Blocking Animal Biotech
Miller, Henry I., Regulation
On January 15, the Food and Drug Administration announced "final guidance" on its regulatory policy toward "genetically engineered" animals. Typical of the agency's current mindset, the policy tortures the science and opts for the most stringent, stultifying regulatory approach among various possible choices. As a result, the new policy 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 stipulated that every genetically engineered animal will be subject to the procedures and regulations for drugs, such as pain relievers and anti-flea medicines, that are used to treat animal diseases. The rationale:
The [Federal Food, Drug and Cosmetics Act] defines "articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. A [recombinant DNA] construct that is in a [genetically engineered] animal and is intended to affect the animal's structure or function meets the definition of an animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and any new products expressed from the inserted construct are safe for the health of the ... animal and, if they are food animals, for food consumption.
However, the introduction of a gene is not the same as the administration of a drug, which makes the FDA's rationale questionable. And it is noteworthy that the proposal 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 FDA policy for almost a decade is an Atlantic salmon that contains a Chinook salmon growth hormone gene that remains turned on all year (instead of during only the warmer months, as in nature). This cuts the salmon's time to reach a 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--a tremendous economic advantage to those farming the fish. There are numerous other applications in various stages of research and development, including livestock with leaner muscle mass, enhanced resistance to disease, and improved use of dietary phosphorous to lessen the environmental effects of animal manure.
ANIMALS AND DRUGS 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 genetically engineered animals crafted for research purposes, which include hundreds of lines of rodents.
The terminology in the FDA's policy announcement is itself interesting. The pre-marketing approval requirement only applies if the animal is crafted with recombinant DNA techniques. So, for example, if the salmon described above were to be the result of some sort of artificial insemination instead of recombinant DNA techniques, it would be exempt from pre-approval evaluation. In other words, the FDA's regulatory trigger is not the risk-related characteristics of an animal, but the use of a certain technology--and the most precise and predictable one, at that. That makes no sense.
The "new drug" paradigm does not fit genetically engineered animals well. A far better model is the approach taken by another FDA unit, 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. …