[Federal Register Volume 68, Number 16 (Friday, January 24, 2003)]
[Rules and Regulations]
[Pages 3425-3428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1518]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0086; FRL-7187-3]


Oxadiazon; Tolerance Revocations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document revokes all tolerances for residues of the 
herbicide oxadiazon. 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 2006 to reassess the tolerances 
in existence on August 2, 1996. The regulatory actions in this document 
pertain to the revocation of 16 tolerances which were previously 
reassessed and counted.

DATES: This regulation is effective April 24, 2003. Objections and 
requests for hearings, identified by docket identification (ID) number 
OPP-2002-0086, must be received on or before March 25, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit IV. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Registration Division 
(7508C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; 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 potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer.
    Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2002-0086. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under 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.

[[Page 3426]]

    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of August 1, 2001 (66 FR 39705) (FRL-6786-
4), EPA issued a proposed rule to revoke all tolerances for oxadiazon 
and tetradifon. Also, the August 1, 2001 proposal provided a 60-day 
comment period which invited public comment for consideration and for 
support of tolerance retention under FFDCA standards.
    This final rule revokes all FFDCA tolerances for residues of the 
herbicide oxadiazon because this pesticide active ingredient is not 
registered under FIFRA for food uses. The tolerances revoked by this 
final rule are no longer necessary to cover residues of the relevant 
pesticides in or on domestically treated commodities or commodities 
treated outside but imported into the United States. Oxadiazon is no 
longer used on the commodities associated with those tolerances within 
the United States. No one commented that there was a need for EPA to 
retain the tolerances to cover oxadiazon residues in or on imported 
foods. However, EPA did receive a comment regarding the need for the 
Agency to retain tetradifon tolerances.
    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.
    Generally, EPA will proceed with the revocation of these tolerances 
on the grounds discussed in Unit II.A. if one of these conditions 
applies, as follows:
    1. Prior to EPA's issuance of a section 408(f) order requesting 
additional data or issuance of a section 408(d) or (e) order revoking 
the tolerances on other grounds, commenters retract the comment 
identifying a need for the tolerance to be retained.
    2. EPA independently verifies that the tolerance is no longer 
needed.
    3. The tolerance is not supported by data that demonstrate that the 
tolerance meets the requirements under FQPA.
    Today's final rule does not revoke those tolerances for which EPA 
received comments stating a need for the tolerance to be retained. In 
response to the proposal published in the Federal Register of August 1, 
2001 (66 FR 39705), EPA did receive comment regarding the need to 
retain tetradifon tolerances, as follows:
    1. Tetradifon. EPA received a comment from Uniroyal Chemical, who 
requested the retention of tetradifon tolerances. Uniroyal noted that 
it had submitted certain studies to EPA in 1998 and 1996 and awaits 
determination of their acceptability by the Agency, and until those 
determinations are made cannot decide whether to support the tetradifon 
tolerances. Uniroyal added it would support two tolerances to allow 
importation of those tetradifon-treated food commodities, but did not 
name them.
    In follow-up communication, Uniroyal expressed interest in 
maintaining tolerances for apples, citrus, and some vegetables, but did 
not commit to support any tetradifon tolerances. Also, in follow-up 
communication, Uniroyal acknowledged that it has not pursued 
correspondence with EPA since 1998 regarding disposition of the 
submitted studies nor submitted a registration petition.
    Agency Response. EPA is still evaluating the issues described in 
the comment. Therefore, EPA is not taking final action on the 
tetradifon tolerances in 40 CFR 180.174 at this time, but may do so 
after evaluation of these issues.
    No comments were received by the Agency concerning oxadiazon.
    2. Oxadiazon. There have been no active registrations for oxadiazon 
concerning food uses since 1991. In a confirmatory letter to EPA, dated 
January 24, 2001, the registrant maintained its previous position that 
it will not support the 16 oxadiazon tolerances; although, it is 
supporting the continued (noncrop) use of oxadiazon for turf and 
ornamentals. Therefore, EPA is revoking all the tolerances in 40 CFR 
180.346 for the combined residues of the herbicide oxadiazon and its 
metabolites in or on milk; cattle, fat; cattle, meat; cattle, meat 
byproducts; goats, fat; goats, meat; goats, meat byproducts; hogs, fat; 
hogs, meat; hogs, meat byproducts; horses, fat; horses, meat; horses, 
meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts. 
The Agency is removing 40 CFR 180.346 in its entirety.
    In addition, because EPA determined on April 21, 2002 that there is 
no reasonable expectation of finite residues of oxadiazon and its 
metabolites in or on meat, milk, poultry, and egg commodities, the 16 
associated tolerances for livestock commodities were considered by the 
Agency to no longer be needed under 40 CFR 180.6(a)(3). Therefore, on 
June 3, 2002, the Agency considered the FQPA safety finding to be met 
and counted the 16 oxadiazon livestock tolerances as reassessed. Copies 
of these Agency memoranda will be placed in the public docket.

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 90 days following publication of 
this final rule in the Federal Register. EPA has delayed the 
effectiveness of these revocations for 90 days following publication of 
this final rule to ensure that all affected parties receive notice of 
EPA's actions. Consequently, the effective date is April 24, 2003. For 
this final rule, tolerances that were revoked because registered uses 
did not exist concerned uses which have been canceled for more than a 
year. Therefore, commodities containing

[[Page 3427]]

these pesticide residues should have cleared the channels of trade.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides 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 these pesticides 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 2006 to reassess the tolerances 
in existence on August 2, 1996. As of January 3, 2003, EPA has 
reassessed over 6,490 tolerances. In this final rule, EPA is revoking 
16 tolerances. These tolerances were previously reassessed and counted 
as described in Unit II.A.

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. The U.S. 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

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections.

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-2002-0086 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 March 25, 
2003.
    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 issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    2. Tolerance 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-
0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2002-0086, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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:

[[Page 3428]]

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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

V. Statutory and Executive Order Reviews

    This final rule revokes tolerances established under section 408 of 
the FFDCA. 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 rule has been exempted from review under Executive Order 
12866 due to its lack of significance, this 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 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 oxadiazon. 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 section 408(n)(4) of the FFDCA. 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: January 3, 2003.
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.


Sec.  180.346  [Removed]

    2. Section 180.346 is removed.

[FR Doc. 03-1518 Filed 1-23-03; 8:45 am]
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