[Federal Register: March 24, 2008 (Volume 73, Number 57)]
[Rules and Regulations]
[Page 15425-15431]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr08-11]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0906; FRL-8355-4]
Pyraclostrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of pyraclostrobin and its desmethoxy metabolite in or on avocado;
canistel; oat, grain; oat, hay; oat, straw; sapodilla; sapote, black;
sapote, mamey; and star apple. It also increases the existing
tolerances in or on barley, grain from 0.4 parts per million (ppm) to
1.4 ppm; mango and Papaya from 0.1 ppm to 0.6 ppm. Interregional
Research Project Number 4 (IR-4) and BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 24, 2008. Objections and
requests for hearings must be received on or before May 23, 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-2007-0906. 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
[[Page 15426]]
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), 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-2007-0906 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 23, 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-2007-0906, 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 April 4, 2007 (72 FR 16352) (FRL-8119-
2); May 9, 2007 (72 FR 26372) (FRL-8121-5); and October 24, 2007 (72 FR
60369) (FRL-8150-8), EPA issued notices pursuant to section 408(d)(3)
of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petitions (PP 6E7165, PP 6F7105 and PP 7E7245) by Interregional
Research Project Number 4 (IR-4), 500 College Road East, Suite 201W,
Princeton, NJ 08540 and BASF Corporation, P.O. Box 13528, Research
Triangle Park, NC 27709. The petitions 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, in or on herbs, fresh at 30.0 parts per
million (ppm); avocado at 0.7 ppm; mango at 0.7 ppm; papaya at 0.7 ppm;
sapote, black at 0.7 ppm; sapote, mamey at 0.7 ppm; canistel at 0.7
ppm; sapodilla at 0.7 ppm; and star apple at 0.7 ppm
(PP6E7165); in or on oat, grain at 1.0 ppm; oat, hay at 17.0
ppm; oat, straw at 17.0 ppm; and oilseed, group at 0.4 ppm
(PP6F7105); and in or on barley, grain at 1.3 ppm; and barley,
straw at 9.0 ppm (PP7E7245). The notices referenced summaries
of the petitions prepared by BASF Corporation, the registrant, which
are available to the public in docket ID numbers EPA-HQ-OPP-2007-0117
(PP 6E7165); EPA-HQ-OPP-2007-0214 (PP 6F7105); and EPA-HQ-OPP-2007-0906
(PP 7E7245); available at http://www.regulations.gov. There were no
comments received in response to the April 4, 2007 or October 24, 2007
notices of filing; comments were received from a private citizen in
response to the May 9, 2007 notice of filing of pesticide petition
6F7105. EPA's response to these comments is discussed in Unit IV.C.
IR-4 has withdrawn its request for a tolerance for combined
residues of pyraclostrobin and its desmethoxy metabolite in or on fresh
herbs; and EPA is deferring to a later date the decision regarding the
proposed tolerances in or on oilseed commodities. Based upon review of
the data supporting the
[[Page 15427]]
petitions, EPA has revised the tolerance levels for the remaining
commodities. The reason for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' 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 avocado at 0.6 ppm; barley, grain at 1.4 ppm; canistel at
0.6 ppm; mango at 0.6 ppm; oat, grain at 1.2 ppm; oat, hay at 18 ppm;
oat, straw at 15 ppm; papaya at 0.6 ppm; sapodilla at 0.6 ppm; sapote,
black at 0.6 ppm; sapote, mamey at 0.6 ppm; and star apple at 0.6 ppm.
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.
Pyraclostrobin has 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. There was no
evidence of increased quantitative or qualitative susceptibility of in
utero rats or offspring following exposure to pyraclostrobin in the rat
developmental or reproduction toxicity studies. There was evidence of
increased qualitative susceptibility of in utero rabbits following
exposure to pyraclostrobin in the rabbit developmental study. Increases
in resorptions/litter and post-implantation losses occurred at doses
that resulted in less severe maternal toxicity (decreases in body
weight gain and food consumption). In both the acute and subchronic
neurotoxicity studies, there were no indications of treatment-related
neurotoxicity.
EPA has evaluated the carcinogenic potential of pyraclostrobin 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 document Pyraclostrobin: Human Health Risk
Assessment for Proposed Uses on Oats, Oilseed Group (Canola and Flax),
Plus Seed Treatment on Oats, Canola, and Flax; Tropical Fruits
(Avocado, Black Sapote, Canistel, Mamey Sapote, Mango; Papaya,
Sapodilla, and Star Apple); Increased Tolerance on Barley; Adding
Aerial Application to Turf and Ornamentals; and Adding In-Furrow
Applications to Corn, Soybean, and Sugar Beets. The referenced document
is available in the docket established by this action, which is
described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0906-
0003 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 document Pyraclostrobin: Human Health Risk Assessment for Proposed
Uses on Oats, Oilseed Group (Canola and Flax), Plus Seed Treatment on
Oats, Canola, and Flax; Tropical Fruits (Avocado, Black Sapote,
Canistel, Mamey Sapote, Mango; Papaya, Sapodilla, and Star Apple);
Increased Tolerance on Barley; Adding Aerial Application to Turf and
Ornamentals; and Adding In-Furrow Applications to Corn, Soybean, and
Sugar Beets at page 21 to 23 in docket ID number EPA-HQ-OPP-2007-0003.
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
[[Page 15428]]
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/kilogram/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 for some commodities (amaranth, leafy;
arugula; chrysanthemum; cress, garden; cress, upland; dandelion,
leaves; fennel; parsley, leaves; radicchio; rhubarb; spinach; swiss
chard; beans, dry; celery; lettuce, head; lettuce, leaf; and pea, dry)
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.
