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Fenbuconazole - Pesticide Tolerance 12/01

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301199; FRL-6816-4]
RIN 2070-AB78
Fenbuconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for the
combined residues of the fungicide fenbuconazole [alpha-(2-(4-
chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-1,2,4-triazole)-1-
propanenitrile]
and its metabolites, cis and trans-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone],
expressed as fenbuconazole, in or on the stone fruit (except plums and
prunes) crop group at 2.0 parts per million (ppm), pecans at 0.1 ppm,
and bananas at 0.3 ppm until December 31, 2004, at which time they will
expire and be revoked. Dow AgroSciences LLC (then Rohm and Haas
Company) requested that these temporary tolerances be made permanent
under the provisions of the Federal Food, Drug, and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective January 15, 2002. Objections and
requests for hearings, identified by docket control number OPP-301199,
must be received by EPA on or before March 18, 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-301199 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, Product
Manager 22, Registration Division (7505C), Office of Pesticide
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
           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.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301199. 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 March 23, 2001 (66 FR 16226) (FRL-6767-
3), 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 pesticide petitions (PP 1F3989, 1F3995, and 2F4154) to
make temporary tolerances permanent by Dow AgroSciences LLC,
9330 Zionsville Road, Indianapolis, IN 46268-1054. This notice included
a summary of the petitions prepared by Rohm and Haas Company, now a
part of Dow AgroSciences LLC, whose name and address are provided
herein. There were no comments received in response to the notice of
filing. The existing time-limited tolerances will expire on December
31, 2001.
    The petitions requested that 40 CFR 180.480 be amended by making
time-limited tolerances for combined residues of the fungicide
fenbuconazole [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile] and its metabolites, cis and trans-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone], expressed as fenbuconazole in or on the stone fruit
(except plums and prunes) crop group at 2.0 parts per million (ppm),
pecans at 0.1 ppm, and bananas at 0.3 ppm permanent. However, the
Agency has determined that it is more appropriate to extend them until
December 31, 2004, while the Agency completes its review of data
submitted to support the continued registration of fenbuconazole.
    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 extension of time-limited tolerances for combined
residues of fenbuconazole [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-
phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile] and its metabolites, cis
and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-
ylmethyl)-2-3H-furanone], expressed as fenbuconazole in or on the stone
fruit (except plums and prunes) crop group at 2.0 ppm, pecans at 0.1
ppm, and bananas at 0.3 ppm until December 31, 2004. EPA's assessment
of exposures and risks associated with extending the tolerances
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, and the no observed adverse
effect levels (NOAEL) and the lowest observed adverse effect levels
(LOAEL) from the fenbuconazole toxicity studies are discussed below.
    1. The acute toxicological tests of the technical product produced
the following results. In the acute oral toxicity study the lethal dose
50% (LD50) was greater than 2 grams per kilogram (g/kg) body
weight. The acute dermal toxicity study produced an LD50 of
greater than 5 g/kg body weight. The acute inhalation lethal
concentration 50% (LC50) was greater than 2.1 milligrams per
liter (mg/L). In both the primary eye irritation and primary skin
irritation studies technical fenbuconazole was classified as non-
irritating, and also tested negative for dermal sensitization.

    2. A 13-week rat feeding study produced a NOAEL of 20 ppm (1.3
milligrams per kilogram per day (mg/kg/day) for males and 1.5 mg/kg/day
for females) and a LOAEL of 80 ppm (5.1 mg/kg/day for males and 6.3 mg/
kg/day for females), the endpoint effect being liver histopathology
changes.
    3. In a 3-month mouse feeding study there was a NOAEL of 20 ppm
(3.8 mg/kg/day for males and 5.7 mg/kg/day for females) and a LOAEL of
60 ppm (11.1 mg/kg/day for males and 17.6 mg/kg/day for females), based
on liver histopathology changes.
    4. A 3-month dog feeding study produced a NOAEL of 100 ppm (3.3 mg/
kg/day for males and 3.5 mg/kg/day for females) and a LOAEL of 400 ppm
(13.3 mg/kg/day for males and 14.0 mg/kg/day for females), the end
point effect being liver histopathology changes.
