[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Rules and Regulations]
[Pages 63745-63751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25548]



40 CFR Part 180

[EPA-HQ-OPP-2011-0759; FRL-9364-9]

Buprofezin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of the 
insecticide buprofezin in or on multiple commodities which are 
identified and discussed later in this document. In addition, this 
regulation removes established tolerances for certain commodities/
groups superseded by this action, and corrects the spelling of some 
commodities. The Interregional Research Project 4 (IR-4) and 
Nichino America Inc. requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 17, 2012. Objections and 
requests for hearings must be received on or before December 17, 2012, 
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-2011-0759, is available at http://www.regulations.gov or in hard copy at the OPP Docket in the 
Environmental Protection Agency Docket Center (EPA/DC), located in EPA 
West, 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: Amaris Johnson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-9542; email address: johnson.amaris@epa.gov.


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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 

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://ecfr.gpoaccess.gov/cgi/t/text/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

[[Page 63746]]

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-2011-0759 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 
December 17, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0759, 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 Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 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.htm. 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 November 9, 2011 (76 FR 69690) (FRL-
9325-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petition (PP) 
1E7908 by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540, and PP 1F7905 by Nichino 
America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE. 
The petitions requested that 40 CFR 180.511 be amended by establishing 
tolerances for residues of the insecticide buprofezin (2-[(1,1-
dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H -1,3,5-
thiadiazin-4-one) in or on bean, succulent at 0.02 parts per million 
(ppm); Brassica, leafy greens, subgroup 5B at 55 ppm; turnip, greens at 
55 ppm; vegetable, fruiting, group 8-10 at 3.0 ppm; fruit, citrus, 
group 10-10 at 2.5 ppm; fruit, pome, group 11-10 at 4.0 ppm; persimmon 
at 1.9 ppm; and tea at 20 ppm (PP 1E7908) and PP 1F7905 requested 
tolerances for residues in or on nut, tree, group 14 at 0.05 ppm and 
pistachios at 0.05 ppm. PP 1E7908 also requested removal of tolerances 
for non-bell pepper; fruiting vegetable group 8, except non-bell 
pepper; fruit, citrus, group 10; and fruit, pome, group 11 which will 
be covered by the newly requested tolerances. That notice referenced a 
summary of the petition prepared by Nichino America, Inc., the 
registrant, which is available in the docket, http://www.regulations.gov. Two general comments were received on the notice 
of filings. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance levels for several commodities. Due to 
insufficient data, EPA is not establishing the citrus group 10-10 
tolerance. The reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 
    Buprofezin has low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It is not an eye or skin irritant; nor 
is it a dermal sensitizer. In subchronic toxicity studies, the primary 
effects of concern in the rat were increased microscopic lesions in 
male and female liver and thyroid, increased liver weights in males and 
females, and increased thyroid weight in males. In chronic studies in 
the rat, an increased incidence of follicular cell hyperplasia and 
hypertrophy in the thyroid of males was reported. Increased relative 
liver weights were reported in female dogs. Buprofezin was not 
carcinogenic to male and female rats. In the mouse, increased absolute 
liver weights in males and females, along with an increased incidence 
of hepatocellular adenomas and hepatocellular adenomas plus carcinomas 
in females were reported. The increase in carcinomas was not 
statistically significant when analyzed separately. Based on the 
increased incidence of combined benign and malignant liver tumors in 
female mice only, no evidence of carcinogenicity in rats, and no 
evidence of genotoxicity in submitted guideline studies using in vitro 
and in vivo genotoxicity assays, EPA classified buprofezin as having no 
greater than suggestive evidence of carcinogenicity.
    Developmental and reproductive toxicity studies do not indicate 
concern for increased susceptibility in offspring. Toxicity in the 
offspring was found at dose levels that were also toxic to the parent 
and the effects observed in the offspring were not more severe, 
qualitatively, than the effects observed in the parent. No neurotoxic 
effects were observed at any dose in a subchronic neurotoxicity study 
in rats at the highest dietary doses of 5,000 ppm. An immunotoxicity 
study did not demonstrate immunotoxic effects by buprofezin. A special 
study is required to generate specific data on the thyroid to protect 
the developing nervous

[[Page 63747]]

system from thyroid hormone disrupting chemicals.
    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 ``Buprofezin Human Health Risk 
Assessment for Proposed Use of Buprofezin on Tree Nut Crop Group 14 
including Pistachio, Brassica Leafy Greens Subgroup 5B, Turnip Greens, 
Tea and Persimmon & Expanded Uses on Fruiting Vegetables, Succulent 
Beans, Citrus Fruit, and Pome Fruit,'' pp. 40--42 in docket ID number 

