FDA Settles FSMA Lawsuit Related to High Risk Foods

Brian German Agri-Business, Regulation

high-risk foods

The U.S. Food and Drug Administration (FDA) will now be designating certain items as high-risk foods after being sued by the Center for Food Safety (CFS) and the Center for Environmental Health (CEH) last fall.   The lawsuit centered on statutory deadlines put forth in the Food Safety Modernization Act (FSMA) which require FDA to assign particular foods with a high-risk classification. The items deemed as having a higher risk would be required to keep more extensive records in the interest of public health.

By September 2020 the FDA will produce the list of foods considered high risk and what special recordkeeping requirements will be necessary for the facilities that handle them.  As part of the settlement, FDA has also agreed to go beyond the original FSMA traceability requirements by issuing a final rule that includes the requirements for recordkeeping by November 2022.  As per the rules put forth under FSMA, the FDA was originally supposed to have designated which foods were high risk by 2012 and have the recordkeeping requirements developed by 2013.  The purpose is to increase the level of food traceability to address any type of food-related outbreak with more expediency.

The FDA takes several factors into consideration when making the designation of high-risk foods.  Known safety risks, which includes a history of foodborne illness outbreaks, as well as the likelihood for contamination are included in the FDA’s decision-making process.  The health and economic impact of an outbreak related to a particular food are also weighed.

It was not the first time that FDA has been sued in relation to FSMA deadlines.  CFS had brought suit against FDA previously after original deadlines had come and gone without action.  Following the most recent settlement, the FDA has indicated that it is already in the process of drafting a rule proposal and with plans for public meetings to offer stakeholders an opportunity to provide feedback.

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Brian German

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Ag News Director, AgNet West