FSMA High Risk

Does your company make “High Risk Food” (HRF)? How does the FDA decide if you are a HRF and how will does that effect the number of inspections the regulators intend to do? The draft FDA methodology for identifying HRF as it relates to the Food Safety Modernization Act (FSMA) can be viewed online

In the meantime, let’s consider these two main factors that dictate if you’re a HRF:

  • Does your type of product have Class 1 recalls (significant health consequence)?
  • What does your regulatory compliance history look like?

Take a look at the FDA’s 4th Annual Reportable Food Registry (RFR) report and look up your type of product to see how often your product type was subject to recalls online.

Take a look at the figure 2 pie chart on page 12. You may be surprised that 90% of the recalls are for undeclared allergens and pathogenic bacteria, specifically Salmonella and Listeria. In addition, please note that the number of recalls due to foreign objects is one-half of 1%. As you can see, many companies put a great deal of time and effort into controlling foreign material when in fact undeclared allergens and pathogens are the most likely reason for recalls.

To summarize, you can be classified as a HRF if you manufacture a food product that has a history of recalls and/or your facility does not have a good compliance history, i.e. you’ve been cited for “violative” or “unsanitary” conditions whereby product is or “may have” become contaminated as defined by Food Drug & Cosmetic Act sections 402 (a) 3 and 402 (a) 4.

If your company makes a HRF or has a history of regulatory citations you can expect to be inspected at a minimum of three years by the State or FDA inspectors. If your food type is not viewed as a HRF and you have a good compliance history, the frequency would be seven years.

For more information on how the seven FSMA rules apply to your company, visit the AIB Food Safety Hot Spot for webinars, FDA recognized training for Preventive Control Qualified Individual(s), FSMA regional courses and 5 Easy Steps to a FSMA Ready Facility!

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