Document ID: EPA-HQ-OPP-2017-0372-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Clomazone
Posted Date: 2018-12-06T05:00Z

[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Rules and Regulations]
[Pages 62724-62730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26345]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0372; FRL-9985-83]

Clomazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
clomazone in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project No. 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 6, 2018. Objections and 
requests for hearings must be received on or before February 4, 2019, 
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-2017-0372, 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 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

[[Page 62725]]

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.
    To access the OCSPP test guidelines referenced in this document 
electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select ``Test 
Methods and Guidelines.''

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-2017-0372 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 
February 4, 2019. 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-2017-0372, 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 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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 
7E8581) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.425 be amended by establishing tolerances for 
residues of the herbicide clomazone, 2-[(2-chlorophenyl)methyl]-4,4-
dimethyl-3-isoxazolidinone, in or on Bean, dry at 0.05 parts per 
million (ppm); Bean, succulent at 0.05 ppm; Broccoli, Chinese at 0.10 
ppm; Cilantro, dried leaves at 0.3 ppm; Cilantro, fresh leaves at 0.05 
ppm; Coriander, seed at 0.05 ppm; Cottonseed subgroup 20C at 0.05 ppm; 
Dill, dried leaves at 0.4 ppm; Dill, fresh leaves at 0.08 ppm; Dill, 
oil at 0.06 ppm; Dill, seed at 0.05 ppm; Kohlrabi at 0.10 ppm; Rapeseed 
subgroup 20A at 0.05 ppm; Stalk and stem vegetable subgroup 22A, except 
kohlrabi at 0.05 ppm; Vegetable, brassica, head and stem, group 5-16 at 
0.10 ppm; and Vegetable, cucurbit, group 9 at 0.1 ppm.
    The petitioner also proposed to remove the following established 
tolerances Asparagus at 0.05 ppm; Bean, snap, succulent at 0.05 ppm; 
Brassica, head and stem, subgroup 5A at 0.10 ppm; Cotton, undelinted 
seed at 0.05 ppm; Cucumber at 0.1 ppm; Pea, southern, dry seed at 0.05 
ppm; Pea, southern, succulent seed at 0.05 ppm; Pumpkin at 0.1 ppm; 
Squash, summer at 0.1 ppm; Squash, winter at 0.1 ppm; Sweet potato, 
roots at 0.05 ppm; Vegetable, cucurbit, group 9 at 0.05 ppm. That 
document referenced a summary of the petition prepared by FMC 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. EPA received one comment the notice of filing. 
EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from the levels requested. The 
reasons for these changes are 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 clomazone including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with clomazone follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The primary target of clomazone is the liver, with hepatocellular 
cytomegaly and increased liver weight noted in the sub-chronic rat 
study. There were no effects up to the limit dose in the chronic dog 
study. The 28-day dermal toxicity study in rats showed no effects up to 
the limit dose.

[[Page 62726]]

