P A N U P S
Pesticide Action Network Updates Service
Action Alert: GE Food Safety
December 17, 1999
The Food and Drug Administration (FDA), the U.S. government
responsible for food safety, has recently held a series of public
meetings on its policy regarding genetically engineered (GE)
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
and local non-governmental organizations including Pesticide
Network North America (PANNA).
FDA will also accept written comments on the policy until January
PANNA urges everyone to write FDA demanding that the Agency:
1. institute thorough pre-market testing and labeling of all GE
2. withdraw all GE foods from the market until they are subject
thorough safety assessments; and
3. place a moratorium on all approvals of new GE food products
required safety and labeling programs are in place.
Every day, millions of infants, children and adults in the U.S.
consuming genetically engineered food without knowing it. Tests
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,
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
received almost 4,000 comments on the policy, most calling for
safety testing and/or labeling, FDA essentially ignored the
and has proceeded with a voluntary program that has yet to
single safety test. While FDA urges corporations to thoroughly
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
the Agency before marketing GE foods. The voluntary consultation
consists of discussions between FDA and the corporation
safety and nutritional assessments prepared by the corporation.
the end of the process, FDA prepares a brief memorandum
the interaction and declaring the consultation complete. The
memorandum typically indicates that the company, not FDA, has
that the GE crop does not differ significantly from
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
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
ACTION -- Write FDA and tell them that current policies do not
the public's need for information and do not adequately protect
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
genetically engineered foods and to insure that no such products
posing a significant health risk are put on the market. FDA
develop detailed protocols for assessing risks including
allergenicity, toxicity, and nutritional changes; require
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
opportunities for citizens to comment on pending approvals.
* to require any GE product which passes FDA's safety review and
marketed to carry a label stating that "This product
genetically engineered material, or was produced with a
engineered material and contains genes from XX sources."
should be mandatory for all genetically engineered products,
or not current testing techniques can detect foreign DNA. The
should be straightforward and informational and not include
value-laden words like "improved with" or
"enhanced by" genetic
* to require imported genetically engineered food, which
receives no safety review, to undergo the same review as domestic
* to withdraw all GE foods from the market until they are subject
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
http://www.fda.gov/oc/biotech/ then click on "Comment on
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
Hansen, Consumer Policy Institute, 1999. "FDA Implements
Food Safety Reviews," December 1994, The Gene Exchange.
Change," Consumer Reports, September 1999.
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Pesticide Action Network North America (PANNA)
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Phone: (415) 981-1771
Fax: (415) 981-1991
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