[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07008]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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. In addition, this regulation removes
an existing tolerance on ``cabbage'' that is superseded by this action.
The 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 2, 2014. Objections and
requests for hearings must be received on or before June 2, 2014, 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-2013-0056, 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), EPA West 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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
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-2013-0056 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 2, 2014. 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-2013-0056, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of Wednesday, February 27, 2013 (78 FR
13295) (FRL-9380-2), 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 2E8136) by the Interregional Research Project Number 4,
IR-4 Project Headquarters, 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
in or on Brassica, head and stem, subgroup 5A at 0.1 parts per million
(ppm), pea, southern, dry seed at 0.05 ppm, pea, southern, succulent
seed at 0.05 ppm, pea, southern, hay at 0.05 ppm, and rhubarb at 0.3
ppm. In addition, the petitioner proposes based upon the establishment
of new tolerances above, removal of the existing cabbage tolerance at
0.1 ppm under 40 CFR 180.425 that is superseded by this action. That
document referenced a summary of the petition prepared by FMC
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to the comment is discussed in Unit IV.C.
Based upon review of data supporting the petition, EPA has removed
and/or established clomazone residue tolerances for certain
commodities. The reason(s) for these changes are explained in Unit
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 their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
The primary target of clomazone is the liver, with hepatocellular
cytomegaly noted in the chronic rat and mouse studies (chronic mouse
study deemed unacceptable due to maximum tolerated dose (MTD) not
achieved), hepatocellular necrosis in the chronic mouse study, and
increased liver weight observed in subchronic and chronic studies. No
neurotoxicity studies with clomazone are available; however, based on a
weight of the evidence approach, the EPA has concluded that a
neurotoxicity battery is not required for clomazone. This approach
considered all of the available hazard and exposure information
including: (1) There is no evidence of clinical signs of neurotoxicity
or neuropathology in adult animals in subchronic and chronic studies;
(2) the liver is the target organ for clomazone, not the neurological
system; (3) clomazone is absorbed and rapidly excreted in rats with 97%
of the radioactivity excreted within 168 hours; and (4) the point of
departure (POD) and endpoint for chronic dietary risk assessment is
based on liver effects in rats which appear to be the most sensitive
endpoint. There is 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 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 no-observed-adverse-effect-levels (NOAELs) and lowest-
observed-adverse-effect-levels (LOAELs) in the study and this study was
used for risk assessment, and therefore, is protective of the
There is no concern for mutagenicity. In the rat carcinogenicity
study, there was no evidence of carcinogenicity. The mouse
carcinogenicity study was inadequate to determine carcinogenic activity
due to the lack of adverse effects at the highest dose tested. Despite
the inadequacy of the mouse carcinogenicity study, EPA has determined
that an additional mouse carcinogenicity study is not needed and that
the rat chronic/carcinogenicity study will be adequate for assessing
chronic risk, including cancer. 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.
Specific information on the studies received and the nature of the
adverse effects caused by clomazone as well as
the NOAEL and the LOAEL from the toxicity studies can be found at
http://www.regulations.gov in document,'' Clomazone: Human Health Risk
Assessment for New Uses in/on Brassica, Head and Stem, Subgroup 5A;
Rhubarb; and Pea, Southern (IR-4 Petition 2E8136)'', dated December 19,
2013, pg. 31 in docket ID number EPA-HQ-OPP-2013-0056.
B. Toxicological Points of Departure/Levels of Concern (LOC)
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological POD and LOC to use in evaluating the risk
posed by human exposure to the pesticide. For hazards that have a
threshold below which there is no appreciable risk, the toxicological
POD is used as the basis for derivation of reference values for risk
assessment. PODs are developed based on a careful analysis of the doses
in each toxicological study to determine the dose at which no adverse
effects are observed (the NOAEL) and the lowest dose at which adverse
effects of concern are identified (the LOAEL). Uncertainty/safety
factors are used in conjunction with the POD to calculate a safe
exposure level--generally referred to as a population-adjusted dose
(PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE).
For non-threshold risks, the Agency assumes that any amount of exposure
will lead to some degree of risk. Thus, the Agency estimates risk in
terms of the probability of an occurrence of the adverse effect
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for clomazone used for
human risk assessment is shown in the following Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Clomazone for Use in Human Health Risk Assessment
Exposure/scenario uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
Acute dietary (general An endpoint was not selected for the general population because no adverse
population including infants effect in adult animals was identified that resulted from a single exposure. A
and children). risk assessment is not required for this population subgroup.
Acute dietary (females 13-49 NOAEL = 100 mg/kg/ Acute Developmental toxicity study--rat,
years of age). day. RfD = 1.0 mg/kg/ developmental
UFA = 10x........ day. LOAEL = 300 mg/kg/day, based on
UFH = 10x........ aPAD = 1.0 mg/kg/ indications of delayed ossification in
FQPA SF = 1x..... day. the form of either partial ossification
or the absence of the manubrium,
sternebrae 3-4, xiphoid, caudal
vertebrae, and meta-carpals.
