Food processors assess the security of products and processes post-September 11
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When a community in Oregon suffered a mysterious outbreak of food-borne illness in 1984, it took more than a year for public health authorities to pinpoint the cause-intentional contamination of restaurant salad bars. Hoping to incapacitate voters during an upcoming county election, members of a religious commune deliberately poured cultures of Salmonella typhimurium directly onto food, sickening hundreds of people. The commune members also contaminated produce in one supermarket and had plans to taint the city water supply.
The possibility that food had been intentionally contaminated was considered early in the investigation, then dismissed. In a 1997 Journal of the American Medical Association article on the outbreak (JAMA, August 6, 1997, Vol. 278, No. 5), public health investigators listed several compelling reasons for rejecting that hypothesis, including the following: “To our knowledge, such an event had never happened. We were aware of only two reports of food-borne illness caused by intentional contamination with biologic agents, and neither incident appeared to be politically motivated.”
Nine months after September 11, the fact that the nation's food supply is vulnerable to deliberate contamination is of utmost concern to public health officials, government regulators and food processors. The concept of “food security,” usually defined as ensuring an adequate food supply to people in need, has taken on a new meaning, at least in the United States.
Food security vs. food safety
In this country, food security now means protecting the nation's food supply from intentional biologic, chemical, physical, nuclear and other forms of contamination. For food producers and processors, it means securing products, personnel and plant facilities against terrorism-inspired tampering and sabotage.
As a discipline, food security differs from food safety because it focuses on the intentional rather than the accidental, the diabolical rather than the chance, contamination event.
“The food industry has a long history of dealing with threats, but after September 11, we look at food security differently,” says Dr. Rhona Applebaum, executive vice president for scientific and regulatory affairs at the National Food Processors Association (NFPA; Washington, DC), a food science and safety trade group.
“There's a difference between individuals bent on destruction and theft and those extremists who would like to destroy the way we live and how our economy runs. Food is a part of our economy, our culture and our way of life,” says Applebaum.
Now, in addition to implementing security measures for more familiar threats, such as theft, crime, disgruntled employees and intentional tampering incidents, food manufacturers are assessing security of their products and processes against this new, more perilous threat.
With so much at stake, the Office of Homeland Security, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the U.S. Customs Service are leading the effort to safeguard the nation's food supply, developing both immediate and long-term strategies for protecting food and agricultural systems.
For example, in his budget proposal for fiscal year 2003, President Bush included $146 million in new spending on food security measures. The proposal calls for spending increases on animal health monitoring and agricultural point-of-entry inspection programs, as well as a $28 million funding increase for the USDA's Food Safety and Inspection Service (FSIS), which oversees meat and poultry processors.
The funds will support FSIS food safety activities, including maintaining approximately 7,600 meat, poultry and egg products inspectors, improving the information technology infrastructure of risk management systems, and conducting slaughter epidemiological surveys and risk prevention activities. In addition, earlier this year, the Defense Appropriations Act provided $328 million in USDA funding for a variety of food-related homeland security protections.
At the FDA, $97.1 million in new food safety funding will be used to increase the FDA's surveillance of domestic and imported foods. The agency is also requesting the authority to strengthen its oversight of food during an emergency, which would allow it to quickly trace the source and distribution of domestic and imported foods.
FDA food security guidance
The FDA also developed a guidance document to help food producers, processors, transporters and retailers access the security of their operations. The document, titled Food Security Preventive Measures Guidance (www.cfsan.fda.gov/~dms/secguid.html), addresses food security as it applies to the plant, employees, raw materials, packaging, and finished products, and it identifies the kinds of preventive measures companies can take to minimize the risk that food under their control will be subject to tampering, criminal or terrorist actions. (The USDA is also developing food security guidelines for producers, processors and food providers, which should be available sometime this year.)
