[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27906]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Broflanilide; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0053 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:
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
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
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
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
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
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-
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-
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
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:
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 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
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 (KF) 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.
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:
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
(6.7x10-11 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.
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
Q1 * that has been calculated for broflanilide based on dose
response data in the appropriate toxicology study (Q1* =
2.48 x 10-3 (mg/kg/day)-1).
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
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
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
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
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments
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
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
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
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
10-3. 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
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
10-6) or less to be negligible. Accordingly, EPA has
concluded the aggregate cancer risk for all broflanilide uses fall
within the range of 1 x 10-6 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
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:
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
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.
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
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
Dated: November 30, 2020.
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
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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
in or on the commodity.
Table 1 to Paragraph (a)(1)
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
Grain, cereal, forage, fodder, and straw, group 16, except 0.01
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-
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)
Cattle, fat................................................. 0.02
Cattle, meat................................................ 0.02
Cattle, meat byproducts..................................... 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
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
[FR Doc. 2020-27906 Filed 12-16-20; 8:45 am]
BILLING CODE 6560-50-P