Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55307 

Commodity Parts per million 

Pistachio ......................... 0.1 

Rice, bran ....................... 15 

Rice, grain ...................... 7.0 

Rice, hulls ....................... 20 

Rice, straw ...................... 18 

Rye, bran ........................ 0.6 

Rye, forage ..................... 1.7 

Rye, grain ....................... 0.3 

Rye, straw ....................... 10 

Sheep, fat ....................... 0.05 

Sheep, kidney ................. 2.0 

Sheep, liver ..................... 2.0 

Sheep, meat ................... 0.05 

Sheep, meat byproducts, 

except liver and kidney 0.05 

Sorghum, grain, forage ... 12 

Sorghum, grain, grain ..... 3.5 

Sorghum, grain, stover ... 15 

Soybean, forage ............. 11 

Soybean, hay .................. 30 

Soybean, seed ................ 2.0 

Spearmint, tops .............. 3.5 

Strawberry ...................... 1.3 

Wheat, bran .................... 0.6 

Wheat, forage ................. 1.7 

Wheat, grain ................... 0.3 

Wheat, hay ..................... 1.4 

Wheat, straw ................... 10 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. A tolerance with regional 

registration, as defined in §180.1(m), is 

established for residues of 1-[[2-(2,4- 

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its 

metabolites determined as 2,4- 

dichlorobenzoic acid and expressed as 

parent compound, in or on the 

following commodities: 

Commodity Parts per million 

Cranberry ........................ 1.0 

Rice, wild ........................ 0.5 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

combined residues of the fungicide 1- 

[[2-(2,4-dichlorophenyl)-4-propyl-1,3- 

dioxolan-2-yl] methyl]-1H-1,2,4-triazole 

and its metabolites determined as 2,4- 

dichlorobenzoic acid and expressed as 

parent compound in or on the following 

commodities when present therein as a 

result of application of propiconazole to 

growing crops in paragraphs (a) and (c) 

of this section: 

Commodity Parts per million 

Alfalfa, forage ................. 0.1 

Alfalfa, hay ...................... 0.1 

[FR Doc. 06–8064 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0170; FRL–8092–2] 

Buprofezin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues or 

residues of buprofezin in or on almond 

hulls; cotton, gin byproducts: 

Cottonseed; and tomato. Nichino 

America, Inc., Linden Park Suite 501, 

4550 New Linden Hill Road, 

Wilmington, DE 19908 requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), as amended 

by the Food Quality Protection Act of 

1996 (FQPA). 

DATES: This regulation is effective 

September 22, 2006. Objections and 

requests for hearings must be received 

on or before November 21, 2006, 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–2006–0170. All documents in the 

docket are listed in the index for the 

docket. 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 Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Sweeney, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5063; e-mail address: 

sweeney.kevin@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: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers. 

This listing is not intended to be 

exhaustive, but rather provides 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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site 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 the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 


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55308 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2006–0170. 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 

on or before November 21, 2006. 

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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0170, 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 Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’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 telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of June 21, 

2000 (65 FR 38549) (FRL–6557–3), 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 0F6087) by 

Nichino America, Inc., Linden Park, 

Suite 501, 4550 New Linden Road, 

Wilmington, DE, 19808. The petition 

requested that 40 CFR 180. 511 be 

amended by establishing a tolerance for 

combined residues or residues of the 

insecticide buprofezin, 2[(1,1-dimethylethyl)imino]tetrahydro-3(1- 

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

thiadizin-4-one, in or on almond hulls 

at 0.7 parts per million (ppm); cotton, 

gin byproducts at 23 ppm; cotton, 

undelinted seed at 1.0 ppm; and tomato 

at 0.8 ppm at tolerance level ppm. That 

notice included a summary of the 

petition prepared by Aventis 

CropScience USA LP (formerly AgrEvo 

USA Company), 2 T.W. Alexander 

Drive, Research Triangle Park, NC 

27709, the registrant. There were no 

comments received in response to the 

notice of filing. Subsequently, in the 

Federal Register of September 5, 2001 

(66 FR 46381) (FRL–6696–6), EPA 

issued a Final Rule to section 408 of 

FFDCA, 21 U.S.C. 345a(d)(3), that 

established time limited tolerances for 

residues of the insecticide [buprofezin, 

2-[(1,1-dimethylethyl)imino]tetrahydro-3(1- 

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

thiadiazin-4–1], in or on almond hulls at 

0.7 ppm; cotton, gin byproducts at 15.0 

ppm; cotton, undelinted seed at 0.4 

ppm; and tomato at 0.40 ppm. These 

tolerances expired on December 31, 

2005. The conditions for these time 

limited tolerances were as follows: A 

comparative thyroid assay (young/adult 

rat), a revised section B, a revised 

section F, Plant Enforcement Method 

(BF/10/97)- Confirmatory Method, 

Interference Study, and successful 

Agency Validation, Plant Enforcement 

Method (BF/02/96) - Confirmatory 

Method and Interference Study, 

Livestock Enforcement Method - 

successful Agency Validation and 

Radiovalidation, Storage Stability Data, 

validation of frozen storage intervals, 

petition method validation, an 

interference study, Additional almond, 

banana, citrus, cotton, and tomato field 

trial data, and a citrus processing study. 

EPA reevaluated the available thyroid 

toxicity data in regard to the severity of 

effects and hormonal measurements and 

concluded that a study evaluating 

thyrioid levels in adult rats would be 

more appropriate. This study is 

confirmatory and is not a condition of 

granting these tolerances. All of the 

conditions above have been addressed 

and the Agency is issuing permanent 

tolerances based on the registrant’s 

proposed final rule request dated 

August 25, 2005 (November 30, 2005 (70 

FR 71838) (FRL–7735–7)). 

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. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for combined 

residues or residues of buprofezin on 

almond, hulls at 2.0 ppm; cotton, gin 

byproducts at 20 ppm; cotton, 

undelinted seed at 0.35 ppm; and 

tomato at 0.40 ppm. EPA’s assessment 

of exposures and risks associated with 

establishing the tolerance 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

buprofezin as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 

be found in the OPP Regulatory Public 

Docket number EPA–HQ–OPP–2006–

0170. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which NOAEL from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the LOAEL 


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identified is sometimes used for risk 

assessment if no NOAEL was achieved 

in the toxicology study selected. An 

uncertainty factor (UF) is applied to 

reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http://www.epa.gov/ 

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for buprofezin used for 

human risk assessment is shown in the 

following Table 1: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR BUPROFEZIN FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario 

Dose Used in Risk Assessment, 

Interspecies and Intraspecies 

and any Traditional UF 

Special FQPA SF and Level of 

Concern (LOC) for Risk Assessment Study and Toxicological Effects 

Acute dietary (females 13-49 years 

of age) 

NOAEL = 200 mg/kg/day 

UF = 100 

Acute RfD = 2.0 mg/kg/day 

Special FQPA SF = 1 

aPAD = acute RfD/Special 

FQPA SF = 2.0 mg/kg/day 

LOAEL = 800 mg/kg/day based on 

incomplete ossification and reduced pup weight 

Acute dietary (general population 

including infants and children) 

NOAEL = NA1 mg/kg/day 

UF = NA 

Acute RfD = NA mg/kg/day 

Special FQPA SF = NA1

aPAD = acute RfD 

Special FQPA SF = NA mg/kg/ 

day 

No appropriate endpoint was identified for the general population 

LOAEL = NA mg/kg/day based on 

NA 

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

UF = 300 

Chronic RfD = 0.0033 mg/kg/day 

Special FQPA SF = 1 cPAD = 

chronic RfD 

Special FQPA SF = 0.0033 

mg/kg/day 

Two–year chronic feeding study - 

rat 

LOAEL = 8.7 mg/kg/day based on 

organ weight changes and microscopic findings in the liver 

and thyroid of both males and females and in the kidney of males 

Short-term incidental oral (1-30 

days) 

