Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Notices 76719

accordance with the provisions of the 

Freedom of Information Act and must 

be addressed to the Freedom of 

Information Office (A–101), 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. Such requests should: 

Identify the product name and 

registration number and specify the data 

or information desired.

A paper copy of the fact sheet, which 

provides more detail on this 

registration, may be obtained from the 

National Technical Information Service 

(NTIS), 5285 Port Royal Rd., 

Springfield, VA 22161.

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. Once in 

the system, select ‘‘search,’’ then key in 

the appropriate docket ID number.

II. Did EPA Conditionally Approve the 

Application?

A conditional registration may be 

granted under section 3(c)(7)(C) of 

FIFRA for a new active ingredient where 

certain data are lacking, on condition 

that such data are received by the end 

of the conditional registration period 

and do not meet or exceed the risk 

criteria set forth in 40 CFR 154.7; that 

use of the pesticide during the 

conditional registration period will not 

cause unreasonable adverse effects; and 

that use of the pesticide is in the public 

interest. The Agency has considered the 

available data on the risks associated 

with the proposed use of 

Chondrostereum purpureum strain PFC 

2139, Oil of Black Pepper, Piperine, and 

information on social, economic, and 

environmental benefits to be derived 

from such use. Specifically, the Agency 

has considered the nature and its 

pattern of use, application methods and 

rates, and level and extent of potential 

exposure. Based on these reviews, the 

Agency was able to make basic health 

and safety determinations which show 

that use of Chondrostereum purpureum

strain PFC 2139, Oil of Black Pepper, 

and Piperine, during the period of 

conditional registration will not cause 

any unreasonable adverse effect on the 

environment, and that use of the 

pesticide is, in the public interest.

Consistent with section 3(c)(7)(C) of 

FIFRA, the Agency has determined that 

these conditional registrations are in the 

public interest. Use of the pesticides are 

of significance to the user community, 

and appropriate labeling, use directions, 

and other measures have been taken to 

ensure that use of the pesticides will not 

result in unreasonable adverse effects to 

man and the environment.

III. Conditionally Approved 

Registrations

1. EPA issued a notice, published in 

the Federal Register of December 31, 

2001 (66 FR 67520) (FRL–6813–7), 

which announced that MycoLogic Inc., 

Department of Biology, University of 

Victoria, P.O. Box 3020, Victoria, BC, 

Canada V8W 3N5, submitted 

applications to register the pesticide 

products, CP-PFC 2139, a manufacturing 

use product, for the formulation of an 

end-use product (EPA File Symbol 

74200–R) and Chontrol Paste (a 

biological herbicide) (EPA File Symbol 

74200–E), containing the active 

ingredient Chondrostereum purpureum

isolate PFC 2139, at 1.68% and 0.67%, 

respectively. These products have not 

previously been registered.

The applications were conditionally 

approved on September 23, 2004, 

containing the active ingredient 

Chondrostereum purpureum strain PFC 

2139 for the manufacturing use product 

CP-PFC 2139 (EPA Registration Number 

74200–1) and for the end-use product 

Chontrol Paste (EPA Registration 

Number 74200–2), for control of alders, 

aspen, and other hardwoods in rights-ofway and forests.

2. EPA issued a notice, published in 

the Federal Register of December 24, 

2003 (68 FR 74576) (FRL–7338–2), 

which announced that Woodstream 

Corporation, 69 N. Locust Street, Lititz, 

PA 17543, had submitted an application 

to conditionally register the pesticide 

product, Animal Repellent Granular, 

animal repellent (EPA File Symbol 

50932–RN), containing the active 

ingredients Oil of Black Pepper at 

0.48% and Piperine at 0.185% as active 

ingredients not included in any 

previously registered product.

The application was conditionally 

approved on March 18, 2004 for the 

end-use product as Animal Repellent 

Granular (EPA Registration Number 

50932–10) for use as an animal 

repellent.

List of Subjects

Environmental protection, Chemicals, 

Pesticides and pests.

Dated: December 10, 2004.

Janet L. Andersen,

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs.

