Andrew Kimbrell and his Center for Food Safety filed a petition with the FDA arguing that all genetically engineered foods should be labeled. The FDA denied his petition last Friday in a 35 page ruling citing both science and existing law.
The petition was co-sponsored by Amy’s Kitchen, Annie’s Homegrown, Beyond Pesticides, the Center for Environmental Health, Consumer Reports (who should be ashamed of themselves), CROPP Cooperative, the Environmental Working Group, Food and Water Watch, Horizon Organic, Midwest Organic and Sustainable Education Service, the National Cooperative Grocer’s Association, the National Family Farm Coalition, Northeast Organic Dairy Producer’s Alliance, Northeast Organic Farmers Association, the National Organic Coalition, the Organic Seed Alliance, the Organic Seed Growers and Trade Association, the Organic Trade Association, Organically Grown Company, the Rural Advancement Foundation International, Save New Mexico Seeds, and Stonyfield Farm. The pro-organic biases of the members of the above groups should be pretty plain. Their 25-page petition is extensive but breaks no new legal or scientific grounds, echoing arguments these groups have been putting forth for years.
The FDA response to the petition notes that the petition “does not provide evidence sufficient to show that foods derived from genetically engineered plants, as a class, differ from foods derived from non-GE plant varieties in any meaningful or uniform way, or that as a class, such foods present any different or greater safety concerns than foods developed by traditional plant breeding.”
In particular, it notes that the petition does not show that the genetic engineering of foods constitutes a “material fact” under the F&DC Act. The FDA means by “material fact” information about the attributes of the food itself. In other words, labeling would be required if omission of that label would mislead the consumer if the food has nutritional or functional properties different from the food it resembles. In the case of bioengineered foods, this has never been found to be the case.
They also note that any new bioengineered food would undergo substantial testing, and all safety questions would be resolved before approval. Their assessment “takes into account questions about known toxicants, potential of the food to contain food allergens, the concentration and bioavailability of important nutrients, the safety and nutritional value of newly introduced proteins, and the identity, composition and nutritional value of modified carbohydrates, or fats and oils.”
Finally, they note that if a bioengineered product differs in properties such that a common or usual name no longer applies, it would require a label. And while the petition suggests that new DNA from genetic engineering should be considered a food additive, “with respect to transferred genetic material (nucleic acids), the agency explained that generally it did not anticipate that transferred genetic material would itself be subject to food additive regulation because nucleic acids are present in the cells of every living organism…”
Alliance for Bio-integrity v Shalala
The FDA noted that many of the points raised by the petition were similar to those in the settled court case of Alliance for Bio-Integrity v. Shalala. Specifically, FDA explained that “in developing the 1992 Policy, the agency considered intended and unintended or unexpected changes in foods derived from genetically engineered plants”, and explained “that it had sought the input and expertise of scientists from around the world, and analyzed reports in the scientific literature, including an evaluation of plants modified through both new and traditional means.” They concluded that as a class bioengineered plants had not resulted “in any risks that differed from their traditional counterparts.”
In this case and in International Dairy Foods v Amestoy, the courts have agreed with the FDA that “consumer curiosity” about a breeding method does not mean that this would require such foods to be labeled. In fact, the FDA noted in this ruling that all of the surveys the plaintiffs presented claiming that “most consumers” wanted biotech foods labeled were skewed by leading questions (“should GMOs be labeled”) rather than more neutral formulations. In fact, there have been some surveys that simply asked what additional information should be on food labels, and in both a US and a UK survey, only about 2% of consumers suggested biotechnology as important. A more recent survey suggested the number might now be as high as 7%.
The petitioners attached an article from Consumer Union’s web site which claims that “Genetic Engineering is not an Extension of Conventional Plant Breeding.” The FDA spent some time criticizing these assertions, noting that while the plants are bred using “different mechanisms,” the article does not provide evidence that the resulting plants differ in safety. However, the FDA notes that the CU article explains that the differences are “normative and philosophically based, not scientific,” and explains that unless the change in the food is material, they lack the authority to label it.
The FDA also refutes the petition’s claim that labeling is required because the breeding methods are “profound” and “radical,” since there are no material changes to the resulting plants. Differing breeding methods do not imply any change in the plant’s safety nor do “individual views on the extent that food production methods differ.”
Summary of Other Claims
- Biotech crops can lead to antibiotic resistance. Kanamycin is used in genetic engineering but the FDA approved this use because kanamycin resistance genes have been found to be safe and occur frequently in nature.
- Biotech foods present unknown health consequences. It has been agreed to by scientists worldwide (and the OECD and WHO) that if a novel food is essentially similar to its conventional counterpart, it is “no more or less likely to be toxic than its counterpart.”
- Aris and Leblanc found Cry1Ab (from Bt) and pesticide metabolites in the sera of pregnant and non-pregnant women. The methods in this study have been questioned and refuted by a number of workers (Blacker, Goldstein and Mueller), and the EPA has concluded that Cry1Ab “do not pose adverse consequences to human health.” It has also been ably dissected by David Tribe.
- They provide no evidence for their assertions that GM crops cause environmental damage.
- The F&DC Act does not require disclosure of how a food is produced without regard to its effect on the resulting product.
- Labeling is misleading when it fails to disclose material facts. However, the FDA has not found that genetically engineered foods as a class warrant additional labeling because they do not present different or greater safety concerns than conventional foods.
- The First Amendment protects commercial speech, too, and the FDA cannot compel commercial speech without a valid reason.
- The fact that most GM seeds are patented does not make them distinctly different. Many conventional seeds have been patented since 1931. Patent laws are to protect the inventor for a limited time, and have nothing to do with food safety.
- Many foreign countries label GM crops, so the US must be “falling behind.” Actually, the position of the Codex Alimentarius (the international organization that sets food standards) has not changed on labeling as long as the labeling is accurate.
Thus, the FDA concludes that the petitioners have not provided sufficient grounds to change their 1992 policy on crops produced using biotechnology, and their petition is denied.
Who is the Center for Food Safety?
The Center for Food Safety has a budget of over $4.5 million which they use to file petitions and suits on issues like this one, some more scientifically valid than others. They pay their leader, attorney Andrew Kimbrell, about $262,000 a year. Their entire budget comes from donations, but they do not disclose their major donors. Judging by the affiliations of their Board of Directors, and of the co-petitioners, it clearly receives substantial support from the organic foods industry, however. It has participated heavily in actions against genetically modified crops.
According to Activist Facts, Kimbrell was mentored by Jeremy Rifkin, “America’s most notable anti-technologist.” Kimbrell debated biologist Nina Federoff last spring in the Wall Street Journal, summarized here, coming out second best. He was also one of principal drafters of California’s failed GMO labeling proposal, Prop 37, according to Henry Miller. And, according to Activist Facts, “The Center for Food Safety, under its façade of nonprofit watch dogging, has all the marks of a black-marketing campaign, run on behalf of organic and ‘natural’ foods.” William Saletan denounces them in his extensively researched Slate article on GMO safety. So while they may take on some valid causes, their focus seems to be against food technology and especially biotechnology.