Pydiflumetofen; Pesticide Tolerances, 39761-39768 [2019-17144]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Rules and Regulations]
[Pages 39761-39768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17144]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0688; FRL-9997-09]


Pydiflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pydiflumetofen in or on multiple commodities which are identified and 
discussed later in this document. Syngenta Crop Protection requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective August 12, 2019. Objections and 
requests for hearings must be received on or before October 11, 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-2018-0688, is available at https://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 https://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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 
Printing Office's e-CFR site at https://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-2018-0688 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 
October 11, 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-2018-0688, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 19, 2019 (84 FR 16430) (FRL-9991-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C.

[[Page 39762]]

346a(d)(3), announcing the filing of a pesticide petition (PP 8F8696) 
by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. 
The petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the fungicide, pydiflumetofen, in or on root 
vegetable crop subgroup 1A at 0.30 parts per million (ppm); bulb 
vegetable crop subgroup 3-07A at 0.20 ppm; bulb vegetable crop subgroup 
3-07B at 2 ppm; brassica leafy greens subgroup 4-16B at 50 ppm; 
brassica head and stem crop group 5-16 at 3 ppm; leaves of root and 
tuber vegetables, crop group 2 at 15.0 ppm; edible-podded legume 
vegetables subgroup 6A at 1.0 ppm; succulent shelled pea and bean 
subgroup 6B at 0.09 ppm; citrus fruit crop group 10-10 at 0.90 ppm; 
citrus oil at 15 ppm; pome fruit crop group 11-10 at 0.20 ppm; apple, 
wet pomace at 1.0 ppm; stone fruit, cherry subgroup 12-12A at 2.0 ppm; 
stone fruit, peach subgroup 12-12B at 1.0 ppm; stone fruit, plum 
subgroup 12-12C at 0.6 ppm; plum, prune at 1.5 ppm; bushberry crop 
subgroup 13-07B at 5 ppm; berries, low growing crop subgroup 13-07G, 
except cranberry and blueberry, at 1 ppm; tree nuts crop group 14-12, 
nutmeat at 0.05 ppm; almond hull at 9.0 ppm; cottonseed subgroup 20C, 
cotton undelinted seed at 0.4 ppm; cotton gin by-products at 7.0 ppm; 
sunflower subgroup 20B at 0.60 ppm; sorghum grain at 3.0 ppm; sorghum 
forage at 1.5 ppm; and sorghum stover at 10 ppm. That document 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which some of the commodities are being set as 
well as some of the commodity definitions. 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 pydiflumetofen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pydiflumetofen 
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 liver was a common target across species tested, likely in part 
due to the extensive first pass metabolism of absorbed pydiflumetofen. 
Liver effects were either concurrent with body weight depression and 
other target organ toxicity as in rats, or the first symptoms of 
treatment-related toxicity as in mice and dogs. Liver toxicity commonly 
manifested as increased liver weight concordant with hepatocyte 
hypertrophy in all species and was accompanied by increased cholesterol 
and triglyceride serum levels and a higher incidence of liver masses 
and eosinophilic foci of cellular alteration in mice and increased 
serum levels of liver enzymes and triglycerides in dogs. Male mice 
further exhibited a dose-dependent increase in the incidence of 
hepatocellular adenomas and carcinomas (accounted for separately and 
combined) and in the frequency of individual mice exhibiting multiple 
liver adenomas following chronic exposure. Treatment-related liver 
tumors were not observed in female mice nor in rats of either sex.
    Body weight effects were also observed in rodents in response to 
treatment. Adult rats experienced depressed body weight following both 
subchronic (concurrent with liver toxicity) and chronic oral exposure 
(in isolation) and mice exhibited body weight depression following 
chronic exposure concurrent with symptoms of liver toxicity. A dose-
dependent increase in the incidence and severity of thyroid gland 
follicular cell hypertrophy was also noted in rats following subchronic 
dietary exposure at doses greater than or equal to 587 milligrams/
kilogram/day (mg/kg/day). The isolated thyroid findings occurred at a 
dose level over an order of magnitude above the subchronic and chronic 
point of departures (PODs) selected for risk assessment. In general, 
short and intermediate duration repeat dose oral exposures were well 
tolerated by adult rodents and dogs. Rodents were, however, 
considerably less tolerant of long-term exposure. Liver and body weight 
effects manifested at doses 25 and 12 times lower in chronic studies as 
compared to subchronic studies in mice and rats, respectively. A 
similar progression of toxicity was not evident in dogs.
    The database does not support a conclusion that the pesticide is a 
neurotoxicant. Although a dose-dependent decrease in two locomotor 
activity parameters, number of rears and total distance traveled, was 
observed in female adult rats only within 6 hours of exposure following 
acute gavage oral exposure to doses greater than or equal to 300 
milligrams/kilogram (mg/kg) in the acute neurotoxicity study, there 
were no neuropathology lesions or consistent evidence of other 
behavioral changes accompanying the depressed locomotor activity up to 
acute doses of 2,000 mg/kg. Detailed functional observations of rats 
and dogs following repeat dose dietary exposure did not identify 
similar changes in locomotor activity or any other behavioral changes 
indicative of neurotoxicity.
    Body weight toxicity was not a unique observation in adults; it was 
also observed in rat offspring. In the two-generation reproduction 
study, rat pups exhibited significantly reduced weight during lactation 
that persisted through weaning and into adulthood. The pup body weight 
decrements were observed in the absence of parental toxicity indicating 
post-natal susceptibility to pydiflumetofen exposure. There was no 
evidence of enhanced fetal susceptibility following gestational 
exposure to pregnant rats or rabbits in the developmental studies.
    Although there is some evidence of carcinogenicity in the database 
(i.e., hepatocellular adenomas and carcinomas in male mice), the Agency

