Tolfenpyrad; Pesticide Tolerances, 29017-29023 [2018-13456]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Rules and Regulations]
[Pages 29017-29023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13456]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0156; FRL-9976-21]


Tolfenpyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective June 22, 2018. Objections and 
requests for hearings must be received on or before August 21, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0156, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

[[Page 29018]]


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0156 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
August 21, 2018. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0156, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
7F8544 and PP 7F8543) by Nichino America, Inc., 4550 New Linden Hill 
Road, Suite 501, Wilmington, DE 19808-2951. The petitions requested 
that 40 CFR 180.675 be amended by establishing tolerances for residues 
of the insecticide tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide, in or on Brassica head and stem 
vegetable group (crop group 5-16) at 5.0 parts per million (ppm) (PP 
7F8544); Brassica leafy greens subgroup (4-16B) at 40 ppm (PP 7F8544); 
Vegetables, cucurbit, group 9 at 0.7 ppm (PP 7F8544); Vegetables, 
fruiting, group 8-10 at 0.7 ppm (PP 7F8544); Fruit, pome, group 11-10 
at 0.7 ppm (PP 7F8544); and Apple, wet pomace at 2.5 ppm (PP 7F8544). 
The petitions also requested that established tolerances be amended for 
residues of tolfenpyrad in or on Fruit, citrus, group 10-10 at 0.9 ppm 
(PP 7F8544; PP 7F8543); Citrus, dried pulp at 3.0 ppm (PP 7F8544; PP 
7F8543); and Citrus, oil at 28.0 ppm (PP 7F8544; PP 7F8543). That 
document referenced a summary of the petition prepared by Nichino 
America, Inc., the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to 
the notices of filing. Consistent with the authority in section 
408(d)(4)(A)(i), EPA is establishing tolerances that vary from what the 
petitioner sought. The reasons for these changes are explained in Unit 
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for tolfenpyrad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tolfenpyrad 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.
    A variety of toxic effects were noted in the toxicology database 
for tolfenpyrad. However, the most consistent finding across species 
and studies was decreased body weight and/or body weight gain, which 
were observed in adults of all species (rat, mice, rabbit, and dog) in 
the majority of the subchronic oral and dermal toxicity studies, and 
all chronic toxicity studies.
    The rat is the species most sensitive to body weight changes, with 
effects observed at much lower doses than in other species. In rats, 
significant decreases in body weight and body weight gain were observed 
in

[[Page 29019]]

