Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 51797 

TABLE 2— AMENDED THIRAM

PRODUCTS

EPA Company No. Company Name and Address 

45728 Taminco, Inc. 

1950 Lake Park Drive 

Smyrna, GA 30080 

III. Summary of Public Comments 

Received and Agency Response to 

Comments 

During the public comment period 

provided, EPA received no comments in 

response to the April 27, 2005 Federal 

Register notice announcing the 

Agency’s receipt of the request for 

voluntary amendment to terminate uses 

of thiram. 

IV. Cancellation Order 

Pursuant to FIFRA section 6(f), EPA 

hereby approves the requested 

amendment to terminate uses of thiram 

registrations identified in Table 1 of 

Unit II. Accordingly, the Agency orders 

that the thiram product registrations 

identified in Table 1 are hereby 

amended to terminate the affected uses. 

Any distribution, sale, or use of existing 

stocks of the products identified in 

Table 1 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. 

Persons other than the registrant may 

continue to sell and/or use existing 

stocks of amended products until such 

stocks are exhausted, provided that such 

use is consistent with the terms of the 

previously approved labeling on, or that 

accompanied, the amended product. 

This order specifically prohibits any use 

of existing stocks that is not consistent 

with such previously approved labeling. 

List of Subjects 

Environmental protection, Pesticides 

and pests. 

Dated: August 18, 2005. 

Debra Edwards, 

Director, Special Review and Reregistration 

Division, Office of Pesticide Programs. 

[FR Doc. 05–17126 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560-50-S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2005–0195; FRL–7730–4] 

Ethalfluralin; 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–

0195, must be received on or before 

September 30, 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, 

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 an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111) 

• Animal production (NAICS code 

112) 

• Food manufacturing (NAICS code 

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–

0195. 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. 

51798 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 

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 on 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–2005–0195. 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–

2005–0195. 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–2005–0195. 

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–2005–0195. 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. 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 51799 

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’s summary of the 

pesticide petition is printed below as 

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

The summary of the petition was 

prepared by Interregional Research 

Project Number 4 (IR-4), 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 1E6326, PP 2E6360 and PP 2E6466 

EPA has received pesticide petitions 

1E6326, 2E6360 and from the 

Interregional Research Project Number 4 

(IR-4), P.O. Box 231, Rutgers University, 

New Brunswick, NJ 08903 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, by establishing tolerances for 

residues of ethalfluralin in or on the raw 

agricultural commodities rapeseed, 

canola, crambe, and mustard seed at 

0.05 parts per million (ppm), potato at 

0.05 ppm, and dill, at 0.05 ppm. IR-4 

submitted the petitions on behalf of the 

registrant, Dow AgroSciences LLC, who 

prepared this notice of filing. EPA has 

determined that the petitions contain 

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. Nature of residue 

studies with 14C-ethalfluralin have 

demonstrated very low terminal 

residues and that ethalfluralin per se is 

the residue of concern in plants grown 

in soil treated with this compound and 

that there are no significant metabolic 

products. These studies indicate that it 

is appropriate to base a tolerance on 

residues of the parent compound, 

ethalfluralin. 

2. Analytical method—i. Rapeseed. A 

residue method has been developed and 

validated at a limit of quantitation 

(LOQ) of 0.02 μg/g for the determination 

of ethalfluralin in rapeseed seed which 

utilizes capillary gas chromatography 

with mass selective detection (GC/ 

MSD). Validation data were generated 

using this method during the analysis of 

the canola seed field samples from the 

magnitude of residue studies. 

ii. Potato. The residue method used 

for determination of ethalfluralin in 

potato was based upon Analytical 

Method No. AM-AA-CA-R025-AB-755, 

‘‘Determination of Ethalfluralin in 

Agricultural Crops and Soil; 

Determination of Ethalfluralin in Potato 

and Potato Processed Products.’’

