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Can your food process guarantee the destruction of pathogens?

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses began in September 2016.

Facilities under this standard need to establish and implement a system that provides evidence of the destruction of pathogenic microorganisms through thermal processes.

The rule sets requirements for a written food safety plan that includes:

  • Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).
  • Preventive controls: These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. They include process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan.
  • Oversight and management of preventive controls. The final rule provides flexibility in the steps needed to ensure that preventive controls are effective and to correct problems that may arise.
    • Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include actual temperature values and be more frequent than monitoring preventive maintenance activities used to minimize metal hazards, which could be a simple record of the date on which the activity took place.
    • Corrective actions and corrections: Corrections are steps taken to timely identify and correct a minor, isolated problem that occurs during food production. Corrective actions include actions to identify a problem with preventive control implementation, to reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent it from entering commerce. Corrective actions must be documented with records.
    • Verification: These activities are required to ensure that preventive controls are consistently implemented and effective. They include validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard; calibration (or accuracy checks) of process monitoring and verification instruments such as thermometers, and reviewing records to verify that monitoring and corrective actions (if necessary) are being conducted.

Through these studies you can guarantee if processes designed to reduce or eliminate biological hazards such as Salmonella or Listeria are effective. The validations must be carried out in each equipment and for each product to be able to demonstrate the logarithmic reduction of Microorganisms.

This is achieved by inoculating the food with a Substitute Microorganism having a greater heat resistance to Salmonella which is subjected to the heat treatment and thereafter evaluating the amount of logarithms which were reduced after being subjected to heat.

Our experts will help you by designing a customized protocol according to the needs of your equipment and process. We have the support of our Food Science Center, located in Chicago and which has internationally renowned experts but also staff who have been trained to carry out these studies locally.

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