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 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62689

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–2004–0224. 

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–

2004–0224. 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–2004–0224.

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–2004–0224. Such 

deliveries are only accepted during the 

docket’s normal hours of operation as 

identified in Unit I.B.1.

D. How Should I Submit CBI to the 

Agency?

Do not submit information that you 

consider to be CBI electronically 

through EPA’s electronic public docket 

or by e-mail. You may claim 

information that you submit to EPA as 

CBI by marking any part or all of that 

information as CBI (if you submit CBI 

on disk or CD ROM, mark the outside 

of the disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

CBI). Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2.

In addition to one complete version of 

the comment that includes any 

information claimed as CBI, a copy of 

the comment that does not contain the 

information claimed as CBI must be 

submitted for inclusion in the public 

docket and EPA’s electronic public 

docket. If you submit the copy that does 

not contain CBI on disk or CD ROM, 

mark the outside of the disk or CD ROM 

clearly that it does not contain CBI. 

Information not marked as CBI will be 

included in the public docket and EPA’s 

electronic public docket without prior 

notice. If you have any questions about 

CBI or the procedures for claiming CBI, 

please consult the person listed under 

FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare 

My Comments for EPA?

You may find the following 

suggestions helpful for preparing your 

comments:

1. Explain your views as clearly as 

possible.

2. Describe any assumptions that you 

used.

3. Provide copies of any technical 

information and/or data you used that 

support your views.

4. If you estimate potential burden or 

costs, explain how you arrived at the 

estimate that you provide.

5. Provide specific examples to 

illustrate your concerns.

6. Make sure to submit your 

comments by the deadline in this 

notice.

7. To ensure proper receipt by EPA, 

be sure to identify the docket ID number 

assigned to this action in the subject 

line on the first page of your response. 

You may also provide the name, date, 

and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition 

as follows proposing the establishment 

and/or amendment of regulations for 

residues of a certain pesticide chemical 

in or on various food commodities 

under section 408 of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 21 

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

this petition contains data or 

information regarding the elements set 

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

however, EPA has not fully evaluated 

the sufficiency of the submitted data at 

this time or whether the data support 

granting of the petition. Additional data 

may be needed before EPA rules on the 

petition.

List of Subjects

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: October 13, 2004.

Phil Hutton,

Acting Director, Biopesticides and Pollution 

Prevention 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 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 

62690 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

the detection and measurement of the 

pesticide chemical residues or an 

explanation of why no such method is 

needed.

Syngenta Seeds, Inc.

PP 4F6838

EPA has received a pesticide petition 

(PP 4F6838) from Syngenta Seeds, Inc., 

P.O. Box 12257, 3054 Cornwallis Road, 

Research Triangle Park, NC 27709–2257, 

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 174 to establish an 

exemption from the requirement of a 

tolerance for the plant-incorporated 

protectant (modified Cry3A protein and 

the genetic material necessary for its 

production) in corn.

Pursuant to section 408(d)(2)(A)(i) of 

the FFDCA, as amended, Syngenta 

Seeds, Inc. has submitted the following 

summary of information, data, and 

arguments in support of their pesticide 

petition. This summary was prepared by 

Syngenta Seeds, Inc. and EPA has not 

fully evaluated the merits of the 

pesticide petition. The summary may 

have been edited by EPA if the 

terminology used was unclear, the 

summary contained extraneous 

material, or the summary 

unintentionally made the reader 

conclude that the findings reflected 

EPA’s position and not the position of 

the petitioner.

A. Product Name and Proposed Use 

Practices

A modified Cry3A insect control 

protein and the genetic material 

necessary for its production in all corn 

is proposed for use as a plantincorporated protectant active 

ingredient. Production of the modified 

Cry3A protein within corn plants 

confers resistance to damage caused by 

the western corn rootworm and 

northern corn rootworm, which are 

major corn pests in the United States. A 

permanent exemption from tolerances is 

being requested in conjunction with an 

application for commercial FIFRA 

section 3 registration of the active 

ingredient for use in corn.

