Food Safety Modernization Act (FSMA)

What is the Food Safety Modernization Act?  FSMA was signed into law in January 2011. It is the most sweeping change to food safety in over 70 years.  It fundamentally changes the way food is regulated in the U.S. and abroad and affects the entire supply chain from farm-to-fork. It aims to enhance the culture of food safety and requires a culture change for most food retailers, while providing consumers with important safeguards to enhance confidence in our food system.

FSMA’s focus is on prevention and will have a direct impact on manufacturing facilities, central kitchens, distribution centers, food imports and even transportation. The law also provides the U.S. Food and Drug Administration (FDA) with new enforcement authorities and new tools to hold imported foods to the same standards as domestic foods.  All FSMA compliance documentation must be accessible within 24 hours and must be retained for at least 2 years.

Who is Responsible for FSMA Compliance?

All food supply chain participants must comply, where applicable.  The Food Safety Modernization Act (FSMA) impacts many aspects of a company and requires additional resources for training, record-keeping, product information/traceability systems, auditors, and food safety and legal staff. FSMA also takes corporate liability to a new level by holding food executives accountable, which is similar to Sarbanes-Oxley.

fda-fsma-logo-290FSMA’s  Seven Major Rules

The Food Safety Modernization Act (FSMA) is composed of seven rules that will have a major impact on participants in the global food supply chain.

Preventive Controls – Human Food
  • Facilities that manufacture, process, pack, or hold human food must maintain and implement a written food safety plan.  It must contain elements like hazard analysis, preventive controls, monitoring procedures and corrective action.
  • FSMA Final Rule for Preventive Controls for Human Food
Preventive Controls – Animal Food
  • Animal feed manufacturers must comply with various aspects of operations such as good hygiene practices, proper maintenance of plants, pest control, sanitation principles, and labeling of ingredients and finished products.
  • FSMA Final Rule for Preventive Controls for Animal Food
Foreign Supplier Verification Program (FSVP)
Third Party Auditor Accreditation
Produce Safety
  • Companies that grow, harvest, pack, and hold produce that is typically consumed raw must comply with standards around water, health, hygiene, equipment, facilities and training.
  • FSMA Final Rule on Produce Safety
Sanitary Transportation
Intentional Adulteration – Food Defense

When Will These Changes Happen?

The seven FSMA rules are now final. Some authorities have already gone into effect, such as the FDA’s new authority to order companies to recall food, and others require FDA to prepare and issue regulations and guidance documents. Compliance dates for each rule vary based on size of company.

The Risk of Waiting?

There is no need to wait for the FDA to demand that you take action. Many of the requirements are already identified in the language of the law. If you are involved in the production or sale of food, it’s in your best interest to act now. You don’t want to rely on the regulators to ensure the safety of your products. Building a supply chain that protects your brand’s reputation from risk is more important now than ever before. Having systems to verify that your suppliers are meeting your expectations with respect to food safety, and having a well-documented, exercised recall plan in case things go wrong are necessary to the continued success and vitality of your business.

When you’re ready to efficiently manage your FSMA record requirements in relation to Food Safety Preventive Controls, your Food Safety Plan, proof that Hazards are effectively controlled, and more, reach out to us.