[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several previously established tolerances that are superseded by this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).
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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