[Federal Register: September 26, 2007 (Volume 72, Number 186)]
[Rules and Regulations]
[Page 54564-54569]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se07-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0522; FRL-8148-6]
Pyraclostrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of pyraclostrobin and its desmethoxy metabolite in or on berry, group
13; cotton, undelinted seed; and cotton, gin byproducts. BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 26, 2007. Objections and
requests for hearings must be received on or before November 26, 2007,
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-2006-0522. 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
[[Page 54565]]
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: Tony Kish, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9443; e-mail address: kish.tony@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), 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-2006-0522 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 26, 2007.
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-2006-0522, 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 July 5, 2006 (71 FR 38150-38151) (FRL-
8074-2), 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
5F7002) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.582 be
amended by establishing tolerances for combined residues of the
fungicide pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-
pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its
desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate), expressed as parent compound, in or on
berry, group 13 at 4.0 parts per million (ppm); cotton, undelinted seed
at 0.4 ppm; and cotton, gin byproducts at 30 ppm. That notice
referenced a summary of the petition prepared by BASF 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 for cotton, undelinted seed from 0.4 ppm to 0.3
ppm. The reason for this change is explained in Unit V.
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
[[Page 54566]]
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 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
tolerances for combined residues of pyraclostrobin and its desmethoxy
metabolite on berry, group 13 at 4.0 ppm; cotton, undelinted seed at
0.3 pm; and cotton, gin byproducts at 30 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerances
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.
Pyraclostrobin has a low to moderate acute toxicity. In repeated
dose oral toxicity studies, the main target organs for pyraclostrobin
are the upper gastrointestinal tract (mainly the duodenum and stomach),
the spleen/hematopoiesis, the immune system, and the liver. In
addition, reduced body weight/gain and feed intake/efficiency are also
common findings. In the developmental toxicity study in rabbits, there
was evidence of increased qualitative susceptibility of in utero
rabbits following exposure to pyraclostrobin (increases in resorptions/
litter and post-implantation losses), but only at doses that also
resulted in maternal toxicity (decreases in body weight gain and food
consumption). There was no evidence of increased quantitative or
qualitative susceptibility of in utero rats or offspring following
exposure to pyraclostrobin. In the 2-generation reproduction study, the
highest dose tested did not cause maternal systemic toxicity, nor did
it elicit reproductive or offspring toxicity. In both the acute and
subchronic neurotoxicity studies, there were no indications of
treatment-related neurotoxicity.
EPA has reevaluated the carcinogenic potential of pyraclostrobin in
light of a new supplementary cancer study in female mice and concluded
that, in accordance with the EPA's Final Guidelines for Carcinogen Risk
Assessment (March, 2005), pyraclostrobin should be classified into the
category ``Not Likely to be Carcinogenic to Humans.'' This
determination is based on no treatment-related increase in tumors in
either sex of rats and mice, which were tested at doses that were
adequate to assess carcinogenicity, and the lack of evidence of
mutagenicity.
Specific information on the studies received and the nature of the
adverse effects caused by pyraclostrobin 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 human health risk assessment document in the
docket established by this action, which is described under ADDRESSES.
The referenced document is identified as EPA-HQ-OPP-2006-0522-0002 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/pesticides/factsheets/riskassess.htm
.
A summary of the toxicological endpoints for pyraclostrobin used
for human risk assessment can be found at http://www.regulations.gov in
the human health risk assessment document identified as document number
0002 in docket ID number EPA-HQ-OPP-2006-0522.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraclostrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pyraclostrobin
tolerances in (40 CFR 180.582). EPA assessed dietary exposures from
pyraclostrobin 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 for the general population (decreased body weight gain seen
after a single oral dose in the rat acute neurotoxicity study) and for
females 13 to 49 years old (increased resorptions/litter and increased
total resorptions seen in the rabbit developmental toxicity study that
are presumed to occur after a single exposure). The aPAD for the
general population has been established at 3.0 milligrams/kilograms/day
(mg/kg/day); whereas, the aPAD for females 13 to 49 years old is
significantly lower (0.05 mg/kg/day), due to the more sensitive
endpoint on which it is based.
