The Food and Drug Administration (FDA) last week released the first of three installments of a draft guidance document designed to support compliance with its intentional adulteration rule, which requires companies to implement protections against potential attacks on the food supply under the Food Safety Modernization Act (FSMA). To help the dairy industry understand the guidance and comply with the rule, IDFA will hold a webinar July 12, 2-3 p.m. Eastern time at no cost to members.
The first part of the draft guidance includes chapters on:
- The components of the food defense plan;
- How to conduct vulnerability assessments using a key activity-type method;
- How to identify and implement mitigation strategies; and
- Food defense monitoring requirements.
The remaining installments are expected to be released later this year. The second installment will contain additional information on conducting vulnerability assessments, including the characteristics of process steps and how they should be considered and training requirements. The third installment will provide more details on the corrective actions, verifications, additional analysis and recordkeeping requirements in the rule.
FDA To Industry: We Hear You
In previous comments to FDA, IDFA said the intentional adulteration rule needed to be flexible and practical. IDFA is pleased FDA Commissioner Scott Gottlieb addressed these issues in a statement issued with the guidance, noting that “we heard consistently from a variety of stakeholders that the rule needed to be practical and that facilities needed flexibility when conducting vulnerability assessments. The draft guidance reflects this approach.” He added, “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.”
Businesses with 500 or more employees must comply with the rule by July 26, 2019, and businesses with fewer than 500 employees will have until July 27, 2020, to comply. Although very small businesses are exempt from the rule, they will be required to have documents that prove they are exempt by July 26, 2021.
IDFA encourages all members to participate in its webinar, “FDA's New Guidance on FSMA Intentional Adulteration Rule.” The webinar is free for members and non-members may register for a fee. Registration is now open.
“The first compliance date is just one year away,” said John Allan, IDFA vice president of regulatory affairs and international standards. “Dairy companies need information to effectively plan and allocate resources so they won’t be caught off guard.”
For more information, contact Allan at jallan@idfa.org.