[Federal Register Volume 66, Number 180 (Monday, September 17, 2001)]
[Rules and Regulations]
[Pages 47971-47979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23086]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301168; FRL-6800-9]
RIN 2070-AB78


Clethodim; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of clethodim in or on green onion, leaf lettuce, Brassica, head and 
stem, subgroup, flax seed, flax meal, mustard seed, canola seed, and 
canola meal. The Interregional Research Project Number-4 (IR-4) and 
Valent U.S.A. Corporation requested these tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA). This final rule establishes permanent 
tolerances for clethodim and as part of that process the Agency has 
reassessed existing tolerances. By law, EPA is required to reassess 66% 
of the tolerances in existence on August 2, 1996, by August 2002, or 
about 6,400 tolerances. All permanent tolerances for clethodim that 
existed on August 2, 1996 were previously reassessed in the Federal 
Register of April 8, 1998 (63 FR 17101) (FRL-5784-9). Consequently, 
regarding the actions in this final rule, no tolerance reassessments 
are counted toward the August 2002 review deadline of FFDCA section 
408(q).

DATES: This regulation is effective September 17, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301168, 
must be received by EPA on or before November 16, 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-301168 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 308-3194; and e-mail 
address: brothers.shaja&epa.gov.

SUPPLEMENTARY INFORMATION:   

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS 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

[[Page 47972]]

document, on the Home Page select ``Laws and Regulations'', 
``Regulations and Proposed Rules,'' and then look up the entry for this 
document under the ``Federal Register--Environmental Documents.'' You 
can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_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-301168. 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 December 3, 1997 (62 FR 63942) (FRL-
5756-1) EPA issued notices pursuant to section 408 of FFDCA, 21 U.S.C. 
346a as amended by FQPA (Public Law 104-170) announcing the filing of 
pesticide petitions (PP 0E6202 and 1E6249) for tolerances by IR-4, 681 
U.S. Highway #1 South, North New Brunswick, NJ 08902 and PP 7F4873 by 
Valent U.S.A. Corporation, 1333 N. California Blvd., Walnut Creek, 
California 94596. These notices included summaries of the petitions 
prepared by Valent U.S.A. Corporation, the registrant. There were no 
comments received in response to the notice of filing.
    The petitions requested that 40 CFR 180.458 be amended by 
establishing tolerances for combined residues of the herbicide 
clethodim, [(E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one] and its metabolites containing the 5-(2-
(ethylthiopropyl)cyclohexene-3-one and 5-(2-(ethylthiopropyl)-5-
hydroxycyclohexene-3-one) moieties and their sulphoxides and sulphones, 
all expressed as clethodim, on various commodities as follows:
    (1). PP 1E6249. IR-4 proposed tolerances for green onion and leaf 
lettuce at 2.0 parts per million (ppm), and Brassica head and stem 
subgroup at 3.0 ppm.
    (2). PP 0E6202. IR-4 proposed tolerance for flax seed and mustard 
seed at 0.5 ppm and flax meal at 1.0 ppm.
    (3). PP 7F4873. Valent U.S.A. Corporation proposed tolerances for 
canola seed at 0.5 ppm and canola meal at 1.5 ppm. The petition was 
subsequently amended to propose tolerances for canola seed at 0.5 ppm 
and canola meal at 1.0 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 
these actions. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for combined residues of clethodim on green 
onion at 2.0 ppm, leaf lettuce at 2.0 ppm, Brassica head and stem 
subgroup at 3.0 ppm, flax seed at 0.50 ppm, flax meal at 1.0 ppm, 
mustard seed at 0.50 ppm, canola seed at 0.50 ppm, and canola meal at 
1.0 ppm. EPA's assessment of exposures and risks associated with 
establishing these tolerances 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 clethodim are 
discussed in Unit III.A. of the Federal Register of March 14, 2001 (66 
FR 14829) (FRL-6770-8).