There was no quantitative or qualitative evidence of susceptibility in 
the developmental toxicity study in rabbits or in the 2-generation 
reproduction toxicity study in rats. In the developmental toxicity 
study in rabbits, no developmental effects were seen at the highest 
dose tested where maternal effects, including mortality, abortions, 
decreased body weight gain and decreased defecation or no feces, 
occurred. In the 2-generation reproduction study, decreased body weight 
was seen at the same dose in both parents and offspring. Qualitative 
susceptibility was observed in the developmental toxicity study in 
rats. Developmental effects, including delayed ossification in the form 
of either partial ossification or the absence of the manubrium 
sternebrae 3-4, xiphoid, caudal vertebrae and metacarpals, occurred at 
the same dose as maternal effects, which included chromorhinorrhea and 
abdominogenital staining. The concern is low since there are clear 
NOAELs and LOAELs in this study and the study was used for risk 
assessment, and, therefore, is protective of the developmental effects. 
Using a weight of evidence approach, the Agency concluded that the 
acute and sub-chronic neurotoxicity studies, mouse carcinogenicity 
study, inhalation study, and immunotoxicity study are not required at 
this time. There are no dermal absorption studies available for 
clomazone. An acceptable dermal toxicity study is available to assess 
hazard through the dermal route therefore, a dermal absorption study is 
not required at this time.
    In the rat and mouse carcinogenicity studies, there was no evidence 
of carcinogenicity. The mouse carcinogenicity study was classified as 
unacceptable/guideline since no systemic toxicity was observed at the 
highest dose tested, however, the study was considered adequate to 
assess the carcinogenicity in mice. The Agency has determined that an 
additional mouse carcinogenicity study is not needed. This finding is 
based upon the following conclusions: (1) The rat is more sensitive 
than the mouse for the chronic assessment; (2) the consistent effect in 
rats (decreased body weight and increased liver weight) has been used 
as the point of departure for the chronic assessment; (3) a new mouse 
study would only use doses well above the current POD for the chronic 
assessment; and (4) even if a new mouse study identified positive 
carcinogenicity effects, that finding would not result in the adoption 
of a quantitative linear assessment of cancer risk due to the negative 
carcinogenicity finding in the rat study and the lack of a positive 
finding for genotoxicity. Clomazone is classified as ``Not Likely to be 
Carcinogenic to Humans''. Quantification of cancer risk is not 
required.
    Clomazone has low acute toxicity (Category III and IV) via the 
oral, dermal and inhalation routes. It is non-irritating to the eyes 
and mildly irritating to the skin. It is not a dermal sensitizer. 
Clomazone is absorbed, metabolized (16 metabolites identified) and 
rapidly excreted in urine and feces in rats following oral 
administration. Most of the administered dose (48-85%) is eliminated 
within 24 hours, mostly in urine. The quantities of metabolites varied 
with dose regimen, sex and route of administration, but were the same 
qualitatively in urine and feces. The total recovery after 48 hours was 
91-100%.
    Specific information on the studies received and the nature of the 
adverse effects caused by clomazone 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 Clomazone: Human Health Risk Assessment 
for Proposed (1) New Uses on Cilantro, Dill, and Rapeseed Subgroup 20A; 
(2) Tolerance Revisions of Cucurbit Vegetable Group 9; (3) Tolerance 
Expansions of Representative Commodities to (i) Cottonseed Subgroup 
20C, (ii) Stalk and Stem Vegetable Subgroup 22A, except Kohlrabi, (iii) 
Dry Bean, and (iv) Succulent Bean; and (4) Tolerance Conversions from 
Crop Subgroup 5A (Head and Stem Brassica) to Crop Group 5-16 (Brassica, 
Head and Stem Vegetable), Chinese Broccoli and Kohlrabi at page 35 in 
docket ID number EPA-HQ-OPP-2017-0372.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for clomazone used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of November 10, 2016 (Vol. 81 FR 
78914) (FRL-9953-88).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to clomazone, EPA considered exposure under the petitioned-for 
tolerances as well as all existing clomazone tolerances in 40 CFR 
180.425. EPA assessed dietary exposures from clomazone 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 clomazone. 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) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA incorporated tolerance level residues, 
assumed 100% crop treated, and used DEEM default processing factors.
    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 USDA's NHANES/WWEIA. As to residue 
levels in food, EPA incorporated tolerance level residues, assumed 100% 
crop treated, and used DEEM default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has

[[Page 62727]]

concluded that clomazone 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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for clomazone. Tolerance level residues and/or 100% 
CT 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 clomazone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of clomazone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Food Quality Protection Act (FQPA) Index Reservoir 
Screening Tool (FIRST), Tier 1 Rice Model and Pesticide Root Zone Model 
Ground Water (PRZM GW), the estimated drinking water concentrations 
(EDWCs) of clomazone and its degradate, FMC 65317 (N-[(2-
chlorophenyl)methyl]-3-hydroxy-2,2-dimenthylpropanamide), for acute 
exposures are estimated to be 550 parts per billion (ppb) for surface 
water and 85.7 ppb for ground water.
    The EDWCs of clomazone plus FMC 65317 for chronic exposures for 
non-cancer assessments are estimated to be 550 ppb for surface water 
and 77.4 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 550 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 550 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). Clomazone is not 
registered for any specific use patterns that would result in 
residential exposure. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at https://www.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 clomazone 
to share a common mechanism of toxicity with any other substances, and 
clomazone does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that clomazone does not have a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
https://www.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 was no evidence of 
increased quantitative or qualitative susceptibility in the prenatal 
developmental toxicity study in rabbits or in the reproductive toxicity 
study in rats with clomazone. In the developmental toxicity study in 
rats, delayed ossification occurred at doses that produced maternal 
effects (chromorhinorrhea and abdominogenital staining). Although 
qualitative susceptibility was observed in the developmental toxicity 
study in rats, the concern is low since there are clear NOAELs and 
LOAELs and the PODs selected for risk assessment are protective of the 
qualitative susceptibility.
    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 clomazone is complete.
    ii. There is no indication that clomazone 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 clomazone results in increased 
quantitative susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to clomazone in drinking water. These assessments 
will not underestimate the exposure and risks posed by clomazone.

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. Using the exposure assumptions discussed in this 
unit for acute exposure analysis, the risk estimate for acute dietary 
exposure from food and water to clomazone is at 3.0% of the aPAD for 
females 13-49 years old, the only population group for which an acute 
dietary endpoint was selected. The acute dietary risk for females 13-49 
years old is not of concern (<100% of aPAD).
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure analysis, EPA has concluded that the risk 
estimates for chronic exposure to clomazone from food and water are not 
of concern (<100% of cPAD) with a risk estimate at 3.6% of the cPAD for 
all infants less

[[Page 62728]]

than 1 year of age, 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). Currently, 
there are no registered or proposed residential uses for clomazone, 
therefore, a short-term aggregate risk is the same as the chronic risk, 
which does not exceed the Agency's level 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). Currently, there are no registered or proposed residential uses 
for clomazone, therefore, an intermediate-term aggregate risk is the 
same as the chronic risk, which does not exceed the Agency's level of 
concern..
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, clomazone 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 clomazone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, gas chromatography (GC) using a 
nitrogen phosphorus detector (NPD) or mass spectrometer (MS), is 
available. A confirmatory procedure (GC/MS-SIM: Gas Chromatography/Mass 
Spectroscopy-Selected Ion Monitoring) is also available (Method I, PAM 
[Pesticide Analytical Manual] II) to enforce the tolerance expression. 
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 not established any MRLs for clomazone.

C. Response to Comments

    One comment was received on the Notice of Filing expressing concern 
about the effects of wind turbines on bats. The comment did not raise 
any issue related to the Agency's safety determination for clomazone 
tolerances. The receipt of this comment is acknowledged; however, this 
comment is not relevant to this action.

D. Revisions to Petitioned-For Tolerances

    For dill oil, the Agency is establishing a tolerance at 0.07 ppm 
rather than 0.06 ppm due to rounding based on the available data. 
Although the petitioner requested a tolerance for vegetable, cucurbit, 
group 9 at 0.1 ppm, the Agency is maintaining the established tolerance 
of 0.05 ppm for cucurbit vegetable group 9 and setting an expiration 
date for the existing tolerances on the individual commodities of 
cucumber, summer squash, winter squash and pumpkin at 0.1 ppm. 
Available residue data demonstrates that the 0.05 ppm tolerance value 
is sufficient to cover residues on the commodities in this group so 
there is no need to maintain the separate higher tolerances. Moreover, 
setting these tolerances at 0.05 ppm would harmonize tolerance values 
with Canada. In addition, the Agency is adding significant figures to 
the tolerances requested for cilantro, dried leaves and dill, dried 
leaves to conform to Agency practice.
    The petitioner requested tolerances on ``bean, dry'' and ``bean, 
succulent''. Although those terms are defined in 40 CFR 180.1(g), the 
Agency is establishing individual tolerances for each of the dry and 
succulent forms of the beans contained in that definition to more 
accurately reflect the commodities as distributed in interstate 
commerce: asparagus bean, chickpea, kidney bean, mung bean, navy bean, 
pinto bean, grain lupin, sweet lupin, white lupin, and white sweet 
lupin come in the dry bean form only; snap bean and wax bean come in 
succulent form only; and broad bean, lima bean, and southern pea come 
in both the dry and succulent forms. Tolerances for snap bean 
(succulent) and southern pea (dry and succulent) are already 
established and are being maintained.

