Send in the Clones
Today’s Dietitian
By Kate Jackson
Vol. 6 No. 6 p. 26

Could food from cloned animals be coming soon to a market near you? Will you dine on roasted rack of cloned lamb, feast on ribs from a cloned pig, or down a glass of cold milk from a cloned cow? The answer is likely to be yes, but the real question is: Will you know it if you do?

A recent announcement by the FDA—based on ongoing assessments indicating that consumption of food from animal clones “appears to be safe”—suggests that it won’t be long until these products are approved to enter the U.S. food supply and find their way into stores and restaurants. If that prospect makes you squeamish, this might make you downright queasy: The FDA currently sees no reason for labels that would let consumers know that they’re purchasing food from animal clones.

The Ongoing Review
Somatic cell nuclear transfer is the name of the process by which animals are cloned. Through this fusion of a cell’s nucleus from the body of the parent animal to an unfertilized egg cell, an identical genetic copy of the parent animal is created. The process has been used for the purpose of improving quality and increasing productivity at a cost of as much as $20,000 to clone a single goat, pig, or cow. At this cost, it’s unlikely that these animal clones will themselves enter the food supply, but their progeny are likely to reach American tables once they are approved by the government.

Before that can happen, the government must conclude its ongoing process of reviewing the scientific research concerning the safety of human consumption of cloned animal products. The FDA’s risk analysis began nearly two years ago when it asked the National Academy of Sciences (NAS) to investigate the evidence. On October 31, 2003, the FDA issued a draft executive summary of its risk assessment, which it says builds upon the NAS findings. The academy determined that although animal clones “posed only a low level of food safety concern, it would be prudent to have more data in order to minimize further safety concerns.” Before it could make policy decisions concerning animal clones, the FDA concluded that a risk assessment was necessary, to be followed by a review of risk management options. Information has and will continue to be communicated at public meetings and all future information will be publicly available through the FDA’s Web site.

With the release of the draft executive summary, the FDA also announced that a voluntary moratorium on releasing animal clones remains in effect until further data are evaluated. The summary reveals that an advisory panel has reached the tentative opinion that food from “animal clones and their offspring is likely to be as safe to eat as food from their nonclone counterparts, based on all the evidence available.” A public meeting was held November 4, 2003, at the Center for Veterinary Medicine in Rockville, Md., during which some panel members insisted on the need for further data to support the FDA’s presumption of safety while others urged the agency to pay greater attention to the ethical issues surrounding animal cloning, including the suffering of cloned animals. The transcripts of this meeting explaining the review process are available online at www.fda.gov/cvm/index/vmac/VMACFall2003.htm.

The FDA is continuing to review the issues and inviting comments from the public before making a final decision. While the biotechnology industry pushes for FDA approval and suggests that cloned animals will provide a reproducible, healthful, cost-effective alternative to natural animal products, others are voicing concerns that cloning animals for food is not only potentially unsafe and perhaps unethical but also unnecessary and just plain distasteful.

Safety
The FDA’s presumption of safety is based on the fact that its Veterinary Medicine Advisory Committee—like an NAS study released the previous year—could discern no difference between mature cloned animals and their counterparts in nature. Its conclusions were based on studies of cattle but extended to pigs and goats. This conclusion supports the FDA’s suggestion that labels on food containing the products of animal clones would be unnecessary. If there’s no difference in the products, the agency indicates, there would be no need for special labels.

In a swift response to the FDA’s announcement of its tentative support of cloning, George Siemon, CEO of Organic Valley, told the press, “American families should not be guinea pigs for corporate greed. Contrary to what the FDA says, there is no level of ‘acceptable risk’ when it comes to putting unproven science on the table for dinner.”

When the FDA comments that consumption of cloned products appears to be safe, adds Michael Levine, president, Organic Meat Company, a wholly owned subsidiary of Organic Valley, it’s taking a leap of faith that hurdles a chasm of uncertainty. The agency indicates that it has no reason to believe cloned products are unsafe. That, suggests Levine, isn’t evidence that they are safe. “What makes me particularly uncomfortable,” he says, “is that there’s a lack of knowledge, so consequently we can’t find the risks because we don’t understand it well enough.”

The notion that since science can’t distinguish a difference between natural and cloned animals there must not be a difference “borders on ignorance and egotism,” says Levine. “We know what we know, and beyond that, we’ll find out.” Rather than cater to business interest, he insists, we should err on the side of caution.

