On Thursday July 14, the House approved legislation authorizing USDA to establish and administer a National Bioengineered Food Disclosure Standard. The bill, S.764, was previously approved by the Senate. The bill had been promoted as an urgent and necessary compromise by its supporters. Upon enactment, it will immediately preempt any state GMO disclosure laws, thereby preventing a state-by-state patchwork of such requirements. Among the state laws preempted will be Vermont’s Act 120, which went in effect on July 1, 2016.
The disclosure requirement will apply to many food products for human consumption, except for food served in restaurants or similar retail establishments. The disclosure requirement appears to apply broadly to food subject to FDA labeling requirements; there is no explicit exemption for subcategories of food such as dietary supplements and infant formula. The disclosure requirement will also apply to foods subject to FSIS labeling requirements if (1) the most predominant ingredient in the food is subject to FDA labeling requirements, or (2) the most predominant ingredient is broth, stock, water, or a similar solution, and the second most predominant ingredient is subject to FDA labeling requirements. Thus, products that contain meat, poultry, or egg products as the most predominant ingredient will not be subject to the disclosure requirement. Not surprisingly, this can be expected to result in anomalies familiar to anyone accustomed to navigating the dividing line between FDA and FSIS jurisdiction (e.g., a cheese pizza containing bioengineered ingredients may be required to bear a disclosure, whereas a similar pizza containing meat as the most predominant ingredient would not be required to bear the disclosure).
Although FDA and USDA-FSIS are the two federal agencies that generally regulate mandatory labeling requirements for foods, the bill gives the USDA Agricultural Marketing Service (AMS) the responsibility for establishing the disclosure standard within 2 years of enactment. Among other things, AMS will be charged with determining the threshold of bioengineered content that triggers the disclosure requirement, establishing a process for determining whether a product is bioengineered, and defining “small food manufacturers” and “very small food manufacturers” (the latter would be exempt). The AMS regulations must provide various options for disclosure, including the use of a symbol denoting genetically engineered ingredients, a “quick response” (Q.R.) code that people with smartphones can scan to retrieve the information, and for certain labels, a 1-800 number. The regulations must also provide other reasonable disclosure options for food in small or very small packages.
With respect to enforcement, the bill makes it a prohibited act to knowingly fail to make a required disclosure. Also, the bill requires a company subject to the disclosure requirement to keep records demonstrating compliance, and authorizes USDA to examine or audit those records. USDA must provide the company notice and an opportunity for a hearing on the results of any examination or audit, after which USDA must make public a summary of that examination or audit. Thus, companies that fail to comply can expect to have that failure made public. Also, the bill disclaims preemption of “any remedy created by a State or Federal statutory or common law right.” However, recalls are off the table; the bill makes clear that USDA has no authority to recall a food that does not provide a required disclosure.
In comments to Congress, FDA and USDA put forward different interpretations of certain provisions in the bill. See FDA’s comments here and USDA’s comments here. For example, FDA commented that the definition of bioengineering seems to be limited to foods that include genetic material, and therefore would not apply to foods from which all such material has been removed, such as soybean oil. In apparent disagreement – but without explanation – USDA stated that the definition authorizes the inclusion in the national disclosure program “all of the commercially grown GMO corn, soybeans, sugar, and canola crops used in food today and reviewed and approved by USDA’s Biotechnolgy Regulatory Service.” USDA also asserted that the definition authorizes inclusion in the national disclosure program of “products of certain gene editing techniques,” including “novel gene editing techniques such as CRISPR when the are used to produce plants or seeds with traits that could not be created with conventional breeding techniques.” However, FDA noted that “[i]t may be difficult to demonstrate that a particular modification could not be obtained through conventional breeding” (emphasis in original).
Once the bill becomes law, USDA will have the opportunity to put forward its interpretations in the context of rulemaking to establish the national disclosure standard. That rulemaking is likely to be contentious, given the tenor of the GMO labeling debate over the past couple of years. Thus, the Congressionally mandated 2-year timeframe for establishment of the disclosure standard could prove unduly optimistic.