Bon Appetite: FDA Proposal on Genetically Engineered Animals Opens for Comment

For those of you who still cannot stomach the decision earlier this year by the Food and Drug Administration to allow the sale of milk and meat from cloned animals, hurry up and swallow, because the next course is on its way.

Today the FDA released its long-awaited—and in some quarters, long feared—proposed new rules for marketing foods from animals that have been genetically engineered to have particular traits.

Among the gene-altered animals that could come through the pipeline first are salmon endowed with extra growth hormone genes, to make them grow faster. Pigs with bacterial genes that make their manure less environmentally damaging. And cattle with genes that help them fight disease or, a little further down the road, genes for omega-3 fatty acids, which could make filet mignon as healthful as a fillet of trout.

The FDA proposal, which is open for public comment for the next 60 days, is sure to raise lots of consumer interest. Thousands weighed in on the agency’s clone ruling, with many expressing disgust over the idea of scarfing down clone-burgers. So wary of clones are our foreign trading partners that the Agriculture Department has asked U.S. farmers to hold off sending their clonal critters to market until the rest of the world gets over its jitters, even though the FDA has declared them safe.

Back then, the FDA and the biotech industry made a big deal about the fact that clones were “just” clones and are not genetically manipulated per se. They are merely conceived in an unusual way that involves just one parent instead of two, we were reminded, which produces an individual genetically identical to that parent. If the government were ever to allow gene-altered animals into the food supply, officials reassured the public, the requirements for approval would be even more stringent than they were for clones.

Well, those rules are out today, with ancillary information from the FDA, and they make for an interesting read.

The good news is that the agency has decided to regulate gene-altered animals under the provisions of its “New Animal Drug” rules rather than through, say, its conventional food safety provisions. That’s good because novel foods for the most part can simply be introduced into the food supply without any restrictions, and enforcement by FDA does not kick in unless something goes wrong, like a lot of people dropping dead. By contrast, under the new animal drug provisions, each new kind of animal produced through genetic engineering will have to get approval from the FDA before it is commercialized. That’s the appropriate approach to something as biologically complex and emotionally charged as gene-altered animal products for the dinner table.

The bad news is that the process of getting such stuff approved is, as is the case with new drugs, extremely secretive. In fact, it would be against the law for the FDA (without permission from the affected company) to reveal that it has even received an application for a new gene-altered food animal until it approves that animal for sale in grocery stores. And once it has given its approval, there is virtually no recourse available to the public if people are not happy with that decision.

There are lots of reasons why the public may want to weigh in on these approvals. Concerns about the welfare of engineered animals. Environmental concerns (what happens when some of those genetically enhanced salmon escape their offshore cages and mate with wild salmon?). Concerns about subtle changes in nutritional values or even economic or ethical issues that the FDA is not really authorized to consider.

In interviews yesterday, FDA and biotech officials made a pretty convincing case that the agency is going to be looking very closely at these applications. The safety of consumers and the welfare of the animals themselves are their twin No. 1 priorities, they said. They also said they intend to make the process as public under the rules as possible, at least at first, to reassure consumers that their interests are being properly handled.

As always, the devils will be in the details: Just how much data the agency demands. How well it coordinates with the USDA and the Environmental Protection Agency, which will share responsibilities for many of the issues raised by engineered animals. But the first test will be how the agency responds to public comments over the next two months. Will it take the time to absorb them, respond to them thoughtfully in a public document, and integrate the best suggestions into a final version of the guidance? Or will it, as some agency-watchers suspect, finalize the proposed guidance very quickly after the 60 days are up, adding it to the bureaucratic bolus being force fed through the Washington policy machine in the waning days of the Bush administration?

Undue delay would be wrong. The nation and the world has been worse off, not better, for lack of guidance on how this next generation of animals is going to be regulated. And importantly, this is about more than just food. Engineered animals are also being made that produce important medicines in their blood, milk, and urine. Others may someday grow organs suitable for transplantation into people. Some animals being made or on various drawing boards are just capricious or quaint, such as the pet fish that glow in the dark and the cats that briefly were being produced under the (questionable) claim that they would not trigger allergies.

There is a world of biological manipulation to be had out there, and while some of it will be offensive a lot of it will be for the better. But the process is important. The FDA has to prove it is really listening, and show in its first few application reviews that it cares about the public interest and the animals themselves as much as it cares about the companies that hope to profit from these living and breathing products.

Tags: FDA, genetics

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