62680 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

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. Offer alternative ways to improve 

the registration activity.

7. Make sure to submit your 

comments by the deadline in this 

notice.

8. 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. Registration Applications

EPA received an application as 

follows to register a pesticide product 

containing an active ingredient not 

included in any previously registered 

product pursuant to the provision of 

section 3(c)(4) of FIFRA. Notice of 

receipt of this application does not 

imply a decision by the Agency on the 

application.

Product Containing an Active Ingredient 

not Included in any Previously 

Registered Product

File Symbol: 67979–L. Applicant: 

Syngenta Seeds, Inc., Field CropsNAFTA, P.O. Box 12257, 3054 

Cornwallis Rd., Research Triangle Park, 

NC 27709–2257. Product Name: Event 

MIR604 Rootworm-Protected Corn. 

Plant-incorporated protectant. Active 

ingredient: Modified Cry3A protein and 

the genetic material necessary for its 

production (via elements of pZM26) in 

Event MIR604 corn SYN-IR604-

8.Proposed classification/Use: None.

List of Subjects

Environmental protection, Pesticides 

and pest.

Dated: October 13, 2004.

Phil Hutton,

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs.

[FR Doc. 04–23691 Filed 10–26–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0273; FRL–7676–1]

BAS 320 I; Notice of Filing a Pesticide 

Petition to Establish a Tolerance for a 

Certain Pesticide Chemical in or on 

Food

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the 

initial filing of a pesticide petition 

proposing the establishment of 

regulations for residues of a certain 

pesticide chemical in or on various food 

commodities.

DATES: Comments, identified by docket 

identification (ID) number OPP–2004–

0273, must be received on or before 

November 26, 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: Ann 

Hanger, Registration Division (7505C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0395; e-mail address: 

hanger.ann@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–

0273. 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 South 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 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62681

system, EPA Dockets. You may use EPA 

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

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

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

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

the appropriate docket ID number.

Certain types of information will not 

be placed in the EPA Dockets. 

Information claimed as CBI and other 

information whose disclosure is 

restricted by statute, which is not 

included in the official public docket, 

will not be available for public viewing 

in EPA’s electronic public docket. EPA’s 

policy is that copyrighted material will 

not be placed in EPA’s electronic public 

docket but will be available only in 

printed, paper form in the official public 

docket. To the extent feasible, publicly 

available docket materials will be made 

available in EPA’s electronic public 

docket. When a document is selected 

from the index list in EPA Dockets, the 

system will identify whether the 

document is available for viewing in 

EPA’s electronic public docket. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Unit I.B. EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket.

For public commenters, it is 

important to note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing in EPA’s electronic public 

docket as EPA receives them and 

without change, unless the comment 

contains copyrighted material, CBI, or 

other information whose disclosure is 

restricted by statute. When EPA 

identifies a comment containing 

copyrighted material, EPA will provide 

a reference to that material in the 

version of the comment that is placed in 

EPA’s electronic public docket. The 

entire printed comment, including the 

copyrighted material, will be available 

in the public docket.

Public comments submitted on 

computer disks that are mailed or 

delivered to the docket will be 

transferred to EPA’s electronic public 

docket. Public comments that are 

mailed or delivered to the docket will be 

scanned and placed in EPA’s electronic 

public docket. Where practical, physical 

objects will be photographed, and the 

photograph will be placed in EPA’s 

electronic public docket along with a 

brief description written by the docket 

staff.

C. How and To Whom Do I Submit 

Comments?

You may submit comments 

electronically, by mail, or through hand 

delivery/courier. To ensure proper 

receipt by EPA, identify the appropriate 

docket ID number in the subject line on 

the first page of your comment. Please 

ensure that your comments are 

submitted within the specified comment 

period. Comments received after the 

close of the comment period will be 

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

consider these late comments. If you 

wish to submit CBI or information that 

is otherwise protected by statute, please 

follow the instructions in Unit I.D. Do 

not use EPA Dockets or e-mail to submit 

CBI or information protected by statute.

1. Electronically. If you submit an 

electronic comment as prescribed in this 

unit, EPA recommends that you include 

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

information in the body of your 

comment. Also include this contact 

information on the outside of any disk 

or CD ROM you submit, and in any 

cover letter accompanying the disk or 

CD ROM. This ensures that you can be 

identified as the submitter of the 

comment and allows EPA to contact you 

in case EPA cannot read your comment 

due to technical difficulties or needs 

further information on the substance of 

your comment. EPA’s policy is that EPA 

will not edit your comment, and any 

identifying or contact information 

provided in the body of a comment will 

be included as part of the comment that 

is placed in the official public docket, 

and made available in EPA’s electronic 

public docket. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment.

i. EPA Dockets. Your use of EPA’s 

electronic public docket to submit 

comments to EPA electronically is 

EPA’s preferred method for receiving 

comments. Go directly to EPA Dockets 

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–2004–0273. 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–

2004–0273. 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–2004–0273.

