This month, the US FDA released its final Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule. Facilities subject to the rule must identify biological, chemical and physical hazards to food and institute preventive measures, such as sanitation controls and recall plans. The oversight of the controls consists of monitoring, corrections and verification, adapted to the situation. Monitoring will ensure that the controls are conducted consistently at a frequency appropriate to the type of hazard. Corrections must be documented, and include implementing preventive controls and reducing the chances of the problem’s recurrence. Verification of the controls’ implementation and efficacy include scientific validation, and calibration of process monitoring and verification instruments. Environmental monitoring and product testing may be used for verification if appropriate. The FDA rule also expanded the definition of farms, which are not subject to the rule on controls, to include operations harvesting, packing or holding crops or animals raised elsewhere. It additionally updated the supply chain program and CGMPs. Compliance dates vary by type and size of business, with September 2016 as the earliest.

Source: FDA