Posted: 13 Apr 2015 01:29 AM PDT
By Jay W. Cormier –
It has been quite some time since the September 2010 Veterinary Medicine Advisory Committee (“VMAC”) meeting that discussed FDA’s review of AquaBounty’s AquAdvantage Salmon application. Earlier this month, Food and Water Watch – a long-time and very vocal opponent to the AquAdvantage Salmon – filed a Citizen Petition (“CP”) and a Food Additive Petition (“FAP”) in an effort to block marketing of AquAdvantage Salmon filets, should an approval ever occur (available here).
In the interest of full disclosure, your author, while working for FDA, helped develop FDA’s approach to the review and approval of genetically engineered animals, was one of the lead reviewers at FDA’s Center for Veterinary Medicine (“CVM”) for the AquAdvantage Salmon, and presented at the 2010 VMAC meeting on behalf of FDA.
By way of background, as it has been such a long time since the FDA Law Blog last discussed the AquAdvantage Salmon (hereand here), the salmon is a genetically engineered Atlantic salmon that has had a single copy of a transgene inserted into its DNA. Atlantic salmon typically take around 4 years of farming (Atlantic salmon are protected as an endangered species, so fishing and sale of wild Atlantic salmon is illegal) to reach market size. During that time, the salmon only grow during specific times of the year, yet they require adequate food, clean water, and space to swim throughout the entire year. The AquAdvantage Salmon, however, are engineered to grow all year; they do not grow any larger than their non-engineered counterparts – they just reach their size sooner.
Importantly, AquAdvantage Salmon are also produced such that, with the exception of a small breeding group of fish, they are rendered sterile. This is done by breeding the salmon so that their genomes contain three copies of each chromosome instead of the usual two copies.
The shorter time to market size means that it would be economically feasible to grow salmon contained in inland tanks rather than in net pens in the open ocean. As a result, water quality can be better managed and the salmon can be isolated from other species. Thus, any number of issues that arise from high density ocean farming operations can be avoided.
AquaBounty first submitted data to FDA in the mid-1990s regarding its AquAdvantage Salmon. It took FDA roughly 15 years, but in 2010, CVM convened its VMAC for a two-day meeting to discuss the scientific review of the data supporting approval of the AquAdvantage Salmon. The review team from CVM presented the conclusions of its review to the VMAC – the AquAdvantage Salmon was as safe to eat as non-engineered salmon, the transgene and its expression product was safe to the salmon and was effective, and the engineered salmon did not pose a significant risk to the human environment.
Over four-and-a-half years have passed since the VMAC meeting. During that time, the AquAvantage Salmon application has languished. CVM formally issued its draft Environmental Assessment and its draft Finding of No Significant Impact for public comment in 2012. To date, FDA has not finalized these documents, and has not approved the AquAdvantage Salmon application. Meanwhile, there have been several failed attempts in Congress to ban AquAdvantage Salmon or to deprive FDA of its ability to approve the application.
In a new twist to this saga, on April 2nd, Food and Water Watch took the very unusual step of filing both a Citizen Petition and a Food Additive Petition for the same issue. Specifically, Food and Water Watch seek to have the AquAdvantage Salmon listed as a substance which is prohibited from use in human food. Under Food and Water Watch’s petitions, FDA would promulgate a regulation that would specifically and explicitly deem AquAdvantage Salmon adulterated food as a matter of law, irrespective of whether the food from AquAdvantage Salmon poses any risk at all to consumers. Seemingly unsure of how to go about making such a request of FDA, Food and Water Watch filed both petitions, each asking FDA to consider the other in the event that one of the petitions is not the proper avenue for making the unusual request.
The Food and Water Watch petitions ask FDA to find that consuming the engineered salmon is injurious to health and should therefore be prohibited as a food additive. The petitioners argue that, notwithstanding the fact that the statutory definition of a food additive excludes new animal drugs, FDA has the flexibility to consider AquAdvantage Salmon as both a new animal drug and a food additive. The petitions take issue with FDA’s review process and the data used to support the approval of the AquAdvantage Salmon. They further argue that the salmon must be reviewed as a food additive.
Whether FDA will agree with these arguments will not be known for some time, but we will continue to watch for any further developments as FDA continues to consider approving AquAdavantage Salmon.
