Document ID: EPA-HQ-OPP-2011-0053-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Prothioconazole
Posted Date: 2011-10-05T04:00Z

[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61587-61592]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25704]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0053; FRL-8884-2]

Prothioconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
prothioconazole in or on multiple commodities which are identified and 
discussed later in this document. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 5, 2011. Objections and 
requests for hearings must be received on or before December 5, 2011, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0053. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Tawanda Maignan, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8050; e-mail address: maignan.tawanda@epa.gov.

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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0053 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 
December 5, 2011. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0053, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 29, 2011 (76 FR 17375) (FRL-8867-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs 
0F7714 and 0F7715) by Bayer CropScience, P.O. Box 12014, 2 T.W. 
Alexander Drive, Research Triangle Park, NC 27709. The petition 
requested that 40 CFR 180.626 be amended by establishing tolerances for 
residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-
3-(2-chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-
thione and its desthio metabolite, in or on the raw or processed 
agricultural commodity rice,

[[Page 61588]]

grain at 0.25 parts per million (ppm); rice, hulls at 1.0 ppm; alfalfa, 
forage and alfalfa, hay at 0.02 ppm and potato, tuber at 0.02 ppm (PP 
0F7714). In a separate petition (PP 0F7715) Bayer CropScience also 
proposed use of the currently established tolerances for residues of 
prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione and its desthio 
metabolite, in or on the raw agricultural commodities pea and bean, 
dried shelled, except soybean, subgroup 6C; soybean, forage; soybean, 
hay; soybean, seed; rice, seed to support the use of prothioconazole as 
a seed treatment on these crops. That notice referenced a summary of 
the petitions prepared by Bayer CropScience, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that it is appropriate to modify the existing grain crop 
groups rather than establish separate rice grain and rice straw 
tolerances. The rice grain tolerance will now be covered by the 
modified tolerance of 0.35 ppm for grain, cereal group 15, except sweet 
corn and sorghum. Likewise, the rice straw tolerance will now be 
covered by the modified tolerance of 5.0 ppm for grain, cereal, forage, 
fodder, and straw, group 16, except sorghum; straw. Also, the EPA is 
establishing a tolerance for rice hulls at 0.90 ppm, instead of the 
proposed tolerance of 1.0 ppm. 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 prothioconazole 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
prothioconazole 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.
    Prothioconazole has low acute toxicity by oral, dermal, and 
inhalation routes. It is not a dermal sensitizer, or a skin or eye 
irritant. Prothioconazole's metabolite, prothioconazole-desthio, also 
has low acute toxicity by oral, dermal, and inhalation routes. It is 
not a dermal sensitizer, or a skin irritant, but it is a slight eye 
irritant. The subchronic and chronic studies show that the target 
organs at the lowest observable adverse effects level (LOAEL) include 
the liver, kidney, urinary bladder, thyroid and blood. In addition, the 
chronic studies showed body weight and food consumption changes, and 
toxicity to the lymphatic and GI systems.
    Prothioconazole and its metabolites may be developmental toxicants, 
producing effects including malformations in the conceptus at levels 
equal to or below maternally toxic levels in some studies; particularly 
those studies conducted using prothioconazole-desthio. Reproduction 
studies in the rat with prothioconazole and prothioconazole-desthio 
suggest that these chemicals may not be reproductive toxicants. Acute 
and subchronic neurotoxicity studies were conducted in the rat using 
prothioconazole. A developmental neurotoxicity study was conducted in 
the rat using prothioconazole-desthio.
    The available data show that the prothioconazole-desthio metabolite 
produces toxicity at lower dose levels in subchronic, developmental, 
reproductive, and neurotoxicity studies as compared with 
prothioconazole and the two additional metabolites that were tested.
    The available carcinogenicity and/or chronic studies in the mouse 
and rat, using both prothioconazole and prothioconazole-desthio, show 
no increase in tumor incidence. Therefore, EPA has concluded that 
prothioconazole and its metabolites are not carcinogenic, and are 
classified as ``Not likely to be Carcinogenic to Humans'' according to 
the 2005 Cancer Guidelines.
    Specific information on the studies received and the nature of the 
adverse effects caused by prothioconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies 
are discussed in the final rule published in the Federal Register of 
May 28, 2010 (75 FR 29910) (FRL-8828-6).

