[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Rules and Regulations]
[Pages 26352-26359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11676]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0674; FRL-9994-08]


Penthiopyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
penthiopyrad in or on multiple commodities that are identified and 
discussed later in this document. In addition, this regulation removes 
certain established penthiopyrad tolerances that are superseded by new 
tolerances established in this final rule. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 6, 2019. Objections and 
requests for hearings must be received on or before August 5, 2019, 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-2017-0674, 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 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 
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-2017-0674 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 
August 5, 2019. 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-2017-0674, 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.

[[Page 26353]]

     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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
7E8616) by Interregional Research Project Number 4 (IR-4), IR-4 Project 
Headquarters, Rutgers, The State University of New Jersey, 500 College 
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 
40 CFR 180.658 be amended by establishing tolerances for residues of 
the fungicide penthiopyrad, (N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-
methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide), in or on 
Brassica, leafy greens, subgroup 4-16B at 50 parts per million (ppm); 
Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup 13-07A at 10 
ppm; Celtuce at 30 ppm; Fennel, Florence at 30 ppm; Fruit, stone, group 
12-12 at 4.0 ppm; Kohlrabi at 5.0 ppm; Leaf petiole vegetable subgroup 
22B at 30 ppm; Leafy greens subgroup 4-16A at 30 ppm; Nut, tree, group 
14-12 at 0.06 ppm; Oilseed group 20 at 1.5 ppm; and Vegetable, 
brassica, head and stem, group 5-16 at 5.0 ppm.
    The petitioner also requested that the following established 
tolerances be removed upon establishment of the petitioned-for 
tolerances: Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, 
leafy greens, subgroup 5B at 50 ppm; Canola at 1.5 ppm; Cotton, seed at 
1.5 ppm; Fruit, stone, group 12 at 4.0 ppm; Nut, tree, group 14 at 0.06 
ppm; Pistachio at 0.06 ppm; Sunflower, seed at 1.5 ppm and Vegetable, 
leafy, except Brassica, group 4 at 30 ppm. That document referenced a 
summary of the petition prepared by DuPont, 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 made 
certain corrections and modifications to petitioned-for tolerances. The 
reasons for these changes are 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 penthiopyrad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with penthiopyrad follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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 liver and thyroid are target organs for penthiopyrad toxicity. 
Metabolism studies show higher radioactive residues in the liver, 
compared to other tissues. Short-term oral exposure resulted in liver 
alterations (weight increases, enzyme changes, hypertrophy, and/or 
histopathology) in rats and mice at similar doses, and dogs at higher 
doses. Of the three species, the liver effects observed in rats were 
more significant (fatty change, hepatocellular degeneration, and 
Kupffer cell proliferation) than the liver effects in the other species 
(e.g., increased liver weight, hepatocellular hypertrophy).
    Short-term exposure also resulted in thyroid changes in mice 
(hypertrophy) and rats (decreased weight, hypertrophy/proliferation, 
and hormone changes). Other effects observed were body weight changes 
and hematological alterations in rats and dogs, along with gallbladder 
effects (inflammation and edema) in dogs. Short-term dermal exposure 
did not result in dermal irritation or systemic effects up to the limit 
dose.
    Subchronic rat studies are also available for penthiopyrad 
metabolites PCA and DM-PCA. Short-term exposure to PCA did not result 
in treatment-related effects up to the limit dose. Short-term exposure 
to DM-PCA resulted in decreased body weight gain and food consumption 
at high doses. However, the effects with DM-PCA were seen at higher 
doses than the effects observed in subchronic rat studies with the 
technical grade active ingredient.
    Long-term exposure in rats (at lower doses) resulted in liver 
effects comparable to those seen in subchronic studies, as well as 
adrenal and thyroid hypertrophy. Higher doses resulted in more 
progressive liver effects (vacuolation, periportal cell swelling, and 
necrosis), thyroid tumors (males), and ovarian hypertrophy. No effects 
were observed in the ovaries in other toxicity studies. In mice, 
chronic exposure led to liver and thyroid effects and liver tumors 
(males). Alveolar foamy cell accumulation was also seen in mice, but it 
was not considered to be an adverse effect. In dogs, effects noted 
(liver, gallbladder, and adrenal gland) were similar to those seen in 
subchronic dog studies, with the addition of gallbladder hypertrophy/
hyperplasia.
    In the developmental toxicity study in rats, comparable toxicity 
was noted in fetal and maternal animals. Effects observed were 
decreased body weight gain and food consumption, increased resorptions 
(resulting in decreased post-implantation survival), decreased litter 
size, and decreased gravid uterine weight at the limit dose. No effects 
were noted in a preliminary study in rats up to the limit dose. In the 
developmental toxicity study in rabbits, decreased fetal body weight 
was seen in the presence of maternal toxicity. Abortion was noted in 
one maternal animal, preceded by a period of markedly reduced food 
consumption and body weight loss, at the highest dose tested. In a 
preliminary study, decreased fetal body weight was seen at the limit 
dose. At lower doses, maternal effects including decreased water and 
food consumption, body

