FDA Issues Final Preventive Controls Rules Under FSMA

They’re here! On Thursday, September 10, 2015, the Food and Drug Administration (“FDA”) released two final rules to implement the FDA Food Safety Modernization Act (“FSMA”): “Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Human Food” (“Preventive Controls”) and “Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Animal Food.” The publication of these final rules is a major milestone in the implementation of FSMA – a landmark piece of legislation. They form the cornerstone of the law and will shape daily food manufacturing operations and FDA inspections for decades to come. As discussed further below, most companies will need to comply with these new requirements in one year, on September 19, 2016.

 

This memorandum provides key takeaways and highlights of the major provisions from the Preventive Controls final rule, focusing on those elements that changed between the proposed rule or supplemental proposed rule and the final rule. Overall, the revisions to the regulations and the discussion in the accompanying preamble clearly reflect the considerable input from industry and the written comments that were submitted during the rulemaking stage. This outcome shows the significant importance and benefit of being engaged in the rulemaking process.