Keller and Heckman Summary of Human HARPC Final Rule
As promised, we have reviewed and analyzed FDA's recently-issued final rule to implement the human hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA). The final rule was published in the Federal Register on September 17, 2015. See Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 80 Fed. Reg. 55908 (Sept. 17, 2015), available at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-17/pdf/2015-21920.pdf.
The final rule achieves three primary goals:
- Promulgating requirements for food facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls (HARPC);
- Modernizing and recodifying existing Current Good Manufacturing Practices (CGMPs); and
- Clarifying the definition of a "farm," which is central to the determination of whether certain entities must register as food facilities (thus generally becoming subject to the HARPC requirements).
At the link please find our summary of the requirements and implications of the final rule:
http://www.khlaw.com/webfiles/HARPC%20Final%20Rule%20Summary%20(2).pdf.
The final rule is effective November 16, 2015. Companies generally have 1 year from the date of publication to comply with the final rule (including both the revised CGMPs and the new HARPC requirements), i.e., September 19, 2016. Small businesses (< 500 full-time equivalent employees regardless of annual sales) must comply within 2 years, i.e., September 18, 2017. Very small businesses (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale) must comply within 3 years, i.e., September 17, 2018.
Keller and Heckman stands ready to assist with any questions you may have about the Human HARPC final rule and other FSMA-related issues in the meantime. We will be hosting a complimentary webinar in the near future to summarize the implications of the Human and Animal HARPC Final rules for the food industry, focusing on both food processors and ingredient suppliers.