53180 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 

larger nominal dimensions and treated to a 

minimum of 0.60 pcf) (C18), Lumber and 

Plywood for Permanent Wood Foundations 

(C22), Round Poles and Posts Used in 

Building Construction(C23), Sawn Timber 

Used To Support Residential and 

Commercial Structures(C24), Sawn 

Crossarms (C25), Structural Glued Laminated 

Members and Laminations Before Gluing 

(C28), Structural Composite Lumber (C33), 

and Shakes and Shingles (C34); and in 

accordance with the respective cited 

standard (noted parenthetically) of the 2002 

edition of the American Wood-Preservers’

Association Standards: Lumber, Timbers and 

Plywood for Cooling Towers (C30). Forest 

products treated with this product may only 

be sold or distributed for uses within the 

AWPA Commodity Standards under which 

the treatment occurred, except where 

otherwise provided above. 

Revised Language Manufacturing Use 

Product (MUP) 

This product may only be used (1) for 

formulation of the following end-use wood 

preservative products: Ammoniacal copper 

zinc arsenate (ACZA) or chromated copper 

arsenate (CCA) labeled in accordance with 

the Directions for Use shown below, or (2) by 

persons other than the registrant, in 

combination with one or more other products 

to make: ACZA wood preservative; or CCA 

wood preservative that is used in accordance 

with the Directions for Use shown below. 

This product may only be used for 

preservative treatment of the following 

categories of forest products and in 

accordance with the respective cited 

standard (noted parenthetically) of the 2001 

edition of the American Wood-Preservers’

Association (AWPA) Standards: Lumber and 

Timber for Salt Water Use Only (C2), Piles 

(C3), Poles (C4), Plywood(C9), Wood for 

Highway Construction (C14), Round, Half 

Round and Quarter Round Fence Posts (C16), 

Poles, Piles and Posts Used as Structural 

Members on Farms, and Plywood Used on 

Farms (C16), Wood for Marine Construction 

(C18), Lumber and Plywood for Permanent 

Wood Foundations(C22), Round Poles and 

Posts Used in Building Construction (C23), 

Sawn Timber Used To Support Residential 

and Commercial Structures (C24), Sawn 

Crossarms (C25), Structural Glued Laminated 

Members and Laminations Before Gluing 

(C28), Structural Composite Lumber (C33), 

and Shakes and Shingles (C34); and in 

accordance with the respective cited 

standard (noted parenthetically) of the 2002 

edition of the American Wood-Preservers’

Association Standards: Lumber, Timbers and 

Plywood for Cooling Towers (C30). Forest 

products treated with this product may only 

be sold or distributed for uses within the 

AWPA Commodity Standards under which 

the treatment occurred. 

Effective December 31, 2004, this product 

may only be used for preservative treatment 

of the following categories of forest products 

and in accordance with the respective cited 

standard (noted parenthetically) of the 2001 

edition of the American Wood-Preservers’

Association (AWPA) Standards: Lumber and 

Timber for Salt Water Use (also includes 

brackish water) Only (C2), Piles (C3), Poles 

(C4), Plywood(C9), Wood for Highway 

Construction (C14), Round, Half Round and 

Quarter Round Fence Posts (C16), Poles, Piles 

and Posts Used as Structural Members on 

Farms, and Plywood Used on Farms (C16), 

Wood for Marine Construction for Salt Water 

Use (also includes brackish water)(immersion 

and/or subject to saltwater (or brackish 

water) splash [‘‘subject to saltwater (or 

brackish water) splash’’ means any member 

of a marine structure which is positioned 

above mean high tide, but is subject to 

frequent wetting from wave action], [Pilings 

(sheet, round and square), Timbers, and 

Plywood; Walers, Framing, Stringers and 

Cross Bracing (2′′ x 8′′ and/or 3′′ x 6′′ and 

larger nominal dimensions and treated to a 

minimum of 0.60 pcf) (C18), Lumber and 

Plywood for Permanent Wood Foundations 

(C22), Round Poles and Posts Used in 

Building Construction(C23), Sawn Timber 

Used To Support Residential and 

Commercial Structures(C24), Sawn 

Crossarms (C25), Structural Glue Laminated 

Members and Laminations Before Gluing 

(C28), Structural Composite Lumber (C33), 

and Shakes and Shingles (C34); and in 

accordance with the respective cited 

standard (noted parenthetically) of the 2002 

edition of the American Wood-Preservers’

Association Standards: Lumber, Timbers and 

Plywood for Cooling Towers (C30). Forest 

products treated with this product may only 

be sold or distributed for uses within the 

AWPA Commodity Standards under which 

the treatment occurred, except where 

otherwise provided above. 

