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U.S. Department of Health and Human Services

Advisory Committees

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Background Document: The VMAC Meeting on Science-Based Issues Associated with AquAdvantage Salmon

 

I.  Background

 
FDA is nearing a decision on an application relating to the first genetically engineered (GE) animal intended to be used as food, the Aqua Bounty Technologies’ (ABT) AquAdvantage Salmon (AA Salmon). To provide the public a chance to attend FDA informational and deliberative sessions relating to this animal, as well as an opportunity to be heard, the agency is planning to hold two separate, but related, public meetings relevant to this decision. 
 
In the first, the agency will convene its Veterinary Medicine Advisory Committee (“VMAC” or “the Committee”) to consider issues regarding the safety and effectiveness of the new animal drug (NAD) that is the subject of the GE fish new animal drug application (NADA).
 
In Guidance 187: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (GFI 187),FDA explained how the NAD provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) apply to GE animals and the scope of the regulated article, or NAD, for GE animals. http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ GuidanceforIndustry/UCM113903.pdf.  
 
A decision on a new animal drug application (NADA) constitutes an agency action under the National Environmental Policy Act (NEPA). FDA regulations (21 CFR Part 25) detail how the Agency will meet NEPA's requirement that it consider potential impacts on the environment resulting from an agency action, including an approval decision. These regulations also identify the opportunities under NEPA for public comment. In order to determine whether to prepare a finding of no significant impact (FONSI) or to prepare an environmental impact statement (EIS), FDA will be considering the possible effects of the potential approval of the AquAdvantage Salmon on the human environment. Our evaluation will be based on current scientific information, including relevant comment and information that may be received from the VMAC and the public.

FDA is holding the second meeting, a public hearing under title 21 of the Code of Federal Regulations Part 15 (a “Part 15 hearing”), to present FDA’s existing legal framework for food labeling, and to receive public input on whether food from AquAdvantage Salmon should be labeled under this framework.  (See accompanying Part 15 Notice at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ VeterinaryMedicineAdvisoryCommittee/ucm201810.htm.)

 
GFI 187 was available for public comment before it was finalized. Few of the substantive public comments received on the draft version were critical of the agency’s interpretation of its statutory authority or the recommendations for data submission; however, many comments expressed a desire for the agency to be more transparent with respect to its overall deliberative and decision-making process. In addition, many comments addressed the issue of labeling the food derived from GE animals (labeling must accompany GE animals). The substance of these comments ranged from a very strong desire to have special labeling of food derived from GE animals to those equally strongly opposed to such labeling. (A summary of the public’s comments and the agency’s response is available on the agency’s website at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/ GeneticallyEngineeredAnimals/ucm113612.htm.)
 
As a result of the comment process, the agency modified the draft guidance to include the following statement in the final version: “The agency is interested in increasing the transparency of its deliberations and actions. At present, we intend to hold public advisory committee meetings prior to approving any GE animal.” 
 
In the spirit of that statement, CVM notes that as part of its review process for the AquAdvantage (AA) salmon produced by ABT, it is planning a VMAC meeting on scientific issues with respect to the safety and effectiveness issues associated with the AA Salmon.
 
This document provides an overview of the agency’s proposal for the VMAC meeting; an anticipated time-line; and mechanisms by which the agency is planning to make its decisions public. This process involves the steps listed immediately below and described in more detail in the rest of this document.
 
The overall process for transparent decision-making on the application for approval of AA Salmon includes the following:
 
  1. Public Orientation Session for the VMAC meeting by agency experts;
  2. Presentation of Data and Information Relevant to AA Salmon to VMAC;
  3. Public Comment at the VMAC meeting;
  4. Charge to VMAC Deliberation/Opinion;
  5. Committee response to charge;
  6. Publish environmental assessment; and  
  7. Agency Decision on approval of NADA.
 

II.  The VMAC Meeting

 
Before approving an application for an article regulated under the NAD provisions of FFDCA, the agency must 
  1. Find the NAD (in this case, the recombinant DNA construct inserted in a particular site in the GE animal’s genome) to be safe and effective for the GE animal;
  2. Find that food or feed from the GE animals is safe; and
  3. Evaluate whether approving the NAD may significantly affect the quality of the environment.
The question of how to label the food derived from AA salmon is separate from the decision about whether to approve the NAD application. If the Commissioner determines that the NAD meets the approval standard, she “shall issue an order approving the application.” (21 U.S.C. 360b(d)(1)). Issues related to the question of whether a food from AA salmon is misbranded, based on its labeling, are separate. Although FDA is not required to address these issues prior to the food being marketed, FDA is planning to consider these simultaneously, and is holding a Part 15 hearing to obtain public input on labeling.
 

A.  The VMAC Process

FDA uses 48 separate advisory committees and panels to obtain independent expert advice on scientific, technical, and policy matters. The VMAC advises CVM and the agency on issues related to assuring safe and effective animal drugs, feeds and feed additives, and, as required, any other product for which CVM has regulatory responsibility.

