This feature is intended to highlight the food defense efforts, projects and initiatives in which the U.S. Food and Drug Administration (FDA)’s Food Defense and Emergency Coordination Staff (FDECS) is engaged and how we’re working across the whole community planning arena to help raise awareness and help our industry stakeholders create a culture of food defense.

“Men of Cornwall stand ye steady: It cannot be ever said ye for the battle were not ready. Stand and never yield.”
—Hymn sung by Rick Rescorla, as he directed the evacuation of more than 2,500 Morgan Stanley employees from the World Trade Center on September 11, 2001

In the years since September 11, 2001, FDA’s Food Defense Oversight Team (now FDECS) has sought ways to develop, create and otherwise make available tools and resources for industry to implement to help decrease the likelihood of intentional contamination of products within their control.

Recent incidents have been reported and described elsewhere, illustrating that small-scale (involving < 10 people) intentional acts of contamination have occurred. Most of these incidents are borne out of domestic disputes or personal relationships or are economically motivated.

Cases of intentional contamination are infrequent but can result in serious adverse public health consequences and economic impact. For example, in 2009, more than 40 people in Kansas became ill after disgruntled restaurant employees intentionally contaminated salsa with a pesticide. In 1996, 12 lab workers at a Texas medical facility became ill after eating pastries that were intentionally contaminated with a virulent strain of Shigella bacteria.

In the years leading up to the terrorist attacks of September 11, Cyril Richard “Rick” Rescorla, the director of security for the financial services firm Morgan Stanley at the World Trade Center, had the foresight to prepare for possible attacks on the Twin Towers and is credited with implementing evacuation procedures that saved more than 2,500 lives. He died in the aftermath of the attacks while leading evacuees from the South Tower. To honor his legacy, the Department of Homeland Security established the Rick Rescorla National Award for Resilience.[1] Today, industry, government and academia stakeholders are encouraged to examine who among them is their Rick Rescorla. In thinking about what could happen, Rescorla is credited with saving lives of his colleagues and friends through dedication, passion and planning.

Herein, FDA’s FDECS seeks to help define the “recipe” for the culture of food defense (below). By leveraging collective resources, FDECS continues to modify this recipe. Tools and resources that FDECS has been working on for quite some time have been recently released, and the group will continue not only to work toward raising awareness of these tools and resources, but also to demonstrate how they can be used.

Food Defense Meets Strategic Planning
Understanding that industry’s culture of food defense is still developing, and that the basis for this recipe is a sound food defense plan, companies need not look any further. FDECS recently released the Food Defense Plan Builder application—our latest effort to help owners and operators of food facilities take appropriate action to defend the food supply. The content in the tool is based on FDA’s food defense guidance documents and as such is consistent with FDA’s current thinking on food defense preparedness. In addition to providing new functionality for food defense planning and implementation, the Food Defense Plan Builder harnesses existing FDA tools and resources into a single application.

This application guides users through a series of substantive questions about the user’s food facility and the food manufactured, processed, packed or held there to develop a comprehensive food defense plan for the facility, which includes a vulnerability assessment, broad and focused mitigation strategies and an action plan.

Chris Hand, quality assurance product manager at Wawa, notes, “I’ve been working with the Food Defense Plan Builder software for the past few weeks and found it intuitive and easy to use. The questions in the broad mitigation strategies section are comprehensive, and any gaps in the process are immediately linked to the built-in action plan template. The program is flexible and allows you to move around within it and customize it where necessary for your operation. Wawa will be recommending this tool to our suppliers and suggest other companies use it as well.”

Currently, food defense plans are voluntary from a regulatory perspective. However, FDA encourages all food facilities to develop and implement one. A food defense plan will help businesses maintain a safe working environment for their employees, provide a quality product to their customers and protect their bottom line.

But once developed, the food defense plan is not the end state. The plan needs to be integrated into the company’s strategic planning efforts, to include, among other elements, training of personnel, exercise and evaluation and subsequent refinement. By developing a food defense plan, the company will have the first and key ingredient in the culture of food defense and begin to control for some of the uncertainties within its operation.