Furthermore, any distribution, sale, or 

use of existing stocks of the products 

identified in Table 2 of Unit II. in a 

manner inconsistent with any of the 

Provisions for Disposition of Existing 

Stocks set forth below in Unit VI. will 

be considered a violation of FIFRA. 

V. What is the Agency’s Authority for 

Taking this Action? 

Section 6(f)(1) of FIFRA provides that 

a registrant of a pesticide product may 

at any time request that any of its 

pesticide registrations be canceled or 

amended to terminate one or more uses. 

FIFRA further provides that, before 

acting on the request, EPA must publish 

a notice of receipt of any such request 

in the Federal Register. Thereafter, 

following the public comment period, 

the Administrator may approve such a 

request. 

VI. Provisions for Disposition of 

Existing Stocks 

Existing stocks are those stocks of 

registered pesticide products which are 

currently in the United States and 

which were packaged, labeled, and 

released for shipment prior to the 

effective date of the cancellation action. 

The cancellation order issued in this 

Notice includes the following existing 

stocks provisions. 

The registrants of affected CCA 

products requested that the voluntary 

use terminations become effective 

December 31, 2004, with no provisions 

for existing stocks. Consequently, the 

Agency is not allowing for any existing 

stocks provisions for those affected 

products in the hands of the registrant 

on or after the effective date of the use 

terminations. Any sale, distribution, or 

use of those affected products on or after 

the effective date of this cancellation 

order is prohibited. This refers to CCA 

product labels that bear the C18 Marine 

Use, ‘‘members out of water and not 

subject to saltwater [or brackish water] 

splash and not in soil use,’’ and which 

do not bear labeling consistent with that 

set forth in Unit IV. above. Sale, 

distribution or use of the stocks in the 

channels of trade by persons other than 

the registrant may continue until 

depleted, provided any sale, 

distribution or use is in accordance with 

the existing label of that product. 

List of Subjects 

Environmental protection, Pesticides 

and pests, Chromated Copper Arsenate, 

CCA, and Treated Wood. 

Dated: August 25, 2005. 

Frank Sanders, 

Acting Director, Antimicrobials Division, 

Office of Pesticide Programs. 

[FR Doc. 05–17530 Filed 9–6–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2005–0215; FRL–7731–1] 

Terbacil; 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–2005–

0215, must be received on or before 

October 7, 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: 

Sidney Jackson, Registration Division 

(7505C), Office of Pesticide Programs, 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53181 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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–2005–

0215. 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.1. 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 

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–2005–0215. The 

system is an ‘‘anonymous access’’

system, which means EPA will not 

know your identity, e-mail address, or 

53182 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 

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–

2005–0215. 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–2005–0215. 

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–2005–0215. 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: August 19, 2005. 

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. 

Interregional Research Project Number 

4 (IR-4) 

PP 3E6640 

EPA has received a pesticide petition 

(PP 3E6640) from Interregional Research 

Project Number 4 (IR-4) on behalf of 

DuPont Crop Protection, P.O. Box 30, 

Newark, Delaware 19714-0030, 

proposing, pursuant to section 408(d) of 

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

40 CFR part 180 by establishing a 

tolerance for residues of the herbicide, 

terbacil (3-tert-butyl-5-chloro-6- 

methyluracil) and its metabolites [3-tertbutyl-5-chloro-6-hydroxymethyluracil], 

[6-chloro-2,3-dihydro-7-hydroxymethyl 

3,3-dimethyl-5H-oxazolo(3,2-a) 

pyrimidin-5-one], and [6-chloro-2,3- 

dihydro-3,3,7-trimethyl-5H-oxazolo(3,2- 

a) pyrimidin-5-one] in or on the raw 

agricultural commodity watermelon at 

1.0 parts per million (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. This 

notice includes a summary of the 

petition that was prepared by DuPont 

Crop Protection. 

A. Residue Chemistry 

1. Plant metabolism. The metabolism 

and chemical nature of residues of 

terbacil in plants and animals are 

adequately understood. The fate of 

terbacil has been extensively studied 

using radioactive tracers in plant and 

animal metabolism/nature of the residue 

studies. 

