[Federal Register Volume 67, Number 22 (Friday, February 1, 2002)]
[Rules and Regulations]
[Pages 4913-4922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2612]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301206; FRL-6818-3]
RIN 2070-AB78


Bifenazate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for (i) combined 
residues of bifenazate (hydrazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethyl ester) and D3598 (expressed as 
bifenazate; diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 
1-methylethylester) in or on raw agricultural commodities (apple, wet 
pomace; cotton, undelinted seed; cotton gin byproducts (gin trash); 
fruit, pome group; grape; grape, raisin; hop, dried cones; nectarine; 
peach; plum; strawberry and in fat of cattle, goat, hog, horse and 
sheep and (ii) combined residues of bifenazate, D3598 (expressed as 
bifenazate), A1530 (1,1'-biphenyl, 4-ol) and A1530-sulfate (expressed 
as A1530; 1,1'-biphenyl, 4-oxysulfonic acid) in meat and meat 
byproducts of cattle, goat, horse, hog and sheep and milk. Uniroyal 
Chemical Company requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act, as amended by the Food Quality Protection Act (FQPA) 
of 1996.

DATES: This regulation is effective February 1, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301206, 
must be received by EPA on or before April 2, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301206 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Suku Oonnithan, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 605-0368; and 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 manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'', ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the Office of Prevention, 
Pesticides, and Toxic Substances (OPPTS) Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301206. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 18, 2001; (66 FR 19935) (FRL-6777-
4), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the FQPA 
of 1996 (Public Law 104-170) announcing the filing of a pesticide 
petition (PP 0F6108) for tolerance by Uniroyal Chemical Company, Benson 
Road, Middlebury, CT 06749. This notice included a summary of the 
petition prepared by Uniroyal Chemical Company, the registrant. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for residues of the insecticide bifenazate in 
or on the raw agricultural commodities apple, wet pomace at 1.2 parts 
per million (ppm); cotton seed at 0.5 ppm; cotton, gin byproducts (gin 
trash) at 20 ppm; fruit, pome, group at 0.75 ppm; fruit, stone, group 
(except cherries) at 1.5 ppm; grape at 0.75 ppm; hop at 15 ppm and 
strawberry at 1.5 ppm. As cotton processed commodities fed to animals 
may be transferred to milk and edible tissue of ruminants, tolerances 
were also proposed for meat at 0.02 ppm and milk at 0.01 ppm.
    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

[[Page 4914]]

determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) 
defines ``safe'' to mean that`` there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(C) requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for combined residues of bifenazate and D3598 
(expressed as bifenazate) in or on apple, wet pomace at 1.2 ppm; 
cattle, fat at 0.1 ppm; cotton, gin byproducts at 35 ppm; cotton, 
undelinted seed at 0.75 ppm; fruit, pome, group at 0.75 ppm; goat, fat 
at 0.1 ppm; grape at 0.75 ppm; grape, raisin at 1.2 ppm; hog, fat at 
0.1 ppm; hop, dried cones at 15 ppm; horse, fat at 0.1 ppm; nectarine 
at 1.7 ppm; peach at 1.7 ppm; plum at 0.3 ppm; sheep, fat at 0.1 ppm; 
strawberry at 1.5 ppm and combined residues of bifenazate and D3598 
(expressed as bifenazate), A1530 and A1530-sulfate (expressed as A1530) 
in: cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm; 
goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; hog, meat at 
0.01 ppm; hog, meat byproducts at 0.01 ppm; horse, meat at 0.01 ppm; 
horse, meat byproducts at 0.01 ppm; milk at 0.01 ppm; sheep, meat at 
0.01 ppm; sheep, meat byproducts at 0.01 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 bifenazate are 
discussed in the following Table 1 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
------------------------------------------------------------------------
                                   Study Type (All
      OPPTS Guideline No.              Studies             Results
                                     Acceptable)
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = 13.8 mg/kg/
                                  toxicity rodents-   day in males, 3.2
                                  rat                 mg/kg/day in
                                                      females.
                                                     LOAEL = 27.7 mg/kg/
                                                      day in males, 16.3
                                                      mg/kg/day in
                                                      females based on
                                                      decreased body
                                                      weight gain in
                                                      both sexes,
                                                      decreased liver
                                                      weight in males,
                                                      increased spleen
                                                      weight in females,
                                                      and histopathology
                                                      in liver in both
                                                      sexes, and
                                                      histopathological
                                                      changes in the
                                                      spleen and adrenal
                                                      cortex in males.
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL = 0.9 mg/kg/
                                  toxicity            day in males, 1.3
                                  nonrodents-dog      mg/kg/day in
                                                      females.
                                                     LOAEL = 10.4 mg/kg/
                                                      day in males, 10.7
                                                      mg/kg/day in
                                                      females based on
                                                      changes in
                                                      hematological
                                                      parameters in both
                                                      sexes, increased
                                                      bilirubin in the
                                                      urine in males,
                                                      increased absolute
                                                      and relative liver
                                                      weight in females
                                                      and liver
                                                      histopathologic
                                                      effects in both
                                                      sexes.
------------------------------------------------------------------------
870.3200                         21-Day dermal       NOAEL = 80 mg/kg/
                                  toxicity-rat        day in males and
                                                      females
                                                     LOAEL = 400 mg/kg/
                                                      day in males and
                                                      females based on
                                                      decreased body
                                                      weight in females,
                                                      decreased food
                                                      consumption in
                                                      both sexes,
                                                      increased urinary
                                                      ketones, increased
                                                      urinary protein,
                                                      increased urinary
                                                      specific gravity,
                                                      and decreased
                                                      urinary volume in
                                                      both sexes, and
                                                      increased
                                                      incidence of
                                                      extramedullary
                                                      hematopoiesis in
                                                      the spleen in both
                                                      sexes.
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal NOAEL = 10
                                  developmental in    mg/kg/day.
                                  rodents-rat
                                                     LOAEL = 100 mg/kg/
                                                      day based on
                                                      increased clinical
                                                      signs, and
                                                      decreased body
                                                      weight, body
                                                      weight gain, and
                                                      food consumption.
                                                     Developmental NOAEL
                                                      = 500 mg/kg/day
                                                     LOAEL = not
                                                      established
------------------------------------------------------------------------
870.3700                         Prenatal            Maternal NOAEL =
                                  developmental in    200 mg/kg/day
                                  nonrodents-rabbit
                                                     LOAEL = not
                                                      established; Doses
                                                      for the main study
                                                      were selected
                                                      based on a range-
                                                      finding study in
                                                      which groups of 5
                                                      rabbits each
                                                      received 0, 125,
                                                      250, 500, 750, or
                                                      1,000 mg/kg/day
                                                      during gestation
                                                      days 6-19 by
                                                      gavage.

[[Page 4915]]

 
                                                     Maternal toxicity
                                                      was seen as
                                                      increased deaths
                                                      and decreased body
                                                      weight at 750 mg/
                                                      kg/day and above.
                                                      A treatment-
                                                      related increase
                                                      in the number of
                                                      does aborting was
                                                      seen at 250 mg/kg/
                                                      day and above.
                                                     Developmental NOAEL
                                                      = 200 mg/kg/day.
                                                     LOAEL = not
                                                      established; Due
                                                      to only one or two
                                                      litters available
                                                      in each of the
                                                      treated groups in
                                                      the range finding
                                                      study, a clear
                                                      assessment of
                                                      developmental
                                                      toxicity was not
                                                      possible. Based on
                                                      these results,
                                                      doses of 10, 50,
                                                      and 200 mg/kg/day
                                                      were selected for
                                                      the main study.
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Systemic
                                  fertility effects-  NOAEL = 1.6 mg/kg/
                                  rat                 day in males, 1.8
                                                      mg/kg/day in
                                                      females.
                                                     LOAEL = 6.5 mg/kg/
                                                      day in males and
                                                      7.4 mg/kg/day in
                                                      females based on
                                                      decreased body
                                                      weight, body
                                                      weight gain, and
                                                      food consumption
                                                      in both sexes.
                                                     Reproductive NOAEL
                                                      = 16.4 mg/kg/day
                                                      in males, 18.3 mg/
                                                      kg/day in females.
                                                     LOAEL = not
                                                      established.
                                                     Offspring NOAEL =
                                                      16.4 mg/kg/day in
                                                      males, 18.3 mg/kg/
                                                      day in females.
                                                     LOAEL = not
                                                      established.
------------------------------------------------------------------------
870.4100                         Chronic toxicity    NOAEL = 1.01 mg/kg/
                                  dogs                day in males, 1.05
                                                      mg/kg/day in
                                                      females
                                                     LOAEL = 8.95 mg/kg/
                                                      day in males,
                                                      10.42 mg/kg/day in
                                                      females based on
                                                      changes in
                                                      hematological and
                                                      clinical chemistry
                                                      parameters in both
                                                      sexes and
                                                      histopathological
                                                      effects in bone
                                                      marrow, liver, and
                                                      kidney in both
                                                      sexes.
------------------------------------------------------------------------
870.4300                         Chronic/            NOAEL = 3.9 mg/kg/
                                  Carcinogenicity     day in males, 4.8
                                  rats                mg/kg/day in
                                                      females.
                                                     LOAEL = 9.7 mg/kg/
                                                      day in males and
                                                      9.7 mg/kg/day in
                                                      females based on
                                                      decreased body
                                                      weight, body
                                                      weight gain, and
                                                      food consumption
                                                      in both sexes.
                                                     No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4300                         Carcinogenicity     NOAEL = 1.5 mg/kg/
                                  mice                day in males, 19.7
                                                      mg/kg/day in
                                                      females.
                                                     LOAEL = 15.4 mg/kg/
                                                      day in males, 35.7
                                                      mg/kg/day in
                                                      females based on
                                                      decreased body
                                                      weight and body
                                                      weight gain in
                                                      females and
                                                      hematological
                                                      effects and
                                                      decreased kidney
                                                      weight in males.
                                                     No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.5265                         Gene Mutation       Non-mutagenic when
                                                      tested up to 5000
                                                      ug/plate, in
                                                      presence and
                                                      absence of
                                                      activation, in S.
                                                      typhimurium
                                                      strains TA98,
                                                      TA100, TA1535 and
                                                      TA1537 and E. coli
                                                      strain WP2uvra.
------------------------------------------------------------------------
870.5300                         Gene Mutation       Non-mutagenic at
                                                      the TK locus in
                                                      L5178Y mouse
                                                      lymphoma cells
                                                      tested up to
                                                      cytotoxic
                                                      concentrations or
                                                      limit of
                                                      solubility, in
                                                      presence and
                                                      absence of S-9
                                                      activation.
------------------------------------------------------------------------
870.5375                         Chromosome          Did not induce
                                  aberration          structural
                                                      chromosome
                                                      aberration in CHO-
                                                      K1 cell cultures
                                                      in the presence
                                                      and absence of
                                                      activation up to
                                                      cytotoxic
                                                      concentrations.
------------------------------------------------------------------------
870.5385                         Chromosomal         Non-mutagenic in
                                  aberration          ICR mouse bone
                                                      marrow
                                                      micronucleus
                                                      chromosomal
                                                      aberrations assay
                                                      up to cytotoxic
                                                      concentrations.

