FDA Extends Comment Period for Third Installment of the Draft Guidance for the Intentional Adulteration Rule
May 27, 2020
The U.S. Food and Drug Administration is extending the comment period for the third installment of the draft guidance designed to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule under the FDA Food Safety Modernization Act (FSMA).
The Agency released the third installment of the draft guidance in February 2020. Since that time, FDA has received a request for extension to allow stakeholders sufficient time to provide comprehensive feedback. The comment period will be extended until August 14, 2020.
This last installment of the IA rule draft guidance adds to the previously published revised draft guidance. Chapters in the last installment cover topics focusing on food defense corrective actions, food defense verification, reanalysis of food defense plans, and recordkeeping; it also includes appendices on FDA’s online Mitigation Strategies Database and how a business can determine if it is a small or very small business under the rule.
Comments can be submitted electronically via Regulations.gov to docket FDA-2018-D-1398.
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- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
- Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration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)
- Food Safety Preventive Controls Alliance (FSPCA) Training Materials and Courses