FSMA Intentional Adulteration Final Rule – US FDA Mitigation Strategies Update

This week afforded us another excellent installment of the webinar series with US Food and Drug Administration (FDA) experts. A further discuss of the Intentional Adulteration (IA) Rule was very informative. The focus of this call was Mitigation Strategies.

I thought I would highlight some important take-aways that I made note of and that may assist my Food Defense colleagues out there who missed this call.

  1. The FDA outlined several Key Terms with very specific meanings in the IA world worth noting:
    1. Vulnerability – The susceptibility of a point, step or procedure in a facility’s food process to IA.
    2. Significant Vulnerability (SV) – A vulnerability that, if exploited, could reasonably be expected to cause wide scale public health harm.
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Protecting Food Against Intentional Adulteration



The Food Safety Modernization Act (FSMA) Final Rule provides us with guidance and law related to protecting food from intentional acts of contamination. To prevent an act of intentional adulteration (IA) that could cause harm to the public on a large scale, the FDA is implementing risk-reducing strategies to combat IA, as detailed in a recently required Food Defense Plan.

Strategies to build this plan include:

  • Vulnerability Assessment
  • Mitigation Strategies
    • Monitoring
    • Corrective Actions
    • Verification
  • Training and Record keeping


The Vulnerability Assessment is the major starting step in the process.… Read More

Food Defense Plans, Do You Have Yours?

As part of the Food Safety Modernization Act and the Rule – Mitigation Strategies to Protect Food Against Intentional Adulteration, you may be required to have a Food Defense Plan in place, are you prepared?  There are very specific sections that must be included in your plan and the plan should be developed both from a corporate level as well as at each facility.  It is important that not only do you develop a Food Defense Plan but that it is reviewed and revised on at least an annual basis.  Some key sections that must be included in your plan are Product Recall, Physical Security, IT Security, Emergency Contact Information and Facility Layouts.… Read More

FSMA Compliance Date Changes – Does It Impact You?

On 8/23/16, the Food & Drug Administration announced changes to their timelines and compliance dates for the Food Safety Modernization Act.  We encourage each company to visit the FDA’s website to determine if you are impacted by these changes.  PRS can assist you and your company with the review and assessment of your Food Defense Program, develop your program and provide approved training.

The FDA has already begun with the issuance of it’s guidance tools that will assist the end users of the Act and supporting Rules.

 … Read More