[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Rules and Regulations]
[Pages 45426-45434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18365]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0161; FRL-9997-41]
Buprofezin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
buprofezin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project No. 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective August 29, 2019. Objections and
requests for hearings must be received
[[Page 45427]]
on or before October 28, 2019, 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-2018-0161, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 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-2018-0161 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
October 28, 2019. 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-2018-0161, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of 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
7E8654) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of buprofezin, 2-(1,1-
dimethylethyl)iminotetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one in or on the following raw agricultural commodities:
Fig at 0.70 parts per million (ppm), Leafy greens subgroup 4-16A,
except head lettuce and radicchio at 35 ppm; Brassica, leafy greens,
subgroup 4-16B at 60 ppm; Vegetable, brassica, head and stem, group 5-
16 at 12.0 ppm; Leaf petiole vegetable subgroup 22B at 35 ppm; Celtuce
at 35 ppm; Fennel, Florence at 35 ppm; Kohlrabi at 12.0 ppm; Tropical
and subtropical, small fruit, edible peel, subgroup 23A at 5.0 ppm;
Tropical and subtropical, small fruit, inedible peel, subgroup 24A at
0.30 ppm; Cottonseed subgroup 20C at 0.35 ppm; Fruit, citrus, group 10-
10 at 2.5 ppm; Fruit, stone, group 12-12, except apricot and peach at
2.0 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 2.5 ppm and Nut, tree, group 14-12 at 0.05 ppm. The petition
also requested to remove the established tolerances for residues of
buprofezin in or on the following raw agricultural commodities: Acerola
at 0.30 ppm; Brassica, head and stem, subgroup 5A at 12.0 ppm;
Brassica, leafy greens, subgroup 5B at 60 ppm; Cotton, undelinted seed
at 0.35 ppm; Fruit, citrus, group 10 at 2.5 ppm; Fruit, stone, group
12, except apricot and peach at 1.9 ppm; Grape at 2.5 ppm; Longan at
0.30 ppm; Lychee at 0.30 ppm; Nut, tree group 14 at 0.05 ppm; Olive at
3.5 ppm; Olive, oil at 4.8 ppm; Pistachio at 0.05 ppm; Spanish lime at
0.30 ppm; Turnip, greens at 60 ppm; Vegetable, leafy, except Brassica,
group 4, except head lettuce and radicchio at 35 ppm; and Wax jambu at
0.30 ppm. That document referenced a summary of the petition prepared
by Nichino America, Inc., the registrant, which is available in the
docket, http://www.regulations.gov. No comments were received on the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being
established and has corrected some of the commodity definitions to be
consistent with Agency nomenclature. The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.''
[[Page 45428]]
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 buprofezin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with buprofezin 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 primary organs of buprofezin toxicity are the liver and the
thyroid. In subchronic toxicity studies in rats, increased microscopic
lesions in liver and thyroid, increased liver weights, and increased
thyroid weight in males were seen. In chronic studies in the rat, an
increased incidence of follicular cell hyperplasia and hypertrophy in
the thyroid of males were reported. In chronic studies in the dog,
increased relative liver weights were reported in females. Effects
observed in a 24-day dermal toxicity study in rats included
inflammatory infiltrate of the liver and an increase in acanthosis and
hyperkeratosis of the skin in females. Following inhalation exposure of
rats, the adrenal gland was the target of buprofezin toxicity (i.e.,
increased weight and microscopic findings of minimal hypertrophy of the
cortex).
