[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Rules and Regulations]
[Pages 70429-70434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27379]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0358; FRL-10001-86]


Fenpropathrin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of fenpropathrin in or on fuzzy kiwifruit. This action is in 
response to EPA's granting of an emergency exemption under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on fuzzy kiwifruit. This regulation establishes a maximum 
permissible level for residues of fenpropathrin in or on this 
commodity. The time-limited tolerance expires on December 31, 2022.

DATES: This regulation is effective December 23, 2019. Objections and 
requests for hearings must be received on or before February 21, 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-2019-0358, 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

[[Page 70430]]

holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at https://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select 
``Test Guidelines for Pesticides and Toxic Substances.''

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2019-0358 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 21, 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-2019-0358, 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/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket, 
along with more information about dockets generally, is available at 
https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing a time-limited tolerance for residues of fenpropathrin, 
(alpha-cyano-3-phenoxy-benzyl 2,2,3,3 
tetramethylcyclopropanecarboxylate), in or on fuzzy kiwifruit at 5 
parts per million (ppm). This time-limited tolerance expires on 
December 31, 2022.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Fenpropathrin on Fuzzy Kiwifruit and FFDCA 
Tolerances

    According to the Alabama Department of Agriculture and Industries 
(ADAI), in 2017 brown marmorated stink bug (BMSB) damage was observed 
in a small block of nursery stock plants. This observation alerted the 
staff at the kiwi nursery to the potential of BMSB for the 2018 crop 
season. ADAI claimed that in 2018, BMSB severely damaged the kiwifruit 
crop, making it unmarketable. ADAI estimated losses as high as 50% for 
2018 and projected 2019 losses to be over $1.6 million without the use 
requested under the section 18 emergency exemption. After having 
reviewed the submission, EPA determined that an emergency condition 
exists for this State, and that the criteria for approval of an 
emergency exemption are met.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by

[[Page 70431]]

residues of fenpropathrin in or on fuzzy kiwifruit. In doing so, EPA 
considered the safety standard in FFDCA section 408(b)(2), and EPA 
decided that the necessary tolerance under FFDCA section 408(l)(6) 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent, non-routine situation and to ensure that 
the resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment as provided in FFDCA 
section 408(l)(6). Although this time-limited tolerance expires on 
December 31, 2022, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amount specified in the tolerance 
remaining in or on fuzzy kiwifruit after that date will not be 
unlawful, provided the pesticide was applied in a manner that was 
lawful under FIFRA, and the residues do not exceed a level that was 
authorized by this time-limited tolerance at the time of that 
application. EPA will take action to revoke this time-limited tolerance 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
fenpropathrin meets FIFRA's registration requirements for use on fuzzy 
kiwifruit or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
fenpropathrin by a State for special local needs under FIFRA section 
24(c), nor does this tolerance by itself serve as the authority for 
persons in any State other than Alabama to use this pesticide on the 
applicable crops under FIFRA section 18, absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for fenpropathrin, 
contact the Agency's Registration Division at the address provided 
under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerance for residues of fenpropathrin on fuzzy 
kiwifruit at 5 ppm. EPA's assessment of exposures and risks associated 
with establishing the time-limited tolerance follows.

A. 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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for fenpropathrin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of November 28, 2012 (77 FR 70904) 
(FRL-9366-1).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpropathrin, EPA considered exposure under the time-
limited tolerance established by this action as well as all existing 
fenpropathrin tolerances in 40 CFR 180.466. EPA assessed dietary 
exposures from fenpropathrin in food as follows:
    i. Acute exposure. Acute effects were identified for fenpropathrin. 
In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
2003-2008 National Health and Nutrition Examination Survey, What We Eat 
in America (NHANES/WWEIA). As to residue levels in food, EPA used 
tolerance level residues for some commodities and refined the 
assessment by incorporating distributions of field trial values and 
Pesticide Data Program (PDP) monitoring data for other commodities. EPA 
translated data from some commodities to other commodities according to 
EPA's guidance documents for translating monitoring data and field 
trial data. EPA also included estimates of percent crop treated in the 
assessment. For most processed commodities, EPA used the Agency's 2018 
default processing factors for those commodities for which they were 
available. In some cases, EPA used empirical processing factors.
    ii. Chronic exposure. Based on the available data for 
fenpropathrin, use of the acute endpoint and dose for risk assessment 
is protective for repeated dose exposure and risk. Therefore, only an 
acute dietary assessment was performed, which is considered protective 
of chronic dietary exposure.
    iii. Cancer. Based on the data cited in Unit IV.A., EPA has 
concluded that fenpropathrin 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 percent crop treated (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 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.

