New Era in Food Safety Regulation: FDA Issues Guides for Small Businesses to Comply with FSMA Preventive Controls Deadlines

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New Era in Food Safety Regulation: FDA Issues Guides for Small Businesses to Comply with FSMA Preventive Controls Deadlines

Source - Presence Marketing December 2016 Newsletter

As deadlines approach to comply with final food safety prevention rules established under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) – the most sweeping reform of U.S. food safety laws in more than 70 years – FDA in October issued guidances for both human and animal food manufacturing to help small businesses with the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules. 

The title for human food says it all: Small Entity Compliance Guide: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. You can download a pdf copy here. 

Enacted in 2011 and now entering the enforcement stage, FSMA “introduces a new era in food safety by focusing on preventing food safety risks rather than on responding to crises after they happen,” reported Food Safety Magazine. “Under the Preventive Controls rule, a facility is required to develop a written food safety plan that includes a risk-based assessment to identify hazards where preventive controls are necessary to significantly minimize or prevent hazards for any food that is manufactured, processed, packed or held at the facility. The written food safety plan must also include procedures for monitoring, corrective actions and verification of each preventive control,” Food Safety Magazine reported, while advising food producers to be prepared to produce a written food safety plan within 24 hours if FDA requests a review.” 

The guidances outline which companies must comply with the rule, which are exempt from parts of the rules or subject to modified requirements, and also key information for qualified facilities (i.e., small businesses). The guides are two of dozens of guidance documents the FDA intends to release as it continues with the implementation of FSMA. 

Food Safety Magazine offers an excellent summary of the new FSMA rules and compliance deadlines in its October/November 2016 issue, here. 

*This content was originally published in the Presence Marketing December 2016 Newsletter.