By Dave Fairfield, Senior Vice President of Feed Services
The U.S. Food and Drug Administration (FDA) on March 5 released the second installment of a draft guidance document designed to support compliance with the intentional adulteration (IA) rule established under the Food Safety Modernization Act (FSMA).
The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to human foods, including through acts of terrorism, with the intent to cause widespread harm to public health. The rule requires covered facilities to implement risk-reducing strategies for processes in human food facilities that are significantly vulnerable to intentional adulteration.
Importantly, the final rule exempts from the intentional adulteration rule requirements facilities that solely manufacture, process, pack or hold (i.e., store) animal feed and pet food. In addition, the final rule exempts facilities, such as grain elevators, that solely store food (e.g., grain) 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 its application 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.
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. The first compliance date is July 26, 2019 for facilities defined as “large” businesses (defined as those with 500 or more full-time equivalent employees and with $10,000,000 or more in average annual human food sales plus the market value of human food not sold).
FDA’s second installment of the draft guidance adds to and incorporates elements of the initial draft guidance made available on June 19, 2018 with chapters covering topics such as:
- The components of the food defense plan;
- How to conduct vulnerability assessments by:
- Using the four key activity types (KAT) method (bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, mixing and similar activities);
- Evaluating the three fundamental elements (potential public health impact, degree of physical access to the product and ability of an attacker to successfully contaminate the product); or
- Using the hybrid approach, which is a combination of the KAT and three fundamental elements methods.
- How to identify and implement mitigation strategies;
- Food defense monitoring requirements;
- Education, training, and experience.
The draft guidance, once finalized, is intended to be a resource that will help the human food industry implement the intentional adulteration rule provisions in a flexible and cost-effective manner. FDA intends to conduct a public meeting on the draft guidance, and additional information about the meeting will be made available in a forthcoming announcement. FDA has provided a 120-day comment period for both the first and second installments of the draft guidance.