[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8447-8454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02241]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0718 and EPA-HQ-OPP-2019-0076; FRL-10002-06]


Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
difenoconazole in or on vegetable, root, subgroup 1A, except ginseng; 
vegetable, leaves of root and tuber, group 2; and tea, dried. In 
addition, this regulation amends the tolerances for residues of 
difenoconazole in or ginseng; cattle, liver; goat, liver; horse, liver; 
and sheep, liver. Syngenta Crop Protection, LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 14, 2020. Objections and 
requests for hearings must be received on or before April 14, 2020, 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-2018-0718 and EPA-HQ-OPP-2019-
0076, is available at http://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) in the 
Environmental Protection Agency Docket Center (EPA/DC), West William 
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805. Please review 
the visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [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 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2018-0718 and EPA-HQ-OPP-2019-0076 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 April 14, 2020. 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-2018-0718 and EPA-
HQ-OPP-2019-0076, 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 June 7, 2019 (84 FR 26630) (FRL-9993-93) 
and in the Federal Register of May 9, 2019 (84 FR 20320) (FRL-9992-36), 
EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of pesticide petitions (PP 8F8695 and 
8E8728, respectively) by Syngenta Crop Protection, LLC, P.O. Box 18300, 
Greensboro, NC 27419. Pesticide

[[Page 8448]]

petition 8F8695 requested that 40 CFR 180.475 be amended by 
establishing tolerances for residues of the fungicide difenoconazole in 
or on root vegetable crop subgroup 1A at 0.60 parts per million (ppm) 
and leaves of root and tuber vegetables crop group 2 at 8.0 ppm; PP 
8E8728 requested the establishment of a tolerance for residues of 
difenoconazole in or on tea at 30 ppm. Those documents referenced 
summaries of the petitions prepared by Syngenta Crop Protection, LLC, 
the registrant, which are available in their respective dockets, http://www.regulations.gov. One comment was received on EPA's May 9, 2019 
notice of filing in docket number EPA-HQ-OPP-2019-0076. EPA's response 
to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that vary from what the petitioner requested as 
permitted by FFDCA section 408(d)(4)(A)(i). These differences 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 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 difenoconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with difenoconazole 
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.
    Subchronic and chronic toxicity studies with difenoconazole in mice 
and rats showed decreased body weights and effects on the liver (e.g., 
hepatocellular hypertrophy, liver necrosis, fatty changes in the 
liver). No systemic toxicity was observed at the limit dose in a rat 
dermal toxicity study. Difenoconazole exhibits low acute toxicity by 
the oral, dermal and inhalation routes of exposure. It is not an eye or 
skin irritant and is not a sensitizer.
    Acute and subchronic neurotoxicity studies showed evidence of mild 
neurotoxic effects. However, the selected endpoints of toxicity for 
risk assessment are protective of any potential neurotoxicity.
    The available toxicity studies indicated no increased 
susceptibility of rats or rabbits from in utero or postnatal exposure 
to difenoconazole. In prenatal developmental toxicity studies in rats 
and rabbits and in the 2-generation reproduction study in rats, fetal 
and offspring toxicity, when observed, occurred at equivalent or higher 
doses than in the maternal and parental animals. In a rat developmental 
toxicity study, developmental effects were observed at doses higher 
than those which caused maternal toxicity. Developmental effects in the 
rat included increased incidence of ossification of the thoracic 
vertebrae and thyroid, decreased number of sternal centers of 
ossification, increased number of ribs and thoracic vertebrae, and 
decreased number of lumbar vertebrae. In the rabbit study, 
developmental effects (increases in post-implantation loss and 
resorptions and decreases in fetal body weight) were also seen at 
maternally toxic (decreased body weight gain and food consumption) 
doses. Since the developmental effects are more severe than the 
maternal effects, qualitative susceptibility is indicated in the rabbit 
developmental study; however, the selected POD is protective of this 
effect. In the 2-generation reproduction study in rats, toxicity to the 
fetuses and offspring, when observed, occurred at equivalent or higher 
doses than in the maternal and parental animals.
    Although there is some evidence that difenoconazole affects 
antibody levels at doses that cause systemic toxicity, there are no 
indications in the available studies that organs associated with immune 
function, such as the thymus and spleen, are affected by 
difenoconazole. Difenoconazole is not mutagenic or genotoxic, and no 
evidence of carcinogenicity was seen in rats. Evidence for 
carcinogenicity was seen in mice as induction of liver tumors at doses 
which were considered to be excessively high for carcinogenicity 
testing. Difenoconazole has been classified as ``Suggestive Evidence of 
Carcinogenic Potential'' based on liver tumors observed in mice. EPA 
has concluded that the chronic point of departure (POD) for assessing 
chronic risk will be protective of any cancer effects for the following 
reasons: (1) Tumors were seen in only one species; (2) carcinoma tumors 
were observed only at the two highest doses in the mouse 
carcinogenicity study; (3) benign tumors and necrosis were observed at 
the mid-dose; (4) the absence of tumors at the study's lower doses; (5) 
the absence of genotoxic or mutagenic effects. The cRfD is well below 
the no-observed- adverse-effect-level (NOAEL) of the mouse 
carcinogenicity study, at which no effects on the biological endpoints 
relevant to tumor development (i.e., hepatocellular hypertrophy, liver 
necrosis, fatty changes in the liver and bile stasis) were seen. As a 
result, EPA has concluded that a nonlinear RfD approach is appropriate 
for assessing cancer risk to difenoconazole and a separate quantitative 
cancer exposure assessment is unnecessary.
    Specific information on the studies received and the nature of the 
adverse effects caused by difenoconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Difenoconazole. Human Health Risk 
Assessment for Proposed New Foliar Uses on All Members of Vegetable, 
Root, Subgroup 1A and Vegetable, Leaves of Root and Tuber, Group 2 and 
Establishment of a Tolerance with No U.S. Registration in/on Imported 
Tea'' in docket ID number EPA-HQ-OPP-2018-0718.

