[Federal Register Volume 67, Number 65 (Thursday, April 4, 2002)]
[Proposed Rules]
[Pages 16073-16078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8155]


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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.

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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

[[Page 16074]]

Ave, NW., Washington, DC 20460; telephone number: (703) 305-5400; 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_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: [email protected], 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

[[Page 16075]]

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:

[[Page 16076]]



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

[[Page 16077]]

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/.

[[Page 16078]]

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]
BILLING CODE 6560-50-S