[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Rules and Regulations]
[Pages 19231-19238]
[FR Doc No: 2015-08079]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0798; FRL-9925-02]

Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
pyraclostrobin in or on the herb subgroup 19A, dill seed, the stone
fruit group 12-12, and the tree nut group 14-12, except
pistachio. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective April 10, 2015. Objections and
requests for hearings must be received on or before

June 9, 2015, 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: The docket for this action, identified by docket
identification (ID) number
EPA-HQ-OPP-2013-0798, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPP Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
    &sbull; Crop production (NAICS code 111).
    &sbull; Animal production (NAICS code 112).
    &sbull; Food manufacturing (NAICS code 311).
    &sbull; Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0798 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing, and must be received by the
Hearing Clerk on or before June 9, 2015. Addresses for mail and hand
delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number
EPA-HQ-OPP-2013-0798, by one of the following
methods:
    &sbull; Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be CBI or other information whose disclosure is restricted by statute.
    &sbull; Mail: OPP Docket, Environmental Protection Agency
Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
    &sbull; Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 25, 2014 (79 FR 10458)
(FRL-9906-77), EPA issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a
pesticide petition (PP 3E8216) by IR-4, 500 College Road East,
Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR
part 180 be amended by establishing tolerances for 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) (BF 500-3), expressed as parent
compound, in or on herb, subgroup 19A at 85 ppm; and dill, seed at 100
ppm and by changing the existing entries for “fruit, stone, group
12” at 2.5 ppm to “fruit, stone, group 12-12”
at 2.5 ppm; and “nut, tree, group 14” at 0.04 ppm to
“nut, tree, group 14-12, except pistachio” at 0.04
ppm. That document referenced a summary of the petition prepared by
BASF, the registrant, which is available 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
modified the levels at which tolerances are being established for some
commodities. The reason for these changes is explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pyraclostrobin including
exposure resulting from the tolerances established by this action.

EPA's assessment of exposures and risks associated with pyraclostrobin
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    There are no concerns for reproductive susceptibility,
neurotoxicity, mutagenicity, genotoxicity, or immunotoxicity. The most
consistently observed effects resulting from pyraclostrobin exposure
across species, genders, and treatment durations were diarrhea and
decreased body weight, body weight gain, and food consumption.
Pyraclostrobin also causes intestinal disturbances, as indicated by
increased incidence of diarrhea or duodenum mucosal thickening. These
intestinal effects appeared to be related to the irritating action on
the mucus membranes as demonstrated by irritation seen in the primary
eye irritation study. In the rat acute and subchronic neurotoxicity
studies, neuropathology and behavior changes were not observed.
    In the rat developmental toxicity study, developmental toxicity
including an increased incidence of dilated renal pelvis and cervical
ribs occurred at a dose greater than the dose causing maternal toxicity
(including decreased body weights and body weight gains and reduced
food consumption and reduced food efficiency). The rabbit developmental
toxicity study indicates qualitative evidence of increased
developmental susceptibility based on increased resorptions per litter,
increased post-implantation loss and dams with total resorptions, in
the presence of maternal toxicity (reduced body weight gain, food
consumption, and food efficiency). In a dose range-finding 1-generation
reproduction study, systemic toxicity was manifested as decreased body
weight and body weight gain in both the parents and offspring. The
effects occurred at the same dose levels for both parental and the
offspring, but the decrease in pup weight was more than that in the
parental animals. However, the body weight effect was not found in the
guideline 2-generation reproduction study in either parental or
offspring animals at similar dose level. No reproductive toxicity was
seen.
    Pyraclostrobin has been classified as not likely to be carcinogenic
to humans based on the lack of treated related increase in tumor
incidence in adequately conducted carcinogenicity studies in rats and
mice. Pyraclostrobin did not cause mutagenicity or genotoxicity in the
in vivo and in vitro assays, nor did it cause immunotoxicity in T-cell
dependent antibody response assays in mice with preliminary review.
    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 document “Pyraclostrobin-Human
Health Risk Assessment for a Section 3 Registration of New Uses on Herb
Subgroup 19A and Dill Seed, Plus Crop Group Conversions on Stone Fruit
Group 12-12 and Tree Nut Group 14-12” at page 29 in
docket ID number EPA-HQ-OPP-2013-0798.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level-generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD)—and
a safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pyraclostrobin used
for human risk assessment is shown in Table 1 of this unit.