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

[[Page 8449]]

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 
NOAEL and 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 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 difenoconazole used 
for human risk assessment is shown in Table 1 of this unit.

Table 1--Summary of Toxicological Doses and Endpoints for Difenoconazole 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 = 25 mg/kg/day  Acute RfD = 0.25 mg/ Acute Neurotoxicity Study in Rats.
                                   UFA = 10x...........   kg/day.             LOAEL = 200 mg/kg/day in males
                                   UFH = 10x...........  aPAD = 0.25 mg/kg/    based on reduced fore-limb grip
                                   FQPA SF = 1x........   day.                 strength in males on Day 1 and
                                                                               increased motor activity on Day
                                                                               1.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 0.96 mg/kg/    Chronic RfD = 0.01   Combined Chronic Toxicity/
                                    day                   mg/kg/day.           Carcinogenicity (rat, dietary).
                                   UFA = 10x...........  cPAD = 0.01 mg/kg/   LOAEL = 24.1/32.8 mg/kg/day (male/
                                   UFH = 10x...........   day.                 female) based on cumulative
                                   FQPA SF = 1x........                        decreases in body-weight gains.
----------------------------------------------------------------------------------------------------------------
Oral short-term (1 to 30 days)...  NOAEL= 1.25 mg/kg/    Residential LOC for  Reproduction and Fertility Study
                                    day                   MOE = <100.          (rat dietary).
                                   UFA = 10x...........                       Parental/Offspring LOAEL = 12.5 mg/
                                   UFH = 10x...........                        kg/day based on decreased pup
                                   FQPA SF = 1x........                        weight in in males on Day 21 and
                                                                               reduction in body weight gain of
                                                                               F0 females prior to mating,
                                                                               gestation and lactation.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   NOAEL = 1.25 mg/kg/   LOC for MOE = <100.  Reproduction and Fertility Study
 and intermediate-term (1 to 6      day (dermal                                (rat, dietary).
 months).                           absorption factor =                       Parental/Offspring LOAEL = 12.5 mg/
                                    6%)                                        kg/day based on decreased pup
                                   UFA = 10x...........                        weight in males on Day 21 and
                                   UFH = 10x...........                        reduction in body weight gain of
                                   FQPA SF = 1x........                        F0 females prior to mating,
                                                                               gestation and lactation.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL= 1.25 mg/kg/    LOC for MOE = <100.  Reproduction and Fertility Study
 days) and intermediate-term (1     day                                        (rat, dietary).
 to 6 months).                     UFA = 10x...........                       Parental/Offspring LOAEL = 12.5 mg/
* Inhalation and oral absorption   UFH = 10x...........                        kg/day based on decreased pup
 assumed equivalent.               FQPA SF = 1x........                        weight in males on Day 21 and
                                                                               reduction in body weight gain of
                                                                               F0 females prior to mating,
                                                                               gestation and lactation.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Difenoconazole is classified ``Suggestive Evidence of Carcinogenic
                                    Potential''. Quantification of cancer risk is not required. The RfD would
                                    address the concern for chronic toxicity, including carcinogenicity, likely
                                    to result from exposure to difenoconazole.
----------------------------------------------------------------------------------------------------------------
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 difenoconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing difenoconazole 
tolerances in 40 CFR 180.475. EPA assessed dietary exposures from 
difenoconazole 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 difenoconazole. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA) 2003 to 2008. As to residue 
levels in food, EPA assumed tolerance-level residues, 100 percent crop 
treated (PCT), and available empirical or default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA 2003 to 2008. As to residue levels in food, EPA used tolerance-
level residues for some commodities, average field trial residues and 
USDA Pesticide Data Program monitoring samples for the remaining 
commodities, available

