[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Rules and Regulations]
[Pages 15748-15753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07651]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0651; FRL-9975-01]


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 multiple commodities which are identified and 
discussed later in this document. In addition, this regulation removes 
several previously established tolerances that are superseded by this 
final rule. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective April 12, 2018. Objections and 
requests for hearings must be received on or before June 11, 2018, 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-2016-0651, 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: Michael L. Goodis, 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].

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. 
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-2016-0651 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 
June 11, 2018. 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-2016-0651, 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/

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DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
     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 March 23, 2017 (82 FR 14846) (FRL-9957-
99), 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 
6E8510) 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-
propenyl]oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one, and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, 
calculated as the stoichiometric equivalent of clethodim, in or on 
almond, hulls at 0.2 parts per million (ppm); Brassica, leafy greens, 
subgroup 4-16B at 3.0 ppm; leaf petiole vegetable subgroup 22B at 0.60 
ppm; leafy greens subgroup 4-16A at 2.0 ppm; nut, tree, group 14-12 at 
0.2 ppm; okra at 1.5 ppm; onion, green, subgroup 3-07B at 2.0 ppm; 
stalk and stem vegetable subgroup 22A at 1.7 ppm; vegetable, Brassica, 
head and stem, group 5-16 at 3.0 ppm; and vegetable, fruiting, group 8-
10, except okra at 1.0 ppm. Upon establishment of proposed tolerances 
above, the Petitioner requests that 40 CFR part 180.458 be amended by 
removing existing tolerances for residues of clethodim in or on the raw 
agricultural commodities asparagus at 1.7 ppm; Brassica, head and stem, 
subgroup 5A at 3.0 ppm; Brassica, leafy greens, subgroup 5B at 3.0 ppm; 
leaf petioles subgroup 4B at 0.60 ppm; leafy greens subgroup 4A at 2.0 
ppm; onion, green at 2.0 ppm; turnip, greens at 3.0 ppm; and vegetable, 
fruiting, group 8-10 at 1.0 ppm that are superseded by this final rule. 
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. Comments were received on the notice of 
filing. EPA's responses to these comments are discussed in Unit IV.C.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is 
issuing tolerances that vary from what the petitioner sought. The 
reason for these changes is explained in Unit IV.D.

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 
children.
    The clethodim toxicity database shows relatively low toxicity with 
the liver being 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 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 and slight elevation of 
glucose levels (in dogs only) were also seen.
    No developmental effects were present in the rabbits. In the rat 
developmental toxicity study, reduced fetal body weights and an 
increase in the incidence of delayed ossification of the lower 
vertebrae were seen at the dose (350 mg/kg/day) where maternal toxicity 
(excessive salivation and lacrimation, red nasal discharge) was also 
observed. No reproductive or offspring effects were seen in the 2-
generation rat reproduction study. Therefore, the toxicity data showed 
no increased susceptibility in the young. The clethodim database also 
showed no potential for neurotoxicity or immunotoxicity.
    Results of rat and mouse carcinogenicity studies did not show 
treatment-related increases in tumor incidence. Therefore, clethodim is 
not shown to be 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 entitled, ``SUBJECT: Clethodim. Human 
Health Aggregate Risk Assessment for the Proposed New Uses on Tree Nut 
Group 14-12; Okra; Crop Group Conversions for Brassica Leafy Greens 
Subgroup 4-16B; Leafy Green Subgroup 4-16A; Leaf Petiole Vegetable 
Subgroup 22B; Stalk and Stem Vegetable Subgroup 22A; Vegetable, 
Brassica Head and Stem, Group 5-16; Expansion of Commodity Residue 
Tolerance to Green Onion Subgroup 3-07B and Response to 6(a)(2) Data 
Submission'' dated March 19, 2018 at 33-38 in docket ID number EPA-HQ-
OPP-2016-0651.

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

[[Page 15750]]

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 discussed in Unit III of the final rule 
published in the Federal Register of May 6, 2016 (81 FR 27339) (FRL-
9945-68).

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.
    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 levels for all commodities and 100 percent crop-
treated (PCT). DEEM version 7.81 default processing factors were 
assumed, except where tolerances were established for processed 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 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 levels for all commodities and 100 PCT. DEEM version 
7.81 default processing factors were assumed, except where tolerances 
were established for processed commodities.
    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 is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue 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.
    Surface and ground water contamination may occur from clethodim as 
well as its sulfoxide and sulfone degradates. Exposure from water 
contamination is primarily associated with clethodim sulfone and 
clethodim sulfoxide rather than parent clethodim based on greater 
persistence and mobility of these degradates. Thus, the exposure 
assessments were based on the total toxic residue rather than parent 
only.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of clethodim for acute exposures 
are estimated to be 330 parts per billion (ppb) for surface water and 
1,430 ppb for ground water. For chronic exposures for non-cancer 
assessments EDWCs 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-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). EPA assessed 
residential exposure using the following assumptions:
    In a reassessment of existing residential uses of clethodim 
conducted to reflect updates to EPA's 2012 Residential SOPs along with 
policy changes for body weight assumptions, the Agency assessed short-
term residential handler (adult only) inhalation exposure. There is 
potential residential dermal post-application exposure from the 
existing use of clethodim on ornamentals. However, since there is no 
adverse systemic hazard via the dermal route of exposure, and there is 
no incidental oral exposure expected from clethodim use on ornamental 
plants, a residential post-application assessment has not been 
conducted. 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

