"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:
"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 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:
"...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."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:
- 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.