[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Rules and Regulations]
[Pages 55513-55519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24013]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0301; FRL-7326-7]


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 cucumber; fruit, stone, group 12, except plum, 
prune, fresh, postharvest; kiwifruit, postharvest; leafy greens 
subgroup 4A, except spinach; plum, prune, dried; plum, prune, fresh; 
vegetable, fruiting, group 8, except nonbell pepper. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA). EPA is also deleting certain 
fenhexamid tolerances that are no longer needed as a result of this 
action.

DATES: This regulation is effective September 26, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0301, 
must be received on or before November 25, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 308-9368; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Industry (NAICS 111), e.g., Crop production.
    [sbull] Industry (NAICS 112), e.g., Animal production.
    [sbull] Industry (NAICS 311), e.g., Food manufacturing.
    [sbull] Industry (NAICS 32532), e.g., 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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0301. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under 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.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of May 21, 2003 (68 FR 27799) (FRL-7308-4), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA (Public Law 104-170), announcing the filing of a 
pesticide petition (PP 2E6463, 2E6496, 3E6532, and 3E6541) by IR-4, 681 
U.S. Highway 1 South, North Brunswick, NJ 08902-3390. That 
notice included a summary of the petitions prepared by Arvesta 
Corporation, 100 First Street, Suite 1700, San Francisco, CA 94105, 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

[[Page 55514]]

fenhexamid, N-(2,3-dichloro-4-hydroxyphenyl)-1-methyl-cyclohexane 
carboxamide, in or on food commodities as follows: cucumber at 2.0 
parts per million (ppm) (PP 2E6496); fruit, stone, group 12, 
postharvest at 10.0 ppm (PP 3E6541); kiwifruit, postharvest at 15.0 ppm 
(PP 2E6463); leafy greens, subgroup 4A, except spinach at 30.0 ppm (PP 
3E6532); vegetable, fruiting, group 8, at 2.0 ppm (PP2E6496). IR-4 
subsequently amended PP 3E6541 to propose tolerances for fruit, stone, 
group 12, except plum, prune, fresh, postharvest at 10.0 ppm and 
separate tolerances for plum, prune, dried at 2.5 ppm and plum, prune, 
fresh at 1.5 ppm. IR-4 also amended PP 2E6496 to propose tolerances for 
vegetable, fruiting, group 8, except nonbell pepper at 2.0 ppm. EPA is 
deleting the established fenhexamid tolerance for fruit, stone, except 
plum, prune, fresh at 6.0 ppm. This tolerance is no longer needed since 
this action establishes a higher tolerance at 10.0 ppm to cover both 
pre- and postharvest application to stone fruit, except plum, prune, 
fresh.
    EPA has received objections to tolerances it established for 
residues of fenhexamid on a variety of berry crops and pistachio (67 FR 
19114) (FRL-6829-9). The objections were filed by the Natural Resources 
Defense Council (NRDC) and raised several issues regarding aggregate 
exposure estimates and the additional safety factor for the protection 
of infants and children. NRDC's objections raise complex legal, 
scientific, policy, and factual matters and EPA has initiated a public 
comment period on them in the Federal Register of June 19, 2002 (67 FR 
41628) (FRL-7167-7), which ended on October 16, 2002. Although that 
proceeding remains ongoing, prior to acting on this current tolerance 
action, EPA reviewed the fenhexamid-specific objections raised by NRDC 
and has addressed them at relevant points throughout this preamble.
    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) of the FFDCA 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) of the FFDCA 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 of the FFDCA 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) of the FFDCA, 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) of the FFDCA, for tolerances for residues of fenhexamid on 
cucumber at 2.0 ppm; fruit, stone, group 12, except plum, prune, fresh, 
postharvest at 10.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy 
greens subgroup 4A, except spinach at 30.0 ppm; plum, prune, dried at 
2.5 ppm; plum, prune, fresh at 1.5 ppm; vegetable, fruiting, group 8, 
except nonbell pepper at 2.0 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by fenhexamid are 
discussed in Unit II.A. of the final rule on Fenhexamid; Pesticide 
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 factors 
(SF) 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 SF.
    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 
Table 1 of this unit:

[[Page 55515]]



