The United States Food and Drug Administration (FDA) issued Notice no. 2022-12361 to develop mitigation strategies to protect food from intentional adulteration.  The notice will be published in the Federal Register on June 8, 2022, with a 30-day feedback period.  The proclamation is intended to address the possible intentional introduction of food hazards, including through terrorism acts intending to cause various hazards to public health.  Domestic and international food facilities that are required to register under the FD&C Act must develop and implement mitigation strategies to significantly reduce or prevent significant vulnerabilities found in operable process steps for food operations.  The relevant provisions, compiled in 21CFR part 121, require that the owner, operator or agent responsible for the facility to:

 (1) Develop and implement written food protection plans, including vulnerability assessments, to identify significant vulnerabilities and actionable process steps and mitigation strategies;
 
 (2) Conduct a vulnerability assessment of each type of food produced, processed, packaged or preserved at the facility by using appropriate methods to assess each point, step or procedure in food handling, thereby identifying any significant vulnerabilities and operable process steps;
 
 (3) Identify and implement mitigation strategies at each operable process step to ensure that significant vulnerabilities at each step will be significantly reduced or prevented and that food manufactured, processed, packaged or preserved by the plant will not be adulterated.  According to the nature of the mitigation strategy and its role in food facilities protection system to ensure that each mitigation strategy implemented correctly, it should also develop and implement food protection monitoring program, protective corrective action program, food protection authentication, set up and run the file save as well as related to the personnel training records.