[[Page 70432]]

     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: Apples, 
15%; apricots 2.5%; blueberries, 2.5%; broccoli, 2.5%; Brussels 
sprouts, 10%; cabbage, 2.5%; cauliflower, 2.5%; cherries, 21%; cotton, 
2.5%; cucumbers, 2.5%; grapefruit, 35%; grapes, 10%; nectarines, 9%; 
oranges, 35%; peaches, 9%; pears, 10%; plums, 2.5%; prune plums, 2.5%; 
squash, 2.5%; strawberries, 50%; tangerines, 15%; tomatoes, 10%; and 
watermelons, 2.5%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 to 7 
years. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency estimated the PCT for new uses as follows: 100% for 
fuzzy kiwifruit.
    The Agency believes that the three conditions discussed in Unit 
IV.B1.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. 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 fenpropathrin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used water 
solubility limit at 25 [deg]C in the dietary exposure analysis and risk 
assessment for fenpropathrin in drinking water. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The water solubility limit of fenpropathrin at 25 [deg]C is 10.3 
parts per billion (ppb). The limit of solubility was directly entered 
into the dietary exposure model. For acute dietary risk assessment, the 
water concentration value of 10.3 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). Fenpropathrin is not 
registered for any specific use patterns that would result in 
residential exposure.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: https://www.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.''
    The agency is required to consider the cumulative risks of 
chemicals sharing a common mechanism of toxicity. The agency has 
determined that the pyrethroids and pyrethrins share a common mechanism 
group (see https://www.regulations.gov; Docket ID EPA-HQ-OPP-2008-0489-
0006). The members of this group share the ability to interact with 
voltage-gated sodium channels ultimately leading to neurotoxicity. The 
cumulative risk assessment for the pyrethroids/pyrethrins was published 
on Nov. 9, 2011 (USEPA, 2011a) and is available at https://www.regulations.gov; Docket ID EPA-HQ-OPP-2011-0746. No cumulative 
risks of concern were identified. This assessment was conservative and 
appropriate to address use expansions, such as this use on kiwifruit. 
For information regarding the EPA's efforts to evaluate the risk of 
exposure to pyrethroids, refer to https://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html. After all of the chemical-
specific interim decisions have been completed for the pyrethroid class 
of pesticides, an update of the cumulative risk assessment may be 
performed in association with registration review.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Evidence of increased 
qualitative or quantitative susceptibility of the offspring was not 
observed in any of the available animal testing guideline toxicity 
studies, including the developmental neurotoxicity study (DNT).
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
required 10X FQPA SF were reduced to 3X for children less than 6 years 
old. For the general population, and including children greater than 6 
years old, EPA is reducing the FQPA SF to 1X. That decision is based on 
the following findings:
    i. While the database is considered to be complete with respect to 
the guideline toxicity studies for fenpropathrin, EPA lacks additional 
data to fully characterize the potential for juvenile sensitivity to 
neurotoxic effects of pyrethroids. In light of the literature studies 
indicating a possibility of increased sensitivity in juvenile rats at 
high doses, EPA identified a need, and requested proposals for, 
additional non-guideline studies to evaluate the potential for 
sensitivity in juvenile rats. A group of pyrethroid registrants is 
currently conducting those studies. Pending the results of those 
studies, however, the available toxicity studies

[[Page 70433]]