The developmental toxicity study in the rat showed reduced
ossification and reduced pup weight at maternally toxic doses (death,
decreased pregnancy rates, increased resorption rates). No
developmental toxicity was observed in the rabbit at or below
maternally toxic dose levels. The reproductive toxicity study showed
decreased pup body weights at dose levels where liver effects
(increased relative and/or absolute liver weights) and decreased body
weight gains were observed in the parental generations. In contrast,
evidence of post-natal offspring sensitivity was observed in the
comparative thyroid toxicity assay (CTA) study. Rat pups experienced
decreased body weight during early lactation and increased thyroid
stimulating hormone (TSH) levels at a dose that did not elicit toxicity
in the dams. Higher doses were required to elicit maternal toxicity
which included increased serum TSH concentration, decreased serum T4
levels and histopathological findings in the thyroid (increased
follicular cell height and follicular cell hypertrophy). Pre-natal
sensitivity was not evident in the CTA study as fetal toxicity
(increased thyroid weight in males and increased TSH levels in males
and females) was observed only at maternally toxic doses.
EPA has classified buprofezin into the category of ``Suggestive
Evidence of Carcinogenicity, but not sufficient to assess human
carcinogenic potential'' based on liver tumors in female mice only.
Buprofezin was negative in in vitro and in vivo genotoxicity assays.
The Agency noted findings from the published literature indicate that
buprofezin causes cell transformation and induces micronuclei in vitro,
but determined that, in the absence of a positive response in an in
vivo micronucleus assay, buprofezin may have aneugenic potential which
is not expressed in vivo. The Agency has determined that the cRfD is
protective for carcinogenic effects.
Aniline is a substance that may be formed in food from buprofezin
and its aniline-containing metabolites as a result of cooking but is
toxicologically different from buprofezin and its other metabolites.
EPA has classified aniline as a B2-probable human carcinogen with an
oral cancer slope factor of 5.7 x 10-3 (mg/kg/
day)-1 which is considered very conservative for cancer
assessment of aniline. The Agency did not identify any other oral
endpoint.
Specific information on the studies received and the nature of the
adverse effects caused by buprofezin 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 ``Buprofezin. Human Health
Risk Assessment for Proposed New Uses on Figs and Greenhouse-Grown
Peppers and the Establishment of Permanent Tolerances in/on Fig and
Tolerance Conversions to Leafy Greens, Subgroup 4-16A, Except Head
Lettuce and Radicchio; Brassica, Leafy Greens, Subgroup 4-16B;
Vegetable, Brassica, Head and Stem, Group 5-16; Leaf Petiole Vegetable
Subgroup 22B; Celtuce; Florence Fennel; Kohlrabi; and Tolerance
Expansions to All Members of Fruit, Citrus Group 10-10; Fruit, Stone,
Group 12-12; Nut, Tree, Group 14-12; Tropical and Subtropical, Small
Fruit, Edible Peel, Subgroup 23A; Tropical and Subtropical, Small
Fruit, Inedible Peel, Subgroup 24A; Cottonseed Subgroup 20C; and Fruit,
Small, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F'' on
pages 59-63 in docket ID number EPA-HQ-OPP-2018-0161.
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-pesticides.
A summary of the toxicological endpoints for buprofezin and aniline
used for human risk assessment is shown in Table 1 of this unit.
[[Page 45429]]
Table 1--Summary of Toxicological Doses and Endpoints for Buprofezin and Aniline for Use in Human Health Risk
Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD for risk Study and toxicological effects
safety factors assessment
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Acute dietary (General population An acute RfD for the general population including infants and children was
including infants and children). not selected because the effects observed in the animal studies that could
be attributed to a single day exposure were not applicable to the general
population.
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Acute dietary (Females 13 to 49 NOAEL = 200 mg/kg/ Acute RfD = 2.0 mg/ Developmental Toxicity Study--Rat.
years of age). day. kg/day. Developmental LOAEL = 800 mg/kg/
UFA = 10x........... aPAD = 2.0 mg/kg/ day based on reduced ossification
UFH = 10x........... day. & decreased fetal body weight.
FQPA SF = 1x........
Chronic dietary (All populations) LOAEL = 10 mg/kg/day Chronic RfD = 0.033 Comparative Thyroid Toxicity
UFA = 3x............ mg/kg/day. Analysis (CTA) Study--rats.
