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clomazone (Command) Pesticide Tolerance 12/00





ENVIRONMENTAL PROTECTION AGENCY


40 CFR Part 180


[OPP-301095; FRL-6761-7]
RIN 2070-AB78



Clomazone; Pesticide Tolerance


AGENCY: Environmental Protection Agency (EPA).


ACTION: Final rule.


-----------------------------------------------------------------------


SUMMARY: This regulation establishes a tolerance for residues of
clomazone in or on rice grain and rice straw. FMC Corporation requested
this tolerance under the Federal Food, Drug, and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996.


DATES: This regulation is effective December 21, 2000. Objections and
requests for hearings, identified by docket control number OPP-301095,
must be received by EPA on or before February 20, 2001.


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 the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301095 in the
subject line on the first page of your response.


FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-5697; and e-mail
address: Tompkins.Jim@epamail.epa.gov.


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            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 this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this


[[Page 80337]]


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/. 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 control number OPP-301095. 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 February 18, 1999 (64 FR 8087) (FRL-
6036-4), 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 7F4896) for tolerance
by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103. This
notice included a summary of the petition prepared by FMC Corporation,
the registrant. There were no comments received in response to the
notice of filing.
    The petition requested that 40 CFR 180.425 be amended by
establishing a tolerance for residues of the herbicide clomazone, (2-
(2-chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone), in or on the
raw agricultural commodities rice grain and rice straw at 0.05 part per
million (ppm). Clomazone residues were not detected any rice samples at
or above the Level of Quantification (LOQ) of 0.02 ppm. EPA is
therefore establishing the tolerances in or on rice grain and rice
straw at 0.02 ppm rather than at the proposed tolerance level of 0.05
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 a tolerance for residues of clomazone on rice grain and
rice straw at 0.02 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 clomazone 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.


                            Table 1.-- Acute, Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type Results
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute oral rat LD50 = 2077.0 mg/kg males
1369.0 mg/kg females
Toxicity Category III
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity in No Observed Adverse Effect Level (NOAEL) =
                                          rats 135.2/160.9 mg/kg/day males/females
Lowest Observed Adverse Effect Level
(LOAEL) = 273/319.3 mg/kg/day males/
females based on decreased body weight,
body weight gains, food consumption and
increased absolute and relative liver
weights in females and increased absolute
liver weights in males.
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity in NOAEL 1,200 mg/kg/day (limit
                                          mouse                       dose)
LOAEL >1,200 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3700a                                Prenatal developmental in Maternal NOAEL = 100 mg/kg/day
                                          rats
LOAEL = 300 mg/kg/day based on
chromorhinorrhea and/or abdominogenital
                                                                      staining
Developmental NOAEL = 100 mg/kg/day


[[Page 80338]]


LOAEL = 300 mg/kg/day based on indications
of delayed ossification in the form of
either partial ossification or the absence
of manubrium, sternebrae 34, xiphoid,
caudal, and metcarpals.
----------------------------------------------------------------------------------------------------------------
870.3700b                                Prenatal developmental in Maternal NOAEL = 240 mg/kg/day
                                          rabbits
LOAEL = 700 mg/kg/day based on effects seen
at 1,000 mg/kg/day, which included
mortality, abortions, decreased body wt.
gain, and decreased defecation or no feces
Developmental NOAEL 700 mg/kg/
day highest dose tested (HDT)
LOAEL > 700 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3800                                 Two-Generation Parental NOAEL = 50 mg/kg/day
                                          Reproduction and
                                          Fertility Effects
LOAEL = 100 mg/kg/day based on
statistically significantly decreased body
wt. & body wt. gain during premating, and
decreased body wt. during gestation &
lactation males and females. In addition
decreased food consumption in females and
hydronephritic kidneys in males.
Offspring NOAEL = 50 mg/kg/day
LOAEL = 100 mg/kg/day based on decreased
body weight in F2a and F2b litters
----------------------------------------------------------------------------------------------------------------
870.4100b                                Chronic toxicity dogs NOAEL 1,038/1012 mg/kg/day,
males/females (HDT)
LOAEL >1,038/1012 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.4300                                 Chronic Toxicity/ NOAEL = 84.4/112.9 mg/kg/day, males/females
                                          Carcinogenicity rats        (HDT)
LOAEL >84.4/112.9 mg/kg/day, males/females
Classified as a ``not likely human
carcinogen''
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice NOAEL = 300 mg/kg/day (HDT)
LOAEL = >300 mg/kg/day
Classified as a ``not likely human
carcinogen''
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene Mutation (Salmonella The test article was assayed up to
                                          typhimurium and cytotoxic concentrations (5,000 g/
                                          Escherichia coli reverse plate), but in no instance were
                                          gene mutation assay) appreciably increased number of revertants
to histidine prototrophy (his+) found in
any of the tester strains, either in the
presence or absence of metabolic
activation.
----------------------------------------------------------------------------------------------------------------
870.5395                                 Cytogenetics In vivo rat Negative. The incidence of aberrations and
the aberrations/cell were not
significantly increased.
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other Effects In vitro UDS Clomazone was tested up to cytotoxicity
                                          assay in primary rat (relative toxicity at 0.10 L/mL
                                          hepatocytes was 88.6%), but in no cultures treated
with test article was a significant
increase in mean net nuclear counts
indicative of UDS recorded.
870.7485                                 Metabolism and Clomazone is extensively metabolized by the
                                          pharmacokinetics liver and excreted in the urine and feces
within 24 hours. Sixteen metabolites,
including the parent, were identified; and
the predominant route of excretion was in
                                                                      urine.
----------------------------------------------------------------------------------------------------------------


