[Federal Register Volume 66, Number 148 (Wednesday, August 1, 2001)]
[Rules and Regulations]
[Pages 39666-39675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19172]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301139; FRL-6787-5]
RIN 2070-AB78


Clomazone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
clomazone, 2-(2-chlorophenyl)methyl-4, 4-methyl-3-isoxazolidinone in or 
on Sugar cane, cane. 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 August 1, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301139, 
must be received by EPA on or before October 1, 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-301139 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Jim 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:

[[Page 39667]]

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of 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 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. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301139. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 28, 2001 (66 FR 16917) (FRL-6775-
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) 9F06056 by FMC Corporation, 
Agricultural Products Group, 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-methyl-3-isoxazolidinone, in or on Sugar cane, 
cane at 0.05 part per million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of clomazone on Sugar cane, 
cane at 0.05 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.

[[Page 39668]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
            Guideline No.                     Study Type          Classification/Doses           Results
----------------------------------------------------------------------------------------------------------------
870.3100                               90-Day oral toxicity     Acceptable/guideline;    NOAEL = 135.2/160.9 mg/
                                        rat                      Males: 0, 1.4, 6.9,      kg/day, males/females;
                                                                 34.5, 68.2, 135.2,       LOAEL = 273/319.3 mg/
                                                                 273, 552.2 mg/kg/day;    kg/day, males/females,
                                                                 Females: 0, 1.6, 8.2,    based on decreased
                                                                 41.9, 83.4, 160.9,       body weight, body
                                                                 319.3, 629.4 mg/kg/day   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     Acceptable/guideline;    NOAEL 1200
                                        mouse                    0, 3, 15, 75, 150,       mg/kg/day (limit
                                                                 300, 600, 1200 mg/kg/    dose); LOAEL >1200 mg/
                                                                 day                      kg/day
----------------------------------------------------------------------------------------------------------------
870.3700a                              Prenatal developmental   Acceptable/guideline;    Maternal NOAEL = 100 mg/
                                        rat                      0, 100, 300, 600 mg/kg/  kg/day; LOAEL = 300 mg/
                                                                 day (gavage)             kg/day based on
                                                                                          chromorhinorrhea and/
                                                                                          or abdominogenital
                                                                                          staining.
                                                                                         Developmental NOAEL =
                                                                                          100 mg/kg/day; LOAEL =
                                                                                          300 mg/kg/day based on
                                                                                          indications of delayed
                                                                                          ossification in the
                                                                                          form of either partial
                                                                                          ossification or the
                                                                                          absence of manubrium,
                                                                                          sternebrae 3-4,
                                                                                          xiphoid, caudal, and
                                                                                          met-carpals.
----------------------------------------------------------------------------------------------------------------
870.3700b                              Prenatal developmental   Acceptable/guideline;    Maternal NOAEL = 240 mg/
                                        rabbit                   0, 30, 240, 1000/700     kg/day; LOAEL = 700 mg/
                                                                 mg/kg/day                kg/day based on
                                                                                          effects seen at 1000
                                                                                          mg/kg/day, which
                                                                                          included mortality,
                                                                                          abortions, decreased
                                                                                          body wt. gain, and
                                                                                          decreased defecation
                                                                                          or no feces.
                                                                                         Developmental NOAEL 700 mg/kg/day
                                                                                          (HDT); LOAEL >700 mg/
                                                                                          kg/day
----------------------------------------------------------------------------------------------------------------
870.3800                               2-Generation             Acceptable/guideline;    Parental NOAEL = 50 mg/
                                        reproduction and         0, 5, 50, 100, 200 mg/   kg/day; LOAEL = 100 mg/
                                        fertility effects rat    kg/day                   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.
                                                                                         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    Acceptable/guideline;    NOAEL 1038/
                                                                 Males: 0, 19, 94, 487,   1012 mg/kg/day, males/
                                                                 1038 mg/kg/day           females (HDT); LOAEL
                                                                 Females: 0, 21, 106,     >1038/1012 mg/kg/day
                                                                 502, 1012 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.4300                               Chronic Toxicity/        Acceptable/guideline;    NOAEL = 84.4/112.9 mg/
                                        Carcinogenicity rats     Males: 0, 0.9, 4.3,      kg/day, males/females
                                                                 21.5, 42.9, 84.8 mg/kg/  (highest dose tested);
                                                                 day; Females: 0, 1.1,    LOAEL >84.4/112.9 mg/
                                                                 5.5, 27.8, 56.5, 112.9   kg/day, males/females;
                                                                 mg/kg/day                Classified as a ``not
                                                                                          likely human
                                                                                          carcinogen''
----------------------------------------------------------------------------------------------------------------
870.4300                               Carcinogenicity mice     Unacceptable/guideline;  NOAEL = 300 mg/kg/day
                                                                 0, 3, 15, 75, 150, 300   (highest dose tested);
                                                                 mg/kg/day                LOAEL = >300 mg/kg/
                                                                                          day; Classified as a
                                                                                          ``not likely human
                                                                                          carcinogen''
----------------------------------------------------------------------------------------------------------------
870.5100                               Gene Mutation            Acceptable; FMC 57020;   The test article was
                                        (Salmonella              (clomazone, 93.4%        assayed up to
                                        typhimurium and          a.i.)                    cytotoxic
                                        Escherichia coli                                  concentrations (5000
                                        reverse gene mutation                             g/plate), but
                                        assay)                                            in no instance were
                                                                                          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.
----------------------------------------------------------------------------------------------------------------

