CFA's Carol Tucker Foreman on FDA's Risk Assessment on Animal Cloning

October 31, 2003
Chris Waldrop, (202) 797-8551

"This morning the Food and Drug Administration declared that milk and meat from clone animals are safe for humans and not harmful to animals. There are both process and substance problems with this action.

"First, FDA has made the assertion of safety based not on a full risk assessment but an eleven page summary document. The full risk assessment is not available, has not been read by top FDA officials, will not be given to the FDA advisory committee next week and won't be available to the public for several months.

"The summary document raises numerous questions about the safety of animal cloning, stating that there are a larger number of problem outcomes from cloning than other assisted reproductive technologies. The document does not assure that food from cloned animals is safe. It acknowledges that the FDA has only limited data on the composition of food from cloned animals and there have been no feeding studies to see the impact of long-term consumption. The FDA itself has conducted no tests. All of the data come from groups who support animal cloning.

"FDA prides itself on being a science driven agency but in this case it seems to have been driven by political pressure to promote animal cloning than to protect public health.

"Furthermore, concerns about animal cloning go beyond narrow scientific issues. The National Academy of Sciences Committee on Animal Biotechnology said it is important for the US government to recognize and address moral, ethical and social concerns raised by animal cloning. While some forms of animal cloning may have inherent benefits, others are hard to justify. FDA needs to make, or ask another government agency to make, some decisions about appropriate uses of cloning.

"The Bush Administration has been extremely cognizant of some of these moral issues in the past; constraining stem cell research and other scientific endeavors, even though they may benefit human life. CFA urges the Bush Administration to address the ethical and moral issues involved in animal cloning as well. We hope the FDA will see a review by the President's Council on Bioethics. That group could review and address the moral and ethical issues inherent in making basic changes in sentient beings.

"We do not suggest banning animal cloning. We do urge that the nation have a discussion of the appropriate uses. One of the first uses anticipated is cloning cows in order to make more milk. The US has a huge surplus of milk that costs taxpayers millions of dollars a year in price support payments. Is there justification in cloning animals to make even more milk and impose even more financial burden on the public? The NAS also noted that cloning is likely to have an impact on the economics of farming. It is likely to be affordable only for the largest animal production enterprises. Is it socially and economically desirable to hasten the demise of smaller dairy farms and cattle operations?

"Every opinion poll ever taken on this subject shows that a majority of Americans oppose animal cloning. Americans demonstrate some ambivalence about plant biotechnology but in a recent poll by the Pew Agricultural Biotechnology Project, 58% of Americans oppose genetic modification of animals; 48 percent were strongly opposed. In an August 2001 poll, ABC news found that 60 percent of Americans opposed animal cloning.

"FDA argues that it is a science agency with no authority to address social or ethical issues but FDA often finds a way to address social concerns about science. For example, FDA banned the use of silicone breast implants for cosmetic surgery but then allowed women who sought implants for reconstructive purposes after breast surgery to use the implants by enrolling in research studies.

"The reasons for FDA's precipitous action are a puzzle. The public doesn't want these products. The food industry doesn't want them. The science isn't in. If the government insists on allowing animal cloning and allowing the milk and meat from cloned animals to enter the U.S. food supply, the public should have the right and the ability to determine whether to support this action by consuming these foods. The only way to do that is to require that products from cloned animals be clearly labeled as such. There are few moral and ethical issues involved in plant biotechnology. Altering animals raises considerable concerns of this nature. These products should not be foisted on an unknowing public."

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Carol Tucker Foreman is Director of the Food Policy Institute of the Consumer Federation of America.