Another Patch in the Quilt? New York Legislature Passes GRAS Reform Bill
In April, the New York legislature passed a bill that would reform the way many food ingredients used in the state are regulated. The "Food Safety and Chemical Disclosure Act," Senate Bill S1239F, now goes to Governor Kathy Hochul's desk for review and signature.
If signed into law as passed, the bill would significantly revise the requirements applicable to some current and future ingredients used in food. This is part of a larger discussion regarding how food ingredients are regulated across the country and the so-called "loophole" that certain ingredients utilize by self-determining that they are "generally recognized as safe" (or GRAS).
The Federal GRAS Standard: Voluntary Notification
Currently, under federal food laws, if a substance used in food is generally recognized by qualified experts as safe for its intended use, it does not need to be reviewed and approved for use by the U.S. Food and Drug Administration (unlike "food additives," which must be pre-approved prior to use in the U.S.). The person or entity that concludes a substance is generally recognized as safe must have substantiation to support its conclusion and may, but is not required to, notify the FDA of their conclusion and substantiation. For years, this voluntary reporting scheme has been pointed to as a loophole in our government's ability to adequately regulate our food system, with calls for reforms increasing exponentially in recent years.
NY Bill Requires Notice and Publication of Ingredient Safety and Manufacturing Data
Under the bill as passed by the New York legislature, it will be unlawful to sell or use in food a substance (that is not otherwise exempt) unless a report about the substance's safety has been submitted to the New York Commissioner of Agriculture and Markets and that report has been published on a public database maintained by the Commissioner. The report must include a range of information about the substance, including, but not limited to, scientific data and information, manufacturing details, dietary exposure, self-limiting levels, evidence of common use prior to 1958 (if applicable), a narrative explaining the GRAS conclusion, a list of the generally available data and information the notifier includes in the notice, and all relevant currently-available safety information. If passed, the provisions would become effective 180 days after it is signed into law.
Federal GRAS Reform is Being Considered
There are a number of bills pending in Congress regarding food ingredient oversight, including H.R. 4958 (the Grocery Reform and Safety (GRAS) Act) and H.R. 7291 (the GRAS Oversight and Transparency Act). The GRAS Act would close the "loophole" by requiring a person "responsible" for a substance to submit a notice to the FDA to use any new substance, or for a new use of an existing substance and by requiring the FDA to issue a statement to not object to that notice (if the FDA does object, the person cannot use the substance). In addition, the FDA would have to reassess a certain number of GRAS substances every three years. The GRAS Oversight and Transparency Act would not directly close the "loophole," but rather would create a Board that would review any self-affirmed GRAS substances that were made prior to the year 2000. These and other bills about the U.S. food system were the subject of a House Committee on Energy & Commerce hearing titled "Healthier America: Legislative Proposals on the Regulation and Oversight of Food." One major point of discussion in the hearing was the tension between federal and state action (or inaction) regarding reforms to the food system—with consumer advocates largely calling for more state action (because states ARE taking action to reform the food system) and industry representatives largely calling for federal action (to eliminate the legal and logistical challenges of needing to meet different requirements in different states, when many food products are sold across the U.S.).
It seems most likely that states will continue to act faster than the federal government (Congress or the relevant agencies) in making reforms to the food system. For companies that sell food in multiple states, the patchwork of requirements created by state legislating presents logistical and legal challenges. For those food and beverage companies that use GRAS substances as an ingredient or as part of the manufacturing process, it is worth keeping tabs on the evolving landscape.
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Alli Condra is of counsel in the food + beverage group in the Portland office of DWT. For questions or more insights, please reach out to Alli or another member of our food + beverage team and sign up for our alerts.