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vinclozolin (Ronilan)
Tolerance Revocations and Notice of Channels of Trade Provision Guidance 5/02

 
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0036; FRL-6835-6]
RIN 2070-AB78
Vinclozolin; Tolerance Revocations and Notice of Channels of
Trade Provision Guidance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This final rule revises the tolerances listed in the
regulatory text for the fungicide vinclozolin (40 CFR 180.380) by
revoking the tolerances in or on strawberries, stone fruits, cucumbers,
and bell peppers. The Environmental Protection Agency previously
published a notice proposing to revoke these four tolerances, subject
to public comment, in the Federal Register on July 10, 2001
(FRL-67797-7). The regulatory actions in this document are
part of the Agency's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the tolerance
reassessment requirements of the Federal Food, Drug, and Cosmetic Act
(FFDCA).
    The Food and Drug Administration (FDA) in a related notice
published else where in this issue of the Federal Register is
announcing the availability of a guidance document presenting FDA's
policy on its planned enforcement approach for foods containing
vinclozolin residues. This guidance will assist firms in understanding
the types of showing under 408(1)(5) of the FFDCA (hereinafter referred
to as the channels of trade provision) that FDA may find satisfactory
in accordance with its planned enforcement approach for such section.
EPA and FDA are cooperating on this effort.
DATES: This final rule is effective June 12, 2002. Objections and
requests for hearings, identified by docket ID number
OPP-2002-0036, must be received by EPA on or before August
12, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please
follow the detailed instructions for each method as provided in Unit
III. To ensure proper receipt by EPA, your objections and hearing
requests must identify docket ID number OPP-2002-0036 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Deanna Scher, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 308-7043; and
e-mail address: scher.deanna@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules," and
then look up the entry for this document under the "Federal
Register Environmental Documents." You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/. A
frequently updated electronic version of 40 CFR part 180 is available
at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/
Title_40/40cfr180_00.html, a beta site currently under
development.
    2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0036. The
official record consists of the documents specifically referenced in
this action, and other information related to this action, including
any information claimed as Confidential Business Information (CBI).
This official record includes the documents that are physically located
in the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703)
305-5805.
II. Background
A. What Action is the Agency Taking?
    This final rule revokes the FFDCA tolerances for residues of the
fungicide vinclozolin in or on strawberries, stone fruits, cucumbers,
and bell peppers. In the Federal Register of July 10, 2001 (66 FR
35921) (FRL-6779-7), EPA issued a proposed rule to revoke
the tolerances listed in this final rule and invited public comment for
consideration and for support of tolerance retention under FFDCA
standards. No comments were received by the Agency during the
60-day comment period. The revocation is effective on the date of
publication of this final rule.
    On July 30, 1998, EPA published a notice in the Federal Register
(63 FR 40710) (FRL-6020-9) announcing BASF Corporation's
request to cancel the FIFRA registered uses for the pesticide
vinclozolin on strawberries and stone fruits. These cancellations were
precipitated by EPA's determination that aggregate exposure to
vinclozolin exceeded the safety standard under FQPA. The notice
informed the public of how it could comment on the request for
cancellation. One comment was received from the California Strawberry
Commission; this comment was fully addressed in a subsequent Federal
Register notice (63 FR 59557) (FRL-6041-7) published on
November 4, 1998 which announced the approval, with one minor change,
of the proposed existing stocks provision for products containing
vinclozolin. Under limitations on the use of existing stocks, the
application of the pesticide vinclozolin on strawberries and stone
fruit became unlawful after January 30, 2000. Therefore, no
domestically treated commodities covered by these tolerances are
expected to be in the channels of trade. No person has provided
comments identifying a need for EPA to retain the tolerances to cover
residues in or on imported strawberries or stone fruits.
    On May 31, 2000, BASF Corporation requested that EPA revoke the
import tolerances for cucumbers and bell peppers, as part of a risk
mitigation proposal designed to address dietary and aggregate risk
concerns identified during reregistration review. BASF requested that
EPA revoke the established import tolerances for bell peppers and
cucumbers not before January 1, 2001. These mitigation measures allowed
the Agency to determine that the use of vinclozolin, with the
amendments proposed by the registrant, would meet the safety standard
of the Food Quality Protection Act (FQPA). Vinclozolin is not
registered for use on bell peppers and cucumbers in the United States.
No person has provided comment identifying a need for EPA to retain the
tolerances to cover residues in or on imported cucumbers or bell
peppers.
B. What is the Agency's Authority for Taking this Action?
    It is EPA's general practice to propose revocation of tolerances
for residues of pesticide active ingredients on crop uses for which
FIFRA registrations no longer exist. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as "import
tolerances," are necessary to allow importation into the United
States of food containing such pesticide residues. However, where there
are no imported commodities that require these import tolerances, the
Agency believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
C. When do These Actions Become Effective?
    These actions become effective on June 12, 2002. Any commodities
listed in the regulatory text of this document that are treated with
vinclozolin, and that are in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(l)(5), the
"channels of trade provision" as established by the FQPA.
