The U.S. Food and Drug Administration held a public meeting to discuss the draft guidance for compliance and implementation of the “Mitigation Strategies to Protect Food Against Intentional Adulteration” rule (Intentional Adulteration rule), which was issued under the FDA Food Safety Modernization Act.
Title: Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry
Date: April 17, 2019
Time: 8:30 a.m. until 2:00 p.m.
Location: Center for Food Safety and Applied Nutrition, Harvey Wiley Building auditorium (first floor), 5001 Campus Drive, College Park, MD 20740
The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. This meeting covered both the first and second installments of the draft guidance which include chapters on topics such as:
- the components of the food defense plan;
- how to conduct vulnerability assessments by
- using the four Key Activity Types method (bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, mixing and similar activities),
- evaluating the Three Fundamental Elements (potential public health impact, degree of physical access to the product, ability of an attacker to successfully contaminate the product), or
- using the Hybrid Approach, which is a combination of the Key Activity Types and Three Fundamental Elements methods;
- how to identify and implement mitigation strategies;
- food defense monitoring requirements;
- education, training, and experience.
This meeting also included a short demo of the FDA’s Food Defense Plan Builder (version 2.0), which will be released later this year.
The first compliance date for large facilities arrives in July 2019.
- Agenda (PDF 116KB)
- Meeting Transcript (PDF 280KB)
- Meeting Presentation (PPT 5.17MB)
- Federal Register notice announcing this meeting
Electronic submissions can be submitted at https://www.regulations.gov and search for docket FDA-2018-D-1398.
Written submissions can be mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.