[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Rules and Regulations]
[Pages 27337-27342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10738]



40 CFR Part 180

[EPA-HQ-OPP-2015-0035; FRL-9945-68]

Clethodim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
clethodim in or on multiple commodities which are identified and 
discussed later in this document. 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 6, 2016. Objections and 
requests for hearings must be received on or before July 5, 2016, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0035, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].


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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2015-0035 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 5, 2016. 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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0035, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of Wednesday, May 20, 2015 (80 FR 28925) 
(FRL-9927-39), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 4E8334) by Interregional Research Project Number 4 (IR-4), 
500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.458 be amended by establishing tolerances for 
residues of the herbicide clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-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, 
calculated as the stoichiometric equivalent of clethodim, in or on 
stevia at 12 parts per million (ppm); pome fruit group 11-10 at 0.2 
ppm; stone fruit group 12-12 at 0.2 ppm; bulb onion subgroup 3-07A at 
0.2 ppm; low growing berry subgroup 13-07G, except cranberry at 3.0 
ppm; rapeseed subgroup 20A, except flax 0.5 ppm;

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sunflower subgroup 20B at 5.0 ppm; cottonseed subgroup 20C at 1.0 ppm; 
and fruiting vegetable group 08-10 at 1.0 ppm. Also, this notice 
further requests amending 40 CFR 180.458 by removing the following 
commodity listings: canola seed at 0.5 ppm, cotton, undelinted seed at 
1.0 ppm, peach at 0.2 ppm, onion, bulb at 0.2 ppm, strawberry at 3.0 
ppm, and sunflower, seed at 5.0 ppm, upon establishment of the 
aforementioned tolerances. That document referenced a summary of the 
petition prepared by Valent USA 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 made 
some modifications to petitioned-for crop tolerances. The reasons for 
these changes are 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA 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 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 their 
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 
    The liver is the target organ based on repeated dosing by either 
oral or dermal routes in rats, mice, and dogs. The observed liver 
effects are characterized by increased liver weights, clinical 
chemistry changes, and centrilobular hepatic hypertrophy. Most of the 
liver effects that occurred at or below 100 milligrams/kilogram body 
weight (mg/kg bw) were considered as adaptive effects and not adverse. 
Decreased body weight was also a common finding across studies and 
species. In the 1-year dog oral toxicity study, hematological changes 
such as increased platelet and leukocyte counts were also noted.
    Developmental effects were not present in rabbits; the rat 
developmental toxicity study showed reduced fetal body weights and an 
increase in the incidence of delayed ossification of the lower 
vertebrae at the same dose where maternal toxicity was found. Neither 
reproductive nor offspring effects were seen in the 2-generation rat 
reproduction study. Therefore, the data did not show an increased 
susceptibility in the young. The clethodim database also showed no 
potential for neurotoxicity or immunotoxicity.
    The rat and mouse carcinogenicity studies did not show treatment-
related increases in tumor incidence. Clethodim is not genotoxic and is 
classified as ``not likely to be carcinogenic to humans.''
    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 in document'', Clethodim. Human Health Aggregate 
Risk Assessment for the Proposed New Uses on Stevia, Pome Fruit Group 
11-10, Stone Fruit Group 12-12, Bulb Onion Subgroup 3-07A, Low Growing 
Berry Subgroup 13-07G, (except Cranberry); Rapeseed Subgroup 20A 
(except Flax Seed), Sunflower Subgroup 20B, Cottonseed Subgroup 20C, 
and Fruiting Vegetable Group 8-10, pages number 29 through 34 in docket 
ID number EPA-HQ-OPP-2015-0035.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for clethodim used for 
human risk assessment is shown in Table 1 of this unit.

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   Table 1--Summary of Toxicological Doses and Endpoints for Clethodim for Use in Human Health Risk Assessment
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
Acute dietary (All populations)..  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity studies--rats.
                                    day.                  day.                LOAEL = 1,000 mg/kg based on
                                   UFA = 10x...........  aPAD = 1 mg/kg/day.   clinical observation from two
                                   UFH = 10x...........                        acute neurotoxicity studies (one
                                   FQPA SF = 1x........                        study was conducted in 2006 and
                                                                               another was completed in 2012).
                                                                               The clinical observation included
                                                                               decreased spontaneous activity,
                                                                               ruffled fur, head tilt, and
                                                                               hunched posture.
Chronic dietary (All populations)  NOAEL = 30 mg/kg/day  Chronic RfD = 0.3    Carcinogenicity study--mice.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 150 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.3 mg/kg/     reduced survival; decreased red
                                   FQPA SF = 1x........   day.                 cell mass; and increased
                                                                               incidences of bile duct
                                                                               hyperplasia, of pigmentation of
                                                                               the liver, and of foci of
                                                                               amphophilic macrophages in the
Incidental Oral Short-Term (1-30   NOAEL = 75 mg/kg/day  LOC for MOE = 100..  90-day oral toxicity--dogs.
 days).                            UFA = 10X...........                       LOAEL = 125 mg/kg/day based on
                                   UFH = 10X...........                        increased absolute and relative
                                   FQPA SF = 1X........                        liver weights, and histological
                                                                               changes characterized by
                                                                               cytoplasmic vesiculation and
                                                                               vacuolation of the central
                                                                               lobular hepatocytes in both
Inhalation Short-Term (1 to 30     NOAEL = 75 mg/kg/day  LOC for MOE = 100..  90-day oral toxicity--dogs
 days).                            UFA = 10X...........                       LOAEL = 125 mg/kg/day based on
                                   UFH = 10X...........                        increased absolute and relative
                                   FQPA SF = 1X........                        liver weights, and histological
                                                                               changes characterized by
                                                                               cytoplasmic vesiculation and
                                                                               vacuolation of the central
                                                                               lobular hepatocytes in both
Cancer (Oral, dermal, inhalation)      Clethodim is classified as ``Not Likely'' to be carcinogenic based no
                                           treatment-related increase in tumor incidence in rat and mouse
                                                              carcinogenicity studies.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