   Table 1-Summary of Toxicological Doses and Endpoints for Pyraclostrobin for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females             NOAEL = 5.0 mg/kg/    Acute RfD = 0.05 mg/ Developmental
 13-50 years of age).         day.                  kg/day.              Toxicity-Rabbit
                                   UFA = 10x...........  aPAD = 0.05 mg/kg/   LOAEL = 10.0 mg/kg/day based on
                                   UFH = 10x...........   day.                 developmental toxicity findings
                                   FQPA SF = 1x........                        of increased resorptions.
Acute dietary (General population  NOAEL = 300 mg/kg/    Acute RfD = 3.0 mg/  Acute Neurotoxicity-Rat
 including infants and children).   day.                  kg/day.             LOAEL = 1,000 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 3.0 mg/kg/     decreased body weight gain in
                                   UFH = 10x...........   day.                 males.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL = 3.4 mg/kg/    Chronic RfD = 0.034  Carcinogenicity-Rat
                                    day.                  mg/kg/day.          LOAEL = 9.2 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 0.034 mg/kg/   decreased body weight, kidney
                                   UFH = 10x...........   day.                 tubular casts and atrophy in both
                                   FQPA SF = 1x........                        sexes; increased incidence of
                                                                               liver necrosis and erosion/
                                                                               ulceration of the glandular-
                                                                               stomach and fore-stomach in
                                                                               males.

Incidental oral short-term (1 to   NOAEL = 5.8 mg/kg/    LOC for MOE = 100..  Subchronic Toxicity-Dog
 30 days) and intermediate-term     day.                                      LOAEL = 12.9 mg/kg/day based on
 (1 to 6 months).                  UFA = 10x...........                        increased incidence of diarrhea,
                                   UFH = 10x...........                        clinical chemistry changes,
                                   FQPA SF = 1x........                        duodenum mucosal hypertrophy, and
                                                                               decreased body weight and food
                                                                               efficiency.
Dermal short-term (1 to 30 days)   Oral study NOAEL =    LOC for MOE = 100..  Developmental
 and intermediate-term (1 to 6      5.0 mg/kg/day                              Toxicity-Rabbit
 months).                           (dermal absorption                        LOAEL = 10.0 mg/kg/day based on
                                    rate = 14%).                               developmental toxicity findings
                                   UFA = 10x...........                        of increased resorptions and
                                   UFH = 10x...........                        maternal toxicity based on
                                   FQPA SF = 1x........                        decreased food efficiency.
Inhalation short-term (1 to 30     Inhalation study      LOC for MOE = 30...  Inhalation Toxicity-Rat
 days) and intermediate-term (1     NOAEL = 0.010 mg/kg/                      LOAEL = 6.9 mg/kg/day (air
 to 6 months).                      day.                                       concentration = 0.03 mg/L) based
                                   UFA = 3x............                        on duodenum mucosal hyperplasia
                                   UFH = 10x...........                        and respiratory system findings
                                   FQPA SF = 1x........                        including alveolar histiocytosis
                                   fHandler =..........                        and olfactory atrophy/necrosis in
                                   16.7 L/min..........                        nasal tissue.
                                   HECHandler =........
                                   0.00131 mg/L........
                                   HECBystander =......
                                   0.00023 mg/L........
                                   HEDHandler =........
                                   0.038 mg/kg/day.....
                                  -----------------------
&qdrt;Cancer (Oral, dermal,         Classification: “Not Likely to be Carcinogenic to Humans” based
 inhalation).                           on the absence of significant tumor increases in two adequate rodent
                                                              carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). HEC = Human Equivalent Concentration. HED = Human Equivalent
  Dose. f = Respiratory frequency.

