PMEP Home Page --> Pesticide Active Ingredient Information --> Herbicides, Growth Regulators and Desiccant --> cacodylic acid to cytokinin --> clethodim (Select) --> clethodim (Select) Pesticide Tolerance 7/02

clethodim (Select) Pesticide Tolerance 7/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0129; FRL-7185-7]
RIN 2070-XXXX

Clethodim; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for the residues of
clethodim in or on alfalfa forage; alfalfa hay; dry bean; Brassica,
leafy greens, subgroup
5B; peanut; peanut hay; peanut meal; peppermint tops; spearmint tops;
spinach; and turnip greens. The Interregional Research Project Number 4
(IR4) and Valent U.S.A. Corporation requested these tolerances under
the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.

DATES: This regulation is effective July 17, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0129,
must be received on or before September 16, 2002.

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 theSUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0129 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; e-mail
address: brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this 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. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at http://
www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0129. 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 April 17, 2002 (67 FR 18890) (FRL-6830-
9), 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 1E6351, 2E6394, and 2E6396) by
IR4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390,
and pesticide petitions (PP 5F4440 and 5F4572) by Valent U.S.A.
Corporation, 1333 North California Boulevard, Suite 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 establishing tolerances for residues
of the herbicide clethodim, (E)-()-2-1-(3-chloro-2-
propenyl)oxyiminopropyl-5-2-(ethylthio)propyl-3-hydroxy-2-cycloh exen-
1-one and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones,
in or on Brassica, leafy greens, subgroup 5B at 3.0 part per million
(ppm), turnip greens at 3.0 ppm, peppermint and spearmint tops at 5.0
ppm, and spinach at 2.0 ppm.
    The petitions also requested that 40 CFR 180.458 be amended by
replacing existing timelimited tolerances, with permanent tolerances
for residues of the herbicide clethodim, (E)-()-2-1-(3-
chloro-2-propenyl)oxyiminopropyl-5-2-(ethylthio)propyl-3-hydroxy-2-
cycloh exen-1-one and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones,
in or on alfalfa forage at 6.0 ppm, alfalfa hay at 10 ppm, dry bean at
2.0 ppm, peanut at 3.0 ppm, peanut hay at 3.0 ppm, and peanut meal at
5.0 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 tolerances for residues of clethodim on alfalfa forage
at 6.0 ppm, alfalfa hay at 10 ppm, dry bean at 2.5 ppm, Brassica, leafy
greens, subgroup at 3.0, peanut at 3.0 ppm, peanut hay at 3.0, peanut
meal at 5.0, and turnip tops at 3.0 ppm, peppermint and spearmint tops
at 5.0 ppm, and spinach at 2.0 ppm. EPA's assessment of exposures and
risks associated with establishing these tolerances follow.

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 is
discussed in Unit III.A. of the Federal Register of March 14, 2001 (66
FR 14829) (FRL-6770-8).

B. Toxicological Endpoints

    A summary of the toxicological endpoints for clethodim used for
human risk assessment is discussed in Unit III.B of the Federal
Register of March 14, 2001 (66 FR 14829) (FRL-6770-8). Chronic, and
short-term, intermediate-term, and long-term aggregate risk assessments
are appropriate for clethodim and were performed by EPA.

