Food Safety Modernization Act

The Food Safety Modernization ACT – More than Just a U.S. Law?

Food Safety Modernization ActIn 2011, the U.S. Food Safety Modernization Act (FSMA) shifted the food-safety focus from reacting to outbreaks to a preventative approach. That was done to better protect public health and reduce the risk of product recalls. What are the implications for your business?

The FSMA represents a major change in the approach to food safety from the U.S. Food and Drug Administration (FDA). The law applies to all sites and products under the FDA’s jurisdiction, including overseas suppliers that export to the United States.

Between August 2015 and May 2016, several key sections of the law were published in the Code of Federal Regulations. Most food firms had 12 months from the date those sections were published to comply with the new regulations.

Key areas of the FSMA include detecting and preventing food-safety problems, responding when food-safety problems arise and improving the safety of foods imported into the U.S.

Food Safety Modernization ActPreventing and responding to food-safety problems

The law makes it clear that food-processing companies are responsible for controlling contamination in their facilities. Each company is required to formally register with the FDA and must evaluate hazards in their operations. Having conducted the analysis, they need to develop effective measures in the form of a written preventative-controls plan to eliminate contamination issues and ensure food is not adulterated, misbranded or incorrectly labelled.

Improving the safety of imported foods

The FSMA law extends beyond U.S.-based food-production facilities. To ensure the safety of foods from non-U.S. manufacturers, the FSMA requires importers to perform supplier-verification audits on companies exporting food products into the US. This part of the Act authorizes the FDA to block imports in the event that the producing facility refuses an FDA inspection.

More than a U.S. law

Companies exporting food products into the U.S. will also be impacted by the law. The law states that they will need to be certified under a Foreign Supplier Verification Program (FSVP). Therefore, the legislation is relevant to a much wider market than the U.S. alone.


Another key change delivered by the FSMA is a move from dependence on the traditional Hazards Analysis Critical Control Points framework (HACCP) to a new Hazard Analysis Risk-Based Preventative Controls approach (HARPC).

The food industry is familiar with HACCP, but HARPC is new for most. HACCP is the cornerstone of the vast majority of food safety standards, including those under the Global Food Safety Initiative umbrella. The principles often are mandated by large brands to their suppliers.

HARPC applies to almost all food-processing facilities and requires companies to have written plans that identify hazards, list the steps needed to minimize or prevent those hazards, identify monitoring procedures, and record the results. The plan must also specify what actions will be taken to correct problems should they arise. The plans will be evaluated by FDA and checked for proper implementation and adherence.

Are you ready to meet the requirements of FSMA?

Detailed information about the FSMA and the implications for your business are available in our free white paper.