The U.S. receives imported food from nearly 200 countries with hundreds of thousands of facilities supplying food to American consumers. Through the Food Safety Modernization Act (FSMA), the U.S. is focusing its efforts on proactively ensuring its food supply, including from global sources, is produced in accordance with its food safety standards to prevent contamination that can cause illness.

With the passing of FSMA, America’s Food and Drug Administration (FDA) moved from reacting to food-borne illness outbreaks to a program focused on prevention. The FDA mandates that food producers, including foreign food importers, take preventive measures to ensure food safety and maintain applicable records. Food facilities must now develop a HARPC plan – current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food – a requirement for compliance with FSMA.

Who needs a HARPC plan?

Any facility that manufactures, processes, packs, distributes, receives, holds or imports food into the U.S. must develop a HARPC according to the law.

If you are a food facility, it’s likely you already have the widely used HACCP (Hazard Analysis Critical Control Points) plan, provided to retailers, auditors, inspectors and in some cases, government authorities. Your facility may continue to use HACCP for certain countries or customers. HACCP is a regulatory standard, unlike HARPC which is mandated by U.S. law for businesses that fall within the legislation’s governance. HARPC covers matters of food safety concern beyond the critical control points and is an FDA requirement.

Although a HARPC plan is similar to a HACCP plan, there are notable differences. Understanding these differences will help you if you need to modify your HACCP to create a compliant HARPC plan.

What’s Different in HARPC?

• HACCP seeks to control three main food safety hazards: biological, chemical and physical. In HARPC, the hazards assessment extends to biological, chemical, physical and radiological hazards. The hazards assessment is broader, beyond the conventional hazards, and considers risks such as: natural toxins; pesticides; drug residues; decomposed material; parasites; allergens; unapproved food and color additives; naturally occurring hazards; unintentionally introduced hazards; and intentionally introduced hazards, including acts of terrorism. When assessing the hazards for a HARPC plan, any facility-specific issues must also be addressed including food defense and emergency management.
• HACCP is designed to focus on critical control points, whereas HARPC focuses on preventive controls that are science or risk-based. These controls aim to “significantly minimize or prevent” known or foreseeable hazards for food that is regulated. HARPC documents identified risks and preventive controls and formulates a plan with corrective actions. A key difference between HACCP to HARPC is that HARPC incorporates science or risk-based preventive controls rather than critical control points. These preventive controls must be supported by scientific data or scientific literature. The FDA may accept proven “tried and true processes” and trade association published data which show that controls are supported by established scientific data. The FDA anticipates evaluating relevant data every 2 years.
• Preventive controls in HARPC extend to such aspects as: sanitation procedures at food surface contact points and with utensils and equipment; staff hygiene training; environmental monitoring program for pathogen controls; food allergen control program; and supplier verification activities. HARPC extends controls to a food processor’s entire supply chain.
• A HARPC plan must be developed, implemented and maintained by an individual or team of “qualified individuals” who are properly trained. You must now have personnel in place (either on staff or a third-party) who can meet the Qualified Individual requirement for preventive controls. This can be a floor operator, supervisor, auditor, PCQI consultant. The law stipulates training in certain areas, while other areas have recommended levels of expertise. (see our article in this issue on training)
• A facility must update its HARPC plan at least once every 3 years if there are no significant changes, or when there is a significant change at the facility (such as a change that increases a potential hazard or introduces a new hazard). A HACCP plan is typically updated on a yearly basis.
• You should be meeting the intent of your food safety plan and documenting your preventive controls, verification and validation of your processes including monitoring, as well as plans for corrective action. To prove that your controls are in place and are effective, you must prepare a written food safety plan which is a requirement of FSMA law as well as maintain records of testing and results. If you identify a potential hazard, you must now have a written recall plan (the recall plan is now required – not just recommended as with HACCP).
• Understanding the HARPC vocabulary will be useful as you incorporate those terms into your plan.

It’s possible to take aspects of your HACCP plan to develop a HARPC plan with consideration given to the broader spectrum of hazards to assess and newly required elements. If you need assistance in making this transition to HARPC, qualified companies can help you. Our company, The Radius Group, Inc. is equipped with the knowledge to serve as an FSVP Importer (Foreign Supplier Verification Programs Importer) and can assist with formulating a comprehensive HARPC plan.

The Radius Group, Inc. (TRGI) is a U.S.-based FSVP Importer located in Elizabeth, New Jersey – in the same building as the Port Newark offices of the U.S. Customs and Border Patrol. TRGI is the preferred FSVP Importer regulatory partner for food and beverage trade show exhibitions in North America. In addition to food safety and FDA food and beverage facility registration, TRGI also acts as a basic importer of alcoholic beverages. The TRGI team also serves as a drug and medical device information agent on behalf of foreign manufacturers importing into the U.S. for trade show exhibition, distribution or sale, or for import processing and then export. In the United States + (201) 400-6616 and on the web at TheRadiusGroupInc.com