Analysis was by gas chromatography 

using an electron capture detector. The 

analytical method was determined to 

have an LOQ of 0.05 ppm and a limit 

of detection (LOD) of 0.016 ppm. 

iii. Canola. A residue method has 

been developed and validated at an 

LOQ of 0.02 μg/g for the determination 

of ethalfluralin in canola seed which 

utilizes capillary gas chromatography 

with mass selective detection (GC/ 

MSD). Validation data were generated 

using this method during the analysis of 

the canola seed field samples from the 

magnitude of residue studies. 

iv. Safflower. Adequate residue 

analytical methods are available for 

purposes of registration based upon the 

analytical method for sunflower. A GC 

method, Method I, with electron capture 

detection is listed in the Pesticide 

Analytical Manual (PAM, Vol. II, 

Section 180.416) for tolerance 

enforcement. Method I is applicable for 

analysis of ethalfluralin residues in or 

on sunflower seed. The LOD is 0.01 

ppm. 

v. Dill. Dill was analyzed by the 

method ‘‘Determination of Ethalfluralin 

in Agricultural Crops and Soil, ’’

Residue Method Number AM-AA-CAR025-AB-755, Lilly Research 

Laboratories, Greenfield, IN (currently 

Dow AgroSciences). The LOQ was 0.050 

ppm by a gas chromatograph with a 

Ni63 electron capture detector(ECD). 

Method validation was performed both 

prior to and concurrently with sample 

analysis. 

3. Magnitude of residues—i. Canola. 

In the magnitude of residue field 

studies, herbicides containing the active 

ingredient ethalfluralin N-ethyl-N-(2- 

methyl-2-propenyl)-2,6-dinitro-4- 

(trifluoromethyl) benzenamine were 

applied in 1996 at eight sites as a 

preplant incorporated application. 

Sonalan* 10G herbicide was applied 

directly to the soil surface and Sonalan* 

HFP herbicide was diluted in water and 

applied in a spray volume of 16–23 

gallon/Acre (gal/A). The applications 

were made to field plots of canola at the 

rate of 1.25 lb active ingredient/Acre 

(a.i./A) at all sites except GA and WA, 

and at the rate of 0.75 lb a.i./A (GA and 

WA). Three to five days after 

application, a second incorporation was 

done and canola seeds were planted. 

Samples of canola seeds were collected 

at normal harvest, 87–216 days after the 

last application. Residues in canola seed 

collected at normal harvest were nondetectable based on a method lower 

limit of detection of 0.004 ppm. 

ii. Potato. In the magnitude of residue 

field studies, ethalfluralin N-ethyl-N-(2- 

methyl-2-propenyl)-2,6-dinitro-4- 

(trifluoromethyl) benzenamine was 

applied as a preemergence broadcast 

treatment at a nominal rate of 1.0 lb a.i./ 

acre and was incorporated into the soil 

51800 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 

with the use of sprinkler irrigation or a 

drag harrow. Samples of marketable 

potatoes were collected at normal 

harvest, 65–143 days after treatment 

application. No residues of ethalfluralin 

above the limit of detection were 

observed in the potato raw agricultural 

commodity (RAC) or processed fractions 

(chips, flakes, and wet peel). 

iii. Safflower. The magnitude of 

residue data from sunflower are 

surrogate data for safflower. The 

registered uses of ethalfluralin on 

sunflowers along with the established 

tolerances on these commodities are 

supported by acceptable field residue 

data from trials reflecting the maximum 

registered use patterns. In all cases, the 

residues were <0.01 ppm. The 

reregistration requirements for 

processing studies were fulfilled. 

Adequate processing studies have been 

conducted on sunflower seed. Field 

residue data resulting from up to 5X 

label rates showed non-detectable (<0.01 

ppm) residues of ethalfluralin in 

sunflower seed. 

iv. Dill. In the magnitude of residue 

field studies, herbicides containing the 

active ingredient ethalfluralin N-ethylN-(2-methyl-2-propenyl)-2,6-dinitro-4- 

(trifluoromethyl) benzenamine were 

applied in 1997 at three sites. 

Ethalfluralin formulated as Curbit EC 

was applied directly to the soil surface, 

diluted in water and applied in a spray 

volume of 36 gal/A. The applications 

were made to field plots of canola at the 

rate of 1.5 lb a.i./A and incorporated by 

sprinkler irrigation. Samples of dill 

were collected at normal harvest, 91–

100 days after the last application. 

Residues in fresh and dried dill 

collected at normal harvest were nondetectable based on a method lower 

limit of detection of 0.05 ppm. 

B. Toxicological Profile 

1. Acute toxicity. Ethalfluralin is of 

relatively low toxicity. The rat oral 

lethal dose, LD50 is >10,000 mg/kg. The 

acute dermal LD50 in rabbits is >2,000 

milligram/kilogram (mg/kg) and the 

acute rat inhalation lethal concentration 

LC50 is >0.94 mg/liter (L) air. 