subchronic oral and acute and subchronic neurotoxicity studies. 
Decreases in body weight and body weight gain were also seen in chronic 
rat studies but at lower doses than observed in the other rat studies. 
Although seen at lower doses, the body weight decrements noted in the 
chronic study were not as pronounced as seen after subchronic exposure 
or in the neurotoxicity studies. Decreases in body weight and body 
weight gain were also observed in reproduction, developmental toxicity, 
and developmental immunotoxicity studies at doses comparable to the 
chronic study. Significant decreases in body weight and body weight 
gain were seen in both mice and dogs after subchronic exposure; these 
effects were also noted in rabbits in a developmental toxicity study. 
Chronic exposure resulted in body weight and body weight gain decreases 
in mice and dogs at lower doses for longer duration studies.
    The body weight changes observed in the database were most often 
seen in the presence of decreased food consumption and in some studies, 
additional toxicity including liver/kidney effects and clinical signs. 
Increased liver and kidney weights, liver and kidney hypertrophy, 
hyaline droplets in the kidney, and color change in the kidney were 
seen after subchronic exposure in rats. Chronic exposure resulted in 
similar effects along with color changes in the liver and liver 
histopathology at slightly lower doses than in the subchronic studies. 
Other effects noted in rats were effects on the harderian gland and 
lymph nodes. In dogs, both changes in liver and kidney histopathology, 
along with testicular atrophy and clinical signs (emaciation, decreased 
movement, and staggering gait) were seen in short-term studies. Long-
term exposure resulted in histopathological changes in the liver, along 
with increased liver enzymes. No treatment-related effects were noted 
in the liver or kidney in mice. However, rough coats, hunched posture, 
ataxia, and hypoactivity were seen in subchronic studies.
    Moribundity and/or mortality were noted in at least one study in 
all tested species at >=3 milligrams/kilogram/day (mg/kg/day). 
Moribundity and mortality were noted in two dams in a rat reproduction 
study. Mortality was also noted in one dam in a rabbit developmental 
toxicity study, as well as in two rats from an inhalation toxicity 
study (range-finding only). In mice and dogs, mortality was observed in 
both subchronic and chronic toxicity studies. In all cases, these 
effects were observed only after repeat-dose exposures, and the current 
points of departure (PODs) for the relevant exposure durations are 
protective of the observed mortality.
    There is no evidence of increased quantitative or qualitative 
susceptibility in the guideline rat and rabbit developmental studies, 
or the rat reproduction study. Although several adverse effects were 
noted in young animals in these studies, the effects were observed in 
the presence of significant maternal toxicity (significant body weight 
changes and/or moribundity/mortality). In a non-guideline rat 
developmental immunotoxicity (DIT) study, decreased survival, body 
weight, body weight gain, increased blackish abdominal cavity, and dark 
green abnormal intestinal contents were observed in offspring animals 
at 3 mg/kg/day. At the same dose, decreased body weight (up to 10%), 
body weight gain (up to 36%) and food consumption were seen in maternal 
animals. This is consistent with the other developmental toxicity 
studies in the database, in which offspring toxicity is observed at the 
same dose as significant maternal toxicity. There was no evidence of 
immunotoxicity observed in the study.
    No evidence of neurotoxicity was observed in acute and subchronic 
neurotoxicity studies for tolfenpyrad. Although hunched posture, 
ataxia, and hypoactivity were seen in mice in a 28-day toxicity study, 
these effects were not seen in a 90-day study or after chronic 
exposure. In dogs, decreased spontaneous movement and staggering gait 
were observed after 13 weeks. In rats, decreased motor activity and 
prone position (lying face down) prior to death were noted in a 
reproduction study. Overall, the effects noted in the database were 
agonal effects mainly seen at high doses, not associated with 
neuropathology, and not noted in long-term studies. The effects 
observed are consistent with the mode of action for tolfenpyrad 
(mitochondrial inhibitor) and are not considered evidence of 
neurotoxicity.
    No evidence of carcinogenicity was observed in cancer studies with 
mice and rats. Therefore, in accordance with EPA's Final Guidelines for 
Carcinogen Risk Assessment (March 2005), tolfenpyrad is classified as 
``not likely to be carcinogenic to humans.'' Specific information on 
the studies received and the nature of the adverse effects caused by 
tolfenpyrad 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 https://www.regulations.gov in document 
``Tolfenpyrad--Aggregate Human Health Risk Assessment of Proposed New 
Uses on Multiple Commodities'' at pages 11-15 in docket ID number EPA-
HQ-OPP-2017-0156.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for tolfenpyrad used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 29020]]



                Table 1--Summary of Toxicological Doses and Endpoints for Tolfenpyrad for Use in
                                          Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 10 mg/kg/day  Acute RfD = 0.1 mg/  Acute Neurotoxicity Study in rats.
 including infants and children).  UFA = 10X...........   kg/day.             LOAEL = 20 mg/kg/day based on
                                   UFH = 10X...........  aPAD = 0.1 mg/kg/     decreased bodyweight, bodyweight
                                   FQPA SF = 1X........   day..                gain and food consumption.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 0.6 mg/kg/day  Chronic RfD = 0.006  Combined Chronic/Carcinogenicity
                                   UFA = 10X...........   mg/kg/day.           Study in rats.
                                   UFH = 10X...........  cPAD = 0.006 mg/kg/  LOAEL = 1.5 mg/kg/day based on
                                   FQPA SF = 1X........   day..                decreased bodyweight, bodyweight
                                                                               gain, and food consumption of
                                                                               females, gross changes in the
                                                                               harderian glands of males, and
                                                                               histopathological changes in the
                                                                               liver, kidney and mesenteric
                                                                               lymph nodes of females and the
                                                                               kidney of males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                            absence of significant tumor increases in two adequate rodent
                                                              carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. 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 tolfenpyrad, EPA considered exposure under the petitioned-
for tolerances as well as all existing tolfenpyrad tolerances in 40 CFR 
180.675. EPA assessed dietary exposures from tolfenpyrad 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 tolfenpyrad. In estimating acute dietary exposure, EPA used food 
consumption information from the 2003-2008 U.S. 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 assumes 100 percent crop treatment (PCT) and tolerance-level 
residues with minor refinements including a factor to account for the 
reduction in residues when wrapper leaves are removed from head lettuce 
and cabbage, as well as empirical processing factors for tomato juice, 
paste, and puree, cottonseed oil, citrus juice, and grape juice (which 
was translated broadly to other juices for which empirical data were 
not available).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 2003-2008 U.S. 
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 assumes 100 PCT and average residue levels 
from crop field trials as well as minor refinements listed above for 
acute exposure. Although partially refined, the chronic exposure 
estimates still retain a high level of conservatism due to the source 
and scope of the refinements, and are likely to overestimate the actual 
chronic dietary risk.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that tolfenpyrad does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residues and percent crop treated. Although EPA did 
not use any percent crop treated estimates for this action, the Agency 
relied on average residue 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.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tolfenpyrad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tolfenpyrad. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
tolfenpyrad for acute exposures are estimated to be 26.9 parts per 
billion (ppb) for surface water and 11.0 ppb for ground water, for 
chronic exposures for non-cancer assessments are estimated to be 12.2 
ppb for surface water and 11.0 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 26.9 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 12.2 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