[FR Doc. 04–27888 Filed 12–21–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0399; FRL–7689–4]

Buprofezin; Notice of Filing an 

Amended Pesticide Petition to 

Increase Tolerances for a Certain 

Pesticide Chemical in or on Food

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the 

filing of a pesticide petition proposing 

the establishment of regulations for 

residues of a certain pesticide chemical 

in or on various food commodities.

DATES: Comments, identified by docket 

identification (ID) number OPP–2004–

0399, must be received on or before 

January 21, 2005.

ADDRESSES: Comments may be 

submitted electronically, by mail, or 

through hand delivery/courier. Follow 

the detailed instructions as provided in 

Unit I. of the SUPPLEMENTARY

INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Richard J. Gebken, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6701; e-mail 

address:gebken.richard@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)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 

32532)

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

76720 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Notices 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Get Copies of this 

Document and Other Related 

Information?

1. Docket. EPA has established an 

official public docket for this action 

under docket ID number OPP–2004–

0399. The official public docket consists 

of the documents specifically referenced 

in this action, any public comments 

received, and other information related 

to this action. Although a part of the 

official docket, the public docket does 

not include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

The official public docket is the 

collection of materials that is available 

for public viewing at the Public 

Information and Records Integrity 

Branch (PIRIB), Rm. 119, Crystal Mall 

#2, 1801 S. Bell St., Arlington, VA. This 

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.

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. Once in 

the system, select ‘‘search,’’ then key in 

the appropriate docket ID number.

Certain types of information will not 

be placed in the EPA Dockets. 

Information claimed as CBI and other 

information whose disclosure is 

restricted by statute, which is not 

included in the official public docket, 

will not be available for public viewing 

in EPA’s electronic public docket. EPA’s 

policy is that copyrighted material will 

not be placed in EPA’s electronic public 

docket but will be available only in 

printed, paper form in the official public 

docket. To the extent feasible, publicly 

available docket materials will be made 

available in EPA’s electronic public 

docket. When a document is selected 

from the index list in EPA Dockets, the 

system will identify whether the 

document is available for viewing in 

EPA’s electronic public docket. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B. EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket.

For public commenters, it is 

important to note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing in EPA’s electronic public 

docket as EPA receives them and 

without change, unless the comment 

contains copyrighted material, CBI, or 

other information whose disclosure is 

restricted by statute. When EPA 

identifies a comment containing 

copyrighted material, EPA will provide 

a reference to that material in the 

version of the comment that is placed in 

EPA’s electronic public docket. The 

entire printed comment, including the 

copyrighted material, will be available 

in the public docket.

Public comments submitted on 

computer disks that are mailed or 

delivered to the docket will be 

transferred to EPA’s electronic public 

docket. Public comments that are 

mailed or delivered to the docket will be 

scanned and placed in EPA’s electronic 

public docket. Where practical, physical 

objects will be photographed, and the 

photograph will be placed in EPA’s 

electronic public docket along with a 

brief description written by the docket 

staff.

C. How and to Whom Do I Submit 

Comments?

You may submit comments 

electronically, by mail, or through hand 

delivery/courier. To ensure proper 

receipt by EPA, identify the appropriate 

docket ID number in the subject line on 

the first page of your comment. Please 

ensure that your comments are 

submitted within the specified comment 

period. Comments received after the 

close of the comment period will be 

marked ‘‘late.’’ EPA is not required to 

consider these late comments. If you 

wish to submit CBI or information that 

is otherwise protected by statute, please 

follow the instructions in Unit I.D. Do 

not use EPA Dockets or e-mail to submit 

CBI or information protected by statute.

