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Farmers Breathe Sigh of Relief, Wait for FDA

Last Thursday, December 28, the Food and Drug Administration made a long-awaited announcement that it had officially found meat and milk from cloned cows, pigs, and goats to be safe for human consumption. In a 678-page report, the agency meticulously detailed the hundreds of scientific studies and mounds of raw data it reviewed over the past five years in order to reach this conclusion. Cloning supporters cheered, critics jeered, and almost everyone speculated about the public’s opinion. But, one important group of stakeholders has been all but ignored by the mainstream press.

For years, dozens of American ranchers have been raising cloned animals in anticipation of the day they finally can be used to breed offspring that would eventually be sold commercially. Although no statute or regulation forbids the sale of cloned animals, their offspring, or meat and milk from either, FDA requested several years ago that cloned livestock be kept off the market until the agency’s analysis could be completed. And, as one is apt to do when an agency with practically unlimited discretion over one’s livelihood makes such a request, agency officials believe these farmers have complied.

Cloning is expensive, however – roughly $20,000 to $60,000 per animal – and while the FDA scoured the data, clone owners were forced to sit idly by and watch their investments go to waste. Maryland dairy farmer Greg Wiles, for example, had been quietly amassing a small herd of cloned cows with the expectation that FDA would eventually green-light their use. In the meantime, Wiles has had to pour thousands of gallons of milk from those clones down the drain. Today, he’s at serious risk of losing his 200-acre farm due to financial shortfalls that might have been ameliorated had he not spent the last few years throwing away valuable product.

Farmers like Wiles surely breathed a deep sigh of relief at last week’s announcement, but their emotions must be mixed. After all, four years ago the National Academy of Sciences concluded that there was no scientific evidence, or any theoretical reason to believe, that meat or milk from clones would be in any way unsafe to eat. And, three years ago, the FDA released the draft executive summary of the risk assessment it issued last week, concluding the same thing. But time ticked on.

FDA finally released its cloning risk assessment last week, along with a draft guidance document and a proposed risk management plan, but it still won’t lift the voluntary moratorium until the public has had an opportunity to submit comments and the agency’s policy is finalized. That could easily take another six months, and may take as long as a year. But why the public must be consulted before these farmers may do what they already have a legal right to do is anyone’s guess.

One big reason for FDA’s delaying seems to have been intense lobbying by the dairy industry and dairy-state members of Congress who fear a consumer backlash from the introduction of cloned livestock. But, evidence for such a backlash is purely speculative. Although consumer opinions are mixed and still in flux, a majority of Americans seem to have an open mind about cloning. In one survey, conducted by the University of Maryland’s Center for Food, Nutrition, and Agriculture Policy, 64 percent of respondents said they would buy or consider buying meat from cloned animals.

Eventually, those consumers who want the choice will be able to reap the benefits of livestock cloning. The technology will let breeders produce better and safer food by cloning rare animals that produce leaner meat, for example, or those that are especially resistant to common livestock diseases.

Still, critics argue that, because many clonal pregnancies result in miscarriage, and some clones have neonatal health problems and birth defects, moving forward now would be inhumane and unethical. But each of these problems is also present in other assisted reproductive technologies, such as in vitro fertilization and embryo transfer, as well as in natural mating. Animal breeders have managed them for decades, so their presence in cloned animals presents no unique ethical or consumer safety issues. And the ability to drastically reduce illness among animals and to improve consumer safety arguably makes cloning more humane, not less, than traditional breeding.

For now, FDA is convinced that it is appropriate to move forward with animal cloning. It’s a shame, though, that farmers like Greg Wiles may be bankrupted by the agency’s unwillingness to move more quickly.

Tags Biology Cloning Cryobiology Dairy Dairy farming Ethics of cloning Food and Drug Administration Greg Wiles Livestock Milk Molecular biology Person Career Pharmaceutical sciences

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