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folpet (Phaltan) Revocation of Pesticide Tolerances 6/96

Mime-Version: 1.0
Date: Wed, 17 Jul 1996 09:34:03 -0500
From: (Will Smith)
Subject: Folpet; Revocation of Pesticide Tolerances
Status: O

>40 CFR Part 180
>[OPP-300363B; FRL-5382-1]
>RIN 2070-AC18
>Folpet; Revocation of Pesticide Tolerances
>AGENCY: Environmental Protection Agency (EPA).
>ACTION: Final Rule.
>SUMMARY: This rule revokes tolerances for folpet residues in or on the
>following commodities: celery, cherries, leeks, onions (green),
>shallots, blackberries, blueberries, boysenberries, crabapples,
>currants, dewberries, gooseberries, huckleberries, loganberries,
>raspberries, citrus fruits, garlic, pumpkins, summer squash, and winter
>squash. This revocation is necessary because the registrant has
>voluntarily canceled use of this fungicide on these commodities.
>EFFECTIVE DATE: This final rule becomes effective September 16, 1996.
>ADDRESSES: Written objections and hearing requests, identified by the
>docket, [OPP-300363B], may 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 should be identified by the docket 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: 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
>[OPP-300363B]. 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, Jeff Morris, Review Manager,
>Special Review Branch (7508W), Office of Pesticide Programs,
>Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
>Office location and telephone number: 3rd floor, Crystal Station, 2800
>Crystal Drive, Arlington, VA 22202, (703) 308-8029; e-mail:
>SUPPLEMENTARY INFORMATION: Following issuance of a proposed rule to
>revoke folpet tolerances (59 FR 61859, December 2, 1994)(FRL-4912-6)
>and considering comments that EPA received in response to the proposed
>rule, this rule serves as a final order to revoke tolerances for folpet
>residues in or on the following commodities: celery, cherries, leeks,
>onions (green), shallots, blackberries, blueberries, boysenberries,
>crabapples, currants, dewberries, gooseberries, huckleberries,
>loganberries, raspberries, citrus fruits, garlic, pumpkins, summer
>squash, and winter squash. The tolerance for folpet residues in or on
>avocados will remain as currently listed in 40 CFR 180.191, and will be
>addressed through the reregistration process (the avocado tolerance was
>not subject to the December 2, 1994 proposed rule). In a separate
>notice, EPA will address the remaining tolerances that were subject to
>the proposed rule; the registrant is currently generating data to
>support those tolerances.
> I. Legal Authorization
>    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. 346(a)]. Without such tolerances or
>exemptions, a food containing pesticide residues is considered to be
>``adulterated'' under section 402 of 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 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
>distributed, the pesticide must not only have appropriate tolerances
>under FFDCA, but also must be registered under the Federal Insecticide,
>Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.).
>    In 1988, Congress amended FIFRA and required EPA to review and
>reassess the potential hazards arising from currently registered uses
>of pesticides registered prior to November 1, 1984. As part of this
>process, EPA must determine whether a pesticide is eligible for
>reregistration or whether any subsequent actions are required to fully
>attain reregistration status. EPA has chosen to include in the
>reregistration process a reassessment of existing tolerances or
>exemptions from the need for a tolerance. Through this reassessment
>process, based on more recent data, EPA can determine whether a
>tolerance must be amended, revoked, or established, or whether an
>exemption from the requirement of one or more tolerances must be
>amended or is necessary.
>    Tolerance procedures are discussed in 40 CFR parts 177 through 180.
>Part 177 establishes the procedures for establishing, amending, or
>revoking tolerances or exemptions from the requirement of tolerances;
>part 178 contains procedures for filing objections and requests for
>hearings; part 179 contains rules governing formal evidentiary
>hearings; and part 180 contains regulations establishing tolerances or
>exemptions from the requirements of a tolerance. The Administrator of
>EPA, or any person by petition, may initiate an action proposing to
>establish, amend, revoke, or exempt a tolerance for a pesticide
>registered for food uses. Each petition or request for a new tolerance,
>an amendment to an existing tolerance, or a new exemption from the
>requirement of a tolerance must be accompanied by a fee. Comments
>submitted in response to EPA's published proposals are reviewed; EPA
>then publishes its final determination regarding the specific tolerance
>actions. Monitoring and enforcement of pesticide tolerances are carried
>out by the U.S. Food and Drug Administration (FDA) and the U.S.
>Department of Agriculture (USDA). This includes monitoring for
>pesticide residues in or on commodities imported into the United
>II. Background
>    Folpet is a broad-spectrum fungicide 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
>registration for all folpet food uses, including the food uses covered
>by the tolerances that are subject to this rule, that EPA suspended in
>1987 for failure of the registrant to supply the data required by EPA
>to support the continued registration of these uses. EPA has classified
>folpet as a B2 (probable) human carcinogen.
>A. Proposed Revocation of Tolerances and Comment Period Extension
>    At the time the proposed rule was published, with the exception of
>data to support the avocado use, the registrant had not submitted the
