The USDA’s Agricultural Marketing Service (AMS) issued its long-awaited proposed rule calling for food manufacturers and other entities that label foods for retail sale to disclose information about bioengineered (BE) food and food ingredients. The proposed rule, once final, would establish a uniform national standard for disclosure of information to consumers about the “BE status of foods,” according to the agency. BE is the term used by AMS, in preference to  Genetically Modified Organism (GMO).

“This rulemaking presents several possible ways to determine what foods will be covered by the final rule and what the disclosure will include and look like,” said Agriculture Secretary Sonny Perdue. “We are looking for public input on a number of these key decisions before a final rule is issued later this year.”

Comments on the proposal are due by July 3, and can be submitted electronically (Docket No. AMS-TM-17-0050). The notice cautions that because of the deadline imposed by Congress on the USDA to issue final rules, this comment deadline will not be extended.

AMS announced the availability of an informational webinar on the proposal in the May 23 Federal Register. AMS said the pre-recorded webinar is to be made available beginning June 1 at http://www.ams.usda.gov/BE.

Background

The National Bioengineered Food Disclosure Standard act (Pub. L. No. 114-216) became law in July 2016, giving AMS two years to establish the National Bioengineered Food Disclosure Standard (NBFDS).

Stakeholders wanting to inform the development of the NBFDS were asked for their input last year when the AMS posted 30 questions. Comments on the questions were due by Aug. 25, and AMS received over 112,000 responses from consumers; food manufacturers and retailers; farmers and processing operations; state and foreign governments; and associations representing various food manufacturers and retailers, farmers and other interest groups. These comments were used in drafting the proposed rule that appeared in the May 4 Federal Register (83 Fed. Reg. 19860).

Further, Study of Electronic or Digital Link Disclosure: A Third-Party Evaluation of Challenges Impacting Access to Bioengineered Food Disclosure was released in early September 2017. It was mandated under Pub. L. No. 114-216 to identify “potential challenges associated with accessing a bioengineering disclosure through an electronic or digital link.” The study showed that although challenges exist in placing QR codes on labels for foods containing a genetically modified organism (GMO), they could prove beneficial to consumers. A QR — quick response — code is an electronic or digital link similar to a barcode.

Coverage

“The proposed rule is intended to provide for disclosure of foods that are or may be bioengineered in the interest of consumers, but also seeks to minimize implementation and compliance costs for the food industry — costs that could be passed on to consumers. To that end, AMS has tried to craft requirements that are clear and straightforward, incorporating flexibility where appropriate,” according to the preamble to the proposed rule. The discussion of the proposed NBFDS is divided into three parts — applicability, disclosure and administration.

Perhaps one of the thorniest issues raised in the rulemaking is how to define “bioengineering” and “bioengineered food.” The National Bioengineered Food Disclosure Standard law defined “bioengineering” with respect to a food as one “(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature” (7 U.S.C. 1639). AMS proposes to incorporate this statutory definition into the definition of “bioengineered food” without further interpretation of what bioengineering means, but said that it “welcomes public comment on what could be considered to constitute ‘bioengineering.’” AMS discusses two general prevailing opinions on how the term should be interpreted, as discussed in responses to its 30 questions posted last year.

For purposes of the proposed rule, AMS developed two lists of foods that would be subject to BE disclosure: (1) a proposed list of BE foods that are commercially available in the U.S. with a high adoption rate, and (2) a proposed list of BE foods that are commercially available in the U.S. that are not highly adopted. Adoption refers to the prevalence with which BE cultivars of a food crop are planted or produced in the U.S., relative to the number of non-BE cultivars of the same crop in production. Only foods or products on either of those lists or made from foods on either of the lists would be subject to disclosure under the NBFDS.

The proposal discusses at length options for disclosure, including text and a new symbol. The proposal presents several options for how the symbol would be designed. The proposed graphics are also depicted at the AMS BE Disclosure & Labeling website.

With regard to a threshold for the amount of a BE substance that may be present in food in order for it to be considered “a BE food,” AMS proposes three alternatives:

1. Food in which an ingredient contains a BE substance that is inadvertent or technically unavoidable, and accounts for no more than 5 percent of the specific ingredient by weight, would not be subject to disclosure as a result of that one ingredient. Any other use of a food or food ingredient that contained a BE substance would be subject to disclosure.
2. Food in which an ingredient contains a BE substance that is inadvertent or technically unavoidable, and accounts for no more than 0.9 percent of the specific ingredient by weight, would not be subject to disclosure as a result of that one ingredient.
3. Regulated entities could use a small amount of BE ingredients up to a certain threshold, such as 5 percent of the total weight of the product, before being required to label a product with a BE disclosure.

Effective Date

AMS intends that the NBFDS rule would become effective 60 days after the date of the final rule’s publication in the Federal Register, with a general compliance date of Jan. 1, 2020, and a delayed compliance date of one year for small food manufacturers. This compliance date would be in alignment with the compliance date of the FDA’s final rules making changes to the Nutrition Facts and Supplement Facts labels and serving size disclosures (83 Fed. Reg. 19619).