Ethalfluralin produced slight eye 

irritation and slight dermal irritation in 

rabbits. A guinea pig dermal 

sensitization study conducted by the 

modified Buehler method found no 

sensitization, whereas a study 

conducted by the Magnusson and 

Kligman maximization method showed 

a positive sensitization reaction. The 

signal word for the technical grade 

active ingredient is ‘‘Caution.’’

2. Genotoxicty. Ethalfluralin was 

weakly mutagenic in activated strains 

TA1535 and TA100 of salmonella 

typhimurium, but not in strains 

TA1537, TA1538, and TA98 in an Ames 

assay. In a modified Ames assay with 

salmonella typhimurium and e- coli, 

ethalfluralin was weakly mutagenic in 

strains TA1535 and TA100, with and 

without activation, and in strain TA98 

without activation, at the highest dose. 

No mutagenicity was found in the 

mouse lymphoma assay for forward 

mutation. Ethalfluralin did not induce 

unscheduled DNA synthesis in rat 

hepatocytes. In Chinese hamster ovary 

cells, ethalfluralin was negative without 

S9 activation, but it was clastogenic 

with activation. 

3. Reproductive and developmental 

toxicity. The maternal no-observed 

adverse effect level (NOAEL) of 

ethalfluralin in rats was 50 mg/kg/day. 

The maternal lowest observed adverse 

effect level (LOAEL) was 250 mg/kg/ 

day, based on decreased body weight 

gain and dark urine. In this rat study 

there was no observable developmental 

toxicity. The developmental NOAEL in 

rats was 1,000 mg/kg/day, the highest 

dose. In rabbits the NOAELs for 

maternal and developmental toxicity 

were 75 mg/kg/day. The maternal 

LOAEL at 150 mg/kg/day was based on 

abortions and decreased food 

consumption. These effects as well as 

decreased weight gain, enlarged liver, 

and orange urine were found at 300 mg/ 

kg/day. In this study developmental 

toxicity was observed. The 

developmental LOAEL in rabbits was 

150 mg/kg/day, based on slightly 

increased resorptions, abnormal cranial 

development, and increased sternal 

variants. In a three-generation rat 

reproduction study, the parental 

NOAEL was 12.5 mg/kg/day. The 

parental LOAEL was 37.5 mg/kg/day, 

based on depressed mean body weight 

gains in males in all generations. No 

treatment-related effects were noted on 

reproductive parameters and the 

NOAEL was 37.5 mg/kg/day or greater. 

A 7–month multigeneration bridging 

study was conducted with doses 

equivalent to 0, 8, 20, or 61 mg/kg/day 

in the diet of Fischer 344 rats. The 

parental NOAEL was 20 mg/kg/day. The 

parental LOAEL was 61 mg/kg/day 

based on increased liver weights. No 

treatment-related effects were noted on 

reproductive parameters and the 

reproductive NOAEL was equal to or 

greater than 61 mg/kg/day. 

4. Subchronic toxicity. Ethalfluralin 

was evaluated in five subchronic dietary 

studies which showed NOAELs of 560 

ppm in a 3-month mouse study, 12 mg/ 

kg/day in a 1–year mouse study, 29 mg/ 

kg/day in a 3-month rat study, 3.9 mg/ 

kg/day in male rats and 4.9 mg/kg/day 

in female rats in a 1–year study, and 

27.5 mg/kg/day in a 3–month dog study. 

A 21–day dermal study in rabbits 

showed no systemic toxicity, while 

slight to severe dermal irritation was 

observed. 

5. Chronic toxicity. Ethalfluralin was 

administered to Fisher 344 rats in the 

diet for 2 years in combined chronic 

toxicity and carcinogenicity replicate 

studies. The doses were equivalent to 0, 

4.2, 10.7, or 32.3 mg/kg/day. The 

NOAEL for systemic effects was 32.3 

mg/kg/day. Mammary gland 

fibroadenomas were found in dosed 

female rats at statistically significant 

incidences in the mid and high doses. 

Ethalfluralin was administered to 

B6C3F1 mice in the diet for 2 years in 

combined chronic toxicity and 

carcinogenicity replicate studies. The 

doses were equivalent to 0, 10.3, 41.9, 

or 163.3 mg/kg/day. No increased 

incidence of neoplasms was attributed 

to the treatment. The NOAEL was 10.3 

mg/kg/day. The mid-dose (LOAEL) and 

high–dose showed focal hepatocellular 

hyperplasia in both sexes. There were 

increased relative liver, kidney, and 

heart weights in females. Some blood 

changes were found also, including 

decreased hematocrit, hemoglobin, and 

erythrocyte count accompanied by 

increased mean corpuscular hemoglobin 

concentration in high dose females. 

