The IAFP Food Defense PDG heard a regulatory update on the
Intentional Adulteration (IA) Rule at the annual meeting in Toronto.
Colin Barthel, a policy analyst at FDA (FDECS, OAO, CFSAN) discussed the status of ongoing Food Defense Plan Quick Checks, the Food Defense Plan Builder version 2.0, and what’s next for future full Food Defense Plan inspections.
Food Defense Plan Quick Checks have been occurring during Food Safety (Preventive Controls) inspections conducted by FDA since October 2020. Inspectors assess if a firm is subject to the IA Rule and conduct a visual inspection for presence or absence of a Food Defense Plan. Currently, about 1,000 Quick Checks have been conducted with 70% occurring at domestic facilities and 30% at foreign facilities. Sixty percent of facilities have used the Key Activity Types to conduct their vulnerability assessment while 5% of facilities did not do a vulnerability assessment or have a Food Defense Plan in place.
The Food Defense Plan Builder version 2.0 is a user-friendly tool available to help owners and operators of a food facility to develop a food defense plan that is specific to their facility and meet the requirements of the IA Rule. It has been downloaded 11,489 times. This is more than the estimated 10,000 registered
domestic facilities revealing that many others are also finding this tool useful. The FDA is accepting feedback on the Food Defense Plan Builder version 2.0 for use in updating a future version.
Next steps for FDA involve developing a Food Defense Inspection Team to begin conducting full Food Defense Plan inspections in the next fiscal year. A supervisor for the team was hired and five investigators are to be trained over the next 12 months to conduct full inspections. The FDA identified 25-30 factors that will be used to identify facilities that will be prioritized for full inspection. Currently, all FDA inspections are transitioning to be unannounced. Violations occurring in full Food Defense Plan inspections will be handled as they are for Preventive Controls inspections; they will begin with a FDA form 482 and end with a FDA form 483 being issued.
IA Rule regulatory requirements for covered facilities include the need for a Food Defense Plan. Components of the Plan are a vulnerability assessment; implemented mitigation strategies; documented monitoring activities, corrective actions, and verification procedures. Training and recordkeeping are also requirements. More information is available on FDA’s website. The Food Defense Plan is overseen by a Food Defense Qualified Individual. Training developed to align with regulatory requirements is available from FSPCA.
Resources to assist industry comply with the IA Rule include:
