CSPI On Transgenic Fish
Statement of CSPI Biotechnology Project Director Greg Jaffe
January 15, 2003
The Pew Initiative's new report on transgenic fish accurately describes the strengths and weaknesses of a regulatory system that relies upon the “animal drug” provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Those provisions provide for a mandatory premarket approval process but require that process to be confidential. They provide FDA with adequate authority to ensure that transgenic fish are safe for human consumption but don't give FDA the legal tools and scientific expertise needed to ensure that those fish won't cause ecological harm.
The gaps and ambiguities in the regulatory process make it unlikely that consumers will trust government assurances that genetically engineered animal foods are safe. For the public to accept and consume transgenic fish, the regulatory process by which the government determines safety is as important as the safety determination itself. Even if FDA determines that transgenic fish are safe to eat and will not harm the environment, the public will not embrace those decisions if they are made in secret.
The Pew report does not propose solutions to the regulatory problems it identifies but Senator Durbin has. He introduced legislation in the last Congress—The Genetically Engineered Foods Act (S. 3095)—which would amend the “animal drug” provisions of FFDCA to provide FDA with explicit authority to assess and address environmental effects of transgenic animals, as well as require that the regulatory process be both transparent and participatory. Congress needs to pass such legislation before transgenic animals are commercialized. The biotechnology industry, the food industry, and the Bush Administration should support such targeted legislation because without it our society will not reap any benefits from safe transgenic animal products.