In its continuing commitment to increased transparency, FDA is sharing more in-depth information on outbreak investigations, providing access to two new resources:
- Executive Incident Summary (EIS) Abstracts. To be released following the close of every completed FDA foodborne outbreak or adverse event investigation there is no longer an ongoing risk to the public, EIS abstracts will share as much information as possible about foodborne illness investigations. As a post-response deliverable, the abstracts often include a high-level overview of the traceback, laboratory, and epidemiological information collected during the investigation, redacted to comply with disclosure laws. The abstracts can be accessed on the CORE Investigations Table or on the new EIS landing page.
- Foodborne Outbreak Overview of Data (FOOD) Reports. FOOD Reports provide information on pathogen-commodity pairs linked to repeated outbreaks of foodborne illness. The reports include highlights of historical epidemiologic data, laboratory analyses, traceback and investigational findings, and post-response prevention activities to help prevent future foodborne illnesses through food safety communication, training, research, and informing of FDA priorities and target resources. Intended to provide a more robust, data-driven, retrospective review of repeated events, the FOOD Reports are released when there is enough data to support their development. They are available on the FOOD Reports landing page.
TAG sees the new issuance of these reports as noteworthy and beneficial to the industry as well as consumers, at least in principle, as they are intended to provide additional clarity into the FDA’s methods and decision-making process in outbreak investigations and pathogen-commodity pair analyses. While the redactions may be seen by some consumer groups as counter to the stated transparency, it is necessary to protect the industry’s trade secrets and confidential commercial information, as well as any personally identifiable information.
The FDA also followed through on its commitment to this expanded transparency by releasing the new versions of the reports on the same day with the FDA CORE Outbreak update including brief information on three active outbreaks, and links to the detailed information on four outbreaks that are closed. FDA’s FOOD Reports publication provides summaries of hepatitis A outbreaks linked to berries and Salmonella outbreaks linked to tahini.
Let’s take a look at a couple of these and what they show us:
- With a WGS report showing that a recent Salmonella positive on an FDA environmental swab collected during a farm inspection matched two recent clinical isolates, the strong epi signal identified cucumbers as the suspect vehicle for this outbreak. The report then goes on to detail the clinical records collection, and step-by-step traceback of samples that matched the isolates, enabling identification of the source and the company’s voluntary recall along with that of several downstream recalls.
- In another case, the source of a cluster of E. coli O145:H28 illnesses which resulted in hospitalizations and one death was unable to be identified. With the lack of identification causing some negative media coverage, the explanation of the traceback in this EIS is helpful to understand why there was not public communication related to the outbreak. That is: no firms were implicated due to limited purchase information and lack of commonalities for the component ingredients; the outbreak investigation did not yield sufficient evidence to identify a definitive source or route of contamination; and the absence of supporting laboratory, traceback, and inspectional evidence limited the team’s ability to confirm a vehicle or develop a hypothesis as to source or route of contamination.
- The FOOD Report on Hepatitis A Virus (HAV) in Berries is a 14-page document overviewing the associated CORE outbreak investigations, summarizing some of the available scientific literature on hepatitis A virus outbreaks and the association with berries; the impacts of associated multi-state outbreaks; and the laboratory and traceback findings (e.g., In each outbreak, the berries implicated were traced back to a foreign supplier); and a post-response analysis and conclusions.
With these documents now being published on a regular basis, they provide insights for the industry into how contaminants are detected, associated, and traced. A potential benefit from these documents is to identify learnings from the various outbreaks and how industry can avoid repeating past mistakes. They also provide concrete evidence (for anyone who had any doubt) that WGS is being used; is implicating food establishments in outbreaks that may never have been associated in the past; and is detecting resident strains which can implicate an extensive range of products across time and space.
While one intent is to better equip the FDA, its investigation partners, and industry to identify root causes of outbreaks and develop collaborative strategies for preventing future outbreaks in order to maintain a safe food supply, it is important to remember that these publications are exactly that: public, intended to also increase transparency for consumers with a “more robust, data-driven, retrospective review of repeated events.” While the topline purpose of safe processes and products should always be consumer safety, the increasing transparency being implemented by FDA creates an increasing risk to your brand and business protection as well.
If you have any questions, or doubts, about your food safety processes, give TAG a call. Our experts have experience in all aspects of the industry and supply chain; we can help.
