[Federal Register Volume 67, Number 75 (Thursday, April 18, 2002)]
[Rules and Regulations]
[Pages 19120-19130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9497]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0003; FRL-6831-8]
RIN 2070-AB78


Fluazinam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an import tolerance for residues 
of fluazinam and its metabolite AMGT3-[[4-amino-3-[[3-chloro-5-
(trifloromethyl)-2-pyridinyl] amino]-2-nitro-6-(trifluoromethyl) 
phenyl] thio]-2-(beta-D-glucopyranosyloxy) propionic acid) in or on 
[wine grapes at 3.0 parts per million (ppm). ISK BioSciences 
Corporation requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective April 18, 2002. Objections and 
requests for hearings, identified by docket control number OPP-2002-
0003, must be received on or before June 17, 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-2002-0003 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-7740; 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
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal 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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0003. 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 December 6, 2000 (65 FR 76253) (FRL-
6573-7), EPA

[[Page 19121]]

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 Food Quality 
Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 9F5079) by ISK BioSciences 
Corporation, 5970 Heisley Road, Suite 200, Mentor, Ohio, 44060. This 
notice included a summary of the petition prepared by ISK BioSciences 
Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.574 be amended by 
establishing a tolerance for residues of the fungicide fluazinam, 3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl) phenyl]-5-
(trifluoromethyl)-2-pyridinamine, in or on peanuts and potatoes at 0.02 
part per million (ppm) and imported wine grapes at 3.0 ppm. In the 
Federal Register of September 7, 2001 (66 FR 46729) (FRL-6797-3), EPA 
established tolerances for peanuts and potatoes.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    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 a tolerance for residues of fluazinam and its metabolite 
AMGT on wine grapes at 3.0. 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 fluazinam and its 
metabolite AMGT 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.--Toxicological Profile of Fluazinam Technical
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL: Males = 3.8
                                   toxicity rats       mg/kg/day;
                                                       Females = 4.3 mg/
                                                       kg/day
                                                      LOAEL Males = 38
                                                       mg/kg/day;
                                                       Females = 44 mg/
                                                       kg/day based on
                                                       increased liver
                                                       weights and liver
                                                       histopathology in
                                                       males, and
                                                       increased lung
                                                       and uterus
                                                       weights in
                                                       females.
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 10 mg/kg/
                                   toxicity dogs       day
                                                      LOAEL = 100 mg/kg/
                                                       day based on
                                                       retinal effects,
                                                       increased
                                                       relative liver
                                                       weight, liver
                                                       histopathology
                                                       and possible
                                                       increased serum
                                                       alkaline
                                                       phosphatase in
                                                       females and
                                                       possible marginal
                                                       vacuolation of
                                                       the cerebral
                                                       white matter
                                                       (equivocal)
------------------------------------------------------------------------
870.3200                          21-Day dermal       Systemic NOAEL =
                                   toxicity rats       10 mg/kg/day
                                                      LOAEL = 100 mg/kg/
                                                       day based on
                                                       increased AST and
                                                       cholesterol
                                                       levels in
                                                       clinical
                                                       chemistry
                                                       determinations
                                                       (males)
                                                      Dermal NOAEL = not
                                                       identified
                                                      LOAEL = 10 mg/kg/
                                                       day based on
                                                       erythema,
                                                       acanthosis, and
                                                       dermatitis
------------------------------------------------------------------------
870.3250                          90-Day dermal       Not Available
                                   toxicity
------------------------------------------------------------------------
870.3465                          90-Day inhalation   Not Available
                                   toxicity
------------------------------------------------------------------------

[[Page 19122]]

