Federal Register / Vol. 69, No. 221 / Wednesday, November 17, 2004 / Notices 67351

∑ Yeasts / g: < 10 CFU 

∑ Molds / g: < 10 CFU 

∑ Coliforms / g most probable number 

(MPN): < 3 CFU 

∑ E. coli / g (MPN): < 3 CFU 

∑ Staphylococcus aureus / 10 g: < 10 

CFU 

∑ Salmonella / 25 g: absent 

The recommended usage level of the 

red cabbage color as a visual pH 

indicator is less than 1%. The color 

value of a 1% solution of the red 

cabbage color is 16 absorbency units 

(determined by spectrophotometry at 

535 nm after dilution in McIlvaine 

buffer at pH 3.0). Here, the color 

principles (and other red cabbage 

components) are less than those which 

are typically contained in an 

unprocessed red cabbage juice.

At a 1% usage level of the red cabbage 

color concentrate, the level of solvents 

and citric acid that are contained in the 

color concentrate are in line with 

current good manufacturing practice 

(cGMP) for foods. In particular, 

propylene glycol is at a level or 0.18%, 

i.e., more than 10-fold lower than the 

level set by cGMP for foods other than 

alcoholic beverages, confectionery and 

frostings, seasoning and flavouring, nuts 

and nut products for which higher 

levels are permitted.

[FR Doc. 04–25502 Filed 11–16–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0357; FRL–7686–6]

Fenbuconazole; 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 extending time-limited 

tolerances for residues of a certain 

pesticide chemical in or on various food 

commodities.

DATES: Comments, identified by docket 

identification (ID) number OPP–2004–

0357, must be received on or before 

December 17, 2004.

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: J. R. 

Tomerlin, Registration Division (7505C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0598; e-mail address: 

tomerlin.bob@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 

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–

0357. 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

67352 Federal Register / Vol. 69, No. 221 / Wednesday, November 17, 2004 / Notices 

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 

at http://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–2004–0357. 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–

2004–0357. 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 

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–2004–0357.

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–2004–0357. 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.

Federal Register / Vol. 69, No. 221 / Wednesday, November 17, 2004 / Notices 67353

Dated: November 3, 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. 

Dow AgroSciences LLC

PP 1F3989, 1F3995, and 2F4154.

EPA has received pesticide petitions 

(1F3989, 1F3995, and 2F4154) from 

Dow AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268 proposing, 

pursuant to section 408(d) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a(d), to amend 40 CFR part 

180.480 by extending the time-limited 

tolerances for the combined residues of 

fenbuconazole (alpha-(2-(4-

chlorophenyl)-ethyl)-alpha-phenyl-3-

(1H-1,2,4-triazole)-1-propanenitrile) and 

its metabolites cis-and trans-5-(4-

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3H-furanone 

in or on the raw agricultural commodity 

fruit, stone, group 12 (except plum, 

prune) at 2.0 parts per million (ppm); 

pecan at 0.1 ppm; banana at 0.3 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 supports granting of 

the petition. Additional data may be 

needed before EPA rules on the petition.

A. Residue Chemistry 

1. Plant metabolism. The metabolism 

of fenbuconazole in plants is adequately 

understood for the purpose of these 

tolerances. Plant metabolism was 

evaluated in three diverse crops - wheat, 

peaches and peanuts. The route of 

metabolism is similar in all crop groups 

and proceeds with three main pathways. 

Oxidation at the benzylic carbon 

(pathway 1) led to the ketone and the 

lactone as metabolites. Oxidation or 

nucleophilic substitution on the carbon 

next to the triazole ring (pathway 2) led 

to triazole alanine (TA) and triazole 

acetic acid (TAA) presumably through 

free triazole. Metabolic pathway 3 

produced the phenolic metabolite RH4911, and led to the glucose conjugates 

found in all crops.

2. Analytical method. An adequate 

enforcement method is available for the 

established and proposed tolerances. 

Quantitation of fenbuconazole residues 

(and lactones RH-9129 and RH-9130) at 

an analytical sensitivity of 0.01 

milligrams/kilogram (mg/kg) is 

accomplished by soxhlet extraction of 

samples in methanol, partitioning into 

methylene chloride, redissolving in 

toluene, cleanup on silica gel, and gas 

liquid chromatography using nitrogen 

specific thermionic detection.

