[Federal Register Volume 65, Number 245 (Wednesday, December 20, 2000)]
[Rules and Regulations]
[Pages 79762-79769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32399]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301084; FRL-6756-1]
RIN 2070-AB78


Clomazone; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance for 
residues of clomazone in or on sugarcane. This action is in response to 
a crisis exemption declared by the state of Louisiana under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on sugarcane. This regulation 
establishes a maximum permissible level for residues of clomazone in 
this food commodity. The tolerance will expire and is revoked on 
December 31, 2002.

DATES: This regulation is effective December 20, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301084, 
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 VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301084 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9364; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected 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

[[Page 79763]]

 
                                  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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301084. 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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for residues of the herbicide 
clomazone, in or on sugarcane at 0.05 ppm part per million (ppm). This 
tolerance will expire and is revoked on December 31, 2002. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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 has established regulations governing 
emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Clomazone on Sugarcane and FFDCA 
Tolerances

    Louisiana availed itself of a crisis exemption under FIFRA section 
18 for the use of clomazone on sugarcane for control of bermudagrass. 
After having reviewed the submission, EPA did not concur that emergency 
conditions existed for this State and use under the crisis exemption 
ceased.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of clomazone in or on 
sugarcane. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to ensure that the resulting food is 
safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6). 
Although this tolerance will expire and is revoked on December 31, 
2002, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
sugarcane after that date will not be unlawful, provided the pesticide 
is applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether clomazone 
meets EPA's registration requirements for use on sugarcane or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of clomazone by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State to use this pesticide on this crop under section 18 of 
FIFRA without following all provisions of EPA's regulations 
implementing section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for clomazone, 
contact the Agency's Registration Division at the address provided 
under FOR FURTHER INFORMATION CONTACT.

[[Page 79764]]

IV. Aggregate Risk Assessment and Determination of Safety

    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) .
    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 clomazone 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for a time-limited tolerance for residues of 
clomazone in or on sugarcane at 0.05 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing the tolerance 
follows.

A. 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 endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (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 level of concern (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 1x10-\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 (MOE cancer = 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 1:

      Table 1.--Summary of Toxicological Doses and Endpoints for Use in Human Risk Assessment for Clomazone
----------------------------------------------------------------------------------------------------------------
                                          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 rat
 age                                    100 mg/kg/day UF = 100   acute RfD FQPA SF =      Developmental LOAEL =
                                        Acute RfD = 1.0 mg/kg/   1.0 mg/kg/day            300 mg/kg/day, based
                                        day                                               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 =      2 year rat feeding
                                        UF = 100 Chronic RfD =   cRfD/FQPA SF =0.84 mg/   study LOAEL > 84.4 mg/
                                        0.84 mg/kg/day           kg/day                   kg/day (highest dose
                                                                                          tested)
----------------------------------------------------------------------------------------------------------------
                                                                                         90-Day oral rat LOAEL =
                                                                                          319.3 mg/kg/day 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 79765]]

 
                                                                                         2-Generation
                                                                                          reproduction rat LOAEL
                                                                                          = 100 mg/kg/day based
                                                                                          on statistically
                                                                                          significantly
                                                                                          decreased body wt. and
                                                                                          body wt. gain during
                                                                                          pre-mating, and
                                                                                          decreased body wt.
                                                                                          during gestation and
                                                                                          lactation male and
                                                                                          female. 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\1\ and Inhalation\2\, Short-    Maternal NOAEL=100 mg/   LOC for MOE = 100        Developmental rat study
 Term (1-7 days) (Occupational/         kg/day                                            Maternal LOAEL = 300
 Residential)                                                                             mg/kg/day, based on
                                                                                          chromorhinorrhea and
                                                                                          abdominogenital
                                                                                          staining
----------------------------------------------------------------------------------------------------------------
Dermal\1\ and Inhalation\2\,           Oral NOAEL= 84.4 mg/kg/  LOC for MOE = 100        2 year rat feeding
 Intermediate-term (1 week--several     day                                               study LOAEL > 84.4 mg/
 months) and Long-Term (several                                                           kg/day (highest dose
 months - lifetime) (Occupational/                                                        tested)
 Residential)
                                      --------------------------------------------------------------------------
                                                                                         90-day oral 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 rat LOAEL
                                                                                          = 100 mg/kg/day based
                                                                                          on statistically
                                                                                          significantly
                                                                                          decreased body wt. and
                                                                                          body wt. gain during
                                                                                          pre-mating, and
                                                                                          decreased body wt.
                                                                                          during gestation and
                                                                                          lactation male and
                                                                                          female. 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, mg/kg/day = milligrams/kilograms/day.
1 Since an oral NOAEL was selected, a dermal absorption factor of 100% (default value) should be used in route-
  to-route extrapolation.
2 Since an oral NOAEL was selected, an inhalation absorption factor of 100% (default value) should be used in
  route-to-route extrapolation.

B. 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. Toxicity observed in oral toxicity studies were not 
attributable to a single dose or one day exposure. Therefore, no 
toxicological endpoint was identified for acute toxicity and no acute 
dietary risk assessment is required.
    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: Tolerance level residues and 100 percent crop treated 
(%CT) assumptions were made for the proposed commodity

[[Page 79766]]

of this emergency exemption, and all other commodities with tolerances 
for residues of clomazone, in order to estimate the Theoretical Maximum 
Residue Contribution (TMRC) for the general population and subgroups of 
interest.
    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 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 68 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).

C. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. 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.
    ii. Developmental toxicity studies --a. Rat. From the rat 
developmental toxicity study, the maternal (systemic) NOAEL was 100 
milligrams/kilograms/day (mg/kg/day), based on decreased locomotion and 
abdominal staining at the LOAEL of 300 mg/kg/day. The developmental 
(pup) NOAEL was 100 mg/kg/day, based on delayed ossification at the 
LOAEL of 300 mg/kg/day.
    b. Rabbit. From the rabbit developmental toxicity study, the 
maternal (systemic) NOAEL was 240 mg/kg/day, based on decreased body 
weight gain at the LOAEL of 700 mg/kg/day. The developmental (pup) 
NOAEL was 700 mg/kg/day at the highest dose tested.
    iii. Reproductive toxicity study--Rat. From the rat reproductive 
toxicity study, the maternal (systemic) NOAEL was 50 mg/kg/day, based 
on decreased body weight, food consumption, clinical signs, and organ 
weight changes at the LOAEL of 100 mg/kg/day. The reproductive (pup) 
NOAEL was 5 mg/kg/ day, based on decreased pup viability, reduced 
survival, and decreased body weight at the LOAEL of 50 mg/kg/day.
    iv. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology data base for clomazone is complete with respect to FQPA 
considerations. 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, the HIARC 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.
     A developmental neurotoxicity (DNT) study is not required 
at this time.
    Neurotoxicity data is not available nor is it required as the 
chemical is not a cholinesterase inhibitor and has shown

[[Page 79767]]

no indications of central or peripheral nervous system effects in any 
other studies and does not appear to be structurally related to any 
other chemical that causes adverse nervous system effects.
    v. 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. The additional 10X safety 
factor to account for increased sensitivity of infants and children was 
reduced to 1X. EPA concluded that the safety factor could be removed 
for clomazone because:
     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).

D. 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 + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 Liters (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to clomazone 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 
clomazone on drinking water as a part of the aggregate risk assessment 
process.
    1. Acute risk. Acute aggregate risk estimates are below EPA's level 
of concern. A Tier 1 acute dietary exposure analysis for clomazone was 
performed using existing and proposed tolerance level residues, 100% CT 
for all commodities, and DEEM\tm\ default processing factors. The acute 
analysis was performed for females 13-50 years old. The acute dietary 
exposure estimate (food only) for this population subgroup was 1% of 
the aPAD at the 95th percentile. Thus, the acute dietary risk 
associated with the existing and proposed uses of clomazone does not 
exceed EPA's level of concern (>100% aPAD). The surface and ground 
water EECs were used to compare against the back-calculated DWLOC for 
aggregate risk assessment. For ground and surface water, the EECs for 
clomazone are less than EPA's DWLOC for clomazone in drinking water as 
a contribution to acute aggregate exposure (Table 2). Therefore, EPA 
concludes with reasonable certainty that residues of clomazone in 
drinking water do not contribute significantly to the acute aggregate 
human health risk at the present time.

                       Table 2.--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 1% of the cPAD for the U.S. population and all 
subpopulations. There are no residential uses for clomazone that result 
in chronic residential exposure to clomazone. In addition, despite the 
potential for chronic dietary exposure to clomazone in drinking water, 
after calculating DWLOCs and comparing them to conservative model 
estimated environmental concentrations of clomazone in surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in the following Table 3:

               Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to 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 yr old                                    0.84            1           23          2.4        8,400
----------------------------------------------------------------------------------------------------------------


[[Page 79768]]

    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 were previously addressed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational 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 riskfrom food and water, which were previously addressed.
    5. Aggregate cancer risk for U.S. population. Clomazone has been 
classified as a ``not likely human carcinogen'' based on the lack of 
carcinogenic response in rats and mice and the lack of mutagenic 
concern. Further, there is no data in the literature or structure 
activity relationship (SAR) information to indicate carcinogenic 
potential. Therefore, a cancer risk assessment is not required.
    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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (GLC/NPD or GLC/MS) are available 
(PAM II) for enforcement of clomazone residues. Additionally, clomazone 
is adequately recovered (>80%) via the FDA Multiresidue Methods of PAM 
I (Pestrak, 1990).

B. International Residue Limits

    There is neither a Codex proposal nor Canadian limits for residues 
of clomazone in/on sugarcane. A Mexican limit of 0.05 ppm is 
established for clomazone per se in/on sugarcane. Therefore, a 
compatibility issue is not relevant to the proposed tolerance.

VI. Conclusion

    Therefore, the time limited tolerance is established for residues 
of clomazone, in or on sugarcane at 0.05 ppm.

VII. 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-301084 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.
    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 VII.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 the docket control number OPP-301084, 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 file format 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.

[[Page 79769]]

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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time limited tolerance under FFDCA 
section 408. 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 Low-Income 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 FIFRA 
section 18 exemption under FFDCA section 408, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

IX. 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 7, 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.

    2. Section 180.425 is amended by alphabetically adding the 
commodity Sugarcane to the table in paragraph (b) to read as follows:


Sec. 180.425   Clomazone; tolerances for residues.

* * * * *
     (b)* * *

 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity             Parts per  million    revocation date
------------------------------------------------------------------------
                      *      *      *      *      *
Sugarcane                         0.05                12/31/02
                      *      *      *      *      *
------------------------------------------------------------------------

* * * * *
[FR Doc. 00-32399 Filed 12-19-00; 8:45 am]
BILLING CODE 6560-50-S