Biotechnology is everywhere these days, from the production of pest-resistant crops to microorganisms that make biofuels to new drugs and vaccines. It's even used to produce animals with novel and valuable traits, but these applications in particular are suffering from inconsistent, uncertain regulation.
After 20 years of dithering, the Food and Drug Administration has not yet managed to publish a policy statement, but a senior official in its Center for Veterinary Medicine strongly hinted the agency's preferred approach. She said every new genetic construction in an animal would require approval for use in the food supply, and that the applicable procedures and regulations would be the same as for drugs used to treat animal diseases.
But introducing a gene is not the same as administering a drug. Not for first time, regulators are trying to force a square peg into a round hole. Far more apposite models are the production of livestock clones, or identical twins, that FDA decided last year were safe to eat; and the agency's oversight of traditional foods.
To understand why, we need to consider the techniques involved and the regulatory procedures for foods generally. "Transgenic" animals usually are created by injecting the desired gene — which may be intended to confer an advantage in husbandry or nutrition, for example — into a single-cell embryo, or by inserting the gene into a skin cell and creating an embryo by a process called cloning. In either case, the embryo that now contains the foreign gene is then implanted into the uterus of a surrogate mother. If the foreign gene is incorporated into the DNA of the offspring, it is passed on like other genes to succeeding generations. Animals to be raised for food are propagated in conventional breeding programs.
The only currently marketed transgenic animal is an ornamental (aquarium) zebra fish that glows because of the insertion and expression of a gene that synthesizes a beautifully colored fluorescent protein (http://www.glofish.com). The fluorescent protein genes were obtained from another marine organism, the sea anemone.
A company called Aqua Bounty Technologies has been trying for about a decade to get regulatory approval to market an Atlantic salmon that contains a newly introduced Chinook salmon growth hormone gene engineered to keep it turned on all year round (instead of during only the warmer months, as in nature). This cuts the time to marketable adult weight from 30 months to 18. The extra gene causes no detectable differences in the salmon's appearance, taste or nutritional value; it just grows faster.
Despite ample evidence the fish is safe to eat and does not differ nutritionally from other Atlantic salmon, the FDA has kept the company treading water for almost a decade.
There are many other applications in various stages of research and development, including transgenic livestock with leaner muscle mass, enhanced resistance to disease and improved use of dietary phosphorous to lessen the environmental impacts of animal manure. But if regulators don't soon begin to let sound science and common sense dictate their regulatory decisions, the entire sector could virtually disappear.
Several kinds of problems plague the FDA's Center for Veterinary Medicine. It has long been considered the weakest of the agency's five regulatory components. Its personnel have never been the best and the brightest, and few are familiar with the nuances of modern molecular biology. Another is that the "new drug" paradigm doesn't fit transgenic animals well. A better model is the way that another FDA component, the Center for Food Safety and Nutrition, regulates other foods. The law places the burden of ensuring the safety of foods and food ingredients on those who produce them. It prohibits the adulteration (contamination) or misbranding (mislabeling) of food, but the agency does not inspect or evaluate food prior to its sale in shops, supermarkets or restaurants. Rather, federal oversight relies on market surveillance, or post-marketing regulation, and the FDA takes action only if there is an apparent problem. With very few exceptions, this has worked quite well over the years.
The law does require a premarketing review for certain food-related products. These include most food additives — a class of ingredients that includes preservatives, emulsifiers, spices and sweeteners, and natural and synthetic flavors or colors, among others. In general, a food additive must be approved if it becomes a component of or otherwise affects the characteristics of a food and it is "not generally recognized as safe (GRAS) by qualified experts for its intended use."
GRAS is an important concept: Before a new food additive is marketed, it is the responsibility of the producer to determine whether the substance is GRAS. The agency routinely reviews food additive applications for safety only when the substance in question has been determined not to be GRAS by the producer. If the producer determines a substance is GRAS, only a notification of that decision to the FDA is necessary (which is then subject to agency review).
This paradigm could be adapted easily to transgenic animals. For example, because adding a GRAS gene to a GRAS organism is likely to yield a GRAS outcome, an FDA premarketing review would not be necessary for genetic constructions like the fast-growing salmon. (And by now we would have had 10 years of the benefits of this product.) But instead the FDA intends to treat every new animal as though it contains a "new drug," the evaluation of which can take many years even if there is minimal likelihood of harm.
The illogic of the FDA's position should not come as a surprise, given that bureaucrats are generally unimaginative and fearful of new technologies, and that, by nature, they tend to arrogate new responsibilities and create new regulatory empires for themselves. "Dogs bark, cows moo, and regulators regulate," an FDA commissioner once quipped.
If animal biotech companies are to bring home the bacon, the FDA will need to get its act together. Maybe when genetically engineered pigs can fly... .
Henry I. Miller, a physician, is a fellow at the Hoover Institution. He headed the Food and Drug Administration's Office of Biotechnology from 1989 to 1993 and is the author, most recently, of "The Frankenfood Myth."