The Food Safety Modernization Act (FSMA) provides regulations for the food industry to prevent illness caused by food.

Food Safety Modernization Act (FSMA)

What is the FSMA?

The Food Safety Modernization Act provides regulations for the food industry to prevent illness caused by food. It creates best practices to address food safety issues along the entire supply chain. The law applies to growers, processors, retailers. and global suppliers. Implementation in commercial baking should address the following:1

  • Identifying hazards
  • Building preventive controls
  • Creating a supply chain approval program
  • Establishing a recall plan

The FSMA sets up control programs where the highest risk for contamination occurs. Bakeries should assess areas of highest risk, identify those risks, and create preventive controls to minimize and prevent the risks. The food safety program should contain validation, traceability, and recordkeeping.2


The FSMA was signed into law on January 4, 2011, by President Obama.2 Food safety issues have increased with modern manufacturing processes. Recalls increased the risk of foodborne illness, and contamination from allergens has grown as the food supply chain tries to meet consumer demands. The FSMA is mandated under the FDA and was finalized in 2015.

Regulatory compliance

The FDA oversees all compliance dates for implementation of the FSMA. On the basis of a business’s size, the FDA staggered compliance dates and created separate dates for the supply chain program. The dates for implementation are as follows:3

  • September 19, 2016: Large food businesses commenced rollout of the FSMA.
  • September 18, 2017: Small food businesses with fewer than 500 full-time employees implemented the FSMA.
  • September 17, 2018: Very small businesses that earn less than $1 million per year begin implementation.


Under FDA guidelines, “FSMA regulations apply to all domestic and foreign food facilities that are registered with section 415 of the Food, Drug, & Cosmetic Act.”3

Key requirements for a food safety plan

Hazard Analysis is the first step in identifying the risks of biological, chemical, and physical hazards in a food manufacturing facility. These hazards will identify where a preventive control is needed.3

Preventive controls are put in place to address potential hazards, and must be available in writing.3 They will minimize or prevent adulteration of food. Preventive controls include process control, food allergen controls, sanitation controls

Once preventive controls are established for hazards, the facility must have a process in place to ensure oversight and management. Management should include the following:3

  • Monitoring
  • Corrections
  • Corrective actions
  • Verification

A supply chain program is risk assessment analysis that focuses on suppliers of a food manufacturer’s raw materials.3 Suppliers should undergo and verification process and be approved as part of the program.

A recall plan is required by all facilities and must be available in writing. The recall plan should describe the procedures to perform when a hazard is identified that requires a preventive control. When a product must be recalled, facilities and employees must know whom to contact, when to notify the public, and how to dispose of the recalled product appropriately.3


  1. Barach, J. FSMA and Food Safety Systems: Understanding and Implementing the Rules. Wiley, 2017. pp. 1-3.
  2.  Sanders, L. “Food Safety.” American Bakers Association,
  3.  Center for Food Safety and Applied Nutrition. “Food Safety Modernization Act (FSMA) – FSMA Final Rule for Preventive Controls for Human Food.” U S Food and Drug Administration Home Page, Center for Food Safety and Applied Nutrition,