1. Electronically. If you submit an 

electronic comment as prescribed in this 

unit, EPA recommends that you include 

your name, mailing address, and an email address or other contact 

information in the body of your 

comment. Also include this contact 

information on the outside of any disk 

or CD ROM you submit, and in any 

cover letter accompanying the disk or 

CD ROM. This ensures that you can be 

identified as the submitter of the 

comment and allows EPA to contact you 

in case EPA cannot read your comment 

due to technical difficulties or needs 

further information on the substance of 

your comment. EPA’s policy is that EPA 

will not edit your comment, and any 

identifying or contact information 

provided in the body of a comment will 

be included as part of the comment that 

is placed in the official public docket, 

and made available in EPA’s electronic 

public docket. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment.

i. EPA Dockets. Your use of EPA’s 

electronic public docket to submit 

comments to EPA electronically is 

EPA’s preferred method for receiving 

comments. Go directly to EPA Dockets 

athttp://www.epa.gov/edocket/, and 

follow the online instructions for 

submitting comments. Once in the 

system, select ‘‘search,’’ and then key in 

docket ID number OPP–2004–0399. The 

system is an ‘‘anonymous access’’

system, which means EPA will not 

know your identity, e-mail address, or 

other contact information unless you 

provide it in the body of your comment.

ii. E-mail. Comments may be sent by 

e-mail to opp-docket@epa.gov, 

Attention: Docket ID Number OPP–

2004–0399. In contrast to EPA’s 

electronic public docket, EPA’s e-mail 

system is not an ‘‘anonymous access’’

system. If you send an e-mail comment 

directly to the docket without going 

through EPA’s electronic public docket, 

EPA’s e-mail system automatically 

captures your e-mail address. E-mail 

addresses that are automatically 

captured by EPA’s e-mail system are 

included as part of the comment that is 

placed in the official public docket, and 

made available in EPA’s electronic 

public docket.

iii. Disk or CD ROM. You may submit 

comments on a disk or CD ROM that 

you mail to the mailing address 

identified in Unit I.C.2. These electronic 

submissions will be accepted in 

WordPerfect or ASCII file format. Avoid 

Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Notices 76721

the use of special characters and any 

form of encryption.

2. By mail. Send your comments to: 

Public Information and Records 

Integrity Branch (PIRIB) (7502C), Office 

of Pesticide Programs (OPP), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001, Attention: Docket ID 

Number OPP–2004–0399.

3. By hand delivery or courier. Deliver 

your comments to: Public Information 

and Records Integrity Branch (PIRIB), 

Office of Pesticide Programs (OPP), 

Environmental Protection Agency, Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA, Attention: Docket ID 

Number OPP–2004–0399. Such 

deliveries are only accepted during the 

docket’s normal hours of operation as 

identified in Unit I.B.1.

D. How Should I Submit CBI to the 

Agency?

Do not submit information that you 

consider to be CBI electronically 

through EPA’s electronic public docket 

or by e-mail. You may claim 

information that you submit to EPA as 

CBI by marking any part or all of that 

information as CBI (if you submit CBI 

on disk or CD ROM, mark the outside 

of the disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

CBI). Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2.

In addition to one complete version of 

the comment that includes any 

information claimed as CBI, a copy of 

the comment that does not contain the 

information claimed as CBI must be 

submitted for inclusion in the public 

docket and EPA’s electronic public 

docket. If you submit the copy that does 

not contain CBI on disk or CD ROM, 

mark the outside of the disk or CD ROM 

clearly that it does not contain CBI. 

Information not marked as CBI will be 

included in the public docket and EPA’s 

electronic public docket without prior 

notice. If you have any questions about 

CBI or the procedures for claiming CBI, 

please consult the person listed under 

FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare 

My Comments for EPA?

You may find the following 

suggestions helpful for preparing your 

comments:

1. Explain your views as clearly as 

possible.

2. Describe any assumptions that you 

used.

3. Provide copies of any technical 

information and/or data you used that 

support your views.

4. If you estimate potential burden or 

costs, explain how you arrived at the 

estimate that you provide.

5. Provide specific examples to 

illustrate your concerns.

6. Make sure to submit your 

comments by the deadline in this 

notice.

7. To ensure proper receipt by EPA, 

be sure to identify the docket ID number 

assigned to this action in the subject 

line on the first page of your response. 

