FDA to verify Intentional Adulteration rule compliance in 2021

In 2019, the U.S. Food and Drug Administration (FDA) announced that inspections of large businesses under the Intentional Adulteration (IA) rule would begin in March 2020 following a compliance date of July 2019. However, the COVID-19 pandemic required the FDA to postpone most routine inspections. As a result, the FDA announced they would halt all routine on-site surveillance inspections in the U.S. until March 2021. This was in an effort to verify a facility’s compliance with the FDA Food Safety Modernization Act’s IA rule.

According to the FDA, routine inspections for facilities covered by the IA rule will consist of a food defense plan “quick checks” during regularly scheduled food safety inspections. These quick checks will consist of 10-minute conversations that will allow the FDA to verify the facility has satisfied the basic requirements of the IA rule. This will also provide an opportunity to educate facilities. During the quick check, the FDA inspector will begin by asking the facility owner or operator a series of questions that may include whether the facility has a food defense plan in place. The inspector may also ask questions based on the IA compliance rule.

For businesses that aren’t familiar with recent updates regarding the IA compliance rule, the following are some important need-to-know facts and dates:

• The IA rule applies to facilities and producers who are not under other FSMA rules. However, operations that produce juice, seafood, water, dietary supplements or infant formula will be required to comply with the IA rule.
• Small businesses with fewer than 500 full-time employees were required to comply by July 27, 2020, but now, small-business inspections will not begin until March 2021.
• Small businesses with sales averaging less than $10 million during the previous three-year period are exempt from most requirements (with sales or market value of human food during the previous three-year period averaging less than $10 million), but starting July 26, 2021, they must provide documented proof that they meet the exemption.

For more information, insurance agents, brokers, and their clients can access a number of reliable resources that include:

• Protecting the Food Supply from Intentional Adulteration
• Second Installment of Intentional Adulteration Draft Guidance
• Mitigation Strategies to Protect Food Against Intentional Adulteration
• FSMA Final Rule on Intentional Adulteration
• Food Defense Plan Builder

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. 

More from these authors:

• What the FDA has to say about food safety amid COVID-19
• The most notable consumer food and product recalls of 2019
• Product refusal of coverage: Are your clients covered?