Facility Rule: Processing Food Safety

Preventive Controls Rule (aka Facility Rule): Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. For facilities that manufacture, process, pack or hold food for human consumption.

Does FSMA Apply to Your Operation? 

Note: Many links on this page go to National Sustainable Ag Coalition's website. They have thoroughly studied FSMA and offer fantastic resources. (Note: the site may be slow to load, but worth the wait).

Use this handy 
flowchart to determine how you are affected 
Diagrama de Alimentos Impactados por las Reglas de FSMA

Where your operation likely falls within the FSMA is determined by reviewing a three year average your annual sales and where the produce is sold or the type of processing your operation is doing.

NOTE: Even if your operation is “exempt” from the Facilities Rule it is still held to CA Dept of Public Health CDPH's Processed Food Registration requirements.

NOTE: The following tables are only intended as a starting point to help you find where your operation likely falls within the Facility Rules, use it in conjunction with the flow chart link above and Facility Rule details below.

PREVENTIVE CONTROLS (FACILITY) RULE

* Exempt operations must keep records of sales to prove they are exempt.

 UNDERSTANDING FDA'S FSMA FACILITY RULE

Links are to National Sustainable Ag Coalition's website:

• Understanding FDA's FSMA Rule for Food Facilities
• Who is Subject to FDA's New FSMA Food Facilities Rule? Part 1
• Who is Subject to FDA's New FSMA Food Facilities Rule? Part 2
• Who is Subject to FDA's New FSMA Food Facilities Rule? Part 3

The following are required elements of good manufacturing practices as outlined by the Code of Federal Regulations, 21 CFR 117:

• Facility (buildings and equipment) 
  
• Sanitation
• Human Hygiene
• Processes and controls* -- Food Safety Plan
• Pest Control
• Training
• Records*
  *Greater emphasis on these items with FSMA.

Food Safety Plan