UFH = 10x........... cPAD = 0.033 mg/kg/ Offspring LOAEL = 10.0 mg/kg/day
FQPA SF = 10x (UFL). day. based on significantly decreased
pup body weight ([darr]8-13% in
males during LD 4-10 and [darr]8-
9% in females during LD 4-7)
compared to controls and
increased TSH levels on LD 4 and
LD 21 ([uarr]23-34% in males).
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Cancer--Buprofezin (Oral, dermal, ``Suggestive Evidence of Carcinogenicity, but not sufficient to assess human
inhalation). carcinogenic potential''. The cRfD is considered protective of the cancer
effects.
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Cancer--Aniline (Oral, dermal, B2--probable human carcinogen with an oral cancer slope factor of 5.7 x 10-3
inhalation). (mg/kg/day)-1
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. NOAEL = no-
observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.
UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to buprofezin, EPA considered exposure under the petitioned-
for tolerances as well as all existing buprofezin tolerances in 40 CFR
180.511. EPA assessed dietary exposures from buprofezin in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for buprofezin.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA
assumed 100 percent crop treated (PCT) for all commodities. Total
residues of concern in crop commodities (i.e., buprofezin and the BF4
Conjugate (2-(2-hydroxy-1,1-dimethylethylimino)-3-isopropyl-5-phenyl-
1,3,5-thiadiazinan-4-one) which is not detectable by data collection
methods but which may be estimated from metabolism data) were based on
tolerance level residues of buprofezin and available metabolism/
magnitude of the data to estimate other residues of concern. Given the
potential for BF9 (3-isopropyl-5-phenyl-1,3,5-thiadiazinan-2,4-dione)
and BF12 (1-isopropyl-3-phenylurea) to concentrate to a greater degree
than buprofezin in processed commodities, Dietary Exposure Evaluation
Model (DEEM) default processing factors were retained for all
commodities, except for tomato paste and puree, which were reduced
based on empirical data. Based on the submitted lemon metabolism data,
which indicated that residues of concern are primarily found in/on the
peel, the maximum theoretical concentration factor for peel was used to
estimate residues of concern in citrus peel. Total residues of concern
in meat (i.e., buprofezin and BF2 (2-tert-butylimino-5-(4-
hydroxyphenyl)-3-isopropyl-1,3,5-thiadiazinan-4-one)) and milk (i.e.,
buprofezin and BF23 (N-(4-hydroxyphenyl) acetamide)) were based on the
feeding study data which were used to establish meat and milk
tolerances. Based on the submitted data, which indicated a 5x
concentration of residues into milk cream and fat and a Log
Kow of 4.31, a default 25x concentration factor was applied
for milk fat.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). A partially refined chronic dietary analysis was
conducted using the same residue estimates used for the acute dietary
analysis and average PCT estimates when available.
iii. Cancer. Buprofezin: Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to buprofezin. Cancer risk was assessed using
the same exposure estimates as discussed in Unit III.C.1.ii., chronic
exposure.
Aniline: EPA determines whether quantitative cancer exposure and
risk assessments are appropriate for a food-use pesticide based on the
weight of the evidence from cancer studies and other relevant data. If
quantitative cancer risk assessment is appropriate, Cancer risk may be
quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or nonlinear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that aniline should be classified as ``Probable human
carcinogen'' and a linear approach has been used to quantify cancer
risk. A refined cancer dietary analysis was conducted for this
[[Page 45430]]
assessment using percent crop treated estimates when available along
with USDA Pesticide Data Program (PDP) monitoring data for buprofezin.
