AquAdvantage Salmon FDA Approval Process

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The AquAdvantage Salmon FDA Approval Process followed the regulations for New Animal Drugs under the Federal Food Drug and Cosmetic Act (FFDCA) and the U.S. FDA's guidance on regulation of genetically engineered animals.[1][2] If approved, the AquAdvantage salmon will be the first genetically engineered (GE) animal to directly enter the U.S. food supply. It is also the first GE animal to undergo the FDA's regulatory process for approving GE animals.

The regulatory and approval process for the AquAdvantage salmon has been criticized for being insufficiently transparent, for failing to provide enough time for public comment, for failing to appoint experts with appropriate and sufficient expertise to the VMAC committee, and for accepting "sloppy" and "misleading" science as the basis for the FDA's initial decision that the GE salmon is safe.[3][4]

About AquAdvantage Salmon

AquAdvantage salmon is a genetically engineered (GE) salmon produced by AquaBounty Technologies. AquAdvantage salmon grow to market size in 16 to 18 months instead of the usual 30 required for Atlantic salmon.[5] AquAdvantage salmon are identified as "Triploid hemizygous, all-female Atlantic salmon (Salmo salar) bearing a single copy of the α-form of the opAFP-GHc2 rDNA construct at the α-locus in the EO-1α lineage."[6] In other words, the salmon will each have three complete sets of chromosomes instead of two, and all of the fish will be females. For more information, see the article on the AquAdvantage salmon.

New Animal Drug Application (NADA)

According to FFDCA's New Animal Drug Provisions, AquaBounty Technologies, the maker of the AquAdvantage salmon, had to submit a New Animal Drug Application (NADA), including an environmental assessment or a claim of categorical exemption. Following an application, the FDA has 180 days to either approve the New Animal Drug or offer the applicant a hearing.

Safety Testing of AquAdvantage Salmon

The FDA released its assessment of AquaBounty's safety testing of AquAdvantage salmon in a 180 page document in September 2010.[7] The science used to justify the GE salmon's safety was quite sloppy, as noted by the FDA in several cases in its analysis and as stated in comments submitted by Consumers' Union. For more information, see the article on Concerns About Science Justifying the Safety of AquAdvantage Salmon.

Environmental Assessment

Prior to FDA approval, the AquAdvantage was required to undergo an Environmental Assessment (EA). One of the main concerns addressed in the assessment is the potential for the GE salmon to escape into the wild, particularly if it would be able to survive there and compete with wild populations and/or interbreed with wild populations.[8] For more information, see the article on the AquAdvantage Salmon Environmental Assessment.

VMAC Meeting, September 19-20, 2010

The Veterinary Medicine Advisory Council (VMAC) met to discuss the approval of the AquAdvantage salmon on September 19-20, 2010, a few weeks after the FDA issued a preliminary finding that the AquAdvantage salmon is safe to humans and the environment.[9] This meeting addressed the scientific issues associated with the approval of GE salmon. Prior to the meeting, 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.[10]

The members of VMAC were not directly asked whether the FDA should legalize the GE salmon. Rather, they were asked four questions:

1. Do the data and information demonstrate that the genes put into the salmon are safe for the salmon?
2. Is there a reasonable certainty of no harm to humans from consumption of foods derived from AquAdvantage salmon?
3. Do the AquAdvantage Salmon demonstrably grow faster than their conventional counterparts?
4. Are any potential environmental impacts from AquAdvantage Salmon production adequately mitigated by AquaBounty Technologies’ proposed conditions of use?[11]

One VMAC member, Jodi Ann Lapidus, a professor of biostatistics at Oregon Health and Science University, told the New York Times: "Given its study design, sample sizes and mixture of fish ... I would have to characterize this body of work as potentially [promising] but preliminary work that would need to be validated and confirmed in other studies."[12] Another member, Jim McKean, a professor of swine veterinary science at Iowa State University, said, "There are questions that have not been answered by the data."

Public Meeting on Labeling, September 21, 2010

The FDA held a public meeting on labeling issues related to the AquAdvantage salmon on September 21, 2010.[13] This meeting offered the public an opportunity to comment.

Updated Draft Environmental Assessment and Finding of No Significant Impact, December 2012

The FDA published an updated draft Environmental Assessment (EA) and a preliminary Finding of No Significant Impact (FONSI) for the AquaAdvantage salmon in the Federal Register on December 26, 2012.[14] This began a 60-day public comment period. Following requests for an extension by Senators Mark Begich, Ron Wyden, Lisa Murkowski, Jeff Merkley, Patty Murray, Barbara Mikulski, and Maria Cantwell, the FDA extended the comment period another 60 days until April 26, 2013. The FDA will review the comments and decide whether to finalize the preliminary EA and FONSI or draft an Environmental Impact Statement (EIS).[15]

The Finding of No Significant, dated May 2012, reads, in part:

"With respect to food safety, FDA has concluded that food from AquAdvantage Salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption of food from triploid AquAdvantage Salmon. Further, FDA has concluded that no significant food safety hazards or risks have been identified with respect to the phenotype of the AquAdvantage Salmon."[16]

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.[17] 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.[18]

Articles and resources

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References

  1. New Animal Drug provisions of the Federal Food Drug and Cosmetic Act (FFDCA), FDA, Accessed September 22, 2010.
  2. CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, FDA, Accessed September 22, 2010.
  3. Letter from Consumers Union to FDA About Concerns On VMAC Committee Members for GE Salmon Hearing, Consumers' Union, September 15, 2010, Accessed September 17, 2010.
  4. 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.
  5. Andrew Pollack, "Modified Salmon Is Safe, F.D.A. Says", New York Times, September 3, 2010, Accessed September 7, 2010.
  6. Briefing Packet for AquAdvantage Salmon Veterinary Medicine Advisory Committee (PDF - 2506KB), U.S. FDA, September 20, 2010.
  7. Briefing Packet for AquAdvantage Salmon Veterinary Medicine Advisory Committee (PDF - 2506KB), U.S. FDA.
  8. Environmental Assessment for AquAdvantage Salmon (Aqua Bounty Technologies, Inc.) (PDF - 1095KB), Food and Drug Administration, August 25, 2010.
  9. Public Meetings on Genetically Engineered Atlantic Salmon, U.S. FDA, Accessed September 7, 2010.
  10. Briefing Packet for AquAdvantage Salmon Veterinary Medicine Advisory Committee (PDF - 2506KB), U.S. FDA.
  11. Jill Richardson, "A recap of the FDA's ‘Frankenfish' hearings," Grist, October 4, 2010.
  12. Paul Voosen, "Panel Advises More Aggressive FDA Analysis of Engineered Salmon," New York Times, Greenwire, September 21, 2010, Accessed March 1, 2013.
  13. Public Meetings on Genetically Engineered Atlantic Salmon, U.S. FDA, Accessed September 7, 2010.
  14. Draft Environmental Assessment," Center for Veterinary Medicine, United States Food and Drug Administration, Department of Health and Human Services, May 4, 2012.
  15. Docket FDA-2011-N-0899, Regulations.gov, Accessed February 27, 2013.
  16. Preliminary FINDING OF NO SIGNIFICANT IMPACT AquAdvantage® Salmon," Center for Veterinary Medicine, United States Food and Drug Administration, Department of Health and Human Services, May 4, 2012.
  17. 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.
  18. Letter from Consumers Union to FDA About Concerns On VMAC Committee Members for GE Salmon Hearing, Consumers' Union, September 15, 2010, Accessed September 17, 2010.

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