In our last issue of the International Food Law Gazette, we reported on the changing legal landscape for the labeling of genetically engineered (GE) foods (more commonly referred to as genetically modified organisms, or GMO). In the intervening months, there have been several key developments. Most significantly, S.764 was passed in Congress and signed by President Obama on July 29, 2016, amending the Agricultural Marketing Act of 1946 to establish the National Bioengineered Food Disclosure Standard (NBFDS or the GE Disclosure Law).1 The new GE Disclosure Law authorizes the U.S. Department of Agriculture (USDA) to create a national disclosure standard for GE human foods. Of particular significance, the NBFDS establishes a definition for “bioengineering,” requires the USDA to promulgate regulations for a national mandatory disclosure standard for GE foods, and broadly preempts state and local GE labeling requirements.
Definition of “Bioengineering”
With respect to human foods, the NBFDS expressly defines “bioengineering” as 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 food.”2
Due to the wide variety of gene editing techniques and the traits of the resulting organisms, the statutory definition will likely be a main point of contention in the future. Prior to the passage of S.764, the USDA took a seemingly straightforward view of the definition’s scope, stating that it includes “all of the commercially grown GMO corn, soybeans, sugar, and canola crops used in food today”; however, it also signaled a potentially more expansive view, explaining that the definition:
provides authority to include food in the national disclosure program, including products of certain gene editing techniques. This would include novel gene editing techniques such as CRISPR when they are used to produce plants or seeds with traits that could not be created with conventional breeding techniques.3
In separate technical comments on S.764, the U.S. Food and Drug Administration (FDA) expressed two concerns about the narrow scope of the definition. First, FDA worried that the phrase “contains genetic material” would inadvertently result in the exclusion of many foods derived from GE sources which do not contain genetic material, such as oil made from GE soy, starches, and purified proteins. Second, FDA commented that “it may be difficult to demonstrate that a particular modification could not be obtained through conventional breeding (or even that it could not occur in nature).”4 The practical scope of the definition remains unclear and therefore presents a significant issue that the USDA will need to address during rulemaking.
Implementing Regulations
The USDA’s Agricultural Marketing Service (AMS) is tasked with responsibility to promulgate regulations to create and implement the mandatory GE disclosure standard for foods covered by the law, which include all human foods subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act and certain human foods subject to the labeling requirements of the Federal Meat Inspection Act, Poultry Products Inspection Act, or Egg Products Inspection Act. The regulations will apply to any such food that meets the definition of “bioengineering,” and must provide requirements for a disclosure that the food is bioengineered. The NBFDS permits a variety of disclosure methods – including on-package text, an on-package symbol, or an on-package digital or electronic link (with accompanying text: “Scan here for more food information”) – all of which must be developed by the AMS through the rulemaking process. Importantly, the choice of such disclosure methods remains subject to the manufacturer’s discretion.
The AMS will also need to satisfy several other specific mandates when developing the regulatory framework, including provisions to:
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Exclude animal-derived foods from the definition of bioengineered foods if the sole reason for the designation would be the animal’s consumption of GE feed;
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Identify the amounts of a GE substance in a food sufficient to trigger the disclosure requirement;
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Establish the process for requesting and granting determinations from the USDA with regard to other factors for which a food may be considered to be “bioengineered”;
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Provide disclosure options for food in small or very small packages;
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Address the needs of small food manufacturers, including setting a later implementation date and providing additional disclosure options, such as a telephone number or website; and
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Exempt very small food manufacturers, restaurants, and retail food establishments from the disclosure requirement.
The USDA has taken initial steps to comply with the mandates of the GE Disclosure Law. For example, on September 19, it issued a policy memo to ensure consistency between the NBFDS and Organic Foods Production Act, including the rules of the National Organic Program.5 In addition, on October 19, the AMS solicited proposals from vendors to conduct a study to identify potential technology challenges that may impact whether consumers would have access to a GE disclosure made through electronic or digital means.6
The USDA faces extremely challenging timeframes to ensure it meets its statutory deadline for final regulations. Based on the AMS’ Fall Unified Agenda, an Advance Notice of Proposed Rulemaking (ANPR) was expected in November (and is therefore imminent) to solicit comments on how the law should be implemented. The proposed rule is scheduled to be published in November 2017, with a final rule due by July 2018.
Preemption
One of the primary drivers behind the NBFDS—and the source of much controversy—was a desire to prevent a patchwork of different state and local GE disclosure requirements, highlighted by Vermont’s Act 120. Within weeks after Vermont’s law went into effect, the GE Disclosure Law was passed with broad federal preemption provisions. The NBFDS unambiguously prohibits all states and localities from imposing GE labeling or other disclosure requirements for foods that are covered under the NBFDS unless such requirements are identical to the federal standard. Furthermore, the NBFDS contains a separate and additional preemption provision that prohibits states and localities from establishing any GE disclosure requirements for any food (whether or not covered by the NBFDS) or seed. Days after S.764 became law, USDA sent letters to the governors of each state to call their attention to these preemption provisions.7 The preemption of state disclosure laws for GE foods was considered a significant victory, welcomed by industry and food manufacturers who can now operate under a uniform standard without expending resources to ensure compliance with a hodge-podge of different and multiple state standards.
If you have questions about the new National Bioengineered Food Disclosure Standard and its impact, or would like to participate in the USDA’s rulemaking activities, please contact Heather Bañuelos or Smitha Stansbury.
1 Pub. L. 114-216, 130. Stat. 834 (July 29, 2016), codified 7 U.S.C. §§ 1639 et seq.
2 7 U.S.C. § 1639(1).
3 See Letter from USDA General Counsel Jeffrey M. Prieto to Sen. Debbie Stabenow (D-MI), Ranking Member of the Senate Committee on Agriculture, Nutrition, and Forestry), 162 Cong. Rec. S4994 (July 12, 2016), available at https://www.gpo.gov/fdsys/pkg/CREC-2016-07-12/pdf/CREC-2016-07-12-pt1-PgS4994.pdf.
4 FDA/HHS Technical Assistance on Senate Agriculture Committee draft legislation to establish a national disclosure standard for bioengineered foods (EDW16734) (June 27, 2016), available at http://www.centerforfoodsafety.org/files/fda-to-senate-ag-on-draft-legislation_29928.pdf.