Alkaline phosphatase values were 

increased at the high dose in both sexes. 

Body weight gain decreased at the high 

dose. 

Beagle dogs were given 0, 4, 20, or 80 

mg/kg/day orally, by capsule, for 1 year. 

The NOAEL was 4 mg/kg/day. The 

LOAEL was 20 mg/kg/day, based on 

increased urinary bilirubin, variations 

in erythrocyte morphology, increased 

thrombocyte count, and increased 

erythroid series of the bone marrow. 

Elevated alkaline phosphatase levels 

were found at the two higher doses and 

siderosis of the liver at the high dose. 

EPA’s Office of Pesticide Program’s 

Carcinogenicity Peer Review Committee 

concluded that, ethalfluralin should be 

classified as Group C, a possible human 

carcinogen, based on increased 

mammary gland fibroadenomas and 

adenomas/fibroadenomas combined in 

female rats. The tumor incidences were 

statistically significant at both the mid 

and high dose, and exceeded the upper 

range of historical controls. Based on a 

low dose extrapolation, the Q1* of 8.9 

x 10-2 (mg/kg/day)-1 has been calculated. 

6. Animal metabolism. Fischer 344 

rats were treated orally with a single 

low dose, a single high dose, or repeated 

low doses of radiolabeled ethalfluralin. 

Absorption of ethalfluralin was 

estimated at 79% - 87% of the dose for 

all dose levels. Ethalfluralin was rapidly 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 51801 

and extensively metabolized, and 95% 

of the chemical was excreted in urine 

and feces by 7 days. The major route of 

elimination for the radiolabel was in the 

feces, 50.9% - 63.2%, and the levels 

remaining in the tissues after 72 hours 

were negligible. The major metabolites 

in urine and feces were identified. 

7. Metabolite toxicology. The residue 

of concern is ethalfluralin per se, as 

specified in 40 CFR 180.416. Thus, there 

is no need to address metabolite 

toxicity. 

8. Endocrine disruption. There is no 

evidence to suggest that ethalfluralin 

has an effect on any endocrine system. 

C. Aggregate Exposure 

1. Dietary exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide if a toxicological study has 

indicated the possibility of an acute 

effect of concern occurring as a result of 

a 1–day or single exposure. EPA has 

previously used a NOAEL of 75 mg/kg/ 

day from a rabbit developmental 

toxicity study as the toxicity endpoint 

for assessing acute dietary risk in 

females 13–50 years of age. An acute 

reference dose (aRfD) of 0.75 mg/kg/day 

was calculated, based on a NOAEL of 75 

mg/kg/day and an uncertainty factor of 

100 (10 for interspecies extrapolation 

and 10 for intraspecies variation). EPA 

has previously added a 3X FQPA safety 

factor, resulting in an acute popution 

adjusted dose (aPAD) of 0.25 mg/kg/day. 

Likewise, in this assessment acute 

dietary risk to females 13–50 years old 

was based on an aPAD of 0.25 mg/kg/ 

day. 

Chronic dietary exposure to 

ethalfluralin is possible due to the 

potential presence of ethalfluralin 

residue in certain foods. Chronic dietary 

risk was evaluated using a chronic RfD 

of 0.04 mg/kg/day, which is based on a 

NOAEL of 4 mg/kg/day from a chronic 

dog study along with an uncertainty 

factor of 100. EPA previously concluded 

that an FQPA Safety Factor of 1X is 

appropriate for assessing chronic dietary 

risk. 

EPA has concluded, that ethalfluralin 

should be classified as group C, a 

possible human carcinogen, based on 

increased mammary gland 

fibroadenomas and adenomas/ 

fibroadenomas combined in female rats. 

