Calgene, Inc.; Availability of Letter Concluding Consultation

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 91A-0330]

Calgene, Inc.; Availability of Letter Concluding Consultation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a letter from FDA to Calgene, Inc., notifying the firm

that the agency has concluded that FLAVR SAVRTM tomatoes have not

been significantly altered when compared to varieties of tomatoes with

a history of safe use. FDA also is announcing the availability of a

written summary of the consultation between Calgene and the agency

concerning FLAVR SAVRTM tomatoes, which consultation was conducted

in accordance with the agency's policy on foods derived from new plant

varieties. FDA is publishing this document to bring to closure the

public process that began with a May 1992 notice announcing a request

from Calgene for an advisory opinion concerning FLAVR SAVRTM

tomatoes.

ADDRESSES: Submit written requests for single copies of the FDA letter

and the written summary (free of charge) to the Food and Drug

Administration, Center for Food Safety and Applied Nutrition,

Biotechnology Policy Branch (HFS-206), 200 C St. SW., Washington, DC

20204. Requests should be identified with the docket number found in

brackets in the heading of this document. Send two self-addressed

adhesive labels to assist that office in processing your request. FDA's

letter and the written summary are available for public examination in

the Dockets Management Branch (HFA-305), Food and Drug Administration,

rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4

p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Linda S. Kahl, Center for Food Safety

and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202-254-9523.

SUPPLEMENTARY INFORMATION:

In a letter dated August 12, 1991, Calgene, Inc., requested an

advisory opinion under Sec. 10.85 (21 CFR 10.85) concerning whether

FLAVR SAVRTM tomatoes are food and, therefore, subject to the same

regulation as other tomato varieties. In developing the FLAVR

SAVRTM tomato, Calgene used recombinant deoxyribonucleic acid

(DNA) techniques to introduce an antisense polygalacturonase (PG) gene.

The sense PG gene, normally present in tomatoes, encodes the enzyme PG,

which is associated with the breakdown of pectin (a constituent of the

cell wall in tomato fruit). The principle underlying the FLAVR

SAVRTM tomato is that the antisense PG gene suppresses the

production of the PG enzyme, resulting in ripe fruit that remains firm

for an extended period, which allows fresh market tomatoes to be vine-

ripened for enhanced flavor.

In the Federal Register of May 29, 1992 (57 FR 22984), FDA issued a

policy statement (the 1992 policy statement) that clarifies the

agency's interpretation of the Federal Food, Drug, and Cosmetic Act

(the act) with respect to foods derived from new plant varieties. On

that same date, FDA announced Calgene's advisory opinion request (57 FR

22772), and requested public comment. FDA believed that such a notice

was in the public interest because that request was the first made to

FDA regarding the status of a whole food produced by the new methods of

gene transfer.

In light of the publication of the 1992 policy statement, FDA now

believes that the status of a particular product, such as the FLAVR

SAVRTM tomato, should be addressed through a consultation with the

agency consistent with the principles outlined in that statement. As a

result of that consultation, FDA has notified Calgene, in a letter

dated May 17, 1994, that the agency has concluded that FLAVR

SAVRTM tomatoes have not been significantly altered when compared

to varieties of tomatoes with a history of safe use (21 CFR

170.30(f)(2)). FDA has prepared a written summary of the agency's

consultation with Calgene. The written summary includes a response to

the comments received on the Calgene advisory opinion request,

including comments contained in a citizen petition (Docket No. 92P-

0222/CP1) filed in accordance with Sec. 10.30 (21 CFR 10.30).

FDA believes that this notice brings to closure the public process

that began with the agency's announcement of Calgene's advisory opinion

request.

FLAVR SAVRTM tomatoes contain the kanamycin resistance gene

(the kanr gene) that encodes the enzyme aminoglycoside-3'-

phosphotransferase II (APH(3')II). In the Federal Register of July 16,

1993 (58 FR 38429), FDA announced that Calgene had filed a food

additive petition (FAP 3A4364) proposing that the food additive

regulations be amended to provide for the safe use of APH(3')II as a

processing aid in the development of new varieties of tomato, oilseed

rape, and cotton. Elsewhere in this issue of the Federal Register, FDA

is publishing a final rule that amends the agency's food additive

regulations to provide for the safe use of APH(3')II as a processing

aid in the development of new varieties of tomato, oilseed rape, and

cotton. The agency evaluated the safety of APH(3')II in the context of

FAP 3A4364 and not as part of the consultation with Calgene that is the

subject of this notice.

Dated: May 17, 1994.

Fred R. Shank,

Director, Center for Food Safety and Applied Nutrition.

[FR Doc. 94-12494 Filed 5-18-94; 12:39 pm]

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