Relevant to all sectors of the farm-to-table food system, the FDA guidance encourages companies to review their current procedures and controls and make appropriate improvements in seven areas: management of food security; physical security; employees; computer systems; raw materials and packaging; operations; and finished products. The document lists steps companies can take to enhance security in each area, such as securing access to air intake points for the facility using fences, sensors, guards and video surveillance.
The agency is also developing a process called Operational Risk Management (ORM) to help operators prioritize the preventive measures that will have the greatest impact on reducing the risk of intentional contamination (see sidebar on this page).
The FDA developed its food security guidance document in conjunction with the Alliance for Food Security, an informal coalition of government and industry formed after Sept. 11. It encourages information exchange and coordination of preparedness activities among all stakeholders in the food chain.
Also developed after Sept. 11 is the NFPA's Food Security Checklist. Like the FDA guidance document, the checklist helps food processors and suppliers assess the level of security at their operations. Organized as a series of questions, the checklist is available by contacting the NFPA at 202-639-5900 or www.nfpa-food.org.
Light it, lock it and limit access
The government and industry documents address security in a “light it, lock it and limit access to it” approach that emphasizes secure entry systems, security points, lighting, fences, loading dock protocols and no unauthorized people in plant areas. Because cleanroom technology also emphasizes security protocols and strictly limited access, confining critical food processing stages to a cleanroom of ISO Class 5 and above may make sense for many food processors.
“Basically cleanrooms are a barrier to people traffic. The cleanroom concept would prevent contamination and provide security by virtue of its being an isolated process. Outside of the cleanroom, a food processor could practice other forms of quality control,” says Dr. Robert Powitz, a forensic and public health sanitarian with R.W. Powitz and Associates (Old Saybrook, CT).
The juice and sausage industries, and certain segments of the dairy industry, have already adopted cleanrooms, but other food segments could also benefit from cleanroom protocols. For example, foods most susceptible to contamination, such as raw materials, protein products and foods with a high water activity and neutral pH, are excellent candidates for contamination control technologies, says Powitz.
Since Sept. 11, food processors have indeed shown a greater interest in clean manufacturing technologies, but few are actually implementing them, says Vern Jackson, head of the food and consumer products group for IDC (Portland, OR), a global cleanroom design/build firm and cleanroom systems supplier.
Over the past few months, Jackson has participated in several food security panel discussions along with government regulators and industry representatives. He has concluded that the tight margins under which food processors operate limit their ability and willingness to invest in new contamination control technologies-at least for now.
Still, since the attacks, the industry's attention to contamination prevention has shifted from due diligence to vigilance, says Jackson. “Food processors are particularly concerned about the quality of raw materials coming from field crops and animal products, and they have increased testing in that area. They are also assessing their site security, the quality of their air and water supplies.”
In addition to testing, filtration and environmental monitoring technologies, the cleanroom industry can offer food processors diagnostic modeling tools that address water and air contamination control. Jackson says IDC is now working with a food processor to model air flows outside and inside the plant to minimize commingling of plant emissions with make-up air, which would pose a potential contamination problem for the plant.
Beyond prevention: containment
The government and industry guidelines and the application of contamination control technologies focus on avoiding deliberate food contamination incidents, but prevention alone is not an absolute guarantee against diabolical human intention. “No matter what food processors do, it is not 100 percent foolproof,” says Dr. Doug Archer, a food security expert at the Institute of Food Technologists (Chicago, IL) and professor in the Food Science and Human Nutrition Department at the University of Florida (Gainesville).
“An event will happen somewhere, so it behooves a manufacturer, processor or distributor of food to know who to deal with in a recall situation if a product happens to become contaminated,” says Archer.
“Most companies might believe they are ready to do a recall if asked to do so, but some of the largest companies seem to have forgotten or are not prepared to get food back off the market quickly.” Archer urges food producers to develop a containment strategy that would remove contaminated food from the distribution channel.
Gone are the days when public health authorities dismiss human intention while investigating food-borne illness outbreaks. Sept. 11 made sure of that, and now the food processing industry, along with the rest of the country, must pay the price.
