FSMA Intentional Adulteration Rule Deadline Approaches - Are You Ready?

On July 26th 2019 the FDA Food Safety Modernization Act (FSMA) final rule on Intentional Adulteration (21 CFR Part 121) becomes effective for large businesses (>500 employees and $10M).

Are you ready?

Food Defense became a front-and-center concern for U.S regulatory agencies after the 9/11 attacks and the subsequent passing of the Bioterrorism Act of 2002. As the food safety leader for a major DOD contractor, I was part of a multi-discipline team with DOD, CDC, FDA, USDA and industry to conduct a risk assessment on the military ration supply chain. Learnings from this assessment were incorporated into the FSMA final rule.

The essential part of this rule is that a food establishment must have a fully implemented and effective Food Defense Plan. Like most FSMA elements, the available guidance can be pretty confusing. I’ve worked with a number of establishments and have seen everything from extortion and theft to natural disasters included. What’s really necessary is a rational assessment and mitigation plan to prevent intentional adulteration of the food, very similar to the Food Safety plan to prevent accidental adulteration.

Here’s a relatively simple and straightforward approach:

  1. Establish a food defense team with leaders from key functions - production, maintenance, quality, safety, HR, IT - perhaps this is already in place for food safety.

  2. Gather existing food safety (HACCP/ HARPC) and facility layout documents.

  3. Conduct on-the-floor assessments to determine where the facility, process and product are vulnerable and/or accessible to “bad actors”.

  4. Implement remediation plans for those areas where the vulnerability + accessibility rankings are highest (use the 80/20 rule).

  5. Document the assessment and reevaluate annually.

Provided the major risks have been mitigated, this should satisfy the FDA inspector who undoubtedly will be checking on the implementation of the final rule during your next routine or for-cause inspection.

Please contact me to discuss this approach further and for assistance in developing your site-specific Food Defense Plan.