B. Toxicological Endpoints

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

[[Page 47973]]

    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 clethodim used for human risk assessment is shown in the 
following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Clethodim 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                          Not applicable           Not applicable           None Selected
All populations......................                                                    There were no effects
                                                                                          observed in oral
                                                                                          toxicity studies
                                                                                          including
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits that could be
                                                                                          attributable to a
                                                                                          single dose
                                                                                          (exposure). Therefore,
                                                                                          a dose and endpoint
                                                                                          were not selected for
                                                                                          this risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary All populations        NOAEL = 1.0 mg/kg/day    FQPA SF = 1              Chronic toxicity-Dog (1
                                       UF = 100...............  cPAD = chronic            year).
                                       Chronic RfD = 0.01 mg/    RfDFQPA SF =    Alterations in
                                        kg/day.                  0.01 mg/kg/day.          hematology and
                                                                                          clinical chemistry
                                                                                          parameters and
                                                                                          increased absolute and
                                                                                          relative liver weights
                                                                                          observed at the LOAEL
                                                                                          of 75 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days)        Oral study maternal      LOC for MOE = 100        Developmental toxicity-
 (Residential)                          NOAEL = 100 mg/kg/day    (Residential)            Rat.
                                       (Dermal absorption rate                           LOAEL = 350 mg/kg/day
                                        = 30%).                                           based on decreased
                                                                                          body weight gain and
                                                                                          clinical signs of
                                                                                          toxicity (salivation).
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to    Oral study NOAEL = 25    LOC for MOE = 100        Subchronic toxicity-Dog
 several months) (Residential)          mg/kg/day                (Residential)            (90 days).
                                       (Dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 30%).                                           based on increased
                                                                                          absolute and relative
                                                                                          liver weights.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    Oral study NOAEL = 1.0   LOC for MOE =100         Chronic toxicity-Dog (1
 lifetime) (Residential)                mg/kg/day                (Residential)            year).
                                       (Dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 30%).                                           based on alterations
                                                                                          in hematology and
                                                                                          clinical chemistry
                                                                                          parameters as well as
                                                                                          increases in absolute
                                                                                          and relative liver
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days)    Oral study Maternal      LOC for MOE =100         Developmental-Rat
 (Residential)                          NOAEL= 100 mg/kg/day     (Residential)           LOAEL = 350 mg/kg/day
                                       (Inhalation absorption                             based on decreased
                                        rate = 100%).                                     body weight gain and
                                                                                          clinical signs of
                                                                                          toxicity (salivation).
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week   Oral study NOAEL = 25    LOC for MOE = 100        Subchronic toxicity-Dog
 to several months) (Residential)       mg/kg/day                (Residential)            (90 days).
                                       (Inhalation absorption                            LOAEL = 75 mg/kg/day
                                        rate = 100%).                                     based on increased
                                                                                          absolute and relative
                                                                                          liver weights.
----------------------------------------------------------------------------------------------------------------

[[Page 47974]]

 
Long-term inhalation (several months   Oral study NOAEL = 1.0   LOC for MOE =100         Chronic toxicity-Dog (1
 to lifetime) (Residential)             mg/kg/day                (Residential)            year).
                                       (Dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 30%).                                           based on alterations
                                                                                          in hematology and
                                                                                          clinical chemistry
                                                                                          parameters as well as
                                                                                          increases in absolute
                                                                                          and relative liver
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      N/A                      N/A                      Clethodim is classified
                                                                                          as a ``Not Likely''
                                                                                          carcinogen
----------------------------------------------------------------------------------------------------------------
* 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 180.458) for the residues of clethodim in or on a 
variety of food commodities. Recent tolerances established for the 
residues of clethodim and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones 
include tuberous and corm vegetables crop subgroup 1c, fruiting 
vegetables crop group, root vegetables (except sugar beets) crop 
subgroup 1b, leaves of root and tuber vegetables (excluding sugar 
beets, crop group 2), sugar beet, tops and sugar beet, molasses at 1.0 
ppm, leaf petioles crop subgroup 4b at 0.6 ppm, melon crop subgroup 9a 
at 2.0 ppm, squash/cucumber crop subgroup 9b and cranberry at 0.5 ppm, 
sugar beets, roots at 0.20 ppm, sunflower seed at 5.0 ppm, strawberry 
at 3.0 ppm, sunflower, meal and clover, forage at 10.0 ppm, and clover, 
hay at 20.0 ppm. Risk assessments were conducted by EPA to assess 
dietary exposures from clethodim 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. An endpoint was not identified for acute dietary 
exposure and risk assessment because no effects were observed in oral 
toxicity studies including developmental toxicity studies in rats or 
rabbits that could be attributable to a single dose (exposure). 
Therefore, an acute dietary exposure assessment was not performed.
    ii. Chronic exposure.In conducting this chronic dietary risk 
assessment 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 chronic 
exposure assessments: The 3-day average of consumption for each sub-
population is combined with residues to determine average exposure as 
mg/kg/day. The chronic analysis was performed using tolerance level 
residues for all crops and livestock commodities. Projected percent 
crop treated (PCT) data were used for lettuce, broccoli, cauliflower, 
cabbage, onions, and Brussels sprouts. Weighted average percent of crop 
treated data were used for certain existing registrations (cotton, 
onions, peanuts, soybeans, sugar beets, and tomatoes) and 100% crop 
treated data were used for the remaining new uses and existing uses.
    iii. Cancer. Clethodim has been classified as ``not likely to be 
carcinogenic in humans'' based on the results of a carcinogenicity 
study in mice and the combined chronic toxicity and carcinogenicity 
study in rats. Therefore, a cancer risk assessment was not performed.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(F) states that the Agency may use data on the actual 
percent of food treated for assessing chronic dietary risk only if the 
Agency can make the following findings: Condition 1, that the data used 
are reliable and provide a valid basis to show what percentage of the 
food derived from such crop is likely to contain such pesticide 
residue; Condition 2, that the exposure estimate does not underestimate 
exposure for any significant subpopulation group; and Condition 3, if 
data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F), 
EPA may require registrants to submit data on PCT.
    The Agency used PCT information for certain registered uses as 
follows:
     3% for cotton;
     8% for onions;
     3% for peanuts;
     4% for soybeans;
     15% for sugar beets, and
     1% for tomatoes.
    The Agency used PCT information for the new uses as follows:
     2% for lettuce, broccoli and cauliflower;
     15% for cabbage;
     25% for onion, and
     1% for brussels sprouts.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates were derived for 
the registered uses (cotton, onions, peanuts, soybeans, sugar beets and 
tomatoes) from Federal and private market survey data, which are 
reliable and have a valid basis. EPA uses a weighted average PCT for 
chronic dietary exposure estimates. This weighted average PCT figure is 
derived by averaging State-level data for a period of up to 10 years, 
and weighting for the more robust and recent data. A weighted average 
of the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to

