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By: Christopher Snabes, TAG Director, Food Safety and IAVA-FDQI Lead Instructor

In July, FDA announced that it would be resuming on-site, prioritized food facility inspections. The inspections would be based on a COVID-19 Advisory Rating system, which uses real-time data to qualitatively assess the number of COVID-19 cases in a local area enabling the FDA to determine when and where it is safest to conduct the inspections. FDA also will continue to conduct for-cause inspections, as it has throughout the pandemic.

Along with the resumption of these inspections, which will be pre-announced, and any for-cause inspections, FDA investigators will be conducting a post-investigative Food Defense Quick Check. All large and small businesses are now required to comply with the food defense requirements of FSMA’s Intentional Adulteration (IA) Rule (see below for compliance notes); but rather than immediately implementing IA Rule inspections, FDA will be using the Quick Checks to “educate while we regulate.” This education period will be made up of 10-minute “conversations”. There is no reference to a specific duration of time the quick check inspections will continue in the future.

So what does a Quick Check “conversation” involve? And what can you do to be prepared?

The purpose of the Quick Check is to verify that the facility has satisfied the basic requirements of the IA Rule. So, the FDA investigator will ask the owner or operator of the facility a series of questions and may provide educational material. While FDA does not have a publication listing all the questions that its investigators could ask, TAG has developed documents to assist the industry in preparing for the Quick Checks.

These include a list of typical questions based on conversations with FDA Food Defense Instructors and experts in the field, and a:

,Potential FDA Quick Check Questions infographic, developed in partnership with SafetyChain.

Typical FDA Quick Check questions include:

  • Do you have a written Food Defense Plan (FDP)? Was it written by a FDQI?
  • Did you conduct a Vulnerability Assessment?
  • Have you identified any KATs?
  • Did you choose the option of using the 3 Key Elements approach?
  • Have you considered the possibility of inside attacker?
  • Have you implemented any mitigation strategies?
  • Has the FDP been signed and dated by the FDQI?
  • Do you have corrective actions in place?
  • How are you verifying your FDP?
  • Have you had a Food Defense Incident? If so, did you contact the FBI?

Similar to this, the Potential FDA Quick Check Questions infographic lists 13 questions in six categories:

  • Food Defense Plan
  • Vulnerability Assessments
  • Internal Evaluation
  • Mitigation Strategies
  • Corrective Actions
  • Prior History

Of course, FDA could ask other questions based on the rule, but being prepared with answers for these, should enable you to answer just about any relevant question the investigator may ask.

A few notes on IA Rule compliance also are important here:

  • The rule applies to facilities and producers who are not under other FSMA rules. If you produce juice, seafood, water, dietary supplements, or infant formula (which are held to other regulations such as Seafood HACCP, Juice HACCP, etc.), you are still required to comply with the IA Rule.
  • Larger businesses were required to be in compliance by July 26, 2019; routine inspections were to begin in March 2020 but were temporarily postponed due to COVID-19.
  • Small businesses, which employ fewer than 500 full-time equivalent employees, were required to comply by July 27, 2020, but small business inspections will not begin until March 2021.
  • Very small businesses (with sales or market value of human food during the previous three-year period averaging less than $10 million) are exempt from most of the requirements, but starting July 26, 2021, must be able to provide documentation to show that they meet the exemption.

Take a look at the questions above and on the Infographic – if you have any concerns or questions, give us a call. We also can assist in your IA Rule compliance efforts, Food Defense Plan, and employee/supervisor or qualified individual training. Contact TAG today!


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