You may also provide the name, date, 

and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition 

as follows proposing the establishment 

and/or amendment of regulations for 

residues of a certain pesticide chemical 

in or on various food commodities 

under section 408 of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 21 

U.S.C. 346a. EPA has determined that 

this petition contains data or 

information regarding the elements set 

forth in FFDCA section 408(d)(2); 

however, EPA has not fully evaluated 

the sufficiency of the submitted data at 

this time or whether the data support 

granting of the petition. Additional data 

may be needed before EPA rules on the 

petition.

List of Subjects

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: December 9, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

Summary of Petition

The petitioner summary of the 

pesticide petition is printed below as 

required by FFDCA section 408(d)(3). 

The summary of the petition was 

prepared by the petitioner and 

represents the view of the petitioner. 

The petition summary announces the 

availability of a description of the 

analytical methods available to EPA for 

the detection and measurement of the 

pesticide chemical residues or an 

explanation of why no such method is 

needed.

Nichino America, Inc.

PP 4F6873

EPA has received a petition (PP 

4F6873) from Nichino America, Inc., 

4550 New Linden Hill Road, Suite 501, 

Wilmington, DE 19808 (the registrant) 

by revising a previous pesticide petition 

(PP 0F6087) that was submitted by 

Aventis Crop Science (formerly AgrEVO 

USA Co, that published in the Federal 

Register of June 21, 2000 (65 FR 38543) 

(FRL–6557–3). Nichino America, Inc. is 

proposing, pursuant to section 408(d) of 

the FFDCA, 21 U.S.C. 346a(d), to amend 

40 CFR 180.511 by establishing 

increased tolerances for residues of 

buprofezin (2-tert-butylimino-3-

isopropyl-5-phenyl-1,3,5-thiadiazinan4-one) in or on the following raw 

agricultural commodities: Fruit, citrus, 

Group 10 at 2.5 parts per million (ppm), 

citrus, dried pulp at 7.5 ppm, and citrus, 

oil at 80 ppm. EPA has determined that 

the petition contains data or information 

regarding the elements set forth in 

section 408(d)(2) of the FFDCA. 

However, EPA has not fully evaluated 

the sufficiency of the submitted data at 

this time or whether the data support 

granting of the petition. Additional data 

may be needed before EPA rules on the 

petition.

A. Residue Chemistry

1. Plant metabolism. The metabolic 

profile of buprofezin has been 

elucidated in a wide range of crops, 

including tomatoes, lettuce, cotton, and 

citrus. In citrus, although buprofezin 

was a major component of the residue, 

a chromatographically well-defined 

region of radioactivity, clearly 

associated with polar conjugates, was 

observed. Mass spectrometry identified 

the principal polar residue as a hexose 

conjugate of BF4 (buprofezin 

hydroxylated in the t-butyl group). 

Although the conjugate was resistant to 

enzyme hydrolysis, acid hydrolysis of 

the polar fraction released 

predominantly BF26 with minor 

amounts of BF9 and BF12. The same 

compounds were observed following 

acid hydrolysis of a standard of BF4 

clearly indicating that BF4 is the 

conjugated metabolite existing in citrus. 

Although only limited metabolism was 

observed in lettuce and cotton, trace 

levels of similar metabolites, including 

the conjugate BF4 were observed 

indicating that the metabolic pathway 

does not differ with plant species.

2. Analytical method. The proposed 

analytical method involves extraction, 

partition, clean-up and detection of 

residues by gas chromatography using 

nitrogen phosphorous detection.

3. Magnitude of residues. Nineteen 

field trials were conducted on oranges 

with buprofezin, the principal residue 

of concern, in Regions 3, 6, and 10 at the 

maximum rate and minimum 

application and the minimum 

preharvest interval (PHI) of 3 days. In 

addition, decline data were generated 

that confirmed that residues of 

buprofezin decreased as the PHI 

76722 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Notices 

increased from 1 to 30 days. The highest 

average residue value for oranges treated 

with buprofezin (HAFT) at a 3–day PHI 

was 1.80 ppm. Results from a previous 

processing study indicate that the 

concentration in citrus oil was 42.7X 

and in citrus dried pulp 2.5X. The 

requested tolerances are adequately 

supported.

