Questions and Answers (September 2010 VMAC)
Q: What is FDA reviewing?
A: FDA is reviewing an application for the approval of a recombinant DNA (rDNA) construct (the AquAdvantage construct) introduced into Atlantic salmon. The resulting genetically engineered salmon are referred to as “AquAdvantage Salmon,” and are intended to grow faster than conventionally farmed Atlantic salmon.
Q: What are the steps in the review?
A: The process for decision-making on the application for approval of AquAdvantage (AA) Salmon includes the following:
- Public orientation session for the VMAC meeting by Agency experts;
- Presentation to VMAC of data and information relevant to AA Salmon;
- Public comment at the VMAC meeting;
- Charge to VMAC; Deliberation; Opinion;
- Committee response to charge;
- Publish environmental assessment; and
- Agency decision on approval of NADA.
Q: Where can information about this application be found?
- A detailed agenda including topics and speakers;
- Briefing materials on Guidance 187 and other information presented for the Orientation Session;
- An overview of the New Animal Drug Application for AquAdvantage Salmon, including a description of the AquAdvantage Salmon and its characteristics;
- Summary data and information relevant to determining safety and validating the sponsor’s claim; and
- The sponsor’s environmental analysis.
Q: How is the public participating in the review process for this application?
The public is participating in a number of ways:
- Reviewing the posted materials
- Attending the VMAC meeting
- Submitting written comments to the VMAC
- Addressing the VMAC at the public meeting
- Reviewing and commenting on the environmental assessment that will be posted following the meeting
In addition, the public is participating in a separate, but related, meeting on the application of food labeling principles to foods from AquAdvantage Salmon, if the application is approved. Participation includes:
- Reviewing the posted labeling materials
- Providing written comments on labeling, both before and after the meeting
- Speaking at the public meeting on labeling
Q: What information has FDA released on this application?
Q: Does the Agency do an environmental analysis?
A: Yes. Decisions on new animal drug applications constitute agency actions under the National Environmental Policy Act (NEPA). FDA will be considering the possible effects on the human environment and possible risk mitigation strategies that may arise from the specific conditions of use that are the subject of this application.
Q: Why is FDA reviewing this application now?
A: FDA reviews applications whenever they are complete. Because the sponsor submitted the application, FDA must make a decision regarding that application. A typical new animal drug application can take as much as 5 to10 years from first filing to a final conclusion.
Q: What are the key requests in the application for AquaAdvantage Salmon?
A: The company is requesting permission to market a specific fish with a specific claim under certain limitations of use. Specifically:
- Product Identity. 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.
- Claim: Significantly more of these Atlantic salmon grow to at least 100 g within 2,700oC-day than their comparators.
- Limitations for Use: These Atlantic salmon are produced as eyed-eggs for grow-out only in the FDA-approved, physically-contained fresh water culture facility.
Approval, should it be granted, would only be for triploid, all female AquAdvantage Salmon that reach the growth requirements in the claim and that are produced in the facilities in the application.
Q: If approved, where would these fish be raised?
A: If this application is approved, the fish would be bred in the broodstock facility in Canada; fertilized, triploid eggs will be shipped to the grow-out facility in Panama, where they will be raised to market size. To raise these fish anywhere else, the company would have to submit another application to the Agency.
Q: What is the source of the data in the application?
A: The data in the application is provided by the company, because the burden of proof is on the sponsor to demonstrate that the article is safe for the animal as well as for humans consuming products from the animal. As part of the review process, whenever FDA had additional questions, the Agency requested additional data from the sponsor. FDA also has the right to inspect, audit, and verify any and all data and information provided to the Agency.
It is illegal for a sponsor to provide false statements or data to the Agency.
In addition to what was provided in the application, the agency also relied on other sources of data and information, including published peer-reviewed literature.
Q: Has FDA already made a decision on approval?
A: No. The Agency has posted its current review of the data and information relevant to the application, and will present its review to the advisory committee for discussion, advice, and recommendations. It will also take into account comments made from the public to the VMAC.
FDA will not make a final decision on approval until it considers any additional information that has been presented. It will not approve the application unless it is satisfied that the rDNA construct is safe for the AquAdvantage Salmon, and that food from the AquAdvantage Salmon is safe to eat. In addition, FDA will meet its obligations under the National Environmental Policy Act to consider possible environmental impacts.
Q: What is a post-market surveillance program?
A: There is post-market surveillance of all FDA-approved new animal drugs. FDA wants to ensure that the product that goes to market has the level of quality that it is purported to have. So for this application, the sponsor will collect data on rates of certain outcomes such as changes in the appearance of the salmon.
Q: What if I have additional comments I want to make on the issues presented before the Veterinary Medicine Advisory Committee concerning the safety and effectiveness of AquAdvantage Salmon?
FDA accepts general correspondence from the public at any time. If you have comments on this topic, you are welcome to send them to the agency for its consideration at AskCVM@fda.hhs.gov
. (See 21 CFR Part 10.)