Food Safety Magazine

RISK MANAGEMENT | April/May 2008

The Value of the Food Defense Plan

By Charles Yoe, Mickey Parish, Doug Eddy, David K.Y. Lei, Bradley Paleg and Jurgen G. Schwarz

The Value of the Food Defense Plan

“For the life of me, I cannot understand why the terrorists have not attacked our food supply because it is so easy to do.”
—Tommy Thompson, former Secretary of the U.S. Department of Health and Human Services, at his farewell news conference

“U.S. residents say protecting the food supply chain and preventing release of chemical or biological agents in public areas is most important.”
—National Center for Food Protection and Defense, University of Minnesota

In April 2007, the Department of Nutrition and Food Science, University of Maryland, College Park, MD, with the support of a grant from the U.S. Department of Agriculture’s Cooperative State Research, Education, and Extension Service (USDA CSREES), sponsored a meeting of food experts from industry, government and academia to examine what food defense means to industry. Twenty-three attendees participated in this workshop, which was held at the Maritime Institute of Technology and Graduate Studies (MITAGS).[1] Attendees, representing eight national/ international industrial organizations (companies and trade groups), seven federal and state government agencies, as well as eight representatives from three academic institutions, expressed a strong consensual view that food defense was but one essential and separate element of an inseparable trio of responsibilities (food quality, safety and defense) that comprise food protection. Park describes food protection as the connection of food safety and food defense elements into a common risk-based food protection platform.[2] The MITAGS workshop defines food protection as the integration of food quality, food safety and food defense concerns into a single unified strategic and operational action plan (Figure 1).

This view marks a maturation of the thinking about food defense, which in the aftermath of 9/11, was viewed as separate and distinct from food safety. Food defense is indeed separate but it cannot pragmatically or strategically be considered as distinct from food safety. Just as measures implemented for food safety, such as the Hazard Analysis and Critical Control Point (HACCP) program, have secondarily impacted food product quality, it can be equally surmised that measures designed to address food defense will have some positive effect on both food quality and safety. For example, enclosing certain unit operations to prevent contamination as a defense measure might prevent unintentional as well as intentional contamination. Likewise, adoption of safety programs and protocols undoubtedly provide an enhanced degree of product defense. The constant monitoring of product and process parameters to ensure that product specifications remain under control enables the manufacturer to maintain a watchful eye over both the safety and defense of the product. The introduction of physical barriers to prevent the accidental injury of production workers has the added benefit of minimizing the capability of potential threats to gain access to the product.

What is Food Defense?
A review of the literature reveals a pervasive and growing usage of the term “food defense” without a widely agreed upon definition. Definitions range from guarding against the intentional contamination of food (ubiquitous) to the following agency definitions:

1. The U.S. Food and Drug Admin-istration (FDA)’s Office of Regulatory Affairs in its Food Defense Terms and Acronym List defines food defense as “the collective term used by the FDA, USDA, DHS, etc. to encompass activities associated with protecting the nation’s food supply from terrorist activities.”[3]

2. Marc L. Ostfield, U.S. Department of Homeland Security, states that “food defense encompasses the steps taken to minimize or mitigate the threat of deliberate contamination of the food supply, and includes identifying points of vulnerability and working to strengthen infrastructure, thereby, making the food supply a less attractive and, more importantly, less vulnerable target.”[4]

3. In its guidance document “Developing a Food Defense Plan for Meat and Poultry Slaughter and Processing Plants,” USDA’s Food Safety and Inspection Service responds to the question of what is food defense with: “Food defense is not the same as food safety. Food defense focuses on protecting the food supply from intentional contamination, with a variety of chemicals, biological agents or other harmful substances by people who want to do us harm. These agents could include materials that are not naturally-occurring or not routinely tested for. An attacker’s goal might be to kill people or disrupt our economy. Intentional acts are generally not reasonable and are hard to predict.”[5]