 
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental       50 mg/kg/day
                                   toxicity rats      LOAEL = 250 mg/kg/
                                                       day based on
                                                       decreased body
                                                       weight gain and
                                                       food consumption
                                                       and increased
                                                       water consumption
                                                       and urogenital
                                                       staining
                                                      Developmental
                                                       NOAEL = 50 mg/kg/
                                                       day
                                                      LOAEL = 250 mg/kg/
                                                       day based on
                                                       decreased fetal
                                                       body weights and
                                                       placental
                                                       weights,
                                                       increased facial/
                                                       cleft palates,
                                                       diaphragmatic
                                                       hernia, and
                                                       delayed
                                                       ossification in
                                                       several bone
                                                       types, greenish
                                                       amniotic fluid
                                                       and possible
                                                       increased late
                                                       resorptions and
                                                       postimplantation
                                                       loss
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL = 4
                                   developmental       mg/kg/day
                                   toxicity rabbits   LOAEL = 7 mg/kg/
                                                       day based on
                                                       decreased food
                                                       consumption and
                                                       increased liver
                                                       histopathology.
                                                      Developmental
                                                       NOAEL = 7 mg/kg/
                                                       day
                                                      LOAEL = 12 mg/kg/
                                                       day based on an
                                                       increase in total
                                                       litter
                                                       resorptions and
                                                       possible fetal
                                                       skeletal
                                                       abnormalities
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL = 3
                                   developmental       mg/kg/day
                                   toxicity rabbits   LOAEL = not
                                                       identified (>3 mg/
                                                       kg/day)
                                                      Developmental
                                                       NOAEL = 3 mg/kg/
                                                       day
                                                      LOAEL = not
                                                       identified (>3 mg/
                                                       kg/day)
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 1.9 mg/kg/
                                   rats                day
                                                      LOAEL = 9.7 mg/kg/
                                                       day based on
                                                       liver pathology
                                                       in F1 males
                                                      Reproductive NOAEL
                                                       = 10.6 mg/kg/day
                                                      LOAEL = 53.6 mg/kg/
                                                       day based on
                                                       decreased number
                                                       of implantation
                                                       sites and
                                                       decreased litter
                                                       sizes to day 4
                                                       post-partum for
                                                       F1 females (F2
                                                       litters).
                                                      Offspring NOAEL =
                                                       8.4 mg/kg/day
                                                      LOAEL = 42.1 mg/kg/
                                                       day based on
                                                       reduced F1 and F2
                                                       pup body weight
                                                       gains during
                                                       lactation.
------------------------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL = Males: 1.9
                                   rats                mg/kg/day;
                                                       Females: 4.9 mg/
                                                       kg/day
                                                      LOAEL = Males: 3.9
                                                       mg/kg/day;
                                                       Females: not
                                                       identified (4.9 mg/kg/
                                                       day) based on
                                                       increased
                                                       testicular
                                                       atrophy in males
                                                       and no effects in
                                                       females
------------------------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL = 1 mg/kg/
                                   dogs                day
                                                      LOAEL = 10 mg/kg/
                                                       day based on
                                                       gastric lymphoid
                                                       hyperplasia in
                                                       both sexes and
                                                       nasal dryness in
                                                       females
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = Males:1.1
                                   mice                mg/kg/day;
                                                       Females: 1.2 mg/
                                                       kg/day
                                                      LOAEL = Males:
                                                       10.7 mg/kg/day;
                                                       Females: 11.7 mg/
                                                       kg/day based on
                                                       increased
                                                       incidences of
                                                       brown macrophages
                                                       in the liver of
                                                       both sexes,
                                                       eosinophilic
                                                       vacuolated
                                                       hepatocytes in
                                                       males, and
                                                       increased liver
                                                       weight in
                                                       females.
                                                      Clear evidence of
                                                       carcinogenicity
                                                       (hepatocellular
                                                       tumors) in male
                                                       mice, but not in
                                                       females
------------------------------------------------------------------------

[[Page 19123]]

 
870.4200                          Carcinogenicity     NOAEL = Males:
                                   mice                <126 mg/kg/day,
                                                       Females: <162 mg/
                                                       kg/day
                                                      LOAEL = Males: 126
                                                       mg/kg/day;
                                                       Females: 162 mg/
                                                       kg/day based on
                                                       increased liver
                                                       weights and liver
                                                       and brain
                                                       histopathology in
                                                       both sexes
                                                      Equivocal/some
                                                       evidence of
                                                       carcinogenicity
                                                       (hepatocellular
                                                       tumors) in male
                                                       mice, but not in
                                                       females
------------------------------------------------------------------------
870.4300                          Combined chronic    NOAEL = Males:
                                   toxicity/           0.38 mg/kg/day;
                                   carcinogenicity     Females: 0.47 mg/
                                   rats                kg/day
                                                      LOAEL = Males: 3.8
                                                       mg/kg/day;
                                                       Females: 4.9 mg/
                                                       kg/day based on
                                                       liver toxicity in
                                                       both sexes,
                                                       pancreatic
                                                       exocrine atrophy
                                                       in females and
                                                       testicular
                                                       atrophy in males.
                                                       Some evidence of
                                                       carcinogenicity
                                                       (thyroid gland
                                                       follicular cell
                                                       tumors) in male
                                                       rats, but not in
                                                       females.
------------------------------------------------------------------------
870.5100                          Bacterial reverse   Negative with and
                                   mutation assay      without S9 up to
                                   (Ames test)         cytotoxic
                                                       concentrations.
------------------------------------------------------------------------
870.5100                          Bacterial reverse   Negative with and
                                   mutation assay      without S9 up to
                                   (Ames test)         cytotoxic
                                                       concentrations.
------------------------------------------------------------------------
870.5300                          In vitro mammalian  Negative with S9
                                   gene mutation       activation up to
                                   assay               9 g/ml.
                                                       Negative without
                                                       S9 activation up
                                                       to 0.3 g/
                                                       ml.
                                                      Compound tested to
                                                       cytotoxic
                                                       concentrations.
------------------------------------------------------------------------
870.5300                          In vitro mammalian  Negative with and
                                   gene mutation       without S9
                                   assay               activation up to
                                                       5 g/ml.
                                                      Compound tested to
                                                       cytotoxic
                                                       concentrations.
------------------------------------------------------------------------
870.5375                          In vitro mammalian  Negative with and
                                   chromosome          without S9 up to
                                   aberration (CHL     cytotoxic
                                   cells)              concentrations.
                                                      Cells harvested at
                                                       24 and 48 hours
                                                       in nonactivated
                                                       studies and at 24
                                                       hours in
                                                       activated
                                                       studies.
------------------------------------------------------------------------
870.5395                          Mammalian           Negative at 24
                                   erythrocyte         hour sacrifice
                                   micronucleus test   (500, 1,000,
                                                       2,000 mg/kg).
                                                      Negative at 24,
                                                       48, and 72 hour
                                                       sacrifices (2,000
                                                       mg/kg).
------------------------------------------------------------------------
870.5550                          UDS in primary rat  Negative; however
                                   hepatocytes         there were
                                                       several serious
                                                       study
                                                       deficiencies:
                                                       Treatment time
                                                       shorter than
                                                       recommended, no
                                                       data supporting
                                                       the claim of
                                                       cytotoxicity,
                                                       data variability
                                                       for major
                                                       endpoints.
------------------------------------------------------------------------
870.5550                          Differential        Negative, however
                                   killing/growth      only one
                                   inhibition in B.    replicate plate/
                                   subtilis            dose was used.
------------------------------------------------------------------------
870.6200                          Acute               Systemic NOAEL =
                                   neurotoxicity       50 mg/kg
                                   screening battery  LOAEL = 1,000 mg/
                                   rats                kg based on soft
                                                       stools and
                                                       decreased motor
                                                       activity on day
                                                       of dosing.
                                                      Neurotoxicity
                                                       NOAEL = 2,000 mg/
                                                       kg
                                                      LOAEL = not
                                                       identified
                                                       (>2,000 mg/kg)
------------------------------------------------------------------------
870.6200                          Subchronic          Neurotoxicity
                                   neurotoxicity       NOAEL = Males:
                                   screening battery   233 mg/kg/day;
                                   rats                Females: 280 mg/
                                                       kg/day
                                                      LOAEL = not
                                                       identified
                                                       (Males: >233 mg/
                                                       kg/day; Females:
                                                       >280 mg/kg/day)
------------------------------------------------------------------------
870.6300                          Developmental       Not Available
                                   neurotoxicity
------------------------------------------------------------------------

