WASHINGTON – The US Food and Drug Administration (FDA) released the first of three installments of draft guidance for compliance to the Intentional Adulteration (IA) rule.
Food companies impacted by the rule are required to develop a food defense plan that identifies significant vulnerabilities in facilities and mitigation strategies to address those vulnerabilities. Companies also are required to demonstrate that their mitigation strategies work.
In a statement, FDA Commissioner Scott Gottlieb, M.D., said the first installment of the draft guidance focuses on vulnerability assessments, how to identify and implement mitigation strategies, and food defense monitoring requirements. He added that the draft guidance reflects the input from industry stakeholders who said the rule needed to be practical and that facilities needed flexibility when conducting vulnerability assessments.
“The new guidance illustrates different ways that each facility can meet the requirements of the rule, and the guidance provides a range of options for identifying and reducing vulnerabilities,” Gottlieb said.
“Many facilities have already implemented at least some of the measures the IA rule calls for. The goal of this draft guidance, in its entirety, is to help provide greater clarity and predictability for manufacturers that need to take additional steps to come into compliance with the rule. We want to help ensure that the new requirements are cost-effective and not overly burdensome, while still being protective of the food system.”
FDA plans to release the second and third installments of the IA draft guidance later this year. The second installment will address a vulnerability assessment that can be customized to a facility along with guidance on training requirements for employees. The third installment will provide greater detail on how to take corrective actions; verify a facility’s food defense system is working and record-keeping requirements.
“We understand that these are issues of the utmost importance,” Gottlieb said. “We’re committed to ensuring that we’re implementing the rule in a way that will best protect our food and allow companies to efficiently meet the requirements. While we’ve listened and incorporated the feedback of stakeholders, we intend to continue to have a public dialogue. We will hold a public meeting on the draft guidance later this year after the second guidance is published. In addition, we’ll also be encouraging feedback on all three documents as they become available and carefully reviewing the comments we receive.”