Preventive Controls for Human Food

Current Good Manufacturing Practice and  Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls Rule)

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule was finalized in September 2015.  Information about the rule and the implementation of the rule can be found on the FDA web site.

Compliance Dates
Compliance dates for businesses are staggered based on dollar amounts of sales.

  • Very small businesses (averaging less than $1 million per year [adjusted for inflation]) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Three years (September 2018), except for records to support its status as a very small business (January 1, 2016).  
  • Businesses subject to the Pasteurized Milk Ordinance (compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule): Three years (September 2018)
  • Small businesses (a business with fewer than 500 full-time equivalent employees): Two years (September 2017)
  • All other businesses: One year (September 2016)


Fact sheet

KEY REQUIREMENTS: Final Rule on Preventive Controls for Human Food 


Other important links:

FDA Food Facility Registration 

As a result of the requirements of the Bioterrorism Act, FDA included in FSMA a requirement that all facilities that manufacture, process, pack, or hold food for consumption in the United States must register with the FDA.  The FDA also reserves the right to inspect any registered food facilities and to suspend registration under certain circumstances. Facilities must re-register every two years.

Food Safety Preventive Controls Alliance

The U.S. Food and Drug Administration is working with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH), who will administer the Food Safety Preventive Controls Alliance (FSPCA) The FSPCA is a public/private alliance consisting of representatives from the FDA, state regulatory agencies, the food industry, and academia, whose mission is to support safe food production.  A standardized core curriculum, training and outreach programs are tools that the Alliance provides to assist food processing businesses that must comply with the Preventive Controls Rule, especially small and medium sized companies.  In addition, the FSPCA Technical Assistance Network (TAN) has been set up to address scientific/technical questions related to FDA’s Preventive Controls human food regulations. (FDA also has a TAN that is more specific to the rules and implementation.)