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FDA has now released its seventh FSMA rule – on intentional adulteration. Published May 27 in the Federal Register, the rule requires registered food facilities to develop a written food defense plan to address intentional adulteration.

In an approach similar to developing a hazard analysis and critical control point (HACCP) plan, facilities must establish food defense monitoring procedures and corrective actions, including a verification step, personnel training and the maintenance of records.

FDA explains that the goal of the rule is to prevent wide-scale public health threats, rather than acts by disgruntled employees or economically motivated adulteration – which is addressed separately in the preventive controls rules for human and animal foods.

The agency knows companies will be working to comply with the other FSMA rules, so it has extended the compliance dates for the intentional adulteration rule. A business that is not defined as “small” or “very small” and does not qualify for exemptions will have three years to comply. A small business employing fewer than 500 employees will have four years to comply, and a very small business will have five years. FDA estimates that the rule will cover 3,400 firms that operate 9,800 food facilities.

In most cases, limiting access to the food product is the key element of an effective food defense plan. But there are other important considerations, such as the volume of food involved and how rapidly the food product is distributed and consumed.

The agency plans to issue guidance on conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions and verification. It is also encouraging stakeholders to look at the existing voluntary food defense program tools at fda.gov/fooddefense.

I believe the process of complying with the FSMA preventive controls requirements should set a lot of the groundwork for the subsequent compliance with the intentional adulteration rule. The vulnerability assessment, risk management, verification and record keeping will be familiar steps for the “qualified individual” who has already mastered the FSMA preventive controls requirements. In addition, EAS consultants can assist in compliance with this additional FSMA rule.

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