In our July 27, 2018 blog , we explained what bioengineered (BE) food is and informed you about the United States Department of Agriculture’s (USDA) Agricultural Marketing Service’s (AMS) new proposed rule for BE foods. The new rule is a result of the 2016 amendment to the Agricultural Marketing Act of 1946, which would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content. The amended Act directs the Secretary to establish the National Bioengineered Food Disclosure Standard (NBFDS) for disclosing any BE food and any food that may be bioengineered. This proposed rule is intended to provide a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. The standardized disclosure of information will facilitate food purchasing for consumers by eliminating the current uncertainty when purchasing food; effectively improving overall consumer confidence, without harming food manufacturing; and providing farms and production companies a logical, consistent standard for future labeling and packaging.
What Will the Disclosure Look Like?
AMS believes that the proposed performance standard would likely provide the BE food disclosure information to consumers in an accessible manner, while allowing the entities responsible for the disclosure to have flexibility in implementing the requirements. The disclosure will have to be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under “ordinary shopping conditions.” While FDA uses the term “customary conditions of purchase,” 21 CFR 101.15, AMS has proposed to utilize the term “ordinary shopping conditions” as the statutory language references “shopping” in 7 U.S.C. 1639b(c)(4).
Placement of Disclosure
The proposed rule would provide that the BE food disclosure be placed in one of the following places:
- The information panel adjacent to the statement identifying the name and location of the manufacturer/distributor or similar information;
- Anywhere on the principal display panel; or
- An alternate panel if there is insufficient space to place the disclosure on the information panel or the principal display panel.
Types of Disclosures
The proposed rule provides three disclosure options for all food subject to the mandatory BE food disclosure, as well as additional options for small food manufacturers, and requires that the Secretary provide reasonable alternative disclosure options for food contained in small and very small packages. 7 U.S.C. 1639b(b)(2)(D), 1639b(b)(F), and 1639b(b)(E).
The amended Act allows for text disclosure of BE food as one option given to regulated entities. At the outset, for all on-package text disclosure options and alternatives, AMS proposes using the terms “bioengineered food” or “bioengineered food ingredient.” AMS is not proposing any similar terms because we believe that the statutory term, “bioengineering,” adequately describes food products of the technology that Congress intended to be within the scope of the NBFDS.
AMS proposes use of the statements “Bioengineered food” or “Contains a bioengineered food ingredient” for disclosure of BE food and BE food ingredients that appear on the list of BE foods with a high adoption rate. A food on this list would be presumed to be a BE food, absent documentation that would verify otherwise.
AMS also proposes that regulated entities would disclose the presence or possible presence of BE food and BE food ingredients that are on the list of BE foods commercially available, but not highly adopted, in the United States using the following statements: “Bioengineered food,” “May be bioengineered food,” “Contains a bioengineered food ingredient,” or “May contain a bioengineered food ingredient.” The default presumption would be that any foods on the non-high adoption BE food list may be bioengineered, and regulated entities would have discretion to use any of these disclosure options.
AMS proposes three alternative symbols with variations of those symbols. AMS recognizes that a multi-colored product label may increase printing costs or disrupt product design in other ways. Therefore, similar to use of the USDA Organic seal, AMS proposes to allow regulated entities to use a black and white version of the symbol. Regardless of colors, the symbol would still be required to meet the appearance and placement requirements.
Electronic or Digital Link Disclosure
The amended Act requires that the use of an electronic or digital link to disclose BE food must be accompanied by the statement “Scan here for more food information” or equivalent language that reflects technological changes. 7 U.S.C. 1639b(d)(1).
Current technology includes, among others, quick response codes that are detectable by consumers and digital watermark technology that is imperceptible to consumers, but can be scanned anywhere on a food package using a smart phone or other device. Consequently, AMS proposes two examples of alternative statements that could appear above or below an electronic or digital link to direct consumers to the link to the BE food disclosure. The proposed examples are: “Scan anywhere on package for more food information” and “Scan icon for more food information.”
AMS’s proposal would incorporate the amended Act’s requirement to include a telephone number that provides access to the BE food disclosure. The proposal would further require that the disclosure be available regardless of the time of day, and that the telephone number be located in close proximity to the electronic or digital link. The proposal would also require that the statement “Call for more food information” be utilized.
Proposed Effective and Initial Compliance Dates
The USDA intends the proposed effective and initial compliance dates to align with FDA’s proposed rule to extend the compliance dates for the changes to the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule. Those dates are January 1, 2020, and with a delayed compliance date of January 1, 2021, for small food manufacturers. See https://www.federalregister.gov/d/2018-09389/p-252.
Furthermore, USDA intends to allow regulated entities to use labels printed by the initial compliance date, regardless of whether they comply with the NBFDS, until the regulated entity uses up remaining label inventories, or until January 1, 2022, whichever date comes first. AMS is not proposing to require regulated entities to change the labels of food products that have entered the stream of commerce prior to January 1, 2022.
Diaz Trade Law specializes in food labeling compliance and will gladly assist in reviewing current labels and recommend label amendments to ensure compliance with federal regulations. Contact DTL at 305-456-3830 or email firstname.lastname@example.org. Sign up for our free monthly newsletter to stay up to date with USDA’s proposed rulemaking.