Risk Based Food Defense Plans – New FSMA requirement

Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR 121) is the newest part of Food Safety Modernization Act. This rule is called for short “Intentional Adulteration or IA Rule”

Regulation requires that Food Defense Qualified Individual develops and implements a risk-based Food Defense Plan.  This concept of food defense is different than what the industry is used to based on 3rd party audit requirements including GFSI.  Under GFSI concept food defense focuses on physical security of food facilities. Here, the company analyzes operations to assess potential for contamination at every step of the process.

Intentional Adulteration rule mandates risk-based food defense plans developed with using HACCP method. Here is a brief overview of requirements:

  • Companies must have a Qualified Individual. Rule requires that Food Defense Qualified Individuals complete training in development of risk-based food defense plans according to standardized curriculum recognized by FDA. Once of those classes is IAVA course (intentional Adulteration Vulnerability Assessment) offered by BD Food Safety Consultants LLC.
  • Qualified Individual must conduct vulnerability assessment that considers 3 elements – a) The potential public health impact (e.g., severity and scale) if a contaminant were added; (b) The degree of physical access to the product; and (c) The ability of an attacker to successfully contaminate the product.
  • Based on vulnerability assessment, QI must identify Actionable Process Steps (APS) for significant vulnerabilities.
  • Each APS must have management components such as monitoring, corrective actions, verification, and records.

Compliance dates for IA Rule were in July 2020 and July 2021. FDA is expected to start regulatory inspection beginning of 2023. As a business you should revise your current food defense system to account for new standard.

At BD Food Safety Consultants LLC, we recognize that some smaller businesses may not have sufficient resources to meet these requirements. Our consulting team can assist your company in development and implementation of risk – based food defense plan. Contact us today at https://bdfoodsafety.com/contact-us/