The U.S. Centers for Disease Control and Prevention estimates that roughly 48 million people contract a foodborne illness every year, resulting in about 128,000 hospitalizations and 3,000 deaths. So, it’s easy to understand why food safety remains a significant concern for those in the food industry, and why Congress passed the Food Safety Modernization Act (FSMA) in 2010. But how did we get here?
A Brief History of HACCP
Before the Obama Administration, the food industry relied primarily on Good Manufacturing Practices (GMPs or CGMPs), which provided a basic framework for manufacturers dealing with food safety. But during the Cold War's space race in the 1960s, it dawned on researchers that food must not only provide balanced nutrition; it also can’t create health issues along the way. That food needed to be safe.
This realization prompted NASA to enlist Pillsbury Co., which began working on cube-sized foods for astronauts. To ensure proper procedures were in place, NASA mandated the use of Critical Control Points (CCPs) in its engineering, but applying such concepts to food production was a novel concept. Nonetheless, Pillsbury and NASA required contractors to identify “critical failure areas” and eliminate them from the system, thus helping to create the first Hazard Analysis and Critical Control Points (HACCP) program.
A few years later, food industry experts realized that “food safety” and “HACCP” weren't necessarily synonymous. Instead, food safety is an integrated system of HACCP programs plus GMPs, which are now usually called prerequisite programs (PRPs) — policies that are now part of government regulations globally, including Codex and ISO 22000.
Several years later, with the passage of FSMA, legislation aimed at guaranteeing the safety of the U.S. food supply, which shifted the focus of federal regulators from responding to contamination events to preventing them altogether. Of particular note are the Hazard Analysis and Risk-based Preventive Controls (HARPC) provision of FSMA, a HACCP alternative.
The design is similar to HACCP but more comprehensive. So, what is HACCP?
While the U.S. Food and Drug Administration also mandates HACCP, its application is specifically for juice, seafood, retail, and foodservice. Still, HACCP’s principles are prevalent across all segments of food production. They’re primarily concerned with raw materials, products, and processes, and often mandated by large brands to their suppliers and the suppliers’ suppliers.
HACCP’s seven principles are:
Conduct a hazard analysis.
Determine the CCPs.
Establish critical limit(s).
Establish a system to monitor control of the CCPs.
Establish corrective action to be taken when monitoring indicates a particular CCP isn’t under control.
Establish procedures for verification to confirm the HACCP system is working effectively.
Establish documentation concerning all procedures and records appropriate to these principles and their application.
Drafting a HACCP plan is a necessity, and a useful practice to identify and define risks that need monitoring.
What is HARPC?
HARPC requires that companies have written plans that identify hazards, list the steps needed to minimize or prevent those hazards, identify monitoring procedures and record the results, and specify what actions to take to correct should problems arise. The FDA evaluates these plans and verifies proper implementation and ongoing adherence.
HARPC requires companies evaluate products and processing for:
Biological, chemical, physical, and radiological hazards.
Natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives.
Naturally occurring or unintentionally introduced hazards.
Intentionally introduced hazards, including acts of terrorism.
What are the Main Differences?
The main difference between HACCP and HARPC is that HACCP, as mentioned above, only applies to seafood and juice processors. In contrast, HARPC applies to almost all food-processing facilities, except those covered by and in compliance with HACCP (and a few other significant exemptions).
According to FoodOnline.com, HARPC mandates that facilities:
Conduct a thorough hazard analysis for all food-processing procedures.
Develop and implement preventive controls and then monitor their effectiveness. (HACCP requires a team and a process flow diagram, while HARPC requires a qualified individual and no diagram).
Prepare a detailed, written plan describing how to control hazards, the preventive controls put in place, and a schedule and methodology for monitoring their efficiency.
Verify the effectiveness of the controls, also maintaining written records of the verification processes.
Reanalyze the HARPC plan at least every three years; more often, when adding new product lines, equipment is changed or upgraded, or other changes require reanalysis. HACCP requires a review of the documentation annually.
Additionally, HARPC includes planning for potential terrorist acts or intentional adulteration, food fraud, and a comprehensive recall plan.
Ultimately, a validated HACCP plan is the best precursor to a successful HARPC plan, but having an effective HARPC plan almost always ensures compliance with HACCP mandates.
A hazard analysis plan, whether HARPC or HACCP, remains a crucial component of every quality program and is critical to avoid costly and dangerous downstream issues. The ultimate goal is to proactively identify food safety problems you might not otherwise know are there.
We've put together a checklist to help companies better navigate their hazard analysis plans, download it here.