[Federal Register Volume 67, Number 236 (Monday, December 9, 2002)]
[Rules and Regulations]
[Pages 72846-72854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31010]


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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: [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] 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
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
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
------------------------------------------------------------------------
870.3200                        21/28-Day dermal   Not available
                                 toxicity
------------------------------------------------------------------------
870.3465                        90-Day inhalation  Not available
                                 toxicity
------------------------------------------------------------------------

[[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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
870.5100                        Bacterial reverse  Negative with or
                                 mutation assay     without S-9
                                 (Ames test)        activation at 5.000
                                                    [mu]g/plate and less
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
870.5385                        In vivo mammalian  Negative at all dose
                                 chromosome         levels tested
                                 aberration (rat
                                 bone marrow)
------------------------------------------------------------------------
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
------------------------------------------------------------------------
870.5450                        Dominant lethal    Not available
                                 assay in rats
------------------------------------------------------------------------

[[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
------------------------------------------------------------------------
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
------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
Acute dietary all populations          Acute RfD = not          No toxicological         None
                                        required                 endpoint attributable
                                                                 to a single exposure
                                                                 was identified
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
* 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: 
[email protected].

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 [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-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: [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

[[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
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------


[[Page 72854]]

* * * * *
[FR Doc. 02-31010 Filed 12-6-02; 8:45 am]
BILLING CODE 6560-50-S