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for buprofezin used for 
human risk assessment is shown in the Table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Buprofezin for Use in Human Health Risk Assessment
                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
Acute dietary (Females 13-49 years   NOAEL = 200 mg/kg/day   Acute RfD = 2.0 mg/kg/  Developmental Toxicity
 of age).                            UFA = 10..............   day.                    Study-Rat.
                                     UFH = 10..............  aPAD = 2.0 mg/kg/day..  LOAEL = 800 mg/kg/day based
                                     FQPA SF = 1x..........                           on reduced ossification &
                                                                                      decreased body weight in
Acute dietary (General population    No endpoint is available for this population because no effect attributable
 including infants and children).            to a single day oral exposure was observed in animal studies.
Chronic dietary (All populations)..  NOAEL= 1.0 mg/kg/day    Chronic RfD = 0.033 mg/ Two-year Chronic Toxicity/
                                     UFA = 3...............   kg/day                  Carcinogenicity Study-Rat.
                                     UFH = 10..............  cPAD = 0.0033 mg/kg/    LOAEL = 8.7 mg/kg/day based
                                     FQPA SF = 10 UFDB.....   day.                    on increased incidence of
                                                                                      follicular cell
                                                                                      hyperplasia and
                                                                                      hypertrophy in the thyroid
                                                                                      of males.
Cancer (Oral, dermal, inhalation)..    Suggestive Evidence of Carcinogenicity. The cRfD would be protective of
                                              potential carcinogenic effects from exposure to buprofezin.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. 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). UFDB = to account for the absence of data or other data deficiency. UFH =
  potential variation in sensitivity among members of the human population (intraspecies).

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 
    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 the population 
subgroup females age 13-49. In estimating acute dietary exposure, EPA 
used food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed tolerance level residues for buprofezin and estimated residue 
levels of the BF4 Conjugate, a metabolite of concern, based on 
buprofezin metabolism data. The BF4 Conjugate is not detectable by data 
collection methods and thus is not included in the tolerance level. 
Given the potential for the buprofezin metabolites BF9 and BF12 to 
concentrate to a greater degree than buprofezin in processed 
commodities, Dietary Exposure Evaluation Model (DEEM) (Version 7.81) 
default processing factors were retained for all commodities, except 
for tomato paste and puree, which were reduced based on empirical data. 
Total residues of concern in meat and milk were based on feeding study 
data. EPA also assumed 100 percent crop treated (PCT) for all 
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. A refined chronic dietary analysis was conducted using 
PCT estimates when available and 100 PCT for all other crops. 
Buprofezin residues in crop commodities were estimated based on average 
residue levels from field trial data, average residue levels from USDA 
Pesticide Data Program (PDP) data, or tolerance level residues. As with 
the acute exposure assessment,

[[Page 63748]]

EPA estimated residue levels of the metabolite BF4 Conjugate were based 
on metabolism data. Given the potential for the buprofezin metabolites 
BF9 and BF12 to concentrate to a greater degree than buprofezin in 
processed commodities, DEEM (Version 7.81) default processing factors 
were retained for all commodities, except for tomato paste and puree, 
which were reduced based on empirical data. Total residues of concern 
in meat and milk were based on feeding study data.
    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 and the cRfD would be 
protective of cancer effects.
    The cRfD was based on an endpoint of toxicity from a rat combined 
chronic/oncogenicity study. The NOAEL in this study was 1.0 mg/kg/day 
based on increased incidence of follicular cell hyperplasia and 
hypertrophy in the thyroid of males at 8.7 mg/kg/day. Buprofezin was 
not carcinogenic in rats. Administration of buprofezin in the diet was 
associated with increased incidence of liver tumors in female mice only 
at the mid- and high-doses but not at the low dose of 1.82 mg/kg/day 
which was considered to be the NOAEL for the females. Because the 
positive evidence of cancer was limited to one sex of one species 
(female mice), there was no evidence of mutagenicity, and no 
carcinogenic effects in rats, EPA concluded that the weight-of-the-
evidence indicated that the carcinogenic findings in female mice are a 
threshold effect. The NOAEL of 1 mg/kg/day from the rat study on which 
the cRfD is based on is lower than the NOAEL for liver tumors of 1.82 
mg/kg/day from the mouse. Therefore, the cRfD would be protective of 
potential carcinogenic effects from exposure to buprofezin.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, 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:
    Almond 1%; Cantaloupes 5%; Cotton 1%; Grapefruit 1%; Honeydew 2.5%: 
Lemons 2.5%; Lettuce (head and leaf) 1%; Oranges 2.5%; Pears 15%; 
Pistachio 5%; Pumpkins 1%; Squash (summer) 1%; Tomatoes 2.5%; 
Watermelons 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. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    Buprofezin has only been registered for use on some commodities 
since late 2009. Therefore, PCT estimates based on actual usage data 
were not deemed sufficient indicators of potential usage on these 
recently registered crops. In 2009 the EPA used PCT estimates for these 
commodities based on the market leader approach and has determined 
these are still appropriate estimates to be used in risk assessment. 
The Agency estimated the PCT for the uses registered in 2009 as 
    Spinach 30%; Celery 18%; Broccoli 55%; Cabbage 40%, Celery 18%, 
Chinese Broccoli 55%; Brussel Sprouts 61%; Cauliflower 48%; Kohlrabi 
5%; Apple 5%; Apricot 51%; Cherry 72%; Nectarine 51%; Peach 13%; Plum 
37%; Grape 15%; Strawberry 39%;
    For additional information regarding the PCT estimates for these 
commodities refer to the final rule published in the Federal Register 
of July 10, 2009 (74 FR 33153) (FRL-8421-3).
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which buprofezin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for buprofezin in drinking water. These simulation models 
take into account