[[Page 26354]]

weight loss, and abnormal feces were seen. At the limit dose, increased 
abortions and mortality were noted in maternal animals. In the 
reproductive toxicity study in rats, body weight changes, liver, 
adrenal, and thyroid effects were seen in maternal animals in 
preliminary and definitive studies. Offspring effects included body 
weight changes, delay in preputial separation, and decreased thymus 
weights at similar doses. Decreased spleen weights were seen in 
offspring animals in the preliminary reproduction study. No 
reproductive toxicity was observed.
    In the developmental neurotoxicity study in rats (definitive 
study), decreased body weight, increased motor activity, and tremors 
were seen in offspring animals in the absence of maternal toxicity. In 
the preliminary study, decreased pup weight, deterioration, and 
mortality were seen in offspring animals in the absence of maternal 
toxicity. Clinical signs were observed in the acute neurotoxicity study 
with penthiopyrad. Transient functional alterations (hunched posture, 
unsteady gait, reduced body temperature, and increased landing 
footsplay) and decreased motor activity were seen at the estimated 
time-to-peak-effect (4 hours). In a subchronic neurotoxicity study, 
decreased body weight gain was seen at the highest dose tested; 
however, no clinical signs were observed, and there was no evidence of 
neurotoxicity.
    Immunotoxicity studies were conducted in both mice and rats for 
penthiopyrad. In the immunotoxicity study in mice, decreased plaque 
forming ability was observed at the limit dose. However, in the 
immunotoxicity study in rats, no evidence of immunotoxicity was 
observed up to the highest dose tested. General toxicity noted in the 
rat study included decreased body weight gain and food consumption, 
increased liver weight, and decreased spleen weight.
    A mutagenicity battery is available for penthiopyrad technical 
ingredient and the majority of the studies were negative; however, 
chromosome aberrations were observed at cytotoxic concentrations in an 
in vitro assay. Mutagenicity studies are also available for several 
penthiopyrad metabolites (PCA, DM-PCA, PAM, and 753-A-OH). These 
studies were usually negative; however, the PAM metabolite induced 
chromosome aberrations (-S9 after 24 hours) and PCA induced a weakly 
positive mutant frequency (after 24 hours); however, based on the 
overall analysis of the available data, penthiopyrad is not considered 
to be mutagenic.
    EPA classified penthiopyrad as having ``suggestive evidence of 
carcinogenicity,'' based on an increased incidence of treatment-related 
liver tumors in male mice. Thyroid tumors were observed in male rats 
but were not considered to be treatment related. In accordance with the 
EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005), the 
Agency has determined that the quantification of risk using a non-
linear approach based on the chronic reference dose (i.e., cRfD) which 
is 7x lower than the dose at which tumors were observed will adequately 
