Locking Down Food Security: FDA Finalizes Final FSMA Rule

The U.S. Food & Drug Administration finalized the last of the seven major rules for the Food Safety Modernization Act and this one looks to lockdown food security and prevent intentional adulteration of food products.

The Mitigation Strategies to Protect Food Against Intentional Adulteration rule is intended to help to prevent wide-scale public health harm by requiring food processing companies to take steps to prevent intentional adulteration of the food supply.

Under the rule facilities, both domestic and foreign, would be required to review their production systems, complete their own vulnerability assessment and maintain a written food defense plan. This plan would need to identify vulnerabilities and set forth actionable procedures in a food process that will require focused mitigation strategies to reduce the risk of intentional adulteration.

Food processing facilities must also establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain records documenting their actions.

Food processors are required to comply with the new regulation within three to five years after publication of the final rule, depending on the size of the operation.

How can you devise a food defense program for your company? Sprague has carefully examined the rule and offers the following summary. If you have questions on how this final rule impacts your operation, let us know and we will be happy to assist you.

Vulnerability Assessment: This is the identification of vulnerabilities and actionable process steps for each type of food manufactured, processed, packed or held at the food facility. For each point, step, or procedure in the facility’s process, these elements must be evaluated:

  • The severity and scale of the potential impact on public health. This would include such considerations as the volume of product, the number of servings, the number of exposures, how fast the food moves through the distribution system, potential agents of concern and the infectious/lethal dose of each; and the possible number of illnesses and deaths.
  • The degree of physical access to the product. Things to be considered would include the presence of such physical barriers as gates, railings, doors, lids, seals and shields.
  • The ability to successfully contaminate the product.

Mitigation Strategies: These should be identified and implemented at each actionable process step to provide assurances that vulnerabilities will be minimized or prevented. The mitigation strategies must be tailored to the facility and its procedures.

  • The final rule removes the distinction between “broad” and “focused” mitigation strategies. The original proposal only required “focused” mitigation strategies because “broad” mitigation strategies, such as a fence around the entire facility, did not protect specific points from being attacked by an insider.
  • The final rule recognizes that a mitigation strategy, applied in a directed and appropriate way to protect the actionable process step from an insider attack, would sufficiently minimize the risk of intentional adulteration.

Management Components: Steps must be taken to ensure the proper implementation of each mitigation strategy. In each of these areas of food defense, the facilities are given more flexibility in the final rule to establish the actions most appropriate to their operation and product.

  • Monitoring: Establishing and implementing procedures, including the frequency with which they are to be performed, for monitoring the mitigation strategies.
  • Corrective Actions: The response if 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.

Training/Recordkeeping: Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training; facilities must maintain records for food defense monitoring, corrective actions, and verification activities.

  • The agency intends to publish guidance documents to provide information relevant to the provisions of the final rule, such as conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions and verification.
Food Processing & Manufacturing