Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Canola Genetically Engineered for Glyphosate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-089-1]

Monsanto Co.; Receipt of Petition for Determination of

Nonregulated Status for Canola Genetically Engineered for Glyphosate

Herbicide Tolerance

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 Monsanto Company

seeking a determination of nonregulated status for a canola line

designated as RT73, which has been genetically engineered for tolerance

to the herbicide glyphosate. 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 canola

line presents a plant pest risk.

DATES: Written comments must be received on or before December 15,

1998.

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

Docket No. 98-089-1, 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. 98-089-1. 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 and

Biological Analysis, PPQ, APHIS, Suite 4C46, 4700 River Road Unit 133,

Riverdale, MD 20737-1236; (301) 734-8761. 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 August 4, 1998, APHIS received a petition (APHIS Petition No.

98-216-01p) from Monsanto Company (Monsanto) of St. Louis, MO,

(Monsanto) requesting a determination of nonregulated status under 7

CFR part 340 for a canola (Brassica napus L.) line designated as RT73,

which has been genetically engineered for tolerance to the herbicide

glyphosate. The Monsanto petition states that the subject canola line

should not be regulated by APHIS because it does not present a plant

pest risk.

As described in the petition, canola line RT73 has been genetically

engineered to express a CP4 EPSPS gene derived from Agrobacterium sp.

strain CP4, and a gox gene derived from Ochrobactrum anthropi strain

LBAA. The CP4 EPSPS gene encodes a 5-enolpyruvylshikimate-3-phosphate

synthase (EPSPS) protein, and the gox gene encodes a glyphosate

oxidoreductase (GOX) protein. The EPSPS and GOX proteins confer

tolerance to the herbicide glyphosate. The Agrobacterium tumefaciens

method was used to transfer the added genes into the parental canola

Westar variety plants, and expression of the added genes is controlled

in part by gene sequences derived from the plant pathogen figwort

mosaic virus.

[[Page 55574]]

Canola line RT73 has been considered a regulated article under the

regulations in 7 CFR part 340 because it contains gene sequences from

plant pathogens. The subject canola line has been field tested since

1996 under APHIS permits. In the process of reviewing the permit

applications for field trials of this canola line, 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.

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. Accordingly, a submission has been made to

EPA for registration of the herbicide glyphosate for use on canola.

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.

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.

Monsanto has completed consultation with FDA on the subject canola

line.

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 Monsanto RT73 canola line 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 9th day of October 1998.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-27828 Filed 10-15-98; 8:45 am]

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