[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Rules and Regulations]
[Pages 66620-66626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26131]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0162; FRL-10002-00]


Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fenpyroximate in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 5, 2019. Objections and 
requests for hearings must be received on or before February 3, 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-2018-0162, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an

[[Page 66621]]

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-2018-0162 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 
February 3, 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-2018-0162, 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 August 14, 2018 (83 FR 40272) (FRL-9981-
10), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E8665) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of fenpyroximate 
determined by measuring only the sum of fenpyroximate, (E)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl] benzoate, calculated as the 
stoichiometric equivalent of fenpyroximate in or on the raw 
agricultural commodities: banana at 1.0 parts per million (ppm); 
blackeyed pea, succulent shelled at 0.40 ppm; broad bean, succulent 
shelled at 0.40 ppm; bushberry subgroup 13-07B at 3.0 ppm; caneberry 
subgroup 13-07A at 3.0 ppm; chickpea, succulent shelled at 0.40 ppm; 
cottonseed subgroup 20C at 0.10 ppm; cowpea, succulent shelled at 0.40 
ppm; crowder pea, succulent shelled at 0.40 ppm; goa bean, pods, 
succulent shelled at 0.40 ppm; lablab bean, succulent shelled at 0.40 
ppm; leaf petiole vegetable subgroup 22B at 4.0 ppm; lima bean, 
succulent shelled at 0.40 ppm; nut, tree, group 14-12 at 0.10 ppm; 
southern pea, succulent shelled at 0.40 ppm; soybean, edible, succulent 
shelled at 0.40 ppm; squash/cucumber subgroup 9B at 0.40 ppm; succulent 
bean, succulent shelled at 0.40 ppm; and velvet bean, succulent shelled 
at 0.40 ppm. The petition also requested to remove the established 
tolerances for residues of fenpyroximate in or on the following raw 
agricultural commodities: Bean, snap, succulent at 0.40 ppm; cotton, 
undelinted seed at 0.10 ppm; cucumber at 0.40 ppm; nut, tree, group 14 
at 0.10 ppm; and pistachio at 0.10 ppm. That document referenced a 
summary of the petition prepared by Nichino America, the registrant, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.
    Pursuant to its authority in FFDCA section 408(d)(4)(A)(i), EPA is 
establishing tolerances that vary slightly from what the petitioner 
requested. The reasons for these changes are located 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 fenpyroximate including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fenpyroximate 
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.
    Following repeated oral exposures to fenpyroximate, general 
systemic toxicity was observed (no specific target organ/tissue 
identified). The most common effect observed across studies and species 
was decreased body weight. In dogs, clinical signs, such as diarrhea, 
torpor, and emaciation, and slight bradycardia were observed at similar 
or higher doses than those that elicited adverse decreases in body 
weight.
    In the rat neurotoxicity battery, effects in the subchronic 
neurotoxicity study were limited to decreased body weights at the 
highest doses tested (16-18 mg/kg/day). In the acute neurotoxicity 
study, decreased motor activity (both sexes) and auditory startle 
response (females only) were observed in the absence of 
neuropathological findings. There were no effects seen in the delayed 
acute neurotoxicity study in hens up to the limit dose (5,000 mg/kg).
    Following repeated dermal exposure, body weight decrements were 
only observed at the limit dose (1,000 mg/kg/day) in the presence of 
clinical signs consisting of red nose and mouth/nasal discharge in 
females. Increased liver weights and hepatocellular necrosis were also 
reported in females.
    In the 4-week inhalation study in rats, clinical signs (rales and 
labored

