[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Rules and Regulations]
[Pages 46884-46888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17869]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0093; FRL-7185-4]
RIN 2070


Aspergillus flavus AF36; Amendment, Temporary Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends an existing temporary exemption from 
the requirement of a tolerance for residues of the atoxigenic microbial 
pesticide, Aspergillus flavus AF36 on cotton consistent with the 
Experimental Use Permit 69224-EUP-1, which will now allow for 
application to cotton in certain counties in Arizona and Texas. 
Interregional Research Project Number 4 (IR-4), on behalf of the USDA/
ARS Southern Regional Research Center, submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act (FQPA) of 1996, requesting the 
temporary tolerance exemption amendment. This regulation eliminates the 
need to establish a maximum permissible level for residues of 
Aspergillus flavus AF36. The temporary tolerance exemption will expire 
on December 30, 2004.

DATES: This regulation is effective July 17, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0093, 
must be received by EPA on or before September 16, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0093 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shanaz Bacchus, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703-308-8097; 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

[[Page 46885]]

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 docket for 
this action under docket ID number OPP-2002-0093. The official docket 
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). Interested parties 
should consult both 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 docket does not include 
any information claimed as CBI. The public version of the official 
docket, 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.

II. Background and Statutory Authority

A. Statutory Authority

    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean 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.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .'' Additionally, section 408(b)(2)(D) requires that the 
Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues'' and ``other substances 
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

B. Factual Background

    This extension of the temporary exemption from the requirement of a 
tolerance is associated with an extension of an Experimental Use Permit 
(69224-EUP-1), which was granted in May 1996 to the Southern Regional 
Research Center, United States Department of Agriculture, Agricultural 
Research Service (USDA ARS), 1100 Robert E. Lee Blvd., New Orleans, LA 
70179-0687. Both the temporary exemption from tolerance and the 
Experimental Use Permit in Arizona expire December 30, 2003.
    In the Federal Register of (March 25 2002, 57 FR 13628) (FRL-6827-
8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170), announcing the 
filing of an amended pesticide tolerance petition (PP 5E4575) by 
Interregional Research Project Number 4 (IR-4), New Jersey Agricultural 
Experiment Station, Technology Center of New Jersey, 681 U.S. Highway 
1 South, North Brunswick, NJ 08902-3390 on behalf of the USDA/
ARS Southern Regional Research Center, 1100 Robert E. Lee Blvd., P.O. 
Box 19687, New Orleans, LA 70179. This notice included a summary of the 
petition prepared by the petitioner, Dr. Michael Braverman. It referred 
to data previously evaluated and summarized by the Agency as published 
in the Federal Register of May 26 1999 (64 FR 28371) (FRL-6081-2), and 
the extension of the temporary tolerance exemption as published in the 
Federal Register of May 23 2001 (66 FR 28383) (FRL-6781-7). The 
petition requested that 40 CFR part 180.1206 be amended by establishing 
a temporary exemption from the requirement of a tolerance for residues 
of Aspergillus flavus AF36 on cotton in certain counties in Texas in 
addition to the current exemption from temporary tolerance on cotton in 
Arizona. This petition also, requested that this temporary exemption 
from a tolerance be extended to December 30, 2005.
    Several comments were received in favor of the amendment to allow 
use of the microbial pesticide in Texas. The growers were of the 
opinion that the use of this active ingredient is likely to reduce the 
high levels of naturally occurring aflatoxin-producing strain. 
Aspergillus flavus AF36 has been found at a range of less than 1 to 
approximately 5% in certain regions of Texas.
    One comment was received requesting the Agency to re-evaluate the 
science of the proposed program and that the risks associated with the 
use of the active ingredient be considered before a permanent exemption 
from a tolerance is issued. The main concerns in this comment were the 
requirement for uniform standards in the expression of aflatoxin levels 
found in the crop; the practical significance of the proposed treatment 
method in reducing aflatoxin contamination; and the significance of the 
host stress in the expression of pathogenicity by Aspergillus flavus.
    Considering each of these points, first, the commenter referred to 
the mixing of units used to measure aflatoxin contamination. This 
comment specifically referred to the experimental researcher's reports, 
which include measurement of aflatoxin levels as micrograms per gram of 
cottonseed rather than the typical expression of micrograms per 
kilogram of cottonseed. In data submitted to the Agency, there is no 
indication that the company was in error or misrepresenting the 
aflatoxin values. In all cases, EPA is careful to pay close scrutiny to 
the units of measure in data they review and the implications made from 
the stated values.
    Secondly, the efficacy of the pesticidal product to reduce the 
level of aflatoxin in commercial crops was questioned in the comments. 
The Agency requires that the company present data to confirm their 
claim to control a public health hazard. The submitted data are 
available in the public docket and have been reviewed. These data 
indicate that when Aspergillus flavus AF36 is used, a higher percentage 
of the treated commodity meets, or is less than, the standards of 
aflatoxin required by the Food and Drug Administration (FDA), and the 
aflatoxin contamination in the experimental region is lowered. The 
growers ultimately decide if the reduced aflatoxin contamination is 
worth the treatment cost, but all cotton and its by-products sold for 
food/feed must meet the FDA aflatoxin standard.

