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contends that the FDA, in its preliminary assessment, used studies on the safety of meat from cloned animals that were not peer-reviewed, standard practice for scientific studies.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.
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.
"The FDA took another three years [after one preliminary report in 2003] looking at not only peer-reviewed data, but also asking outside independent scientists to review the data before publishing the final assessment in December."
Politicians and Retailers Weigh In
The delay in the FDA's move to approve cloned foods may signal that proponents of cloning animals may ultimately have to make concessions. One key point up for debate is whether food from cloned animals will be labeled as such. The FDA has said it does not support labeling. But it appears to be at odds on that point with a number of independent experts. In a 2004 paper, cited by the Center for Food Safety, the National Academy of Sciences advises labeling and tracking cloned foods to give consumers a clear opportunity to avoid such foods and to allow longer-term study of their effects. One of the recommendations in the paper: "Animal identity and identity preservation systems should be improved for tracking animals and animal products through the food chain."
Politicians also have begun to weigh in on the labeling issue. On Jan. 31, Senator Barbara Mikulski (D-Md.) proposed her Cloned Food Labeling Act, which would require food from cloned animals to be clearly labeled as such. She says that Americans want to know whether the food they're eating comes from clones and calls the idea of food from clones "repugnant."
Retailers such as Whole Foods Market (WFMI) and Wild Oats Markets (OATS), as well as milk producers Dean Foods (DF) and Organic Valley, have said they will not offer any milk or meat that comes from cloned animals. Jerry Greenfield, co-founder of the all-natural ice cream maker Ben & Jerry’s, now owned by Unilever (UL), has been one of the most outspoken critics of cloned foods.
There are people who have filed comments with the FDA in support of its preliminary assessment. "I would buy and eat cloned meat," says Jamie Hallinan. "There is no ethical concern about cloning. It is new, so ignorant people fear it. They let religion once again impede the progress of science. These irrational fears have hindered human kind for years."
Still, the vast majority of the comments from individuals are against the proposal. "I cannot believe that you think five years of study is enough and that this next wave of genetically jacked with foods does not need labeling," writes Johnne Fischer. "I refuse to buy meat and dairy products that do not tell me the origin." Says Roland Beres, "To not give the American public the right to identify cloned meat is to stuff cloned meat down our throats without our permission. And that is un-American."
The FDA is expected to issue its final decision on food from cloned animals in the months after the close of the extended comment period, which is likely to be May 2. Approval could come before the end of the year.