Source: FDA

A Conversation with Ryan Newkirk and Jon Woody

As part of the FDA Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) issued on May 27, 2016 a final rule to require domestic and foreign food facilities, with some exceptions, to address hazards that may be introduced with the intention to cause wide-scale harm to public health.  These food facilities are required to identify significant vulnerabilities and take steps to minimize or prevent them. The first compliance date is July 26, 2019.

Ryan Newkirk, Senior Advisor for Intentional Adulteration with the Food Defense and Emergency Coordination Staff at FDA and Jon Woody, Director, Food Defense and Emergency Coordination Staff, talk about the new rule and what the FDA is doing to support industry compliance.

Q: Can you tell us in a nutshell what the rule is all about?
Newkirk:  Sure. The purpose of the rule is to protect food from a person or group of people who are intentionally doing something to the food to either cause illness or death on a large scale. The rule does this by requiring that certain facilities develop and implement a food defense plan.  It applies both to domestic facilities and foreign facilities that export food to the United States.

Q: Why isn’t adulteration that is economically motivated, such as substituting an ingredient for something cheaper, included in this rule?
Newkirk:  Economically motivated adulteration is very different because the goal is financial gain. We decided that addressing economically motivated adulteration worked better under the preventive controls framework, which focuses on hazards that are known or reasonably foreseeable. So the final rules on preventive controls for human and animal food address economically motivated adulteration if it can affect the safety of the food. Economically motivated adulteration that affects product integrity or quality, but not food safety, is out of the scope of those rules. Substitution for something cheaper could result in misbranding, which is subject to the provisions of the Federal Food, Drug, and Cosmetic Act.

Q: What does a food defense plan consist of?
Newkirk: There are several main components to the plan. First, facilities must conduct a vulnerability assessment, which means finding the points in their processes that pose the greatest risk for intentional adulteration. Second, facilities must put in place mitigation, or preventive, strategies to address these vulnerabilities. Third, a system must be put in place for food defense monitoring, food defense corrective action, and food defense verification, which together ensure the system is working as intended to address the vulnerabilities. Fourth is recordkeeping.  Finally, there are training requirements. Personnel, and their supervisors, working at the most vulnerable points in a facility are required to take food defense awareness training and to have the education, training, or experience to properly implement mitigation strategies. In addition, preparing the food defense plan, conducting vulnerability assessments, identifying mitigation strategies, and engaging in reanalysis activities must be done or overseen by personnel with additional training or experience.  

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