[Federal Register Volume 74, Number 193 (Wednesday, October 7, 2009)]
[Rules and Regulations]
[Pages 51490-51496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24058]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0713; FRL-8793-2]
Pyraclostrobin; Pesticide Tolerances
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, expressed as parent
compound, in or on coffee, bean, green at 0.3 parts per million (ppm;
this is a new import tolerance); fruit, stone, group 12 at 2.5 ppm
(this is an increase in the existing domestic tolerance); sorghum,
grain, forage at 5.0 ppm; sorghum, grain, grain at 0.60 ppm; and
sorghum, grain, stover at 0.80 ppm (the sorghum tolerances are new
domestic tolerances). BASF Corporation requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 7, 2009. Objections and
requests for hearings must be received on or before December 7, 2009,
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-2008-0713. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: John Bazuin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7381; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may potentially be 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 electronically available documents 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 e-CFR site
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0713 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 December 7, 2009.
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
[[Page 51491]]
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-2008-0713, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of December 3, 2008 (73 FR 73644) (FRL-
8386-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
8F7385, 8F7390, and 8E7394) by BASF Corporation, 26 Davis Drive,
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]phenyl carbamate, expressed as parent compound, in or on
coffee, bean, green at 0.5 ppm (PP8E7394; a new import
tolerance); fruit, stone, group 12 at 2.5 ppm (8F7390; an increase in
the existing domestic tolerance); sorghum, grain at 0.5 ppm
(PP8F7385; a new domestic tolerance); sorghum, forage at 5.0
ppm (PP8F7385; a new domestic tolerance); and sorghum, stover
at 0.8 ppm (PP8F7385; a new domestic tolerance). 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
reduced the proposed pyraclostrobin tolerance for coffee, bean, green
from 0.5 ppm to 0.3 ppm and has increased the proposed tolerance for
sorghum, grain, grain (termed sorghum, grain in PP8F7385) from
0.5 ppm to 0.60 ppm. The reasons for these changes are explained in
Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure to the petitioned-for
tolerances 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]phenyl carbamate), expressed
as parent compound, in or on coffee, bean, green at 0.3 ppm; fruit,
stone, group 12 at 2.5 ppm; sorghum, grain, forage at 5.0 ppm; sorghum,
grain, grain at 0.60 ppm; and sorghum, grain, stover at 0.80 ppm. EPA's
assessment of exposures and risks associated with establishing
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 via the
oral, dermal, and inhalation routes of exposure. Pyraclostrobin
produces moderate eye irritation, is a moderate dermal irritant, and is
not a dermal sensitizer. The main target organs for pyraclostrobin are
the upper gastrointestinal tract (mainly the duodenum and stomach), the
spleen/hematopoiesis, and the liver. In the 90-day mouse oral toxicity
study, thymus atrophy was seen at doses of 30 milligrams\kil0gram (mg/
kg) or above, but similar effect was not found in the mouse
carcinogenicity study at doses as high as 33 mg/kg. In reproductive and
developmental studies, there was evidence of increased qualitative
susceptibility following in utero exposure in the rabbit, but not in
rats. In both the acute and subchronic neurotoxicity studies, there
were no indications of treatment-related neurotoxicity. EPA classified
pyraclostrobin as ``Not Likely to be Carcinogenic to Humans'' based on
no treatment-related increase in tumors in both sexes 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 Revised Pyraclostrobin: Human
Health Risk Assessment for Proposed Uses on Cotton and Belgian Endive,
page 15 in docket ID number EPA-HQ-OPP-2006-0522-004.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (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
[[Page 51492]]
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-, intermediate-, 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 pyraclostrobin used
for human risk assessment can be found at http://www.regulations.gov in
document Pyraclostrobin: Human Health Risk Assessment for Proposed Uses
on Grain Sorghum (PP#8F7385); Increase of Tolerance for the Stone Fruit
Crop Group 12 to Satisfy European Union (EU) Import Requirement
(PP#8F7390); and Establishment of a Permanent Import Tolerance for
Coffee (PP#8E7394), page 17 in docket ID number EPA-HQ-OPP-2008-0713.
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.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA performed a
slightly refined acute dietary exposure assessment for pyraclostrobin.