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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for prothioconazole used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of May 28, 2010 (75 FR 29910) (FRL-
8828-6).

[[Page 61589]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prothioconazole and its metabolites and/or degradates, EPA 
considered exposure under the petitioned-for tolerances as well as all 
existing prothioconazole tolerances in 40 CFR 180.626. EPA assessed 
dietary exposures from prothioconazole 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA conducted a 
moderately refined acute dietary exposure assessment. Empirical 
processing factors, average field trial residues (since all of the 
plant commodities included in this assessment are blended food forms, 
except sweet corn), and livestock commodity residues derived from 
feeding studies and a reasonably balanced dietary burden (RBDB) were 
incorporated into the moderately refined acute assessment. The 
assessment also assumed 100 percent crop treated (PCT). Since no 
observed effects would be attributable to a single dose exposure for 
the general U.S. population (including infants and children), females 
13-49 years of age was the only population subgroup included in the 
acute assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA conducted a 
moderately refined chronic dietary exposure assessment. Empirical 
processing factors, average field trial residues, and livestock 
commodity residues derived from feeding studies and a reasonably 
balanced dietary burden (RBDB) were incorporated into the chronic 
assessment; 100 PCT was assumed.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or non-linear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used and a cancer RfD is 
calculated based on an earlier non-cancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized.
    Based on the data summarized in Unit III.A., EPA has concluded that 
prothioconazole is ``Not Likely to be Carcinogenic 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. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances. Average 
residues and 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for prothioconazole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of prothioconazole. 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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
prothioconazole for the acute dietary risk assessment, the estimated 
surface water concentration value of 94.7 parts per million (ppb) was 
used to assess the contribution to drinking water. For the chronic 
dietary risk assessment, the estimated surface water concentration 
value of 84.3 ppb was used to assess the contribution to drinking 
water. Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    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).
    Prothioconazole is not registered for any specific use patterns 
that would result in residential exposure.
    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.''
    Prothioconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same, sequence of 
major biochemical events. In conazoles, however, a variable pattern of 
toxicological responses is found. Some are hepatotoxic and 
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some 
induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles produce a diverse range of 
biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no evidence to 
indicate that conazoles share common mechanisms of toxicity and EPA is 
not following a cumulative risk approach based on a common mechanism of 
toxicity for the conazoles. For information regarding EPA's procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Prothioconazole is a triazole-derived pesticide. Triazole-derived 
pesticides can form the common metabolite, 1,2,4-triazole and three 
triazole conjugates (triazole alanine, triazole acetic acid, and 
triazolylpyruvic acid). To support existing tolerances and to establish 
new tolerances for triazole-derivative pesticides, including 
prothioconazole, EPA conducted a human health risk

[[Page 61590]]

assessment for exposure to 1,2,4-triazole, triazole alanine, and 
triazole acetic acid resulting from the use of all current and pending 
uses of any triazole-derived fungicide. The risk assessment is a highly 
conservative, screening-level evaluation in terms of hazards associated 
with common metabolites (e.g., use of a maximum combination of 
uncertainty factors) and potential dietary and non-dietary exposures 
(i.e., high end estimates of both dietary and non-dietary exposures). 
In addition, the Agency retained the additional 10X FQPA safety factor 
(SF) for the protection of infants and children. The assessment 
included evaluations of risks for various subgroups, including those 
comprised of infants and children. The Agency's risk assessment can be 
found in the propiconazole reregistration docket at http://www.regulations.gov, docket ID number EPA-HQ-OPP- 2005-0497 and an 
update to assess the addition of the commodities included in this 
action may be found in docket ID number EPA-HQ-OPP-2010-0621 in the 
document titled ``Common Triazole Metabolites: Updated Aggregate Human 
Health Risk Assessment to Address Tolerance Petitions for 
Metconazole.''

