What is the difference between a HACCP Plan and a FSMA Food Safety Plan?

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First of all, HACCP stands for Hazard Analysis and Critical Control Points. According to the USDA, HACCP is a “systematic approach to the identification, evaluation, and control of food safety hazards.” Basically, the approach centers on identifying the key steps (the “control points”) in food processing where safety risks can be eliminated or reduced to an acceptable level.

So, what is the difference between a Food Safety Plan and a HACCP plan? According to Dr. Mark Morgan Professor of Food Processing and Extension Specialist at UT Knoxville, a Food Safety Plan, under the Preventive Controls for Human Foods Rules of the Food Safety Modernization Act (FSMA) is a replacement or extension of HACCP. Dr. Morgan explains “the difference between a Food Safety Plan (under FSMA) and a HACCP plan is that a Food Safety Plan includes: process preventive controls, sanitation preventive controls, allergen preventive controls, and supply chain preventive controls to address potential hazards.  The HACCP program only has critical control points (CCPs) which are essentially equivalent to process preventive controls. When referring to Grade A milk processing, the PMO covers biological hazards.  So, a Food Safety Plan is only needed (required by FDA) to address chemical and physical hazards. For other dairy products, not part of the PMO, a Food Safety Plan must cover all potential hazards, biological, chemical, and physical.”

When does a dairy processor need a HACCP plan vs. a Food Safety Plan? According to Paul Wadham at the Tennessee Department of Agriculture, the FDA requires a Food Safety Plan for dairy processors that sell across state lines and are included on the Interstate Milk Shippers (IMS) list. Dr. Morgan notes that “Food Safety Plans are now required for essentially any food regulated by FDA except those that have specific regulations such as PMO, juice HACCP, Seafood HACCP, and Meat HACCP, etc.  Also, there is an exemption under FSMA for “qualified facilities”.  This is a complex part of the regulation (21 CFR part 117 subpart D) but basically, someone can claim to be exempt based on being a ‘small’ processor.”

The most common situation where a dairy processor would need a HACCP plan is when they are also processing juice. Producing juice or juice drinks can be a great way to fill out the production schedule for a dairy processor who has unused plant capacity. But doing so requires submitting to FDA inspection and abiding by the Juice HACCP Regulation (link).         

Dairy processors who need to develop or update a Food Safety Plan that complies with FSMA should take the Preventive Controls for Human Foods Course (link). By passing this course, a person can become a Preventive Controls Qualified Individual (PCQI). Having a PCQI on staff or under contract is one of the requirements to implement a Food Safety Plan under FSMA. For those who are looking to expand their product offerings to juice, a short course on HACCP is also available at many universities including UT (link).