By OFW Law and HACCP Consulting Group
Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) made the decision that registered facilities would be required to implement food safety plans based on preventive controls rather than the principles of HACCP. Since HACCP is already mandatory for identified hazards in seafood, juice and foods regulated by the Food Safety and Inspection Service (FSIS), many regulated food companies are trying to understand the differences. Working together, OFW Law and the HACCP Consulting Group (HCG) determined that understanding the terminology can assist processors in complying with the necessary food safety laws.
OFW and HCG developed a simple analogy that all stakeholders in the food industry would understand. The group realized that everyone was familiar with Tex-Mex food, and it serves as a great model for understanding. One great aspect of Tex-Mex is that there are many dishes, but in essence, the same seven major ingredients make up each dish. In simplistic terms, each Tex-Mex dish is a different combination of the same seven ingredients: (1) protein (beef, chicken, pork), (2) cheese, (3) beans, (4) tomatoes, (5) condiments (sour cream, guacamole, salsa), (6) starch (rice, taco shell, nacho chips), and (7) lettuce. How these ingredients are combined depends on the end user. The final dish has a unique character, but all Tex-Mex dishes are similar.
When considering a food safety plan, this too depends on key ingredients. In the case of a food safety plan, the end user must: (1) understand the hazards, (2) manage hazards commensurate with the level of risk, (3) monitor, (4) verify, (5) take corrective actions and make corrections as needed, (6) validate, and (7) document. Each food safety plan has a unique character but all have the same objective – to focus on what matters for the safety of the food being produced. OFW and HCG suggest that if we concentrate not on what we call it (taco vs. tamale), but instead on how we manage it, then the end goal of food safety can be reached.
Questions you may still have include:
- What is the difference between FDA’s preventive controls for human food and HACCP? We would suggest you consider the FDA preventive controls as “HACCP plus more.”
- What is the “plus more?” FDA requires registered facilities to conduct a hazard analysis and identify preventive controls, which include as appropriate for the facility and the food – process controls, allergen controls, supplier controls, and sanitation controls.
- What are preventive controls? FDA describes preventive controls as “the measures that are required to ensure that hazards requiring a preventive control will be minimized or prevented. They include process controls, food allergen controls, and sanitation controls, as well as supply-chain controls and a recall plan.”
- Haven’t some FSIS facilities determined through their hazard analysis that sanitation and supplier controls are a pre-requisite program? How do pre-requisite programs compare to preventive controls?
- FSIS regulated facilities use pre-requisite programs to demonstrate hazards are not reasonably likely to occur.
- FDA regulated facilities use preventive controls to minimize or control hazards that are likely to occur.
- Where do CCPs fit into preventive controls? CCPs can be preventive controls.
- How does FDA view GMPs? FDA considers GMPs as mandatory activities not tied to a specific or likely hazard, e.g., handwashing.
- How do I write my FDA food safety plan? We would encourage you to start with the hazard analysis. As with an FSIS HACCP plan, registered facilities will need to support the decisions they make when meeting FDA requirements for preventive controls.
- Who can write the food safety plan? Registered facilities must have a preventive controls qualified individual (PCQI, either in-house or as a consultant, who is responsible for developing and applying their food safety system. Training provided by Food Safety Preventive Controls Alliance (FSPCA) Lead Instructors will achieve this goal of certifying someone as a PCQI. FDA has indicated that individuals can “otherwise qualify;” however, there are no specific guidelines or assurances that this method will be acceptable to the FDA inspector on a case-by-case basis.
- What is the Food Safety Preventive Controls Alliance? The FSPCA is public private alliance consisting of key industry, academic and government stakeholders whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations.
- Will all these new terms create problems? Not if you manage food safety conditions appropriately and can prove that you have done so. We encourage you to take a FSPCA course to learn how….
We encourage you to contact OFW Law and HCG for assistance with your preventive control plans or training needs that you may have.