FDA’s efforts to implement a multi-jurisdictional approach to foodborne Environmental Assessments (50m Lecture)

An Environmental Assessment (EA) is an investigation that may be conducted in the course of an FDA regulatory inspection related to a foodborne illness outbreak or contamination event. EA’s are typically conducted at the farm level and use a systems-based approach to identify potential contributing factors and environmental antecedents that lead to contamination. The subsequent findings and recommendations provide the basis for corrective actions to prevent potential future contamination events at the site(s), as well as more widely in industry, and assist to identify preventive controls that can be implemented to prevent a recurrence.

In response to the Food Safety Modernization Act (FSMA), FDA proposed to formally integrate the EA process into all investigational and inspectional activities related to FDA-regulated foods –including manufactured foods. To date, FDA’s Coordinated Outbreak Response and Evaluation (CORE) group has been actively working with State partners (Rapid Response Teams), the National Voluntary Environmental Assessment Information System (NVEAIS) within the U.S. Centers for Disease Control and Prevention (CDC), and various Programs within FDA to collaborate and harmonize on necessary training and data elements to capture for analysis. This cooperation will strengthen relationships, build capacity and eliminate duplication of effort among interested parties that share a common goal – ensuring the safety of the U.S. food supply.