Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Tomato Line

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

Inspection Service has received a petition from the Monsanto Company

seeking a determination of nonregulated status for a tomato line

designated as 8338 that has been genetically engineered for delayed

ripening. 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 August 14, 1995.

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

Docket No. 95-042-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1237. Please

state that your comments refer to Docket No. 95-042-1. 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. Susan Koehler,

Biotechnologist, Biotechnology Permits, BBEP, APHIS, 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) 734-7601.

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 February 22, 1995, APHIS received a petition (APHIS Petition No.

95-053-01p) from the Monsanto Company (Monsanto) of St. Louis, MO,

requesting a determination of nonregulated status under 7 CFR part 340

for a tomato line designated as 8338 that has been genetically

engineered for delayed ripening. The Monsanto petition states that the

subject tomato line shall not be regulated by APHIS because it does not

present a plant pest risk.

As described in the petition, tomato line 8338 has been genetically

engineered to express the enzyme 1-aminocyclopropane-1-carboxylic acid

deaminase (ACCd), which catalizes deamination of ACC, an essential

precursor for ethylene biosynthesis. Levels of ethylene control the

rate of fruit ripening, and removal of ACC in the subject tomato line

reduces ethylene production and delays ripening. The accd gene, which

confers the delayed-ripening trait, was isolated from the soil

bacterium Pseudomonas chloroaphis, strain 6G5. Tomato line 8338 also

contains the neomycin phosphotransferase (nptII) selectable marker gene

which encodes the enzyme NPTII. The presence of the NPTII protein in

the plant genome confers tolerance to the antibiotic kanamycin and

allows selection of the transformed cells in the presence of kanamycin.

Expression of the accd gene and the nptII gene is driven by

constitutive 35S promoters derived from the plant pathogenic

caulimoviruses figwort mosaic virus and cauliflower mosaic virus,

respectively. The subject tomato line was transformed through the use

of disarmed vectors from a common soil-borne bacterium, the plant

pathogen Agrobacterium tumefaciens.

Tomato line 8338 is currently considered a regulated article under

the regulations in 7 CFR part 340 because it contains the 35S promoters

and 3' regulatory gene sequences derived from the plant pathogens

mentioned above, and because A. tumefaciens was used as the plant

transformation vector. Tomato line 8338 was evaluated in field trials

conducted under APHIS permits or notifications since 1992. In the

process of reviewing the applications for those field trials, APHIS

determined that the vectors and other elements were disarmed and that

the trials, which were conducted under conditions of reproductive

confinement, 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.

Food or animal feed uses of the subject tomato line may be subject

to [[Page 31140]] regulation by the Food and Drug Administration (FDA)

under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA)

(21 U.S.C. 301 et seq.). 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. Monsanto has completed its

consultation with the FDA on the food safety of the subject tomato

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 Monsanto's tomato line 8338 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 5th day of June 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-14382 Filed 6-12-95; 8:45 am]

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