B. Product Identity/Chemistry

1. Identity of the pesticide and 

corresponding residues A modified 

Cry3A insect control protein is 

produced in transgenic corn plants 

derived from transformation Event 

MIR604. A cry3A gene from Bacillus 

thuringiensis subsp. tenebrionis was 

recreated synthetically to optimize for 

expression in corn. Additional changes 

in this corn-optimized gene were made, 

such that the encoded modified Cry3A 

protein (mCry3A) has enhanced activity 

against larvae of the western corn 

rootworm (Diabrotica virgifera virgifera) 

and northern corn rootworm (D. 

longicornis barberi). Event MIR604-

derived corn plants express the 

synthetic modified cry3A gene, 

introduced via transformation vector 

pZM26, and display resistance to these 

pests. The native Cry3A protein of B. 

thuringiensis subsp. tenebrionis is a ca. 

73 kDa polypeptide of 644 amino acids. 

By comparison, the mCry3A protein 

expressed in Event MIR604 corn is a ca. 

67 kDa polypeptide of 598 amino acids. 

Its amino acid sequence corresponds to 

that of the native Cry3A protein, except 

that (1) its N-terminus corresponds to 

methionine-48 of the native protein and 

(2) a cathepsin G protease recognition 

site has been introduced into the 

protein, conferring markedly enhanced 

commercially exploitable activity 

toward western and northern corn 

rootworms. Residues of the mCry3A 

protein, and/or breakdown products 

thereof, are present in corn grain and 

other tissues of Event MIR604-derived 

plants.

2. Magnitude of residue at the time of 

harvest and method used to determine 

theresidue. A determination of the 

magnitude of residue at harvest is not 

required for residues exempt from 

tolerances. However, the petitioner has 

provided data on the quantity of 

mCry3A protein measured in various 

plant parts. Average mCry3A levels in 

grain from Event MIR604-derived 

hybrid field corn plants were less than 

one part per million (ppm) on a dryweight or fresh-weight basis, as 

measured by ELISA. Average mCry3A 

levels measured in chopped whole 

Event MIR604-derived hybrid corn 

plants were less than or equal to ca. 20 

ppm on a dry-weight basis and less than 

or equal to ca. 8 ppm on a fresh-weight 

basis.

3. A statement of why an analytical 

method for detecting and measuring the 

levels of the pesticide residue are not 

needed. An analytical method is not 

required because this petition requests 

an exemption from tolerances. However, 

the petitioner has submitted an 

analytical method for detection of the 

mCry3A protein by ELISA.

C. Mammalian Toxicological Profile

Syngenta Seeds has provided the 

results of a mammalian toxicology 

study, in vitro digestibility study, heat 

stability study and bioinformatics 

evaluations conducted on the mCry3A 

protein. These studies, summarized 

herein, demonstrate the lack of toxicity 

of the mCry3A protein following acute 

oral high-dose exposure to mice, rapid 

degradation of mCry3A upon exposure 

to simulated mammalian gastric fluid, 

instability of the mCry3A protein upon 

heating, and the lack of significant 

amino acid sequence homology of the 

mCry3A protein to proteins known to be 

mammalian toxins or human allergens.

When proteins are toxic, they are 

known to act via acute mechanisms and 

at very low doses Sjoblad, R.D., J.T. 

McClintock and R. Engler (1992) 

Toxicological considerations for protein 

components of biological pesticide 

products. Regulatory Toxicol. 

Pharmacol. 15: 3–9]. Therefore, when a 

protein demonstrates no acute oral 

toxicity in high-dose testing using a 

standard laboratory mammalian test 

species, this supports the determination 

that the protein will be non-toxic to 

humans and other mammals, and will 

not present a hazard under any realistic 

exposure scenario, including long-term 

exposures. Because it is not feasible to 

extract sufficient mCry3A protein from 

transformed plants for high-dose 

toxicology studies, mCry3A protein was 

produced in recombinant E. coli by over 

expressing the same modified cry3A 

gene that was introduced into Event 

MIR604 corn plants. Following 

purification from E. coli, dialysis and 

lyophilization, the resulting sample, 

designated test substance MCRY3A–

0102, was estimated by ELISA to 

contain ca. 90.3% mCry3A protein by 

weight. Side-by-side comparisons of 

mCry3A in test substance MCRY3A–

0102 with mCry3A extracted from Event 

MIR604-derived corn plants indicated 

that mCry3A from both sources is 

biologically active against the same 

target pest species, has the same 

apparent molecular weight by SDSPAGE, immunoreacts with the same 

anti-Cry3A antibody, and is not 

apparently glycosylated posttranslation. Additionally, peptide 

mapping of ca. 60% of the mCry3A 

polypeptide by mass-spectral analysis 

confirmed the identity and intended 

amino sequence of mCry3A in test 

substance MCRY3A–0102. Nucleotide 

sequencing of the entire DNA insert in 

Event MIR604–derived plants also 

confirmed that the mCry3A protein 

produced in the plants has the exact 

intended amino acid sequence. These 

data justify the use of test substance 

MCRY3A–0102 in safety studies as a 

surrogate for mCry3A as produced in 

Event MIR604-derived plants.

