New Heavy Metal Legislation Proposed in Senate

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Senators Propose Heavy Metal Legislation with Product Testing Requirements

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Wednesday, May 22, 2024

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Earlier this month, Senators Amy Klobuchar and Tammy Duckworth announced the introduction of legislation (the “Baby Food Safety Act of 2024”) intended to increase the safety of certain foods, including baby and toddler foods, with respect to heavy metals and other contaminants.
In particular, the legislation calls on FDA to establish, through an administrative order process:
- Limits for arsenic, cadmium, mercury, and lead in infant and toddler food (defined to include any food marketed for children up to 24 months) as well as food pouches made with fruit or vegetable juice or puree.
- Limits for arsenic and lead in juice. We note that FDA has previously published draft action levels of 10 ppb lead in apple juice and 20 ppb lead in all other juice.
Proposed limits are required to be issued by December 31, 2025, for arsenic and lead, April 30, 2026, for cadmium, and April 30, 2028, for mercury.
The legislation would also require facilities manufacturing infant and toddler food, pouches with fruit or vegetable juice or puree, or juice to develop a control program for these contaminants (consistent with HARPC, or HACCP for juice, and with the mitigation against intentional adulteration regulations) and sample and test such contaminants pursuant to a sampling plan, the contours of which are to be set forth in a future FDA guidance (the sampling and testing requirements would not apply until 2 years from the date of enactment). Among the other provisions is a requirement that manufacturers of infant and toddler food develop an environmental monitoring program to monitor for the presence of environmental pathogens and heavy metals.
The proposed legislation also includes a broad preemption provision which prohibits any state from implementing legislation which is “different from, or in addition to, or not identical to” the provisions of the legislation.
If enacted, this would represent the first mandatory testing requirement for finished food products. We will continue to monitor and report on developments regarding this legislation.