This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

9656

Vol. 60, No. 34

Tuesday, February 21, 1995

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 95–007–1]

Receipt of Petition for Determination of

Nonregulated Status for Genetically

Engineered Corn

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public

that the Animal and Plant Health

Inspection Service has received a

petition from Ciba Seeds seeking a

determination of nonregulated status for

corn designated as ‘‘Event 176 Corn’’

genetically engineered for insect

resistance. The Petition has been

submitted in accordance with our

regulations concerning the introduction

of certain genetically engineered

organisms and products. In accordance

with those regulations, we are soliciting

public comments on whether this corn

presents a plant pest risk.

DATES: Written comments must be

received on or before April 24, 1995.

ADDRESSES: Please send an original and

there copies of your comments to

Docket No. 95–007–1, Animal and Plant

Health Inspection Service, Policy and

Program Development, Regulatory

Analysis and Development, 4700 River

Road Unit 118, Riverdale, MD 20737–

1238. Please state that your comments

refer to Docket No. 95–007–01. A copy

of the petition and any comments

received may be inspected at USDA,

room 1141, South Building, 14th Street

and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing access

to that room to inspect the petition or

comments are asked to call in advance

of visiting at (202) 690–2817.

FOR FURTHER INFORMATION CONTACT: Dr.

Ved Malik, Biotechnologist, Animal and

Plant Health Inspection Service,

Biotechnology, Biologics, and

Environmental Protection,

Biotechnology Permits, 4700 River Road

Unit 147, Riverdale, MD 20737–1237.

The telephone number of the agency

will change when agency offices in

Hyattsville, MD, move to Riverdale, MD,

during February. Telephone: (301) 436–

7612 (Hyattsville): (301) 734–7612

(Riverdale). To obtain a copy of the

petition, contact Ms. Kay Peterson at

(301) 436–7601 (Hyattsville) or (301)

734–7601 (Riverdale).

SUPPLEMENTARY INFORMATION: The

regulations in 7 CFR part 340,

‘‘Information of Organisms and Products

Altered or Produced Through Genetic

Engineering Which Are Plant Pests or

Which There Is Reason to Believe Are

Plant Pests,’’ regulate, among other

things, the introduction (importation,

interstate movement, or release into the

environment) of organisms and products

altered or produced through genetic

engineering that are plant pests or that

there is reason to believe are plant pests.

Such genetically engineered organisms

and products are considered ‘‘regulated

articles.’’

The regulations in § 340.6(a) provide

that any person may submit a petition

to the Animal and Plant Health

Inspection Service (APHIS) seeking a

determination that an article should not

be regulated under 7 CFR part 340.

Paragraphs (b) and (c) of § 340.6

describe the form that a petition for

determination of nonregulated status

must take and the information that must

be included in the petition.

On November 15, 1994, APHIS

received a petition (APHIS Petition No.

94–319–01p) from Ciba Seeds (a

division of Ciba-Geigy Corporation) of

Research Triangle Park, NC, requesting

a determination of nonregulated status

under 7 CFR part 340 for insect-resistant

corn designated as ‘‘Event 176 Corn.’’

Event 176 Corn is genetically

engineered with the synthetic gene that

codes for an insecticidal protein

naturally produced by Bacillus

thuringiensis subsp. kurstaki (Btk). The

Ciba Seeds petition states that the

subject corn should not be regulated by

APHIS because it does not present a

plant pest risk.

As described in the petition, the

subject corn was genetically engineered

to produce an insect control protein

representing a truncated form of the

CryIA(b) protein that occurs naturally in

Btk, a common gram-positive soil

bacterium. This protein is a member of

a class of insecticidal proteins, also

known as delta-endotoxins, that are

produced as parasporal crystals by B.

thuringiensis in nature, and are known

to be quite selective in their toxicity to

specific organisms, while nontoxic to all

other organisms.

