Diflubenzuron. Sept 20, 2002. Pesticide tolerances for Emergency Exemption. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Diflubenzuron. September 20, 2002. Pesticide Tolerances for Emergency Exemption. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-20/p23819.htm

[Federal Register: September 20, 2002 (Volume 67, Number 183)]
[Rules and Regulations]
[Page 59177-59182]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se02-12]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0253; FRL-7273-7]

Diflubenzuron; Pesticide Tolerances for Emergency Exemption

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

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SUMMARY: This regulation establishes time-limited tolerances for
residues of diflubenzuron in or on forage and hay of alfalfa. 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 alfalfa. This regulation
establishes a maximum permissible level for residues of diflubenzuron
in these feed commodities. The tolerances will expire and are revoked
on June 30, 2004.

DATES: This regulation is effective September 20, 2002. Objections and
requests for hearings, identified by docket control number OPP-2002-
0253, must be received on or before November 19, 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 control number OPP-2002-0253 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, a beta site currently
under development. To access the OPPTS Harmonized Guidelines referenced
in this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-2002-0253. The official
record consists of the documents specifically referenced in this
action, and other information related to this action, including any
information claimed as Confidential Business Information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall # 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 tolerances for residues of the insecticide
diflubenzuron, [N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide], in or on alfalfa, forage and alfalfa, hay at 6.0
parts per million (ppm). These tolerances will expire and are revoked
on June 30, 2004. EPA will publish a document in the Federal Register
to remove the revoked tolerances 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

[[Page 59178]]

tolerances can be established without providing notice or period for
public comment. EPA does not intend for its actions on section 18
related tolerances to set binding precedents for the application of
section 408 and the new safety standard to other tolerances and
exemptions. Section 408(e) of the FFDCA allows EPA to establish a
tolerance or an exemption from the requirement of a tolerance on its
own initiative, i.e., without having received any petition from an
outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of 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.
Recently, EPA has received objections to a tolerance it established
for diflubenzuron on a different food commodity. The objections were
filed by the Natural Resources Defense Council (NRDC) and raised
several issues regarding aggregate exposure estimates and the
additional safety factor for the protection of infants and children.
Although these objections concern separate rulemaking proceedings under
the FFDCA, EPA has considered whether it is appropriate to establish
the emergency exemption tolerances for diflubenzuron while the
objections are still pending.
Factors taken into account by EPA included how close the Agency is
to concluding the proceedings on the objections, the nature of the
current action, whether NRDC's objections raised frivolous issues, and
extent to which the issues raised by NRDC had already been considered
by EPA. Although NRDC's objections are not frivolous, the other factors
all support establishing these tolerances at this time. First, the
objections proceeding is not near to conclusion. NRDC's objections
raise complex legal, scientific, policy, and factual matters and on
August 16, 2002, EPA extended (for an additional 30 days) the public
comment period on these objections, first initiated for 60 days in the
Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-7) and on
August 16, 2002 (67 FR 53505) (FRL-7193-6). Second, the nature of the
current action is extremely time sensitive as it addresses an emergency
situation. Third, the issues raised by NRDC are not new matters but
questions that have been the subject of considerable study by EPA and
comment by stakeholders. Accordingly, EPA is proceeding with
establishing these tolerances for diflubenzuron.

