Bifenthrin; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: July 26, 2002 (Volume 67, Number 144)]
[Rules and Regulations]
[Page 48790-48796]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy02-14]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0145; FRL-7187-8]

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

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SUMMARY: This regulation establishes time-limited tolerances for
residues of bifenthrin in or on forage and hay of orchardgrass. 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 orchardgrass. This
regulation establishes a maximum

[[Page 48791]]

permissible level for residues of bifenthrin in these feed commodities.
The tolerance will expire and is revoked on June 30, 2004.

DATES: This regulation is effective July 26, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0145,
must be received on or before September 24, 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-2002-0145 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.
2. In person. The Agency has established an official record for
this action under docket control number OPP-2002-0145. 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
bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro- 3,3,3-
trifluoro-1-propenyl)-2,2-dimethylcyclopropane carboxylate, in or on
orchardgrass, forage and orchardgrass, hay at 0.05 part 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 tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act (FQPA). EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Bifenthrin on Orchardgrass and FFDCA
Tolerances

Oregon produces nearly all of the nation's orchardgrass seed, which
is primarily used as a high protein pasture grass. The key pest of
orchardgrass in Oregon is the orchardgrass billbug, which lays eggs
into the stem where they hatch and are unreachable by

[[Page 48792]]

topical insecticides. The effect of drought conditions in fields as
seen in 2001 serves to magnify damage and loss associated with this
pest. Chlorpyrifos once provided good efficacy against orchardgrass
billbug; however, efficacy has recently dropped below acceptable
levels. In addition, crop practices for long developing seed crops such
as orchardgrass, and lack of readily available market for potential
alternate seed and/or rotational vegetable crops preclude any cultural
practices which might mitigate this pest situation. Significant yield
losses, and subsequently economic losses, are expected without adequate
control. EPA has authorized under FIFRA section 18 the use of
bifenthrin on orchardgrass for control of orchardgrass billbug in
Oregon. After having reviewed the submission, EPA concurs that
emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of bifenthrin in or on
orchardgrass forage and hay. In doing so, EPA considered the safety
standard in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerances under FFDCA section 408(l)(6) would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is establishing 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 FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerances remaining in or on
orchardgrass 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 bifenthrin
meets EPA's registration requirements for use on orchardgrass 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 bifenthrin by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than Oregon to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
bifenthrin, 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
bifenthrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of bifenthrin in or on orchardgrass hay and forage at 0.05
ppm.
No orchardgrass residue data were submitted for this request. The
proposed use rate of bifenthrin for orchardgrass is approximately the
same as that registered for use on alfalfa grown for seed. Therefore,
the data from alfalfa was translated to orchardgrass 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 bifenthrin in/on orchardgrass are not expected to
increase dietary exposure. Since orchardgrass is not consumed by
humans, any exposure to residues of bifenthrin from this emergency
exemption use will result from the consumption of meat or milk. The use
of bifenthrin in orchardgrass is not expected to result in exceedances
of the tolerances that already exist for meat and milk. Therefore,
establishing the orchardgrass tolerances will not increase the most
recent estimated aggregate risks resulting from the use of bifenthrin,
as discussed in the Federal Register for September 27, 2001 (66 FR
49300) (FRL-6801-5) final rule establishing a tolerance for residues of
bifenthrin in/on sweet potatoes, because in that prior action, risk was
estimated assuming all meat and milk commodities contained tolerance
level residues. Refer to the September 27, 2001 Federal Register
document for a detailed discussion of the aggregate risk assessments
and determination of safety. EPA relies upon that risk assessment and
the findings made in the Federal Register document in support of this
action. Below is a brief summary of the aggregate risk assessment.
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. A summary of the toxicological dose and endpoints for
bifenthrin for use in human risk assessment is discussed in Unit IV.A.
of the final rule mentioned above, published in the Federal Register of
September 27, 2001 (66 FR 49300) (FRL-6801-5).
EPA assessed risk scenarios for bifenthrin under acute, chronic,
and short- and intermediate-term exposures.
The Dietary Exposure Evaluation Model (DEEM) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity.
The following assumptions were made for the acute exposure
assessments: A probabilistic Monte Carlo analysis (Tier 3) was used;
PCT (% crop treated) and anticipated residues were used for registered
uses, and 100% crop treated was assumed for all other uses.
Using these exposure assessments, the EPA concluded that exposure
to bifenthrin from food will utilize 60% of the acute population
adjusted dose (aPAD) for the U.S. population, 40% for females 13 years
and older, 75% for all infants 1 year old, and 99.7% of the aPAD for
children 1 to 6 years old. In addition, despite the potential for acute
dietary exposure to bifenthrin in drinking water, after calculating
drinking water levels of concern (DWLOCs) and comparing them to
conservative model estimated environmental concentrations (EECs) of

[[Page 48793]]

bifenthrin in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 1.