Ethics and the Unknown
According to Levine, “There is an enormous amount of uncertainty as to where this will lead.” Once cloned products are released, there’s no returning, he suggests. “You can’t call it back,” he says. “Once it’s out and the genetic material is allowed to blend with regular genetic material, then it essentially infects.”

“Whether it’s genetically engineered crops, cross-pollinating with wild weeds, genetically modified salmon breeding with wild fish, or future concerns with clone mammals, the risks to the balance in ecosystems worldwide are great,” said Siemon. Ethical concerns have been raised as well about the welfare of the animals themselves, many of which are born with deformities or disease as a result of the cloning technology.

The Yuck Factor
Levine believes the prospect of eating the products of cloned animals makes people uncomfortable enough that there will be a strong consumer outcry regarding the need for labeling. “It’s one thing when it’s a tomato, but when it’s a living, breathing animal—a created, processed creature—that’s something else,” he says. Once a need for labeling is established and people see the labels, he speculates, people won’t want the products. Much like irradiated foods, says Levine, “there’s enough uncertainty and discomfort at the consumer level that it will prevent it from widespread distribution.”

Wahida Karmally, DrPH, RD, CDE, director of nutrition, Irving Center for Clinical Research at Columbia University, took an informal survey of colleagues, asking whether or not they’d eat cloned animals or products from cloned animals. Most, she says, were not so inclined. However, among her sampling were three doctors, each of whom had no qualms about it. The scientists among the group claimed they could see no difference, while those opposed to eating cloned animal products cited concerns about safety and the unknowns. Some, in addition, merely question the need for cloning, asking, “Why not leave animal reproduction to nature?”

Karmally, herself not a big meat eater, says she finds the idea distasteful. Although she has no reason to believe these products are hazardous to human health, she’s concerned that the government’s assessment discusses the appearance rather than the certainty of safety. Why, she wonders, do they just appear to be safe, and what’s preventing the government from using more conclusive language? “I’m not totally convinced that it’s without hazards, but I really don’t know,” says Karmally.

“Ultimately what will happen if the business interests push through … somehow they’ll be able to disguise it and then it’s out there and there’s nothing we’ll be able to do because the market, in face of ignorance, will accept it,” she continues. “Knowledge, though, is a remarkably powerful tool, and if consumers have the knowledge that it’s out there, I believe they will opt not to participate.”

Necessity
Like her colleagues, Karmally questions the necessity for cloning in the first place, asking, “Don’t we have enough production?” Katherine Tallmadge, American Dietetic Association spokesperson, agrees. “We have plenty of food. Why do we need to clone?”

“Obviously from my perspective, the organic protocol and the organic system is the right way to raise animals,” says Levine. “But even conventionally speaking, the quality level of animals is high enough. There’s no need.”

Labeling
Even many who believe there’s no harm to human health and/or for concern about eating the products of animal clones believe the public has a right to know where their food comes from. “I think we should let people decide whether they want to eat [food from cloned] animals,” says Karmally, “People need to make informed decisions.” Echoes Tallmadge, “The more educated the consumer is, the better, so the more labeling, the better.” One reason labels may be important, says Karmally, is to assure consumers that the cloned animal has the equivalent nutrient content. They may want to know that the cloned product offers the same amount of protein, for example.

Even though Levine clearly believes that if animal clone products are released into the food supply they should be labeled, he’s uncomfortable with the statement. “I’d rather say it should never get to that.”

Making Choices
If products from animal clones are permitted to enter the food supply and the FDA determines that labeling is necessary, consumers will be able to recognize cloned products and make their own choices. If these products are permitted without labeling, only consumers who purchase organic meat products will be certain that their food is not from animal clones. “Buying organic is a safety valve across so many different levels,” says Levine. “The organic protocol is about raising animals and crops in harmony with nature, as nature intended. So you don’t have any of these issues because they’re not within the organic system.”

Staying Tuned
The FDA risk assessment will continue and its findings will be published on the agency’s Web site, possibly by early this year, after the public has had an opportunity to comment. The FDA will then look at risk management and regulatory options. To stay current, follow the risk assessment process or offer comment on the FDA’s Web site at www.fda.gov/cvm.

— Kate Jackson is a staff writer for Today’s Dietitian.

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