The U.S. Food and Drug Administration (FDA) on June 19 released the first of three installments of a draft guidance document intended to assist human food facilities in complying with the Intentional Adulteration (IA) Rule established under the Food Safety Modernization Act (FSMA). The remaining two installments are expected to be issued later this year.
The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to human foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the human food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.
Importantly, the final rule exempts from the intentional adulteration requirements facilities that solely manufacture, process, pack or store animal feed and pet food. In addition, the final rule exempts facilities, such as grain elevators, that solely store non-liquid food that is intended for human consumption. The exemption also expressly applies to the storage of mineral oil in liquid storage tanks and its application to raw, whole grains or oilseeds. However, the final 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.
Human food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities then will be required to ensure that the mitigation strategies are working. The first compliance date for the largest facilities is in July 2019.
This first part of the draft guidance includes chapters on:
- the components of the food defense plan;
- how to conduct vulnerability assessments using the key activity type method;
- how to identify and implement mitigation strategies; and
- food defense monitoring requirements.
The second installment will focus more specifically on vulnerability assessments and training requirements, with the third including greater detail on corrective action, verification, reanalysis and recordkeeping requirements.
The draft guidance, once finalized, is intended to be a resource that will help the human food industry implement the IA provisions in a flexible and cost-effective manner. To further assist and engage stakeholders, FDA will announce plans to hold a public meeting on the draft guidance when the second installment is released later this year. All three parts will be available for public comment upon release. Dec. 17 is the deadline for comments on the first installment of the draft guidance.