HACCP (Hazard Analysis and Critical Control Points) and HARPC (Hazard Analysis and Risk-Based Preventive Controls) are both systematic food safety frameworks, but they serve different regulatory purposes and apply to different types of facilities. HACCP is a longstanding international standard required under specific regulations such as USDA rules for meat and poultry. HARPC is a newer, broader requirement introduced by the FDA’s Food Safety Modernization Act (FSMA), applying to most other food facilities in the United States. The sections below unpack the key distinctions, from who must comply to how each framework handles hazard analysis and preventive action.
Which industries and facilities must follow HARPC instead of HACCP?
Most food facilities registered with the FDA in the United States are required to follow HARPC under FSMA, rather than HACCP. This includes manufacturers, processors, packers, and holders of food for human or animal consumption. HACCP, by contrast, is mandated for specific sectors, primarily meat, poultry, and seafood processors regulated by the USDA or under existing FDA seafood rules.
In practical terms, HARPC applies to a very wide range of food businesses, including:
- Bakeries, snack food manufacturers, and beverage producers
- Dairy processors not already covered by the Pasteurized Milk Ordinance
- Produce facilities subject to FSMA’s Produce Safety Rule
- Contract manufacturers and co-packers supplying branded food companies
- Facilities producing dietary supplements and animal food
Certain facilities are exempt or subject to modified requirements, including very small businesses below a defined annual sales threshold, farms conducting only primary growing activities, and facilities that sell the majority of their food directly to consumers or to restaurants in the same state. However, these exemptions are narrow, and most mid-to-large food manufacturers will fall squarely within HARPC’s scope. If your facility is already following a HACCP plan under a USDA mandate, that does not automatically satisfy FSMA’s HARPC requirements for any products or processes outside that mandate.
How does a hazard analysis work under HACCP compared to HARPC?
Under both HACCP and HARPC, a hazard analysis is the foundational step that identifies what biological, chemical, and physical hazards are reasonably likely to occur in a food production process. The key difference lies in scope and methodology. HACCP focuses on identifying hazards that must be controlled at specific Critical Control Points (CCPs). HARPC requires a broader risk-based evaluation that considers not just the likelihood of a hazard occurring, but also the severity of its potential consequences.
Hazard analysis under HACCP
The HACCP hazard analysis follows a structured, sequential approach tied to a process flow diagram. Teams evaluate each process step, identify hazards that are reasonably likely to cause harm if not controlled, and determine which of those hazards require a CCP. The analysis is grounded in scientific evidence and must be documented formally. Once a hazard is identified as significant, it must be addressed through a CCP with defined critical limits, monitoring procedures, and corrective actions.
Hazard analysis under HARPC
HARPC’s hazard analysis is more expansive. It requires facilities to evaluate known or reasonably foreseeable hazards, a broader category than HACCP’s “reasonably likely to occur” standard. This includes hazards introduced by intentional adulteration (food defense), radiological hazards, and economically motivated adulteration in some contexts. Crucially, after identifying a hazard, HARPC requires the facility to determine whether that hazard requires a preventive control, which may or may not be a CCP. This risk-based determination gives facilities more flexibility but also demands more rigorous, documented reasoning.
What are preventive controls under HARPC and how do they differ from CCPs?
Preventive controls under HARPC are risk-based, scientifically validated measures implemented to ensure that identified hazards are significantly minimized or prevented. They differ from HACCP’s Critical Control Points in that they are broader in type and application. A CCP is a specific process step where control is essential to prevent or eliminate a food safety hazard. A preventive control under HARPC can be a process control, a sanitation control, a supplier control, an allergen control, or a recall plan, none of which fit neatly into the CCP model.
This distinction matters in practice. Under HACCP, if a hazard cannot be controlled at a defined CCP, it may not be adequately addressed within the framework. HARPC explicitly recognises that some hazards are best managed through supplier verification, environmental monitoring, or sanitation programmes rather than through in-process controls. For example, allergen cross-contact is a significant food safety risk that HACCP often struggled to accommodate cleanly. Under HARPC, allergen controls are a defined preventive control category with their own monitoring, corrective action, and verification requirements.
