GMO Notification and Labeling Bill Introduced in the House

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.

Comments

[Denise Everett]

Aside from other serious problems in that attempted definition, looks like the Dairy lobby had undue influence. What is the "public interest" or scientific basis for restricting the labeling requirements to plants? Is it because nearly every shred of cheese on the American plate contains genetically engineered microbes used to produce FPC (fermentation-produced chymosin), in place of naturally-derived chymosin, an ingredient from the lining of a calf stomach that is essential to the milk curdling process? The development of this technology was itself was motivated by the labeling demands of the vegetarian movement of the 70's. At least the aspect relating to pre-emption of state-attempted labeling requirements is a positive.

[Greg Lannit]

This is very misleading reporting. Pompeo's bill is a "voluntary" GMO labeling bill that expands on the FDA's voluntary labeling option that's been available since 1991. No company has ever used this voluntary label and Pompeo's bill would have the same completely ineffective result. The real purposes of Pompeo's bill are to pre-empt the ability of state and the federal governments to require mandatory GMO labeling and to allow food products with GMO ingredients to be labeled as "natural." Senator Boxer's bill S. 809 is a mandatory GMO labeling bill that was also introduced in the House by U.S. Representative Fazio as H.R. 1699. These bills would actually result in labeling food products with GMO ingredients. Pompeo's bill would not.

[Skeptical]

A couple of immediate thoughts:

"and to have the food containing the bioengineered organism evaluated under the FDA's voluntary consultation process."

If the law requires this, can it still be called "voluntary?"

The dance around material difference would seem to implicate the Myriad decision. If there is a patent (a material difference), then the item is covered under this law. The extent of bio-engineering allowed is only that extent that would fail to earn a patent under the Myriad ruling.

I am not sure what the implications are for those who inadvertently deal with material that would fall under patent coverage - even in trace amounts. Is there a 'trace amounts'-non-intentional clause in the bill?

[GrzeszDeL]

Approximately 3% of the bovine genome is endogenous retrovirus. To my mind, this constitutes "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" Does all beef now need GMO labels?

Incidentally, when Monsanto introduces transgenes into crop plants, they typically use Agrobacter to transform in the new trait. Agrobacter is constantly delivering DNA to plants in the wild, such that even "heirloom" strains of crop plants contain "recombinant" DNA. Does all food sold need the GMO label?

[Donald Zuhn]

Skeptical:

Thank you for the comment. Upon further review, the legislation would require that developers either submit a premarket biotechnology notification or participate in the FDA's voluntary consultation process.

In addition, the bill has some provisions regarding food produced from, containing, or consisting of a bioengineered organism that may be inadvertently present in the food.

Don