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clethodim (Select) Time-Limited Pesticide Tolerance 5/01

ENVIRONMENTAL PROTECTION AGENCY


40 CFR Part 180


[OPP-301134; FRL-6785-5]
RIN 2070-AB78



Clethodim; Time-Limited Pesticide Tolerance


AGENCY: Environmental Protection Agency (EPA).


ACTION: Final rule.


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


SUMMARY: This regulation establishes a time-limited tolerance for
residues/combined residues of clethodim in or on alfalfa forage,
alfalfa hay, dry beans, peanut hay, peanut meal, peanuts, tomato paste,
and tomato puree. Valent U.S.A. Corporation requested this tolerance
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996. The tolerance will expire on April 30,
2003.


DATES: This regulation is effective June 6, 2001. Objections and
requests for hearings, identified by docket control number OPP-301134
must be received by EPA on or before August 6, 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-301134 in the
subject line on the first page of your response.


FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-6224; and e-mail
address: miller.joanne@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 Potentially
            Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                           112  Animal production
                                           311  Food manufacturing
                                         32532  Pesticide manufacturing
------------------------------------------------------------------------


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


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


   1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://
www.epa.gov/. To access this document, on the Home Page select ``Laws
and Regulations,'' ``Regulations and Proposed Rules,'' and then look up
the entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.go v/opptsfrs/home/guidelin.htm. A frequently updated
electronic version of 40 CFR part 180 is available at http://
www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a
beta site currently under development.
   2. In person. The Agency has established an official record for
this action under docket control number OPP-301134. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.


II. Background and Statutory Findings


   In the Federal Register of March 28, 2001 (66 FR 16931) (FRL-6773-
5), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing
the filing of pesticide petitions (PP 5F4440 and 5F4572) for tolerance
by Valent U.S.A. Corporation, 1333 N. California Blvd., Ste. 600,
Walnut Creek, CA 94596-8025. This notice included a summary 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 extending
time-limited 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,
expressed as clethodim, in or on alfalfa forage at 6 parts per million
(ppm), alfalfa hay at 10 ppm, dry beans at 2 ppm, peanut hay at 3 ppm,
peanut meal at 5 ppm, peanuts at 3 ppm, tomato paste at 3 ppm, and
tomato puree at 2 ppm. Time-limited tolerances on these commodities are
extended to allow EPA sufficient time to evaluate new residue data for
these commodities. Valent U.S.A. Corporation is not proposing to extend
the time-limited tolerance for residues on tomatoes at 1.0 ppm because
tolerances are issued for residues on fruiting vegetables (except
cucurbits), which includes tomatoes, at 1.5 ppm. The tolerances will
expire on April 30, 2003.
   Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
   EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).


III. Aggregate Risk Assessment and Determination of Safety


   Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for combined residues of clethodim on
alfalfa forage at 6 ppm, alfalfa hay at 10 ppm, dry beans at 2 ppm,
peanut hay at 3 ppm, peanut meal at 5 ppm, peanuts at 3 ppm, tomato
paste at 3 ppm, and tomato puree at 2 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.


A. Toxicological Profile


   EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by clethodim are
discussed in the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.


           Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
      Guideline Number             Study Type            Results
------------------------------------------------------------------------
870.3100                        Subchronic-        NOAEL= 25 mg/kg/day
                                Feeding-Rat
                                                  LOAEL= 134 mg/kg/day
                                                   based on decreased
                                                   body weights, body
                                                   weight gains, food
                                                   consumption, and
                                                   increased absolute
                                                   and relative liver
                                                   weights, and
                                                   centrilobular
                                                   hypertrophy of liver
                                                   in both sexes.
------------------------------------------------------------------------
870.3150                        Subchronic-        NOAEL= 25 mg/kg/day
                                Feeding-Dog


