Cramer’s Corner – Chapter 1, Slide 4

October 1st, 2022 by Jim Miller

Food Safety Modernization Act

Per Michael Cramer, “In 2011 the Food Safety Modernization Act (FSMA) was signed into law with final implementation in 2015. This law was the most significant piece of food safety legislation since passage of the Pure Food, Drug and Cosmetic Act, and was enacted in part due to a massive peanut butter recall in 2009. In brief, FSMA provides expectations for FDA regulated food facilities with the objective of preventing food safety hazards. The Act not only impacts manufacturing, handling and storage of human foods but also addresses holding and distribution of human food by-products that will be used for animal foods.

FSMA does not necessarily impact USDA/FSIS inspected meat and poultry establishments or egg-producing facilities. However, it’s likely that USDA will review segments of the act and determine if they can be adapted within the Meat Inspection Act or the Poultry Products Inspection Act.

Requirements of FSMA are briefly described in the slide provided in this post, or in greater detail in the book, Food Plant Sanitation: Design Maintenance and Good Manufacturing Practices.”

Slide Content
The Food Safety Modernization Act (FSMA) was signed into law in 2011 and implemented in 2015.

Requirements of FSMA (21 CFR 117) include:
– Covered facilities, FDA regulated, register starting in 2012 and re-registering every two years
– Documented training in food hygiene and food safety principles for all employees
– Development of a comprehensive Food Safety Plan that includes Hazard Analysis Risk-based Preventive Controls (HARPC)
– A Preventive Controls Qualified Individual (PCQI) that guides HARPC development

The Food Safety Plan must also address Allergen Management, a Supply Chain Program and a Recall Program

Sanitation Controls will be a Preventive Control to define how the facility will be maintained in sanitary conditions to prevent or minimize hazards

FSMA is intended to prevent food-borne illness, rather than react to problems


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