Over the last two decades, the use of modern genetic engineering technology to produce pharmaceuticals and new crop plants has given rise to prodigious scientific, humanitarian and financial successes. But its application to animals for food has lagged behind despite the fact that animal protein is expensive and increasingly sought-after worldwide.
The reason for the lag is not technical difficulty. Thousands of animals with genes deleted or added have been engineered for scientific purposes; the catalog of available lines resembles the telephone directory of a small city, and these animals have made incalculable contributions to the understanding of mammalian gene function in health and disease. Rather, the obstacles have their origins in public policy, particularly government regulation.
The Food and Drug Administration is a case in point.
The agency will hold meetings Sept. 19-21 to discuss the possible approval for marketing of a salmon genetically engineered to grow and reach maturity more quickly than its unmodified cohorts. These meetings are the culmination of many years of indecision and fuzzy reasoning.
After more than two decades of deliberation, last year the FDA's Center for Veterinary Medicine chose to require that every genetically engineered animal be subject to the same pre-market approval procedures and regulations as drugs such as pain relievers and anti-flea medicines used to treat animal diseases. The rationale is that a genetically engineered construct "that is in a GE animal and is intended to affect the animal's structure or function meets the definition of an animal drug." But this explanation conveniently ignores the science, the FDA's own precedents and the availability of other, better regulatory options.
What kinds of animals are we talking about? The fish to be discussed at the FDA's meetings is an Atlantic salmon that contains a Chinook salmon growth hormone gene, which is turned on all year instead of during only the warmer months, as in nature. This roughly halves the salmon's time to reach a marketable adult weight.
The genetic change confers no detectable difference in its appearance, taste or nutritional value; it just grows faster, a tremendous economic advantage to those farming the fish and to consumers who will be able to take advantage of greater supply and lower prices. Even the FDA's own (excessively, unnecessarily) exhaustive analysis concludes that the salmon has no detectable differences and that it "is as safe as food from conventional Atlantic salmon." And because the fish to be marketed will be sterile and farmed inland, there is virtually no possibility of any sort of "genetic contamination" of the gene pool or other environmental effects. Nevertheless, this poor salmon has been flopping around in regulatory limbo for 10 years.
Among the other applications of the technology in various stages of research and development, one has been on the market for several years: a beautiful ornamental aquarium fish called the Glofish, a zebra fish genetically altered to make it fluorescent. (The FDA chose not to regulate the Glofish, citing the absence of any risk to public health: "Because tropical aquarium fish are not used for food purposes, they pose no threat to the food supply. There is no evidence that these genetically engineered zebra danio fish pose any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States." I would argue that the same applies to the fast-growing salmon.) Other animals in the pipeline include livestock with leaner muscle mass and improved use of dietary phosphorous to lessen the environmental impacts of manure.
Until the policy announcement last year, the FDA had not regulated new lines of farm animals or, for that matter, animals used for what might be termed "medical purposes." For example, it still does not regulate German shepherds or golden retrievers bred to enhance traits that make them better seeing-eye or companion dogs. Likewise, the FDA has not asserted its jurisdiction over genetically engineered animals crafted for research purposes, which include hundreds of lines of rodents.
The onerous pre-marketing approval requirement applies only if the animal has been modified with state-of-the-art recombinant DNA ("gene-splicing") techniques. Thus, even though used for food, if the fast-maturing Atlantic salmon described above were the result of some sort of artificial insemination instead of genetic engineering techniques, it would be exempt from pre-approval evaluation. That is also true for food animals long produced with less precise, less predictable methods of genetic modification, such as the beefalo, a cow-buffalo hybrid that has never been regulated by the FDA. In other words, the trigger for onerous FDA regulation is not the risk-related traits of an animal but the use of a certain technology, and the most precise and predictable one at that. That makes no sense.
The introduction of a gene that affects some characteristic is not the same as the administration of a drug. A more apposite model is the approach taken by the FDA's food regulator, the Center for Food Safety and Applied Nutrition, which does not perform case-by-case reviews of every new product but limits them to products with characteristics that suggest they pose non-negligible risk. This approach has worked quite well over many years.
The FDA's existing approach to foods should have been applied to genetically engineered animals. But characteristically, regulators chose the most risk-averse and burdensome approach. The result has been an entire innovative business sector burdened with a policy that inflates research and development costs, inhibits innovation and deprives consumers of health-promoting and less-expensive products. Not surprisingly, very few companies are willing to brave the regulatory thicket.
Why would the FDA choose the most stultifying regulatory option? Former FDA head Frank Young used to quip that cows moo, dogs bark and regulators regulate. He could have added an observation about how likely it is that regulators will ever admit that they're over-regulating and rectify missteps in policies: When pigs can fly.
Henry I. Miller, a physician and molecular biologist, is a fellow at the Hoover Institution and at the Competitive Enterprise Institute. He was the founding director of the FDA's Office of Biotechnology and is the coauthor of "The Frankenfood Myth."