Proposed FDA Rules on GE Foods: "Transparency" Uncovered

On January 17, 2001, the Food and Drug Administration (FDA) announced two new proposals regarding biotech foods. One is a proposed regulation that would require biotech companies to give the FDA 120 days advance notice of their intent to market a new genetically engineered food ("premarket notification"), and require them to provide information regarding their product. The other is a proposed "guidance" on how to voluntarily label foods as containing GE ingredients or being free of GE ingredients.

In announcing the proposal, FDA Commissioner Jane Henney, using fashionable bureaucratise, said she hoped the rules would permit the FDA review process to be more "transparent to the public." The word choice is interesting. From the concerned consumer's point of view, FDA oversight is still, indeed, both transparent and insubstantial. The emperor is still wearing no clothes.

In its analysis of food safety issues, the FDA's new release is a bold, contortionist exercise in making contradictions look like consistency. The agency "reiterates its view…that transferred genetic material can be presumed to be GRAS [General Recognized As Safe] [a category previously reserved for foods that had a long history of safe human consumption], and "is not altering its view…that there is unlikely to be a safety question sufficient to question the presumed GRAS status…" However, the agency goes on for the first time to formally concede that "because [genetic engineering] can introduce genetic material from a much wider range of sources than previously possible, there is a greater likelihood that the modified food will contain substances that are significantly different from, or are present in food at a significantly higher level than, counterpart substances historically consumed in food." The agency also concedes that allergenicity is a bigger issue with GE foods: "because genes code for proteins, and virtually all allergens are proteins…by increasing the range of potential proteins that can be introduced into food over that possible by traditional breeding, there is an increased potential for introducing an allergen into a food developed using rDNA technology." Finally, the FDA notes that the future directions of biotechnology suggest the potential for more, not fewer, of these troublesome issues: "FDA expects that with the increased introduction of multiple genes [as opposed to current single gene inserts], unintended effects may become more common." As an example, the agency cited unexpected characteristics of the much-touted Vitamin A "golden rice" under development.

The FDA's response to these issues -- concerns that consumer activists have been raising for years -- appears woefully inadequate. Mandatory premarket notification is clearly a step in the right direction - a step that the Maine Commission to Study Genetic Engineering urged on the FDA five years ago. But it's important to understand that "notification" is not at all the same as "regulation" or "registration," such as we have with new pesticides, or pharmaceuticals. A dig through these lengthy proposals yields the discovery that after receiving notification of a new biotech food, the FDA does not have to confirm, approve, or in anyway put its stamp of approval affirmatively on the company's decision to market the product. All it has to say is that, based on its evaluation of the premarket notice, "the agency has no questions, at this time, regarding [the manufacturer's] view that the bioengineered food is as safe as comparable food…" Somewhat flimsy assurance, isn't it, for all of our tax dollars?

Assuredly, under this new system some diligent agency staff might uncover a problem with a proposal, and stop it before it hits the market. However, without a mandate and guidelines from either Congress or the FDA spelling out standards for a determination of safety, the safeguards provided by premarket notification are entirely a function of agency discretion and resources. Given the anti-regulatory bent of the incoming administration, I am not placing my bets on an adequate safety net. Astonishingly, the guidelines for the premarket notification contain no requirement for any safety testing.

Predictably, the FDA's guidance on GE labeling leave the consumer more, not less in the dark. Producers won't be able to put "GMO-free" on their label. Instead, they may be able to put "We do not use ingredients created through the use of biotechnology in this product," a statement that won't fit on most labels. The FDA's observation that it's difficult to ensure "zero" presence of GE ingredients in food is, in effect, an admission of the failure of another regulatory agency, the USDA. One disturbing sentence in the proposal suggests that any effort to voluntarily label that a product does not contain GE ingredients might draw FDA condemnation: "A statement that a food was not bioengineered…may be misleading if it implies that the labeled food is superior to foods that are not so labeled." One wonders, did the fellow who drafted this "guidance" read all of the admissions in the proposed premarket notification rule about the greater risks with GE technology?

--Sharon Tisher The proposed rule on premarket notification can be accessed at http://www.fda.gov/OHRMS/DOCKETS/98fr/011801a.htm. Comments on the rule are due by March 28, 2001 to Dockets Management Branch (HRA-305), Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. The draft guidance on labeling bioengineered foods is available at http://vm.cfsan.fda.gov/~dms/biolabgu.html. Comments should be submitted by March 13, 2001.