Btk proteins are very effective against

certain lepidopteran (caterpillar)

insects, including European corn borer

(ECB) (Ostrinia nubilalis (Hubner)). ECB

is a major corn pest that reduces yield

by disrupting normal plant physiology

and causing physical damage to the

plant and ear that results in stalk

lodging, dropped ears, and damaged

grain. Results of field tests conducted by

Ciba Seeds under permits granted by

AHPIS and the Environmental

Protection Agency (EPA) indicate that

corn plants producing the CryIA(b)

protein are quite effective in controlling

ECB. The corn plants under evaluation

preferentially express the insect control

protein in leaf tissue and pollen (both

feeding sources for ECB), while

minimizing its production in other plant

tissues, including kernels, where it is

not needed for control of the target pest.

As described in the petition, the

cryIA(b) gene expressed in the

transgenic corn plants encodes a protein

that is identical to the first 648 amino

acids of the full-length, 1,155-aminoacid CryIA(b) protein that occurs in

nature. This truncated protein contains

the portion of the native protein that is

responsible for its insecticidal activity.

Two different tissue-specific promoters,

both derived from corn, confer protein

expression in green tissue and pollen,

respectively. In addition to expressing

the CryIA(b) protein, the plants also

express the enzyme phosphinothricin

acetyltransferase, currently used in the

plant as a selectable marker. Expression

of the selectable market gene is

regulated by the 35S promoter, while

expression of the CryIA(b) protein is

controlled in part by the 35S terminator.

The 35S promoter and the 35S

terminator are derived from the plant

pathogen cauliflower mosaic virus.

Ciba Seeds’ Event 176 Corn is

currently considered a regulated article

under the regulations in 7 CFR part 340

because it contains gene sequences
Federal Register / Vol. 60, No. 34 / Tuesday, February 21, 1995 / Notices 9657

(vectors, promoters, and terminators)

derived from plant pathogenic sources.

Event 176 Corn was evaluated in field

trials conducted under APHIS permits

in 1992 and 1993, and under APHIS

notifications in 1993 and 1994. In the

process of reviewing the applications for

field trials of the subject corn, APHIS

determined that the vectors and other

elements were disarmed and that the

trials, which were conducted under

conditions of reproductive and physical

containment or isolation, would not

present a risk of plant pest introduction

or dissemination.

In the Federal Plant Pest Act, as

amended (7 U.S.C. 150aa et seq.), ‘‘plant

pest’’ is defined as ‘‘any living stage of:

Any insects, mites, nematodes, slugs,

snails, protozoa, or other invertebrate

animals, bacteria, fungi, other parasitic

plants or reproductive parts thereof,

viruses, or any organisms similar to or

allied with any of the foregoing, or any

infectious substances, which can

directly or indirectly injure or cause

disease or damage in any plants or parts

thereof, or any processed, manufactured

or other products of plants.’’ APHIS

views this definition very broadly. The

definition covers direct or indirect

injury, disease or damage not just to

agricultural crops, but also to plants in

general, for example, native species, as

well as to organisms that may be

beneficial to plants, for example,

honeybees, rhizobia, etc.

This genetically engineered corn is

also currently subject to regulation by

other agencies. The EPA is responsible

for the regulation of pesticides under

the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended (7

U.S.C. 136 et seq.). FIFRA requires that

all pesticides, including insecticides, be

registered prior to distribution or sale,

unless exempt by EPA regulation.

Accordingly, Ciba Seeds has submitted

to the EPA an application to register this

transgenic plant pesticide, the Btk

CryIA(b) insect control protein as

produced in corn. On January 13, 1995,

EPA announced receipt of this

application (EPA File Symbol 66736–R)

in the Federal Register (60 FR 3209;

OPP–30377; FRL–4928–9).

Under the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 301 et seq.),

pesticides added to raw agricultural

commodities generally are considered to

be unsafe unless a tolerance or

exemption from tolerance has been

established. Foods containing unsafe

pesticides are deemed to be adulterated.