[[Page 8450]]

empirical or default processing factors, and average PCT assumptions 
for some commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk due to difenoconazole. Cancer risk was assessed using the 
same exposure estimates as discussed in Unit III.C.1.ii., chronic 
exposure.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows: Almond 
15%, apples 25%, apricot 10%, artichoke 15%, blueberry 10%, broccoli 
2.5%, cabbage 10%, cantaloupe 2.5%, carrot 2.5%, cauliflower 2.5%, 
cherry 2.5%, cucumbers 5%, garlic 10%, grapefruit 10%, grape (raisin) 
10%, grape (table) 25%, grape (wine) 15%, hazelnut 2.5%, lemon 5%, 
onions 10%, orange 5%, peach 10%, pear 10%, pecan 5%, peppers 15%, 
pistachio 10%, plum/prune 10%, potato 20%, pumpkin 5%, soybean 2.5%, 
squash 10%, strawberry 2.5%, sugar beets 20%, sweet corn 5%, tangerine 
5%, tomato 35%, walnut 5%, watermelon 15%, and wheat 15%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis. The average PCT figures 
for each existing use is derived by combining available public and 
private market survey data for that use, averaging across all 
observations, and rounding up to the nearest 5%, except for those 
situations in which the average PCT is less than 1% or less than 2.5%. 
In those cases, the Agency would use less than 1% or less than 2.5% as 
the average PCT value, respectively. The maximum PCT figure is the 
highest observed maximum value reported within the most recent 10 years 
of available public and private market survey data for the existing use 
and rounded up to the nearest multiple of 5%, except where the maximum 
PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as 
the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which difenoconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The drinking water 
assessment was performed using a total toxic residue method, which 
considers both parent difenoconazole and its major metabolite, CGA 
205375, or total toxic residues (TTR) from difenoconazole uses, in 
surface and groundwater. The Agency used screening level water exposure 
models in the dietary exposure analysis and risk assessment for 
difenoconazole in drinking water. These simulation models take into 
account data on the physical, chemical, and fate/transport 
characteristics of difenoconazole plus CGA 205375. 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 Tier II Pesticide in Water Calculator (PWC v1.52) 
model and Tier 1 Rice Model, the estimated drinking water 
concentrations (EDWCs) of TTR of difenoconazole for acute exposures are 
estimated to be 33.4 parts per billion (ppb) for surface water and 2.0 
ppb for ground water. Chronic exposure EDWCs for non-cancer assessments 
are estimated to be 27.4 ppb for surface water and 0.60 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 33.4 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 27.4 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). Difenoconazole is 
currently registered for the following uses that could result in 
residential exposures: Treatment of ornamental plants in commercial and 
residential landscapes and interior plantscapes as well as turf 
applications to golf courses. EPA assessed residential exposure using 
the following assumptions: For residential handlers, adult short-term 
dermal and inhalation exposure is expected from mixing, loading, and 
applying difenoconazole on ornamentals (gardens and trees). For 
residential post-application exposures, short-term dermal exposure is 
expected for both adults and children (6 < 11 years old and 11 < 16 
years old) from post-application activities in treated residential 
landscapes and on golf courses. There are no residential uses