[[Page 4916]]

 
870.7485                         Metabolism and      Total recovery of
                                  pharmacokinetics -  the administered
                                  rat                 dose was > 93% for
                                                      all treatment
                                                      groups. Fecal
                                                      excretion was the
                                                      major route of
                                                      elimination (66-
                                                      83% of the dose),
                                                      with eight primary
                                                      metabolites
                                                      detected. These
                                                      metabolites, as
                                                      well as those
                                                      identified in the
                                                      urine and bile,
                                                      were the result of
                                                      metabolic
                                                      reactions
                                                      including
                                                      hydrazine
                                                      oxidation to the
                                                      diazene (D3598),
                                                      demethylation,
                                                      ring
                                                      hydroxylation, and
                                                      molecular scission
                                                      with the loss of
                                                      hydrazinecarboxyli
                                                      c acid portion to
                                                      methoxybiphenyl
                                                      (D1989) with
                                                      subsequent
                                                      conjugation. The
                                                      Metabolism
                                                      Assessment Review
                                                      Committee (MARC)
                                                      determined that
                                                      D1989 is not
                                                      likely to be more
                                                      toxic than the
                                                      parent compound.
------------------------------------------------------------------------

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 intra species variations.
    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 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 Safety Factor.
    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 
variations) the LOC is 100. 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 bifenazate used for human risk assessment is shown in the 
following Table 2:

     Table 2--Summary of Toxicological Dose and Endpoints for bifenazate for Use in Human Risk Assessment\1\
----------------------------------------------------------------------------------------------------------------
                                                                FQPA SF\*\ and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary for general population   None                     An acute dietary         None
 and females 13-50 years old                                     endpoint was not
                                                                 selected based on the
                                                                 absence of an
                                                                 appropriate endpoint
                                                                 attributed to a single
                                                                 dose
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 1.0 mg/kg/day;    FQPA SF = 1X; cPAD =     LOAEL = 8.9/10.4 mg/kg/
                                        UF = 100; Chronic RfD    cRfD/FQPA; SF = 0.01     day [M/F] based on
                                        = 0.01 mg/kg/day         mg/kg/day                changes in
                                                                                          hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in bone
                                                                                          marrow, liver, and
                                                                                          kidney in the One Year
                                                                                          Dog Feeding Study
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short Term (1-30      Oral NOAEL = 10 mg/kg/   LOC = 100                LOAEL = 100 mg/kg/day
 days)                                  day                                               based on clinical
                                                                                          signs, decreased body
                                                                                          weight and food
                                                                                          consumption during the
                                                                                          dosing period in the
                                                                                          Rat Developmental
                                                                                          Study
----------------------------------------------------------------------------------------------------------------