2. Analytical method. There is a 

practical analytical method utilizing 

microcoulometric gas chromatography 

with thermionic or nitrogen 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53183 

phosphorous detection available for 

enforcement with a limit of detection 

that allows monitoring food with 

residues at or above tolerance levels. 

The limit of detection for the method 

determined by the lowest standard of 

0.5 nanogram per microliter (ng/μl) was 

0.05 ppm. 

3. Magnitude of residues. Crop field 

trial residue data from a 69– to 94–day 

preharvest interval (PHI) study show 

that the proposed tolerance in or on 

watermelon at 1.0 ppm will not be 

exceeded when DuPont Sinbar (trade 

name) herbicide is used as directed. 

B. Toxicological Profile 

1. Acute toxicity. Terbacil technical 

has been placed in EPA Toxicity 

Category III for acute oral toxicity (rat 

lethal dose (LD50) 934 milligram/ 

kilogram (mg/kg) in female rats; 1,255 

mg/kg in male rats); Category IV for 

acute inhalation lethal concentration 

(LC50) >4.4 milligrams per liter (mg/L) 

in rats); Category IV for acute dermal 

(rabbit LD50 >5,000 mg/kg); and 

Category III for primary eye irritation 

(mild conjunctival effects clearing in 72 

hours in rabbits). Although a primary 

dermal irritation study is not available 

on terbacil technical, the Agency 

indicated to the Registrant that if no 

dermal irritation was observed in a 21–

day sub-chronic dermal study, then the 

requirements for the primary dermal 

irritation study would be satisfied. No 

dermal irritation was reported in that 

study. A dermal sensitization test on 

terbacil in guinea pigs showed no 

dermal sensitization. 

2. Genotoxicity. Terbacil technical 

was tested and found negative in a 

Chinese hamster ovary (CHO) 

Hypoxanthine guanine phophoribosyl 

transferase (HGPRT) gene mutation 

assay when tested up to cytotoxic levels, 

with and without S-9 activation 

(cytotoxicity >3.0 micromolar (mM) 

without activation; >2.75 mM with 

activation). Terbacil technical was also 

negative for unscheduled DNA 

synthesis when tested up to cytotoxic 

levels (5 mM) in the rat. It was also 

negative for clastogenicity in a 

chromosomal aberration study in rat 

bone marrow cells, at doses up to 500 

mg/kg. 

3. Reproductive and developmental 

toxicity. Terbacil was tested in male and 

female rats at control and dietary levels 

of 50 or 250 ppm (equivalent to 2.5 or 

12.5 mg/kg/day, over three generations. 

The first litter of each generation was 

discarded, and the second litter bred to 

produce the next generation. No 

reproductive effects were seen at the 

highest dose tested. Therefore, the no 

observed adverse effect level (NOAEL) 

for reproductive toxicity was equal to or 

greater than 250 ppm (12.5 mg/kg/day). 

Terbacil has been tested in rats and 

rabbits for its potential to produce 

developmental toxicity. Rats were fed 0, 

250, 1,250 or 5,000 ppm (equivalent to 

0, 12.5, 62.5, or 250 mg/kg/day) of 

terbacil in the diet from days 6 through 

15 of gestation. The developmental 

NOAEL was 250 ppm (12.5 mg/kg/day); 

the developmental LOAEL of 1,250 ppm 

(62.5 mg/kg/day) was based upon 

significantly decreased numbers of live 

fetuses per litter, apparently due to fetal 

loss occurring before or near the time of 

implantation. The maternal NOAEL was 

250 ppm (12.5 mg/kg/day), based on 

decreased body weight at 1,250 ppm 

(62.5 mg/kg/day). Teratogenicity in 

pregnant rats was not demonstrated. 

Rabbits were given doses of terbacil of 

0, 30, 200, or 600 mg/kg/day by gavage, 

on gestation days 7 through 19. The 

maternal NOAEL was 200 mg/kg/day, 

based on maternal deaths (5 died and 2 

were sacrificed in extremis) at the 

LOAEL of 600 mg/kg/day. The 

developmental NOAEL was also 200 

mg/kg/day based on decreased live fetal 

weights in the high dose group. 

Teratogenicity in pregnant rabbits was 

not demonstrated. 

