The safety of U.S. citizens and the global consumers of

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1 UNINTEROPERABILITY Health Care, Public Health, and the Food and Agriculture Critical Infrastructures DIGITAL STOCK Utilizing a Food Product Safety Management Enterprise Architecture BY WILLIAM S. BODDIE AND LUIS KUN The safety of U.S. citizens and the global consumers of U.S. food products is at significant risk. Approximately 76 million people in the United States contract an illness from consuming contaminated food products each year, 325,000 of these victims require hospitalization, and approximately 5,000 die from their illness [1]. Contaminated food product incidents from 2006 to the present highlight the severity of this risk. The spinach Escherichia coli (E. coli) outbreak in 2006, the iceberg lettuce E. coli outbreak at Taco Bell restaurants in 2006, the peanut butter salmonella outbreak in 2007, the contaminated pet food outbreak in 2007, and the nationwide salmonella outbreak initially thought to have been caused by contaminated tomatoes in 2008 caused widespread national concern and demanded that the U.S. Government should adopt a national approach for ensuring U.S. food product safety. With approximately one in four U.S. consumers contracting illnesses from contaminated food products annually, the United States must develop and use a national food product safety management enterprise architecture (EA) to protect this critical national infrastructure industry. An EA describes the current and future state of an enterprise (organization or program) and lays out a plan to transition from the current capabilities to the desired capabilities. An EA is a management practice used to align enterprise resources to improve business performance and help enterprise leaders accomplish their responsibilities more effectively [23]. Although the EA has its origins in the information management discipline, the salient aspects of an EA are specifically applicable to address this global challenge. A food product safety management EA would enable the United States to describe current food product safety capabilities, describe desired capabilities, and develop and implement strategies to dramatically improve food product safety. According to the U.S. Government Accountability Office (GAO), effective use of an EA, or modernization blueprint, is a hallmark of successful public and private organizations [2]. Without a national food product safety management EA, the U.S. food supply will continue to threaten food consumers globally. Digital Object Identifier /MEMB Selected Contaminated Food Product Incidents from 2006 to 2008 In June 2008, the U.S. Food and Drug Administration (FDA) alerted consumers in New Mexico and Texas that a salmonella outbreak had occurred and that it might be linked to raw red tomatoes and food products containing raw red tomatoes. From April to June 2008, 57 cases of salmonella were reported, which resulted in 17 hospitalizations [25]. Additionally, more cases involving salmonella were reported in several southwest and western states. More than 1,000 people in 41 states eventually became sick from the salmonella outbreak, and, as of this writing, the rate of sickness continues at new cases daily. The Centers for Disease Control (CDC) determined this outbreak to be the largest in the last decade [26]. The CDC officials later believed that the outbreak was caused by contaminated fresh jalapenos peppers; however, the CDC was unable to isolate the source of the outbreak [26]. The FDA later rescinded its warning to consumers regarding eating raw red tomatoes and products made with raw red tomatoes [27] and identified jalapenos and Serrano peppers as more probable sources of the outbreak. As of this writing, U.S. federal government officials have been unable to isolate the source of the salmonella outbreak, and the number of people infected with salmonella was more than 1,200 [28]. During September 2006, 205 people across 26 states contracted E. coli from contaminated spinach produced in San Juan Bautista, California. Approximately 103 victims required hospitalization, and three died from their illness [3]. The FDA and the California Department of Health Services (CDHS) were unable to confirm the direct cause of the E. coli outbreak. From August 2006 to March 2007, 714 people across 47 states contracted salmonella after consuming peanut butter, and 120 victims required hospitalization [4]. The salmonella outbreak was traced to a single peanut butter manufacturing facility in Georgia. The FDA and the CDC were unable to determine how the peanut butter became contaminated. During December 2006, 71 people across New Jersey, New York, Pennsylvania, and Delaware became sick after eating Taco Bell restaurant food products that contained iceberg lettuce [3]. Fifty-three of the 71 victims were hospitalized, and eight experienced kidney failure [3]. Although the E. coli outbreak was traced to farm fields in Huron, 54 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE /08/$ IEEE NOVEMBER/DECEMBER 2008

