Send in the Clones: FDA Set to Give Final Approval

By Kisha Lewellyn Schlegel, 1-08-08

	Caption: from the Center for Food Safety

A small paragraph on a back page of Sunday’s Oregonian revealed that after six years of debate over the safety of cloned meat and milk, the Food and Drug Administration is set to give a final approval this week that cloned food is safe to eat.

The FDA made an initial decision on the matter in December of 2006, ruling that cloned cattle, pigs and goats were, ”as safe as the food we eat every day.” The decision was followed by a public comment period in which 145,000 people opposed the FDA’s plans to introduce cloned food.

But these comments seem to have gone unheard as the FDA plans to announce a final approval. The move would come less than a month after the Senate also voted to delay the FDA’s endorsement of cloned food. The Senate’s Farm Bill (HR 2419) included the Mikulski-Specter Amendment (opens pdf), which calls for a rigorous review of human health and economic impacts of cloned food. While the House version of the Bill does not have this provision, the Senate’s amendment would require that two studies would need to be conducted prior to the FDA’s final decision on clones and the National Academy of Sciences would hold a review of the FDA’s initial decision that food cloned from animals is safe.

That decision is under question because, according to the Center for Food Safety, the FDA’s initial risk assessment of cloned food is faulty. Although the FDA claims to have used extensive peer reviewed safety studies, the administration only used three peer-reviewed studies (opens pdf), which focus solely on milk from cloned cows. None focus on meat safety or on the byproducts from cloned offspring and none deal with cloned goats. In turn, the few studies used were also funded by the same biotech firms that produce clones for profit.

The Center for Food Safety argues that comprehensive research is imperative when defects in clones are common and even cloning scientist warn of small imbalances that can lead to food safety problems in milk and meat.

Dr. Michael Hansen of Consumers Union agrees. “The FDA risk assessment ignored the fact that most clones never make it to adulthood because they die in gestation or shortly after birth, and also failed to consider whether clones might need more drug treatments.” Animal rights advocates, such as the Humane Society of the US are also opposed to cloning because it decreases animal welfare, and increases incidence of animal death and deformities. According to Farm Sanctuary, cloning may lead to even harsher conditions for animals used to produce food as they are given more antibiotics and often have brain, liver and respiratory diseases. Even Dolly the Sheep, the first and most famous cloned mammal, suffered from debilitating arthritis and died from a progressive lung disease.

Consumers are increasingly as concerned about the treatment of farm animals as they are wary of cloned ones. A 2007 national survey conducted by Consumers Union found that 69 percent of respondents had concerns about cloned meat and dairy products being introduced to the food supply.  A recent Gallup Poll reported that more than 60 percent of Americans believe that it is actually immoral to clone animals, while the Pew Initiative on Food and Biotechnology found that a similar percentage say that, despite FDA approval, they won’t buy milk from cloned animals.

So why is the FDA in such a hurry?

According to the Center for Food Safety, the FDA’s decision that cloned animal products are safe would prove a major boon to three major biotech companies in the cloning business. These corporations clone animals of superior genetic quality, side-stepping the generations old practice of breeding towards a desired trait. Their cloned animals sell from $10-$20,000 and would primarily be used for breeding purposes; their offspring would be sold for meat and used for milk.

With that price tag, these beasts of cloned burden would not serve small farmers, but would support the breeding programs of large agri-businesses, able to use one expensive bull to produce lots of offspring with increased milk output or meat for sale at a premium. It would also provide opportunities for large corporations to patent their clones, much as businesses like Monsanto have done with genetically modified organisms. This has proven to limit public access to our commonly held and shared seeds. (See my article on this here.)

Those who would benefit are also those who funded the studies that the FDA used to make its decision, and so it seems from the outside that FDA has been swayed by biotech companies rather than the public.

But FDA’s reasons for the push are still unclear, and staff at the FDA were unavailable for comment on Monday morning. It is also unclear if this final safety approval will lift the current, but voluntary hold on the sale of cloned products as food. Should those products be allowed for sale in our grocery stores, the public may not even know it since the FDA currently has no plans to require labeling of cloned food, and a Congressional amendment to support further research may come too late as America’s dinner tables become the testing ground.