[Federal Register Volume 70, Number 18 (Friday, January 28, 2005)]
[Rules and Regulations]
[Pages 4032-4037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1624]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0012; FRL-7696-2]


Bifenazate; 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 the 
combined residues of bifenazate in or on timothy hay and timothy 
forage. 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 timothy. 
This regulation establishes a maximum permissible level for residues of 
bifenazate in these feed commodities. These tolerances will expire and 
are revoked on December 31, 2007.

DATES: This regulation is effective January 28, 2005. Objections and 
requests for hearings must be received on or before March 29, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0012. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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 entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also

[[Page 4033]]

be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. To 
determine whether you or your business may be affected by this action, 
you should carefully examine the applicability provisions in the 
section above. If you have any questions regarding the applicability of 
this action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

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 the combined residues of 
the insecticide bifenazate, (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-
3-yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl, 1-methylethyl ester, in or on timothy, hay at 150 
parts per million (ppm) and timothy, forage at 50 ppm. These tolerances 
will expire and are revoked on December 31, 2007. 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 tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.
    EPA has received objections to a tolerance it established for 
bifenazate 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 this emergency 
exemption tolerance for bifenazate 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 this tolerance at this time. First, the 
objections proceeding is unlikely to conclude prior to when action is 
necessary on this petition. NRDC's objections raise complex legal, 
scientific, policy, and factual matters. EPA has published a notice 
describing the nature of the NRDC's objections in more detail. This 
notice offered an opportunity for the public to comment on this matter 
and published in the Federal Register of June 19, 2002 (67 FR 41628) 
(FRL-7167-7). EPA is now examining the extensive comments received. 
Second, the nature of the current action is extremely time-sensitive 
and 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 the tolerance for bifenazate.

III. Emergency Exemption for Bifenazate on Timothy and FFDCA Tolerances

    The banks grass mite became a pest of economic significance for 
timothy growers beginning in 2002 when it was recognized that the pest 
had developed resistance to the registered alternatives. Based on 
information submitted by the State, without the use of bifenazate to 
control banks grass mites, many timothy growers will experience 
significant economic losses. Dietary risk will be minimal because the 
bulk of the treated hay will be used as horse feed. EPA has authorized 
under FIFRA section 18 the use of bifenazate on timothy, hay and 
timothy, forage for control of banks grass mites in Nevada. 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 bifenazate in or on 
timothy. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance 
under section 408(l)(6) of the FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although these tolerances will expire and are revoked on December 31, 
2007, under section 408(l)(5) of the FFDCA, residues of the pesticide 
not in excess of the amounts specified in the tolerance remaining in or 
on timothy, hay and timothy, forage after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the

[[Page 4034]]

residues do not exceed a 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 bifenazate 
meets EPA's registration requirements for use on timothy or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of bifenazate 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 Nevada to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing FIFRA section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
bifenazate, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
bifenazate and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for time-limited 
tolerances for the combined residues of bifenazate, (1-methylethyl 2-
(4-methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) and 
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl, 1-
methylethyl ester, in or on timothy, hay at 150 ppm and timothy, forage 
at 50 ppm.
    Timothy is a member of the grass, forage, fodder, and hay crop 
group. No timothy residue data were submitted for this specific 
emergency exemption request. The proposed use rate of bifenazate for 
timothy is similar to rates for registered uses. Based on data 
contained in the Food and Feed Crops of the United States (second 
edition; forage grass monograph), approximately 3,700 pounds of hay may 
be produced per acre. Based on the application rate of 0.50 lbs per 
acre and the expected hay production, a theoretical bifenazate residue 
of 135 ppm was calculated. Assuming 25% dry matter content for forage 
and a 80% dry matter content for hay, a theoretical residue of 42 ppm 
was calculated for timothy, forage. To ensure that the tolerance levels 
are adequate, the Agency is establishing levels slightly higher than 
estimated (150 ppm for timothy, hay and 50 ppm for timothy, forage).
    Under the emergency exemption, timothy is being grown as a premium 
feed for race horses. However, it is possible that a fraction of the 
treated crop may be diverted to cattle (timothy is not a poultry feed 
crop). Timothy is not consumed by humans, any inadvertent exposure to 
residues of bifenazate from this emergency exemption will result from 
the consumption of meat or milk. Currently there are bifenazate 
tolerances established for residues of bifenazate in or on ruminant 
meat, meat byproducts, milk and fat. These tolerances are based on 
conservative assumptions that the entire livestock diet contains 
tolerance level residues of bifenazate. Therefore, the Agency has 
concluded that the established ruminant tolerances are sufficient to 
cover any dietary exposure to bifenazate resulting from the requested 
timothy use.
    Residues of bifenazate in or on timothy are not expected to 
increase dietary exposure. The use of bifenazate on timothy is not 
expected to result in exceedances of the tolerances that already exist 
for meat and milk. Therefore, establishing the timothy tolerances will 
not increase the most recent estimated aggregate risks resulting from 
use of bifenazate, as discussed in the February 4, 2004 Federal 
Register (69 FR 5289, FRL-7335-6) Final Rule establishing tolerances 
for combined residues of bifenazate, (hydrazine carboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl-, 1-methylethyl ester) and 
diazenecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl-, 1-
methylethyl ester in or on potatoes, because in that prior action, risk 
was estimated assuming all meat and milk products contained tolerance 
level residues. Refer to the February 4, 2004 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.
    An endpoint for acute dietary exposure was not identified since no 
effects were observed that could be attributable to a single dose in 
oral toxicity studies, including developmental and maternal toxicity in 
the developmental toxicity studies. Therefore, an acute dietary risk 
assessment was not conducted.
    Using the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID\TM\) an analysis evaluated the 
individual food consumption as reported by respondents in the United 
States Department of Agriculture 1994-1996 and 1998 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to bifenazate for each commodity. The chronic 
dietary exposure analysis assumed tolerance level residues and 100% 
crop treated for all registered and proposed crops excluding tomato 
where average field trial residues were used. DEEM\TM\ (ver 7.73) 
default processing factors were assumed for all commodities excluding 
apple juice, grape juice, wine/sherry, tomato paste, and tomato puree. 
The processing factors for these commodities were reduced to 0.23, 
0.17, 0.17, 5.0, and 5.0, respectively, based on data from processing 
studies.
    Using the exposure assumptions described, EPA concluded that 
exposure to bifenazate from food will utilize 25% of the cPAD for the 
U.S. population, 60% of the cPAD for all infants <1 year old, 86% of 
the cPAD for children 1-2 years old (the most highly exposed population 
subgroup), and 17% of the cPAD for females 13-49 years old. Based on 
the use pattern, chronic residential exposure to residues of bifenazate 
is not expected. However, there is potential for chronic dietary 
exposure to bifenazate in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface water and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in Table 1:

[[Page 4035]]



              Table 1.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Bifenazate
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                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.01           25          6.4       <0.001          260
--------------------------------------------------------------
All Infants (<1 year old)                               0.01           60          6.4       <0.001           75
--------------------------------------------------------------
Children (1-2 years old)                                0.01           86          6.4       <0.001           14
--------------------------------------------------------------
Females (13-49 years old)                               0.01           17          6.4       <0.001          290
----------------------------------------------------------------------------------------------------------------

    Short-term and intermediate-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Bifenazate is currently registered for use on the following 
residential non-dietary sites: Commercial application to ornamental 
plants (including bedding plants, flowering plants, foliage plants, 
bulb crops, perennials, trees and shrubs; not turf) and all fruit trees 
which will not bear fruit for a minimum of 12 months as well as 
application by residents/homeowners. EPA anticipates only short-term 
dermal and short-term inhalation exposure from the residential uses. 
The Agency assumed that residential applications will be made via pump 
up sprayers, garden hose-end sprayers or similar ``homeowner'' 
pesticide devices. Exposure from a hose-end sprayer was assessed rather 
than that of a compressed air sprayer. For the treatment of shrubs and 
ornamentals, EPA assumed 100 gallons of finish spray are applied per 
day. The unit exposure value for a residential handler using open pour 
mixing/loading for a garden hose-end sprayer is 11 milligrams/pound 
(mg/lb) handled (dermal) and 0.013 mg/lb handled. Exposures were 
calculated using the Agency's draft Residential Standard Operating 
Procedures.
    Using the exposure assumptions described for short-term exposures, 
EPA concluded that food and residential exposures aggregated result in 
aggregate MOEs of 2,000 for the U.S. population, 2,100 for youth 13-19 
years old, 2,400 for adults 20-49 years old, 2,200 for females 13-49 
years old, and 2,300 for adults 50+ years 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 bifenazate in ground 
water and surface water. After calculating DWLOCs and comparing them to 
the EECs for surface water and ground water, EPA does not expect short-
term aggregate exposure to exceed the Agency's level of concern, as 
shown in Table 2:

                    Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Bifenazate
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                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
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U.S. population                                        2,000          100          6.4       <0.001        3,500
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Youth, (13-19 years old)                               2,100          100          6.4       <0.001        3,000
--------------------------------------------------------------
Adults, (20-49 years old)                              2,400          100          6.4       <0.001        3,500
--------------------------------------------------------------
Females, (13-49 year old)                              2,200          100          6.4       <0.001        3,000
--------------------------------------------------------------
Adults (50+ years old)                                 2,300          100          6.4       <0.001        3,500
----------------------------------------------------------------------------------------------------------------

    Intermediate-term aggregate exposure takes into account non-
dietary, non-occupational exposure plus chronic exposure to food and 
water (considered to be a background exposure level). Residential 
intermediate-term aggregate exposure (30 days to 6 months) is not 
expected from use of this chemical. Thus, the intermediate-term risk 
for the public consists of food and water exposures which were 
previously addressed.
    EPA has classified bifenazate as ``not likely'' to be a human 
carcinogen. Therefore, a cancer dietary exposure and risk assessment 
was not performed.
    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 
bifenazate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    Canada, Codex, and Mexico do not have maximum residue limits for 
residues of bifenazate in/on the proposed crop. Therefore, 
harmonization is not an issue.

VI. Conclusion

    Therefore, tolerances are established for the combined residues of 
bifenazate, (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]3-yl, 1-methylethyl ester, in or on timothy, hay at 150 
ppm and timothy, forage at 50 ppm.

[[Page 4036]]

VII. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0012 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 March 29, 
2005.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. 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) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by the docket ID number OPP-2005-0012, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. 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. Statutory and Executive Order Reviews

    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 FIFRA 
section 18 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

[[Page 4037]]

alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of the FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

IX. Congressional Review Act

    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: January 14, 2005.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.572 is amended by alphabetically adding commodities to 
the table in paragraph (b) to read as follows:


Sec.  180.572  Bifenazate; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
                                * * * * *
Timothy, forage...............................           50     12/31/07
Timothy, hay..................................          150     12/31/07
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-1624 Filed 1-27-05; 8:45 am]
BILLING CODE 6560-50-S