III. Emergency Exemption for Diflubenzuron on Alfalfa and FFDCA
Tolerances

The Applicant (Utah Department of Agriculture and Food) states that
outbreaks of the Mormon cricket and various grasshopper species have
increased in Utah's alfalfa fields this season, due in large part to
the drought being experienced. Because of the drought conditions, there
is no feed on public lands for the insects, and the insects are moving
faster to the private farmland in Utah. Historically, grasshoppers and
crickets have posed a threat to all crops, even plaguing pioneers 150
years ago. The Mormon cricket can be economically devastating, and
destroys sagebrush, alfalfa, small grains, seed, grasses, and vegetable
crops. Grasshoppers have also been increasing in localized areas during
the past four years, and in 2001, the Applicant states that crop
production was hit hard from the heavily infested spots from both the
grasshoppers and the Mormon cricket. Many fields left untreated in 2001
experienced a 100% reduction in yield, and the Applicant states that
the infestation levels for 2002 are even greater than estimated. While
there are several chemical controls registered for use in Utah for
crickets and grasshoppers, regulations prohibiting more than one
application combined with prohibitive costs make multiple applications
an ineffective solution. The Applicant states that diflubenzuron is the
only pesticide that has been proven effective for full-season control
of grasshopper and cricket outbreaks. Diflubenzuron has a longer period
of residual activity than the registered alternatives, which allows for
control of delayed hatching nymphs, later hatching grasshopper species,
and secondary infestations, which precludes the need for additional
applications. The Applicant asserts that the registered alternative
have very short residual activity and/or are prohibitively expensive
for use in this situation. Significant economic losses were expected to
occur this year for alfalfa producers, without the use of diflubenzuron
to control these pests. EPA has authorized under section 18 of FIFRA
the use of diflubenzuron on alfalfa for control of the Mormon cricket
and various grasshopper species in Utah. 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 diflubenzuron in or on
alfalfa forage and hay. In doing so, EPA considered the safety standard
in section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerances under section 408(l)(6) of the FFDCA would be consistent
with the safety standard and with section 18 of FIFRA. 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 these tolerances without notice
and opportunity for public comment as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on June 30, 2004,
under section 408(l)(5)of the FFDCA, residues of the pesticide not in
excess of the amounts specified in the tolerances remaining in or on
alfalfa forage and hay 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 these
tolerances at the time of that application. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether diflubenzuron
meets EPA's registration requirements for use on alfalfa or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of diflubenzuron

[[Page 59179]]

by a State for special local needs under section 24(c) of FIFRA. Nor do
these tolerances serve as the basis for any State other than Utah 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 diflubenzuron, 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
diflubenzuron and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of diflubenzuron in or on alfalfa hay and forage at 6.0 ppm.
No alfalfa residue data were submitted for this request. The
proposed use rate of diflubenzuron for alfalfa is the same as that
registered for use on grass. Therefore, the data from grass was
translated to alfalfa for this section 18 use. The established
tolerances for meat and milk commodities are adequate to cover any
residues which may result from this section 18 use. Based upon previous
feeding studies, the secondary residues in meat and milk will not
exceed the established tolerances as a result of this section 18 use.
Residues of diflubenzuron in/on alfalfa are not expected to
increase dietary exposure. Since alfalfa is not consumed by humans, any
exposure to residues of diflubenzuron from this emergency exemption use
will result from the consumption of meat or milk. The use of
diflubenzuron in alfalfa is not expected to result in exceedances of
the tolerances that already exist for meat and milk. Therefore,
establishing the alfalfa tolerances will not increase the most recent
estimated aggregate risks resulting from the use of diflubenzuron, as
discussed in the Federal Register for February 15, 2002 (67 FR 7085)
(FRL-6821-7) final rule establishing a tolerance for residues of
diflubenzuron in/on pears, because in that prior action, risk was
estimated assuming all meat and milk commodities contained tolerance
level residues. Refer to the February 15, 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.
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
diflubenzuron for use in human risk assessment is discussed in final
rule mentioned above, published in the Federal Register of February 15,
2002.
EPA assessed risk scenarios for diflubenzuron under chronic
exposures only. Acute toxicological endpoints have not been identified
for diflubenzuron, and there are no registered or proposed uses which
would result in short- and intermediate-term exposure; thus these
exposure analyses were not necessary. Although diflubenzuron itself is
not classified as a carcinogen, two of its metabolites, PCA (p-
chloroaniline) and CPU (p-chlorophenylurea) are probable human
carcinogens and have been assigned Q1*s. Since these degradates are
found in mushrooms, milk, and liver, as a result of diflubenzuron use,
EPA has concluded that the residues of concern are diflubenzuron and
its metabolites PCA and CPU.
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 chronic exposure
assessments: Anticipated residue information based on field trial data,
and percent of crop treated (%CT) information for some commodities were
used (Tier 3). A value of 1% was used for %CT values <1%.
Using these exposure assessments, the EPA concluded that exposure
to diflubenzuron from food will utilize <1% of the chronic population
adjusted dose (cPAD) for the US Population, 5% for Infants (<1 yr old),
and <1% for Children (1 to 6 years old). In addition, despite the
potential for dietary exposure to diflubenzuron in drinking water,
after calculating drinking water levels of concern (DWLOCs) and
comparing them to conservative model estimated environmental
concentrations (EECs) of diflubenzuron in surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in the following Table 1.

