[Federal Register Volume 68, Number 83 (Wednesday, April 30, 2003)]
[Rules and Regulations]
[Pages 23056-23068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10400]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0358; FRL-7304-4]


Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
bifenthrin in or on almond, hulls; banana; fruit, citrus, group; herb 
subgroup; pear; nut, tree, group; spinach; tomato; and food/feed 
products in food/feed handling establishments. FMC Corporation and the 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) , as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective April 30, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0358, 
must be received on or before June 30, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer; food/feed or beverage manufacturer, wholesale or retailer; 
restaurant owner/worker; or pesticide manufacturer. Potentially 
affected entities may include, but are not limited to:
    [sbull] Crop producers (NAICS 111), e.g., tree fruit and nut 
growers, tomato growers and herb producers
    [sbull] Animal producers (NAICS 112), including cattle, sheep, 
swine, dairy, and poultry producers
    [sbull] Food and beverage manufacturers (NAICS 311), including 
canners, bottlers, brewers, bakers and other food and beverage 
processors
    [sbull] Food and beverage stores (NAICS 445)
    [sbull] Restaurants (NAICS 722)
    [sbull] Pesticide manufacturers (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0358. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180--00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of February 15, 2002 (67 FR 7159-7163) 
(FRL-6823-3); February 14, 2001 (66 FR 10289-10292) (FRL-6768-7); and 
April 25, 2001 (66 FR 20811-20815) (FRL-6778-4), EPA issued notices 
pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA 
(Public Law 104-170), announcing the filing of pesticide petitions (PP 
2F6390, 6F3454, 0E6216 and 1F6266) by FMC Corporation; (PP 6E4630, 
0E6157, 1E6330 and 2E6402) by the Interregional Research Project Number 
4 (IR-4); and (PP 1E6234) by the Taipei Economic and Cultural 
Representative Office. These notices included summaries of the 
petitions prepared by FMC Corporation, the registrant. There were no 
comments received in response to the notices of filing.
    These petitions requested that 40 CFR 180.442 be amended by 
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, as follows:
    1. PP 2F6390 proposed establishment of a tolerance for food 
products in food handling establishments at 0.01 ppm.
    2. PP 6F3454 proposed establishment of a tolerance for pears at 1.0 
ppm; almond hulls at 2 ppm; and tree nuts crop group at 0.05 ppm.
    3. PP 0E6216 proposed establishment of a tolerance for imported 
bananas at 0.1 ppm.
    4. PP 1F6266 proposed establishment of a tolerance for citrus whole 
fruits, citrus dried pulp, citrus cold pressed oil and citrus juice at 
0.05 ppm.
    5. PP 6E4630 proposed establishment of a tolerance for leaf 
petioles subgroup (4B) at 2.0 ppm.
    6. PP 0E6157 proposed establishment of a tolerance for herb 
subgroup (19A) at 0.05 ppm.
    7. PP 1E6330 proposed establishment of a tolerance for tomato at 
0.15 ppm.

[[Page 23057]]

    8. PP 2E6402 proposed establishment of a tolerance for spinach at 
0.2 ppm.
    9. PP 1E6234 proposed establishment of a tolerance for carambola 
(starfruit) at 1.0 ppm.
    The residue chemistry data submitted in support of PP 6E4630 (leaf 
petioles subgroup) and PP 1E6234 (carambola) were determined by EPA to 
be insufficient to support the proposed tolerances. PP 1E6234 was 
subsequently withdrawn by the Taipei Economic and Cultural 
Representative Office. The requested tolerance for the leaf petioles 
subgroup (PP 6E4630) cannot be established until adequate residue 
chemistry data are submitted and reviewed.
    Based on EPA's review, the remaining petitions described in Unit II 
were revised by the petitioners (FMC Corporation and IR-4) to propose 
tolerances for residues of bifenthrin in or on almond, hulls at 2.0 
ppm; banana at 0.1 ppm; fruit, citrus, group at 0.05 ppm; herb subgroup 
at 0.05 ppm; pear at 0.5 ppm; nut, tree, group at 0.05 ppm; spinach at 
0.2 ppm; tomato at 0.15 ppm; and food/feed products in food/feed 
handling establishments at 0.05 ppm. The revisions were requested for 
the following reasons:
    EPA determined that the tolerance for pear should be set at 0.5 
ppm, not 1.0 ppm as the petitioner originally proposed, based on the 
results of submitted field residue data, showing a maximum residue of 
0.38 ppm. EPA determined that the tolerance for food/feed products in 
food/feed handling establishments should be set at 0.05 ppm, the limit 
of quantitation (LOQ) of the analytical method, rather than 0.01 ppm, 
the limit of detection (LOD), as the petitioner originally proposed. It 
is Agency policy to use the LOQ for setting tolerances when detectable 
residues are not found in the residue trials. No other changes to the 
originally proposed tolerance levels were requested; however, EPA did 
request minor changes in commodity terms to reflect current 
nomenclature practices.
    Although EPA requested changes to the initial petitions, the nature 
of the changes is not considered significant. Therefore, EPA is issuing 
this as a final action.
    EPA is also deleting time-limited tolerances established for 
residues of bifenthrin in or on citrus, dried pulp, at 0.3 ppm, citrus 
oil at 0.3 ppm and citrus, whole fruit, at 0.05 ppm in connection with 
section 18 emergency exemptions granted by EPA. With the establishment 
of the citrus fruit group tolerance (PP 1F6266), these tolerances are 
no longer needed.
    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....''
    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).

