HARPC vs HACCP: The Short Answer
HARPC and HACCP are both hazard based food safety planning approaches. HACCP controls significant hazards at critical control points. HARPC is industry shorthand for the FDA's Hazard Analysis and Risk-Based Preventive Controls rules under FSMA, which cover a wider range of preventive controls, including controls that are not at CCPs, overseen by a PCQI.
What Is HACCP?
HACCP (Hazard Analysis and Critical Control Points) is the internationally recognized system set out in the Codex General Principles of Food Hygiene (CXC 1-1969). It is built on seven principles, starting with a hazard analysis and the identification of critical control points.
What Is HARPC?
HARPC is not a term used in the regulation itself. The requirements sit in 21 CFR Part 117 Subpart C, "Hazard Analysis and Risk-Based Preventive Controls". Preventive controls include "Controls at critical control points (CCPs), if there are any CCPs" and "Controls, other than those at CCPs" (117.135(a)(2)).
The named types of preventive control under 117.135(c) are:
- Process controls
- Food allergen controls
- Sanitation controls
- Supply chain controls
- A recall plan
- Other controls
Comparison Table: Scope, Controls, Records, Who Needs It
| HACCP | HARPC (21 CFR 117 Subpart C) | |
|---|---|---|
| Basis | Codex General Principles of Food Hygiene | FDA regulation under FSMA |
| Controls | Critical control points with critical limits | CCPs where they exist, plus other preventive controls |
| Control types | Focused on CCPs | Process, food allergen, sanitation, supply chain, recall plan and others |
| Hazards considered | Significant hazards identified in the hazard analysis | Biological, chemical (including radiological and allergens) and physical, including hazards that "may be intentionally introduced for purposes of economic gain" (117.130(b)) |
| Oversight | HACCP team | Preventive controls qualified individual (PCQI) |
| Who needs it | Required or expected by law and certification standards in many countries | Facilities that manufacture, process, pack or hold food for sale in the US and must register with FDA, unless exempt (117.1, 117.5) |
| Certification | Schemes may audit HACCP | There is no FDA "HARPC certification" |
What a PCQI Does
A PCQI is "a qualified individual who has successfully completed training in the development and application of risk-based preventive controls" (21 CFR 117.3). Under 21 CFR 117.180(a), one or more PCQIs must do or oversee:
- Preparation of the food safety plan
- Validation of preventive controls
- Written justification for validation after the first 90 calendar days
- A determination that validation is not required
- Records review
- Written justification for records review beyond 7 working days
- Reanalysis of the food safety plan
- A determination that reanalysis can exceed 90 days
Separately, 117.180(b) says "A qualified auditor must conduct an onsite audit" where one is required.
Moving from HACCP to a Food Safety Plan
- Start from your existing HACCP plan and hazard analysis.
- Widen the hazard analysis to consider biological, chemical (including radiological and allergens) and physical hazards, including those that may be introduced for economic gain.
- Identify which hazards need a preventive control, including controls that are not CCPs, such as allergen, sanitation and supply chain controls.
- Add a recall plan where required (see our food product recall guide).
- Assign a PCQI to prepare or oversee the plan.
- Set monitoring, corrective action, verification and records for each control.
Exemptions
Under 21 CFR 117.5, the hazard analysis and preventive controls requirements do not apply to some businesses and activities. These include qualified facilities (very small businesses, which have modified requirements), activities covered by the seafood or juice HACCP rules, low acid canned food for the microbiological hazards it covers, and facilities solely storing raw agricultural commodities. Check the exact wording in 117.5 for your situation.
For US traceability records on certain foods, see our FSMA 204 guide. For other risk based plans, see HACCP vs TACCP vs VACCP.