Under this section, any residue of vinclozolin in or on such
commodities shall not render the commodities adulterated so long as it
is shown to the satisfaction of FDA that, (1) the residue is present as
the result of an application or use of the pesticide at a time and in a
manner that was lawful under FIFRA, and (2) the residue does not exceed
the level that was authorized at the time of the application or use to
be present on the food under a tolerance or exemption from a tolerance.
The channels of trade provision allows for the orderly marketing of
foods that may currently contain legal residues resulting from lawful
applications of vinclozolin.
D. What Action is FDA Taking with Respect to the Tolerance Revocation?
    The FDA in a related notice published elsewhere in this issue of
the Federal Register is announcing the availability of a guidance
document presenting FDA's policy on its planned enforcement approach
for foods containing vinclozolin residues. This guidance will assist
firms in understanding the types of showing under section 408(l)(5) of
the FFDCA that FDA may find satisfactory in accordance with its planned
enforcement approach for such section.
E. What is the Contribution to Tolerance Reassessment?
    By law, EPA is required to reassess 66% or about 6,400 of the
tolerances in existence on August 2, 1996, by August 2002. EPA is also
required to assess the remaining tolerances by August, 2006. As of May
15, 2002, EPA has reassessed over 4,570 tolerances. This document
revokes four vinclozolin tolerances; however, the reassessments were
previously counted in 1997 when all vinclozolin tolerances were
reassessed in order to make a decision on a new tolerance petition.
Consequently, no further vinclozolin reassessments, including these
four revocations, count towards the August, 2002 review deadline of
FFDCA section 408(q), as amended by the Food Quality Protection Act
(FQPA) of 1996.
III. Objections and Hearing Requests
A. What Do I Need to Do to File an Objection or Request a Hearing?
    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0036 in the subject line
on the first page of your submission. All requests must be in writing,
and must be mailed or delivered to the Hearing Clerk on or before
August 12, 2002.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information 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.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202)
260-4865.
    2. Objection/hearing fee payment. If you file an objection or
request a hearing, you must also pay the fee prescribed by 40 CFR
180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m).
You must mail the fee to: EPA Headquarters Accounting Operations
Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA
15251. Please identify the fee submission by labeling it
"Tolerance Petition Fees."
    EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at
tompkins.jim@epa.gov, or by mailing a request for information to Mr.
Tompkins at Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit III.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0036, to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IV. Regulatory Assessment Requirements
    This final rule will revoke tolerances established under FFDCA
section 408.
 The Office of Management and Budget (OMB) has exempted this type of
action (i.e., a tolerance revocation for which extraordinary
circumstances do not exist) from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this final rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this final rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
Nor does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and LowIncome Populations (59 FR 7629, February
16, 1994); or OMB review or any other Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether revocations of tolerances
might significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
This analysis was published on December 17, 1997 (62 FR 66020), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration. Taking into account this analysis, and available
information concerning the pesticides listed in this rule, I certify
that this action will not have a significant economic impact on a
substantial number of small entities. Specifically, as per the 1997
notice, EPA has reviewed its available data on imports and foreign
pesticide usage and concludes that there is a reasonable international
supply of food not treated with canceled pesticides. Furthermore, the
Agency knows of no extraordinary circumstances that exist as to the
present revocations that would change EPA's previous analysis.
    In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure "meaningful and timely input by
State and local officials in the development of regulatory policies
that have federalism implications." "Policies that have
federalism implications" is defined in the Executive Order to
include regulations that have "substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government." This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any "tribal
implications" as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure "meaningful and timely
input by tribal officials in the development of regulatory policies
that have tribal implications." "Policies that have tribal
implications" is defined in the Executive Order to include
regulations that have "substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes." This rule will
not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
V. Submission to Congress and the Comptroller General
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit 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 United States prior
to publication of this final rule in the Federal Register. This final
rule is not a "major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
    Dated: May 20, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:
PART 180 [AMENDED]
    1. The authority citation for part 180 continues to read as
follows:
    Authority: 21 U.S.C. 321(q), 346(a) and 371.
    2. Section 180.[380]
is amended by removing from the table in
paragraph (a) the entries for "cucumbres", "peppers
(bell)", "stonefruits, except plums/fresh prunes" and
"strawberries", and by adding paragraph (e) to read as
follows:
Sec. 180.380  Vinclozolin; tolerances for residues.
* * * * *
    (e) Revoked tolerances subject to the channel of trade provisions.
The following table lists commodities with residues of vinclozolin
resulting from lawful use are subject to the channels of trade
provisions of section 408(l)(5) of the FFDCA:
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Cucumbers                                             1.0
Peppers (bell)                                        3.0
Stonefruits, except plums/fresh prunes    25.0
Strawberries                                         10.0
------------------------------------------------------------------------
[FR Doc. 02-13520 Filed 6-11-02; 8:45 am]