[Federal Register Volume 67, Number 132 (Wednesday, July 10, 2002)]
[Rules and Regulations]
[Pages 45639-45643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16859]


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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: 
[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 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

[[Page 45640]]

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

[[Page 45641]]

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 [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 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: [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).

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

[[Page 45642]]

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:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                         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

[[Page 45643]]

 
Vegetable, leafy, except brassica, group..................                                            0.1                                        9/27/03
Vegetable, root and tuber, group..........................                                            0.1                                        9/27/03
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    (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]
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