[[Page 39763]]

has concluded that pydiflumetofen is not likely to be carcinogenic to 
humans at doses that do not induce a proliferative response in the 
liver. This conclusion is based on the limited nature of tumors seen in 
the available data (liver tumors found only in male mice), the fact 
that pydiflumetofen is not a mutagenic concern in vivo, and available 
mode of action data. The available mode of action data supports the 
Agency's conclusion that liver tumors are likely induced via activation 
of the constitutive androstane receptor (CAR) and subsequent 
stimulation of hepatocellular proliferation, and that hepatocellular 
proliferation is not likely to occur at the doses at which EPA is 
regulating exposure to pydiflumetofen. As a result, a non-linear 
approach using the chronic reference dose would adequately account for 
chronic toxicity, including carcinogenicity.
    Pydiflumetofen exhibited low acute toxicity via the dermal and 
inhalation route. Acute dermal exposure to dermal doses of 5000 mg/kg 
elicited reduced activity in rats similar to observations following 
acute oral exposure, but it did not incur mortality. Acute exposure did 
not irritate the skin nor did it elicit dermal sensitization. No dermal 
or systemic toxicity was observed following repeat-dose dermal 
exposures up to 1000 mg/kg/day. Acute lethality from inhalation 
exposure was limited to high inhalation concentrations and it was a 
mild acute eye irritant. The requirement for the subchronic inhalation 
toxicity study was waived for the pydiflumetofen risk assessment based 
on a weight of evidence (WoE) approach that considered all of the 
available hazard and exposure information for pydiflumetofen, 
including: (1) the physical-chemical properties of pydiflumetofen 
indicated low volatility (vapor pressure is 3.98 x 10-9 mm 
Hg at 25 [deg]C); (2) the use pattern and exposure scenarios; (3) the 
margins of exposure for the worst case scenarios are >=13,000 using an 
oral point of departure and assuming inhalation and oral absorption are 
equivalent; (4) pydiflumetofen exhibits low acute inhalation toxicity 
(Category IV); and (5) the current endpoints selected for risk 
assessment, liver toxicity and pup body weight decrements, were the 
most sensitive effects identified in the database and an inhalation 
study is not likely to identify a lower POD or more sensitive endpoint 
for risk assessment.
    The toxicity of 2,4,6-trichlorophenol--a pydiflumetofen metabolite 
and residue of concern in livestock commodities--was evaluated based on 
studies from the open literature that were provided by the registrant, 
identified in a previous EPA review of 2,4,6-trichlorophenol (https://www.epa.gov/sites/production/files/2016-09/documents/2-4-6-trichlorophenol.pdf) and the Agency for Toxic Substance and Disease 
Registry (ATSDR) review of chlorophenols (https://www.atsdr.cdc.gov/toxprofiles/tp107.pdf), or retrieved in a search of the literature 
conducted for this risk assessment. Based on available information, the 
absorption, distribution, metabolism and elimination (ADME) for 2,4,6-
trichlorophenol is similar to the ADME profile for pydiflumetofen: Near 
complete absorption and extensive metabolism followed by rapid 
excretion without appreciable tissue accumulation. Oral exposure to 
2,4,6-trichlorophenol elicited effects in the liver, kidneys, and 
hematopoietic system as well as body weight depression. Subchronic oral 
exposure in rats elicited an increase in liver, kidney (males only), 
and spleen weight, an increase in total protein and albumin serum 
levels, a moderate to marked increase in splenic hematopoiesis, and an 
increased incidence of hepatocyte vacuolation.
    Following chronic dietary exposure, male rats exhibited an 
increased incidence of leukemias, lymphomas, and nephropathy, and both 