    5. A 21-day rat dermal study produced a NOAEL of 1,000 mg/kg/day
(the limit dose) and therefore a LOAEL greater than 1,000 mg/kg/day.
Poor dermal absorption was indicated.
    6. In a 78-week dietary carcinogenicity study in mice, the NOAEL
was 10 ppm (1.43 mg/kg/day); males had a LOAEL of 200 ppm (28.6 mg/kg/
day) and females had a LOAEL of 650 ppm (92.9 mg/kg/day), based on
hepatocellular enlargement and a greater incidence and severity of
hepatocellular vacuolation. There was also evidence of carcinogenicity
based on the occurrence of an increased trend for malignant liver
tumors in males and an increase in benign and malignant liver tumors in
females.
    7. A 24-month rat chronic feeding/carcinogenicity study with a
systemic NOAEL of 80 ppm (3.03 mg/kg/day for females and 4.02 mg/kg/day
for males) and a systemic LOAEL of 800 ppm (30.62 mg/kg/day for males
and 43.07 mg/kg/day for females), based on decreases in body weight
gains in females, hepatocellular enlargement and vacuolization in
females, increases in thyroid weight in both males and females, and
histopathological lesions in the thyroid glands in both sexes. There
was evidence of carcinogenicity based on the increased occurrence of
thyroid follicular cell benign and malignant tumors in males.
    8. A 24-month male rat chronic feeding/carcinogenicity study that
had a NOAEL of less than 800 ppm and a LOAEL of 800 ppm (30.41 mg/kg/
day), based on decreased body weight gain and increased liver and
thyroid/parathyroid weights and lesions. There was evidence of
carcinogenicity based on the increased occurrence of thyroid follicular
cell benign and malignant tumors in males.
    9. A 1-year dog chronic feeding study with a NOAEL of 15 ppm (0.38
mg/kg/day) for females and 150 ppm (3.75 mg/kg/day) for males. The
LOAEL, 150 ppm for females and 1,200 ppm (30 mg/kg/day) for males, was
based on decreases in body weight gain and on adaptive changes in the
liver which reflected increased metabolic activity.
    10. A 2-generation rat reproduction study with a parental NOAEL of
4 mg/kg/day (80 ppm) and LOAEL of 40 mg/kg/day (800 ppm), based on
decreased body weight and food consumption, increased number of dams
not delivering viable or delivering nonviable offspring, and increases
in adrenal and thyroid/parathyroid weights. The reproductive NOAEL was
40 mg/kg/day (800 ppm; the highest dose tested).
    11. A developmental toxicity study in rabbits produced a maternal
NOAEL of 10 mg/kg/day, a developmental NOAEL of 30 mg/kg/day, an
undeterminable developmental LOAEL and a maternal LOAEL of 30 mg/kg/
day.
    12. A developmental rat toxicity study with a maternal and
developmental NOAEL of 30 mg/kg/day, a maternal LOAEL of 75 mg/kg/day
due to a decrease in maternal body weight compared to controls, and a
developmental LOAEL of 75 mg/kg/day due to an increase in post-
implantation loss and a decreased number of live fetuses per dam.
    13. Mutation studies showed the following. There was no evidence of
gene mutation in a test for induction of gene mutation at the HGPRT
locus in Chinese hamster ovary cells, no increase in the number of
cells with aberrations or observations per cell in an in vivo
cytogenetics assay using bone marrow from treated rats, and no increase
in unscheduled DNA synthesis in a rat primary hepatocyte study.
    14. In a rat metabolism study radiolabeled fenbuconazole was
rapidly absorbed, distributed, and excreted following oral
administration in rats. Biliary excretion data indicted that systemic
absorption of fenbuconazole was high for all dosing groups. The feces
were the major route of excretion. Tissue distribution and
bioaccumulation of fenbuconazole appeared to be minimal.

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 multiplied by 10X to account
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 (Q1*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q1*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q1* 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" (threshold) 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
(MOE-cancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for fenbuconazole used for human
risk assessment follows.
