An F.D.A. policy published for public comment on September 18 threatens the health of a promising new field: the production of animals with novel and valuable traits. After more than 20 years of deliberation, the F.D.A.'s Center for Veterinary Medicine has proposed that every "transgenic" animal crafted with gene-splicing technology will be subject to the procedures and regulations for drugs used to treat animal diseases, such as pain relievers or anti-flea medicines.
But the introduction of a gene is not the same as the administration of a drug. Moreover, the F.D.A.'s approach represents a major shift in the regulation of biotechnology that will be hugely expensive to animal breeders and detrimental to consumers.
What kinds of animals are we talking about? One that has been awaiting an F.D.A. policy for almost a decade is an Atlantic salmon that contains a newly introduced Chinook salmon growth hormone gene that remains 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 confers no detectable differences in the salmon's appearance, taste, or nutritional value; it just grows faster.
There are numerous other applications in various stages of R&D, including livestock with leaner muscle mass, enhanced resistance to disease, or improved use of dietary phosphorous to lessen the environmental impacts of animal manure.
Up till now, the F.D.A. has not regulated new lines of farm animals or, for that matter, animals used for what might be termed "medical purposes." For example, they do not regulate German shepherds or golden retrievers bred to enhance traits that make them better seeing-eye or companion dogs. The F.D.A. has not even asserted its jurisdiction over animals that are "transgenic," or genetically engineered, for research, which include hundreds of lines of rodents.
The "new drug" paradigm doesn't fit transgenic animals well. A better model is the approach taken by another F.D.A. component, the Center for Food Safety and Nutrition, which places the burden of ensuring the safety of foods and food ingredients on those who produce them. The regulations prohibit 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 F.D.A. takes action if there is an apparent problem. This approach has worked quite well over many years.
The law does require a pre-marketing safety review for certain food-related products. These include most food additives -- a class of ingredients that includes preservatives, emulsifiers, spices, sweeteners, and natural and synthetic flavors or colors, among others. In general, a food additive must be pre-approved if it becomes a component of or otherwise affects the characteristics of a food and if 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 or not 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 that a substance is GRAS, only a notification of that decision to the F.D.A. is necessary (which is then subject to agency review).
The F.D.A.'s existing approach to biotechnology and to foods in general could be adapted easily to transgenic animals. Traditionally, the combination of two GRAS substances is still GRAS. Similarly, because adding a GRAS gene to a GRAS organism is likely to yield a GRAS outcome, an F.D.A. pre-marketing review would not be necessary for genetic constructions like the fast-growing salmon. But instead the F.D.A. 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 virtually no likelihood of harm.
The F.D.A.'s approach to "novel" foods, published in 1992, is compatible with the GRAS/food additive paradigm. It emphasizes that the Center for Food Safety and Nutrition does not impose discriminatory regulation based on the use of one technique or another, but that greater scrutiny is applied only when certain safety issues are raised. These include the presence of a completely new substance in the food supply, increase in levels of a natural toxin, or the presence of an allergen where a consumer would not expect it.
Officials at the F.D.A.'s Center for Veterinary Medicine say that a newly introduced gene expressed in an animal is analogous to the injection of a new drug, that the genetic modification mediates the introduction of the substance synthesized under the direction of the new gene—a hormone or enzyme, for example. But this view ignores that neither the F.D.A. nor any other government agency routinely conducts pre-market review of new genetic constructions that occur "naturally." (We call these "mutants.") An example is the Zucker rat, a naturally occurring mutant which is more than four times the size of its normal siblings, and which is available from commercial breeders for research. Another more familiar example is the mule, a horse-donkey genetic hybrid which, by any reasonable definition, is certainly transgenic, although it doesn't involve the use of newfangled genetic techniques.
Why would F.D.A. adopt such a dubious policy? This is an interesting story in itself, and it illustrates how far the F.D.A. has strayed from pursuing policies that are genuinely in the public interest. After a couple of my articles on this subject were published earlier this year, on February 7 I received an e-mail that began thus:
Mr. Miller, my name is Joseph Grogan, Senior Policy Advisor to Commissioner Von Eschenbach at FDA. Can you name a single company working to commercialize Transgenic [sic] animals that wants the food approach as opposed to the new animal drug approach? I note that AquaBounty and Bio [sic] are very vocal and unanimous in their lobbying for a drug approach. These companies tell us the New Animal Drug Approach is essential to creating an industry here. Please tell me what these guys are missing.
That same day, I responded to him with this e-mail:
Dear Mr. Grogan:
I'm not in close touch with companies that produce transgenic animals, nor have I performed a survey of them, so I can't tell you what their views are on the regulation of transgenic animals. Rather, I judge regulatory policy on its scientific merits and likely cost-benefit.
You note that AquaBounty and BIO are "unanimous in their lobbying for a drug approach." I note that BIO has been on the wrong side of virtually every biotech regulatory issue for the past 20 years (documented in "The Frankenfood Myth...", Praeger Publishers, 2004, co-authored by Greg Conko and me). I note also economist Adam Smith's sage observation: "People of the same trade seldom meet together, even for merriment and diversion, but the conversation ends in a conspiracy against the public, or in some contrivance to raise prices."
The agbiotech companies did the same thing during the 1980's. They lobbied for process-based regulation that was excessive and completely unscientific and that ever since has stunted the growth of the industry and the diffusion of recombinant DNA technology to additional applications and parts of the world.
So, what are these guys missing, you ask? They're missing the lessons of history -- that what seems (and, indeed, might be) good for their own self-interest in the short-term can be a fiasco in the longer term. I'll also tell you what they're not missing: that an excessively regulatory, expensive approach to oversight favors big companies with deep pockets and discourages competition. Overall, though, it's bad for the industry's expansion, for the diffusion of the technology (especially to poorer countries that don't have a CVM to perform reviews), for innovation, and for society at large.
There's something here that I might be missing. Why should we care about the special pleading of a company and its trade association when it comes to making regulatory policy?
I'm absolutely delighted to know that this issue is on your radar screen, but I have no confidence at all that you and Commissioner von Eschenbach will make the right decisions. Please prove me wrong.
Instead, he and his colleagues have proved me right. Whenever they can, bureaucrats exhibit a tendency to arrogate new responsibilities and expand. "Dogs bark, cows moo, and regulators regulate," F.D.A. Commissioner Frank E. Young once quipped. Moreover, the "new drug" paradigm is the only vehicle available to the Center for Veterinary Medicine. (Recall the old adage, "When the only tool you have is a hammer, more and more problems begin to look like nails.") But what is especially disconcerting is a senior F.D.A. official's ignorance about the substance of this important subject and his reliance on the views of special interests ? and most important, the emergence of a flawed, excessively regulatory policy. We taxpayers deserve better.
If animal biotech companies are to bring home the bacon, the F.D.A. will need to get its act together. When genetically engineered pigs can fly . . .
Henry I. Miller, a physician and molecular biologist, is a fellow at Stanford University's Hoover Institution. He headed the F.D.A.'s Office of Biotechnology from 1989 to 1993 and is the co-author, most recently, of "The Frankenfood Myth."