Moderator: Welcome to Viewpoint with our guests, Michael Fernandez and John Matheson. Michael and John, thank you for joining us today. Michael, please get us started by explaining what transgenic animals are and what they are used for, or what plans are underway for the use of them?

Michael Fernandez and John Matheson : I'm happy to be participating today and we look forward to some interesting questions.

Animals are "transgenic" when scientists have added DNA from another organism into them. In other words, scientists can take genes from any other living organism -- a different animal, a bacterium, or plant -- and put copies of those genes into any other animal.

The reason that scientists are interested in doing this is because they can give the animal new traits or characteristics. Some of the kinds of things people are working on are changes to improve productivity or disease resistance. Scientists are also interested in transgenic animals as a way to produce medical products such as organs for transplant and drugs in milk.

Moderator: John, the same question for you in terms of cloned animals.

Michael Fernandez and John Matheson : I'm happy to be participating and look forward to lively discussion.

The type of clones we're interested in at CVM are those produced like “Dolly the sheep,” as copies of adult animals. This process is called somatic cell nuclear transfer (SCNT).

Cloning as a science has been evolving for a number of years. While SCNT was first reported in 1997, other types of cloning that have been around since the 1980’s. These earlier techniques include embryo splitting and blastomere clones. Embryo splits and related techniques generate limited numbers of clones of a fertilized embryo and thus a copy is made of the animal without knowledge of the potential of the animal as an adult. In contrast, somatic cell nuclear transfer can generate potentially unlimited numbers of clones of an adult animal with known traits.
Therefore, we anticipate that SCNT technology will find broader acceptance in the marketplace than the other forms of cloning did.

With SCNT it is possible to clone animals of high genetic merit such as high-producing milk cows or champion bulls.

Washington, D.C.: To Michael Fernandez: Your ad for the Pew Initiative asks the question, "What do a tree, a fish and a pig have in common?" The answer is that they've all be subjects of genetic modification. Can you explain in layman's terms what was done to each?

Michael Fernandez and John Matheson : (MF) Domestic animals and crop plants have been "genetically modified" for years using conventional breeding techniques where the "parents" are chosen for their particularly useful characteristics with the hope that those characteristics will be passed on to the next generation.

The kind of genetic modification that we are talking about here--transgenics--broadens the scope of possibilities. Because you are no longer limited by the gene pool of the parents, you have access to desirable genetic traits from virtually any source.

Philadelphia, Pa.: What has become of Dolly the sheep? What was the result of that experiment?

Michael Fernandez and John Matheson : (JM)Dolly is live and well in Scotland in Roslin Institute. I understand she has given birth to a healthy lamb, but she has a weight problem.

Alexandria Va.: Is it possible to create a transgenic Dolly?

Michael Fernandez and John Matheson : (JM and MF) Yes, transgenic animals CAN be cloned. While it is possible, sheep are not the preferred animal for transgenic milk production. Goats and cattle are.

Annapolis, Md.: In your view, how will the public accept foods derived from transgenic animals such as the "enviropig" which promises a reduction in the environmental impacts of various methods of livestock farming?

Michael Fernandez and John Matheson : (MF) We don't really know. We do know that some people have concerns about eating products from transgenic animals. At the same time, uses of this technology that would reduce environmental impacts from agriculture might be very appealing to consumers.

Rochester, Minn.: Is it safe to eat meat from cloned animals?

Michael Fernandez and John Matheson : (JM) We don't know yet. We're still studying the issue.

Food from SCNT cloned animals is not presently in US grocery stores today. As discussed in a statement (issued in July 2001, “Update on Livestock Cloning,” at ), CVM has contacted companies known to be developing SCNT cloned animals and asked the companies not to introduce these cloned animals, their offspring, or their food products (including milk) into the human or animal food supply until CVM has considered all scientific information.

St. Louis, Mo.: Are there currently any transgenic animals under review for approval by the CVM? If so, how soon do you anticipate any approvals?

