key: cord-0800549-8ltxiohc
authors: Bashura, Jason P.
title: Food defense-“Back to the basics”
date: 2020-10-16
journal: Building the Future of Food Safety Technology
DOI: 10.1016/b978-0-12-818956-6.00010-5
sha: 244fdadab4c7bdc552cdebac9a97e02e915b8962
doc_id: 800549
cord_uid: 8ltxiohc

The focus of this chapter can be summed up in three words: risk, vulnerability, and threat. The author provides a glimpse “back” on the journey that the art of food defense, including historical perspectives of food defense and a review of a “hypothetical” intentional adulteration event that could result in public health harm. Also included is a review of potential research needs and elements critical to addressing and minimizing the likelihood of acts of food terrorism from occurring in the future. Finally, some key partnerships and collaborations will be identified and discussed.

Food defense-"Back to the basics" to everything else." Our ability to see and realize these connections is the challenge. The movement of data such as pieces of mail, of people, and of ingredients in our food system is "theoretically" trackable. The challenges are in the HOW it is traced and in the recording of each of those trackable moments.

Having lived in the northeast for most of my life, we endured ice storms, nor'easters, and even an occasional hurricane. When my family and I moved to the mid-Atlantic area in late 2008, we thought that we had "addressed" all of the logistics of our big move, until the first time the power went out-and it was out for more than 6 hrs. This was early 2009 and we were 300 miles from our friends and family of southern Connecticut, when the power went out in the townhouse we were renting in Maryland. I can remember our neighbor at the time-Mr. Cesar, a police officer for the Howard County Police Department-telling me that power outages happen "all the time" as we tried to figure out dealing with the power outage. I can count on one hand how many times we lost power for more than 5 minutes in Connecticut, and for that, we are grateful. It seems the RISK of losing power is greater in Maryland, than it is in Connecticut-at least in our experience. Is it the infrastructure? Is it the preplanning? Is it the proportion of above ground versus underground supply lines? Or, is it just a matter of perspective?

Fast forward to a few years later, we bought our home and settled into a great neighborhood where our neighbors quickly became our family-as most everyone that lives here is not "from" here. In a 7-year period, we probably have lost power three times a year, some of those events spanning multiple days. In early 2018, with the news of a looming ice storm on the horizon, I reached out to a couple of tree trimmers to help trim the tops of some of the spindly pines that dot our backyard and the tops dangle peerlessly close to the power lines when they are wet or topped with snow or ice. So, out of an abundance of concern of losing power with frigid temperatures on the horizon, we opted to have the trees aggressively trimmed, which ultimately led to one of them being cut down altogether. What does this have to do with food defense? Nothing, directly, but everything, indirectly. But how? It all has to do with risk, vulnerability, and threat.

Take a moment and review this last paragraph again, slowly, and think of these questions to yourself:

• What is the RISK being described?

• What is (are) the VULNERABILITY (ies)?

• What is the THREAT?

This chapter will focus on food defense activities and reducing the risk of food terrorism. Additionally, I will provide a glimpse "back" on the journey that the art of what we refer to as food defense today has taken to get to where it is today-this will include some historical perspectives of food defense and a review of a "hypothetical" intentional adulteration event that could result in public health harm. Later in this chapter, I will review some of the potential research needs and elements that are critical to addressing and minimizing the likelihood of acts of food terrorism from occurring in the future. Finally, some key partnerships and collaborations will be identified and discussed.

Answers to the three questions above: The RISK of losing power due to the THREAT of an ice storm led us to trim/cut back the VULNERABLE tree tops/branches. This mitigation strategy-ultimatelymitigated the RISK of losing power by eliminating the vulnerability: branches coming down on the power lines and taking out our power. Perhaps Donald Rumsfeld (then the Secretary of Defense) summed this up best when he stated in a February 12, 2002, DOD news briefing:

Reports that say that something hasn't happened are always interesting to me, because as we know, there are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns-the ones we don't know we don't know. And if one looks throughout the history of our country and other free countries, it is the latter category that tend to be the difficult ones. (Profita, 2006) Defining food defense terms Terms like food security, food biosecurity, and food terrorism have circled the globe since the early 2000s. We need to "level set" on some definitions for the remainder of this chapter. While the content below might be new to you or cause your eyebrows to furl when you read it-that is ok. That means that there is either new information or a different angle being described that youhad not thought of before.

