[Federal Register: November 29, 2002 (Volume 67, Number 230)]
[Rules and Regulations]
[Page 71105-71110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no02-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0314; FRL-7281-2]
Pyriproxyfen; 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 pyriproxyfen in or on strawberry. 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 strawberry. This regulation
establishes a maximum permissible level for residues of pyriproxyfen in
or on this food commodity. The tolerance will expire and is revoked on
December 31, 2004.
DATES: This regulation is effective November 29, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0314,
must be received on or before January 28, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
[[Page 71106]]
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 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 identification (ID) number OPP-2002-0314. 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 residues of the
insecticide pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)
ethoxypyridine], in or on strawberry at 0.30 part 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 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 FFDCA 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) of 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 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 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) of 1996. EPA has
established regulations governing such emergency exemptions in 40 CFR
part 166.
III. Emergency Exemption for Pyriproxyfen on Strawberry and FFDCA
Tolerances
The California Department of Pesticide Regulation has indicated
that populations of the silverleaf whitefly in the State are at levels
which could result in significant damage to the State's strawberry
crop. This pest is relatively newly-introduced into the U.S., and the
registered alternatives have not provided adequate control thus far.
Without adequate control, this pest was expected to result in
significant crop damage and yield losses for strawberry growers,
leading to significant economic losses. EPA has authorized under FIFRA
section 18 the use of pyriproxyfen on strawberry for control of the
silverleaf whitefly in California. 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 pyriproxyfen in or on
strawberry. In doing so, EPA considered the safety standard in section
408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under
section 408(l)(6) of 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
[[Page 71107]]
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 FFDCA. Although this tolerance will expire and is
revoked on December 31, 2004, under section 408(l)(5) of FFDCA,
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on strawberry 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 pyriproxyfen
meets EPA's registration requirements for use on strawberry 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 pyriproxyfen 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 California 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 pyriproxyfen, 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 November 26, 1997 (62 FR 62961) (FRL-
5754-7).
Consistent with section 408(b)(2)(D) of 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
pyriproxyfen and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of FFDCA, for a time-limited
tolerance for residues of pyriproxyfen in or on strawberry at 0.30 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
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 pyriproxyfen, a
summary of the toxicological dose and endpoints for pyriproxyfen 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 August 28, 2002 (67 FR 55150) (FRL-7195-7) Final
Rule establishing tolerances for residues of pyriproxyfen in/on
acerola, bushberry subgroup, feijoa, guava, jaboticaba, juneberry,
lingonberry, longan, lychee, passionfruit, pulasan, rambutan, salal,
Spanish lime, starfruit, stone fruit group, and wax jambu.
Refer to the August 28, 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
strawberry.
B. Exposure Assessment
EPA assessed risk scenarios for pyriproxyfen under chronic and
intermediate and short-term (residential) scenarios. Because there were
no acute endpoints identified, an acute risk assessment was not
conducted. Nor was a cancer aggregate risk assessment conducted,
because pyriproxyfen is classified as ``not likely'' to be a human
carcinogen.
The Dietary Exposure Evaluation Model (DEEMTM) analysis
evaluated the individual food consumption as reported by respondents in
the Department of Agricultural (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 chronic exposure
assessments: Published and proposed tolerance level residues and 100%
crop treated were assumed for all commodities, and the default
processing factors were applied.
Using these exposure assumptions, EPA concluded that pyriproxyfen
chronic exposures from food consumption are below levels of concern (<
100% of the chronic Population Adjusted Dose (cPAD)) for the general
U.S. population and all population subgroups. The cPAD utilized for the
most highly exposed subgroup (children 1-6 years old) is 2.7%. Chronic
risk from dietary exposure for infants (< 1 year old) and children (7-
12 years old) utilizes 2.0% and 1.6% of the cPAD, respectively. Chronic
dietary risk for the general U.S. population is 1.0% 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 pyriproxyfen in drinking water, after calculating drinking
water levels of concern (DWLOCs) and comparing them to conservative
model EECs of pyriproxyfen in surface and ground waters, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
the following table:
Table 1.--Aggregate Risk Assessment for Chronic Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/ %cPAD Water EEC Water EEC Chronic
kg) (Food) (ppb) (ppb) DWLOC (ppb)
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General U.S. population 0.35 1.0 0.4 0.006 12,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.35 2.7 0.4 0.006 3,100
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Children (7-12 years old) 0.35 1.6 0.4 0.006 3,200
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[[Page 71108]]
Infants (< 1 year old) 0.35 2.0 0.4 0.006 3,200
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Short-term and intermediate-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). The term ``residential
exposure'' is used in this document to refer to non-occupational, non-
dietary exposure (e.g., for lawn and garden pest control, indoor pest
control, termiticides, flea and tick control on pets).