III. Aggregate Risk Assessment and Determination of Safety

    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for a tolerance for residues of bifenthrin in 
or on almond, hulls at 2.0 ppm; banana at 0.1 ppm; fruit, citrus, group 
10 at 0.05 ppm; herb subgroup 19A at 0.05 ppm; pear at 0.5 ppm; nut, 
tree, group 14 at 0.05 ppm; spinach at 0.2 ppm; tomato at 0.15 ppm; and 
food/feed products in food/feed handling establishments at 0.05 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by bifenthrin are 
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
            Guideline Number                     Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day Oral Toxicity - Rat  NOAEL = 3.8 mg/kg/day (males); 4.3 mg/kg/
                                          (1984)                      day (females)
                                                                     LOAEL = 7.5 mg/kg/day (males), 8.5 mg/kg/
                                                                      day (females), based on increased
                                                                      incidence of tumors.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day Oral Toxicity - Dog  NOAEL = 2.21 mg/kg/day (males and females)
                                          (1984)                     LOAEL = 4.42 mg/kg/day (males and females)
                                                                      based on increased incidence of tremors.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental Toxicity      Maternal Toxicity
                                          (Gavage; corn oil          NOAEL = 0.88 mg/kg/day
                                          vehicle) - Rat (1983)      LOAEL = 1.77 mg/kg/day based on tremors
                                                                      during gestation.
                                                                     Developmental Toxicity
                                                                     NOAEL = not determined (fetuses not
                                                                      examined)
                                                                     LOAEL = not determined (fetuses not
                                                                      examined)
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------

[[Page 23058]]

 
870.3700                                 Developmental Toxicity      Maternal Toxicity
                                          (Gavage; corn oil          NOAEL = 0.88 mg/kg/day
                                          vehicle) - Rat (1984)      LOAEL = 1.77 mg/kg/day based on tremors
                                                                      during gestation.
                                                                     Developmental Toxicity
                                                                     NOAEL = 0.88 mg/kg/day
                                                                     LOAEL = 1.77 mg/kg/day based on increased
                                                                      fetal and litter incidence of hydroureter
                                                                      without nephrosis.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental Toxicity      Maternal Toxicity
                                          (Dietary) - Rat (2001)     NOAEL = 7.1 mg/kg/day
                                                                     LOAEL = 15.5 mg/kg/day based clinical signs
                                                                      and decreased food consumption, body
                                                                      weight gains, and body weight gains
                                                                      adjusted for gravid uterine weight.
                                                                     Developmental Toxicity
                                                                     NOAEL = 15.5 mg/kg/day
                                                                     LOAEL = not observed.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental Toxicity -    Maternal Toxicity
                                          Rabbit (1984)              NOAEL = 2.36 mg/kg/day
                                                                     LOAEL = 3.5 mg/kg/day based on treatment-
                                                                      related head and forelimb twitching.
                                                                     Developmental Toxicity
                                                                     NOAEL = greater than 7 mg/kg/day
                                                                     LOAEL = not observed
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.3800                                 Multigeneration             Parental/Systemic Toxicity
                                          Reproductive Toxicity -    NOAEL = 3.0 mg/kg/day for females and 5.0
                                          Rat (1986)                  mg/kg/day for males
                                                                     LOAEL = 5.0 mg/kg/day for females, based on
                                                                      tremors and decreased body weight; not
                                                                      observed for males.
                                                                     Reproductive/offspring Toxicity
                                                                     NOAEL = not observed.
                                                                     LOAEL = not observed.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic Toxicity - Dog      NOAEL = 1.3 mg/kg/day (males and females)
                                          (1985)                     LOAEL = 2.7 mg/kg/day (males and females)
                                                                      based on increased incidence of tremors.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined Chronic Toxicity/  NOAEL = 3.0 mg/kg/day (females); 4.7 mg/kg/
                                          Carcinogenicity - Rat       day (males)
                                          (1986)                     LOAEL = 6.1 mg/kg/day (females), based on
                                                                      increased incidence of tremors; 9.7 mg/kg/
                                                                      day (males), based on increased incidence
                                                                      of tremors.
                                                                     Carcinogenicity - No conclusive evidence of
                                                                      carcinogenic potential.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity - Mice      NOAEL = 6.7 mg/kg/day (males); 8.8 mg/kg/
                                          (1986)                      day (females)
                                                                     LOAEL = 25.6 mg/kg/day (males) and 32.7 mg/
                                                                      kg/day (females), based on increased
                                                                      incidence of tremors.
                                                                     Carcinogenicity - carcinogenic potential
                                                                      was evidenced by a dose-related increased
                                                                      in the incidence of leiomyosarcomas in the
                                                                      urinary bladder, a significant dose-
                                                                      related trend for combined hepatocellular
                                                                      adenomas and carcinomas in males, and a
                                                                      significantly higher incidence of combined
                                                                      lung adenomas and carcinomas in females.
                                                                      Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute Neurotoxicity - Rat   NOAEL = 35 mg/kg (32.8 mg ai/kg/day).
                                                                     LOAEL = 75 mg/kg (70.3 mg ai/kg/day) based
                                                                      on mortality (females only), clinical and
                                                                      functional operational battery (FOB)
                                                                      findings and differences in motor
                                                                      activity.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic Neurotoxicity -  NOAEL = 50 ppm (equivalent to 2.9 mg/kg/day
                                          Rat                         in males and 3.7 mg/kg/day in females).
                                                                     LOAEL =100 ppm (equivalent to 6.0 mg/kg/day
                                                                      in males and 7.2 mg/kg/day in females)
                                                                      based on neuromuscular findings (tremors,
                                                                      changes in grip strength and landing foot-
                                                                      splay).
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.3200                                 Dermal Toxicity - Rabbit    NOAEL = 88 mg ai/kg/day (males and females)
                                                                     LOAEL = 442 mg ai/kg/day (males and
                                                                      females), based on loss of muscle
                                                                      coordination and increased incidence of
                                                                      tremors.
----------------------------------------------------------------------------------------------------------------

[[Page 23059]]

