Veterinary Medicine Advisory Committee
The Veterinary Medicine Advisory Committee (VMAC) is a committee that exists to advise the Commissioner of the Food and Drug Administration on matters related to safe and effective drugs, feeds and feed additives, and devices for animal use. VMAC "reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational new animal drugs, feeds, and devices for use in the treatment and prevention of animal diseases and increased animal production, and makes appropriate recommendations to the Commissioner regarding scientific issues and regulatory policies."[1]
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Genetically Engineered Salmon
In September 2010, VMAC will meet to determine the safety of the AquAdvantage salmon, a genetically engineered variety of Atlantic salmon that, if approved, would be the first GE animal to directly enter the U.S. food supply.[2] At the time of the meeting, the committee members were as follows:
- David F. Senior, A.C.V.I.M.N.-S.A., E.C.V.I.M. (Acting Chair)
- Jodi Ann Lapidus, Ph.D.
- Craig Altier, D.V.M., Ph.D.
- James D. McKean, D.V.M., J.D.
- Michael D. Apley, D.V.M., Ph.D.
- Robert H. Poppenga, D.V.M., Ph.D.
- Dicky D. Griffin, D.V.M., M.S.
- Alan G. Mathew, Ph.D.
- John B. Kaneene, D.V.M., Ph.D.
- Paul C. Stromberg, D.V.M., Ph.D.
Additionally, the FDA appointed four temporary voting members for this meeting:
- Gary Thorgaard, PhD
- Kevin D. Wells, PhD
- Alison Van Eenennaam, PhD
- Gregory Jaffe (CONSUMER REP)
Issues With GE Salmon Hearing Process
Days before the September 2010 VMAC meeting, Consumers' Union sent a letter to FDA Commissioner Margaret Hamburg and FDA Principal Deputy Commissioner Joshua Sharfstein laying out a number of concerns with the GE salmon hearing process.[3] They took issue with the amount of time given for the public to submit comments and the membership (and range of expertise) among the VMAC committee. They conclude that: "We believe that without the extension of the review period, and the addition of certain scientific experts to the VMAC, the Committee's findings will not have the needed credibility with the public. We also believe that without these experts, FDA will fail to get the sound scientific advice it needs and deseNes. For these reasons, we urge you to delay next week's VMAC meeting for two months, to allow a standard 60-day public review period of the data that has been released, and to allow FDA to add the necessary and appropriate expertise to the VMAC."
Too Little Time for Comments
Consumers' Union begins its letter saying, "First, we feel that the current fourteen-day review period on the safety assessment of the Aquavantage genetically GE salmon is far too short, and we respectfully request that it be extended to the standard sixty days."[4] Sixty days is a far more standard comment period when the U.S. government solicits public comment. As Consumers Union notes later in the letter, the FDA released 255 pages of technical information on the AquAdvantage salmon, giving the public only 14 days to review and comment on it. They say: "The FDA review discusses the presence of proteins to which some people are acutely allergic, and which may be elevated in the transgenic fish, as well as presence of increased levels of the growth hormone iGF-1. This material raises serious health concerns. Fourteen days are not sufficient to review this material in proper depth." Moreover, since the FDA had 11 years to review the data, they question why there is such a rush for approval now - particularly because "GE salmon is not in any way a lifesaving product such as certain pharmaceuticals or medical devices."
VMAC Lacks Appropriate Expertise
Consumers Union adds:[5] "The VMAC currently lacks any scientists whose primary expertise is in food allergies, endocrinology or fish ecology, the main topics on which the VMAC will have to render judgments in order to conclude that the salmon is safe. We strongly urge you not to make a decision on the safety of the first GE animal to be approved for human consumption without the input of scientists in these fields or without wide public input."
The Committee added four new temporary members for the GE salmon approval meeting. Even with these new members, Consumers Union feels that "the Committee is not constituted so as to provide scientifically sound advice to FDA on this topic." They go on to say that "The topic of GE salmon is very different from the veterinary medicine topics this Committee normally addresses."
Consumers' Union analyzes the composition of the committee as follows: "There is, at present, not one single food safety scientist specializing in food allergies on the Committee despite the relative frequency of acute allergies to fish in the US population. Nor is there an endocrinologist knowledgeable about growth hormones - which are at issue here - on the Committee. There is also not one single fish ecologist. Nine of the 13 members are veterinarians or hold doctorates in animal science. Two more have been involved in developing genetically engineered animals themselves [Wells and Eenennaam], including one who has worked for Monsanto [Eenennaam]. The consumer representative [Jaffe], though knowledgeable, is a lawyer rather than a scientist. We question how the Committee can accurately assess the safety of this salmon for humans and the environment when it lacks the essential expertise to do so." The single fish expert - Thorgaard - on the committee is an expert in polyploidy, a topic that is related to the GE salmon case (as the fish in question are triploids). However, assessing the use of triploids in the GE salmon is only one part of the scientific review that must be done.
Consumers Union continues, listing what it feels is necessary to perform an adequate review of the GE salmon: "We believe that three fish ecologists, four food safety experts (including specialists in food allergies and in the effects of hormones on human health), and scientists from the consumer and environmental community must be added to the Committee, to provide appropriate balance and expertise."
Articles and resources
Related SourceWatch articles
References
- ↑ Veterinary Medicine Advisory Committee, U.S. FDA, Accessed September 13, 2010.
- ↑ Meeting Participants for Aquadvantage Salmon Veterinary Medicine Advisory Committee, U.S. FDA, Accessed September 13, 2010.
- ↑ 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.
- ↑ 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.
- ↑ 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.
External resources
- Briefing Packet for AquAdvantage Salmon Veterinary Medicine Advisory Committee (PDF - 2506KB), U.S. FDA, September 20, 2010.
- Background Document: The VMAC Meeting on Science-Based Issues Associated with AquAdvantage Salmon, U.S. FDA.
- Environmental Assessment for AquAdvantage Salmon (Aqua Bounty Technologies, Inc.) (PDF - 1095KB), U.S. FDA.
- 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.
- Letter from Consumers Union to FDA About Concerns On VMAC Committee Members for GE Salmon Hearing, Consumers' Union, September 15, 2010.
- Peter Bridson, Re: FDA Veterinary Medicine Advisory Committee (VMAC) hearing September 19-20, 2010. AquAdvantage genetically engineered salmon, Seafood Watch Program, Center for the Future of the Oceans, Monterey Bay Aquarium, September 14, 2010.
