[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