(Residential = NA2) 

Oral NOAEL = 13.0 mg/kg/day Residential = NA2 90–day oral toxicity study -rat 

LOAEL 68.6 mg/kg/day based on 

Short-term dermal (1 to 30 days) 

(Residential = NA2

Dermal NOAEL = 300 mg/kg/day 

(dermal absorption rate = 

NA2≠) 

Occupational LOC for MOE = 

<100 

(Residential = NA2) 

24–Day dermal toxicity study - rat 

LOAEL = 1,000 mg/kg/day based 

on inflammatory infiltrate of the 

liver in females and increase in 

acanthosis and hyperkeratosis of 

the skin in females 

Intermediate-term dermal (1 week 

to several months) 

(Residential = NA2) 

Dermal NOAEL = 300 mg/kg/day 

(dermal absorption rate = 

NA2≠) 

Occupational LOC for MOE = 

<100 

(Residential = NA2) 

24–Day dermal toxicity study - rat 

LOAEL = 1,000 mg/kg/day based 

on inflammatory infiltrate of the 

liver in females and increase in 

acanthosis and hyperkeratosis of 

the skin in females 

Long-term dermal (several months 

to lifetime) 

(Residential = NA2) 

Oral NOAEL = 1.0 mg/kg/day 

(dermal absorption rate = 

10%) 

Occupational LOC for MOE = 

<300 

(Residential = NA2) 

Two-year chronic feeding study - 

rat 

LOAEL = 8.7 mg/kg/day based on 

based on increased incidence of 

follicular cell hyperplasia and hypertrophy in the thyroid in males 

Short-term inhalation (1 to 30 days) 

(residential = NA2) 

Oral study NOAEL = 13.0 mg/kg/ 

day (inhalation absorption rate 

= 100%) 

Occupational LOC for MOE = 

<300 

(Residential = NA2) 

90–Day oral toxicity study - rat 

LOAEL = 68.6 mg/kg/day based on 

organ weight changes and microscopic findings in the liver 

and thyroid of both males and females and in the kidney of males 

Intermediate-term inhalation (1 

week to several months) 

(Residential = NA2) 

Oral study NOAEL = 13.0 mg/kg/ 

day (inhalation absorption rate 

= 100%) 

Occupational LOC for MOE = 

<300 

(Residential = NA2) 

90–Day oral toxicity study - rat 

LOAEL = 68.6 mg/kg/day based on 

organ weight changes and microscopic findings in the liver 

and thyroid of both males and females and in the kidney of males 


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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR BUPROFEZIN FOR USE IN HUMAN RISK

ASSESSMENT—Continued 

Exposure/Scenario 

Dose Used in Risk Assessment, 

Interspecies and Intraspecies 

and any Traditional UF 

Special FQPA SF and Level of 

Concern (LOC) for Risk Assessment Study and Toxicological Effects 

Long-term inhalation (several 

months to lifetime) 

(Residential = NA2) 

Oral study NOAEL = 1.0 mg/kg/ 

day (inhalation absorption rate 

= 100%) 

Occupational LOC for MOE = 

<300 

(Residential = NA2) 

Two–year chronic feeding 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) No quantification No quantification No quantification is appropriate because the evidence was limited 

to one sex in one species of animal. The data show no greater 

than suggestive evidence of carcinogenicity. 

1NA = Not applicable. 

2NA = Not applicable. There are no residential uses for buprofezin. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.511) for the 

combined residues or residues of 

buprofezin, in or on a variety of raw 

agricultural commodities. Tolerances of 

buprofezin are established in milk at 

0.01 ppm and in ruminant fat (0.05 

ppm), meat byproducts (0.05 ppm), and 

liver at 0.05 ppm. Risk assessments 

were conducted by EPA to assess 

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. 

The Dietary Exposure Evaluation 

Model (DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII) and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: The acute analysis 

assumed DEEM (ver. 7.76) default 

processing factors and 100% crop 

treated (CT) for all commodities. 

Tolerance level residues were assumed 

for all commodities excluding meat and 

milk. Since meat and milk (LOQ 

tolerances) residues were only detected 

in the feeding study at 6.8–9.3x the 

Maximum Theoretical Dietary Burden 

(MTDB), residues in these commodities 

were normalized to 1x the MTDB. The 

acute analysis also incorporated the 

acute Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM-EXAMS) surface drinking water 

estimate resulting from application of 

buprofezin to citrus in Florida (highest 

acute drinking water estimate). No acute 

endpoint was identified for the 

remaining population subgroups. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEMTM software with 

the FCID, which incorporates food 

consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: The 

chronic analysis assumed DEEM (ver. 

7.76) default processing factors for all 

commodities and incorporated percent 

crop treated (PCT) estimates or 

projected PCT estimates. Tolerance level 

or average field trial residues were 

assumed for all crop commodities and 

since meat and milk (LOQ tolerances) 

residues were only detected in the 

feeding study at 6.8–9.3x the MTDB, 

residue in these commodities were 

normalized to 1x the MTDB. The 

chronic analysis also incorporated the 

chronic PRZM-EXAMS surface drinking 

water estimate resulting from 

application of buprofezin to citrus in 

Florida (highest chronic drinking water 

estimate). 

iii. Cancer. Due to the fact that the 

data showed no greater than suggestive 

evidence of carcinogenicity, the chronic 

exposure and risk assessment was 

deemed protective of any cancer effect. 

iv. Anticipated residue and PCT 

information. 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 the Agency can make the 

following findings: Condition 1, that 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 such pesticide residue; 

Condition 2, that the exposure estimate 

does not underestimate exposure for any 

significant subpopulation group; and 

Condition 3, if 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 

section 408(b)(2)(F) of FFDCA, EPA may 

require registrants to submit data on 

PCT. 

The Agency used PCT information as 

follows: 10% CT for cantaloupes; 5% 

CT for cauliflower; 2.5% CT for cotton, 

grapefruit, grapes, honeydew, lemons, 

oranges, tomatoes, and watermelon; 

market share PCT was projected not to 

exceed 5% for apples, and 13% for 

peaches for the first four to five years 

buprofezin is on the market. All other 

crops currently registered and/or 

proposed commodities were assumed to 

be 100% CT. The Agency believes that 

the three conditions listed in Unit 

C.1.iv. have been met. With respect to 

Condition 1, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. For previously registered crops, 

EPA used an average of the values from 

these surveys over the last 5 years for 

estimating PCT for chronic dietary 

exposure assessments. For most newly 

registered crops, the Agency assumed 

100% CT. In estimating PCT for the 

apples, EPA assumed that the PCT for 


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buprofezin would at least equal or 

exceed the PCT for the leading 

comparable insect growth regulator 

pesticide alternative on that crop. For 

peaches, PCT for buprofezin was 

projected to potentially exceed the 

leading alternative’s PCT because 

buprofezin has a slight cost advantage 

over the alternative on that crop. With 

regards to apples, buprofezin was 

projected to slightly exceed sales of the 

leading alternative’s PCT because 

buprofezin is an excellent technical fit 

as an insect pest management 

insecticide for apples. The Agency is 

reasonably certain that the percentage of 

the food treated is not likely to be an 

underestimation. As to Conditions 2 and 

3, 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 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 lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

buprofezin in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical 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 PRZM/EXAMS and 