3. Magnitude of residues—i. Stone 

fruit-peaches. Ten field trials were 

conducted on peaches. Seven to 10 

applications were made at the 

maximum use rate of 0.1 pounds of 

active ingredient per acre (lb ai/acre) per 

application, and fruit was harvested on 

the last day of application. The highest 

field residue value was 0.51 ppm, and 

the average field residue value was 0.36 

ppm.

ii. Stone fruit-cherries. Eleven field 

trials were conducted on cherries. Five 

to 6 applications were made at the 

maximum use rate of 0.1 lb ai/acre per 

application, and fruit was harvested on 

the last day of application. The highest 

field residue value was 0.63 ppm, and 

the average field residue value was 0.43 

ppm.

iii. Stone fruit-apricots. Four field 

trials were conducted on apricots. Six 

applications were made at the 

maximum use rate of 0.125 lb ai/acre 

per application, and fruit was harvested 

on the last day of application. The field 

residue values in four samples 

measured were 0.17, 0.23, 0.27, and 0.28 

ppm.

iv. Pecans. Four field trials were 

conducted in pecans. Eight to 10 

applications were made at the 

maximum use rate of 0.125 lb ai/acre 

per application, and nuts were 

harvested 28 days after the last 

application. Field residue values in 

nutmeat for all four trials were <0.01 

ppm.

v. Bananas. Eighteen field trials were 

conducted on bagged bananas, which 

are typically used in commerce. Eight 

applications (5 and 7 applications in 

two trials) were made at the maximum 

use rate of 0.09 lb ai/acre per 

application and bananas were harvested 

on the last day of application. The 

highest field residue value in whole 

fruit or in pulp and peel combined was 

0.062 ppm. The average field residue 

value in whole fruit or in pulp and peel 

combined was 0.03 ppm. The results of 

these studies support the proposed 

permanent tolerances for fenbuconazole 

on stone fruit, pecans, and bananas.

B. Toxicological Profile

1. Acute toxicity. Fenbuconazole is 

practically non-toxic after 

administration by the oral and dermal 

routes, and was not significantly toxic to 

rats after a 4 hour inhalation exposure. 

Fenbuconazole is classified as not 

irritating to skin and inconsequentially 

irritating to the eyes. It is not a skin 

sensitizer.

2. Genotoxicty. Fenbuconazole was 

negative (non-mutagenic) in an Ames 

assay with and without hepatic enzyme 

activation. Fenbuconazole was negative 

in a hypoxanthine guanine 

phosphoribosyl transferase (HGPRT) 

gene mutation assay using Chinese 

hamster ovary (CHO) cells in culture 

when tested with and without hepatic 

enzyme activation. In isolated rat 

hepatocytes, fenbuconazole did not 

induce unscheduled DNA synthesis 

(UDS) or repair. Fenbuconazole did not 

produce chromosome effects in rats in 

vivo. On the basis of the results from 

this battery of tests, it is concluded that 

fenbuconazole is not mutagenic or 

genotoxic. 

3. Reproductive and developmental 

toxicity.—i. Developmental toxicity in 

the rat. In the developmental study in 

rats, the maternal (systemic) no 

observed adverse effect level (NOAEL) 

was 30 (mg/kg/day) based on decreases 

in body weight and body weight gain at 

the lowest observed adverse effect level 

(LOAEL) of 75 mg/kg/day. The 

developmental (fetal) NOAEL was 30 

mg/kg/day based on an increase in post 

implantation loss and a significant 

decrease in the number of live fetuses 

per dam at the LOAEL of 75 mg/kg/day.

ii. Developmental toxicity in the 

rabbit. In the developmental study in 

rabbits, the maternal (systemic) NOAEL 

was 10 mg/kg/day based on decreased 

body weight gain at the LOAEL of 30 

mg/kg/day. The developmental (fetal) 

NOAEL was 30 mg/kg/day based on 

increased resorptions at the LOAEL of 

60 mg/kg/day.

iii. Reproductive toxicity. In the 2-

generation reproduction toxicity study 

in rats, the maternal (systemic) NOAEL 

was 4 mg/kg/day based on decreased 

body weight and food consumption, 

increased number of dams delivering 

nonviable offspring, and increases in 

adrenal and thyroid weights at the 

LOAEL of 40 mg/kg/day. The 

reproductive (pup) NOAEL was 40 mg/

kg/day, the highest dose tested. 

