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Biotech to Bring Home the Bacon?
Wednesday, October 1, 2008

A Food and Drug Administration policy published for public comment Sept. 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 FDA'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 FDA'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? One that has awaited an FDA 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.

Until now, the FDA 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 FDA 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 FDA 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 rules 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 FDA 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 FDA is necessary (which is then subject to agency review).

The FDA'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 FDA pre-marketing review would not be necessary for genetic constructions like the fast-growing salmon. 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 virtually no likelihood of harm.

The FDA'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 FDA's Center for Veterinary Medicine say 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 FDA nor any other government agency routinely conducts pre-market review of new genetic constructions that occur "naturally." (We call these

An example is the Zucker rat, a naturally occurring mutant more than 4 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 the FDA adopt such a dubious policy? Whenever they can, bureaucrats exhibit a tendency to arrogate new responsibilities and expand. "Dogs bark, cows moo, and regulators regulate," FDA Commissioner Frank E. Young once quipped. And 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.")

If animal biotech companies are to bring home the bacon, the FDA 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 Food and Drug Administration's Office of Biotechnology from 1989 to 1993 and is the co-author, most recently, of "The Frankenfood Myth."
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