First Two FSMA Rules Are On the Books

Nearly five years in the making, the first two rules for the Food Safety Modernization Act are on the books. The rules cover requirements for good manufacturing practice and hazard analysis and preventive controls for human and animal food.

The rules will impact the manner in which food processing professionals from manufacturers and storage and distribution outlets to transportation companies approach food safety, including pest management.


The rules require facilities to establish and implement a written food safety system that includes an analysis of hazards and risk-based preventive controls. What must the safety plan include?

The Food & Drug Administration website lists the following requirements:

  • 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.


Compliance with the rules is required within one year (September 19, 2016) for companies with more than 500 employees; two years for companies with less than 500 employees; and three years for companies averaging less than USD1 million per year in sales and market value (companies must provide records to supports its small business status annually).

What does this mean for food safety professionals? It means the food processing industry must be on top of its game when it comes to food safety.

One of the key elements is the document verification and validation of the facility’s food safety plan. How important is documentation to FSMA? Many industry observers say that under FSMA, “If you don’t write it down, it didn’t happen.” Facilities must retain records (electronic records are acceptable) for two years and the FDA has the right to review and copy all records during a routine inspection.

The validation step ensures that monitoring activities are in place and appropriate actions are being taken. It also is meant to show the processes and actions being performed are working to eliminate harmful pathogens, including pest-borne bacteria, in the facility.

Agriculture, Food Processing & Manufacturing, Food Retail & Grocery