[Federal Register Volume 75, Number 91 (Wednesday, May 12, 2010)]
[Rules and Regulations]
[Pages 26673-26678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11301]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0307; FRL-8822-7]


Clethodim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
clethodim in or on the raw agricultural commodity artichoke, globe; 
bushberry subgroup 13-07B; caneberry subgroup 13-07A; and peach. This 
regulation additionally removes the existing tolerances on lettuce leaf 
and spinach, as they are covered by the leafy greens subgroup 4A and 
removes the tolerance for flax seed at 0.50 ppm because there is one 
for flax seed at 0.6 ppm. The Interregional Research Project Number 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 12, 2010. Objections and 
requests for hearings must be received on or before July 12, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0307. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:

[[Page 26674]]

     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any 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 Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0307 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
July 12, 2010. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0307, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of June 10, 2009 (74 FR 27538) (FRL-8417-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E7505) by IR-4 Project Headquarters, Rutgers, The State University of 
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. 
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-
(ethylthio)propyl]cyclohexen-3-one and the 5-[2-(ethylthio)propyl]-5-
hydroxycyclohexen-3-one moieties and their sulfoxides and sulfones, 
expressed as clethodim, in or on the raw agricultural commodity 
artichoke, globe at 1.3 parts per million (ppm), bushberry subgroup 13-
07B at 3.0 ppm, caneberry subgroup 13-07A at 0.30 ppm and peach at 0.20 
ppm. That notice referenced a summary of the petition prepared by 
Valent U.S.A. Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the bushberry subgroup 13-07B tolerance from 3.0 ppm to 0.20 
ppm and the globe artichoke tolerance from 1.3 ppm to 1.2 ppm. The 
reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 for clethodim including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with clethodim 
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. Clethodim has a low order of acute toxicity via oral, dermal 
and inhalation routes of exposure. Clethodim produces mild ocular 
irritation and moderate skin irritation. It is not a dermal sensitizer. 
The subchronic and chronic toxicity data show that clethodim produces 
consistent effects in the liver characterized by increased liver 
weights and centrilobular hepatic hypertrophy in rats, mice, and dogs. 
Decreased body weight is also a consistent finding. Treatment related 
increase in tumor incidence is not observed in rat and mouse 
carcinogenicity studies. Clethodim is not genotoxic. The data 
demonstrate no reproductive effect in rats and no developmental effects 
in rabbits. No effects were seen in offspring of the 2-generation 
study. In the rat developmental toxicity study, reduced fetal weights 
and increased incidence of reduced ossification were seen in the 
fetuses at the maternal toxic dose level.

[[Page 26675]]

The data show no increase in susceptibility in the young.
    Specific information on the studies received and the nature of the 
adverse effects caused by clethodim as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov on pages 45-50 of the document titled ``Clethodim 
Human Health Risk Assessment for Proposed Uses on Caneberry Subgroup 
13-07A, Bushberry Subgroup 13-07B, Peach, and Globe Artichoke'' in 
docket ID number EPA-HQ-OPP-2009-0307.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level - generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for clethodim used for 
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Clethodim for Use in Human Health Risk Assessment
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                                       Point of Departure and
          Exposure/Scenario              Uncertainty/Safety     RfD, PAD, LOC for Risk   Study and Toxicological
                                              Factors                 Assessment                 Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                         N/A                      N/A                      None Selected.
 (All Populations)..................                                                    There were no effects
                                                                                         observed in oral
                                                                                         toxicity studies
                                                                                         including developmental
                                                                                         toxicity studies in
                                                                                         rats and rabbits that
                                                                                         could be attributable
                                                                                         to a single dose
                                                                                         (exposure). Therefore,
                                                                                         a dose and endpoint
                                                                                         were not selected for
                                                                                         this exposure scenario.
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Chronic dietary                       NOAEL= 1.0 mg/kg/day     Chronic RfD = 0.01 mg/   Chronic Toxicity-Dog (1-
(All populations)...................  UFA = 10x..............   kg/day                   year).
                                      UFH = 10x..............  cPAD = 0.01 mg/kg/day..  Alterations in
                                      FQPA SF = 1x...........                            hematology and clinical
                                                                                         chemistry parameters
                                                                                         and increased absolute
                                                                                         and relative liver
                                                                                         weights observed at the
                                                                                         LOAEL of 75 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer                                   Classification: ``Not likely to be Carcinogenic to Humans'' based on
(Oral, dermal, inhalation)..........                       feeding studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to clethodim, EPA considered exposure under the petitioned-for 
tolerances as well as all existing clethodim tolerances in 40 CFR 
180.458. EPA assessed dietary exposures from clethodim in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    No such effects were identified in the toxicological studies for 
clethodim; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. The chronic dietary (food and drinking water) exposure 
assessment is partially refined, i.e., based on the assumption of 
tolerance-level residues for most commodities and average percent crop 
treated information for some crops. An anticipated residue (AR) value 
was used for succulent snap bean.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that clethodim is classified as ``Not Likely to be 
Carcinogenic to Humans.'' Therefore, a dietary exposure assessment for 
the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to section 408(f)(1) of FFDCA that data be provided 5 years 
after the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by section 408(b)(2)(E) of FFDCA and authorized under 
section 408(f)(1) of FFDCA. Data will be required to be submitted no 
later than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food

