BOSTON, July 24, 2013 /PRNewswire/ -- Following is AquaBounty Technologies, Inc. comment on a paper published in today's Food Drug Law Institute's Food and Drug Policy Forum. In this publication, three respected scientists with long U.S. Food and Drug Administration relationships finds the process used by the US FDA to regulate products from genetically modified animals so rigorous that it goes far beyond the legally required scientific analysis of food and environmental safety.
"AquaBounty applied for US FDA approval twenty years ago. We have complied with every regulatory requirement. The company and the US FDA have been remarkably transparent," said Ronald L. Stotish, PhD, CEO of AquaBounty. "Yet our salmon, which grows to market weight in half the time and is the most studied fish in the world, still languishes in regulatory limbo. This article describing the onerous and unworkable process helps explain why the FDA's hands have been tied by forces outside the agency's control."
The paper— the authors include a member for the independent advisory panel that reviewed the data for the world's first genetically modified food animal and two noted PhDs who testified at the FDA's public hearings on the topic— says the scrutiny required by this process forces the agency to respond to non-science-based claims and fall victim to political interference. The scientists say in the paper:
"Science is the basis for the FDA's considerations of all products... Lacking the background to interpret the science associated with GE [genetically engineered] animals as presented, activists often offer biased interpretations of the data and criticize the process by which the regulatory decision making goes forward. Further, elected officials criticize agency actions on the basis of perceived risks to narrow constituencies. Regulatory actions...should be based exclusively on science."
The paper confirms facts previously released many times by the US FDA, namely fish grown from AquAdvantage ® Salmon eggs:
The authors also say unaccountable delays have jeopardized the FDA's ability to regulate rDNA animal products and have started to force these technologies offshore, despite their benefits. They quote Dr. Calestous Juma, Harvard's Kennedy School of Government, that this nearly 20-year process:
"is as safe as food from conventional salmon" and that these salmon "will not have any significant impacts on the quality of the human environment of the United States ... when grown and produced under the conditions of use for the proposed action."
The paper also points out that when the science-based process is ignored, regulation can be influenced by those who don't understand basic biology and have financial interests. For example, Rep. Don Young (R-AK) told the Washington Post his objective was to "put the company out of business" even though, the researchers drily note, it is biologically impossible for Atlantic salmon to mate with Pacific salmon -- even if they were able to overcome infertility, escape multiple redundant containment systems and swim hundreds, if not thousands, of miles to his state. The authors make four policy recommendations to help protect the US FDA from non-science-based meddling as follows:
"...sends a message to the rest of the world that 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."
- Maintain and strengthen a science-based regulatory review system for the evaluation of GE animals and continue formal consultation with all agencies with relevant expertise.
- Require hypothesis-driven studies for regulatory evaluation detailing the biologically relevant issue(s) based upon the novel traits or phenotype(s) associated with the species/gene/insertion event combination.
- Focus risk assessments on those unique risks associated with the GE animal application and evaluate them in relation to known risks associated with existing production systems.
- Following submission of all pre-defined required data, impose finite response times for agency decisions at each point in the evaluation process to provide developers and investors with a predictable regulatory timeline for GE animals.