 
870.3200                                 Dermal Toxicity - Rat       NOAEL = 47 mg ai/kg/day (males and females)
                                                                     LOAEL = 93 mg ai/kg/day (males and
                                                                      females), based on loss of muscle
                                                                      coordination and increased incidence of
                                                                      tremors.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism - Rat            Very little of the administered radioactive
                                                                      dose was expired as 14C-CO2 (0.028% for
                                                                      males and 0.053% for females). The
                                                                      majority (about 70%) of the administered
                                                                      radioactivity was found in the feces with
                                                                      about 20% in the urine. A complication of
                                                                      this study is that males were administered
                                                                      a radioactive dose with the label in the
                                                                      acid position, while females were
                                                                      administered a radioactive dose with the
                                                                      label in the alcohol position. This could
                                                                      make comparisons between males and females
                                                                      difficult. Despite the difference in 14C-
                                                                      labeling position in the bifenthrin
                                                                      administered to males and females, the
                                                                      study is acceptable. This conclusion is
                                                                      based on the fact that most (>90%) of the
                                                                      radioactivity was eliminated via the urine
                                                                      and feces, with no significant differences
                                                                      between the sexes in this respect.
                                                                      Further, there were no significant
                                                                      differences between dosage groups in
                                                                      percentages excreted. This suggests that
                                                                      most of the compound is excreted with
                                                                      little or no change, or in a form
                                                                      incorporating both of the labeled sites.
                                                                      The results also show that females
                                                                      retained slightly more radioactivity in
                                                                      their bodies (particularly in adipose
                                                                      tissue) than did males, particularly at
                                                                      the high-dose. Labeling of the material
                                                                      given to the females was in the biphenyl
                                                                      group, and, given a splitting of the
                                                                      molecule between the two labeling sites,
                                                                      this would have tended to give a more
                                                                      lipophilic radiolabeled residue.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism - Rat            Plasma radioactivity in the low-dose (4 mg/
                                                                      kg) animals after dosing slowly rose,
                                                                      indicating a slow rate of absorption from
                                                                      the gastrointestinal tract. The half-life
                                                                      of absorption was calculated to be about
                                                                      1.5 hours, with a lag-time of 0.5 hours
                                                                      following first order kinetics.
                                                                      Radioactivity peaked in plasma for low-
                                                                      dose animals in 4 hours. The elimination
                                                                      of 14C-bifenthrin from the plasma was
                                                                      equally slow, with significant
                                                                      radioactivity still remaining in blood at
                                                                      72 hours. Plasma radioactivity in the high-
                                                                      dose (35 mg/kg) animals appeared to follow
                                                                      a similar course as seen in the low-dose
                                                                      animals. The peak radioactivity for the
                                                                      high-dose group appeared to be somewhat
                                                                      delayed, peaking at about 6 hours.
                                                                      Significant radioactivity still remained
                                                                      after 72 hours in the high-dose animals.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism - Rat            The major metabolic route of radiolabeled
                                                                      bifenthrin appeared to be hydrolysis of
                                                                      the ester linkage with oxidation of the
                                                                      resulting alcohol to the acid. Protein
                                                                      binding of radioactive components or
                                                                      metabolites appears to increase with time.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism - Rat            Fat and skin half-lives were the longest
                                                                      with half-lives of 51 and 50 days,
                                                                      respectively. The half-lives for ovaries,
                                                                      liver, kidneys and sciatic nerve were
                                                                      37.4, 19.0, 28.5, and 42 days,
                                                                      respectively. Radioactive components were
                                                                      measured in fat at numerous time
                                                                      intervals, before and after daily dosing.
                                                                      The major component in fat is parent
                                                                      compound with a half-life of 47.5 days.
                                                                      Other unidentified components included a
                                                                      somewhat polar (Rf = 0.65) compound and
                                                                      two other relatively minor components.
                                                                     Classification: Acceptable-Guideline
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism - Rat            Within 7 days, nearly all bifenthrin and/or
                                                                      metabolites were excreted in either urine
                                                                      or feces. The majority of radioactivity
                                                                      was excreted in the feces within 48 hours.
                                                                      Tissues that retained bifenthrin and/or
                                                                      metabolites beyond 7 days included fat and
                                                                      skin in males and females, and gonads in
                                                                      females.
                                                                     Classification: Unacceptable-Guideline.
                                                                      Although the number of animals/group in
                                                                      this study was 3, and not 5/sex/group as
                                                                      recommended by guidelines, and a quality
                                                                      assurance statement was lacking, the
                                                                      results of this study provide useful
                                                                      information.
----------------------------------------------------------------------------------------------------------------

[[Page 23060]]

