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Send Your Comments on Safety-Testing & Labeling
of GE Foods to the FDA Before Jan. 13

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P A N U P S
Pesticide Action Network Updates Service
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Action Alert: GE Food Safety

December 17, 1999

The Food and Drug Administration (FDA), the U.S. government agency
responsible for food safety, has recently held a series of public
meetings on its policy regarding genetically engineered (GE) food.
The last of the three hearings was held December 13, 1999, in
Oakland, California. Outside more than a thousand people
participated in a rally demanding pre-market safety testing and
labeling. The demonstration was organized by a coalition of national
and local non-governmental organizations including Pesticide Action
Network North America (PANNA).

FDA will also accept written comments on the policy until January
13, 1999.
PANNA urges everyone to write FDA demanding that the Agency:

1. institute thorough pre-market testing and labeling of all GE
foods;

2. withdraw all GE foods from the market until they are subject to
thorough safety assessments; and

3. place a moratorium on all approvals of new GE food products until
required safety and labeling programs are in place.

Every day, millions of infants, children and adults in the U.S. are
consuming genetically engineered food without knowing it. Tests of
everyday groceries by the Consumers Union show that genetically
engineered foods are already on supermarket shelves--in baby
formulas, tortilla chips, drink mixes, taco shells, "veggie"
burgers, muffin mix--and even in fast-food.

FDA's policy for oversight of genetically engineered crops,
presented in 1991, indicated that FDA would treat GE plants no
differently than traditionally bred plants, except in rare
circumstances. In other words, no pre-market notification nor
pre-market safety testing would be required. Even though the Agency
received almost 4,000 comments on the policy, most calling for
safety testing and/or labeling, FDA essentially ignored the comments
and has proceeded with a voluntary program that has yet to require a
single safety test. While FDA urges corporations to thoroughly test
GE foods, it has allowed the corporations themselves to determine
whether these foods are safe.

Under the policy, FDA does not require that companies consult with
the Agency before marketing GE foods. The voluntary consultation
consists of discussions between FDA and the corporation concerning
safety and nutritional assessments prepared by the corporation. At
the end of the process, FDA prepares a brief memorandum summarizing
the interaction and declaring the consultation complete. The
memorandum typically indicates that the company, not FDA, has found
that the GE crop does not differ significantly from non-engineered
varieties.

Consultations between FDA and corporations are conducted entirely
behind closed doors. The FDA gives no public notice that it is
engaged in consultations, provides no information to the public and
gives no opportunity for the public to participate in the process
allowing GE foods on the market.

After consultations are completed, FDA announces its decisions by
merely posting the information on its Web site. Even then, the
company safety assessments, the basis for FDA's decisions, are
available to the public only through Freedom of Information Act
requests. Companies may withhold significant portions of the data
from the public under claims that they are confidential business
information.

ACTION -- Write FDA and tell them that current policies do not meet
the public's need for information and do not adequately protect the
public from potential health risks. Urge FDA:

* to institute a mandatory regulatory program, in place of its
current system of voluntary consultations, to assess the safety of
genetically engineered foods and to insure that no such products
posing a significant health risk are put on the market. FDA should
develop detailed protocols for assessing risks including
allergenicity, toxicity, and nutritional changes; require long-term
feeding studies using the whole engineered food; and thoroughly
review company testing. All data submitted for FDA assessments
should be part of an open and transparent public process that allows
opportunities for citizens to comment on pending approvals.

* to require any GE product which passes FDA's safety review and is
marketed to carry a label stating that "This product contains a
genetically engineered material, or was produced with a genetically
engineered material and contains genes from XX sources." Labels
should be mandatory for all genetically engineered products, whether
or not current testing techniques can detect foreign DNA. The label
should be straightforward and informational and not include
value-laden words like "improved with" or "enhanced by" genetic
engineering.

* to require imported genetically engineered food, which currently
receives no safety review, to undergo the same review as domestic
foods.

* to withdraw all GE foods from the market until they are subject to
thorough safety assessments; and

* to place a moratorium on all approvals of new GE food products
until required safety and labeling programs are in place.

Comments may be sent directly to FDA by visiting their Web site at
<http://www.fda.gov/oc/biotech/>http://www.fda.gov/oc/biotech/ then click on
"Comment on Federal
Register Notice."

Or write to:
Commissioner Jane Henney
FDA Dockets Management Branch
Attn: Docket No. 99n-4282
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

Sources: "A Regulatory Patchwork--with big holes," by Michael
Hansen, Consumer Policy Institute, 1999. "FDA Implements Informal
Food Safety Reviews," December 1994, The Gene Exchange. "Seeds of
Change," Consumer Reports, September 1999.

Contact: PANNA

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