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fluazinam Pesticide Tolerance 8/01


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: giles-parker.cynthia@epa.gov.

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
		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
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.
------------------------------------------------------------------------
                                      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.
----------------------------------------------------------------------------------------------------------------

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.

    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
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),
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 tompkins.jim@epa.gov,
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-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: opp-docket@epa.gov. 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]