[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Rules and Regulations]
[Page 55513-55519]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-18]
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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: jamerson.hoyt@epa.gov.
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/http://.
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
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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.
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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.
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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.
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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.
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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: residuemethods@epa.gov.
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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. 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