jeff Morris, Special Review 
and Reregistration Division (7508W), Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Special Review Branch, Crystal Station #1, 3rd Floor, 2800 
Crystal Drive, Arlington, VA 22202, (703)-308-8029.

SUPPLEMENTARY INFORMATION:

Introduction

    Folpet is a broad-spectrum fungicide that is registered for 
industrial use in paints, stains, coatings, and plastics. In addition, 
two folpet products are registered for food use. One product is 
actively registered for use on avocados in Florida only; the other is a 
suspended registration for all folpet food uses, which include the food 
uses subject to this document.

Legal Background

    The Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 301 et 
seq.] authorizes the establishment of tolerances (maximum legal residue 
levels) and exemptions from the requirement of a tolerance for residues 
of pesticide chemicals in or on raw agricultural commodities pursuant 
to section 408 (21 U.S.C. 346a, 348). Without such tolerances or 
exemptions, a food containing pesticide residues is considered to be 
``adulterated'' under section 402 of the FFDCA, and hence may not 
legally be moved in interstate commerce (21 U.S.C. 342). To establish a 
tolerance or an exemption under section 408 of the FFDCA, EPA must make 
a finding that the promulgation of the rule would ``protect the public 
health'' (21 U.S.C. 346a(b)). For a pesticide to be sold and used in 
the production of a food crop or food animal, the pesticide must not 
only have appropriate tolerances under the FFDCA, but must be 
registered under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA, 7 U.S.C. 136 et seq.). FIFRA requires the registration of 
pesticides that are sold and distributed in the United States.

Regulatory Background

    EPA issued a Registration Standard under FIFRA for folpet in June 
1987. At that time, folpet was registered for industrial use on paints, 
stains, coatings, and plastics, as well as for use on a variety of food 
and terrestrial crops. The Registration Standard states that EPA 
classifies folpet as a B2 (probable) human carcinogen. In November 
1987, EPA issued a Notice of Intent to Suspend (NOIS) letter for all 
nonindustrial uses of folpet, because no data had been submitted--
including residue data for the food uses identified in this document--
to support folpet's nonindustrial uses.
    Makhteshim-Agan (America), Inc., the folpet registrant, and Chevron 
Chemical Co. formed a task force to share the development of data 
identified as data gaps in the folpet Registration Standard. The Folpet 
Task Force indicated that it would only support folpet's industrial 
uses. At this point, the NOIS became a final order of suspension, and 
the only remaining folpet registrations with food uses, EPA Reg. Nos. 
11678-51 and 11678-52, were suspended. In 1990, Makhteshim purchased 
these suspended registrations, which had on their labels the 
commodities subject to this document. Makhteshim subsequently provided 
data to support the avocado use and deleted all food uses except 
avocados from EPA Reg. No. 11678-51. In 1992, EPA Reg. No. 11678-51 was 
changed to EPA Reg. No. 66222-7 (the avocado only label), and EPA Reg. 
No. 11678-52 was changed to EPA Reg. No. 66222-8 (the suspended label 
containing all food uses).
    In a 1993 letter to EPA, Makhteshim indicated that it desired 
import tolerances for some of the uses for which the suspended product 
number 66222-8 is registered, stating that folpet is an important 
pesticide product in many countries. To date, however, EPA has not 
received adequate data to support any folpet tolerances--imported or 
domestic--for the raw agricultural commodities subject to this 
document.

Current Proposal

    This document proposes the revocation of all folpet tolerances--
except the avocado tolerance--established under section 408 of FFDCA, 
21 U.S.C. 346a, for residues of the fungicide folpet (N-
(trichloromethylthio)phthalimide) in or on the following commodities 
listed in 40 CFR 180.191:

    50 parts per million in or on celery, cherries, leeks, lettuce, 
onions (green), and shallots; 25 parts per million in or on apples, 
blackberries, blueberries, boysenberries, crabapples, cranberries, 
currants, dewberries, gooseberries, grapes, huckleberries, 
loganberries, raspberries, strawberries, and tomatoes; and 15 parts 
per million in or on citrus fruits, cucumbers, garlic, melons, 
onions (dry bulb), pumpkins, summer squash, and winter squash.

