Plant Genetic Systems (America), Inc.; Receipt of Petition for Determination of Nonregulated Status for Corn Genetically Engineered for Male Sterility and Glufosinate Herbicide Tolerance as a Marker

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 95-076-1]

Plant Genetic Systems (America), Inc.; Receipt of Petition for

Determination of Nonregulated Status for Corn Genetically Engineered

for Male Sterility and Glufosinate Herbicide Tolerance as a Marker

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health

Inspection Service has received a petition from Plant Genetic Systems

(America), Inc., seeking a determination of nonregulated status for a

corn line designated as event MS3 that has been genetically engineered

for male sterility and tolerance to the herbicide glufosinate as a

marker. 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

line presents a plant pest risk.

DATES: Written comments must be received on or before January 16, 1996.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 95-076-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 95-076-1. 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. James White, Team Leader,

Biotechnology Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit

147, Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the

petition, contact Ms. Kay Peterson at (301) 734-7612.

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,'' 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

[[Page 57571]]

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 August 16, 1995, APHIS received a petition (APHIS Petition No.

95-228-01p) from Plant Genetic Systems (America), Inc., (PGS) of Des

Moines, IA, requesting a determination of nonregulated status under 7

CFR part 340 for a male sterile, glufosinate tolerant corn line

designated as transformation event MS3 (event MS3). The PGS petition

states that corn event MS3 should not be regulated by APHIS because it

does not present a plant pest risk.

As described in the petition, corn event MS3 has been genetically

engineered with a gene from Bacillus amyloliquefaciens encoding a

ribonuclease called barnase, which inhibits pollen formation and

results in male sterility of the transformed plants. Corn event MS3

also contains the bar gene isolated from the bacterium Streptomyces

hygroscopicus that encodes a phosphinothricin acetyltransferase (PAT)

enzyme, which, when introduced into a plant cell, inactivates

glufosinate. Linkage of the barnase gene, which induces male sterility,

with the bar gene, a glufosinate tolerance gene used as a marker,

enables identification of the male sterile line before the plant begins

to flower. Event MS3 was transformed via immature embryo

electroporation in yellow dent corn material. Expression of the

introduced genes is controlled in part by the P35S promoter derived

from the plant pathogen cauliflower mosaic virus and the 3'nos sequence

from the plant pathogen Agrobacterium tumefaciens.

PGS' corn event MS3 is currently considered a regulated article

under the regulations in 7 CFR part 340 because it contains the above-

mentioned gene sequences derived from plant pathogenic sources. The

subject corn line has been evaluated in field trials conducted since

1992 under APHIS permits or notifications. In the process of reviewing

the applications for field trials of the corn event MS3, APHIS

determined 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.

The U.S. Environmental Protection Agency (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 herbicides, be registered prior

to distribution or sale, unless exempt by EPA regulation. In cases in

which the genetically modified plants allow for a new use of an

herbicide or involve a different use pattern for the herbicide, the EPA

must approve the new or different use. In conducting such an approval,

the EPA considers the possibility of adverse effects to human health

and the environment from the use of this herbicide. When the use of the

herbicide on the genetically modified plant would result in an increase

in the residues of the herbicide in a food or feed crop for which the

herbicide is currently registered, or in new residues in a crop for

which the herbicide is not currently registered, establishment of a new

tolerance or a revision of the existing tolerance would be required.

Residue tolerances for pesticides are established by the EPA under the

Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 201 et seq.),

and the Food and Drug Administration (FDA) enforces tolerances set by

the EPA under the FFDCA.

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's

authority for ensuring food safety under the FFDCA, 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

available 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 PGS' corn event MS3 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 8th day of November 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-28326 Filed 11-15-95; 8:45 am]

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