sexes exhibited an increased incidence of bone marrow hyperplasia, 
leukocytosis, fatty metamorphosis in the liver, and chronic 
inflammation of the kidney. Tissue specific toxicity in mice was 
limited to the liver and manifest as an increased incidence of liver 
adenomas and carcinomas following chronic exposure. Adult body weight 
depression was observed in both rodent species. Mortality also occurred 
with greater frequency in both species at or above the limit dose. The 
few studies that examined developmental and offspring effects presented 
equivocal evidence of offspring toxicity following exposure to 2,4,6-
trichlorophenol. Prenatal subchronic drinking water exposure in female 
rats led to a reduction in litter size and perinatal drinking water 
exposure in rats elicited changes in offspring spleen and liver weight; 
however, the health of the dams and its potential contribution to the 
manifestation of the offspring effects was not discussed in this study 
so it is unclear whether the offspring toxicity is a direct result of 
exposure or secondary to maternal toxicity. In a separate study, pup 
body weight decrements were observed in the presence and absence of 
parental toxicity following subchronic exposure, but the body weight 
effect was considered a consequence of the larger litter size rather 
than treatment. In any event, the effects seen in these studies 
occurred at doses above the endpoints selected for regulation of 
pydiflumetofen exposure.
    These studies illustrate a spectrum of responses to increasing oral 
2,4,6-trichlorophenol exposure: Isolated organ weight changes and a 
reduction in litter size were observed at doses as low as 30 mg/kg/day 
with adverse effects in the target tissues and significant body weight 
depression in adult animals manifesting when the oral dose exceeded 200 
mg/kg/day. However, the 2,4,6-trichlorophenol doses that elicited the 
subchronic and chronic toxicity described above were not below the 
empirical no-observed-adverse-effect-levels (NOAELs) established in 
comparable pydiflumetofen guideline studies (after converting both to 
millimoles/kg/day) suggesting that direct exposure to 2,4,6-
trichlorophenol is not more toxic than direct exposure to 
pydiflumetofen. Direct exposure to 2,4,6-trichlorophenol is anticipated 
from dietary exposures only. The PODs selected for pydiflumetofen are 
protective of the adverse effects reported in the 2,4,6-trichlorophenol 
literature and, therefore, are adequate for assessing direct dietary 
exposure to 2,4,6-trichlorophenol.
    The carcinogenic potential of 2,4,6-tricholorophenol was assessed 
in 1990 by EPA and classified as a B2-probable human carcinogen in 
accordance with the 1986 cancer classification guidance based on an 
increased incidence of combined lymphomas and leukemias in male F344 
rats and hepatocellular adenomas or carcinomas in male and female mice. 
Since that evaluation of 2,4,6-trichlorophenol, new literature has been 
published on the human relevance of leukemias in the F344 rat. The EPA 
re-evaluated the 2,4,6-trichlorophenol carcinogenicity literature and 
the broader scientific literature on rodent leukemia to determine if 
the data supported conducting a separate cancer assessment for 2,4,6-
trichlorophenol. The rodent leukemia literature indicated that the 
leukemia finding in male F344 rats is common for this strain of rat, is 
highly variable, and lacks a direct human correlate. Although 
treatment-related, the EPA concluded the leukemia incidence in rats did 
not support a linear approach to cancer quantification given its 
questionable relevance to human health risk assessment. Furthermore, 
the incidence of lymphomas was not remarkable when examined 
independently from the leukemias and thus not evidence of 
carcinogenicity in isolation. The liver

