This week’s tip is about the definition of preventive controls contained in the preventive controls for human food rule.
The rule defines preventive controls to mean “those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis”.
Like preceding tips, let us take the above definition apart and explore practical considerations and applications.
- First, let us look at the definition in relationship to “risk-based”. This part of the definition takes us back to the definition about “hazard requiring a preventive control”. Let us remember that risk-based is a combination of the 1) probability that a “known or reasonable foreseeable hazard” will occur, and if so, then what would be 2) severity on the health consequence. What was interesting about the definition was the part that said “… the probability that the hazard will occur in the absence of preventive controls”. This is important, since such situational analysis allows us to think through very carefully about the chances of a hazard occurring if we did not have an adequate preventive control. Thinking about risk-based in this way allows us to decide on the importance of any preventive control and then on the management elements required.
- Second, “reasonable appropriate procedures, practices, and processes”. Basically what this part of the definition tells us is that preventive controls can be
- A sanitation procedure to clean and/or sanitize a product contact surface, to assure microbiological or allergen control.
- A procedure to control a process step, to assure processing parameters associated with food safety are met consistently.
- A practice, to assure proper personnel practices in a defined area of the plant or process step are maintained.
- A given process step, designed to eliminate or minimize an inherent hazard.
- I am sure many plants have these “appropriate procedures, practices and processes”. Under HARPC, it will be necessary to re-evaluate these and decide whether to rename them as Preventive Controls, and manage them under the Food Safety Plan.
- Third, “a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ”. Again, this part the definition takes us back to the definition about “hazard requiring a preventive control”. Because of its importance, it will be of benefit to reemphasize that:
- The Food Safety Plan must be developed, or its development overseen by a Preventive Control Qualified Individual.
- That such individual must be “knowledgeable about the safe manufacturing…”, making it imperative that such individual(s) be able to demonstrate, through an appropriate combination of training and experience, the correct set of competencies.
- Fourth, “to significantly minimize or prevent the hazards identified under the hazard analysis”. This part of the definition is right out of HACCP. It is worthwhile to emphasize that inherent / unavoidable hazards must be eliminated or significantly minimized with a process step, while non-inherent / avoidable hazards need to be prevented with adequate operational practices and procedures.
- Fifth, “… that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis…”. This last part of the definition makes it clear that the learnings from the last 30 to 40 years, since the food industry began to apply hazard controls, must be used to “document” the reasons 1) why a given hazard is associated with a particular raw material, product, process or process environment, and 2) why the identified preventive control will be adequate, if appropriately implemented. As this part points out, we need to use the most “current scientific understanding”, that is, we must review the scientific sources and select the most current ones to help us understand and justify our findings and conclusions.
For next week’s tip, we will shift gears and begin to look at the hazard analysis part of Part 117. We will start by reviewing the additional hazards considered under HARPC, and why.