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Azoxystrobin - Pesticide Tolerances for Emergency Exemptions 8/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0210; FRL-7195-9]
Azoxystrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of azoxystrobin in or on safflower. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on safflower. This regulation establishes a
maximum permissible level for residues of azoxystrobin in this food
commodity. The tolerance will expire and is revoked on June 30, 2005.

DATES: This regulation is effective August 28, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0210,
must be received on or before October 28, 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 VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0210 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9364; e-mail address: Sec-18-
Mailbox@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially 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--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-2002-0210. 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, Mall ι2, 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 Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for combined residues of the
fungicide azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and the Z isomer of azoxystrobin,
[methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrlate], in or on safflower at 1.0 part per million (ppm). This
tolerance will expire and is revoked on June 30, 2005. EPA will publish
a document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18-related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(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. . . ."
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that "emergency conditions
exist which require such exemption." This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Azoxystrobin on Safflower and FFDCA
Tolerances

    During recent years, growers in Montana and North Dakota have faced
unusual frequent rains during June through August. Frequent rains favor
development of Alternaria leaf spots caused by Alternaria carthami and
A. alternata. Development of these diseases lead to severe yield
losses. Montana and North Dakota have both declared crisis exemptions
under FIFRA section 18 for the use of azoxystrobin on safflower for
control of Alternaria Leafspot (Alternaria carthami and A. alternata).
EPA concurs that emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of azoxystrobin in or on
safflower. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on June 30, 2005, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on safflower after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this tolerance at the time of that application. EPA will take action
to revoke this tolerance earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
    Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether azoxystrobin
meets EPA's registration requirements for use on safflower or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of azoxystrobin by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Montana and North Dakota to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of EPA's regulations implementing section 18 as identified
in 40 CFR part 166. For additional information regarding the emergency
exemption for azoxystrobin, contact the Agency's Registration Division
at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
azoxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of azoxystrobin in or on safflower at 1.0 ppm. The
most recent estimated aggregate risks resulting from the use of
azoxystrobin are discussed in the Federal Register of September 21,
2001 (66 FR 48585) (FRL-6830-1), Final Rule establishing tolerances for
residues of azoxystobin in/on acerola, atemoya, avocado, biriba, black
sapote, leafy greens (Brassica) subgroup (subgroup 5B), bushberry
subgroup (subgroup 13B), canistel, cherimoya, custard apple, eggplant,
feijoa, grass forage, grass hay, guava, ilama, jaboticaba, jackfruit,
juneberry, lingonberry, longan, loquat, lychee, mamey sapote, mango,
okra, passion fruit, pawpaw, papaya, pepper, peppermint (tops),
persimmon, pulasan, rambutan, salal, sapodilla, soursop, Spanish lime,
spearmint (tops), star apple, starfruit, strawberry, sugar apple,
tamarind, turnip (tops), watercress, wax jambu, and white sapote,
because in that prior action, risks were estimated assuming tolerance
level residues in all commodities for established tolerances, as well
as those for which action was being proposed, such as in this safflower
exemption use. Refer to the September 21, 2001 Federal Register
document for a detailed discussion of the aggregate risk assessments
and determination of safety. EPA relies upon that risk assessment and
the findings made in the Federal Register document in support of this
action. Below is a brief summary of the aggregate risk assessment.
    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. A summary of the toxicological dose and endpoints for
azoxystrobin for use in human risk assessment is discussed in Unit
III.A. of the Federal Register of September 29, 2000 (65 FR 58404)
(FRL-6749-1).
    EPA assessed risk scenarios for azoxystrobin under acute, chronic,
and short- and intermediate-term exposures.
    The Dietary Exposure Evaluation Model (DEEMTM) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity.
    The following assumptions were made for the acute exposure
assessments: Tolerance level residues were assumed and it was also
assumed that 100% of the crops and other commodities with proposed or
established azoxystrobin tolerances contained those residues.
Anticipated residues, and percent crop treated (PCT) values of less
than 100%, were not used.
    Using these exposure assessments, EPA concluded that azoxystrobin
exposure from food consumption will utilize 11% of the aPAD for the

