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oxadixyl Tolerance Revocations 6/02


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0047; FRL-7180-4]

Oxadixyl; Tolerance Revocations

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This document revokes all tolerances for the combined residues
of the fungicide oxadixyl and its desmethyl metabolite. 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) section 408(q), as amended by the
Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by
August 2002 to reassess 66% of the tolerances in existence on August 2,
1996, or about 6,400 tolerances. The regulatory actions in this
document pertain to the revocation of 14 tolerances which are counted
among tolerance/exemption reassessments made toward the August 2002
review deadline.

DATES: This regulation is effective July 10, 2002; however, the
tolerance revocations will not occur until the date specified in the
regulatory text. Objections and requests for hearings, identified by
docket ID number OPP-2002-0047, must be received by EPA on or before
September 9, 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 IV. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0047 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph Nevola, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8037; e-mail address:
nevola.joseph@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 Codes         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-2002-0047. 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 the combined
residues of oxadixyl and its desmethyl metabolite in or on specified
commodities listed in the regulatory text because oxadixyl is no longer
registered under FIFRA for uses on those commodities. The tolerances
revoked with an expiration/revocation date by this final rule are not
needed after the expiration date to cover the combined residues of
oxadixyl and its desmethyl metabolite in or on domestically treated
commodities or commodities treated outside but imported into the United
States. While all sale and distribution of existing stocks of oxadixyl
(except for the purposes of shipping such stocks for export consistent
with section 17 of FIFRA or for proper disposal) is permitted until
September 27, 2002, no oxadixyl use on those specified commodities
within the United States is expected after the spring of 2003, and no
one commented that there was a need for EPA to retain the tolerances to
cover residues in or on imported foods. EPA has historically expressed
a concern that retention of tolerances that are not necessary to cover
residues in or on legally treated foods has the potential to encourage
misuse of pesticides within the United States. Thus, it is EPA's policy
to issue a final rule revoking those tolerances for residues of
pesticide chemicals for which there are no active registrations under
FIFRA, unless any person commenting on the proposal demonstrates a need
for the tolerance to cover residues in or on imported commodities or
domestic commodities legally treated.
    In the Federal Register of February 6, 2002 (67 FR 5548) (FRL-6817-
4), EPA issued a proposed rule to revoke the tolerances listed in this
final rule. Also, the February 6, 2002 proposal invited public comment
for consideration and for support of tolerance retention under FFDCA
standards. No comments were received by the Agency.
    On November 1, 2001 (66 FR 55158) (FRL-6808-4), EPA published in
the Federal Register a cancellation order for all oxadixyl product
registrations effective September 27, 2001. Although the manufacture of
oxadixyl products ended years ago and the registrants know of no
products in channels of trade, the cancellation order allowed a period
of 1 year from September 27, 2001, to permit all sale and distribution
of existing stocks (except for the purposes of shipping such stocks for
export consistent with section 17 of FIFRA or for proper disposal). The
Agency believes that existing stocks of oxadixyl will be exhausted by
the spring of 2003. Because no active registrations exist and because
no comments expressed a need to retain these tolerances for import
purposes, EPA is revoking all tolerances in 40 CFR 180.456 for the
combined residues of oxadixyl and its desmethyl metabolite, with an
expiration/revocation date of September 27, 2003. The Agency believes
that this date allows sufficient time for any oxadixyl-treated food
commodities to pass through the channels of trade.
    For FQPA reassessment purposes, EPA counts ``Grass, forage, fodder
and hay, group'' as 3 tolerances (grass, forage; grass, fodder; and
grass, hay) and a total of 14 tolerances as reassessed. In the interim,
before the tolerance expires and to conform to current Agency practice,
EPA is revising tolerance commodity terminology names in 40 CFR 180.456
as follows: for ``Brassica (cole) leafy vegetables group'' to
``vegetable, brassica, leafy, group''; ``cereal grains group (except
wheat)'' to ``grain, cereal, group, except wheat''; ``cotton seed'' to
``cotton, undelinted seed''; ``cucurbit vegetables group'' to
``vegetable, cucurbit, group''; ``fruiting vegetables (except
cucurbits) group'' to ``vegetable, fruiting, group''; ``leafy
vegetables (except Brassica vegetables) group'' to ``vegetable, leafy,
except brassica, group''; ``nongrass animal feeds (forage, fodder,
straw, and hay) group'' to ``animal feed, nongrass, group''; ``peas''
to ``pea''; ``root and tuber vegetables group'' to ``vegetable, root
and tuber, group''; ``soybeans'' to ``soybean''; and ``sunflower seed''
to ``sunflower, seed.''

