Response: Under the FD&C Act and FDA’s implementing regulations, in order to approve a new animal drug, FDA must find the drug safe and effective for the animal (21 U.S.C. Each source, in turn, is given appropriate deference with respect to its relevance to the specific question under consideration. The FDA therefore concludes that the grow-out of AquAdvantage Salmon under the conditions specified in the supplemental application and as described in the Environmental Assessment would not result in significant effects on the quality of the human environment in the United States. The data demonstrate the initial culling did not mask adverse health outcomes for the parameters evaluated. Comment Summary: A number of the comments addressed overall organization of the VMAC meeting held on September 19-20, 2010. AquaBounty’s salmon, touted for its abnormally high growth rate, marks the first time the FDA has allowed a genetically modified animal to be raised and sold for food. The intent in doing so was to determine if subtle, but reproducible, abnormalities would occur and pose risks to animal health or food safety. The reason there are more animals in these safety studies is to assure that there are sufficient animals to meet the study acceptance criteria at critical time points in the study. From the sponsor’s study, mean levels of estradiol, testosterone, 11-ketotestosterone, T3, and T4 were not different in the ABT salmon than levels in comparator non-GE salmon (Table 22). Response: Although AquAdvantage Salmon contain the opAFP-GHc2 rDNA construct, and therefore differ from farm-raised non-GE Atlantic salmon at that locus (a locus is a specific site in the genome of an organism) and thereby grow more quickly than their non-GE counterparts, they are not otherwise significantly different from farm-raised Atlantic salmon. The FDA’s lawyers also gave Chhabria something else to consider: proposing that it actually doesn’t have the authority to approve or reject a drug based on its potential adverse effects on Atlantic salmon. They are a subset of ABT salmon, which are defined as any GE Atlantic salmon from the E0-1α lineage, irrespective of ploidy, zygosity, or gender (i.e., the set of salmon that includes diploid GE salmon that may be used as broodstock, as well as AquAdvantage Salmon or other triploid GE salmon). Based on all previous criteria including statistical analysis, FDA concluded that the levels of all proximate, vitamin, mineral and amino acid analytes in TX salmon except vitamin B6 are similar to levels in one or more appropriate groups of control salmon, and therefore the statistical differences are not biologically relevant. Response: The conditions established in the approved application, AquAdvantage Salmon are to be bred and raised only under the conditions specified in the approved application: breeding in a specific FDA-inspected facility in Canada and grown-out in a specific facility in Panama where FDA and NMFS conducted an extensive site visit. At a hearing Tuesday, U.S. District Judge Vincent Chhabria said he’s concerned that AquaBounty, the biotech company behind the GMO salmon, might use the FDA’s finding of “no significant impact” to expand the program without realizing its full impact on local ecology. CVM is one of the founding members of the U.S. Government’s interagency Joint Subcommittee on Aquaculture (JSA), formed in 1990. Comment Summary: A few comments asserted that because the studies were conducted by ABT (the sponsor) those studies are biased. Nonetheless, FDA has committed to providing heightened transparency for this GE animal-related application and, as demonstrated by our actions on this GE salmon-related application, we are carrying through on that commitment.
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