    1. Acute exposure. For acute dietary risk assessments a reference
dose (acute RfD) of 0.3 mg/kg/day was established for females 13+ years
old, the population subgroup of concern, based on the developmental
toxicity study in the rat, which had a NOAEL of 30 mg/kg/day based on
an increase in post-implantation loss and a significant decrease in the
number of live fetuses per dam at the LOAEL of 75 mg/kg/day. A UF of
100 was used. No appropriate endpoint was available for analyzing the
acute exposure of the overall U.S. population.
    2. Short- and Intermediate-term Exposure. Short- and intermediate-
term endpoints were not identified. Fenbuconazole also has no
residential uses. Therefore, an aggregate risk assessment was not done
for these endpoints.
    3. Chronic exposure. The reference dose (chronic RfD) of 0.03 mg/
kg/day was based on the chronic toxicity study in the rat, which had a
NOAEL of 3.03 and 4.02 mg/kg/day in males and females, respectively,
based on decreased body weight gains (females), hepatocellular
enlargement and vacuolation (females), increases in thyroid weight
(both sexes), and histopathological lesions in the liver and thyroid
glands (both sexes) at the LOAEL of 30.62/43.04 mg/kg/day in males and
females, respectively. A UF of 100 was used.
    4. Cancer. The Agency has concluded that the available data provide
limited evidence of the carcinogenicity of fenbuconazole in both mice
and rats and has classified fenbuconazole as a Group C carcinogen
(possible human carcinogen with limited evidence of carcinogenicity in
animals) in accordance with Agency guidelines, published in the Federal
Register (51 FR 33992, September 24, 1986), and recommended that for
the purpose of risk characterization a low-dose extrapolation model
applied to the experimental animal tumor data should be used for
quantification of human risk (Q1*). This decision was based on the
induction of thyroid follicular cell adenomas and/or combined adenomas-
carcinomas in male rats in two studies, both by pair-wise comparison
with controls and by trend analysis. The studies were combined for the
purpose of deriving the Q1* of 3.59 x 10-3 (mg/kg/
day)-1 in human equivalents.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.480) for the combined residues of the fungicide
fenbuconazole [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile]
and its metabolites, cis and trans-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone], expressed as fenbuconazole, in or on several agricultural
commodities. Risk assessments were conducted by EPA to assess dietary
exposures from fenbuconazole in food as follows. In addition to the
agricultural commodities that are the
subjects of this final rule, the dietary risk analysis included
published FIFRA section 18 temporary tolerances on blueberry;
grapefruit; the fat, kidney, liver, meat, meat byproducts, and other
organ meats of cattle, goats, hogs, and sheep; and horses, meat. The
need for and, if so, results of these analyses follow.
    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 consumed. The following assumptions were made for the acute
exposure assessments: An acute RfD of 0.3 mg/kg/day was used for the
females 13+ years old, the population subgroup of concern, based on the
developmental rat toxicity study. This study had a NOAEL of 30 mg/kg/
day, based on a decrease in the number of live fetuses per dam at the
LOAEL of 75 mg/kg/day and an uncertainty factor of 100. Neither percent
crop treated (PCT) nor anticipated residue data were used in the acute
exposure/risk analysis.
    ii. Short- and intermediate-term exposure. Short- and intermediate-
term endpoints were not identified. Fenbuconazole also has no
residential uses. Therefore, an aggregate risk assessment was not
performed for these endpoints.
    iii. 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 consumed. The
following assumptions were made for the chronic exposure assessments: A
chronic RfD of 0.03 mg/kg/day was used and was based on the rat chronic
toxicity study. This study had NOAELs of 3.03 and 4.02 mg/kg/day in
males and females, respectively, based on decreased body weight gains
(females), hepatocellular enlargement and vacuolation (females),
increases in thyroid weight (both sexes), and histopathological lesions
in the liver and thyroid glands (males) at the LOAELs of 30.62 and
43.04 mg/kg/day in males and females, respectively. An UF of 100 was
again used. Anticipated residues were not used in the exposure/risk
analysis; the only adjusted PCT datum used was 12.8% for the stone
fruit (except plums and prunes) crop group. This percentage was derived
from an annual production cap for fenbuconazole for use on the stone
fruit (except plums and prunes) crop group of 38,000 lb of the Indar 75
WSP product (EPA Registration Number 62719-421; the only fenbuconazole
product registered for use on stone fruits), equal to 28,500 lb of
active ingredient. This amount was calculated by the Agency in 1995 as
being equivalent to treating 12.8% of the total United States acreage
of apricots, cherries, nectarines, and peaches with fenbuconazole and
was made a condition of the registration of this product. The identical
production cap is still in place and no additional fenbuconazole
products have been registered for use on stone fruits.
