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Guidance to Industry for Volunary Labels for GMOs

Note:  These are excerpts from the Federal Register Notice.  For complete text, see below.

[Federal Register: January 18, 2001 (Volume 66, Number 12)]
[Page 4839-4842]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 4839]]



Food and Drug Administration

[Docket No. 00D-1598]

Draft Guidance for Industry: Voluntary Labeling Indicating
Whether Foods Have or Have Not Been Developed Using Bioengineering;

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA (we)) is announcing the
availability of a draft guidance for industry entitled ``Voluntary
Labeling Indicating Whether Foods Have or Have Not Been Developed Using
Bioengineering.'' FDA developed this draft guidance to assist
manufacturers, who wish to voluntarily label their foods (human and
animal) as being made with or without bioengineering or the use of
bioengineered ingredients, to ensure that labeling is truthful and not
misleading. FDA is taking this action in response to requests from food
manufacturers and as part of the Clinton administration's initiatives
to strengthen science-based regulation of bioengineered foods and
consumer access to information.

DATES: Submit written comments on the proposed rule by April 3, 2001.
Submit written comments on the information collection provisions by
February 20, 2001.
See section XIV of this document for the proposed effective date of
a final rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written comments on the information
collection provisions to the Office of Information and Regulatory
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235,
Washington, DC 20503, Attn: Desk Officer for FDA.

Regarding human food issues: Linda S. Kahl, Center for Food Safety
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3101.
Regarding animal feed issues: William D. Price, Center for
Veterinary Medicine (CVM) (HFV-200), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6652.


II. Legal Authority

FDA is responsible for ensuring that all foods \6\ in the American
food supply conform to the applicable provisions of the law. The act
provides FDA with broad authority to regulate the safety and
wholesomeness of food. In particular, the act prohibits the
adulteration of food under section 402 of the act (21 U.S.C. 342) and
the misbranding of food under section 403

[[Page 4709]]

of the act (21 U.S.C. 343). The act also requires that all food
additives (as defined by section 201(s) of the act (21 U.S.C. 321(s)))
be approved by FDA before they are marketed (sections 409 and 402 of
the act (21 U.S.C. 348(a) and 342(a)(2)(C))). FDA is authorized to seek
sanctions against foods that do not adhere to the act's standards,
through seizure of foods that violate the act under section 304 of the
act (21 U.S.C. 334); the agency is also authorized to seek an
injunction against, or criminal prosecution of, those responsible for
introducing such foods into commerce under sections 302 and 303 of the
act (21 U.S.C. 332 and 333).

The agency reiterates its view, as stated in the 1992 policy (57 FR
22990), that transferred genetic material can be presumed to be GRAS.
Likewise, FDA is not altering its view, as set forth in the 1992
policy, that there is unlikely to be a safety question sufficient to
question the presumed GRAS status of the proteins (typically enzymes)
produced from the transferred genetic material, or of substances
produced by the action of the introduced enzymes (such as
carbohydrates, fats, and oils), when these proteins or other substances
do not differ significantly from other substances commonly found in
food and are already present at generally comparable or greater levels
in currently consumed foods. However, FDA recognizes that because
breeders utilizing rDNA technology can introduce genetic material from
a much wider range of sources than previously possible, there is a
greater likelihood that the modified food will contain substances that
are significantly different from, or are present in food at a
significantly higher level than, counterpart substances historically
consumed in food. In such circumstances, the new substances may not be
GRAS and may require regulation as food additives (57 FR 22990).

For complete text, do a search on the FR number at GPO Code of Federal Regulations