[Federal Register Volume 73, Number 57 (Monday, March 24, 2008)]
[Rules and Regulations]
[Pages 15425-15431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5893]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0906; FRL-8355-4]


Pyraclostrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of pyraclostrobin and its desmethoxy metabolite in or on avocado; 
canistel; oat, grain; oat, hay; oat, straw; sapodilla; sapote, black; 
sapote, mamey; and star apple. It also increases the existing 
tolerances in or on barley, grain from 0.4 parts per million (ppm) to 
1.4 ppm; mango and Papaya from 0.1 ppm to 0.6 ppm. Interregional 
Research Project Number 4 (IR-4) and BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 24, 2008. Objections and 
requests for hearings must be received on or before May 23, 2008, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0906. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or

[[Page 15426]]

access available documents. All documents in the docket are listed in 
the docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0906 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before May 23, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0906, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 4, 2007 (72 FR 16352) (FRL-8119-
2); May 9, 2007 (72 FR 26372) (FRL-8121-5); and October 24, 2007 (72 FR 
60369) (FRL-8150-8), EPA issued notices pursuant to section 408(d)(3) 
of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide 
petitions (PP 6E7165, PP 6F7105 and PP 7E7245) by Interregional 
Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, 
Princeton, NJ 08540 and BASF Corporation, P.O. Box 13528, Research 
Triangle Park, NC 27709. The petitions requested that 40 CFR 180.582 be 
amended by establishing tolerances for combined residues of the 
fungicide pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-
pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester; and its 
desmethoxy metabolite; methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate, in or on herbs, fresh at 30.0 parts per 
million (ppm); avocado at 0.7 ppm; mango at 0.7 ppm; papaya at 0.7 ppm; 
sapote, black at 0.7 ppm; sapote, mamey at 0.7 ppm; canistel at 0.7 
ppm; sapodilla at 0.7 ppm; and star apple at 0.7 ppm 
(PP6E7165); in or on oat, grain at 1.0 ppm; oat, hay at 17.0 
ppm; oat, straw at 17.0 ppm; and oilseed, group at 0.4 ppm 
(PP6F7105); and in or on barley, grain at 1.3 ppm; and barley, 
straw at 9.0 ppm (PP7E7245). The notices referenced summaries 
of the petitions prepared by BASF Corporation, the registrant, which 
are available to the public in docket ID numbers EPA-HQ-OPP-2007-0117 
(PP 6E7165); EPA-HQ-OPP-2007-0214 (PP 6F7105); and EPA-HQ-OPP-2007-0906 
(PP 7E7245); available at http://www.regulations.gov. There were no 
comments received in response to the April 4, 2007 or October 24, 2007 
notices of filing; comments were received from a private citizen in 
response to the May 9, 2007 notice of filing of pesticide petition 
6F7105. EPA's response to these comments is discussed in Unit IV.C.
    IR-4 has withdrawn its request for a tolerance for combined 
residues of pyraclostrobin and its desmethoxy metabolite in or on fresh 
herbs; and EPA is deferring to a later date the decision regarding the 
proposed tolerances in or on oilseed commodities. Based upon review of 
the data supporting the

[[Page 15427]]

