
[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: RDFRNotices@epa.gov.

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

[[Page 31726]]

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


