4. What if I need a Preventive Control?

First let us look at two definitions:

  1. 21 CFR 507.3 defines a “Hazard Requiring a Preventive Control” as
    • A known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of animal food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury to humans or animals 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 an animal food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the animal food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.
  2. 21 CFR 507.3 defines a “Preventive Control” as
    • Those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of animal 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.

If your Feed Safety Plan identifies a Hazard Requiring a Preventive Control, you will need to use one of 4 classifications of Preventive Controls to control the hazard. These are: Process Control, Sanitation Control, Supply Chain Applied Control or Other Control. The FSPCA Preventive Controls for Animal Food course defines each of these in detail.

In a livestock feed mill the most common type of preventive control is the Process Control. This is a series of steps that are required that will minimize the risk of the hazard occurring. There are four required components to a process control:

  1. Monitoring requires written procedures defining the specific steps to be taken to prevent the hazard from occurring. Employees responsible for monitoring the process must be trained in the importance of the procedures in controlling the identified hazard.
  2. Corrective Actions and Corrections define the specific steps that must be taken should the process fails to control the hazard. This must describe actions that must be taken to ensure that:
    • Appropriate action is taken to identify and correct a problem that has occurred with implementation of a preventive control;
    • Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur;
    • All affected animal food is evaluated for safety; and
    • All affected animal food is prevented from entering into commerce if you cannot ensure the affected animal food is not adulterated
  3. Validation answers the question… Am I doing the right thing to control the hazard? This requires the documentation of scientific and technical evidence that supports the process selected will control the hazard, when the process is properly implemented.
  4. Verification of Monitoring, Corrective Actions, and Implementation and Effectiveness answers the question… Am I doing it correctly? Are the preventive controls in the Food Safety Plan being properly implemented in a way to control the hazard?

All of these components of the Process Preventive Control must be documented and are subject to the records requirements of the rule.

Sanitation Controls, Supply Chain Applied Controls and Other Controls require some, but not all, of these management components. There is no substitute for the training provided by the FSPCA preventive Controls for Animal Food course to clearly understand the requirements of the rule.