FLUORIDE
ACTION NETWORK PESTICIDE PROJECT
Return to
FAN's
Pesticide Homepage
Return to Fluazinam
Index Page
Fluazinam (ISK).
April 18, 2002. Establishment of an import tolerance
for residues of fluazinam and its metabolite in or on wine grapes at 3.0 ppm.
Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/April/Day-18/p9497.htm
[Federal Register: April 18, 2002 (Volume 67, Number 75)]
[Rules and Regulations]
[Page 19120-19130]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap02-10]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0003; FRL-6831-8]
RIN 2070-AB78
Fluazinam; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an import tolerance for residues
of fluazinam and its metabolite AMGT3-[[4-amino-3-[[3-chloro-5-
(trifloromethyl)-2-pyridinyl]
amino]-2-nitro-6-(trifluoromethyl)
phenyl]
thio]-2-(beta-D-glucopyranosyloxy) propionic acid) in or on
[wine grapes at 3.0 parts per million (ppm). ISK BioSciences
Corporation requested this tolerance under the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective April 18, 2002. Objections and
requests for hearings, identified by docket control number OPP-2002-
0003, must be received on or before June 17, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-2002-0003 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-7740; e-mail
address: 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
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to theFederal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, 
a beta site currently
under development. To access the OPPTS Harmonized Guidelines referenced
in this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-2002-0003. The official
record consists of the documents specifically referenced in this
action, and other information related to this action, including any
information claimed as Confidential Business Information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 6, 2000 (65 FR 76253) (FRL-
6573-7), EPA
[[Page 19121]]
issued a notice pursuant to section 408 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the
filing of a pesticide petition (PP 9F5079) by ISK BioSciences
Corporation, 5970 Heisley Road, Suite 200, Mentor, Ohio, 44060. This
notice included a summary of the petition prepared by ISK BioSciences
Corporation, the registrant. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR 180.574 be amended by
establishing a tolerance for residues of the fungicide fluazinam, 3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl) phenyl]-5-
(trifluoromethyl)-2-pyridinamine, in or on peanuts and potatoes at 0.02
part per million (ppm) and imported wine grapes at 3.0 ppm. In the
Federal Register of September 7, 2001 (66 FR 46729) (FRL-6797-3), EPA
established tolerances for peanuts and potatoes.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of fluazinam and its metabolite
AMGT on wine grapes at 3.0. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by fluazinam and its
metabolite AMGT are discussed in the following Table 1 as well as the
no observed adverse effect level (NOAEL) and the lowest observed
adverse effect level (LOAEL) from the toxicity studies reviewed.
Table 1.--Toxicological Profile of Fluazinam Technical
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL: Males = 3.8
toxicity rats mg/kg/day;
Females = 4.3 mg/
kg/day
LOAEL Males = 38
mg/kg/day;
Females = 44 mg/
kg/day based on
increased liver
weights and liver
histopathology in
males, and
increased lung
and uterus
weights in
females.
------------------------------------------------------------------------
870.3150 90-Day oral NOAEL = 10 mg/kg/
toxicity dogs day
LOAEL = 100 mg/kg/
day based on
retinal effects,
increased
relative liver
weight, liver
histopathology
and possible
increased serum
alkaline
phosphatase in
females and
possible marginal
vacuolation of
the cerebral
white matter
(equivocal)
------------------------------------------------------------------------
870.3200 21-Day dermal Systemic NOAEL =
toxicity rats 10 mg/kg/day
LOAEL = 100 mg/kg/
day based on
increased AST and
cholesterol
levels in
clinical
chemistry
determinations
(males)
Dermal NOAEL = not
identified
LOAEL = 10 mg/kg/
day based on
erythema,
acanthosis, and
dermatitis
------------------------------------------------------------------------
870.3250 90-Day dermal Not Available
toxicity
------------------------------------------------------------------------
870.3465 90-Day inhalation Not Available
toxicity
------------------------------------------------------------------------
[[Page 19122]]
870.3700 Prenatal Maternal NOAEL =
developmental 50 mg/kg/day
toxicity rats LOAEL = 250 mg/kg/
day based on
decreased body
weight gain and
food consumption
and increased
water consumption
and urogenital
staining
Developmental
NOAEL = 50 mg/kg/
day
LOAEL = 250 mg/kg/
day based on
decreased fetal
body weights and
placental
weights,
increased facial/
cleft palates,
diaphragmatic
hernia, and
delayed
ossification in
several bone
types, greenish
amniotic fluid
and possible
increased late
resorptions and
postimplantation
loss
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL = 4
developmental mg/kg/day
toxicity rabbits LOAEL = 7 mg/kg/
day based on
decreased food
consumption and
increased liver
histopathology.
Developmental
NOAEL = 7 mg/kg/
day
LOAEL = 12 mg/kg/
day based on an
increase in total
litter
resorptions and
possible fetal
skeletal
abnormalities
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL = 3
developmental mg/kg/day
toxicity rabbits LOAEL = not
identified (>3 mg/
kg/day)
Developmental
NOAEL = 3 mg/kg/
day
LOAEL = not
identified (>3 mg/
kg/day)
------------------------------------------------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects NOAEL = 1.9 mg/kg/
rats day
LOAEL = 9.7 mg/kg/
day based on
liver pathology
in F1 males
Reproductive NOAEL
= 10.6 mg/kg/day
LOAEL = 53.6 mg/kg/
day based on
decreased number
of implantation
sites and
decreased litter
sizes to day 4
post-partum for
F1 females (F2
litters).
Offspring NOAEL =
8.4 mg/kg/day
LOAEL = 42.1 mg/kg/
day based on
reduced F1 and F2
pup body weight
gains during
lactation.
------------------------------------------------------------------------
870.4100 Chronic toxicity NOAEL = Males: 1.9
rats mg/kg/day;
Females: 4.9 mg/
kg/day
LOAEL = Males: 3.9
mg/kg/day;
Females: not
identified (£
4.9 mg/kg/
day) based on
increased
testicular
atrophy in males
and no effects in
females
------------------------------------------------------------------------
870.4100 Chronic toxicity NOAEL = 1 mg/kg/
dogs day
LOAEL = 10 mg/kg/
day based on
gastric lymphoid
hyperplasia in
both sexes and
nasal dryness in
females
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL = Males:1.1
mice mg/kg/day;
Females: 1.2 mg/
kg/day
LOAEL = Males:
10.7 mg/kg/day;
Females: 11.7 mg/
kg/day based on
increased
incidences of
brown macrophages
in the liver of
both sexes,
eosinophilic
vacuolated
hepatocytes in
males, and
increased liver
weight in
females.
Clear evidence of
carcinogenicity
(hepatocellular
tumors) in male
mice, but not in
females
------------------------------------------------------------------------
[[Page 19123]]
870.4200 Carcinogenicity NOAEL = Males:
mice <126 mg/kg/day,
Females: <162 mg/
kg/day
LOAEL = Males: 126
mg/kg/day;
Females: 162 mg/
kg/day based on
increased liver
weights and liver
and brain
histopathology in
both sexes
Equivocal/some
evidence of
carcinogenicity
(hepatocellular
tumors) in male
mice, but not in
females
------------------------------------------------------------------------
870.4300 Combined chronic NOAEL = Males:
toxicity/ 0.38 mg/kg/day;
carcinogenicity Females: 0.47 mg/
rats kg/day
LOAEL = Males: 3.8
mg/kg/day;
Females: 4.9 mg/
kg/day based on
liver toxicity in
both sexes,
pancreatic
exocrine atrophy
in females and
testicular
atrophy in males.
Some evidence of
carcinogenicity
(thyroid gland
follicular cell
tumors) in male
rats, but not in
females.