Agriculture (Agro) Defense-protecting US agriculture-crops, livestock, and food-from global biothreats, while safeguarding people from zoonotic animal diseases and foodborne pathogens (Kansas State University, 2020).

Food Safety addresses the accidental or unintentional contamination of food products (USDA, 2009) .

Food Security accesses to an ample, nutritious food supply (WHO, 2002) . Food defense 1. The USDA's Food Safety and Inspection Service (FSIS) defines "Food Defense" as ". the protection of food products from contamination or adulteration intended to cause public health harm or economic disruption" (USDA, 2019).

The FDA's definition of "Food Defense" is found in 21 CFR 121 as ". the effort to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm" (FDA, 2020b).

Defense" by including a discussion of their focus on the "farm-to-table" continuum with "Pre-harvest elements . include crops and animals in the field, as well as fertilizers and animal feed" and how "The harvesting or slaughter of agricultural products marks the beginning of the post-harvest food sector," which also includes "processing, storage, transportation, retail, and food service" (DHS, 2007) .

Certification's FSSC 22000-0-005.2 defines "Food Defense" as a process to prevent ". food and feed supply chains from all forms of ideologically or behaviorally motivated, intentional adulteration that might impact consumer health." 5. The National Center for Food Protection and Defense (NCFDP) (2011) defines "Food Defense" in terms of three different risks: a. Industrial Sabotage: "Intentional contamination by an insider or competitor to damage the company, causing financial problems/recall but not necessarily to cause public harm." b. Terrorism: "The reach and complexity of the food system has caused concern for its potential as a terrorist target." c. Economically Motivated Adulteration: "Acts against a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain."

Food Protection a concept that leverages the outputs of food safety and food defense activities (FDA, 2007) .

Food Terrorism is defined as an act or threat of deliberate contamination of food for human consumption with chemical, biological, or radionuclear agents for the purpose of causing injury or death to civilian populations and/or disrupting social, economic, or political stability (WHO, 2002) .

Food Fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging, or false or misleading statements made about a product for economic gain (Congressional Research Service, 2014) .

Vulnerability has been defined as a physical feature or operational attribute that renders an entity open to exploitation or susceptible to a given hazard (DHS, 2008) .

Threat has been defined as something that can cause loss or harm, which arises from the ill intent of people (BSI, 2017) as well as "natural or man-made occurrence, individual, entity, or action that has or indicates the potential to harm life, information, operations, the environment and/or property" (DHS, 2008) .

Risk is defined as "potential for an unwanted outcome resulting from an incident, event, or occurrence, as determined by its likelihood [a function of threats and vulnerabilities] and the associated consequences" (FDA, 2007) .

Intentional adulteration 1. The term "intentional" is defined by Merriam-Webster (n.d.) as "done by intention or design: INTENDED-intentional damage-DELIBERATE." 2. The term "food" is defined in 21 US Code x 342 as a. articles used for food or drink for man or other animals, b. chewing gum, and c. articles used for components of any such article. 3. In terms of food, the term "adulterated," based on 21 US Code x 342, gains the following definition elements:

"A food shall be deemed to be adulterateda. Poisonous, insanitary, etc., ingredients. If it bears or contains any poisonous or deleterious substance which may render it injurious to health; b. Absence, substitution, or addition of constituents i. If any valuable constituent has been in whole or in part omitted or abstracted there from; or ii. if any substance has been substituted wholly or in part therefore; or iii. if damage or inferiority has been concealed in any manner; or iv. if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is." 4. Therefore the term "intentional adulteration" could be defined as "The willful addition of an adulterant or removal of a key component of an ingredient or food to cause public health or economic harm."

The concept of getting "back to the basics" on food defense-in essence-is a nontechnological approach to addressing a problem-intentional adulteration-that requires a HUMAN aggressor with intent (motivation) for the intended outcome to be realized. There are technologies available today to detect nonconformities in food matrices, detect motion, capture video, and analyze ingredient composition and yet other technologies can facilitate restricting access to certain "vulnerable" areas of a food manufacturing, storage, or production areas. However, at the end of the day, Food Defense is about a steady state culture of conscious awareness-a suite of behaviors exhibited by individuals that can hinder, minimize, or prevent an act of intentional adulteration from occurring.