    iv. Cancer. The Agency has concluded that the available data
provide limited evidence of the carcinogenicity of fenbuconazole in
both mice and rats and has classified fenbuconazole as a Group C
carcinogen (possible human carcinogen with limited evidence of
carcinogenicity in animals). A low-dose extrapolation model was applied
to the experimental animal tumor data used for quantification of human
risk (Q1*). This decision was based on the induction of thyroid
follicular cell adenomas and/or combined adenomas-carcinomas in male
rats in two studies, both by pair-wise comparison with controls and by
trend analysis. The studies were combined for the purpose of deriving
the Q1* of 3.59 x 10-3 (mg/kg/day)-1 in human
equivalents. Anticipated residues were not used in the exposure/risk
analysis; the only adjusted PCT datum used was 12.8% for the stone
fruit (except plums and prunes) crop group. This percentage was derived
from an annual production cap for fenbuconazole for use on the stone
fruit (except plums and prunes) crop group of 38,000 lb of the Indar 75
WSP product (EPA Registration Number 62719-421; the only fenbuconazole
product registered for use on stone fruits), equal to 28,500 lb of
active ingredient. This amount was calculated by the Agency in 1995 as
being equivalent to treating 12.8% of the total United States acreage
of apricots, cherries, nectarines, and peaches with fenbuconazole and
was made a condition of the registration of this product. The identical
production cap is still in place and no additional fenbuconazole
products have been registered for use on stone fruits.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F)
states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if the Agency can make
the following findings: Condition 1, that the data used are reliable
and provide a valid basis to show what percentage of the food derived
from such crop is likely to contain such pesticide residue; Condition
2, that the exposure estimate does not underestimate exposure for any
significant subpopulation group; and Condition 3, if data are available
on pesticide use and food consumption in a particular area, the
exposure estimate does not understate exposure for the population in
such area. In addition, the Agency must provide for periodic evaluation
of any estimates used. To provide for the periodic evaluation of the
estimate of PCT as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows. For chronic toxicity
and carcinogenicity a PCT value of 12.8% was used for the stone fruit
(except plums and prunes) crop group. No other PCT data were used for
fenbuconazole exposure/risk analysis.
    When fenbuconazole was first registered, a condition of the
registration of the fenbuconazole-containing product Indar 75 WSP (EPA
Registration Number 62719-421), the only such product being registered
for use on the stone fruit (except plums and prunes) crop group, was
that only 38,000 lb of it (28,500 lb of the active ingredient) could be
manufactured for this use annually. The Agency calculated, in 1995,
that this was equivalent to treating 12.8% of the total United States
acreage of apricots, cherries, nectarines, and peaches with
fenbuconazole. That value has been directly applied to the analysis of
dietary exposure and risk as the PCT for fenbuconazole on the stone
fruit (except plums and prunes) crop group. Since then, this production
cap has remained continuously in place at that same value, and no
additional fenbuconazole products have been registered or labeled for
use on this crop group.
    The Agency believes that the three conditions previously discussed
have been met. With respect to Condition 1, EPA finds that the PCT
information described above for fenbuconazole used on the stone fruit
(except plums and prunes) crop group is reliable and has a valid basis.
Fenbuconazole's use on this crop group is unlikely to exceed the
calculated PCT because of the rigid production cap and restriction of
this use to the one product with the production cap. As to Conditions 2
and 3, regional consumption information and consumption information for
significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which fenbuconazole
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fenbuconazole 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 fenbuconazole.
    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
the Screening Concentration in Ground Water (SCI-GROW) model to predict
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 incorporates 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 fenbuconazole, they are further
discussed in the aggregate risk sections below.
