[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Rules and Regulations]
[Pages 51857-51863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22282]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0311; FRL-9980-56]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective October 15, 2018. Objections and 
requests for hearings must be received on or before December 14, 2018, 
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-2017-0311, 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: Michael Goodis, 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

[[Page 51858]]

determine whether this document applies to them. Potentially affected 
entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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 
Printing 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-2017-0311 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 
December 14, 2018. 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-2017-0311, by one of 
the following methods:
     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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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 
7E8569) by IR-4, Rutgers, The State University of New Jersey, 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 expressed as parent 
compound in or on Brassica, leafy greens, subgroup 4-16B at 16.0 ppm, 
celtuce at 29.0 ppm, Florence, fennel at 29.0 ppm, kohlrabi at 5.0 ppm, 
leaf petiole vegetable subgroup 22B at 29.0 ppm, leafy greens subgroup 
4-16A at 40 ppm, tropical and subtropical, medium to large fruit, 
smooth, inedible peel, subgroup 24B at 0.6 ppm, and vegetable, 
Brassica, head and stem, group 5-16 at 5.0 ppm. The petition also 
requested that the following established tolerances be removed: Avocado 
at 0.6 ppm, banana at 0.04 ppm, Brassica, head and stem, subgroup 5A at 
5.0 ppm, Brassica leafy greens, subgroup 5B, at 16.0 ppm, and 
vegetable, leafy, except Brassica, group 4 at 29 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.

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.
    The most consistently observed effects of pyraclostrobin exposure 
across species, genders, and treatment durations were diarrhea, 
decreased body weight, and decreased food consumption. Pyraclostrobin 
also causes intestinal disturbance 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 redness and chemosis (i.e., swelling of the 
conjunctiva) 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 and rabbit developmental toxicity studies, developmental 
toxicity (i.e. skeletal variations, post-implantation loss, and fetal 
resorption) was observed, as well as maternal toxicity (i.e. diarrhea, 
decreased body weight, food consumption, and clinical signs of 
toxicity). In the reproduction study, systemic toxicity manifested as 
decreased body weight in both the parents and offspring; no 
reproductive toxicity was observed.
    In the rat subchronic inhalation toxicity studies, inhalation 
toxicity

[[Page 51859]]

consisted of both portal of entry effects (i.e., olfactory atrophy/
necrosis and histiocytosis in the lungs) and systemic effects (i.e., 
hyperplasia in the duodenum).
    Pyraclostrobin was classified by the Agency as ``Not Likely to be 
Carcinogenic to Humans'' based on the lack of treatment-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. Pyraclostrobin did not 
cause immunotoxicity in mice assays.
    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 on pages 34-39 in the document titled 
``Pyraclostrobin. Human Health Risk Assessment for a Petition for the 
Establishment of Use on Greenhouse-Grown Leafy Greens, Except Head 
Lettuce, Subgroup 4-16A; Cucurbit Vegetables, Group 9; and Fruiting 
Vegetables, Group 8-10 and Crop Group Conversions and Expansion of 
Tolerances for Brassica, Leafy Greens, Subgroup 4-16B; Celtuce; 
Florence Fennel; Kohlrabi; Leaf Petiole Vegetables, Subgroup 22B; 
Tropical and Subtropical, Medium to Large Fruit, Inedible Peel, 
Subgroup 23B; and Brassica Head and Stem, Group 5-16 and a Revised 
Tolerance Level for Leafy Greens, Subgroup 4-16A'' in docket ID number 
EPA-HQ-OPP-2017-0311.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for pyraclostrobin used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 10, 2015 (80 FR 19231) (FRL-
9925-02).

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 food consumption information from the 
U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, the acute dietary exposure assessments were 
performed assuming 100 percent crop treated (PCT) and incorporating 
tolerance-level or highest field-trial residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, the chronic dietary exposure 
assessments were performed using average percent crop treated estimates 
and tolerance-level or average field-trial residues.
    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:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, and 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 in the chronic 
dietary assessment as follows:
    Almonds 45%; apples 20%; apricots 30%; barley 10%; green beans 5%; 
blueberries 40%; broccoli 5%; Brussels sprouts 15%; cabbage 10%; 
caneberries 50%; cantaloupes 15%; carrots 35%; cauliflower 5%; celery 
<2.5%; cherries 55%; chicory 5%; corn 10%; cotton (seed treatment) 10%; 
cucumber 5%; dry beans/peas 10%; garlic 10%; grapefruit 35%; grapes 
30%; hazelnuts 20%; lemons 5%; lettuce 5%; nectarines 15%; oats 5%; 
onions 30%; oranges 5%; peaches 25%; peanuts 20%; pears 20%; green peas 
5%; pecans 5%; peppers 15%; pistachios 30%; potatoes 20%; pumpkins 15%; 
soybeans (seed treatment) 10%; spinach 5%; squash 15%; strawberries 
65%; sugar beets 50%; sugarcane 5%; sweet corn 5%; tangerines 10%; 
tomatoes 25%; walnuts 10%; watermelons 25%; wheat 5%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS),

[[Page 51860]]