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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is evidence of 
increased susceptibility following prenatal/or postnatal exposure in:
    i. Rat developmental toxicity studies with prothioconazole as well 
as its prothioconazole-desthio and sulfonic acid K salt metabolites.
    ii. Rabbit developmental toxicity studies with prothioconazole-
desthio.
    iii. A rat developmental neurotoxicity study with prothioconazole-
desthio; and
    iv. Multi-generation reproduction studies in the rat with 
prothioconazole-desthio. Effects include skeletal structural 
abnormalities, such as cleft palate, deviated snout, malocclusion, 
extra ribs, and developmental delays. Available data also show that the 
skeletal effects such as extra ribs are not completely reversible after 
birth in the rat, but persist as development continues.
    Although increased susceptibility was seen in these studies, the 
Agency concluded that there is a low concern and no residual 
uncertainties for prenatal and/or postnatal toxicity effects of 
prothioconazole because:
     Developmental toxicity NOAELs and LOAELs from prenatal 
exposure are well characterized after oral and dermal exposure;
     The off-spring toxicity NOAELs and LOAELs from postnatal 
exposures are well characterized; and
     The NOAEL for the fetal effect malformed vertebral body 
and ribs is used for assessing acute risk of females 13 years and older 
and, because it is lower than the NOAELs in other developmental 
studies, is protective of all potential 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 prothioconazole is complete, including 
required functional immunotoxicity testing. The EPA began requiring 
functional immunotoxicity testing of all food and non-food use 
pesticides on December 26, 2007.
    ii. There is an acceptable battery of neurotoxicity studies 
including a developmental neurotoxicity study. Although offspring 
neurotoxicity was found, characterized by peripheral nerve lesions in 
the developmental neurotoxicity studies on prothioconazole-desthio, the 
increase was seen only in the highest dose group at 105 mg/kg/day, was 
not considered treatment related, and a clear NOAEL was established for 
this study.
    iii. Although increased susceptibility was seen in the 
developmental and reproduction studies, the Agency concluded that there 
is a low concern and no residual uncertainties for prenatal and/or 
postnatal toxicity effects of prothioconazole for the reasons explained 
in Unit III.D.2.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessment is moderately refined 
utilizing empirical processing factors, 100 PCT, average crop field 
trial residue levels, and livestock maximum residues. Results from 
ruminant feeding studies and poultry metabolism studies were used to 
determine the maximum residue levels for livestock commodities. The 
crop field trials were performed using maximum application rates and 
minimum pre-harvest intervals. Although the Agency is requiring 
extended confirmatory storage stability data; interim storage stability 
data do not indicate that residue concentrations decline and therefore 
the assessment should not underestimate risk from dietary exposure. EPA 
made conservative (protective) assumptions in the ground water and 
surface water modeling used to assess exposure to prothioconazole in 
drinking water. These assessments will not underestimate the exposure 
and risks posed by prothioconazole.

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.
    Based on the proposed and existing crop uses for prothioconazole, 
dietary aggregate exposures (i.e., food plus drinking water) are 
anticipated. There are no residential uses for prothioconazole and, 
therefore, no residential exposures are anticipated. Consequently, only 
dietary (food plus drinking water) exposures were aggregated for this 
assessment.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and 
drinking water to prothioconazole will occupy 24% of the aPAD for 
females 13-49 years of age, the only population group at risk for acute 
effects.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
prothioconazole from food and drinking water will utilize 21% of the 
cPAD for the general U.S. population and 62% of the cPAD for all 
infants <1 year old, the population group receiving the greatest 
exposure.
    3. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies,

[[Page 61591]]

prothioconazole is not expected to pose a cancer risk to humans.
    4. 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 prothioconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromatography methods with tandem mass 
spectrometry detection (LC/MS/MS) are available to enforce the 
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

