Environmental Assessments

An environmental assessment is an investigation that is triggered by an outbreak of foodborne illness or a food contamination incident. The purpose of the assessment is to determine how the "environment" contributed to the introduction and transmission of pathogens or other hazards that caused illness or contamination.

• FDA works with the involved firm and the appropriate government agencies to explain the findings, including the potential preventive controls.
• FDA also determines if any regulatory action is needed with regard to the involved firm, or if information was learned during the assessment that warrants guidance to the industry as a whole or other measures.
• FDA considers it important to release environmental assessments it has conducted because they may be instructive to other stakeholders, especially when viewed as a collection of environmental assessments.

An environmental assessment is not conducted for every foodborne illness outbreak or contamination event. Factors that are considered include:

• whether a new hazard or pathogen/food combination is causing illness,
• whether product has been widely distributed,
• whether the assessment has the potential to identify new probable causes or preventive controls,
• the public health impact of the outbreak, and
• availability of FDA and other resources.

The investigation is conducted by a multi-disciplinary team that could involve local, state and federal government agencies as well as industry and scientific experts. Team members will vary depending on the setting and expertise needed but the team is usually led by a trained regulatory investigator and can include specialists such as microbiologists, epidemiologists, water quality experts, sanitation experts, food technologists, and veterinarians.