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FDA Likely to Clear Cloned Animals, Despite Fierce Opposition

Jan 4, 2008 | Parker Waichman LLP

After over six years of debating whether consuming meat and milk from cloned animals is safe, the Food and Drug Administration (FDA) is expected to announce that they are.  Clones are genetically identical copies whose gene sequencing is not modified.  While many consumer groups oppose it, the FDA announcement would be a milestone for a small group of biotech companies that want to replicate prize animals.  Cloned cattle cost around $20,000 each, so their high price will result in most being used for breeding; it will be three to five years before consumers see milk and meat from cloned offspring.

Consumer concern toward cloned food safety may lead to increased opposition in Congress and other markets, such as the European Union (EU), concerned not enough data are available for a meaningful study.  There are also ethical worries because cloned animals tend to have more health problems at birth.  The food industry appears to be divided and some big food companies say they're not interested in marketing cloned products.  "Most consumers do not find this appealing," says Marguerite Copel, vice president of corporate communications at Dean Foods Co.  But, some U.S. animal breeders have experimented with animal cloning.  ViaGen Inc., the largest animal-cloning company in the nation, has cloned animals and ViaGen and Trans Ova Genetics recently announced a voluntary tracking system that will help food makers, slaughterhouses, and marketers to prove, if they choose, that they aren't selling such foods; however, the program doesn't cover the offspring of clones.  Dean and others are worried there is no mandatory tracking system and the Food Marketing Institute, which represents food retailers and wholesalers, says its members strongly believe they must be notified when suppliers plan to introduce cloned animals into the food supply.

In 2006, the FDA tentatively ruled that milk and meat from clones are no different from conventionally bred adult animals, calling it a more advanced form of breeding technologies used, such as artificial insemination, embryo transfer, and in vitro fertilization.  Consumer groups and some members of Congress are opposed to cloned foods reaching shelves.  The Senate version of the proposed farm bill contained an amendment that would mandate that the FDA wait until further studies are complete before releasing its final.  Joseph Mendelson, legal director of Center for Food Safety, a consumer-advocacy group, said his group has filed a petition for the FDA to regulate cloned animals as an animal drug adding, "Once the FDA says these products are safe and that they are out there, it's very hard to turn it back.”  The European Forum of Farm Animal Breeders is lobbying the EU to make an exception for bull semen saying,   "Product from cloned animals cannot be distinguished from non-cloned.”

There are clones in Australia, Canada, France, Japan, and New Zealand, but they rarely enter the food supply.  The European Food Safety Authority, EU’s version of the FDA, will likely deliver its initial assessment next week; the final decision isn’t expected for months.  Meanwhile, the European Group for Ethics is conducting studies on whether cloning is inhumane.


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