[Federal Register Volume 59, Number 98 (Monday, May 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12494]


[[Page Unknown]]

[Federal Register: May 23, 1994]


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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]
BILLING CODE 4160-01-F