Both frameworks require monitoring, corrective actions, and verification, but HARPC adds a requirement for validation of preventive controls where technically feasible, and mandates a written food safety plan that is reviewed and updated regularly by a Preventive Controls Qualified Individual (PCQI).
Can a food facility use both HACCP and HARPC at the same time?
Yes, a food facility can operate under both HACCP and HARPC simultaneously, and in some cases is required to. This typically occurs when a facility produces multiple product lines that fall under different regulatory jurisdictions. For example, a facility that produces both USDA-regulated meat products and FDA-regulated packaged goods must maintain a HACCP plan for the meat line and a HARPC-compliant food safety plan for the remaining products.
Even where HACCP is not mandated, many facilities choose to retain HACCP-style CCP structures within a broader HARPC food safety plan. This is permissible and often practical, particularly for facilities that have invested significantly in HACCP training and documentation over many years. The FDA has acknowledged that a facility’s existing HACCP plan can serve as the foundation for a HARPC food safety plan, provided it is updated to meet FSMA’s additional requirements, including supplier verification, allergen controls, and the involvement of a qualified PCQI.
The critical point is that HARPC does not replace HACCP where HACCP is legally required. The two frameworks can coexist within the same facility, but each must be implemented and documented according to its own regulatory standard. Facilities should work with regulatory counsel or a qualified food safety professional to map which products and processes fall under which requirement.
How does contamination control at entry points support HACCP and HARPC compliance?
Physical contamination control at facility entry points is a direct supporting measure for both HACCP and HARPC compliance. Under HARPC, sanitation controls are an explicit preventive control category, and environmental contamination, including particulates and microbial matter introduced via foot traffic and wheeled equipment, represents a known and reasonably foreseeable hazard in food production environments. Controlling contamination at the point of entry reduces the risk of that hazard reaching critical process areas.
Under HACCP, contamination control at entry points supports the prerequisite programme framework that underpins the entire system. Prerequisite programmes, including Good Manufacturing Practices (GMPs) and sanitation standard operating procedures, are the foundational hygiene conditions that HACCP relies upon. Entry point contamination control is a key component of those programmes, particularly in facilities handling ready-to-eat foods, allergen-sensitive products, or products with microbiological critical limits.
Industry experience shows that up to 80% of contaminants entering controlled environments do so at floor level, carried in on footwear and wheeled equipment. Addressing this at the point of entry, before contamination can spread to production zones, is a practical and auditable hygiene measure that supports both frameworks.
How Dycem helps with HACCP and HARPC compliance
Dycem’s reusable contamination control mats provide food facilities with a validated, high-performance solution for managing entry point contamination as part of a broader food safety programme. Whether you are building out a HARPC food safety plan or maintaining HACCP prerequisite programmes, Dycem mats offer measurable, documentable contamination reduction at the most critical transition points in your facility.
- Up to 99.9% particulate capture at entry points, reducing the risk of floor-level contamination reaching production areas
- Biomaster silver-ion antimicrobial technology built into every mat, inhibiting microbial growth by up to 99.9% between cleaning cycles
- 3 to 5 year product lifespan, reducing the operational disruption and recurring cost associated with disposable sticky mat programmes
- ISO-certified manufacturing to EN ISO 9001 and 14001 standards, supporting supplier verification and audit documentation requirements under HARPC
- Customisable formats including CleanZone for pedestrian and light-wheeled traffic zones, and WorkZone for heavy-duty forklift and pallet truck environments
Dycem specialists work with food facilities across the world to assess entry point contamination risks and recommend the right contamination control products for each zone. If you are reviewing your food safety plan ahead of an audit or looking to replace a legacy sticky mat programme with a more sustainable and effective solution, speak to a Dycem specialist today to arrange a free site survey.