Indoxacarb. Sept 18, 2002. Pesticide tolerance for emergency exemption for Massachussets for residues in or on Craneberry at 0.50 ppm. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Indoxacarb. September 18, 2002.
Pesticide Tolerance for Emergency Exemption for the state of Massachussets
for residues in or on Craneberry at 0.50 ppm. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-18/p23745.htm

[Federal Register: September 18, 2002 (Volume 67, Number 181)]
[Rules and Regulations]
[Page 58725-58730]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18se02-11]

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

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0256; FRL-7274-9]

Indoxacarb; Pesticide Tolerance for Emergency Exemption

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

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

SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of indoxacarb in or on cranberry. 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 cranberry. This regulation
establishes a maximum permissible level for residues of indoxacarb in
this food commodity. The tolerance will expire and is revoked on
December 31, 2004.

DATES: This regulation is effective September 18, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0256,
must be received on or before November 18, 2002.

ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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 entities may include, but are not limited to:
[sbull]
Crop producers (NAICS 111)
[sbull]
Animal producers (NAICS 112)
[sbull]
Food Manufacturing (NAICS 311)
[sbull]
Pesticide Manufacturing (NAICS 32532)
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 this unit could also

[[Page 58726]]

be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any 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 Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2002-0256. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under 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.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

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
insecticide indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate]
and
its R-enantiomer [(R)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate], in
or on cranberry at 0.5 parts per million (ppm). This tolerance will
expire and is revoked on December 31, 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 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 of the FFDCA 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) of the FFDCA 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) of the FFDCA 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 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 of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Indoxacarb on Cranberry and FFDCA
Tolerances

The Massachusetts Department of Food and Agriculture have indicated
that populations of the cranberry weevil in the state have developed
resistance to the registered alternative, chlorpyrifos. Without
adequate control, this pest was expected to result in significant crop
damage and yield losses for cranberry growers, leading to significant
economic losses. The state requested indoxacarb for this use, since
field trials have shown it to be effective at controlling this pest.
EPA has authorized under FIFRA section 18 the use of indoxacarb on
cranberry for control of the cranberry weevil in Massachusetts. 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 indoxacarb in or on
cranberry. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance
under section 408(l)(6) of the FFDCA 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) of the FFDCA.
Although this tolerance will expire and is revoked on December 31,
2004, under section 408(l)(5) of the FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerance remaining in or
on cranberry 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.

[[Page 58727]]

Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether indoxacarb
meets EPA's registration requirements for use on cranberry 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 indoxacarb 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 Massachusetts to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for indoxacarb, 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 of the FFDCA 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) of the FFDCA , 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 indoxacarb and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of the FFDCA, for a time-
limited tolerance for combined residues of indoxacarb in or on
cranberry at 0.5 ppm.

A. Toxicological Endpoints

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. The nature of the toxic effects caused by indoxacarb, a
summary of the toxicological dose and endpoints for indoxacarb for use
in this human risk assessment, and the most recent estimated aggregate
risks resulting from registered uses are discussed in the Federal
Register for July 18, 2002 (67 FR 47299) (FRL-7186-2) final rule
establishing tolerances for residues of indoxacarb in/on alfalfa
forage, alfalfa hay, peanut, peanut hay, potato, soybean seed, soybean
aspirated grain fractions, and soybean hulls.
Refer to the July 18, 2002 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, including this use on
cranberry.

B. Exposure Assessment

EPA assessed risk scenarios for indoxacarb under acute and chronic
scenarios. Because there are no residential uses or exposure scenarios,
short- and intermediate-term aggregate risk assessments were not
conducted. Nor was a cancer aggregate risk assessment conducted,
because indoxacarb is classified as ``not likely'' to be a human
carcinogen.
The Dietary Exposure Evaluation Model (DEEM\TM\) 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: An acute Tier 2 (partially refined) dietary assessment was
performed with use of anticipated residues (ARs) from field trial data,
processing factors (where applicable), and assumed 100 percent of crop
treated (%CT). ARs for meat, milk, poultry, and eggs were also
calculated.
Using these exposure assumptions, EPA concluded that indoxacarb
acute exposures from food consumption are below levels of concern
(<100% of the acute Population Adjusted Dose (aPAD)) for the general US
population and all population subgroups. The amount of the aPAD
utilized for the most highly exposed subgroup, Females (13-50 yrs old)
is 41%. Acute risk from dietary exposure for the most highly exposed
infant/children subpopulation, Children (1-6 yrs old) is at 12% of the
aPAD. For the general US Population and all other population subgroups,
acute risk from dietary exposure is estimated at 6% of the aPAD. In
addition, despite the potential for acute dietary exposure to
indoxacarb in drinking water, after calculating drinking water levels
of concern (DWLOCs) and comparing them to conservative model estimated
environmental concentrations (EECs) of indoxacarb in surface and ground
waters, 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 Indoxacarb
---------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------
General US Population 0.12 6 13.7 0.02 3900
Females (13-50 yrs old) 0.12 41 13.7 0.02 350
Children (1-6 yrs old) 0.12 12 13.7 0.02 1100
----------------------------------------------------------------------------------------------

