kalikshama
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Here's the context for the Phil Angell quote:
Playing God in the Garden
Today I planted something new in my vegetable garden -- something very new, as a matter of fact. It's a potato called the New Leaf Superior, which has been genetically engineered -- by Monsanto, the chemical giant recently turned ''life sciences'' giant -- to produce its own insecticide. This it can do in every cell of every leaf, stem, flower, root and (here's the creepy part) spud. The scourge of potatoes has always been the Colorado potato beetle, a handsome and voracious insect that can pick a plant clean of its leaves virtually overnight. Any Colorado potato beetle that takes so much as a nibble of my New Leafs will supposedly keel over and die, its digestive tract pulped, in effect, by the bacterial toxin manufactured in the leaves of these otherwise ordinary Superiors. (Superiors are the thin-skinned white spuds sold fresh in the supermarket.) You're probably wondering if I plan to eat these potatoes, or serve them to my family. That's still up in the air; it's only the first week of May, and harvest is a few months off.
[snip]
I checked with the F.D.A. to find out exactly what had been done to insure the safety of this potato. I was mystified by the fact that the Bt toxin was not being treated as a ''food additive'' subject to labeling, even though the new protein is expressed in the potato itself. The label on a bag of biotech potatoes in the supermarket will tell a consumer all about the nutrients they contain, even the trace amounts of copper. Yet it is silent not only about the fact that those potatoes are the product of genetic engineering but also about their containing an insecticide.
At the F.D.A., I was referred to James Maryanski, who oversees biotech food at the agency. I began by asking him why the F.D.A. didn't consider Bt a food additive. Under F.D.A. law, any novel substance added to a food must -- unless it is ''generally regarded as safe'' (''GRAS,'' in F.D.A. parlance) -- be thoroughly tested and if it changes the product in any way, must be labeled.
''That's easy,'' Maryanski said. ''Bt is a pesticide, so it's exempt'' from F.D.A. regulation. That is, even though a Bt potato is plainly a food, for the purposes of Federal regulation it is not a food but a pesticide and therefore falls under the jurisdiction of the E.P.A.
Yet even in the case of those biotech crops over which the F.D.A. does have jurisdiction, I learned that F.D.A. regulation of biotech food has been largely voluntary since 1992, when Vice President Dan Quayle issued regulatory guidelines for the industry as part of the Bush Administration's campaign for ''regulatory relief.'' Under the guidelines, new proteins engineered into foods are regarded as additives (unless they're pesticides), but as Maryanski explained, ''the determination whether a new protein is GRAS can be made by the company.'' Companies with a new biotech food decide for themselves whether they need to consult with the F.D.A. by following a series of ''decision trees'' that pose yes or no questions like this one: ''Does. . .the introduced protein raise any safety concern?''
Since my Bt potatoes were being regulated as a pesticide by the E.P.A. rather than as a food by the F.D.A., I wondered if the safety standards are the same. ''Not exactly,'' Maryanski explained. The F.D.A. requires ''a reasonable certainty of no harm'' in a food additive, a standard most pesticides could not meet. After all, ''pesticides are toxic to something,'' Maryanski pointed out, so the E.P.A. instead establishes human ''tolerances'' for each chemical and then subjects it to a risk-benefit analysis.
When I called the E.P.A. and asked if the agency had tested my Bt potatoes for safety as a human food, the answer was. . .not exactly. It seems the E.P.A. works from the assumption that if the original potato is safe and the Bt protein added to it is safe, then the whole New Leaf package is presumed to be safe. Some geneticists believe this reasoning is flawed, contending that the process of genetic engineering itself may cause subtle, as yet unrecognized changes in a food.
The original Superior potato is safe, obviously enough, so that left the Bt toxin, which was fed to mice, and they ''did fine, had no side effects,'' I was told. I always feel better knowing that my food has been poison-tested by mice, though in this case there was a small catch: the mice weren't actually eating the potatoes, not even an extract from the potatoes, but rather straight Bt produced in a bacterial culture.
So are my New Leafs safe to eat? Probably, assuming that a New Leaf is nothing more than the sum of a safe potato and a safe pesticide, and further assuming that the E.P.A.'s idea of a safe pesticide is tantamount to a safe food. Yet I still had a question. Let us assume that my potatoes are a pesticide -- a very safe pesticide. Every pesticide in my garden shed -- including the Bt sprays -- carries a lengthy warning label. The label on my bottle of Bt says, among other things, that I should avoid inhaling the spray or getting it in an open wound. So if my New Leaf potatoes contain an E.P.A.-registered pesticide, why don't they carry some such label?
Maryanski had the answer. At least for the purposes of labeling, my New Leafs have morphed yet again, back into a food: the Food, Drug and Cosmetic Act gives the F.D.A. sole jurisdiction over the labeling of plant foods, and the F.D.A. has ruled that biotech foods need be labeled only if they contain known allergens or have otherwise been ''materially'' changed.
But isn't turning a potato into a pesticide a material change?
It doesn't matter. The Food, Drug and Cosmetic Act specifically bars the F.D.A. from including any information about pesticides on its food labels.
I thought about Maryanski's candid and wondrous explanations the next time I met Phil Angell, who again cited the critical role of the F.D.A. in assuring Americans that biotech food is safe. But this time he went even further. ''Monsanto should not have to vouchsafe the safety of biotech food,'' he said. ''Our interest is in selling as much of it as possible. Assuring its safety is the F.D.A.'s job.''
[snip]
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