Within the United States, food defense "activities" can be likened to the concept of "Homeland Security meets food safety"-as they involve food safety policies and procedures being leveraged, refined, and updated to protect food manufacturing environments from those individuals seeking to do harm via the food supply-the very definition of "Food Terrorism."

The tragic events of September 11, 2001, forced us all to rethink how we took certain aspects of safety and security for granted. While concerns over the safety of air travel captured much attention, the US government did not ignore concerns over the safety of the American food supply. Even those in key federal government positions questioned the ease with which terrorist organizations might seek to contaminate parts of our food supply and distribution systems, such as (then) Health and Human Services Secretary Tommy G. Thompson, who stated in 2004 "For the life of me, I cannot understand why the terrorists have not attacked our food supply because it is so easy to do" (Pear, 2004) . By the end of 2001, the FDA and the USDA sought to determine the current state of the American food system's readiness against an intentional attack.

The United States is not alone in this perception, as the World Health Organization (WHO) stated in their post-9/11 document "Food Safety Issues: Terrorist Threats to Food-Guidance for Establishing and Strengthening Prevention and Response Systems": "The key to preventing food terrorism is establishment and enhancement of existing food safety management programmes and implementation of reasonable security measures" (WHO, 2002) .

The Food and Agriculture "sector" was designated one of the United States' critical infrastructure and key resources (CIKR) (DHS, 2009) within Presidential Policy Directive 21 (Obama White House, 2013). The DHS formed the Food and Agriculture Sector Coordinating Council in 2004 (FDA, 2007) . As a result of these activities, the US government assembled experts from across the government, private sector owners and operators, academic communities, and nongovernment organizations-henceforth the food and agriculture "system"-to identify critical elements within the CIKR and to devise the Food and Agriculture Sector's Sector Specific Plan (SSP) (CISA, 2015).

In early 2000s, under the direction of (then) Associate Commissioner for Foods, David Acheson, the FDA convened a series of meetings with the Council of Association Presidents (CAP) (FDA, 2019a) of the various associations of representing the membership of regulatory agencies of varying capacities across the United States (FDA, 2019d) to help with developing and refining some fundamental food defense resources which are still in use today: the Employees FIRST and the ALERT initiatives. I was fortunate to have been able to represent the National Environmental Health Association on the CAP and presented the perspective of the state/local regulatory health official. During one of these last meetings, we participated in a "live" town hall meeting that was seeking to educate the regulatory community about what food defense was all about and some of the activities that the FDA would be working on. Again, in getting back to the basics, Employees FIRST and the ALERT initiatives were focused on educating personnel at the front lines (FIRST) and management (ALERT) (Barringer, 2007) as to what they could do to help develop that "culture" of Food Defense. In 2008, as a direct hire to the FDA, I was humbled, thrilled, scared, nervous, and proud-I was being offered a position to work on the FDA's Food Defense Team, to help build and inform the direction of the Food Defense strategy for the United States-not bad for a culinary school dropout who worked in local and state public health in Connecticut and never lost sight of the BIG picture. The opportunity to work for the FDA would mean additional responsibilities and the opportunity to help provide state/local public health perspective into the Federal "strategy." I had been working at the FDA for maybe 3 months when the Peanut Corporation of American outbreak hit. This incident was an eye-opener to me. I worked down the hall from the Emergency Coordination and Response Team when I received a phone call from a colleague who asked me what I knew about Salmonella in peanut butter. I remember the conversation like it was yesterday because I knew that was going to be a BIG deal, especially as we were working on the Food Safety Enhancement Act, H.R.2749, 111th Cong. (2010) (precursor to FSMA) contents pertaining to a "Food Defense rule."

