September 13, 2011

Alaska Still Fighting FDA Approval of Genetically Engineered Salmon

There's more pushback in Congress against the pending application from AquaBounty for approval of its genetically engineered (GE) salmon (AquAdvantage), in which the growth hormone gene is reengineered so that it is expressed year-round (rather than seasonally), greatly speeding up the maturation process by about half.  A newly engineered growth hormone gene - with a promoter sequence from ocean pout that confers persistent expression - is injected into fertilized eggs, thus ensuring the the gene is permanently taken up into the genome.  More scientific background here.  Or the concise treatment from the FDA, stating that the fish has  "an enhanced growth phenotype when compared to non-genetically engineered (non-GE) salmon which allows them to grow faster. However, at market size the AquAdvantage Salmon are not phenotypically distinguishable from non-GE fish." Shorthand: you can't tell the GE or non-GE fish apart from simple observation.  Detailed DNA analysis is required to identify the genetic identity of an unclassified salmon.

New efforts by the Alaska delegation continue to oppose any approval action by the FDA for the fish.  The FDA locates its authority to regulate GE fish under the Federal Food Drug and Cosmetic Act (FFDCA), stating that "The rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition; the GE animal itself is not a drug."  The FDA application has been pending now for some 15 years. Yet, the Alaska delegation is concerned about potential mating between the GE salmon and the native Alaska salmon, with the potential to decimate the native genetic structure of the salmon over time.  According to the company, the selected fish would be female and sterile and could not breed with the wild salmon.  But assuming less than 100% ability to properly screen and control the stocks, even a minute number of GE fish that could breed into the wild population could initiate the genetic contamination of the wild-type stock.   The FDA's Veterinary Medicine Advisory Committee held public hearings last year, but the FDA took no action; however, at the time the FDA did issue its conclusion that the GE salmon were indeed safe: "ABT salmon meets the standard of identity for Atlantic salmon as established by FDA’s Reference Fish Encyclopedia. All other assessments of composition have determined that there are no material differences in food from ABT salmon and other Atlantic salmon."  Note the significant phrase of "no material differences" which often appears in regulatory literature describing analyses comparing biotechnology-derived products (such as GE fish) to their native counterparts, and is a conclusion that weakens any claim that special regulation is required for the novel product. Now, Senator Murkowski of Alaska has introduced an amendment that would prevent the FDA from using any resources to approve the salmon; the House of Representative already acted to block any approval. Interestingly, Senator Murkowski will be co-chairing a newly established U.S. Senate Oceans Caucus, which will focus on the multiple issues affecting ocean health and resources.

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