What are the FSMA Regulations?

FAQ What are the FSMA Regulations?


The Food Safety Modernization Act or FSMA regulations, became law on January 4, 2011. The goal of the FSMA is to ensure that the U.S. food supply remains safe by focusing first on prevention rather than just responding to contamination issues.

The Food and Drug Administration (FDA) has been granted new powers by the FSMA to do this. These powers include being able to initiate mandatory product recalls and to assist with the regulation of how our foods are grown, harvested, processed, and stored.
From 2000 to 2010, many food based illnesses were reported and it’s because of this that the FSMA was introduced. Each year the CDC reports that approximately 48 million Americans, or one in every six, become ill due to food borne illnesses. The FSMA will work towards preventing these illnesses occurring, leaving the FDA to also concentrate its efforts on preventing rather than reacting to food related problems.


  • Requires food facilities to create and implement a written Hazard Analysis and Risk-based Preventative Controls plan (HARPC)
  • FDA must establish minimum safety standard for food production and harvesting
  • FDA needs to issue regulations which prevent intentional contamination of the food supply


  • Mandated inspection based upon risk analysis of the food or facility
  • Food testing must be undertaken by accredited laboratories
  • FDA will be able to access records from food supply chain businesses


  • Third party agencies are now able to offer inspections
  • Assist state and other local agencies to increase their food safety and defense capabilities
  • Train foreign governments and food producers on the US food safety requirements


  • Importers are accountable in making certain their foreign suppliers produce food which is safe and that they can demonstrate the preventative controls they have in place to do this.
  • Third parties can supply information to the FDA that foreign food facilities do meet the US food safety standards. Able to request third party certification of high risk imported foods.
  • Can refuse entry to the US for foreign foods if access for FDA inspection is denied
The Food Safety Modernization Act has been created to suit businesses of all sizes. Consequently, it does not employ a one size fits all model. It recognizes that the efforts firms are carrying out to protect wildlife and on-farm conservation are important and that the new regulations must not play a detrimental part to these.

FSMA also aims to reduce the amount of paperwork required from businesses through streamlining its processes.

Finally, the way in which both animal and human food is transported is put under the spotlight to make conditions more sanitary. This includes cleaning schedules, maintaining correct temperatures during transport and communicating with other members of the food supply chain to prevent food borne illnesses spreading.


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