[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Rules and Regulations]
[Pages 81799-81805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27906]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0053; FRL-10016-42]


Broflanilide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
broflanilide in or on multiple commodities that are identified and 
discussed later in this document. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 17, 2020. Objections and 
requests for hearings must be received on or before February 16, 2021, 
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-2018-0053, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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: 
<a href="/cdn-cgi/l/email-protection#73213735213d1c071a101600331603125d141c05"><span class="__cf_email__" data-cfemail="e3b1a7a5b1ad8c978a808690a3869382cd848c95">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2018-0053 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 16, 2021. 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-2018-0053, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> 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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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 
7F8646) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research 
Triangle Park, NC 27709. The petition requested to establish tolerances 
in 40 CFR part 180 for residues of the insecticide, broflanilide, 
including its metabolites and degradates, in or on grain, cereal, 
except rice, group 15; amaranth grain; quinoa, grain; spelt, grain; 
canihua, grain; chia, grain; cram-cram, grain; huauzontle, grain; teff, 
grain; and corn, sweet, kernel plus cob with husks removed at 0.01 
parts per million (ppm); and vegetables, tuberous and corm, subgroup 1C 
at 0.04 ppm. Tolerances were also requested for cattle, meat; goat, 
meat; horse, meat; sheep, meat at 0.01 ppm; milk, fat and poultry, fat 
at 0.02 ppm; and cattle, fat; sheep, fat; and goat, fat at 0.05 ppm. 
Additionally, tolerances were requested for grain, cereal, forage, 
fodder and straw, group 16, except rice; quinoa, hay; teff, hay; and 
corn, sweet, stover; corn, sweet, forage at 0.01 ppm; corn, field, 
milled products at 0.015 ppm; and potato, wet peel at 0.1 ppm. In 
addition, BASF proposed to establish a tolerance of 0.01 ppm for 
residues of broflanilide in or on all food items in food handling 
establishments where food and food products are held, processed, 
prepared and/or served. That document referenced a summary of the 
petition prepared by BASF, the registrant, which

[[Page 81800]]