[[Page 66622]]

breathing), increased lung weights, and histopathological findings in 
the nasal turbinates (squamous metaplasia and atrophy of respiratory 
and/or olfactory mucosa) were observed. Body-weight decrements were not 
observed following repeated exposure via the inhalation route.
    There was no evidence of increased susceptibility following 
fenpyroximate exposure. There were no effects observed in the rat and 
rabbit developmental toxicity studies up to the highest doses tested 
(25 mg/kg/day and 5 mg/kg/day in the rat and rabbit, respectively). In 
the reproduction toxicity study, offspring and parental effects 
(decreased body weights for both lifestages) were observed at the same 
dose.
    Fenpyroximate is classified as ``not likely to be carcinogenic to 
humans'' based on lack of evidence of carcinogenicity in rats and mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenpyroximate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Fenpyroximate: Human 
Health Draft Risk Assessment for Registration Review and a Petition to 
Establish Tolerances for Residues in/on the Banana; Leaf Petiole 
Vegetable Subgroup 22B; Caneberry Subgroup 13-07A; Bushberry Subgroup 
13-07B; Squash/Cucumber Subgroup 9B; and Succulent Shelled Beans; and 
Crop Group Conversions for Nut, Tree, Group 14-12; and Cottonseed 
Subgroup 20C'' on pages 37-41 in docket ID number EPA-HQ-OPP-2018-0162.

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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for fenpyroximate used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fenpyroximate 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....................  NOAEL = 37.5 mg/kg/   Acute RfD = 0.375    Acute neurotoxicity study--rat.
(All populations)................   day UFA = 10X.        mg/kg/day aPAD =    LOAEL = 150 mg/kg based on
                                   UFH = 10X...........   0.375 mg/kg/day.     decreased motor activity (total
                                   FQPA SF = 1X........                        activity counts and total time
                                                                               spent in movement) in both sexes,
                                                                               a reduction in auditory startle
                                                                               response in females at 24 hours
                                                                               post dose, and mild dehydration
                                                                               in males.
Chronic dietary (All populations)  NOAEL= 1.0 mg/kg/day  Chronic RfD = 0.01   Combined chronic/carcinogenicity
                                   UFA = 10X...........   mg/kg/day.           study--rat.
                                   UFH = 10X...........  cPAD = 0.01 mg/kg/   LOAEL = 3.1/3.8 (M/F) based on
                                   FQPA SF = 1X........   day.                 decreased body-weight gain (Note:
                                                                               corresponding >10% decrease in
                                                                               absolute body weight observed).
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be carcinogenic to humans.''
----------------------------------------------------------------------------------------------------------------
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 fenpyroximate, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fenpyroximate 
tolerances in 40 CFR 180.566. EPA assessed dietary exposures from 
fenpyroximate 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 fenpyroximate. 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; 2003-2008). 
As to residue levels in food, EPA assumed 100 percent crop treated 
(PCT) and tolerance-level residues using default processing factors for 
all commodities excluding apple, pear, and grape juice (0.11X); grape, 
raisin (2.7X); orange, grapefruit, tangerine, lemon, and lime juice 
(0.06X); tomato paste (1.0X) and puree (1.0X); dried plum (1.0X); and 
peppermint and spearmint oil (0.08X).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA used percent crop 
treated estimates for some commodities and tolerance-level residues 
using default

[[Page 66623]]

processing factors for all commodities excluding apple, pear, and grape 
juice (0.11X); grape, raisin (2.7X); orange, grapefruit, tangerine, 
lemon, and lime juice (0.06X); tomato paste (1.0X) and puree (1.0X); 
dried plum (1.0X); and peppermint and spearmint oil (0.08X).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenpyroximate does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. 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, and 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:
    100 PCT was assumed for the acute analyses. The chronic analysis 
incorporated the following average PCT: Apples, 5.0%; apricots, 1.0%; 
avocados, 1.0%; beans (fresh), 1.0%; cantaloupes, 2.5%; cherries, 5.0%; 
corn, 1.0%; cotton, 1.0%; grapefruit, 10%; grapes, table, 2.5%; grapes, 
raisin, 5.0%; grapes, wine, 5.0%; lemons, 2.5%; oranges, 10%; peaches, 
1.0%; pears, 10%; pecans, 5.0%; peppers, 10%; plums, 5.0%; prunes, 
1.0%; strawberries, 5.0%; tangerines, 5.0%; tomatoes, 1.0%; and 
watermelons, 1.0%.
    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 and a maximum PCT for 
acute dietary risk analysis. The average PCT figures for each existing 
use are 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 fenpyroximate may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for fenpyroximate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenpyroximate. 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 Pesticide Water Calculator (PWC) and Pesticides in 
Flooded Applications Model (PFAM), the estimated drinking water 
concentrations (EDWCs) of fenpyroximate for acute exposures are 
estimated to be 18.8 parts per billion (ppb) for surface water and 
43.92 ppb for ground water, and for chronic exposures are estimated to 
be 4.74 ppb for surface water and 43.42 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 43.92 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 43.42 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).
    Fenpyroximate 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 fenpyroximate to share a common mechanism of 
toxicity with any other substances, and fenpyroximate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fenpyroximate does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity

[[Page 66624]]

and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased quantitative or qualitative susceptibility in the 
developmental toxicity studies in rabbits or rats or the reproduction 
toxicity study in rats.
    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 fenpyroximate is complete.
    ii. Although decreased motor activity and startle response were 
observed in the acute neurotoxicity study in rats, concern is low 
since: (1) There was no evidence of neurotoxicity in the rest of the 
fenpyroximate toxicological database, including the subchronic 
neurotoxicity study and the acute neurotoxicity study in hens; (2) 
clear NOAEL/LOAEL values were identified for the effects observed in 
the rat acute neurotoxicity study; and (3) the selected endpoints are 
protective of the observed effects. Therefore, there is no residual 
uncertainty concerning neurotoxicity and no need to require a 
developmental neurotoxicity study.
    iii. There is no evidence that fenpyroximate results in increased 
susceptibility in utero rats or rabbits in the prenatal developmental 
studies or in young rats in the 2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary analysis is unrefined for acute dietary 
exposures, partially refined for chronic dietary exposures, and both 
acute and chronic dietary analyses incorporated upper bound modeled 
drinking water residues. Therefore, the dietary assessment is unlikely 
to underestimate exposure.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fenpyroximate will occupy 8.7% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenpyroximate from food and water will utilize 60% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fenpyroximate.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, 
fenpyroximate is not registered for any use patterns that would result 
in either short- or intermediate-term residential exposure. Short- and 
intermediate-term risk is assessed based on short- or intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
short- or 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 short- 
or intermediate-term risk), no further assessment of short- or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for fenpyroximate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fenpyroximate 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography method with 
nitrogen/phosphorus detection (GC/NPD), Method S19) is available to 
enforce the tolerance expression. Method S19 has passed an Agency 
validation and has a limit of quantitation (LOQ) of 0.05 ppm for the 
combined residues of fenpyroximate and M-1 in snap beans and avocados. 
A data-gathering liquid chromatography/mass spectroscopy/mass 
spectroscopy (LC/MS/MS) method is also available.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex MRLs are established for residues of fenpyroximate per se in 
tree nuts at 0.05 ppm, squash at 0.06 ppm, and cucumber at 0.3 ppm. 
These are lower than the tolerances that are being established in the 
United States. Harmonization with the Codex MRLs is not possible 
because the U.S. tolerance expression includes an additional isomer and 
the U.S. use patterns require higher numerical values.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing all the tolerances at different levels than 
petitioned for in order to be consistent with the Agency's rounding 
class practice, which is based on the rounding procedures of the 
Organisation for Economic Co-operation

[[Page 66625]]

and Development. Also, although the petitioner has petitioned for the 
removal of the existing tolerance for residues in ``Bean, snap, 
succulent,'' this tolerance is being retained in order to support the 
currently labeled use on this crop.