An acute toxicity study was 

conducted in mice according to EPA 

Test Guideline OPPTS 870.1100. Test 

substance MCRY3A–0102 was 

administered orally by gavage to 5 male 

and 5 female mice at a dose of 2632 mg/

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62691

kg body weight, representing ca. 2,377 

mg of pure mCry3A protein/kg body 

weight. A negative control group (5 

males and 5 females) concurrently 

received the dosing vehicle alone, an 

aqueous suspension of 1% 

methylcellulose, at the same dosing 

volume used for the test substance 

mixture. No test substance-related 

mortalities or clinical signs of toxicity 

occurred during the 14–day study. One 

female mouse in the test group was 

euthanized the day following dosing 

due to adverse clinical signs resulting 

from a dosing injury (confirmed by postmortem examination). At study 

termination, macroscopic and 

microscopic examination of all major 

organs of the surviving mice revealed no 

treatment-related abnormalities. Body 

weight, body weight gain and organ 

weights (brain, liver, kidneys and 

spleen) were comparable in the control 

and test groups. There was no evidence 

of toxicity. Accordingly, the LD50 value 

for MCRY3A–0102 in male and female 

mice is greater than 2,632 mg/kg body 

weight, and the LD50 value for pure 

mCry3A protein is greater than 2,377 

mg/kg body weight, the single dose 

tested. 

Extensive bioinformatics searches of 

public protein databases revealed that 

the mCry3A protein shows no 

significant amino acid homology to 

proteins known to be mammalian toxins 

or known or suspected to be human 

allergens. Additional information and 

testing indicate that the mCry3A protein 

does not have properties that would 

suggest it has the potential to become a 

food allergen. The source of native 

Cry3A protein (Bacillus thuringiensis) is 

not known to produce food allergens. 

Unlike allergenic proteins, which 

typically are present at 1–80% of the 

total protein in an offending food, the 

average mCry3A concentration 

measured in raw grain derived from 

Event MIR604 corn represents less than 

0.0001% of the total protein. (This 

calculation is based on corn grain 

containing 10% total protein by weight, 

and assumes less than 1 ppm mCry3A 

in the grain.) Additionally, due to 

degradation via food processing 

methods, mCry3A will not likely be 

present in processed food products, or 

will be present in only trace quantities. 

The mCry3A protein produced in 

transformed corn plants is not targeted 

to a cellular pathway for glycosylation, 

and shows no evidence of posttranslational glycosylation. Bioactivity 

of mCry3A is lost upon heating at 95 C 

for 30 minutes. Upon exposure to 

simulated mammalian gastric fluid 

containing pepsin, mCry3A rapidly 

degrades.

The native Cry3A protein has had a 

history of safe use as a component of 

spore preparations of the microbial 

insecticide B. thuringiensis subsp. 

tenebrionis, as an encapsulated 

component of a microbial insecticide 

derived from B. thuringiensis subsp. San 

Diego, and as a plant-incorporated 

protectant in Bt potato.