One of my first projects based on education and training was to work on finishing a task order that the Institute of Food Technologists (IFT) was working on, at that time led by Jennifer McEntire and Tejas Bhatt. The Food Related Emergency Exercise Bundle (FREE-B) was a series of tabletop exercises that were designed and intended to be used to help facilitate the development of or to test existing food emergency response plans for regulatory and industry partners. While most of the scenarios were intentional adulteration based, the storylines would lead a participant to believe that the scenarios could have gone either way, depending on the information that was shared with the participants. The FREE-B was literally a "Federal project" in the boundaries and limits of government consternation; between legal approval of the use of logos and endorsements from various other Federal partners, the project seemed to be redefining its scope as we neared completion. However, we held firm and launched the FREE-B at the IFT annual conference in 2011, and it continues to have new scenarios added to it, to this day.

As described above, the FREE-B (FDA, 2017) is a suite of exercises intended to help drive improvements based on focusing on getting back to the basics-communication is ALWAYS a key finding and takeaway from any exercise that is completed; how we communicate, not just when or what is communicated, continues to be a challenge. Developing characteristics and skill sets of leadership and being able to demonstrate those in times of crises, these build capacity and the ability to "clear the room" of the smoke and fog that often accompanies the process of making big decisions. Having the confidence in your knowledge and the ability to articulate your position are key to your success-and the success of the organizationthese are critical in executing against the plan. By participating in exercises as described above, industry stakeholders gain the ability and opportunity to "sharpen their edge."

Another project related to education and training pertinent to Food Defense was the Innovative Food Defense Program-a grant funding opportunity to help develop, predictably, "INNOVATIVE" approaches to food defense. Concepts have leveraged technology to measure/track the distribution of contaminated food (in Wisconsin), while others focused on the use of comic strip-like illustrations to "tell a story," such as in Somerset County, NJ ("Food Safety", 2020). Others examined the ability for an appropriately credentialed regulatory official to "penetrate a facility"-get as far as they could within a retail food setting without being challenged to produce identification-and/or proof of identity/affiliation, such as in Cuyahoga County (OH) Board of Health (Armstrong, 2020) .

While those Innovative Food Defense Program examples shared above are just a few of the programs that the FDA funded, they are shining examples of what COULD happen if the we were to really get back to basics and rethink some of the current approaches to Food Defense in the United States. Inherent challenges have existed within Federal government as they relate to the issuance of grants to state and local regulatory agencies. If there is a NEED for state, local, tribal, and territorial entities to apply for and for the federal government to be able to fund those requests, there is really no telling how much "new" or improved foundational resources could be generated to bolster the consciousness and awareness of a food defense culture within the regulatory community. The last example (Cuyahoga County) focused on imposter health inspectors, but this is an example of a program that COULD be used if applied at the state/federal levels, as well.

Ironically, the Cuyahoga County project was based on "real-life" incidents that were (and still do today) occurring involving imposter health inspectors not just domestically in the United States but globally as well. Those unauthorized personnel illegitimately seek access to the facility or simply try to "scam" the operator for some cash so that they do not have to endure an inspection happen more frequently than we would care to admit. These unauthorized personnel do not limit their scope to retail or food manufacturers, either-there are reports of other critical infrastructure sites being targeted as well. The need for diligence and recognizing WHO should be permitted in to your facility, ensuring that there is a mechanism to verify the credentials of the "inspector" and training your personnel to not be "fooled" in to paying off a scammer inspector (City of Monroe, 2018; Government of USVI, 2020). These are just a few examples of getting back to the basics-limiting access to only those that should/have a legitimate reason to be there.

The Food and Agriculture Sector's (SSP) rewrite for 2010 started shortly after I arrived at the FDA in late 2008. In partnership with a colleague who quickly became a friend at the USDA's FSIS, Michael Bailey and I worked tirelessly to combine a previous "separated" SSP (a USDA section and an FDA section) into one, unified document. Michael and I worked with tremendous secretarial support from the US DHS, and Mariella and Scott were beyond fantastic to work with but always on task with (a) what needed to be done and (b) by when-it was essentially project management 101. Within the 2010 SSP, Michael and I had even proposed some potential workgroups to help reduce risk within the food and agriculture sector. The five working groups that we had suggested were the 1) Education and training working group, 2) Partnership working group, 3) Communications/IT working group, 4) Transportation/shipping working group, and 5) Laboratory capacity working group.

