By Dave Fairfield, Senior Vice President of Feed Services
The U.S. Food and Drug Administration (FDA) has made a new online training course available for facilities that are required to comply with the agency’s final rule for Mitigation Strategies to Protect Food Against Intentional Adulteration.
FDA developed the new course – Intentional Adulteration (IA) Identification and Explanation of Mitigation Strategies – through a partnership with the Food Safety Preventive Controls Alliance’s (FSPCA) Intentional Adulteration Subcommittee. The course provides one way to meet the IA rule’s qualified individual training requirement that individuals identifying and explaining mitigation strategies at actionable process steps identified by a vulnerability assessment “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” [21 CFR 121.4(c)(2)]. This course is the “standardized curriculum” recognized by FDA as being adequate to meet the qualified individual training requirement for identifying and explaining mitigation strategies.
Related to additional aspects of the IA rule’s qualified individual training requirement, FDA and FSPCA previously released a separate online training course for conducting vulnerability assessments using key activity types (KAT). In addition, two more courses are being developed for: 1) conducting non-KAT vulnerability assessments; and 2) preparing and reanalyzing food defense plans.
The new IA Identification and Explanation of Mitigation Strategies course is available on the FSPCA website at https://www.ifsh.iit.edu/fspca/courses/intentional-adulteration. The price for the course is $169.
Facilities Subject to the IA Rule and What’s Required: FDA on May 27, 2016, published final regulations to require domestic and foreign food facilities that are required to register under the Bioterrorism Act to address hazards that may be introduced with the intention to cause wide-scale public health harm. Covered food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. Such mitigation strategies also are required to be monitored and verified, with corrective actions taken when warranted.
FDA’s final rule exempts from the IA requirements facilities that solely manufacture, process, pack or hold animal feed and pet food. In addition, the final rule exempts facilities, such as grain elevators, that solely store food (e.g., grains and oilseeds) that may be destined for human consumption, except the holding of food in liquid storage tanks. However, the rule also expressly exempts from requirements the storage of mineral oil in liquid storage tanks and the application of such oil to raw, whole grains or oilseeds. Significantly, the rule does stipulate that facilities that store and apply mineral oil on other food products – such as baked goods, condiments, spices or confectionary products – evaluate mineral oil storage and use when conducting vulnerability assessments required under the regulations.