Terry Etherton

On December 28, 2006, the Food and Drug Administration (FDA) released a draft risk assessment (RA) on whether cloning affects food safety or animal health, and whether food products from livestock should be sold for consumption. The draft, “A Risk-Based Approach to Evaluate Animal Clones and Their Progeny – DRAFT” presents the FDA’s position. The risk assessment 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.”

The risk assessment employed a “weight of evidence” approach for drawing conclusions regarding risks to animal health and for consumption of food products from clones and their progeny. This approach consisted of four steps:

1. Evaluation of the empirical evidence (i.e., data on molecular mechanisms, physiological measurements, veterinary records, and observations of general health and behavior) for the species being considered;
2. Consideration of biological assumptions predicated on our growing understanding of the molecular mechanisms involved in mammalian development;
3. Evaluation of the coherence of the observations with predictions based on biological mechanisms; and
4. Evaluation of the consistency of observations across all of the species considered, including the mouse model system.

There is a long and distinguished history in the U.S. of assessing the safety of foods introduced into the marketplace. FDA’s Center for Veterinary Medicine (CVM) has the regulatory responsibility for considering the safety of animals and their progeny that are produced as a result of cloning. In addition, CVM is responsible for the regulatory review conducted to determine the safety of food products (e.g., meat, milk, eggs) from animals developed through cloning.

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 understand and 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. It must be emphasized that it is the food product itself, rather the biotechnology process used to generate cloned animals, that is the focus of the evaluation.

Despite the impressive scientific evidence that food from cloned animals is safe, opponents of cloning and animal biotechnology have again “cranked up” their campaign to scare consumers as a strategy to encourage consumers to avoid food from cloned animals. Arthur Caplan, Ph.D, in an MSNBC piece, put this campaign in perspective: “All of this nonsense took a toll. It made Americans forget that cloning is nothing more than artificially creating twins. It made us forget that every drop of wine we drink comes from cloned grapes. It made us ignore the fact that if you want to worry about what you are eating you would be better off fretting over whether the FDA has enough inspectors on the job at meat plants looking for salmonella and E. coli than whether your dinner started off as a clone.”

The release of the draft RA by the FDA is a long-awaited step in the process FDA will follow to formally release regulatory guidance about the entry of edible products from cloned farm animals in the food system. I believe that cloning will benefit animal agriculture (see my previous Blog on cloning at http://blogs.das.psu.edu/tetherton/?p=31). I am hopeful that the regulatory review process will move ahead in a timely manner to enable livestock producers and biotechnology companies to sell cloned animals in the marketplace. Cloned animals will be of value because of their increased genetic merit to provide healthy and nutritious meat and milk. Cloned animals will also increase food production, improve disease resistance, and enhance reproductive efficiency. An additional benefit is that cloning can be used to protect endangered species.

The next step in the ongoing review process is for the FDA to seek comments from the public about the draft risk assessment. Draft Risk Assessment documents will be available for public comment for 90 days (due by Wednesday, March 28, 2007). I encourage readers to provide your comments on these documents. Comments should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with Docket number 2003N-0573. Comments may also be submitted electronically via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.