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Triflumizole. August 23, 2002. Emergency Exemption Pesticide Tolerance; in or on Filbert at 0.05 ppm. Final Rule. Federal Register.


http://www.epa.gov/fedrgstr/EPA-PEST/2002/August/Day-23/p21669.htm


[Federal Register: August 23, 2002 (Volume 67, Number 164)]
[Rules and Regulations]
[Page 54583-54588]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au02-6]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0183; FRL-7194-4]
 
Triflumizole; Pesticide Tolerance for Emergency Exemption

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

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of triflumizole (1-(1-((4-chloro-2-(trifluoromethyl) 
phenyl)imino)-2-propoxyethyl)-1H-imidazole) and its metabolites 
containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as 
the parent in or on hazelnuts, or filberts (EPA preferred term). This 
action is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on filberts. This regulation 
establishes a maximum permissible level for residues of triflumizole in 
this food commodity. The tolerance will expire and is revoked on June 
30, 2004.

DATES: This regulation is effective August 23, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0183, 
must be received on or before October 22, 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-2002-0183 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrea Conrath, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9356; e-mail address: 
conrath.andrea@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, Exit Disclaimer a beta site 
currently under development.
    2.In person. The Agency has established an official record for this 
action under docket ID number OPP-2002-0183. 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

[[Page 54584]]

Information and Records Integrity Branch (PIRIB), Rm. 119, 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 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 residues of the fungicide 
triflumizole, (1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2- 
propoxyethyl)-1H-imidazole) and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent, in or 
on filbert at 0.05 part per million (ppm). This tolerance will expire 
and is revoked on June 30, 2004. 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 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 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 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 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 Triflumizole on Filberts and FFDCA 
Tolerance

    Since the discovery of Eastern Filbert Blight (EFB) in Oregon in 
the late 1980's, none of the control tactics have provided complete 
control, and the disease continues to spread.
    Without adequate control of EFB, not only are significant economic 
losses likely, but the long-term viability of the filbert industry is 
also in jeopardy, as 98% of U.S. filbert production occurs in Oregon. 
Efficacy trials have indicated that the triflumizole provides better 
control, as compared to the currently available alternatives, none of 
which are systemic in nature. EPA has authorized under FIFRA section 18 
the use of triflumizole on filberts for control of Eastern Filbert 
Blight in Oregon. After having reviewed the submission, EPA concurs 
that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of triflumizole in or on 
filberts. 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 establishing 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, 2004, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on filberts 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 the 
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 triflumizole 
meets EPA's registration requirements for use on filberts 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 triflumizole by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances serve as the 
basis for any State other than Oregon 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 
triflumizole, 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 
triflumizole and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of triflumizole in or on filbert at 0.05 ppm.
    The most recent estimated aggregate risks resulting from the use of 
triflumizole are discussed in the Federal Register for June 12, 2002 
(67 FR 40219) (FRL-7180-5), Final Rule establishing tolerances for 
residues of triflumizole in/on cucurbit vegetables, strawberries, sweet 
cherries, and tart cherries, because in that prior action, risks were 
estimated assuming tolerance level residues in all commodities for 
established tolerances, as well as those being proposed, such as this 
exempted use on filberts. Refer to the June 12, 2002 Federal Register 
document for a detailed discussion of the aggregate risk assessments 
and determination of safety. EPA relies upon that risk

[[Page 54585]]

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 
triflumizole for use in human risk assessment is discussed in Unit 
III.A. of the final rule mentioned above, published in the Federal 
Register of June 12, 2002 (67 FR 40219).
    EPA assessed risk scenarios for triflumizole under acute and 
chronic exposure scenarios.
    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: A conservative, unrefined Tier 1 acute dietary exposure 
assessment was conducted for females 13-50 years old using tolerance 
level residues and modified DEEMTM processing factors for 
apples and grapes, based on the results of previously submitted 
processing studies. The Agency assumed 100% crop treated (CT) for all 
other registered and proposed triflumizole food uses.
    Using these exposure assessments, EPA concluded that triflumizole 
exposure from food consumption will utilize 19% of the acute population 
adjusted dose (aPAD) for the US population subgroup of concern, females 
13 years and older. No acute toxicity endpoint was selected for the 
general U.S. population, including infants and children; therefore, an 
acute dietary exposure assessment was not conducted for these groups. 
In addition, despite the potential for acute dietary exposure to 
triflumizole in drinking water, after calculating drinking water levels 
of concern (DWLOCs) and comparing them to conservative model estimated 
environmental concentrations (EECs) of triflumizole 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 Triflumizole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Female (13+ years)                                      0.03           19          191         0.12          710
----------------------------------------------------------------------------------------------------------------

