Document ID: EPA-HQ-OPP-2015-0775-0051
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Pydiflumetofen
Posted Date: 2018-05-24T04:00Z

[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Rules and Regulations]
[Pages 24036-24044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11192]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0775; FRL-9976-66]

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 May 24, 2018. Objections and 
requests for hearings must be received on or before July 23, 2018, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0775, 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

[[Page 24037]]

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 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-2015-0775 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 
July 23, 2018. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0775, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-
86), 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 
6F8474) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested to establish tolerances in 40 CFR part 
180 for residues of the fungicide pydiflumetofen in or on barley, grain 
at 4.0 ppm; barley, hay at 30.0 ppm; barley, straw at 30.0 ppm; corn, 
field, grain at 0.015 ppm; corn, field, forage at 6.0 ppm; corn, field, 
stover at 15.0 ppm; corn, field, milled by products at 0.06 ppm; corn, 
pop, grain at 0.015 ppm; corn, pop, forage at 6.0 ppm; corn, pop, 
stover at 15.0 ppm; corn, sweet, ear at 0.01 ppm; corn, sweet, forage 
at 5.0 ppm; corn, sweet, stover at 9.0 ppm; corn, sweet, cannery waste 
at 2.0 ppm; crop subgroup 4-15A, leafy greens subgroup at 40.0 ppm; 
crop subgroup 22B, leaf petiole vegetable subgroup at 15.0 ppm; fruits, 
small vine climbing, except fuzzy kiwi subgroup 13-07F at 1.5 ppm; 
grape, raisin at 2.0 ppm; grape, wet pomace at 1.5 ppm; grain, 
aspirated fractions at 100.0 ppm; grain, cereal, forage, fodder and 
straw, group 16 at 50 ppm; oat, grain at 2.0 ppm; oat, forage at 10.0 
ppm; oat, hay at 40.0 ppm; oat, straw at 20.0 ppm; peas and bean, dried 
shelled, except soybean, subgroup 6C at 0.4 ppm; peas, hay at 40.0 ppm; 
peas, vine at 6.0 ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil 
at 0.05 ppm; peanut, hay at 20.0 ppm; potato, wet peel at 0.03 ppm; 
potato, dried pulp at 0.05 ppm; potato, processed waste at 0.03 ppm; 
quinoa, grain at 4.0 ppm; rapeseed, subgroup 20A at 0.9 ppm; rye, grain 
at 4.0 ppm; rye, hay at 50.0 ppm; rye, straw at 30.0 ppm; soybean, seed 
at 0.4 ppm; soybean, forage at 30.0 ppm; soybean, hay at 150 ppm; 
tomato, dried pomace at 15.0 ppm; tomato, wet pomace at 1.5 ppm; 
tomato, sun-dried at 3.0 ppm; vegetables, fruiting, crop group 8-10 at 
0.6 ppm; vegetables, tuberous and corm subgroup 1C at 0.015 ppm; 
vegetables, cucurbit, crop group 9 at 0.5 ppm; wheat, grain at 0.3 ppm; 
wheat, forage at 15.0 ppm; wheat, hay at 50.0 ppm; and wheat, straw at 
30.0 ppm.
    Additionally, the petition requested to establish tolerances for 
residues of pydiflumetofen and 2,4,6-trichlorophenol in or on cattle, 
fat at 0.03 ppm; cattle, kidney at 0.02 ppm; cattle, liver at 0.04 ppm; 
cattle, meat at 0.02 ppm; cattle, byproducts at 0.04 ppm; goat, fat at 
0.03 ppm; goat, kidney at 0.02 ppm; goat, liver at 0.04 ppm; goat, meat 
at 0.02 ppm; goat, meat byproducts at 0.04 ppm; horse, fat at 0.03 ppm; 
horse, kidney at 0.02 ppm; horse, liver at 0.04 ppm; horse, meat at 
0.02 ppm; horse, meat byproducts at 0.04 ppm; milk at 0.02 ppm; milk, 
cream at 0.04 ppm; sheep, fat at 0.03 ppm; sheep, kidney at 0.02 ppm; 
sheep, liver at 0.04 ppm; sheep, meat at 0.02 ppm; and sheep, meat 
byproducts at 0.04 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Consistent with the authority in FFDCA section 408(d)(4)(A)(1), EPA 
is establishing tolerances as requested with some variations. The 
reasons for these changes are explained in Unit IV.D.

