FDA Issues Guidance on Qualified Facility Exemption From Food Preventive Controls Rules

The Food and Drug Administration recently issued a new guidance document on partial exemptions for “qualified facilities” from regulations on preventive controls for human and animal food. The guidance explains the definition of a qualified facility under the two rules, and how to calculate whether a company qualifies for qualified facility status, which is generally limited to small businesses. Under the preventive controls regulations, qualified facilities are exempt from complying with the full range of requirements, and must instead notify FDA that they are addressing hazards through preventive controls and monitoring.