[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,
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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