[Federal Register Volume 66, Number 108 (Tuesday, June 5, 2001)]
[Rules and Regulations]
[Pages 30073-30080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14086]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301133; FRL-6783-5]
RIN 2070-AB78


Clethodim; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of clethodim in or on the root vegetable (except sugar beet) subgroup. 
The Interregional Research Project Number 4 (IR-4) requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act (FQPA) of 1996. This final 
rule establishes permanent tolerances for clethodim and as part of that 
process the Agency has reassessed existing tolerances. By law, EPA is 
required to reassess 66% of the tolerances in existence on August 2, 
1996, by August 2002, or about 6,400 tolerances. All permanent 
tolerances for clethodim that existed on August 2, 1996, were 
previously reassessed by April 1998. Consequently, regarding the 
actions in this final rule, no tolerance reassessments are counted 
toward the August 2002 review deadline of FFDCA section 408(q).

DATES: This regulation is effective June 5, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301133, 
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-301133 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; and e-mail 
address: [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
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/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-301133. 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.

[[Page 30074]]

 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 29, 2000 (65 FR 16602) (FRL-6495-
5), EPA issued 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 petition (PP 0E6097) for tolerances by IR-4, 
Rutgers, the State University of New Jersey, 681 U.S. Highway No. 1 
South, North New Brunswick, NJ 08902 and Valent USA Corporation, Walnut 
Creek, CA 94596-8025. This notice included a summary of the petition 
prepared by Valent USA Corporation, the registrant.
    The petition requested that 40 CFR 180.458 be amended by 
establishing tolerances for combined residues of the herbicide 
clethodim, [(E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one] and its metabolites containing the 5-(2-
(ethylthiopropyl)cyclohexene-3-one and 5-(2-(ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, 
on various commodities with the following tolerance levels at parts per 
million (ppm): root vegetables subgroup at 1.0 ppm, leaves of root and 
tuber vegetables group at 2.0 ppm, leafy petiole vegetables subgroup at 
0.5 ppm, melon subgroup at 2.0 ppm, squash/cucumber subgroup at 0.5 
ppm, cranberry at 0.5 ppm, clover forage at 10 ppm, clover hay at 20.0 
ppm, and strawberry at 5.0 ppm. In response to IR-4's petition, EPA 
issued a final rule in the Federal Register of March 14, 2001 (66 FR 
14829) (FRL-6770-8) establishing tolerances for combined residues of 
clethodim and its metabolites in or on carrots at 0.50 ppm, radish 
roots at 0.50 ppm, radish tops at 0.70 ppm, leaf petioles subgroup at 
0.60 ppm, melon subgroup at 2.0 ppm, squash/cucumber subgroup at 0.50 
ppm, cranberry at 0.5 ppm, strawberry at 3.0 ppm, clover forage at 10.0 
ppm, and clover hay at 20.0 ppm. Tolerances were established for carrot 
and radish roots, which are members of the root vegetable (except sugar 
beet) subgroup, in the final rule of March 14, 2001, but not the 
subgroup since EPA had not completed its evaluation of the residue data 
submitted in support of the subgroup tolerance. EPA has now completed 
the review of the residue data and has concluded that the data support 
a tolerance for combined residues of clethodim and its metabolites in 
or on the root vegetable (except sugar beet) subgroup at 1.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
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 the 
root vegetable (except sugar beet) subgroup at 1.0 ppm. EPA's 
assessment of exposures and risks associated with establishing this 
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 Unit III.A. of the Federal Register of March 14, 2001.

B. Toxicological Endpoints

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

[[Page 30075]]

be used for the carcinogenic risk assessment. In this non-linear 
approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure (MOE 
cancer = point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for clethodim used for human 
risk assessment is shown in the following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Clethodim for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 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                      None selected.
                                                                                         There were no effects
                                                                                          observed in oral
                                                                                          toxicity studies
                                                                                          including
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits that could be
                                                                                          attributable to a
                                                                                          single dose
                                                                                          (exposure). Therefore,
                                                                                          a dose and endpoint
                                                                                          were not selected for
                                                                                          this risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL= 1.0 mg/kg/day     FQPA SF = 1              Chronic toxicity-dog (1
                                       UF = 100...............  cPAD =chronic RfD......   year).
                                       Chronic RfD = 0.01 mg/    FQPA SF = 0.01 mg/kg/   Alterations in
                                        kg/day.                  day.                     hematology and
                                                                                          clinical chemistry
                                                                                          parameters and
                                                                                          increased absolute and
                                                                                          relative liver weights
                                                                                          observed at the LOAEL
                                                                                          of 75 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days)        Oral study maternal      LOC for MOE = 100        Developmental toxicity-
(residental).........................  NOAEL= 100 mg/kg/day...  (residential)..........   rat.
                                       (dermal absorption rate                           LOAEL = 350 mg/kg/day
                                        = 30%).                                           based on decreased
                                                                                          body weight gain and
                                                                                          clinical signs of
                                                                                          toxicity (salivation).
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to    Oral study NOAEL =       LOC for MOE = 100        Subchronic toxicity-dog
 several months)                       25 mg/kg/day...........  (residential)..........   (90 days).
(residential)........................  (dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 30%).                                           based on increased
                                                                                          absolute and relative
                                                                                          liver weights.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    Oral study NOAEL = 1.0   LOC for MOE =100         Chronic toxicity-dog (1
 lifetime)                              mg/kg/day               (residential)..........   year).
(residential)........................  (dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 30%).                                           based on alterations
                                                                                          in hematology and
                                                                                          clinical chemistry
                                                                                          parameters as well as
                                                                                          increases in absolute
                                                                                          and relative liver
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days)    Oral study maternal      LOC for MOE =100         Developmental-rat.
(residential)........................  NOAEL= 100 mg/kg/day...  (residential)..........  LOAEL = 350 mg/kg/day
                                       (inhalation absorption                             based on decreased
                                        rate = 100%).                                     body weight gain and
                                                                                          clinical signs of
                                                                                          toxicity (salivation).
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week   Oral study NOAEL = 25    LOC for MOE = 100        Subchronic toxicity-dog
 to several months)                     mg/kg/day               (residential)..........   (90 days).
(residential)........................  (inhalation absorption                            LOAEL = 75 mg/kg/day
                                        rate = 100%).                                     based on increased
                                                                                          absolute and relative
                                                                                          liver weights.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months   Oral study NOAEL =       LOC for MOE = 100        Chronic toxicity-dog (1
 to lifetime)                          1.0 mg/kg/day..........  (residential)..........   year).
(residential)........................  (dermal absorption rate                           LOAEL = 75 mg/kg/day
                                        = 30%).                                           based on alterations
                                                                                          in hematology and
                                                                                          clinical chemistry
                                                                                          parameters as well as
                                                                                          increases in absolute
                                                                                          and relative liver
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      N/A                      N/A                      Clethodim is classified
                                                                                          as a ``Not Likely''
                                                                                          carcinogen.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.458) for the residues of clethodim in or on a 
variety of food commodities: including the representative commodities 
of the root vegetable (except sugar beet) subgroup (carrots and radish 
roots at 0.5 ppm) and the related tuberous and corm vegetable subgroup 
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 1 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.