[[Page 26676]]

derived from such crop is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: 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) of FFDCA, EPA may require 
registrants to submit data on PCT.
    The Agency estimated the percent crop treated for existing uses as 
follows:
    Beets 1%, Broccoli 10%, Cabbage 1%, Cantaloupes 1%, Carrots 10%, 
Celery 5%, Cotton 1%, Cucumbers 1%, Dry beans 5%, Lettuce 1%, Onions 
10%, Peanuts 5%, Potatoes 5%, Pumpkins 5%, Soybeans 5%, Squash 5%, 
Strawberries 1%, Sugar beets 45%, Sunflowers 20%, Sweet potatoes 1%, 
Tomatoes 1%, Watermelons 5%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, 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 reliable 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 used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for clethodim in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of clethodim. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of clethodim for 
chronic exposures for non-cancer assessments are 13.0 ppb for surface 
water and 9.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration value of 13.0 ppb was used to 
assess the contribution to drinking 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 any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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 has not found clethodim to share a common mechanism of toxicity 
with any other substances, and clethodim does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that clethodim does not 
have 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 EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of fetuses as compared to maternal animals 
following in utero and/or postnatal exposure to clethodim in the 
developmental toxicity studies in rats or rabbits, and no increased 
sensitivity in pups as compared to adults in the 2-generation rat 
reproduction toxicity study. There are no residual uncertainties 
concerning prenatal and postnatal toxicity and no neurotoxicity 
concerns.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. Except for the new requirements of an immunotoxicity study and 
an acute and subchronic neurotoxicity battery, the available toxicity 
database for clethodim is sufficient and the exposure data are complete 
or are estimated based on data that reasonably account for potential 
exposures. In the absence of the immunotoxicity and acute and 
subchronic neurotoxicity studies, the available toxicity data for 
clethodim have been thoroughly examined for any information which 
suggests a potential for neurotoxicity or immunotoxicity.

[[Page 26677]]