[[Page 39669]]

 
870.5395                               Cytogenetics; In vivo    Acceptable; FMC 57020;   Negative. The incidence
                                        rat                      (clomazone, 88.8%)       of aberrations and the
                                                                                          aberrations/cell were
                                                                                          not significantly
                                                                                          increased.
----------------------------------------------------------------------------------------------------------------
870.5550                               Other Effects In vitro   Acceptable; FMC 57020;   Clomazone was tested up
                                        UDS assay in primary     (clomazone, 88.8%)       to cytotoxicity
                                        rat hepatocytes                                   (relative toxicity at
                                                                                          0.10 L/mL 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           Acceptable               Clomazone is
                                        pharmacokinetics                                  extensively
                                                                                          metabolized by the
                                                                                          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 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 LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for 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
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and LOC for    Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of  Developmental NOAEL =    FQPA SF = 1X aPAD =      Developmental toxicity
 age)                                   100 mg/kg/day UF = 100   acute RfDFQPA    Rat
                                        Acute RfD = 1.0 mg/kg/   SF = 1.0 mg/kg/day
                                        day
                                                                                         Developmental LOAEL =
                                                                                          300 mg/kg/day, based
                                                                                          on delayed
                                                                                          ossification.
----------------------------------------------------------------------------------------------------------------
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). A risk
                                                assessment is not required for this population subgroup.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 84.4 mg/kg/day   FQPA SF = 1X cPAD =      Two year combined
                                        UF = 100 Chronic RfD =   cRfDFQPA SF      toxicity/
                                        0.84 mg/kg/day           0.84 mg/kg/day           carcinogenicity rat
                                                                                          LOAEL > 84.4 mg/kg/day
                                                                                          (highest dose tested)
                                                                                        ------------------------

[[Page 39670]]

 
                                                                                         90-Day oral toxicity
                                                                                          rat 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-Generation
                                                                                          reproduction toxicity
                                                                                          rat 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)
----------------------------------------------------------------------------------------------------------------
Dermal\a\ and Inhalation\b\, Short-    Maternal NOAEL= 100 mg/  LOC for MOE = 100        Developmental toxicity
 Term (1-7 days) (Occupational/         kg/day                                            rat Maternal LOAEL =
 Residential)                                                                             300 mg/kg/day, based
                                                                                          on chromorhinorrhea
                                                                                          and abdominogenital
                                                                                          staining.
----------------------------------------------------------------------------------------------------------------
Dermal\a\ and Inhalation\b\,           Oral NOAEL= 84.4 mg/kg/  LOC for MOE = 100        Two year combined
 Intermediate-term (1week - several     day                                               toxicity/
 months) and Long-Term (several                                                           carcinogenicity rat
 months - lifetime) (Occupational/                                                        LOAEL > 84.4 mg/kg/day
 Residential)                                                                             (highest dose tested)
                                                                                        ------------------------
                                                                                         90-day oral toxicity
                                                                                          ratLOAEL = 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
                                                                                        ------------------------

[[Page 39671]]

 
                                                                                         2-Generation
                                                                                          reproduction toxicity
                                                                                          ratLOAEL = 100 mg/kg/
                                                                                          day based on
                                                                                          statistically
                                                                                          significantly
                                                                                          decreased body wt. and
                                                                                          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.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
  MOE = margin of exposure, LOC = level of concern
\a\ Since an oral NOAEL was selected, an dermal absorption factor of 100% (default value) should be used in
  route -to- route extrapolation.
\b\ Since an oral NOAEL was selected, an inhalation absorption factor of 100% (default value) should be used in
  route-to-route extrapolation.
\*\ 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) 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 13-50 years old using existing and recommended tolerance level 
residues, 100% crop treated information, DEEM processing 
factors for all registered and proposed commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM 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: The chronic 
analysis was performed for the general U.S. population and all 
population subgroups using existing and recommended tolrance level 
residues, 100% crop treated information, and DEEM default 
processing factors for all registered and proposed commodities.
    iii. Cancer. Clomazone is classified as ``not likely'' to be a 
human carcinogen.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    The Agency used percent crop treated (PCT) information as follows:
    A routine chronic dietary exposure analysis for the wheat 
hybridizing agent X was based on 0.1% of wheat crop treated, and 0.1% 
of the cereal grains group (except rice, wild rice, sweet corn, and 
wheat) and soybeans as rotated crops in fields previously containing 
wheat treated with chemical X. The PCT of 0.1% was based on the 
petitioner's expectations that up to 35,000 acres of wheat grown for 
seed will be treated annually, which amounts to 0.05% of the 70 million 
acres of wheat grown in the United States. The reason for using 0.1% 
instead of 0.05% is to allow expansion of use if other conditions of 
registration are satisfied. Before expansion beyond 0.1% is allowed, 
reevaluation of the dietary exposure may be performed using all 
available information.
    2. Dietary exposure from drinking water. 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.
    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 screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end 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