4. Subchronic toxicity.—i. Rat 90-day 

oral study. A subchronic feeding study 

in rats conducted for 13 weeks resulted 

in a NOAEL of 80 ppm (5.1 and 6.3 mg/

67354 Federal Register / Vol. 69, No. 221 / Wednesday, November 17, 2004 / Notices 

kg/day in males and females, 

respectively). The only effect observed 

at 80 ppm was minimal centrilobular 

hypertrophy (seen in one male) and 

hepatocytic centrilobular vacuolation (3 

males) with no concomitant increase in 

liver weight or clinical chemistry 

correlates and no analogous effects in 

females. As such, these observations are 

not considered to be adverse. Increased 

liver weight, hepatic hypertrophy, 

thyroid hypertrophy, and decreased 

body weight were observed at the higher 

doses of 400 and 1,600 ppm.

ii. Dog 90-day oral study. A 

subchronic feeding study in dogs 

conducted for 13 weeks resulted in a 

NOAEL of 100 ppm (3.3 and 3.5 mg/kg/ 

day in males and females, respectively). 

At the LOAEL of 400 ppm, increased 

liver weight, clinical chemistry 

parameters, and liver hypertrophy 

(males) were observed.

iii. Rat 4-week dermal study. In a 21-

day dermal toxicity in the rat study, the 

NOAEL was greater than 1,000 mg/kg/

day, with no effects seen at this limit 

dose.

5. Chronic toxicity.—i. Dog. A 1-year 

feeding study in dogs resulted in a 

NOAEL of 15 ppm (0.62 mg/kg/day) for 

females and 150 ppm (5.2 mg/kg/day) 

for males. Decreased body weight, 

increased liver weight, liver 

hypertrophy, and pigment in the liver 

were observed at the LOAEL of 150 and 

1,200 ppm in females and males, 

respectively.

ii. Mouse. A 78-week chronic/

oncogenicity study was conducted in 

male and female mice at 0, 10, 200 

(males only), 650, and 1,300 ppm 

(females only). The NOAEL was 10 ppm 

(1.4 mg/kg/day), and the LOAEL was 

200 ppm (26.3 mg/kg/day) for males and 

650 ppm (104.6 mg/kg/day) for females 

based on increased liver weight and 

histopathological effects on the liver, 

which were consistent with chronic 

enzyme induction. There was no 

statistically significant increase of any 

tumor type in males. However, there 

was a statistically significant increase in 

combined liver adenomas and 

carcinomas in females at the high dose 

only (1,300 ppm; 208.8 mg/kg/day). 

There were no liver tumors in the 

control females, and liver tumor 

incidences in the high-dose females just 

exceeded the historical control range. In 

ancillary mode-of-action studies in 

female mice, the increased tumor 

incidence was associated with changes 

in several parameters in mouse liver 

following high doses of fenbuconazole, 

including an increase in P450 enzymes 

(predominately of the CYP 2B type), an 

increase in cell proliferation, an 

increase in hepatocyte hypertrophy, and 

an increase in liver weight. Changes in 

these liver parameters, as well as the 

occurrence of the low incidence of liver 

tumors, were non-linear with respect to 

dose (i.e., effects were observed only at 

high dietary doses of fenbuconazole). 

Similar findings have been shown with 

several pharmaceuticals, including 

phenobarbital, which is not 

carcinogenic in humans. The non-linear 

dose response relationship observed 

with respect to liver changes (including 

the low incidence of tumors) in the 

mouse indicates that these findings 

should be carefully considered in 

deciding the relevance of high-dose 

animal tumors to human dietary 

exposure.

iii. Rat. A 24-month chronic/

oncogenicity study in male and female 

rats was conducted at 0, 8, 80, and 800 

ppm fenbuconazole, and a second 24-

month chronic/oncogenicity study was 

conducted in male rats at 0, 800, and 

1,600 ppm. The NOAEL was 80 ppm (3 

and 4 mg/kg/day in males and females, 

respectively), and the LOAEL was 800 

ppm (31 and 43 mg/kg/day in males and 

females, respectively) based on 

decreased body weight, increased liver 

and thyroid weights, and liver and 

thyroid hypertrophy. Fenbuconazole 

produced a minimal but statistically 

significant increase in the incidence of 

combined thyroid follicular cell benign 

and malignant tumors. These findings 

occurred only in male rats following 

life-time ingestion of very high levels 

(800 and 1,600 ppm in the diet) of 

fenbuconazole.