Screening Concentration in Ground 

Water (SCI-GROW) models, the 

estimated environmental concentrations 

(EECs) of buprofezin for acute exposures 

are estimated to be 19.2 parts per billion 

(ppb) for surface water and 0.1 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 4.5 ppb 

for surface water and 0.1 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the DEEMTM/FCID. For chronic 

dietary risk assessment, the annual 

average concentration of 4.5 ppb was 

used to access 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 use on 

any sites that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

buprofezin and 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 

not assumed that buprofezin has 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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a margin of exposure (MOE) analysis 

or through using uncertainty (safety) 

factors in calculating a dose level that 

poses no appreciable risk to humans. In 

applying this provision, EPA either 

retains the default value of 10X when 

reliable data do not support the choice 

of a different factor, or, if reliable data 

are available, EPA uses a different 

additional safety factor value based on 

the use of traditional UFs and/or special 

FQPA safety factors, as appropriate. 

2. Prenatal and postnatal sensitivity. 

Prenatal and postnatal sensitivity is not 

of concern for buprofezin based on the 

results of the developmental toxicity 

studies in rats and rabbits and the twogeneration reproduction study in rats. 

The results indicate that there is no 

increased susceptibility of rats or rabbits 

following in utero exposure or of rats 

following prenatal/postnatal exposure to 

buprofezin. The toxicology data do not 

indicate a basis for concern for 

neurotoxicity, therefore, acute, 

subchronic, and developmental 

neurotoxicity studies are not required. 

3. Conclusion. Oral exposure to 

buprofezin produced marginal thyroid 

toxicity in adult rats manifested as 

increased incidence of follicular cell 

hyperplasia, increased in thyroid 

weights and microscopic findings in the 

thyroid. Although rats are very 

susceptible to thyroid hormone 

disruption and thyroid follicular cell 

carcinogenesis, no thyroid tumors were 

observed in chronic and carcinogenicity 

studies in mice and rats. It is unknown 

to what extent buprofezin alters thyroid 

hormones (T3, T4 and ThyroidStimulating hormone levels) because 

these were not measured. Given the 

marginal thyroid toxicity found, it is 

anticipated that any effects of 

buprofezin on thyroid hormones may 

also be marginal. Thus, a measurement 

of thyroid hormones in adult rats is 

viewed as a confirmatory test to 

evaluate its effect on thyroid 

homeostasis. A FQPA factor of 10X in 

the form of database UF is applied to 

chronic Referance Dose (cRfD), chronic 

dermal exposure (endpoint based on 

oral study) and all inhalation exposure 

durations as a conservative approach to 

address any residual uncertainty 

associated with potential susceptibility 

of the young to thyroid disruption. This 

FQPA factor in the form of database 

uncertainty is not applicable to acute 

oral RfD because a single dose of a 

chemical 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 compound with short 

half lives, like buprofezin (half-life of a 

couple of days). This FQPA factor in the 


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55312 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

form of database uncertainty is not 

applicable to short-and intermediateterm dermal exposure because the 

endpoint of concern is based on dermal 

study where liver toxicity was the 

critical effect (thyroid effects were not 

observed). Since the thyroid effects were 

seen in rats and it has been established 

that rats are more susceptible to thyroid 

effects than humans, the Agency 

concluded that the interspecies 

extrapolation factor for these 

assessments may be reduced to 3X. The 

intraspecies variability factor remains as 

10x. There is no evidence of increased 

susceptibility due to postnatal exposure 

to buprofezin in rats and rabbits or 

prenatal and postnatal exposure in twogeneration reproduction study. 

Therefore, there is no need to retain the 

FQPA safety factor (SF) based on 

prenatal or postnatal toxicity issues. 

Based on the conservative residue 

assumptions used in the dietary risk 

assessment (there are currently no 

residential exposures), and the 

completeness of the residue chemistry 

and environmental fate databases, there 

is no need to retain the FQPA SF based 

on exposure issues. 