is available in the docket, http://www.regulations.gov. A comment was 
received on the notice of filing. EPA's response to this comment is 
discussed in Unit IV.C.
    In the Federal Register of June 24, 2020 (85 FR 37806) (FRL-10010-
82), EPA issued a second notice amending the previous NOF published in 
the Federal Register on July 24, 2018, by announcing additional 
commodities for which the petitioner was seeking tolerances. BASF 
requested to establish a tolerance in 40 CFR part 180 for residues of 
the insecticide, broflanilide, including its metabolites and 
degradates, in or on amaranth, stover; quinoa, forage; quinoa, straw; 
teff, forage; and teff, straw at 0.01 ppm. (EPA's notice inadvertently 
listed amaranth, grain, which had already been identified in the July 
2018 notice, instead of amaranth, stover, but BASF's petition included 
a request for amaranth, stover.) BASF also requested tolerances for 
food items (animal origin) for hog, meat; poultry, meat; eggs; cattle, 
meat byproducts; goat, meat byproducts; hog, meat byproducts; horse, 
meat byproducts; poultry, meat byproducts; sheep, meat byproducts; hog, 
fat; and horse, fat at 0.02 ppm. No comments were received in response 
to this notice.
    Based upon review of the data supporting the petition, EPA is 
establishing some tolerances at different levels than were petitioned 
for. The reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for broflanilide including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with broflanilide follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The target organs of broflanilide toxicity are the adrenal glands 
(rats, mice, and dogs) and ovaries (rats and mice). Adrenal effects 
include increased adrenal weights, increased incidence of adrenal 
cortex vacuolation, and adrenal cortex hypertrophy in both sexes. 
Ovarian effects include increased incidence of ovarian interstitial 
gland vacuolation.
    There were no parental or developmental effects reported up to the 
limit dose tested (1000 mg/kg/day) in the developmental studies in rats 
and rabbits. In the reproduction study in rats, increased adrenal 
weights with corroborative histopathological findings (increased 
vacuolation and diffuse hypertrophy in the adrenal gland cortex) were 
observed in parental rats of both sexes and generations. Offspring 
showed decreased pup weights in F1 and F2 pups, which occurred at a 
higher dose level than the observed adverse effects in parental rats. 
Reproductive parameters showed increased ovarian weights and increased 
incidence of vacuolation of interstitial gland in the ovary at a higher 
dose level than the adverse effects in parental rats. There were no 
effects on fertility or other measured reproductive parameters.
    There is no evidence of neurotoxicity in acute or subchronic 
neurotoxicity studies and broflanilide is not an immunotoxic chemical. 
In the subchronic inhalation study, there was an increase in absolute 
and relative adrenal weight and increased incidence of adrenal 
vacuolation in both sexes and increased incidence of ovarian 
vacuolation.
    In the chronic toxicity/carcinogenicity study in rats, there were 
treatment-related increases in Leydig cell adenomas in male rats, and 
in luteomas and granulosa cell tumors in the ovaries, as well as in 
uterine adenocarcinomas, and adrenal cortex carcinomas in female rats. 
No treatment-related increase in tumor incidences was observed in mice. 
All mutagenicity studies were negative for both the parent and major 
metabolites (DM-8007, S(PFP-OH)-8007, DC-8007, DC-DM-8007, MFBA, AB-
oxa, S9Br-OH)-8007).
    Specific information on the studies received and the nature of the 
adverse effects caused by broflanilide 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 ``Broflanilide: New Active 
Ingredient Human Health Risk Assessment'' (hereinafter ``Broflanilide 
Human Health Risk Assessment'') on pages 42-58 in docket ID number EPA-
HQ-OPP-2018-0053.

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 broflanilide used for 
human risk assessment can be found in the Broflanilide Human Health 
Risk Assessment.

[[Page 81801]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to broflanilide, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from broflanilide 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.
    No such effects were identified in the toxicological studies for 
broflanilide; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 2003-2008 food consumption data from the U.S. 
Department of Agriculture's National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, for all commodities in the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID), EPA used 
tolerance-level residues, highest average field trials (HAFT) residue 
values, anticipated residues, 100 percent crop treated (PCT), and 
default processing factors resulting from agricultural uses, and the 
food handling establishment (FHE) values (\1/2\ FHE LOQ tolerance and 
4.65% FHE treatment).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that broflanilide should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk. The cancer risk assessment used the same 
assumptions as the chronic assessment.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    <bullet> 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.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> 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 chronic and cancer assessments assumed 100 PCT for agricultural 
uses and the treatment value of 4.65% for FHE uses.
    EPA estimates the percent of commodities treated in Food Handling 
Establishments (FHE) for new uses of active ingredients based on the 
best available information. This includes survey information on 
pesticide usage related to the number of facilities being treated, 
product forms used (e.g., liquids and aerosols), and treatment schedule 
by FHE segments (e.g., warehouse, food processor, distributor, and 
restaurant). EPA also incorporated the best available information 
related to the transfer of commodities between various segments of food 
handling establishments and the percent of food consumed by location, 
either in the home or outside the home.
    All information currently available has been considered and EPA has 
concluded that for any active ingredient, including broflanilide, there 
is at most a 4.65% likelihood that a food commodity could contain 
potential residues resulting from one or more treatments while in the 
food handling establishment channel of trade. Similar to estimates of 
agricultural use, this estimate should be reconsidered in 5 years.
    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 broflanilide 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 broflanilide alone as well as for the combined residues 
of concern (ROC), broflanilide and DC-8007 in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of broflanilide and the ROC, 
broflanilide and DC-8007. 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 in Water Calculator (PWC) model and using 
the Total Residue (TR) method for the ROCs, the estimated drinking 
water concentrations (EDWCs) of broflanilide and DC-8007 for chronic 
exposures for non-cancer assessments are estimated to be 0.9 ppb for 
surface water and for chronic exposures for cancer assessments are 
estimated to be 0.7 ppb for surface water. Since breakthrough of 
broflanilide into groundwater is incomplete after 100 years of 
simulation, post-breakthrough EDWCs are negligible. Due to the high 
Freundlich adsorption coefficient (K<INF>F</INF>) of broflanilide, peak 
EDWCs in groundwater were negligible as well.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration value of 0.9 ppb was used to assess 
the contribution to drinking water. For the cancer dietary risk 
assessment, the water concentration value of 0.7 ppb was used to assess 
the contribution to drinking water.