E. International Trade Considerations

    In this Final Rule, EPA is reducing the existing tolerances for the 
commodities of cucumber, pumpkin, and summer and winter squash from 0.1 
ppm to 0.05 ppm as part of vegetable, cucurbit, group 9. The Agency is 
reducing these tolerances to harmonize with Canadian tolerances on 
cucurbit vegetables and available residue data demonstrates that 
tolerances at 0.05 ppm are sufficient to cover residues on these 
commodities.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of this revision in order to satisfy its obligation. In addition, 
the SPS Agreement requires that Members provide a ``reasonable 
interval'' between the publication of a regulation subject to the 
Agreement and its entry into force to allow time for producers in 
exporting Member countries to adapt to the new requirement. At this 
time, EPA is establishing an expiration date for the existing 
tolerances to allow those tolerances to remain in effect for a period 
of six months after the effective date of this final rule, in order to 
address this requirement. After the six-month period expires, residues 
of clomazone on cucumber, pumpkin, and summer and winter squash cannot 
exceed the vegetable, cucurbit, group 9 tolerance of 0.05 ppm.
    This reduction in tolerance levels is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. The new tolerance levels are 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of clomazone, 2-
[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on Bean, 
asparagus, dry seed at 0.05 parts per million (ppm); Bean, broad, dry 
seed at 0.05 ppm; Bean, broad, succulent seed at 0.05 ppm; Bean, 
kidney, dry seed at 0.05 ppm; Bean, lima, dry seed at 0.05 ppm; Bean, 
lima, succulent seed at 0.05 ppm; Bean, mung, dry seed at 0.05 ppm; 
Bean, navy, dry seed at 0.05 ppm; Bean, pinto, dry seed at 0.05 ppm; 
Bean, wax, succulent seed at 0.05 ppm; Broccoli,

[[Page 62729]]

Chinese at 0.10 ppm; Chickpea, dry seed at 0.05 ppm; Cilantro, dried 
leaves at 0.30 ppm; Cilantro, fresh leaves at 0.05 ppm; Coriander, seed 
at 0.05 ppm; Cottonseed subgroup 20C at 0.05 ppm; Dill, dried leaves at 
0.40 ppm; Dill, fresh leaves at 0.08 ppm; Dill, oil at 0.07 ppm; Dill, 
seed at 0.05 ppm; Grain, lupin, dry seed at 0.05 ppm; Kohlrabi at 0.10 
ppm; Rapeseed subgroup 20A at 0.05 ppm; Stalk and stem vegetable 
subgroup 22A, except kohlrabi at 0.05 ppm; Sweet, lupin, dry seed at 
0.05 ppm; Vegetable, Brassica, head and stem, group 5-16 at 0.10 ppm; 
White lupin, dry seed at 0.05 ppm; and White sweet lupin, dry seed at 
0.05 ppm. Upon the establishment of the tolerances referenced above, 
the following tolerances for residues of the herbicide clomazone, 2-
[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone in or on the 
raw agricultural commodities should be removed: Asparagus at 0.05 parts 
per million (ppm); Brassica, head and stem, subgroup 5A at 0.10 ppm; 
Cotton, undelinted seed at 0.05 ppm; and Sweet potato, roots at 0.05 
ppm. In addition, EPA is imposing an expiration date on the tolerances 
for Cucumber at 0.1 ppm; Pumpkin at 0.1 ppm; Squash, summer at 0.1 ppm; 
and Squash, winter at 0.1 ppm, so that they will expire six months 
after the publication of this rule.

