Intentional Adulteration Overview
Under this rule, most food facilities that are required to register with FDA must develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility. Food Defense Plans should identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification.
Intentional Adulteration Deadlines
Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019. Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) have one additional year to comply. Very small businesses (businesses with less than $10,000,000 in average annual revenue) are exempt from most requirements under FDA’s Intentional Adulteration rule. In order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021.