------------------------------------------------------------------------
870.5100 Bacterial reverse Negative with and
mutation assay without S9 up to
(Ames test) cytotoxic
concentrations.
------------------------------------------------------------------------
870.5100 Bacterial reverse Negative with and
mutation assay without S9 up to
(Ames test) cytotoxic
concentrations.
------------------------------------------------------------------------
870.5300 In vitro mammalian Negative with S9
gene mutation activation up to
assay 9 µg/ml.
Negative without
S9 activation up
to 0.3 µg/
ml.
Compound tested to
cytotoxic
concentrations.
------------------------------------------------------------------------
870.5300 In vitro mammalian Negative with and
gene mutation without S9
assay activation up to
5 µg/ml.
Compound tested to
cytotoxic
concentrations.
------------------------------------------------------------------------
870.5375 In vitro mammalian Negative with and
chromosome without S9 up to
aberration (CHL cytotoxic
cells) concentrations.
Cells harvested at
24 and 48 hours
in nonactivated
studies and at 24
hours in
activated
studies.
------------------------------------------------------------------------
870.5395 Mammalian Negative at 24
erythrocyte hour sacrifice
micronucleus test (500, 1,000,
2,000 mg/kg).
Negative at 24,
48, and 72 hour
sacrifices (2,000
mg/kg).
------------------------------------------------------------------------
870.5550 UDS in primary rat Negative; however
hepatocytes there were
several serious
study
deficiencies:
Treatment time
shorter than
recommended, no
data supporting
the claim of
cytotoxicity,
data variability
for major
endpoints.
------------------------------------------------------------------------
870.5550 Differential Negative, however
killing/growth only one
inhibition in B. replicate plate/
subtilis dose was used.
------------------------------------------------------------------------
870.6200 Acute Systemic NOAEL =
neurotoxicity 50 mg/kg
screening battery LOAEL = 1,000 mg/
rats kg based on soft
stools and
decreased motor
activity on day
of dosing.
Neurotoxicity
NOAEL = 2,000 mg/
kg
LOAEL = not
identified
(>2,000 mg/kg)
------------------------------------------------------------------------
870.6200 Subchronic Neurotoxicity
neurotoxicity NOAEL = Males:
screening battery 233 mg/kg/day;
rats Females: 280 mg/
kg/day
LOAEL = not
identified
(Males: >233 mg/
kg/day; Females:
>280 mg/kg/day)
------------------------------------------------------------------------
870.6300 Developmental Not Available
neurotoxicity
------------------------------------------------------------------------
[[Page 19124]]
870.7485 Metabolism and Only 33-40% of the
pharmacokinetics administered dose
rats was absorbed.
Most of the
administered dose
was recovered in
the feces (>89%).
Excretion via the
urine was minor
(<4%). Total
biliary
radioactivity,
however,
represented 25-
34% of the
administered
dose, indicating
considerable
enterohepatic
circulation.
------------------------------------------------------------------------
870.7600 Dermal penetration Not Available
------------------------------------------------------------------------
Special studies: 4-Week dietary NOAEL = Males: 5.1
(Range-finding) mg/kg/day;
rats Females: 5.3 mg/
kg/day
LOAEL = Males:
26.4 mg/kg/day;
Females: 25.9 mg/
kg/day based on
decreased body
weight gain and
food consumption,
increased serum
phospholipids,
increased total
cholesterol,
increased
relative liver
weights, and
liver
histopathology.
------------------------------------------------------------------------
4-Week dietary NOAEL = Males: 7.6
(Range-finding) mg/kg/day;
mice Females: 8.2 mg/
kg/day
LOAEL = Males: 36
mg/kg/day;
Females: 43 mg/kg/
day based on
decreased body
weight gain,
increased serum
glucose,
increased kidney
weights.
