AgrEvo USA Co.; Receipt of Petition for Determination of Nonregulated Status for Canola Genetically Engineered for Male Sterility, Fertility Restoration, and Glufosinate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-114-1]

AgrEvo USA Co.; Receipt of Petition for Determination of

Nonregulated Status for Canola Genetically Engineered for Male

Sterility, Fertility Restoration, and Glufosinate Herbicide Tolerance

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 AgrEvo USA Company

seeking a determination of nonregulated status for certain canola

transformation events, which have been genetically engineered for male

sterility, fertility restoration, and tolerance to the herbicide

glufosinate. 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 canola

transformation events present a plant pest risk.

DATES: Written comments must be received on or before February 8, 1999.

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

Docket No. 98-114-1, 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. 98-114-1. A copy of the

petition and any comments received may be inspected at USDA, room 1141,

South Building, 14thStreet 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. Susan Koehler, Biotechnology and

Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,

Riverdale, MD 20737-1236; (301) 734-4886. To obtain a copy of the

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

Kay.P[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 October 5, 1998, APHIS received a petition (APHIS Petition No.

98-278-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE,

requesting a determination of nonregulated status under 7 CFR part 340

for canola (Brassica napus L.) designated as In Vigor Hybrid

Canola Transformation Events (transformation events) MS8 and RF3, and

their hybrid combination MS8/RF3. The subject transformation events

have been genetically engineered for male sterility (MS8), fertility

restoration (RF3), and tolerance to the herbicide glufosinate (both MS8

and RF3), to enable the production of pure hybrid canola varieties by

the use of a pollination control system. AgrEvo's petition states that

the subject canola transformation events should not be regulated by

APHIS because they do not present a plant pest risk.

As described in the petition, these canola transformation events

have been genetically engineered to contain a barnase gene (MS8) for

male sterility or the barstar gene (RF3) for fertility restoration. The

barnase gene expresses a ribonuclease that blocks pollen development

and results in a male sterile plant, while the barstar gene encodes a

specific inhibitor of this ribonuclease and restores fertility. The

barnase and barstar genes were derived from Bacillus amyloliquefaciens,

and are linked in the subject transformation events to the bar gene

derived from Streptomyces hygroscopicus. The bar gene encodes the

enzyme phosphinothricin-N-acetyltransferase (PAT), which confers

tolerance to the herbicide glufosinate. The herbicide tolerance trait

allows for selection of plants carrying the linked genes for

pollination control during breeding and for tolerance to the herbicide

during commercial cultivation. Expression of the added genes is

controlled in part by gene sequences derived from Arabidopsis thaliana,

Nicotiana tabacum, and the plant pathogen Agrobacterium tumefaciens.

The A. tumefaciens method was used to transfer the added genes into the

parental canola variety, Drakkar.

Canola transformation events MS8, RF3, and their hybrid combination

MS8/RF3 have been considered regulated articles under the regulations

in 7 CFR part 340 because they contain gene sequences from a plant

pathogen. These canola transformation events have been field tested in

Canada since 1994, in Europe since 1995, and in the U. S. since 1997

under APHIS permits and notifications. In the process of reviewing the

permit applications and notifications for field trials of these canola

transformation events, 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. Canola

transformation events MS8, RF3, and their hybrid combination MS8/RF3

were approved in 1996 by Agriculture and Agri-Food Canada for

unconfined environmental release and use as livestock feed in Canada,

and in 1997, Health Canada

[[Page 67644]]

approved oil from the subject transformation events for sale as human

food in Canada.

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 genetically modified plants allow for a new use of an herbicide

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

the new or different use. 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 EPA under the Federal

Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et

seq.), and the Food and Drug Administration (FDA) enforces tolerances

set by EPA under the FFDCA. Accordingly, AgrEvo has submitted to EPA

both registration and tolerance exemption applications for glufosinate

use on canola.

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 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. AgrEvo

has completed consultation with FDA on the subject canola

transformation events.

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 AgrEvo's canola transformation

events MS8, RF3, and their hybrid combination MS8/RF3, 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 2.22, 2.80, and 371.2(c).

Done in Washington, DC, this 2nd day of December 1998.

Joan M. Arnoldi,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-32519 Filed 12-7-98; 8:45 am]

BILLING CODE 3410-34-P