                                                  LOAEL= 75 mg/kg/day
                                                   based on increased
                                                   absolute and
                                                   relative liver
                                                   weights, severity of
                                                   liver lesions in
                                                   both sexes, and
                                                   increased serum
                                                   cholesterol and
                                                   alkaline phosphatase
                                                   in females.
------------------------------------------------------------------------
870.3200                        21-Day Dermal      Systemic NOAEL= 100
                                Toxicity-Rat       mg/kg/day
                                                  LOAEL= 1000 mg/kg/day
                                                   based on anogenital
                                                   discharge and
                                                   staining in both
                                                   sexes, decreased
                                                   food efficiency and
                                                   body weight gain in
                                                   males, and increases
                                                   in absolute and
                                                   relative liver
                                                   weights in females.
                                                  Dermal NOAEL= not
                                                   established.
                                                  LOAEL= 10 mg/kg/day
                                                   based on observed
                                                   dermal irritation.
------------------------------------------------------------------------
870.3700                        Developmental      Maternal NOAEL= 100
                                Toxicity-Rat       mg/kg/day
                                                  LOAEL= 350 mg/kg/day
                                                   based on decreased
                                                   body weight gain and
                                                   clinical signs.
                                                  Developmental NOAEL=
                                                   100 mg/kg/day
                                                  LOAEL= 350 mg/kg/day
                                                   based on decreased
                                                   fetal body weight
                                                   and increased
                                                   skeletal anomalies.
------------------------------------------------------------------------
870.3700                        Developmental      Maternal NOAEL= 25 mg/
                                Toxicity-Rabbit    kg/day
                                                  LOAEL= 100 mg/kg/day
                                                   based on decreased
                                                   weight gain and food
                                                   consumption and
                                                   clinical signs.
                                                  Developmental NOAEL
                                                   > 300 mg/kg/day
                                                  LOAEL= Not determined
                                                   because no
                                                   developmental
                                                   toxicity observed.
------------------------------------------------------------------------
870.3800                        Reproductive       Parental/Systemic
                                Toxicity- 2        NOAEL= 51 mg/kg/day
                                Generation Rat
                                                  LOAEL= 263 mg/kg/day
                                                   based on decreased
                                                   body weight in both
                                                   sexes, and
                                                   particularly in both
                                                   generations of
                                                   males, decreased
                                                   food consumption.
                                                  Reproductive NOAEL=
                                                   263 mg/kg/day
                                                   (highest dose
                                                   tested)
                                                  LOAEL= Not determined
                                                   because no effects
                                                   were noted for
                                                   fertility, length of
                                                   gestation or growth
                                                   and development of
                                                   offspring.
                                                  Offspring NOAEL= 263
                                                   mg/kg/day (highest
                                                   dose tested)
                                                  LOAEL= Not determined
                                                   (see above).
------------------------------------------------------------------------
870.4100                        Chronic-Feeding-   NOAEL= 1 mg/kg/day
                                Dog
                                                  LOAEL= 75 mg/kg/day
                                                   based on increased
                                                   absolute and
                                                   relative liver
                                                   weights in both
                                                   sexes with
                                                   histopathological
                                                   changes (males only)
                                                   and increased liver
                                                   enzymes.
------------------------------------------------------------------------
870.4200                        Carcinogenicity-   NOAEL= 30 mg/kg/day
                                Mouse (78-week)
                                                  LOAEL= 150 mg/kg/day
                                                   based on decreased
                                                   survival, decreased
                                                   hematology
                                                   parameters,
                                                   increased absolute
                                                   and relative liver
                                                   weights (female
                                                   only), centrilobular
                                                   hypertrophy,
                                                   increased pigment
                                                   and bile duct
                                                   hyperplasia in both
                                                   sexes. No evidence
                                                   of carcinogenicity.
------------------------------------------------------------------------
870.4300                        Chronic Toxicity/  NOAEL= 19 mg/kg/day
                                Carcinogenicity-
                                Rat
                                                  LOAEL= 100 mg/kg/day
                                                   based on decreased
                                                   body weight means,
                                                   body weight gains,
                                                   food consumption,
                                                   and food efficiency
                                                   (males only), and
                                                   increased absolute
                                                   and relative liver
                                                   weights with
                                                   centrilobular
                                                   hypertrophy (at 12
                                                   months) in both
                                                   sexes. No evidence
                                                   of carcinogenicity.
------------------------------------------------------------------------
870.5100                        Gene Mutation -    Negative for reverse
                                Salmonella         mutation in
                                                   Salmonella (and E.
                                                   coli) exposed to
                                                   cytotoxic levels
                                                   (10,000 g/
                                                   plate) with/without
                                                   activation.
------------------------------------------------------------------------
870.5300                        CHO Assay          Positive for inducing
                                                   structural
                                                   aberrations only in
                                                   the absence of
                                                   activation (negative
                                                   +S9) at dose near
                                                   limit of solubility
                                                   and cytotoxicity
                                                   (1.0 to 1.2 L/ml).
------------------------------------------------------------------------
870.5395                        Micronucleus       Negative for
                                Assay              chromosomal damage
                                                   in bone marrow cells
                                                   of rats treated
                                                   orally up to toxic
                                                   doses (1,500 mg/kg).
------------------------------------------------------------------------
870.5550                        Unscheduled DNA    Negative for
                                Synthesis          unscheduled DNA
                                                   synthesis (UDS) in
                                                   hepatocytes from
                                                   mice treated orally
                                                   up to toxic doses
                                                   (5,000 mg/kg).
------------------------------------------------------------------------
870.7485                        Metabolism Rat     Clethodim is readily
                                                   absorbed and
                                                   eliminated (87-92%,
                                                   urine; 9-17%, feces;
                                                    1% expired air)
                                                   after 7 days.
                                                   Gastrointestinal
                                                   absorption estimated
                                                   at 89-96%. No
                                                   evidence of
                                                   bioconcentration.
                                                   Extensively
                                                   metabolized with <
                                                   1% eliminated as
                                                   unchanged parent
                                                   compound.
                                                   Predominant
                                                   metabolite is
                                                   clethodim sulphoxide
                                                   (48-68%) after 48
                                                   hours.
------------------------------------------------------------------------
870.7600                        Dermal Absorption  At 10 hours after
                                Rat                receiving a single
                                                   dermal application
                                                   of 0.05 mg/rat the
                                                   dermal absorption
                                                   factor was 30%.
------------------------------------------------------------------------