 
870.7485                                 Metabolism - Rat            Results showed minimal breakage of the
                                                                      ester linkage of the parent compound in
                                                                      the material eliminated via the feces in
                                                                      the period of 0-48 hours after dosage,
                                                                      when most of the administered
                                                                      radioactivity is identifiable as coming
                                                                      from unmodified parent compound. However,
                                                                      the material was subsequently eliminated,
                                                                      although a relatively small proportion of
                                                                      the administered dose appears to have
                                                                      undergone more modification. Since a
                                                                      greater proportion of the radioactivity
                                                                      was eliminated via the feces in the period
                                                                      of 48-168 hours in the form of 2-Methyl-3-
                                                                      phenylbenzyl alcohol and 2-Methyl-3-
                                                                      phenylbenzoic acid than the parent
                                                                      compound, this is evidence that extensive
                                                                      breakage of the ester linkage does occur,
                                                                      either in the material retained in the
                                                                      intestines for more than 46 hours, or in
                                                                      the material absorbed and subsequently
                                                                      eliminated via the feces.
                                                                     Classification: Unacceptable-Guideline.
                                                                      While this study is limited, it dose
                                                                      provide some insight into the incomplete
                                                                      absorption of bifenthrin from the
                                                                      intestine, and the lack of modification of
                                                                      most of the unabsorbed material,
                                                                      particularly that eliminated via the feces
                                                                      during the period of 0-48 hours. However,
                                                                      the metabolism of the absorbed compound
                                                                      (radioactivity primarily excreted via the
                                                                      urine, despite differences in labeling) is
                                                                      less clear.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism - Rat            The results of the study demonstrated that
                                                                      the majority of radioactivity excreted in
                                                                      the feces was the parent compound and its
                                                                      intact hydroxylated metabolites. Much of
                                                                      the radioactivity excreted in urine was
                                                                      hydrolytic and hydrolytic/oxidative
                                                                      degradation products of the parent
                                                                      compound.
                                                                     Classification: Unacceptable-Guideline.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal Penetration - Rats   For animals in group A, means of 4.6, 14.2,
                                                                      12.8 and 14.7% total dose were recovered
                                                                      from the skin at 0, 4, 10 and 24 hours
                                                                      post-dose; corresponding percentages in
                                                                      the wash were 94.6, 80.8, 78.6 and 70%.
                                                                      For animals in group B, means of 20.0,
                                                                      37.9, 42.0 and 41.2% remained (and were
                                                                      recovered from) the skin at 0, 4, 10 and
                                                                      24 hours post-dose; corresponding
                                                                      percentages in the wash were 73.9, 50.6,
                                                                      41.3 and 37.7% respectively.
                                                                     This dermal absorption study is classified
                                                                      as acceptable. However, because only one
                                                                      dose was used, this study, by itself, does
                                                                      not satisfy the guideline requirement for
                                                                      a dermal penetration study in the rat for
                                                                      technical bifenthrin (FMC 54800). However,
                                                                      it can be used, in conjunction with other
                                                                      dermal penetration studies, as supporting
                                                                      data for the purposes of registration and/
                                                                      or reregistration of products containing
                                                                      or consisting of bifenthrin.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal Penetration - Rats   Means of 96.83, 84.75, 76.86 and 72.88% of
                                                                      the radioactivity were recovered in the
                                                                      skin wash at 0, 4, 10 and 24 hours post
                                                                      dosage, respectively. By the time the 4-
                                                                      hour post-dose and later skin samples were
                                                                      collected the emulsifying solvents had
                                                                      evaporated. Means of 4.04, 12.00, 16.55
                                                                      and 19.44% total dose were recovered from
                                                                      the washed skin of the application site at
                                                                      0, 4, 10 and 24 hours respectively;
                                                                      corresponding mean percentages recovered
                                                                      from the carcass were 0.09, 0.87, 0.85 and
                                                                      1.67%. Mean percentages recovered in urine
                                                                      and feces were 0, 0.14, 0.43 and 3.23%.
                                                                     This dermal absorption study is classified
                                                                      as acceptable. However, because only one
                                                                      dose was used, this study, by itself, does
                                                                      not satisfy the guideline requirement for
                                                                      a dermal penetration study in the rat for
                                                                      technical bifenthrin (FMC 54800). However,
                                                                      it can be used, in conjunction with other
                                                                      dermal penetration studies, as supporting
                                                                      data for the purposes of registration and/
                                                                      or reregistration of products containing
                                                                      or consisting of bifenthrin.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal Penetration - Rats   In general, only very small amounts of
                                                                      radioactivity were present in blood,
                                                                      excrement, and carcasses, with almost all
                                                                      (approximately 99%) of the absorbed
                                                                      radioactivity localized in skin at the
                                                                      application site, and in the skin adjacent
                                                                      to the application site. Average
                                                                      percentages of FMC 54800 dosages absorbed
                                                                      at 10 hours were 55.8%, 54.1%, and 37.5%
                                                                      for the 49.2, 514 and 5253 [mu]g/rat
                                                                      groups respectively. Corresponding
                                                                      percentages for the 3 groups at the 0.5
                                                                      hour sacrifice were 54.6%, 56.4%, and
                                                                      52.5%, so the percentage absorption of FMC
                                                                      54800 did not seem to depend on time-to-
                                                                      sacrifice. At 10 hours and the lowest dose
                                                                      level, the percentages present were as
                                                                      follows: excreta: <0.44%; carcass: <1.8%;
                                                                      skin at application site: 50.3%; skin
                                                                      adjacent to application site: 5.5%. At 10
                                                                      hours and the highest dose level, the
                                                                      percentages of total dose present were as
                                                                      follows: excreta: 0.07%; carcass: 0.5%;
                                                                      skin at application site: 34.6%; skin
                                                                      adjacent to application site: 2.7%.
                                                                     Classification: This dermal absorption
                                                                      study is classified as acceptable.
                                                                      However, by itself, does not satisfy the
                                                                      guideline requirement for a dermal
                                                                      penetration study in the rat for technical
                                                                      bifenthrin (FMC 54800). However, it can be
                                                                      used, in conjunction with other dermal
                                                                      penetration studies, as supporting data
                                                                      for the purposes of registration and/or
                                                                      reregistration of products containing or
                                                                      consisting of bifenthrin.
----------------------------------------------------------------------------------------------------------------

[[Page 23061]]

