On August 23rd 2016, the U.S. Food and Drug Administration (FDA) released draft guidance (“Draft Guidance”) to assist industry in complying with the Preventive Controls for Human Food Rule.  The agency also announced that it is delaying compliance dates for certain aspects of the PC Rule and other FSMA Rules.  For more information please see this Lieberman PLLC Regulatory Alert.

The Draft Guidance on the Preventive Controls for Human Food Rule is not complete.  It contains only five of a total of fourteen expected chapters.  The Draft Guidance is similar to the information in the Food Safety Preventive Controls Alliance (FSPCA) coursebook, but is not identical and differs in certain ways.  Consequently, retailers, wholesalers and manufacturers should reassess their existing food safety plans in light of the Draft Guidance.  It is important to consider that as is generally the case with FDA’s Seafood HACCP Rule, inspectors will be evaluating facilities for compliance with the Preventive Controls for Human Food Rule based on the guidance rather than the FSPCA handbook or other templates.  It is therefore critical that food industry businesses closely evaluate the Draft Guidance.  Comments are requested by FDA on the Draft Guidance by February 21, 2017.

Please contact Erik Lieberman at 202.830.0300 or erl1@liebermanpllc.com for more information.