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U.S. Department of Health and Human Services

Animal & Veterinary

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Transcript Available for VMAC Meeting on Animal Cloning

FDA Veterinarian Newsletter November/December 2003 Volume XVIII, No 6

A link to the transcript of the proceedings for the November 4, 2003, FDA Veterinary Medicine Advisory Committee (VMAC) meeting is available on the FDA/CVM Home Page.

VMAC met to discuss a draft executive summary of a draft risk assessment designed to identify the hazards and characterize the risks of the somatic cell nuclear transfer (SCNT) method of cloning to animal health and food consumption. The draft risk assessment is being prepared by scientists in FDA's Center for Veterinary Medicine (CVM.) Ten committee members were present at the meeting, and they heard presentations from CVM experts on the subject. At the meeting, 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?

Dr. Stephen Sundlof, Director of FDA's Center for Veterinary Medicine, said "I am happy that this transcript is now available to the public. CVM was not looking for simple vote or "yes" or "no" responses to the questions we posed to the Committee. We were asking for the Committee members' thoughts and scientific opinions concerning these two questions. The transcript provides important information on their answers."

Individuals who are unable to access the transcript on the Internet may view a copy at: FDA/Division of Dockets Management, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852. Dockets can be contacted by e-mail at: fdadockets@oc.fda.gov, by phone at 301-827-6860, by fax at 301-827-6870, or by TTY/TDD Users at 1-800-735-2258. If paper copies are needed, there will be a charge for duplicating the transcript.

A draft executive summary of the animal cloning risk assessment is posted on the CVM Home Page. The complete draft risk assessment will be released in the next few months.