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

[[Page 24038]]

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 mg/kg/day. 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 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 2000 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 
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 [gteqt]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. The absorption,

[[Page 24039]]

distribution, metabolism and elimination (ADME) information available 
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 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. Furthermore, direct exposure to 2,4,6-
trichlorophenol is anticipated from dietary exposures only and the 
dietary PODs selected for pydiflumetofen are protective of all adverse 
effects reported in the 2,4,6-trichlorophenol literature.
    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 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 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 referenced in this 
section and the nature of the adverse effects caused by pydiflumetofen 
and its metabolite 2,4,6-triclorophenol, as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Pydiflumetofen. Human 
Health Risk Assessment for Foliar Uses on Cereals (Wheat, Triticale, 
Barley, Rye, and Oat), Quinoa, Corn (Field, Pop, and Sweet), Cucurbits 
Crop Group 9 (Including Greenhouse Use on Cucumber), Fruiting 
Vegetables Crop Group 8-10, Small Fruit Vine Climbing Subgroup 13-07F 
(Except Fuzzy Kiwifruit), Peas and Beans Dried Shelled Subgroup 6C, 
Leafy Greens Subgroup 4-16A, Leaf Petiole Vegetables Subgroup 22B, 
Peanuts, Rapeseed Subgroup 20A, Soybean, Tuberous and Corm Vegetable 
Subgroup 1C, Golf Course Turf, and Ornamentals (Including Greenhouse 
Use'' on pages 61-73 in docket ID number EPA-HQ-OPP-2015-0775.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment.

[[Page 24040]]

PODs are developed based on a careful analysis of the doses in each 
toxicological study to determine the dose at which no adverse effects 
are observed (the NOAEL) and the lowest dose at which adverse effects 
of concern are identified (the LOAEL). Uncertainty/safety factors are 
used in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a 
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will 
lead to some degree of risk. Thus, the Agency estimates risk in terms 
of the probability of an occurrence of the adverse effect expected in a 
lifetime. For more information on the general principles EPA uses in 
risk characterization and a complete description of the risk assessment 
process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for pydiflumetofen used 
for human risk assessment is shown in Table 1 of this unit. Because the 
Agency concludes that that the pydiflumetofen toxicity database 
accounts for 2,4,6-trichlorophenol toxicity that would result from 
exposure to pydiflumetofen, that exposure to the metabolite 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-trichlorophenol.

Table 1--Summary of Toxicological Doses and Endpoints for Pydiflumetofen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations     NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity study--rat.
 including infants and children).   day UFA = 10x.        day.                LOAEL = 300 mg/kg/day based on a
                                   UFH = 10x...........  aPAD = 1 mg/kg/day.   decrease in locomotor activity
                                   FQPA SF = 1x........                        (the number of rears and total
                                                                               distance traveled) in females.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 9.2 mg/kg/day  Chronic RfD = 0.092  Carcinogenicity study--mouse.
                                    UFA = 10x.            mg/kg/day.          MRID 49557940.
                                   UFH = 10x...........  cPAD = 0.092 mg/kg/  LOAEL = 45.4 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 liver weight increase concordant
                                                                               with higher incidence of liver
                                                                               masses, eosinophilic foci of
                                                                               cellular alteration, and
                                                                               centrilobular hypertrophy.
----------------------------------------------------------------------------------------------------------------
Oral short-term (1 to 30 days)...  NOAEL= 36.1 mg/kg/    LOC for MOE = 100..  2-generation reproduction study--
                                    day UFA = 10x.                             rat.
                                   UFH = 10x...........                       LOAEL = 116.2 mg/kg/day based on
                                   FQPA SF = 1x........                        reduced pup weight in the F1
                                                                               generation.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  NOAEL = 36.1 mg/kg/   LOC for MOE = 100..  2-generation reproduction study--
                                    day (dermal                                rat.
                                    absorption rate =                         LOAEL = 116.2 mg/kg/day based on
                                    17%.                                       reduced pup weight in the F1
                                   UFA = 10x...........                        generation.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not Likely to be Carcinogenic to Humans'' at doses that do
                                    not induce a proliferative response in the liver. EPA has determined that a
                                    nonlinear approach is appropriate and that the cRfD will be protective of
                                    cancer effects.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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. 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

[[Page 24041]]