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 2.5%, in which case 
2.5% is used as the average PCT, or less than 1%, in which case 1% is 
used as the average PCT.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model and Exposure Analysis 
Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water 
(PRZM GW), the estimated drinking water concentrations (EDWCs) of 
pyraclostrobin for acute exposures are estimated to be 35.6 parts per 
billion (ppb) for surface water and 0.02 ppb for ground water and for 
chronic exposures 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 the acute dietary risk 
assessment, the water concentration value of 35.6 ppb was used to 
assess the contribution to drinking water. For the 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 less than 2 years old. Intermediate-term exposures are 
not likely because of the intermittent nature of applications in 
residential settings.
    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:
     Adult short-term aggregate assessment--residential dermal 
post-application exposure via activities on treated turf.
     Youth (11 to 16 years old) short-term aggregate 
assessment--residential dermal exposure from post-application golfing 
on treated turf.
     Children (6 to 11 years old) short-term aggregate 
assessment--residential dermal exposures from post-application 
activities in treated gardens.
     Children (1 to less than 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found pyraclostrobin to share a common mechanism of 
toxicity with any other substances, and pyraclostrobin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pyraclostrobin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence that 
pyraclostrobin results in increased quantitative susceptibility in rats 
or rabbits in the prenatal developmental studies or in young rats in 
the 2-generation reproduction study. Although there is evidence of 
increased qualitative 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 
quantitative 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

[[Page 51861]]

evidence of increased qualitative 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 average 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to pyraclostrobin will occupy 88% 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 29% 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 to 2 years old, 360 for children 6 to 11 years old, 1500 for youth 11 
to 16 years old, and 230 for adults. 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).
    Intermediate-term adverse effects were identified; however, 
pyraclostrobin is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
pyraclostrobin.
    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 has established MRLs for pyraclostrobin in or on various 
commodities including kale, collards, curly kale, Scotch kale, 
thousand-headed kale (not including marrow stem kale) at 1 ppm; radish 
leaves (including radish tops) at 20 ppm; lettuce, head at 2 ppm; 
banana at 0.02 ppm; mango at 0.05 ppm; papaya at 0.15 ppm; Brussels 
sprouts at 0.3 ppm; cabbages, head at 0.2 ppm; and flower-head 
brassicas (includes broccoli, broccoli Chinese and cauliflower) at 0.1 
ppm. These MRLs are different than the tolerances established for 
pyraclostrobin in the United States, however, they cannot be harmonized 
because the tolerance/MRL expressions for the U.S. and Codex are not 
harmonized and the submitted residue data support higher tolerance 
levels than those set by Codex, indicating that harmonization would 
cause legal application of pyraclostrobin by U.S. users to result in 
exceedances of domestic tolerances.

C. Revisions to Petitioned-for Tolerances

    For tolerance values that vary from what the petitioner requested, 
EPA is

[[Page 51862]]

establishing tolerance values in order to conform to current Agency 
policy on significant figures. The tolerance for tropical and 
subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B 
is not being established at this time. The request for a tolerance for 
subgroup 24B was submitted in connection with an application for 
registration of a pesticide product with multiple active ingredients. 
Because one of those active ingredients is not currently approved for 
use on the commodities in subgroup 24B, EPA is not approving use of the 
combination product on commodities in subgroup 24B. Therefore, EPA is 
not establishing the tolerance for subgroup 24B because it is not 
necessary at this time. Because a tolerance is not being established 
for subgroup 24B, the existing tolerances for avocado and banana are 
not being removed as proposed.

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 
Brassica, leafy greens, subgroup 4-16B, except watercress at 16 ppm; 
celtuce at 29 ppm; fennel, Florence at 29 ppm; kohlrabi at 5.0 ppm; 
leaf petiole vegetable, subgroup 22B at 29 ppm; leafy greens, subgroup 
4-16A at 40 ppm; and vegetable, Brassica, head and stem, group 5-16 at 
5.0 ppm. Additionally, the following established tolerances are removed 
as unnecessary due to the establishment of the above tolerances: 
Brassica, head and stem, subgroup 5A; Brassica leafy greens, subgroup 
5B; and vegetable, leafy, except brassica, group 4.

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), nor is it a regulatory action 
under Executive Order 13771, entitled ``Reducing Regulations and 
Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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: October 2, 2018.
Michael L. Goodis,
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 Sec.  180.582:
0
i. Add alphabetically the commodities ``Brassica, leafy greens, 
subgroup 4-16B, except watercress''; ``celtuce''; ``fennel, Florence''; 
``kohlrabi''; ``leaf petiole vegetable, subgroup 22B''; ``leafy greens, 
subgroup 4-16A''; and ``vegetable, Brassica, head and stem, group 5-
16'' to the table in paragraph (a)(1); and
0
ii. Remove the entries for ``Brassica, head and stem, subgroup 5A''; 
``Brassica, leafy greens, subgroup 5B''; and ``vegetable, leafy, except 
brassica, group 4'' from the table in paragraph (a)(1).
    The additions read as follows:


Sec.  180.582   Pyraclostrobin; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B, except watercress...          16
 
                                * * * * *
Celtuce.....................................................          29
 
                                * * * * *
Fennel, Florence............................................          29
 
                                * * * * *
Kohlrabi....................................................         5.0
Leaf petiole vegetable, subgroup 22B........................          29
Leafy greens, subgroup 4-16A................................          40
 
                                * * * * *
Vegetable, Brassica, head and stem, group 5-16..............         5.0
 

[[Page 51863]]

 
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[FR Doc. 2018-22282 Filed 10-12-18; 8:45 am]
 BILLING CODE 6560-50-P