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Mandatory Safety Testing Bill for GE Foods Introduced in US Congress

Office of Congressman Dennis J. Kucinich
10th District, Ohio

PRESS ADVISORY
For Immediate Release Contact: John Edgell
Friday, March 10, 2000 202/225-5871

Introduction of the Genetically Engineered Food Safety Act
Washington, DC --- Representatives Dennis J. Kucinich (D-OH) and Jack
Metcalf (R-WA) this week introduced the bipartisan Genetically Engineered
Food Safety Act. The legislation, with the support of five other primary
cosponsors, will overhaul the current unscientific review process of
genetically engineered foods by the Food and Drug Administration (FDA).
"FDA's current policy for genetically engineered food appears to do more to
protect the biotechnology industry than to protect consumers," said
Kucinich. "FDA's current policy strongly favors food manufacturers at the
expense of consumer protection."
Several recent scientific studies indicate that some important questions
remain unanswered. Many food safety experts believe that biotech companies
and government regulators have failed to ask the right questions with their
research. The issues of concern include allergenicity, unintended effects,
toxicity, and antibiotic resistance.
Under FDA's genetically engineered food policy, the FDA only reviews
summaries of company safety assessments that are voluntarily submitted.
Furthermore, the FDA acknowledges that it "does not conduct a comprehensive
scientific review." Under the Kucinich-Metcalf proposal, all genetically
engineered foods would be required to go through FDA's current food additive
process to ensure genetically engineered foods are safe for human
consumption.
FDA's policy appears to significantly weaken the long-standing requirement
under food safety law that food manufacturers must establish scientifically
the safety of new substances added to food before selling them to the
public.
"For traditional food additives, the word 'safe' is defined as 'reasonable
certainty that no harm would result from the substance.' But for GEFs, the
FDA defines safe as what the industry tells them is safe despite the
potential for health concerns," said Kucinich.
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Summary of "The Genetically Engineered Food Safety Act"
Purpose of the Legislation
Genetically engineered food (GEF) has become a major component of many foods
in the diets of consumers in the United States. Potential health concerns
have arisen as it has become clear that the Food and Drug Administration
(FDA), our food safety regulatory body, takes a minimal approach to safety
testing of GEFs. The potential health concerns include hidden allergens,
unexpected impacts and increased toxins. Long-term safety research does not
exist today, making a cautious approach the appropriate course of action.
The Food Additive Process for Strong Safety Testing
The bill will require all GEFs to go through FDA's current food additive
process to ensure GEFs are safe for human consumption. The bill will also
require that unique concerns of GEFS are explicitly examined in the review
process. The concerns to be examined include, but are not limited to,
allergenicity, unintended effects, toxicity, functional characteristics, and
nutrients levels. However, the food additive process gives the FDA
discretion in applying the safety factors that are generally recognized as
appropriate.
A Public Review Process
The bill requires FDA to conduct a public comment period of at least 30 days
once the completed safety application is available to the public. The bill
requires that all studies performed by the applicant must be made available
including all data unfavorable to the petition. Limits on confidentiality of
the information within application are also included. The FDA will maintain
a publicly available registry of the GEFs for which food additives are
pending or have been approved. The NEPA process is clarified to ensure a
full environmental review when necessary for a GEF.
Removing Hidden Food Allergens From the Market
GEF's that contain proteins transferred from "commonly or severely
allergenic" foods must undergo serum or skin tests, the best available
technologies for testing known allergens. For all other foods, the best
available tests for unknown allergens must be used. If testing shows that
the proteins are likely to be "commonly or severely allergenic," the foods
made with such proteins are prohibited. The National Institute of Health is
to be consulted on the testing methods used.
Antibiotic Resistance Marker Phaseout
Antibiotic resistance markers, used to efficiently create GEFs, may lead to
increased antibiotic resistance. The bill phases them out by June 2004,
unless they have been removed prior to commercialization. Other alternatives
for GEFs are being researched and will soon be available.
Independent Testing
The FDA is granted discretion to conduct or contract out for independent
testing of any GEF undergoing a food additive review. Since all current
testing is performed by the food company, the FDA has the option to conduct
their own tests.
Current GEFs on the Market
Current GEFs on the market must go though this food additive process within
2 years from the date FDA issues a final rulemaking. Any GEFs on the market
in 2 years without FDA approval from this food additive process must be
removed from the market until they complete this food additive process.
Ensuring Adequate FDA Resources for this Task
A user fee is authorized to pay for FDA regulatory efforts including the
food additive approval process, FDA's long-term research fund and any
independent testing. The purpose of this funding mechanism is to ensure that
FDA has the resources to ensure GEFs can move through the process in an
acceptable amount of time.
FDA Research for an Efficient Regulatory Process
The FDA is authorized to fund necessary long term scientific research on
issues regarding genetically engineered food that will support FDA's
regulatory review. The research shall address fundamental questions and
problems that arise repeatedly during the review process and shall not
directly support development of new GEFs.
National Academy's Institute of Medicine
The National Academy's Institute of Medicine shall conduct a review of the
all generic FDA rulemakings and report to Congress any concerns raised.
For more information on the Genetically Engineered Food Safety Act, please
contact the office of Representative Dennis Kucinich at (202) 225-5871.

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