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 using a total toxic residues approach. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pydiflumetofen and degradate SYN545547. 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 Pesticides Water Calculator (PWC) modeling, the 
estimated drinking water concentrations (EDWCs) of pydiflumetofen for 
acute exposures are estimated to be 17 parts per billion (ppb) for 
surface water and 95 ppb for ground water and for chronic exposures are 
estimated to be 3.62 ppb for surface water and 93.4 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 95 ppb was used to assess 
the contribution to drinking water.
    For the chronic dietary risk assessment, the water concentration of 
value 93.4 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 proposed for the following uses that could result 
in residential exposures: Golf course turf and ornamentals in 
greenhouses, nurseries, fields, and outdoor residential landscapes. EPA 
assessed residential exposure using the following assumptions: 
Residential handler exposures are not expected since the proposed 
residential uses require that handlers wear specific clothing (e.g., 
long-sleeved shirt and long pants; shoes plus socks) and/or personal 
protective equipment, and the turf and ornamental use labels will 
indicate that the product is intended for use by professional 
applicators, while the crop use labels will include the statement ``Not 
for residential use.'' As a result, a residential handler assessment 
was not conducted. 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 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 pydiflumetofen to share a common mechanism of 
toxicity with any other substances, and although pydiflumetofen 
metabolizes into 2,4,6-trichlorophenol, this metabolite does not appear 
to be produced by other registered pesticides. 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 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. 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

[[Page 24042]]

rats did not exhibit any symptoms of neurotoxicity following acute 
exposure up to 2000 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 an 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 to assess post-application exposure 
of children. 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 8.5% of the aPAD at the 95th percentile 
of exposure for children 3-5 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 21% of the cPAD for 
children 3-5 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, 
590 for children 6 to less than 11 years old, and 2,500 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).
    Intermediate-term adverse effects were 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). 
QuEChERS has been proposed as the enforcement analytical method for 
plant commodities.
    The livestock analytical method was derived from the QuEChERS (EN 
15662:2009-02) multi-residue method. It is based on extraction and 
clean-up procedures, and subsequent LC-MS/MS determination.
    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.

[[Page 24043]]

C. Revisions to Petitioned-For Tolerances

    The applicant requested a few tolerances on commodities that EPA 
does not consider to be food or feed items (``corn, sweet, cannery 
waste,'' ``grape, wet pomace,'' ``potato, dried pulp,'' ``tomato, dried 
pomace,'' and ``tomato, wet pomace''); therefore, tolerances are 
unnecessary. With respect to rye grain, the applicant proposed a 
tolerance based on barley residue data, but the Agency determined that 
translating the rye grain tolerance from wheat residue data was more 
appropriate. For the petitioner-proposed tolerances for soybean forage 
and hay, there is a feeding restriction on the label, which makes these 
tolerances unnecessary; therefore, the Agency is not establishing 
tolerances for those two commodities. The pop corn stover tolerance was 
revised due to only pop corn stover residues used. For the oat grain 
and peanut hay tolerances, the petitioner included residues from both 
formulations, whereas EPA assessed the emulsifiable concentrate (EC) 
and soluble concentrate (SC) separately to determine if there was a 
formulation difference and set the tolerance at the higher level to 
cover residues from either formulation.
    Although the petitioner requested tolerances for livestock 
commodities based on the aggregate residues of the parent and 
metabolite, EPA is establishing tolerances for livestock commodities 
based only on measuring residues of the parent compound, in order to 
harmonize tolerances with Canada. EPA is establishing a meat byproduct 
tolerance, which covers residues found in liver and kidney, instead of 
separate liver and kidney tolerances since separate tolerances are not 
needed. A tolerance for Grain, Cereal, Forage, Fodder and Straw, Group 
16 was not set since residue data among the representative commodities 
varied by more than a factor of five; instead, EPA is establishing 
individual tolerances. The Agency used the Langmuir model to determine 
the tolerances for livestock tissue and milk. The milk tolerance was 
raised to harmonize with Canada's MRLs and in effect would cover the 
expected cream residues. With respect to wheat germ, milled byproducts, 
and field corn flour, the median concentration factor was used by the 
Agency which resulted in different tolerances than those proposed by 
the petitioner. In addition, EPA has modified some of the commodity 
definitions, and numerical expression of the tolerance values in order 
to conform to current Agency policy on significant figures.

