F.D.A. stands its ground on the labeling of G.E. foods

by Jay Sjerven
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The U.S. Food and Drug Administration on Nov. 19 denied a citizen petition submitted by the Center for Food Safety and several other consumer and organic food industry associations that held the F.D.A. should require the mandatory labeling of genetically engineered foods. The rejection was contained in a 31-page letter from Leslie Kux, the F.D.A.’s associate commissioner for policy, to Andrew Kimbrell, executive director of the C.F.S. The letter disputed the petition’s assertions regarding G.E. foods and the agency’s responsibility to require their labeling.

The rejection of the petition was one of a series of decisions relating to the safety and labeling of G.E. foods that was announced on Nov. 19. These included the F.D.A.’s first approval of a genetically engineered animal intended for food, AquAdvantage Salmon; the issuance of a draft guidance for industry on the voluntary labeling of food that has or has not been derived from the genetically engineered Atlantic salmon, and the issuance of a final guidance for food manufacturers who wish to voluntarily label their products as containing ingredients from G.E. or non-G.E. sources.

While each of the announcements was important in its own right, the rejection of the mandatory labeling petition seemed to establish a foundation for all the others and may provide fuel to those seeking passage of the Safe and Accurate Food Labeling Act (SAFE), which was passed by the House of Representatives in July and now is before the Senate. The SAFE Act would preempt state and local laws mandating the labeling of genetically engineered foods and instead provide for voluntary national standards governing the use and labeling relating to G.E. foods.

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Agency says consumer interest alone is not a sufficient basis to require labeling.

The petition filed in 2012 asserted the F.D.A.’s failure to require labeling of G.E. foods is an “abdication of its statutory mandate to require labeling for foods that are ‘misbranded’ because they are misleading.”

The C.F.S. petitioners said the F.D.A. should rescind its 1992 Statement of Policy: Food Derived from New Plant Varieties. That policy statement provides the underpinning for the F.D.A.’s long-held view that, as summarized by Ms. Kux, “the regulatory status of a food ‘is dependent on objective characteristics of the food and the intended use of the food (or its components)’ and not the fact that a new method is used to produce or develop the food.”

The petitioners sought to substitute a new policy declaring a production process “material” under the Food, Drug and Cosmetic Act “if it results in a change to a food at the molecular or genetic level because a significant share of consumers would find it relevant to their purchasing decisions.” Following from this, the petitioners sought regulations requiring labeling for all food produced using genetic engineering.

Ms. Kux disputed the petitioners’ assertions point by point and stated the petition did not provide “a sufficient basis for F.D.A. to rescind or otherwise deviate from its 1992 Policy with respect to the labeling of foods derived from genetically engineered plants or otherwise acquire additional labeling for such foods.”

Ms. Lux said, “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-G.E. 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.

“Further, while we appreciate consumer interest in the labeling of food derived from genetically engineered plants, 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 genetic engineering,” Ms. Kux asserted. “Absent a sufficient basis to require such labeling, the agency cannot compel food manufacturers to label their foods with information regarding whether such foods were produced through the use of genetic engineering.”

Pamela G. Bailey, president and chief executive officer of the Grocery Manufacturers Association, said, “The F.D.A. made the right decision for the right reasons, standing with sound science and recognizing that the world’s most respected and authoritative scientific and regulatory bodies have repeatedly found genetically engineered (G.E.) ingredients to be safe.”

Randy Gordon, president of the National Grain and Feed Association, said, “The F.D.A. states correctly, in our view, that the determination of whether labeling should be required should not depend on the process used to produce a food, without regard to its effect on the food.”

Mr. Gordon noted lawmakers were considering using the omnibus spending package as a vehicle to preempt states from mandating G.E. labels on foods that contain ingredients manufactured through genetic engineering. He said Congress has until Dec. 11 to pass the fiscal 2016 spending bill, while the first state G.E. food labeling law takes effect in Vermont in July 2016.

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