 
870.7600                                 Dermal Penetration - Rats   The report states that at 24 hours
                                                                      postdose, 5.11% of the dose was absorbed
                                                                      (application-site skin + carcass + urine +
                                                                      feces) in this second trial. However, it
                                                                      is noted that there was poor recovery (68%
                                                                      of the total dose) from one of the rats
                                                                      (C32545) sacrificed at 24 hours in the
                                                                      second trial; disregarding the findings
                                                                      from this one animal then the mean value
                                                                      of the dose that was absorbed was 5.88%,
                                                                      and this can be taken as a reasonable
                                                                      estimate of the dermal absorption at this
                                                                      dose level.
                                                                     This dermal absorption study is classified
                                                                      as acceptable. However, because only one
                                                                      dose was used, this study, by itself, does
                                                                      not satisfy the guideline requirement for
                                                                      a dermal penetration study in the rat for
                                                                      technical bifenthrin (FMC 54800). However,
                                                                      it can be used, in conjunction with other
                                                                      dermal penetration studies, as supporting
                                                                      data for the purposes of registration and/
                                                                      or reregistration of products containing
                                                                      or consisting of bifenthrin.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences. In this 
case, EPA has determined that an additional 10X data base uncertainty 
factor (UFDB) is needed to account for the lack of a 
developmental neurotoxicity (DNT) study when assessing acute (single 
dose) exposure scenarios. EPA has further determined that for repeated 
dose exposure scenarios (i.e., chronic dietary; short- and 
intermediate-term incidental oral; and short-, intermediate-, and long-
term dermal and inhalation scenarios) a 3X UFDB is adequate 
to account for the lack of the DNT study. The factors which EPA 
considered in making these determinations are discussed in detail below 
in Unit III.D.3.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF) 
is retained due to concerns unique to the FQPA, this additional factor 
is applied to the RfD by dividing the RfD by such additional factor. 
The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. In this case, since 300 is the appropriate 
UF for repeated dose exposure scenarios (10X to account for 
interspecies differences;10X for intraspecies differences and 3X for 
data base uncertainty) the LOC is 300. To estimate risk, a ratio of the 
NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for bifenthrin used for human risk assessment is shown in 
Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Bifenthrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      NOAEL = 32.8 mg ai/kg    FQPA SF = 1X             Acute Neurotoxicity
 including infants and children)       UF = 1,000.............  aPAD = acute RfD / FQPA   Study in Rats
                                       Acute RfD = 0.033 mg/kg/  SF = 0.033 mg/kg/day.   LOAEL = 70.3 mg/kg/day
                                        day.                                              based on observations
                                                                                          of mortality (females
                                                                                          only), clinical and
                                                                                          functional operational
                                                                                          battery (FOB) findings
                                                                                          and differences in
                                                                                          motor activity.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 1.3 mg/kg/day    FQPA SF = 1X             1-Year Oral Study in
                                       UF = 300...............  cPAD = chronic RfD /      Dogs
                                       Chronic RfD = 0.004 mg/   FQPA SF = 0.004 mg/kg/  LOAEL = 2.7 mg/kg/day
                                        kg/day.                  day.                     based on observations
                                                                                          of increased incidence
                                                                                          of tremors in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------

[[Page 23062]]

 
Incidental Oral Short-Term (1 - 30     NOAEL = 2.21 mg ai/kg/   FQPA SF = 1X             90-Day Oral Study in
 Days) Residential Only                 day                     LOC for MOE = 300......   Dogs
                                       UF = 300...............                           LOAEL = 4.42 mg ai/kg/
                                                                                          day based on
                                                                                          observations of
                                                                                          increased incidence of
                                                                                          tremors in both sexes.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Intermediate-Term (1 - NOAEL = 2.21 mg ai/kg/   FQPA SF = 1X             90-Day Oral Study in
  6 Months) Residential Only            day                     LOC for MOE = 300......   Dogs
                                       UF = 300...............                           LOAEL = 4.42 mg ai/kg/
                                                                                          day based on
                                                                                          observations of
                                                                                          increased incidence of
                                                                                          tremors in both sexes.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 30 days)       dermal study NOAEL = 47  FQPA SF = 1X             21-Day Dermal Study in
 (Residential)                          mg/kg/day               LOC for MOE = 300         Rats
                                                                 (Residential).          LOAEL = 93 mg/kg/day
                                                                                          based on observations
                                                                                          of clinical signs
                                                                                          (staggered gait and
                                                                                          exaggerated hindlimb
                                                                                          flexion).
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 to 6       dermal study NOAEL = 47  FQPA SF = 1X             21-Day Dermal Study in
 months) (Residential)                  mg/kg/day               LOC for MOE = 300         Rats
                                                                 (Residential).          LOAEL = 93 mg/kg/day
                                                                                          based on observations
                                                                                          of clinical signs
                                                                                          (staggered gait and
                                                                                          exaggerated hindlimb
                                                                                          flexion).
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    dermal study NOAEL = 47  FQPA SF = 1X             21-Day Dermal Study in
 lifetime) (Residential)                mg/kg/day               LOC for MOE = 300         Rats
                                                                 (Residential).          LOAEL = 93 mg/kg/day
                                                                                          based on observations
                                                                                          of clinical signs
                                                                                          (staggered gait and
                                                                                          exaggerated hindlimb
                                                                                          flexion).
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   oral study NOAEL = 2.21  FQPA SF = 1X             90-Day Oral Study in
 (Residential)                          mg/kg/day               LOC for MOE = 300         Dogs
                                                                 (Residential).          LOAEL = 4.42 mg/kg/day
                                                                                          based on observations
                                                                                          of increased incidence
                                                                                          of tremors in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 to 6   oral study NOAEL = 2.21  FQPA SF = 1X             90-Day Oral Study in
 months) (Residential)                  mg/kg/day               LOC for MOE = 300         Dogs
                                                                 (Residential).          LOAEL = 4.42 mg/kg/day
                                                                                          based on observations
                                                                                          of increased incidence
                                                                                          of tremors in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   oral study NOAEL = 1.3   FQPA SF = 1X             1-Year Oral Study in
 to lifetime) (Residential)             mg/kg/day               LOC for MOE = 300         Dogs
                                                                 (Residential).          LOAEL = 2.7 mg/kg/day
                                                                                          based on observations
                                                                                          of increased incidence
                                                                                          of tremors in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         EPA's Carcinogenicity Peer Review Committee (CPRC) has characterized
                                        bifenthrin as a Category C (possible human) carcinogen, primarily on the
                                          basis of the mouse carcinogenicity study in which the high-dose males
                                           (81.3 mg/kg/day) showed a highly significant increased incidence of
                                          urinary bladder tumors. Other findings in the mouse study included a
                                           dose-related trend of increased combined incidences of adenoma and
                                          adenocarcinoma of the liver (males only), and increased incidences of
                                         bronchioalveolar adenomas and adenocarcinomas of the lung in females at
                                         some, but not all, doses relative to their controls. The Agency did not
                                        recommend assignment of a Q1* but has determined that the reference dose
                                            (RfD) approach should be used for quantification of human risk.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.442) for the residues of bifenthrin in or on a 
variety of raw agricultural commodities. Tolerances have been 
established on plant commodities ranging from 0.05 ppm for corn grain, 
peas, beans and eggplant to 10 ppm for dried hops and on animal 
commodities ranging from 0.01 ppm for meat byproducts to 1.0 ppm for 
milk fat and fat of cattle, goats, hogs, horses, and sheep. Risk 
assessments were conducted by EPA to assess dietary exposures from 
bifenthrin in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: A probabilistic dietary exposure assessment was 
conducted for the general U.S. population and all population subgroups, 
including infants and children. The highly refined assessment 
incorporated the most recent USDA Pesticide Data Program (PDP) 
monitoring data, field trial data and processing factor data (for 
grapes and pending uses). It assumed 100% crop treated for the new and 
existing uses.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM[reg] analysis evaluated the