    EPA is proposing this action because the establishment of a 
tolerance under section 408 of FFDCA requires a finding that the 
tolerance will protect the public health. EPA does not have adequate 
data to make such a finding. The registrant has not submitted the 
following residue chemistry data, which, according to the June 1987 
folpet registration standard, are needed to make a public-health 
finding on folpet for the commodities subject to this document:
    Nature of the residues (metabolism) studies (guideline no. 171-
4a) for representative crops; storage stability studies (guideline 
no. 171-4e) for representative crops; analytical method validation; 
crop field trials (guideline no. 171-4k) for the subject 
commodities; and processing studies (guideline no. 171-4l) for 
applicable commodities.

    These studies, which are important to assessing the health risks 
posed by folpet use, have not been submitted to EPA. Makhteshim 
indicated in 1987 that it would not provide the necessary data to 
support the commodities subject to this document, and Makhteshim has 
not attempted to provide any such data since that time, except for data 
to support the avocado use.

    Domestically produced commodities subject to this proposal should 
no longer contain folpet residues following revocation of the 
tolerances. In the absence of folpet tolerances, any agricultural 
commodity or processed food domestically produced and/or imported into 
the United States found to contain folpet residues is adulterated under 
section 402 of the FFDCA.
    There is no expectation of a residue problem due to environmental 
contamination. Consequently, EPA will not recommend action levels to 
replace the tolerances upon their revocation.

Other Regulatory Requirements

Executive Order 12866

    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 this Executive Order, it has been 
determined that this rule is not a ``significant regulatory action,'' 
because over the past few years there has been only very minor domestic 
usage of folpet on the suspended use sites. The time elapsed since 
suspension of the food uses, along with the recent usage data showing a 
very limited amount of usage, indicate that the loss of the tolerances 
subject to this document should not cause a significant economic impact 
on domestic users. Although overseas usage of folpet on grapes--one of 
the commodities subject to this document--is substantial, U.S. imports 
of grapes are relatively small and mostly from Chile, which does not 
use folpet. Thus, this action was not submitted to OMB for review.

Regulatory Flexibility Act

    This proposed rule has been reviewed under the Regulatory 
Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et 
seq.), and EPA has determined that it will not have a significant 
economic impact on a substantial number of small businesses, small 
governments, or small organizations.
    Accordingly, I certify that this proposed rule does not require a 
separate regulatory flexibility analysis under the Regulatory 
Flexibility Act.

Paperwork Reduction Act

    This proposed regulatory action does not contain any information 
collection requirements subject to review by OMB under the Paperwork 
Reduction Act of 1980, 44 U.S.C. 3501 et seq.

Public Comment Procedures

    Interested persons are invited to submit written comments, 
information, or data in response to this proposed rule. Comments must 
be submitted by (insert date 30 days after date of publication in the 
Federal Register). Comments must bear a notation indicating the 
document control number. Three copies of the comments should be 
submitted to either location listed under ADDRESSES above in this 
document.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any 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 a 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.
    Documents considered and relied upon by EPA pertaining to this 
action, and all written comments filed pursuant to this Notice, will be 
available for public inspection in Rm. 1132, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, between 8 a.m. and 4 p.m., 
Monday through Friday, except public holidays. Any person who has 
registered, or who has submitted an application for registration of 
folpet under FIFRA, may request that this proposal be referred to an 
advisory committee. Such a request must be made within 30 days of the 
publication of this proposal. To satisfy requirements for analysis 
specified by Executive Order 12866 and the Regulatory Flexibility Act, 
EPA has analyzed the impacts of this proposal. This analysis is 
available for public inspection in Rm. 1132 at the Virginia address 
given above.

List of Subjects in 40 CFR Part 180

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

Dated: October 31, 1994.

Louis P. True,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

    Therefore, it is proposed that part 180 be amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.191 is revised to read as follows:


Sec. 180.191   Folpet; tolerances for residues.

    A tolerance of 25 parts per million is established for the 
fungicide folpet (N-(trichloromethylthio)phthalimide) in or on 
avocados.

[FR Doc. 94-29689 Filed 12-1-94; 8:45 am]
BILLING CODE 6560-50-F