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. Such effects were identified
for pyraclostrobin.
    In estimating acute dietary exposure, EPA used Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 3.16, which uses food consumption data from
the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA)
from 2003 through 2008. As to residue levels in food, EPA used
tolerance-level residues or highest field trial residues, 100 percent
crop treated (PCT), and empirical or default processing factors.
Experimentally-derived processing factors were used for fruit juices,
tomato, sugarcane, and wheat commodities. For all other processed
commodities, 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's
2003-2008 NHANES/WWEIA. As to residue levels in food, EPA
included tolerance-level or average field trial residues, average PCT
estimates when available, and empirical processing factors.
Experimentally-derived processing factors were used for fruit juices,
tomato, sugar cane, and wheat commodities. For all other processed
commodities, DEEM default processing factors were assumed.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that pyraclostrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
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:
    &sbull; 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.
    &sbull; Condition b: The exposure estimate does not
underestimate exposure for any significant subpopulation group.
    &sbull; Condition c: Data are available on pesticide use and
food consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Almonds 40%; apples 15%; apricots 25%; barley 10%; green beans
<2.5%; blueberries 45%; broccoli 5%; cabbage 10%; caneberries 50%;
cantaloupes 15%; carrots 35%; cauliflower <2.5%; celery <2.5%;
cherries 50%; corn 10%; cotton <2.5%; cotton (seed treatment) 10%;
cucumber 10%; dry beans/peas 10%; garlic 10%; grapefruit 30%; grapes
30%; hazelnuts (filberts) 20%; lemons <2.5%; lettuce 5%; nectarines
10%; onions 25%; oranges 5%; peaches 20%; peanuts 25%; pears 15%; green
peas 5%; pecans <2.5%; peppers 10%; pistachios 30%; plums/prunes 5%;
potatoes 20%; pumpkins 20%; rice <1%; soybeans 5%; soybeans (seed
treatment) 5%; spinach 5%; squash 15%; strawberries 65%; sugar beets
45%; sweet corn 5%; tangelos 15%; tangerines 10%; tomatoes 25%; walnuts
<1%; watermelons 30%; wheat 5%; wheat (seed treatment) <1%.
    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
6-7 years. EPA uses an average PCT for chronic dietary risk
analysis. The average PCT figure for each existing use is derived by
combining available public and private market survey data for that use,
averaging across all observations, and rounding to the nearest 5%,
except for those situations in which the average PCT is less than one.
In those cases, 1% is used as the average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis.
The maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which pyraclostrobin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment 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 Pesticide Root Zone Model for Groundwater
(PRZM-GW) 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. 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 handler and post-application exposures:
Treated gardens, fruit or nut trees, tomato transplants, and turf. EPA
assessed residential exposure using the following assumptions: Short-
term adult handler exposures via the dermal and inhalation routes
resulting from application of pyraclostrobin to gardens, trees, and
turf. Short-term dermal post-application exposures were assessed for
adults, youth 11 to 16 years old, and children 6 to 11 years old.
Short-term dermal and incidental oral exposures were assessed for
children 1 to <2 years old. Based on the registered uses of
pyraclostrobin on residential and golf course turf, intermediate-term
post-application exposures are possible. However, since the short- and
intermediate-term endpoints and PODs for dermal and oral routes are the
same, the short-term exposure and risk estimates are considered to be
protective of potential intermediate-term exposure and risk.
    For the aggregate assessment, inhalation and dermal exposures were
not aggregated together because the toxicity effect from the inhalation
route of exposure was different than the effect from the dermal route
of exposure. The scenarios with the highest residential exposures that
were used in the short-term aggregate assessment for pyraclostrobin are
as follows:
    &sbull; Adult short-term aggregate
assessment-residential dermal post-application exposure via
activities on treated turf.
    &sbull; Youth (11-16 years old) short-term aggregate
assessment-residential dermal exposure from post-application
golfing on treated turf.
    &sbull; Children (6-11 years old) short-term aggregate
assessment-residential dermal exposures from post-application
activities in treated gardens.
    &sbull; Children (1<2 years old) short-term aggregate
assessment-residential dermal and hand-to-mouth exposures from
post-application exposure to treated turf.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 Web site at &fnl;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 Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence that
pyraclostrobin results in increased susceptibility in 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.
    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 complete.
    ii. There is no indication that pyraclostrobin is a neurotoxic
chemical. Effects seen in the acute and subchronic neurotoxicity
studies in rats are considered to reflect perturbations in
mitochondrial respiration leading to effects on energy production
rather than signs of neurotoxicity; therefore, 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 rats in the prenatal developmental study or in young
rats in the 2-generation reproduction study. The prenatal rabbit
developmental toxicity study showed qualitative evidence of increased
susceptibility to prenatal rabbits; however, this study was chosen for
endpoint selection for the acute dietary (females 13-49) and
short-term dermal exposure scenarios. This study has a clearly defined
NOAEL of 5.0 mg/kg/day. EPA 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 exposure assessments were performed
assuming 100 PCT and tolerance-level or highest field trial residues.
The chronic dietary exposure assessments were performed using average
PCT estimates, when available, and tolerance-level or highest field
trial residues. These data are reliable and are not expected to
underestimate risks to adults or children. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pyraclostrobin in drinking water. 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 dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
pyraclostrobin will occupy 87% of the aPAD for females 13-49
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 27% 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-term residential exposures to pyraclostrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 110 for children
1-2 years old, 380 for children 6-11 years old, 1,600 for
youth 11-16 years old, and 230 for adults from post-application
exposures. Because EPA's level of concern for pyraclostrobin is a MOE
of 100 or below, these MOEs are not of 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; however, since the
short- and intermediate-term endpoints and PODs for dermal and oral
routes are the same, the short-term exposure and risk estimates are
considered to be protective of potential intermediate-term exposure and
risk and an intermediate-term aggregate assessment was not performed.

