January 15, 2008

FDA Rules Food From Cloned Animals Safe To Eat

After six years of study and analysis, The U.S. Food & Drug Administration (FDA) announced Tuesday that meat and milk from clones of cows, pigs, goats, and their offspring are as safe to eat as food from conventionally bred animals.  The agency further ruled against requiring labels that indicate if food is derived from cloned animals.

This announcement removes the last regulatory obstacle to bringing food products from cloned animals to market.

A press release sent out by the FDA on Tuesday said it had issued three documents on animal cloning outlining the agency's regulatory approach "“ a risk assessment; a risk management plan; and guidance for industry.   The documents were originally released in draft form in December 2006.  Since that time, the risk assessment has been updated to include new scientific information that reinforces the food safety conclusions of the drafts.
Tuesday's ruling, while expected, comes after a contentious fight with cloning opponents and amid consumer concerns about the safety of food from cloned animals.   The FDA said it had received over 30,500 comments from the public prior to issuing its ruling, many of them negative. 

But the agency concluded that cloned animals that are born healthy are no different than their non-cloned counterparts during their prime food-producing years, and go on to reproduce normally as well. 

"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, swing, and goat clones are as safe as food we eat every day," said Stephen F. Sundlof, D.V.M., PhD., Director of the FDA's Center for Food Safety and Applied Nutrition, in the FDA's press release. 

"We found nothing in the food that could potentially be hazardous.  The food in every respect is indistinguishable from food from any other animal," added Dr. Sundlof in an Associated Press article. 

Last week, European regulators issued a draft report that reaches the same safety conclusion as the FDA's.

However, the government has called for producers to continue a voluntary moratorium on sales of meat or milk from cloned animals for a short transition period to allow the Department of Agriculture extra time to disseminate safety findings to foreign trade partners and food companies.

Viagen Inc. and Trans Ova Genetics, two major U.S. cloning firms, have already produced more than 600 cloned animals for U.S. breeders.  These animals include clones of prize-winning cows and rodeo bulls.   The companies said they will abide by the government's request for a continued moratorium, but noted it applied only to cloned, not conventionally produced, offspring.

Because of their cost and rarity, clones are intended to be used as elite breeding animals to introduce desirable traits into herds more rapidly than would be possible using conventional breeding.   

For this reason, the FDA said it does not expect cloned animals to enter the food supply in any significant number.  Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace. 

Economics also plays a key role in using cloned animals primarily for breeding purposes. At a cost of $10,000-$20,000, a cloned animal is many times more expensive than a non-cloned animal.

An animal clone is a genetic copy of a donor animal, similar to an identical twin, but born at a different time.  Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA.  In cloning, the gene sequence does not change

The first successfully cloned animal was a sheep named Dolly, cloned by Scottish scientists in 1997.  However, Dolly was euthanized in 2003 due to lung disease.  Her lifespan was much shorter than that of conventionally bred sheep, raising concerns about the aging process in cloned animals.    

At this time, the agency said it continued to recommend that food from clones of species other than cattle, swine and goat (e.g., sheep) not be introduced into the food supply, as there is insufficient information for the agency to reach a conclusion on the safety of clones of these species. 

Last month, Congress passed legislation advising further study on cloning.  Many advocacy groups, concerned about both food safety and animal welfare, are also urging further study, and requesting that cloned foods carry appropriate labeling.

The FDA concedes in its report that, "Currently, it is not possible to draw any conclusions regarding the longevity of livestock clones or possible long-term health consequences" for cloned animals. 

The agency is collaborating with a group of international scientists to issue guidelines on how to clone while minimizing risk to animals.  The guidelines are expected by the end of this year.

The FDAs announcement can be viewed on the agency's website at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01776.html

Further information regarding the agency's cloning studies can be viewed at http://www.fda.gov/cvm/cloning.htm.