[[Page 39764]]

tumors observed in male and female mice were considered treatment-
related; however, the tumors could not be solely attributed to 2,4,6-
trichlorophenol exposure because the investigators did not account for 
known carcinogenic contaminants of commercial 2,4,6-trichlorophenol 
solutions that may have contributed to the induction of the liver 
tumors. These carcinogenic contaminants would not be present when 
2,4,6-trichlorophenol is formed through metabolism; therefore, these 
data were not considered strong evidence of carcinogenicity and did not 
support a linear approach to 2,4,6-trichlorophenol cancer 
quantification for exposure resulting from pydiflumetofen use. The 
literature also did not suggest 2,4,6-trichlorophenol was a mutagenic 
concern in vivo.
    Based on the limited evidence of carcinogenicity and mutagenicity 
for the metabolite, the EPA concluded that using the reference dose 
(RfD) approach with the chronic dietary POD selected for the 
pydiflumetofen dietary assessment would be adequate for assessing 
direct dietary exposure to 2,4,6-trichlorophenol from the proposed 
pydiflumetofen uses. Because the chronic POD selected for 
pydiflumetofen is 66 and 165x lower than the 2,4,6-trichlorophenol dose 
(on a molar basis) that elicited tumors in rats and mice, respectively, 
this approach will be protective of potential carcinogenicity from 
exposure to the metabolite. Consequently, a separate cancer dietary 
assessment for 2,4,6-trichlorophenol is not warranted at this time.
    Specific information on the studies received and the nature of the 
adverse effects caused by pydiflumetofen as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at https://www.regulations.gov in the document titled, 
``Pydiflumetofen. Human Health Risk Assessment for New Foliar Uses on 
Berries, Low Growing, Crop Subgroup 13-07G; Brassica Head and Stem Crop 
Group 5-16; Brassica Leafy Greens Subgroup 4-16B; Bulb Vegetable Crop 
Subgroup 3-07A; Green Onion Crop Subgroup 3-07B; Bushberry Crop 
Subgroup 13-07B; Citrus Fruit Crop Group 10-10; Cottonseed Subgroup 
20C; Edible-podded Legume Vegetables Subgroup 6A; Succulent Shelled Pea 
and Bean Subgroup 6B; Pome Fruit Crop Group 11-10; Root Vegetable Crop 
Subgroup 1A; Sorghum; Stone Fruit Crop Subgroups 12-12A, 12-12B, and 
12-12C; Sunflower Subgroup 20B; Tree Nut Crop Group 14-12; Leaves of 
Root and Tuber Vegetable Crop Group 2; and New Seed Treatment Uses on 
Rapeseed Crop Subgroup 20A and Soybean; and Registration of a New Seed 
Treatment End-Use Product'' on pages 56-69 in docket ID number EPA-HQ-
OPP-2018-0688.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological 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 the NOAEL and the LOAEL are identified. 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 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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for pydiflumetofen used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of May 24, 2018 (83 FR 24036) (FRL-
9976-66). Because the available data indicate that exposure to 2,4,6-
trichlorophenol is not more toxic than direct exposure to 
pydiflumetofen and that there is insufficient information to warrant a 
separate cancer assessment of the metabolite at this time, EPA 
concludes that the endpoints for pydiflumetofen will be protective of 
effects from exposure to the metabolite 2,4,6-triclorophenol.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pydiflumetofen, EPA considered exposure under the 
petitioned-for tolerances as well as all existing pydiflumetofen 
tolerances in 40 CFR 180.699. EPA assessed dietary exposures from 
pydiflumetofen 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 pydiflumetofen. In estimating 
acute dietary exposure, EPA used 2003-2008 food consumption data from 
the US Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed tolerance-level residues and 100 
percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from USDA's NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues and 100 PCT.
    iii. Cancer. As discussed in Unit III.A., the Agency has determined 
that a separate cancer assessment is not necessary for assessing 
exposure to pydiflumetofen. Because the chronic reference dose (cRfD) 
is below 10 mg/kg/day, i.e., the lowest dose known to induce 
hepatocellular proliferation based on available MOA data, the chronic 
assessment will be protective for assessing direct dietary exposure to 
pydiflumetofen. Also discussed in Unit II.A. is the Agency's conclusion 
that a separate cancer assessment is not required for assessing 
exposure to 2,4,6-trichlorophenol (free and conjugated) and the cRfD 
will be protective of potential carcinogenic effects.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
pydiflumetofen. 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 pydiflumetofen and its degradate SYN545547 in drinking 
water. These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of pydiflumetofen. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticides in Water Calculator (PWC) the estimated 
drinking water concentrations (EDWCs) of

