[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
[Pages 18456-18461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07008]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0056; FRL-9907-62]


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. 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an existing tolerance on ``cabbage'' that is superseded by this action.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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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.

[[Page 18457]]

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 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of 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 
clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, 
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 
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 their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The 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 
developmental effects.
    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

[[Page 18458]]

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
----------------------------------------------------------------------------------------------------------------
                                     POD and
       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.
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½---------------------------------------------------------------------------------
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/
                                                                       females
                                                                      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
                                                                       parental
                                                                      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

[[Page 18459]]

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 
food commodities.
    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 
water.
    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 
residential exposure.
    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 
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, 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 
findings:
    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 
neurotoxicity.
    iii. For the reasons described above, there is low concern 
regarding increased susceptibility in the young from exposure to 
clomazone.
    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.

[[Page 18460]]

Therefore, clomazone is not expected to pose an acute risk to these 
groups.
    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 
years old.
    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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex MRLs for 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 
tolerance petition.
    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 
substances.

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, 
as follows:
    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''.

V. Conclusion

    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

[[Page 18461]]

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 
recordkeeping requirements.

    Dated: March 21, 2014.
Lois Rossi,
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. Section 180.425 is amended by removing the entry for ``Cabbage'' 
from the table in paragraph (a), and by alphabetically adding the 
following entries
    ``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 
as follows.


Sec.  180.425  Clomazone; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
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
 
                                * * * * *
Rhubarb.....................................................        0.30
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-07008 Filed 4-1-14; 8:45 am]
BILLING CODE 6560-50-P