Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33153 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0589; FRL–8421–3] 

Buprofezin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for the residues of buprofezin 

in or on Brassica, head and stem, 

subgroup 5A; coffee, green bean; and 

pomegranate. Interregional Research 

Project Number 4 (IR–4) requested the 

tolerances for residues in or on coffee 

and pomegranates under the Federal 

Food, Drug, and Cosmetic Act (FFDCA). 

Nichino America, Inc., requested the 

tolerances for residues in or on Brassica, 

head and stem, subgroup 5A under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

10, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0589. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Samantha Hulkower, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0683; e-mail address: 

hulkower.samantha@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0589 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before September 8, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0589, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of June 4, 2008 

(73 FR 31862–31864) (FRL–8365–3), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8F7343) by 

Nichino America, Inc., 4550 New 

Linden Hill Rd., Suite 501, Wilmington, 

Delaware 19808. The petition 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 Brassica, head 

and stem, subgroup 5A at 7.0 parts per 

million (ppm). In the Federal Register 

of August 13, 2008 (73 FR 47184) (FRL– 

8376–8), EPA issued a notice pursuant 

to section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8E7386) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

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 coffee at 0.35 

ppm and in or on pomegranate at 1.9 

ppm. Those notices referenced a 


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33154 Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 

summary of the petition prepared by 

Nichino America, Inc., the registrant, 

which is available to the public in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notices of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels for 

buprofezin in or on Brassica, head and 

stem, subgroup 5A. The reason 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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 

tolerances for residues of buprofezin, 2- 

[(1,1-dimethylethyl)imino]tetrahydro3(1-methylethyl)-5-phenyl-4H-1,3,5- 

thiadiazin-4-one, in or on Brassica, head 

and stem, subgroup 5A at 12.0 ppm, in 

or on coffee, green bean at 0.35 ppm, 

and in or on pomegranate at 1.9 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

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. Based on the increased 

incidence of 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 

suggestive evidence of carcinogenicity, 

but not sufficient to assess human 

carcinogenic potential. 

There is no evidence that buprofezin 

results in increased susceptibility of in 

utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

Toxicity in the offspring was found at 

dose levels that were also toxic to the 

parent(s), and the effects observed in the 

offspring were not more severe, 

qualitatively, than the effects observed 

in the parent(s). 

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 Revised Human Health Risk 

Assessment for Proposed Use of 

Buprofezin on Coffee, Pomegranate, and 

Brassica Head and Stem Crops 

(Subgroup 5A). The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES, and is 

identified as document ID number EPA– 

HQ–OPP–2008–0589–0005 in that 

docket. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 can be found at 

http://www.regulations.gov in document 

Buprofezin Revised Human Health Risk 

Assessment for Proposed Use of 

Buprofezin on Coffee, Pomegranate, and 

Brassica Head and Stem Crops 

(Subgroup 5A) page 18 in docket ID 

number EPA–HQ–OPP–2008–0589. 

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: 


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Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33155 

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 

in the toxicological studies for 

buprofezin for the population subgroup 

females 13–50 years old; no such effects 

were identified for the general 

population or other population 

subgroups. 

In estimating acute dietary exposure 

of females 13–50 years old, 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 

that residues are present at tolerance 

levels in all commodities except meat 

and milk. Anticipated residues were 

calculated for meat and milk 

commodities as follows: Tolerances for 

meat and milk are established at the 

analytical method limit of quantitation 

(LOQ). For milk, the residues of concern 

are buprofezin and an additional 

metabolite, BF23. Combined residues 

were included in the dietary exposure 

assessment, as appropriate, based on 

amounts detected in the dietary feeding 

study. Since residues were only 

detected in milk samples collected from 

cows fed feed containing 9.3x the 

maximum theoretical dietary burden 

(MTDB) for dairy cattle, residues in milk 

were normalized to 1x the MTDB in the 

acute dietary exposure assessment. For 

ruminant tissues, the residues of 

concern are buprofezin and an 

additional metabolite, BF2. Combined 

residues were included in the dietary 

exposure assessment as appropriate, 

based on amounts detected in the 

dietary feeding study. Since residues 

were only detected in tissue samples 

collected from cows fed feed containing 

6.8x the MTDB, residues in meat, 

kidney, liver, fat, and meat byproducts 

were normalized to 1x the MTDB in the 

acute dietary exposure assessment. For 

fruits and crops with an extended 

interval from initial application to 

harvest (>50 day), additional 

metabolites of toxicological concern 

(BF4 and its conjugates, and BF12) were 

included in the dietary exposure 

assessment, as appropriate, based on the 

ratio of metabolite to parent found in 

plant metabolism studies. No 

adjustment was made to account for the 

percent of crops treated with buprofezin 

in the acute dietary exposure 

assessment. 100 percent crop treated 

(PCT) was assumed for all commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Departmemt of 