[[Page 23063]]

individual food consumption as reported by respondents in the USDA 
1989-1992 nationwide CSFII and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: A highly refined chronic exposure assessment was 
conducted which incorporated the most recent PDP monitoring data, field 
trial data and processing factor data (for grapes and pending uses). It 
assumed 100% crop treated for the new and existing uses.
    iii. Cancer. Bifenthrin has been classified as a Category C 
(possible human) carcinogen. The Agency has determined that the 
reference dose (RfD) approach should be used for quantification of 
human risk. For further discussion of the weight-of-the-evidence 
considered by EPA in making this determination, see the proposed rule 
for Bifenthrin tolerances (59 FR 9167, February 25, 1994) (FRL-4756-1). 
Under this approach, chronic dietary exposures that are less than the 
RfD (or cPAD) are assumed to be protective for cancer dietary exposure 
as well. Therefore, a separate cancer dietary risk assessment was not 
conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E) of the FFDCA, 
EPA will issue a data call-in for information relating to anticipated 
residues to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency did not use percent crop treated information for 
assessing dietary risk from bifenthrin.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for bifenthrin in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of bifenthrin.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow groundwater. For a screening-level assessment for surface water 
EPA will use FIRST, a tier 1 model, before using PRZM/EXAMS, a tier 2 
model. The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to bifenthrin they are further 
discussed in the aggregate risk sections in Unit III.E.
    Based on the FIRST and SCI-GROW models the estimated environmental 
concentrations (EECs) of bifenthrin for acute exposures are estimated 
to be 0.1 parts per billion (ppb) for surface water and 0.006 ppb for 
ground water. The EECs for chronic exposures are estimated to be 0.1 
ppb for surface water and 0.006 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Bifenthrin is currently registered for use on the following 
residential non-dietary sites: ornamental gardens, lawns, turf, and 
general insect control in, around and on buildings, structures, and 
immediate surroundings. There are also uses for spot treatments and 
crack and crevice treatments for insects in, on, and around homes, 
buildings, and other structures and for subsoil treatment around 
structures for control of termites (termiticide use). The risk 
assessment was conducted using the following residential exposure 
assumptions: Adults and children are potentially exposed to bifenthrin 
residues after application of bifenthrin products in residential 
settings. Short- and intermediate-term post-application dermal 
exposures for adults, and short- and intermediate-term post-application 
dermal and incidental oral exposures for children are anticipated. Risk 
estimates were generated for potential contact with lawn, soil, and 
treated indoor surfaces using EPA's Draft Standard Operating Procedures 
for Residential Exposure Assessment; and for the lawn exposure 
scenarios, dissipation data from a chemical specific turf transferable 
residue (TTR) study. Indoor surface residues in homes were based on 
crack and crevice data collected for bifenthrin and another 
insecticide, malathion. These estimates are considered conservative 
screening level estimates, since the study data were adjusted to 
reflect maximum application rates.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA

[[Page 23064]]