4. Subchronic toxicity. Subchronic 

oral toxicity was tested in a 90–day 

feeding study in rats. A NOAEL of 100 

ppm (equivalent to 5 mg/kg/day) and a 

LOAEL of 500 ppm, equivalent to 25 

mg/kg/day highest dose tested (HDT) 

were established, based on increased 

absolute and relative liver weights, 

vacuolization and hypertrophy of 

hepatocytes. The data requirement for 

subchronic oral toxicity in a nonrodent 

was satisfied by a 2–year feeding study 

in beagle dogs, in which a NOAEL of 50 

ppm (equivalent to 1.25 mg/kg/day) and 

a LOAEL of 250 ppm (equivalent to 7.2 

mg/kg/day) were established, based on 

increased thyroid to body weight ratios, 

slight increase in liver weights, and 

elevated alkaline phosphatase levels. 

Subchronic dermal toxicity was tested 

in a 21–day study in rabbits. Terbacil 

(80% active ingredient (a.i.)) was 

applied to prepared skin of male and 

female rabbits at 5,000 mg/kg/day, 5 

hours/day, 5 days/week. No systemic 

toxicity was observed; mild scaling and 

staining were reported at the test sites. 

5. Chronic toxicity. Terbacil 80% a.i. 

was administered to beagle dogs (4/sex/ 

group) in the diet for 2 years, at doses 

of 50, 250, or 2,500/10,000 ppm 

(equivalent to 1.25, 6.25, 62.5/250 mg/ 

kg/day). The NOAEL was 50 ppm (1.25 

mg/kg/day) and the LOAEL was 250 

ppm (6.25 mg/kg/day) based on 

increased thyroid to body weight ratios, 

slight increase in liver weights, and 

elevated alkaline phosphatase levels. 

Relative liver weights were also 

increased at 2,500 and 10,000 ppm in 

dogs sacrificed at 1 year and 2 years, 

respectively. 

A 2–year rat study was conducted 

using terbacil 97.4% a.i. administered to 

male and female rats at dietary levels of 

0, 25, 1,500, or 7,500 ppm (approximate 

doses for males of 0,0.9, 58, and 308 mg/ 

kg/day and for females of 0, 1.4, 83/484 

mg/kg/day). The systemic NOAEL is 25 

ppm and the LOAEL is 1,500 ppm based 

on liver weight and centrilobular 

hypertrophy. The study was conducted 

at adequate dosages as demonstrated by 

the decrement in body weight gain in 

both sexes. There was no evidence of 

increased tumor incidence in the treated 

animals when compared to the controls. 

Terbacil has been tested in a chronic 

2–year feeding/oncogenicity study in 

mice at doses of 0, 50, 1,250, or 5,000/ 

7,500 ppm (equivalent to 7, 179, 714/ 

1,071 mg/kg/day). The increase in dose 

occurred after week 54. A systemic 

NOAEL of 50 ppm is based on the 

LOAEL of 1,250 ppm that resulted in 

mild hypertrophy of the centrilobular 

hepatocytes and decreased pituitary 

weights in males. Pituitary weight was 

also decreased in high-dose females. 

There was an increased incidence of 

lung neoplasms (adenomas and 

adenocarcinomas) in all treated male 

mice, which was not dose-related; in 

addition, these tumors were within the 

range of similar tumors observed in 

historical control mice. 

6. Animal metabolism. Radiolabeled 

terbacil was tested in rats in single 

doses of 6.5 or 500 mg/kg; 97-103% of 

radioactivity was recovered within 5 

days: 70-86% in urine, and 28% in 

feces. The major metabolites were 

glucuronide, sulfate, and Nacetylcysteine conjugates. The primary 

metabolic pathway is hydroxylation of 

the 6-methyl group to form the alcohol, 

which is conjugated to form the 

glucuronide (35% of the dose) and the 

sulfate derivatives (11%). Terbacil is 

also metabolized to the 5-hydroxy 

intermediate, which is further 

conjugated to form a sulfate derivative 

(17%). 

7. Metabolite toxicology. The parent 

molecule is the only moiety of 

toxicological significance appropriate 

for regulation in plant and animal 

commodities. 

8. Endocrine disruption. No observed 

effects reported. 

