Animal Biotechnology: Letter in Support of a Science-Based Review Process at FDA

Dear Senators Reid and McConnell and Representatives Boehner and Pelosi:

We are deeply concerned about recent action in the U.S. House of Representatives to amend H.R. 2112, the Fiscal Year 2012 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, to prohibit the Food and Drug Administration (FDA) from spending appropriated funds to finalize its review of an application for genetically enhanced Atlantic salmon.

We do not write to support or oppose this specific application, but rather to register our concern with the House’s action, which if allowed to become law, would disrupt the FDA’s Congressional mandate to base its assessments of human and animal drugs, devices, vaccines, and process applications on the best-available science underlying an application. Such a disruption would diminish the credibility of the FDA approval process at home and overseas. The global reputation of FDA’s science-based review procedure is based on the Agency’s objectivity.

At a June 23, 2011, hearing to examine the benefits of agricultural biotechnology held by the House Agriculture Committee’s Subcommittee on Rural Development, Research, Biotechnology, and Foreign Agriculture, esteemed global hunger expert Dr. Calestous Juma, who currently serves on the staff of Harvard’s Kennedy School of Government, testified as follows regarding his concern about the House’s recent action on genetically enhanced Atlantic salmon:

“I understand this House passed an amendment to the Agriculture Appropriations Bill that would effectively prevent the Food and Drug Administration from completing its safety assessment of the first food fish that makes use of (bio)technology. . . It is not this particular fish that is at stake. It is the principle behind the amendment and its wider ramifications. It sends the message to the rest of the world that the science-based regulatory oversight as embodied in the FDA review process is subject to political intervention. Furthermore, it signals to the world that the United States may cede its leadership position in the agricultural use of biotechnology. . . I believe it is imperative that the United States stay the course it has set in not letting politics interfere with its science-based regulatory system that is truly the envy of the world.”

We share Dr. Juma’s views and strongly urge you to reject the House-passed provision. Thank you for considering our views.

Sincerely,

Members of the Animal Agriculture Coalition