Chronic dietary (all NOAEL = 84.4 mg/ Chronic RfD = 2-year chronic toxicity study--rats,
populations). kg/day (highest 0.84 mg/kg/day. NOAEL = 84.4/112.9 mg/kg/day, males/
dose tested). cPAD = 0.84 mg/kg/ females (highest dose tested),
UFA = 10x........ day. LOAEL was not attained co-critical 90-day
UFH = 10x........ oral rat study
FQPA SF = 1x..... NOAEL = 135.2/160.9 mg/kg/day, males/
LOAEL = 273/319.3 mg/kg/day, males/
females, based on decreased body weight,
body weight gains, food consumption and
increased absolute and relative liver
weights in females and increased absolute
liver weights in males. Co-critical 2-
generation reproduction toxicity study
NOAEL = 50 mg/kg/day parental
LOAEL = 100 mg/kg/day based on
statistically significantly decreased
body weight & body weight gain during pre-
mating, and decreased body weight during
gestation & lactation M & F. In addition,
decreased food consumption in females and
hydronephritic kidneys in males.
Cancer (oral, dermal, The chronic endpoint is protective against any effects resulting from long-term
inhalation). exposure to clomazone.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). Point of Departure (POD) = A data point or an estimated point
that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine
risk associated with lower environmentally relevant human exposures.
C. Exposure Assessment
i. Dietary exposure from food and feed uses. In conducting the
acute dietary exposure assessment EPA used the Dietary Exposure
Evaluation Model--Food Consumption Intake Database (DEEM-FCID, ver.
3.16), which incorporates consumption information from the United
States 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 incorporated tolerance level residues
for proposed and registered crops, assumed 100 percent crop treated
(PCT) and used default processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID, ver. 3.16 which incorporates
consumption information from the USDA NHANES/WWEIA; 2003-2008. As to
residue levels in food, EPA conducted an unrefined assessment that
assumed 100 PCT, used DEEM default processing factors, and tolerance-
level residues for all existing and proposed uses.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that the chronic PAD for clomazone will be protective of any
cancer risk posed by the pesticide. Additionally, EPA is relying on the
chronic dietary exposure assessment to evaluate cancer risk.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
clomazone. Tolerance level residues and 100 PCT were assumed for all
1. 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 http://www.epa.gov/oppefed1/models/water/index.htm.
The Agency generated the surface water estimated drinking water
concentrations (EDWCs) based on the Food Quality Protection Act (FQPA)
Index Reservoir Screening Tool (FIRST) and the Tier 1 Rice Model.
Screening Concentration in Ground Water (SCI-GROW) and Pesticide Root
Zone Model Ground Water (PRZM GW) models were used for ground water
EDWCs of clomazone. EDWCs were derived based on the maximum registered/
proposed use rate (1.5 pound active ingredient per acre (lb ai/A)
existing for tuberous and corm vegetables and proposed for rhubarb) and
the maximum registered use rate on rice (dry-seeded 0.8 lb ai/A). The
Tier 1 Rice model (dry-seeded scenario) produced the highest EDWCs for
both acute and chronic exposure.
The EDWCs of clomazone for acute exposures are estimated to be 550
parts per billion (ppb) for surface water and 85.7 ppb for ground
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 both acute and chronic
dietary risk assessment, the water concentration value of 550 ppb was
used to assess the contribution to drinking water. These drinking water
estimates account for parent plus FMC65317 (N-[(2-chlorophenyl)methyl]-
3-hydroxy-2,2-dimenthylpropanamide) which are the residues of concern
in drinking water.
2. 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
3. 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 Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
2. Prenatal and postnatal sensitivity. There 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, effects in the fetuses (delayed ossification) occurred at doses
that produced maternal effects (chromorhinorrhea and abdominogenital
staining) but were qualitatively more severe. Although qualitative
susceptibility was observed in the developmental toxicity study in
rats, the concern is low since there are clear NOAELs and LOAELs in
this study and the NOAEL in the study was used as the POD for
assessment of acute risk. EPA's assessment of acute risk is therefore
protective of any developmental effects.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
i. The toxicity database for clomazone is complete.
ii. Though there are no acute or subchronic neurotoxicity studies
available for clomazone, there is no indication that clomazone is a
neurotoxic chemical based on results of available subchronic, chronic,
reproductive or developmental toxicity studies and no evidence of
immunotoxicity. EPA concluded, based upon its assessment of available
data, that acute and subchronic neurotoxicity studies are not required
nor an additional uncertainty factor (UFs) needed to account for
iii. For the reasons described above, there is low concern
regarding increased susceptibility in the young from exposure to
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to clomazone in drinking water. There are no
existing or pending residential uses. Therefore, these assessments will
not underestimate the exposure and risk 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). 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. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected for the
general population including infants and children.