Food Defense Staff Training
Based on the need for free, self-paced food defense training, FDA developed the Food Defense 101 (FD 101) online training course to streamline our training tools and resources into a single application. The course has been broken down into four segments as described below:

•    Food Defense Awareness for the Food Professional

This course provides an understanding of food defense and guidance for professionals in the food industry. The course modules progress through food defense planning, including broad mitigation strategies, vulnerability assessments, focused mitigation strategies and food defense plans.

•    Food Defense Awareness for Front-line Employees (Employees FIRST)

This course provides guidance specific to frontline workers and simple procedures for these employees to follow in food defense. The FIRST initiative, which emphasizes that employees are the first line of food defense, is offered in both English and Spanish.

•    FDA Regulations
This course presents the three FDA regulations that have been developed to address the safety of our nation’s food supply and their impact on the food industry.

•    ALERT

FDA developed this course to help stakeholders better understand food defense and how it applies to the food industry. ALERT has been updated to include FDA’s Food Safety Modernization Act (FSMA) guidance and provides specific examples of ways to protect a company from the threat of intentional contamination. ALERT is available in English and Spanish. Additional languages are coming soon.

The food industry plays an integral part in protecting the nation’s food infrastructure. FD 101 provides training in preparedness against an intentional attack against our food supply. The courses provide an understanding of and guidance for developing a food defense plan based on a common-sense approach.

Mix Collaboration and Buy-In
As we prepared this feature, a simple search of the Food Safety Magazine website yielded 57 returns on the term food defense. These articles were provided by leaders from industry, academia, government and nongovernment entities—representatives of the “whole community” as defined by the Department of Homeland Security’s Federal Emergency Management Agency. Companywide collaboration for a culture of food defense shouldn’t end at the perimeter of the facility or the edge of the property. Assessing community resources that are available—law enforcement, fire, emergency medical services, emergency management personnel, etc.—can help your company’s food defense culture become not only well rounded but also integrated into the needs of the community. As incidents of various origins happen every day—natural disasters and anthropogenic events alike—a company’s ability to aid in the resilience of the community afterward can and will only benefit everyone.  

The need for management buy-in to support the development of the food defense culture is obvious. If the culture is not embraced by management, this, as with any other effort, is destined for failure. Intermittent management buy-in can lead to an inability of the food defense culture to rise, and to unevenness of completion. Worse yet, inadequate management buy-in can expose the business to potential incidents that could have been prevented—and could have devastating outcomes.

The food defense activities that industry will be integrating are grounded in basic emergency preparedness. To that end, partner agencies across all levels of government are striving to reach the National Preparedness Goal. This goal, released in September 2011, defines what it means for the whole community to be prepared for all types of emergencies. The goal itself is succinct: “A secure and resilient nation with the capabilities required across the whole community to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk.” These risks include natural disasters, disease pandemics, chemical spills and other man-made hazards and terrorist and cyber-attacks.  

Large Exercise Bowl: Food-Related Emergency Exercise-Bundle
It has been said that “prior planning prevents poor performance” and that “plans are nothing, planning is everything.” As these statements resonate within the emergency management and preparedness communities, they should also echo within the boardrooms, manufacturing/processing environments and preparation and service areas across the food and agriculture sectors. The ability to gauge readiness, assessing capability in the face of myriad events, is a solid approach to meeting the framework established within the National Preparedness Goal. However, it also helps to be able to visualize and realize where strengths and gaps exist within your company to mitigate weaknesses and further fortify the integrity of the food system. Appreciating the needs for the whole community to be able to plan and prepare together for food contamination incidents—intentional or unintentional—the Food Related Emergency Exercise-Bundle (the FREE-B) was created.

The purpose of any exercise is to assess and test the component parts of the plan that is being evaluated. To that end, FDA has developed the FREE-B—which is a compilation of scenarios based on both intentional and unintentional food contamination events. It is designed to assist government (regulatory and public health) agencies, industry stakeholders and first responders in assessing existing emergency response plans, protocols and procedures that may be in place, or those in development, related to food incidents. The FREE-B is designed to allow for multiple jurisdictions and organizations to “play” with the host agency or, quite simply, for an individual agency to test its own plans, protocols and procedures independently.