The following assumptions were made for the chronic exposure
assessments: The chronic dietary assessment assumed tolerance level
residues, default processing factors and 100% CT. Refinements using
ARs, actual processing factors, and %CT data would result in lower
chronic dietary exposure estimates.
Using these exposure assumptions, EPA concluded that indoxacarb
chronic exposures from food consumption are below levels of concern
(<100% of the cPAD) for the general US population and all population
subgroups. The cPAD utilized for the most highly exposed subgroup,
Children (1-6 yrs old) is 90%. Chronic risk from dietary exposure for
Infants (<1 year old) is 4% of the cPAD, and for Children (7-12 yrs
old) it is 52% of the cPAD. Chronic dietary risk for the general US
Population is 36% of the cPAD, and the estimated chronic risk for all
other population subgroups is below this level. In addition, despite
the potential for chronic dietary exposure to

[[Page 58728]]

indoxacarb in drinking water, after calculating DWLOCs and comparing
them to conservative model EECs of indoxacarb in surface and ground
waters, 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 Exposure to Indoxacarb
-------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/ % cPAD Water EEC Water EEC Chronic
kg) (Food) (ppb) (ppb) DWLOC (ppb)
-------------------------------------------------------------------------------------------
General US Population 0.02 36 3.7 0.02 450
Children (1-6 yrs old) 0.02 90 3.7 0.02 21
Children (7-12 yrs old) 0.02 52 3.7 0.02 97
Infants (<1 yr old) 0.02 49 3.7 0.02 100
-------------------------------------------------------------------------------------------

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). Indoxacarb is not
registered for use on any sites that would result in residential
exposure, and thus short- and intermediate-term exposures are not
expected, so these risk assessments were not conducted.
Indoxacarb is classified as ``not likely'' to be a human
carcinogen, so the Agency did not conduct a cancer aggregate risk
assessment.
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
indoxacarb residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (HPLC/UV Method AMR 2712-93) 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 20460-0001; telephone number: (703) 305-5229; e-mail
address: furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex, Canadian, or Mexican maximum residue limits
established for indoxacarb residues in/on any crop commodities.
Therefore, no compatibility problems exist for this tolerance.

C. Conditions

A maximum of four applications may be made. A maximum of 0.11 pound
active ingredient (lb. a.i.) may be applied using ground, aerial, or
chemigation equipment. No more than 0.44 lb. a.i. may be applied per
acre per season.

VI. Conclusion

Therefore, the tolerance is established for combined residues of
indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate]
and its R-enantiomer [(R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate], in or on cranberry at 0.50
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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA 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)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. 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-2002-0256 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 November
18, 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 20460-0001. You may also deliver your 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

[[Page 58729]]

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 20460-0001.
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 20460-0001.
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.1. Mail your
copies, identified by the docket ID number OPP-2002-0256, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. 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 section
408 of the FFDCA. 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 section 408 of the FFDCA, 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 section 408(n)(4) of the
FFDCA. 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 (59 FR 22951, 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

[[Page 58730]]

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: September 11, 2002.
Peter Caulkins,
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 371.

2. Section 180.564 is amended by adding the following language and
table to paragraph (b) to read as follows:

Sec. 180.564 Indoxacarb; tolerances for residues.

(a) * * *
(b) Time-limited tolerances are established for the residues of
indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]
amino]carbonyl]indeno [1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate]
and its R-enantiomer [(R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate 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
------------------------------------------------------------------------
Cranberry 0.50 12/31/04
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-23745 Filed 9-17-02; 8:45 am]
BILLING CODE 6560-50-S