    Based on the GENEEC model, the maximum EEC of fenbuconazole in
surface water, based on aerial application of the highest labeled
annual use rate of 0.75 lb of active ingredient per acre (ai/A), is 6.7
parts per billion (ppb) for acute exposures and 3.6 ppb for chronic
exposures. Based on the SCI-GROW model, the maximum EEC of
fenbuconazole in ground water, for both acute and chronic exposure, is
0.03 ppb. Since the ground water EECs for fenbuconazole are so much
lower than the surface water EECs, only the surface water EECs were
used for the purpose of comparisons with the calculated DWLOCs.
    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). Fenbuconazole 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, at this time, have available data to determine
whether fenbuconazole has a common mechanism of toxicity with other
substances or to determine how to include this pesticide in a
cumulative risk assessment. Unlike other pesticides for which EPA has
followed a cumulative risk approach based upon common mechanism of
toxicity, fenbuconazole does not appear to produce a toxic metabolite
produced by other substances. For purposes of this tolerance action,
EPA has not assumed that fenbuconazole has a common mechanism of
toxicity with other substances. For further 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. The
applicable studies are as follows.
    2. Prenatal and postnatal sensitivity. A 2-generation rat
reproduction study with a parental NOAEL of 4 mg/kg/day (80 ppm) and
LOAEL of 40 mg/kg/day (800 ppm), based on decreased body weight and
food consumption, increased number of dams not delivering viable or
delivering nonviable offspring, and increases in adrenal and thyroid
weights.The reproductive NOAEL was 40 mg/kg/day HDT.
    A developmental toxicity study in rabbits produced a maternal NOAEL
of 10 mg/kg/day, a developmental NOAEL of 30 mg/kg/day, an
undeterminable developmental LOAEL of 60 mg/kg/day (due to increased
resorptions), and a maternal LOAEL of 30 mg/kg/day.
    A developmental rat toxicity study resulted in a maternal and
developmental NOAEL of 30 mg/kg/day, a maternal LOAEL of 75 mg/kg/day
due to a decrease in maternal body weight compared to controls, and a
developmental LOAEL of 75 mg/kg/day due to an increase in post-
implantation loss and a decreased number of live fetuses per dam.
    3. Conclusion. Therefore, a complete toxicity data base for
fenbuconazole exists and exposure data are complete or
are estimated based on data that reasonably account for potential
exposures. Based on the developmental and reproductive toxicity studies
there is no increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to fenbuconazole. In the developmental
toxicity studies in rats and rabbits, as well as the 2-generation
reproduction study in rats, toxicity to the fetuses/offspring, when
observed, occurred at equivalent or higher doses and was not judged to
be more severe than in the maternal/parental animals. EPA therefore
determined that the 10X safety factor to protect infants and children
should be removed. The FQPA factor is removed because:
    i. The toxicology data base is complete.
    ii. There is no indication of increased susceptibility of rat or
rabbit fetuses to in utero or and/or postnatal exposure in the
developmental and reproductive toxicity studies.
    iii. Dietary (food) exposure estimates are slightly refined (using
limited PCT data for the stone fruit (except plum and prune) crop
group) but likely result in overestimates of the actual dietary
exposure.
    iv. Models are used for ground and surface source drinking water
exposure assessments, resulting in estimates that are upper-bound
concentrations.
    v. There are currently no registered residential uses for
fenbuconazole and, as a result, this type of infant and children
exposure is not expected.

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 points of comparison with 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 per 70 kg body weight (adult male), 2L per 60 kg body weight
(adult female), and 1L per 10 kg body weight (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 ground water 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. For the population subgroup of concern, females 13
years old and older, the acute RfD is 0.3 mg/kg/day, the estimated
acute food exposure is 0.015 mg/kg/day, the maximum estimated acute
water exposure is 0.29 mg/kg/day, the acute DWLOC is 8.6 x
103 microgram/liter (μg/L), and the acute EEC is 6.7
μg/L. Therefore, the Agency concludes with reasonable certainty
that residues of fenbuconazole in drinking water (when considered along
with other sources of acute exposure for which reliable data exist)
will not result in unacceptable levels of acute aggregate human health
risk estimates for the population subgroup females 13 years old and
older.