[[Page 39765]]

pydiflumetofen for acute exposures are estimated to be 10.4 parts per 
billion (ppb) for surface water and 113.3 ppb for ground water and for 
chronic exposures are estimated to be 3.37 ppb for surface water and 
101 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 113.3 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 101 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).
    Pydiflumetofen is registered for the following uses that could 
result in residential exposures: Golf course turf; and ornamentals 
grown in greenhouses, nurseries, and fields for residential planting. 
EPA assessed residential exposure using the following assumptions: 
Residential handler exposures are not expected since the turf and 
ornamental use labels indicate that the product is intended for use by 
professional applicators, while the crop use labels include the 
statement ``Not for residential use.'' As a result, residential handler 
exposures are not expected. There is the potential for residential 
short-term post-application exposure for individuals exposed as a 
result of being in an environment that has been previously treated with 
pydiflumetofen.
    The quantitative exposure/risk assessment for residential post-
application exposures is based on the short-term dermal exposure from 
contact with residues on treated golf course turf while golfing for 
adults, children 6 to less than 11 years old, and children 11 to less 
than 16 years old, and short-term dermal exposure from post-application 
activities with treated ornamental plants for adults and for children 
ages 6 to less than 11. Intermediate-term exposures are not expected.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://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 pydiflumetofen to share a common mechanism of 
toxicity with any other substances, and pydiflumetofen does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pydiflumetofen 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 https://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 was no evidence of 
fetal sensitivity or toxicity in rat and rabbit developmental studies; 
however, quantitative offspring sensitivity was noted in the 2-
generation reproduction study. Pup body-weight depression starting on 
day 4 of lactation and persisting into adulthood was observed at doses 
that did not elicit an adverse response in the parental rats. Although 
body weight was depressed in these animals after maturity and during 
the mating and post-mating period (specifically in males), it was 
considered evidence of offspring susceptibility because the lower body 
weight was a result of impaired growth in the pups. Reduced pup weight, 
reduced litter size, and increased liver and spleen weight in offspring 
was also noted following prenatal and perinatal exposure to the 
pydiflumetofen metabolite, 2,4,6-trichlorophenol. PODs were selected 
for each exposure scenario to be protective of the parent and 
metabolite offspring toxicity and offspring susceptibility in the risk 
evaluation.
    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 pydiflumetofen is complete.
    ii. Regarding neurotoxicity, evidence of behavioral changes in the 
pydiflumetofen toxicity database was limited to adult rats in the acute 
neurotoxicity study (ACN). Female rats exhibited depressed locomotor 
activity in the form of fewer number of rears and less distance 
traveled following acute exposure to doses of pydiflumetofen >= 300 mg/
kg (3x to 30x higher than the PODs selected for risk assessment). Male 
rats did not exhibit any symptoms of neurotoxicity following acute 
exposure up to 2,000 mg/kg/day. No evidence of neurotoxicity was 
observed in the subchronic rat and dog dietary studies that included 
additional detailed functional observations to identify neurological 
impairment nor in the routine clinical observations of the chronic 
studies and the guideline requirement for a subchronic neurotoxicity 
(SCN) study was waived. The concern for neurotoxicity in sensitive 
populations is low because the behavioral effects observed in the acute 
neurotoxicity studies have well-defined NOAEL/LOAELs, the PODs selected 
for risk assessment are protective of the acute behavioral change 
observed in females, there were no corresponding neuropathology changes 
in females exhibiting decreased locomotor activity, and there was no 
evidence of neurotoxicity following repeat-dose exposure.
    iii. There was evidence of quantitative offspring sensitivity in 
the 2-generation reproduction study; however, as noted in Section D.2., 
PODs were selected for each exposure scenario to be protective of the 
offspring susceptibility in the risk evaluation.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to pydiflumetofen in drinking water. EPA used 
similarly conservative assumptions

[[Page 39766]]

to assess residential post-application exposure. These assessments will 
not underestimate the exposure and risks posed by pydiflumetofen.