C. Aggregate Exposure 

1. Dietary exposure—i. Food. 

Tolerances have been established for the 

residues of terbacil in or on a variety of 

agricultural commodities. For purposes 

53184 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 

of assessing dietary exposure, chronic 

and acute dietary assessments have been 

conducted using all existing and 

pending tolerances for terbacil. To 

estimate acute dietary risk, the endpoint 

selected was based on a rat development 

toxicity study in which the maternal 

and fetal NOAEL were 12.5 mg/kg/day. 

The reference dose (RfD) for systemic 

toxicity was determined for terbacil as 

0.013 mg/kg/day, by the Agency’s RfD 

committee in 1986. The RfD was 

calculated from a 2–year feeding study 

in dogs in which the NOAEL was 1.25 

mg/kg/day (based on increased relative 

liver weights and increased serum 

alkaline phosphatase, seen at 7.25 mg/ 

kg/day), and an uncertainty factor of 

100. The RfD of 0.013 mg/kg/day was 

reaffirmed by the Agency’s RfD 

Committee on September 1, 1994. 

A Tier 1 (screening) assessment was 

conducted by DuPont; tolerance values, 

indicated below, were used in the 

assessment with no adjustments for 

processing or usage. (Alfalfa feed 

commodities are not included in the 

assessment because they are not 

consumed by humans.) 

Commodity Tolerance 

(ppm) 

Apple 0.3 

Asparagus 0.4 

Blueberry 0.2 

Caneberry Crop Subgroup 

13B 0.2 

Peach 0.2 

Peppermint 2.0 

Spearmint 2.0 

Strawberry 0.1 

Sugarcane 0.4 

Watermelon 1.0 

(proposed) 

The chronic risk values were 

calculated with a chronic reference dose 

(cRfD) of 0.013 mg/kg body weight 

(bwt)/day. The chronic dietary exposure 

for the U.S. population was 0.000725 

mg/kg bwt/day (5.6% of the cRfD). The 

most sensitive subpopulation was 

children 1-6 years old with a chronic 

dietary exposure of 0.002991 mg/kg 

bwt/day (23.0% of the cRfD). 

The acute risk values were calculated 

with an acute reference dose (aRfD) of 

0.125 mg/kg bwt/day. The acute dietary 

exposure (at the 95th percentile) for the 

U.S. population was 0.003071 mg/kg 

bwt/day (2.5% of aRfD). The most 

sensitive subpopulation was children 1- 

2 years old with an acute dietary 

exposure (at the 95th percentile) of 

0.015641 mg/kg bwt/day(12.5% aRfD). 

These results of Tier 1 (screening) 

assessments support the registrant’s 

view that there is reasonable certainty of 

no harm from the use of this product as 

labeled/proposed. 

Terbacil is classified as a Group E 

carcinogen—no evidence of 

carcinogenicity in either rats or mice. 

Therefore, a carcinogenicity risk 

analysis for humans is not required. 

ii. Drinking water. Other potential 

dietary sources of exposure of the 

general population to pesticides are 

residues in drinking water. 

For acute drinking water risk, the 

Drinking Water Levels of Concern 

(DWLOCs) were calculated using an 

aRfD (acute) endpoint of 0.125 mg/kg 

and compared to surface water or 

ground water EEC (estimated 

environmental concentration) values of 

0.154 ppm and 0.125 ppm, respectively. 

The DWLOC values are as follows: 

Population Subgroups 

DWLOC 

Values 

(ppm) 

U.S. Population 4.3 

Non-Nursing Infants 1.1 

Children 1-6 Years 1.1 

Children 7-12 Years 1.2 

Females 13+ Nursing 3.6 

Males 13-19 Years 4.3 

Seniors 55+ 4.3 

For chronic drinking water risk, the 

DWLOCs were calculated using a cRfD 

(chronic) endpoint of 0.013 mg/kg and 

compared to surface water or ground 

water EEC values of 0.105 ppm and 

0.0089 ppm, respectively. The DWLOC 

values are as follows: 

Population Subgroups 

DWLOC 

Values 

(ppm) 

U.S. Population 0.43 

Non-Nursing Infants 0.10 

Children 1-6 years 0.10 

Children 7-12 Years 0.12 

Females 13+ Nursing 0.36 

Males 13-19 years 0.43 

Seniors 55+ 0.44 

The estimated environmental 

concentrations are within acceptable 

ranges. Because of the conservative 

nature of the screening level dietary 

assessments performed, and the fact that 

actual ground water monitoring data, 

although limited, are not showing large 

amounts of terbacil present, DuPont 

does not believe that drinking water 

sources of terbacil are of concern. 

