49224 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices

entry for this document under ‘‘Rules

and Regulations’’ (http://www.epa.gov/

fedrgstr/).

EPA issued a notice, published in the

Federal Register of September 27, 1995

(60 FR 49838; FRL–4971–4), which

announced that Kaken Pharmaceutical

Co., Ltd. Agrochemical and Animal

Health Products Division, of Japan,

represented by Stewart Pesticide

Registration Associates, Inc., Suite 603,

1901 North Moore St., Arlington, VA

22209, had submitted applications to

register the pesticide products STOPIT

Wettable Powder Turf Fungicide and

Polyoxin D Zinc Salt Technical (EPA

File Symbols 68173–E and 68173–R),

containing the new active ingredient

polyoxin D zinc salt (1:1), zinc 5-[[2-

amino-5-O-(aminocarbonyl)-2-deoxy-Lxylonoyl]amino]-1-(5-carboxy-3,4-

dihydro-2,4-dioxo-1 (2H)-pyrimidinyl)-

1,5-dideoxy-β-D-allofuranuronate at 2.5

and 23.8 percent respectively, an active

ingredient not included in any

previously registered products.

The applications were approved on

August 20, 1997, as STOPIT Wettable

Powder Turf Fungicide for use on turf

of golf courses, home lawns, parks, and

commercial and institutional grounds

(EPA Registration Number 68173–2) and

Polyoxin D Zinc Salt Technical for

formulation into fungicidal end-use

products (EPA Registration Number

68173–1).

The Agency has considered all

required data on risks associated with

the proposed use of polyoxin D zinc salt

(1:1), zinc 5-[[2-amino-5-O-

(aminocarbonyl)-2-deoxy-Lxylonoyl]amino]-1-(5-carboxy-3,4-

dihydro-2,4-dioxo-1 (2H)-pyrimidinyl)-

1,5-dideoxy-β-D-allofuranuronate, and

information on social, economic, and

environmental benefits to be derived

from use. Specifically, the Agency has

considered the nature of the chemical

and its pattern of use, application

methods and rates, and level and extent

of potential exposure. Based on these

reviews, the Agency was able to make

basic health and safety determinations

which show that use of polyoxin D zinc

salt (1:1), zinc 5-[[2-amino-5-O-

(aminocarbonyl)-2-deoxy-Lxylonoyl]amino]-1-(5-carboxy-3,4-

dihydro-2,4-dioxo-1 (2H)-pyrimidinyl)-

1,5-dideoxy-β-D-allofuranuronate when

used in accordance with widespread

and commonly recognized practice, will

not generally cause unreasonable

adverse effects to the environment.

More detailed information on these

registrations is contained in an EPA

Pesticide Fact Sheet on Polyoxin D zinc

salt.

A copy of this fact sheet, which

provides a summary description of the

pesticides, use patterns and

formulations, science findings, and the

Agency’s regulatory position and

rationale, may be obtained from the

National Technical Information Service

(NTIS), 5285 Port Royal Road,

Springfield, VA 22161.

In accordance with section 3(c)(2) of

FIFRA, a copy of the approved label, the

list of data references, the data and other

scientific information used to support

registration, except for material

specifically protected by section 10 of

FIFRA, are available for public

inspection in the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Rm. 1132, CM #2, Arlington,

VA 22202 (703-305–5805). Requests for

data must be made in accordance with

the provisions of the Freedom of

Information Act and must be addressed

to the Freedom of Information Office (A101), 401 M St., SW., Washington, D.C.

20460. Such requests should: (1)

Identify the product name and

registration number and (2) specify the

data or information desired.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pests, Product registration.

Dated: September 9, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–24938 Filed 9–18–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–759; FRL–5739–9]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition (PP

7F4826), submitted by Plant Genetic

Systems (America), Inc., proposing the

establishment of a regulation for an

exemption from the requirement of a

tolerance for residues of plant-pesticides

Bacillus thuringiensis subsp. tolworthi

Cry9C and the genetic material

necessary for the production of this

protein in or on all raw agricultural

commodities.

DATES: Comments, identified by the

docket control number PF–759, must be

received on or before October 20, 1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7506C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Michael Mendelsohn,

Biopesticides and Pollution Prevention

Division (7511W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Rm. CS51B6, Westfield

Building North Tower, 2800 Crystal

Drive, Arlington, VA 22202, (703) 308–

8715; e-mail:

mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various food commodities under section

408 of the Federal Food, Drug, and

Comestic Act (FFDCA), 21 U.S.C. 346a.

EPA has determined that these petitions

contain data or information regarding

the elements set forth in section

408(d)(2); 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.
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices 49225

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–759]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [PF–759] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: August 29, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. 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.

Plant Genetic Systems (America), Inc.