------------------------------------------------------------------------
4-Week dietary NOAEL = not
(Range-finding) identified
mice (Males; <555 mg/
kg/day; Females:
<658 mg/kg/day)
LOAEL = Males: 555
mg/kg/day;
Females: 658 mg/
kg/day based on
vacuolation of
white matter in
brain, increased
liver weights,
histopathology in
liver.
------------------------------------------------------------------------
90-Day dietary NOAEL = not
(Special liver determined
study) rats (Males: <37.6 mg/
kg/day, Females:
<44.7 mg/kg/day)
LOAEL = Males:
37.6 mg/kg/day,
Females: 44.7 mg/
kg/day based on
increased
relative liver
weights and liver
histopathology.
------------------------------------------------------------------------
11-Week oral NOAEL/LOAEL not
toxicity (Special determined.
retinal study)
dogs
------------------------------------------------------------------------
7-Day inhalation NOAEL = Males:
toxicity rats 1.38 mg/kg/day;
Test Material: Females: 1.49 mg/
Frowncide WP kg/day
(51.9% a.i.). LOAEL = Males:
3.97 mg/kg/day;
Females: 4.25 mg/
kg/day based on
increased testes
weight (males)
and increased
liver weight
(females).
------------------------------------------------------------------------
Developmental Maternal and
toxicity (range- developmental
finding) rats NOAELS and LOAELS
were not
assigned.
------------------------------------------------------------------------
Eight special White matter
mechanistic vacuolation in
studies to assess the CNS of mice,
the CNS white rats, and dogs
matter was found to be
vacuolation due to Impurity-
5.
------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional
safety factor retained due to concerns unique to the FQPA.
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to
[[Page 19125]]
determine the LOC. For example, when 100 is the appropriate UF (10X to
account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer= point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for fluazinam used for human risk assessment is shown in the
following Table 2:
Table 2.--Summary of Toxicological Toxicological Doses and Endpoints for Fluazinam for Use in Human Risk
Assessments1
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF* and Endpoint Study and Toxicological
Exposure Scenario Assessment, UF for Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of Developmental FQPA SF = 10 Developmental toxicity,
age NOAEL = 7 mg/kg/day.... aPAD = acute RfD/FQPA rabbits.
UF = 100............... SF = 0.007 mg/kg/day. Developmental LOAEL =
Acute RfD = 0.07 mg/kg/ 12 mg/kg/day based on
day. increased incidence of
total litter
resorptions and
possibly increased
incidence of fetal
skeletal
abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute dietary general population NOAEL= 50 mg/kg/day FQPA SF = 3 Acute neurotoxicity,
including infants and children UF = 100............... aPAD = acute RfD/FQPA rats.
Acute RfD = 0.50 mg/kg/ SF = 0.167 mg/kg/day. LOAEL = 1,000 mg/kg/day
day. based on decreased
motor activity and
soft stools on day of
dosing.
----------------------------------------------------------------------------------------------------------------
Exposure scenario Dose used in risk FQPA SF* and endpoint Study and Toxicological
assessment, UF for risk assessment Effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL= 1.1 mg/kg/day FQPA SF = 3 Carcinogenicity, mice.
UF = 100............... cPAD = chr RfD = FQPA LOAEL = 10.7 mg/kg/day
Chronic RfD = 0.011 mg/ SF 0.00367 mg/kg/day. based on liver
kg/day. histopathology and
increased liver
weight.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL= 1.1 mg/kg/day FQPA SF = 3 Carcinogenicity, mice.
UF = 100............... cPAD = chr RfD = FQPA LOAEL = 10.7 mg/kg/day
Chronic RfD = 0.011 mg/ SF 0.00367 mg/kg/day. based on liver
kg/day. histopathology and
increased liver
weight.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Suggestive evidence Quantification of human Increases in thyroid
of carcino-genicity, cancer risk not gland follicular cell
but not sufficient to required. 2 tumors in male rats;
assess human increases in
carcinogenic hepatocellular (liver)
potential''2 tumors in male mice.2
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any safety factor retained or reduced due to concerns unique
to the FQPA.