iv. Carcinogenicity. The Agency has 

concluded that the available data 

provide limited evidence of the 

carcinogenicity of fenbuconazole in 

both mice and rats and has classified 

fenbuconazole as a Group C carcinogen 

(possible human carcinogen with 

limited evidence of carcinogenicity in 

animals) in accordance with Agency 

guidelines, published in the Federal 

Register (51 FR 33992, September 24, 

1986), and recommended that for the 

purpose of risk characterization a lowdose extrapolation model applied to the 

experimental animal tumor data should 

be used for quantification of human risk 

(Q1*). EPA’s 26Feb98 Hazard 

Identification Assessment Review 

Committee (HIARC) report concluded 

that 0.00359 (mg/kg/day)-1 is the 

appropriate q* for fenbuconazole; this 

q* is based on the fenbuconazole mouse 

liver tumor data, along with a power 

surface area scaling factor.

6. Animal metabolism. The 

absorption, distribution, excretion, and 

metabolism of fenbuconazole in rats, 

goats, and hens were investigated. 

Following oral administration, 

fenbuconazole was completely and 

rapidly absorbed, extensively 

metabolized by oxidation/hydroxylation 

and conjugation, and rapidly and 

essentially completely excreted, 

predominately in the feces. 

Fenbuconazole did not accumulate in 

tissues.

7. Metabolite toxicology. There are no 

toxicological concerns for 

fenbuconazole based on differential 

metabolic pathways in plants and 

animals. Triazole fungicides are known 

to produce three common metabolites, 

1,2,4-triazole, triazolylalanine and 

triazole acetic acid. To support the 

extension of existing parent triazolederivative fungicide tolerances, EPA 

conducted an interim human health 

assessment for aggregate exposure to 

1,2,4-triazole. This interim assessment 

was summarized in the Federal Register

notice of August 4, 2004 (69 FR 47005) 

(FRL–7352–1) and titled Propiconazole; 

Time-Limited Pesticide Tolerances. EPA 

concluded that for all exposure 

durations and population subgroups, 

aggregate exposures to 1,2,4-triazole are 

not expected to exceed its level of 

concern.

8. Endocrine disruption. The 

mammalian endocrine system includes 

estrogen and androgens as well as other 

hormonal systems. Fenbuconazole is not 

known to interfere with reproductive 

hormones; thus, fenbuconazole should 

not be considered to be estrogenic or 

androgenic. There are no known 

instances of proven or alleged adverse 

reproductive or developmental effects to 

people, domestic animals, or wildlife as 

a result of exposure to fenbuconazole or 

its residues.

C. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary 

exposure assessments for fenbuconazole 

were conducted using the Dietary 

Exposure Evaluation Model (DEEM) 

software with the Food Commodity 

Intake Database (DEEM-FCID, version 2) 

which incorporates food consumption 

data as reported in the Continuing 

Survey of Food Intake by Individuals 

(CSFII) Survey 1994–1996, and 1998. 

These exposure assessments include all 

existing uses under section 3 

registrations (stone fruit except plums or 

prunes, pecans and bananas) and 

section 18 registrations (grapefruit, 

blueberry, and meat and meat byproducts resulting from grapefruit pulp 

as animal feedstuff). The assessments 

were performed in two levels. In the 

first assessment (Level 1), a Tier 1 

analysis was conducted with the 

assumption that 100% of the crops 

would be treated with fenbuconazole 

and that residues would be present at

Federal Register / Vol. 69, No. 221 / Wednesday, November 17, 2004 / Notices 67355

the tolerance levels. In the second 

assessment (Level 2), residues at 

tolerance levels were still assumed but 

the percent crop treated (PCT) was 

adjusted using the 4 or 5 year average 

for chronic assessment and the highest 

PCT for acute assessment. PCT values 

were based on data available for apricot, 

cherry, peach, grapefruit and pecan 

from the Doane database. Additionally, 

the default processing factors were used 

for all processed commodities except 

citrus oil. The tolerance of 35 ppm was 

used for citrus oil based on the residue 

data in grapefruit.

a. Acute dietary exposure. Although 

no acute adverse effect was observed as 

a result of exposure to a single dose, 

EPA has established an acute reference 

dose (aRfD) for the purpose of the acute 

dietary assessment. This aRfD was set at 

0.3 mg/kg/day for females 13+ years old, 

the population sub-group of concern. 

