Known or Reasonable Foreseeable Hazard

Continuing with our FSMA tip series, this week’s tip is about the definition of known or reasonable foreseeable hazard contained in the preventive controls rule for human food.

The rule defines a known or reasonable foreseeable hazard to mean a biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.

Like preceding tips, let us take the above definition of a food hazard apart and explore practical considerations and applications. We will take biological hazards as an example.

  • First, let us look at the definition in relationship to the “food”.
    • Since the first applications of HACCP were implemented in the food industry in the early eighties, a lot of knowledge about hazards associated with food has been gained from food safety failures, outbreaks and research. So much so, that we can today say with a high degree of confidence, what hazards are associated with many raw materials, ingredients and food contact substances, and therefore with certain food categories.
    • Another way of understanding “known” hazards is to define them as being inherent to or associated with the food product. In other words these hazards are un-avoidable. For example, known pathogenic bacteria are associated with certain agricultural commodities, such as fruits and vegetables which are eaten in their raw state. Similar pathogenic bacteria which are inherent to the sources of red meat, poultry, eggs and raw milk. Certain natural toxins which are associated with other agricultural commodities, such as grains and coffee beans. These toxins are the result of certain fungi, which generate toxins under certain environmental growth conditions.
    • Thus, the advantage of “knowing” which biological hazards are inherent to, or associated with these types of “food” provides us with the needed scientific knowledge to identify and implement appropriate controls to prevent, eliminate, or minimize hazards to acceptable levels in the final food product. Generally, these controls would be process steps and/or preventive control programs.
  • Let us now take a look at the definition in relationship to the “facility”.
    • This association is somewhat more challenging than the first. Let us start by assuming that we have a facility with an appropriate sanitary design, well-constructed and maintained. What could be “known or reasonable foreseeable hazards” associated with such a manufacturing environment?
    • Let us approach it this way. Knowing that the facility will be subject to un-avoidable “known or reasonable foreseeable biological hazards” associated with incoming inputs what biological hazards can we reasonably foresee occurring in the manufacturing environment, or are known to have occurred in manufacturing facilities?
    • These biological hazards were not present when the facility originally started, however, due to their association with inputs, employees and ubiquitous nature could suddenly appear in the manufacturing environment, take residence and could then end up adulterating the food product.
    • So the question is how can we prevent these non-inherent hazards from appearing, taking residence and adulterating the product? What are the appropriate preventive controls which would succeed in maintaining the appropriate structural and operational sanitary and maintenance conditions and thus negate such “avoidable” hazards the opportunity to occur in the manufacturing environment?
    • These preventive controls are rooted in the cGMPs, which formalized as preventive prerequisite programs for those activities that are effective in preventing biological hazards associated with employees, maintenance requirements, construction and sanitary conditions of the floors, drains, ceiling walls and equipment, utensils, traffic controls, air handling, etc.

In summary, “Known or Reasonable Foreseeable Hazards” can be split into two groups, those who cannot be avoided since they are associated (inherent) with the inputs/products, and those which are not inherent but will become present unless effective preventive measures are in place. With a couple of exceptions, the first group is minimized / eliminated with process controls, while the second group is prevented from occurring with appropriate preventive controls, such as sanitation controls, sanitary design and maintenance, and personnel practices. The preventive controls are critical after a “kill step” which will control biological hazards, since any recontamination is likely to reach the consumer if it is RTE foods.

Next week’s tip will look into the definition known as “hazard requiring a preventive control”. Again, we will explore some practical understanding and applications.

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