1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference
dose, LOC = level of concern, MOE = margin of exposure
2Cancer Assessment Document - Evaluation of the Carcinogenic Potential of Fluazinam, March 29, 2001, HED Doc.
No. 014512.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established for the residues of fluazinam in and or on potatoes and
peanuts. Risk assessments were conducted by EPA on these crops and wine
grapes to assess dietary exposures from fluazinam in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: A DEEM acute dietary exposure analysis was
performed using tolerance residue levels and 100% CT data for all
commodities (Tier 1). The DEEM defaults were used for all processing
factors. The DEEM analysis included wine and sherry grapes, peanuts and
potatoes using anticipated residues of fluazinam and its metabolite
(AMGT) and processing factors for wine grapes (Tier 3).
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model DEEM analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide CSFII and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the chronic exposure assessments: A DEEM chronic dietary exposure
analysis was performed using tolerance residue levels and 100% CT data
for all commodities (Tier 1). The DEEM defaults were used for all
processing factors. The DEEM analysis included wine and sherry grapes,
peanuts and potatoes using anticipated
[[Page 19126]]
residues of fluazinam and its metabolite (AMGT) and processing factors
for wine grapes.
iii. Cancer. Since fluazinam has been classified as ``Suggestive
evidence of carcinogenicity, but not sufficient to assess human
carcinogenic potential,'' an exposure assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fluazinam in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of fluazinam.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
Screening Concentrations in Ground Water (SCI-GROW), which predicts
pesticide concentrations in ground water. In general, EPA will use
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a
screening-level assessment for surface water. The GENEEC model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to fluazinam they are further
discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of fluazinam for
acute exposures are estimated to be 18.0 parts per billion (ppb) for
surface water and 0.10 ppb for ground water. The EECs for chronic
exposures are estimated to be 3.15 ppb for surface water and 0.10 ppb
for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fluazinam is not registered for use on any sites that would result
in residential exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether fluazinam has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fluazinam does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that fluazinam has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. Qualitative evidence of
increased susceptibility of fetuses to fluazinam was demonstrated in a
developmental toxicity study in rats. Increased incidences of facial/
palate clefts and other rare deformities in the fetuses were observed
in the presence of minimal maternal toxicity. In a developmental
toxicity study in rabbits and in a 2-generation reproduction study in
rats, neither quantitative nor qualitative evidence of increased
susceptibility of fetuses or pups to fluazinam was observed. Because of
the neurotoxic lesion observed in the white matter of the brain in
mice, dogs and rats and the qualitative evidence of increased
susceptibility of rat fetuses to fluazinam, a developmental
neurotoxicity study will be required to be submitted to the Agency.
Further, because of the lack of a developmental neurotoxicity study and
the qualitative evidence of increased susceptibility of rat fetuses to
fluazinam, the Food Quality Protection Act (FQPA) safety factor (SF)
for protection of infants and children, as required by the FQPA of
1996, will be retained at 10X when assessing acute dietary exposure for
``females 13-50 years of age'' due to concern for the developing fetus.
Additionally, the FQPA SF will be reduced to 3X when assessing
exposures for ``all populations'' for all exposure durations (acute and
chronic) because of uncertainty resulting from lack of a developmental
neurotoxicity study.