account for all chronic toxicity, including carcinogenicity, that could 
result from penthiopyrad exposure.
    Specific information on the studies received and the nature of the 
adverse effects caused by penthiopyrad as well as the no-observed-
adverse-effects-level (NOAEL) and the lowest-observed-adverse-effects-
level (LOAEL) identified from the toxicity studies can be found at 
http://www.regulations.gov in document SUBJECT: Penthiopyrad. Human 
Health Risk Assessment for Proposed New Use on Caneberry Subgroup 13-
07A and Bushberry Subgroup 13-07B; and Crop Group/Subgroup Conversions 
and Expansions at page 39 in docket ID number EPA-HQ-OPP-2017-0674.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (PODs) 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 previously applied penthiopyrad toxicological 
endpoints for human risk assessment is discussed in Unit III of the 
final rule published in the Federal Register of March 9, 2012 (77 FR 
14291) (FRL-9335-7). That database was recently re-evaluated/updated 
based on current practices and includes updated dermal endpoints and 
PODs selected for adults and children. As a result of the database 
update, one endpoint and POD based on the 28-day oral toxicity study in 
the dog is used for all populations, and also used to derive the 
endpoints/PODs for the incidental oral and inhalation routes of 
exposure. The updated NOAELs, LOAELs, and the PODs are summarized below 
for the affected exposure/scenarios:
    i. Children and adult dermal exposures. Children and adult dermal 
exposures were previously assessed with separate endpoints/PODs. Dermal 
exposure is now being evaluated using the same endpoint and POD for all 
ages, from the 28-day dog study. The revised dermal NOAEL is 80 
milligrams per kilogram (mg/kg/day), based on mucosal edema in gall 
bladder as well as clinical chemistry and increased organ weight/
histopathology in the livers of females at the LOAEL of 269 mg/kg/day.
    ii. Previous adult dermal assessment. The developmental rabbit 
study was previously used for the adult dermal assessment with a NOAEL 
of 75 mg/kg/day based on abortions in one animal at the LOAEL of 225 
mg/kg/day. The endpoint is not strong, and the dose spacing is 
comparable to the selected 28-day dog study.
    iii. Previous children's dermal assessment. Previously the 
developmental neurotoxicity (DNT) was selected for the children's 
dermal assessment. The respective NOAEL and LOAEL for that study are 
100 mg/kg/day and 250 mg/kg/day. Again, due to dose spacing, the study 
is comparable to the 28-dog study, whose NOAEL is protective of the DNT 
NOAEL. In addition, the effects seen in the 28-day dog study include 
gallbladder effects, an organ rats do not have, which is a potentially 
human-relevant effect.
    iv. Inhalation and incidental oral assessments. The 28-day dog 
study, which previously was used and continues to also be used for the 
inhalation and incidental oral assessments was also updated. The NOAEL 
is now 80 mg/kg/day, based on mucosal edema in the gallbladder; as well 
as clinical chemistry, increased

