Bejo Zaden BV; Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Radicchio Rosso

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-067-1]

Bejo Zaden BV; Receipt of Petition for Determination of

Nonregulated Status for Genetically Engineered Radicchio Rosso

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 Bejo Zaden BV seeking a

determination of nonregulated status for Radicchio rosso lines

designated as RM3-3, RM3-4, and RM3-6, which have 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 these

Radicchio rosso lines present a plant pest risk.

DATES: Written comments must be received on or before October 27, 1997.

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

Docket No. 97-067-1, 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. 97-067-1. 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

to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnology

Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,

Riverdale, MD 20737-1236; (301) 734-8761. To obtain a copy of the

petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail:

[email protected].

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 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 May 28, 1997, APHIS received a petition (APHIS Petition No. 97-

148-01p) from Bejo Zaden BV (Bejo) of Warmenhuizen, The Netherlands,

requesting a determination of nonregulated status under 7 CFR part 340

for male sterile, glufosinate-tolerant Radicchio rosso (red-hearted

chicory) lines designated as RM3-3, RM3-4, and RM3-6. The Bejo petition

states that the subject Radicchio rosso lines should not be regulated

by APHIS because they do not present a plant pest risk.

As described in the petition, Radicchio rosso (Cichorium intybus

L.) lines RM3-3, RM3-4, and RM3-6, have been genetically engineered

with a barnase gene from Bacillus amyloliquefaciens encoding a

ribonuclease which inhibits pollen

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formation and results in male sterility of the transformed plants. The

subject Radicchio rosso lines also contain the nptII selectable marker

gene and the bar gene isolated from the bacterium Streptomyces

hygroscopicus. The bar gene 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 for

use in the production of pure hybrid seed. The subject Radicchio rosso

lines were transformed by the Agrobacterium tumefaciens method, and

expression of the introduced genes is controlled in part by gene

sequences derived from the plant pathogen A. tumefaciens.

Radicchio rosso lines RM3-3, RM3-4, and RM3-6 are currently

considered regulated articles under the regulations in 7 CFR part 340

because they contain gene sequences derived from the plant pathogen A.

tumefaciens. The subject Radicchio rosso lines have been evaluated in

field trials conducted since 1993 in Europe, and since 1995 in the

United States. In the process of reviewing the permit applications for

the U.S. field trials of these Radicchio rosso lines, 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. 301 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.

Bejo has begun consultation with FDA on the subject Radicchio rosso

lines.

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 the Bejo Zaden BV Radicchio rosso

lines RM3-3, RM3-4, and RM3-6 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 21st day of August 1997.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-22760 Filed 8-26-97; 8:45 am]

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