[Federal Register Volume 66, Number 109 (Wednesday, June 6, 2001)]
[Rules and Regulations]
[Pages 30325-30334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14084]


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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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                 Examples of 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://

[[Page 30326]]

www.epa.gov/. To access this document, on the Home Page select ``Laws 
and Regulations,'' ``Regulations and Proposed Rules,'' and then look up 
the entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a 
beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-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

[[Page 30327]]

 
                                                   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%.
------------------------------------------------------------------------


[[Page 30328]]

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).
----------------------------------------------------------------------------------------------------------------

[[Page 30329]]

 
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

[[Page 30330]]

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

[[Page 30331]]

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

[[Page 30332]]

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: [email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-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

[[Page 30333]]

I.B.2. You may also send an electronic copy of your request via e-mail 
to: [email protected]. Please use an ASCII file format and avoid the 
use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any 
CBI in your electronic copy. You may also submit an electronic copy of 
your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

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

[[Page 30334]]



------------------------------------------------------------------------
                                                             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]
BILLING CODE 6560-50-S