[[Page 81802]]

    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).
    There are several proposed residential uses for broflanilide. These 
uses include, but are not limited to, insecticide treatments in and 
around homes, apartments, schools, picnic areas, hospitals, and nursing 
homes. In addition, there are several proposed termiticide products 
that may be used around the exterior of homes, apartments, schools, and 
other residential use sites. EPA assessed residential exposure using 
the following assumptions:
    <bullet> Residential handler: Although there is one proposed 
broflanilide product label with residential use sites (e.g., homes, 
apartments, mobile homes), this product is formulated as a ready-to-use 
pressurized can, which, once dispensed, rapidly expands to generate a 
dry foam. One ounce (weight) of the product is being dispensed in 
approximately 5 seconds, and the ready-to-use pressurized can produces 
about 1 quart of foam. Based on the areas to which it is applied (i.e., 
with actuators in voids, cracks, and other places where insects 
harbor), dermal exposure is expected to be negligible. In addition, 
considering the low vapor pressure of broflanilide 
(6.7x10<SUP>-11</SUP> mmHg) and formulation into foam, inhalation 
exposure is also expected to be negligible. Therefore, neither a 
quantitative non-cancer nor cancer residential handler exposure and 
risk assessment was conducted.
    <bullet> Post-application exposure: There is the potential for 
short-term post-application exposure for individuals exposed as a 
result of being in an environment that has been previously treated with 
broflanilide. Due to a lack of dermal hazard for broflanilide, a dermal 
non-cancer assessment was not conducted. The quantitative non-cancer 
exposure and risk assessment for residential short-term post-
application exposures is based on the following maximum application 
rate scenarios: Inhalation and incidental oral exposure from indoor 
crack and crevice, banded, and spot applications.
    The PODs for the oral and inhalation routes are based on the same 
effects: Therefore, oral and inhalation routes can be combined. Since 
the LOCs for both incidental oral and inhalation are different (100 and 
30), the aggregate risk index (ARI) approach was used:

Aggregate Risk Index (ARI) = 1 / [(Incidental Oral LOC / Incidental 
Oral MOE) + (Inhalation LOC / Inhalation MOE)].