    The following assumptions were made for the chronic exposure 
assessments: A partially refined, Tier 3 chronic dietary assessment was 
conducted for the general U.S. population and all population subgroups 
(including infants and children) using anticipated residues, modified 
DEEMTM processing factors for apples and grapes based on the 
results of previously submitted processing studies, and average 
weighted percent crop treated information for apples, grapes, and 
pears.
    Using these exposure assessments, EPA concluded that exposure to 
triflumizole from food will utilize 11% of the cPAD for the population 
subgroup infants <1 year old, 18% for children 1-6 years old, and 8% 
for the overall U.S. population and as well as all other population 
subgroups. The most highly exposed subpopulation is children 1-6 years 
old at 18% of the cPAD. Based on the use pattern, chronic residential 
exposure to residues of triflumizole is not expected. In addition, 
despite the potential for chronic dietary exposure to triflumizole in 
drinking water, after calculating DWLOCs and comparing them to 
conservative model EECs of triflumizole in surface water 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 Triflumizole
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (48 contiguous states)                 0.005            8           40         0.12          160
Infants (<1 year old)                                  0.005           11           40         0.12           45
Children (1-6 years old)                               0.005           18           40         0.12           41
----------------------------------------------------------------------------------------------------------------

    Triflumizole is classified as a ``Group E'' chemical (evidence of 
non-carcinogenicity in humans) based on adequate studies in 2 species 
of animal. Therefore, a cancer dietary exposure assessment was not 
performed.
    Short- and intermediate-term aggregate exposure takes into account 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). For triflumizole, the 
Agency did not perform short-term or intermediate-term assessments 
because there are currently no registered or proposed uses for 
homeowner application and residential post-application exposures are 
expected to be negligible.
    Based on these risk assessments, EPA concludes that there is a 
reasonable certainty that no harm will result to the general 
population, and to infants and children from aggregate exposure to 
triflumizole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Francis 
Griffith, Analytical Chemistry Branch, Environmental Science Center, 
U.S. Environmental Protection Agency, 701 Mapes Road, Fort George G. 
Meade, MD 20755-5350; telephone number (410)

[[Page 54586]]

305-2905; e-mail address: griffith.francis@epa.gov.

B. International Residue Limits

    There are no Codex maximum residue limits established for 
triflumizole residues in/on any crop commodities. Therefore, no 
compatibility problems exist for the proposed tolerance.

C. Conditions

    A maximum of four applications may be made. A maximum of 0.125-0.25 
pound active ingredient may be applied using ground or aerial 
equipment. No more than 1 pound active ingredient may be applied per 
acre per season.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
triflumizole (1-(1-((4-chloro-2- (trifluoromethyl)phenyl)imino)-2-
propoxyethyl)-1H-imidazole) and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent, in or 
on filbert at 0.05 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-2002-0183 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 
22, 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  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-2002-0183, 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

[[Page 54587]]

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 180.476 is amended by adding text and a table to 
paragraph (b) to read as follows:

Sec. 180.476  Triflumizole; tolerances for residues.

* * * * *
    (b) Time-limited tolerances are established for the residues of 
triflumizole (1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-
propoxyethyl)-1H-imidazole) and its metabolites containing the 4-
chloro-2-trifluoromethylaniline moiety, calculated as the parent in 
connection with use of the pesticide under section 18 emergency 
exemptions granted by EPA. The tolerances are specified in the 
following table, and will expire and are revoked on the dates 
specified.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Filbert                                          0.05            6/30/04
------------------------------------------------------------------------

[[Page 54588]]

* * * * *
[FR Doc. 02-21669 Filed 8-21-02; 2:17pm]
BILLING CODE 6560-50-S