Michael Fernandez and John Matheson : (JM and MF) The publicly acknowledged application before CVM is for transgenic Atlantic salmon containing extra genes for growth hormone.

The company, AquaBounty, estimates several years before any approvals in the US. The time frame is really in the hands of the company to demonstrate food and environmental safety of their product.

Mountainside, N.J.: Have import tolerance requirements been established for meat from animals raised and treated with any substance outside the U.S. and destined for the U.S. market (i.e., what do I need to do to be able to sell my meat -- including fish -- in the U.S.)

Michael Fernandez and John Matheson : (JM) Import tolerances are safe levels for residues of animal drugs used in foreign countries, but not in the United States. To date, only one import tolerance has been set for a product used overseas. It is possible that this process could be used for transgenic animals that might be exported from a foreign country. Import tolerances include only an evaluation of food safety.

Alexandria, Va.: What to each of you feel are the strongest environmental benefits from this technology, and what are some of the potential environmental problems?

Michael Fernandez and John Matheson : (JM and MF) Some of this is speculative because products have not yet made it to the market. The people developing these products claim benefits in more efficient production of animal-derived foods. In other words, it takes fewer resources to produce the same amount of food resulting in less waste.

The problem most frequently cited is the possibility that genetically engineered animals, such as fish, could escape and breed with wild populations in the environment. The concern is that this cross-breeding could harm the wild populations.

San Diego, Calif.: Regarding your response to the import tolerance question from N.J. -- what is the one import tolerance and is it for a transgenic animal?

Michael Fernandez and John Matheson : (JM) The import tolerance is for a drug used in Australian sheep and it is NOT a transgenic product.

Rochester, Minn.: What information would you require to determine whether it was safe to eat products from cloned animals?

Michael Fernandez and John Matheson : (JM) FDA is making a science-based decision on the most appropriate way to regulate clones and their offspring. The agency contracted with National Academy of Sciences/National Research Council (NAS/NRC) to identify science-based concerns associated with animal biotechnology (including SCNT techniques) and to prioritize them for the level of concern. As part of the process of gathering information for the report, the NAS/NRC held a public meeting on animal biotechnology that included presentations on cloned elite livestock. (Elite livestock are the best of the breed developed with traditional breeding practices, and not cloning.) We're also gathering information from scientific literature and public meetings, like the one we're co-sponsoring with the Pew Initiative on Food and Biotechnology on September 26, that will allow us to assess the risks and how best to manage them. This should result in a report from FDA/CVM on our findings. For more information, see our July 13, 2002, announcement, “CVM To Cosponsor Public Symposium On Livestock Cloning,” at .

Alexandria, Va.: A question for the gentleman from the FDA. My understanding is that Bush administration is opposed to human cloning. What is their position on animal cloning?

Michael Fernandez and John Matheson : (JM) The administration opposes cloning humans, but it has not taken a position on SCNT animal cloning. That's part of what we're doing now.

Silver Spring, Md.: What about the ethics of altering the very genetic structure of our fellow sentient beings? So far, much of this experimentation has resulted in serious abnormalities involving pain, suffering and death for the resultant animals. The prospective life which surviving animals face is also grim, pumping out vast quantities of substances or growing to grotesquely unnatural proportions. Bioengineering is objectionable in principle because it prevents animals from living in accordance with their natural end in life. Why is more attention not being given to the ethics of bioengineering animals?

Michael Fernandez and John Matheson : (MF) Ethical considerations must be an important part of the public debate about animal biotechnology. At our conference later this month in Dallas we hope to start a dialog amongst producers, bioethicists and regulators to explore some of these issues. For more information about the conference, go to http://pewagbiotech.org/events/0924/

Univ. Vienna, Austria: Like in the field of genetically modified plants, safety relevant genetically modified animals seem to be more an environmental problem than a problem of direct food safety. Yes? Is the knowledge in science, e.g. ecolgy, good enough to risk-assess, e.g.introgression, or do we need precaution? What kind of nature do we want to preserve?