requires that, when considering whether to establish, modify, or revoke 
a tolerance, the Agency consider ``available information'' concerning 
the cumulative effects of a particular pesticide's residues and ``other 
substances that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether bifenthrin has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to bifenthrin 
and any other substances and bifenthrin does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that bifenthrin has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. EPA concluded that there is 
not a concern for pre- and/or postnatal toxicity resulting from 
exposure to bifenthrin. There was no quantitative or qualitative 
evidence of increased susceptibility of rat or rabbit fetuses to in 
utero exposure to Bifenthrin in developmental toxicity studies and no 
quantitative or qualitative evidence of increased susceptibility of 
neonates (as compared to adults) to bifenthrin in a 2-generation 
reproduction study in rats. In addition, there are no concerns or 
residual uncertainties for pre and/or post-natal toxicity following 
exposure to Bifenthrin.
    3. Conclusion. No special FQPA safety factor is needed based on 
concerns for pre- and/or postnatal toxicity to bifenthrin. However, EPA 
has concluded that in light of the lack of the DNT study there is no 
reliable basis for removing the additional FQPA 10X safety factor when 
assessing acute (single dose) exposure scenarios. The following points 
were considered in this determination:
    i. It is assumed that the DNT study will be conducted at dose 
levels similar to those used in the rat reproduction study with 
Bifenthrin wherein the offspring NOAEL was 5.0 mg/kg/day, the highest 
dose tested (no effects were observed in offspring at this dose); but 
that the DNT study would not be conducted at dose levels higher than 10 
mg/kg/day since a range-finding study indicates excessive fetotoxicity 
occurred at this dose (all pups from 2 of the 4 litters at 10 mg/kg/day 
died within 14 days of birth).
    ii. The DNT study may impact the currently selected acute 
regulatory dose since the NOAEL used to establish the acute Reference 
dose for dietary risk assessment is 33 mg/kg/day, a level which is more 
than 5-fold higher than the offspring NOAEL in the rat reproduction 
study of 5.0 mg/kg/day ( a level which is similar to dose levels likely 
to be used in the DNT study).
    EPA has further determined that for repeated dose exposure 
scenarios a 3X UFDB is adequate to account for the lack of 
the DNT study. Repeated dose exposure scenarios include chronic dietary 
exposure; short-term (repeated exposure up to 30 days) and 
intermediate-term (repeated exposure from 1 to 6 months) incidental 
oral exposure; and short-term, intermediate-term, and long-term 
(several months to lifetime) dermal and inhalation exposure scenarios. 
EPA's determination that a 3X UFDB is adequate for repeated 
dose exposure scenarios is based on the following considerations:
    a. As stated above, the DNT study will likely be conducted at dose 
levels similar to the rat reproduction study.
    b. The results of the DNT study are not expected to impact the 
current regulatory doses selected for repeated exposure scenarios since 
the NOAELs used for these risk assessment endpoints (e.g., 1.3 mg/kg/
day from the chronic dog study for chronic RfD) are approximately 4-
fold lower than the offspring NOAEL (5.0 mg/kg/day) in the rat 
reproduction study conducted with Bifenthrin. Although the results of 
the DNT are not expected to impact the current regulatory dose given 
the 4-fold difference observed in the rat and dog studies, EPA does not 
have sufficient reliable data to apply no additional FQPA safety 
factor. Rather, EPA believes that the 4X difference between the 
offspring NOAEL in the rat reproduction study and the NOAELs used for 
risk assessment endpoints provides reliable data supporting a 3X UF for 
repeated dose exposure scenarios. The use of a 3X provides roughly a 
10-fold difference between the NOAEL associated with the identified 
effects in the rat necessitating the DNT study and the NOAELs used for 
setting regulatory doses. Therefore, a UFDB of 3X will be 
applied as a FQPA safety factor to repeated dose exposure scenarios to 
account for the lack of the DNT study with Bifenthrin.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA are used to calculate DWLOCs: 2 liter (L)/
70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). 
Actual body weights and drinking water consumption values vary on an 
individual basis. This variation will be taken into account in more 
refined screening-level and quantitative drinking water exposure 
assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the

[[Page 23065]]

calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
bifenthrin will occupy 32% of the aPAD for the U.S. population, 19% of 
the aPAD for females 13 to 50 years old, 52% of the aPAD for infants 
less than 1 year old and 38% of the aPAD for children 1 to 6 years old. 
In addition, there is potential for acute dietary exposure to 
bifenthrin in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of 
this unit:

                      Table 3.--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)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.033           32          0.1        0.006          780
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                              0.033           52          0.1        0.006          160
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               0.033           38          0.1        0.006          200
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                              0.033           19          0.1        0.006          800
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
bifenthrin from food will utilize 12% of the cPAD for the U.S. 
population, 13% of the cPAD for infants less than 1 year old and 24% 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, there is potential for chronic dietary exposure to 
bifenthrin in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of 
this unit:

                     Table 4.--Aggregate Risk Assessment for Chronic 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                                        0.004           12          0.1        0.006          120
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                              0.004           13          0.1        0.006           35
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               0.004           24          0.1        0.006           30
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-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 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.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 544 to 1,070 for adult male and 
female homeowners applying bifenthrin to turf, treating structural wood 
or making crack and crevice applications indoors. EPA has further 
concluded that food and residential exposures aggregated result in 
aggregate MOEs of 354 for children (toddlers) with post-application 
exposure outdoors and 694 for children (toddlers) with post-application 
exposure following indoor crack and crevice treatments. 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 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 Table 5 of this unit:

[[Page 23066]]



                    Table 5.--Aggregate Risk Assessment for Short-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 Female: Structural Wood Treatment                  544          300          0.1        0.006          100
----------------------------------------------------------------------------------------------------------------
Adult Male: Structural Wood Treatment                    546          300          0.1        0.006          120
----------------------------------------------------------------------------------------------------------------
Adult Female: Indoor Crack and Crevice                   855          300          0.1        0.006          140
 Treatment
----------------------------------------------------------------------------------------------------------------
Adult Male: Indoor Crack and Crevice Treatment           858          300          0.1        0.006          170
----------------------------------------------------------------------------------------------------------------
Children (Toddler): Outdoor Post-application             354          300          0.1        0.006           11
 Exposure
----------------------------------------------------------------------------------------------------------------
Children (Toddler): Indoor Post-application              694          300          0.1        0.006           42
 Exposure
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. 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 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for bifenthrin. However, since short-term 
risk estimates for residential handler and post-application exposures 
to bifenthrin represent worst-case risk estimates for intermediate-term 
scenarios, separate intermediate-term aggregate risks were not 
estimated. Short-term risk estimates are considered to represent worst-
case risk estimates for intermediate-term scenarios for the following 
reasons.
    The toxic endpoints used to estimate risks for intermediate-term 
dermal, incidental oral, and inhalation exposures for bifenthrin are 
the same as those used to estimate risks from short-term exposures. In 
addition, EPA used the same residue data from outdoor (turf) and indoor 
(hard-surface) studies to estimate short and intermediate-term 
exposures. Any differences in the exposure estimates are a result of 
the assumptions used for activity patterns, which may differ for short 
versus intermediate-term exposure depending on the scenario assessed. 
As a result of these differences, exposure estimates for intermediate-
term exposure scenarios are either equal to or lower than exposure 
estimates for short-term scenarios. Consequently, risk estimates (MOEs) 
for intermediate-term exposures are equal to or greater than MOEs for 
short-term exposures. Since short-term risk estimates are below levels 
of concern, intermediate-term risk estimates are also below levels of 
concern.
    5. Aggregate cancer risk for U.S. population. Bifenthrin has been 
classified as a Category C (possible human) carcinogen. The Agency has 
determined that the reference dose (RfD) approach should be used for 
quantification of human risk. Therefore, the chronic aggregate risk 
assessment described above in Unit III.E.2. also encompasses chronic 
aggregate cancer risk from bifenthrin.
    6. Determination of safety. 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of the 
regulated bifenthrin residue in plants. Crop field trial samples were 
analyzed for residues of bifenthrin using FMC Methods P-1073, P-1089, 
P-1645M, P-2132M, P-3133, or P-3346. These methods are variations of 
two other methods which have been submitted for inclusion in PAM II 
(FMC's Methods P-1031 and RAN-0140). These methods have been adequately 
validated and are adequate for data collection.
    The methods 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