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), nor is it considered a 
regulatory action under 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: November 14, 2018.
Donna S. Davis,
Acting 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.  180.425, amend the table in paragraph (a) by:
0
a. Removing the commodities: ``Asparagus''; ``Brassica, head and stem, 
subgroup 5A''; ``Cotton, undelinted seed''; and ``Sweet potato, 
roots''.
0
b. Adding alphabetically the commodities: ``Bean, asparagus, dry seed'' 
at 0.05 ppm; ``Bean, broad, dry seed'' at 0.05 ppm; ``Bean, broad, 
succulent seed'' at 0.05 ppm; ``Bean, kidney, dry seed'' at 0.05 ppm; 
``Bean, lima, dry seed'' at 0.05 ppm; ``Bean, lima, succulent seed'' at 
0.05 ppm; ``Bean, mung, dry seed'' at 0.05 ppm; ``Bean, navy, dry 
seed'' at 0.05 ppm; ``Bean, pinto, dry seed'' at 0.05 ppm; ``Bean, wax, 
succulent seed'' at 0.05 ppm; ``Broccoli, Chinese'' at 0.10 ppm; 
``Chickpea, dry seed'' at 0.05 ppm; ``Cilantro, dried leaves'' at 0.30 
ppm; ``Cilantro, fresh leaves'' at 0.05 ppm; ``Coriander, seed'' at 
0.05 ppm; ``Cottonseed subgroup 20C'' at 0.05 ppm; ``Dill, dried 
leaves'' at 0.40 ppm; ``Dill, fresh leaves'' at 0.08 ppm; ``Dill, oil'' 
at 0.07 ppm; ``Dill, seed'' at 0.05 ppm; ``Grain, lupin, dry seed'' at 
0.05 ppm; ``Kohlrabi'' at 0.10 ppm; ``Rapeseed subgroup 20A'' at 0.05 
ppm; ``Stalk and stem vegetable subgroup 22A, except kohlrabi'' at 0.05 
ppm; ``Sweet, lupin, dry seed'' at 0.05 ppm; ``Vegetable, Brassica, 
head and stem, group 5-16'' at 0.10 ppm; ``White lupin, dry seed'' at 
0.05 ppm; and ``White sweet lupin, dry seed'' at 0.05 ppm.
0
c. Revise the entries for ``Cucumber''; ``Pumpkin''; ``Squash, 
summer''; and ``Squash, winter'' by adding a footnote.
    The additions and revisions read as follows:

Sec.  180.425  Clomazone; tolerances for residues.

    (a) * * *

[[Page 62730]]

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Bean, asparagus, dry seed...............................            0.05
Bean, broad, dry seed...................................            0.05
Bean, broad, succulent seed.............................            0.05
Bean, kidney, dry seed..................................            0.05
Bean, lima, dry seed....................................            0.05
Bean, lima, succulent seed..............................            0.05
Bean, mung, dry seed....................................            0.05
Bean, navy, dry seed....................................            0.05
Bean, pinto, dry seed...................................            0.05
 
                              * * * * * * *
Bean, wax, succulent seed...............................            0.05
Broccoli, Chinese.......................................            0.10
Chickpea, dry seed......................................            0.05
Cilantro, dried leaves..................................            0.30
Cilantro, fresh leaves..................................            0.05
Coriander, seed.........................................            0.05
Cottonseed subgroup 20C.................................            0.05
 
                              * * * * * * *
Cucumber *..............................................             0.1
Dill, dried leaves......................................            0.40
Dill, fresh leaves......................................            0.08
Dill, oil...............................................            0.07
Dill, seed..............................................            0.05
Grain lupin, dry seed...................................            0.05
Kohlrabi................................................            0.10
 
                              * * * * * * *
Pumpkin *...............................................             0.1
Rapeseed subgroup 20A...................................            0.05
 
                              * * * * * * *
Squash, summer *........................................             0.1
Squash, winter *........................................             0.1
Stalk and stem vegetable subgroup 22A, except kohlrabi..            0.05
 
                              * * * * * * *
Sweet lupin, dry seed...................................            0.05
Vegetable, Brassica, head and stem, group 5-16..........            0.10
 
                              * * * * * * *
White lupin, dry seed...................................            0.05
White sweet lupin, dry seed.............................            0.05
------------------------------------------------------------------------
* This tolerance expires on June 5, 2019.

* * * * *
[FR Doc. 2018-26345 Filed 12-4-18; 8:45 am]
 BILLING CODE 6560-50-P