FDA Has Started to Enforce the New IA Rule. So Now What?

While the FDA began enforcing its new FSMA intentional adulteration rule on March 1, the rule actually went into effect months earlier. Earl Arnold, manager of food defense/FSMA, operations and quality assurance at AIB International, said the FDA agreed to delay inspections until this month to allow for more complete training materials.

“While most facilities were still required to initiate their plans on July 26, 2019, the FDA only conducted ‘quick checks’ beginning in March that focused on education,” said Arnold. “However, the FDA may still ask for records or plans confirming your compliance date.”

This is the first time the FDA has required this Food Defense Plan and training component. Now, Food Defense Qualified Individuals (FDQI) are required to:

• Conduct or oversee the development of the vulnerability assessment
• Develop mitigation strategies
• Develop a Food Defense Plan
• Review the Food Defense Plan

The regulation also states that facilities must train Qualified Individuals on mitigation strategies and specifically on their implementation and documentation. This may include:

• Food defense monitoring
• Food defense corrective actions (when deviation occurs in a mitigation strategy)
• Food defense verification activities

In preparation for inspections, we recommend all personnel participate in food defense training. A great option is our upcoming Intentional Adulteration Prevention Week seminars. While April’s session in Chicago is sold out, you can still enroll for Seattle in August, or Washington, D.C., in October. For a limited time, receive a 20% discount for the Seattle and Washington, D.C. seminars, with the code EARLY20.

For training without travel, we’re also offering our Food Defense Coordinator seminar on April 15-16 through Virtual Classroom. This course represents the current industry thinking and best practices on food defense.

If you’d like to register more than one individual in either of these seminars, email us at info@aibinternational.com.

The FDA also recently released the Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration, which you can learn more about in our blog “4 Highlights from FDA’s Supplemental Draft Guidance for the Intentional Adulteration Rule.”

You will find additional insight in the “Scoring Observations for the New Intentional Adulteration Rule” webinar presented by AIB International’s Earl Arnold.   

For more information, please contact us at info@aibinternational.com.