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The need for defense in the post-9/11 era Can the risk be ignored? Many people are familiar with “.” It has been likely to occur in the food supply. recognized for many years as being essential for businesses The key words are obviously “unintentional” for food that supply food products anywhere in the supply chain. safety and “intentional” for food defense. The food The term “food defense,” however, is another issue. industry has the personnel and infrastructure in place for food safety, but many in the industry are struggling with Shortly after the tragic events of September 11, 2001, how to approach food defense. the U.S. government became concerned that terrorist organizations might seek to contaminate parts of the Long before 2001, there was documentation of intentional American food supply. In December 2001, the Food food contamination incidents throughout the world. A and Drug Administration (FDA) and the United States study by the Centre of Excellence for National Security Department of Agriculture (USDA) began a dialogue with (CENS) in Singapore, written by G.R. Dalzeil, reported that a number of security professionals in the food industry between 1950 and 2008, there were approximately 398 to determine the current state of readiness against an confirmed incidents of contamination and approximately intentional attack. The information gathered was not 125 unconfirmed incidents. The information for this study encouraging. Prior to 2001, security departments in the was gathered worldwide; however, 42 percent of the food industry were mostly concerned with protecting incidents occurred in the U.S.; the U.S., UK, and Australia people and assets. Protecting products was considered combined accounted for 60 percent of the incidents. to be mostly the responsibility of a food safety or quality assurance department. Certainly, many of the physical One recent example of intentional contamination of the security measures put in place, such as access control, food supply occurred in July 2012, when needles were closed-circuit television, locks, and alarms could be found in sandwiches served on a U.S.-based international helpful in securing the products. But for some companies, airline on four separate flights. These incidents, and others protecting the product from intentional contamination like it, underline the risks that a food defense-related was not a priority of the security department, if such a incident may pose to a company. The reputation of the department even existed in the company. brand and the company may be at risk, which could then become an enterprise risk, should their customers and As awareness increased throughout the U.S. industry, the the general public lose faith in their ability to protect their role of protection against intentional contamination, or products. A company may could face heavy scrutiny from “agroterrorism,” was called “,” but that term the press, public, and regulators, and market capitalization was already in use by the World Health Organization to may also be affected. describe a country’s ability to sustain its food supply. In 2003, government agencies such as the FDA, USDA, and the Department of Homeland Security began using the term “food defense” to describe the efforts to protect food products from deliberate or intentional acts of contamination or tampering. By 2010, both the FDA and USDA had begun using the same “working definitions” of food safety and food defense in their presentations.

Food safety may be defined as:the protection of food products from unintentional contamination by an agent reasonably likely to occur in the food supply (e.g., E. coli,, Listeria).

Food defense may be defined as:the protection of food from intentional contamination by biological, chemical, physical, or radiological agents that are not reasonably

2 What are the regulatory requirements related to Food defense is an issue the industry should take seriously. food defense? The risk of an internal contamination event to a company’s Until late 2010, neither the USDA nor the FDA had direct product could very well present an enterprise risk, which regulatory authority over preventive measures for food may threaten not only the consumer, but also the company defense. Several efforts were undertaken to provide itself. Even though the regulations for food defense under guidance and requirements and to manage and encourage the FSMA have not yet been proposed, there are a number their adoption. The Food Safety Modernization Act (FSMA) of basic security tools and programs that should be put of 2010 is the first regulatory law to use the term “food in place and may provide an increased level of protection defense” and to provide the FDA with that direct regulatory against intentional contamination incidents. An evaluation authority. The regulations to explain and support the FSMA of an organization’s food defense preparedness may as it relates to food defense have not yet been forthcoming serve to highlight the vulnerabilities in physical, human, from the FDA. The current efforts by both agencies related process and/or product protection, and also identify good to food defense can be found on the FDA and USDA food mitigation strategies. defense websites. The USDA Food Safety Inspection Service has developed a voluntary food defense program for the food companies they regulate, providing a general food defense plan template on its website. The FDA has training tools for managers and line workers to assist the industry with evaluating specific vulnerabilities.

How can you mitigate your risk? Food defense planning cannot be generic or one size fits all; each facility that grows, manufactures, processes, stores, or distributes food products may present its own security and food defense challenges. However, there are some basics to consider in a facility: 1. Maintain control of the facility. Entrances should be secured against unauthorized and undetected intrusion. 2. Establish a system of vetting people who work in a facility, or are permitted in a facility unescorted and are considered trustworthy. 3. Identify the vulnerabilities to the products and processes that exist in the facility, how much risk they pose, and what the applicable mitigation strategies might be to lower or abate those risks. 4. Identify the vulnerabilities in your supplier base, evaluate how much risk they pose, and what are the applicable mitigation strategies to lower or abate those risks. 5. Develop policies, procedures, and training to support the food defense program, which may likely include a method for investigating, reporting, and mitigating the causes of a security breach.

The case for change 3 References G.R. Dalzeil, “1950-2008: A Chronology and Analysis of Incidents Involving the Malicious Contamination of the Food Supply Chain,” CENS, Singapore, 2009. http://www.rsis.edu.sg/cens/publications/reports/RSIS_Food%20Defence_170209.pdf Richard Esposito and Mark Schone, “Needles Found in Sandwiches on Four Delta Flights,” ABC World News, July 2012. http://abcnews.go.com/Blotter/needles-found-sandwiches-delta-flights/story?id=16790585 “Melamine Pet Food Recall,” U.S. Food and Drug Administration, 2009. (In 2007, the FDA found contaminants in vegetable proteins imported into the United States from China and used as ingredients in pet food.) http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/ucm129932.htm “The New Food Safety Modernization Act,” U.S. Food and Drug Administration. http://www.fda.gov/Food/FoodSafety/FSMA/default.htm “Public Meeting on Economically Motivated Adulteration,” U.S. Food and Drug Administration, May 1, 2009. http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm163619.htm “Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health,” United States Government Accountability Office, GAO-12-46, October 2011. http://www.gao.gov/assets/590/585861.pdf “Food Defense & Emergency Response,” U.S. Food and Drug Administration. (List of tools and resources.) http://www.fda.gov/Food/FoodDefense/default.htm Tools & Resources http://www.fda.gov/Food/FoodDefense/ToolsResources/default.htm FDA-Food Defense and Acronym List- 2007 http://www.fda.gov/Food/FoodDefense/EducationOutreach/ucm296330.htm

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