U.S. population, 11% of the aPAD for females 13 years and older, and
20% of the aPAD for children 1 to 6 years, the subpopulation at
greatest exposure. In addition, despite the potential for acute dietary
exposure to azoxystrobin in drinking water, after calculating drinking
water levels of concerns (DWLOCs) and comparing them to conservative model estimated
environmental concentrations (EECs) of azoxystrobin in surface water
and ground water, EPA does not expect the aggregate exposure to exceed
100% of the aPAD, as shown in the following Table 1.
Table 1.—Aggregate Risk Assessment for Acute Exposure to Azoxystrobin
Population Subgroup
aPAD (mg/kg)
% aPAD (Food)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Acute DWLOC (ppb)
U.S. population 0.67 11 107 0.06 21,000
Females (13 to 50 years) 0.67 11 107 0.06 18,000
Children (1 to 6 years) 0.67 20 107 0.06 5,400
    The following assumptions were made for the chronic exposure
assessments: Tolerance level residues were assumed and it was also
assumed that 100% of the crops and other commodities with proposed or
established azoxystrobin tolerances contained those residues.
Anticipated residues and PCT values of less than 100%, were not used.
    Using these exposure assumptions, EPA concluded that exposure to
azoxystrobin from food will utilize 12% of the cPAD for the U.S.
population, 11% of the cPAD for females 13 to 50 years, and 18% of the
cPAD for children 1 to 6 years, the subpopulation at greatest exposure.
Based on the use pattern, chronic residential exposure to residues of
azoxystrobin is not expected. In addition, there is potential for
chronic dietary exposure to azoxystrobin in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 2:
Table 2.—Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Azoxystrobin
Population Subgroup
cPAD mg/kg/day
%cPAD (Food)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Chronic DWLOC
(ppb)
U.S. population 0.18 12 33 0.06 5,600
Females (13 to 50 years) 0.18 11 33 0.06 4,800
Children (1 to 6 years) 0.18 18 33 0.06 1,500
Seniors 55+ 0.18 12 33 0.06 5,600
    Short-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Azoxystrobin is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for azoxystrobin. A short-term risk assessment is required
for adults because there is a residential handler inhalation exposure
scenario. In addition, a short-term risk assessment is required for
infants and children because there is a residential post-application
oral exposure scenario. As no short-term or intermediate-term dermal
endpoint was established, there is no dermal component to these
aggregate risk assessments. For adults, the daily inhalation dose is
aggregated with the chronic exposure to food and water. For infants and
children, the incidental oral exposure from residential post-
application activities for infants and children was aggregated with
chronic exposure from food and water. EPA has concluded that food and
residential exposures aggregated result in aggregate margin of
exposures (MOEs) of 1,183 for adults and 490 for children 1 to 6 years.
These aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term were calculated and compared to the EECs for chronic exposure of
azoxystrobin in ground water and surface water. After calculating
DWLOCs and comparing them to the EECs for surface water and ground
water, EPA does not expect short-term aggregate exposure to exceed the
Agency's level of concern, as shown in the following Table 3:
Table 3.—Aggregate Risk Assessment for Short-Term Exposure to Azoxystrobin
Population Subgroup
Aggregate MOE
(Food + Residential)
Aggregate Level of
Concern (LOC)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Short-Term DWLOC
(ppb)
U.S. population 1,183 100 33 0.06 8,050
Children (1 to 6 years) 490 100 33 0.06 2,000
    Intermediate-term aggregate exposure takes into account non-
dietary, non-occupational exposure plus chronic exposure to food and
water (considered to be a background exposure level).
    Azoxystrobin is currently registered for use(s) that could result
in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic food and water
and intermediate-term exposures for azoxystrobin. An intermediate-term
risk assessment is not required for adults because residential handler
scenarios are not expected to occur for longer than a short-term
timeframe. However, an intermediate-term risk assessment is required
for infants and children because of the residential post-application
oral exposure scenario. As no dermal endpoint was established, there is
no dermal component to this aggregate risk assessment. As was necessary
for the short-term aggregate assessment, the incidental oral exposure
from residential post-application activities for infants and children
was aggregated with average exposure from food and water. EPA has
concluded that food and residential exposures aggregated result in an
aggregate MOE of 580 for children 1 to 6 years. This aggregate MOE does
not exceed the Agency's level of concern for aggregate exposure to food
and residential uses. In addition, intermediate-term DWLOCs were
calculated and compared to the EECs for chronic exposure of
azoxystrobin in ground water and surface water. After calculating
DWLOCs and comparing them to the EECs for surface water and ground
water, EPA does not expect intermediate-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table 4:
Table 4.—Aggregate Risk Assessment for Intermediate-Term Exposure to Azoxystrobin
Population Subgroup
Aggregate MOE
(Food + Residential)
Aggregate Level of
Concern (LOC)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Intermediate-Term
DWLOC (ppb)
Children (1 to 6 years) 580 100 33 0.06 2,100
V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Calvin Furlow,
PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue levels have been
established for residues of azoxystrobin in or on these commodities.
Therefore, no tolerance discrepancies exist between countries for this
chemical.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of
azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and the Z isomer of azoxystrobin,
[methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrlate] in or on safflower at 1.0 ppm.

VII. 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 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-2002-0210 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 October
28, 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 (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your written request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall ι 2, 1921 Jefferson
Davis Hwy., Arlington, VA. 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 (703) 603-0061.
    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 tompkins.jim@epa.gov,
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 VII.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 the docket ID number OPP-2002-0210, 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: opp-docket@epa.gov. 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
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 (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under 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 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). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under FFDCA section 408, such as the tolerance 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. 601 et
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 levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure "meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications." "Policies that have federalism
implications" is defined in the Executive Order to include regulations
that have "substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government." This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any "tribal implications" as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure "meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications."
"Policies that have tribal implications" is defined in the Executive
Order to include regulations that have "substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes."
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175.

 Thus, Executive Order 13175 does not apply to this rule.

IX. 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: August 17, 2002.

Debra Edwards,

Acting Director, Registration 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 180.507 is amended by alphabetically adding the
following commodity to the table in paragraph (b) to read as follows:

Sec. 180.507  Azoxystrobin; tolerances for residues.

* * * * *
    (b)  *  *  *

----------------------------------------------------------------------------------------------------------------
Commodity                             Parts per million        Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
                                          *      *      *      *      *
Safflower..................................... 1.0                       6/30/05
                                          *      *      *      *      *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 02-21679 Filed 8-27-02; 8:45 am]