[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Rules and Regulations]
[Page 51732-51736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se08-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-1199; FRL-8376-6]
Uniconazole-P; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of uniconazole-P, its R-enantiomer and its Z-isomer in or on vegetable,
fruiting, group 8. Interregional Research Project Number 4 (IR-4)
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective September 5, 2008. Objections and
requests for hearings must be received on or before November 4, 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-2007-1199. 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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 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-2007-1199 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 November 4, 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-2007-1199, 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 (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of February 6, 2008 (73 FR 6964) (FRL-8350-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E7268) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR part 180 be amended by adding a section for the fungicide
uniconazole-P and
[[Page 51733]]
establishing a tolerance therein for residues of uniconazole-P per se
in or on vegetable, fruiting, group 8 at 0.01 parts per million (ppm).
That notice referenced a summary of the petition prepared by Valent USA
Corporation, 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 filing.
Based upon review of the data supporting the petition, EPA has
modified the tolerance expression to include uniconazole-P, its R-
enantiomer and its Z-isomer. The reason for this change is explained in
Unit IV.C.
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 the petitioned-for
tolerance for combined residues of uniconazole-P, its R-enantiomer and
its Z-isomer on vegetable, fruiting, group 8 at 0.01 ppm. EPA's
assessment of exposures and risks associated with establishing this
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.
Uniconazole-P (hereafter referred to as uniconazole) is rapidly
absorbed after oral ingestion and extensively metabolized by the liver.
There is no accumulation in the tissues, and the metabolites are
rapidly excreted in the feces and urine. Uniconazole has moderate acute
oral toxicity and low acute dermal and inhalation toxicity. It is a
slight eye irritant but not a skin irritant or skin sensitizer. In
mouse, rat and dog repeated-dose studies, oral ingestion of high doses
caused an increase in the size and weight of the liver. Fat
accumulation in the liver was also consistently observed at high doses.
Although observed less consistently, increases in the activity of some
enzymes indicated altered liver function as a response to uniconazole
exposure. There was no evidence of carcinogenicity in the combined
chronic toxicity/carcinogenicity study in the rat; however, in the
mouse study an increase in liver neoplasms was noted. Mutagenicity
studies were generally negative except for the in vitro mammalian
chromosome aberration test (CHO), which was positive with metabolic
activation. Based on the limited evidence of carcinogenicity in the
mouse, EPA classified uniconazole as a Group C (Possible Human)
carcinogen but concluded that quantification of cancer risk using a low
dose extrapolation model was not appropriate. The point of Departure
(POD) selected for deriving the chronic reference dose will adequately
account for all chronic effects determined to result from exposure to
uniconazole in chronic animal studies, including potential cancer
effects. Uniconazole had no effects on reproductive performance of rats
in the 2-generation reproduction toxicity study and no effect on fetal
development in the rabbit developmental toxicity study. In the
developmental toxicity study in rats, developmental toxicity (increased
incidence of 14th ribs) was noted, but only at doses that
were also maternally toxic. There was no evidence of neurotoxicity in
the submitted uniconazole toxicity studies or in the open literature.
Specific information on the studies received and the nature of the
adverse effects caused by uniconazole, 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 in the document Uniconazole-P Human Health Risk
Assessment for Proposed Uses on Fruiting Vegetables (Except Cucurbits),
Crop Group 8 pages 52-75 in docket ID number EPA-HQ-OPP-2007-1199.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological POD is identified as the basis for
derivation of reference values for risk assessment. The POD may be
defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk
assessment. Uncertainty/safety factors (UFs) are used in conjunction
with the POD 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 dietary
risks by comparing aggregate food and water 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
POD by all applicable UFs. Aggregate short-term, intermediate-term, and
chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
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
greater than that 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 uniconazole used for
human risk assessment can be found at http://www.regulations.gov in the
document Uniconazole-P Human Health Risk Assessment for Proposed Uses
on Fruiting Vegetables (Except Cucurbits), Crop Group 8 pages 26-27 in
docket ID number EPA-HQ-OPP-2007-1199.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
[[Page 51734]]
exposure to uniconazole, EPA considered exposure under the petitioned-
for tolerance on fruiting vegetables, the first food use of
uniconazole. EPA assessed dietary exposures from uniconazole 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. EPA identified such an
effect relevant to the population group females, 13 years of age and
older (increased incidence of 14th rib following in utero
exposure to uniconazole in the rat developmental toxicity study). No
acute effects were identified for the general population, including
infants and children.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 Nationwide Continuing Surveys of Food Intakes by Individuals
(CSFII). As to residue levels in food, EPA assumed that all foods
covered by the fruiting vegetable tolerance contain tolerance-level
residues and that 100% of fruiting vegetables are treated with
uniconazole.
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 again assumed that
all foods covered by the fruiting vegetable tolerance contain
tolerance-level residues and that 100% of fruiting vegetables are
treated with uniconazole.
iii. Cancer. Based upon statistically significant increases in
hepatocellular neoplasms in high-dose male mice, EPA classified
uniconazole as a Group C (Possible Human) carcinogen but concluded that
quantification of cancer risk using a low dose extrapolation model was
not appropriate. This determination was based on the fact that the
tumor induced is primarily of a benign nature, occurred at the highest
dose tested in one sex of one species only with no acceleration in the
rate of tumor formation and did not exhibit any uncommon biological
behavior. The POD selected for deriving the chronic reference dose
(cRfD) will adequately account for all chronic effects determined to
result from exposure to uniconazole in chronic animal studies,
including potential cancer effects.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for uniconazole. Tolerance level 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 uniconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of uniconazole. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of uniconazole for
acute exposures are estimated to be 3.1 parts per billion (ppb) for
surface water and 0.076 ppb for ground water; and for chronic exposures
for non-cancer assessments are estimated to be 1.5 ppb for surface
water and 0.076 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 3.1 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 1.5 ppb was used to assess
the contribution to drinking 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). Uniconazole 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.''