Michael Fernandez and John Matheson : (JM and MF) The recent NAS report did identify some potential environmental issues like escape, survival, and gene flow into the wild populations.

These are issues that will need to be considered on a case by case basis before any approval for an individual transgenic animal.

Burlington Vt.: Is the AquaBounty salmon actually transgenic or just modified to incorporate additional copies of salmon genes producing growth hormone?

Michael Fernandez and John Matheson : (JM) It is transgenic and contains two genes not found in Atlantic salmon.

Alexandria, Va.: How could these two processes ease organ shortage? Would it be by cloning human cells or using animals to create human compatible organs? What are the ethical issues of using animals in such a manner?

Michael Fernandez and John Matheson : (MF) Scientists are working to develop transgenic animals that can be used to produce organs for human transplant. Currently, one of the major issues with organs from animals is that they are rejected by the human recipient. Transgenics is used to change the organ so that compatibility is improved.

In terms of the ethical considerations, society must strike a balance between the benefits to individuals receiving organs and animal welfare. This is a complicated issue and one that warrants significant public discussion.

College Station, Texas: It appears that the process of regulating transgenic plants has worked well. Controlling gene flow with transgenic animals seems easier than with plants! This being said, why shouldn't the approval process that has been used with plants also be appropriate for animals?

Michael Fernandez and John Matheson : (MF) Although some of the issues are similar, there are obviously differences between plants and animals.

The plant process is an outgrowth of three different regulatory regimes in three departments of the federal government. It's not automatically apparent that we would want to use the same authorities for animals.

The laws we might use to regulate animals may be different, but the approach can be consistent, with additions like animal safety considerations. Bear in mind, the existing laws and regulations governing biotechnology were put together before many of these new products were conceived. It's a fast moving technology and we want to ensure that we have the ability to effectively regulate these products.

It was always envisioned that the federal government would update these regulations as the technology moved forward.

Mountainside, N.J. (again): Will the human food safety requirements be the same for cloned and transgenic animals?

Michael Fernandez and John Matheson : (JM) In general, all food derived from cloned and transgenic animals must be shown to be safe before being sold.

Rome, Italy: What are the potentials of genetic engineering on animals for developing countries? How can poor countries establish means to regulate, manage or control the risks associated with the use of transgenically altered cattle? How can they make use of modern biotechnology without increasing dependency on the developed countries?

Michael Fernandez and John Matheson : (JM and MF) Actually there is quite a bit of interest in transgenic animals for food production throughout the world. In fact, Cuba and China are investigating transgenic fish as are researchers in developed countries such as Great Britain, France and Canada.

Regulation will be a challenge for all of us to reap the benefits of these products. The potential gains in productivity may be particularly attractive for protein-poor populations.

There are discussions in international standard setting organizations that are focusing on transgenic animals.

Alexandria, Va.: What is the regulatory scheme contolling this technology? It was said in an earlier response that members of the agricultural community are asked not to allow cloned products in the food market. Does the FDA have the authority to prevent them from doing so? Is a permitting scheme being developed?

Michael Fernandez and John Matheson : (JM) FDA/CVM wants to first evaluate whether there are any risks associated with SCNT cloning and then to design an appropriate science-based regulatory approach that manages the risks. FDA has broad authority to ensure the safety of our food supply and there are several legal approaches that could be used to provide regulatory oversight for clones or the foods derived from them. We want to develop an approach that is appropriate for the level of risk.

Michael Fernandez and John Matheson : (JM and MF) Thank you all for submitting your questions. Sorry time didn't permit us to answer all of them. It's clear that there is a high level of interest in the issues and that continued public discussion is important. Please visit our web sites if you want more information on the topic.

We will be having a live audio Webcast of our conference from Dallas, Texas on these issues on September 24 through 26. Thanks again.

Moderator: Our thanks to Michael Fernandez, John Matheson, the Pew Initiative on Food and Biotechnolgy and all who participated.