PP 7F4826

EPA has received a pesticide petition

(PP 7F4826) from Plant Genetic Systems

(America), Inc., proposing the

establishment of a regulation for an

exemption from the requirement of a

tolerance for residues of plant-pesticides

Bacillus thuringiensis subsp. tolworthi

Cry9C and the genetic material

necessary for the production of this

protein in or on all raw agricultural

commodities.

A. Bacillus thuringiensis subsp.

tolworthi Cry9C protein uses

Corn plants have been protected from

lepidopteran insect pests such as

European corn borer [Ostrinia nubilalis

(Huber)], by expressing a Cry9C protein.

The Cry9C protein expressed by the

corn plants corresponds to the

insecticidal moiety of the Cry9C crystal

protein of a Bacillus thuringiensis

subsp. tolworthi strain. The Cry9C

protein poses no foreseeable risks to

non-target organisms, including

mammals, birds and non-target insects.

Transgenic corn plants, expressing

Cry9C protein, represents an excellent

addition to growers’ options for insect

control that reduces or eliminates the

need for chemical inputs and fits well

within an integrated pest management

program.

B. Product Identity/Chemistry

The Cry9C gene, was isolated from the

B.t. tolworthi strain, truncated and

modified before it was stably inserted

into corn plants. The tryptic core of the

microbially produced Cry9C deltaendotoxin is similar to the Cry9C

protein found in event CBH351. The

Cry9C protein was produced and

purified from a bacterial host, for the

purposes of mammalian toxicity studies.

Product analysis that compared the

Cry9C protein from the two sources

included: SDS-PAGE, Western blots, Nterminal amino acid sequencing,

glycosylation tests (for possible posttranslational modifications) and insect

bioassays.

No analytical method is included

since this petition requests an

exemption from the requirement of a

tolerance.

C. Mammalian Toxicological Profile

Bacillus thuringiensis proteins have

insecticidal properties and have been

used commercially for more than 30

years. This long history of safe use is the

primary reason that Bt proteins have

been chosen as the basis for the first

insecticidal plants produced by

biotechnology. Bt mode-of-action can be

divided into a series of critical steps:

ingestion by the insect, specific binding

to brush border membrane receptors,

membrane insertion, and pore

formation. Bt proteins do not bind or

cause any other effects to mammalian

gut membranes thereby displaying

human safety properties. The Cry9C

protein mode-of-action is apparently

similar to that of the well known Cry1A

proteins. Although Bt strains have been

used for decades as sprayable microbial

products, no confirmed cases of allergic

reactions have been documented,

despite dermal, oral and inhalation

exposures. A reference to this is made

by the EPA in a Federal Register notice,

dated August 16, 1995 [60 FR 42443].

In addition to the safe history of Bt

proteins outlined above, several other

studies were performed to provide

evidence for mammalian safety of the

Cry9C protein. An acute toxicological

study was performed with mice, which

demonstrated that the Cry9C protein

had an LD50 > 6,500 mg/kg. A test for

in vitro digestibility under simulated

gastric conditions showed that the

Cry9C protein found in bacteria and the

protein produced in plants was stable

for 4 hours when exposed to simulated

gastric juice. An amino acid sequence

homology search performed using three

different data banks (against 135,867

sequences) only found homology to

other related Bt proteins. All other

proteins in the data bank have no major

stretches of sequence homology,

indicating that the sequence homology

is not significant. Therefore, no

homology with any known allergen or

protein toxin could be demonstrated.

The Cry9C protein or metabolites of

the protein are not expected to interact

with the immune system, the endocrine

system or to have any carcinogenic

activity since the protein sequence does

not match any known allergens,

hormones or since proteins, in general,

are not known to be carcinogenic.

All living organisms contain DNA and

there are no examples of nucleic acids

causing any toxicological effects from

dietary consumption. The genetic

material necessary for the production of

the Cry9C protein in plants includes the

genetic construct that encodes the

Cry9C protein and all other necessary

genetic elements for it’s expression.

These elements include: a promotor,

polylinker sequences, leader sequences

and terminators and none of which are

expected to cause any toxicological

effects.

Taken together, the data supports the

lack of mammalian toxicological effects

for the plant-pesticide Bacillus

thuringiensis subsp. tolworthi Cry9C

protein and the genetic material

necessary for the production of this

protein in or on all raw plant

agricultural commodities.
49226 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices

D. Aggregate Exposure

Since the Cry9C protein is expressed

in plant tissues, dermal or inhalation

will be negligible to non-existent.

Drinking water is unlikely to be

contaminated with Cry9C protein due to

the rapid degradation of plant materials

in the soil. Processed plant products

may allow for low levels of exposure to

the Cry9C protein, but the lack of

mammalian toxicity and the lack of

sequence homology to known toxins or

allergens, has already been

demonstrated.

E. Cumulative Exposure

The unique mode-of-action of Bt

proteins in general, coupled with the

lack of mammalian toxicity for the

Cry9C protein provides no basis for the

expectation of cumulative exposure

with other compounds.

