Differences between the HACCP plan and the Food Safety Plan [HARPC plan] required by the FDA under the FSMA legislation on the safety of food products to be exported to the United States of America

The Food Safety Plan involves a series of protocols similar to those of HACCP but starts from different assumptions and adopts a different approach in identifying and preventing the risks inherent in food production and preparation

How to prepare the Food Safety Plan to export food products to America

The HARPC manual focuses on the risks inherent in food preparation processes

ExportUSA provides advice and practical assistance for preparation of the Food Safety Plan and HARPC manual for exporting food products to the United States

A complete service of analysis, consultancy and implementation of the procedures necessary to comply with FSMA and for the preparation and adoption of the Food Safety Plan / HARPC

The HACCP system is a global standard, developed in the 1950s and 1960s by a group of engineers and scientists from three different organizations, including NASA, to prepare and adopt a global food safety standard in line with the Codex Alimentarius.

The evolution of HACCP has been continuous, resulting in an effective and efficient global food safety management system (FSMS).

The Food Safety Plan for FSMA [summarized in the HARPC manual] has a similar, but different, objective to that of HACCP and places an emphasis on identifying risks [of raw material procurement, food production processes, storage of finished products and their transport] with a focus on the implementation of appropriate corrective actions in a proactive way to prevent contamination.

To date, the Food Safety Plan and HARCP manual are not a global standard but rather an all-American standard that has been incorporated into the FSMA [Food Safety Management Act]

Basic elements for preparation of the Food Safety Plan / HARPC plan

• Risk analysis for all food processing procedures;
   
• Prepare and implement preventive controls and monitor the effectiveness of the controls themselves;
   
• Prepare a detailed plan in writing that describes: how the risks will be controlled, the preventive controls put in place, the program and methodology to monitor the efficiency of the controls;
   
• Verify the effectiveness of controls, keeping a written record of the verification processes;
   
• Review the HARCP plan at least every three years; or more often, however, if new product lines are added or if machinery is changed or new production lines are adopted.

Example of risks to be identified in the HARPC manual

• Physical and radiological, biological, chemical, natural toxins, pesticides, drug residues, decay residues, parasites, allergens, and unapproved food additives and dyes;
   
• Hazards / risks present in nature and/or unintentionally introduced into the food chain;
   
• Intentionally introduced hazards / risks (including also as a result of acts of terrorism).

Some examples of preventative checks listed by FSMA for HARPC plans

• Sanitation procedures at the contact points of the food surface;
   
• Hygiene of tools and equipment;
   
• Staff training;
   
• Environmental monitoring program (for pathogenic controls);
   
• Food allergen control program;
   
• Record keeping activities;
   
• Current Good Manufacturing Practices (GMP);
   
• Supplier verification activity.

Typical requirements to keep in mind when preparing the Food Safety Plan [HARPC plan] required by FSMA for food safety:

• Written risk analysis (assessment of the dangers that could reasonably compromise food safety);
   
• Validated preventive checks in writing (specifying which preventive measures or controls will be implemented to significantly reduce or prevent risks, and how the controls will be monitored in the plant to ensure that they are effective);
   
• Written records of routine monitoring actions;
   
• Written procedures of corrective actions for each identified risk (specifying which actions will be necessary to correct the problems that arise);
   
• Written approval of the suppliers of the hygienic conditions of supply in compliance with the FSMA regulations and verification program;
   
• Written verification procedures for monitoring of identified risks by suppliers as well as by the downstream manufacturer. Let us consider the case of a slice of chicken in a sealed bag which is added to a sealed bag of salad to form a single packet of a "ready to eat" meal.
   
• In cases like these, the program must include specific verification activities for the preventive control of each risk, sometimes with also an on-site inspection. The receiving plant must therefore also keep the documentation of the review carried out;
   
• Written recall plan for those foods that present a reasonably probable danger of malfunctioning of a preventive control and its respective corrective action;
   
• Regular self-assessments by the management and employees at a food facility. It can be useful for demonstrating preventive checks and any corrective actions implemented to resolve non-compliant preventive checks.
   

To conclude, if you have a well prepared HACCP plan and if you follow the procedures, adopting a HARPC plan compliant with the FSMA regulations will primarily involve paperwork.