Extra Innings for the Cloned Food Debate

Amid pressure from organizations that want more time to consider the issue, the FDA is expected to extend the period for public comment by 30 days

by Pallavi Gogoi

On Dec. 28, the U.S. Food & Drug Administration said in a preliminary assessment that the meat and milk from cloned animals and their offspring were "as safe to eat as food from conventionally bred animals," suggesting that it would allow cloned foods onto supermarket shelves in the near future. The agency did, however, provide 90 days for the public to comment on the tentative approval, a period that was set to expire Apr. 2.

Now the debate over cloned food is going into overtime. The FDA on Apr. 2 announced a 30-day extension of the period for public comment until May 3. Several organizations had asked for more time to examine the issue, including the activist group Center for Food Safety and industry associations such as the American Frozen Food Institute, the American Bakers Assn., the Food Marketing Institute, and the International Dairy Foods Assn. "The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments," says the FDA in a news release.

Just the Science, Ma'am

The FDA declined to confirm or give any explanation for the extension, but the provision for additional time comes amid a broad public outcry against the agency's plans to make the U.S. the first country in the world to allow milk, meat, and other products from cloned animals into the general food supply. Nearly 4,000 comments have been made on the FDA's Web site. Many of them are from individuals who object to the agency's preliminary plans on the grounds of ethics, safety, or morality. Ledia Elraheb says that scientists should stop trying to play God and bestow life: "God is the only creator," she says (see BusinessWeek.com, 3/7/07, "The Case Against Cloning").

Such opinions, without scientific backing, will carry little weight with the FDA. The agency has said that it will limit its judgment to the science of cloning because it does not have the legal authority to address the ethics or morality of the debate.

Among the public comments, however, are some that address the science behind cloning—and these may have something to do with the agency's decision to provide more time for comments. One of the most critical is a report from the Center for Food Safety released on Mar. 21. It contends that the FDA, in its preliminary assessment, used studies on the safety of meat from cloned animals that were not peer-reviewed, standard practice for scientific studies. It also points out that the FDA relied on data from two companies involved in animal cloning, Cyagra and Viagen. The report says that Viagen "stands to benefit from the FDA's approval of cloned food," and that its data are "sorely lacking."

Andrew Kimbrell, executive director of the Center, says, "FDA's flawed approach falls far short of providing the kind of rigorous scientific assessment that Americans deserve before these experimental animals are allowed into the food supply." The organization requested more time, at least 90 days, to allow a more thorough review of the data.

Data Debate

One of the concerns about cloned animals is that the science is so new that long-term data are scant. The first cow was cloned in 1999. Still, the FDA says the scientific evidence on the issue is clear. "Based on FDA's analysis of hundreds of peer-reviewed publications and other studies on the health and food composition of clones and their offspring, the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day," says Stephen Sundlof, director of the FDA's Center for Veterinary Medicine.

Independent experts say the agency has done a thorough job in its review. "To say the FDA didn't do its job or looked at only a handful of studies is negative hyperbole," says Maureen Storey, director of the Center for Food Nutrition & Agriculture Policy and research professor at the University of Maryland.