3. Conclusion. Because of the lack of a developmental neurotoxicity
study and the qualitative evidence of increased susceptibility of rat
fetuses to fluazinam, the Agency determined that the FQPA safety factor
should be retained at 10X when assessing acute dietary exposure for
``females 13-50 years of age'' since, in addition to the need for a
developmental neurotoxicity study, increased susceptibility of rat
fetuses was observed following in utero exposure (an acute effect) in
the rat developmental toxicity study resulting in concern for the
developing fetus. The Agency also determined that the FQPA safety
factor should be reduced to 3X
[[Page 19127]]
when assessing exposure for ``all populations'' for all exposure
durations (acute and chronic) since there is uncertainty due to the
lack of a developmental neurotoxicity study. This study will further
characterize the toxicity of fluazinam and may provide endpoints and
NOAELs that could be used in risk assessments for any subpopulation/
exposure duration.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water EECs. DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure to fluazinam from
food will occupy 2% or less of the aPAD for the U.S. population, 60% of
the aPAD for the most highly exposed population subgroup, females 13-50
years old. All other population subgroups occupy 2% or less of the
aPAD. In addition, there is potential for acute dietary exposure to
fluazinam in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 3:
Table 3.--Aggregate Risk Assessment for Acute Exposure to Fluazinam
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.17 2% 18 0.10 5,800
----------------------------------------------------------------------------------------------------------------
Adult male 20+ yrs 0.17 2% 18 0.10 5,800
----------------------------------------------------------------------------------------------------------------
Adult female 13-50 yrs 0.007 60% 18 0.10 84
----------------------------------------------------------------------------------------------------------------
Children 1-6 yr 0.17 <1% 18 0.10 1,700
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to fluazinam
from food will utilize <1% of the cPAD for the U.S. population and 1%
of the cPAD for the most highly exposed population subgroup, children
1-6 years old. There are no residential uses for fluazinam that result
in chronic residential exposure to fluazinam. There is potential for
chronic dietary exposure to fluazinam in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fluazinam
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Food Water EEC Water EEC Chronic
day (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.0037 <1 3.15 0.10 130
----------------------------------------------------------------------------------------------------------------
Adult male 13-19 yrs 0.0037 <1 3.15 0.10 130
----------------------------------------------------------------------------------------------------------------
Adult fmale 13-50 yrs 0.0037 <1 3.15 0.10 110
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs 0.0037 1 3.15 0.10 37
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
[[Page 19128]]
Fluazinam is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Fluazinam is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
5. Aggregate cancer risk for U.S. population. In accordance with
the EPA Draft Guidelines for Carcinogen Risk Assessment (July 1999),
the Agency classified fluazinam into the category ``Suggestive evidence
of carcinogenicity, but not sufficient to assess human carcinogenic
potential'' based on the following weight-of-the-evidence
considerations:
i. There was some evidence in that fluazinam induced an increase in
thyroid gland follicular cell tumors in male rats, but not in female
rats. In one study in mice, there was clear evidence that an increased
incidence of hepatocellular tumors observed in the male mice was
treatment-related. In another study in mice, there was equivocal/some
evidence that fluazinam may have induced an increase in hepatocellular
tumors in the male mice. Increases in hepatocellular tumors observed in
the female mice in the latter study were not statistically significant
and some occurred at an excessively toxic dose level. The thyroid gland
follicular cell tumors of concern were seen only in male rats and the
hepatocellular tumors of concern were seen only in male mice.
ii. Fluazinam was negative in mutagenicity assays. Based on the
proposed 1999 EPA Cancer Risk Assessment Guidelines, the Agency
classified fluazinam as having ``suggestive evidence of
carcinogenicity,'' but not sufficient to assess human carcinogenic
potential and further determined that therefore no quantification of
cancer risk is required. Therefore, a cancer risk assessment is not
required.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to fluazinam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For the metabolite AMGT3-[[4-amino-3-[[3-chloro-5-(trifloromethyl)-
2-pyridinyl]
amino]-2-nitro-6-(trifluoromethyl) phenyl]
thio]-2-(beta-
D-glucopyranosyloxy) propionic acid) in/on grapes, the submitted ILV
using reversed-phase HPLC with UV absorbance (at 254 nm) detector has
been received and the method has been forwarded to the Agency's
laboratory for validation. The petitioner will be required to make any
modifications or revisions to the proposed method resulting from EPA's
validation. The petitioner must also submit multiresidue method data as
a confirmatory procedure. Upon successful completion of the EPA
validation, the mehtod will be forwarded to FDA for publication in a
future revision of the Pesticide Analytical Manual, Vol-II (PAM-II).
