NASA created the HACCP (Hazard Analysis Critical Control Points), which is a global standard developed as part of Codex Alimentarius to improve upon and synchronize international food standards, guidelines, and codes of practice to protect the health of consumers.
The FDA created HARPC (Hazard Analysis and Risk-Based Preventive Controls for Human Food). HARPC is written within Section 103 of FSMA (Food Safety Modernization Act) guidelines, and requires that food manufacturers or processing facilities operate with the strategies and guidelines in place, including:
- Food Safety Plan - Every facility should have someone on staff to prepare the food safety plan and successfully complete training from an accredited food safety program.
- Identify Hazards – Have a plan for unapproved additives, drug residues, toxins, and even radiological hazards.
- Validation of Preventive Controls – Test/ensure process controls work and at reducing microorganisms.
- Record Keeping – Verification and monitoring is documented, as it will be essential to provide readily available data in instances of an inspection/audit. The FDA will require a written record of the entire plan, including the process, proof, and problems (if any).
- Continuous Analysis of the Food Safety Plan – Determine if and when plan needs to be updated throughout its implementation.
HARPC is a US Standard which affects a number of FDA-regulated products & HACCP is a global standard.
HACCP & HARPC both define hazards (such as biological, chemical and physical) but HARPC includes radiological and intentional hazards to its high risk category.
HACCP Hazard Analysis is performed using procedures and controls guides outlined by the seafood, juice, etc. The HARPC rule affects all food processing companies, while HACCP is performed in juice and seafood processing, and meat processing by the USDA/FSIS.
In light of the latest FSMA requirements, companies affected by this ruling are highly encouraged to comply with the HARPC plan. At this time, there is no statutory requirement to submit an HARPC procedure to FDA within a designated time frame, but companies are encouraged to do so in case the FDA comes knocking. An obvious conclusion would be that most suppliers, shippers, manufacturers, and transporters of food commodities do want to have a plan in place to curtail any exorbitant fines or loss of business.
In any instance where a safety plan is not set in place, and a non-compliant company poses a potential food safety risk, the FDA is authorized to suspend this company’s registration and prohibit the facility from conducting business until it is cleared by the FDA.
If there are still questions food suppliers have as to whether they should adhere to HACCP or HARPC standards, a good rule of thumb would be to put operational semantics aside, and apply both systems into their business procedures, especially if the industry falls into the ‘high-risk’ category.
In short, HARPC is HACCP, but with an added ounce of prevention and a high concentration of risk mitigation.