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Track & Trace
Understand how to comply with the requirements of the FDA Reportable Food Registry
by Scott Scdoris
What’s scarier than a contamination event? Not properly planning for reporting to the U.S. Food and Drug Administration (FDA) when your product is involved in one. Fortunately, compliance with the FDA Reportable Food Registry (RFR) is easier than you think.
A contamination event is a reality all food and beverage manufacturers must plan for. That’s why it’s critical to have a strategy in place to protect your company’s brand and to get your production line back on track as quickly as possible. While many manufacturers have followed the “ship and pray” method of getting products out to market before they have been confirmed free of bioburden, the recent approval of the new FDA Food Safety Modernization Act has made it more important than ever to have reliable and efficient lean manufacturing practices in place as part of your overall recovery and prevention plan.
The FDA Food Safety Modernization Act, signed into law Jan. 4 by President Obama, aims to ensure that the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. This legislation supports the FDA’s efforts to create a truly integrated food safety system.
An important part of your recovery plan is having a record-keeping system in place and knowing how to retrieve the right records easily. Questions you might ask include:
- How confident is our company in the organization of our records?
- Do we know everything the FDA will require from us if a contamination event occurs?
- How quickly can we compile a report?
Additionally, implementing a good rapid microbial method (RMM) will provide you with the tools to comply with the new FDA Food Safety Modernization Act, as well as the FDA’s RFR, and will provide security and peace of mind as you institute a positive release method.
As part of the RFR, the FDA requires manufacturers to report any products that have left the plant that could potentially cause illness to consumers. These reports are made through an electronic portal, opened by the FDA in September 2009. Reports must be submitted to the FDA within 24 hours of realizing that a contaminated product has left your facility. These reports may be primary, meaning that you notify the FDA that your product has been contaminated, or subsequent, meaning that you are reporting contaminated products received from a supplier.
Likewise, your recipients could report that products received from you are contaminated in some way. Because of this requirement, even if you are confident that all products leaving your facility are clean and contamination-free, you may need to produce detailed records of your quality testing for the FDA.
While the RFR adds work for manufacturers, it was mandated by Congress to help the FDA better protect consumers by tracking patterns of food and beverage adulteration and by targeting the agency’s limited inspection resources. The first reporting period of the RFR was September 2009 through March 2010 (see Table 1). During this time, 125 contamination incidents were reported across 25 commodities and fell into seven categories of contamination:
- E. coli;
- Foreign object;
- Listeria monocytogenes;
- Undeclared allergens and intolerances;
- Uneviscerated fish; and
Additionally, the RFR collected a subsequent 1,638 reports from recipients of these declared foods and ingredients.
“Industry is increasingly detecting contamination incidents through its own testing,” said FDA Deputy Commissioner for Foods Michael Taylor recently in a statement regarding the success of the RFR. “FDA access to this information permits us to better target our inspection resources and verify that appropriate corrective measures have been taken.”
In addition to reducing your production cycle by several days, allowing you to further ensure the quality and safety of your products before they are released, RMMs also simplify and streamline your record-keeping process. These significant benefits also contribute to lean manufacturing practices, including reduced working capital requirements due to shortened cycle times, improved return on invested capital, and minimized warehouse space requirements.
Recipients of your products can report that they were contaminated in some way. Even if you are confident that all products leaving your facility are clean and contamination-free, you may need to produce detailed records of your quality testing for the FDA.
If you are involved in a contamination event, the right RMM system can help you not only report the incident to the FDA quickly and accurately, but also physically recover from the event faster. The rapid results provided by RMMs mean you can detect contamination earlier in the process, while your product is still in your warehouse (see Figure 1). This allows you to identify the source of the contamination, take corrective action, pull the affected products before they are released into distribution, and get your production cycle back up and running, all at a much higher speed than traditional methods.
Planning for a potential contamination event keeps you ready for the unexpected. Whether you are new to the idea of RMMs or already have a rapid microbial detection system in place, take time today to make sure you are ready for that request for records from the FDA. Investigate the different features of RMMs and see how they could help you get your products to your customers quickly and safely—while reducing your chances of ever having to submit a report to the RFR.
Look at your record-keeping system and think about how a more secure, organized system could simplify your compliance with track-and-trace requirements. You can’t always predict when you might get that dreaded notice from the FDA, but RMMs can help you establish a strong program today that helps your company respond in the fastest and best way possible.
Scott Scdoris serves as director of food and beverage for Celsis Rapid Detection. Experienced in microbiological testing procedures for the dairy and beverage industry, he has been with Celsis for more than 10 years and works closely with Celsis’ business development managers and technical support representatives to help prospective customers successfully implement rapid methods. He can be contacted at firstname.lastname@example.org.