[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)]
[Rules and Regulations]
[Pages 31722-31728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14085]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0595; FRL-9962-06]
Buprofezin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
buprofezin in or on rice grain. Nichino America, Inc. requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 10, 2017. Objections and
requests for hearings must be received on or before September 8, 2017,
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-2016-0595, 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,
[[Page 31723]]
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
Printing 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-2016-0595 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
September 8, 2017. 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-2016-0595, 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 December 9, 2016 (81 FR 89036) (FRL-
9953-69), 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
6E8494) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE, 19808. The petition requested that 40 CFR 180.511 be
amended by establishing a tolerance for residues of the insecticide
buprofezin in or on rice at 0.3 parts per million (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. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the level at which the tolerance is being established. The
reason for this change is 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.'' 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.
The developmental toxicity study in the rat showed reduced
ossification and reduced pup weight at maternally toxic doses (death,
decreased pregnancy rates,
[[Page 31724]]
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.
However, in a comparative thyroid toxicity assay, pup toxicity
(decreased pup body weight during early lactation and increased TSH
levels) occurred at a dose that was not maternally toxic. Maternal
toxicity resulted in increased serum TSH concentration, decreased serum
T4 levels in pregnant rats and histopathological findings in the
thyroid (increased follicular cell height and follicular cell
hypertrophy). In this same study, fetal and maternal toxicity occurred
at the same dose. Fetal toxicity was expressed as increased thyroid
weight in males and increased TSH levels in males and females. No
neurotoxic effects were observed in a subchronic neurotoxicity study in
rats at the highest dietary dose tested of 5,000 ppm. There was no
evidence of neurotoxicity or immunotoxicity in the submitted studies.
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 cPAD is
protective for carcinogenic effects.
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 Tolerance with No U.S. Registration
in/on Imported Rice Grain'' on page 29 in docket ID number EPA-HQ-OPP-
2016-0595.
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 used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Buprofezin for Use in
Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (General population An acute RfD for the general population or any population subgroups (other
including infants and children). than females 13-50 years of age) was not selected because no effect
attributable to a single (or few) day(s) oral exposure was observed in
animal studies.
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Acute dietary (Females 13-50 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 body weight in
FQPA SF = 1x........ offspring.
Maternal LOAEL = 800 mg/kg/day
based on mortality, decreased
food consumption, weight loss,
clinical signs, decreased
pregnancy rates and increased
resorption rates.
Chronic dietary (All populations) LOAEL= 10 mg/kg/day. Chronic RfD = 0.033 Comparative Thyroid Toxicity Study-
UFA = 3x............ mg/kg/day. rats.
UFH = 10x........... cPAD = 0.033 mg/kg/ Offspring LOAEL = 10.0 mg/kg/day
UFL = 10x........... day. based on significantly decreased
FQPA SF = 1x........ 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 (Oral, dermal, inhalation) Possible human carcinogen. (No Q1*). The cRfD is considered protective of the
cancer effects.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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.
[[Page 31725]]
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 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 and
BF12 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) and milk (i.e., buprofezin and BF23) 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 percent crop treated estimates when available.
iii. Cancer. 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.
Cancer risk is 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 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.
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, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the PCT for existing uses as follows:
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%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis.
Average percent of crop treated--Values are calculated by merging
data sources together; averaging by year, averaging across all years, &
rounding to the nearest multiple of 5. Note: If the estimated value is
less than 2.5, then the value is labeled <2.5. If the estimated value
is less than 1, then the value is labeled <1.
Maximum percent of crop treated--Value is the single maximum value
reported across all data sources, across all years, & rounded up to the
nearest multiple of 5. Note: If the estimated value is less than 2.5,
then the value is labeled <2.5.
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) model, 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
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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.
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.''
EPA has not found buprofezin to share a common mechanism of
toxicity with any other substances, and buprofezin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
buprofezin 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 Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Developmental toxicity
studies in rats and rabbits and the 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, the comparative thyroid toxicity study
demonstrated offspring susceptibility, but not fetal susceptibility to
buprofezin oral (gavage) administration. The point of departure (POD)
for risk assessment is derived from this study and is based on the most
sensitive endpoint of concern. Previous risk assessments imposed a
database uncertainty factor of 10X for a lack of a comparative thyroid
toxicity study. With the submission of an acceptable comparative
thyroid study, and lack of susceptibility in the developmental and
reproduction studies, the FQPA factor is now reduced to 1x.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for buprofezin is complete.
ii. Thyroid toxicity was seen following subchronic and chronic
exposures to rats as well as chronic exposures to dogs characterized by
decreases in serum thyroxine levels and increased thyroid weights in
dogs and histopathological lesions in in rats. Disruption of thyroid
homeostasis is the initial, critical effect that may lead to adverse
effects on the developing nervous system.
Normally, if a neurodevelopmental concern is raised by existing
data on a pesticide, a rat developmental neurotoxicity (DNT) study is
requested. However, a DNT study is not required for buprofezin since
this study would not address thyroid toxicity concerns. Thus, in lieu
of the rat DNT study, a special study evaluating the hormonal responses
associated with the developing fetal nervous system was required and
has since been conducted and submitted to the Agency. This study
demonstrated offspring susceptibility, but not fetal susceptibility to
buprofezin oral (gavage) administration.
Based on the lack of any neurotoxic effects in a subchronic
neurotoxicity study at doses as high as 5,000 ppm and the absence of
neurotoxicity in subchronic and chronic tests, an acute neurotoxicity
study was waived.
iii. Developmental toxicity studies in rats and rabbits and the
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, the
comparative thyroid toxicity study demonstrated offspring
susceptibility, but not fetal susceptibility to buprofezin oral
(gavage) administration. The chronic point of departure (POD) for risk
assessment is derived from this study and is based on the most
sensitive endpoint of concern.
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 model
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. 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 for females 13-49 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 48% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for buprofezin.
[[Page 31727]]
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. 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.
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 PAM I and PAM II for
enforcement of buprofezin tolerances, including GC methods with
nitrogen phosphorus detection (GC/NPD), and a GC/mass spectrometry (MS)
method for confirmation of buprofezin residues in plant commodities.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for buprofezin in or on rice
grain.
C. Revisions to Petitioned-For Tolerances
The petitioned-for tolerance in/on rice, grain has been revised
from 0.3 ppm to 1.5 ppm. The proposed tolerance level (0.3 ppm) is
actually for the processed rice commodity, hulled rice grain (i.e.,
brown rice), and not for the recognized rice raw agricultural commodity
(RAC), unhulled/whole rice grain. The recommended tolerance (1.5 ppm)
in/on rice, grain (i.e., unhulled/whole rice grain) will cover residues
in/on hulled rice grain (i.e., brown rice) treated at the maximum
proposed use rate.
V. Conclusion
Therefore, a tolerance is established for residues of buprofezin in
or on rice, grain at 1.5 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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). 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 31728]]
Dated: May 18, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.511, add alphabetically the commodity ``Rice, grain''
to the table in paragraph (a); redesignate footnote 1 to the table as
footnote 2; and add a new footnote 1 to the table to read as follows:
Sec. 180.511 Buprofezin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Rice, grain \1\............................................ 1.5
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 10, 2017 for use on rice.
* * * * *
[FR Doc. 2017-14085 Filed 7-7-17; 8:45 am]
BILLING CODE 6560-50-P