[[Page 47975]]

underestimate an individual's acute dietary exposure. The Agency is 
reasonably certain that the percentage of the food treated is not 
likely to be an underestimation. With respect to the new uses (lettuce, 
broccoli, cabbage, and onion) the registrant estimated PCT based on 
percent market share information. The registrant based their projected 
clethodim PCT for these new uses based on the share of each crop that 
is treated with registered herbicides that control the same pests. They 
then projected what part of the market they could capture from those 
products. The Agency used a similar process for projecting percent of 
crop treated for Brussels sprouts and cauliflower. The Agency considers 
the clethodim percent of crop treated projections to be reasonable and 
conservative.
    As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which clethodim may 
be applied in a particular area.
    2. Dietary exposure from drinking water. Surface and ground water 
contamination may occur from the sulfoxide and sulfone degradates of 
clethodim, as well as from parent clethodim. However, the risk of water 
contamination is primarily associated with clethodim sulfone and 
clethodim sulfoxide rather than parent clethodim based on greater 
persistence and mobility for the degradates.
    The only significant routes of dissipation of clethodim are 
microbial degradation in soil and movement by leaching or runoff. 
Parent clethodim is moderately persistent to hydrolysis at pH 5 with 
half-lives of 26-42 days and stable at pH 7 and 9 with half-lives of 
greater than 300 days. Even though acceptable water and soil photolysis 
studies show half-lives of 1.5 to 9.3 days, this may not be an 
important route of dissipation because of suspended sediment and 
shading. Photolysis is only an important route of dissipation in 
shallow, well-mixed surface water with no shading. The half-lives in 
aerobic soil are 2-3 days for parent clethodim, and 30-38 days for 
total toxic residues (parent + sulfoxide + sulfone). The sulfoxide and 
sulfone metabolites are more persistent than parent clethodim and are 
formed in significant quantities in soil. All residues of clethodim 
(parent and metabolites) are very mobile in soil with five out of six 
soil dissorption coefficients (Kd) less than one. The field dissipation 
studies show that parent clethodim was only found at levels at or near 
the quantitation limit of 0.02 ppm, which is consistent with the rapid 
degradation in soil. Clethodim sulfoxide had an apparent half-life of 
2.5 to 3.7 days, indicating that movement from the treated field may 
have been an important route of dissipation.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
clethodim 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 clethodim.
    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 ground water. 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 percent referenced dose or 
percent population adjusted dose. 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 clethodim they are further discussed in the aggregate risk 
sections below. Tier 1 surface water concentrations for parent 
clethodim and total toxic residues (parent + sulfoxide + sulfone) were 
estimated using the GENEEC model. Based on the GENEEC model, the peak 
EECs of clethodim for surface water were estimated to be 24.2 parts per 
billion (ppb), and 18.3 ppb for chronic exposure. The agency allows for 
a 3-fold reduction of GENEEC 56-day estimates, which result in a 
chronic value of 6.1 ppb for surface water. Based on the SCI-GROW 
model, the EECs of clethodim for ground water were estimated to be 0.49 
ppb for acute exposure and 0.08 ppb for chronic exposure.
    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).
    Clethodim is not registered for use on any sites that would result 
in residential exposure. Based on recently revised clethodim labels, 
there are no use sites through which homeowners or the public are 
likely to become exposed to clethodim residues, either directly through 
application or indirectly by contact with residues on treated surfaces. 
Therefore, non-occupation exposure assessment was not performed.
    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.''