[[Page 19124]]

 
870.7485                          Metabolism and      Only 33-40% of the
                                   pharmacokinetics    administered dose
                                   rats                was absorbed.
                                                       Most of the
                                                       administered dose
                                                       was recovered in
                                                       the feces (>89%).
                                                      Excretion via the
                                                       urine was minor
                                                       (<4%). Total
                                                       biliary
                                                       radioactivity,
                                                       however,
                                                       represented 25-
                                                       34% of the
                                                       administered
                                                       dose, indicating
                                                       considerable
                                                       enterohepatic
                                                       circulation.
------------------------------------------------------------------------
870.7600                          Dermal penetration  Not Available
------------------------------------------------------------------------
Special studies:                  4-Week dietary      NOAEL = Males: 5.1
                                   (Range-finding)     mg/kg/day;
                                   rats                Females: 5.3 mg/
                                                       kg/day
                                                      LOAEL = Males:
                                                       26.4 mg/kg/day;
                                                       Females: 25.9 mg/
                                                       kg/day based on
                                                       decreased body
                                                       weight gain and
                                                       food consumption,
                                                       increased serum
                                                       phospholipids,
                                                       increased total
                                                       cholesterol,
                                                       increased
                                                       relative liver
                                                       weights, and
                                                       liver
                                                       histopathology.
------------------------------------------------------------------------
                                  4-Week dietary      NOAEL = Males: 7.6
                                   (Range-finding)     mg/kg/day;
                                   mice                Females: 8.2 mg/
                                                       kg/day
                                                      LOAEL = Males: 36
                                                       mg/kg/day;
                                                       Females: 43 mg/kg/
                                                       day based on
                                                       decreased body
                                                       weight gain,
                                                       increased serum
                                                       glucose,
                                                       increased kidney
                                                       weights.
------------------------------------------------------------------------
                                  4-Week dietary      NOAEL = not
                                   (Range-finding)     identified
                                   mice                (Males; <555 mg/
                                                       kg/day; Females:
                                                       <658 mg/kg/day)
                                                      LOAEL = Males: 555
                                                       mg/kg/day;
                                                       Females: 658 mg/
                                                       kg/day based on
                                                       vacuolation of
                                                       white matter in
                                                       brain, increased
                                                       liver weights,
                                                       histopathology in
                                                       liver.
------------------------------------------------------------------------
                                  90-Day dietary      NOAEL = not
                                   (Special liver      determined
                                   study) rats         (Males: <37.6 mg/
                                                       kg/day, Females:
                                                       <44.7 mg/kg/day)
                                                      LOAEL = Males:
                                                       37.6 mg/kg/day,
                                                       Females: 44.7 mg/
                                                       kg/day based on
                                                       increased
                                                       relative liver
                                                       weights and liver
                                                       histopathology.
------------------------------------------------------------------------
                                  11-Week oral        NOAEL/LOAEL not
                                   toxicity (Special   determined.
                                   retinal study)
                                   dogs
------------------------------------------------------------------------
                                  7-Day inhalation    NOAEL = Males:
                                   toxicity rats       1.38 mg/kg/day;
                                  Test Material:       Females: 1.49 mg/
                                   Frowncide WP        kg/day
                                   (51.9% a.i.).      LOAEL = Males:
                                                       3.97 mg/kg/day;
                                                       Females: 4.25 mg/
                                                       kg/day based on
                                                       increased testes
                                                       weight (males)
                                                       and increased
                                                       liver weight
                                                       (females).
------------------------------------------------------------------------
                                  Developmental       Maternal and
                                   toxicity (range-    developmental
                                   finding) rats       NOAELS and LOAELS
                                                       were not
                                                       assigned.
------------------------------------------------------------------------
                                  Eight special       White matter
                                   mechanistic         vacuolation in
                                   studies to assess   the CNS of mice,
                                   the CNS white       rats, and dogs
                                   matter              was found to be
                                   vacuolation         due to Impurity-
                                                       5.
------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional
  safety factor retained due to concerns unique to the FQPA.

