Changes

== Regulation and Approval Process ==The U.S. government will regulate the recombinant DNA in the salmon as a drugNew Animal Drug (NAD). Thus, it falls under the regulatory authority of the FDA. A few weeks after issuing its initial finding that the GE salmon is safe to eat, the FDA will hold two public meetings on the issue September 19-21, 2010.<ref>[http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm224089.htm Public Meetings on Genetically Engineered Atlantic Salmon], U.S. FDA, Accessed September 7, 2010.</ref> The first, a meeting of the FDA's [[Veterinary Medicine Advisory Committee]] (VMAC) will take place September 19-20, addressing the scientific issues associated with the approval of GE salmon. The second, a public hearing in which the FDA will present the legal principles for food labeling and offer the public an opportunity to comment, will take place on September 21, 2010. Prior to the meetings, the FDA released a number of documents, including a briefing packet for the VMAC meeting describing the science used to determine the GE salmon's safety.<ref>[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf Briefing Packet for AquAdvantage Salmon Veterinary Medicine Advisory Committee (PDF - 2506KB)], U.S. FDA.</ref> === Concerns With the Approval Process ===In comments submitted to the FDA, [[Consumers' Union]] noted that the FDA was violating the law for approving New Animal Drugs, as all of the safety data about the GE salmon came from salmon raised in Prince Edward Island (PEI) and the approval, if given, would be for salmon raised in Panama.<ref>[http://www.consumersunion.org/pdf/CU-comments-GE-salmon-0910.pdf Consumers Union’s Senior Scientist to Appear at Veterinary Medicine Advisory Committee Meeting on Genetically Engineered Salmon, September 19-20: Data Suggests Increased Allergy Risk; FDA Needs Much More Data Before Approval], Consumers' Union, September 17, 2010.</ref> Consumers' Union added that the FDA itself admitted that there would likely be phenotypic differences in fish raised in Panama compared to those raised in Prince Edward Island: 'A fundamental problem with all the phenotypic characterization data, and indeed all the nutritional and food safety assessment data, is that they all come from GE Salmon raised in the PEI facility, not at the facility in Panama. FDA admits that the culture/husbandry conditions at the facility in Panama will likely differ significantly from the conditions at the PEI facility with unknown effect on the GE salmon’s phenotype but then concludes that it has no concerns with the different culture conditions: "the culture (e.g., water temperature, pH, alkalinity, etc.) were likely to be significantly different from the facility at PEI as a result of differences in, among others, water surface, facility design, and environmental factors due to geographic location. . . . the effect of the difference between the PEI and Panama facilities, especially temperature, on the resulting AquAdvantage phenotype is unknown." ... We do not understand how FDA can conclude, in the absence of any data on the phenotype of GE salmon raised at the Panama facility, that there are no animal health concerns with GE salmon raised at the Panama facility... This should be unacceptable for a GE animal approval, as it appears to violate the NAD regulations.' Consumers' Union continues, explaining: "FDA is regulating the GE salmon as a New Animal Drug, with the NAD being the genetic (e.g. rDNA) construct itself. Thus, the husbandry and rearing conditions of GE fish into which the genetic construct has been inserted would constitute the production process. Under the NAD provisions of the Federal Food Drug and Cosmetics Act (FFDCA), a NAD is granted for a specific production process; if a company changes the production process for a NAD, the company must submit data to the FDA to show that such a change does not have an effect on the safety or efficacy of the NAD, i.e. the FDA does not assume that drugs made with different production processes are equivalent and requires data to show they are equivalent. Since the husbandry/rearing conditions differ between Panama and PEI—the former being in the tropics, the latter in the temperate zone—this means that the production process (e.g. husbandry/rearing conditions) differs as well, and FDA should require Aqua Bounty to submit data showing that it does not impact the safety of the NAD. FDA should insist, for example, that the rearing conditions in Panama do not increase the levels or potency of allergenic proteins in the salmon." In a separate letter, one sent to FDA Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein, Consumers' Union also notes that the public comment period is exceptionally short - 14 days as opposed to the usual 60 or 90 days given - and that the members of the [[Veterinary Medicine Advisory Committee]] are not qualified or unbiased in their expertise to make the approval decision.