[[Page 29021]]

(e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Tolfenpyrad is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 tolfenpyrad to share a common mechanism of 
toxicity with any other substances, and tolfenpyrad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
tolfenpyrad does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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. Although evidence is noted 
for qualitative susceptibility in the young in the developmental 
immunotoxicity study (DIT) in rats, there is low concern and there are 
no residual uncertainties regarding increased quantitative or 
qualitative prenatal and/or postnatal susceptibility for tolfenpyrad. 
When the DIT study is considered along with the reproduction study, the 
offspring toxicity in the DIT study was observed at the same dose as 
comparable maternal toxicity (moribundity/mortality) in the 
reproduction study. Therefore, EPA does not consider the isolated 
incident in the DIT a true indicator of qualitative susceptibility. 
Additionally, the effects observed in the DIT study are well-
characterized, a clear NOAEL was identified, and the endpoints chosen 
for risk assessment are protective of potential offspring effects.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for tolfenpyrad is complete.
    ii. There is no indication that tolfenpyrad is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. Although there is some evidence that tolfenpyrad may result in 
increased susceptibility, the concern for developmental or reproductive 
effects is low for the reasons contained in Unit III.D.2., and thus, a 
10X FQPA safety factor is not necessary to protect infants and 
children.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues for the acute dietary exposure 
and average residue levels from crop field trials for the chronic 
dietary exposure. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 
tolfenpyrad in drinking water. These assessments will not underestimate 
the exposure and risks posed by tolfenpyrad.

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 margin of exposure (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 tolfenpyrad will occupy 54% of the aPAD for children 1-2 years of 
age, 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 
tolfenpyrad from food and water will utilize 68% of the cPAD for 
children 1-2 years of age, the population group receiving the greatest 
exposure. There are no residential uses for tolfenpyrad.
    3. Short- and Intermediate-term risk. Short- and intermediated-term 
aggregate exposures take into account short- and intermediate-term 
residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, tolfenpyrad 
is not registered for any use patterns that would result in short- or 
intermediate-term residential exposures. Short- and intermediate-term 
risks are assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure. Because there are no short- or 
intermediate-term residential exposures 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 short- and 
intermediate-term risk), no further assessment of short- and 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for tolfenpyrad.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, tolfenpyrad is not expected to pose a cancer risk to humans.
    5. 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 tolfenpyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies, utilizing high-performance 
liquid chromatography with tandem mass spectrometric detection (LC/MS/
MS), are available for enforcement of tolfenpyrad residue tolerances 
in/on plant commodities (Morse Laboratories Analytical Method #Meth-
183, Revision #2). For livestock, a method described in PTRL West Study 
No. 1841W is available. The livestock method adequately determines 
residues of tolfenpyrad and its metabolites, PT-CA,

[[Page 29022]]

OH-PT-CA, and PCA in milk, bovine meat, kidney, liver and fat. Residues 
are determined by LC/MS/MS analysis. These methods are adequate for 
enforcement and 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 tolfenpyrad in 
commodities in this action.

C. Revisions to Petitioned-For Tolerances

    EPA's tolerance levels are expressed to provide sufficient 
precision for enforcement purposes, and this may include the addition 
of trailing zeros (such as 0.30 ppm rather than 0.3 ppm). This is done 
to avoid the situation where rounding of an observed violative residue 
to the level of precision of the tolerance expression would result in a 
residue considered non-violative (such as 0.34 ppm being rounded to 0.3 
ppm). EPA added additional zeros for fruiting vegetables group 8-10 and 
cucurbit vegetables group 9. EPA is establishing tolerances for 
residues in or on fruit, citrus, group 10-10 at 0.80 ppm instead of 0.9 
ppm; citrus, oil at 30 ppm instead of 28.0 ppm; and citrus, dried pulp 
at 4.0 ppm instead of 3.0 ppm, based on the previously reviewed orange 
processing study, and the newly submitted lemon field trial residues as 
the input dataset for the Organization for Economic Cooperation and 
Development (OECD) MRL calculation procedure. In addition, the 
tolerances in fruits, pome, group 11-10 and apple wet pomace are based 
on the petitioner's revision of the proposed maximum annual use rate on 
pome fruits, from 0.42 lb ai per acre (lb ai/A) to 0.57 lb ai/A.