Agriculture (USDA) 1994–1996 and 

1998 CSFII. As to residue levels in food, 

EPA conducted a refined dietary 

analysis. The chronic analysis assumed 

average field trial, average USDA 

Pesticide Data Program (PDP), or 

tolerance-level crop residues, based on 

the available data. The chronic analysis 

employed the same anticipated residue 

estimates for meat and milk as those 

employed in the acute analysis. As in 

the acute analysis, for fruits and crops 

with an extended interval from initial 

application to harvest (>50 day), 

additional metabolites of toxicological 

concern (BF4 and its conjugates, and 

BF12) were included in the dietary 

exposure assessment, as appropriate, 

based on the ratio of metabolite to 

parent found in plant metabolism 

studies. The chronic analysis used 

available screening-level PCT estimates 

or projected PCT estimates for some 

commodities. If no PCT data were 

available, 100 PCT was assumed. 

Default processing factors were assumed 

for all commodities excluding tomato 

paste and puree. The tomato paste and 

puree processing factors were reduced 

to 1.2x based on the results of a tomato 

processing study. 

iii. Cancer. EPA has classified 

buprofezin as having suggestive 

evidence based on the occurrence of 

liver tumors in female mice. Since the 

increased incidence of liver tumors 

occurred in female mice only and there 

was no evidence of carcinogenicity in 

rats or evidence of genotoxicity in 

submitted guideline studies using in 

vitro and in vivo genotoxicity assays, 

EPA regards the carcinogenic potential 

of buprofezin as very low. Therefore, an 

exposure assessment for evaluating 

cancer risk was not conducted. 

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 CallIns 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 used PCT information as 

follows: 

PCT estimates for existing uses: 

Almond 1%; cantaloupe 5%; cotton 1%; 

grapefruit juice 1%; grapefruit 1%; 

orange juice 1%; other citrus 2.5%; 

honeydew 2.5%; pear 15%; pistachio 

1%; pumpkin 10%; squash 10%; and 

watermelon 2.5%. 

In most cases, EPA uses available data 

from USDA National Agricultural 

Statistics Service (NASS), proprietary 

market surveys, and the National 

Pesticide Use Database for the chemical/ 

crop combination for the most recent 6 

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%. 

The Agency used projected percent 

crop treated (PPCT) information as 

follows: 

EPA used PPCT estimates for the 

following commodities: Apple 5%; 

peach 13%; apricot 51%; nectarine 

60%; cherry 72%; plum 37%; grapes 

15%; broccoli 55%; cabbage 40%; 

kohlrabi 5%; Chinese broccoli 55%; 


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33156 Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 

cauliflower 48%; cabbage 40%; Brussels 

sprouts 61%; mustard 13%; celery 18%; 

head lettuce 67%; lettuce leaf 63%; 

spinach 30%; strawberry 39%; tomato 

(fresh) 42%; and tomato (processing) 

25%. 

EPA estimates PPCT for a new 

pesticide use by assuming that the PCT 

during the pesticide’s initial five years 

of use on a specific use site will not 

exceed the average PCT of the market 

leader (i.e., the one pesticide with the 

greatest PCT) on that site over the three 

most recent surveys. Comparisons are 

only made among the chemicals of the 

same pesticide type (i.e., the leading 

insecticide on the use site is selected for 

comparison with the new insecticide). 

The PCT values included in the 

averages may be for the same pesticide 

or for different pesticides, since the 

same or different pesticides may 

dominate for each year selected. 

Typically, EPA uses USDA/NASS as the 

primary source for PCT data. When a 

specific use site is not surveyed by 

USDA/NASS, EPA uses other sources 

including proprietary data and 

calculates the PPCT. 

