On December 24, 2013, the FDA issued a proposed rule entitled “Focused Mitigation Strategies to Protect Food against Intentional Adulteration.”   Passed under the Food Safety Modernization Act (“FSMA”) in 2011, the FDA issued this rule to focus on food defense, which would require all domestic and foreign food facilities to address potential issues in their facilities’ operations that would make the facilities susceptible to large-scale, intentional public harm.  The proposed rule would apply to all domestic and foreign food facilities that process, manufacture, pack, or hold food and are required to register as a food facility, with a few exceptions.

In the rule, the FDA has identified four key areas within the food system that may be most susceptible to intentional harm:  (1) liquid storage and handling activities; (2) bulk liquid receiving and loading; (3) activities involving how secondary ingredients (ingredients other than the primary ingredients) are handled before being combined with the primary ingredient; and (4) mixing activities.  The proposed rule would require food facilities to review their food production systems to determine if there are any of the identified areas or to complete their own assessment for vulnerable activities.  Once identified, the facility must then establish mitigation strategies that would reduce the risk of intentional adulteration and prepare a written food defense plan.  The proposed rule would require food facilities to establish measures to protect against food terrorism.

The written food defense plan must include the following items:

  • Actionable process steps – food facilities must identify actionable process steps by looking for one of the four key areas set forth above or conduct their own vulnerability assessment;
  • Focused mitigation strategies – implement mitigation strategies at every point of vulnerability to minimize such vulnerability;
  • Monitoring – establish procedures for monitoring the focused mitigation strategies at certain intervals;
  • Corrective actions – use corrective actions to address any focused mitigation strategies that are not properly implemented;
  • Verification – ensure that monitoring is being conducted or corrective actions are taken at appropriate intervals;
  • Training – train personnel assigned to the actionable process steps in food defense awareness; and
  • Recordkeeping – maintain certain records, including the written food defense plan and documentation of monitoring, verification, corrective action, and training of personnel.

The FDA has proposed that compliance with the rule will generally be required starting 60 days after the date of the final rule.  However, the FDA has adjusted the compliance dates for small or very small businesses.

The public comment period will remain open until March 31, 2014.  Review the proposed rule.