IS THE FDA DOING ITS JOB?
Carmelo Ruiz-Marrero
September 15 2008
http://bistandsaktuelt.typepad.com/the_gmo_debate/

Published by the Norwegian development journal "Bistandsaktuelt".

[Ruiz Marrero is founder and director of the Puerto Rico Project on Biosafety. http://bioseguridad.blogspot.com/ ]

The main argument of defenders of products derived from genetically modified organisms (GMO's) is that the US Food and Drug Administration (FDA) determined in 1992 that they are safe and therefore need no further safety testing.

The FDA refused to allow the public to view the internal documents related to these tests, which caused in 1998 a lawsuit by a coalition of civil society and public interest groups headed by the Alliance for Biointegrity demanding that these be made public. The judge ruled in the plaintiffs' favor, resulting in the release of over 44,000 pages of documents. These show that contrary to the agency's top officials' assurances, staff scientists had major misgivings about the safety of GM foods.


The declassified documents are revealing and extremely interesting. In one of them, dated March 6 1992, microbiologist Louis Pribyl says that “The unintended effects cannot be written off so easily by just implying that they too occur in traditional breeding. There is a profound difference between the types of unintended effects of traditional breeding and genetic engineering.”

Compliance officer Linda Kahl warned in a memo dated January 8 1992 that by “trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices” the FDA was “trying to fit a square peg into a round hole... The processes of genetic engineering and traditional breeding are different and according to the technical experts in the agency, they lead to different risks.”

The man put in charge of overseeing the GMO evaluations at the FDA, Michael Taylor, was not a scientist but a lawyer. He had previously represented US biotechnology giant Monsanto. After leaving the FDA he went back to his private practice, eventually becoming Monsanto's vice president. This is a classic case of the revolving door syndrome, the conflict of interest caused by the constant movement of professionals back and forth between the private and public sectors.

Taylor's case is in no way unique. US Supreme Court judge Clarence Thomas was a Monsanto lawyer. Former US defense secretary Donald Rumsfeld was for eight years the CEO of the Searle pharmaceutical company, which Monsanto bought in 1985. And Anne Veneman, first agriculture secretary of the Bush-Cheney administration, was a member of the board of directors of the Calgene corporation, bought by Monsanto in 1997.

Activist and researcher Beth Burrows, president of the Edmonds Institute, investigated for years the biotechnology revolving door in the United States but eventually gave it up, reasoning that it would be more useful to document cases of public servants that were NOT moving into the biotechnology industry.

Michael Taylor's direct supervisor at the FDA was James Maryanski. French film maker Marie Monique Robin confronted him in her recent documentary Le Monde Selon Monsanto regarding the internal memoranda that indicated that staff scientists had doubts about the safety of GM foods. Marynski acknowledged the dissent but stated that in the end everyone agreed GM was perfectly safe.

The FDA is required to approve a food or medication only if there is a broad consensus among its staff about its safety and if there is a substantial body of peer reviewed studies supporting its safety. GM foods did not meet either requirement.

REFERENCES:

Cummins, Claire. “Uncertain Peril: Genetic Engineering and the Future of Seeds”. Beacon Press, 2008.

Edmonds Institute revolving door database. http://www.edmonds-institute.org/door.html

Robin, Marie Monique. Le Monde Selon Monsanto. http://www.arte.tv/lemondeselonmonsanto

Smith, Jeffrey. “Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods”. Yes! Books, 2007.