B. Toxicological Profile

An extensive battery of toxicology 

studies has been conducted with 

buprofezin. 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 

The nature of the toxic effects caused by 

buprofezin is discussed in Unit III.A. of 

the final rule on Buprofezin Pesticide 

Tolerance published in the Federal 

Register on September 5, 2001 (66 FR 

46381) (FRL–6796–6). An assessment of 

toxic effects caused by buprofezin, 

including the toxicological endpoints of 

concern, is also discussed in Unit III.A. 

and Unit III.B. of the June 25, 2003 

Federal Register (68 FR 37765) (FRL–

7310–7).

1. Animal metabolism. The 

metabolism of buprofezin has been 

extensively studied in various species of 

animals and fish. Buprofezin has several 

groups that can metabolize in a variety 

of ways thus potentially producing a 

very large number of metabolites. 

Extensive metabolism to many minor 

metabolites was observed in all the 

animal species. Metabolism in fish was, 

however, much more limited and 

clearly defined. Although not all 

metabolic intermediates have been 

detected in all the species, the major 

routes of metabolism have been 

identified in animals and fish and a 

consistent pattern is observed 

throughout these species. The proposed 

metabolic pathway was provided in the 

tolerance petition, PP 0F6087. For 

convenience, degradates are referred to 

by an internal code: BF1 through 13. 

Corresponding chemical structures were 

provided in the tolerance petition, PP 

0F6087.

i. Metabolism in rats. The major 

metabolite found in rat excreta was 

parent buprofezin in addition to several 

compounds formed after extensive 

metabolism. Whereas plant metabolism 

appeared restricted mainly to oxidation 

of the tertiary butyl group, oxidation of 

the butyl group and hydroxylation of 

the phenyl ring were both observed in 

rats. Oxidation of the t-butyl group 

proceeded beyond an alcohol to an acid 

and was accompanied by ring opening. 

The most extensively metabolized 

compound identified in rats was BF23 

(acetylated p-aminophenol).

ii. Metabolism in ruminants and hens. 

Residue levels were low (0.05 ppm) in 

all ruminant and poultry tissues and 

commodities, following treatment at 

exaggerated rates (approximately 20X 

and 7,500X the anticipated dietary 

burden, respectively). The only 

exceptions were cow liver (1.21 ppm), 

cow kidney (0.41 ppm), hen liver (0.15 

ppm), and egg yolk (0.11 ppm). 

Extensive metabolism was observed in 

both species with a large number of 

minor metabolites being produced. The 

principal metabolites identified in the 

cow were BF2 and BF23, indicating that 

the major pathway of degradation in 

ruminants is hydroxylation of the 

phenyl ring followed by opening and 

degradation of the heterocyclic ring. The 

identification of trace levels of BF13 

confirms this pathway. As in rats, BF23 

was the most extensively metabolized 

compound identified. Trace levels of 

BF12 were also detected. This indicates 

that the parallel pathway of heterocyclic 

ring opening without hydroxylation of 

the phenyl ring is also in operation. 

Similarly in hens, the identified 

metabolites were derived from 

degradation of the heterocyclic ring 

either with (BF13) or without (BF9 and 

BF12) phenyl ring hydroxylation. No 

single unidentified compound 

accounted for more than 6% of the total 

residue in any animal tissue or 

commodity, with the exception of a 

component comprising 8.7% of egg 

white. The total residue in egg white 

was, however, only 0.02 ppm even at 

this highly exaggerated dose rate.

iii. Metabolism in fish. Analysis of 

fish tissues, following a 

bioaccumulation study, found a much 

simpler metabolic profile. Buprofezin 

was present in both edible and nonedible tissues, but the principle 

metabolites were polar conjugates of 

BF4. Trace levels of BF12 were also 

detected.

2. Endocrine disruption. No special 

studies have been conducted to 

investigate the potential of buprofezin to 

induce estrogenic or other endocrine 

effects. The standard battery of required 

toxicity studies has been completed. 

These studies include an evaluation of 

the potential effects on reproduction 

and development and an evaluation of 

the pathology of the endocrine organs 

following repeated or long-term 

exposure. These studies are generally 

considered to be sufficient to detect any 

endocrine effects. The only effect noted 

on endocrine organs was an increased 

incidence of follicular cell hypertrophy 

and C-cell hyperplasia of the thyroid 

gland in rats administered buprofezin. 