This estimated PPCT, based on the 

average PCT of the market leader, is 

appropriate for use in chronic dietary 

risk assessment. The method of 

estimating a PPCT for a new use of a 

registered pesticide or a new pesticide 

produces a high-end estimate that is 

unlikely, in most cases, to be exceeded 

during the initial five years of actual 

use. The predominant factors that bear 

on whether the estimated PPCT could 

be exceeded are whether a new 

pesticide use or new pesticide controls 

a broader spectrum of pests than the 

dominant pesticide; whether there are 

concerns that increasing pest pressure 

may intensify the use of alternate 

pesticides; and/or whether the new 

pesticide has a shorter pre-harvest or reentry interval than alternative 

insecticides. Based on all information 

currently available, EPA concludes that 

it is unlikely that actual PCT for 

buprofezin will exceed the PPCT during 

the next five years. A discussion of the 

factors considered in making this 

determination can be found in the 

documents Update of PPCT Values 

Provided Previously for Use of 

Buprofezin on Grapes, Apricots, 

Nectarines, Sweet and Tart Cherries, 

Plums, Apples and Peaches (December 

5, 2008); PPCT for the Insecticide 

Buprofezin on five crops: Celery, 

Lettuce, Spinach, Strawberries, and 

Tomatoes (January 9, 2008); PPCT 

Values for Buprofezin Use on Six New 

Crops: Broccoli, Cabbage, Cauliflower, 

Brussels sprout, Kohlrabi, and Mustard 

(December 5, 2008); and in Attachment 

#2 to the document Buprofezin - Acute 

and Chronic Dietary and Drinking Water 

Exposure and Risk Assessments 

(January 14, 2009). The referenced 

documents are available at 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0589. 

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 

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 57.4 parts per billion 

(ppb) for surface water and 0.09 ppb for 

ground water. The EECs 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 57.4 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

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 website 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 

of in utero rat or rabbit fetuses from 

exposure to buprofezin in prenatal 


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developmental toxicity studies; and 

there is no evidence of increased 

quantitative or qualitative susceptibility 

of rat offspring in the 2-generation 

reproduction study. There is evidence of 

thyroid toxicity following subchronic 

and chronic exposures of rats and dogs 

to buprofezin; however, data to 

determine whether young animals are 

more susceptible to these effects are not 

available. 

3. Conclusion. EPA has determined 

that the FQPA safety factor of 10X must 

be retained and applied to all 

subchronic and chronic exposures 

whose endpoint is based on thyroid 

effects. For acute exposures, EPA has 

determined that the FQPA safety factor 

may be reduced to 1X. These decisions 

are based on the following findings: 

i. The toxicity database for buprofezin 

lacks immunotoxicity testing; acute and 

subchronic neurotoxicity testing; and 

developmental thyroid testing. EPA 

began requiring functional 

immunotoxicity and acute and 

subchronic neurotoxicity testing of all 

food and non-food use pesticides on 

December 26, 2007. These studies are 

not yet available for buprofezin. In the 

absence of these data, EPA has 

evaluated the available buprofezin 

toxicity data to determine whether an 

additional database uncertainty factor is 

needed. In the available toxicity studies, 

there are no indications of effects on 

organs associated with immune 

function, such as the thymus and 

spleen. In addition, there are no 

indications of neurotoxic effects. Based 

on that, EPA does not believe that 

immurotoxicity or acute and subchronic 

testing would result in a lower POD for 

buprofezin that currently used. As such, 

an additional database uncertainty 

factor is not needed to account for 

potential immunotoxicity or acute and 

subchronic neurotoxicity. 

However, there is uncertainty 

regarding potential thyroid effects seen 

in some of the toxicity studies. Based on 

the evidence of thyroid toxicity 

following subchronic and chronic 

exposures of rats (histopathological 

lesions) and dogs (decreases in serum 

thyroxine levels and increased thyroid 

weights), EPA has required that 

develomental thyroid testing be 

conducted. 

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 in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. However, the 

developmental studies were not 

adequate to fully assess the potential for 

thyroid susceptibility from subchronic 

and chronic exposures. Consequently, 

there is concern for potential increased 

sensitivity or susceptibility in offspring 

regarding thyroid effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were refined for some commodities 

using reliable PCT/PPCT information 

and anticipated residue values 

calculated from the available monitoring 

data and field trial results. Dietary 

drinking water exposure is based on 

conservative modeling estimates. 

Residential exposures are not expected. 

These assessments will not 

underestimate the exposure and risks 

posed by buprofezin. 

Although there are no residual 

uncertainties identified in the exposure 

databases, no neurotoxic concerns for 

buprofezin, and no evidence of 

increased susceptibility of offspring in 

available studies, there is sufficient 

uncertainty regarding thyroid effects, 

particularly thyroid effects in the young, 

that EPA is retaining the 10X FQPA 

safety factor for all subchronic and 

chronic exposures whose endpoint is 

based on thyroid effects. The FQPA 

Safety Factor of 10X is not applicable to 

the acute endpoint, since a single dose 

of buprofezin would not be expected to 

perturb thyroid homeostasis in the adult 

or young due to the buffering of thyroid 

hormone concentrations by homeostatic 

mechanisms for compounds with short 

half lives, like buprofezin. 