>following residue chemistry data, which, according to the June 1987
>folpet registration standard, are needed to support registration of the
>commodities subject to this rule: nature of the residues (metabolism)
>studies (guideline no. 171-4a) for representative crops; analytical
>method validation (guideline no. 171-4c); storage stability studies
>(guideline no. 171-4e) for representative crops; crop field trials
>(guideline no. 171-4k) for the subject commodities; and processing
>studies (guideline no. 171-4l) for applicable commodities. These data
>are required under 40 CFR part 158, and are needed to allow EPA to
>determine whether a proposed tolerance level is practical and
>achievable. Because the establishment of a tolerance under section 408
>of FFDCA requires a finding that a tolerance will protect the public
>health, and because EPA did not have adequate data to make such a
>finding, EPA issued a proposed rule to revoke all folpet tolerances,
>except the avocado tolerance. The proposed rule was published in the
>Federal Register on December 2, 1994 (59 FR 61859).
>    In a Federal Register notice dated January 3, 1995 (60 FR 89)(FRL-
>4982-3), EPA extended the end of the comment period for the proposed
>rule from January 3, 1995, to March 3, 1995. The January 3 notice also
>requested the following: (1) That interested parties identify which
>tolerances they were willing to support by providing the data necessary
>to maintain the tolerances, and (2) that interested parties identify
>specific existing data they were prepared to submit in support of the
>B. Registrant's Response to the Proposed Rule
>    1. Commitment to support tolerances. In its comments to the
>December 2, 1994 proposed rule, Makhteshim-Agan, the sole folpet
>registrant, committed to generate the data necessary to establish
>tolerances in or on the following nine commodities: apples,
>cranberries, cucumbers, grapes, lettuce, melons, onions, strawberries,
>and tomatoes. (Makhteshim-Agan had previously submitted the required
>data for the use of folpet on avocados.) Makhteshim-Agan also submitted
>use information on the other nine commodities and a summary of the
>residue chemistry data that had thus far been generated for those
>    2. Request to delete uses. In a letter to EPA dated June 11, 1995,
>Makhteshim-Agan requested that EPA delete the following uses from its
>folpet registration number 66222-8: blackberries, boysenberries,
>dewberries, loganberries, raspberries, blueberries, huckleberries,
>summer/winter squash, pumpkins, celery, cherries (red tart), citrus
>(oranges, grapefruit, lemons, limes, tangelos, and tangerines),
>gooseberries, currants, and garlic. EPA published a notice of receipt
>of this request in a Federal Register notice dated April 17, 1996 (61
>FR 16779)(FRL-5360-5). Following the 90-day comment period for this
>notice, the deletion of the uses is expected to take effect on July 16,
>III. Final Actions
>    In response to comments made to the December 2, 1994 proposed rule,
>through meetings and other communication with the folpet registrant,
>and in accord with EPA's policy regarding data requirements to support
>tolerances, EPA is issuing this final order to revoke the 20 tolerances
>that have received no commitment for support.
>    This final rule revokes the following folpet tolerances listed in
>40 CFR 180.191: blackberries, blueberries, boysenberries, celery,
>cherries, citrus fruits, crabapples, currants, dewberries, garlic,
>gooseberries, huckleberries, leeks, loganberries, onions (green),
>pumpkins, raspberries, shallots, summer squash, and winter squash. EPA
>is revoking these tolerances for two reasons: (1) The registrant is no
>longer supporting the uses on its folpet registrations, and (2) EPA
>does not have the data necessary to make a finding that the tolerances
>are protective of the public health, as is required by section 408 of
>FFDCA and 40 CFR part 158. The 25 ppm avocado tolerance is being
>supported through the reregistration program for domestic registrations
>and is not subject to this rule, and therefore remains unchanged. The
>remaining nine supported tolerances will be the subject of a separate
>notice that EPA will issue in the future.
>    Because folpet food-use registrations have been suspended since
>1987 and therefore commodities may not be legally treated with any
>existing folpet stocks, EPA expects no folpet residues to be in or on
>the commodities associated with the tolerances subject to
>this rule; nor, for the same reason, are folpet residues expected to
>persist in the environment. Following revocation of the tolerances, any
>imported commodities containing folpet residues will be subject to
>seizure as a result of FDA and USDA monitoring; this should prohibit
>any treated imported commodities from entering domestic channels of
>trade. Therefore, final expiration of the tolerances will occur 60 days
>from the date of publication of this rule in the Federal Register,
>barring submission of a petition for a stay of the effective date of
>this rule, and EPA will not require action levels following expiration
>of the tolerances.
>IV. Comments Received on Proposed Rule and Response to Comments
>    The following section summarizes the comments received to the
>December 2, 1994 proposed revocation of folpet tolerances, and EPA's
>response to those comments. The actual comments are in the folpet
>A. Revocation Will Negatively Impact Importation of Commodities
>    Many commentors stated that the revocation of the U.S. folpet
>tolerances may have a significant negative impact on the present and
>future importation of agricultural products into the United States.
>Commentors were particularly concerned that revocation of the grape
tolerance would negatively affect wine imports.

