About FSMA

The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

FSMA contains several major rules dealing with all aspects of the food supply chain. The rules are intended to create a modern, risk-based framework for food safety. These rules include:

Preventive Controls for Human Food Rule

Intended to ensure safe manufacturing/processing, packing, and holding of food products for human consumption. The regulation requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”.

Preventive Controls for Animal Food Rule

Establishes Current Good Manufacturing Practices and preventive controls for food for animals.

Produce Safety Rule

Establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.

Accredited Third-Party Certification Rule

Establishes a voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.

Foreign Supplier Verification Programs Rule

Requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

Sanitary Transportation of Human and Animal Food Rule

Establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.

Mitigation Strategies to Protect Food Against Intentional Adulteration Rule

Requires mitigation (risk-reducing) strategies for processes in certain registered food facilities in order to prevent acts intended to cause wide-scale harm to public health.

The Produce Safety Rule and Preventive Controls for Human Food Rule are the rules most likely to affect local producers and processors.