In addition, residues of aniline from the B4 conjugate was estimated
using a cooking residue study.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the PCT for registered uses as follows:
The acute dietary exposure analyses assumed 100 PCT. Average PCT
was used for the following crops for refinement of the chronic
analyses: Almond 1%, apple 2.5%, apricot 10%, broccoli 5%, Brussels
sprout 2.5%, cabbage 5%, cantaloupe 5%, cauliflower 10%, cherry 2.5%,
cotton 1%, grapefruit 5%, grape 5%, lemon 2.5%, lettuce 10%, nectarine
5%, olive 2.5%, orange 2.5%, peach 5%, pear 10%, pepper 2.5%, pistachio
10%, plum/prune 5%, pomegranate 15%, pumpkin 1%, spinach 1%, squash 1%,
strawberry 15%, tomato 1%, walnut 1%, and watermelon 2.5%. These
average PCT data were also used to refine the cancer dietary exposure
analysis for buprofezin-derived aniline.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for buprofezin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of buprofezin. 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 Root Zone Model version 5 and Variable
Volume Water Model (PRZM5/VVWM) and Pesticide Root Zone Model Ground
Water (PRZM GW) models, the estimated drinking water concentrations
(EDWCs) of buprofezin for acute exposures are estimated to be 78.8
parts per billion (ppb) for surface water and for chronic exposures are
estimated to be 19 ppb for surface water. There was no breakthrough of
buprofezin into ground water during a 100-year simulation using the
PRZM-GW model. Buprofezin, therefore, is not expected to be detected in
shallow ground water. For aniline, the Agency has determined that there
is no expectation of buprofezin-derived aniline in drinking water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 78.8 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 19 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).
Buprofezin is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
In 2016, EPA's Office of Pesticide Programs released a guidance
document entitled ``Pesticide Cumulative Risk Assessment: Framework for
Screening Analysis'' (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework). This document provides guidance on how to screen groups of
pesticides for cumulative evaluation using a two-step approach
beginning with the evaluation of available toxicological information
and if necessary, followed by a risk-based screening approach. This
framework supplements the existing guidance documents for establishing
common mechanism groups (CMGs) and conducting cumulative risk
assessments (CRA). EPA has utilized this framework for buprofezin and
determined that the available toxicological data suggests buprofezin
does not share a similar toxicological profile, and thus no common
mechanism of toxicity, with other pesticides. No further cumulative
evaluation is necessary for buprofezin.
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
[[Page 45431]]
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. Developmental toxicity
studies in rats and rabbits and reproduction studies in rats provided
no indication of increased susceptibility of rats or rabbits following
in utero exposure or of rats following pre/postnatal exposure to
buprofezin. However, a comparative thyroid study demonstrated offspring
susceptibility, but not fetal susceptibility to buprofezin oral
(gavage) administration. Points of departure (PODs) for risk assessment
that are derived from this comparative thyroid study are based on the
most sensitive endpoint of concern.
3. Conclusion. For exposure scenarios using a NOAEL as POD (i.e.,
acute dietary exposure for females 13 to 49 years of age), EPA has
determined that the FQPA SF which was previously retained due to data
deficiency may be reduced to 1x. However, for assessments that use the
comparative thyroid study to derive a POD (i.e., chronic dietary,
incidental oral, short-term and intermediate-term dermal, and cancer),
a FQPA SF of 10x is retained to account for the lack of a NOAEL. That
decision is based on the following findings:
i. The toxicity database for buprofezin is complete, with the
exception of a NOAEL in the comparative thyroid study.
ii. There was no evidence of neurotoxicity in the toxicity
database.
iii. There was no evidence in developmental and reproductive
toxicity studies of quantitative or qualitative sensitivity in the
young; however, the comparative thyroid study demonstrated enhanced
sensitivity in pups but not fetuses relative to maternal animals. A
NOAEL could not be established for rat pups in the comparative thyroid
study and, as a result, the 10x FQPA SF was retained to account for the
uncertainty in the offspring sensitivity introduced by the lack of a
NOAEL.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment uses conservative
assumptions which result in protective estimates of dietary exposure.