Table 1.--Aggregate Risk Assessment for Acute Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
US Population (48 states) 0.01 60 0.1 0.006 140
Female 13+ years old 0.01 40 0.1 0.006 180
Children (1-6 years old) 0.01 99.7 0.1 0.006 0.30
----------------------------------------------------------------------------------------------------------------

The following assumptions were made for the chronic exposure
assessments: The Agency used anticipated residue values which were
determined from field trial data collected from studies conducted with
maximum label rates and minimum preharvest intervals. Mean anticipated
residue values were calculated. 100% crop treated was assumed for all
crops except hops (43%) and cottonseed oil and meal (4%).
Using these exposure assessments, the EPA concluded that exposure
to bifenthrin from food will utilize 3% of the chronic population
adjusted dose (cPAD) for the US population, 3% for females 13 years and
older, and 8.2% of the cPAD for children 1 to 6 years old. Based on the
use pattern, chronic residential exposure to residues of bifenthrin is
not expected. In addition, despite the potential for chronic dietary
exposure to bifenthrin in drinking water, after calculating DWLOCs and
comparing them to conservative model EECs of bifenthrin in surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 2.

Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 states) 0.015 3 0.032 0.006 530
Females 13+ years old 0.015 3 0.032 0.006 450
Children (1-6 years old) 0.015 8.2 0.032 0.006 140
----------------------------------------------------------------------------------------------------------------

Bifenthrin has been classified as a Group C chemical (possible
human carcinogen) based upon urinary bladder tumors in mice. No Q* was
assigned because the Reference dose (RfD) approach was recommended for
cancer risk assessment. Based on this recommendation, a quantitative
dietary cancer risk assessment was not performed since dietary risk
concerns due to long-term consumption of bifenthrin are adequately
addressed by the chronic exposure analysis using the RfD.
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). Bifenthrin is currently
registered for use(s) that could result in short-term residential
exposure and the Agency has determined that it is appropriate to
aggregate chronic food and water and short-term exposures for
bifenthrin. EPA has concluded that food and residential exposures
aggregated result in aggregate margin of exposure (MOEs) of 940 for
adults, 350 for children (1-6 years old), and 470 for infants 1 year
old. These aggregate MOEs do not exceed the Agency's level of concern
for aggregate exposure to food and residential uses. In addition,
short-term DWLOCs were calculated and compared to the EECs for chronic
exposure of bifenthrin in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
3:

Table 3.--Aggregate Risk Assessment for Short and Intermediate-Term Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adult 940 100 0.032 0.006 320
Children (1-6 years old) 350 100 0.032 0.006 270
Infants 1 year old 470 100 0.032 0.006 71
----------------------------------------------------------------------------------------------------------------

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
bifenthrin 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

[[Page 48794]]

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
bifenthrin on grass forage and hay. Therefore, no compatibility
problems exist for the proposed tolerances.

C. Conditions

One application may be made. A maximum of 0.10 pound of active
ingredient may be applied per acre using ground equipment. Bifenthrin
is not to be applied within 30 days of grazing, feeding, or harvesting
(cutting) forage or hay.

VI. Conclusion

Therefore, the tolerances are established for residues of
bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3-
trifluoro-1-propenyl)-2,2-dimethylcyclopropane carboxylate, in or on
orchardgrass forage, and orchardgrass hay at 0.05 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-2002-0145 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 September
24, 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 (1900),
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. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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 (202) 260-4865.
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-2002-0145, to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VIII. Regulatory Assessment Requirements

This final rule establishes a time limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections

[[Page 48795]]

subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review
or any Agency action under Executive Order 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a FIFRA section 18
exemption under FFDCA section 408, such as the tolerance in this final
rule, do not require the issuance of a proposed rule, the requirements
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not
apply. In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

IX. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: July 12, 2002.
Ricard P. Keigwin, Jr.,
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 180.442 is amended by alphabetically adding commodities
to the table in paragraph (b) to read as follows:

Sec. 180.442 Bifenthrin; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Orchardgrass, forage 0.05 6/30/04
Orchardgrass, hay 0.05 6/30/04
* * * * *
------------------------------------------------------------------------

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* * * * *
[FR Doc. 02-18867 Filed 7-25-02; 8:45 am]
BILLING CODE 6560-50-S

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Bifenthrin; Pesticide Tolerances for Emergency Exemptions

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