USDA Publishes Proposed GMO Labeling Regulations

The Agricultural Marketing Service of the US Department of Agriculture (USDA) recently published a proposed rule containing regulations to implement the National Bioengineered Food Disclosure Standard mandated by Congress in 2016. See 83 Fed. Reg. 19860 (May 4, 2018). The proposed regulations would govern the labeling of raw agricultural products and packaged foods whose labeling is governed the federal Food, Drug & Cosmetics Act, including wines below 7 percent alcohol by volume and non-malt beer (e.g., “hard seltzers”). The proposed regulations would not directly apply to alcohol beverages whose labeling is governed by the Federal Alcohol Administration Act, including all distilled spirits, wines containing 7 percent alcohol by volume or greater, and beer containing malted barley and hops. Nevertheless, the Alcohol and Tobacco Tax and Trade Bureau may look to the bioengineered food disclosure regulations as persuasive guidance in developing its own policies towards the disclosure of bioengineered ingredients (often called “genetically modified organisms” or “GMOs”).

The National Bioengineered Food Disclosure Standard aims to create a uniform national standard for bioengineered substance label disclosure. As such, one of its primary purposes is to pre-empt conflicting state and local disclosure standards. USDA’s proposed disclosure rules feature the following:

1. Mandatory disclosure of the presence of bioengineered ingredients in foods through one of four means:
   1. Text label disclosure;
   2. Symbolic label disclosure using one of three proposed symbols;
   3. Electronic or digital link disclosure; or
   4. Text message disclosure.
2. The exact disclosure required may vary based on whether the bioengineered substance comes from a “high adoption bioengineered food” or a “non-high adoption bioengineered food.” USDA will compile and update a list determining whether a bioengineered food has an adoption rate of 85 percent or more, making it a “high adoption bioengineered food.”
3. Somewhat different disclosure rules would apply to “small” and “very small” packages.
4. The regulations would exempt the following from the disclosure rules:
   1. Food served in a restaurant;
   2. “Very small” food producers (those with annual receipts of less than $2.5 million);
   3. An exemption for foods containing de minimis amounts of bioengineered substances, with three alternatives proposed (g., foods containing a bioengineered substance that is inadvertent or technically unavoidable and accounts for no more than 5 percent by weight of the specific ingredient, or foods in which the bioengineered ingredient accounts for no more than 5 percent of the total weight of the final food);
   4. Foods made from animals that consumed bioengineered feed; and
   5. Food certified as organic under the National Organic Program.
5. The regulations do not prohibit other claims regarding bioengineered foods (g., “no GMOs”), “provided that such claims are consistent with applicable federal law.”
6. The regulations give USDA audit and inspection authority to enforce the bioengineered disclosure standard, with penalties for “knowing” violations.
7. The regulations propose an effective date of January 1, 2020, for most manufacturers, and January 1, 2021 for “small food manufacturers” (those with annual receipts of less than $10 million that are larger than “very small” manufacturers). But the Act also includes a provision permitting foods produced, labeled and introduced into commerce prior to January 1, 2022 to be sold using their existing labels.

The USDA’s Federal Register notice requests comments on the proposed regulations by July 3, 2018.