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Tip of the Week: Understanding Effective Date, Compliance Date, and Enforcement Date for FSMA’s Intentional Adulteration Rule
Tip of the Week: Understanding Effective Date, Compliance Date, and Enforcement Date for FSMA’s Intentional Adulteration Rule

We’ve been getting many questions about the different dates the FDA has published for the FSMA Intentional Adulteration Rule. This FAQ addresses the differences and what they mean. If you need more help, please send us an email for assistance.

What is the Intentional Adulteration Rule?

This Rule, formally known as Mitigation Strategies to Protect Food Against Intentional Adulteration, is aimed at preventing intentional adulteration from acts intended to cause harm to public health. Commonly, food facilities refer to this as their Food Defense Program.

Assistance with understanding the requirements of the legislation and developing a compliant program are available through the FDA and through AIB International.

What is the effective date for the Intentional Adulteration Rule?

The effective date for the IA Rule was July 26, 2016. This refers to the date that the final version of the Rule was published in the Federal Register. It is also the date that triggers the countdown for compliance.

What is the compliance date for the Intentional Adulteration Rule?

Compliance dates refer to the date at which the facility is required to have a compliant program in place. As with other FSMA Rules, the Intentional Adulteration has staggered compliance dates based on business size.

The compliance dates for the Intentional Adulteration Rule are:

Business Size Time from Effective Date Date
Very Small Business (<$10MM/yr) 5 years July 27, 2021
Small Business (<500 employees) 4 years July 27, 2020
All Other Business 3 years July 26, 2019
When will FDA begin inspections for compliance?

Historically, the compliance date and the enforcement dates are the same. However, the FDA has stated that they will not begin inspections for the Intentional Adulteration Rule until March 2020. This means that routine visits specific to the Rule will not take place before this date. However, when enforcement begins, the FDA Investigators will be looking for evidence that a compliant program has been in place since the compliance date.

In addition, while routine visits for the purpose of evaluating compliance to the Intentional Adulteration rule will not begin until March 2020, if there is an incident that is traced to non-compliance to the Mitigations Strategies to Protect Food Against Intentional Adulteration Rule, the food business will be held accountable.

How is AIB International addressing the gap between compliance date and enforcement date in its proprietary inspections against the AIBI Consolidated Standards?

AIB International has maintained requirements for a Food Defense Program within its Consolidated Standards for more than 15 years. Inspections will continue to assess for compliance to these requirements. Additionally, AIB International has adopted a step-wise approach to align with the FDA in evaluation of any requirements that are unique to the regulation, during inspections up until March 2020, Food Safety Professionals (auditors) will review current IA requirements for FDA-regulated facilities that are subject to the Intentional Adulteration Rule. The following items will be reviewed;

Food Defense Plan

  • a. Vulnerability assessment (KAT, three elements, or hybrid) conducted by a Food Defense Qualified Individual (FDQI).
  • b. Mitigation Strategies of Actionable Process Steps (if identified) conducted or developed by FDQI
  • c. Management components
    • i. Food Defense Monitoring conducted by Qualified Individuals (QI)
    • ii. Food Defense Corrective Actions conducted by QI
    • ii. Food Defense Verification Activities conducted by QI
  • Training records
  • Re-evaluation as required conducted by FDQI

Between July 26, 2019 and March 1, 2020, AIB International is assessing each site’s Food Defense Program and compliance to the IA Rule. Gaps between the site’s program and elements that are already covered by the AIB International Consolidated Standard are documented in the report and rated according to AIBI established rating criteria. Gaps between the site’s program and any elements that are unique to the IA Rule, are documented in the report, but are not being rated.

Beginning on March 1, 2020, any gaps identified between the program of facilities for which compliance dates have passed and the entire Rule will be documented and rated accordingly. Prior to March 1 2020 AIBI will communicate how this process will be rated.

Where can I get more information about the Intentional Adulteration Rule and AIB International Inspections?

Contact us at info@aibinternational.com.








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