Fenhexamid; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: April 18, 2002 (Volume 67, Number 75)]
[Rules and Regulations]
[Page 19114-19120]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap02-9]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301228; FRL-6829-9]
RIN 2070-AB78

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fenhexamid in or on caneberry subgroup, bushberry subgroup, juneberry,
lingonberry, salal, and pistachio. The Interregional Research Project
Number 4 (IR-4) requested these tolerances 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-301228,
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-301228 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 308-3194; e-mail
address: brothers.shaja@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 the Federal 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-301228. 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 February 8, 2002 (67 FR 6028) (FRL-6821-
2), 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 1E6339, 1E6341, and 1E6343) by
IR-4, 681 US Highway #1 South, North Brunswick, NJ 08902-3390. This
notice included a summary of the petitions prepared by Tomen Agro,
Incorporated, the registrant. There were no comments received in
response to the notice of filing.
The petitions requested that 40 CFR 180.553 be amended by
establishing tolerances for residues of the fungicide fenhexamid, (N-
2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide), in or
on food commodities as follows:
1. PP 1E6339 proposed a tolerance for caneberry (corrected to read
caneberry subgroup) at 20 part per million (ppm),
2. PP 1E6341 proposed tolerances for bushberry (corrected to read
bushberry subgroup) at 5.0 ppm, juneberry at 5.0 ppm, longanberry
(corrected to read lingonberry) at 5.0 ppm, and salal at 5.0 ppm, and
3. PP 1E6343 proposed a tolerance for pistachio at 0.02 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include

[[Page 19115]]

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
these actions. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of fenhexamid on caneberry
subgroup at 20 ppm, bushberry subgroup at 5.0 ppm, juneberry at 5.0
ppm, lingonberry at 5.0 ppm, salal at 5.0 ppm, and pistachio at 0.02
ppm. EPA's assessment of exposures and risks associated with
establishing these tolerances follow.

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 fenhexamid are
discussed in Unit II.A. of the Final Rule on Fenhexamid Pestcide
Tolerance published in the Federal Register of April 13, 2000 (65 FR
19842) (FRL-6553-7).

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 intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in
a million). Under certain specific circumstances, MOE calculations will
be used for the carcinogenic risk assessment. In this non-linear
approach, a ``point of departure'' is identified below which
carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOE_cancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for fenhexamid used for human
risk assessment is shown in the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for fenhexamid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary None Not Applicable Available studies do
not indicate the
possibility of an
acute effect as a
result of a one-day or
single exposure.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL= 17 mg/kg/day FQPA SF = 3X........... Dog-1 Year Feeding
UF = 100............... cPAD = chronic RfD/FQPA Study
Chronic RfD = 0.17 mg/ SF = 0.057 mg/kg/day. NOAEL = 17 mg/kg/day
kg/day. based on decreased RBC
count, hemoglobin and
hematocrit and
increased Heinz bodies
in males and females;
increased adrenal
weights and
intracytoplasmic
vacuoles in adrenal
cortex in females.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days) dermal study NOAEL= LOC for MOE = 100 Rabbit - 21 Day Dermal
1,000 mg/kg/day (HDT) (Dermal) LOAEL = 1,500 mg/kg/day
(dermal) absorption based on decreased
rate = 20%). body weight gain and
food consumption.
NOAEL= 500 mg/kg/day
(dermal equivalent
dose).
----------------------------------------------------------------------------------------------------------------

[[Page 19116]]