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 South Bell 

St., Arlington, VA, Attention: Docket ID 

Number OPP–2004–0273. 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 

62682 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

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: October 19, 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.

BASF Corporation

Pesticide Petition 4F6839

EPA has received a pesticide petition 

(PP 4F6839) from BASF Corporation, 

P.O. Box 13528, Research Triangle Park, 

NC 27709 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 a tolerance for 

residues of BAS 320 I, a mixture 

comprising 4-{(2E)-2-({[4-

(trifluoromethoxy)anilino] carbonyl}

hydrazono)-2-[3-

(trifluoromethyl)phenyl]ethyl}

benzonitrile and 4-{(2Z)-2-({[4-

(trifluoromethoxy)anilino] carbonyl}

hydrazono)-2-[3-(trifluoromethyl) 

phenyl]ethyl} benzonitrile in or on the 

raw agricultural commodity tuberous 

and corm vegetables (crop subgroup 1–

C) at 0.05 parts per million (ppm), leafy 

vegetables (crop group 4) at 35 ppm, 

head and stem brassica (crop subgroup 

5–A) at 5 ppm, leafy brassica greens 

(crop subgroup 5–B) at 25 ppm, fruiting 

vegetables (crop group 8) at 1.0 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. In three plant 

metabolism studies (cabbage, tomato 

and cotton), the major component of the 

residue was BAS 320 I (E- and Zisomers). The major degradate was the 

ketone, M320I04 and an oxidized and 

cyclized metabolite, M320I23, was 

present in lesser amounts. These four 

compounds were defined as the 

residues of concern and were 

incorporated into an analytical method. 

In the confined rotational crop studies 

plant uptake was very limited and the 

residues were a mixture of minor and 

polar components.

2. Analytical method. BASF 

Analytical Method No. 531/0 was 

developed to determine residues of BAS 

320 I (E- and Z-Isomer) and its 

metabolites M320I04 and M320I23, the 

residues of concern in plants, in crop 

matrices. In this method, residues of 

BAS 320 I are extracted from plant 

matrices with methanol/water (70:30; v/

v) and then partitioned into 

dichloromethane. For oily matrices, the 

residues are extracted with a mixture of 

isohexane/acetonitrile (1:1; v/v). The 

final determination of BAS 320I and its 

metabolites is performed by LC/MS/MS.

3. Magnitude of residues. Field trials 

were carried out in order to determine 

the magnitude of residue in the 

following crops: Broccoli, cabbage, 

celery, head lettuce, leaf lettuce, 

mustard greens, pepper (bell and nonbell), potato, spinach, and tomato. Field 

trials were conducted in the required 

regions. Field trials were carried out 

using the maximum label rate, the 

maximum number of applications and 

the minimum preharvest interval. In 

addition, processing studies were 

conducted on potatoes and tomatoes to 

determine the concentration factor 

during normal processing of the raw 

agricultural commodities. No animal 

feeding studies were conducted.

B. Toxicological Profile

1. Acute toxicity. Based on the 

available acute toxicity data BAS 320 I 

and its formulated product do not pose 

acute toxicity risks.

FOR TECHNICAL BAS 320 I:

Oral LD50 Rat Lethal dose 50 (LD50 > 5,000 milligrams/kilogram body weight 

(mg/kg b.w.)

Category IV

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62683

FOR TECHNICAL BAS 320 I:—Continued

Oral LD50 Mouse LD50 > 5,000 mg/kg b.w. Category IV

Dermal LD50 Rat LD50 > 5,000 mg/kg b.w. Category IV

Inhalation LC50 Rat >5.2 mg/liters (L) Category IV

Eye irritation Rabbit Not irritating Category IV

Skin irritation Rabbit Not irritating Category IV

Skin sensitization (Maximization 

test)

Guinea pig Not sensitizing

FOR THE BAS 320 00 I SC FORMULATION:

Oral LD50 Rat LD50> 2,000 mg/kg b.w. Category III

Dermal LD50 Rat LD50> 4,000 mg/kg b.w. Category III

Inhalation LC50 Rat >5.2 mg/L Category IV

Eye irritation Rabbit Slightly irritating Category III

Skin irritation Rabbit Not irritating Category IV

Skin sensitization (Modified Buehler 

Method)

Guinea pig Not sensitizing

2. Genotoxicty. In a battery of three in 

vitro and two in vivo mutagenicity 

assays consisting of all required endpoints (point mutation, chromosomal 

damage, and DNA damage and repair), 

the weight of the evidence for BAS 320 

I indicates a lack of potential 

genotoxicity.

