[Federal Register Volume 67, Number 75 (Thursday, April 18, 2002)]
[Rules and Regulations]
[Pages 19114-19120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9498]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301228; FRL-6829-9]
RIN 2070-AB78


Fenhexamid; Pesticide Tolerance

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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           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 
(MOEcancer = 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: 
[email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental 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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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

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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