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.
    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

[[Page 19125]]

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. 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 fluazinam used for human risk assessment is shown in the 
following Table 2:

    Table 2.--Summary of Toxicological Toxicological Doses and Endpoints for Fluazinam for Use in Human Risk
                                                  Assessments1
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF* and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   Developmental            FQPA SF = 10             Developmental toxicity,
 age                                   NOAEL = 7 mg/kg/day....  aPAD = acute RfD/FQPA     rabbits.
                                       UF = 100...............   SF = 0.007 mg/kg/day.   Developmental LOAEL =
                                       Acute RfD = 0.07 mg/kg/                            12 mg/kg/day based on
                                        day.                                              increased incidence of
                                                                                          total litter
                                                                                          resorptions and
                                                                                          possibly increased
                                                                                          incidence of fetal
                                                                                          skeletal
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute dietary general population       NOAEL= 50 mg/kg/day      FQPA SF = 3              Acute neurotoxicity,
 including infants and children        UF = 100...............  aPAD = acute RfD/FQPA     rats.
                                       Acute RfD = 0.50 mg/kg/   SF = 0.167 mg/kg/day.   LOAEL = 1,000 mg/kg/day
                                        day.                                              based on decreased
                                                                                          motor activity and
                                                                                          soft stools on day of
                                                                                          dosing.
----------------------------------------------------------------------------------------------------------------
Exposure scenario                      Dose used in risk        FQPA SF* and endpoint    Study and Toxicological
                                        assessment, UF           for risk assessment      Effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL= 1.1 mg/kg/day     FQPA SF = 3              Carcinogenicity, mice.
                                       UF = 100...............  cPAD = chr RfD = FQPA    LOAEL = 10.7 mg/kg/day
                                       Chronic RfD = 0.011 mg/   SF 0.00367 mg/kg/day.    based on liver
                                        kg/day.                                           histopathology and
                                                                                          increased liver
                                                                                          weight.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL= 1.1 mg/kg/day     FQPA SF = 3              Carcinogenicity, mice.
                                       UF = 100...............  cPAD = chr RfD = FQPA    LOAEL = 10.7 mg/kg/day
                                       Chronic RfD = 0.011 mg/   SF 0.00367 mg/kg/day.    based on liver
                                        kg/day.                                           histopathology and
                                                                                          increased liver
                                                                                          weight.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Suggestive evidence    Quantification of human  Increases in thyroid
                                        of carcino-genicity,     cancer risk not          gland follicular cell
                                        but not sufficient to    required. 2              tumors in male rats;
                                        assess human                                      increases in
                                        carcinogenic                                      hepatocellular (liver)
                                        potential''2                                      tumors in male mice.2
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any safety factor retained or reduced due to concerns unique
  to the FQPA.
1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
  lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference
  dose, LOC = level of concern, MOE = margin of exposure
2Cancer Assessment Document - Evaluation of the Carcinogenic Potential of Fluazinam, March 29, 2001, HED Doc.
  No. 014512.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established for the residues of fluazinam in and or on potatoes and 
peanuts. Risk assessments were conducted by EPA on these crops and wine 
grapes to assess dietary exposures from fluazinam 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) 
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 DEEM acute dietary exposure analysis was 
performed using tolerance residue levels and 100% CT data for all 
commodities (Tier 1). The DEEM defaults were used for all processing 
factors. The DEEM analysis included wine and sherry grapes, peanuts and 
potatoes using anticipated residues of fluazinam and its metabolite 
(AMGT) and processing factors for wine grapes (Tier 3).
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model DEEM analysis 
evaluated the 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 DEEM chronic dietary exposure 
analysis was performed using tolerance residue levels and 100% CT data 
for all commodities (Tier 1). The DEEM defaults were used for all 
processing factors. The DEEM analysis included wine and sherry grapes, 
peanuts and potatoes using anticipated

