By Donald Zuhn --
Last month, Rep. Mike Pompeo (R-KS) introduced a bill in the House to amend the Food, Drug, and Cosmetic Act with respect to the commercialization of food produced from, containing, or consisting of a bioengineered organism. The bill (H.R. 4432), entitled the "Safe and Accurate Food Labeling Act of 2014," would require developers of bioengineered organisms (defined in the legislation as plants "contain[ing] genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques," wherein "the modification could not otherwise be obtained using conventional breeding techniques") to take several steps before the bioengineered organism is "introduced or delivered for introduction into interstate commerce for a food use or application." Among the required steps would be to provide a "premarket biotechnology notification" to the U.S. Food and Drug Administration or have the food containing the bioengineered organism evaluated under the FDA's voluntary consultation process.
Under the bill's premarket biotechnology notification scheme, the developer of a bioengineered organism would have to provide notification to the FDA at least 210 days before the bioengineered organism is first introduced or delivered for introduction into interstate commerce for a food use or application. Such notification would need to contain, inter alia, the basis for the developer's determination that the food containing the bioengineered organism is "as safe for use by humans or animals, as applicable, as one or more comparable marketed foods that are not produced from, do not contain, or do not consist of such bioengineered organism." Within 30 days of receipt of the notification, the FDA would have to inform the developer that the notification was complete or deficient, and if the notification was complete, the FDA would have to provide a substantive response with 180 days of informing the developer that the notification was complete.
With respect to labeling requirements under the bill, if the FDA "determines that there is a material difference between a food produced from, containing, or consisting of a bioengineered organism and its comparable marketed food and that disclosure of such difference is necessary to protect health and safety or to prevent the label or labeling of such food from being false or misleading," the FDA may "specify labeling that would adequately inform consumers of such material difference." The legislation indicates, however, that "[t]he use of bioengineering does not, by itself, constitute a material difference." The bill would also prohibit any State from establishing any requirement for the labeling of food that was developed or contains an ingredient that was developed using bioengineering.
Following introduction of the bill in the House, the legislation was referred to the Subcommittee on Health.