V. Conclusion

    Therefore, tolerances are established for residues of fenpyroximate 
in or on Banana at 1 ppm; Blackeyed pea, succulent shelled at 0.4 ppm; 
Broad bean, succulent shelled at 0.4 ppm; Bushberry subgroup 13-07B at 
3 ppm; Caneberry subgroup 13-07A at 3 ppm; Chickpea, succulent shelled 
at 0.4 ppm; Cottonseed subgroup 20C at 0.1 ppm; Cowpea, succulent 
shelled at 0.4 ppm; Crowder pea, succulent shelled at 0.4 ppm; Goa 
bean, pods, succulent shelled at 0.4 ppm; Lablab bean, succulent 
shelled at 0.4 ppm; Leaf petiole vegetable subgroup 22B at 4 ppm; Lima 
bean, succulent shelled at 0.4 ppm; Nut, tree, group 14-12 at 0.1 ppm; 
Southern pea, succulent shelled at 0.4 ppm; Soybean, edible, succulent 
shelled at 0.4 ppm; Squash/cucumber subgroup 9B at 0.4 ppm; Succulent 
bean, succulent shelled at 0.4 ppm; and Velvet bean, succulent shelled 
at 0.4 ppm.
    Additionally, the following existing tolerances are removed as 
unnecessary due to the establishment of the above tolerances: Cotton, 
undelinted seed; Cucumber; Nut, tree, group 14; and Pistachio.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies tolerances under FFDCA section 
408(d) in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: November 19, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.566, amend the table in paragraph (a)(1) as follows:
0
a. Add alphabetically the entries ``Banana''; ``Blackeyed pea, 
succulent shelled''; ``Broad bean, succulent shelled''; ``Bushberry 
subgroup 13-07B''; ``Caneberry subgroup 13-07A''; ``Chickpea, succulent 
shelled''; and ``Cottonseed subgroup 20C'';
0
b. Remove the entry for ``Cotton, undelinted seed'';
0
c. Add alphabetically the entries ``Cowpea, succulent shelled'' and 
``Crowder pea, succulent shelled'';
0
d. Remove the entry for ``Cucumber'';
0
e. Add alphabetically the entries ``Goa bean, pods, succulent 
shelled''; ``Lablab bean, succulent shelled''; ``Leaf petiole vegetable 
subgroup 22B''; ``Lima bean, succulent shelled''; and ``Nut, tree, 
group 14-12'';
0
f. Remove the entries for ``Nut, tree, group 14'' and ``Pistachio''; 
and
0
g. Add alphabetically the entries ``Southern pea, succulent shelled''; 
``Soybean, edible, succulent shelled''; ``Squash/cucumber subgroup 
9B''; ``Succulent bean, succulent shelled''; and ``Velvet bean, 
succulent shelled''.
    The additions read as follows:


Sec.  180.566   Fenpyroximate; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Banana......................................................           1
 
                                * * * * *
Blackeyed pea, succulent shelled............................         0.4
Broad bean, succulent shelled...............................         0.4
Bushberry subgroup 13-07B...................................           3
Caneberry subgroup 13-07A...................................           3
 
                                * * * * *
Chickpea, succulent shelled.................................         0.4
 
                                * * * * *
Cottonseed subgroup 20C.....................................         0.1
Cowpea, succulent shelled...................................         0.4

[[Page 66626]]

 
Crowder pea, succulent shelled..............................         0.4
 
                                * * * * *
Goa bean, pods, succulent shelled...........................         0.4
 
                                * * * * *
Lablab bean, succulent shelled..............................         0.4
Leaf petiole vegetable subgroup 22B.........................           4
Lima bean, succulent shelled................................         0.4
 
                                * * * * *
Nut, tree, group 14-12......................................         0.1
 
                                * * * * *
Southern pea, succulent shelled.............................         0.4
Soybean, edible, succulent shelled..........................         0.4
 
                                * * * * *
Squash/cucumber subgroup 9B.................................         0.4
 
                                * * * * *
Succulent bean, succulent shelled...........................         0.4
 
                                * * * * *
Velvet bean, succulent shelled..............................         0.4
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-26131 Filed 12-4-19; 8:45 am]
 BILLING CODE 6560-50-P


