[Federal Register Volume 67, Number 113 (Wednesday, June 12, 2002)]
[Rules and Regulations]
[Pages 40185-40189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13520]


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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

[[Page 40186]]

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: [email protected].

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.

[[Page 40187]]

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 [email protected], 
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: [email protected]. 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.

[[Page 40188]]

 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).

[[Page 40189]]

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]
BILLING CODE 6560-50-S