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: Barley, grain at 4.0 ppm; Barley, hay at 30 ppm; Barley, 
straw at 30 ppm; Cattle, fat at 0.03 ppm; Cattle, meat at 0.01 ppm; 
Cattle, meat byproducts at 0.03 ppm; Corn, field, flour at 0.02 ppm; 
Corn, field, forage at 6.0 ppm; Corn, field, grain at 0.015 ppm; Corn, 
field, milled byproducts at 0.06 ppm; Corn, field, stover at 15 ppm; 
Corn, pop, forage at 6.0 ppm; Corn, pop, grain at 0.015 ppm; Corn, pop, 
stover at 10 ppm; Corn, sweet, forage at 5.0 ppm; Corn, sweet, kernel 
plus cob with husks removed at 0.01 ppm; Corn, sweet, stover at 9.0 
ppm; Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-
07F at 1.5 ppm; Goat, fat at 0.03 ppm; Goat, meat at 0.01 ppm; Goat, 
meat byproducts at 0.03 ppm; Grain, aspirated fractions at 100 ppm; 
Grape, raisin at 2.0 ppm; Horse, fat at 0.03 ppm; Horse, meat at 0.01 
ppm; Horse, meat byproducts at 0.03 ppm; Leaf petiole vegetable 
subgroup 22B at 15 ppm; Leafy greens subgroup 4-16A at 40 ppm; Milk at 
0.03 ppm; Oat, forage at 10 ppm; Oat, grain at 3.0 ppm; Oat, hay at 40 
ppm; Oat, straw at 20 ppm; Pea, field, forage at 6.0 ppm; Pea, field, 
hay at 40 ppm; Peanut at 0.02 ppm; Peanut, hay at 30 ppm; Peanut, 
refined oil at 0.05 ppm; Peas and bean, dried shelled, except soybean, 
subgroup 6C at 0.40 ppm; Potato, processed potato waste at 0.03 ppm; 
Potato, wet peel at 0.03 ppm; Quinoa, grain at 4.0 ppm; Rapeseed 
subgroup 20A at 0.90 ppm; Rye, grain at 0.30 ppm; Rye, hay at 50 ppm; 
Rye, straw at 30 ppm; Sheep, fat at 0.03 ppm; Sheep, meat at 0.01 ppm; 
Sheep, meat byproducts at 0.03 ppm; Soybean, seed at 0.40 ppm; Tomato, 
dried at 3.0 ppm; Vegetable, cucurbit, group 9 at 0.50 ppm; Vegetable, 
fruiting, group 8-10 at 0.60 ppm; Vegetable, tuberous and corm subgroup 
1C at 0.015 ppm; Wheat, forage at 15 ppm; Wheat, germ at 0.40 ppm; 
Wheat, grain at 0.30 ppm; Wheat, hay at 50 ppm; Wheat, milled 
byproducts at 2.0 ppm; and Wheat, straw at 30 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

[[Page 24044]]

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: May 17, 2018,
Richard P. Keigwin, Jr.,
Director, 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. Add Sec.  180.699 to subpart C to read as follows:

Sec.  180.699  Pydiflumetofen; Tolerances for residues.

    (a) General. Tolerances are established for residues of 
pydiflumetofen, including its metabolites and degradates, in or on the 
commodities in the table below. 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:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................         4.0
Barley, hay.................................................          30
Barley, straw...............................................          30
Cattle, fat.................................................        0.03
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.03
Corn, field, flour..........................................        0.02
Corn, field, forage.........................................         6.0
Corn, field, grain..........................................       0.015
Corn, field, milled byproducts..............................        0.06
Corn, field, stover.........................................          15
Corn, pop, forage...........................................         6.0
Corn, pop, grain............................................       0.015
Corn, pop, stover...........................................          10
Corn, sweet, forage.........................................         5.0
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................         9.0
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup         1.5
 13-07F.....................................................
Goat, fat...................................................        0.03
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.03
Grain, aspirated fractions..................................         100
Grape, raisin...............................................         2.0
Horse, fat..................................................        0.03
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.03
Leaf petiole vegetable subgroup 22B.........................          15
Leafy greens subgroup 4-16A.................................          40
Milk........................................................        0.03
Oat, forage.................................................          10
Oat, grain..................................................         3.0
Oat, hay....................................................          40
Oat, straw..................................................          20
Pea, field, forage..........................................         6.0
Pea, field, hay.............................................          40
Peanut......................................................        0.02
Peanut, hay.................................................          30
Peanut, refined oil.........................................        0.05
Peas and bean, dried shelled, except soybean, subgroup 6C...        0.40
Potato, processed potato waste..............................        0.03
Potato, wet peel............................................        0.03
Quinoa, grain...............................................         4.0
Rapeseed subgroup 20A.......................................        0.90
Rye, grain..................................................        0.30
Rye, hay....................................................          50
Rye, straw..................................................          30
Sheep, fat..................................................        0.03
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.03
Soybean, seed...............................................        0.40
Tomato, dried...............................................         3.0
Vegetable, cucurbit, group 9................................        0.50
Vegetable, fruiting, group 8-10.............................        0.60
Vegetable, tuberous and corm subgroup 1C....................       0.015
Wheat, forage...............................................          15
Wheat, germ.................................................        0.40
Wheat, grain................................................        0.30
Wheat, hay..................................................          50
Wheat, milled byproducts....................................         2.0
Wheat, straw................................................          30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2018-11192 Filed 5-23-18; 8:45 am]
 BILLING CODE 6560-50-P