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organ weight and histopathology in the liver of females at the LOAEL of 
269 mg/kg/day. The updated NOAEL is comparable to or protective of 
other NOAEL and LOAEL values in the database, including those relating 
to susceptibility.
    v. Residential incidental oral, inhalation, and dermal exposures. 
The 28-day dog study is now being used to assess residential incidental 
oral, inhalation, and dermal exposures.
    A summary of the toxicological endpoints for penthiopyrad used for 
dietary and non-occupational human health risk assessment is shown in 
the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Penthiopyrad for Use in Dietary and Non-Occupational
                                          Human Health Risk Assessment
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                                    Point of departure    RfD, PAD, level of
        Exposure/scenario            and uncertainty/      concern for risk     Study and toxicological effects
                                      safety factors          assessment
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Acute dietary (All populations)..  NOAEL = 125 mg/kg/    Acute RfD = 1.25 mg/ Acute Neurotoxicity in Rats.
                                    day.                  kg/day.             LOAEL = 500 mg/kg/day, based on
                                   UFA = 10x...........  aPAD = 1.25........   transient functional alterations
                                   UFH =10x............  mg/kg/day..........   (e.g., hunched posture, unsteady
                                   FQPA SF = 1x........                        gait, reduced body temperature,
                                                                               and increased landing footsplay)
                                                                               and decreased motor activity at
                                                                               the estimated time[dash]to-peak-
                                                                               effect (4 hours) on the day of
                                                                               administration.
Chronic dietary (All populations)  NOAEL = 27 mg/kg/day  Chronic RfD = 0.27   Co-Critical Studies:
                                   UFA = 10x...........   mg/kg/day.          Chronic Toxicity/Carcinogenicity
                                   UFH =10x............  cPAD = 0.27........   in Rats LOAEL = 83 mg/kg/day,
                                   FQPA SF = 1x........  mg/kg/day..........   based on decreased body weight
                                                                               gain and adrenal effects in
                                                                               females and hepatic periportal
                                                                               fatty degeneration in males
                                                                               (NOAEL = 27 mg/kg/day).
                                                                              Chronic Toxicity in Rats.
                                                                              LOAEL = 100 mg/kg/day, based on
                                                                               altered plasma chemistry profile,
                                                                               increased liver weight and
                                                                               alterations in the adrenal and
                                                                               thyroid glands. (NOAEL = 25 mg/kg/
                                                                               day).
Incidental oral short-term (1-30   NOAEL = 80 mg/kg/day  Residential LOC for  28-Day Oral Toxicity in Dogs.
 days) and Intermediate-term (1-6  UFA = 10x...........   MOE = 100.          LOAEL = 269 mg/kg/day, based on
 months).                          UFH = 10x...........                        mucosal edema in the gall
                                   FQPA SF = 1x........                        bladder; clinical chemistry,
                                                                               increased organ weight and
                                                                               histopathology in the liver of
                                                                               females.
Dermal short-term (1-30 days);     NOAEL = 80 mg/kg/day  Residential LOC for  28-Day Oral Toxicity in Dogs.
 Intermediate-term (1-6 months).   UFA = 10x...........   MOE = 100.          LOAEL = 269 mg/kg/day, based on
                                   UFH = 10x...........                        mucosal edema in the gall
                                   FQPA SF = 1x........                        bladder; clinical chemistry,
                                   DAF = 40%...........                        increased organ weight and
                                                                               histopathology in the liver of
                                                                               females.
Inhalation short-term (1-30        NOAEL = 80 mg/kg/day  Residential LOC for  28-Day Oral Toxicity in Dogs.
 days); Intermediate-term (1-6     UFA = 10x...........   MOE = 100.          LOAEL = 269 mg/kg/day, based on
 months).                          UFH = 10x...........                        mucosal edema in the gall
                                   FQPA SF = 1x........                        bladder; clinical chemistry,
                                                                               increased organ weight and
                                                                               histopathology in the liver of
                                                                               females.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification: ``Suggestive Evidence of Carcinogenicity'' based on liver
                                    tumors in male mice. The Agency has determined that a nonlinear approach
                                    based on the chronic reference dose will be protective of potential
                                    carcinogenicity.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk estimates associated with lower
  environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed
  adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
  potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety
  Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of
  exposure. LOC = level of concern. DAF = dermal absorption factor. IAF = inhalation absorption factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to penthiopyrad, EPA considered exposure under the petitioned-
for tolerances as well as all existing penthiopyrad tolerances in 40 
CFR 180.658. EPA assessed dietary exposures from penthiopyrad 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 penthiopyrad. In estimating acute 
dietary exposure, EPA used 2003-2008 food consumption information from 
the United States Department of Agriculture (USDA) National Health and 
Nutrition Survey/What We Eat in America (NHANES/WWEIA). The acute 
dietary (food and drinking water) exposure assessment was conducted 
using the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID), Version 3.16. As to residue 
levels in food, EPA assumed 100 percent crop treated (PCT) and 
tolerance-level residues for all existing and proposed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 2003-2008 food consumption information from the 
USDA NHANES/WWEIA. The chronic dietary (food and drinking water) 
exposure assessment was conducted using DEEM-FCID, Version 3.16. As to 
residue levels in food, EPA assumed 100 PCT and tolerance-level 
residues for all existing and proposed commodities.

