[Federal Register: December 9, 2002 (Volume 67, Number 236)]
[Rules and Regulations]
[Page 72846-72854]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de02-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0326; FRL-7282-1]
Carboxin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of carboxin (5,6-dihydro-2-methyl-N-phenyl-1,4-oxathiin-3-carboxamide)
and its metabolite 5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-
oxide (calculated as carboxin) (from treatment of seed prior to
planting) in or on canola, seed. Gustafson LLC requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA) , as amended by
the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective December 9, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0326,
must be received on or before February 7, 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: Mary Waller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address: waller.mary@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] Crop production (NAICS Code 111)
[sbull] Animal production (NAICS Code 112)
[sbull] Food manufacturing (NAICS Code 311)
[sbull] Pesticide manufacturing (NAICS Code 32532)
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.
[[Page 72847]]
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-2002-0326. 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. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
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 February 23, 2000 (65 FR 8970) (FRL-
6390-1), 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 9F6036) by Gustafson LLC, 1400
Preston Road, Suite 400, Plano, Texas 75093. That notice included a
summary of the petition prepared by Gustafson, LLC, the registrant.
There were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.301 be amended by
establishing a tolerance for combined residues of the fungicide
carboxin, 5,6-dihydro-2-methyl-1,4-oxathiin-3-carboxanilide] and its
sulfoxide metabolite 5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-
4-oxide], each expressed as the parent compound], in or on canola, seed
at 0.03 parts per million (ppm).
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) 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 November 26, 1997 (62 FR 62961) (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 a tolerance for combined residues of
carboxin (5,6-dihydro-2-methyl-N-phenyl-1,4-oxathiin-3-carboxamide) and
its metabolite 5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-
oxide (calculated as carboxin) (from treatment of seed prior to
planting) on canola, seed at 0.03 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 carboxin are
discussed in Table 1 of this unit as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
Table 1.-- Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.3100 90-Day oral NOAEL = Males: not
toxicity in rats identified; Females:
10 mg/kg/day
LOAEL = Males: 10 mg/
kg/day based on
chronic nephritis,
increased urea
nitrogen, increased
creatinine; Females:
40 mg/kg/day based
on chronic nephritis
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870.3200 21/28-Day dermal Not available
toxicity
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870.3465 90-Day inhalation Not available
toxicity
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[[Page 72848]]
870.3700 Prenatal Maternal NOAEL = 10
developmental in milligrams/kilogram/
rats day (mg/kg/day)
LOAEL = 90 mg/kg/day
based on decreased
body weights and
body weight gain,
decreased food
consumption, and
increased hair loss
Developmental NOAEL =
175 mg/kg/day
LOAEL = not
identified
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870.3700 Prenatal Maternal NOAEL = 75
developmental in mg/kg/day
rabbits LOAEL = 375 mg/kg/day
based on increased
abortions
Developmental NOAEL =
75 mg/kg/day
LOAEL = 375 mg/kg/day
based on increased
abortions
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870.3800 Reproduction and Parental NOAEL =
fertility Males and Females: 1
effects in rats mg/kg/day
LOAEL = Males: 10 mg/
kg/day based on
decreased body
weight gains in F1
parents, gross and
histopathological
changes in kidneys;
Females: 15 mg/kg/
day based on
equivocal
histopathological
changes in kidneys
Reproductive NOAEL =
Males: 10 mg/kg/day;
Females: 15 mg/kg/
day
LOAEL = Males: 20 mg/
kg/day; Females: 30
mg/kg/day based on
decreased fertility
indices for F1b
parents due to
decreased number of
pregnancies for F2b
generation
Offspring NOAEL =
Males: 10 mg/kg/day;
Females: 15 mg/kg/
day
LOAEL = Males: 20 mg/
kg/day; Females: 30
mg/kg/day based on
decreased body
weights for F2b male
pups
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870.4100 Chronic toxicity NOAEL = Males: 16 mg/
in dogs kg/day; Females: 1.3
mg/kg/day
LOAEL = Males: 158 mg/
kg/day based on
decreased RBC,
hematocrit and
hemoglobin,
increased MCH and
MCV, increased
alkaline phosphatase
and cholesterol,
increased liver
weights; Females: 15
mg/kg/day based on
decreased body
weight gains
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870.4300 Combined Chronic/ NOAEL = Males: 0.8 mg/
Carcino-genicity kg/day; Females: 1.0
in rats mg/kg/day
LOAEL = Males: 9 mg/
kg/day based on
decreased body
weight and body
weight gain,
increased urea
nitrogen and
creatinine,
increased water
consumption and
urine volume,
decreased urine
specific gravity,
histopathological
changes in kidneys;
Females: 16 mg/kg/
day based on
histopathological
changes in kidneys
Negative for
carcinogenicity
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870.4200 Carcino-genicity NOAEL = Males: 752 mg/
in mice kg/day; Females: 9
mg/kg/day
LOAEL = Males: not
identified; Females:
451 mg/kg/day based
on increased
mortality
Negative for
carcinogenicity
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870.5100 Bacterial reverse Negative with or
mutation assay without S-9
(Ames test) activation at 5.000
[mu]g/plate and less
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870.5375 In vitro Negative without S-9
mammalian activation
chromosome Positive with S-9
aberration (CHO activation. Highly
cells) significant
increases in
chromosomal
aberrations at
several toxic dose
levels ranging from
400 to 1,400 Fg/mL
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870.5385 In vivo mammalian Negative at all dose
chromosome levels up to 48-
aberration (rat hours post-dosing
bone marrow) Study is unacceptable
due to lack of
clinical toxicity,
lack of a multiple
dosing schedule, and/
or lack of evidence
of transport to
target tissue
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870.5385 In vivo mammalian Negative at all dose
chromosome levels tested
aberration (rat
bone marrow)
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870.5385 In vivo mammalian Positive. Dose-
chromosome related
aberration (rat statistically
bone marrow) significant
increased percent of
aberrant cells at
191 mg/kg/day
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870.5450 Dominant lethal Not available
assay in rats
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[[Page 72849]]
870.5550 UDS in primary Positive. Dose-
rat hepatocytes dependent positive
responses were
observed at
treatment levels
from 5.13 to 103
[mu]g/mL in the
absence of moderate
to severe toxicity
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870.7485 Metabolism and Following oral
pharmaco treatment of rats
kinetics in rats with phenyl-UL-C14
carboxin,
approximately 78.3-
81.1% and 77.0-81.5%
of the low and high
doses, respectively,
were recovered.
