What clients should know about FSMA rule to protect food from harm

Food facilities are now required to establish mitigation strategies against intentional adulteration meant to harm public health.

The FDA says the “final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.” (Photo: Shutterstock)

In March 2020, the Food and Drug Administration’s Food Safety Modernization Act (FSMA) implemented intentional adulteration provisions through a rule titled “Mitigation Strategies to Protect Food Against Intentional Adulteration,” adding several new sections to the Federal Food, Drug, and Cosmetic Act.

The FSMA’s Intentional Adulteration (IA) rule was created to address intentional acts whose objective is to cause widespread harm to public health. The IA rule differs from other FSMA rules in that instead of targeting specific foods or hazards, it requires mitigation strategies for processes in certain registered food facilities that are determined to be significantly vulnerable to intentional adulteration.

What are intentional adulteration acts?

An “intentional adulteration act” is defined as an act intended to cause wide-scale public health harm associated with intent to cause significant human morbidity and mortality. Examples of intentional adulteration include:

Strategies for protecting food products

According to the FDA, the first step for those who are subject to IA requirements is to identify specific vulnerabilities at their facility. Next, they must be proactive and implement mitigation strategies, mitigation strategy management components, and a systematic approach to their food defense program to protect food from intentional adulteration intended to cause wide-scale public health harm.

Compliance dates

As of May 2020, the FDA has established deadlines for facilities to comply with the IA rule. Businesses are encouraged to review the FDA website for additional compliance requirements and updates.

FDA Issues a constituent update on the IA rule

In February of 2020, the FDA released the third and last installment of the IA rule that includes topics focused on food defense corrective actions, food defense verification, reanalysis of food defense plans, and record-keeping; it also includes appendices on the FDA’s online Mitigation Strategies Database and how a business can determine whether it is a small or very small business under the rule.

However, in May of this year, the FDA granted an extension of the rule until Aug. 14, 2020, in response to a request to allow interested persons additional time to submit comments and provide feedback. Businesses can submit comments electronically or in written/paper form. Visit the Federal Register website for information on submitting comments.

David Fiske (dfiske@wwfi.com) is a senior vice president, and Lori Hunter (lhunter@wwfi.com) is an executive vice president at Worldwide Facilities, a national wholesale insurance broker, managing general agent and program underwriter.

This article first appeared on Worldwide Facilities’ blog and is republished here with the authors’ consent. 

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