Hoover Daily Report

Potato-Head Regulators

via Wall Street Journal Europe
Monday, April 19, 2010

The Wall Street Journal

Potato-Head Regulators

Treating genetically engineered products as though they pose inherent, unique risks, despite all the evidence to the contrary, is not very smart.

By HENRY MILLER, MD

The theater of the absurd is alive and well in Brussels. The circumstances surrounding the European Union's recent approval of cultivation of a genetically engineered potato—its first approval for any genetically engineered plant in 12 years—are reminiscent of Beckett and Ionesco: abstruse and bewildering.

For one thing, the approval took 13 years. A more appropriate period of review would have been closer to 13 hours. What makes me an expert on approval times? In 1982 I directed the U.S. Food & Drug Administration's review of the first genetically engineered biopharmaceuticals—human insulins produced in bacteria that are now used by millions of diabetics. We approved the insulins in record time: five months. Subsequently, I was the founding director of the FDA's Office of Biotechnology.

Second, European officials approved the potato, called Amflora by its German creator BASF, only for commercial production of starch for industrial purposes, not for food use. The product is excellent but this "split approval" by regulators is a disaster waiting to happen.

Some background is necessary to understand why this product should be considered anything but a "hot potato." Conventional potato varieties contain starch granules made up of two glucose polymers: amylopectin, a highly branched molecule; and amylose, which has a linear molecular arrangement. The amylose component is responsible for some of the characteristics of, for example, corn flour and wheat flour, which makes them thicken sauces while cooling.

However, although the alignment of the linear amylose chains may be useful in food preparation, it is undesirable and so must be removed for many industrial applications, such as making the coating on glossy printing paper. The availability of Amflora means that potatoes with low-amylose starch appropriate for industrial uses will now be grown in Europe, and offer economic benefits to both local industry and farmers.

But the split approval—which permits a product for animal feed or industrial uses but not human consumption—invites all sorts of mischief. Consider for instance the debacle surrounding a similar decision by the U.S. Environmental Protection Agency more than a decade ago on a genetically engineered corn variety called StarLink, which contains a bacterial protein, Cry9C, toxic to certain insects.

Because of unresolved, dubious concerns about the possible allergenicity of the novel StarLink protein—which takes slightly longer than most proteins to be digested in a laboratory simulation of human digestion, a characteristic it has in common with many known allergens—the EPA approved the variety only for animal, but not human, consumption.

Following StarLink's commercialization, an activist organization paid a laboratory to test a large selection of packaged food products made with corn (including corn chips, tortillas, and taco shells) and found the unintended presence of small amounts of the Cry9C protein in some of them. After sensational newspaper and television news reports announced that the unapproved protein—which the EPA regulated as a pesticide—was found in food products on grocery-store shelves, 28 people reported that they had experienced allergic-like reactions after eating food products that contained corn. (Perhaps these are some of the same people now claiming that their Toyotas experience "spontaneous acceleration.")

However, an intensive investigation by the U.S. Centers for Disease Control was not able to confirm a single allergic reaction: "Although the study participants may have experienced allergic reactions, based upon the results of this study alone, we cannot confirm that a reported illness was a food-associated allergic reaction."

Despite the absence of evidence of harm of any kind to a single person, because there was no regulatory approval for StarLink in human food, a class-action lawsuit alleging that consumers ate food unfit for human consumption was successfully concluded with a settlement against Aventis, producer of the StarLink corn variety.

The EPA has since decided that it will never again approve a genetically engineered crop for split use. Any crop intended for feed or industrial uses that could conceivably find its way into the food supply has to meet standards for human food use in order to gain government approval.

The StarLink saga should provide a cautionary tale for BASF and its Amflora potato: Genetically engineered crops not approved for human consumption present the risk of legal liability even if no consumer has suffered any toxic, allergic, or other health-related harm. This should also concern EU regulators but likely will not: For decades, they have been largely brain-dead on issues concerning genetic engineering applied to agriculture.

The bottom line is that the StarLink contretemps resulted from a fault not with the product itself or the legal system that decides liability, but from flawed regulatory policy and an unwise series of decisions by EPA officials. Such problems are the inevitable result of a regulatory approach that treats genetically engineered products as though they pose some inherent, unique risks, although all the evidence is to the contrary. Some regulators, like some children, insist on making their own mistakes rather than learning from others'.

Dr. Miller, a physician and molecular biologist, is a fellow at Stanford University's Hoover Institution.