B. Toxicological Endpoints


    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety 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


[[Page 80339]]


occurrence of additional cancer cases (e.g., risk is expressed as 1 x
10-\6\ or one in a million). EPA's Hazard Identification
Assessment Review Committee (HIARC) classified clomazone as a not
likely human carcinogen based on the lack of carcinogenic response in
rats and mice and the lack of mutagenic concern. There is no data in
the literature or structure activity relationship (SAR) information to
indicate carcinogenic potential. A cancer risk assessment is not
required. A summary of the toxicological endpoints for clomazone used
for human risk assessment is shown in the following Table 2:


      Table 2.--Summary of Toxicological Dose and Endpoints for Clomazone 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 (females 13-50 years of  Developmental NOAEL=     FQPA SF = 1X             Developmental rat
 age)                                   100 mg/kg/day
                                       UF = 100                 aPAD = acute RfD/FQPA    Developmental LOAEL =
                                                                 SF =1.0 mg/kg/day        300 mg/kg/day, based
on delayed
ossification
                                       Acute RfD = 1.0 mg/kg/
                                        day
----------------------------------------------------------------------------------------------------------------
Acute Dietary (general population       A dose and endpoint were not selected for this population group because
 including infants and children)           there were no effects observed in oral toxicology studies including
                                           maternal toxicity in the developmental toxicity studies in rats and
                                               rabbits that are attributable to a single exposure (dose).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (all populations)      NOAEL = 84.4 mg/kg/day   FQPA SF = 1X             Two year rat feeding
study
----------------------------------------------------------------------------------------------------------------
                                       UF = 100                 cPAD = cRfD/FQPA SF =    LOAEL  84.4
                                                                 0.84 mg/kg/day           mg/kg/day (HDT)
                                       Chronic RfD = 0.84 mg/ 90-day oral rat
                                        kg/day
LOAEL = 319.3 mg/kg/day
based on based on
decreased body weight,
body weight gains,
food consumption and
increased absolute and
relative liver weights
in females and
increased absolute
liver weights in males
2-Gen Repro.
LOAEL = 100 mg/kg/day
based on statistically
significantly
decreased body wt. &
body wt. gain during
pre-mating, and
decreased body wt.
during gestation &
lactation M & F. In
addition decreased
food consumption in
females and hydro-
nephritic kidneys in
males.
----------------------------------------------------------------------------------------------------------------
Oral, Short-term (1-7 days)                   No residential uses. An endpoint was not proposed/selected.
 (Residential)
----------------------------------------------------------------------------------------------------------------
Oral, Intermediate-term (1 week -             No residential uses. An endpoint was not proposed/selected.
 several months) (Residential)
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor 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 180.425) for the residues of clomazone, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from clomazone in food as
follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated 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 following assumptions were made for the acute
exposure assessments: An acute analysis was performed for females 1350
years old using existing and recommended tolerance level residues and
100% of the crop treatment information. The aPAD for females 13-50
years old is 1.0 mg/kg/day.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated 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 following assumptions were made for the chronic exposure
assessments: A chronic analysis was performed for the general U.S.
population using existing and recommended tolerance level residues and
100% of the crop treatment information. The cPAD for the general U.S.
population and all population subgroups is 0.84 mg/kg/day.
    iii. Cancer. Based on the lack of carcinogenic response in rats and
mice and the lack of mutagenic effects, and that there is no data in
the literature or SAR information to indicate carcinogenic potential,
EPA does not consider clomazone to pose a cancer risk.
    2. Dietary exposure from drinking water.