[[Page 26356]]

    iii. Cancer. EPA classified penthiopyrad as having ``suggestive 
evidence of carcinogenicity,'' based on an increased incidence of 
treatment-related liver tumors in male mice and determined that the 
quantification of risk using a non-linear approach (i.e., RfD) will 
adequately account for all chronic toxicity, including carcinogenicity, 
that could result from penthiopyrad exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
penthiopyrad. Tolerance level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for penthiopyrad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of penthiopyrad. 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 First Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of penthiopyrad are based on the 
use pattern of highest exposure, which is the currently labeled use on 
turf at 2.9 lbs active ingredient per acre per year. The residues of 
concern assessed in drinking water included penthiopyrad and its 
cleavage product PAM. For acute exposures, EDWCs are estimated to be 
240 parts per billion (ppb) for surface water and 1,330 ppb for ground 
water. For chronic exposures for non-cancer assessments, EDWCs are 
estimated to be 131 ppb for surface water and 978 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 1,330 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 978 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).
    Although the proposed new uses do not include any residential use, 
registered residential uses including turf, lawn, and sod could result 
in residential exposure and have been reassessed in support of this 
rulemaking to reflect updates to new dermal, inhalation, and incidental 
oral PODs. There is the potential for post-application exposure for 
individuals exposed as a result of being in an environment that has 
been previously treated with penthiopyrad. The quantitative exposure/
risk assessment for residential post-application exposures is based on 
the following scenarios:
    i. Adult dermal post-application exposure resulting from contact 
with treated turf;
    ii. Dermal post-application exposure to youth 11-16 yrs. old 
resulting from mowing and playing golf on turf;
    iii. Dermal post-application exposure to children 6-11 yrs. old 
resulting from playing golf on turf;
    iv. Dermal post-application exposure to children 1 to <2 yrs. old 
resulting from playing on turf; and
    v. Incidental oral post-application exposure to children 1 to <2 
yrs. old resulting from playing on 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 penthiopyrad to share a common mechanism of 
toxicity with any other substances, and penthiopyrad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
penthiopyrad 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 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. No evidence of increased 
quantitative or qualitative susceptibility was observed in 
developmental toxicity studies in rats or rabbits or in a reproduction 
toxicity study in rats. However, increased quantitative susceptibility 
was seen in DNT studies in rats. Decreased body weight (250 mg/kg/day), 
and increased motor activity and tremors were seen in offspring animals 
at 500 mg/kg/day. Decreased body weight was seen at 300 mg/kg/day, and 
mortality was noted at 1,000 mg/kg/day in offspring animals. The 
effects observed in offspring animals in the DNT studies were seen in 
the absence of maternal toxicity.
    EPA concluded that there is a low concern and no residual 
uncertainties for prenatal and/or postnatal toxicity effects of 
penthiopyrad, notwithstanding observed increased susceptibility seen in 
the preliminary and definitive DNT studies, based on the following 
data:
    i. The pup body weight changes noted in the definitive and 
preliminary DNT studies were also observed in developmental and 
reproduction studies at similar doses. Additionally, the body weight 
changes in these studies occurred in the presence of significant 
maternal toxicity. Although clinical signs (tremors and increased motor 
activity) were noted in offspring animals in the definitive study, the 
neurotoxic potential of penthiopyrad has been adequately characterized 
in the available neurotoxicity studies. Tremors and changes in motor 
activity were observed at very high doses in the acute neurotoxicity 
study and were not present in the subchronic neurotoxicity study. In 
the preliminary DNT study, mortality was observed in the offspring 
animals at the limit dose. However, this finding is attributed to the 
poor condition (body weight loss, under

[[Page 26357]]

activity, pallor) of the offspring animals in this dose group.
    ii. A clear NOAEL has been identified for all offspring effects in 
the DNT studies, and the PODs used in the risk assessments are 
protective of the observed effects.
    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 penthiopyrad is complete.
    ii. There is no concern for neurotoxicity after exposure to 
penthiopyrad. A complete neurotoxicity battery is available for 
penthiopyrad. The database includes acute neurotoxicity, subchronic 
neurotoxicity, and DNT studies in rats. As a result, the neurotoxic 
potential of penthiopyrad is well characterized, and no additional data 
are needed.
    iii. As discussed in Unit IV.D.2., EPA has concluded that there are 
no residual uncertainties concerning prenatal and postnatal effects, 
that would warrant retaining the 10X FQPA safety factor.
    iv. There are no residual uncertainties identified in the exposure 
databases. There are no residual uncertainties with regard to dietary 
and residential exposure. The dietary food exposure assessments were 
performed based on conservative assumptions that ensure that exposures 
to penthiopyrad are not underestimated, including tolerance-level 
residues and 100 PCT estimates for all registered commodities. The use 
of default assumptions did not result in risk estimates of concern for 
the proposed new uses. Actual exposures and risk estimates from 
penthiopyrad will likely be lower. Furthermore, conservative, upper-
bound assumptions were used to determine exposure through drinking 
water and residential sources, such that these exposures have not been 
underestimated. 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 penthiopyrad.