[[Page 4917]]

 
Incidental Oral, Intermediate Term     Oral NOAEL = 0.9 mg/kg/  LOC = 100                LOAEL = 10.4/10.7 mg/kg/
 (30 days - 6 months)                   day                                               day [M/F] based on
                                                                                          changes in hematologic
                                                                                          parameters in the 90-
                                                                                          Day Subchronic Dog
                                                                                          Study
----------------------------------------------------------------------------------------------------------------
Short-, Intermediate- and Long-Term    Dermal NOAEL = 80 mg/kg/ LOC for MOE = 100        LOAEL = 400 mg/kg/day
 Dermal (1-30 days, 30 days-6 months,   day                                               based on decreased
 and 6 months to lifetime)                                                                body weight and food
 (Occupational/Residential)                                                               consumption,
                                                                                          hematologic effects,
                                                                                          increased spleen
                                                                                          weight and
                                                                                          extramedullary
                                                                                          hemapoiesis in the
                                                                                          spleen in the 21-Day
                                                                                          Dermal Toxicity Study
                                                                                          in Rats
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1-30 days)      Oral NOAEL= 10 mg/kg/    LOC for MOE = 100        LOAEL = 100 mg/kg/day
 (Occupational/Residential)             day (inhalation                                   based on decreased
                                        absorption rate =                                 body weight and food
                                        100%)                                             consumption in the Rat
                                                                                          Developmental Study
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (30 days- Oral study NOAEL= 0.9    LOC for MOE = 100        LOAEL = 10.4/10.7 mg/kg/
 6 months) (Occupational/Residential)   mg/kg/day (inhalation                             day based on changes
                                        absorption rate =                                 in hematologic
                                        100%)                                             parameters in the 90-
                                                                                          Day Dog Feeding Study
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (6 months-        Oral study NOAEL= 1.0    LOC for MOE = 100        LOAEL = 8.9/10.4 mg/kg/
 lifetime) (Occupational/Residential)   mg/kg/day (inhalation                             day [M/F] based on
                                        absorption rate =                                 changes in
                                        100%)                                             hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in bone
                                                                                          marrow, liver, and
                                                                                          kidney in the One Year
                                                                                          Dog Feeding Study
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Cancer classification    Risk Assessment not      No evidence of
                                        not likely               conducted                carcinogenicity
----------------------------------------------------------------------------------------------------------------
\1\ FQPA SF = Food Quality Protection Act safety factor, LOAEL = lowest observed adverse effect level, LOC =
  level of concern, MOE = margin of exposure, NOAEL = no observed adverse effect level, PAD = population
  adjusted dose (a = acute, c = chronic), RfD = reference dose, UF = uncertainty factor.
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor 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 180.572 for the combined residues of bifenazate and 
D3598 (expressed as bifenazate) in or on raw agricultural commodities 
and animal fat and combined residues of bifenazate, D3598 (expressed as 
bifenazate), A1530 and A1530-sulfate (expressed as A1530) in animal 
tissues (excluding fat) and milk. Risk assessments were conducted by 
EPA to assess dietary exposures from bifenazate in food as follows:
    i. Acute exposure. The Agency did not identify an acute endpoint 
for the general population, infants, children, and females 13 to 50 
years old. Therefore, an acute dietary exposure analysis is not 
necessary.
    ii. Chronic exposure. A chronic dietary exposure analysis was 
conducted using the Dietary Exposure Evaluation Model (DEEM 
ver 7.73) which incorporates consumption data from the USDA 1989-92 
Continuing Surveys of Food Intake by Individuals (CSFII). The dietary 
exposure analysis assumed tolerance level residues and 100% crop 
treated for all registered and proposed crops. Processing factors for 
apple juice and grape juice were reduced to 0.23 and 0.17, 
respectively. The DEEM default processing factor ratio 
between juice and concentrate was maintained and default processing 
factors were assumed for all other commodities.
    There is a Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA) sec 18 registration for application of bifenazate to greenhouse 
grown tomatoes. The potential for fresh market tomatoes to enter the 
processed market channel from this use is minimal for the following 
reasons: (a) this sec 18 approval will treat only about 300 acres of 
greenhouse grown tomatoes in Colorado, Texas and Virginia, (b) the 
tomato variety grown is an indeterminant type unsuitable for processing 
due to less solids and higher water content, (c) fresh market tomatoes 
do not tolerate the bulk handling required for processing, (d) higher 
price for fresh tomatoes would dictate the growers not to divert 
greenhouse grown tomatoes to the processing market. Therefore, the 
dietary contribution of bifenazate residues from treated tomatoes was 
determined to be negligible and a zero residue in/on tomatoes was 
assumed for this action.
    The chronic dietary food exposure estimates to bifenazate were less 
than The Agency 's level of concern (< 100% cPAD) for the general U.S. 
population and all population subgroups. The most highly exposed 
population was infants (< 1 year) at 52% of the cPAD.
    iii. Cancer. The Agency classified bifenazate as ``not likely'' to 
be a human carcinogen according to EPA Proposed Guidelines for 
Carcinogen Risk Assessment (April 10, 1996). Therefore, a cancer 
dietary exposure analysis is not necessary.
    2. Dietary exposure from drinking water. The available 
environmental fate data indicate that bifenazate may not persist in the 
environment nor have the ability to leach into ground water resources. 
Bifenazate dissipates quickly through metabolic processes under aerobic 
soil conditions (with a half-life of 30 minutes), by aqueous photolysis 
(half-life of 0.67 day), and by hydrolysis, especially in alkaline 
water (half-life of 0.08 day). In neutral and acidic water systems, 
bifenazate may persist for approximately one day or longer (half-lives 
of 0.8 day at pH 7, and 5.4 days in pH 5). Although photodegradation of 
bifenazate in soil may be possible, it could not be confirmed in the 
laboratory