Urine was the major
route of excretion.
The major urinary
metabolites were 4-
acetamidophenol and
its glucuronide,
acetanilide, and
hydroxylated
carboxin sulfoxide
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B. Toxicological Endpoints
The dose at which 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 carboxin used for human risk assessment is shown in Table
2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for carboxin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
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Acute dietary all populations Acute RfD = not No toxicological None
required endpoint attributable
to a single exposure
was identified
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Chronic dietary all populations NOAEL = 0.8 mg/kg/day FQPA SF = 3 Combined chronic/
UF = 100............... cPAD = chr RfD......... carcinogenicity - rat
Chronic RfD = 0.008 mg/ FQPA SF = 0.00267 mg/kg/ LOAEL = Males: 9 mg/kg/
kg/day. day. day based on decreased
body weight and body
weight gain, increased
urea nitrogen and
creatinine, increased
water consumption and
urine volume,
decreased urine
specific gravity,
histopathological
changes in kidneys;
Females: 16 mg/kg/day
based on
histopathological
changes in kidneys
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Cancer (oral, dermal, inhalation) Not likely to be Negative for Combined chronic/
carcinogenic to humans carcinogenicity in carcinogenicity - rat
rats and mice and carcinogenicity -
mouse
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* 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 180.301) for the combined residues of carboxin and
its sulfoxide metabolite, in or on a variety of raw agricultural
commodities (RAC). Risk assessments were conducted by EPA to assess
dietary exposures from
[[Page 72850]]
carboxin and its sulfoxide metabolite 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 1-day or
single exposure. No toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies on
carboxin. As a result, an acute endpoint was not identified and an
acute dietary exposure assessment was not performed.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the Department of Agriculture (USDA) 1989-1992
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The chronic
dietary exposure analysis was an unrefined assessment. Tolerance level
residues and 100% crop treated assumptions were used.
iii. Cancer. Carboxin was classified as ``not likely to be
carcinogenic to humans.'' Therefore, a cancer dietary exposure
assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for carboxin and its sulfoxide
metabolite] 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 carboxin and its sulfoxide
metabolite.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow ground water. For a screening-level assessment for surface
water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that
uses a specific high-end runoff scenario for pesticides. While both
FIRST and PRZM/EXAMS incorporate an index reservoir environment, the
PRZM/EXAMS model includes a percent crop (PC) area factor as an
adjustment to account for the maximum PC coverage within a watershed or
drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to carboxin and its sulfoxide
metabolite they are further discussed in the aggregate risk sectionsin
Unit E.
Based on the FIRST and SCI-GROW models the estimated environmental
concentrations (EECs) of carboxin and its sulfoxide metabolite for
acute exposures are estimated to be 29.6 parts per billion (ppb) for
surface water and 0.09 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.63 ppb for surface water and 0.09 ppb
for ground water.
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). Carboxin is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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 carboxin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
carboxin 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 carboxin has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. 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 database 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. The developmental toxicity
and reproduction studies performed with carboxin did not indicate
evidence for enhanced susceptibility to the fetuses/offspring of rats
or rabbits. Neither quantitative nor qualitative increased
susceptibility was observed in the developmental toxicity study in
rats, the developmental toxicity study in rabbits, or the 2-generation
reproduction toxicity study in rats. In none of the toxicity studies on
carboxin was there any toxicologically significant evidence of
treatment-related neurotoxicity. A developmental neurotoxicity study in
rats is not required. There is, however, a concern for possible
germinal cell toxicity.
