"The Food and Drug Administration (FDA) lacks both the authority and the information to adequately evaluate the safety of genetically engineered (GE) foods," claims the Center for Science in the Public Interest (CSPI) in a just-released study. An uncritical Washington Post story about the study describes CSPI as "moderate" on the issue because the activist group claims it is not in principle opposed to genetically enhanced crops. But with this new report, they join the unmoderate ranks of the activist groups trying to effectively block crop biotechnology.
What does CSPI see as the solution to the gaping holes in the regulatory safety net that allegedly imperil the health of all Americans? Establish "a mandatory pre-market approval system that requires biotechnology companies to submit much more detailed testing information and obtain FDA approval before marketing the product."
The CSPI report claims that, by mining the data voluntarily submitted by biotech companies to the FDA, it uncovered a number of serious lapses in protecting consumer health. For example, the CSPI claims that the FDA was given incomplete data about a type of corn, MON 809, modified to increase its resistance to insects. The CSPI declared that the company had failed to supply data to show that it was nutritionally equivalent to conventional corn fed to cattle. The only problem is that the MON 809 was never put on the market, so there was simply no need for the company to submit a complete set of data. However, CSPI does acknowledge that the company did submit adequate data for the MON 810 variety that it actually did commercialize.
Another alleged FDA lapse occurred when the agency supposedly failed to question a developer about the dietary history of a viral gene that it had included in its tomatoes and cantaloupes. But was the FDA really negligent? The developer argued that including the gene in its crop varieties is safe because human beings are already naturally exposed to proteins made by the T3 virus in question. As evidence, the developer submitted a peer-reviewed scientific study showing that the T3 virus has been found in the human colon and small intestine. This did not satisfy the CSPI, which argues that the FDA should have demanded evidence that T3 virus regularly passes through the entire digestive tract from mouth to anus. "How do they think the T3 viruses got into the colon in the first place if not by passing through the entire digestive tract?" asks Val Giddings, director of food and agricultural policy at the Biotechnology Industry Organization.
The important point here is that scientific inquiry has no obvious endpoint. There are always more questions that can be asked. The CSPI could just as easily have insisted that regulatory approvals be held up until the developer provided scientific studies on the entire life cycle of the T3 virus in the human gut or what its chances of virulently recombining with smallpox would be in the event of a bioterrorism attack. Activist lawyers are masters at ginning up endless interrogatories designed to jam up the regulatory process.
It turns out that many of the "lapses" that the CSPI claims to have found in the FDA's written records could have been easily cleared up had its researchers bothered to call the FDA or the biotech companies. "The report either knowingly misleads or is the product of unbelievable incompetence," says Giddings.
In any case, do the regulators at the FDA think the agency needs more authority to police foods made from genetically enhanced crops? No. Back in 1992, the FDA issued a report, Foods Derived From New Plant Varieties, which declared that its "existing statutory authority" was "fully adequate to ensure the safety of new food ingredients and foods derived from new varieties of plants, regardless of the process by which such foods and ingredients are produced." Indeed, food producers have "a clear legal duty…to assure the safety of foods they offer to consumers." Not only would producers who offer products that harm their customers be subject to the usual civil penalties, but they could also be hauled into criminal court.
Do genetically enhanced crops pose any novel dangers to the health of consumers such that the CSPI's desired level of scrutiny is justified? No. North Carolina State University entomologist Fred Gould, who headed up a prestigious National Academy of Sciences (NAS) panel that issued a report on the safety of biotech crops in 2000 declared on National Public Radio: "Looking through all the information available to us, looking through piles of data that were submitted by the companies for the registration process, as well as literature in the peer review journals, we found no evidence there was any reason to suspect these crops of not being safe."
Gregory Conko, the director of food safety policy at the free-market Competitive Enterprise Institute in Washington, D.C., argues, "There is no evidence at all that genetically modified crops are any riskier than crops produced using conventional breeding techniques." He adds, "No crop plants produced using conventional breeding techniques could possibly pass the tests required for approving genetically modified crops."
Gould points out that the NAS panel compared the safety of conventionally bred crops with genetically enhanced crops. "What we did find was that if you were comfortable with the level of safety in conventionally bred crops, we could say that there was no added concern from having genetically engineered crops with the same kind of traits," he said. "There's nothing special about the genetic engineering… process, that's going to make the plant less safe." In other words, if you're afraid of biotech crops, you should be equally afraid of conventional crops. Perhaps the CSPI will call for the strict regulation of all food crops, both biotech and conventional. The soaring prices for food that would result should make consumers happy.
So, is the health of millions of Americans imperiled by FDA regulatory toothlessness with regard to biotech crops? After all, some 70 percent of all processed foods in the United States are made using ingredients from biotech crops. If there were a major problem with biotech foods it should be apparent by now.
Despite the absence of evidence that there is any problem, the biotech crop regulatory scheme that the CSPI appears to be calling for would be similar to the FDA's strict regulation of pharmaceuticals. It is worth pondering that it costs an estimated $800 million to bring a new drug to market. Consequently, you find some bottles of pills costing $120. However, it is doubtful that consumers would be willing to pay $120 per pound for genetically enhanced tomatoes or potatoes. Ultimately, the CSPI position with regard to biotech crops would more accurately be summed up as, "We're not against genetically modified crops in principle; we're just against each and every variety individually."