The compliance date for the Food Safety Modernization Act (FSMA), Preventive Controls for Human Foods is just around the corner.
Most facilities will need to be ready for this new rule by September 18, 2017, unless they fall into the category of a very small facility.
(<500 full time employees)
(<$1 million per year in annual sales of human food, including inventory)
The new Food Safety Modernization Act (FSMA) includes seven foundational rules. One of the seven foundational rules is Preventive Controls for Human Food (PCHF).
The PCHF rule replaces the cGMPs for food (21 CFR Part 110) with the updated expectations for food GMPS now found in 21 CFR part 117. A link to the new regulation is shown below. We recommend you bookmark it on your computer and become familiar with the expectations.
Within the PCHF rule is the requirement to have a Preventive Controls Qualified Individual (PCQI). A Preventive Controls Qualified Individual (PCQI) is needed to establish, implement, and monitor the Food Safety Plan (FSP). A FSP includes a hazard analysis for any food products, including dietary supplement ingredients, manufactured in the U.S. or being shipped to the United States for human consumption. If a hazard is identified during the written hazard analysis, you must fully develop your FSP to include preventive controls, monitoring, and validation.
This means any company manufacturing, packaging, holding, or distributing food products consumed in the U.S. is required to be compliant with 21 CFR Part 117 including general foods, dietary supplements, dietary ingredients, and dietary supplement components.
How does this affect me?
All ingredient suppliers will need to be compliant with 21 CFR Part 117 including having a Food Safety Plan administered by a qualified PCQI.
Finished dietary supplements are exempt from only two of the seven subparts in the FSMA-Preventive Controls for Human Foods rule. The dietary supplement exemption (from Subpart C and G only) is if the facility is in compliance with:
· 21 CFR part 111 (Current Good Manufacturing Practice in the manufacturing, processing, packaging, labeling, holding and operations for Dietary Supplements)
· 21 USC Section 379aa-1 (Serious Adverse Events Reporting for Dietary Supplements).
We recommend, and we have found through our training program, most companies have more than one person trained as a PCQI. A certificate is provided to an individual for the successful completion of the "standardized curriculum" recognized by the FDA. Having redundant PCQIs helps to account for promotion, job turnover, and vacations/sick time. This cross training is necessary since the PCQI is responsible for monitoring FSP records. By regulation, these records must be reviewed within seven days.
The responsibilities of the PCQI (21 CFR Part 117.180) include to oversee or perform:
1. Preparation of the Food Safety Plan
2. Validation of the preventative controls
3. Records review
4. Reanalysis of the Food Safety Plan, and other activities as appropriate for the food
At UNPA we offer both public training and in-house training for the FSMA-Preventive Controls for Human Foods standardized curriculum. Our next public training will be held in Utah in December.
For additional information regarding training check the UNPA website:
What should you do next?
1) Read and understand the new regulation
2) Obtain training for you and your staff
3) Be sure you have a Preventive Controls Qualified Individual (PCQI) to write and manage your Hazard Analysis.
4) Write, implement, monitor your Food Safety Plan as defined in the new regulation.
Let us know if you have any questions or if you want to discuss your training needs. We would be happy to help.
V.P. Global Regulatory and Compliance
United Natural Products Alliance