Track & Trace

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.

click for large version

Figure 1. A good rapid microbial method can help you detect contamination before your product leaves the warehouse.

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.

click for large version

Table 1. Distribution of 125 Primary RFR Entries by Commodity and Food Safety Hazard September 2009–March 2010 RFR Commodities Definitions

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;
• Salmonella;
• Undeclared allergens and intolerances;
• Uneviscerated fish; and
• Other.

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.”