FDA Guidance - Small Company Version of Preventive Controls for Human Foods

FDA released their guidance titled: Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide.   LINK

This guide was developed to help small companies comply with the FSMA Preventive Controls Rule.

The guide does not introduce anything new.  It is basically a simplified version of the original rule.  Being simplified, the document does make the regulation more approachable.  One particular area is On-Farm Packing and Holding of Food (pg 22).  The guidance discusses those activities not subject to the requirements for Hazard Analysis and Preventive Controls when conducted on farms.

It also reviews the Qualified facility -  a facility that does not need to comply with the Preventive Controls component of the rule (21 CFR 117).  It has been our opinion however, for companies who fit into that definition to consider taking the step and completing the Preventive Controls component.  Why?  If the company grows, looks to gain sales from a customer requiring a HACCP type plan, or just wants to improve the safety of their product, they really need to consider taking this step.