Silver Spring, MD—The FDA on Thursday released the Foodborne Outbreak Response Improvement Plan (FORIP), which is intended to enhance the speed, effectiveness, coordination, and communication of investigations into foodborne illness outbreaks.
The goal is to improve FDA’s ability to identify the sources and causes of foodborne illness outbreaks, the agency explained.
Observations by and recommendations from FDA leadership and staff across the foods program played a key role in the development of the outbreak improvement plan. The plan was also informed by an independent review of the agency’s structural and functional capacity to support, participate in, or lead multistate foodborne illness outbreak investigation activities.
That independent report examined FDA’s roles and responsibilities, processes, priorities, decision trees, and procedures for foodborne outbreak response in three specific areas: product tracing, root cause investigations, and the use of Coordinated Outbreak Response and Evaluation (CORE) Network data. FDA believes that improvements in these three areas will play a significant role in improving the speed, accuracy, and effectiveness of its overall outbreak response and coordination with relevant federal, state, local, tribal, territorial, and international counterparts, and industry stakeholders.
While the plan focuses heavily on actions FDA pledges to undertake, the agency acknowledged the interdependencies that exist in outbreak response requiring a true food systems approach for suc cess.
In addition, FDA has added a fourth category to the FORIP, operational improvements, as it recognizes that several recommendations fit well into this category.
FDA’s Foodborne Outbreak Response Improvement Plan, which is focused on outbreaks associated with human food, is divided into four priority areas:
Tech-enabled product traceback: The FORIP focuses on smarter ways to digitize and routinize the traceback process. FDA plans to improve its utilization of consumer purchase data to better specify critical traceback information the agency needs from industry, which will streamline additional traceback steps.
FDA will facilitate and expedite how it will receive the data, and it will use more advanced methods and computational approaches to prioritize the highest value traceback leads to pursue. The agency will work to harmonize its efforts with its relevant counterparts so that they too will be able to advance how they request, receive, and analyze traceback data.
FDA will also work with industry and other stakeholders involved in tracebacks to show them new processes and encourage/help them adopt these new techniques for their traceback efforts.
Root cause investigations (RCIs): The FORIP focuses on systematizing, expediting, and sharing FDA RCIs. FDA will adapt and strengthen protocols and procedures for conducting timely RCIs to ensure it can conduct simultaneous investigations, when necessary.
The agency will standardize criteria and formats for producing reports on RCIs of outbreaks, and will expedite the release of investigation findings and their implications directly with the affected industry and to the public.
FDA said it will determine the most expedited process for disseminating necessary public health information and actions to prevent a reoccurrence. With appropriated funds, the agency will seek to enhance staff and resources to manage anticipated increases in root cause analyses.
Analysis and dissemination of outbreak data: The FORIP focuses on ways to strengthen analysis and dissemination of outbreak data. FDA will work with the CDC, USDA’s Food Safety and Inspection Service (FSIS), and others to identify reoccurring, emerging, and persistent strains of pathogens. FDA will facilitate sharing of data with CDC and other regulatory partners, and will increase transparency of outbreak investigations to increase widespread public confidence in results and help facilitate improved collaboration on investigation activities.
Operational improvements: The FORIP focuses on continuous operational improvements that will enhance product tracing, root cause analysis, and the use and dissemination of outbreak data. FDA will streamline the internal process used to make field assignments and information requests.
FDA will work to assure that RCI findings result in an actionable prevention strategy and help determine FDA food program priorities, and will build in performance measures across the agency’s foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities.