      Table 1.--Summary of Toxicological Dose and Endpoints for Fenhexamid for Use in Human Risk Assessment
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                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General Population      None                     FQPA SF = 1X              Not selected. No
 including infants and children)       UF = NA................  aPAD = acute RfD / FQPA   appropriate
                                       Acute RfD = None.......   SF = None.               toxicological endpoint
                                                                                          attributable to a
                                                                                          single exposure was
                                                                                          identified in the
                                                                                          available toxicology
                                                                                          studies.
-----------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 17 mg ai/kg/day  1X                        1-Year Feeding-Dog.
                                       UF = 100...............  cPAD = chronic RfD /     Decreased RBC count,
                                       Chronic RfD = 0.17 mg/    FQPA SF = 0.17 mg/kg/    hemoglobin and
                                        kg/day.                  day.                     hematocrit and
                                                                                          increased Heinz bodies
                                                                                          in males and females;
                                                                                          increased adrenal
                                                                                          weights and
                                                                                          intracytoplasmic
                                                                                          vacuoles in adrenal
                                                                                          cortex in females at
                                                                                          the LOAEL of 124 mg/kg/
                                                                                          day.
-----------------------------------------------------------------------------------------
Short-Term (1-30 days) and             NOAEL = 1,000 mg ai/kg/  Residential MOE = Not     21-Day Dermal-Rabbit.
 Intermediate-Term (1-6 months)         day                      applicable              In the developmental
 Dermal                                Dermal absorption rate                             toxicity study in
                                        = 20%.                                            rabbits, decreased
                                                                                          body weight gain and
                                                                                          food consumption at
                                                                                          LOAEL of 1,500 mg/kg/
                                                                                          day (dermal equivalent
                                                                                          dose using 20% dermal
                                                                                          absorption factor);
                                                                                          NOAEL was 500 mg/kg/
                                                                                          day (dermal equivalent
                                                                                          dose). Dermal exposure
                                                                                          is not expected since
                                                                                          there are no
                                                                                          residential uses.
-----------------------------------------------------------------------------------------
Long-Term Dermal (> 6 months)          None                     Residential MOE = Not     Not selected. Long-
                                       Dermal absorption rate    applicable               term dermal exposure
                                        = 20%.                                            is not expected since
                                                                                          there are no
                                                                                          residential uses.
-----------------------------------------------------------------------------------------
Short-Term (1-30 days), Intermediate-  None                     Residential MOE = Not    Not selected.
 Term (1-6 months), and Long-term (>                             applicable               Inhalation exposure is
 6 months) Inhalation                                                                     not expected since
                                                                                          there are no
                                                                                          residential uses.
-----------------------------------------------------------------------------------------
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 SF refers to any additional SF 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 a 
variety of raw agricultural commodities. 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 EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\) which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. An 
unrefined, Tier 1 chronic dietary exposure assessment was performed 
using tolerance level residues (established and recommended) and 100% 
crop treated. DEEM\TM\ default processing/concentration factors were 
used for all processed commodities.
    iii. Cancer. Fenhexamid has been classified as a ``not likely'' 
human carcinogen. Therefore, a quantitative cancer dietary exposure 
assessment was not performed.
    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.
    2. Dietary exposure from drinking water. The Agency uses the FQPA 
Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone 
Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce 
estimates of pesticide concentrations in an index reservoir. The 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. FIRST and PRZM/EXAMS 
incorporate an index reservoir environment, and include 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

[[Page 55516]]

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.
    Based on the FIRST and SCI-GROW models the estimated environmental 
concentrations (EECs) of fenhexamid for 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 effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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 Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to fenhexamid 
and any other substances and 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 policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA 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 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. In the rat and the rabbit 
developmental toxicity studies, neither quantitative nor qualitative 
evidence of increased susceptibility of fetuses to in utero exposure to 
fenhexamid was observed. In the rat reproduction study, qualitative 
susceptibility was evidenced 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) in the presence of 
lesser maternal toxicity (alterations in clinical chemistry parameters 
and decreased organ weights without collaborative histopathology). 
Considering the overall toxicity profile and the doses and endpoints 
selected for risk assessment for fenhexamid, the degree of concern for 
the effects observed in this study was characterized as low, noting 
that there is a clear NOAEL and well-characterized dose response for 
the offspring effects observed and that these effects occurred in the 
presence of parental toxicity. No residual uncertainties were 
identified. The NOAEL of 17 mg/kg/day from the chronic dog study used 
to establish the chronic Reference Dose (cRfD) for the General 
Population (no aRfD was established for any population subgroup) is 
lower than the NOAEL of 38.2 mg/kg/day in the reproduction study in 
which the offspring effects of concern were observed (LOAEL = 406 mg/
kg/day).
    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 1X for the following reasons:
    [sbull] There are no residual uncertainties for pre and/or post 
natal toxicities via the oral route since the doses selected for 
overall risk assessments would address the concerns for the 
developmental and offspring toxicities seen in the above mentioned 
studies.
    [sbull] There are no residual uncertainties for pre and/or post 
natal toxicities via the dermal route since the dose/endpoint/study/
species of concern was used for dermal-risk assessment.
    [sbull] The toxicology data base is complete.
    [sbull] Developmental neurotoxicity studies are not required for 
fenhexamid based on the following weight-of-the-evidence 
considerations:
    - Lack of evidence of abnormalities in the development of the fetal 
nervous system in the pre/post-natal studies.
    - Neither brain weight nor histopathological examination of the 
nervous system was affected in the subchronic and chronic studies.
    - Decreased body temperatures observed in male rats in the acute 
neurotoxicity study were not considered to be toxicologically 
significant.
    [sbull] The dietary (food) exposure assessment utilizes existing 
and proposed tolerance level residues and assumes 100% of crops treated 
with fenhexamid. The assessment is based on reliable data and is not 
expected to underestimate exposure/risk.
    [sbull] Conservative assumptions are used in the drinking water 
models. The drinking water exposure assessment is not expected to 
underestimate exposure/risk.
    [sbull] Fenhexamid is not registered for use sites that would 
result in residential exposure.