Sheila Galatowitsch is a special correspondent to CleanRooms magazine.
U.S. food safety measures jumpstart food security
Dr. Doug Archer |
Given the decentralized nature of the country's food processing industry, it's highly unlikely that terrorists could stage a food-borne contamination event of catastrophic proportions, at least in terms of human lives lost. That's the opinion of two food security experts with the Institute of Food Technologists (Chicago, IL).
The new focus on food security means “we have heightened awareness, and we are in better shape than we were, but we were in good shape to start with,” says Dr. Doug Archer, a past chair of the Food Science and Human Nutrition Department at the University of Florida (Gainesville), where he is also a professor.
Because food products are produced and distributed in discrete production lots, it would be difficult for saboteurs to “bring the nation to its knees,” says Archer. A contamination event could cause severe economic disruption and a loss of public confidence, but these are consequences that could result from either natural or intentional outbreaks.
Terrorists will find it very difficult to cause a wide-scale outbreak infecting thousands and thousands of people, says Dr. Fergus Clydesdale, professor and head of the food science department at the University of Massachusetts (Amherst). “The food processing industry is well positioned to deal with food security because it has in place so many controls for food safety.”
The industry's major contamination control paradigm that addresses microbiological contamination, the Hazard Analysis and Critical Control Point (HACCP) system, is a useful tool to start thinking about a plant's design and flow of the product. “Many parts of the seven HACCP principles could be incorporated into a food security plan,” says Archer. “For example, food processors could do a risk assessment to determine what it is they are afraid will happen and what are the ramifications. They could use the verification step of HACCP to verify the steps in a food security plan and the documentation step to document them.”
The HACCP paradigm alone, however, is not enough to combat food terrorism, he adds. “HACCP never anticipated doing background checks on employees, and those types of things have to be considered. Food processors have to think like a criminal.”
Defining and assessing the threat using ORM
According to the Operational Risk Management (ORM) System Approach document from the FDA's Center for Food Safety and Applied Nutrition (CFSAN), there are three components of an operation against food and water systems: aggressors; tactics used by aggressors; and the agent used by an aggressor.
Potential aggressors include criminals, protesters, terrorists, subversives, and rogue or disgruntled insiders, who would use the following tactics:
- Exterior attacks from outside the facility;
- Forced entry made by creating a new opening in the facility in order to gain access;
- Covert entry accomplished by using false credentials or other means of deception or stealth in order to gain access to food or water systems; and
- Insider compromise that involves using someone with legitimate access.
The agents used by aggressors include:
- Biological agents (bacteria, toxins, viruses, parasites, etc.) delivered in the form of liquids, aerosols, or solids;
- Chemical agents delivered as airborne droplets, liquids, aerosols, or solids (categorized as classical chemical warfare agents, such as nerve, blister, blood and choking agents, and toxic industrial chemicals, such as pesticides, rodenticides and heavy metals);
- Radiological agents or radioactive elements that can be delivered in liquid or solid form; and
- Physical agents that could cause adverse health effects if eaten, such as bone slivers, glass fragments and metal filings.
Food processors can use the ORM approach to minimize the risk of contamination at each step in food production from the farm to the fork. The document helps food processors identify hazards and conduct risk assessment and risk management. “The goal is the best food safety and security at the least cost (not at any cost),” according to the document. The four ORM rules are:
- Accept no unnecessary risk.
- Make risk decisions at the appropriate level to establish clear accountability.
- Accept risk when benefits outweigh the costs. “All identified benefits should be compared to all identified costs. As an example a lock on a door, lighting and alarms cost less than a 24-hour guard for the door. We accept the risk of entry by an aggressor because we have put in redundant controls, and the benefits of the 24-hour guard do not outweigh the additional cost.”
- Integrate ORM into planning at all levels.
The FDA continues to modify the ORM document, but once finalized it will be available on the CFSAN web site at www.cfsan.fda.gov.