This was based on the developmental 

rat toxicity study with a NOAEL of 30 

mg/kg/day and an uncertainty factor of 

100. The 100-fold safety factor includes 

intraspecies and interspecies variations. 

Using the above assumptions for Level 

1 assessment, the food exposure for 

females 13+ years old at the 95th

percentile was estimated to be less than 

0.005 mg/kg/day which utilized less 

that 2% of the aRfD. For the level 2 

assessment, the estimated food exposure 

at the 99.99th percentile was less than 

0.003 mg/kg/day which utilizes less 

than 1.0% of the RfD.

b. Chronic dietary exposure. EPA has 

established a chronic reference dose 

(cRfD) for fenbuconazole at 0.03 mg/kg/

day for all population subgroups. The 

cRfD is based on the 2-year combined 

chronic feeding-carcinogenicity study in 

rats with a NOAEL of 3.03 and 4.02 mg/

kg/day in males and females 

respectively, and an uncertainty factor 

of 100. The 100-fold safety factor 

includes intraspecies and interspecies 

variations. No additional FQPA safety 

factor is required. The food exposure for 

the overall U.S. population was 

estimated to be 0.000552 mg/kg/day 

which utilizes less then 2% of the cRfD. 

The population subgroup with the 

highest potential for exposure was nonnursing infants at 10.6% of the cRfD 

with estimated food exposure of 

0.003185 mg/kg/day. For the level 2 

assessment, the estimated food exposure 

drops to 0.6% of the cRfD for the 

general population and 2.8% of the 

cRfD for non-nursing infants.

c. Cancer dietary exposure. EPA has 

classified fenbuconazole as a Group C 

carcinogen (possible human carcinogen 

with limited evidence of carcinogenicity 

in animals) and has established a Q1* 

of 0.00359 (mg/kg/day)-1 in human 

equivalents. Using the above 

assumptions for Level 1 assessment, the 

food exposure was estimated to be 

0.00552 mg/kg/day with a cancer risk 

estimate of 1.98 x 10-6. Using the 

refinements of PCT in the Level 2 

assessment results in a more realistic 

cancer risk assessment of 6.9 x 10-7 and 

a food exposure of 0.000191 mg/kg/day.

ii. Drinking water. The estimated 

drinking water concentration was 

calculated using the Pesticide Root 

Zone/Exposure Analysis Modeling 

System (PRZM/EXAMS) which predicts 

and annual average of 0.22 ppb. These 

results are considered a conservative 

assessment of possible concentration of 

fenbuconazole in drinking water. Using 

this value of 0.22 ppb, for dietary 

consumption of water in the DEEMFCID chronic analysis results in the 

exposure from drinking water to be 

insignificant at <0.1% of the cRfD for all 

population subgroups. Additionally in a 

later assessment the Agency used 

(Generic Estimated Environmental 

Concentration) GENEEC and (Screening 

Concentration in Ground Water) SCIGROW models to estimate the 

environmental concentrations (EECs) for 

surface water and ground water. The 

EECs for fenbuconazole are 6.7 ppb for 

acute and 3.6 ppb for chronic exposure. 

Since the EECs in ground water are 

much lower than the EECs in surface 

water, conservatively only the surface 

water EECs were used for comparison 

with the drinking water levels of 

comparison (DWLOC). DWLOC is a 

theoretical upper limit on a pesticide’s 

concentration in drinking water in light 

of total aggregate exposure to a pesticide 

in food, and from residential uses. 