[[Page 30076]]

    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 milligram/
kilogram/day (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 percent crop 
treated (PCT) 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 was not performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F) 
states that the Agency may use data on the actual percent of food 
treated for assessing chronic dietary risk only if the Agency can make 
the following findings: Condition 1, that the data used are reliable 
and provide a valid basis to show what percentage of the food derived 
from such crop is likely to contain such pesticide residue; Condition 
2, that the exposure estimate does not underestimate exposure for any 
significant subpopulation group; and Condition 3, if data are available 
on pesticide use and food consumption in a particular area, the 
exposure estimate does not understate exposure for the population in 
such area. In addition, the Agency must provide for periodic evaluation 
of any estimates used. To provide for the periodic evaluation of the 
estimate of PCT as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Cotton 3%, onions 8%, peanuts 3%, soybeans 4%, sugar beets 15%, and 
tomatoes 1%.
    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. Clethodim does 
not show a significant potential for bio-accumulation in aquatic 
organisms. Although they have not 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 
Screening Concentrations in Ground Water (SCI-GROW), which predicts 
pesticide concentrations in ground water. In general, EPA will use 
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated

[[Page 30077]]

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

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An endpoint for acute dietary exposure was not 
identified since no effects were observed in oral toxicity studies that 
could be attributable to a single dose.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to clethodim 
from food will utilize 29% of the cPAD for the U.S. population, 43% of 
the cPAD for all infants (< 1 year) 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 2.

[[Page 30078]]



               Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clethodim
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD (mg/      % cPAD     Water EEC    Water EEC     Chronic
                                                     kg)         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                                 0.01           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 and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Clethodim is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    4. Aggregate cancer risk for U.S. population. Clethodim has been 
classified as 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

    Method RM-26B-2 was validated by IR-4 for the analyses of residues 
of clethodim in/on radish and carrots. The limit of quantitation (LOQ) 
was determined to be 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 and 
carrots is acceptable for data collection and meets the requirements 
for a residue analytical method to enforce tolerances.
    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 and RM-26D-2 have completed an 
Independent Laboratory Validation (ILV) and also have completed 
Tolerance Methods Validations (TMVs) in the Agency's laboratory. 
Additionally, the compound specific method, EPA-RM-26D-2 is also 
available and is suitable for residue data collection and as a residue 
analytical methold to enforce tolerances. Both methods have been 
forwarded to FDA for inclusion in a future edition of the Pesticide 
Analytical Manual, Volume II (PAM II).
    The methods may be requested from: Francis Griffith, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort 
George G. Mead, Maryland, 20755-5350; telephone number: (410) 305-2905; 
e-mail address: [email protected].

B. International Residue Limits

    There are no established Codex maximum residue limits (MRLs) for 
residues of clethodim and its metabolites in/on commodity members of 
the root vegetable (except sugar beet subgroup); therefore, there are 
no questions with respect to Codex/U.S. tolerance compatibility.

V. Conclusion

    Therefore, this 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, 
in or on the root vegetable (except sugar beet) subgroup at 1.0 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301133 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

[[Page 30079]]

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-301133, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations as required by Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or require OMB review or any Agency action under 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Since tolerances and exemptions that are established on the 
basis of a 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

[[Page 30080]]

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 23, 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 alphabetically adding the entry 
vegetable, root (except sugar beet) subgroup to the table in paragraph 
(a)(3), by revising the entry for vegetable, tuberous and corm group, 
and by deleting the entries for carrot and radish roots to read as 
follows:


Sec. 180.458  [((E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one); tolerances for residues.

    (a) *    *    *
    (3) *    *    *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                  *        *        *        *        *
Vegetable, root (except sugar beet) subgroup..........                                                       1.0
                                  *        *        *        *        *
Vegetable, tuberous and corm, subgroup................                                                       1.0
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 01-14086 Filed 6-4-01; 8:45 am]
BILLING CODE 6560-50-S