Specifically, for the battery of three in 

vitro mutagenicity assays with BAS 320 

I, no positive responses were observed 

for increased revertant frequencies with 

and without metabolic activation 

bacterial reverse mutation assay or for 

increased mutant frequencies with and 

without metabolic activation 

Hypoxanthine guanine phophoribosyl 

transferase (HGPRT) locus assay. 

Although there was a positive result for 

a statistically increased number of 

structurally aberrant metaphases in the 

chromosomes, which indicates 

clastogenic potential under in vitro

conditions, this result was only 

observed without metabolic activation 

cytogenicity study with V79 cells.

Importantly, the potential biological 

significance of this apparent 

chromosome damage observed in vitro

only without metabolic activation, was 

evaluated in vivo using the mouse 

micronucleus assay. Testing in the in 

vivo micronucleus study with NMRI 

mice was conducted at a high dose level 

(2,000 mg/kg b.w.) that demonstrated 

clinical symptoms of toxicity, including 

piloerection and poor general state, in 5 

of 5 animals. No significant or doserelated increases in chromosomal 

damage were observed in this in vivo

test, indicating that BAS 320 I does not 

cause chromosomal aberrations in intact 

animals.

Moreover, it has also been recognized 

by EPA that more weight should be 

placed on in vivo systems than in vitro

systems as expressed in the Agency’s 

weight of evidence for genotoxic 

evaluation of a chemical included in the 

‘‘Guidelines for Mutagenicity Risk 

Assessment’’ (Federal Register, 

September 24, 1986, Vol. 51: 34006–

34012). Thus, the negative in vivo

results (non-clastogenicity for 

chromosomal aberrations) observed in 

the mouse micronucleus assay and the 

rat hepatocytes assay, should override 

the positive results obtained in the in 

vitro assay only without metabolic 

activation. Furthermore, it has been 

noted that in vitro systems may simulate 

abnormal physiological conditions from 

prolonged exposure to a chemical in the 

absence of S–9 metabolic activation 

(Brusick, D.J. (editor) 1987. Genotoxicity 

Produced in Cultured Mammalian Cell 

Assay by Treatment Conditions.

Mutation Research, Vol. 189, No.1: 1–69 

and Sofuni, T. 1993. Japanese 

Guidelines for Mutagenicity Testing.

Environmental and Molecular 

Mutagenesis, Vol. 21, No.1: 2–7). 

Consequently, based on the weight of 

the evidence presented above, BAS 320 

I does not pose a genotoxic concern.

3. Reproductive and developmental 

toxicity. Potential reproductive toxicity 

of BAS 320 I was investigated in a 2–

generation reproduction toxicity study 

in Wistar rats by oral gavage 

administration. Originally, the highest 

dose tested (HDT) by oral gavage was 75 

mg/kg b.w./day, which induced both 

excessive maternal toxicity (very high 

incidences of poor general health in 

females during premating, gestation, 

and lactation; and statistically decreased 

food consumption, body weights, and 

body weight gain) as well as excessive 

developmental toxicity (statistically 

impaired pup body weights and body 

weight gain), which altogether resulted 

in high pup mortality. Consequently, a 

meaningful assessment of the potential 

reproductive toxicity of the test 

compound at this excessively toxic dose 

level was not possible. Thereafter, for 

the next two successive parental 

generations of rats, which were 

originally derived from the parents 

treated at 75 mg/kg b.w./day, the HDT 

was 50 mg/kg b.w./day.

Subsequently, the no observable 

adverse effect level (NOAEL) for 

parental toxicity was 20 mg/kg b.w./day, 

based on the following effects for 

females at 50 mg/kg b.w./day (HDT for 

two consecutive generations) –

62684 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

increased incidences of poor general 

health in females during premating, 

gestation, and lactation; 3 of 25 dams 

with complete litter losses; and 

statistically significantly reduced body 

weights during premating, gestation, 

and lactation.

The NOAEL for offspring/pup toxicity 

was 20 mg/kg b.w./day, based on a 

slight increased incidence of pup 

mortality at 50 mg/kg b.w./day. Whereas 

the NOAEL for fertility in this study was 

50 mg/kg b.w./day (HDT for two 

generations), the NOAEL for 

reproductive performance was 

considered to be 20 mg/kg b.w./day, 

based on 3 of 25 dams with complete 

litter losses, of which 2 of these 3 dams 

had indications of poor nursing for their 

first generation of pups. It is noteworthy 

that because most of the pup mortality 

was due to poor nursing in only 2 of 25 

dams, this finding may be considered to 

be incidental. Importantly, no 

comparable impairment of reproductive 

performance occurred for the 

succeeding parental generation treated 

by oral gavage administration at 50 mg/

kg b.w./day.