    EPA responds that the folpet registrant has committed to generate
the necessary data for nine tolerances, including a grape tolerance.
EPA will not revoke tolerances for those commodities if adequate data
are submitted by the agreed-upon due date.

B. Need for an Import Tolerance Policy

    Other commentors expressed concern regarding the lack of a policy
outlining the data necessary to establish import tolerances, and that
the approach taken in EPA's Federal Register notice of December 2, 1994
is not an efficient regulatory process. They stated that deciding
complex issues, such as data requirements, on a case-by-case basis
cannot be efficient and detracts from regulatory transparency; they
added that an import tolerance policy presented for public comment
would permit EPA to evaluate the appropriateness of the data required
in the December 2, 1994 notice.
    EPA's response is that it has an import tolerance policy. EPA's May
3, 1995 letter to Makhteshim-Agan states: ``EPA requires the same
product chemistry and toxicology data for import tolerances as are
required to support U.S. registrations of pesticide products and any
resulting tolerances. In addition, EPA needs residue chemistry data
that are representative of growing conditions in exporting countries.''
It is because EPA has received neither the data required in the 1987
Registration Standard nor a commitment to generate the data necessary
to establish tolerances, that EPA is revoking the tolerances subject to
this rule. EPA is currently reviewing its import tolerance policy to
address issues raised by folpet and other similar cases. In application
of its policy, EPA is committed to consistency and, when possible,
harmonization with international standards.

C. Potential GATT and NAFTA Violations

    Some commentors claimed that EPA's proposed action would violate
international obligations of the United States. They stated that the
World Trade Organizations's Sanitary and Phytosanitary (SPS) Agreement
permits EPA to deviate from Codex in exceptional circumstances, but any
higher level of sanitary or phytosanitary protection must have a
scientific justification. Such justification requires a finding by EPA
that the forthcoming Codex standard for folpet is not sufficient to
achieve its appropriate level of protection.
    EPA responds that Codex has proposed to revoke most of the folpet
Maximum Residue Limits (MRLs), including the grape MRL, because the
data submitted to Codex are inadequate. The crop field trial program
for the supported import-only tolerances initiated by the folpet
registrant is expected to provide data adequate for setting U.S. and
international residue levels for folpet. Since no data are available
for the remaining tolerances subject to this rule, EPA is revoking
those tolerances.

D. U.S. Standards Must Not Be Compromised

    One commentor argued that EPA should revoke folpet tolerances
unless the existing data enable EPA to make the FFDCA public health
finding, and that the unsupported tolerances should not remain in
effect while the data are being developed and submitted. The commentor
also stated that nothing in international trade agreements requires any
deviation from FFDCA's public health mandate.
    EPA agrees that its mandate to protect the public health must not
be compromised. All remaining permanent folpet tolerances will be based
on adequate data that demonstrate that such tolerances are protective
of the public health.