2 California, the FDA and the CDC were again unable to determine the cause of the contamination. During December 2006, 80 people in Minnesota and Iowa became sick after eating food products from Taco John s restaurants that included iceberg lettuce. Fifty-six persons contracted E. coli, and 43 victims required hospitalization [4]. Although this incident was traced to farm lands in coastal and central California, once again, the FDA and the CDC could not determine how the lettuce became contaminated. Recent U.S. food product incidents have also involved contaminated pet food. Commercially prepared pet food containing imported contaminated wheat resulted in illness and death in many dogs and cats in 2006 and 2007 [5]. The pet food wheat was contaminated with melamine, a chemical used to create products such as plastics, cleaning products, glues, inks, and fertilizers. The contaminated wheat was traced to a Chinese source that illegally imported the wheat into the United States. These and other recent U.S. food product incidents confirm that the health care, public health, and the food and agriculture critical infrastructures are at significant risk! These risks are not constrained exclusively for the United States and are applicable to our global food partners. Food Product Industry The U.S. food product industry is the largest industry and employer in the United States [6] and generates more than US$1 trillion in economic activity each year, which equates to approximately 13% of the U.S. gross domestic product [1]. Supermarkets and store food sales account for US$507 billion in economic activity, and restaurant food sales account for US$537 billion in economic activity and employ approximately 13 million people [7]. Imported food products contribute substantially to the U.S. food product supply. Approximately 15% of U.S. food products are imported, and 189,000 registered foreign entities located in more than 150 countries manufacture, process, pack, or store food products for import into the United States [8]. Around 60% of fresh fruits and vegetables consumed in the United States are imported, and 75% of seafood is imported. The United States imports US$72 billion worth of agricultural products and expects to import a record US$75 billion in fiscal year (FY) 2008 [9]. Given the magnitude of the U.S. food product industry, managing its safety is a national imperative. Food Product Safety Management The United States has a patchwork approach to food product safety management. Fifteen U.S. government agencies contribute to the patchwork, including the U.S. Department of Health and Human Services (HHS), U.S. Department of Agriculture (USDA), U.S. Department of Homeland Security (DHS), and the CDC. Role of the HHS The HHS s mission is to protect and promote the health and well-being of all Americans while providing world-class leadership in the areas of biomedical research, public health, and social services [10]. The HHS employs more than 64,000 employees and had an FY 2008 operating budget of approximately US$708 billion [11]. The FDA is a critical HHS food product safety management partner. The FDA is responsible for ensuring U.S. food product safety, employs approximately 9,000 people, and had an FY 2008 operating budget of approximately US$2.1 billion [5]. It regulates approximately 80% of the U.S. food product supply and annually regulates domestic food products valued at US$417 billion and imported food products valued at US$49 billion [8]. The FDA oversees more than 136,000 registered domestic food product manufacturing facilities and regulates more than 2 million food product producing farms, almost 1 million restaurants and food service establishments, and approximately 114,000 supermarkets, grocery stores, and food outlets [8]. It developed a food protection plan (FPP) to improve its food product safety management capability [8]. It refuses approximately 0.12% of the food requested to be imported into the United States. USA Today published a list of all the contaminated imported food products and identified the countries that imported these products [29]. Role of the USDA The USDA s mission is to provide leadership on food, agriculture, natural resources, rural development, and related issues based on sound public policy, the best available science, and efficient management [12]. It has more than 100,000 employees and US$128 billion in assets and had an FY 2008 operating budget of US$77 billion [13]. The USDA regulates approximately 20% of the U.S. food product supply. The USDA s agencies most directly accountable for the food product safety management responsibilities are the Food Safety and Inspection Service (FSIS) and the Animal and Plant Health Inspection Service (APHIS). The FSIS s mission is to protect consumers by ensuring that meat, poultry, and egg products are safe, secure, wholesome, and correctly labeled and packaged [14]. The FSIS employs more than 9,500 people and had an FY 2008 operating budget of approximately US$930 million [14]. The APHIS s mission is to protect the health and value of American agriculture and natural resources [15]. It employs more than 8,500 people and had an operating budget of US$1.4 billion in FY 2007 [16]. Role of the DHS The DHS is responsible for U.S. food product safety. The DHS s mission is to lead the unified national effort to secure America, prevent and deter terrorist attacks, protect against and respond to threats and hazards to the nation, ensure safe and secure borders, welcome lawful immigrants and visitors, and promote the free flow of commerce [17]. It is responsible for food product safety prevention, protection, and preparedness and food safety product incident detection, response, and recovery [18]. It employs more than 180,000 employees and had a discretionary FY 2008 operating budget of US$37.3 billion. Role of the CDC The CDC is a key U.S. food product safety management partner. The CDC s mission is to promote health and quality of life by preventing and controlling disease, injury, and disability [4]. It employs more than 8,400 people and had an FY 2008 operating budget of US$8.8 billion [3]. Food Product Safety Management Challenges Although U.S. government agencies responsible for food product safety management had a combined FY 2008 operating budget of more than US$820 billion, the global consumers of the U.S. food products remain at risk. The GAO found the nation s food product safety to be at significant risk and concluded that a national strategy is needed to integrate national food product management rather than merely coordinating a wide array of federal activities [19]. It designated U.S. food IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE NOVEMBER/DECEMBER