Within the SSP was a section on the Joint Committee on Research (JCR)-an opportunity whereas the private sector and government leadership within the Food and Agriculture Sector had identified a series of food defense related activities or research that were identified as being needed. The JCR "is a body through which the SCC and GCC can collaborate and identify sector research needs" (SSP, 2010). The JCR, unfortunately, is not functional at this time (2020). Some of the work that the JCR had indicated for select agent research/declassification of material that can help industry to prioritize their R&D efforts only stands to benefit all of the food and agriculture sector owners and operators.

In their October 2017 Blue Ribbon Study Panel Report titled Special Focus: Defense of Animal Agriculture, the Bipartisan Commission on Biodefense stated "Although the nation has made great strides, it still falls critically short in rapid biodetection, diagnosis, and integrated biosurveillance of outbreaks" (Bipartisan, 2017). As a "gap" that can be seen and has been described, getting BACK to the BA-SICS through open dialogue and identifying strengths and opportunities in research can and will help to protect the food supply. That collaboration comes with a cost though-and it is knowledge-which can be a powerful tool, and it can be hard for agencies/departments to share information if the focus or objective of the information sharing is not addressing an aligned goal.

The JCR recommended the development of an academic entity developing a resource that could enable an open search of research in an area of focus or concern. The Food Protection and Defense Institute (FPDI) developed the Food Defense Research Database (FDRD) in 2009. Additionally, the FDRD was capable of sorting and archiving open source news, presentations, and peer-reviewed articles of content pertaining to food and agriculture defense (FDA, DHS, & USDA, 2011) . Unfortunately, along with other funding cuts and resource reprioritization, the FDRD was not sustained by the FPDI.

The FDA developed the Food Protection Task Force (FPTF) grant program as a means to "create an effective nationwide infrastructure for enhancing outreach, response, integration and information sharing in state, local, and tribal governments" (FDA, 2019b) . Shortly after establishing the FPTF grants, the FDA expanded a novel concept known as the Food Protection Rapid Response Teams (RRT)-spearheaded by committed FDA personnel that continually seek to develop, grow, and share best practices via the RRT playbook (FDA, 2019c) .

The FDA funds their Division of Food Defense Targeting (DFDT)-formerly known as the Prior Notice Center (FDA, 2020a)-that leverages a Predictive Riskbased Evaluation for Dynamic Import Compliance Targeting (PREDICT) program. PREDICT assists entry reviewers in targeting higher-risk shipments for examination. This TECHNOLOGY behind the essential work that the DFDT does could be amplified if there was an opportunity for the private sector to be able to inform and fine-tune the focus of the work that is being done. This is "future" thinking, but the progress realized tomorrow has to be sewn through the seeds of ideas in the fields of hope today. The FDA's DFDT also "coordinates a broad range of activities that focus on protecting the food supply" (Spink, 2013) .

Some of the collaborations that I was fortunate to be associated with while I was with the FDA include the US FBI's Agroterrorism Workshops (FBI, 2014) and the Early Warning Infectious Disease Surveillance (EWIDS) (GlobalSecurity, 2011). EWIDS included "the Great Lakes Border Health Initiative," which was an amazing interaction with dedicated professionals that actually resulted in the birth of another FREE-B exercise, based on specific issues that some of the regulatory officials that were present there were experiencing. The Multi-State Partnerships for Security in Agriculture (MSPAS) and the Southern Agriculture and Animal Disaster Response Alliance (SAADRA) were "state stakeholder"-based groups that were focusing on trying to comply with the DHS Homeland Infrastructure Threat and Risk Analysis Center data calls, intending to identify/protect CIKR within the states, but the data call always seemed to produce a lot of work and not a lot of return on investmente illustration of tier 1 or 2 critical infrastructure within the states. Both the MSPAS and SAADRA convened regular meetings and drove information sharing through to the private sector owners and operators within their respective states and jurisdictions. Other amazing collaborations that helped to drive and improve our knowledge base in the food defense arena include the NCFDP, which is currently known as the Food Protection and Defense Institute (FPDI), and the Association of Food and Drug Officials (AFDO) Food Protection and Defense working group.

