The Food Safety Modernization Act’s Preventive Controls Rule seeks to ensure that agricultural facilities have established procedures of preventing, and, if necessary, correcting potential threats to food safety. The Preventive Controls Rule applies to food facilities – operations that manufacture, process, pack or hold human food, and are required to register with the FDA.
Unless exempted (click here to determine whether your facility may be exempted), facilities are required to create a food safety plan, to be revised at least every three years. This plan must be created, implemented, and overseen by a preventive controls qualified individual, which refers to any individual who has completed certain training or had requisite work experience to be qualified in establishing a food safety plan. This training or experience must provide knowledge equivalent to that which would be provided by FDA standardized curricula.
In general, the required food safety plan must identify potential hazards specific to the facility and identify preventive controls by which the facility can reduce these risks. The primary regulations within this rule fall under subpart C, Requirements for Hazard Analysis and Risk-Based Preventive Controls (HARPCs). The rule also outlines standards for national Current Good Manufacturing Practices (CGMPs). State and local regulations may also outline additional such CGMPs. For further specifics on these HARPC requirements, download the FDA’s Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. The former Requirements for Hazard Analysis and Critical Controls Program (HACCP), which many facilities currently employ, are similar to HARPCs (and form the foundation for these new requirements), but HARPCs expands the use of safety controls at locations other than critical points. Even if you know that your facility adheres to HACCP requirements, you still should ensure that you will be complying with HARPC, the next generation of food safety preventive controls.
Resources Regarding the FSMA Preventive Controls Rule for Farms
- Click here to read the Pennsylvania Department of Agriculture’s summary document on how the Preventive Controls Rule applies to farmers and growers.
- Click here to read the National Sustainable Agriculture Coalition’s post What is the Preventive Controls Rule?
- Click here to read the National Sustainable Agriculture Coalition’s post Who is Affected?
- Click here to read the National Sustainable Agriculture Coalition’s post Do I Operate a Farm or a Facility?
For further information, visit the FDA’s website on the Preventive Controls Rule: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm#PC_Rules
We hope that this guide gave you what you needed to know about FSMA! For more information on this Rule, FSMA, and other agricultural compliance issues, browse through our other coverage.