The notion of “food defense” was begun in the aftermath of 9/11 and was initiated by U.S. government agencies. The initial term adopted for this purpose was “food security.” This was confusing to many because the term was already in wide usage with an alternative meaning. Food security is defined by the Food and Agriculture Organization of the United Nations (FAO) as: “Physical and economic access, at all times, to sufficient, safe and nutritious food to meet dietary needs and food preferences for an active and healthy life.”[6] Government agencies have begun to use the term food defense and they have treated it as a separate program, reflecting the manner in which government agencies organize to consider new ideas. Industry, on the other hand, is less inclined to see food defense as a stand-alone program or function. The food industry readily expands the notion of food safety to food protection, which includes food defense. Most recently, federal agencies are adopting the term “food protection” as an umbrella term to encompass food safety and food defense.

Developing a Definition
When important words are not clearly understood, misinterpretation may result, sometimes with severe consequences. In fact, substantive disagreements can arise because people use the same words to mean different things or because they use different words to mean the same thing. As noted above, early attempts to use the term “food security” in relation to the defense of our food supply were met with concerns expressed by nutritionists and others who interpret the term in its classic context of nutrient consumption. As another example, despite many years of discussions within the international community about HACCP, there remain differences as to how it is understood and practiced. There is sometimes a lack of clarity surrounding the words validation and verification, with people using the words interchangeably and in an incorrect context. For the sake of clarity and understanding, it is critical that we think, speak and act in ways that are more inclusive than exclusive as food becomes increasingly global.

The National Center for Food Protection and Defense conference in April 2007 recommended the following as part of its breakout workshop conclusions: “Develop/promote common definitions and metadata terms to achieve consistency, interoperability and clarity in educational programs to help students, industry, etc.”[7] To this end, the MITAGS participants sought to offer the growing food protection community some clarity on the words we might use to discuss these important issues. Therefore, one of the most important objectives of the MITAGS workshop was to develop a definition of food defense that met the needs of the participants. In the process used, each attendee was asked to provide a definition for food defense. Working from these personal definitions, small group definitions were developed and then these were winnowed down in a simple consensual voting process to finalize their definition of food defense.

In reviewing the personal definitions of food defense presented by the twenty-three participating individuals, there were varieties of perspectives on just what is being defended. The general consensus was that the food supply is to be protected. But the practical definition varied depending on whether one takes the viewpoint of an individual company, an industry or a nation as a whole.

Industry representatives tended to focus on the company’s supply chain, production and marketing functions. Their approach encompassed the entire product cycle including producers, processors, transportation, storage and point of sale. Infrastructure and brand were specifically included as assets to be protected in addition to the food itself. Government and academia attendees tended to take a more holistic view of the food supply. Food defense was seen as more of a responsibility to be shared by all parties in the product lifecycle or the farm to the table “food chain.” In a food safety context, “food chain” is sometimes used loosely to include all food related activities from production of the food to its consumption. A few participants held the opinion that food defense was, at least to some degree, the defense of consumers/customers. Most expressed the view of protecting the food itself and the equipment used to produce, process and provide it.

There was widespread linking of food defense to reducing various risks associated with intentional tampering of food supplies. Some definitions indicated a clear assumption that food defense would be conducted within a risk analysis framework. Some focused on the risk of an attack of some sort, some on the risk of a successful attack and others focused on risks to consumers.

It is clear that intentionality is an important distinguishing characteristic of food defense. The prevailing food protection focus clearly linked the intentional contamination of food defense to the unintentional contamination of food safety. Intentional threat, adulteration, contamination, sabotage or other malicious acts are included in the definition.

The likely hazards to the food or food facilities include biological, chemical, radiologic, physical or financial hazards. The physical hazards include damage and destruction to infrastructure and equipment as well as the entire range of physical materials that can be added to food. A few participants noted that the mere threat or claim of an attack could be sufficient to inflict economic damage on a producer.

