Wednesday 24 January 2018

New FSMA Rule; FDA Proposed Rule: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

The US Food and Drug Administration (FDA) announced a new rule today under the Food Safety Modernization Act (FSMA).  The subject of this proposed rule is to protect food from intentional adulteration when the intent is to cause large-scale public harm. Below is a summary of the proposed rule’s key provisions. A more detailed analysis of the rule will follow the holiday break.


Highlights of the Proposed Rule

The subject of this proposed rule is to protect food from intentional adulteration when the intent is to cause large-scale public harm. The FDA has identified four key activities within the food system that are most vulnerable to such forms of adulteration. They include:

  • bulk liquid receiving and loading;
  • liquid storage and handling;
  • secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and
  • mixing and similar activities.

Facilities would be required to review their production system to determine if they have any of these activity types or complete their own vulnerability assessment. Once that is completed, they would need to identify actionable process steps, which are points, steps, or procedures in a food process that will require focused mitigation strategies to reduce the risk of intentional adulteration. Facilities are also required to complete a written food defense plan. Once in place, this proposed rule would establish measures that a food facility would be required to implement to protect against the intentional adulteration of food.

Food Defense Plan

Each facility covered by this rule would be required to prepare and implement a written food defense plan, which would include the following:

  • Actionable process steps: Identify any actionable process steps, using one of two procedures. The FDA analyzed data from vulnerability assessments conducted using the CARVER+Shock methodology and identified four key activity types, as described above. The FDA has determined that the presence of one or more of these key activity types at a process step indicates a significant vulnerability to intentional adulteration aimed at large-scale public harm. Facilities may identify actionable process steps using the FDA-identified key activity types or conduct their own facility-specific vulnerability assessments.
  • Focused mitigation strategies: Identify and implement focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and that food manufactured, processed, packed, or held by the facility will not be adulterated.
  • Monitoring: Establish and implement procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies.
  • Corrective actions: Using corrective actionsif focused mitigation strategies are not properly implemented.
  • Verification:  Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made. It would also help ensure that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing any significant vulnerabilities. In addition, the rule includes requirements for periodic reanalysis of the food defense plan every three years or under certain conditions.
  • Training: Personnel and supervisors assigned to the actionable process steps would be trained in food defense awareness and in their responsibilities for implementing focused mitigation strategies.
  • Recordkeeping: Establish and maintain certain records, including the written food defense plan; records documenting monitoring, verification activities and corrective actions, and documentation related to training of personnel.
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