[[Page 63749]]

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://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
buprofezin for acute exposures are estimated to be 58.2 parts per 
billion (ppb) for surface water and 0.09 ppb for ground water. The 
EDWCs for chronic exposures are estimated to be 18.6 ppb for surface 
water and 0.09 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 58.2 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 18.6 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://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10x, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased quantitative or qualitative susceptibility following in utero 
(rats and rabbits) and pre-and post-natal exposure (rats) to 
    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 for acute exposures. However, the 10x FQPA 
safety factor has been retained for chronic exposure. These decisions 
are based on the following findings:
    i. The toxicity database for buprofezin is complete except for 
submission of the thyroid toxicity study that will inform the Agency's 
understanding of buprofezin's chronic effects. A chronic POD of 1.0 mg/
kg/day (NOAEL) was selected for the general population from a 2-year 
chronic feeding study in rats based on increased incidence of 
follicular cell hyperplasia and hypertrophy in the thyroid in males at 
the LOAEL of 8.7 mg/kg/day. A UF 300x (10x for intraspecies variation; 
3x for interspecies extrapolation--reduced from 10x based on 
demonstrated evidence that rats are more susceptible to thyroid effects 
than humans; 10x for protection of infants and children) was applied to 
the dose to obtain a cPAD. The 10x FQPA Safety Factor was retained due 
to uncertainty caused by the lack of a thyroid assay in young rats. In 
rat chronic, subchronic, and reproductive toxicity studies effects such 
as thyroid enlargement and follicular cell hyperplasia were seen in 
adult animals. However, hormone levels, thyroid organ weights, and 
histopathology were not evaluated for pups in any reproductive studies. 
To assess the potential toxic characteristics to thyroid structure or 
hormone homeostasis during development, the Agency is requiring a 
developmental thyroid study.
    ii. There is no indication that buprofezin is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that buprofezin results in increased 
susceptibility to in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment was performed 
based on 100 PCT and a conservative estimate of total residues of 
concern for buprofezin. The chronic dietary food exposure assessment 
was performed based, in part on, average field trial residues, average 
USDA PDP residues, and PCT were used where available. Nonetheless, the 
chronic exposure assessment is conservative and is likely to 
overestimate risks based on a number of factors including, use of 100 
PCT assumptions for several crops for which data were unavailable, use 
of a conservative factor to account for the BF4 Conjugate, use of 
default processing factors, and use of drinking water exposure 
estimates for application of buprofezin to coffee, which is grown in 
limited areas of the U.S. (e.g., Puerto Rico, Hawaii). Likewise, EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to buprofezin in drinking water. 
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 5% of the aPAD for females 13-49 years old, 
the population group receiving the greatest exposure.

[[Page 63750]]

    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 91% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for buprofezin.
    3. Short and intermediate-term risk. Short and intermediate-term 
aggregate exposure takes into account short-term residential exposure 
plus chronic exposure to food and water (considered to be a background 
exposure level). A short and intermediate-term adverse effect was 
identified; however, buprofezin is not registered for any use patterns 
that would result in short-term residential exposure. Short and 
intermediate-term risk is assessed based on short and intermediate-term 
residential exposures plus chronic dietary exposure. Because there is 
no short and intermediate-term residential exposures 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 and intermediate-term risk), no further assessment of 
short and 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. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of any aggregate cancer risk. Based on the limited evidence 
of carcinogenicity (driven by benign liver tumors) of buprofezin to 
female mice only and not males or rats, and no mutagenicity, EPA 
concluded a threshold approach is appropriate for the risk assessment. 
Therefore, the chronic assessment is considered protective for the 
cancer risk estimate.
    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 gas chromatography with nitrogen phosphorus detection (GC/
NPD) and a GC/mass spectrometry (MS) method for confirmation of 
buprofezin residues in plant commodities is available to enforce the 
tolerance. These methods are available in the Pesticide Analytical 
Manual (PAM) Volumes I & II for enforcement of buprofezin tolerances.