DWLOC is not a regulatory standard for 

drinking water, but is used as a point of 

comparison against the estimated 

potential concentrations in groundwater 

or surface water. It is calculated by 

subtracting the food dietary exposure 

(from DEEM analysis) from the RfD and 

then expressed as μg/L using default 

body weights (70 kg for adult and 10 kg 

for infants) and drinking water 

consumption (2 L/day for adults and 1 

L/day for children). The acute DWLOC 

for females 13 years and older 

(population sub-group of concern) was 

calculated to be 8,915 μg/L. The chronic 

DWLOC for the general U.S. population 

and non-nursing infants (population 

sub-group of concern) was calculated to 

be 1,043 μg/L and 292 μg/L, 

respectively. The cancer DWLOC is the 

concentration in drinking water that 

results in a negligible cancer risk of 1 x 

10-6. Using the Level 2 assessment, the 

estimated chronic food exposure is 

0.000191 mg/kg/day for the general U.S. 

population. Assuming a negligible 

cancer risk of 1 x 10-6 and the Q1* of 

0.00359 (mg/kg/day)-1, the maximum 

allowable water exposure is 0.00009 

mg/kg/day resulting in a calculated 

cancer DWLOC of 3 μg/L. When 

comparing the EEC to the cancer 

DWLOC, the Agency policy states that a 

factor of 3 will be applied to GENEEC 

modeled values because the estimated 

environmental concentration is derived 

from a 56-day average value and not a 

longer-term average. Applying a factor 

of 3, the EEC is 1.2 μg/L which is less 

than the calculated cancer DWLOC of 3 

μg/L. The DWLOCs are substantially 

greater than the estimated residue 

concentration in ground water or 

surface water, therefore, exposure to 

fenbuconazole would not result in 

unacceptable levels of aggregate human 

health risk.

2. Non-dietary exposure. 

Fenbuconazole is not currently 

registered for use on any sites that 

would result in residential exposure. 

Thus, the risk from non-dietary 

exposure would be considered 

negligible.

D. Cumulative Effects

Fenbuconazole is a member of the 

triazole class of fungicides. At this time, 

EPA does not have available data to 

determine whether fenbuconazole 

exhibits a common mechanism of 

toxicity with other triazole fungicides. 

For purposes of this tolerance action, it 

is assumed that fenbuconazole does not 

have a mechanism of toxicity common 

with other substances and no 

cumulative risk is required.

E. Safety Determination

1. U.S. population. Using the 

conservative exposure assumptions 

(Level 1/Tier 1) and taking into account 

the completeness and reliability of the 

toxicity data, the chronic dietary food 

exposure from all supported section 3 

and section 18 registered uses will 

utilize 1.8% of the cRfD for the U.S. 

population. The major identifiable subgroup with the highest chronic food 

exposure is non-nursing infants at 

10.6% of the cRfD. EPA generally has no 

concern for exposures below 100% of 

the RfD because the RfD represents the 

level at or below which daily aggregate 

dietary exposure over a lifetime will not 

pose appreciable risks to human health. 

Thus, there is a reasonable certainty that 

no harm will result from aggregate 

exposure to fenbuconazole residues 

from the proposed uses. The acute 

dietary food exposure at the 95th

percentile for females 13+ years, the 

population sub-group of concern, is 

<2% of the aRfD. Therefore, there is no

67356 Federal Register / Vol. 69, No. 221 / Wednesday, November 17, 2004 / Notices 

concern for acute exposure because the 

acute RfD represents the level at or 

below which a single daily exposure 

will not pose appreciable risk to human 

health. Additionally, the potential 

contribution of fenbuconazole residues 

in drinking water is expected to be 

minimal. Using a slight refinement for 

PCT, the cancer risk assessment is 6.9 x 

10-7. Generally the Agency has no 

concern for exposures that result in a 

cancer risk estimate below 1 x 10-6. 

Including the potential for exposure in 

drinking water, the cancer risk is not 

expected to exceed 1x 10-6 for the U.S. 

population as a whole. 

2. Infants and children. In assessing 

the potential for additional sensitivity of 

infants and children to residues of 

fenbuconazole, data from 

developmental toxicity studies in rats 

and rabbits and a 2-generation 

reproduction study in the rat are 

considered. The developmental toxicity 

studies are designed to evaluate adverse 

effects on the developing organism 

resulting from pesticide exposure 

during prenatal development. 

Reproduction studies provide 

information relating to effects from 

exposure to the pesticide on the 

reproductive capability and potential 

systemic toxicity of mating animals and 

on various parameters associated with 

the well-being of offspring. The 

completeness and adequacy of the 

toxicity database is also considered. No 

indication of increased susceptibility to 

infants and children was noted in these 

studies for fenbuconazole. EPA has 

previously determined that no 

additional safety factor to protect infants 

and children is necessary for 

fenbuconazole and that the RfD of 0.03 

mg/kg/day is appropriate for assessing 

risk to infants and children.

