On May 4, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) proposed a rule to establish the first ever National Bioengineered Food Disclosure Standard (NBFDS) mandated by Congress in 2016. This column discusses the proposal, what it intends to achieve, and its implications.
On July 29, 2016, Congress enacted legislation amending the Agricultural Marketing Act of 1946 by directing the USDA Secretary to establish the NBFDS for disclosing any bioengineered food (BF) and any food that “may” be bioengineered. The law also directs the Secretary to establish requirements and procedures necessary to carry out the new standard and conduct a study to identify potential technological challenges related to electronic or digital disclosure methods. The law also specifies that certification of food under the USDA National Organic Program “shall” suffice to make claims about the absence of bioengineering in the food.
To follow Congress’ intent, last year AMS solicited comment on 30 questions on the topic of developing the proposed NBFDS. AMS received more than 112,000 comments on this controversial topic.
The goal of the standard, according to AMS, is to provide “a uniform way to offer meaningful disclosure for consumers who want more information about their food and avoid a patchwork system of state or private labels that could be confusing for consumers and would likely drive up food costs.” The rulemaking aims “to provide a mandatory uniform national standard for disclosure of information to consumers about the [bioengineered (BE)] status of foods.” AMS is careful to note that nothing in the disclosure requirements is designed to convey information about the health, safety or environmental attributes of BE food compared with non-BE food.
Under the proposal, BE refers only to foods that have been created by splicing foreign genes from one species into another. Specifically, “bioengineering” means a food that “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques” and for which “the modification could not otherwise be obtained through conventional breeding or found in nature.” Given the proposal’s adoption of this statutory definition of BE, some stakeholders claim foods gene-edited in any way are “genetically modified” and thus the proposal is under-inclusive. The standard will cover all foods regulated by the U.S. Food and Drug Administration (FDA) except, curiously, foods whose primary (but not sole) ingredient is meat.
Under the proposed rule, AMS is tasked with compiling two lists of BE foods. One list will include ingredients that are generally always genetically engineered. These include, for example, canola, field corn, soybeans and sugar beets. A second list includes crops that are not as commonly genetically engineered. For these commodities, such as apple, non-browning cultivars; corn, sweet; papaya; potato; and squash, summer varieties, a packaging label could state the product “may” contain BE food.
Provisions exempt “very small food manufacturers” (annual receipts of less than $2,500,000), and, as noted above, foods already certified organic. The proposed rule also contains a provision that gives entities the option to label BE ingredients via an electronic (QR code) or digital link.
Under the proposal, current genetically modified organism (GMO)-free certifications would arguably be broader than the somewhat narrowly defined BE label proposed by AMS. In addition, some claim the “BE” designation isn’t broadly recognized by consumers and thus may not fulfill Congress’ goal of providing information to consumers regarding the bioengineered nature of food they are purchasing. We expect this will be the source of considerable comment on the proposal. In addition, some stakeholders are likely to question the wisdom of the QR code labeling option. Some claim consumers are confused by such electronic approaches and could thwart the underlying goals of disclosure mandates.
AMS should be praised for its hard work in proposing the rule and considering the many comments tendered last year. Given the hyper-charged nature of the topic and the divisive debate that’s been ongoing for decades on all things GMO, AMS can expect to receive many comments on the proposal. In essence, the proposal is merely a labeling and communication requirement. Reasonable people will disagree as to whether the proposal gets it right.
Comments on the proposed rule must be received by July 3, 2018. The FDA’s announcement stated that, due to the Congressionally mandated timeline for this rulemaking, the comment period won’t be extended.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.