The dietary drinking water assessment uses values generated by models
and associated modeling parameters which are designed to provide
protective, high-end estimates of water concentrations. These
assessments will not underestimate the exposure and risks posed by
buprofezin.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to buprofezin will occupy 4.8% of the aPAD at the 95th percentile of
exposure for females 13 to 49 years old, the only population group of
concern.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
buprofezin from food and water will utilize 51% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, buprofezin
is not registered for any use patterns that would result in either
short- or intermediate-term residential exposure. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short- or intermediate-term risk), no further assessment of
short-or intermediate-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for buprofezin.
4. Aggregate cancer risk for U.S. population. Buprofezin: As
explained in Unit III.A., the Agency has determined that the
quantification of risk using a non-linear (i.e., RfD) approach will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from exposure to buprofezin. Therefore, based on the
results of the chronic risk assessment discussed in Unit III.E.2.,
buprofezin is not expected to pose a cancer risk to humans.
Aniline: A highly refined cancer dietary exposure and risk
assessment for buprofezin-derived aniline residues was conducted for
cooked foods only using an oral cancer slope factor of 5.7 x
10-3 (mg/kg/day)-1 for aniline. Average residues
of buprofezin and its aniline-containing metabolites in/on foods prior
to cooking were estimated using (1) monitoring data for uncooked raw
agricultural commodities (RACs) provided by USDA PDP, where available,
(2) an additional factor based on metabolism data (1.8x) to estimate
aniline-containing metabolites, where needed, and (3) average
buprofezin PCT data where available. A conversion factor of 18.9%, the
highest found in the hydrolysis study, was applied to estimate residues
of buprofezin-derived aniline which may form in food as a result of
cooking. Only cooked food forms were included in the dietary analysis.
The highly refined estimated exposure of the highest exposed adult
population (adults 20 to 49 years old) to buprofezin-derived aniline is
0.000053 mg/kg/day which results in an upper bound cancer risk estimate
of 3 x 10-7 and is below the Agency's level of concern.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to buprofezin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available in Pesticide Analytical
Manual Volume I (PAM I) and PAM II for enforcement of buprofezin
tolerances, including gas chromatography (GC) methods with nitrogen
phosphorus detection (GC/NPD), and a GC/mass spectrometry (MS) method
for confirmation of buprofezin residues in plant commodities. The
validated limit of quantitation (LOQ) is 0.05 ppm.
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
[[Page 45432]]
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.
No Codex MRLs have been established for residues of buprofezin in/
on fig.
Codex has established several MRLs for residues of buprofezin in/on
other raw agricultural commodities (RACs) included in this petition,
including cherries, plums, grapes, almonds, and table olives, which are
harmonized with the U.S. tolerances being established in this action.
Additionally, Codex has an established MRL on dried grapes (including
currants, raisins, and sultanas), which is harmonized with the U.S.
tolerance being established for grape, raisin. Codex has also
established a more restrictive MRL in/on citrus fruits which is too low
to harmonize with U.S. tolerances due to significant differences in
good agricultural practices (GAP).
C. Revisions to Petitioned-For Tolerances
The tolerances being established by the Agency differ from the
requested tolerances as follows:
All trailing zeroes have been removed from petitioned-for
tolerances in accordance with Agency policy.
The following requested commodity definitions have been revised to
be consistent with Agency nomenclature: Florence fennel is changed to
fennel, Florence, fresh leaves and stalk; and vegetable, brassica, head
and stem, group 5-16 is changed to vegetable, Brassica, head and stem,
group 5-16.
The petitioned-for tolerance in/on the fruit, stone, group 12-12,
except apricot and peach at 2.0 ppm which is based on cherry and plum
data has been revised to fruit, stone, group 12-12, except nectarine
and peach at 2 ppm. The petitioned-for stone fruit crop group
conversion from group 12 to 12-12 has resulted in a change of the
representative commodity for apricot from peach to plum; hence, the
petitioned-for tolerance was revised to remove the exclusion for
apricot and the established tolerance in/on apricot (9.0 ppm) is
removed as inappropriate, thus lowering the tolerance level for apricot
from 9.0 ppm to the appropriate tolerance level of 2 ppm. Nectarine was
added to the tolerance exclusion since the higher established tolerance
in/on peach (9.0 ppm) also covers residues in/on nectarine (40 CFR
180.1(g)). This does not represent a tolerance level change for
nectarine.