The analysis did not reveal such information and the Agency does not 
believe that conducting these studies will result in a NOAEL less than 
the currently selected NOAELs for risk assessment. Therefore, a 
database uncertainty factor (UFdb) is not needed to account 
for the lack of these studies.
    ii. There is no evidence of susceptibility following in utero and/
or postnatal exposure in the developmental toxicity studies in rats or 
rabbits, and in the 2-generation rat reproduction study. There are no 
residual uncertainties concerning prenatal and postnatal toxicity.
    iii. There is no evidence that clethodim is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iv. There are no residual uncertainties identified in the exposure 
data base. The chronic dietary food exposure assessment utilized 
tolerance level residues for most commodities and incorporated average 
PCT data for some commodities. There is no potential for residential 
exposure. The dietary (food and drinking water) exposure assessment 
will not underestimate the potential exposure for infants, children, 
and/or women of childbearing age.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. 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 chronic exposure to 
clethodim from food and drinking water will utilize 79% of the cPAD for 
all infants <1 year old, the population group receiving the greatest 
exposure. There are no residential uses for clethodim.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    A short-term adverse effect was identified; however, clethodim is 
not registered for any use patterns that would result in short-term 
residential exposure. Short-term risk is assessed based on short-term 
residential exposure plus chronic dietary exposure. Because there is no 
short-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short-term risk), no 
further assessment of short-term risk is necessary, and EPA relies on 
the chronic dietary risk assessment for evaluating short-term risk for 
clethodim.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and drinking water (considered to be a background 
exposure level).
    An intermediate-term adverse effect was identified; however, 
clethodim is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
clethodim.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, clethodim is not expected to pose a cancer risk to humans.
    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 or to infants and children from aggregate 
exposure to clethodim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate plant analytical methods are available for tolerance 
enforcement. Method RM-26B-2 (a gas chromatography method with flame 
photometric detection in the sulfur mode (GC/FPD-S) and the 
confirmatory method RM-26D-2 (a high performance liquid chromatography 
method with ultraviolet detection (HPLC/UV) have been forwarded to FDA 
as enforcement methods for publication in the Pesticides Analytical 
Manual, Volume II (PAM II). Method RM-26B-2 has undergone a successful 
validation in an EPA laboratory. Method RM-26B-2 and Method RM-26B-3 (a 
modification of Method RM-26B-2) determine the combined residues of 
clethodim and its metabolites containing the 2-cyclohexen-1-one moiety 
determined as the dimethyl esters of clethodim sulfoxide and 5-OH 
clethodim sulfone (DME and DME-OH, respectively) and reported as 
clethodim equivalents.
    A modification of Method RM-26B-3 (GC/FPD-S) was used for 
quantitation of clethodim residues in/on blueberry, caneberry, peach 
and globe artichoke samples from the submitted field trials. The method 
is adequate for data collection based on validation data.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs)/tolerances established at this time for residues of clethodim in 
or on the commodities receiving tolerances in this document. However, 
Agriculture and Agri-Food Canada (AAFC) and IR-4 developed residue 
field trial data for blueberry jointly and submitted these data to the 
Pest Management Regulatory Agency (PMRA) and EPA. Both PMRA and EPA 
will be establishing MRLs for bushberry subgroup 13-07B at the same 
level.

C. Revisions to Petitioned-For Tolerances

    The globe artichoke tolerance is a reduction from the proposed 1.3 
ppm to 1.2 ppm based on the tolerance spreadsheet summary of clethodim 
field trial data under the Guidance for Setting Pesticide Tolerances 
Based on Field Trial Data SOP.
    The recommended bushberry subgroup 13-07B tolerance is a reduction 
from the proposed 3.0 ppm to 0.20 ppm. The 0.20 ppm recommended 
tolerance is based on the lowest level of method validation and 
excludes the lowbush blueberry data since the lowbush blueberry data 
were obtained by over-the-top foliar spray instead of

[[Page 26678]]

according to the proposed use of spray directed at the base of the 
plants and only one study was submitted on low-growing berries.
    The paragraph and table in (a)(2) is being removed because the 
tolerances in this section have expired.
    The tolerances for lettuce leaf and spinach are being removed in 
paragraph (a)(3) as they are covered by the leafy greens subgroup 4A.
    The tolerance for flax seed at 0.50 ppm is being removed in 
paragraph (a)(3) because there is one for flax seed at 0.6 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of clethodim, 
including its metabolites and degradates, in or on the raw agricultural 
commodities artichoke, globe at 1.2 ppm, bushberry subgroup 13-07B at 
0.20 ppm, caneberry subgroup 13-07A at 0.30 ppm and peach at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 4, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.458 is amended as follows:
0
i. Remove paragraph (a)(2);
0
ii. Redesignate paragraph (a)(3) as (a)(2);
0
iii. Alphabetically add the commodities to newly designated paragraph 
(a)(2);
0
iv. Redesignate paragraph (a)(4) as (a)(3);
0
v. Remove the existing tolerances on lettuce leaf, and spinach in newly 
designated paragraph (a)(2);
0
vi. Remove the tolerance for flax seed at 0.50 ppm in newly designated 
paragraph (a)(2).
    The amendments read as follows:


Sec.  180.458  Clethodim; tolerances for residues.

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

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Artichoke, globe.....................................                1.2
                                * * * * *
Bushberry subgroup 13-07B............................               0.20
Caneberry subgroup 13-07A............................               0.30
                                * * * * *
Peach................................................               0.20
                                * * * * *
------------------------------------------------------------------------

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* * * * *

[FR Doc. 2010-11301 Filed 5-11-10; 8:45 am]
BILLING CODE 6560-50-S