April 21, 2018

FDA Announces Intentional Adulteration Rule

FDAThe FDA has released a part of the Food Safety and Modernization Act (FSMA) that addresses intentional adulteration of the food supply. The rule, called “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” addresses acts of terrorism.

Domestic and foreign facilities must addresses vulnerable processes to prevent this type of terrorism, which is intended to cause large-scale public harm. Food businesses will be required to have a written food defense plan.

This type of adulteration includes the goal of inflicting massive public health harm, such as acts of terrorism. While the FDA states that this type of adulteration is unlikely, it could have catastrophic results. In addition to many people becoming ill or dying, loss of public confidence in food safety and adverse economic effects are factors.

The four areas in the food system that are most vulnerable to attack include bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing. The food defense plans must include actionable process steps, mitigation strategies, monitoring, corrective actions, verification, training, and record keeping.

Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, said, “the goal is to protect the food supply from those who may attempt to cause large-scale public health harm.” The proposed rule will be published in the Federal Registers on December 24, 2013. The comment period will be open through March, 2014.

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