Buprofezin also caused mild to 

moderate hepatotoxic effects at this 

dietary concentration. The effect on the 

thyroid is consistent with an increased 

turnover of T3/T4 in the liver with a 

resultant rise in TSH secretion (due to 

the hepatotoxicity). The rat is known to 

be much more susceptible than humans 

to these effects due to the very rapid 

turnover of thyroxine in the blood in 

rats (12 hours vs. about 5 to 9 days in 

humans). Therefore, the thyroid 

pathological changes which have been 

noted following administration of high 

doses of buprofezin are considered to be 

of minimal relevance to human risk 

assessment, particularly considering the 

low levels of buprofezin to which 

humans are likely to be exposed.

C. Aggregate Exposure

1. Dietary exposure. Acute and 

chronic dietary risk analyses were 

conducted to estimate the potential 

buprofezin residues in/on the following 

crops: Avocado, banana, canistel, 

cotton, grape, grape raisin, longan, 

lychee, mango, papaya, mamey sapote, 

Spanish lime, head lettuce, leaf lettuce, 

snap bean, tomato, curcurbit vegetables, 

citrus oil, citrus orange, citrus 

grapefruit, citrus lemon, pome fruit, 

apples, pome fruit pear, peach, almond, 

and pistachio using the Dietary 

Exposure Evaluation Model (DEEMFCID, ver. 1.30) software. Exposure 

estimates to water were based on 

modeling and on percent crop treated.

2. Food. The acute dietary exposure 

was based on the following 

assumptions: Residues at tolerance 

levels, 100% crop treated, and DEEM 

(ver. 7.76) default processing factors for 

all registered/proposed commodities 

(Tier 1). The Hazard Identification 

Assessment Review Committee (HIARC) 

met on February 15, 2000, and 

determined the endpoint selection for 

buprofezin (HED Doc. No. 014093) and 

subsequently on October 22, 2002, to 

evaluate the potential for increased 

susceptibility of infants and children 

from exposure to buprofezin. Based on 

toxicological considerations, the special 

FQPA safety factor was set at 1X when 

assessing acute and chronic dietary 

exposures. The acute dietary aPAD 

(acute Population Adjusted Dose) was 

set at 2.0 milligrams/kilogram/day (mg/

kg/day) for females aged 13–50 years old 

based on a developmental toxicity study 

in rats that had an oral no observed 

adverse effect level (NOAEL) of 200 mg/

kg/day. The chronic dietary cPAD 

(chronic Population Adjusted Dose) was 

determined to be 0.01 mg/kg/day for the 

general population based on a oral 

NOAEL of 1.0 mg/kg/day in the 2–year 

rat chronic/oncogenicity study. The 

Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Notices 76723

uncertainty factor of 100 was used to 

account for interspecies and 

intraspecies variations. Since the only 

evidence of carcinogenicity was 

‘‘suggestive,’’ this endpoint was not 

deemed relevant to this assessment.

The resulting food exposure estimate 

for females 13–49 years old was less 

than 5.4% of the Population Adjusted 

Dose (aPAD). No acute endpoint was 

identified for the remaining population 

subgroups. The chronic dietary 

exposure was based on the following 

assumptions: Percent crop treated, 

average field trial residues at maximum 

label rates, and minimum PHIs with no 

reduction factors for common washing, 

cooking, or preparation practices. The 

food exposure estimates from residues 

of buprofezin for the U.S. population 

was 38% of the cPAD. The 

subpopulation with the highest 

exposure was children 1–2 years old 

with < 81% of the cPAD used. These are 

considered conservative values.

3. Drinking water. The residue of 

concern in drinking water was 

determined to be buprofezin. There are 

no established maximum contaminant 

levels or health advisory levels for 

residues of buprofezin in drinking 

water.

