Animal Cloning: FDA Safety Call Not Enough

Gregory Jaffe of the Center for Science in the Public Interest seeks proof that animal cloning's benefits outweigh risks and ethical concerns

by Gregory Jaffe

The results are in. After a review of the scientific data surrounding the safety of meat and milk from cloned animals, the Food & Drug Administration (FDA) has concluded that such products are "as safe to eat as food from conventionally bred animals."

The FDA found that it could not distinguish between a healthy clone and a healthy conventionally bred animal and that there was no evidence that meat or milk from cloned animals or their sexually reproduced offspring differed from those same products from conventional animals.

In 2007, the FDA will take public comment on its assessment and make a final decision on the safety of those meat and milk products. Barring new research indicating problems, the FDA will lift the voluntary marketing moratorium later this year or next. Food manufacturers might—pardon the pun—send in the clones sometime next year.

Press reports on the FDA's announcement stressed that many consumers are uncomfortable with animal cloning and don't want to eat products from those animals. Some consumers questioned the science behind the FDA's determination. Others questioned why cloning is needed. And some stated that cloning animals and then eating them was unethical, simply wrong, or plain "yucky."

Safety First

Whether consumers or retailers such as Kroger (KR), Safeway Stores (SWY), or Costco Wholesale (COST) will buy products made from cloned animals and their progeny is unclear. Regardless, certain issues must be addressed by the livestock industry and the government before consumers are offered foods made from animal clones.

For most consumers, the key issue surrounding foods from cloned animals and their offspring is safety. Consumers want to go to the supermarket and know that all meat and dairy products, whether produced conventionally, organically, or from animal clones, are as safe as possible. The FDA's release of the safety data on meat and milk from cloned animals and their offspring is an important first step in determining the safety of cloned products.

Subjecting that data and the FDA's risk assessment to public scrutiny and scientific peer review over the next few months will help ensure that the initial FDA conclusion is defensible, based on all available scientific evidence. While we don't anticipate new information that will change the FDA's initial determination, a transparent and participatory decision-making process may give the public confidence that a thoughtful decision has been made using the best information available.

Needing Proof

But an FDA decision that cloned animals are safe to eat will not, by itself, result in widespread adoption of animal cloning if that technology does not provide benefits to society. The cloning industry has provided the public with little information about why cloned animals are needed. Will cloning really lead to better tasting meat, less expensive milk, or disease-resistant herds? What are the societal benefits of using cloning technology and do they outweigh any potential risks?

Until the cloning industry makes its case for why using animal clones in food production is beneficial, why should livestock farmers, retailers, or consumers accept those products? The cloning industry must show that using its technology will lead to safer or cheaper food or more environmentally sustainable agricultural practices.

Furthermore, no matter how beneficial cloning may turn out to be, it still will raise significant ethical concerns. Studies show that the typical health problems surrounding pregnancy and birth for livestock occur more often in surrogate mothers with implanted embryo clones. Similarly, livestock clones have more health problems at birth and may die at birth more often than conventionally bred animals. Is it wrong to clone animals if the process impairs the health and welfare of the animal?

National Dialogue Needed

Some people have raised other ethical objections, stating that cloning animals is "playing God" or interfering with the natural needs and interests of animals. The FDA has acknowledged those concerns but stated—appropriately—that they will not be a part of its scientific decision-making process, which is legally limited to safety issues.

High-level forums are needed to explore the ethical and social issues surrounding cloning and to adopt appropriate policies. Congress should hold hearings on those issues. The President's Council on Bioethics should analyze the merits of different objections and propose any needed policies that go beyond the FDA's pure safety decision. Religious leaders and ethicists should contribute to the debate by presenting their views on the merits of using animal cloning as well as recommending any limitations on cloning. A national dialogue on the ethical issues may help us decide whether this technological advance is something our society wants to swallow.

Jaffe is biotechnology project director for the Center for Science in the Public Interest, based in Washington, D.C.