In a developmental (teratology) 

toxicity study in the Wistar rat, the 

results indicated that the NOAEL for 

maternal toxicity was 40 mg/kg b.w./

day, based on statistically decreased 

food consumption and body weight 

gains at 120 mg/kg b.w./day (HDT). The 

NOAEL for fetal (prenatal)/

developmental toxicity was 120 mg/kg 

b.w./day (HDT). In addition, there were 

no indications of any teratogenic effects 

in the rat fetuses at 120 mg/kg b.w./day 

(HDT). Therefore, BAS 320 I is 

considered to be neither a 

developmental toxicant nor a 

teratogenic agent in the rat.

In a developmental (teratology) 

toxicity study in the Himalayan rabbit, 

the results indicated that the NOAEL for 

maternal toxicity was 100 mg/kg b.w./

day, based on several clinical symptoms 

of toxicity (including ataxia and poor 

general state) occurring in 4 of 25 does 

at 300 mg/kg b.w./day, for which 2 of 

these 4 does had abortions prior to being 

sacrificed early, with a third doe at 300 

mg/kg b.w./day being sacrificed 

moribund. Similarly, the NOAEL for 

fetal (prenatal)/developmental toxicity 

was 100 mg/kg b.w./day, based on 

slightly decreased mean fetal body 

weights as well as an increased rate for 

a certain skeletal variation, namely 

incomplete ossification of sternabrae. 

Because developmental toxicity was 

only observed at dose levels that were 

maternally toxic, BAS 320 I is not 

selectively toxic to the fetal rabbit.

Lastly, in this rabbit developmental 

toxicity study, there were no indications 

of any teratogenic effects in the rabbit 

fetuses at 300 mg/kg b.w./day (HDT). 

Therefore, BAS 320 I is not teratogenic 

in the rabbit.

4. Subchronic toxicity. In the SpragueDawley rat, treatment by oral gavage 

with BAS 320 I for a subchronic 

duration (90–day timepoint in the 

chronic toxicity/carcinogenicity study) 

resulted in reduced food consumption 

and/or decreased mean body weight 

and/or body weight gains in males and 

females at 300 mg/kg b.w./day and in 

increased incidences of hepatocellular 

centrilobular hypertrophy in the livers 

of males at 300 mg/kg b.w./day. Under 

the conditions of the study, the NOAEL 

for oral administration of BAS 320 I for 

90 days was 60 mg/kg b.w./day.

In the beagle dog, treatment by oral 

gavage with BAS 320 I for a subchronic 

duration (90–day timepoint in the 

chronic toxicity study) resulted in 

reduced body weight gain and/or 

decreased food consumption in several 

dogs at 30 mg/kg b.w./day and slightly 

decreased mean cell hemoglobin 

concentration (MCHC) at 30 mg/kg b.w./

day. Under the conditions of the study, 

the NOAEL for oral administration of 

BAS 320 I for 90 days was 12 mg/kg 

b.w./day.

Lastly, in a subchronic (90–day) 

dermal toxicity study conducted with 

BAS 320 I technical in Wistar rats, the 

results support a NOAEL of 100 mg/kg 

b.w./day, based on decreased food 

consumption (females) and decreased 

body weight change in males and 

females at 300 mg/kg b.w./day, the next 

HDT.

5. Chronic toxicity. In the SpragueDawley rat, treatment by oral gavage 

with BAS 320 I for a 2–year chronic 

duration resulted in dose-related 

increased incidences of hepatocellular 

centrilobular hypertrophy in the livers 

of males and females at 60 mg/kg b.w./

day and at 300/200 mg/kg b.w./day and 

hepatocellular basophilic alteration in 

males at 60 and 300 mg/kg b.w./day. 

(Note: Beginning the first day of Week 

3, the dose level of the high-dose 

females was lowered from 300 to 200 

mg/kg b.w./day, due to an adverse effect 

of –71% decreased body weight gain as 

compared to controls.)

Therefore, the NOAEL for systemic 

toxicity following oral administration of 

BAS 320 I for 24 months to SpragueDawley rats was 30 mg/kg b.w./day for 

males and females. Importantly, 

treatment with BAS 320 I to rats for 2 

years resulted in no test substancerelated neoplastic findings, and 

therefore, the NOAEL for oncogenicity 

was 300/200 mg/kg b.w./day (HDT).

In the CD–1 mouse, treatment by oral 

gavage with BAS 320 I for an 18–month 

chronic duration resulted in a 

treatment-related increased incidence of 

increased brown pigment in the spleens 

of male and female animals 

administered 1,000 mg/kg b.w./day 

(HDT), as compared to controls. Under 

the conditions of the study, the NOAEL 

for systemic toxicity following oral 

administration of BAS 320 I for 18 

months to CD–1 mice was 250 mg/kg 

b.w./day (the next HDT) for males and 

females. Importantly, treatment with 

BAS 320 I to mice for 18 months 

resulted in no test substance-related 

neoplastic findings, and therefore, the 

NOAEL for oncogenicity was 1,000 mg/

kg b.w./day (HDT).

