FDA denies GMO labeling petition: What matters is the characteristics of the food itself, not the process by which it was made

In a 30-page letter that will provide a boost to those supporting federal voluntary GMO labeling legislation such as Mike Pompeo's Safe and Accurate Food Labeling Act (a.k.a. the 'DARK Act'), FDA Associate Commissioner for Policy Leslie Kux said it doesn’t make sense that a technology - rather than the foods actually produced​ via that technology – should trigger mandatory labeling.

In the letter, addressed to Andrew Kimbrell, executive director of the Center for Food Safety, which filed the petition​ ​in 2012, Kux said that what matters - whether the breeding process involves modern rDNA techniques or more traditional ones - is whether the resulting plant is materially (ie. meaningfully) different from its conventional counterpart.

For example, might the new plant contain toxic components, new food allergens or proteins, or higher levels of certain nutrients?   

And if the answer is yes, firms are already obliged to label it as such under the FDA’s current policy – established in 1992 – she said: “If a food derived from a new plant variety differs from its traditional counterpart such that the common or usual name no longer applies to the food, or if a safety or usage issue exists to which consumers must be alerted, such information must be disclosed in the food's labeling.”​

What matters is the end product, not the process​

Meanwhile, “the​ simple fact that a plant is produced by one method over another does not necessarily mean that there will be a difference in the safety or other characteristics of the resulting foods,” ​she stressed, noting that g​enetic modification of plant varieties through DNA manipulation also occurs in traditional methods of plant breeding.

“The determining factor is the final food product and its objective characteristics in comparison to its traditional counterpart, not the process used to produce the plant from which the food was derived.”​

“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.”​

Lenape potato – bred via conventional techniques – proved unsafe​

She went on to cite the example of the ‘Lenape potato’, which was developed using conventional breeding techniques, but was found to have elevated levels of solanine (a glycoalkaloid poison found in some members of the nightshade family), and subsequently withdrawn from the market.

“The case of the Lenape potato is an example demonstrating that it is the objective characteristics of the food, and not the method used to develop it, that are determinative of a food 's safety.”​

Consumer interest alone not sufficient to trigger mandatory labeling​

While the FDA appreciates that consumers are interested in GE foods, she said, “Consumer interest alone does not provide a sufficient basis to require labeling disclosing whether a food has been produced with or without the use of such genetic engineering. Absent a sufficient basis to require such labeling, the agency cannot compel food manufacturers to label their foods …”​

And the courts, she argued, “have repeatedly and correctly rejected the notion that consumer interest alone is sufficient to constitute a material fact under section 201(n) of the Food, Drug & Cosmetic Act”.​

The best-known example is the IDFA (International Dairy Foods Association) v Amestoy case of 1996 in which the 2nd circuit court concluded that a 1994 Vermont statute requiring mandatory labeling of milk treated with artificial growth hormones (rBST) was unconstitutional under the First Amendment, as it compelled food companies to choose speech instead of silence, said Kux.

‘Loaded’ consumer survey questions​

She also queried the methodology of some of the consumer surveys submitted by the Center for Food Safety as evidence that the vast majority of consumers want GMO labeling, pointing out that many featured “loaded” ​questions and multiple choice answers.

For example, one choice of answer to a question on whether GE foods should be labeled, was ‘Yes, I have a right to know what I am eating​.’

As for environmental impacts, she said: “You provided no information to support your assertions that GE crops cause adverse environmental impacts and, therefore, that a categorical determination regarding the environmental impacts of all genetically engineered crops is warranted.” ​

Just because GM crops can be patented doesn’t mean they are ‘materially different’​

Addressing the apparent paradox that a GE crop could be patentable (ie novel) but not “materially different​” from a conventionally-bred equivalent for food labeling purposes, she said: “The fact that a food product or its method of production is considered novel within the context of patent law does not mean that, as a result, such food product is required to bear labeling disclosing its method of production under the FD&C Act.”​

In response to Kimbrell's point that irradiated foods require labeling, she highlighted that in 2007, the FDA had proposed to “limit mandatory labeling to only those irradiated foods in which the irradiation causes a material change in the food's characteristics​ [eg. organoleptic, nutritional, or functional properties]”.

The safety assessment process​

Finally, the fact that the FDA is reliant on safety data submitted by crop developers – rather than conducting its own research - is not something that is unique to GE crops, she pointed out. The same is true for all​ new food crops or food additives and ingredients.

“This is no different from the agency's traditional interactions with sponsors or developers of other FDA-regulated products. For example, the sponsor of a new food additive, a new dietary ingredient, conducts the safety studies (or contracts with a third party to have the studies completed) and FDA evaluates the results of those studies.”​

GMA et al: Move increases momentum behind federal GMO labeling initiatives​

The letter was welcomed by food and biotech trade associations, with the Snack Food Association and the Grocery Manufacturers Association predicting that it would give momentum to the federal voluntary GMO labeling bill currently being discussed in the Senate.

"The fact remains that Vermont's mandatory labeling law is set to take effect next July​," said Claire Parker, spokesperson for the Coalition for Safe Affordable Food. 

"As members of Congress from both sides of the aisle continue to iron out a reasonable national solution, they should be heartened by the FDA's announcement, which we are confident will increase momentum behind a deal.  It is imperative we get this passed this year."​

GMA hopeful that GMO labeling legislation will be passed before Christmas​

Asked about the likelihood of GMO labeling legislation passing in the Senate this year, the GMA told FoodNavigator-USA: “We continue to be encouraged by ongoing negotiations and we look forward to the Congress reaching a bipartisan compromise on a reasonable, uniform national standard that can be adopted this year.”​  ​​

The Center for Food Safety told FoodNavigator-USA that it is considering its legal options. Senior attorney George Kimbrell said: "We are reviewing the denial and considering all legal options.  FDA has robust authority to require the labeling of GE foods and any decision to the contrary is legally wrong and contrary to good governance and the overwhelming public will."​

Download the FDA’s full response to the petition HERE​​. 

Click HERE​​ to read the FDA's guidance on labeling of foods derived from genetically engineered plants, and click HERE​​ to read its guidance on how to label foods that are NOT derived from GE plants.