The genetic material occurring in the 

subject plant-incorporated protectant 

active ingredient has been adequately 

characterized. This genetic material (i.e., 

the nucleic acids DNA and RNA), 

including regulatory regions, necessary 

for the production of mCry3A in all corn 

will not present a dietary safety 

concern. ‘‘Regulatory regions’’ are the 

DNA sequences such as promoters, 

terminators, and enhancers that control 

the expression of the genetic material 

encoding the protein. Based on the 

ubiquitous occurrence and established 

safety of nucleic acids in the food 

supply, a tolerance exemption under the 

regulations has been established for 

residues of nucleic acids that are part of 

plant-incorporated protectants 40 CFR 

174.475; 66 FR (139): 37817–37830, July 

19, 2001. Therefore, no mammalian 

toxicity is anticipated from dietary 

exposure to the genetic material 

necessary for the production of mCry3A 

protein in all corn.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Average 

mCry3A levels measured in grain from 

Event MIR604–derived hybrid field corn 

plants were less than one part per 

million (ppm) on a dry- or fresh-weight 

basis. Processed corn products or byproducts used in food are unlikely to 

have measurable mCry3A protein, or 

will have only trace amounts. Oral 

exposure is not expected to result in 

adverse health effects, because of a 

demonstrated lack of toxicity to 

mammals and the rapid digestibility of 

the mCry3A protein. It is expected that 

any mCry3A protein consumed will be 

digested as conventional dietary 

protein.

ii. Drinking water. Little to no 

exposure via drinking water is 

anticipated. Due to the demonstrated 

mammalian safety profile of mCry3A, 

such exposure would not present a risk.

2. Non-dietary exposure. Non-dietary 

exposure is not anticipated, due to the 

proposed use pattern of the product. 

Exposure via dermal or inhalation 

routes is unlikely because the active 

ingredient is contained within plant 

cells. However, if exposure were to 

occur by non-dietary routes, no risk 

would be expected because the mCry3A 

protein is not toxic to mammals.

E. Cumulative Exposure

Because there is no indication of 

mammalian toxicity of the mCry3A 

protein or the genetic material necessary 

for its production, it is reasonable to 

conclude, that there will be no 

cumulative effects for this active 

ingredient.

F. Safety Determination

1. U.S. population. The lack of 

mammalian toxicity at high levels of 

exposure to the mCry3A protein 

demonstrates the safety of the product at 

levels well above possible maximum 

exposure levels anticipated via 

consumption of all food commodities 

produced from corn plants that produce 

mCry3A. Moreover, little to no human 

dietary exposure to mCry3A protein is 

expected to occur via transformed corn. 

Due to the digestibility and lack of 

toxicity of the mCry3A protein, and its 

very low potential to become an allergen 

in food, dietary exposure, if it occurred, 

is expected to not pose any harm for the 

U.S. population. No special safety 

provisions are applicable for 

consumption patterns or for any 

population sub-groups.

2. Infants and children. Based on the 

mammalian safety profile of the active 

ingredient and the proposed use pattern, 

there is ample evidence to conclude a 

reasonable certainty of no harm to 

infants and children.

G. Effects on the Immune and Endocrine 

Systems

The active ingredient is derived from 

sources that are not known to exert an 

influence on the endocrine or immune 

systems.

H. Existing Tolerances

The registrant is not aware of any 

existing tolerances or tolerance 

exemptions for mCry3A protein and the 

genetic material necessary for its 

production as an active ingredient. The 

applicant has previously submitted a 

petition (File Symbol 4G6808) for 

temporary exemption from tolerances 

for the same active ingredient 

concurrently with an application for an 

Experimental Use Permit for use of the 

active ingredient in Event MIR604 corn. 

Exemptions from tolerances exist for use 

of the native form of Cry3A protein as 

a plant-incorporated protectant in Bt 

potato (40 CFR 180.1147) and as a 

component of an encapsulated Bacillus 

thuringiensis microbial insecticide (40 

CFR 180.1108).

62692 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

I. International Tolerances

No codex maximum residue levels 

exists for the plant-incorporated 

protectant modified Cry3A protein and 

the genetic material necessary for its 

production in corn.

[FR Doc. 04–23586 Filed 10–26–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–7830–6] 

Florida Petroleum Reprocessors 

Superfund Site; Notice of Proposed 

Settlement

AGENCY: Environmental Protection 

Agency.

ACTION: Notice of proposed de minimis 

settlement. 

SUMMARY: Under Section 122(g)(4) of the 

Comprehensive Environmental 

Response Compensation and Liability 

Act (CERCLA), the Environmental 

Protection Agency has offered a de 

minimis settlement at the Florida 

Petroleum Reprocessors Superfund Site 

(Site) located in Davie, Florida. EPA 

will consider public comments 

November 26, 2004. EPA may withdraw 

from or modify the proposed settlement 

should such comments disclose facts or 

considerations which indicate the 

proposed settlement is inappropriate, 

improper, or inadequate. Copies of the 

proposed settlement are available from: 

Ms. Paula V. Batchelor, U.S. 