[[Page 46886]]

    Regarding testing of the atoxigenic fungus, Aspergillus flavus 
AF36, on stressed or immunosuppressed species to detect any pathogenic 
potential in plants, insects, or mammals, EPA's guideline requirements 
are designed to address the normal immune response to microbial 
exposure. These tests include non-self/foreign recognition and response 
or clearance by the immune system over time. EPA is examining new 
methods that may address the potential of a microbe to infect stressed 
or immunocompromised hosts. In the interim, special measures have been 
included in the experimental treatments to reduce exposure to 
Aspergillus flavus AF36 outside of the designated treatment areas. The 
experimental plan also requires extensive data collection to examine 
the fate and persistence of Aspergillus flavus AF36 as a component of 
the local fungal population.
    Exposure to Aspergillus flavus is inevitable, because the fungus 
normally occurs in the environment. Given the ubiquitous nature of 
various strains of Aspergillus flavus, the precautions associated with 
this experimental program, data indicating no undue adverse health 
effects to test rodent species by oral ingestion of Aspergillus flavus 
AF36, as well as the current FDA monitoring of aflatoxin levels, there 
is a reasonable certainty of no harm resulting from the use of the non-
aflatoxin-producing fungus, Aspergillus flavus AF36.

III. Toxicological Profile and Risk Assessment

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness, and 
reliability and the relationship of this information to human risk. EPA 
has also considered available information concerning the variability of 
the sensitivities of major identifiable subgroups of consumers, 
including infants and children.
    Based on the data and analyses outlined in the Federal Register of 
May 26 1999 (66 FR 28371), and summarized below, EPA has concluded that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to the U.S. population, including infants and children, to 
residues of Aspergillus flavus AF36 arising from the limited use 
pattern of the experimental use permit. This includes all anticipated 
dietary exposures and all other exposures for which there is reliable 
information.
    1. Food. The cultural practice allows application of the microbial 
pesticide prebloom to cotton. This precludes the potential for direct 
residues of Aspergillus flavus AF36 per se to remain on the treated 
cotton. Only the seed of the treated commodity, cotton, is likely to be 
processed as food for cottonseed oil. Residues of Aspergillus flavus 
AF36 or its metabolites are likely to be removed from cotton seed oil 
during this processing.
    In addition, the data submitted demonstrate that the proposed 
strain of Aspergillus flavus AF36, has a low toxicity potential, and, 
therefore, is likely to pose a minimal to non-existent hazard if used 
as labeled. The acute oral LD50 of rats treated by gavage 
for 14 days is greater than 5,000 mg/kg. Further, the proposed strain 
of Aspergillus flavus, AF36, does not produce aflatoxin. Aflatoxin is 
regulated on the by-products of cotton by the Food and Drug 
Administration. The May 23 2001 Federal Register Notice also, discusses 
that no adverse effects were reported in the annual reports of the 
Experimental Use Permit 69224-EUP-1, and, in some instances, aflatoxin 
levels of cotton seed were reduced in treated cotton (May 23, 2001, 66 
FR 28383).
    2. Dermal exposure. Non-occupational dermal exposure and risk to 
adults, infants and children are not likely if the pesticide is used as 
labeled. If the microbe exhibits dermal sensitizing properties which is 
associated with this genus of fungi, the boundaries are likely to 
maintain distribution near treated areas thus protecting nearby at-risk 
populations. To further minimize exposure to immunocompromised or 
sensitive populations, infants and children, the Agency continues to 
require that the pesticide must not be applied within a boundary of 400 
feet of schools, daycare and health care facilities and hospitals.
    3. Inhalation exposure. Based on the method of application to the 
soil of cultivated cotton fields, prebloom with set boundaries, non-
occupational inhalation exposure and risk to human adults, children and 
infants are likely to be minimal.
    4. Determination of safety for U.S. population, infants and 
children. FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (safety) for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base unless EPA determines 
that a different margin of exposure (safety) will be safe for infants 
and children. In this instance, based on the above findings, EPA 
believes there are reliable data to support the conclusion that there 
are no threshold effects of concern to infants, children, and adults 
when Aspergillus flavus AF36 is used as labeled, and that no additional 
margin of exposure is necessary.
    5. Cumulative effects. This is the only microbe in the genus 
Aspergillus which is in an experimental use program at this time. 
Aspergillus species are naturally occurring ubiquitous fungi, such that 
exposure to various species is normal. The data submitted to the Agency 
support the claim that Aspergillus flavus AF36 is non-aflatoxin 
producing. When applied prior to flowering, Aspergillus flavus has been 
shown to exclude aflatoxin-producing fungi competitively from the 
developing crop and to reduce aflatoxin contamination of cottonseed. 
Data show that the proposed use will not result in appreciable 
increases in the long-term populaton of Aspergillus flavus on the crop 
beyond naturally occurring levels. Furthermore, there is no expectation 
of cumulative effects with other pesticides.