Therefore, a cancer risk assessment was 

included. Based on a low dose 

extrapolation, the Q1* of 8.9 x 10-2 (mg/ 

kg/day)-1 has been calculated and was 

used in this cancer risk assessment. 

i. Food. The dietary exposure 

assessment was based on all 

commodities with tolerances for 

ethalfluralin established at 40 CFR 

180.416 together with the proposed 

tolerances of 0.05 ppm for rapeseed, 

0.05 ppm for potatoes, and 0.05 ppm for 

dill, canola and safflower. The Dietary 

Exposure Evaluation Model (DEEMTM), 

which is produced by Novigen Sciences, 

Inc. and licensed to Dow AgroSciences, 

was used to estimate dietary exposure. 

This software used the food 

consumption data for the 1989–1991 

USDA Continuing Surveys of Food 

Intake by Individuals (CSFII 1989–

1991). 

a. Acute. An acute dietary risk 

assessment was conducted with the 

conservative assumptions of 100% crop 

treated and tolerance level residues for 

all crops. These assumptions result in a 

very conservative estimate of human 

exposure and risk. Acute dietary risk for 

females 13+ years old was assessed 

using an acute population adjusted dose 

(aPAD) of 0.25 mg/kg/day. Even with 

conservative assumptions used in this 

analysis acute dietary exposure was 

estimated to occupy only 0.05% of the 

aPAD for females 13+ years old. 

Adverse effects are not expected for 

exposures occupying 100% or less of 

the aPAD. Therefore, acute exposure 

and risk from food is well within 

acceptable levels. 

b. Chronic. Chronic dietary exposure 

and risk was estimated with the 

conservative assumptions of 100% crop 

treated and tolerance level residues for 

all crops. The estimate of potential 

chronic exposure and risk is very 

conservative and estimated risk would 

be substantially reduced with further 

refinement to the exposure estimate. 

Even with the conservative assumptions 

used in this analysis, chronic exposure 

is estimated to occupy only 0.2% of the 

RfD for the general U.S. population. 

Chronic dietary exposure is estimated to 

occupy 0.4% of the RfD for non-nursing 

infants, the population subgroup 

estimated to have highest potential 

exposure. Therefore, chronic exposure 

and risk from food is well within 

acceptable levels. 

c. Cancer. Cancer risk was estimated 

based on percent crop treated and 

anticipated residues (AR) as provided in 

EPA’s Reregistration Eligibility Decision 

(RED) for ethalfluralin and EPA’s final 

rule concerning tolerances for residue of 

ethalfluralin in or on canola seed and 

safflower seed (67 FR 2333, January 17, 

2002). Since ethalfluralin residue in 

potatoes was below the LOD, a residue 

of c the LOD or 0.008 ppm was assigned 

to potatoes for use in cancer risk 

assessment. Additionally, this dietary 

risk assessment was based on 40% of 

the U.S. potato crop being treated with 

ethalfluralin. Based on both registered 

and proposed product uses, exposure to 

ethalfluralin from food is estimated to 

not exceed a lifetime cancer risk of 8.47 

x 10-7. Cancer risks of less than 1 x 10-6

are generally considered to be 

negligible. 

ii. Drinking water. There are no 

established maximum contaminant 

levels (MCLs) for residues of 

ethalfluralin in drinking water and 

health advisory levels (HALs) for 

ethalfluralin have not been established. 

EPA has previously used modeling for 

a screening level assessment of potential 

ethalfluralin exposure through drinking 

water. The Agency has used EPA’s 

pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/ 

EXAMS) and screening concentration in 

ground water (SCI-GRO) to provide a 

screening level assessment for surface 

water and ground water, respectively. 

Based on these models EPA has 

indicated the estimated environmental 

concentrations (EECs) for acute 

exposures are 2.3 parts per billion (ppb) 

for surface water and 0.02 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 0.052 ppb 

for surface water and 0.02 ppb for 

ground water. Estimated concentrations 

of a pesticide are compared to a 

Drinking Water level of Comparison 

(DWLOC) as a surrogate estimate of 

exposure and risk. The DWLOC is the 

concentration of a pesticide in drinking 

water that would be acceptable as an 

upper limit in light of total aggregate 

exposure to that pesticide. 

a. Acute. As indicated previously, 

EPA has used surface water and ground 

water EECs of 2.3 ppb and 0.02 ppb, 

respectively, for comparison with the 

DWLOC in an acute assessment. The 

DWLOC for acute exposure in females 

13+ years old was based on an aPAD of 

0.25 mg/kg/day and was calculated to be 

7,500 ppb. Therefore, the acute DWLOC 

for ethalfluralin is over 3,000 fold 

greater than the EEC for surface water or 

ground water, indicating that potential 

acute exposure and risk from drinking 

water is well within acceptable levels. 

b. Chronic. As indicated previously, 

EPA has used surface water and ground 

water EECs of 0.052 ppb and 0.02 ppb, 

respectively, for comparison with the 

DWLOC in a chronic assessment. The 

chronic DWLOC was calculated based 

on a chronic RfD of 0.04 mg/kg/day and 

accounted for potential chronic 

exposure to ethalfluralin through 

residues in food. The chronic DWLOC 

for the general U.S. population and nonnursing infants was calculated to be 

1,400 ppb and 400 ppb, respectively. 

