
[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Rules and Regulations]               
[Page 51490-51496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc09-10]                         

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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: bazuin.john@epa.gov.

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
------------------------------------------------------------------------
Almond                                                                35
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Apple                                                                 10
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Apricot                                                               10
------------------------------------------------------------------------
Barley                                                                 1
------------------------------------------------------------------------
Black bean seed                                                        5
------------------------------------------------------------------------
Broad bean (succulent)                                               2.5
------------------------------------------------------------------------
Broad bean seed                                                        5
------------------------------------------------------------------------
Cowpea (succulent)                                                   2.5
------------------------------------------------------------------------
Cowpea seed                                                            5
------------------------------------------------------------------------
 Great northern bean seed                                              5
------------------------------------------------------------------------
Kidney bean seed                                                       5
------------------------------------------------------------------------
Lima bean (succulent)                                                2.5
------------------------------------------------------------------------
Lima bean seed                                                         5
------------------------------------------------------------------------
Mung bean seed                                                         5
------------------------------------------------------------------------
Navy bean seed                                                         5
------------------------------------------------------------------------
Pink bean seed                                                         5
------------------------------------------------------------------------
Pinto bean seed                                                        5
------------------------------------------------------------------------
Snap bean (succulent)                                                2.5
------------------------------------------------------------------------
Sugar beet                                                            35
------------------------------------------------------------------------

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Blackberry                                                            20
------------------------------------------------------------------------
Blueberry                                                             20
------------------------------------------------------------------------
Broccoli                                                               5
------------------------------------------------------------------------
Cabbage                                                               10
------------------------------------------------------------------------
Napa cabbage                                                          10
------------------------------------------------------------------------
Chinese mustard cabbage                                               10
------------------------------------------------------------------------
Cantaloupe                                                            15
------------------------------------------------------------------------
Carrot                                                                25
------------------------------------------------------------------------
Celery                                                               2.5
------------------------------------------------------------------------
Cherry                                                                30
------------------------------------------------------------------------
Field corn                                                             5
------------------------------------------------------------------------
Pop corn                                                               5
------------------------------------------------------------------------
Sweet corn                                                             5
------------------------------------------------------------------------
Cucumber                                                               5
------------------------------------------------------------------------
Currant                                                                5
------------------------------------------------------------------------
Filbert                                                               10
------------------------------------------------------------------------
Garlic                                                                10
------------------------------------------------------------------------
Grape                                                                 25
------------------------------------------------------------------------
Grapefruit                                                            25
------------------------------------------------------------------------
Head lettuce                                                           5
------------------------------------------------------------------------
Leaf lettuce                                                           5
------------------------------------------------------------------------
Nectarine                                                             15
------------------------------------------------------------------------
Dry bulb onion                                                        15
------------------------------------------------------------------------
Green onion                                                           15
------------------------------------------------------------------------
Orange                                                                 5
------------------------------------------------------------------------
Succulent pea                                                          5
------------------------------------------------------------------------
Pigeon pea (succulent)                                                 5
------------------------------------------------------------------------
Peach                                                                 15
------------------------------------------------------------------------
Peanut                                                                25
------------------------------------------------------------------------
Pear                                                                  10
------------------------------------------------------------------------
Pecan                                                                2.5
------------------------------------------------------------------------
Bell pepper                                                           10
------------------------------------------------------------------------
Non-bell pepper                                                       10
------------------------------------------------------------------------
Pistachio                                                             25
------------------------------------------------------------------------
Plum                                                                   5
------------------------------------------------------------------------
Potato                                                                10
------------------------------------------------------------------------
Pumpkin                                                               20
------------------------------------------------------------------------
Raspberry                                                             35
------------------------------------------------------------------------
Soybean                                                                5
------------------------------------------------------------------------
Spinach                                                               10
------------------------------------------------------------------------
Summer squash                                                         10
------------------------------------------------------------------------
Winter squash                                                         10
------------------------------------------------------------------------
Strawberry                                                            50
------------------------------------------------------------------------
Tangerine                                                             15
------------------------------------------------------------------------
Tomato                                                                20
------------------------------------------------------------------------
Watermelon                                                            30
------------------------------------------------------------------------
Wheat                                                                  5
------------------------------------------------------------------------

    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

[[Page 51494]]

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: residuemethods@epa.gov.

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
