FDA Announces FSMA Intentional Adulteration Rule

The U.S Food and Drug Administration has filed its rule on intentional adulteration under the Food Safety Modernization Act (FSMA), keeping to a court-ordered deadline of Dec. 20.  “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” will require domestic and foreign food facilities to address hazards that may be intentionally introduced by acts of terrorism.  “The goal is to protect the food supply from those who may attempt to cause large-scale public health harm,” said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine. “Such events, while unlikely to occur, must be taken seriously because they have the potential to cause serious public health and economic consequences.”  The rule targets certain processes within a facility that are most likely to be vulnerable to attack: bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling (where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient), and mixing and similar activities. Food facilities will be required to have a written defense plan addressing these vulnerabilities.  This is the sixth proposed rule issue under FSMA, and it is the first time FDA has proposed a regulatory approach for preventing intentional adulteration of the food supply.  The rule will be published in the Federal Register on Dec. 24, and a comment period on the rule will be open through March 31, 2014.