Contamination of the food supply by experimental genetically engineered (GE) crops is deemed “acceptable” under a new policy expected to be released today by the Food and Drug Administration. As the biotechnology industry conducts more open-air field tests of increasingly complex and risky genetic transformations in common foods, contamination of the food supply through pollen drift and other avenues becomes more likely.  Yet today’s final FDA guidance on “early food safety evaluation” of GE crops sanctions contamination of the food supply, and establishes no requirements for comprehensive safety testing of experimental GE varieties.

“FDA has refused to require labeling or safety testing of the gene-altered foods in our markets, and now they say it’s okay to have genes from pre-market crop experiments hidden in our foods,” said Joseph Mendelson, Legal Director for the Center for Food Safety (CFS). “The agency is clearly committed to putting the biotech industry’s interests ahead of food safety.” Just two weeks ago, CFS sued FDA for its failure to regulate GE foods.

The FDA guidance document outlines a process for the “early food safety evaluation” of GE crops that has no required tests and no recommendations for any animal feeding studies.  FDA acknowledges it is establishing no “requirements,” but only recommendations for a voluntary review of the experimental proteins used in GE crop trials. The agency’s focus solely on the GE protein ignores safety risks from the unintended effects on whole foods caused by genetic engineering, even though such effects are common in GE plants. For example, a study last December found that a protein that is safe in beans produced a potentially allergenic protein when engineered into peas - a result that would likely be missed by a company following FDA’s suggested “food safety” guidance.  Other unintended effects that would be missed by FDA’s recommended testing include increased levels of toxins and/or anti-nutrients in the GE food.

The biotechnology and grain industries have called on the US government to “vigorously promote global adoption” of rules to accept so-called “trace amounts” of genetic contamination of the food supply, suggesting that such a policy could shield them from liability when their experimental crops escape and enter the food supply [1]. While FDA’s guidance assumes that contamination of the food supply will be at trace levels, it sets no maximum allowable level for such contamination. In fact, some people may face high exposures in some contamination incidents, in crops that may be eaten whole and that could contain substantial amounts of the GE protein. The FDA guidance essentially gives industry blanket approval for unlimited levels of food contamination.

Mendelson noted that such a policy would likely lead to an increase in contamination incidents. “With the FDA rubber-stamping these GE proteins as safe, companies field-testing these crops will have no incentive to prevent contamination of our food. On the contrary, this new policy will encourage sloppiness that may result in food disasters.”

Contamination incidents from GE field experiments have already been documented, including at least two field trials of a drug-producing GE corn that contaminated crops intended for the food supply. Government records show that over 47,000 separate GE crop field tests were authorized on over half a million acres in the U.S. from 1987 to 2004.  The field tests include crops genetically engineered to produce pesticides, pharmaceuticals or industrial chemicals, to survive application of herbicides, to have sterile pollen or seeds, as well as nutritionally-altered crops for animal feed.  The identity of most genes, however, is withheld from the public as a trade secret of the biotech company, so the precise nature of these experimental GE crops is often unknown.

In January 2004, the U.S. Dept. of Agriculture proposed a similar policy for its sphere of GE crop regulation (plant pest risks), though it has not issued a final policy.  The Environmental Protection Agency (EPA) is expected to issue a corresponding proposal applicable topesticide-producing GE crops.

FDA release of the policy was announced at:http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0369-nad0002.pdf

The guidance is available here
http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0369-gdl0002.pdf

For CFS comments on a 2004 draft version of today’s final guidance document: http://www.centerforfoodsafety.org/pubs/
CommentsFDAContaminationGuidance1.24.2005.pdf

Information on the CFS lawsuit and petition calling on FDA to require safety testing and labeling of GE foods is at:
http://www.centerforfoodsafety.org/2006/06/07/lawsuit-calls-genetically-engineered-alfalfa-a-risk-to-farmers-and-the-environment/

NOTES:[1] “US Grain Industry, BIO Urge US Government to Expedite “Trace-Amounts” Policy for Biotech Products,” press release, Biotechnology Industry Organization, National Grain & Feed Association, and other trade groups, April 7, 2004: http://www.bio.org/news/newsitem.asp?id=2004_0407_01