[[Page 8451]]

for difenoconazole that would result in incidental oral exposure to 
children.
    The scenarios used in the aggregate assessment were those that 
resulted in the highest exposures. The highest exposures consist of the 
short-term dermal exposure to adults from post-application activities 
in treated gardens and short-term dermal exposure to children 6 to 11 
years old from post-application activities in treated gardens. 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to difenoconazole and any 
other substances, although EPA has previously concluded that there are 
no conclusive data that difenoconazole shares a common mechanism of 
toxicity with other conazole pesticides. Although the conazole 
fungicides (triazoles) produce 1,2,4 triazole and its acid-conjugated 
metabolites (triazolylalanine and triazolylacetic acid), 1,2,4 triazole 
and its acid-conjugated metabolites do not contribute to the toxicity 
of the parent conazole fungicides (triazoles). A separate aggregate 
risk assessment was conducted for triazole and the conjugated triazole 
metabolites (Common Triazole Metabolites: Updated Aggregate Human 
Health Risk Assessment to Address New Section 3 Registrations For Use 
of Difenoconazole and Mefentrifluconazole; DP451447, dated May 15, 
2019) and it can be found at https://www.regulations.gov at docket ID 
number EPA-HQ-OPP-2018-0002. These new uses of difenoconazole 
considered with existing uses of triazole compounds do not result in a 
risk of concern for 1,2,4-trizaole and its metabolites. Difenoconazole 
does not appear to produce any other toxic metabolite produced by other 
substances. For the purposes of this action, therefore, EPA has not 
assumed that difenoconazole has 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://www.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. The available toxicity 
studies indicated no increased quantitative susceptibility of rats or 
rabbits from in utero or postnatal exposure to difenoconazole. In 
prenatal developmental toxicity studies in rats and rabbits and in the 
2-generation reproduction study in rats, fetal/offspring toxicity, when 
observed, occurred at equivalent or higher doses than in the maternal/
parental animals. In rabbits there was qualitative susceptibility since 
the developmental effects were more severe than the maternal effects 
seen at the same dose; however, the selected POD is protective of this 
effect. In a rat developmental toxicity study, developmental effects 
were observed at doses higher than those which caused maternal 
toxicity. Developmental effects in the rat included increased incidence 
of ossification of the thoracic vertebrae and hyoid, decreased number 
of sternal centers of ossification, increased number of ribs and 
thoracic vertebrae, and decreased number of lumbar vertebrae. In the 
rabbit study, developmental effects (increases in post-implantation 
loss and resorptions and decreases in fetal body weight) were also seen 
at maternally toxic (decreased body weight gain and food consumption) 
doses. In the two-generation reproduction study in rats, toxicity to 
the fetuses/offspring (reduction in the body weight of F1 male pups), 
when observed, occurred at equivalent or higher doses than in the 
maternal/parental animals (reductions in body weight gain).
    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 difenoconazole is sufficient for a 
full hazard evaluation and is considered adequate to evaluate risks to 
infants and children.
    ii. There are no clear signs indication that difenoconazole is a 
neurotoxic chemical following acute, subchronic, or chronic dosing in 
multiple species in the difenoconazole database. The effects observed 
in acute and subchronic neurotoxicity studies are considered non-
adverse as they were transient in nature and were only observed in one 
sex (males as reduced fore-limb grip strength with no histologic 
findings) and the selected endpoints of toxicity for risk assessment 
are protective of any potential neurotoxicity. There is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that difenoconazole results in increased 
quantitative susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. However, in the developmental toxicity study in rabbits, 
developmental effects (increases in post-implantation loss and 
resorptions and decreases in fetal body weight) were also seen at 
maternally toxic doses (decreased body weight gain and food 
consumption). Because these effects are more severe, qualitative 
susceptibility is evident in the rabbit. The PODs selected to assess 
dietary exposures are protective of these effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on tolerance-level residues and 100% CT for the acute assessment while 
the chronic assessment used USDA Pesticide Data Program (PDP) 
monitoring data, average field trial residues for some commodities, 
tolerance level residues for remaining commodities, and average percent 
crop treated for some commodities. These assumptions will not 
underestimate dietary exposure to difenoconazole. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to difenoconazole in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children. These

[[Page 8452]]

assessments will not underestimate the exposure and risks posed by 
difenoconazole.