petitions, EPA has revised the tolerance levels for the remaining 
commodities. The reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for combined residues of pyraclostrobin and its desmethoxy 
metabolite on avocado at 0.6 ppm; barley, grain at 1.4 ppm; canistel at 
0.6 ppm; mango at 0.6 ppm; oat, grain at 1.2 ppm; oat, hay at 18 ppm; 
oat, straw at 15 ppm; papaya at 0.6 ppm; sapodilla at 0.6 ppm; sapote, 
black at 0.6 ppm; sapote, mamey at 0.6 ppm; and star apple at 0.6 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Pyraclostrobin has low to moderate acute toxicity. In repeated dose 
oral toxicity studies, the main target organs for pyraclostrobin are 
the upper gastrointestinal tract (mainly the duodenum and stomach), the 
spleen/hematopoiesis, the immune system, and the liver. There was no 
evidence of increased quantitative or qualitative susceptibility of in 
utero rats or offspring following exposure to pyraclostrobin in the rat 
developmental or reproduction toxicity studies. There was evidence of 
increased qualitative susceptibility of in utero rabbits following 
exposure to pyraclostrobin in the rabbit developmental study. Increases 
in resorptions/litter and post-implantation losses occurred at doses 
that resulted in less severe maternal toxicity (decreases in body 
weight gain and food consumption). In both the acute and subchronic 
neurotoxicity studies, there were no indications of treatment-related 
neurotoxicity.
    EPA has evaluated the carcinogenic potential of pyraclostrobin and 
concluded that, in accordance with the EPA's Final Guidelines for 
Carcinogen Risk Assessment (March 2005), pyraclostrobin should be 
classified into the category ``Not Likely to be Carcinogenic to 
Humans.'' This determination is based on no treatment-related increase 
in tumors in either sex of rats and mice, which were tested at doses 
that were adequate to assess carcinogenicity, and the lack of evidence 
of mutagenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyraclostrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document Pyraclostrobin: Human Health Risk 
Assessment for Proposed Uses on Oats, Oilseed Group (Canola and Flax), 
Plus Seed Treatment on Oats, Canola, and Flax; Tropical Fruits 
(Avocado, Black Sapote, Canistel, Mamey Sapote, Mango; Papaya, 
Sapodilla, and Star Apple); Increased Tolerance on Barley; Adding 
Aerial Application to Turf and Ornamentals; and Adding In-Furrow 
Applications to Corn, Soybean, and Sugar Beets. The referenced document 
is available in the docket established by this action, which is 
described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0906-
0003 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyraclostrobin used 
for human risk assessment can be found at http://www.regulations.gov in 
the document Pyraclostrobin: Human Health Risk Assessment for Proposed 
Uses on Oats, Oilseed Group (Canola and Flax), Plus Seed Treatment on 
Oats, Canola, and Flax; Tropical Fruits (Avocado, Black Sapote, 
Canistel, Mamey Sapote, Mango; Papaya, Sapodilla, and Star Apple); 
Increased Tolerance on Barley; Adding Aerial Application to Turf and 
Ornamentals; and Adding In-Furrow Applications to Corn, Soybean, and 
Sugar Beets at page 21 to 23 in docket ID number EPA-HQ-OPP-2007-0003.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyraclostrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing pyraclostrobin 
tolerances in 40 CFR 180.582. EPA assessed dietary

[[Page 15428]]

exposures from pyraclostrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. EPA identified such an 
effect for the general population (decreased body weight gain seen 
after a single oral dose in the rat acute neurotoxicity study) and for 
females 13 to 49 years old (increased resorptions/litter and increased 
total resorptions seen in the rabbit developmental toxicity study that 
are presumed to occur after a single exposure). The aPAD for the 
general population has been established at 3.0 milligrams/kilogram/day 
(mg/kg/day); whereas, the aPAD for females 13 to 49 years old is 
significantly lower (0.05 mg/kg/day), due to the more sensitive 
endpoint on which it is based.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed that residues are 
present at tolerance levels or for some commodities (amaranth, leafy; 
arugula; chrysanthemum; cress, garden; cress, upland; dandelion, 
leaves; fennel; parsley, leaves; radicchio; rhubarb; spinach; swiss 
chard; beans, dry; celery; lettuce, head; lettuce, leaf; and pea, dry) 
at the highest residue level found in residue field trials. One hundred 
percent crop treated (PCT) was assumed for all commodities in the 
assessment. Default processing factors were applied to all commodities 
except those for which experimentally-derived processing factors were 
available: apple juice, grape juice, citrus juices, cottonseed oil, 
tomato paste, tomato puree, wheat flour, and wheat germ.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed that residues 
are present at tolerance levels in all crops except apple, broccoli, 
celery, collard, grape, lettuce, citrus, pepper, mustard green and 
tomato. EPA relied on anticipated residues (average residues from field 
trials) for these crops. One hundred PCT was assumed for all 
commodities in the assessment. Default processing factors were applied 
to all commodities except those for which experimentally-derived 
processing factors were available: apple juice, grape juice, citrus 
juices, tomato paste, tomato puree, wheat flour, and wheat germ.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA has concluded that pyraclostrobin is ``not likely to 
be carcinogenic to humans.'' Consequently, a quantitative cancer 
exposure and risk assessment is not appropriate for pyraclostrobin.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA, must pursuant to section 408(f)(1) of FFDCA, 
require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such Data Call-Ins as are required by section 
408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. 
Data will be required to be submitted no later than 5 years from the 
date of issuance of this tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for pyraclostrobin in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the environmental 
fate characteristics of pyraclostrobin. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
pyraclostrobin for acute exposures are estimated to be 35.6 parts per 
billion (ppb) for surface water and 0.02 ppb for ground water. The EECs 
for chronic exposures are estimated to be 2.3 ppb for surface water and 
0.02 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 35.6 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 2.3 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Pyraclostrobin is currently registered for the following 
residential non-dietary sites: Residential and recreational turfgrass. 
EPA assessed residential exposure using the following assumptions: 
Residential and recreational turf applications are applied by 
professional pest control operators (PCOs) only, and, therefore, 
residential handler exposures do not occur. There is, however, a 
potential for short- and intermediate-term postapplication exposure of 
adults and children entering lawn and recreation areas previously 
treated with pyraclostrobin. Exposures from treated recreational sites 
are expected to be similar to, or in many cases lower than, those from 
treated residential turf sites; therefore, a separate exposure 
assessment for recreational turf sites was not conducted. EPA assessed 
exposures from the following residential turf postapplication 
scenarios:
    i. Adult and toddler postapplication dermal exposure from contact 
with treated lawns,
    ii. Toddlers' incidental ingestion of pesticide residues on lawns 
from hand-to-mouth transfer,
    iii. Toddlers' object-to-mouth transfer from mouthing of pesticide-
treated turfgrass, and
    iv. Toddlers' incidental ingestion of soil from pesticide-treated 
residential areas. The postapplication risk assessment was conducted in 
accordance with the Residential Standard Operating Procedures (SOPs) 
and recommended approaches of the Health Effects Division's (HED's) 
Science Advisory Council for Exposure (ExpoSAC).
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to pyraclostrobin and any 
other substances