[[Page 4918]]

due to rapid biodegradation of bifenazate under aerobic soil 
conditions. In the laboratory soil column studies, bifenazate showed 
low to no mobility in the soils tested.
    Two major degradates of bifenazate were identified in the aqueous 
photolysis and aerobic soil metabolism studies D3598 (diazinecarboxylic 
acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethylester) and D1989 
(4-methoxybiphenyl). Similar to parent bifenazate, D3598 seemed to 
metabolize quickly under aerobic soil conditions (half-life of 8.3 
hours). D1989 on the other hand, is believed to be more persistent and 
have some potential to leach into the ground water resources. D1989 has 
an aerobic soil metabolism half-life of 60 days and was observed to 
have slight mobility in laboratory leaching studies. D1989 was the only 
degradate of bifenazate detected in terrestrial field dissipation 
studies, but only the 0 - 6 inches soil depth.
    Since parent bifenazate and its degradate D3598 are not persistent 
in the environment and since there are no acute dietary endpoint data 
for these compounds, the Agency has decided not to consider bifenazate 
and D3598 as residues of concern in drinking water. Instead, D1989 was 
assumed to have the possible potential to contaminate the drinking 
water resources.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
bifenazate 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 bifenazate.
    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 Screening Concentration in Ground Water (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 bifenazate they are further 
discussed in the aggregate risk sections below.
    Based on the FIRST or PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of D1989 for acute exposures are 
estimated to be 18 parts per billion (ppb) for surface water and less 
than 1 part per trillion (ppt) for ground water. The EECs for chronic 
exposures are estimated to be 5 parts per billion (ppb) for surface 
water and <1 ppt for ground water. These concentrations were based on 
one application of bifenazate on hops at a maximum rate of 0.75 lb ai/
acre/year, and on the assumption that bifenazate totally metabolizes 
and degrades to D1989.
    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). The currently 
registered Floramite (EPA Reg. No. 400-481) and the proposed 
new product for food uses (Acramite; EPA File Symbol: 400 
LNG) of bifenazate are not expected to result in residential exposures. 
The Floramite label allows application of bifenazate to 
landscape ornamentals at residential/recreational sites by commercial 
applicators only. The Acramite label specifies agricultural 
use only. Therefore, this action assumes that bifenazate products will 
not be used by homeowners, so no homeowner exposure assessment is 
included. With respect to post-application residential exposures, the 
Agency contends that no significant post-application exposure is 
anticipated from treated ornamentals, either by residents or 
professional applicators; therefore, no residential post-application 
assessment is warranted.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 bifenazate has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
bifenazate 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 bifenazate 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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 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 margin of exposure 
(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. There is no qualitative or 
quantitative toxicity evidence of increased susceptibility of rats and 
rabbits during

[[Page 4919]]

in utero exposure or during post-natal exposure based on developmental 
toxicity and reproductive toxicity studies performed with bifenazate.
    3. Conclusion. There is a complete toxicity database for bifenazate 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. Based on the lack of 
increased susceptibility and the completeness of the toxicity and 
exposure databases, EPA has concluded that an additional 10X safety 
factor is not needed to protect infants and children.

