[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Rules and Regulations]
[Pages 62724-62730]
[FR Doc No: 2018-26345]

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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.

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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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; 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.
    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.

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

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

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:<PHONE_NUMBER>; 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,

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) * * *

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


[Federal Register Volume 77, Number 122 (Monday, June 25, 2012)]
[Notices]
[Page 37911]
[FR Doc No: 2012-15393]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Oncologic Drugs Advisory Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Oncologic Drugs Advisory Committee.
This meeting was announced in the Federal Register of May 31, 2012 (77
FR 32125-32126). The amendment is being made to reflect a change in the
Date and Time, and Procedure portions of the document. The Date and
Time of the meeting will change to July 24, 2012, from 8 a.m. to 6 p.m.
The Procedure portion of the document has changed to reflect an updated
public participation time of 10:30 a.m. to 11 a.m., and 4:30 p.m. to 5
p.m. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Caleb Briggs, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting.

SUPPLEMENTARY INFORMATION:  In the Federal Register of May 31, 2012,
FDA announced that a meeting of the Oncologic Drugs Advisory Committee
would be held on July 24, 2012. On page 32125, in the third column, the
Date and Time portion of the document is changed to read as follows:
    Date and Time: The meeting will be held on July 24, 2012 from 8
a.m. to 6 p.m.
    On page 32126, in the first column, the third sentence in the
Procedure portion of the document is changed to read as follows:
    Procedure: Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 4:30 p.m. to 5 p.m.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: June 20, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-15393 Filed 6-22-12; 8:45 am]
BILLING CODE 4160-01-P