[[Page 15429]]

and pyraclostrobin does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that pyraclostrobin has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for pyraclostrobin includes the rat and rabbit 
developmental toxicity studies and the 2-generation reproduction 
toxicity study in rats. There was no evidence of increased quantitative 
or qualitative susceptibility of in utero rats or offspring following 
exposure to pyraclostrobin in the rat developmental and reproduction 
studies. In the rabbit developmental study, there was evidence of 
increased qualitative susceptibility of in utero rabbits following 
exposure to pyraclostrobin (increases in resorptions/litter and post-
implantation losses). However, the concern is low for the qualitative 
susceptibility in the rabbit developmental study because: The 
developmental effects were seen in the presence of maternal toxicity; 
there are clear NOAELs for maternal and developmental toxicities; and 
this endpoint is used in the acute dietary (reference dose) exposure 
assessment for females, 13 years and older, as well as for short- and 
intermediate-term dermal risk assessments.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. This determination was exhaustively discussed in a prior order 
concerning pyraclostrobin, 72 FR 52108, 52118-52123 (September 12, 
2007). In summary, the safety factor decision is based on the following 
findings:
    i. The toxicity database for pyraclostrobin is complete.
    ii. There is no indication that pyraclostrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that pyraclostrobin results in increased 
susceptibility in in utero rats in the prenatal developmental study or 
in young rats in the 2-generation reproduction study. Although there is 
qualitative evidence of increased susceptibility in the prenatal 
developmental study in rabbits, the Agency did not identify any 
residual uncertainties after establishing toxicity endpoints and 
traditional UFs to be used in the risk assessment of pyraclostrobin. 
The degree of concern for prenatal toxicity is low.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues or anticipated residues derived 
from reliable field trial data. Conservative ground and surface water 
modeling estimates were used. Similarly, conservative assumptions were 
used to assess post-application dermal exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by pyraclostrobin.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, EPA performed two different acute risk 
assessments - one focusing on females 13 to 49 years old and designed 
to protect against prenatal effects and the other focusing on acute 
effects relevant to all other population groups. The more sensitive 
acute endpoint was seen as to prenatal effects rather than other acute 
effects. For females 13 to 49 years old, the acute dietary exposure 
from food and water will occupy 80% of the aPAD addressing prenatal 
effects. As to acute effects other than prenatal effects, the acute 
dietary exposure from food and water to pyraclostrobin will occupy 2.4% 
of the aPAD for children 1 to 2 years old, the population subgroup with 
the highest estimated acute dietary exposure to pyraclostrobin.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyraclostrobin from food and water will utilize 48% of the cPAD for 
children 1 to 2 years old, the population subgroup with the highest 
estimated exposure and risk. Based on the use pattern, chronic 
residential exposure to residues of pyraclostrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Pyraclostrobin is currently registered for uses that could result 
in short-term residential exposure and the Agency has determined that 
it is appropriate to aggregate chronic food and water and short-term 
exposures for pyraclostrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of 200 for adults and 100 
for children, 1 to 2 years old. The aggregate MOE for adults is based 
on the residential turf scenario and includes combined food, drinking 
water and post-application dermal exposures. The aggregate MOE for 
children includes food, drinking water, post-application dermal and 
incidental oral exposures from entering turf areas previously treated 
with pyraclostrobin.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pyraclostrobin is currently registered for uses that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for pyraclostrobin. Since the endpoints and 
points of departure (NOAELs) are identical for short- and intermediate-
term exposures, the

