The U.S. Food and Drug Administration (FDA) recently announced that it will not begin inspecting food facilities until March 2020 to verify compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration regulations at 21 C.F.R. part 121, also known as the Intentional Adulteration (IA) rule. FDA has determined this additional time is necessary due to the novel nature of the rule and to provide more lead time for food companies to develop their food defense plans. Additionally, FDA is still in the process of developing guidance, tools, and training for the industry.

The IA rule, issued under FDA’s Food Safety Modernization Act (FSMA) authority, is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread public health harm. Under the rule, food facilities are required to develop and implement a food defense plan that identifies significant vulnerabilities and mitigation strategies that address those vulnerabilities, as well as ensure those mitigation strategies are working. The first compliance date for the IA rule is July 26, 2019 for certain food facilities.

What to Expect During Initial Inspections

Similar to other FSMA rules, FDA plans to “educate while we [FDA] regulate” during the initial compliance inspections for the IA rule. This means that routine FDA inspections after March 2020, such as those already-scheduled to verify compliance with Preventive Controls for Human Food, Juice HACCP, Seafood HACCP, or other regulatory programs, will include a food defense plan “quick check” to verify that the facility has met the basic requirements of the IA rule. This quick check will include questions such as “Do you have a food defense plan?” and an inspector providing educational materials regarding the IA rule. This could later lead to a more comprehensive food defense inspection as FDA further develops its inspection program for the IA rule.

Guidance for Industry

To assist with compliance for this novel regulation, FDA has issued two parts of a three part guidance document that covers topics such as:
• The components of the food defense plan,
• How to conduct a vulnerability assessment using three different approaches,
• How to identify and implement mitigation strategies,
• Food defense monitoring requirements, and
• Guidance on Education, training, and experience requirements.
When complete, the guidance document is intended to be a resource that will assist the food industry in implementing the IA rule. FDA is currently accepting comments on this draft guidance until July 5, 2019.

Want to Learn More?

Husch Blackwell LLP attorney Emily Lyons is presenting alongside FDA officials at the International Dairy Foods Association’s annual Regulatory RoundUp on June 5, 2019 in Washington, DC on the IA rule. This session will offer food manufacturers, especially those in the dairy processing industry, a chance to better understand the IA rule as well as how to address key compliance issues.

Contact Us

Husch Blackwell has experience working with food manufacturers in complying with FDA regulations, including the IA rule, and has members with the required scientific and technical backgrounds to assist companies with compliance. Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney.