[Federal Register Volume 68, Number 228 (Wednesday, November 26, 2003)]
[Proposed Rules]
[Pages 66390-66394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29322]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0209; FRL-7332[dash]4]


Proposed Revocation of Tolerance Exemptions for Certain 
Biopesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revoke exemptions from the 
requirement of a tolerance, as expressed in 40 CFR part 180, on 
residues of the following pesticide active ingredients because there 
are no active Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) product registrations applicable to these exemptions: 
Dihydroazadirachtin; Kontrol HV; Metarhizium anisopliae strain ESF1 in 
attractant stations; polyhedral occlusion bodies of Autographa 
californica NPV; Pseudomonas fluorescens EG-1053; Pseudomonas 
fluorescens NCIB 12089; and Puccinia canaliculata ATCC (40199). In 
addition, this document proposes to revoke the tolerance exemption for 
Bacillus thuringiensis CryIA(b) delta-endotoxin and the genetic 
material necessary for its production in corn because that tolerance 
exemption has been replaced by a tolerance exemption that applies to 
all plants. 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 2006 to reassess tolerances in existence on August 2, 1996. For 
counting purposes, the proposed revocations would count as nine FQPA 
tolerance/exemption reassessments made toward the August 2006 review 
deadline.

DATES: Comments, identified by docket (ID) number OPP-2003-0209, must 
be received on or before January 26, 2004.

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 ID number 
OPP-2003-0209 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Barbara Mandula, 
Biopesticides and Pollution Prevention Division (7511C), Office of 
Pesticide Programs Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-7378; 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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provide a 
guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.  A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2003-0209. 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 ID number OPP-2003-0209 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

[[Page 66391]]

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 ID number OPP-2003-0209. 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.
    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 
ID 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 Exemption 
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 exemption proposed 
for revocation. If EPA receives a comment within the 60-day period to 
that effect, EPA will not proceed to revoke the tolerance exemption 
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 issues 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?

    EPA is proposing to revoke various exemptions from the requirement 
of a tolerance, as expressed in specific sections of 40 CFR part 180, 
for residues of the following active ingredients because of non-payment 
of maintenance fees and because there are no currently registered 
products to which the subject tolerance exemptions apply: Polyhedral 
occlusion bodies of Autographa californica NPV in 40 CFR 180.1125; 
Dihydroazadirachtin in 40 CFR 180.1169; Kontrol HV in 40 CFR 180.1063; 
Metarhizium anisopliae strain ESF1 in attractant stations in 40 CFR 
180.1116; Pseudomonas fluorescens EG-1053 in 40 CFR 180.1088; 
Pseudomonas fluorescens NCIB 12089 in 40 CFR 180.1129; and Puccinia 
canaliculata ATCC 40199 in 40 CFR 180.1123.
    It is EPA's general practice to propose revocation of those 
tolerance exemptions for residues of pesticide active ingredients on 
food for which there are no active registered uses under FIFRA, or for 
which there are no registered products to which the tolerance exemption 
applies, or for tolerance exemptions that have been superseded, unless 
any person commenting on the proposal indicates a need for the 
tolerance exemption to cover residues in or on imported commodities or 
domestic commodities legally treated.
    Following are the details of the final product cancellations for 
the above active ingredients and the number of tolerances that will be 
counted as reassessed once a final rule is issued.
    1. Dihydroazadirachtin. Product 70051-29 canceled on August 25, 
2000 for non-payment of maintenance fees. Announced on September 6, 
2000 (67 FR 54114) (FRL-6737-7). According to Agency records, this 
product was the last FIFRA registered product containing the active 
ingredient Dihydroazadirachtin, which is exempt from the requirement of 
a tolerance in or on all raw agricultural commodities when applied as 
specified under 40 CFR 180.1169. The Agency believes that sufficient 
time has passed for stocks to have been exhausted and for treated 
commodities to have cleared channels of trade. Revocation of this 
tolerance exemption in a final rule will count as one tolerance 
reassessment.
    2. Kontrol HV. Product 17217-2 canceled on July 21, 1998 for non-
payment of 1998 maintenance fees. Announced on July 31 1998 (63 FR 
41145) (FRL-6015-8). According to Agency records, this product was the 
last FIFRA registered product containing the active ingredient Kontrol 
HV, which is exempt from the requirement of a tolerance when used on 
cotton to control the tobacco budworm under 40 CFR 180.1063. The Agency 
believes that sufficient time has passed for stocks to have been 
exhausted and for treated commodities to have cleared channels of 
trade. Revocation of this tolerance exemption in a final rule will 
count as one tolerance reassessment.
    3. Metarhizium anisopliae strain ESF1 in attractant stations. 
Product 64296-2 canceled on August 25, 2000 for non-payment of 
maintenance fees. Announced on September 6, 2000 (65 FR 54114) (FRL-
6737-7). According to Agency records, this product was the last FIFRA 
registered product containing the active ingredient metarhizium 
anisopliae strain ESF1 for use in attractant stations. Currently, there 
are three tolerance exemptions in 40 CFR 180.1116 for metarhizium 
anisopliae ESF1 in or on all raw agricultural commodities, animal feed, 
and processed food when used in attractant stations. The Agency 
believes that sufficient time has passed for stocks to have been 
exhausted and for treated

[[Page 66392]]

commodities to have cleared channels of trade. Revocation of this 
tolerance exemption in a final rule will count as three tolerance 
reassessments.
    4. Polyhedral occlusion bodies of Autographa californica nuclear 
polyhedrosis virus (NPV). Product 70051-43 canceled on July 21, 1998 
for non-payment of maintenance fees. Announced on July 31, 1998 (63 FR 
41145) (FRL-6015-8). According to Agency records, this product was the 
last FIFRA registered product containing the active ingredient 
polyhedral occlusion bodies of Autographa californica NPV, which is 
exempt from the requirement of a tolerance in or on all raw 
agricultural commodities under 40 CFR 180.1125. The Agency believes 
that sufficient time has passed for stocks to have been exhausted and 
for treated commodities to have cleared channels of trade.
    The tolerance exemption in 40 CFR 180.1125 for polyhedral occlusion 
bodies of Autographa californica nuclear polyhedrosis virus in or on 
all raw agricultural commodities was previously reassessed in 2002 and 
counted at that time. Therefore, revocation of this tolerance exemption 
in a final rule would not be counted toward the tolerance reassessment 
total.
    5. Pseudomonas fluorescens EG-1053. Product 55638-5 canceled on 
July 9, 1997 for non-payment of maintenance fees. Announced on July 23, 
1997 (62 FR 39517) (FRL-5729-8). According to Agency records, this 
product was the last FIFRA registered product containing the active 
ingredient Pseudomonas fluorescens EG-1053, which is exempt from the 
requirement of a tolerance when used in or on cottonseed and cotton 
forage under 40 CFR 180.1088. The Agency believes that sufficient time 
has passed for stocks to have been exhausted and for treated 
commodities to have cleared channels of trade. Revocation of this 
tolerance exemption in a final rule will count as two tolerance 
reassessments.
    6. Pseudomonas fluorescens NCIB 12089. Product 67186-1 canceled 
June 27, 1997 for non-payment of fees for 1997. Announced on July 23, 
1997 (62 FR 39517) (FRL-5729-8). According to Agency records, this 
product was the last FIFRA registered product containing the active 
ingredient Pseudomonas fluorescens NCIB 12089, which is exempt from the 
requirement of a tolerance when used in or on mushrooms under 40 CFR 
180.1129. The Agency believes that sufficient time has passed for 
stocks to have been exhausted and for treated commodities to have 
cleared channels of trade. Revocation of this tolerance exemption in a 
final rule will count as one tolerance reassessment.
    7. Puccinia canaliculata ATCC 40199. Product 65263-1 canceled July 
29, 1999 for non-payment of fees for 1999. Announced on August 11, 1999 
(64 FR 43820) (FRL-6086-8). According to Agency records, this product 
was the last FIFRA registered product containing the active ingredient 
Puccinia canaliculata ATCC 40199, which is exempt from the requirement 
of a tolerance in or on all raw agricultural commodities when applied 
as specified under 40 CFR 180.1123. The Agency believes that sufficient 
time has passed for stocks to have been exhausted and for treated 
commodities to have cleared channels of trade. Revocation of this 
tolerance exemption in a final rule will count as one tolerance 
reassessment.
    8. Bacillus thuringiensis. EPA is proposing to revoke the exemption 
from a requirement of a tolerance for residues of Bacillus 
thuringiensis CryIA(b) delta-endotoxin and the genetic material 
necessary for its production in corn listed as (plasmid vector 
pCIB4431) in 40 CFR 180.1152. That tolerance exemption is no longer 
necessary, having since been subsumed by a tolerance exemption, 40 CFR 
180.1173, announced on August 2, 1996 (61 FR 40343) (FRL-5391-3), that 
applies to all plants and all genetic material necessary to produce 
CryIA(b). The text of 40 CFR 180.1152 exempts this active ingredient 
from the requirement of a tolerance when used as a plant pesticide in 
or on the raw agricultural commodities field corn, sweet corn, and 
popcorn. Because this tolerance exemption was previously reassessed, as 
explained below, the number of tolerances that will be counted as 
reassessed by revocation of 40 CFR 180.1152 is zero.
    EPA has found previously that the exemption in 40 CFR 180.1152, 
Bacillus thuringiensis CryIA(b) delta-endotoxin and the genetic 
material necessary for its production (plasmid vector pCIB4431) in 
corn, is superseded by the exemption in 40 CFR 180.1173, covering all 
plant-incorporated protectants. In a registration decision document 
titled ``Biopesticides Registration Action Document: Bacillus 
thuringiensis Plant-Incorporated Protectants,'' issued October 15, 
2001, EPA states:
    By this reassessment, EPA has completed its tolerance 
reassessment for Cry1A(b) (Sec. 180.1173) and for Cry3A 
(Sec. 180.1147) under 408(q) of the FFDCA. The following tolerance 
exemptions allow the use of the listed plant-incorporated 
protectants in food and/or feed.
    c. Bacillus thuringiensis Cry1A(b) delta-endotoxin and the 
genetic material necessary for its production in all plants are 
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in all plant raw agricultural commodities 
40 CFR 180.1173, August 2, 1996 (61 FR 40343) (FRL-5391-3).
    The October 15, 2001 Biopesticides Registration Action Document 
further states that the tolerance exemption in 40 CFR 180.1152 is also 
considered reassessed because it is included in the broader tolerance 
exemption described in (c) above. The report continues:
    The Agency plans on revoking this more narrow tolerance 
exemption in the near future in order to reduce confusion.
    Therefore, in this document EPA is proposing to revoke the 
exemption in 40 CFR 180.1152 because it is no longer needed. The final 
rule will not change availability or use of the pesticide mentioned. A 
hardcopy of the Executive Summary of the October 15, 2001 document is 
available in the public docket for this rule, while an electronic copy 
is available through EPA's electronic public docket and comment system, 
EPA Dockets at http://www.epa.gov/edocket/. You may search for docket 
ID number OPP-2003-0209, then click on that docket number to view its 
contents.