[[Page 15430]]

aggregate MOEs for intermediate-term exposure are the same as those for 
short-term exposure (200 for adults and 100 for children, 1 to 2 years 
old).
    5. Aggregate cancer risk for U.S. population. EPA has classified 
pyraclostrobin into the category ``Not Likely to be Carcinogenic to 
Humans.'' Pyraclostrobin is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to pyraclostrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography/mass 
spectrometry (LC/MS/MS) method (BASF Method D9808), and a high 
performance liquid chromatography using untraviolet detection (HPLC/UV) 
method (BASF Method D9904)) is available to enforce the tolerance 
expression. The methods may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    The Codex Alimentarius Commission has established maximum residue 
limits (MRLs) for residues of pyraclostrobin, per se, at 0.5 ppm in or 
on oats and barley and at 0.05 ppm in or on papaya. The U.S. tolerance 
levels on these commodities are higher than the corresponding CODEX 
MRLs because the U.S. tolerances, unlike the Codex MRLs, include both 
pyraclostrobin and its desmethoxy metabolite.

C. Response to Comments

    EPA received comments from a private citizen in response to the 
notice of filing of several pesticide petitions (including PP 6F7105; 
docket ID number EPA-HQ-OPP-2007-0214) which was published in the 
Federal Register on May 9, 2007 (72 FR 26372-26375) (FRL-8121-5). 
Although none of the comments specifically addressed pyraclostrobin, 
the commenter expressed concerns generally about the testing of 
pesticides, their toxicity (including potential carcinogenicity), 
residues in food and potential effects on bees. Comments received 
contained no scientific data or other substantive evidence to rebut the 
Agency's finding that there is a reasonable certainty that no harm will 
result from aggregate exposure to pyraclostrobin from the establishment 
of these tolerances. The Agency has received these same or similar 
comments from this commenter on numerous previous occasions. Refer to 
the Federal Register of June 30, 2005 (70 FR 37686) (FRL-7718-3), 
Janaury 7, 2005 (70 FR 1354) (FRL-7691-4), and October 29, 2004 (69 FR 
63096-63098) (FRL-7681-9) for the Agency's previous responses to these 
objections. In response to the commenter's question about potential 
effects on bees, EPA would note that the environmental effects of a 
pesticide are considered in the registration process for pesticides 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 
7 U.S.C. 136 et seq.

D. Changes to Proposed Tolerances

    Based upon review of the data supporting the petitions, EPA has 
modified the proposed tolerances as follows: (1) Revised the tolerance 
levels for oat, grain from 1.0 ppm to 1.2 ppm; oat, hay from 17 ppm to 
18 ppm; and oat, straw from 17 ppm to 15 ppm; (2) decreased the 
tolerances for avocado, canistel, mango, papaya, sapodilla, sapote 
(black and mamey) and star apple from 0.7 ppm to 0.6 ppm; and (3) 
revised the barley, grain tolerance from 1.3 ppm to 1.4 ppm and 
determined that the existing tolerance of 6.0 ppm for barley, straw is 
adequate and should not be raised to 9.0 ppm, as proposed by IR-4. EPA 
made these changes based on analyses of the residue field trial data 
using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy 
metabolite; methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate, in or on avocado at 0.6 ppm; barley, 
grain at 1.4 ppm; canistel at 0.6 ppm; mango at 0.6 ppm; oat, grain at 
1.2 ppm; oat, hay at 18 ppm; oat, straw at 15 ppm; papaya at 0.6 ppm; 
sapodilla at 0.6 ppm; sapote, black at 0.6 ppm; sapote, mamey at 0.6 
ppm; and star apple at 0.6 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to petitions submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology

[[Page 15431]]

Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 
section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 18, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.582 is amended in the table in paragraph (a)(1) by 
revising the tolerances for ``barley, grain'', ``mango'' and 
``papaya''; removing the footnote; and alphabetically adding new 
commodities to read as follows:


180.582  Pyraclostrobin; tolerances for residues.

    (a)* * * (1)* * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Avocado....................................................          0.6
                                * * * * *
Barley, grain..............................................          1.4
                                * * * * *
Canistel...................................................          0.6
                                * * * * *
Mango......................................................          0.6
                                * * * * *
Oat, grain.................................................          1.2
Oat, hay...................................................           18
Oat, straw.................................................           15
Papaya.....................................................          0.6
                                * * * * *
Sapodilla..................................................          0.6
Sapote, black..............................................          0.6
Sapote, mamey..............................................          0.6
                                * * * * *
Star apple.................................................          0.6
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-5893 Filed 3-21-08; 8:45 am]
BILLING CODE 6560-50-S