Many definitions included some notion of risk management. Several participants specifically suggested that food defense needed to be proactive while others pointed to the need to include “reacting” to an attack as an element of their definition of food defense. Perhaps “response” to an attack is a more faithful interpretation of their intent, based on discussions that attended the development of the definition. Management measures were sometimes described in terms of controlling the various procedural operations in the food chain. Taking action to prevent attacks was also an element within several definitions. Relatively few people included any explicit mention of “vulnerabilities” but one offered a definition centered on this concept. It included understanding, anticipating and evaluating vulnerabilities, as well as taking subsequent steps to mitigate these vulnerabilities. Numerous definitions mentioned taking measures to reduce risks, without explicitly addressing the need to assess the hazards that cause the risks.

Terrorists, bioterrorists, individuals and inside saboteurs were mentioned as the likely types of people to perpetrate an attack. Several participants offered a definition that specified that food defense should be a strategic initiative, as opposed to a tactical measure. When participants included actions to be taken in their definitions they tended to use such verbs as training, screening, assessing, managing, communicating, planning, analyzing, implementing, preventing, recalling, recovering and responding.

After lengthy discussions and debates, the participants of the MITAGS Workshop proposed the following definition of food defense: “Food defense means having a system in place to prevent, protect, respond to and recover from the intentional introduction of contaminants into our nation’s food supply designed specifically to cause negative public health, psychological, and/or economic consequences.”

What is a Food Defense Plan?
The USDA’s Food Safety And Inspection Service (2006b) defines a food defense plan as follows: “A food defense plan is a document that sets out control measures developed by an establishment to prevent intentional adulteration of product. A food defense plan should be developed, written, implemented, tested, assessed, and maintained if it is to be functional. All establishments are encouraged to operate with a food defense plan.”[8] The elements of such a food defense plan include the following:[5]

Assessment. As part of the assessment the establishment: looks for vulnerable points at the establishment, determines what the risk factor is for each point, develops defense measures at each point that it has identified as high risk, and creates a written plan to implement defense measures.

Implement. The food defense plan is implemented when the defense measures identified in the plan are in place and used as intended.

Test. The establishment tests the written plan by monitoring periodically to evaluate the effectiveness of its defense measures.

Assess. The establishment assesses the plan by reviewing the plan and revising it as necessary whenever new risks are discovered

Maintain. The establishment maintains its plan by ensuring that the defense measures it implements continue to be effective.

In November 2007, the FDA introduced the Food Protection Plan as a complement to the interagency Import Safety Action Plan.[9,10] The Food Protection Plan emphasizes three core elements:

Prevention. Promotion of improved food safety and defense capabilities throughout the product lifecycle.

Intervention. Coordinate risk-based interventions among federal, state, local and foreign agencies.

Response. Develop rapid and comprehensive methods to communicate with consumers and other agencies before, during and after an event.

The Value of a Defense Plan
It is likely that different food industry sectors will view value in different ways, although it could be expected that a common understanding will be that the effort will be worthwhile, at least in the economic long run.[11] The MITAGS group identified five primary sources of value for a food defense plan. These were:

1. Protection of employees, customers and consumers, a company’s brand and brand name, assets and security as well as the economic/financial stability of the company.

2. Defense helps a company avoid crisis and aids a company’s crisis management and risk communication capabilities while better assuring an effective response to any threat of attack or an actual attack.

3. Sound business practice means, in part, being a responsible and conscientious citizen; customer confidence and the public perception of the firm and increased profitability depend on food defense.

4. Products will be safer with improved quality, tighter loss control and recall avoidance.

5. Legal reasons include minimizing liability, avoiding litigation and regulatory compliance.

By far the most frequent intentional acts of food tampering occur as a result of attempts by disgruntled employees to seek some form of retribution against employers who, for some reason, have caused them upset. The act is intended to cause economic or market loss to the company or place the senior officers in a position where their employment is threatened.

Whatever the intent, these incidents have an impact on the wider consumer community through consumer sickness, the withdrawal of products from the supermarket shelves or fear generated by the adverse publicity that accompanies such acts. Although a value estimate of these types of events cannot always be accurately quantified, the economic impact can be devastating for the business, and in some cases the industry sector itself.

