Key  Requirements

1. Covered facilities must establish  and implement a food safety system that includes an analysis of hazards and  risk-based preventive controls. 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.

 Product testing and environmental monitoring are possible verification  activities but are only required as appropriate to the food, facility, nature  of the preventive control, and the role of that control in the facility’s  food safety system. Environmental monitoring generally would be required if  contamination of a ready-to-eat food with an environmental pathogen is a  hazard requiring a preventive control.

2. The definition of a ‘farm’ is  clarified to cover two types of farm operations. Operations defined as farms  are not subject to the preventive controls rule.

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