What is FSMA?

According to the Center for Disease Control and Prevention, about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food-borne diseases.


In response to these staggering numbers, 2016 has brought new requirements to cold chain monitoring and food safety as the Food Safety and Modernization Act (FSMA) regulations start to come into effect. For the first time since 1938, food safety legislation has been passed that greatly expands the powers of the Food and Drug Administration (FDA) to enforce regulations that significantly improve the protection of our food supply.


Key Requirements

Specifically, FSMA would establish requirements for:

  • Vehicles and transportation equipment: Design and maintenance of vehicles and transportation equipment to prevent transported food from becoming unsafe.
  • Transportation operations: Measures taken during transportation to ensure food safety, such as adequate temperature controls and separation of food and non-food items.
  • Training: Training the carrier personnel in sanitary transportation practices and documenting the training.
  • Records: Maintain records of written procedures, agreements and training.


These regulations will come into effect on a rolling basis – large companies within one year of the published final rule, 2 years for smaller businesses, and 3 years for the smallest companies.


Increased Scrutiny

FDA culture is becoming more enforcement-minded and inspection oriented. They plan to conduct more domestic inspections, in addition to becoming more strategic in the sites they inspect. Likewise comes an expansion in their definition of “high risk”, an expansion which may lead to an increase in demanding access to records.

The FDA will certainly be viewed as increasingly critical due to the rule changes. This means regulators will be more likely to identify issues while visiting sites. Instead of the past environment of working with facilities to make sure they make changes, the government looks to put more emphasis on taking action in the form of warning letters, increases in court injunctions, heightened use of import alerts, and a new authority for mandatory recalls and suspensions.


Looking Ahead to the Impact of FSMA

In light of these changes, using technology to update unreliable reporting and compliance processes, in addition to making records easily accessible to inspectors is of the utmost interest for food industry players to ensure that the health and survival of the business is not put in jeopardy. The FDA will know what happened not only on the day of their visit, but last week, month, or year. Making these records as easily accessible as possible on inspection day is a key component of coming FDA inspections.


It is vital to take proactive action to meet the new FSMA requirements. As more companies adopt technology to accomplish formerly manual compliance and operational processes, industry best practices will shift, giving technologically advanced food companies a competitive advantage over organizations that still apply traditional methods to tasks that are now being automated. But most importantly, these technological advancements are doing the one thing we all care about most: ensuring that the food on all of our plates is safe.