Prior to publication and upon request, the method will be available
prior to the harvest season from the /analytical Chemistry Branch
(ACB), BEAD (75053), Environmental Science Center, 701 Mapes Road, Ft.
George C. Meade, MD 20755-5350. Contact Francis D. Griffith, Jr.,
telephone (410) 305-2905, e-mail: griffith.francis@epa.gov. The
analytical standards are also available from the EPA National Standard
Repository at the same location. The submitted HPLC/UV method is
adequate for collecting data on residues of AMGT in/or grapes with a
validated LOQ for residues of AMGT in grape commodites of 0.01 ppm.
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.
B. International Residue Limits
There are currently no Codex maximum residue levels established for
residues of fluazinam on any crop.
C. Conditions
The toxicological data base for fluazinam is adequate at this time
to support the requested registration and tolerances according to
Subdivision F Guideline requirements and 40 CFR 158.690. The Agency has
determined that there is a high degree of confidence in the hazard
endpoints and dose-response assessments conducted for this chemical.
However, the Agency is requiring that the following additional
toxicology studies be performed and submitted within a reasonable
period of time in order to more clearly and fully characterize the
toxicity of this chemical.
870.3465 -- 28-Day inhalation toxicity in rats due December 2003.
870.6300 -- Developmental neurotoxicity study in rats. The protocol
should be submitted by July 2002 to EPA for approval/comment before the
start of the study and should include full neurohistopathological
examination of dams. The study is due 2 years after approval of the
protocol.
870.6200 -- Subchronic neurotoxicity screening battery in rats
(conditional requirement). Based on a consideration of the results in
the developmental neurotoxicity study in rats required above, the
Agency will subsequently recommend whether a repeat of the subchronic
neurotoxicity study in rats (870.6200) should also be required to
support the registration of fluazinam products. This study must be
submitted, if required by the Agency, 2 years after notification by the
Agency.
D. Residue Chemistry
Multiresidue methods data for AMGT, due December 2002
Dislodgeable foliar residue
V. Conclusion
Therefore, the import tolerance is established for residues of
fluazinam, 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-
5-(trifluoromethyl)-2-pyridinamine and its metabolite AMGT 3-[[4-amino-
3-[[3-chloro-5-(trifloromethyl)-2-pyridinyl]
amino]-2-nitro-6-
(trifluoromethyl) phenyl]
thio]-2-(beta-D-glucopyranosyloxy) propionic
acid) in or on wine grapes at 3.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a
[[Page 19129]]
tolerance issued by EPA under new section 408(d), as was provided in
the old FFDCA sections 408 and 409. However, the period for filing
objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-2002-0003 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before June 17,
2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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-2002-0003, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: 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). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that
[[Page 19130]]
have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 9, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.574 is amended by revising paragraph (a) to read as
follows:
Sec. 180.574 Fluazinam; tolerances for residues.
(a)(1) General. Tolerances are established for residues of
fluazinam, (3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)
phenyl]-5-(trifluoromethyl)-2-pyridinamine) in or on the following
commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Peanuts........................................ 0.02
Potatoes....................................... 0.02
------------------------------------------------------------------------
(a)(2) Tolerances are established for residues of fluazinam and its
metabolite AMGT 3-[[4-amino-3-[[3-chloro-5-(trifloromethyl)-2-
pyridinyl]amino]-2-nitro-6-(trifluoromethyl) phenyl]
thio]-2-(beta-D-
glucopyranosyloxy) propionic acid) in or on the following commodity:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Wine grapes1................................... 3.0
------------------------------------------------------------------------
1 No US registration as of March 15, 2002.
* * * * *
[FR Doc. 02-9497 Filed 4-17-02; 8:45 am]
BILLING CODE 6560-50-S