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 
aPAD and 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 difenoconazole will occupy 52% of the aPAD for all infants <1 year 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
difenoconazole from food and water will utilize 53% of the cPAD for all 
infants <1 year 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 
difenoconazole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus average exposure levels to 
food and water (considered to be a background exposure level). 
Difenoconazole 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 difenoconazole.
    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 180 for adults 
and 240 for children 6 to <11 years old. Because EPA's level of concern 
for difenoconazole is an 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, 
difenoconazole 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 
difenoconazole.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has determined that use of the chronic reference dose will 
be protective of the potential for cancer risk. Because the chronic 
exposure does not exceed the Agency's level of concern, EPA concludes 
that exposure to difenoconazole would not pose an unacceptable cancer 
risk.
    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 difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate tolerance enforcement method, gas chromatography with 
nitrogen-phosphorus detection (GC/NPD) method AG-575B, is available for 
the determination of residues of difenoconazole in/on plant 
commodities. An adequate enforcement method, gas chromatography with 
mass spectrometry detection (GC/MSD) method AG-676A, is also available 
for the determination of residues of difenoconazole per se in/on canola 
and barley commodities. A confirmatory method, GC/MSD method AG-676, is 
also available.
    An adequate tolerance enforcement method, Method REM 147.07b, is 
available for livestock commodities. The method determines residues of 
difenoconazole and CGA-205375 in livestock commodities by liquid 
chromatography with tandem mass spectrometry detection (LC-MS/MS). 
Adequate confirmatory methods, Method AG-544A and Method REM 147.06, 
are available for the determination of residues of difenoconazole and 
CGA-205375, respectively, in livestock commodities.
    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.
    Codex has established MRLs for difenoconazole in or on carrot at 
0.2 ppm; edible offal at 1.5 ppm; sugar beet at 0.2 ppm; ginseng at 
0.08 ppm; ginseng, dried at 0.8 ppm; and ginseng, extracts at 0.6 ppm. 
Several of these MRLs are different than the tolerances established for 
difenoconazole in the United States. The U.S. tolerance in/on crop 
subgroup 1A, except ginseng (0.6 ppm), being established in this 
rulemaking, is based on radish root data and cannot be harmonized with 
the Codex MRL for carrot, which is lower than the subgroup tolerance; 
doing so could result in exceedances of the tolerances even when 
growers followed label directions. The U.S. tolerance for ginseng has 
been harmonized with the Codex MRL for ginseng, dried and is inclusive 
of the lower tolerances for ginseng and ginseng, extracts. The 
tolerances for cattle, liver; goat, liver; horse, liver; and sheep, 
liver cannot be harmonized with Codex MRLs due to different dietary 
burdens.

C. Response to Comments

    EPA received one comment opposing pesticide residues in food, 
although no substantive information was provided for EPA to take into 
consideration in its safety assessment. Although the commenter 
generally expressed concern about the potential for exposure to 
difenoconazole to be carcinogenic, EPA has evaluated the available data 
on

[[Page 8453]]

carcinogenicity and exposure and determined that aggregate exposure to 
difenoconazole will not cause a cancer risk. The FFDCA authorizes EPA 
to establish tolerances that permit certain levels of pesticide 
residues in or on food when the Agency can determine that such residues 
are safe. EPA has made that determination for the tolerances subject to 
this action; the commenter provided no information relevant to that 
conclusion.