F. Safety Determination

Bt microbial pesticides containing Cry

proteins have been applied for more

than 30 years to food and feed crops

consumed by the U.S. population. There

have been no human safety problems

attributed to Cry proteins. The extensive

mammalian toxicity studies performed

to support the safety of Bacillus

thuringiensis - containing pesticides

clearly demonstrate that the tested

isolates are not toxic or pathogenic

(McClintock, et al., 1995, Pestic. Sci.

45:95-105). The lack of mammalian

toxicity or allergenic properties of the

Cry9C protein provides support for our

request of an exemption from the

requirement of a tolerance set forth in

this petition. Non-dietary exposure of

infants, children or the US population

in general, to the Cry9C protein

expressed in plant materials, are not

expected due to the uses of this product

within agricultural settings.

G. Existing Tolerances

No tolerances or tolerance exemptions

have been granted for the Bacillus

thuringiensis subsp. tolworthi Cry9C

and the genetic material necessary for

the production of this protein in or on

all raw agricultural commodities.

[FR Doc. 97–24940 Filed 9–18–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–5895–2]

Notice of Proposed Assessment of

Clean Water Act Class II Administrative

Penalty to Arizona Public Service

Company and Opportunity To

Comment

AGENCY: Environmental Protection

Agency.

ACTION: Notice of proposed

administrative penalty assessment and

opportunity to comment.

SUMMARY: EPA is providing notice of a

proposed administrative penalty

assessment and proposed Consent

Agreement for alleged violations of the

Clean Water Act. EPA is also providing

notice of the opportunity to comment on

the proposed penalty assessment.

Under section 309(g) of the Clean

Water Act, 33 U.S.C. 1319(g), EPA is

authorized to issue orders assessing

civil penalties for various violations of

the Act after providing the person

subject to the penalty notice of the

proposed penalty and the opportunity

for a hearing, and after providing

interested persons public notice of the

proposed penalty and a reasonable

opportunity to comment on its issuance.

Class II proceedings are conducted

under EPA’s Consolidated Rules of

Practice Governing the Administrative

Assessment of Civil Penalties and the

Revocation and Suspension of Permits,

40 CFR part 22. The procedures through

which the public may comment on a

proposed Class II penalty or participate

in a Class II penalty proceeding are set

forth in the Consolidated Rules. The

deadline for submitting public comment

of a proposed Class II order is thirty

days after publication of this document.

On the date identified below, EPA

commenced the following Class II

proceeding for the assessment of

penalties:

In the matter of Arizona Public

Service Company, P.O. Box 52034,

Phoenix, AZ; EPA Docket No. CWA–IX–

FY97–16; filed on September 11, 1997,

with Mr. Steven Armsey, Regional

Hearing Clerk, U.S. EPA Region 9, 75

Hawthorne Street, San Francisco,

California 94105, (415) 744–1389,

proposed penalty of $42,000 for

unpermitted discharges in August 1994,

January 1997, February 1997 and March

1997 into the Gila River from their water

reclamation supply system pipeline.

EPA and Arizona Public Service

Company have agreed to a proposed

Consent Agreement in which Arizona

Public Service Company shall pay a

civil penalty of $42,000.

FOR FURTHER INFORMATION: Persons

wishing to receive a copy of EPA’s

Consolidated Rules, review the

complaint or other documents filed in

this proceeding, comment upon a

proposed assessment, or otherwise

participate in the proceeding should

contact the Regional Hearing Clerk

identified above. The administrative

record for this proceeding is located in

the EPA Regional Office identified

above, and the file will be open for

public inspection during normal

business hours. All information

submitted by the Respondent is

available as part of this administrative

record, subject to provisions of law

restricting public disclosure of

confidential information. In order to

provide opportunity for public

comment, EPA will take no final action

in these proceedings prior to thirty (30)

days after the date of publication of this

document.

Dated: September 11, 1997.

John Ong,

Acting Director, Water Division.

[FR Doc. 97–24946 Filed 9–18–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–5895–4]

EPA’s Final Decision To Withdraw

Phase I Total Maximum Daily Loads

(TMDLs) for Copper in certain New

Jersey Waters of New York-New Jersey

Harbor

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has determined that

certain New Jersey waters of the New

York-New Jersey Harbor are not water

quality-limited for copper, and

therefore, Phase I copper TMDLs are not

required for these water segments. The

New Jersey Harbor waters for which

Phase I Copper TMDLS are being

withdrawn are defined as Newark Bay,

Hackensack River below the Oradell

Dam, Passaic River below the Dundee

Dam, Raritan River below the Fieldsville

Dam, and Raritan Bay. EPA is hereby

issuing public notice of its final

decision to withdraw the Phase I

TMDLs for copper established by EPA

on January 24, 1996.

DATES: September 19, 1997.

ADDRESSES: Copies of the

responsiveness summary and relevant

supporting documents may be obtained

by writing to Mr. Steven Wood, Fate &

Effects Team, U.S. Environmental