The introduction of a systematic evaluation of the points of greatest risk along the food production and processing chain can only strengthen the ability of the organization to assess, prevent and respond proactively to a potential attack on the food chain. Such a system can be viewed as an internal insurance policy by which the company seeks to understand the relative areas of risk across the production and processing area and then sets in place mechanisms to tighten security and minimize the success of a threat to the food. While this strategy may be most useful at limiting the capability of external threats from terrorism, it can also provide a diminished risk from internal sabotage and acts of willful mischief from company employees and visitors.

The value to the industry from looking proactively at introducing a food defense plan may also translate to improving food quality and production control variations, and thereby improving the overall status of the protection and consistency of the food. While food quality may not directly affect the safety of any given food product, improvements to the quality of products can have advantageous impacts in terms of consumer perception and repeat purchase, market share, shelf stability and competitive advantage. Although many government agencies currently view food protection as having a safety and defense focus only, it was obvious from the MITAGS meeting that industry has an interest to include quality as an element of the protection rubric. The reasoning is that efforts to improve product quality may have a direct affect on safety and defense, in addition to the protection of the brand from economic losses. As a company or industry improves the food safety of their products, and initiates tighter controls of the management of production processes, other benefits, such as better occupational health and safety for workers, less waste and higher efficiencies, are likely to flow on to the company bottom line.

Another aspect is in the legal area. A company with a well-developed and well-maintained food defense plan would likely be viewed in a court of law as having taken every effort to minimize the risk to their customers. Their efforts would go a long way to establishing due diligence in minimizing or eliminating the food safety risk to the extent that they could reasonably be expected to take action. Conversely, a company without a food defense plan would have considerable difficulty in advocating that they had done all that was reasonably possible under their control to have averted the incident. Therefore, the introduction of a food defense plan can be expected to provide both economic benefits and influence consumer perception as to the intensity with which they are committed to providing a safe food product to the market.

Attributes of a Good Plan
The first principle for a good food defense plan is that it be science-based. This makes it compatible with a risk analysis framework that expands to include vulnerabilities as well as risks.

A good plan is easy to use and to understand. It includes strategy, tactics and standard operating procedures as appropriate. It is practical and implementable. It is also flexible, that is, clear in principles but flexible in its details, as well as adaptable. As a living document it is in a perpetual state of iterative refinement.

The plan should be comprehensive including suppliers, contractors, manufacturing employees, transporters, distributors, and all partners along the food supply chain. Such a comprehensive plan, of necessity, must also be standardized and harmonized within the food supply chain, the organization and the industry. Industry, government and academia are all partners in the best plans and they are global in outlook.

Validation and verification are essential for the best plans, which should include external assessment as well as internal record keeping and audits. Employee training and support is a critical element of the best plans. Periodic simulations may be a useful element of this training. Organization-wide awareness of the plan is essential.

The best plans will include a detailed strategy for communication within and without the organization. Documentation of the plan and of events and the responses to them is a critical element of any communication strategy. In addition to these attributes, the MITAGS Workshop identified several operational elements of a good plan. It should include a vulnerability assessment and be specific to the facility for which it is developed. Controlling access to the facility will be an important component of any plan. Thus, security may be even more important than science. A good plan details supply chain control including the ability to trace forward and trace back. The best plans are proactive and focus on prevention but will also include a crisis management component that includes response and recovery strategies and procedures.

The Best Offense
According to the results of the MITAGS meeting, defense is an essential addition to a food protection strategy, but industry does not need a stand alone food defense plan. Food defense is the last piece in an integrated food protection jigsaw and it complements the food quality and food safety components. Food defense means having a system in place to prevent, protect, respond to and recover from the intentional introduction of contaminants into our nation’s food supply designed specifically to cause negative public health, psychological, and/or economic consequences. A food defense plan is a proactive, strategic approach to protect the entire food supply chain from an intentional deliberate chemical, microbiological, radiological or physical contamination to reduce the risk for consumers. As such, it overlaps with the company’s food quality and safety goals. The critical components of food defense are both the protection of food facilities and the ability to rapidly respond to crisis.

