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Home FASS Scientific Advisory Committee on Biotechnology Position Statement on FDA Draft Risk Assessment on Cloning Re: Docket No. 2003N-0573; Department of Health and Human Services, Food and Drug Administration; Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; 72 Fed. Reg. 136 (Jan. 3, 2007)FASS Scientific Advisory Committee on Biotechnology Statement on FDA Draft Risk Assessment “A Risk-Based Approach to Evaluate Animal Clones and Their Progeny” On December 28, 2006, the Food and Drug Administration (FDA) releases a draft risk assessment (RA), “A Risk-Based Approach to Evaluate Animal Clones and Their Progeny”. The draft RA presents the agency’s position on whether cloning affects food safety or animal health. The RA concludes that “....the available data has not identified any food consumption risks or subtle hazards in healthy clones of cattle, swine, or goats. Thus, edible products from healthy clones that meet existing requirements for meat and milk in commerce pose no increased food consumption risk(s) relative to comparable products from sexually-derived animals.” FASS endorses the draft RA issued by FDA, and believes that the advent of techniques to propagate animals by nuclear transfer (cloning) will benefit animal agriculture. Cloned animals will be of potential value because of their increased genetic merit to provide healthy and nutritious meat and milk, and to increase food production, disease resistance, and reproductive efficiency. Cloning is a term used to describe the process of somatic cell nuclear transfer (SCNT). SCNT involves the transfer of a nucleus from a somatic cell into an oocyte from which the nucleus has been removed. The offspring arising from cloning will be identical to the original donor animal in terms of their nuclear DNA. There is a long history in the U.S. of assessing the safety of foods introduced into the marketplace. FASS believes that consumers need to appreciate that we have the safest food supply ever witnessed in recorded history. Assessment of food safety involves an integrated multi-disciplinary approach that incorporates molecular biology, protein chemistry and biochemistry, food chemistry, nutritional sciences, and toxicology. Consumers should appreciate that absolute safety is not the objective with respect to any approach used to evaluate complex substances such as food. The standard that has been adopted by FDA is that the food under evaluation should be as safe as an appropriate counterpart that has a long history of safe use. FASS endorses the position that the foundation of establishing substantial equivalence of any food being evaluated is the use of this comparative evaluation process. It must be emphasized that it is the food product itself, rather than the biotechnology process used to generate cloned animals that should be the focus of the evaluation. FASS is supportive of the FDA seeking comments from the public for the next 90 days as a part of moving the regulatory review process ahead in a timely manner to enable livestock producers and biotechnology companies to sell their products in the marketplace. Federation of Animal Science Societies Scientific Advisory Committee on Biotechnology Members: Dr. Kirk Klasing, (Chair) Professor University of California Dept of Animal Science Davis, CA 95616 Email: kcklasing@ucdavis.edu Dr. Derek McLean Washington State University ASLB 210 Dept Animal Sciences Box 646353 Pullman, WA 99164-6353 Email: dmclean@wsu.edu Dr. Michael Spurlock Iowa State University 1109 HNSB Ames, IA 50011 Email: mspurloc@iastate.edu Dr. Fuller Bazer Texas A&M University Dept of Animal Science 442 Kleberg Center College Station, TX 77843-2471 Email: fbazer@cvm.tamu.edu Dr. Mark Cook University of Wisconsin Dept of Animal Science 1675 Observatory Drive Madison, WI 53706 Email: mcook@wisc.edu Dr. Marjorie Faust Director, External Research ABS Global, Inc. 1525 River Road DeForest, WI 53532 Email: mfaust@absglobal.com Dr. Gary Hartnell Ph.D., PAS, Dipl. ACAN Monsanto Company Ag Regulatory Animal Feed and Nutrition 800 North Lindbergh Blvd - O3F St. Louis, MO 63167 Email: gary.f.hartnell@monsanto.com Dr. Calvin Keeler University of Delaware Dept Animal & Food Sciences Newark, DE 19716-2150 Email: ckeeler@udel.edu Dr. Max Rothschild Professor Iowa State University Dept of Animal Science 2255 Kildee Hall Ames, IA 50011 Email: mfrothsc@iastate.edu |
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