B. Toxicological Endpoints


   The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
   For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
   For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
   The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of 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 2:


     Table 2.--Summary of Toxicological Dose and Endpoints for Clethodim for Use in Human Risk Assessment
--------------------------------------------------------------------- -------------------------------------------
                                                             FQPA SF* and Level of
        Exposure Scenario              Dose Used in Risk    Concern (LOC) for Risk    Study and Toxicological
                                        Assessment, UF Assessment                  Effects
--------------------------------------------------------------------- -------------------------------------------
Acute Dietary All Populations        N/A                     N/A 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; cPAD       Chronic Toxicity-Dog (1
                                     UF = 100; Chronic RfD =chronic RfD/FQPA SF    year).
                                     = 0.01 mg/kg/day        = 0.01 mg/kg/day
Alterations in 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-Rat.
(Residential)                        NOAEL= 100 mg/kg/day    (Residential)
                                     (dermal absorption
                                     rate = 30%)
LOAEL = 350 mg/kg/day 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 (90
several months) (Residential)        mg/kg/day (dermal (Residential)           days).
                                     absorption rate =
                                     30%)
LOAEL = 75 mg/kg/day 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 (dermal (Residential)           year).
                                     absorption rate =
                                     30%)
LOAEL = 75 mg/kg/day 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)
                                     (inhalation
                                     absorption rate =
                                     100%)
LOAEL = 350 mg/kg/day based
on decreased body weight
gain and clinical signs of
toxicity (salivation).
--------------------------------------------------------------------- -------------------------------------------


Intermediate-Term Inhalation (1      Oral study NOAEL = 25   LOC for MOE = 100       Subchronic Toxicity-Dog (90
week to several months)              mg/kg/day (inhalation (Residential)           days).
(Residential)                        absorption rate =
                                     100%)
LOAEL = 75 mg/kg/day based
on increased absolute and
relative liver weights.
--------------------------------------------------------------------- -------------------------------------------
Long-Term Inhalation (several        Oral study NOAEL= 1.0   LOC for MOE =100        Chronic Toxicity-Dog (1
months to lifetime) (Residential)    mg/kg/day (dermal (Residential)           year).
                                     absorption rate =
                                     30%)
LOAEL = 75 mg/kg/day 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 combined residues of clethodim, in
or on a variety of raw agricultural commodities. Tolerances are
established on fat, meat, and meat by products (mbyp) of cattle, goats,
hogs, horses, poultry, and sheep at 0.20 ppm, milk at 0.05 ppm, eggs at
0.20 ppm, carrots at 0.50 ppm, cranberry at 0.50 ppm, clover forage at
10.0 ppm, clover hay at 20.0 ppm, cottonseed at 1.0 ppm, cottonseed
meal at 2.0 ppm, fruiting vegetable group at 1.0 ppm, leaf petioles
subgroup at 0.60 ppm, melon subgroup at 2.0 ppm, potatoes at 0.5 ppm,
potato flakes and granules at 2.0 ppm, radish roots at 0.50 ppm, radish
tops at 0.70 ppm, squash/cucumber subgroup at 0.50 ppm, strawberry at
3.0 ppm, sunflower meal at 10.0 ppm, sunflower seed at 5.0 ppm,
soybeans at 10.0 ppm, soybean soapstock at 15.0 ppm, dry bulb onions at
0.20 ppm, sugar beet roots at 0.20 ppm, sugar beet tops at 1.0 ppm,
sugar beet molasses at 1.0 ppm, and tuberous and corm vegetables at 1.0
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 animal commodities. The weighted average
percent of crop treated data for existing registrations, and 100% crop
treated (CT) data (for new uses) were used for the analyses.
   iii. Cancer. Clethodim has been classified as a group E carcinogen.
Therefore, a cancer risk assessment is not required.
   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 percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
   The Agency used percent crop treated (PCT) information as follows:
   3% for cotton, 8% for onions, 3% for peanuts, 4% for soybeans,
15% for sugar beets, and 1% for tomatoes