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 raw agricultural commodities. 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 fooduse 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: Chronic analysis used tolerance level residues for all
crops and livestock commodities. The projected [percnt]
crop treated
data (2[percnt]
for lettuce, broccoli and cauliflower, 15[percnt]
cabbage, and 1[percnt]
for brussels sprouts), and the weighted average
[percnt]
crop treated data (3[percnt] for cotton, 8[percnt] for onions,
3[percnt]
for peanuts 4[percnt] for soybeans, 15[percnt] for sugar
beets, and 1[percnt]
for tomatoes) were used for the analysis;
100[percnt]
crop treated (CT) data were assumed for the leafy Brassica
greens, turnip greens, dry bean, peanuts, and the other crops for the
analysis. DEEM default concentration factors were used for all
commodities. The analysis is considered Tier 2 because percent of crop
treated information was used.
    iii. Cancer. Clethodim has been classified as a group E carcinogen.
Therefore, a cancer risk assessment was not performed.
    iv. Anticipated residue and percent crop treated information.
    Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant sub- population 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.
    2[percnt]
for lettuce, broccoli and cauliflower; 15[percnt]
cabbage, and 1[percnt]
for brussels sprouts; (weighted average PCT)
3[percnt]
for cotton, 8[percnt] for onions, 3[percnt] for peanuts,
4[percnt]
for soybeans, 15[percnt] for sugar beets, and 1[percnt] for
tomatoes.
    The Agency believes that the three conditions listed III.C.1.iv
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 sub-populations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant sub-populations 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 sub-population 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.
    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 First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The SCIGROW model is used to predict pesticide concentrations in
shallow groundwater. For a screening-level assessment for surface water
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. While both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, 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 [percnt]
RfD or [percnt] 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 III.E.
    Summary: Surface and ground water contamination may occur from the
sulfoxide and sulfone degradates of clethodim, as well as from parent
clethodim. However, the risk of water contamination is primarily
associated with clethodim sulfone and clethodim sulfoxide rather than
parent clethodim based on greater persistence and mobility for the
degradates. The drinking water estimates are based on a maximum
application rate of 0.5 pounds of active ingredient per acre per year.
    Surface Water: Parent clethodim may move from the treated field to
surface water or ground water through run-off or leaching which occurs
shortly after application (e.g. rainfall). Also, the sulfoxide and
sulfone degradates may migrate by runoff or leaching for longer periods
of time since they are more persistent. All residues of clethodim
(parent and degradates) are very mobile in soil. Tier 1 surface water
concentrations for parent clethodim and total toxic residues (parent +
sulfoxide + sulfone) estimations are as follows:
    Based on the FIRST model, the estimated environmental
concentrations (EECs) of clethodim for acute exposure are estimated to
be 38.9 parts per billion (ppb), and for chronic exposure the EECs are
estimated to be 7.6 ppb for surface water.
    Ground Water: Parent clethodim is mobile, but has a short metabolic
half-life in soil under aerobic conditions. Therefore, parent compound
should not be a ground water concern in most environments. While it is
expected that parent clethodim be transformed to sulfoxide or sulfoxone
products quickly by soil metabolism (t[frac1s2]
= 1 to 3 days), it may
be more persistent since it is leached below the more biologically
active top soil. In such instances (i.e., leaching rainfall shortly
after application) parent clethodim concentrations may be higher than
estimated. 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 estimation for both parent
clethodim and total toxic clethodim (parent + sulfoxide+sulfone) is as
follows: Based on the SCIGROW model, the EEC for ground water is 0.49
ppb.
    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 currently registered for use on the following noncrop
sites: rights of way such as railroads, highways, roads, dividers,
medians, pipelines, public utility lines, pumping stations, transformer
stations and substations, around airports, electric utilities,
commercial buildings, manufacturing plants, storage yards, rail yards,
fence lines, parkways, greenhouse benches, and around golf courses (not
on golf courses). It is possible that the public could be exposed to
clethodim residues in these noncrop areas.
    Homeowner use of clethodim is not prohibited on the label,
therefore the Agency assumes clethodim products are available for use
by untrained applicators. A residential handler assessment was
performed to determine the risk potential to homeowners. The following
assumptions were made in conducting the assessment: clethodim would be
applied by low pressure handwand (spot treatment); the highest label
rate of 1.3 ounces per gallon was used; five gallons of spray are used;
applicators mix, load and apply; and short sleeved shirt and short
pants are worn by homeowners.
    Clethodim is typically used to control unwanted weeds of all types
(grass and broadleaf) through spot treatment, usually resulting in a
small treated area. Broadcast treatment is not expected. It is unlikely
that adults and children would be exposed to treated areas which would
most likely consist of a single spot. Therefore, a non-occupational
post-application 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 tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The oral perinatal and
prenatal data demonstrated no indication of increased sensitivity of
rats or rabbits to in utero exposure to clethodim.
    3. Conclusion. There is a complete toxicity data base for clethodim
and exposure data 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 because there is no indication of
quantitative or qualitative increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure; a developmental neurotoxicity
study is not required; and the dietary (food and drinking water) and
non-dietary (residential) exposure assessments will not underestimate
the potential exposures for infants and children.

