[Federal Register: March 19, 2008 (Volume 73, Number 54)]
[Rules and Regulations]
[Page 14714-14719]
[DOCID:fr19mr08-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0178; FRL-8353-2]

Prothioconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
of prothioconzole and prothioconazole-desthio, calculated as parent, in
or on soybean, forage; soybean, seed; soybean, hay; and sugar beet,
roots. Bayer CropScience requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 19, 2008. Objections and
requests for hearings must be received on or before May 19, 2008, 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-2007-0178. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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: Bryant Crowe, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
    Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
    Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0178 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before May 19, 2008.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0178, 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'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<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), and in the Federal Register of July 12, 2006 (71 FR 39313) (FRL-
8074-9), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (6F7134
and 6F7073, respectively) by Bayer CropScience, P.O. Box 12014, 2 T.W.
Alexander Dr., Research Triangle. These petitions requested that 40 CFR
180.626 be amended by establishing a tolerance for combined 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 prothioconazole-desthio, in or onsoybean, forage at 5 parts per
million (ppm); soybean, seed at 0.15 ppm; soybean, hay at 22 ppm; and
sugar beet, roots at 0.25 ppm and sugar beet, tops at 9 ppm. Those
notices referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filings.

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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    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 the petitioned-
for tolerance for combined residues of prothioconazole, and
prothioconazole-desthio, calculated as parent, in or on soybean, forage
at 4.5 ppm; soybean, seed at 0.15 ppm; soybean, hay at 17 ppm; sugar
beet, roots at 0.25 ppm. Sugar beet, tops do not need a tolerance
because they are not a human food commodity. EPA's assessment of
exposures and risks associated with establishing the tolerance 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-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. Subchronic studies show that
the target organs at the LOAEL include the liver, kidney, urinary
bladder, thyroid and blood. Significant clinical chemistry findings
were also made. NOAEL/LOAEL values across the family of chemicals
(i.e., prothioconazole, and prothioconazole-desthio and prothioconazole
sulfonic acid potassium salt metabolites) in the toxicity database
indicate that prothioconazole-desthio is a most toxic chemical. In
addition to the target organs and effects observed in the subchronic
studies (i.e., liver, kidney, urinary bladder, thyroid, hematology and
clinical chemistry), chronic toxicity at the LOAEL also included body
weight and food consumption changes, and toxicity to the lymphatic and
GI systems. The relative potency of prothioconazole-desthio was greater
than prothioconazole.
    Studies in the rat and mouse, using both prothioconazole and
prothioconazole-desthio, showed no evidence of carcinogenicity. The
data show that dosing was adequate, except in the rat cancer study
using prothioconazole, where the dosing was considered too high.
    The data indicate that prothioconazole and the three metabolites
evaluated (i.e., prothioconazole-desthio, prothioconazole sulfonic acid
potassium salt, and prothioconazole-deschloro) variously produce pre-
natal developmental effects at levels equal to or below maternally
toxic levels. Prothioconazole-desthio is the most toxic orally and
dermally, with LOAELs significantly below that of the other chemicals.
The rabbit is the more sensitive species. Lastly, prothioconazole-
desthio is a developmental neurotoxicant, producing changes in brain
morphometrics and increases in the occurrence of peripheral nerve
lesions in the neonate. A NOAEL was not determined, since these
observations were looked for only at the high dose level. Reproduction
studies in the rat, conducted using prothioconazole and
prothioconazole-desthio, suggested that these chemicals may not be
primary reproductive toxicants. Reproductive and offspring toxicities
were observed only in the presence of parental toxicity. Indeed, the
parental LOAELs are lower. The data show that prothioconazole-desthio
is more toxic by an order of magnitude. The nature of parental toxicity
is similar to what was observed in the subchronic studies, such as body
weight and food consumption changes, liver effects, etc. Reproductive
effects included decreases in reproductive indices such as those that
indicate pup survival and growth. Offspring toxicity was manifested by
decreased pup weights and malformations such as cleft palate.
    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 lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov. The referenced document is available in the docket
established by this action, which is described under ADDRESSES, and is
identified as ``Prothioconazole: Human Health Risk Assessment for
Proposed Uses on Soybeans and Sugarbeets'' in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/oppfead1/trac/science;http://www.epa.gov/pesticides/
factsheets/riskassess.htm; and http://www.epa.gov/pesticides/trac/
science/aggregate.pdf.
    A summary of the toxicological endpoints for prothioconazole used
for human risk assessment can be found at http://www.regulations.gov in
the document ``Prothioconazole: Human Health Risk Assessment for
Proposed Uses on Soybeans and Sugarbeets'' at page 24 in docket ID
number EPA-HQ-OPP-2007-0178.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to prothioconazole, 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 residues 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 U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA relied