    Although a non-cancer dermal risk assessment was not performed due 
to the lack of an adverse effect in the non-cancer dermal study, a 
dermal cancer exposure and risk assessment was performed because dermal 
exposure does contribute to the overall cancer risk for broflanilide.
    Post-application cancer risk estimates for adults were calculated 
using a linear low-dose extrapolation approach in which a Lifetime 
Average Daily Dose (LADD) is first calculated and then compared with a 
Q<INF>1</INF> * that has been calculated for broflanilide based on dose 
response data in the appropriate toxicology study (Q<INF>1</INF>* = 
2.48 x 10<SUP>-3</SUP> (mg/kg/day)<SUP>-1</SUP>).
    The residential exposure scenario used in the adult non-cancer 
aggregate assessment is short-term post-application inhalation exposure 
following an indoor surface directed spot application. The residential 
exposure scenario used in the non-cancer aggregate assessment of 
children 1 to less than 2 years old is the combined inhalation and 
hand-to-mouth exposures from short-term post-application exposure to 
indoor perimeter/spot coarse and pin stream surface spray applications 
on carpet.
    The residential exposure scenario used in the adult cancer 
aggregate assessment is post-application dermal and inhalation exposure 
following an indoor surface directed perimeter/spot application.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found broflanilide to share a common mechanism of 
toxicity with any other substances, and broflanilide does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
broflanilide does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Broflanilide did not 
demonstrate any evidence of increased qualitative or quantitative 
susceptibility in the rat and rabbit developmental toxicity studies or 
the 2-generation rat reproduction study. In the rabbit and rat 
developmental toxicity studies, there were no developmental effects up 
to the limit dose tested (1000 mg/kg/day). In the reproduction study in 
rats, decreased pup weights in F1 and F2 pups occurred at a higher dose 
levels than the dose with adverse parental findings.
    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 broflanilide is complete.
    ii. Acute and subchronic neurotoxicity studies showed no evidence 
of neurotoxicity in male or female rats. There was no other evidence in 
any species tested to indicate neurotoxicity potential. Therefore, 
there is no concern for acute or subchronic neurotoxicity resulting 
from exposure to broflanilide.
    iii. There is no evidence that broflanilide results in increased 
susceptibility in 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 food exposure assessments

[[Page 81803]]

were performed based on 100 PCT for agricultural uses, a treatment 
value of 4.65% for FHE uses, and some anticipated residue data. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to broflanilide in drinking 
water. EPA used similarly conservative assumptions to assess post-
application exposure of children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by broflanilide.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
broflanilide is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
broflanilide from food and water will utilize less than 1% of the cPAD 
for children 1 to 2 years old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
broflanilide is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Broflanilide is proposed for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to broflanilide.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate ARIs of 320 for adults 
and 4.4 for children 1 to <2 years old. Because EPA's level of concern 
for broflanilide is an ARI of 1 or below, these ARIs are not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
broflanilide is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
broflanilide.
    5. Aggregate cancer risk for U.S. population. A cancer aggregate 
risk assessment was completed for the proposed residential and dietary 
uses of broflanilide using the linear slope factor (Q1 *) of 2.48 x 
10<SUP>-3</SUP>. The assessment incorporates the adult post-application 
dermal and inhalation exposure following an indoor surface directed 
perimeter/spot application. The residential assessment is a 
conservative calculation which assumes 12 retreatments a year as 
allowed by the label at the maximum rate proposed, 365 days of exposure 
in the residential setting, and 10% dissipation of residues per day. 
The cancer dietary exposure estimate for adults 20-49 years old, the 
most highly-exposed adult population subgroup, assumed 100% crop 
treated for agricultural uses and the FHE treatment value of 4.65% for 
FHE uses. The resulting aggregate cancer risk estimate is 1 x 
10<SUP>-6</SUP>.
    EPA generally considers cancer risks (expressed as the probability 
of an increased cancer case) in the range of 1 in 1 million (or 1 x 
10<SUP>-6</SUP>) or less to be negligible. Accordingly, EPA has 
concluded the aggregate cancer risk for all broflanilide uses fall 
within the range of 1 x 10<SUP>-6</SUP> and are thus negligible.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to broflanilide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner proposed a multi-residue method, BASF method D1417/
01, based on QuEChERS (quick, easy, cheap, effective, rugged, safe) for 
the determination of broflanilide residues in plant matrices. This 
method has been proven to be suitable for the determination of residues 
of broflanilide in plant matrices.
    BASF method D1604/01 is proposed as the enforcement method for the 
determination of residues of broflanilide and DM-8007 in livestock 
commodities by LC-MS/MS. This method has been proven to be suitable for 
the determination of residues of broflanilide and DM-8007 in livestock 
matrices.
    The methods 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: 
<a href="/cdn-cgi/l/email-protection#5a283f29333e2f3f373f2e32353e291a3f2a3b743d352c"><span class="__cf_email__" data-cfemail="8ffdeafce6ebfaeae2eafbe7e0ebfccfeaffeea1e8e0f9">[email protected]</span></a>.

