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.
September 13, 2011
Alaska Still Fighting FDA Approval of Genetically Engineered 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.
No comments:
Post a Comment