Charles Yoe, Ph.D., is a Professor of Economics at the College of Notre Dame of Maryland and an adjunct professor in the Department of Nutrition and Food Sciences at the University of Maryland. Food safety risk analysis, food defense, and risks of engineering systems are his current areas of primary research, and he has developed courses in risk assessment and risk management for several agencies of the U.S. federal government and private industry.

Mickey Parish, Ph.D., is Professor and Chair of the Department of Nutrition and Food Science, and the Acting Director of the Center for Food Systems Security and Safety at the University of Maryland, College Park. Parish focuses research efforts on food microbiology related to safety, quality and defense policy. Reach him at mparish@umd.edu.

David K. Y. Lei, Ph.D., is a Professor at the Department of Nutrition and Food Science at the University of Maryland at College Park. He is the principal investigator of an ongoing food defense grant from USDA. His current research is focused on the influence of zinc status as well as food and medicinal plant materials with bioactivities on cell cycle modulation.

Doug Eddy, has worked in the Australian dairy industry for nearly 30 years, the majority in research and development areas. He is currently General Manager, Knowledge Management with Dairy Food Safety Victoria, the state-based dairy regulation authority that is responsible for assuring the safety of Victorian dairy food to the consumer.

Bradley Paleg, Distance Learning Specialist in the Office of Information and Education Technology’s Distance Learning Unit, University of Maryland, brings more than 22 years of experience in the application of teaching, learning and collaborative technologies. He is the co-principal investigator of an ongoing food defense grant from USDA.

Jurgen G. Schwarz, Ph.D., is the Director of the Food Science and Technology Ph.D. Program at the University of Maryland Eastern Shore. His research and teaching activities focus on food processing, food safety and food defense. Dr. Schwarz worked on product and process development for one of the major food companies and worked as a consultant for organic processing.


References
1. A workshop sponsored by the Department of Nutrition and Food Science, University of Maryland held at the Maritime Institute of Technology and Graduate Studies. (http://69.63.139.129).
2. Park, David K. 2007. New thinking on food protection: unlocking ways to achieve food safety and food defense goals. Food Safety Magazine, December/January 2007. www.foodsafetymagazine.com.
3. FDA. www.fda.gov/ora/training/Satellite/Announcements/fd_list.html.
4. Ostfield, Marc L. 2007. Biodefense: U.S. Vision of Broader Cooperation. European Affairs Spring 2007. www.europeanaffairs.org/current_issue/2007_spring/2007_spring_10.php4.
5. USDA. 2006a. Elements of a Food Defense Plan. Food Safety Inspection Service, 20 April 2006a. www.fsis.usda.gov/pdf/Elements_of_a_Food_Defense_Plan.pdf.
6. FAO. 2005. www.fao.org/ag/wfe2005/glossary_en.htm.
7. Walker, Kevin. 2007. “Food: A Global Perspective. Food Defense Education: Post 9/11.” A Report from the Education Group of the National Center for Food Protection and Defense from the Science and Technology Directorate.
8. USDA. 2006b. PBIS Profile Extension Instructions on Food Defense Plans for Meat and Poultry Establishments. Food Safety Inspection Service, 20 April 2006. www.fsis.usda.gov/OPPDE/rdad/FSISNotices/28-06.pdf.
9. HHS. 2007. Food Protection Plan: An integrated strategy for protecting the nation’s food supply. Food and Drug Administration, November. www.fda.gov/oc/initiatives/advance/food/plan.html.
10. U.S. Interagency Working Group on Import Safety. 2007. Action Plan for Import Safety: A roadmap for continual improvement. www.importsafety.gov/report/actionplan.pdf.
11. Strong, Robert. 2007. Adapting to new terrain in food security. Food Manufacturing. www.foodmanufacturing.com/scripts/ShowPR.asp?RID=7030&CommonCount=0.

Categories: Management: Food Defense