Pyraclostrobin; Pesticide Tolerances, 42324-42330 [2010-17793]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Rules and Regulations]
[Pages 42324-42330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17793]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0528; FRL-8834-8]


Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyraclostrobin in or on alfalfa and poultry, and increases tolerances 
for residues in or on soybean. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 21, 2010. Objections and 
requests for hearings must be received on or before September 20, 2010, 
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-2010-0528. All documents in the 
docket are listed in the docket index available at https://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 https://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: Shaunta Hill, Registration Division 
(7504P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8961; e-mail address: hill.shaunta@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may 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 https://www.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 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-2010-0528 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 20, 2010. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0528, by one of the following methods:
     Federal eRulemaking Portal: https://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. Summary of Petitioned-For Tolerance

    In the Federal Register of February 4, 2010 (75 FR 5792) (FRL-9110-
5) and June 8, 2010 (75 FR 32465) (FRL-8827-5), 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 9F7590 and PP 9F7528, 
respectively, by BASF Corporation, P.O. Box 13528, Research

[[Page 42325]]

Triangle Park, NC 27709. The petitions requested that 40 CFR 180.582 be 
amended by increasing tolerances for residues of the fungicide 
pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester, in or on soybean, forage 
at 11.0 parts per million (ppm) (PP 9F7590), and soybean, hay at 14.0 
ppm (PP 9F7590), and by establishing tolerances for residues for 
alfalfa, forage at 10 ppm (PP 9F7528), alfalfa, hay at 30 ppm (PP 
9F7528), poultry, fat at 0.1 ppm (PP 9F7528); poultry, meat byproducts 
at 0.1 ppm (PP 9F7528); poultry, meat at 0.1 ppm (PP 9F7528); and 
poultry, eggs at 0.1 ppm (PP 9F7528). These notices referenced a 
summary of the petition prepared by BASF Corporation, the registrant, 
which is available in the docket at https://www.regulations.gov. There 
were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for pyraclostrobin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pyraclostrobin 
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/kilogram (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 https://www.regulations.gov in document ``Revised Pyraclostrobin: Human Health 
Risk Assessment for Proposed Uses on Cotton and Belgian Endive'' at 
page 15 in docket ID number EPA-HQ-OPP-2006-0522.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyraclostrobin used 
for human risk assessment can be found at https://www.regulations.gov in 
document ``Pyraclostrobin: Human Health Risk Assessment for Proposed 
Uses on Grain Sorghum (PP8F7385); Increase of Tolerance for 
the Stone Fruit Crop Group 12 to Satisfy European Union (EU) Import 
Requirement (PP8F7390); and Establishment of a Permanent 
Import Tolerance for Coffee (PP8E7394)'' at 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% 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

[[Page 42326]]

derived processing factors were used for fruit juices, tomato, and 
wheat commodities but for all other processed commodities Dietary 
Exposure Evaluation Model (DEEMTM) 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 estimated the PCT for existing uses as follows:

------------------------------------------------------------------------
                         Commodity                               PCT
------------------------------------------------------------------------
Almond.....................................................          35%
Apple......................................................          10%
Apricot....................................................          10%
Barley.....................................................           1%
Bell pepper................................................          10%
Black bean seed............................................           5%
Blackberry.................................................          20%
Blueberry..................................................          20%
Broad bean (succulent).....................................         2.5%
Broad bean seed............................................           5%
Broccoli...................................................           5%
Cabbage....................................................          10%
Cantaloupe.................................................          15%
Carrot.....................................................          25%
Celery.....................................................         2.5%
Cherry.....................................................          30%
Chinese mustard cabbage....................................          10%
Cowpea seed................................................           5%
Cowpea (succulent).........................................         2.5%
Cucumber...................................................           5%
Currant....................................................           5%
Dry bulb onion.............................................          15%
Field corn.................................................           5%
Filbert....................................................          10%
Garlic.....................................................          10%
Grape......................................................          25%
Grapefruit.................................................          25%
Great northern bean seed...................................           5%
Green onion................................................          15%
Head lettuce...............................................           5%
Leaf lettuce...............................................           5%
Kidney bean seed...........................................           5%
Lima bean seed.............................................           5%
Lima bean (succulent)......................................         2.5%
Mung bean seed.............................................           5%
Napa cabbage...............................................          10%
Navy bean seed.............................................           5%
Nectarine..................................................          15%
Non-bell pepper............................................          10%
Orange.....................................................           5%
Peach......................................................          15%
Peanut.....................................................          25%
Pear.......................................................          10%
Pecan......................................................         2.5%
Pigeon pea (succulent).....................................           5%
Pink bean seed.............................................           5%
Pinto bean seed............................................           5%
Pistachio..................................................          25%
Plum.......................................................           5%
Pop corn...................................................           5%
Potato.....................................................          10%
Pumpkin....................................................          20%
Raspberry..................................................          35%
Snap bean (succulent)......................................         2.5%
Soybean....................................................           5%
Spinach....................................................          10%
Strawberry.................................................          50%
Succulent pea..............................................           5%
Sugar beet.................................................          35%
Summer squash..............................................          10%
Sweet corn.................................................           5%
Tangerine..................................................          15%
Tomato.....................................................          20%
Watermelon.................................................          30%
Wheat......................................................           5%
Winter squash..............................................          10%
------------------------------------------------------------------------

