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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Receives NAS/NRC Report On Animal Biotechnology

August 21, 2002

FDA's Center for Veterinary Medicine (CVM) has received a report entitled, "Animal Biotechnology: Science-Based Concerns" from a committee of the National Academy of Science (NAS)/National Research Council (NRC.)

CVM contracted for the report in order to identify food, animal, and environmental safety issues with bioengineered animals and cloning that would be appropriate to address in any science-based regulatory scheme developed for these products. FDA's CVM intends to use the information in the report to help it develop its regulatory approach to animal bioengineering and cloning.

A special NAS/NRC committee -- Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology -- developed the report to identify and prioritize any safety concerns associated with animal bioengineering and cloning. For this report, NAS consulted with experts from both the public and private sector, and it conducted a public meeting late last year to collect additional data and viewpoints from researchers and representatives from public interest groups. CVM funded half the cost of the study. NAS funded the rest.

Experts that the committee consulted came from the areas of pharmaceuticals; veterinary medicine, aquatic and terrestrial animal physiology; transgenic methods, and chromosome set manipulation; risk assessment; aquaculture biotechnology; cloning; and gene therapy.

The goals of the report are to:

  • Develop a consensus listing of concerns in the food safety, animal safety, and environmental safety areas for various animal biotechnology product categories. These categories include, but are not limited to, gene therapy, germ line modifications, knockout technologies, and cloning.
  • Provide criteria for selection of those concerns considered to be most important that need to be addressed or managed for the various product categories.
  • Identify and justify concerns that were considered but not identified as important for certain product categories.

The report is posted on the NAS Home Page. Paper copies of the report will be available for purchase from the National Academies Press, phone 888-624-8373 (toll-free) or 202-334-3313 (all other calls.)


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855