    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, pyraclostrobin is not expected to pose a cancer risk to
humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to pyraclostrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Two adequate methods are available to enforce the tolerance
expression for residues of pyraclostrobin and the metabolite BF
500-3 in or on plant commodities: A liquid chromatography with
tandem mass spectrometry (LC/MS/MS) method, BASF Method D9908; and a
high-performance LC with ultraviolet detection (HPLC/UV) method, Method
D9904. The methods may be found in the Pesticide Analytical Manual,
Volume I.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex and U.S. residue definitions for pyraclostrobin residues
on plant commodities are different. The Codex definition is
pyraclostrobin, whereas the U.S. definition is pyraclostrobin and its
desmethoxy metabolite. Codex has not established MRLs for
pyraclostrobin on herbs or dill seed, and therefore there are no
harmonization issues for those commodities. Codex has established MRLs
for some members of the stone fruit group, i.e., cherries (3 mg/kg),
peach/nectarine (0.3 mg/kg), and plums (0.8 ppm), but does not have a
group tolerance. EPA has decided to issue a single group tolerance as
requested for the stone fruit crop group, rather than harmonize with
the individual MRLs for cherry, peach/nectarine, and plum, because
adequate data supports the crop group tolerance. Codex has established
a tree nut group tolerance at 0.02 mg/kg. The U.S. tolerance cannot be
lowered, as it includes parent and a metabolite, each at 0.02 ppm, or
0.04 ppm total.

C. Revisions to Petitioned-for Tolerances

    The tolerances being established for the herb subgroup 19A (40 ppm)
and dill seed (40 ppm) are different than what the petitioner requested
(85 ppm and 100 ppm, respectively). The requested tolerance levels for
the herb subgroup 19A and dill seed were based on the use of field
trial data without adjustment for the exaggerated application rate
(2.7X) represented by those trials. Each of the two applications of
pyraclostrobin were conducted at 2.7X the label rate, and the total
seasonal rate was 2.7X the label rate. Using the assumption of
proportionality, i.e., that the residue levels are proportional to the
rate of application, the residue results may be adjusted to the
concentrations expected at the 1X rate. The tolerance estimates at the
1X rate are 40 ppm for herb subgroup 19A and 40 ppm for dill seed.

 V. Conclusion

    Therefore, tolerances are established for residues of
pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate) (BF 500-3), expressed as parent
compound, in or on herb, subgroup 19A at 40 ppm; and dill, seed at 40
ppm. Additionally, the existing entries for “fruit, stone, group
12” at 2.5 ppm is modified to read “fruit, stone, group
12-12” at 2.5 ppm; and “nut, tree, group 14” at
0.04 ppm is modified to read “nut, tree, group 14-12,
except pistachio” at 0.04 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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 action
has been exempted from review under Executive Order 12866, this action
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 action 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: April 1, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    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. In §&thnsp;180.582:
0
a. Add alphabetically the entries for “Dill, seed”,
“Fruit, stone, group 12-12”, “Herb
subgroup19A”, and “Nut, tree, group 14-12, except
pistachio” to the table in paragraph (a)(1).
0
b. Remove the entries for “Fruit, stone, group 12”, and
“Nut, tree, group 14” in the table in paragraph (a)(1).
    The amendments read as follows:

§&thnsp;180.582  Pyraclostrobin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

*    *    *   &em
                      sp;*    *
Dill, seed..............................................              40

*    *    *   &em
                      sp;*    *
Fruit, stone, group 12-12.........................             2.5

*    *    *   &em
                      sp;*    *
Herb subgroup 19A.......................................              40

*    *    *   &em
                      sp;*    *
Nut, tree, group 14-12, except pistachio..........            0.04

*    *    *   &em
                      sp;*    *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-08079 Filed 4-9-15; 8:45 am]
 BILLING CODE 6560-50-P?>