Gene-altered Animals and Food Safety
By Rick Weiss
November 10, 2008
Perhaps you're still getting used to the idea that some of the meat, milk, and cheese you are eating may come from cloned cows or their offspring, a controversial culinary advance that the Food and Drug Administration green-lighted in January after deeming food from clones to be safe. Well, hurry up and swallow, because the next course is on its way.
Largely unnoticed due to the mayhem of the markets and the presidential race, the FDA recently proposed rules that would allow, for the first time, the marketing of foods from genetically engineered farm animals as well. Unlike clones - which are weirdly procreated from a single parent but are otherwise conventional creatures - engineered animals have had their DNA codes rewritten to endow them with traits never before seen in those species.
Among the gene-altered animals angling to appear on our dinner tables are farmed salmon with novel DNA that makes them grow faster; pigs with bacterial genes that make their manure less environmentally damaging; and perhaps even cattle bearing fish genes for omega-3 fatty acids. Imagine filet mignon as healthful as fillet of sole.
The good news is that the agency wants to regulate gene-altered animals under its strict "new animal drug" provisions. Usually novel foods can be introduced into the food supply without restrictions, and the FDA does not get involved unless problems arise. But under the new animal drug provisions, each new kind of animal produced through genetic engineering would have to get FDA approval before being commercialized, the way new drugs are approved. That's the right approach for dealing with the biological complexities and cultural sensitivities of allowing gene-altered animal products on supermarket shelves.
The bad news is that the drug approval process in this country is extremely secretive. Under its provisions it would be illegal for the FDA (without a company's permission) to reveal that it had even received an application for a new gene-altered food animal until after the agency had approved it for marketing. Once approved, there would be virtually no recourse available to consumers. And although the agency would ultimately release a summary of safety data, details could remain hidden forever as "confidential business information."
Most of us accept this approach for new medicine approvals, but such a closed-door system is inappropriate for new foods. For one thing, patients understand that medicines carry both benefits and risks, and we count on trusted intermediaries - our doctors - to sort through those details. With no such experts to help with our grocery shopping, we deserve more information on gene-altered food.
A good start would be to require that applications for gene-altered food animals get an initial public review, perhaps through the FDA's veterinary medicine advisory committee, which publically advises the agency on animal drug issues. FDA also needs to take seriously consumer demands that DNA-doped foods be labeled as such. And it should strengthen its system of post-marketing surveillance to watch for unanticipated outcomes.
Beyond human health concerns, rapid commercialization of engineered animals risks disrupting trade with countries not ready for future food. There may also be environmental issues (what happens when gene-enhanced salmon escape their offshore cages and mate with their wild cousins?). And there may be legitimate concerns about the welfare of some engineered animals. In a transparent system, citizens could at least weigh in on industry priorities and shoppers could vote with their pocketbooks.
The United States needs a system for approving some gene-altered animals, in part because this is about more than just food. Scientists are also engineering animals to make human medicines in their blood and milk. Others are striving to craft animals bearing life-saving organs suitable for human transplantation. Still others simply want to give animals new genes to help them resist debilitating diseases.
The proposed FDA rules, open for public comment through Nov. 18, could speed the advancement of these and other innovative endeavors. But they will do more harm than good if they don't also promise transparency and accountability. As demonstrated by this year's Korean riots over US beef imports and by the repeated domestic incidents of tainted food, trust is the American food supply's most precious ingredient.