Pyriproxyfen is currently registered for various residential non-
dietary sites, and is used for flea and tick control (home environment
and pet treatments) as well as products for ant and roach control. Pet
owners could potentially be exposed to pyriproxyfen during applications
to pets; however, since no short-term dermal or inhalation endpoints
were identified, only a post-application residential assessment was
conducted. Both adults and toddlers could potentially be exposed to
pyriproxyfen residues on treated carpets, floors, upholstery, and pets,
but it is anticipated that toddlers will have higher exposures than
adults due to behavior patterns. Therefore, the residential risk
assessment addressed post-application exposures of toddlers, which is
considered to be a worst-case scenario. Short-term, intermediate-term,
and long-term toddler hand-to-mouth exposures (consisting of petting
treated animals and touching treated carpets/flooring) were assessed;
long-term dermal exposures were also assessed for products with
anticipated efficacy of more than 6 months (carpet powders and pet
collars). Toddler exposures to combined treatment scenarios, where a
pet owner treats the home environment and the pet in the same period
were also assessed.
The Agency has determined that it is appropriate to aggregate
chronic food and water and short-term and intermediate-term exposures
for pyriproxyfen. Using the exposure assumptions described above for
short-term and intermediate-term exposures, EPA has concluded that food
and residential exposures aggregated result in aggregate MOEs as shown
in the following table:
Table 2.--Aggregate Risk Assessment for Short-Term and Intermediate-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Intermediate-
Short-Term Term Surface, Short-Term Intermidate-
Population Subgroup Target MOE Aggregate Aggregate MOE Ground DWLOCs Term DWLOCs
MOE (Food + (Food + Water EECs (ppb) (ppb)
Residential) Residential) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 100 29,000 10,000 0.4, 0.006 35,000 12,000
----------------------------------------------------------------------------------------------------------------
Infants (< 1 year old) 100 1,800 650 0.4, 0.006 9,400 3,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 100 1,700 620 0.4, 0.006 9,400 2,900
----------------------------------------------------------------------------------------------------
Children (7-12 years) 100 1,900 670 0.4, 0.006 9,500 3,000
----------------------------------------------------------------------------------------------------------------
These aggregate MOEs do not exceed the Agency's level of concern
for aggregate exposure to food and residential uses. For surface and
ground water, the EECs for pyriproxyfen are significantly less than the
DWLOCs as a contribution to intermediate-term and short-term aggregate
exposure. Therefore, EPA concludes with reasonable certainty that
residues of pyriproxyfen in drinking water do not contribute
significantly to the intermediate-term or short-term aggregate human
health risk at the present time.
Pyriproxyfen is classified as not likely to be a human carcinogen,
so the Agency did not conduct a cancer aggregate risk assessment.
Based upon 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
pyriproxyfen residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas liquid chromatography with
nitrogen-phosphorus (GLC/NP) detector) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits for
residues of pyriproxyfen in/on strawberry, so international
harmonization is not an issue.
C. Conditions
A maximum of two applications may be made, at a maximum rate of 30
grams active ingredient (a.i.), using ground application equipment
only. No more than 60 grams a.i. may be applied per acre per season.
VI. Conclusion
Therefore, the tolerance is established for residues of
pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy) ethoxypyridine], in or
on strawberry at 0.30 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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.
[[Page 71109]]
Although the procedures in those regulations require some modification
to reflect the amendments made to FFDCA by FQPA, EPA will continue to
use those procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) of 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-2002-0314 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 January
28, 2003.
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 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-2002-0314, 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
[[Page 71110]]
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 (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: November 8, 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 371.
2. Section 180.510 is amended by alphabetically adding
``strawberry'' to the table in paragraph (b) to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
* * * * *
(b) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
Strawberry................................................ 0.30 12/31/04
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 02-30260 Filed 11-27-02; 8:45 am]
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