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Press Coverage Story

FDA Finds Clones Safe

By Sarah Muirhead, Feedstuffs

January 21, 2008

Meat and milk from cloned cattle, swine and goats is safe for human consumption, the Food & Drug Administration ruled last week in making its final risk assessment on the cloning of food-producing animals.

Likewise, in the case of animal feed, FDA said there are no risks unique to clones, so no additional measures related to the use of clones of any age or species for the production of feed are necessary.

That conclusion applies to rendered products from any clones as well as the use of milk from clones for animal feed.

FDA also said no anomalies have been observed in animals produced by cloning that are not also observed in animals produced by other assisted reproductive technologies and natural mating. The frequency of those anomalies, however, is higher than in other assisted reproductive technologies, but the agency said this is improving with time.

Since insufficient information was available on sheep clones, the agency recommended that edible products from clones of animals other than cattle, swine or goats (e.g., sheep) not be introduced into the human food supply.

FDA said it anticipates that most food products from somatic cell nuclear transfer technology will be derived from clone progeny, the sexually reproduced offspring of clones, rather than from the clones themselves.

The FDA findings were similar to those of New Zealand and, most recently, the European Union (Feedstuffs, Jan. 14). The findings also are in line with those of the National Academies of Science, which said there are no human food or animal feed risks associated with the progeny of any clone of a species traditionally consumed for food that are not present in other sexually reproduced animals of the same species.

The risk assessment presents an overview of assisted reproductive technologies widely used in animal agriculture, the extensive scientific information available on the health of animal clones and their sexually reproduced offspring and an assessment of whether food from clones or their sexually reproduced offspring could pose food consumption risks different from the risks posed by food from conventionally bred animals.

FDA first presented these conclusions in draft documents more than a year ago. Since then, the agency has updated the risk assessment with data that became available, as well as taking into account comments from the public comment period.

"After reviewing additional data and the public comments in the intervening year since the release of our draft documents on cloning, we conclude that meat and milk from cattle, swine and goat clones are as safe as food we eat every day," said Dr. Stephen Sundlof, director of FDA's Center for Food Safety & Applied Nutrition. "Our additional review strengthens our conclusions on food safety."

Sundlof said no special labeling provisions are required on food products from cloned animals or their offspring.

The total number of animals involved in agricultural cloning is likely to be quite small (a few hundred to a few thousand) relative to the total number of domesticated animals used for food.

Clones are intended as breeding stock, so although much of FDA's risk assessment is concerned with the food consumption risk for animal clones, in reality, only a small number of clones will likely be eaten for meat or their milk used for human consumption, said FDA.

The U.S. Department of Agriculture concurred with the FDA finding of no risk but asked for continuation of the existing voluntary moratorium to keep cloned animals out of the food system until any pending trade issues can be addressed.

Bruce Knight, USDA undersecretary for marketing and regulatory programs, said he was committed to keeping the moratorium to a few months.

"USDA fully supports and agrees with FDA's final assessment that meat and milk from cattle, swine and goat clones pose no safety concerns, and these products are no different than food from traditionally bred animals," said Knight. "Cloning is another breeding technique that has evolved and has now been demonstrated to be safe. It is helpful in creating genetic twins of the very best animals that can transmit superior characteristics to their offspring and quickly improve a herd."

Several dairy groups, including the International Dairy Foods Assn. (IDFA) and the National Milk Producers Federation, applauded a continuation of the moratorium.

"Numerous surveys reveal that consumers are not comfortable with the idea of buying milk from cloned cows, and more time is needed for the American public to gain a better understanding of this new technology," said IDFA.

American Farm Bureau Federation president Bob Stallman was supportive of the FDA announcement, saying, "Cloning technology will give farmers and ranchers an additional production option. It has gone through the appropriate regulatory review process and has been found to be safe; therefore, farmers should have the option of using it. The technology will improve breeding stock and, eventually, the quality, safety and healthfulness of our food. Animal cloning offers great benefits for consumers and farmers."

Animal activist groups said the agency's running failed consumers.

Farm Sanctuary denounced the decision and called for a mandatory moratorium on cloned animals and their offspring to be established immediately.

"While the FDA is charged with assessing the safety issues surrounding animal cloning, it's not the agency's job to address other objections that make cloned animals controversial. Congress should hold hearings on the animal welfare, ethical and environmental implications of cloning," said Center for Science in the Public Interest director Gregory Jaffe.

Wenonah Hauter, Food & Water Watch executive director, said the ruling "leaves consumers at risk and releases another questionable technology into the food supply."

Hauter also was critical of the cloning industry's effort to create a voluntary registry of cloned food animals, saying, "It does nothing to address the very real safety questions and ethical concerns that remain about this technology."

Sundlof said while FDA's job is the assessment of safety issues surrounding animal cloning, as an agency, it does care about the health of animals and is working extensively with other animal scientists to develop care standards for cloned animals. The International Embryo Transfer Society will release those details later this year.