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 penthiopyrad will occupy 21% of the aPAD for all infants (<1-year-
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 
penthiopyrad from food and water will utilize 29% of the cPAD for all 
infants (<1-year-old), the population group receiving the greatest 
exposure.
    3. Short-and Intermediate-term risk. Short- and intermediate-term 
risk aggregate exposure takes into account short- and intermediate-term 
risk residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). The short- and 
intermediate-term toxicological endpoints for penthiopyrad are the same 
for each route of exposure. Therefore, for residential exposure 
scenarios, only short-term exposures were assessed, and are protective 
of intermediate-term exposure and risk.
    Penthiopyrad is proposed for registration for uses that could 
result in short-/intermediate-term residential exposures, and the 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short -term residential exposures 
to penthiopyrad. These assessments include exposure through the dermal 
route for adults and youth, and from dermal and incidental oral 
exposure for children (1 to <2 yrs.).
    EPA selected the following two residential exposure scenarios which 
represent the highest exposure and risk scenarios for each population: 
(1) Adult post-application exposure and (2) children's (1 to <2 yrs.) 
post-application exposure resulting from contact with treated turf. The 
level of concern for these assessments is 100. The chronic dietary 
exposure estimate for adults was the background exposure added to the 
dermal residential post-application exposure estimates. The adult 
short-term aggregate risk assessment resulted in estimated MOEs of 440. 
The chronic dietary exposure estimate for the subgroup children 1 to <2 
years old was the background exposure added to the children's dermal 
and incidental oral residential post-application exposure estimates. 
The children's short-term aggregate risk assessment resulted in 
estimated MOEs of 220. These risk estimates are not of concern to EPA.
    5. Aggregate cancer risk for U.S. population. EPA classified 
penthiopyrad as having ``suggestive evidence of carcinogenicity'' based 
on liver tumors in male mice. The quantification of risk using a non-
linear approach (i.e., the RfD) adequately accounts for all chronic 
toxicity, including carcinogenicity, therefore cancer risk is not of 
concern.
    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 penthiopyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a Liquid chromatography-tandem 
mass spectrometry (LC/MS/MS) method known as Method CEM 3399-001) is 
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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 U.S. tolerance definition for penthiopyrad is harmonized with 
those of Canada and Codex and most relevant established tolerance 
levels are harmonized with Canadian and Codex MRLs. There are currently 
no established Canadian or Codex MRLs for

[[Page 26358]]

the proposed new uses for bushberries or caneberries.

C. Revisions to Petitioned-For Tolerances

    In accordance with its authority in FFDCA section 408(d)(4)(A)(i), 
EPA is establishing tolerances in this rule that vary slightly from 
what the petitioner sought. These variations are explained below.
    1. The petitioner requested tolerances in Fruit, stone, group 12-12 
at 4.0 ppm, Kohlrabi at 5.0 ppm, and Vegetable, brassica, head and 
stem, group 5-16 at 5.0 ppm; EPA is establishing those tolerances 
without the additional zero to be consistent with OECD calculation 
procedures.
    2. The petitioner requested a tolerance for ``Fennel, Florence''; 
EPA is establishing a tolerance for the commodity ``Fennel, Florence, 
fresh leaves and stalk'' to be consistent with commodity terms the 
Agency uses in tolerances.
    3. EPA is establishing a tolerance for the Nut, tree group 14-12 
tolerance at 0.05 ppm instead of 0.06 ppm as requested in order to 
harmonize with Codex MRL. The established tolerance level is 
appropriate as the highest average field trial residue was 0.037 ppm 
while other residues were below LOQ (0.01 ppm).

