Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

FDA Statement

• For Immediate Release: June 19, 2018

In the U.S., we enjoy one of the safest food supplies in the world. The FDA takes its responsibility to protect the U.S. food supply very seriously. And while we work diligently to prevent accidental contaminations, it’s also our duty to take measures to protect our food from those who seek to deliberately do us harm.

The likelihood of an incident at a particular facility is low, but the intentional adulteration of the U.S. food supply represents a very serious threat – one that could have devastating public health consequences. That’s why the FDA is taking important steps toward preventing the intentional contamination, or adulteration, of the U.S. food supply. Recognizing these risks, Congress entrusted the FDA with new authorities and resources, as part of the FDA Food Safety Modernization Act (FSMA), to strengthen the FDA’s ability to oversee efforts to protect against the possibility of someone using our food supply to harm American consumers.

In 2016, using these new authorities, we released an important final rule designed to address hazards that may be intentionally introduced to foods. These include 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 Intentional Adulteration (IA) rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

The final rule was informed by our in-depth understanding of various process vulnerabilities. And it is designed to help address them. For example, consider the possibility of an attack perpetrated by someone who has legitimate access to a facility, like an employee. The rule considers this kind of attack and requires preventive measures that can help to prevent or minimize such an insider attack.

To be successful, protecting the U.S. food supply requires a partnership. As we work toward the July 2019 implementation date for large facilities, we’re committed to supporting industry in its efforts.

Toward these goals, as I promised earlier this year, the FDA is releasing today the first of three installments of draft guidance designed to support compliance with the IA rule.

Food facilities covered by the IA rule will be required to develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies for those vulnerabilities. They must also ensure that the mitigation strategies are working.

This first installment focuses on the components of the food defense plan; how to conduct vulnerability assessments using the key activity type method and how to identify and implement mitigation strategies and food defense monitoring requirements.

This is new regulatory territory for both the FDA and industry. We’ve engaged directly with stakeholders while drafting this guidance to understand their perspectives and any concerns they have about complying with this rule. We’ve listened to their valuable feedback. Much of that feedback is reflected in the draft guidance we’re releasing today, as well as in the next two parts of the guidance.

For example, we heard consistently from a variety of stakeholders that the rule needed to be practical and that facilities needed flexibility when conducting vulnerability assessments. The draft guidance reflects this approach. The new guidance illustrates different ways that each facility can meet the requirements of the rule, and the guidance provides a range of options for identifying and reducing vulnerabilities.

Many facilities have already implemented at least some of the measures the IA rule calls for. The goal of this draft guidance, in its entirety, is to help provide greater clarity and predictability for manufacturers that need to take additional steps to come into compliance with the rule. We want to help ensure that the new requirements are cost-effective and not overly burdensome, while still being protective of the food system.

The second and third installments are intended to follow later this year. In the second draft guidance, we will focus on a vulnerability assessment approach that can be more tailored to a facility. We will also provide guidance on training requirements for a food facility’s employees.

In the third guidance, we’ll provide greater detail on how to take corrective action; how to verify that a facility’s system is working; food defense plan reanalysis requirements and record-keeping requirements.

We understand that these are issues of the utmost importance. We’re committed to ensuring that we’re implementing the rule in a way that will best protect our food and allow companies to efficiently meet the requirements. While we’ve listened and incorporated the feedback of stakeholders, we intend to continue to have a public dialogue. We will hold a public meeting on the draft guidance later this year after the second guidance is published. In addition, we’ll also be encouraging feedback on all three documents as they become available and carefully reviewing the comments we receive.

Finally, we’re working on additional ways in which we can support the food industry as they comply with the new food safety law. Our staff have been working diligently to create training and technical assistance opportunities. This includes our work with the Intentional Adulteration Subcommittee of the Food Safety Preventive Controls Alliance to develop and provide a new food defense awareness training module for food manufacturers. More training is in the works. And the FDA looks forward to continuing to work with the Alliance to get those trainings out as soon as we can.

We’re not alone in our effort to protect the American food supply from the potential threat of intentional adulteration. We recognize and appreciate the contributions of those who’ve been actively working to ensure our food safety, including Congress, other federal agencies and state and local governments.

The FDA will be taking new efforts to build on this work and the collaborations with our partners, industry and other affected stakeholders. Our shared goal is to keep food safe for American consumers.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.