Therefore, chronic DWLOCs are 

substantially greater than estimated 

residue concentration in surface water 

or ground water over a chronic exposure 

period, indicating that chronic exposure 

51802 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 

and risk from drinking water are well 

within acceptable levels. 

c. Cancer. The DWLOC for the cancer 

risk assessment was calculated to be 

0.12 ppb. Surface water and ground 

water EECs of 0.052 ppb and 0.02 ppb, 

respectively, were used for comparison 

with the DWLOC. The EECs are below 

the DWLOC, indicating that the cancer 

risk would generally be considered 

negligible. 

2. Non-dietary exposure. Ethalfluralin 

is not currently registered for use on any 

residential non-food sites, and thus, it is 

not expected that non-occupational, 

non-dietary exposures will occur. 

D. Cumulative Effects 

EPA at this time has not established 

methodologies to resolve the complex 

issues concerning common mechanism 

of toxicity in a meaningful way. 

Although, ethalfluralin is a member of 

the dinitroaniline class of herbicides, 

there is no information available at this 

time to determine whether ethalfluralin 

has a common mechanism of toxicity 

with other substances or how to include 

this pesticide in a cumulative risk 

assessment. Based on the metabolic 

profile, the registrant concludes that 

ethalfluralin does not appear to produce 

a toxic metabolite produced by other 

substances. Therefore, only aggregate 

exposure and risk were considered. 

E. Safety Determination 

1. U.S. population. Using conservative 

exposure assumptions previously 

described, chronic dietary exposure to 

residues of ethalfluralin from current 

and proposed uses was estimated to 

occupy only 0.2% of the RfD for the 

general U.S. population. EPA generally 

has no concern for exposures below 

100% of the RfD since the RfD 

represents the level at or below which 

daily exposure over a lifetime will not 

pose appreciable risks to human health. 

Additionally, the chronic DWLOC was 

found to be substantially greater than 

EECs for ethalfluralin in surface water 

or ground water, indicating risk is well 

within acceptable levels. Cancer risk 

resulting from potential exposure to 

ethalfluralin through food and drinking 

water was estimated. Cancer risk from 

potential dietary and drinking water 

exposure for the general U.S. population 

was found to be within a range that EPA 

has generally considered negligible. 

Thus, based on the completeness and 

reliability of the toxicity data and the 

conservative exposure assessment, it is 

concluded that, there is a reasonable 

certainty that no harm will result to the 

general U.S. population from aggregate 

exposure to ethalfluralin residues from 

current and proposed uses. 

2. Infants and children. Risk for 

developmental toxicity from acute 

exposure to ethalfluralin was evaluated 

for females 13+ years old. As indicated 

in the previous discussion, risk from 

aggregate acute exposure to ethalfluralin 

through food and drinking water is well 

within acceptable levels. It can be 

concluded that there is a reasonable 

certainty that no harm will result for 

both females 13+ years old and for the 

pre-natal development of infants from 

aggregate acute exposure to 

ethalfluralin. 

Chronic aggregate exposure and risk 

was evaluated for non-nursing infants, 

the population subgroup predicted to be 

most highly exposed. As indicated 

previously, risk from aggregate chronic 

exposure through food and drinking 

water is well within acceptable levels. 

Thus, based on the completeness and 

reliability of the toxicity data and the 

conservative exposure assessment, it 

can be concluded with reasonable 

certainty that no harm will result to 

infants and children from chronic 

aggregate exposure to ethalfluralin 

based on current and proposed uses. 

F. International Tolerances 

There are no Codex, Canadian or 

Mexican maximum residue limits 

established for ethalfluralin. 

[FR Doc. 05–17124 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPP–2005–0235; FRL–7733–1] 

Fenarimol; 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–

0235, must be received on or before 

September 30, 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: 

Barbara Madden, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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–

0235. 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