[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Rules and Regulations]
[Pages 19231-19238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08079]


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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.

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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

[[Page 19232]]

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 (202) 566-1744, and the telephone number for the 
OPP Docket is (703) 305-5805. 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: (703) 305-7090; email address: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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.

[[Page 19233]]

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.

[[Page 19234]]

 
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

[[Page 19235]]

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

[[Page 19236]]

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.

[[Page 19237]]

    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).

[[Page 19238]]

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?>