Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Corn

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 Sec. 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 Sec. 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-amino-acid 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 [[Page 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

delta-endotoxin 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 Sec. 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]

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