[Federal Register Volume 66, Number 174 (Friday, September 7, 2001)]
[Rules and Regulations]
[Pages 46729-46739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22525]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301160; FRL-6797-3]
RIN 2070-AB78


Fluazinam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
fluazinam in or on peanuts and potatoes. 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 September 7, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301160, 
must be received by EPA on or before November 6, 2001.

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-301160 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

[[Page 46730]]

Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-7740; 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 theFederal Register listings 
at http://www.epa.gov/fedrgstr/. To access the 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-301160. 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 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) for tolerance 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 part 180 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).
    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 on peanuts and 
potatoes at 0.02 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 fluazinam 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 toxicity rats            NOAEL: Males = 3.8 mg/kg/day;
                                                                               Females = 4.3 mg/kg/day

[[Page 46731]]

 
                                                                              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 toxicity dogs            NOAEL = 10 mg/kg/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 toxicity rats          Systemic NOAEL = 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 toxicity               Not Available
----------------------------------------------------------------------------------------------------------------
870.3465                                 90-Day inhalation toxicity           Not Available
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental toxicity      Maternal NOAEL = 50 mg/kg/day
                                          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 developmental toxicity      Maternal NOAEL = 4 mg/kg/day
                                          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 developmental toxicity      Maternal NOAEL = 3 mg/kg/day
                                          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 fertility effects   Parental/Systemic NOAEL = 1.9 mg/
                                          rats                                 kg/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 rats                NOAEL = Males: 1.9 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 dogs                NOAEL = 1 mg/kg/day
                                                                              LOAEL = 10 mg/kg/day based on
                                                                               gastric lymphoid hyperplasia in
                                                                               both sexes and nasal dryness in
                                                                               females
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined chronictoxicity/            NOAEL = Males: 0.38 mg/kg/day;
                                          carcinogenicity rats                 Females: 0.47 mg/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.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity mice                 NOAEL = Males:1.1 mg/kg/day;
                                                                               Females: 1.2 mg/kg/day

[[Page 46732]]

 
                                                                              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
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity mice                 NOAEL = Males:<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
----------------------------------------------------------------------------------------------------------------
870.5100                                 Bacterial reverse mutation assay     Negative with and without S9 up to
                                          (Ames test)                          cytotoxic concentrations.
----------------------------------------------------------------------------------------------------------------
870.5100                                 Bacterial reverse mutation assay     Negative with and without S9 up to
                                          (Ames test)                          cytotoxic concentrations.
----------------------------------------------------------------------------------------------------------------
870.5300                                 In vitro mammalian gene mutation     Negative with S9 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 gene mutation     Negative with and without S9
                                          assay                                activation up to 5 g/ml.
                                                                              Compound tested to cytotoxic
                                                                               concentrations.
----------------------------------------------------------------------------------------------------------------
870.5375                                 In vitro mammalian chromosome        Negative with and without S9 up to
                                          aberration (CHL cells)               cytotoxic concentrations. Cells
                                                                               harvested at 24 and 48 hours in
                                                                               nonactivated studies and at 24
                                                                               hours in activated studies.
----------------------------------------------------------------------------------------------------------------
870.5395                                 Mammalian erythrocyte micronucleus   Negative at 24 hour sacrifice
                                          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 hepatocytes       Negative; however 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 killing/growth          Negative, however only one
                                          inhibition in B. subtilis            replicate plate/dose was used.
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity screening        Systemic NOAEL = 50 mg/kg
                                          battery rats
                                                                              LOAEL = 1,000 mg/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 screening   Neurotoxicity NOAEL = Males: 233
                                          battery rats                         mg/kg/day; Females: 280 mg/kg/day
                                                                              LOAEL = not identified (Males:
                                                                               >233 mg/kg/day; Females: > 280 mg/
                                                                               kg/day)
----------------------------------------------------------------------------------------------------------------
870.6300                                 Developmental neurotoxicity          Not Available
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and pharmacokinetics      Only 33-40% of the administered
                                          rats                                 dose 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 (Range-finding) rats  NOAEL = Males: 5.1 mg/kg/day;
                                                                               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 (Range-finding) mice  NOAEL = Males: 7.6 mg/kg/day;
                                                                               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.
                                        ------------------------------------------------------------------------

