FDA Releases Third Installment of the Draft Guidance for the Intentional Adulteration Rule

Constituent Update

February 13, 2020

Today, the U.S. Food and Drug Administration released a supplemental draft guidance designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). This is the third and last installment of the draft guidance for the IA rule.

The FSMA final rule on intentional adulteration is aimed at addressing hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

This last installment of the IA rule draft guidance adds to the previously published draft guidance with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. The installment also includes appendices on FDA’s online Mitigation Strategies Database and how businesses can determine their status as a small or very small businesses under the rule. 

Food facilities covered by the rule are required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities are also required to ensure that the mitigation strategies are working by implementing mitigation strategy management components. Compliance requirements for large facilities began in July 2019; inspections will begin in March 2020.

For More Information

• Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
• Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
• Food Defense Plan Builder (Version 2.0)
• Protecting the Food Supply from Intentional Adulteration, Such as Acts of Terrorism
• Food Safety Preventive Controls Alliance (FSPCA) Training Materials and Courses
• FSMA Final Rule on Intentional Adulteration