Having released the FREE-B in July 2011, and after soliciting and receiving comments, input and feedback from end-users, FDA determined there was a need to improve the FREE-B and expand its functionality and use (see “FREE-B Improvements” ). Currently, new content for the FREE-B is being developed to address thematic areas of feed, water and recovery—all of which will have industry perspectives represented.

Combine All Ingredients: Operationalizing Tools and Resources
The FDECS continues to conduct outreach opportunities, raise awareness and offer educational interactions with all of our stakeholders. Within the past several years, FDECS has provided numerous workshops at multiple industry, government and nongovernment organization-based conferences to share updates on the various tools and resources touched upon within this feature, both domestically and internationally. The efforts described below provide a glimpse into how FDECS has tried to help engender the culture of food defense across the country and around the world.

FREE-B Workshops: FDECS has offered fiscal support to our state and local regulatory entities through a small-grant opportunity encouraging jurisdictions to use the FREE-B tool. In 2012, FDECS funded 12 such workshops, and in 2013, we were pleased to be able to fund 19 workshops. The feedback we received further enables us to refine the tool, improve the contents and make the scenarios more plausible and realistic. However, the bigger benefit of the workshops is the opportunity for industry, government and academia to come together in a no-fault environment and role-play through an event, thereby helping learn each other’s response capabilities and identify resource/capability gaps.  

Domestic Food Defense Workshops: Within the last several months, FDECS has been convening a series of Food Defense Awareness Workshops around the country. The goal of the full-day workshop is to provide food industry members with an understanding of food defense and the tools and resources available, and to walk participants through a series of exercises on how to create a food defense plan for their facilities. Much of the day is spent introducing FDA’s Food Defense Plan Builder software. Participants are guided through a series of exercises using the tool and there are open discussions and question-and-answer sessions throughout the day.

Previously completed workshops include Pleasanton and Fresno, CA, in late May 2013 and San Juan, Puerto Rico, in early June 2013. Additional workshops are being planned, and interested stakeholders are encouraged to visit for an up-to-date listing of these workshops.

Food Defense Blogs: FDECS has recently provided input to FDA’s Voice—FDA’s official blog from the agency’s senior leadership and staff stationed at home and abroad—sharing news, background, announcements and other information about the work done at FDA. The FREE-B and the Food Defense Plan Builder were spotlighted in the November 2012 and May 2013 editions, respectively.

Presentations at Conferences: FDECS offers focused, as well as general, food defense presentations at conferences organized by industry, government and nongovernment organizations. Last year, FDECS presented at the Public Health Preparedness Summit, the Food Safety Summit and the ADT/TYCO Food Defense Strategy Exchange, among others.

Additional Ingredients to Taste
Mitigations Strategies Database: The food defense Mitigation Strategies Database (MSD) is one of several tools developed by FDA for the food industry to help protect our nation’s food supply from deliberate contamination or tampering. This resource is designed for companies that produce, process, store, package, distribute and/or transport food or food ingredients. The MSD provides a range of preventive measures that companies may choose to implement to better protect their facility, personnel, products and operations.

Patience: As good things come to those who wait, with the release of the Food Defense Plan Builder tool and FD 101, FDECS has been able to put together a virtual path forward for food defense education and training for your company, plus an application to help bring it all together. Using these tools, and incorporating comments and feedback to FDECS—and with a little more patience—we can and will continue to refine and improve these and other food defense tools and resources.