[[Page 47976]]

    EPA does not have, at this time, available data to determine 
whether clethodim 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, 
clethodim 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 clethodim has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The oral perinatal and 
prenatal data demonstrated no indication of increased sensitivity of 
rats or rabbits to in utero exposure to clethodim.
    3. Conclusion. There is a complete toxicity data base for clethodim 
and exposure data is complete or is estimated based on data that 
reasonably account for potential exposures. Based on the above, EPA 
determined that the 10X safety factor to protect infants and children 
should be removed.

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 ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An endpoint for acute dietary exposure was not 
identified since no effects were observed in oral toxicity studies that 
could be attributable to a single dose.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to clethodim 
from food will utilize 30% of the cPAD for the U.S. population, 23% of 
the cPAD for females (13-50 years old) and 61% of the cPAD for children 
1-6 years old. There are no residential uses for clethodim that result 
in chronic residential exposure to clethodim. In addition, there is 
potential for chronic dietary exposure to clethodim 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 2:

               Table 2.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Clethodim
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD (mg/      % cPAD     Water EEC    Water EEC     Chronic
                                                     kg)         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                                 0.01          30%          6.1         0.08          250
----------------------------------------------------------------------------------------------------------------
Children (1-6 years)                                    0.01          61%          6.1         0.08           40
----------------------------------------------------------------------------------------------------------------
Females (13-50 years)                                   0.01          23%          6.1         0.08          230
----------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Clethodim 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. Aggregate cancer risk for U.S. population. Clethodim has been 
classified as ``not likely to be carcinogenic in humans'' based on the 
results of a carcinogenicity study in mice and the combined chronic 
toxicity and carcinogenicity study in rats. Therefore, clethodim is not 
expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that

[[Page 47977]]

no harm will result to the general population, and to infants and 
children from aggregate exposure to clethodim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method RM-26A-1, a gas-liquid chromatographic (GLC) procedure, was 
validated for the analyses of residues of clethodim sulfoxide and its 
metabolite (5-OH clethodim sulfone) in/on flax at fortification levels 
of 0.05 ppm and 0.5 ppm, and on canola at a fortification level of 0.2 
ppm. Method RM-26A-1 can determine all clethodim metabolites retaining 
the cyclohex-1-one moiety (DME and DME-OH). The Method RM-26A-1 for the 
determination of clethodim and its metabolites in mustard, seed and 
flax is acceptable for data collection.
    Method RM-26B-2 was validated for the analyses of residues of 
clethodim sulfoxide and its metabolite (5-OH clethodim sulfone) in/on 
broccoli. The fortification levels for clethodim sulfoxide and 5-OH-
clethodim sulfone were each 0.05 ppm, 1.0 ppm and 2.0 ppm. Recoveries 
of residues of clethodim sulfoxide in broccoli were within the 
acceptable range at the fortification level of 0.05 ppm. Recoveries of 
residues of 5-OH-clethodim sulfone in broccoli were within the 
acceptable range at fortification levels of 0.05, 1.0 and 2.0 ppm. 
Recoveries of residues of clethodim sulfoxide in broccoli were low at 
the fortification levels of 1.0 and 2.0 ppm. The Method RM-26B-2 for 
the determination of clethodim and its metabolites in broccoli is 
acceptable for data collection and enforcement purposes.
    Method RM-26B-3 (a modification of RM-26B-2) was validated for the 
analyses of residues of clethodim sulfoxide and its metabolite (5-OH 
clethodim sulfone) in/on green onions, leaf lettuce, and cabbage. The 
fortification levels for clethodim sulfoxide and 5-OH clethodim sulfone 
were 0.11 ppm - 2.0 ppm for green onions, 0.11 ppm - 0.91 ppm for leaf 
lettuce, 0.11 ppm - 1.1 ppm for cabbage. Recoveries of residues of 
clethodim sulfoxide in green onions, leaf lettuce, and cabbage were 
within the acceptable range at all fortification levels tested. 
Recoveries of residues of 5-OH-clethodim sulfone were within the 
acceptable range except for low recoveries in green onions fortified at 
2.0 ppm and cabbage fortified at 0.77 and 0.98 ppm. The Method RM-26B-3 
for the determination of clethodim and its metabolites in green onions, 
leaf lettuce, and cabbage is acceptable for data collection.
    The common moiety Method RM-26B-3 for the determination of 
clethodim and its metabolites is similar to the common moiety Method 
RM-26B-2. The Method RM-26B-2 has previously undergone a successful 
Petition Method Validation by the Agency. Method RM-26B-2 as an 
enforcement method and Method RM-26B-3 as a letter method have been 
forwarded to FDA for inclusion in PAM II.
    Livestock feed items are associated with canola and flax seed uses. 
The Agency has previously concluded that adequate analytical 
methodology is available to enforce tolerances for residues of 
clethodim in livestock commodities. The compound specific method, EPA-
RM-26D-2, is suitable for enforcement of tolerances for total clethodim 
residues in crops and livestock tissues, and it has been forwarded to 
FDA for publication in the Pesticide Analytical Manual, Volume II (PAM 
II). The common moiety method, RM-26B-2, serves as the enforcement 
method for milk as RM-26D-2 and is not quantitative for residues in 
milk.
    The Methods may be requested from: Francis Griffith, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort 
George G. Mead, Maryland, 20755-5350; telephone number: (410) 305-2905; 
e-mail address: epa.gov">griffith.francis@epa.gov.