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.
    Broflanilide is a new active ingredient and no MRLs have yet been 
established by Codex.

C. Response to Comments

    One comment was received in response to the Notice of Filing. The 
comment stated in part that ``the notice of the application for these 
uses does not contain any information about human toxicity, water 
solubility, granular transmissibility, or other information which could 
help evaluate the risk of higher levels of use of

[[Page 81804]]

broflanilide'' and that ``perhaps EPA should reissue the notice with 
attached information on toxicity and transmission levels.'' A 
supporting document summarizing the information on the residue 
chemistry, toxicological profile, as well as an estimate of the 
aggregate exposure expected was available in the docket at the time the 
notice was published. The NOF published on July 24, 2018, referred to 
the docket and noted that the summary was available. That document 
provided information to help evaluate the risks of broflanilide.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance in/on potato, wet peel at 0.08 
ppm rather than the petitioned-for tolerance of 0.1 ppm. The Agency's 
practice is to use the HAFT value from the field trials and the median 
processing factor. Based on these data, the appropriate tolerance for 
potato, wet peel is 0.08 ppm.
    EPA is not establishing a separate tolerance for corn, sweet, 
kernel plus cob with husks removed because it is covered under grain, 
cereal, group 15, except rice. Similarly, separate tolerances for corn, 
sweet, stover; and corn, sweet forage are not being established because 
they are covered under grain, cereal, forage, fodder, and straw, group 
16, except rice.
    EPA is including the livestock metabolite DM-8007 as a residue of 
concern for tolerance enforcement and risk assessment. Therefore, the 
tolerance expression for livestock commodities is being revised to 
include the metabolite DM-8007.
    EPA is establishing a tolerance for residues in milk at 0.02 ppm to 
harmonize with Canadian livestock LOQ MRLs. The tolerance of 0.02 ppm 
for residues in milk is higher than the anticipated residues in milk 
fat; therefore, although the available data support a tolerance for 
residues in milk fat at 0.01 ppm, a separate milk fat tolerance is not 
necessary at this time.
    Lastly, the commodity definitions for the FHE use, egg and crop 
group 16 are being modified to be consistent with Agency nomenclature.

V. Conclusion

    Therefore, tolerances are established for residues of broflanilide, 
including its metabolites and degradates, in or on the following plant 
commodities: Amaranth, grain, grain at 0.01 ppm; Amaranth, grain, 
stover at 0.01 ppm; Ca[ntilde]ihua, grain at 0.01 ppm; Chia, grain at 
0.01 ppm; Corn, field, milled byproducts at 0.015 ppm; Cram-cram, grain 
at 0.01 ppm; Grain, cereal, group 15, except rice at 0.01 ppm; Food and 
feed commodities (other than those covered by a higher tolerance) at 
0.01 ppm; Grain, cereal, forage, fodder, and straw, group 16, except 
rice at 0.01 ppm; Huauzontle, grain at 0.01 ppm; Potato, wet peel at 
0.08 ppm; Quinoa, forage at 0.01 ppm; Quinoa, grain at 0.01 ppm; 
Quinoa, hay at 0.01 ppm; Quinoa, straw at 0.01 ppm; Spelt, grain at 
0.01 ppm; Teff, forage at 0.01 ppm; Teff, grain at 0.01 ppm; Teff, hay 
at 0.01 ppm; Teff, straw at 0.01 ppm; and Vegetable, tuberous and corm, 
subgroup 1C at 0.04 ppm.
    Tolerances are also established for residues of broflanilide, 
including its metabolites and degradates, in or on the following 
livestock commodities: Cattle, fat at 0.02 ppm; Cattle, meat at 0.02 
ppm; Cattle, meat byproducts at 0.02 ppm; Egg at 0.02 ppm; Goat, fat at 
0.02 ppm; Goat, meat at 0.02 ppm; Goat, meat byproducts at 0.02 ppm; 
Hog, fat at 0.02 ppm; Hog, meat at 0.02 ppm; Hog, meat byproducts at 
0.02 ppm; Horse, fat at 0.02 ppm; Horse, meat at 0.02 ppm; Horse, meat 
byproducts at 0.02 ppm; Milk at 0.02 ppm; Poultry, fat at 0.02 ppm; 
Poultry, meat at 0.02 ppm; Poultry, meat byproducts at 0.02 ppm; Sheep, 
fat at 0.02 ppm; Sheep, meat at 0.02 ppm; and Sheep, meat byproducts at 
0.02 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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.


