methoxychlor (Marlate) Tolerance Revocations 6/02
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Methoxychlor; Tolerance Revocations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This document revokes all tolerances for residues of
methoxychlor because all registrations of pesticides containing
methoxychlor are suspended or canceled, and there are insufficient data
to find the pesticide safe in accordance with section 4(b)(2)(A) of the
Federal Food, Drug, and Cosmetic Act (FFDCA). The primary registrant of
methoxychlor (Kincaid Enterprises, Inc.) has failed to submit the
necessary data required to support continued registration under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of
pesticide products containing methoxychlor. As a result, all
methoxychlor products are currently suspended. The regulatory actions
specified in this document contribute toward the Agency's tolerance
reassessment requirements of 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 79 tolerances and exemptions
which are counted among tolerance/exemption reassessments made toward
the August 2002 review deadline.
DATES: This regulation is effective October 15, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0118,
must be received by EPA on or before September 16, 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 VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0118 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Beth Edwards, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5400; e-mail address:
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:
Categories NAICS codes potentially
Industry 111 Crop production
112 Animal production
311 Food 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
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0118. 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.
A. What Action is the Agency Taking?
This final rule revokes all tolerances for residues of
methoxychlor. In the Federal Register of April 4, 2002 (67 FR 16073)
(FRL-6828-8), EPA issued a proposed rule to revoke all methoxychlor
tolerances because all registrations of pesticides containing
methoxychlor are suspended or canceled, and there are insufficient data
to find the pesticide safe in accordance with section 4(b)(2)(A) of
FFDCA. The primary registrant of methoxychlor (Kincaid Enterprises,
Inc.) has failed to submit the necessary data required to support
continued registration of pesticide products containing methoxychlor.
As a result, all methoxychlor products are currently suspended. The
April 4, 2002 proposal invited public comment for consideration and for
support of tolerance retention under FFDCA standards, but no comments
were received during the 60-day comment period that changed the
Agency's position concerning methoxychlor.
B. What is the Agency's Authority for Taking this Action?
It is EPA's general practice to revoke 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
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 October 15, 2002.
For this final rule, EPA believes that all existing stocks of pesticide
products labeled for the uses associated with the tolerances proposed
for revocation have already been exhausted since such products have
been suspended since June 26, 2000. Similarly, the Agency believes that
commodities legally treated with methoxychlor have by this time cleared
the channels of trade.
Any commodities listed in 40 CFR 180.120 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, 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 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 April
29 2002, EPA has reassessed over 4,140 tolerances. In this rule, EPA is
revoking a total of 79 tolerances which count as 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
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 Reregistration Eligibility Decisions. 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-2002-0118 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
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
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@example.com,
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-2002-0118, 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: firstname.lastname@example.org. 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
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 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
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
Dated: June 28, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
Authority: 21 U.S.C. 321(q), 346(a) and 371.
Sec. 180.120 [Removed]
2. Section 180.120 is removed.
[FR Doc. 02-17873 Filed 7-16-02; 8:45 am]