E. Aggregate Risks and Determination of Safety

    Because The Agency does not have ground and surface water 
monitoring data to calculate a quantitative aggregate exposure, DWLOCs 
were calculated. A DWLOC is a theoretical upper limit on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food, drinking water, and through residential uses. A 
DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, body weights, and pesticide uses. Different populations 
will have different DWLOCs. The Agency uses DWLOCs in the risk 
assessment process to assess potential concern for exposure associated 
with pesticides in drinking water. DWLOC values are not regulatory 
standards for drinking water. The Agency compares DWLOC values for each 
relevant population subgroup to the estimated concentration of 
bifenazate in surface water and ground water from the Agency' screening 
models. If the DWLOC values are greater than the estimated 
concentration of bifenazate in surface water and ground water, The 
Agency concludes with reasonable certainty that exposures to bifenazate 
in drinking water do not pose a significant human health risk.
    To calculate the chronic DWLOCs, the food estimates (from 
DEEM) were subtracted from the appropriate PAD value to 
obtain the maximum water exposure level. DWLOCs were then calculated 
using the standard body weights and drinking water consumption figures: 
70kg/2L (adult male and U.S. population), 60 kg/2L (adult female), and 
10kg/1L (infants and children). Because there is no residential 
exposure to bifenazate, only chronic aggregate exposures are necessary.
    1. Acute risk. The Agency did not identify an acute endpoint for 
the general U.S. population, infants, children, and females 13-50 years 
old. Therefore, an acute risk is expected.
    2. Chronic risk. The chronic dietary food exposure to bifenazate 
was estimated at 0.005242 mg/kg/day (52% of cPAD) for infants (< 1 year 
old) and 0.001557 mg/kg/day (16% of cPAD) for the general U.S. 
population. The calculated DWLOCs ranged between 48 to 320 ppb for all 
the population subgroups. The surface and ground water chronic EECs for 
the bifenazate metabolite D1989 were estimated to be 5 ppb and < 1 part 
per trillion (ppt), respectively. Since the chronic EECs are less than 
the Agency's DWLOCs for all population subgroups including infants, the 
chronic aggregate risk estimates are below the Agency's level of 
concern. Table 3 summarizes the chronic aggregate exposure to 
bifenazate.

                          Table 3--Chronic Aggregate Exposures to Bifenazate Residues.
----------------------------------------------------------------------------------------------------------------
                                                                Maximum
                                                   Chronic      Chronic       Ground      Surface      Chronic
   Scenario/Population Subgroup     cPAD, mg/kg/     Food        Water        Water        Water      DWLOC\3\,
                                        day      Exposure mg/ Exposure\1\  EEC\2\, ppt  EEC\2\, ppb      ppb
                                                    kg/day     mg/kg/day
----------------------------------------------------------------------------------------------------------------
U.S. Population                            0.01     0.001557     0.008443           <1            5          300
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                 0.01     0.005242     0.004758           <1            5           48
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                   0.01     0.003941     0.006059           <1            5           61
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                  0.01     0.002343     0.007657           <1            5           77
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                  0.01     0.001088     0.008912           <1            5          270
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                    0.01     0.000931     0.009069           <1            5          320
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                      0.01     0.001050      0.00895           <1            5          310
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                    0.01     0.001924     0.008076           <1            5         280
----------------------------------------------------------------------------------------------------------------
\1\ Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from DEEM
  (mg/kg/day); no residential exposure
\2\ EECs resulting from one applications at 0.75 lbs ai/acre;
\3\ The chronic DWLOCs were calculated as follows: DWLOC (/L) = maximum water exposure (mg/kg/day) x
  body weight (kg)/consumption (L/day) x 0.001 mg/g

    3. Short-term risk. A short term risk assessment was not performed 
because there are no significant exposures anticipated from registered 
residential non-food uses of bifenazate.
    4. Intermediate-term risk. An intermediate term risk assessment was 
not performed because there are no significant post-application 
exposures anticipated from registered residential non-food uses of 
bifenazate.
    5. Aggregate cancer risk for U.S. population. Bifenazate is not 
carcinogenic.
    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 bifenazate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The analytical methods used in the field trial, processing, and 
ruminant feeding have been adequately validated and are appropriate for 
data gathering purposes. The following paragraphs pertain to the 
proposed plant and livestock enforcement methods.
    1. Plant. The method proposed for enforcement of the plant 
tolerances

[[Page 4920]]

