Aug 17, 2011: Markey Letter to FDA Supporting Review Process for Biotechnology Applications
WASHINGTON, D.C. - Today, Massachusetts Congressmen Edward J. Markey (D-Malden), Barney Frank and James P. McGovern sent a letter to Federal Drug Administration (FDA) Commissioner Dr. Margaret Hamburg in support of the science and risk-based review process the agency uses in its handling of biotechnology applications. The Congressmen encouraged the agency to proceed with full review of the Aquabounty Technologies Inc. application. Text of the letter is below.
August 17, 2011
Commissioner Margaret A. Hamburg, M.D.
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Hamburg:
We believe that the rigorous science and risk-based review process developed by the Food and Drug Administration (FDA) to handle biotechnology applications is an essential component of the proper conduct and mission of the FDA. As a matter of policy, we believe that FDA review processes should continue until their conclusions and should not be unnecessarily interrupted. We are aware that some have argued that the review process for one particular application – for genetically-engineered farm raised Atlantic salmon submitted by AquaBounty Technologies Inc.- should be terminated before FDA has finalized its conclusions. While we take no position on the merits of the AquaBounty application, we strongly encourage the agency to permit the review process of this application to proceed to completion.
It is our understanding that for the last 15 years FDA has been working with AquaBounty Technologies Inc. to collect the appropriate health, safety and environmental data on which a decision for approval would be based. This review has sought technical input from outside agencies such as the National Marine Fisheries Service (NMFS) and the Fish and Wildlife Service (FWS) who have provided expertise and consulted on the impacts these genetically engineered salmon may have on endangered species or their environmental habitat. FDA has also used its scientific expertise to evaluate the safety and effectiveness of the genetically engineered salmon to ensure that it would be safe food for human consumption. To date, we have been informed that FDA has found that the food from the genetically engineered salmon is as safe as food from conventional Atlantic salmon.
Massachusetts has a long history of providing high quality seafood to the American consumer while being an epicenter of American technological advancements. We believe that fair consideration should be given to this new technology and encourage you to proceed with the science-based evaluation and review of AquaBounty’s application.
Edward J. Markey Barney Frank
James P. McGovern