IV. Other considerations

    1. Endocrine disruptors. EPA does not have any information 
regarding endocrine effects of this microbial pesticide at this time.
    2. Analytical methods. Starter cultures are screened on the basis 
of vegetative incompatibility with the toxigenic strain. Aspergillus 
flavus AF 36 does not demonstrate vegetative compatibility with the 
aflatoxin-producing S strain. Aflatoxin production is monitored by 
standard thin layer chromatography (tlc) procedures and visualization 
via scanning fluorescence densitometry and there is a zero tolerance 
for aflatoxin. Human pathogens are reported to be within regulatory 
levels (May 26 1999, 64 FR 28371). Treated cotton and its by-products 
are screened for aflatoxin prior to introduction into the channels of 
commerce. FDA does not allow cotton seed products containing aflatoxin 
above 20 parts per billion (ppb) to be used in dairy rations or above 
300 ppb to be used for feeding beef cattle.
    3. Codex maximum residue level. There is no codex maximum residue 
level for Aspergillus flavus AF36.

V. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the

[[Page 46887]]

FFDCA by the FQPA of 1996, EPA will continue to use those procedures, 
with appropriate adjustments, until the necessary modifications can be 
made. The new section 408(g) provides essentially the same process for 
persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d), as 
was provided in the old FFDCA sections 408 and 409. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0093 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before September 
16, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket ID number OPP-2002-0093, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VI. Regulatory Assessment Requirements

    This final rule establishes an amended exemption from the temporary 
tolerance requirement under FFDCA section 408(d) in response to a 
petition submitted to the Agency. The Office of Management and Budget 
(OMB) has exempted these types of actions from review under Executive 
Order 12866, entitled Regulatory Planning and Review (October 4 1993, 
58 FR 51735). Because this rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (May 22 2001, 
66 FR 28355). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (February 16 1994, 59 FR 7629); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (April 23 1997, 62 FR 19885). 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). Since tolerances and 
exemptions that are established on the basis of a petition under FFDCA 
section 408(d), such as the amended temporary tolerance exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 
seq.) do not apply. 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

[[Page 46888]]

levels of government, as specified in Executive Order 13132, entitled 
Federalism (August 10 1999, 64 FR 43255). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive Order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). For these same reasons, the 
Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (November 
6, 2000, 65 FR 67249). Executive Order 13175, requires EPA to develop 
an accountable process to ensure ``meaningful and timely input by 
tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule ''as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: June 27, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.1206 is revised to read as follows:


Sec. 180.1206  Aspergillus flavus AF36.

    Aspergillus flavus AF36 is temporarily exempt from the requirement 
of a tolerance in or on cotton. The temporary exemption from a 
tolerance will expire on December 30, 2004, consistent with the 
Experimental Use Permit 69224-EUP-1.

[FR Doc. 02-17869 Filed 7-16-02; 8:45 am]
BILLING CODE 6560-50-S