Provides Practical, Mandatory Disclosure and Preempts State GMO Labeling Laws

Senate Agriculture Committee leaders reached agreement June 23, 2016, on a bill that would require food containing genetic material modified by recombinant DNA techniques to be labeled or to provide a link to a disclosure indicating that the food is "bioengineered." This compromise legislation follows a voluntary genetically modified organism (GMO) disclosure bill that died in the House earlier this year. If adopted, the bill would also preempt all state GMO labeling laws. GMO labeling is particularly controversial because it is often perceived as a warning, suggesting to consumers that foods carrying the disclosure are unsafe or less safe than other foods. In fact, the U.S. Food and Drug Administration (FDA), World Health Organization, National Academy of Sciences and the British Royal Society (among others) all agree that GMO labeling is unwarranted from a health or safety perspective because GMO foods are developed through conventional breeding techniques.

Why It Matters

The compromise was driven by the desire to establish a federal disclosure rule and preempt controversial Vermont GMO food labeling requirements before they go into effect on July 1, 2016. Preempting state GMO disclosure initiatives is important to the industry to avoid a patchwork of potentially inconsistent state labeling requirements that are incompatible with national product labeling and distribution systems. Connecticut and Maine have adopted analogous GMO food disclosure laws, but they are not yet in effect. The compromise legislation will not beat the Vermont deadline, but it appears federal rules could be in place later this year if the bipartisan approach gathers sufficient support and priority on congressional calendars. Until then, retailers and food product manufacturers distributing in Vermont will need to comply with the state labeling rule—unless the federal courts act more quickly. Food industry trade associations challenged the Vermont mandatory GMO labeling rules on First Amendment grounds (unconstitutional compelled commercial speech). The District Court's denial of a preliminary injunction is currently under review by the U.S. Court of Appeals for the Second Circuit. The case was argued in October 2015 and could be decided at any time.

Proposed Federal GMO Labeling Approach

Under the compromise legislation, the United States Department of Agriculture (USDA), and not the FDA, would issue rules requiring "bioengineered" foods to either display a text disclosure (e.g., "genetically engineered" or "produced using modern biotechnology") or, at the producer's option, a QR code, telephone number or similar device accompanied by a neutral instruction to the consumer to call or scan the device to link the consumer to "additional food information" at a website or similar off-label source. There, the consumer would receive GMO food content information (and likely other food content information) in a fuller context not possible on most product labels, and in a manner that would not imply that GMO foods were unsafe. Appropriately, the rules would be issued under the USDA's agricultural marketing authorities, not the FDA's food safety authorities.

GMO Foods Exempt From Disclosure

Several categories of GMO foods would be exempt from disclosure obligations, including most meats, eggs and poultry not regulated by the FDA; foods with very low concentrations of GMO content (thresholds to be determined by rule); food derived from animals that are not themselves bioengineered even if they were fed GMO foods; and food served in restaurants and similar retail food establishments.

Bioengineering Techniques Exempt From Triggering GMO Disclosure

The "bioengineered" foods subject to disclosure under the compromise legislation are limited to those produced in part by "in vitro recombinant DNA (rDNA) techniques" that could not have been achieved by breeding or are not found in nature. Recombinant DNA techniques are generally understood to be those that, by a variety of means, introduce natural or synthetic DNA into the organism that was not part of the original. However, there are a number of genetic modification techniques that do not use the rDNA approach. Food products made with organisms modified by these other techniques apparently would not be regulated under the disclosure regulation. These other techniques include classic breeding, interspecific and intergeneric plant hybridization, and chemically or radiation-induced DNA mutagenesis (the source, for example, of certain "organic" red grapefruit).

Also apparently exempt from GMO labeling would be food products made with organisms modified by the most recent and perhaps most powerful genetic editing techniques: RNA interference (RNAi), zinc-finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs) and clustered regularly interspaced short palindromic repeats (CRISPRs). These techniques modify the genome of an organism by editing (cutting out or suppressing) DNA sequences without introducing any foreign DNA elements. The USDA Animal and Plant Health Inspection Service (APHIS) recently ruled that a CRISPR-edited version of a common commercial mushroom (edited to reduce browning) was not subject to its plant pest review jurisdiction in substantial part because the genetic modifications did not leave any exogenous DNA sequences. If commercialized for food use, the CRISPR-modified mushroom would be subject only to the same FDA standards as other more conventional foods, and no FDA premarket clearance or special labeling would necessarily be required. In contrast, the FDA studied a fast-growing rDNA-modified salmon for more than five years before allowing its sale as food late last year.

Labeling Debate Coincides With Broad Review of Federal Biotech Regulatory Policy

Congressional debate on the nature of appropriate GMO labeling is particularly timely as it coincides with the conclusion of a yearlong interagency (FDA, EPA, USDA) effort organized by the Office of Science Technology Policy at the White House to modernize the federal coordinated framework for the regulation of biotechnology products and to establish mechanisms for periodic updates of that system. Part of that review includes consideration whether products of new genetic modification techniques require different regulatory approaches, and more broadly, to consider in what circumstances the current framework reasonably can be scaled back or should be more demanding. Current policy is to evaluate bioengineered products based on their characteristics, not on the way they were produced. That review is scheduled for completion in July.

First Amendment May Ultimately Bar Mandatory GMO Labeling

While the prepared foods industry now largely supports the compromise federal mandatory GMO food labeling bill, it strongly opposed Vermont's mandatory GMO labeling statute as unwarranted and sued to overturn it, arguing that it violated the First Amendment to the Constitution because it compelled commercial speech in circumstances where there is no legitimate and substantial stated objective, and the message conveyed is controversial and reflects the state's point of view. The trial court denied industry's request to stop enforcement of the law until reaching a decision on their challenge. Industry's appeal of that decision is now pending in the U.S. Court of Appeals for the Second Circuit, and could be decided at any time. Grocery Manufacturers Assn v. Sorrell, No 15-1504-CV (2d. Cir.). It is perhaps significant that the Constitutional arguments raised by industry against Vermont's rules likely also could be raised against the rules under the proposed federal legislation. The prepared foods industry may have no interest in disturbing a practicable federal rule that preempts state GMO labeling laws, but "organic" food marketers may see competitive advantage in more direct federal GMO food disclosures, or reopening the door to state-by-state GMO labeling.