Intermediate-Term Dermal (1 week to dermal study NOAEL = LOC for MOE = 100 Rabbit- 21 Day Dermal
several months) (Residential) 1,000 mg/kg/day HDT (Dermal) LOAEL = 1,500 mg/kg/day
(dermal) absorption based on decreased
rate = 20%). body weight gain and
food consumption.
NOAEL= 500 mg/kg/day
(dermal equivalent
dose).
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to None Not Applicable None. The use pattern
lifetime) does not indicate a
potential long-term
dermal exposure. This
risk assessment was
not performed.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) None Not Applicable Fenhexamid is
classified as a not
likely human
carcinogen based on
the lack of evidence
of carcinogenicity in
mice and rats and the
lack of genotoxicity
in a battery of
mutagenicity studies.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.553) for the residues of fenhexamid, in or on
the following raw agricultural commodities: almond, hull at 2.0 ppm;
almond, nutmeat at 0.02 ppm; grapes at 4.0 ppm; plum (fresh prune) at
0.5 ppm; prune, dried at 1.0 ppm; raisins at 6.0 ppm; stone fruit,
except plum (fresh prune) at 6.0 ppm; and strawberries at 3.0 ppm. A
time-limited tolerance has been established for pears at 15 ppm. The
tolerance will expire on December 31, 2002. Risk assessments were
conducted by EPA to assess dietary exposures from fenhexamid 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. An acute risk assessment was not performed. No
toxicological endpoint attributable to a single (acute) dietary
exposure was identified.
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 Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments: A Tier 1 (assumptions: tolerance level residues
and 100% crop treated) chronic dietary exposure analysis was performed
using the DEEM. The analysis incorporated all the current,
pending, and proposed tolerances for fenhexamid. Percent of crop
treated and anticipated residues were not used for this assessment.
iii. Cancer. Fenhexamid has been classified as a not likely human
carcinogen.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fenhexamid 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 fenhexamid.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The screening concentrtion in groundwater (SCI-GROW) model is used to
predict pesticide concentrations in shallow groundwater. For a
screening-level assessment for surface water EPA will use FIRST (a tier
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, 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 fenhexamid they are further
discussed in the aggregate risk sections in Unit III.E.
In soil, fenhexamid is relatively immobile and non-persistent.
Fenhexamid is not expected to be a ground water contaminant, but has
some potential to reach surface water on eroded soil particles. In
surface water, fenhexamid would be expected to photodegrade rapidly.
Based on the FIRST and SCI-GROW models the estimated environmental
concentrations (EECs) of fenhexamid for

[[Page 19117]]

acute and chronic surface water exposures are estimated to be 28.7
parts per billion (ppb) and 1.14 ppb, respectively. The EECs for acute
and chronic ground water exposure is estimated to be 0.0007 ppb.
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).
Fenhexamid 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 fenhexamid 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,
fenhexamid 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 fenhexamid 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. The toxicology data base is
complete for the assessment of the effects of fenhexamid following in
utero and/or postnatal exposure. There is no indication of increased
susceptibility to in utero exposure in the prenatal developmental
toxicity studies with fenhexamid. In the prenatal developmental
toxicity study in rats, no evidence of developmental toxicity was seen
even at the highest dose tested. In the prenatal developmental toxicity
study in rabbits, developmental toxicity was seen only in the presence
of maternal toxicity. In the two-generation reproduction study in rats,
quantitatively (i.e., based on NOAELs/LOAELs in parental animals versus
offspring), there was no evidence of increased susceptibility of the
pups. Qualitatively, however, there was evidence of increased
susceptibility based on the comparative severity of effects at the
LOAEL (406 mg/kg/day): Parental toxicity was characterized as
alterations in clinical chemistry parameters and decreased organ
weights without collaborative histopathology; while offspring toxicity
was manifested as significantly decreased pup body weights in both
generations during the lactation period (on lactation days 7, 14, and
21 in the F₂ generation and lactation days 14 and 21 in the
F₁ generation offspring).
3. Conclusion. There is a complete toxicity data base for
fenhexamid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
reduced to 3X. The 3X safety factor is appropriate for the chronic
dietary assessment and is applicable to all populations, which includes
infants and children. The FQPA factor is reduced because:
i. The increased susceptibility demonstrated in the two-generation
reproduction study was only qualitative (not quantitative) evidence and
was observed only in the presence of parental toxicity.
ii. The qualitative offspring effect was limited to decreased body
weight and no other adverse effects (e.g., decreased pup survival,
behavioral alterations, etc) were observed.
iii. The toxicology data base is complete for the assessment of the
effects of fenhexamid following in utero and/or postnatal exposure.
iv. There is no indication of increased susceptibility of rat or
rabbit fetuses to in utero exposure in the prenatal developmental
toxicity studies with fenhexamid.
v. Adequate data are available or conservative modeling assumptions
are used to assess dietary food and drinking water exposure.
vi. There are currently no residential uses for fenhexamid.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes
with reasonable certainty that exposures to the pesticide in drinking
water (when considered along with other sources of exposure for which
OPP has reliable data) would not result in unacceptable levels of
aggregate human health risk at this time. Because OPP considers the
aggregate risk resulting from multiple exposure pathways associated
with a pesticide's uses, levels of comparison in drinking water may
vary as those uses change. If new uses are added in the future, OPP
will reassess the potential impacts of residues of the pesticide in
drinking water as a part of the aggregate risk assessment process.

