12/09/2021 — Tackling foodborne outbreaks faster and revealing the root cause are essential for the prevention of future outbreaks. We have a plan to do that.
Foodborne disease remains a significant public health problem in the United States. The FDA’s Foodborne Outbreak Response Improvement Plan (FORIP), described in this document, is an important step that the FDA is taking to enhance the speed, effectiveness, coordination, and communication of outbreak investigations. (Unless stated otherwise, this report focuses exclusively on the response to human food and not animal food.)
Our ultimate goal is to bend the curve of foodborne illness in this country.
Foodborne pathogens are estimated to sicken one in six Americans each year. This results in an estimated 128,000 hospitalizations and 3,000 deaths. The food system in the United States is large, distributed, and decentralized, with a broad array of widely distributed products. Foodborne outbreaks require multidisciplinary efforts and often multijurisdictional coordination.
Changes in identifying, investigating, and controlling foodborne disease outbreaks present new challenges and opportunities in the 21st century. Our ability to detect more outbreaks and smaller outbreaks through new technologies and advances in subtyping, such as whole genome sequencing, has likely increased the number of multistate outbreaks identified in recent years.
While progress has been made, we need faster and more streamlined investigations to identify and remove contaminated food from the market, and more effective investigations to identify deficiencies in the food system to help prevent similar outbreaks in the future. These are serious concerns that we must address.
What will this FORIP focus on and why?
The independent report examined the 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 CORE data. We believe that improvements in these three areas will play a significant role in improving the speed, accuracy, and effectiveness of the FDA’s overall outbreak response and coordination with relevant federal, state, local, tribal, territorial, and international counterparts, and industry stakeholders. Themes of increased transparency and trust with partners are woven throughout.
While the plan focuses heavily on actions FDA pledges to undertake, we acknowledge the interdependencies that exist in outbreak response requiring a true food systems approach for success.
In addition, we have added a fourth category to the FORIP, operational improvements, as we recognize that several recommendations fit well into this category.
- Tech-enabled product traceback – The FORIP focuses on smarter ways to digitize and routinize the traceback process. We will improve our utilization of consumer purchase data to better specify critical traceback information we need from industry, which will streamline additional traceback steps. We will facilitate and expedite how FDA will receive the data, and we will use more advanced analytical methods and computational approaches to prioritize the highest value traceback leads to pursue. We will also work to harmonize our efforts with our relevant federal, state, local, tribal, and territorial counterparts so that they too will be able to advance how they request, receive, and analyze traceback data. We 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. We will adapt and strengthen protocols and procedures for conducting timely RCIs to ensure we can conduct simultaneous investigations, when necessary. We will standardize criteria and formats for producing reports on RCIs of outbreaks. We will expedite the release of investigation findings and their implications directly with the affected industry and to the public. We will determine the most expedited process for disseminating necessary public health information and actions to prevent a reoccurrence. With appropriated funds, we 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 our analysis and dissemination of outbreak data. We will work with CDC, USDA-FSIS, and other health partners to identify reoccurring, emerging, and persistent strains of pathogens. We will facilitate sharing of data with CDC and other regulatory partners. We 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. We will streamline the internal process used to make field assignments and information requests. We will work to assure that RCI findings result in an actionable prevention strategy and help determine FDA food program priorities. Importantly, we will build in performance measures across the FDA’s foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities.