    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (USDA/NASS), proprietary market 
surveys, and the National Pesticide Use Database for the chemical/crop 
combination for the most recent 6-7 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 pyraclostrobin 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

[[Page 42327]]

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 https://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 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:
    (1) Short-/intermediate-term adult and toddler post-application 
dermal exposure from contact with treated lawns.
    (2) Short-/intermediate-term toddlers' incidental ingestion of 
pesticide residues on lawns from hand-to-mouth transfer.
    (3) Short-/intermediate-term toddlers' object-to-mouth transfer 
from mouthing of pesticide-treated turfgrass.
    (4) 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 https://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 pre-natal 
and post-natal toxicity and the completeness of the database on 
toxicity and exposure unless EPA determines based on reliable data that 
a different margin of safety will be safe for infants and children. 
This additional margin of safety is commonly referred to as the FQPA 
Safety Factor (SF). In applying this provision, EPA either retains the 
default value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Pre-natal and post-natal sensitivity. The pre-natal and post-
natal 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 rabbit, 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 pre-natal 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 (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. 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 pre-
natal and post-natal exposures. Increased spleen weights observed in 
28-day and 90-day rat studies were accompanied with mild hemolytic 
anemia (a hematopoieses 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/

[[Page 42328]]

day. A similar conclusion was reached in an earlier action on 
pyraclostrobin. (See 72 FR 52108, 52120 (September 12, 2007)) (FRL-
8144-4). 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 UFs to account for neurotoxicity.
    iii. There is no evidence that pyraclostrobin results in increased 
quantitative 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 pre-natal and/or post-natal 
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% crop 
treated. The chronic dietary food exposure assessments were performed 
using tolerance-level or average field trial residues and 100% CT 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. 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 to 49 
years old, and 3% 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 to 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-term residential exposures to pyraclostrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 230 for adults 
and 120 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, 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 through 
food and water with intermediate-term residential exposures to 
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 result in 
aggregate MOEs of 230 for adults and 120 for children 1 to 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. MOEs above 100 are considered to be of no concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, pyraclostrobin is not expected to pose a cancer risk to 
humans.
    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

Analytical Enforcement Methodology

    There are adequate residue analytical methods for tolerance 
enforcement. The analytical methods for plant commodities are liquid 
chromatography with tandem mass spectroscopy/mass spectroscopy detector 
(LC/MS/MS) and high pressure liquid chromatography with ultraviolet 
detector (HPLC/UV), which both measure pyraclostrobin and its 
desmethoxy metabolite. The analytical methods for live stock 
commodities, gas chromatography with mass spectroscopy detector (GC/MS) 
and LC/MS/MS, convert pyraclostrobin and related metabolites to 
chlorophenylpyrazolol (BF 500-5) and hydroxylated chlorophenylpyrazolol 
(BF 500-8) in goats and chlorophenylpyrazolol (BF 500-5) and 
hydroxylated chlorophenylpyrazolol (BF 500-9) in poultry.
     The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

[[Page 42329]]

B. International Residue Limits

    There are currently no proposed or established Codex, Canadian, or 
Mexican Maximum Residue Limits (MRLs) for residues of pyraclostrobin on 
alfalfa and soybeans. However, there are Canadian MRLs for various 
livestock commodities, including poultry meat, meat byproducts and 
eggs. The U.S. tolerance and Canadian MRL expressions are the same for 
both plant and livestock commodities, but several of the recommended 
changes in tolerances on livestock commodities will result in 
differences between the U.S. tolerances and the respective Canadian 
MRLs, due to increase in poultry dietary burden as a result of 
registration of alfalfa.

V. Conclusion

    Therefore, tolerances are established for residues of 
pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl] phenyl]methoxy-, methyl ester, in or on alfafa, forage 
at 10 ppm; alfalfa, hay at 30 ppm; poultry, fat at 0.1 ppm; poultry, 
meat byproducts at 0.1 ppm; poultry, meat at 0.1 ppm; poultry, eggs at 
0.1 ppm; and tolerances are increased for residues in or on soybean; 
forage at 11 ppm; and soybean, hay; at 14 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 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 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: July 12, 2010.
Lois Ann 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 as follows:
    a. Revise the introductory text of paragraph (a)(1).
    b. Add alphabetically the commodities ``Alfalfa, forage'' and 
``Alfalfa, hay'' to the table in paragraph (a)(1).
    c. Revise the entries for ``Soybean, forage'' and ``Soybean, hay.'' 
in the table in paragraph (a)(1).
    d. Add alphabetically four commodities to the table in paragraph 
(a)(2).


Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide pyradostrobin, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum 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), calculated as the stoichiometric equivalent of 
pyraclostrobin, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................           10
Alfalfa, hay...............................................           30
 
                                * * * * *
Soybean, forage............................................           11
Soybean, hay...............................................           14
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Poultry, eggs..............................................         0.10

[[Page 42330]]

 
Poultry, fat...............................................         0.10
Poultry, meat..............................................         0.10
Poultry, meat by-products..................................         0.10
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-17793 Filed 7-20-10; 8:45 am]
BILLING CODE 6560-50-S