The U.S. Food and Drug Administration (FDA) has launched an updated version of the Food Defense Plan Builder to help companies meet the requirements of 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.

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.

While not required to be used by the FDA, the updated plan builder has been aligned with the requirements in the IA rule so that it can be used to easily create food defense plans and support compliance with the rule.  FDA will host a webinar to provide stakeholders with a brief demonstration of the Food Defense Plan Builder v. 2.0 and offer a question and answer session about the tool on October 10, 2019 at 1 p.m. eastern time.

The first compliance date for largest facilities subject to the IA rule was July 26, 2019.  Earlier this year the FDA announced that inspections would begin in March 2020 to allow industry time to revise their food defense plans as appropriate with forthcoming FDA guidance, training, and tools.

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.