[[Page 46733]]

 
                                         4-Week dietary (Range-finding) mice  NOAEL = not identified (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 (Special liver        NOAEL = not determined (Males:
                                          study) rats                          <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 toxicity (Special       NOAEL/LOAEL not determined.
                                          retinal study) dogs
                                        ------------------------------------------------------------------------
                                         7-Day inhalation toxicity rats       NOAEL = Males: 1.38 mg/kg/day;
                                          (Test Material: Frowncide WP         Females: 1.49 mg/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 toxicity (range-       Maternal and developmental NOAELS
                                          finding) rats                        and LOAELS were not assigned.
                                        ------------------------------------------------------------------------
                                         Eight special mechanistic studies    White matter vacuolation in the
                                          to assess the CNS white matter       CNS of mice, rats, and dogs was
                                          vacuolation                          found to be due to Impurity-5.
----------------------------------------------------------------------------------------------------------------

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 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 Doses and Endpoints for Fluazinam for Use in Human Risk Assessments\1\
----------------------------------------------------------------------------------------------------------------
                                          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 NOAEL = 7  FQPA SF = 10; aPAD =      Developmental
 age                                    mg/kg/day; UF = 100;     acute RfD/FQPA SF =      toxicity, rabbits.
                                        Acute RfD = 0.07 mg/kg/  0.007 mg/kg/day
                                        day
                                                                                          Developmental LOAEL =
                                                                                          12 mg/kg/day based on
                                                                                          increased incidence of
                                                                                          total litter
                                                                                          resorptions and
                                                                                          possibly increased
                                                                                          incidence of fetal
                                                                                          skeletal
                                                                                          abnormalities.
----------------------------------------------------------------------------------------------------------------

[[Page 46734]]

 
Acute Dietary general population       NOAEL = 50 mg/kg/day UF  FQPA SF = 3; aPAD =      Acute neurotoxicity,
 including infants and children         = 100; Acute RfD =       acute RfD/FQPA SF =      rats.
                                        0.50 mg/kg/day           0.167 mg/kg/day
                                                                                          LOAEL = 1,000 mg/kg/
                                                                                          day based on decreased
                                                                                          motor activity and
                                                                                          soft stools on day of
                                                                                          dosing.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 1.1 mg/kg/day UF  FQPA SF = 3; cPAD =      Carcinogenicity, mice.
                                        = 100; Chronic RfD =     chronic RfD/FQPA SF =
                                        0.011 mg/kg/day          0.00367 mg/kg/day
                                                                                          LOAEL = 10.7 mg/kg/day
                                                                                          based on liver
                                                                                          histopathology and
                                                                                          increased liver
                                                                                          weight.
----------------------------------------------------------------------------------------------------------------
 Cancer (oral, dermal, inhalation)     Suggestive evidence of   Quantification of human  Increases in thyroid
                                        carcino-genicity, but    cancer risk not          gland follicular cell
                                        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
\2\Cancer 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. No tolerances have 
been established for the residues of fluazinam. Risk assessments were 
conducted by EPA 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 1 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.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the 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.
    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 
SCI-GROW, which predicts pesticide concentrations in groundwater. 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 percent of reference dose (%RfD) 
or percent of adjusted dose (%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.

[[Page 46735]]

    Based on the GENEEC and SCI-GROW models the estimated environmental 
concentrations (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. Safety factor for infants and children--i. 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 
database 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.
    ii. 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.
    iii. 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 
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 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, the Office of Pesticide Programs (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 <1% of the aPAD for the U.S. population, 2% of the 
aPAD for the

[[Page 46736]]

most highly exposed population subgroup, females 13-50 years old. All 
other population subgroups occupy <1% 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          <1%           18         0.10        5,900
Adult Male 20+ yrs.............................         0.17          <1%           18         0.10        5,900
Adult Female 13ndash;50 yrs....................        0.007           2%           18         0.10          210
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 8% of the cPAD for the U.S. population and 11% 
of the cPAD for the most highly exposed population subgroup, females 
13-50 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            8         3.15         0.10          120
Adult Male 13-19 yrs...........................       0.0037           <1         3.15         0.10          130
Adult Female 13-50 yrs.........................       0.0037           11         3.15         0.10           99
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).
    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 1999 draft Agency Cancer Risk Assessment Guidelines, 
the classification of suggestive evidence of carcinogenicity a dose-
response assessment is not indicated (i.e. no Q*, no MOE) therefore, 
sufficient protection is afforded by the RFD approach so a risk 
assessment was not performed.
    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 fluazinam, the gas chromatography/electron capture detection 
(GC/ECD) methods are adequate for collecting data on residues of 
fluazinam per se in/on peanuts and potatoes and have a validated limit 
of quantitation of 0.01 ppm in/on all associated plant matrices. The 
method has been adequately radiovalidated, and has undergone a 
successful ILV trial in conjunction with the time-limited tolerance 
petition for use on peanuts. The method has been forwarded to the 
Analytical Chemistry Branch (ACB) for a petition method validation to 
determine if it is suitable as an enforcement method. ACB has 
determined that the method is suitable for collecting pesticide residue 
monitoring data and food tolerance enforcement of fluazinam in/on 
peanut nutmeat.
    This method is currently being validated by the Analytical 
Chemistry Branch Laboratories, BEAD (7503C),

[[Page 46737]]

Office of Pesticide Programs. Upon successful completion of the EPA 
validation and the granting of this registration, the method 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 (7503C), Environmental 
Science Center, 701 Mapes Road, Ft. George C. Meade, MD 20755-5350. 
Contact Francis D. Griffith, Jr., telephone (410) 305-2905, e-mail: 
griffith.francis @epa.gov. The analytical standards are also available 
from the EPA National Pesticide Standard Repository at the same 
location.

B. International Residue Limits

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

C. Conditions

    1. Toxicology. The toxicological database 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.
     870.6300 Developmental neurotoxicity study in rats. Test 
material to be technical grade fluazinam containing the maximum level 
of Impurity-5 permitted in the current specification for technical 
grade fluazinam. The protocol should be submitted to EPA for comment 
before the start of the study and should include full 
neurohistopathological examination of dams.
     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 
(870.6300), 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.
    2. Residue chemistry. The submitted potato processing studies did 
not include quantifiable residues in the RAC samples. However, the 
tests were conducted at only 2.6-2.8X the proposed maximum rate instead 
of the required 5X rate, the maximum theoretical concentration factor 
for potatoes. Despite these factors, the Agency has concluded that it 
is unlikely that residues in processed potatoes will exceed the 0.02 
ppm RAC tolerance based on the level of parent compound in the raw 
tuber being about 0.001 ppm in the plant metabolism study. However, for 
confirmatory purposes, the Agency is requiring the registrant to submit 
the following study as a condition of registration:
     860.1850 Residue Chemistry. Potato processed commodity 
study at a higher treatment level of 5X).

V. Conclusion

    Therefore, the tolerance is established for residues of 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 
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 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-301160 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 November 
6, 2001.
    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

[[Page 46738]]

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-301160, 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). 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 other 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 
recordkeeping requirements.


    Dated: August 9, 2001.
Anne E. Linday,

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 180.574 is added to read as follows:

[[Page 46739]]

Sec. 180.574  Fluazinam; tolerances for residues.

    (a) 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:

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

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 01-22525 Filed 9-6-01; 8:45 am]
BILLING CODE 6560-50-S