[[Page 19118]]

1. Acute risk. An acute risk assessment was not performed. No
toxicological endpoint attributable to a single (acute) dietary
exposure was identified.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fenhexamid from food will utilize 7% of the cPAD for the U.S.
population, 66% of the cPAD for all infants < 1 year old and 17% of the
cPAD for children 1-6 years old. There are no residential uses for
fenhexamid that result in chronic residential exposure to fenhexamid.
However, there is potential for chronic dietary exposure to fenhexamid
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 2:

Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to fenhexamid
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.057 7 1.14 0.0007 1,850
----------------------------------------------------------------------------------------------------------------
All infants < 1 year old 0.057 66 1.14 0.0007 190
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old 0.057 17 1.14 0.0007 470
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.057 4 1.14 0.0007 1,650
----------------------------------------------------------------------------------------------------------------

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). Although short-term
endpoints were identifiable, there are no residential uses for
fenhexamid. Thus, a short-term risk assessment was not performed.
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). Although
intermediate-term endpoints were identifiable, there are no residential
uses for fenhexamid. Thus, an intermediate-term risk assessment was not
performed.
5. Aggregate cancer risk for U.S. population. A cancer (chronic)
dietary risk assessment was not conducted for fenhexamid. EPA has
classified fenhexamid as a not likely human carcinogen.
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 fenhexamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Bayer AG Method 00362 has previously undergone a successful method
trial and method validation, and is the enforcement method for all the
fenhexamid established tolerances. The method may be requested from:
Francis Griffith, Analytical Chemistry Branch, Environmental Science
Center, Environmental Protection Agency, 701 Mapes Road, Fort George G.
Mead, MD 20755-5350; telephone number: (410) 305-20905; e-mail address:
griffith.francis@epa.gov.

V. Conclusion

Therefore, the tolerances are established for residues of
fenhexamid, (N-2,3-dichloro-4-hydroxyphenyl)-1-methyl
cyclohexanecarboxamide), in or on caneberry subgroup at 20 part per
million (ppm), bushberry subgroup at 5.0 ppm, juneberry at 5.0 ppm,
lingonberry at 5.0 ppm, salal at 5.0 ppm, and pistachio at 0.02 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301228 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

[[Page 19119]]

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-301228, 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 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

[[Page 19120]]

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 4, 2002.
Robert A. Forrest,
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 374.

2. Section 180.553 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:

Sec. 180.553 Fenhexamid; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Bushberry subgroup 13B..................................... 5.0
Caneberry subgroup 13A..................................... 20.0
* * * * *
Juneberry.................................................. 5.0
Lingonberry................................................ 5.0
Pistachio.................................................. 0.02
* * * * *
Salal...................................................... 5.0
* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 02-9498 Filed 4-17-02; 8:45 am]
BILLING CODE 6560-50-S

Fenhexamid; Pesticide Tolerance

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