associated with this petition has been adequately radiovalidated and 
validated by an independent laboratory. The Agency's Analytical 
Chemistry Laboratory (ACL) is currently doing a Petition Method 
Validation (PMV). After reviewing the independent validation, EPA 
believes that the PMV will at most show that relatively minor 
modifications or revisions may need to be made. The registrant will be 
required to make any modifications or revisions to the proposed 
enforcement method resulting from the PMV.
    2. Livestock. The method proposed for enforcement of the animal 
product tolerances associated with this petition has been adequately 
validated by an independent laboratory. The independent laboratory 
validation study resulted in marginal recoveries for bifenazate (milk 
and kidney), D3598 (liver), and A1530-sulfate (kidney). A 
radiovalidation of the method was not undertaken by the registrant, as 
the total radioactive bifenazate and its metabolite residues were very 
low for analytical purposes. However, the analytical method used for 
quantifying residues in animal tissues were satisfactorily validated on 
freshly spiked matrices. The ACL is currently doing a PMV. After 
reviewing the independent validation, EPA believes that the PMV will at 
most show that relatively minor modifications or revisions may need to 
be made. The registrant will be required to make any modifications or 
revisions to the proposed enforcement method resulting from the PMV.
    3. Multiresidue method (MRM). The registrant submitted data 
concerning the recovery of bifenazate and D3598 using FDA multiresidue 
method protocols A, C, D, E, and F (Pesticide Analytical Manual Vol. 
I). Acceptable results were only attained using Protocol C. These data 
were forwarded to FDA for inclusion in the Pesticide Analytical Manual 
I. The tolerance expression for livestock commodities includes A1530 
and A1530-sulfate. The registrant should submit information concerning 
the behavior of these compounds through the FDA multiresidue protocols.
    Adequate enforcement methodology (utilizing reversed phase high 
pressure liquid chromatography (HPLC) and oxidative coulometric 
electrochemical detection) is available to enforce the tolerance 
expression. The method may be requested from: Francis Griffith, 
Analytical Chemistry Branch, Environmental Science Center, 
Environmental Protection Agency, 701 Mapes Road, Fort George G. Mead, 
MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected]. In addition, Mulitresidue Enforcement Method, 
Protocol C, has been shown to be adequate for enforcing these 
tolerances.

B. International Residue Limits

    There is neither a CODEX proposal, nor Canadian or Mexican limits 
for residues of bifenazate and D3598 in/on pome fruit, stone fruit, 
strawberry, hops, cotton, or grape or for resides of bifenazate, D3598, 
A1530 and A1530-sulfate in/on livestock commodities. Therefore, 
harmonization is not an issue for this pesticide tolerance.

C. Conditions

    The submitted residue chemistry and toxicological studies are 
adequate for a conditional registration of bifenazate for food uses. 
There is high confidence in the hazard end points used for human health 
risk assessment. However, the following data are being required within 
2 years time in order to confirm the results of the studies already 
reviewed by the Agency and/or to complete the database requirements 
prior to approval of an unconditional registration of bifenazate:
    a. Confirmatory method and interference study for proposed plant 
and livestock enforcement.
    b. Radio validation of proposed livestock enforcement method.
    c. FDA multi residue methods testing of A1530 and A1530-sulfate.
    d. Storage stability data for hops, strawberry, apple juice, and 
wet apple pomace.
    e. Additional peach field trial data.
    f. Additional plum field trial data.
    g. Additional grape field trial data.
    h. Additional cotton field trial data.
    i. 28-day inhalation toxicity study. This study was requested by 
the Agency for further characterization of inhalation risk assessments. 
Due to the potential for inhalation exposure, there is concern for 
toxicity by the inhalation route. The 28-day inhalation toxicity study 
would give a dose and endpoint examined via the route of exposure of 
concern (i.e., route specific study) and thus would avoid using an oral 
study and route-to-route extrapolation. The protocol for the existing 
90-day inhalation toxicity study (OPPTS 870.3465) should be followed 
with the exposure (treatment) ending after 28 days, instead of 90 days.
    The rationale for not requiring these data before registration of 
food uses are provided below:
    1. Deficiencies a, b and c. Adequate analytical methods are 
available for enforcement purposes. These methods were independently 
validated and a petition method validation is in progress at the 
Agency's Analytical Chemistry Laboratory. In addition, a Mulitresidue 
Enforcement Method, Protocol C, has been shown to be adequate for 
enforcing these tolerances.
    2. Deficiencies d through h. The storage interval of almost all 
commodity samples collected from the field trial and processing have 
been validated. The storage interval for hops, strawberry, apple juice, 
and wet apple pomace were not validated as required and are necessary 
to confirm the submitted residue chemistry data. The Agency concluded 
that the interval from sampling until analysis was reasonable and will 
not invalidate the submitted data due to lack of stability of 
bifenazate residues of concern. For peach, plum, grape and cotton, the 
requirements are additional field trials to fulfil the geographical 
distribution and also to confirm the data already submitted and 
reviewed by the Agency. The crops and number of trials required are 
peach(2), plum(1), grape(1) and cotton(1).
    3. Deficiency i. Bifenazate is not acutely toxic by oral, dermal or 
inhalation routes (Toxicity category IV). Because of low inhalation 
toxicity, the registrant did not do a subchronic inhalation toxicity 
and its absence, the Agency used for endpoint selection the oral NOAELs 
for short-, intermediate- and long-term inhalation exposure risk 
assessment for this action. To fully characterize the toxicity 
potential by inhalation route of exposure over long term use of 
bifenazate, a 28-day inhalation study is required.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
bifenazate and D3598 (expressed as bifenazate) in or on apple, wet 
pomace at 1.2 ppm; cattle fat at 0.1 ppm; cotton, undelinted seed at 
0.75 ppm; cotton, gin byproducts at 35 ppm; fruit, pome, group at 0.75 
ppm; goat fat at 0.1 pm; grape 0.75 ppm; grape, raisin at 1.2 ppm; hog 
fat at 0.1 ppm; hop, dried cones at 15 ppm; horse fat at 0.1 ppm; 
nectarine at 1.7 ppm; peach at 1.7 ppm; plum at 0.30 ppm; sheep fat at 
0.1 ppm strawberry at 1.5 ppm and combined residues of bifenazate, 
D3598 (expressed a bifenazate), A1530 and A1530-sulfate (expressed as 
A1530) in cattle meat at 0.01 ppm; cattle meat byproducts at 0.01 ppm; 
goat meat at 0.01 ppm; goat meat byproducts at 0.01 ppm; hog meat at 
0.01 ppm; hog meat byproducts at 0.01 ppm; horse meat at 0.01 ppm; 
horse meat byproducts at 0.01 ppm; milk at 0.01 ppm; sheep meat at 0.01 
ppm; and sheep meat byproducts at 0.01 ppm.
    Some of the tolerance values requested by the registrant in their 
petition are different from that

