FDA releases Intentional Adulteration Rule installment

The Food and Drug Administration has released the third and final installment of the Intentional Adulteration Rule under the Food Safety Modernization Act.

The rule is designed to address problems that are intentionally introduced to foods, including acts of terrorism, according to a news release. Other FSMA rules address specific foods and hazards, but the Intentional Adulteration Rule requires the industry to enact risk-reducing strategies for processes in facilities that are significantly vulnerable to intentional adulteration.

The Intentional Adulteration Rule chapters include defensive correction actions, food defense verification, reanalysis and record keeping, according to the release. This installment also includes appendices on the FDA’s online Mitigation Strategies Database. 

Facilities covered by the rule must develop and implement a food defense plan that identifies vulnerabilities and plan on how to mitigate them. Compliance for large facilities began in July, and inspections begin in March.

Related stories:

FDA issues updated version of Food Defense Plan Builder

FDA meeting focuses on FSMA Intentional Adulteration Rule

FDA seeks comment on document about adulterated foods