D. International Trade Considerations

    In this rule, EPA is reducing the existing tolerances for citrus 
commodities as follows: Fruit, citrus, group 10-10 from 1.5 ppm to 0.80 
ppm; citrus, dried pulp from 8.0 ppm to 4.0 ppm; and citrus, oil from 
70 ppm to 30 ppm. The Agency is reducing these tolerances because these 
reductions requested by the petitioner are supported by available data. 
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.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA will notify the WTO of 
its tolerance revision. In addition, the SPS Agreement requires that 
Members provide a ``reasonable interval'' between the publication of a 
regulation subject to the Agreement and its entry into force in order 
to allow time for producers in exporting Member countries to adapt to 
the new requirement. At this time, EPA is establishing an expiration 
date for the existing tolerances to allow those tolerances remain in 
effect for a period of six months after the effective date of this 
final rule, in order to address this requirement. Prior to the 
expiration date, residues of tolfenpyrad up to the existing tolerance 
levels will be permitted; after the expiration date, residues will need 
to comply with the reduced tolerance levels.

V. Conclusion

    Therefore, tolerances are established for residues of tolfenpyrad, 
4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-
carboxamide, in or on Vegetable, Brassica, head and stem, group 5-16 at 
5.0 parts per million (ppm); Brassica, leafy greens, subgroup 4-16B at 
40 ppm; Vegetable, cucurbit, group 9 at 0.70 ppm; Vegetable, fruiting, 
group 8-10 at 0.70 ppm; Fruit, pome, group 11-10 at 1.0 ppm; and Apple, 
wet pomace at 3.0 ppm. Furthermore, established tolerances are amended 
for residues of tolfenpyrad in or on Fruit, citrus, group 10-10 from 
1.5 ppm to 0.80 ppm; Citrus, dried pulp from 8.0 ppm to 4.0 ppm; and 
Citrus, oil from 70 ppm to 30 ppm. Finally, the tolerances for 
``Vegetable, fruiting, group 8-10'' at 0.70 ppm and ``Watermelon'' at 
0.70 ppm in paragraph (b), which cover residues resulting from the 
section 18 emergency exemptions, are removed as it is superseded by the 
tolerances established for group 9 in this action.

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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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,

[[Page 29023]]

1999) and Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000) do not apply to this action. In addition, this action does not 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 8, 2018.
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.  180.675:
0
a. Revise the table in paragraph (a)(1); and
0
b. Remove the entries for ``Vegetable, fruiting, group 8-10'' and 
``Watermelon'' in the table in paragraph (b).
    The revision reads as follows:


Sec.  180.675  Tolfenpyrad; tolerance for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond hulls................................................         6.0
Apple, wet pomace...........................................         3.0
Brassica, leafy greens, subgroup 4-16B......................          40
Citrus, dried pulp 1........................................         8.0
Citrus, dried pulp..........................................         4.0
Citrus, oil 1...............................................        70.0
Citrus, oil.................................................          30
Cotton, gin byproducts......................................        15.0
Cotton, undelinted seed.....................................        0.70
Fruit, citrus, group 10-10 1................................         1.5
Fruit, citrus, group 10-10..................................        0.80
Fruit, pome, group 11-10....................................         1.0
Fruit, stone, group 12-12...................................         2.0
Grape.......................................................         2.0
Grape, raisin...............................................         6.0
Nuts, tree, group 14-12.....................................        0.05
Persimmon...................................................         2.0
Plum, prune.................................................         3.0
Pomegranate.................................................         2.0
Potato......................................................        0.01
Tea.........................................................        30.0
Vegetable, Brassica, head and stem, group 5-16..............         5.0
Vegetable, cucurbit, group 9................................        0.70
Vegetable, fruiting, group 8-10.............................        0.70
Vegetable, leafy, except Brassica, group 4..................        30.0
------------------------------------------------------------------------
1 This tolerance expires on December 24, 2018.

* * * * *
[FR Doc. 2018-13456 Filed 6-21-18; 8:45 am]
BILLING CODE 6560-50-P