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

[[Page 55517]]

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: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute risk assessment was not performed. No 
toxicological endpoint attributable to a single (acute) dietary 
exposure was identified. Therefore, acute risk from exposure to 
fenhexamid is not expected.
    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 9.9 % of the cPAD for the U.S. 
population, 19.6 % of the cPAD for all infants < 1 year, 21.8% of the 
cPAD for children 1 to 2 years, the population subgroup at greatest 
exposure, and 8.8% of the cPAD for females 13 to 50 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 Table 2 of this unit:

               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                                         0.17          9.9         1.14       0.0007        5,363
---------------------------------------------------------------------------
All infants < 1 year                                    0.17         19.6         1.14       0.0007        1,367
---------------------------------------------------------------------------
Children 1 to 2 years                                   0.17         21.8         1.14       0.0007        1,330
---------------------------------------------------------------------------
Females 13-50 years                                     0.17          8.8         1.14       0.0007        4,980
----------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). In its objections to a separate fenhexamid 
tolerance action, NRDC claims that residential short-term and 
intermediate-term risk assessments are data gaps for fenhexamid. EPA 
did not conduct short-term and intermediate-term risk assessments for 
fenhexamid since the pesticide is not registered for use on any sites 
that would result in residential exposure. Therefore, the aggregate 
risk is the sum of risk from chronic exposure to residues in food and 
water, which do not exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. EPA has classified 
fenhexamid as a ``not likely'' human carcinogen. The Agency concludes 
that pesticidal uses of fenhexamid do not pose a cancer risk to humans.
    5. 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: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: [email protected].

V. Conclusion

    Therefore, the tolerance is established for residues of fenhexamid, 
N-2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide, in or 
on cucumber at 2.0 ppm; fruit, stone, group 12, except plume, prune, 
fresh, postharvest at 10.0 ppm; kiwifruit, postharvest at 15.0 ppm; 
leafy greens subgroup 4A, except spinach at 30.0 ppm; plum, prune, 
dried at 2.5 ppm; plum, prune, fresh at 1.5 ppm; vegetable, fruiting 
group 8, except nonbell pepper at 2.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made.

[[Page 55518]]

 The new section 408(g) of the FFDCA 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) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
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 ID number OPP-2003-0301 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
25, 2003.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 [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-
0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2003-0301, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA 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 section 408(d) of the FFDCA, 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

[[Page 55519]]

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 section 408(n)(4) of the FFDCA. 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. Congressional Review Act

    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: September 10, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.553 is amended as follows:
    a. By revising the commodities plum, prune, dried and plum, prune, 
fresh in the table in paragraph (a).
    b. By removing the commodity fruit, stone, except plum, prune, 
fresh in the table in paragraph (a).
    c. By alphabetically adding commodities in the table in paragraph 
(a).


Sec.  180.553  Fenhexamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
 Cucumber                                                            2.0
Fruit, stone, group 12, except plum, prune, fresh,                  10.0
 postharvest
                                * * * * *
Kiwifruit, postharvest                                              15.0
                                * * * * *
Leafy greens, subgroup 4A, except spinach                           30.0
                                * * * * *
Plum, prune, dried                                                   2.5
Plum, prune, fresh                                                   1.5
                                * * * * *
Vegetable, fruiting, group 8, except nonbell pepper                  2.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-24013 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S