In March of 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.
About the IA Rule
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:
- Acts of terrorism on the nation’s food supply.
- Acts by disgruntled employees, consumers or competitors.
- Economically motivated adulteration — the deliberate adulteration of food that is motivated by greed or a political agenda.
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.
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.
- Very small businesses (including any subsidiaries and affiliates) averaging less than $10 million in food sales per year must comply with modified requirements within five years after the publication of the final rule.
- Small businesses with fewer than 500 employees must comply four years after the publication of the final rule.
- Other businesses that aren’t considered small or very small and don’t qualify for exemptions must comply three years after the publication of the final rule.
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.
Resources for Businesses
- FSMA Final Rule on Intentional Adulteration
- Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
We understand that you and your clients might have questions regarding food safety, food recalls, and updates to the FSMA’s IA rule. At Worldwide Facilities, we are committed to staying informed and providing the resources that our retail brokers need during this challenging time.