for fenpropathrin can be used to characterize toxic effects including 
potential developmental and reproductive toxicity, immunotoxicity, and 
neurotoxicity. Acceptable developmental toxicity studies in rats and 
rabbits, reproduction studies in rats, neurotoxicity studies (acute, 
subchronic, and developmental) in rats, and immunotoxicity studies in 
rats are available. In addition, a route-specific dermal toxicity study 
is available, and the inhalation study has been waived.
    ii. After reviewing the extensive body of data and peer-reviewed 
literature on pyrethroids, the Agency has reached a number of 
conclusions regarding fetal and juvenile sensitivity for pyrethroids. 
Based on an evaluation of over 70 guideline toxicity studies for 24 
pyrethroids submitted to the Agency, including prenatal developmental 
toxicity studies in rats and rabbits, and pre- and postnatal multi-
generation reproduction toxicity studies and DNTs in rats in support of 
pyrethroid registrations, there is no evidence that pyrethroids 
directly impact developing fetuses. None of the studies show any 
indications of fetal toxicity at doses that do not cause maternal 
toxicity.
    iii. Increased susceptibility was seen in offspring animals in the 
DNT study with the pyrethroid zeta-cypermethrin (decreased pup body 
weights) and DNT and reproduction studies with another pyrethroid, 
beta-cyfluthrin (decreased body weights and tremors). However, the 
reductions in body weight and the other non-specific effects occur at 
higher doses than neurotoxicity, the effect of concern for pyrethroids. 
The available developmental and reproduction guideline studies in rats 
with zeta-cypermethrin did not show increased sensitivity in the young 
to neurotoxic effects. Overall, findings of increased sensitivity in 
juvenile animals in pyrethroid studies are rare. Therefore, the 
residual concern for the postnatal effects is reduced. High-dose LD50 
studies (studies assessing what dose results in lethality to 50% of the 
tested population) in the scientific literature indicate that 
pyrethroids can result in increased quantitative sensitivity to 
juvenile animals. Examination of pharmacokinetic and pharmacodynamic 
data indicates that the sensitivity observed at high doses is related 
to pyrethroid age-dependent pharmacokinetics--the activity of enzymes 
associated with the metabolism of pyrethroids. Furthermore, a rat 
physiologically-based pharmacokinetic (PBPK) model predicts a 3-fold 
increase of pyrethroid concentration in juveniles' brains compared to 
adults at high doses. In vitro pharmacodynamic data and in vivo data 
indicate that adult and juvenile rats have similar responses to 
pyrethroids at low doses and therefore juvenile sensitivity is not 
expected at relevant environmental exposures. Further, data also show 
that the rat is a conservative model compared to the human based on 
species-specific pharmacodynamics of homologous sodium channel 
isoforms. The Agency has retained a 3X uncertainty factor to protect 
for exposures of children less than 6 years of age based on increased 
quantitative susceptibility seen in literature studies on pyrethroid 
pharmacokinetics (PKs), and the increased quantitative juvenile 
susceptibility observed in high dose studies in the literature.
    iv. There are no residual uncertainties identified in the exposure 
databases. The Agency used tolerance level residues for some 
commodities and refined the assessment by incorporating distributions 
of field trial values and Pesticide Data Program (PDP) monitoring data 
for other commodities. EPA translated data from some commodities to 
other commodities according to EPA's guidance documents for translating 
monitoring data and field trial data. EPA also included estimates of 
percent crop treated in the assessment. For most processed commodities, 
EPA used the Agency's 2018 default processing factors for those 
commodities for which they were available. In some cases, EPA used 
empirical processing factors.
    For this kiwifruit section 18 request, EPA updated the 2016 dietary 
exposure assessment by including kiwifruit. As residue data are not 
available for kiwifruit, the Agency translated grape PDP data to 
kiwifruit. For section 18 requests, the Agency assumes the proposed 
commodity will be treated to a level of 100% across the country. As a 
result, 100% crop treated was assumed for kiwifruit. EPA also made 
refinements to the residue data for dried cranberry, dried mango, and 
dried papaya. In the 2016 assessment, EPA used tolerance level residues 
for these commodities. For this section 18 request, EPA translated 
strawberry PDP data to dried cranberries, avocado field trial data to 
dried mango, and avocado field trial data to dried papaya. The Agency 
assumed 100% crop treated for the three dried commodities: Cranberry, 
mango, and papaya.
    EPA made a conservative (protective) assumption in the water 
concentration used to assess exposure to fenpropathrin in drinking 
water. These assessments will not underestimate the exposure and risk 
posed by fenpropathrin.

D. 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 fenpropathrin will occupy 99.5% of the aPAD for children 1 to 2 
years old, the population group receiving the greatest exposure.
    2. Chronic risk. A chronic dietary exposure assessment was not 
conducted because the acute endpoint adequately protects against 
chronic effects. There are no residential uses for fenpropathrin.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). A short-term 
adverse effect was identified; however, fenpropathrin is not registered 
for any use patterns that would result in short-term residential 
exposure. Because there is no short-term residential exposure and acute 
dietary exposure has already been assessed under the appropriately 
protective aPAD (which is at least as protective as the POD used to 
assess short-term risk), no further assessment of short-term risk is 
necessary, and EPA relies on the acute dietary risk assessment for 
evaluating short-term risk for fenpropathrin.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Because no intermediate-term adverse effect 
was identified, fenpropathrin is not expected to pose an intermediate-
term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fenpropathrin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes

[[Page 70434]]

that there is a reasonable certainty that no harm will result to the 
general population, or to infants and children, from aggregate exposure 
to fenpropathrin residues, including anticipated residues on fuzzy 
kiwifruit.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology utilizing gas chromatography with 
electron capture detector (GC/ECD), Residue Method Numbers RM-22-4 
(plants) and RM-22A-1 (animals), is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for fenpropathrin on fuzzy 
kiwifruit.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
fenpropathrin, (alpha-cyano-3-phenoxy-benzyl 2,2,3,3 
tetramethylcyclopropanecarboxylate), in or on kiwifruit, fuzzy at 5 
ppm. This tolerance expires on December 31, 2022.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA sections 408(e) and 
408(l)(6). 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, titled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive 
Order 13045, titled ``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, titled ``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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), 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).

VIII. 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: December 5, 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.  180.466, revise paragraph (b) to read as follows:


Sec.  180.466  Fenpropathrin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in Table 2 to this paragraph (b) are established for residues 
of fenpropathrin, (alpha-cyano-3-phenoxy-benzyl 2,2,3,3 
tetramethylcyclopropane carboxylate) in or on the specified 
agricultural commodities, resulting from use of the pesticide pursuant 
to FIFRA section 18 emergency exemptions. The tolerance expires on the 
date specified in Table 2.

                        Table 2 to Paragraph (b)
------------------------------------------------------------------------
                                                Parts per    Expiration
                  Commodity                      million        date
------------------------------------------------------------------------
Kiwifruit, fuzzy............................            5    12/31/2022
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-27379 Filed 12-20-19; 8:45 am]
 BILLING CODE 6560-50-P