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 pydiflumetofen will occupy 9.5% of the aPAD for children 3 to 5 
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 
pydiflumetofen from food and water will utilize 29% of the cPAD for 
children 1 to 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 
pydiflumetofen 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).
    Pydiflumetofen 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 pydiflumetofen.
    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 400 for adults, 
560 for children 6 to less than 11 years old, and 2400 for children 11 
to less than 16 years old. Because EPA's level of concern for 
pydiflumetofen 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).
    An intermediate-term adverse effect was identified; however, 
pydiflumetofen 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 
pydiflumetofen.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III., the Agency has concluded that regulating on the chronic reference 
dose will be protective of potential carcinogenicity from exposure to 
pydiflumetofen. Because the chronic risk assessment did not exceed the 
Agency's level of concern, the Agency concludes there is not an 
aggregate cancer risk from exposure to pydiflumetofen.
    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 pydiflumetofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Analytical multi-residue method QuEChERS (Quick, Easy, Cheap, 
Effective, Rugged, and Safe) as described in Eurofins validation study 
S14-05402 was independently validated in the following crop matrices: 
Lettuce (high water content), wheat grain (high starch content), oil 
seed rape (high oil content) and coffee bean (difficult commodity).
    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: 
[email protected].

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 not established any MRLs for pydiflumetofen at this 
time.

C. Revisions to Petitioned-for Tolerances

    EPA has modified several of the commodity definitions to be 
consistent with Agency nomenclature as well as the numerical expression 
of many of the proposed tolerance values to conform to current EPA 
policy on trailing zeroes.
    For the tolerance in or on berries, low growing crop subgroup 13-
07G, the proposed exceptions to the tolerance for lowbush blueberry and 
for cranberry are not appropriate, since use on both lowbush blueberry 
and cranberry are included on the proposed label 100-1601 and listed 
under directions for use on strawberry and low growing berry crop 
subgroup 13-07G.
    EPA has modified several of the petitioned-for tolerances for the 
following reasons. For the tolerances in/on vegetable, root, subgroup 
1A; nut, tree, group 14-12; pea and bean, succulent shelled, subgroup 
6B; and fruit, citrus, group 10-10, the petitioner combined the 
individual commodities together in one calculator analysis when it is 
Agency practice to separate commodities. For the tolerances in/on 
vegetable, leaves of root and tuber, group 2 and sunflower subgroup 
20B, the petitioner used U.S. residue data only where the Agency used 
both U.S. and Canadian residue data for harmonization purposes. For the 
tolerance in prune, the petitioner used the highest residue (HR) value 
from the field trials while the Agency's practice is to use the highest 
average field trial (HAFT) value from the field trials. For the 
tolerance in citrus oil, the Agency's practice is to use the HAFT and 
median concentration factor, and based on these data, the appropriate 
tolerance in citrus oil is 30 ppm; hence, the petitioned-for tolerance 
(15 ppm), the basis for which was not explained in the petition, is too 
low. As a result, several of the tolerance levels being established are 
different than those proposed by the petitioner.

