The US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR 117) is now final, and compliance dates for some businesses began in September 2016. However, as of September 2018, 21 CFR 117 regulation is in full effect for all wholesaling food related businesses.
Fact Sheets:
Key Facts about Preventive Controls for Human Food (FDA)
Understanding the Current Good Manufacturing Practice, Hazards Analysis, and Risk-Based Preventive Controls for Human Food (PDF) provides a brief summary of the different components of the new Title 21 CFR Part 117 regulation. This regulation affects any person or business engaged in the manufacturing/processing, packing or holding of food for human consumption in the United States.
External Resources:
Food Safety Modernization Act (FSMA) (FDA) - This website summarizes and provides direct links to the seven major rules that encompass FSMA. In addition, this site provides guidance documents, training, and technical assistance for industry.
FSMA Final Rule for Preventive Controls for Human Food (FDA) - This website contains a direct link to the regulation that regulates most food manufacturers, processors, and warehouses. Also, there are numerous food industry specific guidance documents found on this site.
Food Safety Plan Builder (FDA) - If your facility is required to develop a food safety plan, the Food Safety Plan Builder is a free, FDA-developed application that businesses can download and guide them, step-by-step, through the creation of a food safety plan.
FSMA Frequently Asked Questions (FDA) - A wide range of industries are represented in this listing of frequently asked questions.
FSMA Technical Assistance Network (FDA) - You can submit your FSMA regulation related questions electronically to the FDA Technical Assistance Network.
FSMA Preventive Controls Qualified Individual Training (FSPCA) - The regulation requires that certain activities are conducted by a "preventive controls qualified individual (PCQI)" who has "successfully completed training in the development and application of risk-based preventive controls". This website provides a link to the Preventive Controls for Human Food course developed by the Food Safety Preventive Controls Alliance (FSPCA). This course is recognized as the "standard curriculum" by FDA; successful completion of this course is one way to meet the requirements for a "preventive controls qualified individual".
References for Facilities with Gross Annual Food Sales of $1 Million or Less
Food manufacturers or processors with gross annual food sales of $1 million dollars or less may be considered a Qualified Facility or a very small business under the new regulation. A business that meets the definition of a "qualified facility" is subject to the modified requirements of the 21 CFR 117 regulation. Minnesota food facilities can fulfill the modified requirements by submitting the Qualified Facility Form (Form FDA 3942a), and attest that the facility is implementing preventive controls to address hazards associated with its food. Information for qualified facilities can be found using the following links:
Instructions for Submitting a Qualified Facility Attestation
