Post-Outbreak Response and Prevention Strategies to Enhance Food Safety (Updated January 17, 2025)
FDA’s Foodborne Outbreak Response Improvement Plan
The FDA oversees the safety of the U.S. food supply and is responsible for helping to protect consumers from foodborne illnesses. Outbreaks of foodborne illness occur when food is contaminated with disease-causing bacteria or pathogens, potentially leading to illnesses that may range from mild to severe, and in some cases, death. Effective protection against these outbreaks requires not only a rapid response once they occur but also a concerted effort to prevent them from happening in the first place.
Outbreak Investigations
When a foodborne illness outbreak occurs, the FDA, through its Coordinated Outbreak Response and Evaluation (CORE) Network, and federal, state, local, territorial, tribal, and international public health partners work together to determine what food may have caused the outbreak and how it became contaminated. Over the last decade, following enactment of the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA), the FDA has investigated more outbreaks and conducted more research to advance our scientific understanding of the pathogens that contaminate our food than any other time in history. We now know more than ever about the contributing factors that can cause contamination of certain foods by specific disease-causing bacteria.
Post-Outbreak Response
After the outbreak investigation ends, a formal post-response process is conducted aimed at 1) identifying the root cause or likely causal factors of the outbreak and 2) identifying the levers of prevention that are and can be pulled to prevent future outbreaks from the identified root cause or likely causal factors. The post-response process includes collection, review, and analysis of outbreak and other regulatory, scientific, and industry information to characterize the hazard. The information learned from this process, along with historical outbreak and other scientific data, can contribute to ongoing or new prevention efforts which may include the development of a targeted prevention strategy for that food.
Prevention Strategies
A prevention strategy is an affirmative, deliberate approach undertaken by the FDA and interest holders to address the root cause or likely causal factors of outbreaks linked to certain FDA-regulated foods and help limit or prevent future outbreaks. These strategies are not developed for every outbreak. They generally target scenarios where the likely root cause or contributing factors are more clearly identified and similar operations or historical outbreak patterns suggest a repeated risk.
Framework and Implementation
Our prevention strategies are built upon the foundational principles established by the FDA Food Safety Modernization Act (FSMA), the FDA Strategy for the Safety of Imported Food, and other U.S. food safety policies. They also utilize the latest available data on the issue to inform the development of strategies to effectively tackle the casual factors and contributing factors to foodborne illness outbreaks.
Specific Strategy Development
The FDA pursues a prevention strategy after some outbreaks. For example, this may happen if the root cause or likely causal factors have been identified for the outbreak, if these factors could be associated with similar operations linked to the outbreak, or if there is a history of similar outbreaks suggesting the same causal factors.
Interest holder Engagement
When addressing a foodborne illness outbreak, collaboration with interest holders is essential to understand what can be done to keep it from happening again. As part of the post-response and prevention strategy development process, the FDA food safety experts engage with industry, state, international, and other partners to discuss, investigate, and analyze causal factors and potential mitigations. This may include:
- Review outbreak trends associated with certain commodities.
- Exploring environmental factors that may contribute to contamination in various locations, such as facilities or in more open landscapes like farms.
- Understanding and adhering to traceback. The FDA’s traceback process examines the complex path of food as it travels through the supply chain and how FDA works with interest holders during this process.
- Reviewing issues related to specific foodborne hazards to identify potential mitigation measures or knowledge gaps.
- Review regulations to identify provisions that may be strengthened.
- Identifying knowledge gaps to expand our understanding of food safety issues and limit recurrences of underlying root causes responsible for an outbreak or adverse event.
- Conducting and/or reviewing root cause analyses
- Identifying prevention measures that can be taken to reduce future incidences of foodborne illness.
- Discussing the underlying root cause(s) and contributing factors, and research gaps including what we don’t know or understand, what interventions are in play, and what other interventions there might be.
- Identifying and discussing goals and objectives to serve as a framework for a prevention strategy.
- Reviewing the prevention strategy elements, obtaining feedback, and seeking input on areas of collaboration and interest holder ownership of strategy actions.
- Presenting updates on a release timeline of the public facing prevention strategy.
- Socializing the prevention strategy with relevant interest holders.
Summaries of the prevention strategies are provided publicly to encourage continued external interest holder engagement.
This page is designed to share the latest information on the FDA’s prevention strategies.
Prevention Strategy Documents
| Prevention Strategy | Date Posted | FDA Strategy Summary | Additional Resources |
|---|---|---|---|
| Fresh and Frozen Berries | January 2025 | Fresh and Frozen Berries | FDA Releases Prevention Strategy for the Control of Enteric Viruses in Berries |
| Soft Fresh Queso Fresco-Type Cheese | March 2023 | Soft Fresh Queso Fresco-Type Cheese Strategy | Resources for the Control of Listeria monocytogenes for Manufacturers of Soft Fresh Queso Fresco-type Cheeses |
| Imported Enoki and Wood Ear Mushrooms | September 2022 | Imported Enoki and Wood Ear Mushroom Strategy | FDA issues country wide import alert for Enoki Mushrooms from RoK |
| Bulb Onions | July 2022 | Bulb Onion Strategy | Factors Potentially Contributing to the Contamination of Red Onions Implicated in the Summer 2020 Outbreak of Salmonella Newport |
| Powdered Infant Formula | November 2022 | Powdered Infant Formula Strategy Outline | FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022) Abbott Voluntarily Recalls Powder Formulas Manufactured at One Plant |