[[Page 39672]]

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-GROW models the estimated environmental 
concentrations (EECs) of clomazone 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. EPA determined that the 
10X safety factor to protect infants and children should be removed. 
The FQPA factor was reduced to 1X. The rationale was based on the 
following: there is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure; a developmental neurotoxicity study is not 
required; and the dietary (food and drinking water) exposure 
assessments will not underestimate the potential exposures for infants 
and children (there are currently no registered residential uses).

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 are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and 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 the Office of Pesticide 
Programs (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

[[Page 39673]]

drinking water as a part of the aggregate risk assessment process.
    1. Acute risk. A Tier 1 acute dietary exposure analysis for 
clomazone was performed using existing and recommended tolerance level 
residues, 100% crop treated information, and DEEM default 
processing factors. The acute analysis was performed for females 13-50 
years old only. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food to clomazone 
will occupy 1% of the aPAD for females 13 years and older at the 95th 
percentile. 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
            Population Subgroup             aPAD (mg/kg)     % aPAD       Water EEC   Ground Water   Acute DWLOC
                                                             (Food)         (ppb)       EEC (ppb)       (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs old.....................             1      0.000265            95           2.4        30,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. A Tier 1 chronic dietary exposure analysis for 
clomazone was performed using existing and proposed tolerance level 
residues, 100% crop treated for all commodities, and DEEM 
default processing factors. The chronic analysis applied to the U.S. 
population and all population subgroups. Using the exposure assumptions 
described in this unit for chronic exposure, EPA has concluded that 
exposure to clomazone from food will utilize 1% of the cPAD for the 
U.S. population, 1% of the cPAD for all infants (1 years old) and 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     0.000099           23          2.4       29,000
 All infants (1 year old)......................         0.84     0.000332           23          2.4         8400
Children (1-6 years old).......................         0.84     0.000182           23          2.4         8400
Children (7-12 years old)......................         0.84     0.000122           23          2.4         8400
Females (13-50 years old)......................         0.84     0.000079           23          2.4       25,000
Males (13-19 years old)........................         0.84     0.000085           23          2.4       29,000
Males (20+ years old)..........................         0.84     0.000080           23          2.4       29,000
Seniors (55+ years old)........................         0.84     0.000091           23          2.4       29,000
----------------------------------------------------------------------------------------------------------------

    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. EPA has classified 
clomazone as a ``not likely'' to be a human carcinogen; therefore, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
risk exposure to clomazone residues.
    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 methods are available for the determination of 
the residues of clomazone. The resulting samples are analyzed by gas 
chromatography (GC) using a nitrogen phosphorus detector (NPD) or mass 
spectrometer (MS). A confirmatory procedure (GC/MS-SIM) is available 
(Method I, PAM II).
    Clomazone residues were analysed using the FMC Method P-2640, 
virtually the same as the PAM-II enforcement method, modified to use 
gas chromatography/mass selective detection (GC-MSD) for extract 
analysis. Validation data indicate that this method is adequate to 
enforce the tolerance expression.

B. International Residue Limits

    There is neither a Codex proposal nor Canadian maximum residue 
limit (MRL) for residues of clomazone in/on Sugar cane. A Mexican MRL 
of 0.05 ppm is established for clomazone per se in/on Sugar cane. 
Therefore, a compatibility issue is not relevant to the proposed 
tolerance.

V. Conclusion

    Therefore, the tolerance is established for residues of clomazone, 
2-(2-chlorophenyl)methyl-4, 4-methyl-3-isoxazolidinone, in or on Sugar 
cane, cane at 0.05 ppm.

[[Page 39674]]

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-301139 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 October 
1, 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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301139, 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 special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between

[[Page 39675]]

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).
    For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.''

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 10, 2001.
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.

    2. Section 180.425 is amended by alphabetically adding the 
commodity Sugar cane, cane, to the table in paragraph (a) to read as 
follows:


Sec. 180.425  Clomazone; tolerance for residues.

    (a)    *    *    *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
 *                 *                *                *                *
Sugar cane, cane.....................................
0.05.................................................
 *                 *                *                *                *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-19172 Filed 7-31-01; 8:45 am]
BILLING CODE 6560-50-S