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 assumed that residues are
present at tolerance levels or at the highest residue level found in
residue field trials. One hundred percent crop treated (PCT) was
assumed for all commodities in the assessment. Default processing
factors were applied to all commodities except those for which
experimentally-derived processing factors were available: Apple juice,
grape juice, citrus juices, cottonseed oil, tomato paste, tomato puree,
wheat flour, and wheat germ.
[[Page 54567]]
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 assumed that residues
are present at tolerance levels in all crops except grape, celery,
spinach, tomato, pepper, citrus, apple, leaf lettuce and head lettuce.
EPA relied on anticipated residues (average residues from field trials)
for these crops. One hundred PCT was assumed for all commodities in the
assessment. Default processing factors were applied to all commodities
except those for which experimentally-derived processing factors were
available: Apple juice, grape juice, citrus juices, cottonseed oil,
tomato paste, tomato puree, wheat flour, and wheat germ.
iii. Cancer. EPA has classified pyraclostrobin as ``Not Likely to
be Carcinogenic to Humans.'' Therefore, a cancer exposure assessment
was not conducted.
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 pursuant
to section 408(f)(1) of FFDCA 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 section 408(b)(2)(E) of FFDCA and authorized under
section 408(f)(1) of FFDCA. 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 pyraclostrobin 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 pyraclostrobin. 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 Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
pyraclostrobin for acute exposures are estimated to be 10.2 parts per
billion (ppb) for surface water and 0.02 ppb for ground water. The EECs
for chronic exposures are estimated to be 0.8 ppb for surface water and
0.02 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 10.2 ppb was used to
access the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.8 ppb was used to access
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).
Pyraclostrobin is currently registered for the following
residential non-dietary sites: Residential and recreational turfgrass.
EPA assessed residential exposure using the following assumptions:
Residential and recreational turf applications are applied by
professional pest control operators (PCOs) only, and, therefore,
residential handler exposures do not occur. There is, however, a
potential for short- and intermediate-term postapplication exposure of
adults and children entering lawn and recreation areas previously
treated with pyraclostrobin. Exposures from treated recreational sites
are expected to be similar to, or in many cases lower than, those from
treated residential turf sites; therefore, a separate exposure
assessment for recreational turf sites was not conducted. EPA assessed
exposures from the following residential turf postapplication
scenarios:
i. Adult and toddler postapplication dermal exposure from contact
with treated lawns,
ii. Toddlers' incidental ingestion of pesticide residues on lawns
from hand-to-mouth transfer,
iii. Toddlers' object-to-mouth transfer from mouthing of pesticide-
treated turfgrass, and
iv. Toddlers' incidental ingestion of soil from pesticide-treated
residential areas. The postapplication risk assessment was conducted in
accordance with the Residential Standard Operating Procedures (SOPs)
and recommended approaches of the Health Effects Division's (HED's)
Science Advisory Council for Exposure (ExpoSAC).
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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to pyraclostrobin and any
other substances and pyraclostrobin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that pyraclostrobin
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative
.
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. The prenatal and postnatal
toxicology database for pyraclostrobin includes the rat and rabbit
developmental toxicity studies and the 2-generation reproduction
toxicity study in rats. There was no evidence of increased quantitative
or qualitative susceptibility of in utero rats or offspring following
exposure to pyraclostrobin in the rat developmental and reproduction
studies. In the rabbit developmental study, there was evidence of
increased qualitative susceptibility of in utero rabbits following
exposure to
[[Page 54568]]
pyraclostrobin (increases in resorptions/litter and post-implantation
losses), but only at doses that also resulted in maternal toxicity
(decreases in body weight gain and food consumption).
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for pyraclostrobin is complete.
ii. There is no indication that pyraclostrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that pyraclostrobin results in increased
susceptibility in in utero rats in the prenatal developmental study or
in young rats in the 2-generation reproduction study. Although there is
qualitative evidence of increased susceptibility in the prenatal
developmental study in rabbits, the Agency did not identify any
residual uncertainties after establishing toxicity endpoints and
traditional UFs to be used in the risk assessment of pyraclostrobin.
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 based
on 100 PCT and tolerance-level residues or anticipated residues derived
from reliable field trial data. Conservative ground and surface water
modeling estimates were used. Similarly, conservative Residential SOPs
were used to assess post-application dermal exposure of children as
well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by pyraclostrobin.
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, EPA performed two different acute risk
assessments, one focusing on females 13 to 49 years old and designed to
protect against prenatal effects and the other focusing on acute
effects relevant to all other population groups. The more sensitive
acute endpoint was seen as to prenatal effects rather than other acute
effects. For females 13 to 49 years old, the acute dietary exposure
from food and water will occupy 78% of the aPAD addressing prenatal
effects. As to acute effects other than prenatal effects, the acute
dietary exposure from food and water to pyraclostrobin will occupy 2.3%
of the aPAD for children 1 to 2 years old, the population group with
the highest estimated acute dietary exposure to pyraclostrobin.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pyraclostrobin from food and water will utilize 48% of the cPAD for
children 1 to 2 years old, the population group with the highest
estimated exposure and risk. Based on the use pattern, chronic
residential exposure to residues of pyraclostrobin is not expected.
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).
Pyraclostrobin is currently registered for uses that could result
in short-term residential exposure and the Agency has determined that
it is appropriate to aggregate chronic food and water and short-term
residential exposures for pyraclostrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of 170 for adults and 100
for children, 1 to 2 years old. The aggregate MOE for adults is based
on the residential turf scenario and includes combined food, drinking
water and post-application dermal exposures. The aggregate MOE for
children includes food, drinking water, post-application dermal and
incidental oral exposures from entering turf areas previously treated
with pyraclostrobin.
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).
Pyraclostrobin is currently registered for uses that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term residential exposures for pyraclostrobin. Since the
endpoints and points of departure (NOAELs) are identical for short- and
intermediate-term exposures, the aggregate MOEs for intermediate-term
exposure are the same as those for short-term exposure (170 for adults
and 100 for children, 1 to 2 years old).
5. Aggregate cancer risk for U.S. population. EPA has classified
pyraclostrobin into the category ``Not Likely to be Carcinogenic to
Humans.'' Therefore, a cancer aggregate exposure assessment was not
conducted. Pyraclostrobin 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 pyraclostrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (an LC/MS/MS method (BASF Method
D9808), and an HPLC/UV method (BASF Method D9904)) is available to
enforce the tolerance expression. The methods 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
There are no established or proposed Codex maximum residue limits
(MRLs) for pyraclostrobin.
V. Conclusion
EPA determined that the proposed tolerance level for ``cotton,
undelinted seed'' of 0.4 ppm should be revised to 0.3 ppm based on
review of the supporting residue field trial data. As the majority of
cottonseed samples had residues below the limit of quantitation (LOQ)
of the method (0.04 ppm), the recommended tolerance for undelinted seed
could not be determined using the Agency's Tolerance/MRL Harmonization
Spreadsheet. Rather, the recommended tolerance of 0.3 ppm is based on
the maximum combined residues of pyraclostrobin and its desmethoxy
metabolite observed in seeds (0.17 ppm).
Therefore, the tolerances are established for combined residues of
pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl
[[Page 54569]]
ester) and its desmethoxy metabolite, (methyl-N-[[[1-(4-chlorophenyl)-
1H-pyrazol-3-yl]oxy]methyl]phenylcarbamate), expressed as parent
compound, in or on berry, group 13 at 4.0 ppm; cotton, undelinted seed
at 0.3 ppm; and cotton, gin byproducts at 30 ppm, respectively.
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: September 18, 2007.
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 180.582 is amending paragraph (a)(1) in the table as
follows:
0
i. By revising the entry for ``Berry group 13''; and
0
ii. By alphabetically adding ``Cotton, gin byproducts'' and ``Cotton,
undelinted seed.''
The amendments read as follows:
Sec. 180.582 Pyraclostrobin; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Berry, group 13...................................... 4.0
* * * * *
Cotton, gin byproducts............................... 30
Cotton, undelinted seed.............................. 0.3
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-18858 Filed 9-25-07; 8:45 am]
BILLING CODE 6560-50-S