Food Safety Modernization Act
As an important step toward eventually modernizing the entire food safety system and preventing hundreds of thousands of foodborne illnesses, FSMA includes mandates for FDA to establish new requirements regarding food defense, produce safety and preventive controls for facilities that produce both animal and human food. FDA is proposing requirements that facilities implement a written food safety plan that focuses on preventing foreseeable hazards in the foods they manufacture or process. Additionally, FDA is proposing standards in five key produce areas identified as possible routes of contamination, and preventive measures that will ensure the safety of fresh produce. FDA has been and will continue to be engaged with stakeholders on these important proposals, so that when final rules are issued, they will not only better protect the public health, but will also be practical and reasonable for producers to comply with and implement. Other efforts related to FSMA that FDECS has been involved in include the Protection Against Intentional Adulteration (Section 106), National Agriculture and Food Defense Strategy (Section 108), Food and Agriculture Coordinating Councils (Section 109), Improving the effectiveness of federal, state and local partnerships to coordinate food safety and defense resources (205c2), plus several others with food defense elements.

FDA’s FDECS looks forward to continuing to engage industry, academia, other government and nongovernment stakeholders to provide for, develop and otherwise contribute to the protection and resilience of the food supply for not only the U.S. but also our neighbors and colleagues around the globe. FDECS continues to work toward developing mechanisms that let us gauge progress on the various prevention, detection, response and recovery elements described within FSMA. It is hoped that through these collaborative, open efforts, FDA has demonstrated that the whole community can achieve the efforts described within the National Preparedness Goal.

In appreciation of National Food Safety Awareness Month and National Preparedness Month, this article has tried to bridge the gap between food defense and national preparedness. In trying to help industry realize the importance of thinking about the uncertainties in life, and challenging our industry, government and academia partners to identify their Rick Rescorla, this culture of food defense recipe is here for the taking and subsequent modification. However, as with any good recipe, it must be shared. And through sharing and leveraging these food defense tools and resources embedded in this recipe, government, industry and academia can work together toward protecting the food supply as well as the public’s health and well-being.

FDA is pleased to provide access to free, adaptable, functional food defense tools and resources, provide food defense education and training opportunities and ensure that continuous improvement and feedback loops are integrated into the development of every tool and resource created to enable our industry stakeholders to help us to further enhance and cultivate a culture of food defense and reduce the likelihood of intentional contamination of the food supply. We hope this feature has raised your awareness that food defense truly is everybody’s business!   

Jason P. Bashura, M.P.H., R.S., is a senior food defense analyst with FDA’s Food Defense and Emergency Coordination Staff. He has an M.P.H. from the University of Connecticut. For more information on FDA’s food defense tools and resources, please visit

The recipe box image is courtesy of David Weingaertner, Center for Food Safety and Applied Nutrition, FDA.


FREE-B Improvements

Following a presentation at the 2013 Food Safety Summit, FDA was approached by a Waffle House® representative to fine-tune FREE-B to make it more usable by executives of quick service family dining-style restaurants.

The relationship between the franchise and FDA was built on openness and a willingness to help the common good for the benefit of the whole community. After several discussions on how FDA could develop a new type of food-related emergency scenario for industry to adapt and use, new scenario content was born. Waffle House is integrating this exercise into its education and training program. And plans are underway to include this new scenario in the FREE-B for wider use in the coming months.

The Waffle House collaboration didn’t stop at just drafting a new simulation. Continued communication was needed to tailor the scenario to the particular company culture.

“I found FDA’s FREE-B to be an excellent template for a cross-jurisdictional tabletop exercise to measure readiness and response to a food emergency,” remarks Mick Miklos, former vice president of food safety and training for Waffle House Inc. “Never having done something similar at Waffle House, however, it was important that I initially insulate our executive team by creating a strictly internal learning event. I needed it to be both impactful and ‘safe.’ Our executives needed to experience a ‘Waffle-ized’ version without the initial involvement of outside stakeholders. My plan was to build on the success of this ‘first step’ so that engaging in a broader exercise such as those posited by FREE-B would be a logical ‘next step’ for our team.

“I spoke with Jason Bashura [at FDA] about my challenge to create a food safety/food defense scenario that would be both real enough to be plausible within the normal framework of Waffle House operations and limited enough in scope to only our executive team and key department heads. Jason, with his customary enthusiasm and can-do attitude, grasped the need immediately and offered to help me design something suitable. Our collaboration spanned approximately 2 months.

“Together we have successfully designed an executive learning event that promises to help our evolving food safety and defense culture reach the next stage in its maturity.”