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?

    EPA is revoking the tolerances for oxadixyl with an expiration/
revocation date of September 27, 2003. EPA believes that by this date
all existing stocks of pesticide products labeled for the uses
associated with the tolerances proposed for revocation will have been
exhausted and that there is ample time for any treated food commodities
to clear trade channels. Therefore, EPA believes the revocation/
expiration dates in this document are reasonable.
    Any commodities listed in the regulatory text of this document that
are treated with the pesticide subject to this final rule, and that are
in the channels of trade following the tolerance revocations, shall be
subject to FFDCA section 408(1)(5), as established by the FQPA. Under
this section, any residue of this pesticide in or on such food shall
not render the food 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. Evidence
to show that food was lawfully treated may include records that verify
the dates that the pesticide was applied to such food.

D. What is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2002 to reassess 66% or about
6,400 of the tolerances in existence on August 2, 1996. EPA is also
required to assess the remaining tolerances by August 2006. As of June
25, 2002, EPA has reassessed over 5,140 tolerances. The oxadixyl
tolerance depicted as ``Grass, forage, fodder and hay, group'' is
counted as three tolerances because at the start of FQPA, the Agency's
Tolerance Index System listed grass, forage; grass, fodder; and grass,
hay tolerances for oxadixyl. In this rule, EPA is revoking
all oxadixyl tolerances, which count as 14 reassessments toward the
August 2002 review deadline of FFDCA section 408(q), as amended by FQPA
in 1996.

III. Are There Any International Trade Issues Raised by this Final
Action?

    EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. When possible, EPA seeks
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain in a Federal Register document the
reasons for departing from the Codex level. EPA's effort to harmonize
with Codex MRLs is summarized in the tolerance reassessment section of
individual REDs. EPA has developed guidance concerning submissions for
import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This
guidance will be made available to interested persons. Electronic
copies are available on the internet at http://www.epa.gov/. On the
Home Page select ``Laws and Regulations,'' then select ``Regulations
and Proposed Rules'' and then look up the entry for this document under
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.

IV. 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-2002-0047 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 September
9, 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 IV.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-2002-0047, 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).

V. 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 Low-Income 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 pesticide 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 oxadixyl. Furthermore, for the
pesticide named in this final rule, 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.

VI. 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: June 12, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 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 180.456 is revised to read as follows:

Sec. 180.456  Oxadixyl; tolerances for residues.

    (a) General. Tolerances are established for the combined residues
of the fungicide oxadixyl [2-methoxy-N-(2-oxo-1,3-oxazolidin-3-yl)-
acet-2',6'-xylidide]
and its desmethyl (M-3) metabolite (2-hydroxy-N-
(2-oxo-1,3-oxazolidin-3-yl)-acet-2',6'-xylidide), calculated as
oxadixyl in or on the following raw agricultural commodities:

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                         Commodity Parts per million                          Expiration/Revocation Date
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Animal feed, nongrass, group.............................. 0.1                                        9/27/03
Cotton, undelinted seed................................... 0.1                                        9/27/03
Grain, cereal, group, except wheat........................ 0.1                                        9/27/03
Grass, forage, fodder and hay, group...................... 0.1                                        9/27/03
Pea....................................................... 0.1                                        9/27/03
Soybean................................................... 0.1                                        9/27/03
Sunflower, seed........................................... 0.1                                        9/27/03
Vegetable, brassica, leafy, group......................... 0.1                                        9/27/03
Vegetable, cucurbit, group................................ 0.1                                        9/27/03
Vegetable, fruiting, group................................ 0.1                                        9/27/03
Vegetable, leafy, except brassica, group.................. 0.1                                        9/27/03
Vegetable, root and tuber, group.......................... 0.1                                        9/27/03
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 02-16859 Filed 7-9-02; 8:45 am]