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methoxychlor (Marlate) Proposed Revocation of Tolerances 3/02


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301226; FRL-6828-8]
RIN 2070-AC18

Methoxychlor; Proposed Revocation of Tolerances

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

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

SUMMARY: This document proposes to revoke specific tolerances for
residues of methoxychlor because (1) all registrations of pesticides
containing methoxychlor are suspended or canceled, and (2) 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 proposed in this document contribute toward the Agency's
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 proposed in this
document pertain to the proposed revocation of 79 tolerances and/or
exemptions which would be counted among tolerance/exemption
reassessments made toward the August 2002 review deadline.

DATES: Comments, identified by docket control number OPP-301226, must
be received on or before June 3, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify docket control
number OPP-301226 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: edwards.beth@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_180/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 control number OPP-301226. 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-301226 in the subject line on
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described in this unit. Do not submit any information electronically
that you consider to be CBI. Electronic comments must be submitted as
an ASCII file avoiding use of special characters and any form of
encryption. Comments and data will also be accepted on standard disks
in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic
form must be identified by docket control number OPP-301226. Electronic
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or
collection activity.
    7. Make sure to submit your comments by the deadline in this
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

F. What Can I Do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?

    This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not
proceed to revoke the tolerance immediately. However, EPA will take
steps to ensure the submission of any needed supporting data and will
issue an order in the Federal Register under FFDCA section 408(f) if
needed. The order would specify data needed and the time frames for its
submission, and would require that within 90 days some person or
persons notify EPA that they will submit the data. If the data are not
submitted as required in the order, EPA will take appropriate action
under FFDCA.
    EPA will issue a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.

II. Background

 A. What Action is the Agency Taking?

    The Agency is not able to make a finding that existing tolerances
for methoxychlor are safe. Based on currently available information,
the Agency has significant concerns with the effects of methyoxychlor
on human health and the environment. Furthermore, as of mid 2000, all
product registrations of methoxychlor are either suspended due to
registrants' noncompliance with a Data Call-In notice issued under
FIFRA section 3(c)(2)(B) or canceled pursuant to registrants voluntary
cancellation request under FIFRA section 6(f). EPA believes that all
existing stocks of pesticide products labeled for the uses associated
with the tolerances proposed for revocation have already been
exhausted. A detailed description of the events leading to the
methoxychlor suspension follows.
    On December 9, 1988, EPA issued the Guidance for the Reregistration
of Pesticide Products Containing Methoxychlor as the Active Ingredient
(i.e., Methoxychlor Registration Standard). The Registration Standard
included a Data Call-In Notice (DCI) issued pursuant to FIFRA section
3(c)(2)(B), which required registrants of products containing
methoxychlor used as the active ingredient to develop and submit
certain data. The Administrator had determined these data to be
necessary to support continued registration of pesticide products
containing methoxychlor as the active ingredient. Failure to comply
with the requirements of a Data Call-In Notice is a basis for
suspension under section 3(c)(2)(B) of FIFRA.
    Kincaid Enterprises Inc. (Kincaid) was the sole registrant who
committed to produce the generic data for methoxychlor. All other
registrants of end-use products requested a Generic Data Exemption
(GDE) in response to the DCI. These GDE requests were granted which
allowed the end-use registrants to rely on Kincaid's data.
    On April 7, 1998, the Agency issued a Notice of Intent to Suspend
to Kincaid because of their failure to submit certain data required by
the DCI. On May 13, 1998, Kincaid requested a hearing by filing a
hearing request with the Agency. On September 3, 1998, Kincaid and the
Agency entered into a settlement agreement that specified the
outstanding data requirements from the 1988 DCI and set forth a new
schedule for their submission. The Settlement Agreement stated that if
Kincaid failed to comply with any of the terms and conditions relating
to any of the requirements for data generation and submission, the
Agency would request that the Administrative Law Judge (ALJ) issue an
order suspending the registrations of Kincaid's affected products
without any opportunity for a hearing. On September 14, 1998, the ALJ
issued an accelerated decision and order incorporating the Settlement
Agreement. The Judge's accelerated decision and order incorporating the
Settlement Agreement was entered into the public docket for the matter.
    Subsequently, on December 3, 1999, Kincaid failed to satisfy
certain data requirements as required by the DCI and the ALJ's Order/
Settlement Agreement. The Agency requested that the ALJ enter a
suspension order and a suspension order was entered for all
methoxychlor pesticide product registrations held by Kincaid. The
suspension became effective on January 14, 2000. Subsequently, Kincaid
missed a second deadline of March 3, 2000, for a number of other
studies. The Agency filed a request to the ALJ that he amend the
January 14, 2000 suspension order to include these studies, and on
April 12, 2000, the ALJ amended the January 14, 2000 suspension order
to include the additional overdue studies as bases for suspension.
    Because Kincaid failed to submit the data in violation of the 1988
DCI and the accelerated decision and order incorporating the Settlement
Agreement and was no longer in compliance with the DCI, registrants of
methoxychlor end-use products who were previously eligible for the GDE
were also considered to be in noncompliance with the 1988 DCI
requirements as amended by the accelerated decision and order
incorporating the Settlement Agreement. Letters were mailed to all end-
use registrants on April 14, 2000, notifying them that their GDEs for
products containing methoxychlor were revoked. The letters explained
that if these data requirements were not satisfied within 30 days,
registrants who had received the DCI would be subject to a Notice of
Intent to Suspend and those whose registrations had been granted
subsequent to issuance of the DCI would be subject to a Notice of
Intent to Cancel. No data were received. Notices of Intent to Suspend
were issued on June 26, 2000. No Notices of Intent to Cancel were
necessary because all products registered after the issuance of the DCI
were voluntarily canceled. No hearings were requested, and therefore,
pursuant to sections 3(c)(2)(B)(iv) and 6(e)(2), the proposed
suspensions became final. The data requirements that are overdue are as
follows:

------------------------------------------------------------------------
            Guideline                    Study             Due Date
------------------------------------------------------------------------
Guideline 161-3                   Photodegradation -  12/3/99
                                   soil
Guideline 163-1                   Leaching/           12/3/99
                                   adsorption/
                                   desorption
Guideline 83-3                    Teratogenicity -    3/3/00
                                   rat
Guideline 83-3                    Teratogenicity -    3/3/00
                                   rabbit
Guideline 162-2                   Anaerobic           3/3/00
                                   metabolism
Guideline 171-4                   Storage stability   3/3/00
Guideline 171-4                   Magnitude of        3/3/00
                                   residue - meat,
                                   milk
Guideline 85-1                    General metabolism  9/3/01
------------------------------------------------------------------------

    Additional data requirements that are still outstanding are:

------------------------------------------------------------------------
            Guideline                    Study             Due Date
------------------------------------------------------------------------
Guideline 83-1                    Chronic toxicity -  9/3/02
                                   rodent
Guideline 83-1                    Chronic toxicity -  9/3/02
                                   non-rodent
Guideline 83-2                    Oncogenicity - rat  9/3/02
Guideline 83-2                    Oncogenicity -      9/3/02
                                   mouse
Guideline 83-4                    Two-generation      9/3/02
                                   reproduction
------------------------------------------------------------------------