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 
    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.
    Such effects were identified for clethodim. In estimating acute 
dietary exposure, EPA used the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID), Version 
3.16, which incorporates 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA conducted unrefined acute dietary analyses 
assuming tolerance-level residues for all commodities and 100 percent 
crop treated (PCT). Unless tolerances were established for processed 
commodities, DEEM version 7.81 default processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, Version 3.16, which incorporates 
2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to 
residue levels in food, EPA conducted unrefined chronic dietary 
analyses assuming tolerance-level residues for all commodities and 100 
PCT. Unless tolerances were established for processed commodities, DEEM 
version 7.81 default processing factors were assumed.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that clethodim does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for clethodim. Tolerance-level residues and 100 PCT 
were assumed for all food commodities.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated 
drinking water concentrations (EDWCs) of clethodim for acute exposures 
are 330 parts per billion (ppb) for surface water and 1,430 ppb for 
ground water.
    For chronic exposures for non-cancer assessments are estimated to 
be 137 ppb for surface water and 1,150 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
1,430 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 1,150 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-

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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 the following uses that could 
result in residential exposures: In and around ornamental plant beds, 
landscaped area, trees, and ground covers (mulch). There are no 
residential uses associated with proposed new uses. EPA has previously 
assessed clethodim residential exposure using the following 
assumptions: Short-term residential handler inhalation exposures 
represent the ``worst case'' high-end exposure. Because a dermal hazard 
was not identified, residential handler and post-application dermal 
risk assessments were not conducted. No other post-application 
exposures were assessed either because the potential for exposure via 
non-dietary ingestion for young children is unlikely due to the limited 
residential uses for clethodim products. The extent to which young 
children engage in the types of activities associated with these areas 
(i.e., ornamental landscapes) or utilize these areas for prolonged 
periods of play is low. No intermediate-term or chronic exposures are 
expected from the currently registered residential uses.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 Web site at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 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 
    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 
    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 
    i. The toxicity database for clethodim is complete.
    ii. There is no indication that clethodim is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. 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. In the rat 
developmental study, reduced ossification seen at the same dose that 
resulted in maternal toxicity is considered secondary to reduced 
maternal body weight, and is not considered qualitative susceptibility. 
There are no residual uncertainties concerning prenatal and postnatal 
toxicity and no neurotoxicity concerns.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to clethodim in drinking water. Post application 
exposure of children and incidental oral exposures to toddlers are 
expected to be negligible. All exposure estimates are based on 
conservative assumptions that will not underestimate the exposure and 
risks posed by clethodim.

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. Acute exposure is not expected for the residential 
exposure pathway. Therefore, the acute aggregate risk would be 
equivalent to the acute dietary exposure estimates.
    Using the exposure assumptions discussed in this unit for acute 
exposure, the acute dietary exposure from food and water to clethodim 
will occupy 29% of the aPAD for all infants <1 year old, the population 
group receiving the greatest exposure.
    2. Chronic risk. There are no chronic residential exposure 
scenarios. Therefore, the chronic aggregate risk would be equivalent to 
the chronic dietary exposure (food and drinking water) estimate. Using 
the exposure assumptions described in this unit for chronic exposure, 
EPA has concluded that chronic exposure to clethodim from food and 
water will utilize 30% of the cPAD for all infants <1 year old, the 
population group receiving the greatest exposure.
    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). Clethodim is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to

[[Page 27341]]

clethodim. Using the exposure assumptions described in this unit for 
short-term exposures, EPA has concluded the combined short-term food, 
water, and residential exposures result in the short-term aggregate 
risk estimate for adults ages 20-49 is a MOE of 2,200. Because EPA's 
level of concern for clethodim is a MOE of 100 or below, this MOE is 
not of concern.
    4. Intermediate-term risk. 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 enforcement methodologies are available: FDA Multiresidue 
Methods, gas chromatography/flame photometric detection in the sulfur 
mode (GC/FPD-S) and gas chromatography method with mass selective 
detection (GC/MSD).
    These methods have been adequately validated for the analyses of 
residues of clethodim in/on crop matrices.
    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; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for clethodim in or on onion bulb 
and garlic at 0.5 ppm, tomato at 1 ppm, rapeseed at 0.5 ppm, sunflower 
seed at 0.5 ppm, and cotton seed at 0.5 ppm. The U.S. tolerances for 
rapeseed subgroup 20A, fruiting vegetables crop group 8-10, and onion, 
bulb, subgroup 3-07A are harmonized with the Codex MRLs for rapeseed, 
tomato, and bulb onion and garlic, respectively.
    However, the U.S. tolerances for sunflower subgroup 20B and 
cottonseed subgroup 20C are not harmonized with the corresponding Codex 
MRLs for sunflower seed and cotton seed since the MRL values are lower 
than the U.S tolerances. The U.S. tolerances cannot be lowered to 
harmonize because doing so could result in residues above the 
tolerances when following the U.S. approved label directions.