Uniconazole is a member of the triazole-containing class of
pesticides, sometimes referred to as conazoles. Although conazoles act
similarly in 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 efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www.epa.gov/pesticides/cumulative.
Uniconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and several
triazole conjugates (including triazole alanine, triazole acetic acid,
triazole pyruvic acid and triazole lactic acid). To support existing
tolerances and to establish new tolerances for triazole-derivative
pesticides, including uniconazole, EPA conducted a human health risk
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. Triazole pyruvic acid and
triazole lactic acid were not included in the risk assessment due to
their low occurrence in metabolism studies. 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 ID EPA-
[[Page 51735]]
HQ-OPP-2005-0497). Additional information regarding the uses proposed
for uniconazole in this action can also be found at http://
www.regulations.gov in the documents Dietary Exposure Assessments for
the Common Triazole Metabolites 1,2,4-Triazole, Triazolylalanine,
Triazolylacetic Acid, and Triazolylypyruvic Acid; Updated to Include
New Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and
Uniconazole; and a Change in Plant-back Restriction for Tetraconazole
and Uniconazole-P: Acute, Chronic and Cancer Aggregate Dietary (Food
and Drinking Water) Exposure Analyses for the Section 3 Registration
Action in docket ID number EPA-HQ-OPP-2007-1199.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database for uniconazole includes rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. There was no evidence of increased qualitative or
quantitative susceptibility of rabbit fetuses following in utero
exposure to uniconazole and no evidence of increased susceptibility of
offspring in the 2-generation reproduction study in rats. There was
evidence of increased qualitatative susceptibility of fetuses in the
rat developmental study. In this study, an increased incidence of
14th rib in the fetuses was observed in the presence of
minimal maternal toxicity (decreased body weight). The degree of
concern for the qualitative susceptibility seen in the rat
developmental study is low because:
The additional rib was the only skeletal variation noted
The fetal effect occurred only in the presence of maternal
toxicity
In the reproduction study in rats, higher doses resulted
in minimal pup toxicity (slightly reduced body weights); and:
The NOAEL for the fetal effect is used for assessing acute
risk of females 13 years and older and is, therefore, protective of
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 uniconazole database is adequate to assess prenatal and
postnatal toxicity.
ii. There is no indication that uniconazole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. Although there is qualitative evidence of increased
susceptibility in the prenatal developmental study in rats, EPA did not
identify any residual uncertainties after establishing toxicity
endpoints and traditional UFs to be used in the risk assessment of
uniconazole. The degree of concern for prenatal and/or postnatal
toxicity is low.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed
assuming 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to uniconazole in drinking water. Residential
exposure to uniconazole is not expected. These assessments will not
underestimate the exposure and risks posed by uniconazole.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
uniconazole will occupy <1% of the aPAD for females 13 to 49 years old,
the only population group for which an acute endpoint of concern was
identified.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
uniconazole from food and water will utilize <1% of the cPAD for the
general population and all population subgroups, including infants and
children. There are no residential uses for uniconazole.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Uniconazole
is not registered for any use patterns that would result in residential
exposure. Therefore, the short- and intermediate-term aggregate risk is
the sum of the risk from exposure to uniconazole through food and water
and will not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. The Agency has
determined that the chronic risk assessment based on the established
cPAD is protective of potential cancer effects. Based on the results of
the chronic risk assessment discussed above in Unit E.2, EPA concludes
that uniconazole is not expected to pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to uniconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Gas Chromatography/Nitrogen
Phosphorus Detector (GC/NPD); Valent Method RM-25-1b) is 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
No Codex, Canadian, or Mexican MRLs have been established for
uniconazole.
[[Page 51736]]
C. Revisions to Petitioned-For Tolerance
The petitioner proposed a tolerance for residues of uniconazole-P
per se in or on vegetable, fruiting, group 8. However, based on the
results of plant metabolism studies, EPA has determined that the
residues of concern to be included in the tolerance expression for
fruiting vegetables are uniconazole-P, its R-enantiomer and its Z-
isomer. Therefore, EPA has modified the tolerance expression to include
all three compounds.
V. Conclusion
Therefore, the tolerance is established for combined residues of
uniconazole-P, (E)-(S)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-
triazol-1-yl)pent-1-en-3-ol, its R-enantiomer and its Z-isomer in or on
vegetable, fruiting, group 8 at 0.01 ppm.
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, 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 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) (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: August 26, 2008.
Debra Edwards,
Director, 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.
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2. Section 180.643 is added to read as follows:
Sec. 180.643 Uniconazole; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide/plant growth regulator uniconazole-P, (E)-(S)-1-(4-
chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pent-1-en-3-ol, its
R-enantiomer and its Z-isomer in or on the following raw agricultural
commodities:
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Parts per
Commodity million
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Vegetable, fruiting, group 8............................... 0.01
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(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertant residues. [Reserved]
[FR Doc. E8-20548 Filed 9-4-08; 8:45 am]
BILLING CODE 6560-50-S