In genotoxicity studies, carboxin demonstrated clear evidence of
clastogenic potential. It was also noted that in the 2-generation
reproduction study in rats, treatment-related decreased fertility
indices for the F1b male and female parents (due to a decreased number
of pregnancies for the F2b generation) were observed. Based on these
considerations, the registrant will be required to submit a germinal
[[Page 72851]]
cell assay, specifically a dominant lethal assay in rats, to the Agency
in order to evaluate possible interaction between carboxin and germinal
cell targets.
3. Conclusion. Based upon clear evidence of clastogenic activity
and the requirement for a dominant lethal study, EPA concluded that a
FQPA safety factor of 3X is appropriate for this risk assessment. The
safety factor of 10X was reduced to 3X because: i. There is no
indication of quantitative or qualitative increased susceptibility of
rats or rabbits to in utero and/or postnatal exposure; ii. A
developmental neurotoxicity study is not required; iii. The dietary
(food and drinking water) exposure assessments will not underestimate
the potential for exposures to infants and children; and iv. There are
no registered residential uses for carboxin.
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 EECs of a
pesticide. 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 ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA 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, EPA 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. No toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies on
carboxin. As a result, carboxin is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to carboxin
and its sulfoxide metabolite from food will utilize 41% of the cPAD for
the U.S. population and 92% of the cPAD for children 1-6 years, the
most highly exposed population. There are no residential uses for
carboxin. In addition, there is potential for chronic dietary exposure
to carboxin and its sulfoxide metabolite in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to carboxin and its sulfoxide metabolite
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.00267 41 0.63 0.09 56
----------------------------------------------------------------------------------------------------------------
Children 1-6 years 0.00267 92 0.63 0.09 2
----------------------------------------------------------------------------------------------------------------
3. Short-term and Intermediate-term risk. Both short-term aggregate
exposure and intermediate-term aggregate exposure take into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Since carboxin is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern as
described in Table 3.
4. Aggregate cancer risk for U.S. population. Carboxin was
classified as ``not likely to be carcinogenic to humans.'' Therefore,
carboxin is not expected to pose a cancer risk.
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 residues of carboxin and its sulfoxide metabolite.
IV. Other Considerations
A. Endocrine Disruptor Effects
FQPA requires EPA to develop a screening program to determine
whether certain substances (including all pesticides and inerts or
inactive ingredients) ``may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen, or such other
endocrine effect...'' EPA has been working with interested stakeholders
to develop a screening and testing program as well as a priority
setting scheme. In the available toxicity studies for carboxin, there
is no evidence of endocrine disruptor effects. When appropriate
screening and/or testing protocols being considered under the Agency's
Endocrine Disruptor Screening Program have been developed, carboxin may
be subjected to further screening and/or testing to better characterize
effects related to endocrine disruption.
B. Analytical Enforcement Methodology
The current available enforcement methods for tolerances of the
combined residues of carboxin and its carboxin sulfoxide metabolite are
described in the Pesticide Analytical Manual (PAM)
[[Page 72852]]
Vol. II. Method I is a colorimetric method which is used for
determination of residues in or on corn, peanuts, rice, rice straw,
sorghum, soybeans, eggs, meat, and milk. Method II and its
modification, Method A, are gas liquid chromatography (GLC) methods
which are used for wheat, oats, barley, peanuts, peanut oil and meal,
sorghum, cottonseed, and cottonseed oil and meal. Adequate recovery
data were submitted to validate the methods used in the canola field
trials. Residues in canola seeds were converted to aniline, which was
derivatized with heptafluorobutyric anhydride prior to gas
chromatography mass selective detector (GC/MSD) analysis. Recoveries
were 100-103% for 0.025 ppm fortifications in canola seeds.
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Francis
Griffith, Analytical Chemistry Branch, Environmental Science Center,
U.S. Environmental Protection Agency, 701 Mapes Road, Fort George G.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
griffith.francis@epa.gov.
C. International Residue Limits
There are no CODEX, Canadian, or Mexican maximum residue levels
(MRLs) for carboxin in/on onion seed. As a result, harmonization of
tolerances is not an issue.
V. Conclusion
Therefore, the tolerance is established for combined residues of
carboxin, (5,6 dihydro-2-methyl-N-phenyl-1,4-oxathiin-3-carboxamide)
and its metabolite 5,6-dihydro-3-carboxanilide-2-methyl-1,4-oxathiin-4-
oxide (calculated as carboxin) (from treatment of seed prior to
planting) insert regulated chemical, in or on canola, seed at 0.03 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.
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-2002-0326 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 February
7, 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-2002-0326, 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
[[Page 72853]]
issues(s) in the manner sought by the requestor would be adequate to
justify the action requested (40 CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under 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 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. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 26, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.301 is amended by alphabetically adding the
commodity ``canola, seed'' to the table in paragraph (a) to read as
follows:
Sec. 180.301 Carboxin; tolerances for residues.
(a) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
* * * * *
Canola, seed 0.03
* * * * *
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[[Page 72854]]
* * * * *
[FR Doc. 02-31010 Filed 12-6-02; 8:45 am]
BILLING CODE 6560-50-S