V. Effective Date and Stays of Effective Date

    This final rule shall become effective September 16, 1996. A person
filing objections to this Order may submit with the objections a
petition to stay the effective date of this Order. Such stay petitions
must be submitted to the Hearing Clerk on or before August 16, 1996. A
copy of the stay request filed with the Hearing Clerk shall be
submitted to the Office of Pesticide Programs Public Docket. A stay may
be requested for a specific time period or for an indefinite time
period. The stay petition must include a citation to this Order and the
specific food additive regulation(s) as to which the stay is sought,
the length of time for which the stay is requested, and a full
statement of the factual and legal grounds upon which the petitioner
relies for the stay. If a petition for a stay is submitted, EPA will
automatically stay the effective date of the Order as to the particular
regulation(s) for which the stay is sought for such time as is required
to review the stay petition, if necessary. In determining whether to
grant a stay, EPA will consider the criteria set out in FDA's
regulations regarding stays of administrative proceedings at 21 CFR
10.35. Under those rules, a stay will be granted if it is determined
that: (1) The petitioner will otherwise suffer irreparable injury; (2)
the petitioner's case is not frivolous and is being pursued in good
faith; (3) the petitioner has demonstrated sound public policy grounds
supporting the stay; and (4) the delay resulting from the stay is not
outweighed by public health or other public interests. Under FDA's
criteria, EPA may also grant a stay if EPA finds that such action is in
the public interest and in the interest of justice.
    If a stay petition is submitted, EPA will publish a notice of
receipt in the Federal Register, stating that the effective date of
this Order is stayed as to the regulation(s) to which the stay is
requested pending EPA consideration of the stay request. Any affected
person may submit objections to a stay request to the Hearing Clerk on
or before 15 days after the date of publication in the Federal Register
of the notice of receipt. Any decision lifting the stay will be
published in the Federal Register.

VI. Hearing Request

    Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the regulation and may also request
a hearing on those objections. Objections and hearing requests must be
filed with the Hearing Clerk, at the address given above (40 CFR
178.20). A copy of the objections and/or hearing requests filed with
the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issue(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). A request for
a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established,
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issue(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR

VII. Public Docket

    A record has been established for this rulemaking under docket
number [OPP-300363A] (including any 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
4:30 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.
    Electronic comments may be sent directly to EPA at:

    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 any copies of 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 comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

    To satisfy the requirements for analysis specified by Executive
Order 12866, the Regulatory Flexibility Act, the Paperwork Reduction
Act, the Unfunded Mandates Reform Act, and the Small Business
Regulatory Enforcement Fairness Act, EPA has considered the impacts of
this final rule.

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 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.

B. Regulatory Flexibility Act

    EPA has reviewed this final rule under the Regulatory Flexibility
Act of 1980 [5 U.S.C. 601 et seq.], and 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 final rule does not require a separate regulatory
flexibility analysis under the Regulatory Flexibility Act.

C. Paperwork Reduction Act

    This 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.

D. Unfunded Mandates Reform Act

    This final rule contains no Federal mandates under Title II of the
Unfunded Mandates Reform Act of 1995, Pub. L. 104-4 for State, local,
or tribal governments or the private sector, because it would not
impose enforceable duties on them.

E. Small Business Regulatory Enforcement Fairness Act

    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the General Accounting Office prior to publication of this
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

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

    Dated: June 24, 1996.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.

    Therefore, 40 CFR, chapter I, part 180 is amended as follows:


    The authority citation for part 180 would continue to read as
    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.

    Tolerances are established for the fungicide folpet (N-
(trichloromethylthio)pthalimide) in or on raw agricultural commodities
as follows:

                                                              Parts per
                         Commodity                             million
Apples.....................................................           25
Avocados...................................................           25
Cranberries................................................           25
Cucumbers..................................................           15
Grapes.....................................................           25
Lettuce....................................................           50
Melons.....................................................           15
Onion (dry bulb)...........................................           15
Strawberries...............................................           25
Tomatoes...................................................           25

[FR Doc. 96-16588 Filed 7-16-96; 8:45 am]