Must Your Company Adhere to New Food Safety Modernization Act Regulations and When?

Our staff at TechHelp and the University of Idaho receives many questions about the Food Safety Modernization Act (FSMA). Most questions are about who must comply with FSMA and when. We hope the following guidelines will help you decide if and when you must comply with FSMA.

Who must comply and who is exempt from the FSMA Preventive Controls for Human Food (PCHF) regulation (21 CFR 117)

This regulation applies to food processors who manufacture, process, pack, or hold human food and must register with the FDA in the USA and abroad.  Companies that are exempt include:

  • Seafood processors (except for implementing the new GMP’s in 21 CFR 117 Subpart B)
  • Juice processors (except for implementing the new GMP’s in 21 CFR 117 Subpart B)
  • Low acid canned food processors (except for those hazards identified in a hazard analysis that are not microbiological, such as chemical, physical, and radiological hazards).
  • Meat and poultry processors who are under USDA FSIS regulation
  • Alcoholic beverage production
  • Dietary supplement production
  • Farming operations
  • Very small food processors that apply for an exemption (except for implementing the new GMP’s in 21 CFR 117 Subpart B); see regulation for more specific details for “Qualified Facilities”.
  • Retail Food Business: Restaurants, Grocery Stores, etc.
  • Farmers markets and food banks


How urgent is the need to take this training?

The PCHF regulation has the following compliance schedule, based on the size of the company. The requirements to complete the training to comply with the FDA requirement for the “Preventive Controls Qualified Individual”, write a Food Safety Plan, and then implement the Plan are based on the size of the company:

  • Large Company:  500 or more Full Time Equivalent Employees:  Comply by September 19, 2016
  • Small Business: Less than 500 Full Time Equivalent Employees: Comply by September 18, 2017
  • Very Small Business: Less than $1 Million Annual Food Sales: Comply by September 17, 2018