[Federal Register Volume 65, Number 246 (Thursday, December 21, 2000)]
[Rules and Regulations]
[Pages 80336-80343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32571]


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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.

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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: [email protected].

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: [email protected].

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 [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 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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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