Scientists Clone, Bureaucrats Clown

After six years of deliberation, in January 2008, the Food and Drug Administration finally—and rightly—concluded that food from cloned animals is safe and may be sold and consumed. This decision was based on voluminous and incontrovertible scientific data. But two things took the luster off the announcement.

First, it was far too long in coming. Scientists have known for years that the clones are indistinguishable genetically, biochemically, and nutritionally from the parent.

Second, on the very day that the decision was announced, another federal agency attempted to undo the positive effects of FDA’s proclamation. While not quibbling with the consensus about safety, Bruce I. Knight, Under Secretary for Marketing and Regulatory Programs with the U.S. Dept. of Agriculture, called for an indefinite continuation of the existing “voluntary moratorium” on the marketing of cloned animals and their offspring. He said that, “given the emotional nature of this issue,” U.S. and foreign consumers will need “an acceptance process” for the next few years.

This could represent a new nadir in bureaucratic reasoning and the sort of stunning debacle that makes policy wonks wonder—not for the first time—whether anyone is actually in charge of federal agencies’ decision-making. Where is the decider-in-chief when we need him?

My advice to Knight is to worry less about the emotions of consumers and more about the importance of permitting new, innovative technologies to provide safer, cheaper, and more nutritious food. Why not simply let the marketplace decide the viability and demand for these demonstrably safe products? Cloning technology of one sort or another is widely applied to a variety of foods that we consume routinely and uncontroversially. As the journal Nature Biotechnology observed in a January 2007 editorial: “The irony in all this is that food from clones has been a part of our diet for years. Many common fruits (e.g., pears, apples, oranges and lemons) and several vegetables (e.g., potatoes and truffles) are clones. And most of us have probably ingested meat and dairy products from livestock cloned by natural reproduction (monozygotic siblings), mechanical embryo-splitting, or even nuclear transfer from an embryonic donor cell into an enucleated oocyte. Regulators traditionally paid scant attention to clones as a group—and rightly so.”

The animal clones that were the subject of FDA’s risk assessment are produced by taking a single cell from an animal that one wants to replicate and fusing it with a cow egg that has had its DNA removed. Then, a small electric shock induces the egg to grow into a copy of the original animal, resulting in the creation of an embryo that can be transferred to and gestated in a surrogate mother animal. The newborn is a replica of the animal that donated the initial cell. As one farmer who owns a pair of clones of a prize-winning Holstein cow observed, they are essentially twins of “a cow that was already in production.” Farmers want copies of exemplary animals.

Certain sectors of the food industry have expressed fears that consumers might reject milk and meat from cloned cows, but history argues otherwise. Twenty years ago, there were similar concerns when dairy farmers began using a protein called bovine somatotropin, or bST, to stimulate milk production in cows; some analysts predicted that its introduction would so frighten consumers that milk consumption could drop as much as 20%. Although the milk is in no way different or less wholesome than that obtained from untreated cows, activists demanded special regulations, including mandatory labeling of dairy products from bST-treated animals.

FDA demurred; the product was hugely successful; and a decade after milk from bST-treated cows began to be marketed, an analysis from the USDA’s Economic Research Service concluded: “Scientific evidence about food safety will not prevent controversy… Even intense controversy may have minimal or no effect on total demand [and] the absence of reports of harm from consumption contributes to continued consumption.”

The bST experience serves as a reminder that the mere presence of controversy—or pseudo-controversy generated by anti-technology activists and bureaucrats—should not cause industry or government regulators to overreact.

Cloning technology offers yet another tool for animal breeders to make foods cheaper and more consistent, nutritious, and tasty—if the know-nothing bureaucrats can be held at bay. The producers of clones have waited too long and should push ahead without further delay.

Henry I. Miller, M.D., who headed the FDA’s Office of Biotechnology from 1989–1993, is a physician and Fellow at the Hoover Institution, Stanford University, Stanford, CA 94305 ([email protected]).