3 The U.S. food product safety management functions include governance, strategic planning, EA, portfolio management, and CPIC. safety as a high-risk series area [1] and concluded that although the FDA s FPP is a positive first step, the FDA needs to provide more specific information about its strategies and the resources it needs to implement the plan [1]. The FDA s Science Board concluded that the nation s food supply is at risk [20], found the critical challenges in the U.S. food product safety management quilt, and reported that the FDA is not positioned to meet current or emerging regulatory responsibilities [20]. It concluded that the FDA cannot fulfill its mission [20] because its scientific base has eroded and its scientific organizational structure is weak, its scientific workforce does not have sufficient capacity and capability, and its information technology infrastructure is inadequate [20]. The fragmentation of multiple organizations and agencies having discrete food product safety management responsibilities is also a critical national or global food product safety management challenge. Although 15 U.S. federal agencies are responsible to manage the U.S. food product safety quilt, a national U.S. food product safety strategy does not exist [2]. Additionally, the GAO reported this fragmentation as a 21st century challenge [19]. Significant food product safety management challenges also exist for the DHS. The Customs and Border Protection (CBP) Agency did not develop performance measures sufficient for its food product safety management responsibilities, did not develop or use a risk-based staffing model for agriculture specialists, and did not use available data effectively for food product inspection management [6]. Additionally, the CBP and APHIS were challenged in sharing food product safety management information and did not complete financial fund transfers critical to inspection activities [6]. Because of the many interdependencies that exist between these and other agencies that are responsible for critical infrastructure protection [e.g., U.S. Environmental Protection Agency (EPA), water contamination], interoperability is a most critical factor for the accomplishment of the mission. Further, the DHS reported that it has limited food product safety management experience and expertise [18]. The United States must develop and implement an effective food product safety EA to protect its critical food supply. An EA is a management tool that enables enterprise leaders to describe current and desired capabilities and to develop and implement strategies to realize desired capabilities [6]. A food product safety management EA can enable the United States to more effectively protect its food product supply and ultimately protect the global consumers of U.S. food products. Food Product Safety Management EA An effective EA enables organizations to achieve improvements in agency mission performance and other measurement areas... [and] helps to organize and clarify the relationships between agency strategic goals, investments, business solutions, and measurable performance improvements [22]. An actionable EA is a recognized tenet of the organizational transformation in public and private organizations [6]. An effective EA is fully integrated with other practice areas including strategic planning, capital planning and investment control (CPIC), and program and project management [22]. An effective EA enables organizations to develop sound enterprise plans, make informed human, material, and technology resource investment and management decisions, and optimize key enterprise business processes [24]. Without an EA, it is unlikely that an organization will be able to transform business processes and modernize supporting systems to minimize overlap and maximize interoperability [6]. An example of an organization that leveraged leadership, governance, strategic planning, EA, portfolio management, and capital planning and investment management to realize dramatic performance outcomes is the U.S. Department of Labor (DOL). The DOL embraced EA as an integral aspect of its enterprise management. As a result of the President s Management Agenda (PMA) quarterly scorecards, the DOL was the first U.S. government department to earn green ratings in all five of the PMA evaluative categories. Additionally, the DOL was the single U.S. government department to earn green in all five PMA evaluative categories in nine of the previous ten quarters [30]. The EA was a critical enabler for the DOL performance outcomes. Food Product Safety Enterprise Management Framework Figure 1 describes the relationships that should exist to enable an effective U.S. food product safety. The U.S. food product safety management functions include governance, strategic planning, EA, portfolio management, and CPIC. Governance involves establishing the rules, roles, and responsibilities for enterprise decision making. Effective food product safety governance would enable the government to develop a food product strategic plan. Inputs and considerations from international partners and global food product supply chain sources are also needed as a component of food product safety governance. Generically, a strategic plan enables an organization to establish an overarching direction and establishes specific performance goals and objectives. It also establishes a comprehensive framework for considering organizational changes, making resource decisions, and holding key players accountable for achieving real and sustainable results [19]. A U.S. food product safety management strategic plan, coordinated with global partners, would codify national food product safety management goals and objectives and would provide a framework of federal missions and goals within which individual federal agencies could align their own missions and goals 56 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE NOVEMBER/DECEMBER 2008

