Food Safety Modernization Act (FSMA)

Congress enacted the Food Safety Modernization Act (FSMA) to improve the country’s ability to prevent food safety problems, respond quickly if a problem does occur and ensure the safety of imported foods. The sweeping act was signed into law in 2011, giving the Food and Drug Administration (FDA) new authority to regulate domestic and imported food for humans and animals at several points in the food supply chain.

FDA has finalized seven major rules to implement the FSMA mandate.    

• Preventive Controls for Human Food
  • (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food)
  • This rule requires food companies that manufacture, process, pack or store food to develop stronger controls and plans to reduce the risk of contamination. Read more.

• Preventive Controls for Food for Animals
  • (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals)
  • This rule applies to facilities that manufacture, process, pack or hold animal food. It specifically mentions “waste” diverted from human food facilities for use in animal food, and the dairy industry is a significant source of these products. Read more.

• Accredited Third-Party Certification
  • (Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications)
  • This rule establishes a program for approving third-party organizations that can conduct food safety audits and certify that foreign food facilities and their products meet FDA food safety requirements. Read more.

• Foreign Supplier Verification Programs (FSVP) 
  • (Foreign Supplier Verification Programs for Importers of Food for Humans and Animals)
  • This rule requires food importers to verify that their non-U.S. suppliers are producing food that meets U.S. safety standards. Read more.

• Produce Safety
  • (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption)
  • This rule sets safety standards for produce farms to eliminate food safety risks during harvesting, packaging and storing fruits and vegetables. 

• Sanitary Transportation
  • (Sanitary Transportation of Human and Animal Food)
  • This rule requires food shippers, carriers and receivers to use sanitary practices and to prevent food safety risks that could result from improper refrigeration of food, inadequate cleaning of vehicles between loads and failure to protect food. Read more.

• Food Defense
  • (Mitigation Strategies to Protect Food Against Intentional Adulteration)
  • This rule requires food companies to create and maintain a written food defense plan for their facilities. The plan would counter acts of intentional adulteration, however unlikely, that could affect the U.S. food supply and cause widespread public harm. Read more.

Our Position

With the major rulemaking related to FSMA now complete, FDA is issuing guidance and beginning inspections and enforcement of the new requirements. IDFA is working to ensure that the guidance aligns with the flexibility allowed by the rules. We’re also making sure that inspections required under FSMA are conducted appropriately and efficiently, with minimal disruption to daily dairy operations.

Resources

• IDFA has prepared several webinars, now available online, to explain the rules in more detail. Visit IDFA’s Knowledge Center to read more.
• FSMA Rules and Guidance for Industry

For more information, contact John Allan, IDFA vice president, regulatory affairs and international standards, at jallan@idfa.org.

Staff Contact

John Allan

Vice President, Regulatory Affairs and International Standards