    The Agency has significant concerns about the effects of
methoxychlor on human health and the environment. Methoxychlor is being
used by the U.S. and the Organization for Economic Cooperation and
Development (OECD) as one of the key chemicals in validating components
of the Endocrine Disruption Screening Program. Methoxychlor has been
discussed extensively in the public literature in connection with
endocrine disruption. Kupfer and Bulger (Ref. 5) found that both
methoxychlor and metabolites have estrogen-like activity with several
metabolites having proestrogen activity. They used an in vitro system
involving rat liver microsomes and nicotinamide adenine dinucleotide
phosphate (NADPH) for a metabolizing system with estrogen receptors
from immature rat uteri as a detection system.
    Gray et al. (Ref. 3) investigated the effects of methoxychlor on
the pubertal development and reproductive function in the male and
female rat (Long-Evans hooded) by dosing rats from gestation, weaning,
lactation, through puberty with either 25, 50, 100, or 200 milligrams/
kilograms/day (mg/kg/day) of methoxychlor. In females they found an
acceleration of vaginal opening, abnormal estrus cycle, inhibition of
luteal function and a blockage of implantation. In males they found an
inhibition of somatic growth and accessory gland weight, elevated
pituitary and serum prolactin levels, and a suppression of testicular
Leydig cell function. Some of these effects occurred at levels as low
as 25 mg/kg/day. These observations are consistent with the earlier
reports that methoxychlor mimics estrogen both in vivo and in vitro.
    Goldman et al. (Ref. 2) investigated the subchronic effects of
methoxychlor on the rat (Long-Evans hooded) reproductive system by
dosing for 8 weeks with 25 mg/kg or 50 mg/kg of methoxychlor by oral
gavage. No effect was observed on the pituitary weight, serum
lutenizing hormone (LH), follicle stimulating hormone (FSH), or
prolactin levels and the pituitary LH of FSH concentrations. Pituitary
prolactin levels were increased at both levels. There was an increase
in gonadotropin-releasing hormone (GnRH) levels in the mediobasal
hypothalamus at the high-dose level. The authors determined that the
reproductive effects of methoxychlor are mediated in part by an
increase in prolaction release which in turn influences the
hypothalamic levels of GnRH. This may be considered an early effect of
methoxychlor on the rat reproductive system.
    Cummings and Gray (Ref. 1) of the U.S. EPA Health Effects Research
Laboratory found that methoxychlor affects the decidual cell response
of the rat uterus, suggesting a direct effect of the compound on the
uterus with no effects on uterine weight, serum progesterone levels, or
corpora lutea maintenance. Long-term exposure to methoxychlor reduced
fertility and induced fetotoxicity. The effects of reduced fertility
and fetotoxicity were noted in a 3-generation reproduction study.
Although the available data for these three studies were limited, it is
apparent that methoxychlor at 1,000 parts per million (ppm) produced
reproductive effects in the form of reduced fertility index, reduced
litter size, and reduced viability index.
    Khera et al. (Ref. 4) on the teratogenicity of methoxychlor found
that treatment of pregnant rats with either technical grade or
formulation of methoxychlor produced maternal toxicity in the form of
reduced body weight gain at all doses tested (50 to 300 mg/kg/day).
Developmental toxicity was noted as fetotoxicity at doses of 200 and
400 mg/kg/day and as a dose-related increase of wavy ribs at 100, 200,
and 400 mg/kg/day.
    Methoxychlor is a member of the organochlorine class of pesticides.
Other members of this class include DDT, chlorobenzilate, dicofol, and
ethylan. Less closely related members of the class include lindane,
dieldrin, endrin, chlordane, heptachlor, aldrin, endosulfan, depone,
and toxaphene (Ref. 6). Methoxychlor was developed as a replacement for
DDT and is a structural analog of DDT. Methoxychlor has also been
identified as a persistent bioaccumulative toxic substance. Since there
are data gaps for all of the major studies, there is no way to assess
the safety of the existing tolerances to either the adult populations
and especially to infants and children. Existing data concerning
methoxychlor suggest significant hazards resulting from exposure to the
pesticide, such that the Agency cannot (in the absence of exculpatory
data) determine that there is a reasonable certainty of no harm (see
Unit II.B., below).
    On February 19, 2002, the Agency received a letter from Kincaid
indicating that the company intends to formally request the
cancellation of all crop uses for methoxychlor; however, the company
intends to support the use of methoxychlor on livestock.

