What you need to know about new FSMA-related requirements

In January, the FDA issued the Hazard Analysis and Risk-Based Preventive Controls (HARPC) as a new rule under the two-year-old Food Safety Modernization Act (FSMA). HARPC lays out requirements for food manufacturing facilities to develop written food safety plans, implement preventive controls, and maintain documentation of the safety measures. Food processors are tasked with evaluating microbiological, chemical, and other contaminants, and then institute preventive controls to mitigate the hazards.


The FDA also issued revised requirements for Good Manufacturing Practices (GMP). Under the new provision, protocols for food allergen and environmental pathogen controls, worker training, and food-contact surface sanitation would become mandatory.
The primary effect of the new requirements relates to proof of effective implementation by food processors. Plant operators will now need to prove and document the efficacy of their sanitation procedures, down to the microbiological level, instead of simply passing visual inspections.
Implementing the updated HARPC and GMP requirements could mean a significant expenditure for food and beverage plants. The FDA’s estimated first-year cost to the food industry sectors regulated by HARPC is roughly $701 million, plus an ongoing annual compliance cost of $472 million. That works out to about $1,000 to $25,000 per facility, depending on the current procedures in place.

Wright Process Systems can help companies address the requirements of HARPC and GMP through forward-thinking sanitary design of equipment and facilities. For existing plants, we can assess your systems and develop solutions to meet the requirements. We design everything with the long-term sustainability of your plant in mind, from sanitary system design to sterile installation to the smart implementation of clean-in-place systems. Contact us today to learn how our solutions can help your plant stay ahead of the regulations.
See more of Wright Process Systems’ sanitary solutions at www.wrightps.com. Learn more about FSMA updates in our Industry News.