D. Revisions to Petitioned-For Tolerances

    The terms ``tea;'' ``root vegetable crop subgroup 1A;'' ``leaves of 
root and tuber vegetables crop group 2'' requested in the petition are 
being replaced with ``tea, dried;'' ``vegetable, root, subgroup 1A, 
except ginseng;'' and ``vegetable, leaves of root and tuber, group 2'', 
respectively, to reflect the correct commodity definitions. The EPA has 
modified the tolerance on tea, dried from the requested 30 ppm to 15 
ppm to harmonize with Japan's draft MRL. The ginseng tolerance has been 
removed from the vegetable, root, subgroup 1A and set at 0.8 to 
harmonize with the highest Codex MRL. Tolerances for cattle, liver; 
goat, liver; horse, liver; and sheep, liver have been increased from 
0.40 to 0.7 ppm based on the re-calculated dairy cattle dietary burden 
and the available feeding study data for residues of difenoconazole and 
its metabolite CGA-205375. Trailing zeroes have been removed from 
tolerances in accordance with current Agency practices.

E. International Trade Considerations

    In this final rule, EPA is reducing the existing tolerance for 
ginseng from 1.0 ppm to 0.8 ppm in order to harmonize with the Codex 
MRL. Available residue data demonstrates that the new tolerance is 
sufficient to cover residues on ginseng.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of this revision in order to satisfy its obligation. In addition, 
the SPS Agreement requires that Members provide a ``reasonable 
interval'' between the publication of a regulation subject to the 
Agreement and its entry into force to allow time for producers in 
exporting Member countries to adapt to the new requirement. At this 
time, EPA is establishing an expiration date for the existing ginseng 
tolerance to allow that tolerance to remain in effect for a period of 
six months after the effective date of this final rule, in order to 
address this requirement. After the six month period expires, residues 
of difenoconazole on ginseng cannot exceed the new tolerance of 0.8 
ppm.
    This reduction in tolerance levels is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods. The new tolerance levels are 
supported by available residue data.

V. Conclusion

    Therefore, tolerances are established for residues of 
difenoconazole, difenoconazole, in or on vegetable, root, subgroup 1A, 
except ginseng at 0.6ppm; vegetable, leaves of root and tuber, group 2 
at 8 ppm; and tea, dried at 15 ppm. Tolerances are amended for ginseng 
from 1.0 to 0.8 ppm; and cattle, liver; goat, liver; horse, liver; and 
sheep, liver from 0.40 ppm to 0.7 ppm. In addition, the Agency is 
removing the existing tolerances for beet, sugar; and carrot as they 
are unnecessary upon the establishment of the tolerance for vegetable, 
root, subgroup 1A, except ginseng. Finally, the Agency is amending the 
existing tolerance for ginseng by adding an expiration date.

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.


[[Page 8454]]


    Dated: December 19, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.475:
0
 a. In the table in paragraph (a)(1):
0
i. Remove the entries ``Beet, sugar'' and ``Carrot''.
0
 ii. Revise the entry for ``Ginseng''.
0
 iii. Add a second entry for ``Ginseng'' after the existing entry for 
``Ginseng'' and add alphabetically the entries ``Tea, dried''; 
``Vegetable, leaves of root and tuber, group 2''; and ``Vegetable, 
root, subgroup 1A, except ginseng''.
0
 iv. Add footnotes 1 and 2 to the end of the table.
0
b. Revise the entries ``Cattle, liver''; ``Goat, liver''; ``Horse, 
liver''; and ``Sheep, liver'' in the table in paragraph (a)(2).
    The additions and revisions read as follows:


Sec.  180.475  Difenoconazole; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Ginseng \2\.................................................         1.0
Ginseng.....................................................         0.8
 
                                * * * * *
Tea, dried \1\..............................................          15
 
                                * * * * *
Vegetable, leaves of root and tuber, group 2................           8
Vegetable, root, subgroup 1A, except ginseng................         0.6
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities.
\2\ This tolerance expires on August 14, 2020.

    (2) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, liver...............................................         0.7
 
                                * * * * *
Goat, liver.................................................         0.7
 
                                * * * * *
Horse, liver................................................         0.7
 
                                * * * * *
Sheep, liver................................................         0.7
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-02241 Filed 2-13-20; 8:45 am]
 BILLING CODE 6560-50-P