upon average residues and 100% percent crop treated (PCT) information.
    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 relied upon
anticipated residues, and 100% percent crop treated (PCT) information
for all commodities.
    iii. Cancer. The available toxicology studies in the mouse and rat
showed no increase in tumor incidence, and therefore the Agency has
concluded that neither prothioconazole, nor its metabolites are
carcinogenic. Thus classified, by the Agency, as ``Not Likely to be
Carcinogenic to Humans'' according to the 2005 Cancer Guidelines.
Consequently, a quantitative dietary cancer assessment was not
performed.
    iv. Anticipated residue 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 pursuant to FFDCA section 408(f)(1) require
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 this
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for prothioconazole in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate 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 acute exposures are estimated to be 29 parts per
billion (ppb) for surface water and 0.67 ppb for ground water. The
EDWCs for chronic exposures are estimated to be 13 ppb for surface
water and 0.67 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 29 ppb was used to assess
the contribution from drinking water. For chronic dietary risk
assessment, the water concentration of value 13 ppb was used to assess
the contribution from drinking water. EPA used the EDWCs from surface
water only in assessing the risk from prothioconazole because the EDWCs
from groundwater are minimal in comparison to surface water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Prothioconazole is not registered for use on any sites 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 (EPA, 2002). 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 website at http://www.epa.gov/pesticides/
cumulative.
    Prothioconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite, 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including prothioconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazolylalanine, and triazolylacetic 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 for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, Docket
Identification (ID) Number EPA-HQ-OPP-2005-0497.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold 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. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional FQPA safety factor value based on the use of
traditional UFs and/or special FQPA safety factors, as appropriate.

    2. Prenatal and postnatal sensitivity. Available evidence from rat
developmental toxicity studies with prothioconazole (oral) and its
desthio (oral and dermal) and sulfonic acid K salt (oral) metabolites,
rabbit developmental with desthio metabolite (oral), and rat
developmental neurotoxicity with desthio metabolite (oral), as well as
a multi-generation reproduction study with the desthio metabolite,
indicates that there is concern for prenatal toxicity. Effects include
skeletal structural abnormalities, such as cleft palate, deviated
snout, malocclusion, and extra ribs; developmental delays; other
effects include changes in brain morphometry, peripheral nerve lesions,
and death.
    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. Data from the developmental neurotoxicity
study also show that brain morphometry is abnormal postnatally, and
there is an increased incidence of lesions of the peripheral nerves
postnatally.
    3. Conclusion. The toxicity database for prothioconazole (and its
metabolites) is adequate for endpoint selection for exposure risk
assessment scenarios and for FQPA evaluation, with the exception of the
lack of data on brain morphometry at the lower and mid doses from the
developmental neurotoxicity study. Data on brain morphometry at these
doses have now been submitted and is currently in review.
    Effects are seen in the 2-generation reproduction studies in rats;
developmental studies in rats and rabbits; and a developmental
neurotoxicity study in rats which suggest that pups are more
susceptible: Pup effects were seen at levels below the LOAELs for
maternal toxicity and, in general, were of comparable or greater
severity compared to the effects observed in adults. Additionally,
there is uncertainty concerning the LOAEL/NOAEL for developmental
effects seen in the developmental neurotoxicity study in rats (abnormal
brain morphometry at high dose) due to a lack of information on brain
morphometry at lower doses. Given that both quantitative and
qualitative sensitivity was observed in pups in several studies and in
more than one species and in at least one of these studies there is
uncertainty concerning identification of the LOAEL/NOAEL for
developmental effects, the additional 10X factor for the protection of
infants and children is being retained.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to prothioconazole will occupy 76% of the aPAD for the population group
(females 13 years and older).
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
prothioconazole from food and water will utilize 94% of the cPAD for
the population group (infants less than 1 year old). There are no
residential uses for prothioconazole that result in chronic residential
exposure to prothioconazole.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Prothioconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Prothioconazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    5. Aggregate cancer risk for U.S. population. The available studies
in the mouse and rat show no increase in tumor incidence, therefore the
Agency has concluded that neither prothioconazole nor its metabolites
are carcinogenic, and are classified ``Not likely to be Carcinogenic to
Humans'' according to the 2005 Cancer Guidelines. Therefore,
prothioconazole is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to prothioconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology are available to enforce the
tolerance expression, consisting of liquid chromatography/tandem mass
spectrometry (LC/MS/MS) for both plant and livestock commodities, using
tandem mass spectrometry electrospray ionization in both the positive
and negative modes. Both methods (LC/MS/MS Method RPA JA/03/01 for
plants and LC/MS/MS Method Bayer Report No. 200537 for animals) have
successfully passed tolerance method validation at ACB/BEAD. The method
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no maximum residue limits (MRLs) (tolerances) established
for prothioconazole in Codex or in Mexico.

V. Conclusion

    Therefore, tolerances are established for combined residues of
prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione, and
prothioconazole-desthio, [alpha]-(1-chlorocyclopropyl)-[alpha]-[(2-
chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, calculated as parent,
in or on the following commodities: soybean, forage at 4.5 ppm;
soybean, seed at 0.15 ppm; soybean, hay at 17 ppm; sugar beet, roots at
0.25 ppm. A tolerance is not needed for sugar beet tops because it is
not a human food commodity.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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 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 6, 2000) do not apply to this rule. In addition, This
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) (Public Law 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: March 10, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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 adding alphabetically entries to the
table in paragraph (a)(1) to read as follows:

Sec.  180.626  Prothioconazole; tolerances for residues.

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

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Beet, sugar, roots......................................            0.25
                                * * * * *
Soybean, forage.........................................             4.5
Soybean, hay............................................              17
Soybean, seed...........................................            0.15
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-5290 Filed 3-18-08; 8:45 am]

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