[[Page 39767]]

V. Conclusion

    Therefore, tolerances are established for residues of 
pydiflumetofen including its metabolites and degradates, in or on the 
following commodities. Compliance with the tolerance levels specified 
below is to be determined by measuring only pydiflumetofen (3-
(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-(2,4,6-
trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in or on the 
commodity: Almond, hulls at 9 ppm; apple, wet pomace at 1 ppm; berry, 
low growing, subgroup 13-07G at 1 ppm; brassica, leafy greens, subgroup 
4-16B at 50 ppm; bushberry subgroup 13-07B at 5 ppm; cherry subgroup 
12-12A at 2 ppm; cotton, gin byproducts at 7 ppm; cottonseed subgroup 
20C at 0.4 ppm; fruit, citrus, group 10-10 at 1 ppm; fruit, citrus, 
group 10-10, oil at 30 ppm; fruit, pome, group 11-10 at 0.2 ppm; nut, 
tree, group 14-12 at 0.07 ppm; onion, bulb, subgroup 3-07A at 0.2 ppm; 
onion, green, subgroup 3-07B at 2 ppm; pea and bean, succulent shelled, 
subgroup 6B at 0.1 ppm; peach subgroup 12-12B at 1 ppm; plum, prune, 
dried at 1 ppm; plum subgroup 12-12C at 0.6 ppm; sorghum, grain, forage 
at 1.5 ppm; sorghum, grain, grain at 3 ppm; sorghum, grain, stover at 
10 ppm; sunflower subgroup 20B at 0.5 ppm; vegetable, brassica, head 
and stem, group 5-16 at 3 ppm; vegetable, leaves of root and tuber, 
group 2 at 10 ppm; vegetable, legume, edible podded, subgroup 6A at 1 
ppm; and vegetable, root, subgroup 1A at 0.5 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), 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 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: 7/26/2019.
Daniel Rosenblatt,
Acting 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.  180.699, add alphabetically the commodities almond, hulls; 
apple, wet pomace; berry, low growing, subgroup 13-07G; Brassica, leafy 
greens, subgroup 4-16B; bushberry subgroup 13-07B; cherry subgroup 12-
12A; cotton, gin byproducts; cottonseed subgroup 20C; fruit, citrus, 
group 10-10; fruit, citrus, group 10-10, oil; fruit, pome, group 11-10; 
nut, tree, group 14-12; onion, bulb, subgroup 3-07A; onion, green, 
subgroup 3-07B; pea and bean, succulent shelled, subgroup 6B; peach 
subgroup 12-12B; plum, prune, dried; plum subgroup 12-12C; sorghum, 
grain, forage; sorghum, grain, grain; sorghum, grain, stover; sunflower 
subgroup 20B; vegetable, Brassica, head and stem, group 5-16; 
vegetable, leaves of root and tuber, group 2; vegetable, legume, edible 
podded, subgroup 6A; and vegetable, root, subgroup 1A to the table in 
paragraph (a) to read as follows:


Sec.  180.699  Pydiflumetofen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................               9
Apple, wet pomace.......................................               1
 

[[Page 39768]]

 
                              * * * * * * *
Berry, low growing, subgroup 13-07G.....................               1
Brassica, leafy greens, subgroup 4-16B..................              50
Bushberry subgroup 13-07B...............................               5
 
                              * * * * * * *
Cherry subgroup 12-12A..................................               2
 
                              * * * * * * *
Cotton, gin byproducts..................................               7
Cottonseed subgroup 20C.................................             0.4
Fruit, citrus, group 10-10..............................               1
Fruit, citrus, group 10-10, oil.........................              30
Fruit, pome, group 11-10................................             0.2
 
                              * * * * * * *
Nut, tree, group 14-12..................................            0.07
 
                              * * * * * * *
Onion, bulb, subgroup 3-07A.............................             0.2
Onion, green, subgroup 3-07B............................               2
Pea and bean, succulent shelled, subgroup 6B............             0.1
Peach subgroup 12-12B...................................               1
 
                              * * * * * * *
Plum, prune, dried......................................               1
Plum subgroup 12-12C....................................             0.6
 
                              * * * * * * *
Sorghum, grain, forage..................................             1.5
Sorghum, grain, grain...................................               3
Sorghum, grain, stover..................................              10
 
                              * * * * * * *
Sunflower subgroup 20B..................................             0.5
 
                              * * * * * * *
Vegetable, Brassica, head and stem, group 5-16..........               3
 
                              * * * * * * *
Vegetable, leaves of root and tuber, group 2............              10
Vegetable, legume, edible podded, subgroup 6A...........               1
 
                              * * * * * * *
Vegetable, root, subgroup 1A............................             0.5
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-17144 Filed 8-9-19; 8:45 am]
 BILLING CODE 6560-50-P