Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) was signed into law January 2011. This act focuses on preventing food safety related risks in manufactured food for human food and animal food versus reacting to them when they occur. FSMA is also noted for giving the FDA a role in enforcement to improve compliance, prevention, and response time when a problem does occur, ability to inspect imported foods to ensure they meet same standards as U.S. produced foods and Building partnerships between FDA, states, and local authorities.

FSMA applies to operations that manufacture, process, pack or hold food, and facilities required to register with FDA under sec. 415 of the FD&C Act. It excludes farms and retail food operations. Covered facilities are required to have a hazard analysis and risk-based preventive controls plan that is implemented as stated by the regulation. Operations must have a Preventive Control Qualified Individual (PCQI) to comply with the Preventive Control Rule. To become a PCQI an individual is required to complete an FDA-recognized curriculum course such as the one developed by the Food Safety Preventive Controls Alliance (FSPCA), that is recognized by the FDA. This person will oversee the implementation of the facility’s food safety plan and other key tasks.

Preventive Control for Human Food and Animal Food Courses are available through Clemson Cooperative Extension. Both courses are 2.5-days using the standardized curriculum developed by the Food Safety Preventive Control Alliance (Illinois Institute of Technology). It includes a certificate of successful completion by the Association of Food and Drug Officials (AFDO). There are a limited number of seats in each course to ensure that participants obtain a thorough understanding of the concepts.

Attendees are required to demonstrate competency in Preventive Controls and Risk-based principles to receive the certificate. This is accomplished by attending the class in its entirety and participating in the classroom exercises. Individuals completing the course will become Preventive Control Qualified Individuals (PCQI) and can perform all the food safety activities as outlined in FSMA. FDA requires one PCQI per facility to remain in operation.

For assistance registering for classes, please contact Frances Seel.

For general questions, please contact Kimberly Baker.

Additional Resources

FDA Food Safety Modernization Act (FSMA)

Food Safety Preventive Controls Alliance (FSPCA)