After leaving the federal government and joining industry in 2014, I quickly learned that there were disparate groups that were working on similar concepts related to food defense-namely the development of comments in advance of the Intentional Adulteration Rule (IA Rule) (FDA, 2016) embedded within the Food Safety Modernization Act (FSMA)-but these groups were not "coordinated." On June 8, 2016, I convened the first Food Defense Consortium call-a loosely coordinated call to bring together private sector owners and operators to focus on a variety of elements embedded within FSMA's IA Rule. As of March 2020, the Food Defense Consortium developed and submitted comments on FSMA's IA Rule, related guidance, sought an extension for compliance date, and is currently working to engage with membership on a suite of food defense "best practices" that will encourage and focus on getting "back to the basics" related to foundational programs and existing measures that decrease vulnerability through accessibility restriction and/or feasibility reduction for an act of intentional adulteration to occur.

Working through the Food Defense Consortium, we have developed an "updated" pneumonic to help get back to the basics about food defense: helping to ensure that industry Knows the Food Defense FACTS and that front-line personnel are being Food Defense AWARE:

Know the food defense FACTS Be food defense AWARE Food defense plan: The facility has a food defense team and developed a plan that includes the outcomes of RISK assessment (that includes vulnerability and threat contributions) Access control is limited/ controlled Commit to helping develop a CULTURE of food defense Training has been completed Say something if you SEE or HEAR something out of place or unusual Pay Attention to your workplace and know who you should report unusual findings to Watch out for unauthorized personnel in areas they should not be in Access control matters-follow physical security best practices Respond and tell management or a supervisor if something is out of the ordinary. Everyone, all the time . no exceptions!

Recognizing that there is not a formal mechanism for information sharing within the food and agriculture sector as there is for other critical infrastructure sectors, the concept of the Food Defense TRUST was conceived within the Food Defense Consortium. The TRUST is a double entendre for the term used to describe a group with similar intentions or objectives, but, more importantly, that it is about actually developing trusted relationships. While the need for an information sharing and analysis center (ISAC) has been a challenging issue to share among the food and agriculture sector, in the midst of the COVID-19 pandemic, an ISAC would certainly have made information sharing simpler, clearer, and easier.

The "reality" of a food terrorism event is even clearer in the "infamous" salmonellosis outbreak that transpired in The Dalles, OR, in 1984 . Some of the followers of the Bagwan Shree Rajneesh attempted to influence a local zoning election by sickening greater than 750 people by intentionally contaminating salad bars and selfserve areas in several restaurants with Salmonella (Tӧrӧk et al., 1997) , which was not actually "solved" until a year later-though many of the clues that are listed above had indeed been visible as well. After the outbreak had subsided, and life had returned to "normal"-there was an investigation in to the Rajneesh compound that resulted in an "admission" to local/federal officials-affirming what was believed to be true but could not be proven-that the outbreak indeed had a direct connection to the Ranjesspuram. Moreover, officials "found glass vials containing Salmonella 'bactrol disks' in the laboratory of a Rajneeshpuram medical clinic"-the epitome of the "smoking gun."

Germany experienced one of their largest outbreaks of a foodborne infection in 2011. Recorded illnesses caused by enterohaemorrhagic Escherichia coli (EHEC) with the serotype O104:H4 numbered at 2987 (nearly triple Germany's annual average) with 18 deaths. Further, the number of recorded illnesses caused by hemolytic uremic syndrome (HUS) numbered at 855 (more than 13 times Germany's annual average of 65 cases) with 35 deaths (Berger, 2012) .

Several "unknowns" plagued investigators as they sought to determine the source of the outbreak. According to some sources, Egyptian fenugreek sprouts are the suspected food vehicle for the outbreak (Neuman & Sayare, 2011; Radosavljevic, Finke, & Belojevic, 2014) . According to other sources, the ". sudden and unexplainable emerging of a fast-increasing number of cases and deaths from bloody diarrhea and HUS might have been caused naturally, accidently, or intentionally" ("Deliberate act," 2012). We have seen this time and time again whereas "armchair" quarterbacks seem to forget that, while hindsight is 20/20, maintaining an open mind can help to see the BIG picture in the midst of the investigation.

Teams investigating the fenugreek seeds in the 2011 outbreak noted many clues. As described in the Medical Aspects of Biological Warfare (Dembek, Pavlin, Siwek, & Kortepeter, 2018) , these include Clue 1: A highly unusual event with large numbers of casualties. Clue 2: Higher morbidity or mortality than is expected. Clue 3: Uncommon disease. Clue 4: Point source outbreak. Clue 5: Multiple epidemics. Clue 6: Lower attack rates in protected individuals.