B. What is the Agency's Authority for Taking this Action?

    A tolerance represents the maximum level for residues of pesticide
chemicals legally allowed in or on raw agricultural commodities and
processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as
amended by the FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods (21 U.S.C. 346(a)). Without a tolerance or exemption,
food containing pesticide residues is considered to be unsafe and
therefore adulterated under section 402(a) of the FFDCA. If food
containing pesticide residues is considered to be adulterated, you may
not distribute the product in interstate commerce (21 U.S.C. 331(a) and
342(a)). For a food-use pesticide to be sold and distributed, the
pesticide must not only have appropriate tolerances under the FFDCA,
but also must be registered under FIFRA (7 U.S.C. et seq.). Food-use
pesticides not registered in the United States have tolerances for
residues of pesticides in or on commodities imported into the United
States.
    FFDCA section 408(b)(2)(A) provides that the Administrator may
establish or leave in effect a tolerance for a pesticide chemical
residue in or on a food only if the Administrator determines that the
tolerance is safe. The section further provides that the term ``safe,''
with respect to a tolerance for a pesticide chemical residue, means
that the Administrator has determined that there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information. For the reasons stated in Unit II.A., above, existing data
concerning methoxychlor suggest significant hazards resulting from
exposure to the pesticide, such that the Agency cannot (in the absence
of exculpatory data) determine that there is a reasonable certainty of
no harm. In addition, EPA's general practice is to propose revocation
of tolerances for residues of pesticide active ingredients on crops for
which FIFRA registrations no longer exist and on which the pesticide
may therefore no longer be used in the United States. The same
principles apply to uses that have been suspended but not canceled. 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 or suspended 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.
    Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of the FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops uses for which FIFRA registrations no longer exist or have
been suspended, unless someone expresses a need for such tolerances.
Through this proposed rule, the Agency is inviting individuals who need
these import tolerances to identify themselves and the tolerances that
are needed to cover imported commodities.
    Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.

C. When Do These Actions Become Effective?

    EPA is proposing that the tolerances for methoxychlor be revoked
upon publication of the 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. Consequently, these
tolerances are no longer needed. If you have comments regarding
existing stocks and whether the effective date accounts for these
stocks, please submit comments as described under SUPPLEMENTARY
INFORMATION.
    Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(l)(5), as
established by FQPA. Under this section, any residues of these
pesticides in or on such food shall not render the food adulterated so
long as it is shown to the satisfaction of the Food and Drug
Administration (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 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 to reassess 66% or about 6,400 of the
tolerances in existence on August 2, 1996, by August 2002. EPA is also
required to assess the remaining tolerances by August 2006. As of March
8, 2002, EPA has reassessed over 3,910 tolerances. This document
proposes to revoke 79 tolerances which would be counted as
reassessments in a final rule toward the August 2002 review deadline of
FFDCA section 408(q), as amended by FQPA in 1996. For reassessment
counting purposes, sweet potatoes and yams are counted as one tolerance
and ``with or without tops'' is counted as two tolerances each for
beets, radishes, rutabagas, and turnips.

III. Are The Proposed Actions Consistent with International
Obligations?

    The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically produced and imported
foods meet the food safety standards established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods. 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. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision documents. 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. References

    1. Cummings, A.M. and L.E. Gray. 1987. Methoxychlor affects the
decidual cell response of the uterus but not other progestational
parameters in female rats. Toxicol. Appl. Pharmacol. 90(2): 330-336.
    2. Goldman, J.M., R.L. Cooper, G.L. Rehnberg, J.F. Hein, W.K.
McElroy, and L.E. Gray Jr. 1986. Effects of low subchronic doses of
methoxychlor on the rat hypothalamic-pituitary reproductive axis.
Toxicol. Appl. Pharmacol. 86(3): 474-483.
    3. Gray, L.E. Jr., J. Ostby, J. Ferrell et al. 1989. A dose-
response analysis of methoxychlor-induced alterations of reproductive
development and function in the rat. Fund. Appl. Toxicol. 12(1): 92-
108.
    4. Khera, K.S., C. Whalen, and G. Trivett. 1978. Teratogenicity
studies on linuron, malathion, and methoxychlor in rats. Toxicol. Appl.
Pharmacol. 45(2): 435-444.
    5. Kupfer, D. and W.H. Bulger. 1987. Metabolic activation of
pesticides with proestrogenic activity. Fed. Proc. 46(5): 1864-1869.
    6. Ware, G.W. 1982. Fundamentals of Pesticides, Thompson
Publications.

V. Regulatory Assessment Requirements

    In this proposed rule, EPA is proposing to revoke specific
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
proposed rule has been exempted from review under Executive Order 12866
due to its lack of significance, this proposed 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 proposed 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 proposed
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, for the pesticides named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposed revocations that would change EPA's previous analysis. Any
comments about the Agency's determination should be submitted to EPA
along with comments on the proposal, and will be addressed prior to
issuing a final rule. 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 proposed 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 proposed 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 proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 27, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be 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. 180.120 [Removed]

    2. Section 180.120 is removed.

[FR Doc. 02-8155 Filed 4-3-02; 8:45 am]