[Federal Register Volume 67, Number 113 (Wednesday, June 12, 2002)]
[Rules and Regulations]
[Pages 40211-40219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14769]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0028; FRL-7180-6]


Carboxin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combinedresidues 
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 onion, dry bulb. Uniroyal Chemical Company, Inc. 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. In 
addition, this regulatory action is part of the tolerance reassessment 
requirements of section 408(q) of the Federal Food, Drug, and Cosmetic 
Act (FFDCA) 21 U.S.C. 346a(q), as amended by the Food Quality 
Protection Act (FQPA) of 1996. By law, EPA is required to reassess 66% 
of the tolerances in existence on August 2, 1996, by August 2002, or 
about 6,400 tolerances. This regulatory action will count for 47 
reassessments toward the August 2002 deadline.

DATES: This regulation is effective June 12, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0028, 
must be received on or before August 12, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of theSUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0028 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9354; e-mail address: [email protected].

[[Page 40212]]


SUPPLEMENTARY INFORMATION:  

I. General Information

A. Does this Action Apply to Me?

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

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of 
thisdocument, and certain other related documents that might be 
available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws 
and Regulations,'' ``Regulations and Proposed Rules,'' and then look up 
the entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0028. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 29, 2000 (65 FR 16608) (FRL-6493-
8), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing 
the filing of a pesticide petition (PP 9F3727) by Uniroyal Chemical 
Company, Inc., 74 Amity Road, Bethany, CT. This notice included a 
summary of the petition prepared by Gustafson LLC, the registrant. No 
comments were received in response to the notice of filing.
    The petition requested that 40 CFR 180.301 be amended by 
establishing atolerance for 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 onions (dry bulb) at 
0.2 part 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) 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) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
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), for tolerances 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 
onion, dry bulb at 0.2 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 the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

[[Page 40213]]



                             Table 1.--Subchronic, Chronic, and Other Toxicity Data
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                           Results
---------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity in    NOAEL = Males: not identified; Females: 10
                                          rats                       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 toxicity  Not available
----------------------------------------------------------------------------------------------------------------
870.3465                                 90-Day inhalation          Not available
                                          toxicity
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in  Maternal
                                          rats                      NOAEL = 10 mg/kg/day......................
                                                                    LOAEL = 90 mg/kg/day based on decreased
                                                                     body weights andbody weight gain,
                                                                     decreased food consumption, and
                                                                     increasedhair loss.
                                                                    Developmental.............................
                                                                     NOAEL = 175 mg/kg/day....................
                                                                    LOAEL = not identified....................
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in  Maternal
                                          rabbits                   NOAEL = 75 mg/kg/day......................
                                                                    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
                                          fertility effects in      NOAEL = Males and Females: 1 mg/kg/day....
                                          rats                      LOAEL = Males: 10 mg/kg/day based on
                                                                     decreased bodyweight gains in F1 parents,
                                                                     gross and histopathological changesin
                                                                     kidneys; Females: 15 mg/kg/day based on
                                                                     equivocal histopathological changes in
                                                                     kidneys.
                                                                    Reproductive..............................
                                                                    NOAEL = Males: 10 mg/kg/day; Females: 15mg/
                                                                     kg/day.
                                                                    LOAEL = Males: 20 mg/kg/day; Females: 30
                                                                     mg/kg/day basedon 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 in dogs   NOAEL = Males: 16 mg/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.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity in mice    NOAEL = Males: 752 mg/kg/day; Females: 9
                                                                     mg/kg/day
                                                                    LOAEL = Males: not identified; Females:
                                                                     451 mg/kg/day basedon increased mortality.
                                                                    Negative for carcinogenicity..............
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined chronic/          NOAEL = Males: 0.8 mg/kg/day; Females: 1.0
                                          carcinogenicity in rats    mg/kg/day
                                                                    LOAEL = Males: 9 mg/kg/day based on
                                                                     decreased body weightand 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..............
----------------------------------------------------------------------------------------------------------------
870.5100                                 Bacterial reverse          Negative with or without S-9 activation at
                                          mutation assay (Ames       5,000 g/plate andless
                                          test)
----------------------------------------------------------------------------------------------------------------
870.5375                                 In vitro mammalian         Negative without S-9 activation
                                          chromosome                Positive with S-9 activation. Highly
                                          aberration(CHO cells)      significant increases inchromosomal
                                                                     aberrations at several toxic dose levels
                                                                     rangingfrom 400 to 1,400 g/mL..
----------------------------------------------------------------------------------------------------------------
870.5385                                 In vivo mammalian          Negative at all dose levels up to 48-hours
                                          chromosome aberration      post-dosing
                                          (ratbone marrow)          Study is unacceptable due to lack of
                                                                     clinical toxicity, lack of amultiple
                                                                     dosing schedule, and/or lack of evidence
                                                                     of transportto target tissue..
----------------------------------------------------------------------------------------------------------------
870.5385                                 In vivo mammalian          Negative at all dose levels tested.
                                          chromosome aberration
                                          (ratbone marrow)
----------------------------------------------------------------------------------------------------------------