The total UF for chronic dietary, 

inhalation assessments (all durations) 

and long-term dermal assessment is 

300X (10X FQPA database uncertainty, 

3X interspecies variation, and 10X 

intraspecies variation) and the total UF 

for acute dietary and dermal 

assessments (short-term and 

intermediate-term) is 100X (10X 

interspecies variation and 10x 

intraspecies variation). 

E. Aggregate Risks and Determination of 

Safety 

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 acute 

population adjusted dose (aPAD) for 

females 13-49 years old. EPA does not 

expect the aggregate exposure to exceed 

100% of the aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to buprofezin from food 

will utilize 40% of the chronic 

population adjusted dose (cPAD) for the 

U.S. population, 56% of the cPAD for 

all infants less than 1–year old, and 

87% of the cPAD for children 1-2 years 

old. There are no residential uses for 

buprofezin that result in chronic 

residential exposure to buprofezin. 

Therefore, the EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD. 

3. Aggregate cancer risk for U.S. 

population. 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. 

Buprofezin was negative in vitro and in 

vivo genotoxicity assays. The findings 

from the published literature indicate 

that buprofezin causes cell 

transformation and induces micronuclei 

in vitro. In the absence of a positive 

response in an in vivo micronucleus 

assay, the Agency concluded that 

buprofezin may have aneugenic 

potential, which is not expressed in 

vivo. In summary, buprofezin was 

negative in the rat, negative for 

mutagenicity and negative for male 

mice; however, in female mice, a slight 

or marginal increase in combined 

adenomas and carcinomas was 

observed. Given these findings in the 

cancer and mutagenicity studies, EPA 

regards the carcinogenic potential of 

buprofezin as very low and concludes 

that it poses no greater than a negligible 

cancer risk to humans. 

4. 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, and to infants and children 

from aggregate exposure to buprofezin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement 

Methodology-Plants 

Adequate enforcement methodology 

using gas chromatography with nitrogen 

phosphorous detection (GC/NPD) is 

available to enforce the tolerance 

expression. 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no Canadian, Mexican, or 

Codex maximum residue limits 

established for buprofezin in/on any of 

the commodities associated with the 

current petition. 

V. Conclusion 

Therefore, the tolerance is established 

for combined residues or residues of 

buprofezin, in or on almond, hulls at 2.0 

ppm; cotton, gin byproducts at 20 ppm; 

cotton, undelinted seed at 0.35 ppm; 

and tomato at 0.40 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55313 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

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 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: September 12, 2006. 

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. Section 180.511 is amended by 

alphabetically revising commodities and 

adding cotton seed to the table in 

paragraph (a) to read as follows: 

§ 180.511 Buprofezin; tolerance for 

residues 

(a) *** 

Commodity Parts per million Expiration/revocation 

dates 

*****

Almond hulls ...................................................................................................................................... 2.0 None 

*****

Cotton, gin byproducts ....................................................................................................................... 20.0 None 

Cotton seed ....................................................................................................................................... 0.35 None 

*****

Tomato ............................................................................................................................................... 0.40 None 

*****

* * * * * 

[FR Doc. 06–8065 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0299; FRL–8093–8] 

Trifloxystrobin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

Trifoxystrobin (Benzeneacetic acid, 

(E,E)-a-(methoxyimino)-2-[[[[1-[3- 

(trifluoromethyl) 

phenyl]ethylidene]amino]oxy]methyl]-, 

methyl ester and the free form of its acid 

metabolite CGA-321113 ((E,E)- 

methoxyimino-(2-[1-(3- 

trifluoromethylphenyl) 

ethylideneaminooxymethyl] 

phenyl)acetic acid)) in or on soybean, 

forage at 10.0 parts per million (ppm), 

soybean, hay at 25.0 ppm, and soybean, 

seed at 0.08 ppm. Bayer CropScience 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 22, 2006. Objections and 

requests for hearings must be received 

on or before November 21, 2006, 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–2005–0299. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 


rwilkins on PROD1PC63 with RULES_1