The Food and Drug Administration (FDA) last summer released the first of three installments of a draft guidance document designed to support compliance with its intentional adulteration rule under the Food Safety Modernization Act. Responding to FDA’s request for comments, IDFA last month commended the agency for its commitment to making implementation flexible and practical for dairy companies and asked FDA to more clearly lay out compliance options in the guidance.
The “Mitigation Strategies to Protect Food Against Intentional Adulteration” rule requires companies to determine vulnerabilities and implement protections against potential major attacks on the food supply.
“Our goal is to make certain that the dairy industry can continue to implement food defense practices in a way that is tailored to their operations and that FDA investigators do not treat the recommendations and examples in the guidance as binding requirements,” IDFA said in its comments.
This first installment of draft guidance includes chapters on the components of food defense plans, how to conduct vulnerability assessments using a key activity-type method, how to identify and implement mitigation strategies, and food defense monitoring requirements.
Specifically, IDFA asked FDA to:
- Clarify a variety of methods companies can use to conduct vulnerability assessments required by the rule;
- Stress that what works in one facility may not work in another and that companies should carefully consider what is needed when selecting mitigation strategies;
- Add a variety of examples to demonstrate flexible mitigation strategy options, noting that these examples include, but are not limited to, the options listed; and
- List additional examples demonstrating the flexibility available to facilities when creating their food defense plans and documenting their food defense activities.
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.
Read IDFA’s comments here.
IDFA expects the agency to release the second installment of guidance for public comment in the coming months. IDFA plans to seek members’ views and again provide comments, as needed, on the first and second installments at that time.
For more information, contact John Allan, IDFA vice president of regulatory affairs and international standards, at email@example.com.