Monsanto Co.; Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Tomato

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-114-1]

Monsanto Co.; Receipt of Petition for Determination of

Nonregulated Status for Genetically Engineered Tomato

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 tomato line

designated as 5345, which has been genetically engineered for

resistance to certain lepidopteran insect pests. 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 tomato line presents a plant pest risk.

DATES: Written comments must be received on or before January 27, 1998.

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

Docket No. 97-114-1, 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. 97-114-1. 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. Sivramiah Shantharam,

Biotechnology Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road

Unit 147, Riverdale, MD 20737-1236; (301) 734-4882. 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 October 14, 1997, APHIS received a petition (APHIS Petition No.

97-287-01p) from Monsanto Company (Monsanto) of St. Louis, MO,

requesting a determination of nonregulated status under 7 CFR part 340

for a genetically engineered, insect-resistant tomato line designated

as 5345. The petition states that the subject tomato line should not be

regulated by APHIS because it does not present a plant pest risk.

As described in the petition, tomato line 5345 has been genetically

engineered to express a CryIA(c) insect control protein derived from

the common soil bacterium Bacillus thuringiensis subsp. kurstaki HD-73

(Btk). The petitioner states that expression of the Btk delta-endotoxin

protein protects the subject tomato line from damage caused by certain

lepidopteran insect pests. Tomato line 5345 also expresses the NPTII

protein which serves as a selectable marker in the plant transformation

process. While the subject tomato line contains the aad gene, tests

indicate that the AAD protein, which serves as a selectable marker in

the laboratory prior to plant transformation, is not expressed in the

plant. The added genes were introduced into the UC82B parental tomato

plants by the Agrobacterium tumefaciens transformation system, and

their expression is controlled in part by gene sequences derived from

the plant pathogens cauliflower mosaic virus and A. tumefaciens.

The subject tomato line is currently considered a regulated article

under the regulations in 7 CFR part 340 because it contains gene

sequences derived from plant pathogenic sources. Tomato line 5345 has

been evaluated in field trials conducted since 1994 under APHIS

notifications. In the process of reviewing the notifications for field

trials of this tomato 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 insecticides, be registered

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

cases in which the genetically modified plant allows for a new or

different use pattern for a pesticide, EPA must approve the new or

different use. Residue tolerances for pesticides are established by the

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 the EPA under the FFDCA. The EPA has granted

exemptions from the requirement of a tolerance for residues of the

CryIA(c) and NPTII proteins and the genetic material necessary for

their production in all plants.

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.

[[Page 63313]]

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 Monsanto's insect-resistant tomato

line 5345 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 20th day of November 1997.

Craig A. Reed,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-31222 Filed 11-26-97; 8:45 am]

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