EPA assumed that 100 percent of crops covered by existing or proposed
tolerances were treated with pyraclostrobin and that these crops either
had tolerance-level residues or residues at the highest level found in
field trials. Experimentally derived processing factors were used for
fruit juices, tomato, and wheat commodities but for all other processed
commodities Dietary Exposure Evaluation Model (DEEM) default processing
factors were assumed.
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 performed a refined
chronic dietary exposure assessment for pyraclostrobin. EPA used data
on average percent crop treated (PCT) (when available) and either
tolerance-level residues or average field trial residues.
Experimentally derived processing factors were used for fruit juices,
tomato, and wheat commodities, but for all other processed commodities
DEEM\TM\ default processing factors were assumed.
iii. Cancer. EPA classified pyraclostrobin as ``Not Likely to be
Carcinogenic to Humans'' based on no treatment-related increase in
tumors in both sexes of rats and mice, which were tested at doses that
were adequate to assess carcinogenicity, and the lack of evidence of
mutagenicity. Accordingly, an exposure assessment to evaluate cancer
risk is unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such Data Call-Ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition A: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition B: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition C: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows:
------------------------------------------------------------------------
Commodity PCT
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Almond 35
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Apple 10
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Apricot 10
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Barley 1
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Black bean seed 5
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Broad bean (succulent) 2.5
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Broad bean seed 5
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Cowpea (succulent) 2.5
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Cowpea seed 5
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Great northern bean seed 5
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Kidney bean seed 5
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Lima bean (succulent) 2.5
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Lima bean seed 5
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Mung bean seed 5
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Navy bean seed 5
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Pink bean seed 5
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Pinto bean seed 5
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Snap bean (succulent) 2.5
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Sugar beet 35
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Blackberry 20
------------------------------------------------------------------------
Blueberry 20
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Broccoli 5
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Cabbage 10
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Napa cabbage 10
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Chinese mustard cabbage 10
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Cantaloupe 15
------------------------------------------------------------------------
Carrot 25
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Celery 2.5
------------------------------------------------------------------------
Cherry 30
------------------------------------------------------------------------
Field corn 5
------------------------------------------------------------------------
Pop corn 5
------------------------------------------------------------------------
Sweet corn 5
------------------------------------------------------------------------
Cucumber 5
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Currant 5
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Filbert 10
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Garlic 10
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Grape 25
------------------------------------------------------------------------
Grapefruit 25
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Head lettuce 5
------------------------------------------------------------------------
Leaf lettuce 5
------------------------------------------------------------------------
Nectarine 15
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Dry bulb onion 15
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Green onion 15
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Orange 5
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Succulent pea 5
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Pigeon pea (succulent) 5
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Peach 15
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Peanut 25
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Pear 10
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Pecan 2.5
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Bell pepper 10
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Non-bell pepper 10
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Pistachio 25
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Plum 5
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Potato 10
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Pumpkin 20
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Raspberry 35
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Soybean 5
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Spinach 10
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Summer squash 10
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Winter squash 10
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Strawberry 50
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Tangerine 15
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Tomato 20
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Watermelon 30
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Wheat 5
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In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition A, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions B and C, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which pyralostrobin may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyraclostrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport 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 drinking water concentrations (EDWCs) 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 and for
chronic exposures for non-cancer assessments 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 of value 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 uses that could result in
residential exposures: Residential turf grass and recreational sites.
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 post-application exposure of
adults and children entering lawn and recreation areas previously
treated with pyraclostrobin. Exposures from treated recreational sites
are expected to be
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similar to, or in many cases lower than, those from treated residential
turf sites so a separate exposure assessment for recreational turf
sites was not conducted. EPA assessed exposures from the following
residential turf post-application scenarios:
i. Short-/intermediate-term adult and toddler post-application
dermal exposure from contact with treated lawns,
ii. Short-/intermediate-term toddlers' incidental ingestion of
pesticide residues on lawns from hand-to-mouth transfer,
iii. Short-/intermediate-term toddlers' object-to-mouth transfer
from mouthing of pesticide-treated turfgrass, and
iv. Short-/intermediate-term toddlers' incidental ingestion of soil
from pesticide-treated residential areas. The post-application risk
assessment was conducted in accordance with the Residential Standard
Operating Procedures and recommended approaches of the Health Effects
Division's Science Advisory Council for 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.''
