On July 29, 2016, President Barack Obama signed S.764 into law. The law amends the Agricultural Marketing Act of 1946 to require that the U.S. Department of Agriculture (“USDA”) establish and oversee a national bioengineered food disclosure standard. Under the law, USDA has two years to promulgate regulations that establish the disclosure standard, as well as any related requirements and procedures that the Agency deems necessary.
Under the law, any disclosure regulations that USDA promulgates shall: (i) prohibit a food from being considered “bioengineered” solely because the animal from which it was derived consumed feed that was bioengineered; (ii) set the amounts of a bioengineered substance that need to be in a food for it to be considered “bioengineered”; (iii) establish a process by which other considerations may be given to whether a food is “bioengineered”; (iv) require that the bioengineered disclosure be a text, symbol, or electronic or digital link (e.g. a QR or Quick Response Code), with the disclosure option to be selected by the food manufacturer; (v) provide alternative reasonable disclosure options for food with small packaging; (vi) for “small food manufacturers,” provide at least one additional year for compliance with the disclosure regulations, as well as the additional option to disclose that the food contains bioengineered material through a phone number or internet website, (provided that they indicate that the number or URL provides access to additional information); and (vii) exclude food served in restaurants or “very small food manufacturers”—to be defined by USDA—from the disclosure requirements.
While the law should ultimately lead to more information on food labeling and enable consumers to make more informed choices about their food, it has also received significant criticism. For example, opponents of the law say that the definition of “bioengineered foods” is unduly narrow.
The Act defines “bioengineered foods” as any food—as defined by the Federal Food Drug and Cosmetic Act (“FDCA”)—“(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.” But, as highlighted in comments provided by the Food and Drug Administration (“FDA”) during the bill’s drafting, many foods that are derived from genetically engineered sources do not themselves contain genetic material. Further, it may be difficult to demonstrate that a particular modification “could not otherwise be obtained through conventional breeding or found in nature.”
Additionally, it is unclear whether the law is meant to exclude foods that are essentially meat, poultry, and eggs. The scope provisions note that the new law applies only to “foods” that are subject to: (1) the labeling requirements under the FDCA; or (2) the labeling requirements under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act but only where (i) the most predominant ingredient of the food would be independently subject to the labeling requirements under the FDCA, or (ii) the most predominant ingredient of the food is broth, stock, water, or a similar solution and the second most predominant ingredient would be independently subject to the labeling requirements under the FDCA. As FDA explained in its comments, all foods—as defined by the FDCA—are subject to the FDCA labeling requirements, and, as such, paragraph (2) appears superfluous. FDA interpreted the intent of the scope provision to exclude foods that are essentially meat, poultry, or eggs, and noted that the drafters may have assumed, incorrectly, that products covered by the Meat, Poultry, and Egg Inspection Acts are not covered by the FDCA.
Further criticisms include: (i) the bill’s federal preemption section, which appears to knock out a number of enacted or pending state labeling laws—including those in Vermont, Maine, Alaska, and Connecticut; (ii) the potential for the labeling required by FDA and the labeling required by USDA to be too voluminous to fit onto most food packaging; (iii) the lack of penalties provided for failure to ultimately comply with the labeling requirements; and (iv) the likelihood that electronic and digital disclosures might be inadequate for consumers without access to a smartphone or reliable data/wireless service. Congress appears to share this last concern, as the law directs USDA to conduct a study on whether these potential technical challenges may prevent consumers from accessing the bioengineering information and may necessitate other means for bioengineering disclosures.
Perhaps a number of these criticisms will be addressed in the rules and regulations that USDA ultimately promulgates under the law. Undoubtedly, it will be interesting to monitor this develop from legislative action to implementation in the coming months and years.