4 The United States must coordinate its food product safety management strategies, goals, objectives, and plans with its global food product partners. that would cascade down to individual employees [19]. The food product safety management strategic plan would need to have a global focus rather than an exclusive U.S. perspective. This strategic plan would enable, initially, the development of a U.S. food product safety management EA, which could become the basis for a global EA. A food product safety management EA would describe current food product safety management capabilities, desired capabilities, and strategies to realize the desired capabilities. The food product safety management EA would reveal information that would enable informed decisions regarding food product safety management and human, material, and technology resource needs. An effective U.S. food product safety management portfolio management capability would enable informed capital planning and budget execution and would result in a more effective food safety management capability. Where applicable, the food product safety management framework would need to be coordinated with our global partners. Conclusions The safety of U.S. citizens and the global consumers of U.S. food products is at significant risk. The salmonella outbreak in 2008, the contaminated spinach E. coli outbreaks in 2006, the contaminated peanut butter salmonella outbreak in 2007, and the contaminated pet food outbreak in 2007 caused widespread national concern. The United States needs a food product safety management EA for ensuring food product safety. A food product safety management EA would enable the United States to describe current and desired food product safety management capabilities and to develop and implement strategies to realize the desired capabilities. The food product safety management EA would enable the United States to make informed decisions regarding needed food product safety management investments. If a national food product safety management EA is absent, the United States will continue to experience contaminated food product incidents that threaten U.S. food consumers and threaten the U.S. national security. U.S. Food Product Safety Enterprise Management Framework Governance (Decision-Making Rules, Roles, and Responsibilities) Food Safety Management Capability Coordination and Sharing with Global Food Product Partners (Organizations, Agencies, Countries, etc.) Capital Planning and Investment Control (Budget Execution and Auditability) FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 Time Mission Vision Strategy (Overarching Direction) Enterprise Architecture (Current, Desired, and Transition Plan Descriptions) Portfolio Management (Resource Investment Analysis, Selection, Control, and Evaluation) Current U.S. Food Product Safety Enterprise Business Case Project Management Capability Implementation Mission Desired U.S. Food Product Safety Enterprise Vision Strategies Technologies Capabilities Current U.S. Food Product Safety Environment Strategy Transitional Activities Desired U.S. Food Product Safety Environment Human Material Technology Strategy Human Material Technology Fig. 1. Food product safety enterprise management framework. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE NOVEMBER/DECEMBER

5 Finally, the United States must coordinate its food product safety management strategies, goals, objectives, and plans with its global food product partners. To implement these capabilities and progress toward a safer United States, food product supply will require the instruments of government such as designated authorities based on legislation or policy, program management plans, clear lines of authority, funding and budget allocation, and skilled human resources. Acknowledgments The views expressed in this article are those of the authors and do not represent official positions or policies of the Information Management (IRM) College, the National Defense University (NDU), the Department of Defense, or the U.S. Government. William S. Boddie received M.A. and M.S. degrees in 1995 and 1998, respectively, and received a doctor of management degree in organizational leadership from the University of Phoenix in He is a professor of systems management at the IRM College, NDU. He led program and project management support to numerous U.S. public and private sector organizations and led the U.S. Internal Revenue Service Information Technology Services implementation of the Economic Growth and Tax Relief Reconciliation Act of 2001 legislation. He developed several frameworks and models that enable organizational leaders to improve enterprise performance. He was recognized as the IRMC Professor of the Year for the academic year. Luis Kun is a senior research professor of Homeland Security at the IRM College of the NDU in Washington, DC. He holds B.S.E.E., M.S.E.E., and Ph.D. degrees in biomedical engineering, all from UCLA. In the past 30 years, he has made numerous seminal contributions to the IT, health care, and public health policy disciplines. He is a Fellow of the IEEE and the AIMBE. He received the 2002 IEEE-USA Citation of Honor Award for exemplary contributions in the inception and implementation of a health care information technology vision in the United States, and his AIMBE Fellow induction read, For outstanding leadership and contributions in the creation, development, and implementation of the health care information infrastructure and related policies. Address for Correspondence: Luis Kun, Systems Management, IRM College, National Defense University, 300 5th Avenue, SE, Building 62, Fort McNair, Washington, DC USA. KunL@ndu.edu. References [1] U.S. Government Accountability Office. (2007, Apr.). Federal oversight of food safety. High-risk designation can bring attention to limitations in the government s food recall programs [Online]. Available: d07785t.pdf [2] U.S. Government Accountability Office. (2008, Jan.). Federal oversight of food safety. 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