[[Page 19126]]

residues of fluazinam and its metabolite (AMGT) and processing factors 
for wine grapes.
    iii. Cancer. Since fluazinam has been classified as ``Suggestive 
evidence of carcinogenicity, but not sufficient to assess human 
carcinogenic potential,'' an exposure assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fluazinam 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 fluazinam.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
Screening Concentrations in Ground Water (SCI-GROW), which predicts 
pesticide concentrations in ground water. In general, EPA will use 
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. 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 fluazinam they are further 
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of fluazinam for 
acute exposures are estimated to be 18.0 parts per billion (ppb) for 
surface water and 0.10 ppb for ground water. The EECs for chronic 
exposures are estimated to be 3.15 ppb for surface water and 0.10 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).
    Fluazinam is not registered for use on any sites that would result 
in residential exposure.
    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 fluazinam 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, 
fluazinam 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 fluazinam 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. Qualitative evidence of 
increased susceptibility of fetuses to fluazinam was demonstrated in a 
developmental toxicity study in rats. Increased incidences of facial/
palate clefts and other rare deformities in the fetuses were observed 
in the presence of minimal maternal toxicity. In a developmental 
toxicity study in rabbits and in a 2-generation reproduction study in 
rats, neither quantitative nor qualitative evidence of increased 
susceptibility of fetuses or pups to fluazinam was observed. Because of 
the neurotoxic lesion observed in the white matter of the brain in 
mice, dogs and rats and the qualitative evidence of increased 
susceptibility of rat fetuses to fluazinam, a developmental 
neurotoxicity study will be required to be submitted to the Agency. 
Further, because of the lack of a developmental neurotoxicity study and 
the qualitative evidence of increased susceptibility of rat fetuses to 
fluazinam, the Food Quality Protection Act (FQPA) safety factor (SF) 
for protection of infants and children, as required by the FQPA of 
1996, will be retained at 10X when assessing acute dietary exposure for 
``females 13-50 years of age'' due to concern for the developing fetus. 
Additionally, the FQPA SF will be reduced to 3X when assessing 
exposures for ``all populations'' for all exposure durations (acute and 
chronic) because of uncertainty resulting from lack of a developmental 
neurotoxicity study.
    3. Conclusion. Because of the lack of a developmental neurotoxicity 
study and the qualitative evidence of increased susceptibility of rat 
fetuses to fluazinam, the Agency determined that the FQPA safety factor 
should be retained at 10X when assessing acute dietary exposure for 
``females 13-50 years of age'' since, in addition to the need for a 
developmental neurotoxicity study, increased susceptibility of rat 
fetuses was observed following in utero exposure (an acute effect) in 
the rat developmental toxicity study resulting in concern for the 
developing fetus. The Agency also determined that the FQPA safety 
factor should be reduced to 3X

[[Page 19127]]

when assessing exposure for ``all populations'' for all exposure 
durations (acute and chronic) since there is uncertainty due to the 
lack of a developmental neurotoxicity study. This study will further 
characterize the toxicity of fluazinam and may provide endpoints and 
NOAELs that could be used in risk assessments for any subpopulation/
exposure duration.

