FDA’s Final Risk Assessment, Management Plan and Industry Guidance on Animal Clones and their Progeny

FDA’s Final Risk Assessment

Q: What did FDA’s Final Risk Assessment conclude?

A. After years of detailed study and analysis, FDA concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. FDA has insufficient information to reach a conclusion on the safety of food from clones of other animal species, such as sheep.

Q: Are the data reviewed in the FDA risk assessment sufficient to justify the conclusions made?

A. FDA performed a thorough risk assessment and evaluated a large body of data in reaching its conclusions. The risk assessment finds that meat and milk from clones of cattle, pigs and goats, and food from the sexually reproduced offspring of clones from species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They agreed with the methods FDA used to evaluate the data and the conclusions set out in the document.

Voluntary Moratorium

Q: What is the voluntary moratorium?

A. In June of 2001, FDA posted on its Web site a request that animal clones and their progeny be kept out of the food supply until FDA had had a chance to evaluate whether cloning posed any additional food consumption risks. By complying with that request, producers and breeders of clones can be considered to be observing a voluntary moratorium on putting food from clones and their progeny into the food supply.

Q: What is the status of the voluntary moratorium now that the FDA has released its final risk assessment on products derived from animal clones or their progeny entering the U.S. food supply?

A. Currently, the cloning industry is adhering to a voluntary moratorium on putting cloned products into the food chain. USDA encourages the cloning industry to continue its voluntary moratorium for a sufficient period of time to prepare so that a smooth and seamless transition into the marketplace can occur.

Animal Clones, the Food Supply & Export Channels

Q: Will consumers be able to identify products derived from animal clones or their progeny in the marketplace?

A. Because FDA has determined that food from clones of specified species and the offspring of clones from any species traditionally consumed as food are safe and no different than food from conventionally bred animals, there is no basis to require labeling of food products from clones or their progeny.

Q: Is it inevitable that clone-derived food products will be in the food chain? If other scientific studies identify food safety problems not found in the final FDA risk analysis, does USDA have the authority to put a halt to inspection and commerce of clone products?

A. FDA has deemed the products derived from animal clones of the specified animal species and the offspring of clones from species traditionally consumed as food are safe to eat - that’s the most important point. Industry has expressed an interest in USDA assisting with a transition. USDA believes it is likely that at some point in the future, these products will enter the marketplace, though not immediately and understands that a transition will be necessary.

USDA encourages the cloning industry to maintain its voluntary moratorium until industry can come together and discuss the necessary steps before lifting it.

Q: Have products from animal clones or their progeny already entered the U.S. food supply or export channels?

A. FDA has determined through its risk assessment animal clones of the specified animal species and the offspring of clones from species traditionally consumed as food are safe to eat. USDA is not aware of any instance where product from a cloned animal has entered the food supply or export channels.

Q: Can the United States guarantee that products derived from animal clones or their offspring will not enter the food supply or export channels?

A. As USDA works with industry on a smooth and orderly transition into the marketplace, industry will implement its livestock cloning supply chain management program which will establish protocols for tracking animal clones. Industry previously announced this program in Dec. 2007. USDA would be open to discussion with industry on possible verification of its supply chain management plan to ensure that trading partners are aware of whether or not they receive cloned or non-cloned products.

Q: Will the United States Government play any role in the identification or tracking of animal clones or their progeny, or food products derived from these animals?

A. This will depend on industry and marketplace needs in the future. USDA understands that industry, through its livestock cloning supply chain management program, would be able to provide assurance to customers on the product supplied. Should industry request its engagement, USDA is standing by to work with them to address this issue.

Animal Cloning & USDA’s National Organic Program

Q: When consumers hear that USDA will *not* certify products from cloned animals or their offspring as ORGANIC, doesn’t that indeed send the signal that the products are not healthy?

A. No, it simply reflects the fact that organics is a marketing program. As such, by consensus of the market participants, many production methods and materials are excluded from use.

Q: Is cloning as a livestock production practice allowed under the USDA National Organic Program regulations?

A. No. Cloning as a production method is incompatible with the Organic Foods Production Act and is prohibited under the NOP regulations.

Q: Can animals produced using cloning technology, or clones, be considered organic under the National Organic Program regulations?

A. No. Animals produced using cloning technologies are incompatible with Organic Foods Production Act and cannot be considered organic under the National Organic Program regulations.

Q: What about the progeny of animals produced using cloning technology or clones – can they be organic under the NOP regulations in organic livestock production?

A. Based on a recommendation of the National Organic Standards Board, USDA’s Agricultural Marketing Service is preparing the necessary public rulemaking to address the organic status of the progeny of animal clones.