Keller and Heckman Summary of Final Rule on CGMPs and HARPC for Food for Animals
We have reviewed and analyzed FDA's recently-issued final rule to implement Good Manufacturing Practices and Hazard Analysis and Risk-based Preventive Controls (HARPC) for food for animals under the 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 Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015), available at http://www.gpo.gov/fdsys/pkg/FR-2015-09-17/pdf/2015-21921.pdf.
Notably, the final rule accomplishes the following:
- It establishes for the first time CGMPs for food for animals, which are akin to the CGMPs that have long applied to human food;
- It requires animal food facilities to develop a written food safety plan that includes hazard analysis and imposes risk-based preventive controls;
- It requires the establishment of a supply chain program; and
- It clarifies the facilities that are subject to CGMPs and HARPC requirements, and the exemptions from these requirements, including exemptions for "farms."
At the link please find our summary of the requirements and implications of the final rule: http://www.khlaw.com/webfiles/Animal%20HARPC%20Final%20Rule%20Summary.pdf.
The final rule is effective November 16, 2015. For the CGMP requirements, food facilities generally have one year from publication of the final rule (September 19, 2016) to comply. "Small Businesses" (a business employing fewer than 500 full-time equivalent employees, regardless of sales) and "Qualified Facilities" (which includes "Very Small Businesses," i.e., businesses averaging less than $2.5 million per year (adjusted for inflation) in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale) have two years (September 18, 2017) and three years (September 17, 2018), respectively, to comply with the CGMPs. For the HARPC requirements, the general compliance date is two years from publication of the final rule (September 18, 2017), while small businesses and qualified facilities (including very small businesses) must comply in three years (September 17, 2018) and four years (September 17, 2019), respectively. In addition, Qualified Facilities must retain records to support their qualified status by January 1, 2017.
We will continue to monitor and report on FDA's activities to implement the HARPC requirements and other FSMA related activities. Please let us know if you have any questions or if you would like to discuss the impact of the final rule.Keller and Heckman stands ready to assist with any questions you may have about the Animal 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.