Environmental Protection Agency, 

Region 4, Superfund Enforcement and 

Information Management Branch, Waste 

Management Division, 61 Forsyth St., 

SW., Atlanta, Georgia 30303, (404) 562–

8887, email: batchelor.paula@epa.gov.

Written or email comments may be 

submitted to Paula V. Batchelor at the 

above address within 30 days of the date 

of publication.

Dated: October 13, 2004. 

Anita Davis, 

Acting Chief, Superfund Enforcement 

Information & Management Branch, Waste 

Management Division.

[FR Doc. 04–24042 Filed 10–26–04; 8:45 am] 

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS 

COMMISSION 

Notice of Public Information 

Collection(s) Being Reviewed by the 

Federal Communications Commission, 

Comments Requested 

October 19, 2004.

SUMMARY: The Federal Communications 

Commission, as part of its continuing 

effort to reduce paperwork burden 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on the 

following information collection(s), as 

required by the Paperwork Reduction 

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

agency may not conduct or sponsor a 

collection of information unless it 

displays a currently valid control 

number. No person shall be subject to 

any penalty for failing to comply with 

a collection of information subject to the 

Paperwork Reduction Act (PRA) that 

does not display a valid control number. 

Comments are requested concerning (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Commission, including whether the 

information shall have practical utility; 

(b) the accuracy of the Commission’s 

burden estimate; (c) ways to enhance 

the quality, utility and clarity of the 

information collected; and (d) ways to 

minimize the burden of the collection of 

information on the respondents, 

including the use of automated 

collection techniques or other forms of 

information technology.

DATES: Written Paperwork Reduction 

(PRA) comments should be submitted 

on or before December 27, 2004. If you 

anticipate that you will be submitting 

comments, but find it difficult to do so 

within the period of time allowed by 

this notice, you should advise the 

contact listed below as soon as possible.

ADDRESSES: Direct all Paperwork 

Reduction Act (PRA) comments to 

Judith B. Herman, Federal 

Communications Commission, Room 1–

C804, 445 12th Street, SW., Washington, 

DC 20554 or via the Internet to JudithB.Herman@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For 

additional information or copies of the 

information collection(s), contact Judith 

B. Herman at 202–418–0214 or via the 

Internet at Judith-B.Herman@fcc.gov.

SUPPLEMENTARY INFORMATION: 

OMB Control Number: 3060–0600. 

Title: Application to Participate in an 

FCC Auction. 

Form No.: FCC Form 175. 

Type of Review: Revision of a 

currently approved collection. 

Respondents: Business or other forprofit, not-for-profit institutions, and 

state, local or tribal government. 

Number of Respondents: 500. 

Estimated Time per Response: 90 

minutes. 

Frequency of Response: On occasion 

reporting requirement. 

Total Annual Burden: 750 hours. 

Total Annual Cost: None. 

Privacy Act Impact Assessment: Not 

applicable. 

Needs and Uses: The information 

collected on FCC Form 175 will be used 

by the Commission to determine if the 

applicant is legally, technically, and 

financially qualified to participate in an 

FCC auction. In addition, if the 

applicant applies for status as a 

particular type of auction participant 

pursuant to the Commission’s rules, the 

Commission will use the information to 

determine if the applicant is eligible for 

the status requested. The Commission’s 

auction rules and requirements are 

designed to ensure that the competitive 

bidding process is limited to serious 

qualified applicants, to deter possible 

abuse of the bidding and licensing 

process, and to enhance the use of 

competitive bidding to assign 

Commission licenses in furtherance of 

the public interest. Proposed revisions 

to current FCC Form 175 would revise 

the format for collecting information 

and incorporate into FCC Form 175 

information previously collected in 

attachments. The Commission also 

proposes integrating ownership 

information collected in the FCC Form 

175 with ownership information 

collected in other forms in order to 

reduce the need for applicants to file 

duplicative information. The preceding 

estimated time of response reflects the 

incorporation of previously separate 

information collections and is an 

average that will depend in part on 

whether the applicant has previously 

submitted ownership information on 

other integrated forms. The Commission 

plans to use this form for all upcoming 

auctions.

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary.

[FR Doc. 04–24037 Filed 10–26–04; 8:45 am] 

BILLING CODE 6712–01–P