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, shortterm, intermediateterm, chronic, and cancer.
    When EECs for surface water and groundwater are less than the
calculated DWLOCs, 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 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, clethodim is not expected to pose an acute risk.
    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 33[percnt]
of the cPAD for the U.S. population,
26[percnt]
of the cPAD for females 1350 years old and 66[percnt] of the
cPAD for children (16 years old). Based the use pattern, chronic
residential exposure to residues of clethodim is not expected. 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[percnt]
of the cPAD, as shown in the following
Table 1:
Table 1.--Aggregate Risk Assessment for Chronic (NonCancer) Exposure to Clethodim
Population Subgroup
cPAD mg/
kg/day
% cPAD
(Food)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
Chronic
DWLOC
(ppb)
U.S. Population 0.01 33 7.6 0.49 201 Females
(13-50
years old)
0.01 26 7.6
0.49 220
Children (1-
6 years old)
0.01 66 7.6
0.49 34
     

    3. Short-term risk. Shortterm aggregate exposure takes into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Clethodim is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for clethodim.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated resulted in an aggregate MOE of 29,000 for males (13 to 19
years old). The dietary exposure of all adult population subgroups is
comparable to that of the subgroup with the highest exposure (males 13
to 19 years old). This

[[Page 46898]]

aggregate MOE does not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of clethodim in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern, as shown below in Table 2. Additionally, no
incidental oral exposure is anticipated for infants and children, since
postapplication exposure is not expected.
Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Clethodim
Population Subgroup
Aggregate
MOE (Food
+ Residential)
Aggregate
Level of
Concern
(LOC)
Surface
Water EEC
(ppb)
Ground
Water EEC
(ppb)
ShortTerm
DWLOC
(ppb)
  US Population   29,000   100   7.6
0.49         30,000
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Intermediate-
term oral, dermal and inhalation aggregate risks are made up of
exposures from these routes of exposure.
    Although, clethodim is currently registered for use(s) that could
result in intermediateterm residential exposure dermal, inhalation and
incidental oral exposures were not calculated because neither handler
nor post-application intermediate-term exposure for these routes of
exposure are expected. Therefore, no intermediate-term risk is expected
from these routes of exposure.
    5. Aggregate cancer risk for U.S. population. Clethodim was
negative for carcinogenicity in feeding studies in rats and mice and is
classified as ``not likely%rdquo; to be a human carcinogen.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to clethodim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for enforcement of tolerances for
clethodim and its metabolites in/on Brassica, leafy greens, subgroup,
turnip greens, and other commodities (including livestock). Analytical
Method RM26B3 (a modification of RM26B2) has been successfully
validated for use with many commodities including livestock commodities
and has been submitted to the FDA for publication in PAM II.
    Adequate enforcement methodology (example--gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Francis Griffith, Analytical Chemistry Branch,
Environmental Science Center, Environmental Protection Agency, 701
Mapes Road, Fort George G. Mead, MD 20755-5350; telephone number (410)
305-2905; griffith.francis@epa.gov.

B. International Residue Limits

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

V. Conclusion

    Therefore, these tolerances are established for residues of
clethodim, (E)-()-2-1-(3-chloro-2-propenyl)oxyiminopropyl-
5-2-(ethylthio)propyl-3-hydroxy-2-cyclohexe n-1-one and its metabolites
containing the 5-(2-ethylthiopropyl)cyclohexen-3-one and 5-(2-
ethylthiopropyl)-5-hydroxycyclohexen-3-one moieties and their
sulphoxides and sulphones, in or on alfalfa forage at 6.0 ppm, alfalfa
hay at 10 ppm, dry bean at 2.5 ppm, Brassica, leafy greens, subgroup at
3.0 ppm, peanut at 3.0 ppm, peanut hay at 3.0 ppm, peanut meal at 5.0
ppm, and turnip greens at 3.0 ppm, peppermint and spearmint tops at 5.0
ppm, and spinach at 2.0 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 ID number OPP-2002-0129 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 September
16, 2002.
    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 email at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0129, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive 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 theFederal 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: July 2, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.458 is amended by removing the entries for
``Alfalfa, forage''; ``Alfalfa, hay''; ``Dry beans''; ``Peanuts'';
``Peanut, hay''; and ``Peanut, meal'' from the table in paragraph
(a)(2) and alphabetically adding the following commodities to the table
in paragraph (a)(3) to read as follows:

Sec. 180.458  Clethodim, tolerances for residues.

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

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage......................................                6.0
Alfalfa, hay.........................................                 10
Bean, dry............................................                2.5
*                  *                  *
                  *                  *
Brassica, leafy greens, subgroup.....................                3.0
*                  *                  *
                  *                  *
Peanut...............................................                3.0
Peanut, hay..........................................                3.0
Peanut, meal.........................................                5.0
Peppermint, tops.....................................                5.0
*                  *                  *
                  *                  *
Spearmint, tops......................................                5.0
Spinach..............................................                2.0
*                  *                  *
                  *                  *
Turnip, greens.......................................                3.0
*                  *                  *
                  *                  *
------------------------------------------------------------------------

[FR Doc. 02-17871 Filed 7-16-02; 8:45 am]

--