[Federal Register Volume 67, Number 144 (Friday, July 26, 2002)]
[Rules and Regulations]
[Pages 48790-48796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18867]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0145; FRL-7187-8]


Bifenthrin; Pesticide Tolerances for Emergency Exemptions

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: 
[email protected].

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_0 0.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
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                                                                             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
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    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: [email protected].

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 [email protected], 
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: [email protected]. 
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
*      *      *      *      *
------------------------------------------------------------------------


[[Page 48796]]

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