News & Resources

FDA Issues First Intentional Adulteration Guidance Document

July 5, 2018

On June 19, the U.S. Food and Drug Administration (FDA) released the first of three draft guidance documents designed to support compliance with the Intentional Adulteration (IA) Rule under the agency’s Food Safety Modernization Act (FSMA). The remaining two documents are expected to come out later this year.

In the coming weeks, NMPF will review the nearly 100-page guidance document and provide feedback to FDA. Following initial review, the document appears to be consistent with the views NMPF has expressed during the numerous vulnerability assessments that it has engaged in over the years. However, a more thorough review is still warranted.

The final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that addresses specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. Dairy processing facilities are covered by the rule, but dairy farms are not. The first compliance date for large facilities is in July 2019.  Small businesses have an additional year.

FDA will announce plans to hold a public meeting on the draft guidance when the second installment is released. All three parts will be available for public comment upon release. NMPF has been collaborating with FDA on intentional adulteration since 9/11. It has participated in numerous vulnerability assessments and exercises, chaired the Food & Agriculture Sector Coordinating Council (FASCC), and is part of the Food Safety Preventive Controls Alliance Intentional Adulteration Subcommittee, which develops IA training programs for FDA.