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U.S. Department of Health and Human Services

Animal & Veterinary

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by Jon F. Scheid
FDA Veterinarian Newsletter 2002 Volume XVI, No VI

As the Center for Veterinary Medicine (CVM) is nearing a decision on the type of regulatory structure that will be needed for cloned animals, it has sponsored a public meeting along with the Pew Initiative on Food and Biotechnology to give all parties-including the companies developing the cloned animals, the livestock producers who might use cloned animals, and consumer groups-a chance to share their perspectives on the issue.

"New technologies like cloning bring up many questions, and not just from scientists, but from consumers, livestock producers, and food companies," according to Michael Fernandez, director of science for the Pew Initiative. "We are pleased to have a chance to work with CVM to provide a forum for all parties to talk about these important issues," he added.

The meeting, "Animal Cloning and the Production of Food Products-Perspectives from the Food Chain," held September 26 in Dallas, Texas, included time for an open microphone so any attendees could make comments for the record. (You can listen to an audio web cast recording of the conference and review some of the presentations.)

SCNT Cloning Technology

While the concept of cloning is not new, it has taken on new meaning with the development of the "somatic cell nuclear transfer" technology, also know as SCNT. This was the technology used to clone Dolly the sheep in 1996, according to John Matheson, senior regulatory scientist for CVM. The SCNT type of cloning has the potential to produce a great number of all species of food-producing animals, he said at the meeting.

SCNT technology involves replacing the nucleus in an egg with the nucleus from a cell of the animal to be cloned. The resulting embryo is implanted into a surrogate mother. With this technology, a company could make hundreds, even thousands, of copies of one animal.

The livestock production industry tried cloning in the past, using embryo splitting or blastomere cloning. Both methods turned out to be expensive because only a few animals could be produced from one source animal, and unpredictable because scientists couldn't clone an animal they knew. Instead, they were cloning an embryo, which had unknown traits. With SCNT, technicians can clone the adult animal, so they will know what traits to expect.

The cloned animal itself is not likely to be used for food. It will instead be used to produce high-quality offspring that will be used for food. The results of cloning could be spread throughout the food supply, which was not the case with the earlier types of cloning.

CVM Director Dr. Stephen Sundlof told the audience that the general public still might not be focusing on the agricultural uses of SCNT. After Dolly was born, the public's initial attention was focused on the use of the technology to clone humans. Scientists, meanwhile, were interested in cloning animals for use in producing biomedical products. But the agricultural community, which had tried cloning unsuccessfully before, quickly starting working with the SCNT technology. As the agriculture community became interested, CVM began to take steps to evaluate the technology for food and animal safety issues, before cloned animals enter the food chain.

In 2003

Matheson told the audience that CVM plans to develop its policy on regulating clones sometime in 2003, possibly in the first half of the year. Before that, the Center will develop and release two "White Papers," one describing food safety risks from cloned animals and their progeny, and one describing health risks to individuals and populations of cloned animals and their offspring. The White Papers could be released by the beginning of the year, he said.

The White Papers are risk assessments. Any policy or guidance is a risk management document. The Center will use the White Papers as the basis for developing risk management or regulatory measures that are appropriate for the food and animal health risks. When the guidance or policy is announced, he said, the Center will ask for public comment.

According to Matheson, "There are some basic principles that we are committed to following in arriving at a risk assessment for animal clones and their offspring."

One is transparency. The Center will use only that information that is publicly available to make its risk assessments. To the extent possible, CVM officials are planning to use published, peer-reviewed literature as the basis for developing the risk assessment, Matheson said. "You will know what we know about the risks," he added.

The second is that CVM will limit its policy decisions to those that can be made based on science. CVM will consider safety of food, and safety to the animal and to the environment. Other factors, such as the effect cloning regulations could have on trade, livestock industry economics, or social and aesthetic issues, may be legitimate to discuss, he said, but cannot be part of CVM's policies, because CVM's authority does not extend to those issues. "We're not making any judgment about a consumer's 'right to choose' or 'right to know,' only to say that those rights are determined by the Congress, not CVM," he added.

Symposium's Goal

According to Dr. Sundlof, the goal of the cloning symposium was to have all sectors of the food production and consumption in the same room to discuss their perceptions about SCNT cloning and identify any areas that need to be addressed.

CVM worked with the Pew Initiative on Food and Biotechnology whose mission is "to be an independent and objective source of credible information on agricultural biotechnology for the public, media, and policymakers." The Pew Initiative is a project of the University of Richmond and the Pew Charitable Trusts.

Along with officials from CVM, the program included representatives of companies already developing SCNT cloned animals, including Steven Stice from ProLinia, and Erik Forsberg of Infigen, Inc. The panel included scientists: Dr. Eric Hallerman who worked on the National Academy of Sciences/National Research Council team that developed a report on cloning, released in August (See FDA Veterinarian, September/October 2002, page 1), and Dr. Mark Westhusin of the College of Veterinary Medicine, Texas A&M University.

Buyers and sellers of cloned animals were represented by Donald Coover of SEK Genetics and Ron Gillespie of Cyagra. Food producers were represented by Christopher Galen of the National Milk Producers Federation, and Eric Hentges of the National Pork Board.

Consumers were represented by Carol Tucker Foreman of the Consumer Federation of America, and Gregory Jaffe of the Center for Science in the Public Interest.

More information about the meeting and many of the presentations are available on the Pew Initiative's web site, listed above.

Jon Scheid is the Director of CVM's Communications Staff.