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 tolerance level 
being established by this action for tree nut group 14 is harmonized 
with the Codex MRL for almond. There is an established Codex MRL of 2.0 
ppm in/on pepper and 1.0 ppm in/on tomato. The petitioner proposed a 
tolerance of 3.0 ppm for the Fruiting vegetable group 8-10, which 
contains both peppers and tomatoes. EPA cannot harmonize the U.S. 
tolerance on tomatoes with the tomato MRL because the residue field 
trial data submitted to support the fruiting vegetable group 8-10 
tolerance reported residues higher than the 1.0 ppm level established 
by Codex for tomato. However, the residue field trial data was 
consistent with a tolerance of 2.0 ppm for the fruiting vegetable group 
8-10, so EPA was able to harmonize with the Codex MRL for peppers. For 
pome fruit, the Codex MRLs and the U.S. tolerances are harmonized for 
``fruit, pome (except pear and pear, Asian) at 3.0 ppm and pear and 
pear, Asian at 6.0 ppm. There are currently no established Codex MRLs 
for buprofezin in/on the remainder of the tolerances being established.

C. Response to Comments

    EPA received two comments to the notice of filings PP 1E7908 and 
1F7905, which said that toxic chemicals should not be allowed on food 
that Americans eat. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops. However, the existing legal framework 
provided by section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. This citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.

D. Revisions to Petitioned-for Tolerances

    The tolerance for fruit, citrus, group 10-10 is not being 
established at this time due to a lack of residue chemistry data. Based 
on the data supporting the petition, EPA has revised the proposed 
tolerance on Brassica, leafy greens, subgroup 5B and turnip greens from 
55 ppm to 60 ppm. The Agency revised these tolerance levels based on 
analysis of the residue field trial data using the Organization for 
Economic Co-operation and Development (OECD) tolerance calculation 
    Additionally, the Agency revised the proposed tolerance in or on 
vegetables, fruiting, group 8-10 from 3.0 to 2.0 to harmonize with the 
Codex MRL on pepper and will establish separate tolerances for fruit, 
pome, group 11-10 (except pear and pear, Asian) at 3.0 ppm and pear and 
pear, Asian oriental at 6.0 ppm to harmonize with Codex. A tolerance is 
not needed for pistachio since there is already a pistachio tolerance 
in Sec.  180.511. Finally, the Agency is correcting language for 
established commodities that are spelled incorrectly--Llama should be 
Ilama and Loganberry should be Logan.

V. Conclusion

    Therefore, tolerances are established for residues of buprofezin 2-
[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H -
1,3,5-thiadiazin-4-one, in or on bean, succulent at 0.02 ppm; Brassica, 
leafy greens, subgroup 5B at 60 ppm; fruit, pome, group 11-10 (except 
pear and pear, Asian) at 3.0 ppm; nut, tree, group 14 at 0.05 ppm; pear 
at 6.0 ppm; pear, Asian at 6.0 ppm; persimmon at 1.9 ppm; tea at 20 
ppm; Turnip, greens at 60 ppm; vegetable, fruiting, group 8-10 at 2.0 
ppm. Additionally, this regulation removes tolerances of buprofezin in 
or on almond at 0.05 ppm, fruit, pome group 11 at 4.0 ppm, okra at 4.0 
ppm, nonbell pepper at 4.0 ppm and vegetable, fruiting group 8, except 
nonbell pepper at 1.3 ppm as they will be superseded by the tolerances 
being established with this action.

[[Page 63751]]

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: October 4, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.511 the table in paragraph (a) is amended as follows:
i. Remove the entries for Almond; Fruit, pome, group 11; Okra; Pepper, 
nonbell and Vegetable, fruiting, group 8, except nonbell pepper;
ii. Revising the entries for Llama and Loganberry to read Ilama and 
Logan respectively; and
iii. Add alphabetically new entries.
    The revisions and additions read as follows:

Sec.  180.511  Buprofezin; tolerances of residues.

    (a) * * *

                                                             Parts per
                        Commodity                             million
                                * * * * *
Bean, succulent.........................................            0.02
                                * * * * *
Brassica, leafy greens, subgroup 5B.....................           60
                                * * * * *
Fruit, pome, group 11-10, except pear and pear, Asian...            3.0
                                * * * * *
Ilama...................................................            0.30
                                * * * * *
Logan...................................................            0.30
                                * * * * *
Nut, tree group 14......................................            0.05
                                * * * * *
Pear....................................................            6.0
Pear, Asian.............................................            6.0
Persimmon...............................................            1.9
                                * * * * *
Tea\1\..................................................           20
Turnip, greens..........................................           60
                                * * * * *
Vegetable, fruiting, group 8-10.........................            2.0
                                * * * * *
\1\ There are no U.S. registrations at this time.

* * * * *
[FR Doc. 2012-25548 Filed 10-16-12; 8:45 am]