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 apple, broccoli,
celery, collard, grape, lettuce, citrus, pepper, mustard green and
tomato. 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, tomato paste, tomato puree, wheat flour, and wheat germ.
iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA has concluded that pyraclostrobin is ``not likely to
be carcinogenic to humans.'' Consequently, a quantitative cancer
exposure and risk assessment is not appropriate for pyraclostrobin.
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 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 Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
pyraclostrobin for acute exposures are estimated to be 35.6 parts per
billion (ppb) for surface water and 0.02 ppb for ground water. The EECs
for chronic exposures are estimated to be 2.3 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 35.6 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 2.3 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).
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
[[Page 15429]]
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 pyraclostrobin (increases in resorptions/litter and post-
implantation losses). However, the concern is low for the qualitative
susceptibility in the rabbit developmental study because: The
developmental effects were seen in the presence of maternal toxicity;
there are clear NOAELs for maternal and developmental toxicities; and
this endpoint is used in the acute dietary (reference dose) exposure
assessment for females, 13 years and older, as well as for short- and
intermediate-term dermal risk assessments.
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. This determination was exhaustively discussed in a prior order
concerning pyraclostrobin, 72 FR 52108, 52118-52123 (September 12,
2007). In summary, the safety factor 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 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 assumptions 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 80% 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 2.4%
of the aPAD for children 1 to 2 years old, the population subgroup 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 subgroup 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
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 200 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 exposures for pyraclostrobin. Since the endpoints and
points of departure (NOAELs) are identical for short- and intermediate-
term exposures, the
[[Page 15430]]
aggregate MOEs for intermediate-term exposure are the same as those for
short-term exposure (200 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.'' 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 (a liquid chromatography/mass
spectrometry (LC/MS/MS) method (BASF Method D9808), and a high
performance liquid chromatography using untraviolet detection (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
The Codex Alimentarius Commission has established maximum residue
limits (MRLs) for residues of pyraclostrobin, per se, at 0.5 ppm in or
on oats and barley and at 0.05 ppm in or on papaya. The U.S. tolerance
levels on these commodities are higher than the corresponding CODEX
MRLs because the U.S. tolerances, unlike the Codex MRLs, include both
pyraclostrobin and its desmethoxy metabolite.
C. Response to Comments
EPA received comments from a private citizen in response to the
notice of filing of several pesticide petitions (including PP 6F7105;
docket ID number EPA-HQ-OPP-2007-0214) which was published in the
Federal Register on May 9, 2007 (72 FR 26372-26375) (FRL-8121-5).
Although none of the comments specifically addressed pyraclostrobin,
the commenter expressed concerns generally about the testing of
pesticides, their toxicity (including potential carcinogenicity),
residues in food and potential effects on bees. Comments received
contained no scientific data or other substantive evidence to rebut the
Agency's finding that there is a reasonable certainty that no harm will
result from aggregate exposure to pyraclostrobin from the establishment
of these tolerances. The Agency has received these same or similar
comments from this commenter on numerous previous occasions. Refer to
the Federal Register of June 30, 2005 (70 FR 37686) (FRL-7718-3),
Janaury 7, 2005 (70 FR 1354) (FRL-7691-4), and October 29, 2004 (69 FR
63096-63098) (FRL-7681-9) for the Agency's previous responses to these
objections. In response to the commenter's question about potential
effects on bees, EPA would note that the environmental effects of a
pesticide are considered in the registration process for pesticides
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
7 U.S.C. 136 et seq.
D. Changes to Proposed Tolerances
Based upon review of the data supporting the petitions, EPA has
modified the proposed tolerances as follows: (1) Revised the tolerance
levels for oat, grain from 1.0 ppm to 1.2 ppm; oat, hay from 17 ppm to
18 ppm; and oat, straw from 17 ppm to 15 ppm; (2) decreased the
tolerances for avocado, canistel, mango, papaya, sapodilla, sapote
(black and mamey) and star apple from 0.7 ppm to 0.6 ppm; and (3)
revised the barley, grain tolerance from 1.3 ppm to 1.4 ppm and
determined that the existing tolerance of 6.0 ppm for barley, straw is
adequate and should not be raised to 9.0 ppm, as proposed by IR-4. EPA
made these changes based on analyses of the residue field trial data
using the Agency's Tolerance Spreadsheet in accordance with the
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial
Data.
V. Conclusion
Therefore, tolerances are established for combined residues of
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, in or on avocado at 0.6 ppm; barley,
grain at 1.4 ppm; canistel at 0.6 ppm; mango at 0.6 ppm; oat, grain at
1.2 ppm; oat, hay at 18 ppm; oat, straw at 15 ppm; papaya at 0.6 ppm;
sapodilla at 0.6 ppm; sapote, black at 0.6 ppm; sapote, mamey at 0.6
ppm; and star apple at 0.6 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to petitions 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 tolerances 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
[[Page 15431]]
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 18, 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 180.582 is amended in the table in paragraph (a)(1) by
revising the tolerances for ``barley, grain'', ``mango'' and
``papaya''; removing the footnote; and alphabetically adding new
commodities to read as follows:
180.582 Pyraclostrobin; tolerances for residues.
(a)* * * (1)* * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Avocado.................................................... 0.6
* * * * *
Barley, grain.............................................. 1.4
* * * * *
Canistel................................................... 0.6
* * * * *
Mango...................................................... 0.6
* * * * *
Oat, grain................................................. 1.2
Oat, hay................................................... 18
Oat, straw................................................. 15
Papaya..................................................... 0.6
* * * * *
Sapodilla.................................................. 0.6
Sapote, black.............................................. 0.6
Sapote, mamey.............................................. 0.6
* * * * *
Star apple................................................. 0.6
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-5893 Filed 3-21-08; 8:45 am]
BILLING CODE 6560-50-S