In the beagle dog, treatment via 

gelatin capsules with BAS 320 I for a 

12–month chronic duration resulted in 

reduced body weight gain and/or 

decreased food consumption in several 

dogs at 30 mg/kg b.w./day and slightly 

decreased mean MCHC at 30 mg/kg 

b.w./day. Under the conditions of the 

study, the NOAEL for oral 

administration of BAS 320 I for 12 

months was 12 mg/kg b.w./day.

i. Threshold effect. For estimated 

chronic exposure, the calculation of the 

chronic reference dose (chronic RfD) is 

based on the results of the chronic 

toxicity studies in the rat, mouse, and 

dog, and the two–generation 

reproduction study in the rat. For BAS 

320 I, the lowest NOAEL for chronic 

toxic effects is 12 mg/kg b.w./day from 

the 12–month dog study. A safety factor 

of 100 is applied to the NOAEL of 12 

mg/kg b.w./day, which results in a 

chronic RfD of 0.12 mg/kg b.w./day.

ii. Non threshold effect. Since there 

were no test substance-related 

neoplastic findings following long-term 

treatment with BAS 320 I to mice for 18 

months or to rats for 24 months, the 

NOAEL for oncogenicity in both studies 

was established at the respective HDT. 

Therefore, BAS 320 I should be 

classified as ‘‘not likely to be a human 

carcinogen.’’

6. Animal metabolism. In the rat and 

goat metabolism studies, the majority of 

the dose was rapidly excreted in the 

feces. The low levels that were absorbed 

were distributed throughout various 

tissues. BAS 320 I was the major 

component of the extractable residues in 

all tissues and milk and is the only 

residue of concern. Metabolism of BAS 

320 I occurs by hydroxylation and 

conjugation on either of the phenyl 

rings or at the ethylene bridge and are 

the major routes of detoxification. 

Cleavage of the semicarbazide bond to 

yield M320I04 also occurs, usually with 

accompanying conjugation. The only 

residue of concern is BAS 320 I.

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62685

7. Metabolite toxicology. Toxicity of 

the metabolites of BAS 320 I with 

potential exposure to humans was 

concurrently evaluated during toxicity 

testing of the parent except for the 

metabolite M320I23 that was not 

observed in the rat metabolism study. 

The Z-isomer (M320I02) of BAS 320 I 

was evaluated in additional toxicity 

tests to confirm no differences between 

the minor Z-isomer component and BAS 

320 I technical with a 9 to 1 E-isomer 

to Z-isomer ratio, respectively. The 

results show no toxicological concerns:

i. Toxicity studies with the metabolite 

M320I23.

• Acute toxicity study with metabolite 

M 320I023

•The metabolite M 320I023 of BAS 

320 I technical demonstrates low acute 

toxicity via the oral route of exposure in 

the rat.

• Oral LD50 > 2,000 mg/kg b.w. 

(category III).

ii. Subchronic toxicity study with 

metabolite M 320I023.

In the Sprague-Dawley rat, treatment 

by oral gavage with metabolite M 

320I023 of BAS 320 I technical for a 

subchronic (90–day) duration resulted 

in systemic toxicity effects of increased 

relative liver weights (females) and 

increased incidences of liver 

hepatocellular centrilobular 

hypertrophy in males and females at 

1,000 mg/kg b.w./day (HDT), as 

compared to controls. Under the 

conditions of the study, the NOAEL for 

oral administration of the metabolite M 

320I023 of BAS 320 I for 90 days was 

200 mg/kg b.w./day (next HDT) in males 

and females.

iii. Mutagenicity/Genotoxicity studies 

with metabolite M 320I023.

In a battery of three in vitro and one 

in vivo mutagenicity assays consisting of 

all required end-points (point mutation, 

chromosomal damage, and DNA damage 

and repair), the weight of the evidence 

for the metabolite M 320I023 (parent 

ketone) of BAS 320 I technical indicates 

a lack of potential genotoxicity.

Specifically, for the battery of three in 

vitro mutagenicity assays with 

metabolite M 320I023 of BAS 320 I 

technical, no positive responses were 

observed for increased revertant 

frequencies with and without metabolic 

activation bacterial reverse mutation 

assay or for increased mutant 

frequencies with and without metabolic 

activation HGPRT locus assay. Although 

there was a positive result for a 

statistically increased number of 

structurally aberrant metaphases in the 

chromosomes, which indicates 

clastogenic potential under in vitro

conditions, this result was only 

observed with metabolic activation 

cytogenicity study with V79 cells.