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 hereinafter collectively referred to as 
(``food''). 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 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. 331a) 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.
    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

[[Page 66393]]

therefore, no longer be used in the United States. EPA also revokes 
tolerances that have been superseded or replaced. EPA has historically 
been concerned that retention of tolerances that are not necessary to 
cover residues in or on legally treated foods may encourage misuse of 
pesticides within the United States. Nonetheless, EPA will establish 
and maintain tolerances even when corresponding domestic uses are 
canceled if the tolerances, which EPA refers to as ``import 
tolerances,'' are necessary to allow importation into the United States 
of food containing such pesticide residues. However, where there are no 
imported commodities that require these import tolerances, the Agency 
believes it is appropriate to revoke tolerances for unregistered 
pesticides in order to prevent potential misuse.
    Furthermore, and as a general matter, the Agency believes that 
retention of import tolerances not needed to cover any imported food 
may result in an 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 and 
exemptions for residues on crop uses for which FIFRA registrations no 
longer exist, unless someone expresses a need for such tolerances. 
Through this proposed rule, the Agency is inviting individuals who need 
these import tolerance exemptions to identify themselves and those 
exemptions that are needed to cover imported commodities.
    Parties interested in retention of the tolerance exemptions 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 or exemption, EPA may require 
that parties interested in maintaining the tolerances or exemptions 
provide the necessary information. If the requisite information is not 
submitted, EPA may issue an order revoking the tolerance or exemption 
at issue.

C. When Do These Actions Become Effective?

    EPA is proposing that revocation of these tolerance exemptions 
become effective on the day the final rule revoking these tolerance 
exemptions is published in the Federal Register. The Agency believes 
that the revocation date allows users to exhaust stocks and allows 
sufficient time for passage of treated commodities through the channels 
of trade. However, if EPA is presented with information that existing 
stocks would still be available and that information is verified, the 
Agency will consider leaving the existing tolerance exemption in place. 
If you have comments regarding existing stocks and whether the 
effective date allows sufficient time for treated commodities to clear 
the channels of trade, please submit comments as described under Unit 
I.C. Similarly, if you have comments regarding these tolerance 
exemption revocations or the effective date of the revocations, please 
submit comments as described under Unit I.C.
    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(i)(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 by August 2006 to reassess the tolerances 
in existence on August 2, 1996. For counting purposes, and based on 
this proposed action, nine exemptions would be counted as reassessments 
toward the August 2006 review deadline of FFDCA section 408(q), as 
amended by FQPA in 1996.

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. EPA has developed guidance concerning submissions 
for import tolerance support (June 1, 2000 65 FR 35069) (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. Regulatory Assessment Requirements

    In this proposed rule, EPA is proposing to revoke specific 
tolerance exemptions established under FFDCA section 408. The Office of 
Management and Budget (OMB) has exempted this type of action, i.e., a 
tolerance exemption 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

[[Page 66394]]

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, entitled 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 procedures, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: November 7, 2003.
James Jones,
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. Sec.  180.1063, 180.1088, 180.1116, 180.1123, 180.1125, 
180.1129, 180.1152, and 180.1169 [Removed]

    2. Sections 180.1063, 180.1088, 180.1116, 180.1123, 180.1125, 
180.1129, 180.1152, and 180.1169 are removed.
[FR Doc. 03-29322 Filed 11-25-03; 8:45 am]
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