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From: Food Quality & Safety magazine, June/July 2011

Track & Trace

Understand how to comply with the requirements of the FDA Reportable Food Registry

by Scott Scdoris

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.

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

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

Why RMMs?

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 sscdoris@celsis.com.

Key Steps to Ensure Compliance and Avoid Contamination Events

Dairy time to results with the traditional agar method, top, versus the Celsis ATP test method.
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Dairy time to results with the traditional agar method, top, versus the Celsis ATP test method.

1. Do everything you can to ensure the safety of your products before they leave your facility. You probably feel pressure to get your products out the door as quickly as possible. This may mean you’re releasing lots from your facility before all quality testing is complete. Some people call this the “ship and pray” method. You ship your products and then test the lots that have already left your site, knowing that 99% of the time they will be clean and you won’t have a problem. But what happens when there is a problem? Although your products are clean most of the time, if there is a contamination event and your products have left your facility, they must be reported to the FDA and recalled—whether they are on trucks moving around the country or, even worse, on shelves and in the homes of your consumers.

While the FDA requires reporting on all contaminated products that leave your facility, it does not require contaminated products to be reported if they have not yet left the plant, because they do not pose a risk to consumers if they never leave your facility. This makes it all the more important to test your products before releasing them.

2. Employ rapid microbial testing methods. Of the 125 contamination incidents reported through the RFR during its first testing period, which ended last year, 15% were microbial in nature.

This statistic can be reduced through the adoption of fast, reliable testing methods. While traditional microbial testing methods can add four to 14 days to your production cycle, a Celsis Rapid Detection system provides reliable microbiological quality results in just two to five days. By removing days from your product screening process, you will be able to hold each lot until you have confirmation that it is free of microbiological contamination, preventing the need for a recall.

While the FDA requires reporting on all contaminated products that leave your facility, it does not require contaminated products to be reported if they have not left the plant.

3. Ensure that your solution includes robust record-keeping technology. Complying with the RFR—and having the appropriate microbial testing in place to ensure your products are safe when they leave your facility—isn’t enough. As mentioned earlier, you may be required to provide records to the FDA even if you have previously tested your products and confirmed that they were clean when they left your plant. In addition to the RFR, the FDA enforces specific regulations in its guidelines on the Establishment and Maintenance of Records (EMR), which includes the source of your ingredients as well as what happens to your products once they leave your facility.

The FDA’s regulations on the EMR require a detailed list of information, including, but not limited to, the name and contact information for the source of each ingredient, dates ingredients were received, quantity and type of packaging of these ingredients, details about the transportation companies that delivered ingredients to you and transported products to your recipients, dates your products are released, and more. These records must be created for all lots you manufacture, held for as long as two years, and kept well organized so that you are able to provide them to the FDA in the event of a contamination at any point in the production cycle.

These regulations can be overwhelming for food and beverage manufacturers, but help is available. Although one of the primary benefits of RMMs may be increasing the speed at which you can release your products safely, they can also provide valuable assistance in complying with FDA record-keeping requirements.

For example, advanced RMMs like the Celsis Rapid Detection system include a fully customizable database that allows for storage of records related to quality micro testing and provides query and reporting capabilities that can make accessing specific data quick and easy. The databases allow results to be exported as Excel files to facilitate simple data sharing, and can even be configured for remote access. Results are secure and protected; the database can be installed on a networked server, allowing for scheduled backup. Additionally, the software that supports the Celsis CellScan Innovate system used for dairy, food, and beverage products, called Innovate.im, supports you in your efforts to comply with 21CFR through features like password security, protected data, easy search capabilities, report exporting, record logging, and more.

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