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CERT ID White Paper Series-Issue 1 – Series 5 – Managing Food Safety Risks:HACCP and HARPC
Food safety risk management is the process of identifying food hazards based on risk of exposure to consumers and applying controls to reduce or eliminate identified hazards to an acceptable level that protects public health.
Two food safety risk management methodologies for reducing foodborne illness utilized by regulatory authorities include:
Hazard Analysis and Critical Control Point (HACCP)
HACCP is a hazard-based food safety management system with Critical Control Points (CCP) to reduce or eliminate hazards in the food product to acceptable levels which protect consumers.
Hazard Analysis and Risk-based Preventive Controls (HARPC)
HARPC is an evolution of HACCP methodology, which employs a risk-based food safety management approach. The development of a HARPC system utilizes qualitative and quantitative risk assessments to identify significant food safety hazards and apply effective preventive controls to reduce or eliminate identified hazards.
The most significant difference between HACCP and HARPC lies in the underlying principle that preventive controls under HARPC may be required at points other than CCP’s where critical limits are not established. Other differences include a stronger focus on risk assessment in identifying hazards, which correlate to public health significance based on risk of exposure to the hazard.
Development of FDA’s Preventive Controls rule and HARPC methodology aligns with
(but is not the same as) traditional HACCP methodology to meet the requirements of
FSMA regulation as described in the Food, Drug & Cosmetic (FD&C) Act section 103.
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