Table 1.--Aggregate Risk Assessment for Acute Exposure to Diflubenzuron
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/ % cPAD Water EEC Water EEC Chronic
kg) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.02 <1 0.09 0.0023 700
All Infants (<1 yr) 0.02 5 0.09 0.0023 190
Children (1-6 yr) 0.02 <1 0.09 0.0023 200
----------------------------------------------------------------------------------------------------------------

Cancer aggregate risk assessments were not performed for
diflubenzuron and PCA, since diflubenzuron is not a carcinogen and PCA
is not a significant degradate in drinking water. The potential cancer
risk from dietary (food only), exposure to residues of PCA is 4.7 x
10-\7\, which is negligible. The results of the cancer
analysis for CPU indicate that the estimated cancer dietary (food only)
risk from CPU 3.8 x 10-\8\ associated with the proposed use
of diflubenzuron is below the Agency's level of concern. In addition,
there is potential for chronic dietary exposure to CPU in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA

[[Page 59180]]

does not expect the aggregate cancer risk to exceed EPA's level of
concern, as shown in the following Table 2:

Table 2.--Aggregate Cancer Risk Assessment for Exposure to Diflubenzuron
----------------------------------------------------------------------------------------------------------------
Aggregate
Residential Cancer Risk Surface Ground Cancer
Population Subgroup Exposure (food and Water EEC Water EEC DWLOC (ppb)
residential) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0 3.8 x 10-\8\ 0.23 0.065 2.2
----------------------------------------------------------------------------------------------------------------

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
diflubenzuron residues.

V. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

There are no Codex maximum residue limits (MRLs) established for
diflubenzuron on alfalfa forage and hay. Therefore, no compatibility
problems exist for the proposed tolerances.

C. Conditions

One application may be made using ground or aerial equipment, at a
rate of 2 fl. oz. of product (0.0325 lb. active ingredient) per acre. A
14-day pre-harvest interval and a 12-hour re-entry interval must be
observed.

VI. Conclusion

Therefore, the tolerances are established for residues of
diflubenzuron, [N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide], in or on alfalfa forage, and alfalfa hay at 6.0
ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old 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 control number OPP-2002-0253 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
19, 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 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 control number OPP-2002-0253, 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

[[Page 59181]]

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 time limited tolerances 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
section 18 FIFRA exemption under section 408 of the FFDCA, such as the
tolerances 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
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 374.

2. Section 180.377 is amended by adding the following language and
table under paragraph (b) to read as follows:

Sec. 180.377 Diflubenzuron; tolerances for residues.

* * * * *
(b)Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of diflubenzuron and its metabolites PCA
(p-chloroaniline) and CPU (p-chlorophenylurea), expressed as the parent
diflubenzuron, in connection with use of the pesticide under section 18
emergency exemptions granted by

[[Page 59182]]

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
------------------------------------------------------------------------
Alfalfa, forage................... 6.0 6/30/2004
Alfalfa, hay...................... 6.0 6/30/2004
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-23819 Filed 9-19-02; 8:45 am]
BILLING CODE 6560-50-S