It has been quite some time since the September 2010 Veterinary Medicine Advisory Committee (“VMAC”) meeting that discussed FDA’s review of AquaBounty’s AquAdvantage Salmon application. Earlier this month, Food and Water Watch – a long-time and very vocal opponent to the AquAdvantage Salmon – filed a Citizen Petition (“CP”) and a Food Additive Petition (“FAP”) in an effort to block marketing of AquAdvantage Salmon filets, should an approval ever occur (available here).
In the interest of full disclosure, your author, while working for FDA, helped develop FDA’s approach to the review and approval of genetically engineered animals, was one of the lead reviewers at FDA’s Center for Veterinary Medicine (“CVM”) for the AquAdvantage Salmon, and presented at the 2010 VMAC meeting on behalf of FDA.
By way of background, as it has been such a long time since the FDA Law Blog last discussed the AquAdvantage Salmon (hereand here), the salmon is a genetically engineered Atlantic salmon that has had a single copy of a transgene inserted into its DNA. Atlantic salmon typically take around 4 years of farming (Atlantic salmon are protected as an endangered species, so fishing and sale of wild Atlantic salmon is illegal) to reach market size. During that time, the salmon only grow during specific times of the year, yet they require adequate food, clean water, and space to swim throughout the entire year. The AquAdvantage Salmon, however, are engineered to grow all year; they do not grow any larger than their non-engineered counterparts – they just reach their size sooner.
Importantly, AquAdvantage Salmon are also produced such that, with the exception of a small breeding group of fish, they are rendered sterile. This is done by breeding the salmon so that their genomes contain three copies of each chromosome instead of the usual two copies.
The shorter time to market size means that it would be economically feasible to grow salmon contained in inland tanks rather than in net pens in the open ocean. As a result, water quality can be better managed and the salmon can be isolated from other species. Thus, any number of issues that arise from high density ocean farming operations can be avoided.
AquaBounty first submitted data to FDA in the mid-1990s regarding its AquAdvantage Salmon. It took FDA roughly 15 years, but in 2010, CVM convened its VMAC for a two-day meeting to discuss the scientific review of the data supporting approval of the AquAdvantage Salmon. The review team from CVM presented the conclusions of its review to the VMAC – the AquAdvantage Salmon was as safe to eat as non-engineered salmon, the transgene and its expression product was safe to the salmon and was effective, and the engineered salmon did not pose a significant risk to the human environment.
Over four-and-a-half years have passed since the VMAC meeting. During that time, the AquAvantage Salmon application has languished. CVM formally issued its draft Environmental Assessment and its draft Finding of No Significant Impact for public comment in 2012. To date, FDA has not finalized these documents, and has not approved the AquAdvantage Salmon application. Meanwhile, there have been several failed attempts in Congress to ban AquAdvantage Salmon or to deprive FDA of its ability to approve the application.
In a new twist to this saga, on April 2nd, Food and Water Watch took the very unusual step of filing both a Citizen Petition and a Food Additive Petition for the same issue. Specifically, Food and Water Watch seek to have the AquAdvantage Salmon listed as a substance which is prohibited from use in human food. Under Food and Water Watch’s petitions, FDA would promulgate a regulation that would specifically and explicitly deem AquAdvantage Salmon adulterated food as a matter of law, irrespective of whether the food from AquAdvantage Salmon poses any risk at all to consumers. Seemingly unsure of how to go about making such a request of FDA, Food and Water Watch filed both petitions, each asking FDA to consider the other in the event that one of the petitions is not the proper avenue for making the unusual request.
The Food and Water Watch petitions ask FDA to find that consuming the engineered salmon is injurious to health and should therefore be prohibited as a food additive. The petitioners argue that, notwithstanding the fact that the statutory definition of a food additive excludes new animal drugs, FDA has the flexibility to consider AquAdvantage Salmon as both a new animal drug and a food additive. The petitions take issue with FDA’s review process and the data used to support the approval of the AquAdvantage Salmon. They further argue that the salmon must be reviewed as a food additive.
Whether FDA will agree with these arguments will not be known for some time, but we will continue to watch for any further developments as FDA continues to consider approving AquAdavantage Salmon.
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