Hazard Requiring Preventive Control

This week we will talk about the definition of Hazard Requiring a Preventive Control contained in the Preventive Controls for Human Food rule.

The rule defines a “hazard requiring a preventive control to mean a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's food safety system”.

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 “a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would”.
    • This part contains to the requirement of the Preventive Controls for Human Food rule, that the food safety plan has to be developed, or its development overseen by a Preventive Controls Qualified Individual.
    • The emphasis is on the word “safe”. Therefore, it is imperative that such individual(s) be able to demonstrate, through an appropriate combination of training and experience, the correct set of competencies to fully understand the process.
  • Next, let us look at the definition in relationship to “based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls)”.
    • This part of the definition is straight forward, based on the risk assessment, which is a combination of the probability of a hazard occurring, and its severity, should such hazard reach the consumer. Since under FSMA we are using the science behind “known or reasonable foreseeable hazards”, plus the guidance documents issued by the FDA, the risk assessment results can be achieved.
    • What makes this part of the definition interesting is the portion, which reads “the probability that the hazard will occur in the absence of preventive controls”. It provides for a very practical way of rationalizing about the probability. In other words, the likelihood of a known or reasonable foreseeable hazard will increase if it is a hazard needing a preventive control. Since the intent is to prevent, minimize, or eliminate a hazard, such reasoning helps strengthen the awareness as to why a given preventive control is needed, and what type it must be to be effective.
  • Third, let us look at the definition in relationship to “establish one or more preventive controls to significantly minimize or prevent the hazard in a food”.
    • The message here is to be sure all potential preventive controls have been considered, and where such preventive controls will be applied to achieve the objective, namely to significantly minimize or prevent the hazard in a food. Let us remember that the preventive controls could be applied before the materials are received at the facility, within the facility, or by the customer of the receiving facility (food processor).
  • Finally, let us review the part regarding “components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's food safety system”.
    • This part of the definition pretty much follows HACCP principles, and in the PC rule, validation is contained within verification.
    • What is interesting is the emphasis on “as appropriate to … system”. This additional remark is most likely due to the many findings during past plant inspections, which identified deficiencies such as incomplete hazard analysis, lack of or inaccurate critical limits, inadequate monitoring and verification activities, improper validations or ineffective corrections and corrective actions.
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