Investigating Foodborne Illness Outbreaks: The FSMA Process

As we covered in an earlier post, consumer groups who are upset about the unresolved outbreak of E. coli related to romaine lettuce have demanded that failures in the FDA traceability process be repaired before the end of the year. In this follow-up post, we’ll take a closer look at this process as required by the Food Safety Modernization Act (FSMA) passed in 2011.

Trace Back and Trace Forward Investigations

Once an outbreak is confirmed, city and county agencies will mobilize to investigate local events. If the outbreak is eventually reported in more than one city or county, the state’s health department works with the state department of agriculture to expand the scope of the investigation. When the outbreak affects more than one state, the Centers for Disease Control and Prevention (CDC) takes the lead, and often collaborates with the Food and Drug Administration (FDA), the USDA’s Food Safety and Inspection Service (FSIS), And the Environmental Protection Agency (EPA).

Public health officials track the contaminated food product back to its original source, as well as its movement forward along the food chain. This bi-directional perspective is important for understanding which geographic markets require product recalls.

A traceback analysis compels investigators to act as both detectives and scientists, identifying the pathogen itself, the food or foods it has infected, and the point of origin at which it first contaminated the supply chain. In short, traceback efforts attempt to find out how, where, and why an outbreak occurred. Investigators test victims who have become ill to discover which pathogen is involved, as well as interview them to help determine which foods may be involved and where they were purchased or consumed.

Next, a trace-forward analysis is conducted to identify the pathways of exposure along the chain, so that further contamination can be prevented. Processors, packagers, distributors, retail outlets, and restaurants are interviewed to gain an understanding of how they may have handled the product. This process involves collecting, reviewing, and analyzing hundreds – if not thousands – of invoices and shipping documents. The success of a food recall will be only as good as the documentation that leads the investigation in the right direction.

Connecting Foodborne Illness Cases to Detect Outbreaks

Introduced in 1995, the CDC’s PulseNet is a national laboratory network that connects foodborne illness cases to detect outbreaks. Using whole genome sequencing (DNA fingerprinting) of the suspected pathogen, the CDC can then enter it into its massive PulseNet database and compare it to all similar illnesses across the country. Three types of data are analyzed:

1. Epidemiologic Data: Patterns of patients who reported eating or shopping at a common location.
2. Traceback Data: A common point of contamination in the distribution chain from farm to fork, based upon the epidemiologic patterns.
3. Food and Environmental Testing Data: The pathogen causing the foodborne illness found in a food item collected from a sick person’s home, a retail location, or along the production, packaging and distribution chain.

By assessing this data, health officials can better pinpoint the time and place of outbreaks, and then issue the appropriate recalls.

FDA CORE Network

If evidence points to an FDA-regulated product, such as romaine lettuce, then the FDA will take the lead. The agency’s Coordinated Outbreak Response and Evaluation (CORE) Network was created to manage both outbreak response (such as recalls) and post-outbreak efforts to prevent future outbreaks. Three teams share these responsibilities:

1. Signals and Surveillance: This team handles early detection to limit or prevent the spread of the illness.
2. Response: This team finds the source of the pathogen and takes the contaminated product out of circulation.
3. Post-Response: This team looks at all aspects and factors of the outbreak to identify how the contamination could be prevented in the future.

Improving FDA internal processes is also a key interest of the Post-Response Team, which evaluates the FDA response to incorporate lessons learned and constantly improve future responses.

Record-Keeping Enhancements

The FDA surely recognizes that inadequate record-keeping has prevented a timely and satisfactory resolution of the ongoing romaine lettuce outbreak. The Food Safety and Monitoring Act (FSMA) clearly requires the agency to establish record-keeping protocols for facilities that manufacture, process, package, distribute, and store high-risk foods. But as the recent letter by consumer groups to the FDA points out, when FSMA compliance is not followed and lacks proper enforcement, bad records lead to dead ends – especially for products such as fresh produce, which often have no labels attached to them.

Better record-keeping would improve internal processes, reduce insurance costs, maintain consumer confidence, and ensure good brand reputation. In particular, the FDA acknowledges that digital monitoring and record-keeping are the preferred methods for tracking data, as they allow for automation and easy transmittal. At the same time, the FDA also must streamline data entry to eliminate inconsistencies in terminology, formatting, legibility, and language that require additional time for traceback analysts to sort out and confirm data for accuracy. Only time will tell if FDA heeds the warnings of activists and takes the initiative to follow the letter of the law.

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