    The Agency generally has no concern for exposures below 100% of the
acute RfD (when the FQPA Safety Factor has been removed, as is the case
for fenbuconazole) because the acute RfD represents the level at or
below which a single daily exposure will not pose appreciable risks to
human health. Despite the potential for exposure to fenbuconazole in
drinking water, the Agency does not expect the acute aggregate exposure
to exceed 100% of the acute RfD for the subpopulation of cencern
(females 13 years old and older). The Agency concludes that there is a
reasonable certainty that no harm will result to females 13 years old
and older from chronic aggregate exposure to fenbuconazole residues.
    2. 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). Short-term endpoints
were not identified. Fenbuconazole is also not registered for use on
any sites that would result in residential exposure. Therefore, the
short-term aggregate risk assessment was not performed.
    3. 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). Intermediate-
term endpoints were not identified. Fenbuconazole is also not
registered for use on any sites that would result in residential
exposure. Therefore, the intermediate-term aggregate risk assessment
was not performed.
    4. Chronic risk. The following values were used or derived in
calculations of chronic exposure and risk. The percentages of the
chronic RfD that food exposure to fenbuconazole represented were <1.0%
for the overall U.S. population, 2.5% for all infants (<1 year old),
1.1% for nursing infants (<1 year old), 3.1% for non-nursing infants
(<1 year old), 1.5% for children (1-6 years old), <1.0% for non-
Hispanic (other than Black or White), and 1.0% for seniors (55 years
old or older). The adult population subgroup with the highest food
exposure, non-Hispanic (other than black or white), was the subgroup
used in the full analysis. For males the chronic RfD is 0.03, the
estimated chronic food exposure is 0.00030 mg/kg/day, the maximum
estimated water exposure is 0.030 mg/kg/day, DWLOC is 1.0 x
103 μg/L, and the chronic EEC is 3.6 μg/L.
For females the chronic RfD is 0.03, the estimated chronic food
exposure is 0.00030 mg/kg/day, the maximum estimated water exposure is
0.030 mg/kg/day, DWLOC is 8.9 x 102 μg/L, and the
chronic EEC is 3.6 μg/L.
    The estimated 56-day concentration of fenbuconazole in surface
water (3.6 μg/L) is less than the Agency's levels of comparison
for fenbuconazole in drinking water as a contribution to chronic
aggregate exposure (1.0 x 103 μg/L and 8.9 x
102 μg/L for males and females respectively).
Therefore, taking into account the registered uses, the Agency
concludes with reasonable certainty that residues of fenbuconazole in
drinking water (when considered along with other sources of chronic
exposure for which the Agency has reliable data) would not result in
unacceptable levels of chronic aggregate
human health risk estimates for adult population subgroups.
    The Agency generally has no concern for exposures below 100% of the
chronic RfD (when the FQPA Safety Factor has been removed, as is the
case for fenbuconazole) because the chronic RfD represents the level at
or below which average daily lifetime exposure will not pose
appreciable risks to human health. Despite the potential for exposure
to fenbuconazole in drinking water, the Agency does not expect the
chronic aggregate exposure to exceed 100% of the chronic RfD for
population subgroups which include adults. The Agency concludes that
there is a reasonable certainty that no harm will result to adults from
chronic aggregate exposure to fenbuconazole residues.
    5. Aggregate cancer risk for U.S. population. Fenbuconazole has
been classified as a Group C carcinogen with a Q1* of 3.59 x
10-3 (mg/kg/day)-1. The group used in this
analysis was U.S. population (48 contiguous states), the U.S.
population as a whole. The cancer analysis, using all of the existing
fenbuconazole tolerances (including section 18 tolerances), results in
a cancer risk estimate of 8.3 x 10-7 for food consumption
for the U.S. population as a whole. This analysis used 100% crop
treatment values except for the stone fruit (except plum and prune)
crop group, where a value of 12.8% crop treated was used. Based on the
cancer dietary (food only) exposure and using default body weights and
water consumption figures, a cancer DWLOC was calculated. The values
used or calculated as part of the calculation of the DWLOC are the Q 1*
of 3.59 x 10-3 (mg/kg/day)-1, a food exposure of
0.00023 mg/kg/day, a maximum water exposure of 4.6 x 10-5
mg/kg/day, a DWLOC of 1.6 μg/L, and a chronic EEC of 3.6
μg/L.