The petitioned-for tolerance in/on the citrus crop group 10-10 has
been revised from 2.5 ppm to 4 ppm. The tolerance level has been
increased to harmonize with the Canadian MRL for citrus fruit
commodities. The Canadian MRL was determined using U.S. orange data and
the Organization for Economic Cooperation and Development (OECD)
calculation procedures, while the established U.S. tolerance was
determined with older tolerance calculation procedures, including the
North American Free Trade Agreement (NAFTA) spreadsheet.
The petitioned-for tolerance in/on the fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F has been revised from 2.5 ppm
to 1 ppm to harmonize with the currently established Codex and Canada
MRLs in/on grapes.
A tolerance of 2 ppm in/on grape, raisin has been be added due to
the crop group expansion and lowering of the currently established
tolerance in/on grape (2.5 ppm) to the fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F (1 ppm).
The petitioned-for tolerance in/on leafy greens subgroup 4-16A,
except head lettuce and radicchio at 35 ppm is changed to leafy greens
subgroup 4-16A at 35 ppm. The tolerances in/on head lettuce and
radicchio are covered by the crop subgroup 4-16A tolerance and are
being increased to 35 ppm to harmonize with the Canadian MRLs for head
lettuce and radicchio. Currently established separate tolerances in/on
head lettuce and radicchio at 6.0 ppm are being removed as unnecessary.
D. International Trade Considerations
In this final rule, EPA is reducing the existing tolerances for the
commodities of apricot from 9 ppm to 2 ppm and of grape from 2.5 ppm to
1 ppm. The Agency is reducing the tolerances since data indicate the
higher tolerance is no longer needed to cover residues from approved
domestic uses and in order to harmonize the tolerance in/on grapes with
Codex and Canadian MRLs.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of this revision in order to satisfy its obligation. In addition,
the SPS Agreement requires that Members provide a ``reasonable
interval'' between the publication of a regulation subject to the
Agreement and its entry into force to allow time for producers in
exporting Member countries to adapt to the new requirement. At this
time, EPA is establishing an expiration date for the existing
tolerances to allow those tolerances to remain in effect for a period
of six months after the effective date of this final rule, in order to
address this requirement. After the six-month period expires, residues
of buprofezin on apricot and grape cannot exceed the new tolerance
levels established in this rulemaking.
This reduction in tolerance levels is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance levels are
supported by available residue data.
V. Conclusion
Therefore, tolerances are established for residues of buprofezin in
or on Brassica, leafy greens, subgroup 4-16B at 60 ppm; celtuce at 35
ppm; cottonseed subgroup 20C at 0.35 ppm; fennel, Florence, fresh
leaves and stalk at 35 ppm; fig at 0.7 ppm; fruit, citrus, group 10-10
at 4 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 1 ppm; fruit, stone, group 12-12, except nectarine and peach
at 2 ppm; grape, raisin at 2 ppm; kohlrabi at 12 ppm; leaf petiole
vegetable subgroup 22B at 35 ppm; leafy greens subgroup 4-16A at 35
ppm; nut, tree, group 14-12 at 0.05 ppm; tropical and subtropical,
small fruit, edible peel, subgroup 23A at 5 ppm; tropical and
subtropical, small fruit, inedible peel, subgroup 24A at 0.3 ppm; and
vegetable, Brassica, head and stem, group 5-16 at 12 ppm.
Additionally, the existing tolerances on the following commodities
are removed as unnecessary due to the establishment of the above
tolerances: Acerola; Brassica, head and stem, subgroup 5A; Brassica,
leafy greens, subgroup 5B; cotton, undelinted seed; fruit, citrus,
group 10; fruit, stone, group 12, except apricot and peach; lettuce,
head; longan; lychee; nut, tree group 14; olive; olive, oil; pistachio;
radicchio; Spanish lime; turnip, greens; vegetable, leafy, except
Brassica, group 4, except head lettuce and radicchio; and wax jambu.