   The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived 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 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. 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. Known environmental
characteristics of clethodim depict a compound which is stable to
hydrolysis, except in acid conditions, but highly susceptible to
photolysis and metabolism.
   Parent clethodim is mobile, but has a short metabolic half-life of
1-3 days in soil under aerobic conditions. Therefore, parent compound
should not be a ground water concern in most environments. In the event
that parent clethodim did reach ground water, the available routes of
disappearance would be dilution, some metabolism to persistent
degradates, and slow hydrolysis with the rate depending on the pH of
the ground water.
   The environmental fate data indicate that clethodim, and its
sulphoxide and sulphone metabolites may migrate into surface water
bodies through run-off which occurs shortly after application (e.g.
rainfall). Since they are not adsorbed readily to soil (Kds
of < 0.1 to 7) , they are likely to remain in the aqueous phase, where
they are subject to rapid photolysis and biodegradation. They may
remain long enough to exert acute effects on resident biota, but are
unlikely to cause chronic effects.
   Clethodim does not show a significant potential for bio-
accumulation in aquatic organisms. Although they have been individually
tested, the primary degradates are highly polar, and would not be
expected to bio-accumulate.
   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 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 clethodim they are further
discussed in the aggregate risk sections below.
   Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of clethodim for chronic exposures are estimated
to be 24.2 ppb for surface water and 0.49 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).
   Clethodim is not registered for use on any sites that would result
in residential exposure. Based on clethodim labels, Select
and Select 2EC are both available for weed control use in
residential and/or public areas. However, the registrant has indicated
that the product is not for use by homeowners. Therefore, homeowners
will not handle clethodim products, and a non-occupational handler
exposure assessment is not necessary. Following treatment by
professional applicators, the public could potentially come into
contact with clethodim residues in areas such as patios, along
driveways and around golf courses and fence lines. However, weed
control with clethodim in theses areas generally consists of a spot
treatment, resulting in a very small treated area, and it is unlikely
that children would be exposed to these treated areas. Therefore, a
non-occupational postapplication 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.''
   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 ten-fold 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 database 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 database for clethodim
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. EPA determined that the
10X safety factor to protect infants and children should be removed.
The FQPA factor is removed primarily because there is no indication of
quantitative or qualitative increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure.


E. Aggregate Risks and Determination of Safety


   To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
   A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
   When EECs for surface water and groundwater are less than the
calculated DWLOCs, the Office of Pesticides Programs (OPP) concludes
with reasonable certainty that exposures to the pesticide in drinking
water (when considered along with other sources of exposure for which
OPP has reliable data) would not result in unacceptable levels of
aggregate human health risk at this time. Because OPP considers the
aggregate risk resulting from multiple exposure pathways associated
with a pesticide's uses, levels of comparison in drinking water may
vary as those uses change. If new uses are added in the future, OPP
will reassess the potential impacts of residues of the pesticide in
drinking water as a part of the aggregate risk assessment process.
   1. Acute risk. 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 29% of the cPAD for the U.S. population, 43% of
the cPAD for infants less than one year old]
and 60% 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 3:


              Table 3.--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 29         24.2         0.49          250
--------------------------------------------------------------------- -------------------------------------------
All Infants (< 1 year)                                      0.01 43         24.2         0.49           57
--------------------------------------------------------------------- -------------------------------------------
Children 1-6 years                                          0.01 60         24.2         0.49           40
--------------------------------------------------------------------- -------------------------------------------
Children 7-12 years                                         0.01 42         24.2         0.49           58
--------------------------------------------------------------------- -------------------------------------------
Females 13-50 years                                         0.01 22         24.2         0.49          230
--------------------------------------------------------------------- -------------------------------------------


   3. Short-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 a group E carcinogen. 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 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


   The method RM-26B-3 (a modification of RM-26B-2) was validated for
potatoes, processed potato commodities, sugar beets, sunflowers, bell
peppers, non-bell peppers, celery, cantaloupes, and clover. The limit
of quantitation (LOQ) was determined to be 0.1 ppm for cantaloupes and
bell peppers, 0.2 ppm for potatoes, sugar beets, sunflowers, celery and
non-bell
peppers, and 0.5 ppm for clover. Average recoveries for all the
commodities were within the acceptable range at all fortification
levels tested. The common moiety method RM-26B-3 for the determination
of clethodim and its metabolites in potatoes, processed potato
commodities, sugar beets, sunflowers, bell peppers, non-bell peppers,
celery, cantaloupes, and clover is acceptable for data collection and
enforcement purposes.
   Method RM-26B-2 was validated for the analyses of residues of
clethodim in/on radish, carrots, cucumbers, cranberries, and
strawberries. The limit of quantitation (LOQ) was determined to be 0.05
ppm for strawberries and cranberries, 0.1 ppm for carrots, and 0.16 ppm
for radish. Average recoveries were within the acceptable range for all
fortification levels tested and all commodities. The method RM-26B-2
for the determination of clethodim and its metabolites in radish,
carrots cucumbers, cranberries, and strawberries is acceptable for data
collection and enforcement purposes.
   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
Independent Laboratory Validation (ILV) and an Agency Petition Method
Validation. Additionally, a confirmatory method, EPA-RM-26D-2 is also
available. Both methods (RM-26B-2 and RM-26D-2) have been forwarded to
FDA as enforcement methods for inclusion in the Pesticide Analytical
Manual, Volume II (PAM II).
   The method may be requested from: Calvin Furlow, PIRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 305-5229; e-mail address: furlow.calvin@epa.gov.


B. International Residue Limits


   There are no established Codex maximum residue limits (MRLs) for
residues of clethodim and its metabolites in/on the commodities
discussed in the subject petition; therefore, there are no questions
with respect to Codex/U.S. tolerance compatibility.


V. Conclusion


   Therefore, the tolerance is 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,
expressed as clethodim, in or on alfalfa forage at 6 ppm, alfalfa hay
at 10 ppm, dry beans at 2 ppm, peanut hay at 3 ppm, peanut meal at 5
ppm, peanuts at 3 ppm, tomato paste at 3 ppm, and tomato puree at 2
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-301134 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 August 6,
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 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-301134, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit
I.B.2. You may also send an electronic copy of your request via e-mail
to: opp-docket@epa.gov. Please use an ASCII file format and avoid the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any
CBI in your electronic copy. You may also submit an electronic copy of
your request at many Federal Depository Libraries.


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


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


VII. Regulatory Assessment Requirements


   This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any 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 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 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: May 21, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.


   Therefore, 40 CFR chapter I is amended as follows:


PART 180--[AMENDED]


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


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



   2. Section 180.458 is amended by revising the section heading and
by revising paragraph (a)(2) to read as follows:



Sec. 180.458  Clethodim, tolerances for residues.


   (a) General.* * *
   (2) Time limited tolerances are established for the 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,
expressed as clethodim in or on the following raw agricultural
commodities:


------------------------------------------------------------------------
                                                            Expiration/
                   Commodity                     Parts per   Revocation
                                                  million       Date
------------------------------------------------------------------------
Alfalfa, forage.................................          6      4/30/03
Alfalfa, hay....................................         10      4/30/03
Dry beans.......................................          2      4/30/03
Peanuts.........................................          3      4/30/03
Peanut, hay.....................................          3      4/30/03
Peanut, meal....................................          5      4/30/03
Tomato, paste...................................          3      4/30/03
Tomato, puree...................................          2      4/30/03
------------------------------------------------------------------------


* * * * *


[FR Doc. 01-14084 Filed 6-5-01; 8:45 am]