Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Rules and Regulations 63745 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by December 17, 

2012. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. Parties with objections to this 

direct final rule are encouraged to file a 

comment in response to the parallel 

notice of proposed rulemaking for this 

action published in the Proposed Rules 

section of today’s Federal Register, 

rather than file an immediate petition 

for judicial review of this direct final 

rule, so that EPA can withdraw this 

direct final rule and address the 

comment in the proposed rulemaking. 

This action may not be challenged later 

in proceedings to enforce its 

requirements (see section 307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: September 27, 2012. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal 

Regulations is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.222 is amended by 

adding paragraph (a)(2)(iii) to read as 

follows: 

§ 52.222 Negative declarations. 

(a) * * * 

(2) * * * 

(iii) Fiberglass and Boat 

Manufacturing Materials and 

Automobile and Light-Duty Truck 

Assembly Coatings were submitted on 

July 12, 2012 and adopted on March 22, 

2012. 

* * * * * 

[FR Doc. 2012–25383 Filed 10–16–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

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. 

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. 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

INFORMATION CONTACT. 

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 


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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]tetrahydro3(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 nonbell 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 children. 

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 


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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-observedadverse-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 EPA– 

HQ–OPP–2011–0759. 

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/risk

assess.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

Exposure/scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (Females 13– 

49 years of age).

NOAEL = 200 mg/kg/day 

UFA = 10 

UFH = 10 

FQPA SF = 1x 

Acute RfD = 2.0 mg/kg/day 

aPAD = 2.0 mg/kg/day 

Developmental Toxicity Study-Rat. 

LOAEL = 800 mg/kg/day based on reduced ossification & decreased body weight in offspring. 

Acute dietary (General population including infants 

and children).

No endpoint is available for this population because no effect attributable to a single day oral exposure was observed in animal studies. 

Chronic dietary (All populations).NOAEL= 1.0 mg/kg/day 

UFA = 3 

UFH = 10 

FQPA SF = 10 UFDB

Chronic RfD = 0.033 mg/ 

kg/day 

cPAD = 0.0033 mg/kg/day 

Two-year Chronic Toxicity/Carcinogenicity Study-Rat. 

LOAEL = 8.7 mg/kg/day based 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 

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 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 

commodities. 

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, 


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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 fooduse 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-theevidence 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 follows: 

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 


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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 nonoccupational, 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 factor. 

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 

buprofezin. 

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 300× 

(10× for intraspecies variation; 3× for 

interspecies extrapolation—reduced 

from 10× based on demonstrated 

evidence that rats are more susceptible 

to thyroid effects than humans; 10× for 

protection of infants and children) was 

applied to the dose to obtain a cPAD. 

The 10× 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 study. 

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. 


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63750 Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Rules and Regulations 

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 procedures. 

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 § 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. 


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Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Rules and Regulations 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 note). 

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: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 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: 

§ 180.511 Buprofezin; tolerances of 

residues. 

(a) * * * 

Commodity Parts per 

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 

* * * * * 

Tea1 .................................... 20 

Turnip, greens .................... 60 

* * * * * 

Vegetable, fruiting, group 

8–10 ................................ 2 .0 

* * * * * 

1There are no U.S. registrations at this 

time. 

* * * * * 

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

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412 

[CMS–1588–F2] 

RIN 0938–AR12 

Medicare Program; Hospital Inpatient 

Prospective Payment Systems for 

Acute Care Hospitals and the LongTerm Care Hospital Prospective 

Payment System and Fiscal Year 2013 

Rates; Hospitals’ Resident Caps for 

Graduate Medical Education Payment 

Purposes; Quality Reporting 

Requirements for Specific Providers 

and for Ambulatory Surgical Centers; 

Correcting Amendment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correcting 

amendment. 


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