Overcoming The Challenges Of Building A HARPC-Based Food Safety Plan

By Sam Lewis

Obviously, FSMA is a food safety game changer, shifting the paradigm of the food industry from reaction to food safety events to one of preventing them. Because of this, many food manufacturers and processors are not only scrambling to comply with new rules, but they have many questions about how to get there. Here, Anne Sherod, MS, director of food safety at The Acheson Group, answers my questions about creating and implementing a food safety plan based on HARPC thinking.

Food Online: What is the biggest challenge companies face when creating a food safety plan (FSP) based on HARPC thinking?

Sherod: I believe there are two equally challenging topics. The first is how to determine if you need to develop a food safety plan. Based on the proposed rule, if a facility does not fit into the following categories, it will have to develop a food safety plan.

Full Exemptions

• very small facilities
• company with less than $500,000 in annual sales
• company solely engaged in the storage of raw agricultural commodities (other than fruit and vegetables) intended for food that is fully packaged and is not exposed to the environment
• seafood and juice facilities subject to HACCP
• facilities that produce dietary supplements
• farms and mixed-type facilities subject to FSMA’s Produce Rule
• very small or small farms or mixed-type facilities engaged with low-risk foods or activities

Partial Exemption

• Facilities that produce low-acid canned goods are exempt from the micro hazards, but must apply chemical (including radiological) and physical hazards.

The second challenging question is identifying “significant hazards” in the context of the new HARPC approach and their subsequent components of preventive control management. Significant hazards are more than just hazards that are reasonably likely to occur in HACCP and controlled via critical control points.

Food Online: What can companies do to address those two challenges? How do they approach them?

Sherod: I recommend companies have a person who is knowledgeable about safe food manufacturing, processing, packaging, and holding. The Food Safety Plan using the HARPC approach must be developed by a “Qualified Individual.” The proposed rule requires the Qualified Individual (QI) to be qualified by experience and education. It is imperative to consider safe food manufacturing in the context of many different risks, including:

• inherent ingredient risks, which could be ready-to-eat or not ready-to-eat, temperature controlled for safety, allergen, pits, bones, etc.
• supplier risks, including primary or alternative suppliers and their practices
• processing risk, such as time and temperature for cooking cooling, formulation control, pH, aW, antimicrobials, etc.
• sanitation risks — how long can you run the operation before it needs cleaned? What data is used to support that position?
• environmental cross-contamination and allergen cross-contact risk. — e.g., environmental pathogens Salmonella and Listeria monocytogenes and allergen scheduling, storage, and labeling
• data analysis and understanding test results to develop corrective actions, preventive measures, and continuous improvement programs to ensure remediation of any potential and persistent issues
• equipment risks and preventive maintenance — e.g., replacing O-rings before they crack or break, work order prioritization based on environmental health and safety and food safety equally, and cleaning tools.

Processors and manufacturers are not alone in creating a HARPC-based food safety plan. If they are having trouble creating their food safety plan, they can reach out to external third-party subject matter experts for assistance. These experts can offer a step-wise approach to develop a food safety plan. They also can transform an existing food safety system, including HACCP and prerequisite programs, into a robust food safety plan.

Food Online: Regarding the QI who develops an FSP, you say that person “must have education and experience relevant to food safety.” What exactly does that entail? What are some examples of that education and experience?

Sherod: The FDA has not defined “education and experience.” They define a QI as “a person who has successfully completed training in the development and application of risk-based preventive controls equivalent to that of an FDA-recognized standardized curriculum or is otherwise qualified through job experience to develop and apply a food safety system.” The Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) has created the Food Safety Preventive Controls Alliance (FSPCA) and published a draft training curriculum program to assist with the proposed Human and Animal Preventive Controls Rule. It may be easier to have a training certificate than to develop a resume or curriculum vitae and discuss qualifications with the FDA.

Food Online: A complete FSP requires a food recall plan. What are the requirements of this? What should companies do to ensure their food recall plan is effective?

Sherod: It is important for all companies to be prepared and have a recall plan. In the Preventive Controls proposed rule, foods determined to have a significant hazard are required to have a written recall plan. For an effective recall plan, the following is the sequence of steps to be taken, as well as roles and responsibilities of the recall team members:

• Assemble a recall team, including identification of a coordinator and their supporting staff.
• Complete an internal review of all affected products, including all pertinent records and determination of location of all implicated products.
• Directly notify first-level consignees (the customers/consumers that received the food from the recalling firm) of the food being recalled. This communication needs to have instructions on how to return or dispose of the affected food and track inventories accordingly.
• For a class 1 recall, you must notify the public about any hazard presented by the food to protect public health. The FDA has a template to use, and companies will work in conjunction with the agency to finalize the public notice.
• Conduct effectiveness checks to verify that the recall instructions are carried out by first-level consignees.
• Appropriately dispose and document the recalled food “through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.”
• Have procedures for effectively communicating this to the proper authorities on the local, state, and federal levels as appropriate.
• Post recall assessments to determine how well the procedures were carried out and learnings that can be applied to further improve the program.
• Complete an annual review of the recall plan and conduct a mock recall to ensure recall readiness.

The proposed rule also discusses testing the system and using what was learned to continue to improve. Recall plans do not seem “preventive.” However, a solid plan that is well executed can limit the further distribution of contaminated product and protect risk to the public health.

Read more about the differences between HACCP and HARPC here.