FASS Statement : FDA Reports Food Products From Cloned Animals Safe posted on 10/31/2003 4:58:22 PM
FASS endorses these scientific assessments by FDA, and believes that the advent of techniques to propagate animals by nuclear transfer (cloning) will benefit animal agriculture.
The Food and Drug Administration (FDA) release of a report on cloning, Animal Cloning: A Risk Assessment, presents the agency’s position on whether cloning affects food safety or animal health. The agency concludes that “the current weight of evidence suggests there are no biological reasons, either based on underlying scientific assumptions or empirical studies to indicate that consumption of edible products from clones of cattle, pigs, sheep or goats poses a risk greater than consumption of these products from their non-clone counterparts.”
In addition, FDA concluded that while cloning “can pose an increased frequency of health risks to animals involved in the cloning process, but these do not differ qualitatively from those observed in other assisted reproductive technologies or natural breeding.”
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, reproductive efficiency, or will be valued because they have been genetically modified to produce organs for transplantation or products with biomedical application.
Cloning is a term used to describe the process of somatic cell nuclear transfer (SCNT). SCNT involves the transfer 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 the biotechnology process used to generate cloned animals that should be the focus of the evaluation.
FASS is supportive of a FDA moving the regulatory review process ahead in a timely manner to enable livestock producers and biotechnology companies to move their products to the marketplace.