Pew Initiative/FDA Conferences on Animal Biotechnology and Cloning Suggest Regulation and Ethical Discussions Must Keep Pace With Scientific Developments

Development and commercialization of transgenic and cloned animals present new challenges for regulators, and may be ahead of important public debate about ethical and animal rights issues, according to some of the nation's leading voices on these topics who spoke at two consecutive conferences on animal biotechnology and cloning sponsored last year by the Pew Initiative on Food and Biotechnology and the U.S. Food and Drug Administration (FDA).

The Pew Initiative made proceedings of the conferences available today in advance of a risk assessment on cloned animals, expected later this summer from the FDA.

"Biotechnology is enabling scientists to explore how animals could be used to provide vital services to humans including treating human disease and easing the shortage of organs for transplant," said Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology. "But transgenic and cloned animals raise unique concerns about food safety, animal welfare, the environment and the tools regulators need to adequately evaluate new biotech products. Our conferences were designed to give all stakeholders the opportunity to articulate their points of view and exchange information because such interaction helps these products come to market in a manner consumers can trust."

Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at the Food and Drug Administration, said "The Center for Veterinary Medicine co-sponsored last year's conference on animal cloning along with the Pew Initiative to inform regulators, scientists, and consumers about the science behind the cloning of food-producing animals."

The first conference, Biotech in the Barnyard, held September 24-26, 2002, was hosted by the Pew Initiative on Food and Biotechnology. The second conference, "Animal Cloning and the Production of Food Products--Perspectives from the Food Chain," was held September 26, 2002 and was co-hosted by the Pew Initiative on Food and Biotechnology and FDA. More than 150 participants attended the conferences including scientists, industry and government representatives, animal welfare advocates, consumer rights representatives and policy analysts. Over the course of three days, speakers and attendees addressed the potential uses of genetically engineered animals, ethical and animal welfare considerations, human health and environmental concerns, the state of the technology and future trends, marketing issues, and regulation of transgenic and cloned animals.

Some of the key points that emerged from the conferences include:

• Animal biotechnology could have dramatic, positive impacts on human health and agriculture. Biotech firms are developing transgenic animals to: provide organs for human transplantation, provide proteins for pharmaceutical and industrial production, limit environmental harm from agricultural practices, and improve production traits such as disease resistance.       
• The introduction of transgenic and cloned animals is accompanied by complex concerns about ethics and animal welfare--and a new venue, where such concerns can be vetted, may need to be created. While the possibility of improving--even saving--human lives seems to offer an ethical imperative, animal welfare activists point out that transgenic and cloning technology present new risks to animal health. In addition, there is extensive discussion about the appropriateness of changing an animal's genetic makeup.       
• It is unclear if consumers are prepared for the arrival of food products from cloned and transgenic animals. Although transgenic and cloning technologies could be accepted as just another technique food producers can use to improve the quality of food, consumer research suggests that public sentiment about animal and plant biotechnology is very different. Those differences are essential to understand before cloned and transgenic animals are introduced into the food supply.       
• Government regulators need more information so they can provide guidance to developers on marketing cloned products. Although biotech companies are poised to bring the products of animal cloning to market, FDA has asked them to observe a voluntary moratorium on the sale of such products until the Center for Veterinary Medicine at FDA can evaluate the food safety, environmental impact and animal health implications of cloning.       
• Regulations guiding review of transgenic and cloned products may need to be updated. Although a number of federal statutes could come into play regarding regulation of transgenic or cloned animal products, it is not clear which provide the clearest pathway to the marketplace or the greatest level of transparency.