Finally, expiration dates are added to the existing tolerances for
apricot and grape.
[[Page 45433]]
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.
Dated: August 16, 2019.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.511, amend the table in paragraph (a) as follows:
0
a. Remove the entry for ``Acerola'';
0
b. Revise the entry for ``Apricot'';
0
c. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and
``Brassica, leafy greens, subgroup 5B'';
0
d. Add alphabetically the entries for ``Brassica, leafy greens,
subgroup 4-16B'' and ``Celtuce'';
0
e. Remove the entry for ``Cotton, undelinted seed'';
0
f. Add alphabetically the entries for ``Cottonseed subgroup 20C'';
``Fennel, Florence, fresh leaves and stalk''; ``Fig''; and ``Fruit,
citrus, group 10-10'';
0
g. Remove the entry for ``Fruit, citrus, group 10'';
0
h. Add alphabetically the entries for ``Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F'' and ``Fruit, stone, group 12-
12, except nectarine and peach'';
0
i. Remove the entry for ``Fruit, stone, group 12, except apricot and
peach'';
0
j. Revise the entry for ``Grape'';
0
k. Add alphabetically the entries for ``Grape, raisin''; ``Kohlrabi'';
``Leaf petiole vegetable subgroup 22B''; and ``Leafy greens subgroup 4-
16A'';
0
l. Remove the entries for ``Lettuce, head''; ``Longan''; ``Lychee'';
and ``Nut, tree group 14'';
0
m. Add alphabetically the entry for ``Nut, tree, group 14-12'';
0
n. Remove the entries for ``Olive''; ``Olive, oil''; ``Pistachio'';
``Radicchio''; and ``Spanish lime'';
0
o. Add alphabetically the entries for ``Tropical and subtropical, small
fruit, edible peel, subgroup 23A'' and ``Tropical and subtropical,
small fruit, inedible peel, subgroup 24A'';
0
p. Remove the entry for ``Turnip, greens'';
0
q. Add alphabetically the entry for ``Vegetable, Brassica, head and
stem, group 5-16'';
0
r. Remove the entries for ``Vegetable, leafy, except Brassica, group
4, except head lettuce and radicchio'' and ``Wax jambu''; and
0
s. Add footnote 3.
The revisions and additions read as follows:
Sec. 180.511 Buprofezin; tolerances for residues.
* * * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Apricot \3\................................................. 9.0
* * * * *
Brassica, leafy greens, subgroup 4-16B...................... 60
* * * * *
Celtuce..................................................... 35
* * * * *
Cottonseed subgroup 20C..................................... 0.35
* * * * *
Fennel, Florence, fresh leaves and stalk.................... 35
Fig......................................................... 0.7
Fruit, citrus, group 10-10.................................. 4
* * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit, 1
subgroup 13-07F............................................
Fruit, stone, group 12-12, except nectarine and peach....... 2
* * * * *
Grape \3\................................................... 2.5
Grape, raisin............................................... 2
[[Page 45434]]
* * * * *
Kohlrabi.................................................... 12
Leaf petiole vegetable subgroup 22B......................... 35
Leafy greens subgroup 4-16A................................. 35
* * * * *
Nut, tree, group 14-12...................................... 0.05
* * * * *
Tropical and subtropical, small fruit, edible peel, subgroup 5
23A........................................................
Tropical and subtropical, small fruit, inedible peel, 0.3
subgroup 24A...............................................
Vegetable, Brassica, head and stem, group 5-16.............. 12
* * * * *
------------------------------------------------------------------------
* * * * *
\3\ This tolerance expires on March 2, 2020.
* * * * *
[FR Doc. 2019-18365 Filed 8-28-19; 8:45 am]
BILLING CODE 6560-50-P