EPA has not found pyraclostrobin to share a common mechanism of
toxicity with 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 assumed that
pyraclostrobin does not have 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(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 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 pyraclostrobin includes the rat and rabbit
developmental toxicity studies and the 2-generation reproduction
toxicity study in rats. In reproductive and developmental studies there
was evidence of increased qualitative susceptibility following in utero
exposure in the rabbits, but not in rats. In the 2-generation
reproduction study, the highest dose tested did not cause maternal
systemic toxicity, nor did it elicit reproductive or offspring
toxicity. There is low concern for prenatal developmental effects seen
in the rabbit because there are clear NOAELs for maternal and
developmental effects, this toxicity endpoint is used to establish the
acute dietary RfD, and the developmental effect was seen at the same
dose level as that produced for the maternal effect.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for pyraclostrobin is considered adequate
to support toxicity endpoint selection for risk assessment and FQPA
evaluation. However, under the current 40 CFR 158.500 data requirement
guidelines, the immunotoxicity data (OPPTS 780.7800) is required as a
condition of approval. In the absence of specific immunotoxicity
studies, EPA has evaluated the available pyraclostrobin toxicity data
to determine whether an additional database uncertainty factor is
needed to account for potential immunotoxicity. For pyraclostrobin a
complete battery of subchronic, chronic, carcinogenicity, developmental
and reproductive studies, and acute and subchronic neurotoxicity
screening studies are available for consideration. The immunotoxic
potential of pyraclostrobin has been well characterized in relationship
to other adverse effects seen in the submitted toxicity studies. Under
the conditions of the studies the results do not indicate the immune
system to be the primary target and, other than the high-dose thymus
effects seen in the 90-day mouse study, no significant evidence of
pyraclostrobin-induced immunotoxicity was demonstrated in the studies
conducted either in adult animals or in the offspring following
prenatal and postnatal exposures. Increased spleen weights observed in
28-day rat studies were accompanied by mild hemolytic anemia (a
hematopoi-response) indicating these effects are unrelated to an
immunotoxic response. Currently, the point of departure in establishing
the chronic RfD is 3.4 mg/kg/day. The Agency does not believe that
conducting a special series 870.7800 immunotoxicity study will result
in a NOAEL less than 3.4 mg/kg/day. A similar conclusion was reached in
an earlier action on pyraclostrobin. (See 72 FR 52108, September 12,
2007). In light of these conclusions, EPA does not believe an
additional uncertainty or safety factor is needed to address the lack
of the required immunotoxicity study.
ii. There is no indication that pyraclostrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional safety factors to account for neurotoxicity.
iii. There is no evidence that pyraclostrobin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. Although there is qualitative evidence of increased
susceptibility in the prenatal development 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 acute dietary food exposure assessments were performed
using tolerance-level or highest field trial residues and 100 PCT. The
chronic dietary food exposure assessments were performed using
tolerance-level or average field trial residues and 100 PCT or average
PCT. Average PCT is conservatively derived from multiple data sources
and is averaged by year and then across all years. The field trials
represent maximum application rates and minimum PHIs. A limited number
of experimentally derived processing factors from pyraclostrobin
processing studies were also used to refine the analysis. The results
of the refined chronic dietary analysis are based on reliable data and
will not underestimate the exposure and risk. Conservative surface
water modeling estimates were used. Similarly, residential standard
operating procedures were used to assess post-application dermal
exposure
[[Page 51495]]
of children as well as incidental oral exposure of toddlers. EPA used
similarly conservative assumptions to assess post-application 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
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-, intermediate-, 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to pyraclostrobin will occupy 81% of the aPAD for females 13-49 years
old, and 2.5% of the aPAD for children 1-2 years old, the population
group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyraclostrobin from food and water will utilize 24% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
pyraclostrobin is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term 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 exposure through food and water
with short- and intermediate-term residential exposures to
pyraclostrobin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food,
water, and residential exposures aggregated result in aggregate MOEs of
230 for adults and 120 for children 1-2 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, and post-
application dermal and incidental oral exposures from entering turf
areas previously treated with pyraclostrobin. MOEs above 100 are
considered to be of no concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term 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 exposure to pyraclostrobin
through food and water with intermediate-term exposures for
pyraclostrobin.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures aggregated
result in aggregate MOEs of 230 for adults and 120 for children 1-2
years old. The endpoints and points of departure (NOAELs) are identical
for short- and intermediate-term exposures, so the aggregate MOEs for
intermediate-term exposure are the same as those for short-term
exposure.