[[Page 40214]]

 
870.5385                                 In vivo mammalian          Positive. Dose-related statistically
                                          chromosome aberration      significant increased percent of aberrant
                                          (ratbone marrow)           cells at  191 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
870.5450                                 Dominant lethal assay in   Not available
                                          rats
----------------------------------------------------------------------------------------------------------------
870.5550                                 UDS in primary rat         Positive. Dose-dependent positive
                                          hepatocytes                responses were observed at treatment
                                                                     levels from 5.13 to 103 g/mL in the
                                                                     absence of moderate to severe toxicity.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and             Following oral treatment of rats with
                                          pharmacokinetics in rats   [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 no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as1 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 the 
following Table 2:

       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
                                                                 exposurewas identified
----------------------------------------------------------------------------------------------------------------
Chronic dietaryall populations         NOAEL= 0.8 mg/kg/day     FQPA SF = 3              Combined chronic/
                                       UF = 100...............  cPAD = Chronic RfD/FQPA   carcinogenicity - rat
                                       Chronic RfD =0.008 mg/    SF= 0.00267 mg/kg/day.  LOAEL = Males: 9 mg/kg/
                                        kg/day.                                           day based on decreased
                                                                                          body weightand body
                                                                                          weight gain, increased
                                                                                          urea nitrogen and
                                                                                          creatinine,increased
                                                                                          water consumption and
                                                                                          urine volume,
                                                                                          decreasedurine
                                                                                          specific gravity,
                                                                                          histopathological
                                                                                          changes inkidneys;
                                                                                          Females: 16 mg/kg/day
                                                                                          based on
                                                                                          histopathological
                                                                                          changes inkidneys
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,inhalation)       Not likely to be         Negative for             Combined chronic/
                                        carcinogenic to humans   carcinogenicity in       carcinogenicity - rat
                                                                 rats and mice            andcarcinogenicity -
                                                                                          mouse
----------------------------------------------------------------------------------------------------------------
 *The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.


[[Page 40215]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances havebeen 
established (40 CFR 180.301) for the combined residues or residues of 
carboxin and its sulfoxide metabolite, in or on a variety of raw 
agricultural commodities. Risk assessments were conducted by EPA to 
assess dietary exposures from 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 
riskassessment, the Dietary Exposure Evaluation Model (DEEM) 
analysisevaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The 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 
thePesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produceestimates of pesticide concentrations in an index reservoir. 
The Screening Concentrations in Ground Water (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 reservoirenvironment, the PRZM/EXAMS model 
includes a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparisons (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 sections 
in Unit E.
    Based on the FIRST and SCI-GROW models, the 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) 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. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The developmentaltoxicity 
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

[[Page 40216]]

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 
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 clastogenicactivity 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: (1) There is no indication of 
quantitative or qualitative increased susceptibility of rats or rabbits 
toin utero and/or postnatal exposure; (2) a developmental neurotoxicity 
study is not required; (3) the dietary (food and drinking water) 
exposure assessments will not underestimate the potential for exposures 
to infants and children; and (4) 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 estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking 
waterconsumption, and body weights. Default body weights and 
consumption values as used by the USEPA Office of Water are used to 
calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-leveland 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 
calculatedDWLOCs, 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 apesticide'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 asingle 
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. populations                                     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). 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 above.
    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 beendeveloped, 
carboxin may be subjected to further screening and/or testing to better 
characterize effects related to endocrine disruption.

[[Page 40217]]

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) 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 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 dry bulb onion 
field trials. Onions were analyzed by a modified version of Method II 
wherein carboxin and its metabolite are hydrolyzed to aniline, which 
was determined by GC/ECD.
    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 for 
carboxin in/on onion seed. As a result, harmonization of tolerances is 
not an issue.

D. Conditions

    Submission of a dominant lethal assay in rats will be required as a 
condition of registration due to the evidence of clastogenic potential 
for carboxin and its potential effect on male germinal cells.

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) in or on onion, dry bulb at 0.2 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0028 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 August 
12, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0028, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility

[[Page 40218]]

that available evidence identified by the requestor would, if 
established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitledFederalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as addedby 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 theU.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: May 31, 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 374.

    2. Section 180.301 is amended by alphabetically adding an entry for 
the commodity ``Onion, dry bulb'' to the table in paragraph (a); 
removing the text in paragraph (b); and reserving paragraph (b) with a 
heading to read as follows:


Sec. 180.301   Carboxin; tolerances for residues.

    (a) *    *    *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                          *      *      *      *      *
Onion, dry bulb.......................................                                                       0.2
                                          *      *      *      *      *
----------------------------------------------------------------------------------------------------------------


[[Page 40219]]

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 02-14769 Filed 6-11-02; 8:45 am]
BILLING CODE 6560-50-S