In addition to rules for certain farms regarding growing produce and keeping records, the FDA has extensive new authority under FSMA with respect to the processing, manufacturing, packing, and storage of a wide range of foods. The FSMA rules on Preventive Controls for Human Food and Preventive Controls for Animal Food (Preventive Controls Rules) affect many businesses, including in some cases establishments that pack or store raw agricultural commodities (RACs).
The Preventive Controls Rules are very complex, and this tool does not provide detailed information about who may be covered or the Rules’ specific requirements. But it will give you some basic guidance on what you need to think about if your business activities include food or feed manufacturing, packing or storage.
The Preventive Controls Rules have two main components:
- regulations on sanitary operations, known as Good Manufacturing Practices (GMPs); and
- regulations on Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Supply-Chain Programs (SCP).
GMPs
GMPs are not new for human food products, and a non-farm operation packing human food, including RACs, is a facility that has likely already been complying with these standards. The Preventive Controls Rule for Human Food made some changes to GMP regulations, which took effect Sept. 2018, for all businesses that have to register with the FDA as food facilities.
NOTE: The GMP requirements for animal feed facilities under the Preventive Controls for Animal Food rule are new, and many animal feed businesses will have a steep learning curve here. This tool is not designed to address issues for animal feed businesses.
To learn more about the FSMA rules governing animal feed, farmers and food businesses:
- In North Carolina - Contact George Ferguson, Feed Program Administrator at the NC Dept. of Agriculture and Consumer Services, george.ferguson@ncagr.gov, 919-733-7366.
- In South Carolina - Contact Angie Culler-Matthews, Food/Feed Safety & Compliance Manager at the South Carolina Dept. of Agriculture, aculler@scda.sc.gov, 803-734-7321.
HARPC & SCP
HARPC and SCP are a new set of prevention-oriented food safety requirements. Not all food or feed facilities have to comply with these new standards. The following questions will help you determine if you RAC packing facility or non-farm food manufacturing business is covered by HARPC and SCP or not.
NOTE: The PC Rules do not apply to meat products and foods regulated by the US Department of Agriculture.