EPA has also determined that the 

traditional 10X uncertainty factor to 

account for interspecies variation may 

be reduced to 3X for subchronic and 

chronic exposures, since it has been 

established that rats are more 

susceptible to thyroid effects than 

humans. These factors, together with the 

traditional 10X uncertainty factor to 

account for intraspecies variation, result 

in a total uncertainty factor of 300X 

(10X, 3X and 10X) for subchronic and 

chronic exposures. The total uncertainty 

factor for acute exposures is 100X (10X 

intraspecies variation and 10X 

interspecies variation). 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

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 7% of the aPAD 

for the population group females 13–49 

years old. No adverse effect resulting 

from a single-oral exposure was 

identified for the remaining population 

groups and no acute dietary endpoint 

was selected. Therefore, buprofezin is 

not expected to pose an acute risk. 

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 80% of 

the cPAD for the population groups 

receiving the greatest exposure, all 

infants <1 year old and children 1–2 

years old. 

Therefore, buprofezin is not expected 

to pose a chronic risk. 

There are no residential uses for 

buprofezin. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Buprofezin is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

short-term and intermediate-term 

aggregate risk is the sum of the risk from 

exposure to buprofezin through food 

and water and will not be greater than 

the chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. As discussed in Unit 

III.C.1.iii. EPA regards the carcinogenic 

potential of buprofezin as very low and 

concludes that it poses no greater than 

a negligible cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to buprofezin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The gas chromatography/nitrogen 

phosphorus detector methods used in 


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the field trial studies were adequately 

validated and similar to the method 

validated by EPA’s Analytical 

Chemistry Branch (ACB) and forwarded 

to the Food and Drug Administration for 

publication in the Pesticide Analytical 

Manual I. Since adequate method 

validation and concurrent recoveries 

were attained in the field trial studies, 

EPA concludes that the method 

validated by ACB is appropriate for 

enforcement of the tolerances associated 

with these petitions. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no Canadian, Mexican, or 

Codex maximum residue limits (MRLs) 

established for buprofezin in/on any of 

the commodities associated with the 

current petitions, except tomato. There 

are Codex and Mexican MRLs for 

residues of buprofezin per se on tomato 

of 1 ppm and 0.5 ppm, respectively. 

Both MRLs are lower than the tolerance 

of 1.3 ppm being established for fruiting 

vegetables, a group which includes 

tomato; however, since the field trial 

data considered in determining the U.S. 

tolerance level indicate the potential for 

residues in/on tomato to exceed the 

international MRLs, harmonization is 

not possible at this time. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petitions, EPA has 

revised the tolerance level for Brassica, 

head and stem, subgroup 5A from 7.0 

ppm to 12.0 ppm. EPA revised this 

tolerance level based on analyses of the 

residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. EPA also revised the 

tolerance expression to clarify 1. That, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of buprofezin not specifically 

mentioned; and 2. That compliance 

with the specified tolerance levels is to 

be determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. This change 

makes no substantive change to the 

meaning of the tolerance but rather only 

clarifies the existing language. 

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 Brassica, head 

and stem, subgroup 5A at 12.0 ppm; in 

or on coffee, green bean at 0.35 ppm; 

and in or on pomegranate at 1.9 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 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: July 1, 2009. 

G. Jeffery Herndon, 

Acting 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. Section 180.511 is amended in 

paragraph (a) by revising the 

introductory text and alphabetically 

adding the following commodities to the 

table to read as follows: 

§ 180.511 Buprofezin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of buprofezin, 

including its metabolites and degradates 

in or on the commodities in the table 

below. Compliance with the tolerance 

levels specified below is to be 

determined by measuring only the 

buprofezin, 2-[(1,1- 

dimethylethyl)imino]tetrahydro-3(1- 


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Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33159 

methylethyl)-5-phenyl-4H-1,3,5- 

thiadiazin-4-one, in the commodity. 

Commodity Parts per million 

*****

Brassica, head and stem, subgroup 5A .............................................................................................................................. 12.0 

*****

Coffee, green bean .............................................................................................................................................................. 0.35 

*****

Pomegranate ....................................................................................................................................................................... 1.9 

*****

* * * * * 

[FR Doc. E9–16367 Filed 7–9–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0271; FRL–8424–9] 

Indoxacarb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

indoxacarb and its metabolites and 

degradates, to be determined by 

measuring only indoxacarb and its Renantiomer, in or on beet, garden, roots; 

beet, garden, tops; and bushberry 

subgroup 13–07B. Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

10, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0271. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0271 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before September 8, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0271, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 


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