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 Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default 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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP 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 to fluazinam from 
food will occupy 2% or less of the aPAD for the U.S. population, 60% of 
the aPAD for the most highly exposed population subgroup, females 13-50 
years old. All other population subgroups occupy 2% or less of the 
aPAD. In addition, there is potential for acute dietary exposure to 
fluazinam 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 the 
following Table 3:

                       Table 3.--Aggregate Risk Assessment for Acute Exposure to Fluazinam
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.17           2%           18         0.10        5,800
----------------------------------------------------------------------------------------------------------------
Adult male 20+ yrs                                      0.17           2%           18         0.10        5,800
----------------------------------------------------------------------------------------------------------------
Adult female 13-50 yrs                                 0.007          60%           18         0.10           84
----------------------------------------------------------------------------------------------------------------
Children 1-6 yr                                         0.17          <1%           18         0.10        1,700
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to fluazinam 
from food will utilize <1% of the cPAD for the U.S. population and 1% 
of the cPAD for the most highly exposed population subgroup, children 
1-6 years old. There are no residential uses for fluazinam that result 
in chronic residential exposure to fluazinam. There is potential for 
chronic dietary exposure to fluazinam 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 the following Table 4:

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fluazinam
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/   %cPAD Food   Water EEC    Water EEC     Chronic
                                                     day                      (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       0.0037           <1         3.15         0.10          130
----------------------------------------------------------------------------------------------------------------
Adult male 13-19 yrs                                  0.0037           <1         3.15         0.10          130
----------------------------------------------------------------------------------------------------------------
Adult fmale 13-50 yrs                                 0.0037           <1         3.15         0.10          110
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs                                      0.0037            1         3.15         0.10           37
----------------------------------------------------------------------------------------------------------------

    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).

[[Page 19128]]

    Fluazinam is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    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).
    Fluazinam is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. In accordance with 
the EPA Draft Guidelines for Carcinogen Risk Assessment (July 1999), 
the Agency classified fluazinam into the category ``Suggestive evidence 
of carcinogenicity, but not sufficient to assess human carcinogenic 
potential'' based on the following weight-of-the-evidence 
considerations:
    i. There was some evidence in that fluazinam induced an increase in 
thyroid gland follicular cell tumors in male rats, but not in female 
rats. In one study in mice, there was clear evidence that an increased 
incidence of hepatocellular tumors observed in the male mice was 
treatment-related. In another study in mice, there was equivocal/some 
evidence that fluazinam may have induced an increase in hepatocellular 
tumors in the male mice. Increases in hepatocellular tumors observed in 
the female mice in the latter study were not statistically significant 
and some occurred at an excessively toxic dose level. The thyroid gland 
follicular cell tumors of concern were seen only in male rats and the 
hepatocellular tumors of concern were seen only in male mice.
    ii. Fluazinam was negative in mutagenicity assays. Based on the 
proposed 1999 EPA Cancer Risk Assessment Guidelines, the Agency 
classified fluazinam as having ``suggestive evidence of 
carcinogenicity,'' but not sufficient to assess human carcinogenic 
potential and further determined that therefore no quantification of 
cancer risk is required. Therefore, a cancer risk assessment is not 
required.
    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 fluazinam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For the metabolite AMGT3-[[4-amino-3-[[3-chloro-5-(trifloromethyl)-
2-pyridinyl] amino]-2-nitro-6-(trifluoromethyl) phenyl] thio]-2-(beta-
D-glucopyranosyloxy) propionic acid) in/on grapes, the submitted ILV 
using reversed-phase HPLC with UV absorbance (at 254 nm) detector has 
been received and the method has been forwarded to the Agency's 
laboratory for validation. The petitioner will be required to make any 
modifications or revisions to the proposed method resulting from EPA's 
validation. The petitioner must also submit multiresidue method data as 
a confirmatory procedure. Upon successful completion of the EPA 
validation, the mehtod will be forwarded to FDA for publication in a 
future revision of the Pesticide Analytical Manual, Vol-II (PAM-II). 
Prior to publication and upon request, the method will be available 
prior to the harvest season from the /analytical Chemistry Branch 
(ACB), BEAD (75053), Environmental Science Center, 701 Mapes Road, Ft. 
George C. Meade, MD 20755-5350. Contact Francis D. Griffith, Jr., 
telephone (410) 305-2905, e-mail: [email protected]. The 
analytical standards are also available from the EPA National Standard 
Repository at the same location. The submitted HPLC/UV method is 
adequate for collecting data on residues of AMGT in/or grapes with a 
validated LOQ for residues of AMGT in grape commodites of 0.01 ppm.
    Adequate enforcement methodology (example--gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There are currently no Codex maximum residue levels established for 
residues of fluazinam on any crop.

