Food Defense Rule

Food Defense Rule

The Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense) final rule establishes requirements for companies to create a food defense plan, aimed at preventing intentional adulteration from acts intended to cause wide-spread harm to public health, including acts of terrorism targeting the food supply. The final rule primarily covers large companies whose products reach many people, and thus the regulation exempts very small businesses and sets a higher dollar threshold for the definition of very small business than under the other FSMA final rules. The food defense plan must include:

  1. a vulnerability assessment to identify significant vulnerabilities and actionable process steps;
  2. mitigation strategies for identified actionable process steps;
  3. procedures for food defense monitoring of the implementation of the mitigation strategies;
  4. procedures for food defense corrective actions; and
  5. procedures  for food defense verification.

All food defense activities must be documented by the facility and would be subject to FDA inspection.

In an attempt to assist food facilities comply with the Food Defense Plan requirement, FDA identified four “key activity types” that FDA automatically considers significant vulnerabilities. These activities are (1) bulk liquid receiving and loading; (2) liquid storage and handling; (3) secondary ingredient handling; and (4) mixing and similar activities. Instead of conducting its own vulnerability assessment, a facility can meet the requirements of the rule by addressing these key activity types to identify actionable process steps and develop its Food Defense Plan. To learn more about the Food Defense Proposed Rule go to the GMA Resources section below.

Important Dates: The earliest compliance date for most entities will be three (3) years  and sixty (60) days after the final rule is published. For Compliance Periods go to the GMA Resources section below. 

GMA Resources:

In-Depth Analysis of the Food Defense Rule
GMA Comments on the Food Defense Proposed Rule
FSMA Timeline and Milestones
GMA Reference Sheet for FSMA Compliance Dates
GMA Summary Reference Sheet for FSMA Compliance Dates
Hogan Lovells Memorandum

Links to FSMA Documents:

Full Text of the Food Defense Rule
Food Defense PRIA

Links to FDA Resources:

FDA’s Food Defense page
Food Defense Docket

Contact Information: Warren Stone

Disclaimer: The materials on this website are provided for informational purposes only and do not constitute legal advice. GMA does not advise on the application of law to an individual’s or company’s specific circumstances.  Although we go to great lengths to make sure our information is accurate and useful, we recommend you consult a lawyer if you want professional assurance that our information, and your interpretation of it, is appropriate to your particular situation.