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 pyraclostrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Two adequate methods were proposed for enforcing the tolerances for
residues of pyraclostrobin and its desmethoxy metabolite in/on plant
commodities: A liquid chromatography/mass spectrometry/mass
spectrometry (LC/MS/MS) method (BASF Method D9908), and a high pressure
liquid chromatography/ultraviolet (HPLC/UV) method (BASF Method D9904).
The validated method level of quantitation (LOQ) for both
pyraclostrobin and its desmethoxy metabolite is 0.02 ppm in all tested
plant matrices, for a combined LOQ of 0.04 ppm. Adequate independent
method validation and radiovalidation data were submitted for both
methods. Following the standard operating procedure for reviewing
tolerance methods, EPA has determined that Method D9904 is suitable as
an enforcement method.
Adequate enforcement methodology is available to enforce the
tolerance expression. The method (D9904) 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: [email protected].
B. International Residue Limits
The Codex Alimentarius Commission (CAC) has established maximum
residue limits (MRLs) for residues of pyraclostrobin on stone fruit and
coffee beans. However, the residue definitions for pyraclostrobin
differ in the CAC MRLs and United States tolerances. The CAC definition
contains parent only, whereas the United States residue definition
includes a metabolite. EPA is unwilling to modify the residue
definition for the United States tolerance because both parent and its
metabolite are major residues in crop matrices and are measured by the
enforcement method. Additionally, the CAC MRL and United States
tolerance values differ for stone fruit. They are the same for coffee
beans. The CAC value for stone fruits of 1 ppm is based on evaluation
of United States residue data for cherries, where the highest residue
was 0.63 ppm. This action sets a United States tolerance of 2.5 ppm
based on results from new trials conducted in 2007 on cherries,
peaches, and plums using a water dispersible granule formulation
containing pyraclostrobin and boscalid. Use of this particular
formulation requires an increase in the United States tolerance from
its present value of 0.9 ppm (40 CFR 180.582) because measured residues
were as high as 1.9 ppm. For this reason the United States tolerance
value cannot be harmonized with the CAC MRL. Canada has established
tolerances for various stone fruits at 0.7 ppm. The United States and
Canadian residue definitions are the same; however, the United States
tolerance for stone fruits being set in this action is higher than the
Canadian tolerances for individual stone fruit commodities because of
the new formulation uses of pyraclostrobin in the United States that
result in higher residues in stone fruits.
C. Revisions to Petitioned-For Tolerances
EPA reduced the pyraclostrobin tolerance for coffee, bean, green
from 0.5 ppm, as proposed by BASF Corporation,
[[Page 51496]]
to 0.3 ppm because the Agency's tolerance spreadsheet determined that
the lower value was more appropriate based on the field trial data. EPA
increased the tolerance for sorghum, grain, grain (termed sorghum,
grain in PP8F7385) from 0.5 ppm to 0.60 ppm because the
Agency's tolerance spreadsheet determined that the higher value was
more appropriate based on the 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]phenyl carbamate), expressed as parent compound, in or on
coffee, bean, green at 0.3 ppm; fruit, stone, group 12 at 2.5 ppm;
sorghum, grain, forage at 5.0 ppm; sorghum, grain, grain at 0.60 ppm;
and sorghum, grain, stover at 0.80 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, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the 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: September 25, 2009.
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 by alphabetically adding the following
commodities to the table and by revising fruit, stone, group 12 in the
table in paragraph (a)(1) read as follows:
180.582 Pyraclostrobin; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Coffee, bean, green........................................ 0.3\1\
* * * * *
Fruit, stone, group 12..................................... 2.5
* * * * *
Sorghum, grain, forage..................................... 5.0
Sorghum, grain, grain...................................... 0.60
Sorghum, grain, stover..................................... 0.80
* * * * *
------------------------------------------------------------------------
\1\ There is no U.S. registration on coffee, bean, green as of September
30, 2009.
* * * * *
[FR Doc. E9-24058 Filed 10-06-09; 8:45 am]
BILLING CODE 6560-50-S