[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