[[Page 80340]]


    The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
clomazone 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 clomazone and its major
environmental degradate, N-[(2-chlorophenol)methyl]-3-hydroxy-2, 2-
dimethyl propanamide.
    The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screeninglevel assessment for surface water. The
GENEEC model is a subset of the PRZM/EXAMS model that uses a specific
highend runoff scenario for pesticides. GENEEC incorporates a farm pond
scenario, while PRZM/EXAMS incorporate an index reservoir environment
in place of the previous pond scenario. 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 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 clomazone they are further
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW2 models the estimated
environmental concentrations (EECs) of both clomazone and N-[(2-
chlorophenol)methyl]-3-hydroxy-2, 2-dimethyl propanamide for acute
exposures are estimated to be 95 parts per billion (ppb) for surface
water and 2.4 ppb for ground water. The EECs for chronic exposures are
estimated to be 23 ppb for surface water and 2.4 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).
    Clomazone 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 clomazone 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,
clomazone 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 clomazone 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. There is no quantitative or
qualitative evidence of increased susceptibility of rats or rabbit
fetuses to in utero exposure in developmental studies. Although there
was a suggestion of susceptibility in the rat developmental study based
on the presence of delayed ossification in the fetuses, EPA concluded
that the fetal effects were no more severe than the maternal effects
because there is no dose response relationship for delayed ossification
(i.e., absence of increased incidence with increase in dose, low fetal/
litter incidences, delayed ossifications were not considered to be
severe, and no visceral or skeletal malformations were seen).
    3. Conclusion. There is a complete toxicity data base for clomazone
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. Further, there is no
indication of quantitative or qualitative increased susceptibility of
rats or rabbits to in utero and/or postnatal exposure. Therefore, EPA
determined that the 10X safety factor to protect infants and children
should be removed (reduced to 1X).


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 water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water


[[Page 80341]]


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 screeninglevel and quantitative
drinking water exposure assessments. Different populations will have
different DWLOCs. Generally, a DWLOC is calculated for each type of
risk assessment used: acute, short-term, intermediate-term, chronic,
and cancer.
    When EECs for surface water and groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
clomazone will occupy less than 1% of the aPAD for females 13 years and
older. In addition, there is potential for acute dietary exposure to
clomazone 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 aPAD, as shown in the
following Table 3:


                      Table 3.-- Aggregate Risk Assessment for Acute Exposure to Clomazone
----------------------------------------------------------------------------------------------------------------
Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg) (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs old                                      1 < 1           95          2.4       30,000
----------------------------------------------------------------------------------------------------------------


    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to clomazone
from food will utilize less than 1% of the cPAD for the U.S.
population, less than 1% of the cPAD for all infants (less than 1 year
old) and less than 1% of the cPAD for children 1-6 years old. There are
no residential uses for clomazone that result in chronic residential
exposure to clomazone. In addition, there is potential for chronic
dietary exposure to clomazone 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 4:


              Table 4.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to clomazone
----------------------------------------------------------------------------------------------------------------
Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.84 <1           23          2.4       29,000
All infants ( 1 year old)                              0.8 4 <1           23          2.4        8,400
Children (1-6 years old)                                0.84 <1           23          2.4        8,400
Females (13-50 years old)                               0.84 <1           23          2.4       25,000
----------------------------------------------------------------------------------------------------------------


    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Clomazone 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.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Clomazone 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.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
carcinogenic response in rats and mice and the lack of mutagenic
effects, and that there is no data in the literature or SAR information
to indicate carcinogenic potential, no cancer risk is posed.
    6. 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 clomazone residues.


IV. Other Considerations


A. Analytical Enforcement Methodology


    Adequate enforcement methodology (gas chromatography) is available
to enforce the tolerance expression. A confirmatory procedure (GC/
MSSIM) is available (Method I, PAM II).
    The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number:
(703) 305-5229; email address: furlow.calvin@epa.gov.


B. International Residue Limits


    There are no Codex Alimentarius Commission (Codex) Maximum Residue
Levels (MRLs), nor Canadian or Mexican limits for residues for
clomazone in/on rice grain or rice straw.


V. Conclusion


    Therefore, the tolerance is established for residues of clomazone,
(2-(2-chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone), in or on
rice grain and rice straw at 0.02 ppm.


[[Page 80342]]


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 control number OPP-301095 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
20, 2001.
    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. PMail 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 email at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    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 control number OPP-301095, 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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.


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


    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).


VII. 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). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and LowIncome Populations
(59 FR 7629, February 16, 1994); or require 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


[[Page 80343]]


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 FFDCA section 408(n)(4).


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: December 13, 2000.
James Jones,
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.


Sec. 180.425  [Amended]


    2. Section 180.425 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:
    (a)*      *    *


------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                 *        *        *          *        *
Rice, grain                                 0.02
Rice, straw                                 0.02
                 *        *        *          *        *
------------------------------------------------------------------------


* * * * *


[FR Doc. 00-32571 Filed 12-20-01; 8:45 am]
BILLING CODE 6560-50-S