FDA Extends Comment Period on Food Adulteration Rule

The plan, issued under the nearly 3-year-old Food Safety Modernization Act (FSMA) and more than 12 years after the deadliest terrorist attack on U.S. soil, calls for a food facility to develop a written food defense plan that tackles large vulnerabilities in the food production process.

WASHINGTON—The U.S. Food and Drug Administration (FDA) has expanded the comment period for a proposed rule that is intended to combat intentional contamination of food.

The agency has granted a 90-day extension to June 30, 2014 for comments on the rule, "Focused Mitigation Strategies to Protect Food Against Intentional Adulteration", and an associated draft quality risk assessment.

The proposed rule, issued last December under the nearly 3-year-old Food Safety Modernization Act (FSMA) and more than 12 years after the deadliest terrorist attack on U.S. soil, calls for a food facility to develop a written food defense plan that tackles large vulnerabilities in the food production process.

FDA said facilities would be required to identify and implement strategies to address weak areas, establish monitoring procedures and corrective actions and ensure the system is functioning. The proposal also includes recordkeeping requirements and a mandate that personnel assigned to vulnerable areas are properly trained.

The comment period was extended in response to requests that "conveyed concern that the current 100-day comment period does not allow time to thoroughly analyze the proposed rule since this is unlike any other proposal and due to the inherent complexity and unique nature of food defense issues," according to a document that is scheduled to be published tomorrow in the Federal Register.

According to FDA, it's unlikely someone would intentionally contaminate the food supply with the intent to cause public harm. "However, iintentional adulteration could have catastrophic results including human illness and death, loss of public confidence in the safety of food, and significant adverse economic impacts, including trade disruption, all of which can lead to widespread public fear," the agency stated in a summary of the proposed rule.

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