The US Department of Agriculture (USDA), through its Agricultural Marketing Service (AMS) published its final rule (NBFDS Final Rule) on December 21 establishing a nationwide labeling disclosure requirement for foods containing bioengineered (BE) ingredients, defined as foods or substances that contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or be found in nature. While a more thorough analysis is still being conducted, here we provide a summary of the major topics addressed in the NBFDS Final Rule.
The US Department of Agriculture issued a proposed rule requiring that foods containing bioengineered (i.e., genetically modified organisms or “GMO”) ingredients display a food label to indicate to consumers that it is a “bioengineered food.” The proposed rule is far-reaching and, if adopted, would impact labeling obligations for a substantial percentage of food products offered for sale in the United States. This includes, but is not limited to, raw produce, seafood, dietary supplements, and most prepared foods, such as breads, cereals, non-meat canned and frozen foods, snacks, desserts, and drinks. As explained in greater detail in the preamble, it also applies to some of the meat, poultry, and egg products independently regulated by the USDA, but only if an ingredient regulated by the US Food and Drug Administration (FDA) predominates. Read the full LawFlash.
USDA’s Agricultural Marketing Service (AMS) posted 30 questions for stakeholder input regarding the establishment of a national disclosure requirement for identifying bioengineered foods and food ingredients. The legislation requiring the disclosure of bioengineered foods was enacted on July 29, 2016, and gave AMS two years to establish a national standard and the procedures necessary for implementation (see our LawFlash, New GMO Legislation Signed Into Law, for more information on the legislation). AMS is now seeking input from stakeholders in order to issue a proposed rule this fall, such that it may promulgate a final rule by the mandated July 2018 deadline.
On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying bioengineered foods and food ingredients, known colloquially as “GMO” (genetically modified organism) or “GE” (genetically engineered) foods. The disclosure requirement will apply to foods subject to labeling requirements under the Federal Food, Drug, and Cosmetic Act. Please see our LawFlash, New GMO Legislation Signed Into Law, for more information.
The food industry has become a fertile ground for class-action lawsuits over the last few years and shows no signs of slowing down. New cases are decided daily. There are several factors that drive this trend and that are likely to propel forward new cases in the coming years. As a detailed review of some of the cases in this area reveals, these factors make it probable that litigation in this area is likely to continue, even if not at the same rate that it has over the last couple of years.
In the white paper titled “Appetite for Litigation: Why Plaintiffs’ Lawyers Hunger for Food-Labeling Lawsuits,” partner Tom Sullivan provides an overview of federal statutes and regulations, outlines the different types of cases, summarizes the recent court trends and defenses to food-labeling litigation, and forecasts the emerging trends in the industry.
As our readers are aware, many states have introduced legislation that would mandate genetically modified organism (GMO) labeling requirements. There is much uncertainty surrounding state GMO-labeling initiatives, with Vermont successfully enacting legislation (that is being challenged in court) and several high-profile failures in California and, more recently, in Oregon. Although the Organic Foods Production Act sets a clear non-GMO standard for certified organic food, a lack of a clear federal definition or preemption for conventional foods has contributed to a wave of costly litigation in this area. As a result, industry is left with the threat of state-based initiatives that have the potential to create the same unworkable patchwork of laws that prompted the Nutrition Labeling and Education Act in the 1990s and the recently finalized Menu Labeling Rule, both of which have federal preemptive effect.
Vermont’s Office of Attorney General recently released its draft rule detailing how manufacturers and retailers could be required to label genetically modified organism–processed (GMO-processed) food sold in the state. The draft rule is expansive and will affect several sectors of the food industry, including producers, processors, distributors, and retailers. Significantly, Vermont’s GMO rule could serve as a model for future regulation by other states with GMO legislation and even the federal government.
This rule will place significant burdens on retailers and manufacturers to understand the composition of source ingredients. Vermont’s Act 120 defines “genetic engineering” as a process by which food is produced from organisms that are changed through the application of in vitro acid or hybridization techniques that do not occur by natural manipulation. Food products manufactured through “genetic engineering” and/or that contain GMO components must be labeled as such. The proposed rule is intended to clarify this mandate and provides that products produced with GMOs must be labeled by retailers and manufacturers as “Produced with Genetic Engineering.” In certain instances, retailers and manufacturers may label products as “Partially Produced with Genetic Engineering” (when the item is composed of less than 75% GMO material) or “May be Produced with Genetic Engineering” (when the seller does not know whether the food itself is genetically modified or contains items produced with GMOs). No label is required when 0.9% of the product’s total weight consists of items produced with GMOs.