    Agency policy states that a factor of three will be applied to
GENEEC model values when determining whether or not a level of
comparison has been exceeded. If the GENEEC model value is less than or
equal to three times the DWLOC, the pesticide is considered to have
passed the screen and no further assessment is needed. The estimated
56-day (chronic) concentration of fenbuconazole in surface water (3.6
μg/L) is less than three times the level of comparison (3 x 1.6
= 4.8 μg/L) for fenbuconazole in drinking water as a
contribution to chronic (cancer) aggregate exposure. Therefore, it is
concluded with reasonable certainty that residues of fenbuconazole in
drinking water, when considered along with other sources of chronic
(cancer) exposure for which there is reliable data, would not result in
unacceptable levels of cancer aggregate human health risk estimates for
the overall U.S. population. The chronic food exposure estimate is
partially refined. Further refinement would lower the food exposure
estimate and result in a higher DWLOC.
    The Agency generally has no concern for exposures that result in a
cancer risk estimate below 1 x 10-6. Despite the potential
for exposure to fenbuconazole in drinking water, the Agency does not
expect the chronic (cancer) aggregate exposure to exceed 1 x
10-6 for the U.S. population as a whole. The Agency
concludes that there is a reasonable certainty that no harm will result
to the overall U.S. population from chronic (cancer) aggregate exposure
to fenbucanazole residues.
    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, or to infants and children from aggregate
exposure to fenbuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. This method involves extraction of parent and
metabolites into solvent followed by concentration, clean up,
separation by gas chromatography, and detection with a nitrogen
phosphorus detector. This method was submitted for inclusion in PAM II.
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 no CODEX, Canadian, or Mexican Maximum Residue Limits for
fenbuconazole in or on pecans, bananas, and the stone fruit (except
plums and prunes) crop group.

C. Conditions

    Discuss conditions for registration (i.e., additional residue field
trials required), regional registration, etc.
    The conditions of registration for fenbuconazole were submissions
of the following items. Five additional studies had to be submitted:
(1) Fish life cycle, (2) growth and reproduction of aquatic plants, (3)
droplet size spectrum, (4) drift field evaluation, and (5) 49-month
storage stability study. Several corrections to the labels were
required. Mitigation measures to address chronic non-target organism
toxicity concerns had to be identified and submitted. Production of the
Indar 75 WSP product could not exceed 38,000 lb (28,500 lb ai) for each
year of conditional registration and information on its production had
to be submitted for the first federal fiscal year during which
fenbuconazole was registered for use on stone fruits and pecans.
Production information had to be submitted for the Enable 2F product
(EPA Registration Number 62719-416) for the first federal fiscal year
during which this product was registered for use on pecans. The company
has subsequently submitted studies, information, and corrected labels,
and participated in task forces, intended to satisfy all these
condition-of-registration requirements. All such submissions that have
been reviewed have been found to satisfy the appropriate registration
condition.

V. Conclusion

    Therefore, the tolerances are extended until December 31, 2004 for
the combined residues of the fungicide fenbuconazole [alpha-(2-(4-
chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-1,2,4-triazole)-1-
propanenitrile]
and its metabolites, cis and trans-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone],
expressed as fenbuconazole, in or on the stone fruit (except plums and
prunes) crop group at 2.0 ppm, pecans at 0.1 ppm, and bananas at 0.3
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-301199 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 March 18,
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-301199, 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 extends tolerances 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 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: December 26, 2001.
Peter Caulkins,
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.

Sec. 180.480  [Amended]

    2. In Sec. 180.480(a)(1) is amended by revising the "Expiration/
Revocation Date" in the table "12/31/01" to read "12/31/04." for
the entries "bananas (whole fruit)"; "pecans"; and "stone fruit
crop group (except plums and prunes)".

[FR Doc. 02-962 Filed 1-14-02; 8:45 am]