Dissecting The FSMA Preventive Controls Rules

By James Gorny, VP Food Safety & Technology, Produce Marketing Association

I felt a bit like a deer in the headlights last week when all 450 pages of the FDA’s Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules were published in the Federal Register and dropped on my desk with a thud. It seemed like an overwhelming and daunting task to read, understand, and immediately communicate the meaning and implications of these rules to PMA members, the media, and food safety colleagues. This post is all about how you may wish to consider approaching these new rules.

Background: The Hierarchy Of Regulations
FSMA Statute — the FSMA statute passed by Congress and signed into law by President Obama in 2011 authorizes and directs the FDA to create a new and modern food safety regulatory framework. The law is written at the 50,000-foot level of detail and provides a framework and road map for the FDA to create a series of new food safety regulations. As an aside, the FSMA statute did not provide the FDA with Congressional appropriations (i.e. funding) to actually implement this new law and that’s a whole other story. See “Not Funding FSMA Doesn’t Make It Go Away”.

FSMA Regulations — secondly, the newly issued final regulations are written at the 10,000-foot level of detail to provide flexibility in the way firms implement and achieve compliance with the new regulations and for the FDA to verify compliance. However, with great flexibility comes great ambiguity.

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