B. International Residue Limits

    There are no established Codex maximum residue limits (MRLs) for 
residues of clethodim in/on the commodities discussed in the subject 
petition; therefore, there are no questions with respect to Codex/U.S. 
tolerance compatibility. Codex MRLs are currently established on 
various crop and livestock commodities in terms of the sum of clethodim 
and its metabolites containing 5-(2-ethylthiopropyl)cyclohexene-3-one 
and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their 
sulphoxides and sulphones, expressed as clethodim. There are 
established Canadian residue limits for clethodim residues and its 
metabolites containing the 2-cyclohex-1-enone moiety on mustard, seed 
at 0.4 ppm, on flax at 0.3 ppm and on canola at 0.5 ppm. However, based 
on the submitted residue data, HED can not harmonize the tolerances of 
flax and mustard, seed with Canadian residue limits.

C. Conditions

    The registration for the use of clethodim on leaf lettuce will be 
made conditional based upon the need for additional crop field trial 
data for clethodim on leaf lettuce. The registration for use of 
clethodim on canola and flax will be made conditional based upon the 
requirement for a canola processing study.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
clethodim, [[(E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one] and its metabolites containing the 5-(2-
(ethylthiopropyl)cyclohexene-3-one and 5-(2-(ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones], 
in or on green onion at 2.0 ppm, leaf lettuce at 2.0 ppm, brassica head 
and stem subgroup at 3.0 ppm, flax seed at 0.50 ppm, flax meal at 1.0 
ppm, mustard seed at 0.50 ppm, canola seed at 0.50 ppm, and canola meal 
at 1.0 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301168 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 November 
16, 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

[[Page 47978]]

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 epa.gov">tompkins.jim@epa.gov, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301168, 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: epa.gov">opp-docket@epa.gov. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations as required 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104- 113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
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

[[Page 47979]]

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: September 6, 2001
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.458 is amended by revising the section heading, the 
introductory text paragraph (a)(3), and alphabetically adding 
commodities to the table in paragraph (a)(3) to read as follows:


Sec. 180.458  Clethodim; tolerances for residues.

    (a)   *  *  *
    (3) Tolerances are established for the combined residues of the 
herbicide clethodim [(E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one] and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones, 
expressed as clethodim tolerance residues for the following 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                      *      *      *      *      *
Brassica, head and stem, subgroup..........................          3.0
Canola, meal...............................................          1.0
Canola, seed...............................................         0.50
                      *      *      *      *      *
Flax, meal.................................................          1.0
Flax, seed.................................................         0.50
                      *      *      *      *      *
Lettuce, leaf..............................................          2.0
                      *      *      *      *      *
Mustard, seed..............................................         0.50
                      *      *      *      *      *
Onion, green...............................................          2.0
                      *      *      *      *      *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-23086 Filed 9-14-01; 8:45 am]
BILLING CODE 6560-50-S