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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ORA Outbreak Response Field Guides

Foodborne outbreak investigations have been increasing. This has been influenced by direct food safety hazards and our improved outbreak detection capability. FDA is working toward reducing foodborne outbreaks by continuing a strong, effective surveillance, compliance, and enforcement program, supporting preventative controls, supporting corporate accountability to understand and have confidence in their supply chain, and providing education/outreach to agency stakeholders.

To support outbreak response, FDA is developing and issuing a series of outbreak response field guides. You will find the guides as well as videos introducing the guides in the list below.  The guides are product/hazard-specific and reflect: the expected steps to undertake during an investigation, the best practices learned over the years, the latest scientific and regulatory thought processes. 

The approaches captured in these guides should be followed when FDA is investigating an outbreak and we encourage our regulatory partners to follow them as well to harmonize our approaches and rely upon each other’s work. To assure that these guides continue to represent best practices and latest scientific advances, we encourage our staff and regulatory partners to send comments and detailed suggestions for improvement using our feedback form.  


These guides are possible due to the hard work and thoughtful consideration of many people who developed the strategy behind these guides. Thanks to staff at CFSAN and ORA and a special thanks and acknowledgement to the Response Workgroup members under the 50-state Partnership for Food Protection initiative and members of CalFERT who significantly contributed to the strategy and the content of the ORA Outbreak Response Field Guide #1, Pathogen: E. coli, Listeria, Salmonella; Product: Sprouts.