[[Page 4921]]

determined by the Agency. The differences are due to the following 
reasons: The registrant requested a group tolerance for stone fruits. 
This is not appropriate at this time as no field trial data were 
submitted on cherry and apricot and/or the maximum peach (1.45 ppm) and 
plum (0.15 ppm) residue varied by a factor > 5x. In the case of 
undelinted cotton seeds and cotton gin byproducts, the Agency concluded 
that a higher tolerance of 0.75 ppm and 35 ppm are required as compared 
with 0.5 ppm and 20 ppm, respectively, for the combined residues of 
bifenazate and D3598 (expressed as bifenazate) due to the correction 
factors applied to the percent recoveries of residues for concern in 
the storage stability study. For meat of cattle, goat, hog, horse and 
sheep the registrant requested a 0.02 ppm tolerance; however, the 
Agency concluded that the bifenazate level used in the animal feeding 
study (maximum theoretical dietary burden) supports only 0.01 ppm for 
the combined residues of bifenazate, D3598 (expressed as bifenazate), 
A1530 and A1530-sulfate (expressed as A1530).

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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301206 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 April 2, 
2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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.2. Mail your 
copies, identified by docket control number OPP-301206, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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

[[Page 4922]]

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

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

    Dated: January 15, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.572 is amended by adding text to paragraph (a) to 
read as follows:


Sec. 180.572  Bifenazate; tolerances for residues.

    (a) General. (1) Tolerances are established for combined residues 
of bifenazate (hydrazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-
yl), 1-methylethyl ester) and D3598 expressed as bifenazate 
(diazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-
methylethylester) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace..........................................          1.2
Cattle, fat................................................          0.1
Cotton, gin byproducts.....................................           35
Cotton, undelinted seed....................................         0.75
Fruit, pome, group.........................................         0.75
Goat, fat..................................................          0.1
Grape......................................................         0.75
Grape, raisin..............................................          1.2
Hog, fat...................................................          0.1
Hop, dried cones...........................................           15
Horse, fat.................................................          0.1
Nectarine..................................................          1.7
Peach......................................................          1.7
Plum.......................................................          0.3
Sheep, fat.................................................          0.1
Strawberry.................................................          1.5
------------------------------------------------------------------------

    (2) Tolerances are established for combined residues of bifenazate 
(hydrazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-
methylethyl ester) and D3598 expressed as bifenazate (diazinecarboxylic 
acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethylester), A1530 
(1,1'-biphenyl, 4-ol) and A1530-sulfate expressed as A1530 (1,1'-
biphenyl, 4-oxysulfonic acid) in the following animal commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, meat...............................................         0.01
Cattle, meat byproducts....................................         0.01
Goat, meat.................................................         0.01
Goat, meat byproducts......................................         0.01
Hog, meat..................................................         0.01
Hog, meat byproducts.......................................         0.01
Horse, meat................................................         0.01
Horse, meat byproducts.....................................         0.01
Milk.......................................................         0.01
Sheep, meat................................................         0.01
Sheep, meat byproducts.....................................         0.01
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-2612 Filed 1-31-02; 8:45 am]
BILLING CODE 6560-50-S