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 U.N. 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 established MRLs for residues of desthio-
prothioconazole in barley at 0.2 ppm; oats, rye, and wheat at 0.05 ppm 
each; in the fodder (dry) of cereal grains at 5 ppm; and in the straw 
(dry) of cereal grains at 4 ppm. There are currently no established 
Mexican MRLs for prothioconazole. Canadian MRLs have been established 
for prothioconazole per se in/on several commodities, including barley 
(0.35 ppm), wheat (0.07 ppm). Harmonization of the proposed tolerances 
with the existing Codex for prothioconazole is not possible at this 
time because of differences in tolerance expression and use patterns. 
The MRL expression for Codex is prothioconazole-desthio and is thus not 
compatible with the U.S. tolerance definition, the sum of 
prothiocoanzole and prothioconazole-desthio. EPA generally includes the 
parent in all residue definitions for tolerance enforcement, whereas 
Codex routinely excludes the parent if it is shown to be a small part 
of the actual total residue. Prothioconazole is a minor component of 
the total residue on the crops tested. Much of the Codex cereal grain 
supervised field trial data are from Europe, where the use pattern is 
different resulting in lower measured residues.
    The tolerance definition for plant commodities in Canada was 
recently changed and is now harmonized with the U.S. residue 
definition. The barley tolerance of Canada agrees with the U.S. 
tolerance for cereal grains (except sweet corn, sorghum, and rice) of 
0.35 ppm. However, the Canada tolerance for wheat is lower (0.07 ppm) 
than the existing U.S. group tolerance. EPA establishes crop group 
tolerances, as opposed to individual commodity tolerances, whenever 
there are adequate data for the representative commodities of that 
group and proposed use. There must be an acceptable range of residues 
over all the representative commodities. Wheat falls under this crop 
group practice in this case. Canada does not routinely establish animal 
feed commodity tolerances, and therefore there are no harmonization 
issues with forage, stover, hay, and straw.

C. Revisions to Petitioned-For Tolerances

    The proposed rice grain tolerance level of 0.25 ppm is lower than 
the existing tolerance level (0.35 ppm) for grain, cereal group 15, 
except rice and sweet corn and sorghum. The existing cereal grain group 
15 tolerance excludes rice, but the present evaluation of rice field 
trial data allows expansion of that group to include rice. Therefore, 
in this action, EPA is revising the existing cereal group to read 
grain, cereal group 15 (except sweet corn and sorghum). Likewise, the 
rice straw tolerance level is lower than the existing tolerance level 
(5.0 ppm) for grain, cereal, forage, fodder, and straw, group 16, 
except sorghum and rice straw, and therefore this crop group is being 
revised to include rice straw. Also, the submitted data support a 
tolerance of 0.90 ppm for rice hulls as determined from the rice to 
hull processing factor (from the rice processing study) applied to the 
highest average field trial residue, or 4.4 x 0.19 ppm, or 0.9 ppm 
instead of the proposed tolerance of 1.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of 
prothioconazole (2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion) and its 
metabolite prothioconazole-desthio ([alpha]-(1-chlorocyclopropyl)-
[alpha]-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol), in or on 
alfalfa, forage at 0.02 ppm; alfalfa, hay at 0.02 ppm, potato at 0.02 
ppm and rice, hulls at 0.90 ppm. The existing tolerance for Grain, 
cereal, group 15, except sweet corn, sorghum, and rice is changed to 
Grain, cereal, group 15, except sweet corn and sorghum and the existing 
tolerance for Grain, cereal, forage, fodder and straw, group 16, except 
sorghum and rice; straw is changed to Grain, cereal, forage, fodder and 
straw, group 16, except sorghum, straw.
    Further, seed treatment uses on soybean, dried shelled pea and bean 
(except soybean) subgroup 6C and rice are covered by existing and 
currently established tolerances for these commodities.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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

[[Page 61592]]

relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 
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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: September 26, 2011.
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 180.626 is amended by revising the table in paragraph (a)(1) 
to read as follows:

Sec.  180.626  Prothioconazole; tolerances for residues.

    (a) * * * (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................         0.02
Alfalfa, hay...............................................         0.02
Beet, sugar, roots.........................................         0.25
Corn, sweet kernel plus cob with husks removed.............         0.04
Grain, aspirated grain fractions...........................        11
Grain, cereal, forage, fodder and straw, group 16, except           8.0
 sorghum, and rice; forage.................................
Grain, cereal, forage, fodder and straw, group 16, except           7.0
 sorghum, and rice; hay....................................
Grain, cereal, forage, fodder and straw, group 16, except          10
 sorghum, and rice; stover.................................
Grain, cereal, forage, fodder and straw, group 16, except           5.0
 sorghum, straw............................................
Grain, cereal, group 15, except sweet corn and sorghum.....         0.35
Pea and bean, dried shelled, except soybean, subgroup 6C...         0.9
Peanut.....................................................         0.02
Potato.....................................................         0.02
Rapeseed, seed.............................................         0.15
Rice, hulls................................................         0.90
Soybean, forage............................................         4.5
Soybean, hay...............................................        17
Soybean, seed..............................................         0.15
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-25704 Filed 10-4-11; 8:45 am]
BILLING CODE 6560-50-P