C. Revisions to Petitioned-for Tolerances

    The Agency made changes to the naming of certain petitioned-for 
commodities to reflect the current commodity definitions and 
significant figures used by the Agency. Although the petitioner 
requested a tolerance on stevia only, EPA established a tolerance on 
stevia, dried leaves because the dried commodity represents stevia that 
will be found in the U.S. trade market. Moreover, the Agency is 
removing certain commodities from the table at Sec.  180.458(a) in 
order to eliminate redundancies upon the establishment of new crop 
group tolerances that were not identified in the petition: mustard, 
seed at 0.5 ppm, safflower, seed at 5.0 ppm, sesame, seed at 0.35 ppm, 
vegetable, fruiting group 8 at 1.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of clethodim, 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, calculated as the stoichiometric equivalent 
of clethodim, in or on berry, low growing, subgroup 13-07G, except 
cranberry at 3.0 ppm; cottonseed subgroup 20C at 1.0 ppm; fruit, pome, 
group 11-10 at 0.20 ppm; fruit, stone, group 12-12 at 0.20 ppm; onion, 
bulb, subgroup 3-07A at 0.50 ppm; rapeseed subgroup 20A, except flax 
seed at 0.50 ppm; stevia, dried leaves at 12 ppm; sunflower subgroup 
20B at 5.0 ppm; and vegetable, fruiting, group 8-10 at 1.0 ppm. EPA is 
also removing the following established tolerances that are superseded 
by this action: Canola seed, at 0.50 ppm; cotton, undelinted seed at 
1.0 ppm; mustard, seed at 0.50 ppm; peach at 0.20 ppm; onion, bulb at 
0.20 ppm; strawberry at 3.0 ppm; safflower, seed at 5.0 ppm; sesame, 
seed at 0.35 ppm; sunflower, seed at 5.0 ppm; vegetable, fruiting group 
8 at 1.0 ppm. Finally, as a housekeeping measure, the Agency is 
removing two individual tolerances that are subsumed within other crop 
group tolerances contained in Sec.  180.458: Bean, dry, seed at 2.5 ppm 
is covered by the entry for vegetable, legume, group 6, except soybean 
at 3.5 ppm and potato at 0.5 ppm is covered by the entry for vegetable, 
tuberous and corm, subgroup 1C at 1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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

[[Page 27342]]

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 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.
    This action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: April 28, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.458, in the table in paragraph (a):
a. Remove the entry for ``Bean, dry, seed;''
b. Add alphabetically an entry for ``Berry, low growing, subgroup 13-
07G, except cranberry;''
c. Remove the entry for ``Canola seed;''
d. Add alphabetically an entry for ``Cottonseed subgroup 20C;''
e. Remove the entry for ``Cotton, undelinted seed;''
f. Add alphabetically entries for ``Fruit, pome, group 11-10'' and 
``Fruit, stone, group 12-12;''
g. Remove the entries for ``Mustard, seed'' and ``Onion, bulb;''
h. Add alphabetically an entry for ``Onion, bulb, subgroup 3-07A;''
i. Remove the entries for ``Peach'' and ``Potato;''
j. Add alphabetically an entry for ``Rapeseed subgroup 20A, except flax 
k. Remove the entries for ``Safflower, seed,'' ``Sesame, seed,'' and 
l. Add alphabetically an entry for ``Stevia, dried leaves;''
m. Remove the entries for ``Sunflower, seed,'' and ``Vegetable, 
fruiting group 8;'' and
n. Add alphabetically the entries for ``Sunflower subgroup 20B'' and 
``Vegetable, fruiting, group 8-10.''
    The additions read as follows:

Sec.  180.458  Clethodim; tolerance for residues.

    (a) * * *

                                                              Parts  per
                          Commodity                             million
                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry.......         3.0
                                * * * * *
Cottonseed subgroup 20C.....................................         1.0
                                * * * * *
Fruit, pome, group 11-10....................................        0.20
Fruit, stone, group 12-12...................................        0.20
                                * * * * *
Onion, bulb, subgroup 3-07A.................................        0.50
                                * * * * *
Rapeseed subgroup 20A, except flax seed.....................        0.50
                                * * * * *
Stevia, dried leaves........................................          12
                                * * * * *
Sunflower subgroup 20B......................................         5.0
                                * * * * *
Vegetable, fruiting, group 8-10.............................         1.0
                                * * * * *

* * * * *
[FR Doc. 2016-10738 Filed 5-5-16; 8:45 am]