The Food Safety Modernization Act (FSMA) is a law applicable to food producers, processors and transporters. The purpose of the law is to protect the public from foodborne illness. Data from the Center for Disease Control and Prevention data indicates that over 3,000 people in the United States die from foodborne illnesses each year while approximately 48 million people in total suffer with sickness caused simply from eating unsafe food. FSMA is based on the understanding that a significant amount of death and illness could be avoided if food producers, processors, and transporters implemented risk-based preventative controls designed to minimize hazards in the food production process.

Thus, Congress passed FSMA in 2011 to combat this problem by establishing procedures to minimize hazards in the food production process. Pursuant to FSMA the Food and Drug Administration (FDA) more recently developed and now implements comprehensive controls across the food supply chain. The rules are a game-changer for the food industry, and all food producers, processors, and transporters need to be aware of the rules and the schedule of implementation. There are seven core FSMA rules as follows:

  • Produce Safety Regulation
  • Preventative Controls for Human Food
  • Preventative Controls for Animal Food
  • Foreign Supplier Verification Program
  • Intentional Adulteration
  • Sanitary Transportation of Food
  • Accredited Third-Party Certification

These rules require the creation and maintenance of food safety plans that identify hazards, the likelihood of food encountering those hazards, preventative controls, and protocols for monitoring, correcting, and verifying food safety risks. As a result, the players responsible for delivering food to consumers’ grocery carts and plates carry the burden of reducing the risk of adulteration of products and the spread of foodborne diseases, such as salmonella and E. coli. Failure to adequately identify, track, and report conditions under FSMA that could contribute to foodborne illness may result in mandatory recalls, fines, sanctions, and criminal penalties under the Food Drug and Cosmetic Act.

The first phase of FSMA rules took effect in September 2015. The rules will continue to be implemented on a gradual, phased basis through 2024. These alerts will cover rules under FSMA and their impact on the food industry. Our next post will address the Foreign Supplier Verification Program regulations scheduled to take effect on July 26, 2018.


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