D. International Trade Considerations

    In this final rule, EPA is reducing the existing tolerances for the 
commodities in the nut, tree group 14-12 from 0.06 ppm to 0.05 ppm. The 
Agency is reducing these tolerances to harmonize with Codex MRLs, and 
available residue data demonstrates that tolerances at 0.05 ppm are 
sufficient to cover residues on these commodities.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of this revision. In addition, the SPS Agreement requires that 
members provide a ``reasonable interval'' between the publication of a 
regulation subject to the agreement and its entry into force to allow 
time for producers in exporting member countries to adapt to the new 
requirement. At this time, EPA is establishing an expiration date for 
the existing tolerances to allow those tolerances to remain in effect 
for a period of six months after the effective date of this final rule, 
in order to address the requirement to provide a reasonable interval. 
After the six-month period expires, residues of penthiopyrad on 
commodities included in the nut, tree group 14-12 cannot exceed the 
newly established tolerances of 0.05 ppm.
    This reduction in tolerance levels is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. The new tolerance levels are 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of penthiopyrad, 
(N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide), in or on Brassica, leafy greens, subgroup 4-
16B at 50 ppm; Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup 
13-07A at 10 ppm; Celtuce at 30 ppm; Fennel, Florence, fresh leaves and 
stalk at 30 ppm; Fruit, stone, group 12-12 at 4 ppm; Kohlrabi at 5 ppm; 
Leaf petiole vegetable subgroup 22B at 30 ppm; Leafy greens subgroup 4-
16A at 30 ppm; Nut, tree, group 14-12 at 0.05 ppm; Oilseed group 20 at 
1.5 ppm; and Vegetable, brassica, head and stem, group 5-16 at 5 ppm. 
In addition, EPA is removing the following tolerances from paragraph 
(a)(1) because they are superseded by the new tolerances being 
established in this rulemaking: Brassica, head and stem, subgroup 5A at 
5.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm; Canola at 1.5 
ppm; Cotton, seed at 1.5 ppm; Fruit, stone, group 12 at 4.0 ppm; 
Sunflower, seed at 1.5 ppm; and Vegetable, leafy, except brassica, 
group 4 at 30 ppm. Finally, EPA is establishing a six-month expiration 
date for the established pistachio and tree nut group tolerances.

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 considered 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This 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).

[[Page 26359]]

List of Subjects in 40 CFR Part 180

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

    Dated: May 29, 2019.
Michael 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 the table in Sec.  180.658(a)(1):
0
a. Remove the entries ``Brassica, head and stem, subgroup 5A'' and 
``Brassica, leafy greens, subgroup 5B'';
0
b. Add alphabetically the commodities ``Brassica, leafy greens, 
subgroup 4-16B'', ``Bushberry subgroup 13-07B'', and ``Caneberry 
subgroup 13-07A'';
0
c. Remove the entry ``Canola'';
0
d. Add alphabetically the commodity ``Celtuce'';
0
e. Remove the entry ``Cotton, seed'';
0
f. Add alphabetically the commodity ``Fennel, Florence, fresh leaves 
and stalk'';
0
g. Remove the entry ``Fruit, stone, group 12'';
0
h. Add alphabetically the commodities ``Fruit, stone, group 12-12'', 
``Kohlrabi'', ``Leaf petiole vegetable subgroup 22B'', and ``Leafy 
greens subgroup 4-16A'';
0
i. Revise the entry ``Nut, tree, group 14'';
0
j. Add alphabetically the commodities ``Nut, tree, group 14-12'' and 
``Oilseed group 20'';
0
k. Revise the entry ``Pistachio'';
0
l. Remove the entry ``Sunflower, seed'';
0
m. Add alphabetically the commodity ``Vegetable, brassica, head and 
stem, group 5-16'';
0
n. Remove the entry ``Vegetable, leafy, except brassica, group 4''; and
0
o. Add footnote 1 to the table.
    The additions and revisions read as follows:


Sec.  180.658  Penthiopyrad; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B......................          50
 
                                * * * * *
Bushberry subgroup 13-07B...................................           6
Caneberry subgroup 13-07A...................................          10
Celtuce.....................................................          30
 
                                * * * * *
Fennel, Florence, fresh leaves and stalk....................          30
 
                                * * * * *
Fruit, stone, group 12-12...................................           4
 
                                * * * * *
Kohlrabi....................................................           5
Leaf petiole vegetable subgroup 22B.........................          30
Leafy greens subgroup 4-16A.................................          30
 
                                * * * * *
Nut, tree, group 14 \1\.....................................        0.06
Nut, tree, group 14-12......................................        0.05
 
                                * * * * *
Oilseed group 20............................................         1.5
 
                                * * * * *
Pistachio \1\...............................................        0.06
 
                                * * * * *
Vegetable, brassica, head and stem, group 5-16..............           5
 
                                * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on December 6, 2019.

* * * * *
[FR Doc. 2019-11676 Filed 6-5-19; 8:45 am]
 BILLING CODE 6560-50-P