Clue 7: Dead animals. Clue 8: Reverse or simultaneous spread. Clue 9: Unusual disease manifestation. Clue 10: Downwind plume pattern. Clue 11: Direct evidence.

If these "clues" are to be followed, then, the road map can help to guide decisions that are being made. Going back to the basics of the investigation-leveraging an open-minded approach-could help to inform the investigation, while not focusing explicitly on the anticipated path forward.

The United Kingdom's response to the 2013 "horse meat scandal" included the establishment of the UK's National Food Crime Unit, headed by Andy Morling ("First assessment of food crime in the UK published," 2015). Similarly, Australia revised their food protection regulations based on intentional adulteration incidents in 2018 when acts of sabotage involved needles inserted into strawberry in all six Australian states (Siddique, 2018) . This pushed law enforcement entities in Australia and beyond into unfamiliar territory. Specifically, leaders introduced new laws and policies pertaining to differentiating a tampering event where someone was seeking retaliatory action against another person, or a firm, or if the actions equate with terrorism.

The conclusions and recommendations section of these food protection regulations identified several specific goals, including the need to improve communication, collaboration elements, traceability, and industry preparedness and response (Food Standards Australia New Zealand, 2018; "Recommendations made in strawberry tampering report," 2019).

As Category B of the New Era of Smarter Food Safety (FDA, 2019e) calls out "To fully realize a preventive controls system that rapidly incorporates new knowledge, we must also ask if we can make processes and communications more effective, efficient, and in some cases, simpler" (FDA, 2019e).

This section on Food Defense: Getting Back to Basics has stressed the point that we must embrace the opportunity to identify improvements to facilitate access to Food Defense research, tools, technologies, and resources developed over the last 20 years. We must also prioritize those solutions-the future of food safety technology-that can be developed to support the greatest return on investment of time and financial need to actually minimize the likelihood of an act of intentional adulteration.

With current examples of devices, software, and platforms, along with the hype around IOT, AI, machine learning, and digital end-to-end traceability solutions and their roles in Food Safety-including Food Defense-leaders must remember that technology alone cannot solve all the challenges our modern food supply systems face.

Some suggestions to support future efforts and technology include • The need for an Information Sharing and Analysis Center or Organization in order to facilitate the exchange of information in a non attributable manner.

• More collaborative environments where threat intelligence information can be freely shared between and among the food and beverage industry are needed. Examples like the Food Defense Consortium described above are "grass root" solutions where challenges previously existed. As included within the FDA's Food Protection Plan (FDA, 2007b) , the key elements of prevention, intervention, and response are plainly evident in the approach that was taking in the crafting of the FSMA language, as well. • Research needs should be reassessed and practical solutions to these knowledge gaps can be identified, predictive analytical tools. If the University of Minnesota's FPDI and the Texas A&M University's National Center for Foreign Animal and Zoonotic Disease (FAZD) were FULLY funded within the last decade, these gaps wouldn't exist today. If a hybrid government and industry approach to support the FPDI and FAZD could support, coordinate, and synthesize these research needs, gaps in education and training could be identified, and risk assessment-based resources could be developed to illustrate where limited resources need to be focused to minimize impacts to the system. • Access to tools and resources-The FDA's New Era of Smarter Food Safety (FDA, 2019e) asks industry to consider and evaluate all available and innovative solutions that can increase access to tools and resources that have been developed to reduce risks within the Food and Agriculture sector. We must acknowledge that while some are presently at arms length, will the "connection" to these tools and resources become greater challenges over time? If the US government is able to fund the development of these resources, it should be able to make these resources freely available across the Food and Agriculture sector. • Streamlining the terms and definitions used-in a GLOBAL landscape-will directly benefit the education and training needs described herein. The ability to align on terminology, concepts, and requirements-like what the Global Food Safety Initiative seeks to accomplish-will help to ensure that we are all speaking one language, not saying something, but meaning something else.

With the establishment of new policies designed to protect the critical infrastructure within the United States, industry experts continue to ask if they are being leveraged to the extent possible. Enforcement of laws to the maximum extent could help to decrease the likelihood of other, copycat incidents, but only time will tell.