In the absence of comprehensive 

water monitoring data, the Agency uses 

the FQPA Index Reservoir Screening 

Tool (FIRST) or the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) to produce 

estimates of pesticide concentrations in 

an index resevoir. The Screen 

Concentrations in Groundwater (SCIGROW) model is used to predict 

pesticide concentrations in shallow 

ground water. For a screening-level 

assessment for surface water, EPA will 

use FIRST (a Tier 1 model) before using 

PRZM/EXAMS (a Tier 2 model). The 

FIRST model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides. Both 

FIRST and PRZM/EXAMS incorporate 

an index reservoir environment, and 

both models include a percent crop area 

factor as an adjustment to account for 

the maximum percent crop coverage 

within a watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern.

The estimated drinking water 

concentrations (EDWCs) in surface 

water were determined using the Tier II 

PRZM (Pesticide Root Zone Model) and 

EXAMS (Exposure Analysis Modeling 

Stystem (PE4-PL, version 01). PRZM is 

used to simulate pesticide transport as 

a result of runoff and erosion and spray 

drift from an agricultural field and 

EXAMS estimates environmental fate 

and transport of pesticides in surface 

water. The long-term average-estimated 

environmental concentrations (EEC) was 

3.5 parts per billion (ppb). The acute 

EDWCs are 19.2 ppb, and for chronic 4.5 

ppb. In ground water, using Tier I SCIGROW, the acute level is 0.1 ppb and 

chronic is 0.1 ppb.

4. Non-dietary exposure. The term 

residential exposure is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., for lawn and 

garden pest control, indoor pest control, 

termiticides, and flea and tick control 

on pets). Buprofezin is not registered for 

use on any sites that would result in 

residential exposure.

D. Cumulative Effects

A determination has not been made 

that buprofezin has a common 

mechanism of toxicity with other 

substances. Buprofezin does not appear 

to produce a common toxic metabolite 

with other substances. A cumulative 

risk assessment was, therefore, not 

performed for this analysis. 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.’’

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 OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

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

cumulative/.

E. Safety Determination

1. U.S. population—i. Acute risk. 

Using the conservative assumptions 

discussed above, based on the 

completeness and reliability of the 

toxicity data, it is concluded that 

aggregate exposure to the proposed uses 

of buprofezin will utilize at most 5.4% 

of the acute reference dose of females 

(13–49 years) and is likely to be much 

less, as more realistic data and models 

are developed. EPA generally has no 

concern for exposures below 100% of 

the aPAD Drinking Water Levels of 

Comparison (DWLOC) were calculated 

based on an aPAD of 2.0 mg/kg/day. 

After calculating DWLOCs and 

comparing them to the EECs for surface 

water and ground water, EPA does not 

expect the aggregate exposure to exceed 

100% of the aPAD.

ii. Chronic risk. Based on the 

toxicology data base and available 

information on anticipated residues, the 

chronic dietary exposure to the U.S. 

population (total) was estimated as 

0.003769 mg/kg/day and was 38% of the 

estimated cPAD. Exposure to potential 

residues in drinking water are expected 

to be negligible. Based on these 

assessments, it can be concluded that 

there is reasonably certainty of no harm 

to the U.S. population or any population 

subgroup from exposure to buprofezin.

2. Infants and children. Chronic 

exposure to children ages 1–2, the 

highest exposed population subgroup, 

was 0.008116 mg/kg/day (81% of the 

cPAD). Exposure to potential residues in 

drinking water is expected to be 

negligible. EPA has determined that 

reliable data support using the standard 

margin of exposure (MOE) and 

uncertainty factor (100 for combined 

interspecies and intraspecies variability) 

for buprofezin and that an additional 

safety factor of 10 is not necessary to be 

protective of infants and children. EPA 

generally has no concern for exposures 

below 100% of the cPAD. The acute 

EEC of 19 ppb is considerably less than 

the DWLOC of 59,076 ppb. For the 

chronic assessment, the children 1–2 

years old subpopulation generated the 

lowest chronic DWLOC of 

approximately 46 ppb. Thus, the 

chronic DWLOC of 46 ppb is higher 

than the chronic EEC of 4.5 ppb. The 

Agency has considered the potential 

aggregate exposure from food, water and 

non-occupational exposure routes and 

has concluded aggregate exposure is not 

expected to exceed 100% of the chronic 

reference dose, and consequently, has 

determined there is a reasonable 

76724 Federal Register / Vol. 69, No. 245 / Wednesday, December 22, 2004 / Notices 

certainty that no harm will occur to 

infants and children from aggregate 

exposure to residues of buprofezin.

