FSMA Intentional Adulteration Rule Announced By FDA

By Sam Lewis

New proposal marks the first regulatory approach of preventing intentional adulteration of the food supply chain in the U.S.

Adhering to its court-ordered deadline, the FDA has filed its rule on the intentional adulteration of food under the Food Safety Modernization Act (FSMA) on Dec 20. The rule is scheduled to be published in the Federal Register on Tuesday, Dec 24 with its comment period closing on March 31 of next year.

The new rule, called “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration,” addresses acts of terrorism in the food supply chain. It will require both domestic and foreign food facilities to approach and tackle hazards that could potentially cause massive harm to public health. “The goal is to protect the food supply from those who may attempt to cause large-scale public health harm,” says Michael Taylor, the 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 places its emphasis on processes in food producing facilities that would most likely be vulnerable to attack including: liquid receiving and loading, liquid storage and handling, secondary ingredient handling, mixing, blending, and other processing activities. Food facilities will be required to create and follow a written defense plan which includes actionable process steps, mitigation strategies, monitoring, corrective actions, verification, training, and recordkeeping in addressed areas of vulnerability. These rules are not intended to apply to farms and food for animals as of now.

Early estimates from companies both overseas and domestically suggest $500 million will be spent in the next decade to comply with the sixth proposal under FSMA. This may seem like a hefty investment, but early estimates also indicate that preventing a catastrophe, like a terrorist attack on the US food supply, could prevent as much as $130 billion in damages.

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