Importantly, the potential biological 

significance of this apparent 

chromosome damage observed in vitro

only with metabolic activation, was 

evaluated in vivo using the mouse 

micronucleus assay. Testing in this in 

vivo micronucleus study with NMRI 

mice was conducted at a high dose level 

(2,000 mg/kg b.w.), that demonstrated 

no clinical symptoms of toxicity but 

which represents the limit dose for this 

assay. No significant or dose-related 

increases in in vivo chromosomal 

damage were observed, indicating that 

the metabolite M 320I023 of BAS 320 I 

technical does not cause chromosomal 

aberrations in intact animals.

Moreover, it has also been recognized 

by U.S. EPA that more weight should be 

placed on in vivo systems than in vitro

systems as expressed in the Agency’s 

weight of evidence for genotoxic 

evaluation of a chemical included in the 

‘‘Guidelines for Mutagenicity Risk 

Assessment’’ (Federal Register, 

September 24, 1986, Vol. 51: 34006–

34012). Thus, the negative in vivo

results (non-clastogenicity for 

chromosomal aberrations) observed in 

the mouse micronucleus assay should 

override the positive results obtained in 

the in vitro assay only with metabolic 

activation. Furthermore, it has been 

noted that in vitro systems may simulate 

abnormal physiological conditions 

(Brusick, D.J. (editor) 1987. Genotoxicity 

Produced in Cultured Mammalian Cell 

Assay by Treatment Conditions. 

Mutation Research, Vol. 189, No.1: 1–

69). Additionally, it has been reported 

in the literature that S–9 metabolic 

activation does not often have adequate 

cofactors for activating detoxifying 

mechanisms found in the whole animal 

system Ashby, J. 1983. The Unique Role 

of Rodents in The Detection of Possible 

Human Carcinogens and Mutagens. 

Mutation Research, Vol. 115: 117–213 

Galloway, S.M. 1994. Chromosome 

Aberrations Induced In Vitro: 

Mechanisms. Delayed Expression, and 

Intriguing Questions. Environmental 

and Molecular Mutagenesis, Vol. 23, 

Supplement 24: 44–53. Consequently, 

based on the weight of the evidence 

presented above, the metabolite M 

320I023 of BAS 320 I technical does not 

pose a genotoxic concern.

Therefore, as indicated from the 

results of the mammalian toxicity 

studies as well as the mutagenicity 

assays, metabolite M 320I023 of BAS 

320 I does not demonstrate more 

adverse toxicity when compared to the 

BAS 320 I.

iv. Toxicity studies with the Z-Isomer 

of technical BAS 320 I.

• Acute toxicity study with Z-Isomer. 

The Z-isomer of BAS 320 I technical 

demonstrates low acute toxicity via the 

oral route of exposure in the rat.

• Oral LD50 > 5,000 mg/kg b.w. 

(category IV).

v. Subchronic toxicity study with ZIsomer. In the Sprague-Dawley rat, 

treatment by oral gavage with the Zisomer of BAS 320 I for a subchronic 

(90–day) duration resulted in impaired 

body weight gain only in females at the 

mid-dose (300 mg/kg b.w./day) and the 

high-dose (1,000 mg/kg b.w./day), as 

compared to controls. Several 

microscopic changes were observed in 

female animals at these two dose levels, 

but all morphologic changes were 

regarded to be indirect effects of the 

impaired body weight gain. Under the 

conditions of the study, the NOAEL for 

oral administration of the Z-isomer of 

BAS 320 I for 90 days was 1,000 mg/kg 

b.w./day (HDT) in males and 100 mg/kg 

b.w./day (lowest dose tested) in females.

vi. Mutagenicity/Genotoxicity study 

with Z-Isomer. In an in vitro

mutagenicity assay with the Z-isomer of 

BAS 320 I, there were no positive 

responses observed for increased 

revertant frequencies with and without 

metabolic activation bacterial reverse 

mutation assay.

Therefore, as indicated from the 

results of the mammalian toxicity 

studies as well as the mutagenicity 

assay, the minor isomer of BAS 320 I, 

namely the Z isomer, does not 

demonstrate more adverse toxicity when 

compared to BAS 320 I. 8. Endocrine 

disruption. Data from the reproduction 

/ developmental toxicity and short- and 

long-term repeated dose toxicity studies 

with BAS 320 I in the rat, rabbit, mouse, 

or dog, do not suggest any endocrine 

disruption activity. This information is 

based on the absence of any treatmentrelated effects from the 

histopathological examination of 

reproductive organs as well as a low 

level of concern for possible effects on 

fertility, reproductive performance, or 

any other aspect of reproductive 

function, or on growth and development 

of the offspring.

C. Aggregate Exposure

1. Dietary exposure—i. Food.

Assessments were conducted to 

evaluate the potential risk due to acute 

and chronic dietary exposure of the U.S. 

population to residues of BAS 320 I. 