Therefore, clomazone is not expected to pose an acute risk to these
An acute endpoint was identified for females 13-49 years old due to
effects observed in fetuses. Using the exposure assumptions discussed
in this unit for acute exposure, the acute dietary exposure from food
and water to clomazone will occupy 3.0% of the aPAD for females 13-49
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clomazone from food and water will utilize 3.6% of the cPAD for all
Infants < 1 year of age, the population group receiving the greatest
exposure. There are no residential uses currently registered or
proposed for clomazone, and thus no chronic exposures from residential
use of clomazone.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposures take into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Clomazone is
not registered for any use patterns that would result in short-term or
intermediate-term residential exposures. Because there is no short-term
or intermediate-term residential exposure and chronic dietary exposure
has already been assessed under the appropriately protective cPAD
(which is at least as protective as the POD used to assess short-term
risk), no further assessment of short-term or intermediate-term risk is
necessary. EPA relies on the chronic dietary risk assessment for
evaluating short-term and intermediate-term risk for clomazone.
Therefore, short-term and intermediate-term aggregate risk assessments
are not required.
4. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., EPA has concluded that the cPAD is
protective of any cancer risk clomazone poses to humans. As noted
above, chronic dietary exposure is 3.6% of the cPAD for the highest
exposed population subgroup.
5. 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 to enforce the tolerance expression. Samples are acid
hydrolyzed, hexane extracted, Na2CO3 washed, and
cleaned-up with a Florisil column. The resulting samples are analyzed.
The limit of quantitation (LOQ) for this method is 0.05 ppm. A
confirmatory procedure (GC/MS-SIM) is available (Method I, PAM II).
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:
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 residues of clomazone.
C. Response to Comments
One comment was received from ``American Citizen'' indicating
concerns over what he/she believes to be unacceptable toxic effects to
human health, plants, and the environment if EPA approves the proposed
new uses of clomazone. The commenter indicated a general opposition to
the use of pesticides. The commenter also cited toxic effects shown in
clomazone toxicity studies and the alleged irrelevance of chronic
animal studies to chronic human exposure as grounds for denying the
EPA's response: The Agency has received similar categorical
objections to the establishment of pesticide tolerances from several
commenters on numerous previous occasions. Refer to Federal Register 70
FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), 69 FR 63096
(October 29, 2004) for the Agency's response to these types of
comments. EPA disagrees with the commenter's assertion that a pesticide
can cause toxic effects at high doses in animal studies necessarily
means that a pesticide tolerance is unsafe. A determination on the
safety of a tolerance must not only consider potential toxic effects of
the pesticide but anticipated pesticide exposure levels as well. EPA's
risk assessment did just that in finding 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. EPA also
disagrees with the assertion that chronic animal studies are not
relevant to assessing human risk. Chronic animal studies have been
relied upon by national and international health agencies for over 50
years in evaluating risks to humans from exposure to chemical
D. Revisions to Petitioned-For Tolerances
After reviewing supporting data and information, EPA modified
certain elements of the petition as proposed in the notice of filing,
1. EPA corrected the proposed commodity definition, ``Brassica,
stem and head subgroup 5A'' to read ``Brassica, head and stem, subgroup
5A'' for consistency in naming of commodities, and
2. In place of the proposed tolerance for ``pea, southern, hay'',
EPA is establishing tolerances for ``cowpea, forage'', and ``cowpea,
hay'' because pea, southern, hay is a very minor feed, where as
``cowpea'' is a type of ``pea, southern''.
Therefore, tolerances are established for residues of clomazone, 2-
[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on
Brassica, head and stem, subgroup 5A at 0.10 ppm; cowpea, forage at
0.05 ppm; cowpea, hay at 0.05 ppm; pea, southern, dry seed at 0.5 ppm;
pea, southern, succulent seed at 0.05 ppm; and rhubarb at 0.30 ppm.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children From Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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
Dated: March 21, 2014.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.425 is amended by removing the entry for ``Cabbage''
from the table in paragraph (a), and by alphabetically adding the
``Brassica, head and stem, subgroup 5A'', ``Cowpea, forage'',
``Cowpea, hay'', ``Pea, southern, dry seed'', ``Pea, southern,
succulent seed'', and ``Rhubarb'' to the table in paragraph (a) to read
Sec. 180.425 Clomazone; tolerances for residues.
(a) General. * * *
* * * * *
Brassica, head and stem, subgroup 5A........................ 0.10
* * * * *
Cowpea, forage.............................................. 0.05
Cowpea, hay................................................. 0.05
* * * * *
Pea, southern, dry seed..................................... 0.05
Pea, southern, succulent seed............................... 0.05
* * * * *
* * * * *
* * * * *
[FR Doc. 2014-07008 Filed 4-1-14; 8:45 am]
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