FDA has released small entity compliance guidances under the Food Safety Modernization Act (FSMA) to support the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules for small and very small businesses.

  • As previously covered on this blog, over the past several months, FDA has issued guidance documents to support the implementation of various FSMA requirements, see e.g., herehere, and here.
  • On October 31, 2016, FDA released small entity compliance guidances (available here and here) under FSMA to assist small and very small businesses with the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food. This follows on guidance issued in August 2016 for both the human and animal food rules. Key takeaways from the small entity compliance include:
    • Small businesses, i.e., those with fewer than 500 full-time employees, must comply with the human and animal food rules by September 18, 2017.
    • Very small businesses, i.e., those typically averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales, are required to maintain records supporting Qualified Facility status as of January 1, 2016.
    • Qualified facilities must come into compliance with the human and animal food rules by September 17, 2018.
  • Comments may be submitted to FDA on the small entity compliance guidances at any time.  Additional FDA guidance documents to support the implementation of FSMA are forthcoming.