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U.S. Department of Health and Human Services

Advisory Committees

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Meeting Synopsis - 2003 VMAC

The FDA Veterinary Medicine Advisory Committee (VMAC) met November 4, 2003 at the Double Tree Hotel & Executive Meeting Center in Rockville, Maryland. The committee met to discuss the merits of a risk assessment designed to identify the hazards and characterize the risks of somatic cell nuclear transfer (SCNT) method of cloning to animal health and food consumption. There were ten members of the committee present and they heard presentations from CVM experts on the subject and the committee was allowed to query these presenters as to the summary data and conclusions. The committee also entertained over an hour of open comment from the public. The FDA posed two questions to VMAC:

  1. Based on what we have presented, has the risk assessment adequately identified the hazards and characterized the risks relating to animal health?
     
  2. Based on what we have presented, has the risk assessment adequately identified the hazards and characterized the risks relating to food consumption?

The following is offered as the Chair’s synopsis of the committee’s responses to these questions. Please note that this summary does not necessarily represent the views of the FDA-CVM.

As to the first question concerning the portion of the risk assessment that addresses risks relating to animal health, the committee did not reach a consensus. The cloning risk assessment asked the question: "Do the risks experienced by animals involved in the cloning process differ qualitatively from those experienced by animals undergoing other assisted reproductive technologies?” While most of the committee members applauded FDA for the work to date on the risk assessment, a common theme from the committee's comments was that data is lacking to fully evaluate whether the risks could be characterized. While the committee decried that lack of data to actually characterize the risk involved in cloning, comments also reflected the need for continued research and for the industry to provide data as it becomes available. A common theme of the comments was the scarcity of data regarding both the clones and the clone offspring. While the committee seemed to agree that there was a lack of data to actually answer the first question, many members of the committee commented that the FDA risk assessment had "gone as far as they could given the current data available". The committee also did not reach consensus on whether cloning risk differed qualitatively from those risks experienced with other assisted reproductive technologies. The data gaps were again cited by some members of the committee while also commending the FDA for identifying methods and plans for filling those gaps. Some committee members also offered suggestions for methodology in addressing the data gaps.

The second question to the committee dealt with the hazards and risks of cloning relating to food consumption. A clear majority of the committee members supported the FDA in this question. As with the first question posed to the committee, the most common reason for not affirming this question cited by the members was the lack of data. Many of the comments offered by the members in support of their position on this question were very similar to those given in support of their position on the first question. Again, the majority of the committee supported the FDA risk assessment in the question concerning food consumed that originates from cloning however some of those responses were qualified with comments concerning lack of available data. Again, the committee was in agreement that while there is a scarcity of data, the FDA has "gone as far as they can go given the current available data". The members of the committee in the dissent decried the lack of data and offered suggestions for addressing those concerns.