[[Page 81805]]


    Dated: November 30, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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

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


0
2. Add Sec.  180.714 to subpart C to read as follows:


Sec.  180.714  Broflanilide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
broflanilide, including its metabolites and degradates, in or on the 
commodities to Table 1 of this section. Compliance with the tolerance 
levels specified in Table 1 is to be determined by measuring only 
broflanilide, 3-(benzoylmethylamino)-N-[2-bromo-4-[1,2,2,2-tetrafluoro-
1-(trifluoromethyl)ethyl]-6-(trifluoromethyl)phenyl]-2-fluorobenzamide, 
in or on the commodity.

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Amaranth, grain, grain......................................        0.01
Amaranth, grain, stover.....................................        0.01
Ca[ntilde]ihua, grain.......................................        0.01
Chia, grain.................................................        0.01
Corn, field, milled byproducts..............................       0.015
Cram-cram, grain............................................        0.01
Grain, cereal, group 15, except rice........................        0.01
Food and feed commodities (other than those covered by a            0.01
 higher tolerance)..........................................
Grain, cereal, forage, fodder, and straw, group 16, except          0.01
 rice.......................................................
Huauzontle, grain...........................................        0.01
Potato, wet peel............................................        0.08
Quinoa, forage..............................................        0.01
Quinoa, grain...............................................        0.01
Quinoa, hay.................................................        0.01
Quinoa, straw...............................................        0.01
Spelt, grain................................................        0.01
Teff, forage................................................        0.01
Teff, grain.................................................        0.01
Teff, hay...................................................        0.01
Teff, straw.................................................        0.01
Vegetable, tuberous and corm, subgroup 1C...................        0.04
------------------------------------------------------------------------

    (2) Tolerances are established for residues of broflanilide, 
including its metabolites and degradates, in or on the commodities to 
Table 2 of this section. Compliance with the tolerance levels specified 
in Table 2 is to be determined by measuring the sum of broflanilide, 3-
(benzoylmethylamino)-N-[2-bromo-4-[1,2,2,2-tetrafluoro-1-
(trifluoromethyl)ethyl]-6-(trifluoromethyl)phenyl]-2-fluorobenzamide, 
and its metabolite 3-benzamido-N-[2-bromo-4-(perfluoropropan-2-yl)-6-
(trifluoromethyl)phenyl]-2-fluorobenzamide, calculated as the 
stoichiometric equivalent of broflanilide, in or on the commodity.

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.02
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.02
Egg.........................................................        0.02
Goat, fat...................................................        0.02
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.02
Hog, fat....................................................        0.02
Hog, meat...................................................        0.02
Hog, meat byproducts........................................        0.02
Horse, fat..................................................        0.02
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.02
Milk........................................................        0.02
Poultry, fat................................................        0.02
Poultry, meat...............................................        0.02
Poultry, meat byproducts....................................        0.02
Sheep, fat..................................................        0.02
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.02
------------------------------------------------------------------------

    (b)-(d) [Reserved]
[FR Doc. 2020-27906 Filed 12-16-20; 8:45 am]
BILLING CODE 6560-50-P


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