[[Page 15751]]

which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website 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 
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.
    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. The toxicity database for clethodim is complete and sufficient 
for selecting toxicity endpoints and PODs for assessing risks.
    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 that clethodim results in increased 
susceptibility of fetuses as compared to maternal animals following in 
utero and/or postnatal exposure to clethodim in the prenatal 
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.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were determined 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. The acute aggregate risk is equivalent to the acute 
dietary risk.
    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, at the 95th percentile of exposure for all 
infants (<1 year old), the population group receiving the greatest 
exposure.
    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 water will utilize 30% of the cPAD for all 
infants (<1 year old) the population group receiving the greatest 
exposure. 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.
    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 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 a short-term aggregate risk 
estimate for adults ages 20 to 49 is a MOE of 2,100. 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. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Intermediate-term exposure is not expected for the residential 
exposure pathway. Therefore, the intermediate-term aggregate exposure 
would be equivalent to the chronic dietary exposure estimate.
    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 analytical methods are available for enforcing clethodim 
tolerances in/on the proposed/registered plant commodities. Samples 
were analyzed for residues of clethodim and metabolites containing the 
2-cyclohexen-1-one moiety using the gas chromatography/mass 
spectroscopy (GC/MS) Method YARL-0602D, adapted from Method RM-26B-3 
entitled, ``The Determination of Clethodim Residues in Crops, Chicken 
and Beef Tissues, Milk and Eggs'' (revision dated January 20, 1994). 
The method converts residues of clethodim and metabolites to clethodim 
sulfoxide (CSO) and clethodim 5 hydroxy sulfoxide (5-OH 
CSO2), which are determined as their dimethyl esters (DME 
and DME-OH, respectively).

[[Page 15752]]

Method RM-26B-3 is the enforcement method for tolerances for clethodim 
including its metabolites and degradates.
    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.
    There are no Codex MRLs for clethodim and its metabolites in or on 
the crops associated with this action.

C. Response to Comments

    The Agency received four comments on the notice of filing (NOF) for 
this petition. While none of the commenters mentioned any specific 
concerns with the clethodim tolerances noticed in the NOF, two comments 
generally opposed the use of chemicals or pesticides in or food and two 
comments generally urged the Agency to ensure protection of the 
environment and human health by reviewing science and determining 
whether use of pesticide is safe for human consumption.
    The Agency recognizes that some individuals believe that certain 
pesticides are ``toxic chemicals'' that should not be permitted in our 
food; however, no new information demonstrating toxicity or exposure of 
clethodim that EPA could use to evaluate the safety of the pesticide 
was provided by commenters. The existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states 
that tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. When new or amended tolerances are 
requested for residues of a pesticide in food or feed, the Agency, as 
is required by section 408 of FFDCA, estimates the risk of the 
potential exposure to these residues. The Agency has conducted that 
risk assessment, which includes the consideration of long-term animal 
studies with clethodim, and concluded that there is a reasonable 
certainty that no harm will result from aggregate human exposure to 
clethodim and that, accordingly, the use of clethodim on petitioned-for 
food commodities is ``safe.''

D. Revisions to Petitioned-For Tolerances

    In accordance with its standard practice to provide greater 
precision about the levels of residues that are permitted by a 
tolerance, EPA is adding an additional significant figure to the 
petitioned-for tolerance values for Almond hulls and Nut, tree, group 
14-12. This is to avoid the situation where residues may be higher than 
the tolerance level, but as a result of rounding would be considered 
non-violative (for example, Almond tolerance proposed at 0.2 ppm was 
established at 0.20 ppm, to avoid an observed hypothetical tolerance at 
0.24 ppm being rounded to 0.2 ppm).

