On May 3, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced its proposed bioengineered food disclosure standard.  Consistent with the federal mandate signed into law on July 29, 2016, the proposed National Bioengineered Food Disclosure Standard (NBFDS) establishes the first-ever nationwide labeling requirements for bioengineered food.  USDA is charged with finalizing its implementing rules by July 29, 2018, and is accepting public comments on its proposal for 60 days.

The NBFDS aims to provide uniform information to consumers about bioengineered food ingredients while reducing compliance costs for the food industry. The proposal concentrates on the “what,” “when,” and “how” of the 2016 mandate:

1. what is “bioengineered food”?
2. when is it subject to disclosure? and
3. how will it be disclosed?

Compliance with the proposal’s requirements would begin for small food manufacturers by January 1, 2021, and for all other entities by January 1, 2020.  AMS invites comment on a wide range of regulatory alternatives within its proposal.  Significantly, for example, AMS’s proposal suggests and seeks comment on three potential thresholds below which a food containing an “inadvertent or technically unavoidable” bioengineered substance might not trigger the disclosure standard: five percent of the specific ingredient by weight, nine-tenths percent of the specific ingredient by weight, or five percent of the total weight of the product.  These and other elements of the proposal are subject to specific requests for public comment before the July 3, 2018 deadline.   

What is “bioengineered food”?

The 2016 law defines “bioengineering” to mean 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.” 7 U.S.C. § 1639(1).  The NBFDS incorporates this meaning into its definition of the term “bioengineered food,” while proposing to exclude incidental additives (for example, certain enzymes) that may be present in the food at an insignificant level and that do not have any technical or functional effect in the food.

In addition, AMS acknowledges the position of some commenters that highly refined products (such as high-fructose corn syrup or canola oil) do not fall within the statutory definition of “bioengineering” because (i) they have undergone processes that have removed genetic material such that it cannot be detected using common testing methods and (ii) when made from bioengineered crops, they are chemically identical to those products made from non-bioengineered crops.  Noting that other commenters, by contrast, have expressly asked for a regulatory presumption that highly refined products meet the statutory definition of “bioengineering,” AMS requests additional comment on this specific aspect of the scope of the regulatory definition of “bioengineered food.”   

AMS also seeks comment on whether additional definitions should be included in its rules for the terms “conventional breeding” and “found in nature,” both of which are components of the underlying law’s definition of “bioengineering.” AMS suggests that a definition for “conventional breeding” might be drawn from the Environmental Protection Agency’s (EPA) definition of that term for plant-incorporated protectants under the U.S. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and asks whether patent protections should be evaluated when determining if a modification can otherwise be “found in nature.”

When is bioengineered food subject to disclosure?

Under the proposal, AMS would maintain separate lists of “high adoption” and “non-high adoption” bioengineered foods that are subject to the disclosure standard.  Only foods that appear on one of the two proposed lists would be subject to disclosure:

• “High adoption” bioengineered foods (canola, field corn, cotton, soybean, and sugar beet) represent those commercially available bioengineered foods that have an adoption rate of 85 percent or more in the United States.
• “Non-high adoption” bioengineered foods (non-browning apple, sweet corn, papaya, potato, and summer squash) represent those commercially available bioengineered foods that have an adoption rate of less than 85 percent in the United States.

Labels for those foods that appear on the “non-high adoption” list are subject to slightly less stringent disclosure requirements.  AMS notes that it has intentionally omitted genetically engineered foods such as rice cultivars, pink-fleshed pineapple cultivars, and salmon from its proposed lists, since it has “no indication” that they are currently commercially available.  AMS would establish a process to review and revise both lists on an annual basis, with invitations extended to interested parties to recommend additions and subtractions from the lists every year.  AMS notes that this proposed process would also provide a vehicle for AMS to continuously evaluate whether a particular crop meets the definition of “bioengineering” as technologies continue to evolve.

A listed “high adoption” or “non-high adoption” food would not be subject to disclosure only if supported by documentation sufficient to verify that the food is not a bioengineered food and does not contain a bioengineered food ingredient.  According to AMS, such documentation might include supply chain documents, purchase orders, sales confirmations, bills of lading, supplier attestations, purchase receipts, written records, labels, contracts, brokers’ statements, analytical test results, or process certifications.  In the proposal, AMS states that it believes that records regularly kept and maintained by food manufacturers, importers, or food retailers will satisfy the disclosure standard’s recordkeeping requirements. 

How will it be disclosed?

Label disclosures may be made in one of four proposed forms:

1. label text indicating:
   1. “Bioengineered food” or “Contains a bioengineered food ingredient” for high adoption bioengineered foods, or
   2. “May be a bioengineered food” or “May contain a bioengineered food” for non-high adoption bioengineered foods
2. a prescribed bioengineered food symbol
3. an electronic or digital link to a product information website that includes the required bioengineered food text or symbol disclosure
4. a text message option that responds with the required bioengineered food text disclosure.

Implications

Food manufacturers and other stakeholders should continue to pay close attention to and consider commenting on AMS’s proposal.  AMS’s implementation of a de minimis threshold for bioengineered substances, along with the proposed exceptions to the regulatory definition of “bioengineered food” and the process that will be established to determine whether or not a given food item may be regulated, should also be considered carefully by developers of biotechnology products.

Beveridge & Diamond's Pesticides and Biotechnology practices have worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use conventional pesticides and pesticides produced through biotechnology. We represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Pesticides & Biotechnology practices help clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives.  We will continue to track developments concerning the implementation of the federal labeling scheme for bioengineered foods and the rulemaking process more broadly.  If you have any questions, please contact the authors.