F. International Tolerances

International CODEX values are 

established for apricot, banana, barley, 

barley straw and fodder, cattle fat, meat, 

milk and edible offal, cherries, 

cucumber, eggs, grapes, melon except 

watermelon, peach, plum, pome fruits, 

poultry fat, meat and edible offal, rape 

seed, rye, summer squash, sunflower, 

and wheat. 

[FR Doc. 04–25501 Filed 11–16–04; 8:45 am] 

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS 

COMMISSION 

Notice of Public Information 

Collection(s) being Reviewed by the 

Federal Communications Commission 

for Extension Under Delegated 

Authority. 

November 9, 2004.

SUMMARY: The Federal Communications 

Commission, as part of its continuing 

effort to reduce paperwork burden 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on the 

following information collection(s), as 

required by the Paperwork Reduction 

Act (PRA) of 1995, Pub. L. 104–13. An 

agency may not conduct or sponsor a 

collection of information unless it 

displays a currently valid control 

number. No person shall be subject to 

any penalty for failing to comply with 

a collection of information subject to the 

Paperwork Reduction Act (PRA) that 

does not display a valid control number. 

Comments are requested concerning (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Commission, including whether the 

information shall have practical utility; 

(b) the accuracy of the Commission’s 

burden estimate; (c) ways to enhance 

the quality, utility and clarity of the 

information collected; and (d) ways to 

minimize the burden of the collection of 

information on the respondents, 

including the use of automated 

collection techniques or other forms of 

information technology.

DATES: Written Paperwork Reduction 

(PRA) comments should be submitted 

on or before January 18, 2005. If you 

anticipate that you will be submitting 

comments, but find it difficult to do so 

within the period of time allowed by 

this notice, you should advise the 

contact listed below as soon as possible.

ADDRESSES: Direct all Paperwork 

Reduction Act (PRA) comments to 

Cathy Williams, Federal 

Communications Commission, Room 1-

C823, 445 12th Street, SW., Washington, 

DC 20554 or via the Internet to 

Cathy.Williams@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For 

additional information or copies of the 

information collection(s), contact Cathy 

Williams at 202–418–2918 or via the 

Internet at Cathy.Williams@fcc.gov.

SUPPLEMENTARY INFORMATION: 

OMB Control Number: 3060–0216. 

Title: Section 73.3538, Application to 

Make Changes in an Existing Station. 

Form Number: Not applicable. 

Type of Review: Extension of a 

currently approved collection. 

Respondents: Business or other forprofit entities; not-for-profit institutions. 

Number of Respondents: 50. 

Estimated Time per Response: 1 hour. 

Frequency of Response: On occasion 

reporting requirement. 

Total Annual Burden: 50 hours. 

Total Annual Cost: None. 

Privacy Act Impact Assessment: No 

impact(s). 

Needs and Uses: On February 14, 

2001, the Commission adopted a Report 

and Order, In the Matter of An Inquiry 

Into the Commission’s Policies and 

Rules Regarding AM Radio Service 

Directional Antenna Performance 

Verification, MM Docket No. 93–177. 

This Report and Order relaxed the 

technical requirements for AM stations 

using directional antennas. Among 

other things, this Report and Order

eliminated the need to file an informal 

application to specify new AM station 

directional antenna field monitoring 

points. 47 CFR Section 73.3538(b) 

requires a broadcast station to file an 

informal application to modify or 

discontinue the obstruction marking or 

lighting of an antenna supporting 

structure. The requirement to file an 

informal application to relocate the 

main studio outside the principal 

community contour has approval under 

47 CFR Section 73.1125 (3060–0171). 

The data is used by FCC staff to ensure 

that the modification or discontinuance 

of the obstruction marking or lighting 

will not cause a menace to air 

navigation.

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary.

[FR Doc. 04–25518 Filed 11–16–04; 8:45 am] 

BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS 

COMMISSION 

Notice of Public Information 

Collection(s) being Reviewed by the 

Federal Communications Commission, 

Comments Requested 

November 9, 2004.

SUMMARY: The Federal Communications 

Commission, as part of its continuing 

effort to reduce paperwork burden 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on the 

following information collection(s), as 

required by the Paperwork Reduction 

Act (PRA) of 1995, Pub. L. 104–13. An 

agency may not conduct or sponsor a 

collection of information unless it 

displays a currently valid control