This insecticide and its metabolites 

(M320I04, M320I23) were expressed as 

the parent compound (BAS 320 I). The 

dietary analysis was conducted on all 

proposed crops which include potatoes, 

sweet potatoes, yams, leafy greens 

subgroup, leaf petioles subgroup, head & 

62686 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

stem brassica subroup, leafy brassica 

greens subgroup, and fruiting vegetables 

except cucurbits.

Secondary residues from meat, milk, 

and eggs were not included in this 

assessment since the proposed crops are 

only considered for human 

consumption with the exception of 

processed potato commodities being 

potentially utilized in animal feed. 

Animal feeding studies were not 

required on potatoes based on results of 

residues of BAS 320 I and its 

metabolites (M320I04 and M320I23) in 

unwashed potatoes. Following an 

application rate 18 times the proposed 

seasonal rate, residues in potatoes were 

at or below the limit of quantitation 

(LOQ) and thus the proposed tolerance 

level was set at the LOQ and no feeding 

studies were needed.

The acute and chronic dietary 

exposure estimates were based on the 

proposed tolerance values, 100 percent 

crop treated values, concentration/

processing factors and consumption 

data from the USDA Continuing Survey 

of Food Intake by Individuals (CSFII 

1994 – 1996, 1998) and the EPA Food 

Commodity Ingredient Database (FCID) 

using Exponent’s Dietary Exposure 

Evaluation Module (DEEM-FCID) 

software. Result exposure estimates 

were compared against the BAS 320 I 

acute Population Adjusted Dose (aPAD) 

and chronic Population Adjusted Dose 

(cPAD) of 20 mg/kg b.w./day and 0.12 

mg/kg b.w./day, respectively. Exposure 

estimates for the BAS 320 I acute dietary 

assessment were well under 100% of 

the aPAD at the 99.9th percentile (see 

table below). The overall U.S. 

population and the highest exposed 

subpopulation (all infants) used only 

1.16% and 3.26% of the aPAD, 

respectively. Additional refinements 

including the use of anticipated 

residues and predicted percent crop 

treated would further reduce the acute 

exposure estimates.

ACUTE DIETARY EXPOSURE ESTIMATES

FOR BAS 320 I

Population 

Subgroups 

Exposure 

Estimate 

(mg/kg 

b.w./day) 

%aPAD1

U.S. population 0.231788 1.16

All infants 0.651674 3.26

1–2 years 0.607989 3.04

3–5 years 0.424105 2.12

1–6 years 0.444105 2.22

6–12 years 0.269403 1.35

13–19 years 0.153397 0.77

Females 13–49 

years

0.212264 1.06

Adults 20–49 

years

0.210816 1.05

Males 20+ 

years

0.190737 0.95

Adults 50+ 

years

0.183849 0.92

1 99.9th percentile

Results of the chronic dietary 

assessments are listed in the table 

below. The estimated chronic dietary 

exposure was less than 14.5% of the 

cPAD for all subpopulations. Additional 

refinements such as the use of 

anticipated residues and predicted 

percent crop treated would further 

reduce the estimated chronic dietary 

exposure.

CHRONIC DIETARY EXPOSURE

ESTIMATES FOR BAS 320 I

Population subgroups 

Exposure 

Estimate 

(mg/kg 

b.w./day) 

%cPAD 

U.S. population 0.014905 12.4

All infants 0.007363 6.1

1–2 years 0.016032 13.4

3–5 years 0.016745 14.0

1–6 years 0.016241 13.5

6–12 years 0.014179 11.8

13–19 years 0.012417 10.3

Females 13–49 

years

0.015466 12.9

Adults 20–49 

years

0.015226 12.7

Males 20+ 

years

0.014347 12.0

Adults 50+ 

years

0.015557 13.0

ii. Drinking water. Drinking water 

level of comparison (DWLOC) 

calculation and comparison to surface 

water and ground water estimations are 

given in the tables below. The expected 

environmental concentrations (EEC) for 

both ground water and surface water are 

well below the allowable level.

ESTIMATED ACUTE DRINKING WATER VALUES FOR BAS 320 I

DWLOC acute Adult Males (20–49 years) Adult Females (13–49 

years) Children (1–6 years) Children (birth to 1 year) 

DWLOC acute (μg/L) 696138.8 596355.81 197403.28 196273.27

DEC’s 

PRZM/EXAMS (BASF) 

Surface water (μg/L)

0.85 0.85 0.85 0.85

Sci-Grow (BASF) 

Ground water (μg/L)

0.006 0.006 0.006 0.006

ESTIMATED CHRONIC DRINKING WATER VALUES FOR BAS 320 I

DWLOC chronic Adult Males (20–49 years) Adult Females (13–49 

years) Children (1–6 years) Children (birth to 1 year) 

DWLOC chronic (μg/L) 3904.9150 3329.5500 1101.1200 1156.8500

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62687

ESTIMATED CHRONIC DRINKING WATER VALUES FOR BAS 320 I—Continued

DWLOC chronic Adult Males (20–49 years) Adult Females (13–49 

years) Children (1–6 years) Children (birth to 1 year) 

DEC’s 

PRZM/EXAMS (BASF) 

Surface water (μg/L)

0.04 0.04 0.04 0.04

Sci-Grow (BASF) 

Ground water (μg/L)

0.006 0.006 0.006 0.006

iii. Aggregate exposure (Diet + Water).