E. International Trade Considerations

    In this final rule, EPA is establishing a crop subgroup tolerance 
for subgroup 22A (stalk and stem vegetable) at 1.7 ppm. This subgroup 
includes the commodity kohlrabi, for which a tolerance is currently set 
at 3.0 ppm, as one of the commodities in the currently established 
tolerance for Brassica, head and stem subgroup 5A. Setting a new 
tolerance at 1.7 ppm on kohlrabi as part of subgroup 22A has a 
potentially trade restrictive effect on the import of kohlrabi. In the 
2016 crop grouping rule, kohlrabi was moved to the stalk and stem 
vegetable subgroup 22A. See 81 FR 26471 (May 3, 2016).
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to promptly 
publish this action with the WTO. In addition, EPA is allowing the 
existing kohlrabi tolerance to remain in effect for six months 
following publication of this rule in order to provide a six-month 
reasonable interval for producers in exporting countries to adapt the 
modified tolerances. Before that date, residues of clethodim in or on 
kohlrabi will be permitted at the current tolerance levels; after that 
date, residues will need to be in compliance with the new tolerance 
levels.
    The tolerance level is appropriate based on available data and 
residue levels resulting from registered use patterns. The tolerance 
levels are not discriminatory; the same food safety standard contained 
in the FFDCA applies equally to domestically produced and imported 
foods. None of the other tolerance actions taken in this rulemaking 
restrict permissible pesticide residues below currently allowed levels 
in the United States.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the expiration of the tolerance, 
shall be subject to FFDCA section 408(1)(5). Under this unit, any 
residues of these pesticides in or on such food shall not render the 
food adulterated so long as it is shown to the satisfaction of the Food 
and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA.
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-5-
[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites 
containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-
ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their 
sulphoxides and sulphones, calculated as the stoichiometric equivalent 
of clethodim, in or on Almond, hulls at 0.20 ppm; Brassica, Leafy, 
greens, subgroup 4-16B at 3.0 ppm; Leaf petiole vegetable subgroup 22B 
at 0.60 ppm; Leafy greens subgroup 4-16A at 2.0 ppm; Nut, tree, group 
14-12 at 0.20 ppm; Okra 1.5 ppm; Onion, green, subgroup 3-07B at 2.0 
ppm; Stalk and stem vegetable subgroup 22A at 1.7 ppm; Vegetable, 
Brassica, head and stem, group 5-16 at 3.0 ppm; and Vegetable, 
fruiting, group 8-10, except okra at 1.0 ppm. In addition, established 
tolerances in or on ``Asparagus''; ``Brassica, head and stem, subgroup 
5A''; ``Brassica, leafy greens, subgroup 5B''; ``Leaf petioles subgroup 
4B'';

[[Page 15753]]

``Leafy greens subgroup 4A''; ``Onion, green''; ``Turnip, greens''; and 
``Vegetable, fruiting, group 8-10'' are removed as they are superseded 
by this final tolerance rule. To minimize the potential for trade 
irritation, the Agency is allowing the existing tolerance for kohlrabi 
to remain in place for six months by adding an expiration date of six 
months following publication of this rule to each individual tolerance. 
Since kohlrabi is currently contained within the existing subgroup 5A 
tolerance, which is being removed by this action, the Agency is listing 
kohlrabi as a separate tolerance at 3.0 ppm to remain in effect for a 
six-month period.

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)); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). 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 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: March 19, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.458:
0
a. Remove the entries for ``Asparagus''; ``Brassica, head and stem, 
subgroup 5A''; ``Brassica, leafy greens, subgroup 5B''; ``Leaf petioles 
subgroup 4B''; ``Leafy greens subgroup 4A''; ``Onion, green''; 
``Turnip, greens''; and ``Vegetable, fruiting, group 8-10''; from the 
table in paragraph (a).
0
b. Add alphabetically the entries to the table in paragraph (a) 
``Almond, hulls''; ``Brassica, Leafy, greens, subgroup 4-16B''; 
``Kohlrabi''; ``Leaf petiole vegetable subgroup 22B''; ``Leafy greens 
subgroup 4-16A''; ``Nut, tree, group 14-12''; ``Okra''; ``Onion, green, 
subgroup 3-07B''; ``Stalk and stem vegetable subgroup 22A''; 
``Vegetable, Brassica, head and stem, group 5-16''; and ``Vegetable, 
fruiting, group 8-10, except okra''.
0
c. Add footnote 1 to the table in paragraph (a).
    The additions and revisions read as follows:


Sec.  180.458  Clethodim; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Almond, hulls...............................................        0.20
 
                                * * * * *
Brassica, leafy, greens, subgroup 4-16B.....................         3.0
 
                                * * * * *
Kohlrabi 1..................................................         3.0
Leaf petiole vegetable subgroup 22B.........................        0.60
Leafy greens subgroup 4-16A.................................         2.0
 
                                * * * * *
Nut, tree, group 14-12......................................        0.20
Okra........................................................         1.5
 
                                * * * * *
Onion, green, subgroup 3-07B................................         2.0
 
                                * * * * *
Stalk and stem vegetable subgroup 22A.......................         1.7
 
                                * * * * *
Vegetable, brassica, head and stem, group 5-16..............         3.0
Vegetable, fruiting, group 8-10, except okra................         1.0
 
                                * * * * *
------------------------------------------------------------------------
1 This tolerance expires on October 12, 2018.

* * * * *
[FR Doc. 2018-07651 Filed 4-11-18; 8:45 am]
BILLING CODE 6560-50-P