One of the questions embedded within the New Era of Smarter Food Safety (FDA, 2019e) is "What are the most significant actions FDA could undertake to promote and support the use of smarter tools for prevention?" I would offer we consider getting Back to the Basics:

(1) Leveraging risk-based approaches to developing tools and resources targeted at education and training of an "all of industry" approach to aid in reducing the risk of intentional adulteration of the food supply.

(2) Ensure adequate access to adequate modular-based education and training opportunities for personnel within the food and agriculture system. (3) FOCUS on the outcome-not the solution.

(4) COLLABORATE with and listen to feedback from industry and LISTEN to aid in understanding the comments, questions, and concerns that are raised. (5) Leverage existing or indicate the need for new TECHNOLOGY to "fill gaps" that might exist.

The art of what we refer to today as food defense is predicated on the shared experiences, collective expertise and research that has evolved in the last 20þ years, This chapter did not cover what needs to be done in order to develop a food defense plan as per government or for GFSI scheme compliance; it was intended to be an "overview" of the foundation and history of food defense activities, research and collaborations that have occurred and to emphasize the need to ensure clear lines of information sharing in order to get BACK TO THE BASICS. Reducing the risk of an act of Food Terrorism is not a responsibility to be taken lightly. This author is currently working on a future publication to aid in clarifying the nuances of various government-based regulations and GFSI scheme compliance requirements.

Cuyahoga county (OH) board of health

Staying ALERT about food defense. Food Safety Magazine

Bipartisan report of the Blue Ribbon Study Panel on Biodefense. Special focus: Defense of animal agriculture

EHEC O104:H4 In Germany 2011: Large Outbreak of Bloody Diarrhea and Haemolytic Uremic Syndrome by Shiga Toxin-Producing E.coli via Contaminated Food

History of quarantine

Water department utility imposters

Food fraud and "economically motivated adulteration" of food and food ingredients

Food and agriculture sector's 2010 sector specific plan

Deliberate act cannot be ruled out for Germany's

Office of the Surgeon General Borden Institute US Army Medical Department Center and School Health Readiness Center of Excellence

The department of Homeland security's role in food defense and critical infrastructure protection. Office of Inspector General

risk steering committee

Critical infrastructure and key resources (CIKR)

Commercial facilities: Food defense awareness and outreach

Prior Notice of imported foods

National infrastructure protection plan

Food protection plan: An integrated strategy for protecting the nation's food supply

Mitigation strategies to protect food against intentional adulteration

Food related emergency exercise Bundle (FREE-B)

Mitigation strategies to protect food against intentional adulteration: Guidance for industry

Food protection task force (FPTF)

Rapid response teams (RRTs)

Regulatory associations

New era of smarter food safety

Food defense

2011 sector annual report: Food and agriculture

First assessment of food crime in the UK published

Report to government: Strawberry tampering incident

Beware: Health Inspector Imposters. Individuals posing as health inspectors are targeting restaurants and retail operators in the territory. Dept. of Health/Division of Environmental Health

About the facility and U.S. bio/agrodefense policy. National Bio and Agro-defense Facility

Backgrounder: Defining the public health threat of food Fraud

Egyptian seeds are linked to E. coli in Germany and France. The New York Times

December 4). U.S. Health chief, stepping down, issues warning. The New York Times

Known knowns, known unknowns and unknown unknowns: A retrospective. CBS News

Escherichia coli O104:H4 outbreak in Germany-clarification of the origin of the epidemic

85 million mail items processed at anthrax-contaminated facilities

Strawberry needle sabotage scare spreads to all six Australian states. The Guardian

Food safety

Economically motivated adulteration: Another dimension of the "expanding umbrella of food defense

PAS 96:2017 Guide to protecting and defending food and drink from deliberate attack. Sponsored by the Department for Environment, Food & Rural Affairs (Defra) and the (UK) Food Standards Agency (FSA)

A large community outbreak of salmonellosis caused by intentional contamination of restaurant salad bars

Food defense guidelines for slaughter and processing establishments

Food defense overview

Food safety issues: Terrorist threats to food e guidance for establishing and strengthening prevention and response systems. Food Safety Department

Contact tracing