The acute and chronic aggregate 

exposure of BAS 320 I residues is 

summarized in the table below.

ESTIMATED AGGREGATE EXPOSURE OF BAS 320 I RESIDUES FROM FOOD AND WATER

Exposure Infants (0–1 year) Children (1–6 years) Males (20–49 years) Females (13–49 

years) 

FOOD1

Acute exposure (mg/kg b.w./day) 0.651674 0.444105 0.190737 0.212264

Chronic Exposure (mg/kg b.w./day) 0.007363 0.016241 0.014347 0.015466

%aPAD 3.26 2.22 0.95 1.06

%cPAD 6.14 13.5 12.0 12.9

WATER 

Acute exposure (mg/kg b.w./day) 0.000085 0.000057 0.000024 0.000027

Chronic exposure (mg/kg b.w./day) 0.00000400 0.000003 0.000001 0.000001

%aPAD 0.0004 0.0003 0.0001 0.0001

%cPAD 0.0033 0.0022 0.0010 0.0011

AGGREGATE 

Acute exposure (mg/kg b.w./day) 0.651759 0.444162 0.190761 0.212291

Chronic exposure (mg/kg b.w./day) 0.007367 0.016244 0.014348 0.015467

%aPAD 3.26 2.22 0.95 1.06

%cPAD 6.14 13.5 12.0 12.9

1 99.9th percentile

These results indicate the aggregate 

exposure of BAS 320 I from potential 

residues in food and water, will not 

exceed the U.S. EPA’s level of concern 

(100% of PAD). The percent acute and 

chronic PAD were < 4 and 14% for all 

subpopulations, respectively. Overall, 

considering a ‘‘worst-case’’ scenario, we 

can conclude with reasonable certainty 

that no harm will occur from either 

acute or chronic aggregate exposure of 

BAS 320 I residues from the proposed 

uses.

D. Cumulative Effects

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

when considering whether to establish, 

modify, or revoke a tolerance, the 

Agency consider ‘‘available 

information’’ concerning the cumulative 

effects of a particular pesticide’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’

The EPA is currently developing 

methodology to perform cumulative risk 

assessments. At this time, there is no 

available data to determine whether 

BAS 320 I has a common mechanism of 

toxicity with other substances or how to 

include this pesticide in a cumulative 

risk assessment

E. Safety Determination

1. U.S. population. Using the 

conservative exposure assumptions 

described above and based on the 

completeness and the reliability of the 

toxicity data, BASF has estimated the 

aggregate exposure to BAS 320 I will 

utilize less than 2% and 14% of the 

aPAD and cPAD for the U.S. population, 

respectively. For the highest exposed 

age-related subpopulation the maximum 

aggregate exposure is predicted to be 

less than 3.5% of the aPAD (infants) and 

15% of the cPAD (3–5 years).

2. Infants and children. All 

subpopulations based on age were 

considered. Infants and children 

remained below 3.5 and 15% of the 

aggregate aPAD and cPAD for food and 

water, respectively. BASF, considering a 

worst-case situation, concludes with 

reasonable certainty that no harm will 

result to infants or children from 

aggregate exposure to BAS 320 I 

residues.

No additional FQPA safety factor(s) 

are considered to be appropriate for 

BAS 320 I, for the following reasons: 

There is a complete toxicity database for 

BAS 320 I and the exposure data are 

complete or are estimated based on data 

that reasonably accounts for potential 

exposures. There is no evidence of 

susceptibility following in utero 

exposure to rats and there is a low level 

of concern for any uncertainties in the 

developmental toxicity study in rabbits 

or the 2–generation reproduction study, 

62688 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment. Based on these 

data and conclusions, a FQPA safety 

factor of 1X appears to be appropriate 

for BAS 320 I.

F. International Tolerances

No Maximum residue levels (MRLs) 

have been established for BAS 320 I by 

the Codex Alimentarius Commision 

(CODEX) or in Canada and Mexico.

[FR Doc. 04–24039 Filed 10–26–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

[OPP–2004–0224; FRL–7370–1]

Modified Cry3A Protein mCry3A and 

the Genetic Material Necessary for its 

Production in Corn; 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, entified by docket 

identification (ID) number OPP–2004–

0224, must be received on or before 

November 26, 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:

Mike Mendelsohn, Biopesticides and 

Pollution Prevention Division (7511C), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8715; e-mail address: 

mendelsohn.mike@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–

0224. 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 South 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