2. Non-dietary exposure. Terbacil is 

not registered for any use that could 

result in non-occupational, non-dietary 

exposure to the general population. 

Alfalfa feed commodities were not 

included in the assessment because they 

are not consumed by humans. 

D. Cumulative Effects 

Section 408(b)(2)(D)(v) requires that, 

when considering whether to establish, 

modify, or revoke a tolerance, the 

Agency considers ‘‘available 

information’’ concerning the cumulative 

effects of a particular pesticide’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’

For most pesticides, although the 

Agency has some information in its files 

that may turn out to be helpful in 

eventually determining whether a 

pesticide shares a common mechanism 

of toxicity with any other substances, 

EPA does not at this time have the 

methodologies to resolve the complex 

scientific issues concerning common 

mechanism of toxicity in a meaningful 

way. EPA has begun a pilot process to 

study this issue further through the 

examination of particular classes of 

pesticides. The Agency hopes that the 

results of this pilot process will increase 

the Agency’s scientific understanding of 

this question such that EPA will be able 

to develop and apply scientific 

principles for better determining which 

chemicals have a common mechanism 

of toxicity and evaluating the 

cumulative effects of such chemicals. 

The Agency anticipates, however, that 

even as its understanding of the science 

of common mechanisms increases, 

decisions on specific classes of 

chemicals will be heavily dependent on 

chemical specific data, much of which 

may not be presently available. 

In assessing the potential risk from 

cumulative effects of terbacil and other 

chemical substances, the Agency has 

considered structural similarities that 

exist between terbacil and other 

substituted uracil compounds such as 

bromacil and lenacil. 

A comparison of the available 

toxicological database for terbacil and 

bromacil revealed no clear common 

mode of toxicity for these chemicals. 

The toxicology database for lenacil was 

not considered because there are 

currently no registered uses of lenacil. A 

summary of the most prominent clinical 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices 53185 

signs from terbacil and bromacil 

follows. 

The following clinical signs were 

observed in the terbacil toxicology 

database: Decrease in body weight, 

increase in liver weights, vacuolization 

and hypertrophy of hepatocytes, 

hypertrophy of centrilobular 

hepatocytes in males, decreased 

pituitary weights in males and females, 

increase in thyroid/body weight ratio, 

and elevated alkaline phosphatase. 

The following clinical signs were 

observed in the bromacil toxicology 

database: Decreased body weight, focal 

atrophy of seminiferous tubules 

(testicular abnormalities), 

hydronephrosis, suggestive histological 

evidence for antithyroid activity (cystic 

follicles in the thyroid and enlargement 

of centrilobular cells of the liver), and 

a positive trend in thyroid tumors for 

male rats (basis of C classification for 

carcinogenicity). 

Based on these data, DuPont 

concludes that there is no clear common 

mode of toxicity (thyroid or liver) 

between terbacil and bromacil. With 

both chemicals, there is marginal 

evidence of liver effects (principally 

enlargement of centrilobular cells). 

Enlargement of liver cells is not a 

specific enough effect to be considered 

a common mode of toxicity. The thyroid 

effects observed with bromacil were 

cystic follicles. Terbacil induced an 

increase in relative thyroid weights but 

no increase in absolute thyroid weights. 

An increase in relative weight without 

a corresponding increase in absolute 

weight has very little meaning, 

especially without any supporting 

histological or hormonal evidence. This 

conclusion was based on the marginal 

liver effects noted in the databases, and 

the absence of thyroid effects in the 

terbacil database (with the exception of 

increases in relative thyroid weights). 

DuPont has no information indicating 

that any other chemical has a common 

mode of toxicity with terbacil and, 

therefore concludes that an aggregate 

risk assessment will indicate risks 

resulting only from terbacil. 

E. Safety Determination 

1. U.S. population. EPA has 

determined that the established 

tolerances for terbacil meet the safety 

standards under the FQPA amendments 

to section 408(b)(2)(D) for the general 

population. In reaching this 

determination, EPA has considered 

available information on aggregate 

exposures (both acute and chronic) from 

non-occupational sources, food and 

drinking water, as well as the possibility 

of cumulative effects from terbacil and 

other chemicals with similar 

mechanism of toxicity. 