Residue tolerances for pesticides are

established by EPA under the Federal

Food, Drug, and Cosmetic Act; the Food

and Drug Administration (FDA)

enforces the tolerances set by the EPA.

Ciba Seeds has also submitted to the

EPA a pesticide petition (pp 4F4395)

proposing to amend 40 CFR part 180 to

establish a tolerance exemption for

residues of the plant pesticide active

ingredient B. thuringiensis deltaendotoxin as produced in corn by a

cryIA(b) gene and its controlling

sequences. On February 1, 1995, EPA

announced receipt of this petition in the

Federal Register (60 FR 6092–6093; PF–

618; FRL–4930–3).

Consistent with the ‘‘Coordinated

Framework for Regulation of

Biotechnology’’ (51 FR 23302–23350,

June 26, 1986), APHIS and the EPA are

coordinating their review of this

genetically engineered corn to avoid

duplication and assure that all relevant

issues are addressed.

The FDA published a statement of

policy on foods derived from new plant

varieties in the Federal Register on May

29, 1992 (57 FR 22984–23005). The FDA

statement of policy includes a

discussion of the FDA authority for

ensuring food safety under the Federal

Food, Drug, and Cosmetic Act, and

provides guidance to industry on the

scientific considerations associated with

the development of foods derived from

new plant varieties, including those

plants developed through the

techniques of genetic engineering.

In accordance with § 340.6(d) of the

regulations, we are publishing this

notice to inform the public that APHIS

will accept written comments regarding

the Petition for Determination of

Nonregulated Status from any interested

person for a period of 60 days from the

date of this notice. The petition and any

comments received are available for

public review, and copies of the petition

may be ordered (see the ADDRESSES

section of this notice).

After the comment period closes,

APHIS will review the data submitted

by the petitioner, all written comments

received during the comment period,

and any other relevant information.

Based on the avaible information,

APHIS will furnish a response to the

petitioner, either approving the petition

in whole or in part, or denying the

petition. APHIS will then publish a

notice in the Federal Register

announcing the regulatory status of Ciba

Seeds’ Event 176 Corn and the

availability of APHIS’ written decision.

Authority: 7 U.S.C. 150aa–150jj, 151–167,

and 1622n; 31 U.S.C. 9701; 7 CFR 2.17, 2.51,

and 371.2(c).

Done in Washington, DC, this 13th day of

February 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–4182 Filed 2–17–95; 8:45 am]

BILLING CODE 3410–34–M

[Docket No. 95–010–1]

Receipt of Permit Applications for

Release Into the Environment of

Genetically Engineered Organisms

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public

that seven applications for permits to

release genetically engineered

organisms into the environment are

being reviewed by the Animal and Plant

Health Inspection Service. The

applications have been submitted in

accordance with 7 CFR part 340, which

regulates the introduction of certain

genetically engineered organisms and

products.

ADDRESSES: Copies of the applications

referenced in this notice, with any

confidential business information

deleted, are available for public

inspection in room 1141, South

Building, U.S. Department of

Agriculture, 14th Street and

Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect an application are requested to

call ahead on (202) 690–2817 to

facilitate entry into the reading room.

You may obtain copies of the

documents by writing to the person

listed under FOR FURTHER INFORMATION

CONTACT.

FOR FURTHER INFORMATION CONTACT:

Dr. Arnold Foudin, Deputy Director,

Animal and Plant Health Inspection

Service, Biotechnology, Biologics, and

Environmental Protection,

Biotechnology Permits, 4700 River Road

Unit 147, Riverdale, MD 20737–1237.

The telephone number for the agency

contact will change when agency offices

in Hyattsville, MD, move to Riverdale,

MD, during February. Telephone: (301)

436–7612 (Riverdale).

SUPPLEMENTARY INFORMATION: The

regulations in 7 CFR part 340,

‘‘Introduction of Organisms and

Products Altered or Produced Through

Genetic Engineering Which Are Plant

Pests or Which There Is Reason to

Believe Are Plant Pests,’’ require a

person to obtain a permit before

introducing (importing, moving