    The Codex Alimentarius Commission has established several maximum 
residue limits (MRLs) for residues of bifenthrin in/on various 
commodities. The Codex MRLs are expressed in terms of bifenthrin per 
se. The Codex MRL and the U.S. tolerance expressions are compatible.
    Of the new commodities for which tolerances are being established, 
Codex MRLS exist only for pear, grapefruit, lemon and orange. The Codex 
MRLs of 0.5 ppm for pear and 0.05 ppm for grapefruit, lemon and orange 
are compatible with the new U.S. tolerances for pear (0.5 ppm) and 
citrus fruit (0.05 ppm). Codex MRLs have not been established for 
bananas, herbs, tomatoes, spinach or tree nuts.
    The following conclusions can be made regarding efforts to 
harmonize existing (i.e., previously established) U.S. tolerances with 
Codex MRLs: (i) Compatibility between the U.S. tolerances and Codex 
MRLs exists for maize and chicken commodities except eggs; (ii) 
incompatibility of the U.S. tolerances and Codex MRLs remains for maize 
forage and fodder, strawberry, eggs, and cattle commodities because of 
differences in agricultural practices and/or method limits of 
quantitation. No questions of compatibility exist with respect to 
commodities where Codex MRLs have been established but U.S. tolerances 
do not exist.
    There are no Canadian MRLs established for bifenthrin. Mexican MRLs 
have been established for bifentrin at 0.5 ppm for cottonseed, 0.05 ppm 
for maize, and 3 ppm for strawberry. These levels are compatible with 
the U.S. tolerance levels.

V. Conclusion

    Therefore, 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 almond, hulls 
at 2.0 ppm; banana at 0.1 ppm; fruit, citrus, group 10 at 0.05 ppm; 
herb subgroup 19A at 0.05 ppm; pear at 0.5 ppm; nut, tree, group 14 at 
0.05 ppm; spinach at 0.2 ppm; tomato at 0.15 ppm; and food/feed 
products in food/feed handling establishments at 0.05 ppm.

[[Page 23067]]

VI. 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 FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0358 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 June 30, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, PO 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-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2002-0358, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [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).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. 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

[[Page 23068]]

tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of the FFDCA. For these same reasons, 
the Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. 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: April 16, 2003.
Debra Edwards,
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), 346(a) and 371.

0
2. Section 180.442 is amended in paragraph (a) by designating the text 
following the paragraph heading as paragraph (a)(1); by adding 
alphabetically commodities to the table in newly designated paragraph 
(a)(1), by adding paragraph (a)(2), and in the table to paragraph (b) 
by deleting the entries for ``Citrus;'' ``Citrus, dried pulp;'' and 
``Citrus, oil.''.


Sec.  180.442  Bifenthrin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................          2.0
                                * * * * *
Banana\1\..................................................          0.1
                                * * * * *
Fruit, citrus, group 10....................................         0.05
                                * * * * *
Herb subgroup 19A..........................................         0.05
                                * * * * *
Nut, tree, group 14........................................         0.05
                                * * * * *
Pear.......................................................          0.5
                                * * * * *
Spinach....................................................          0.2
                                * * * * *
Tomato.....................................................         0.15
                               * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of April 30, 2003.

    (2) A tolerance of 0.05 ppm is established 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, as follows:
    (i) In or on all food/feed items (other than those covered by a 
higher tolerance as a result of use on growing crops) in food/feed 
handling establishments.
    (ii) The insecticide may be present as a residue from application 
of bifenthrin in food handling establishments, including food service, 
manufacturing and processing establishments, such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries, feed handling 
establishments including feed manufacturing and processing 
establishments, in accordance with the following prescribed conditions:
    (A) Application shall be limited to general surface and spot and/or 
crack and crevice treatment in food/feed handling establishments where 
food/feed and food/feed products are held, processed, prepared and 
served. General surface application may be used only when the facility 
is not in operation provided exposed food/feed has been covered or 
removed from the area being treated. Spot and/or crack and crevice 
application may be used while the facility is in operation provided 
exposed food/feed is covered or removed from the area being treated 
prior to application. Spray concentration shall be limited to a maximum 
of 0.06 percent active ingredient. Contamination of food/feed or food/
feed contact surfaces shall be avoided.
    (B) To assure safe use of the insecticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency and shall be used in accordance with such label and labeling.
* * * * *
[FR Doc. 03-10400 Filed 4-29-03; 8:45 am]
BILLING CODE 6560-50-S