Since there are no residential or lawn 

uses of terbacil, no dermal or inhalation 

exposure is expected in and around the 

home. 

In assessing acute dietary risk from 

food, the endpoint selected was 

developmental toxicity. Because the 

endpoint of concern is a developmental 

effect, the only sub-population of 

concern is females of child-bearing age 

(i.e., females, 13+ years old). 

The acute risk values were calculated 

by DuPont with an aRfD of 0.125 mg/kg 

bwt/day. The acute dietary exposure (at 

the 95th percentile) for the U.S. 

population was 0.003071 mg/kg bwt/ 

day (2.5% of aRfD). The most sensitive 

subpopulation was children 1-2 years 

old with an acute dietary exposure (at 

the 95th percentile) of 0.015641 mg/kg 

bwt/day (12.5% aRfD). 

The chronic risk values were 

calculated by DuPont with a cRfD of 

0.013 mg/kg bwt/day. The chronic 

dietary exposure for the U.S. population 

was 0.000725 mg/kg bwt/day (5.6% of 

the cRfD). The most sensitive 

subpopulation was children 1-6 years 

old with a chronic dietary exposure of 

0.002991 mg/kg bwt/day (23.0% of the 

cRfD). 

In evaluating the potential for 

cumulative effects, EPA compared 

terbacil with other structurally similar 

substituted uracil compounds, such as 

bromacil and lenacil, and then with 

other compounds producing similar 

effects. A comparison of the available 

toxicological database for terbacil and 

bromacil revealed no clear common 

mode of toxicity for the chemicals. The 

toxicology database for lenacil was not 

considered because there are currently 

no registered uses of lenacil. Based on 

the available data, the Agency has 

determined that there is no clear 

common mode of toxicity between 

terbacil and bromacil. 

2. Infants and children. EPA has 

determined that the established 

tolerances for terbacil meet the safety 

standard under the FQPA amendment to 

section 408(b)(2)(C) for infants and 

children. The safety determination for 

infants and children considers the 

factors noted above for the general 

population, but also takes into account 

the possibility of increased dietary 

exposure due to the specific 

consumption patterns of infants and 

children, as well as the possibility of 

increased susceptibility to the toxic 

effects of terbacil residues in this 

population subgroup. 

In determining whether or not infants 

and children are particularly susceptible 

to toxic effects from terbacil residues, 

EPA considered the completeness of the 

database for developmental and 

reproductive effects, the nature of the 

effects observed, and other information. 

Based on current data requirements, 

terbacil has a complete database for 

developmental and reproductive 

toxicity. Because the developmental 

NOAELs were the same as those for 

maternal toxicity, and the NOAEL for 

systemic (parental) toxicity was higher 

than the NOAEL for reproductive 

toxicity, DuPont believes that these data 

do not suggest an increased pre- or postnatal sensitivity of children and infants 

to terbacil exposure. Therefore, DuPont 

concludes that the available toxicology 

data do not support an uncertainty 

factor of 1,000 as specified in FQPA and 

that the present uncertainty factor of 

100 is adequate to ensure the protection 

of infants and children from exposure to 

terbacil. 

It is estimated by DuPont that terbacil 

exposure from the chronic diet is as 

follows: All infants less than 1 year—

18% of the cRfD; Nursing infants—9.7% 

of the cRfD; Non-nursing infants—

21.2% of the cRfD; Children 1-6 years—

23% of the cRfD. 

F. International Tolerances 

There are no established Codex 

maximum residue levels (MRL’s) or 

international tolerances for terbacil on 

watermelon. 

[FR Doc. 05–17529 Filed 9–6–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPPT–2005–0045; FRL–7735–9] 

Certain New Chemicals; Receipt and 

Status Information 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: Section 5 of the Toxic 

Substances Control Act (TSCA) requires 

any person who intends to manufacture 

(defined by statute to include import) a 

new chemical (i.e., a chemical not on 

the TSCA Inventory) to notify EPA and 

comply with the statutory provisions 

pertaining to the manufacture of new 

chemicals. Under sections 5(d)(2) and 

5(d)(3) of TSCA, EPA is required to 

publish a notice of receipt of a 

premanufacture notice (PMN) or an 

application for a test marketing 

exemption (TME), and to publish 

periodic status reports on the chemicals 

under review and the receipt of notices 

of commencement to manufacture those 

chemicals. This status report, which