C. Conditions

    The toxicological data base for fluazinam is adequate at this time 
to support the requested registration and tolerances according to 
Subdivision F Guideline requirements and 40 CFR 158.690. The Agency has 
determined that there is a high degree of confidence in the hazard 
endpoints and dose-response assessments conducted for this chemical. 
However, the Agency is requiring that the following additional 
toxicology studies be performed and submitted within a reasonable 
period of time in order to more clearly and fully characterize the 
toxicity of this chemical.
    870.3465 -- 28-Day inhalation toxicity in rats due December 2003.
    870.6300 -- Developmental neurotoxicity study in rats. The protocol 
should be submitted by July 2002 to EPA for approval/comment before the 
start of the study and should include full neurohistopathological 
examination of dams. The study is due 2 years after approval of the 
protocol.
    870.6200 -- Subchronic neurotoxicity screening battery in rats 
(conditional requirement). Based on a consideration of the results in 
the developmental neurotoxicity study in rats required above, the 
Agency will subsequently recommend whether a repeat of the subchronic 
neurotoxicity study in rats (870.6200) should also be required to 
support the registration of fluazinam products. This study must be 
submitted, if required by the Agency, 2 years after notification by the 
Agency.

D. Residue Chemistry

    Multiresidue methods data for AMGT, due December 2002
    Dislodgeable foliar residue

V. Conclusion

    Therefore, the import tolerance is established for residues of 
fluazinam, 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-
5-(trifluoromethyl)-2-pyridinamine and its metabolite AMGT 3-[[4-amino-
3-[[3-chloro-5-(trifloromethyl)-2-pyridinyl] amino]-2-nitro-6-
(trifluoromethyl) phenyl] thio]-2-(beta-D-glucopyranosyloxy) propionic 
acid) in or on wine grapes at 3.0 ppm.

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

[[Page 19129]]

tolerance issued by EPA under new section 408(d), as was provided in 
the old FFDCA sections 408 and 409. However, the period for filing 
objections is now 60 days, rather than 30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-2002-0003 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 17, 
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-2002-0003, 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 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

[[Page 19130]]

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 
recordkeeping requirements.


    Dated: April 9, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.574 is amended by revising paragraph (a) to read as 
follows:


Sec. 180.574  Fluazinam; tolerances for residues.

    (a)(1) General. Tolerances are established for residues of 
fluazinam, (3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl) 
phenyl]-5-(trifluoromethyl)-2-pyridinamine) in or on the following 
commodities:

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Peanuts........................................                     0.02
Potatoes.......................................                     0.02
------------------------------------------------------------------------

    (a)(2) Tolerances are established for residues of fluazinam and its 
metabolite AMGT 3-[[4-amino-3-[[3-chloro-5-(trifloromethyl)-2-
pyridinyl]amino]-2-nitro-6-(trifluoromethyl) phenyl] thio]-2-(beta-D-
glucopyranosyloxy) propionic acid) in or on the following commodity:

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Wine grapes1...................................                      3.0
------------------------------------------------------------------------
1 No US registration as of March 15, 2002.

* * * * *

[FR Doc. 02-9497 Filed 4-17-02; 8:45 am]
BILLING CODE 6560-50-S