The administration's two main classifying criteria are known safety risks of foods, such as related Class 1 recalls and illness outbreaks, and the facility's compliance history. Under the Food Safety Modernization Act, high-risk facilities must be inspected once in the first five years after enactment of the Food Safety Modernization Act, then once every three years after the initial inspection. Not-high-risk facilities must be inspected at least once in the first seven years after enactment of the Food Safety Modernization Act, then once every five years after the initial inspection.
Of the 82,000 domestic facilities listed in the Food and Drug Administration's inventory, 22,325 are considered to be high-risk facilities. To determine if a facility is classfied as "high-risk," the administration uses a decision-making process based on the risk factors identified in section 421(a)(1) of the FD&C Act, including:
- Known safety risks of the food manufactured;
- Compliance history of a facility;
- Facility's hazard analysis and risk-based preventative controls;
- Facility's priority under section 801(h)(1) of the FD&C Act;
- Certifications for imported food;
- Any other criteria deemed necessary