F. International Tolerances

Canada, Codex, and Mexico do not 

have maximum residue limits for 

residues of buprofezin in/on the 

proposed crops. Therefore, 

harmonization is not an issue.

[FR Doc. 04–27772 Filed 12–21–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0403; FRL–7689–6]

Pyriproxyfen: Notice of Filing a 

Pesticide Petition to Establish a 

Tolerance for a Certain Pesticide 

Chemical in or on Food

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the 

initial filing of a pesticide petition 

proposing the establishment of 

regulations for residues of a certain 

pesticide chemical in or on various food 

commodities.

DATES: Comments, identified by docket 

identification (ID) number OPP–2004–

0403, must be received on or before 

January 21, 2005.

ADDRESSES: Comments may be 

submitted electronically, by mail, or 

through hand delivery/courier. Follow 

the detailed instructions as provided in 

Unit I. of the SUPPLEMENTARY

INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Joseph Tavano, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6411; e-mail address: 

tavano.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by 

this action if you an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to:

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 

32532)

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 Get Copies of this 

Document and Other Related 

Information?

1. Docket. EPA has established an 

official public docket for this action 

under docket ID number OPP–2004–

0403. The official public docket consists 

of the documents specifically referenced 

in this action, any public comments 

received, and other information related 

to this action. Although a part of the 

official docket, the public docket does 

not include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

The official public docket is the 

collection of materials that is available 

for public viewing at the Public 

Information and Records Integrity 

Branch (PIRIB), Rm. 119, Crystal Mall 

#2, 1801 S. Bell St., Arlington, VA. This 

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.

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B.1. Once in 

the system, select ‘‘search,’’ then key in 

the appropriate docket ID number.

Certain types of information will not 

be placed in the EPA Dockets. 

Information claimed as CBI and other 

information whose disclosure is 

restricted by statute, which is not 

included in the official public docket, 

will not be available for public viewing 

in EPA’s electronic public docket. EPA’s 

policy is that copyrighted material will 

not be placed in EPA’s electronic public 

docket but will be available only in 

printed, paper form in the official public 

docket. To the extent feasible, publicly 

available docket materials will be made 

available in EPA’s electronic public 

docket. When a document is selected 

from the index list in EPA Dockets, the 

system will identify whether the 

document is available for viewing in 

EPA’s electronic public docket. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B. EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket.

For public commenters, it is 

important to note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing in EPA’s electronic public 

docket as EPA receives them and 

without change, unless the comment 

contains copyrighted material, CBI, or 

other information whose disclosure is 

restricted by statute. When EPA 

identifies a comment containing 

copyrighted material, EPA will provide 

a reference to that material in the 

version of the comment that is placed in 

EPA’s electronic public docket. The 

entire printed comment, including the 

copyrighted material, will be available 

in the public docket.

Public comments submitted on 

computer disks that are mailed or 

delivered to the docket will be 

transferred to EPA’s electronic public 

docket. Public comments that are 

mailed or delivered to the docket will be 

scanned and placed in EPA’s electronic 

public docket. Where practical, physical 

objects will be photographed, and the 

photograph will be placed in EPA’s 

electronic public docket along with a 

brief description written by the docket 

staff.

C. How and to Whom Do I Submit 

Comments?

You may submit comments 

electronically, by mail, or through hand 

delivery/courier. To ensure proper 

receipt by EPA, identify the appropriate 

docket ID number in the subject line on 

the first page of your comment. Please 

ensure that your comments are 

submitted within the specified comment 

period. Comments received after the 

close of the comment period will be 

marked ‘‘late.’’ EPA is not required to 

consider these late comments. If you 

wish to submit CBI or information that