The VMAC is composed of members in technical specialties necessary to provide recommendations on the scientific and technical issues before the Center. Members are thoroughly vetted to determine whether they have conflicts of interest with the matter before the Committee. As part of that process, members are required to provide detailed information to permit evaluation of possible sources of conflict of interest. Detailed information regarding FDA’s Advisory Committees in general can be found at http://www.fda.gov/AdvisoryCommittees/default.htm, and information on CVM’s VMAC can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ VeterinaryMedicineAdvisoryCommittee/default.htm
 
Scientific members of the Committee are generally technically qualified experts in their field (e.g., veterinary medicine, animal science, microbiology, biostatistics, and food sciences) and have experience interpreting complex data in a public health context. In addition, the VMAC contains one member representing consumer groups. The current composition of the VMAC can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ VeterinaryMedicineAdvisoryCommittee/ucm123833.htm. From time to time, for specific matters before the Committee, the agency may determine that it needs additional scientific expertise related to the matter under discussion. In those cases, the agency may supplement the membership of the VMAC with additional expertise. These individuals are subject to the same conflict of interest screening as other members of the Committee.
 
In the case of the AA Salmon, CVM determined that additional technical expertise was needed to address the issues presented by genetic engineering and the specific issues associated with salmon in general. Additional members have been added to the Committee on an ad hoc basis,  to address expertise in molecular biology and the production of GE animals, and issues associated with Atlantic salmon, and salmonids in general.
 

B.  Orientation Session

Because the composition of the VMAC is intended to provide general expertise useful to the agency, especially for non-traditional issues such as genetic engineering, VMAC members may vary in their familiarity with the technology or how it is regulated. Therefore, CVM’s experience has been that it is best to provide the panel with background information on both general scientific issues and the statutory and regulatory constraints under which the agency must operate. To address this need, CVM holds an “orientation session” for the members of the Committee prior to the VMAC meeting.

During the orientation session¸ topics will be presented by subject area experts from the agency. For example, a representative of the Office of Chief Counsel (OCC) will present the statutory requirements; appropriate members of CVM’s staff will present the recommendations of GFI-187 for each step of the process, and answer any questions that may arise regarding each step or how the overall evaluation is conducted. No issues specific to the matter before the VMAC (i.e., AA salmon) will be discussed prior to the formal seating of the Committee at the public meeting.
 
This session will be open to the public because many of these issues may be of general interest and useful to understanding the issues to be presented at the formal VMAC meeting. The public will have opportunities to ask clarifying questions of the subject matter experts.
 

C.  Posting of Materials

In general, the Committee receives material for review well in advance of the public meeting, at which time materials will also be available to the public. FDA anticipates making the meeting materials available approximately 16 days before this meeting, but in any event no later than 2 business days before the meeting.

We anticipate posting those materials on the CVM website, and will direct the public to the background materials on GE animals already present there at  http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/ GeneticallyEngineeredAnimals/default.htm

 
Materials to be presented at the VMAC meeting include the following:
 
  1. A detailed agenda including topics and speakers;
  2. Briefing materials on Guidance 187 and other information presented for the Orientation Session;
  3. An overview of the New Animal Drug Application for AA Salmon, including a description of the AA Salmon and its characteristics;
  4. Summary data and information relevant to determining safety and validating the sponsor’s claim; and
  5. The environmental analysis.
 
Confidential business information, if present in any of the material made available to the VMAC, will be redacted in the publicly available versions.
 

D.  What the VMAC will Consider

 
FDA will ask the VMAC to consider issues related to our evaluation of the safety and effectiveness requirements under the New Animal Drug provisions of the FFDCA as well as NEPA requirements as they pertain to the AA Salmon/GE animal. The specific questions to be put in front of the Committee will be made available to the public approximately 14 business days before the meeting.
 
In order to help the VMAC and the public understand the context of this application, the agency has arranged to have several speakers from various government agencies and the academic community to address the following issues prior to the presentation of the actual data and information on which the VMAC will provide input. These issues include the following:
 
  1. The state of world fisheries, focusing on Atlantic salmon, providing a general description of the status of wild fish stocks; of the fishing and disease pressures on them, including susceptibility to disease; and of inland facilities;
  2. The natural history of Atlantic Salmon, providing a description of the genetics, life cycle, and world-wide prevalence of Atlantic salmon, including its endangered status. This would include a discussion of the relative successes of farming Atlantic salmon in different parts of the world; and
  3. Environmental risk issues associated with fish, including a discussion of the nature of the potential risks that might be posed by GE fish and types of mitigation/containment strategies that can be used to overcome those risks.
This contextual session will be followed by a short presentation by the sponsor, Aqua Bounty Technologies, describing AA fish and proposed business plan for commercialization.
 
Following these introductory presentations, members of CVM’s review team will present the overall structure employed to evaluate the data and information submitted in support of the application, including detailed presentation of the actual data and information submitted to the agency to demonstrate safety and effectiveness. Once these presentations have been completed, the VMAC will be allowed to ask questions of the speakers and CVM staff. Prior to the committee’s deliberations, there will be a public comment period (see below). Following those comments, the VMAC will receive its formal charge from the agency, deliberate in open session, and issue its recommendation(s).
 

E.  Opportunities for Public Comment

As part of the VMAC meeting, FDA will provide an opportunity for public comments; individuals wishing to speak at the meeting will preregister as described in the Federal Register notice announcing the meeting.

F.  Agency Decision Making and Announcement

The agency will consider the VMAC’s opinion, as well as comments from the public. We cannot anticipate how long it will take to carefully but expeditiously consider the comments received, and for the agency to reach a decision.