What Do the FDA's Preventive Controls Rules Mean to You?

David Acheson and Melanie Neumann offer insight on complying with the new FSMA rules.

By David Acheson and Melanie Neumann of The Acheson Group

FDA on Sept. 17 released the first two final rules of the 2010 Food Safety Modernization Act: Preventive Controls for Human Food and Preventive Controls for Animal Food. As FDA notes, each has elements of both the original and supplemental proposals in addition to new requirements that are the outgrowth of public input received during outreach and the comment period for both proposals.

As we review these general applications and requirements, we’re not really seeing any radical changes from the proposed preventive controls. But at this stage, with almost 1,600 pages to read through, there may be some changes we haven’t found yet. However, some noteworthy areas we have noticed are that training is now a regulatory requirement for the first time in history, and there is a new definition for a “preventive controls qualified individual” that is separate and distinct from the “qualified individual” under the proposed rule.

To see the timelines and the full text of Mr. Acheson and Ms. Neumann's post, visit The Acheson Group

 

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