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From: Food Quality & Safety magazine, February/March 2008

Food Safety in the Retail World

FDA has enhanced tools for food chain defense, but is it enough?

by Linda L. Leake, MS

You could say everything old is new again when it comes to the U.S. Food and Drug Administration (FDA) and food security. In 2003, the FDA issued a set of five food and cosmetic security preventive measures guidance documents designed to help participants in virtually all sections of the food chain minimize the risk of malicious, criminal, or terrorist actions involving products under their control. Their target audience: operators of food and cosmetic establishments, along with businesses that produce, process, store, repack, relabel, distribute, sell, or transport food, food ingredients, and cosmetics.

Five years ago is not ancient history, but the FDA has already revamped these 2003 documents. In December 2007, as part of its comprehensive Food Protection Plan, the FDA released some revitalized self-assessment tools designed to help industry minimize the risk of intentional contamination of food and cosmetics.

“There are no changes in the actual content from the 2003 documents,” says Edmundo Garcia, an FDA policy analyst. Garcia serves on the FDA’s food defense oversight team, which completed the recent project as a function of the Office of Food Defense, Communication, and Emergency Response within the Center for Food Safety and Applied Nutrition (CFSAN).

Using feedback from industry and other government agencies, the FDA repackaged the information found in the original guidance documents and created a corresponding Food Defense Self Assessment Tool (FDSAT) for each one.

“Courtesy of an added checklist format, the revised guides are much more user friendly than the original guidance documents,” Garcia says. “By using these tools, industry members can get a quick and detailed assessment of the measures they currently have in place against intentional contamination of their products. With this information, it should be quite easy for them to see where meaningful improvements to their current practices can be made.” The tools are divided into five sections: management, human element-staff, human element-public, facility, and operations.

Retail Food Security

The original 20-page document, specifically designed for the retail grocery and food service segments, is the “Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance.” The updated version can be found at

Because using the revised guidance documents is voluntary, there’s no way to know how many retail food stores and food service entities are downloading and using them, Garcia notes. “We hope industry will take advantage of the new tools and find them useful,” he says. “If stores and food service operators don’t already have security measures in place, the FDSAT will help them develop a baseline that will give them a better sense of what they can and should be doing to secure their enterprises from criminal and terrorist threats.”

To be successful, implementing enhanced preventive measures requires the commitment of management and staff. “Accordingly, FDA recommends that both management and staff participate in the development and review of such measures,” Garcia says.

The guidance documents revised in 2007 are a reflection of, and complement to, the FDA’s ongoing stance regarding food security, which is that the best defense is to be prepared. In 2006, the FDA developed a food defense awareness initiative based on information in the five original guidance documents. The five-part program, which goes by the acronym ALERT, is intended to raise awareness on the part of state and local government agencies and the food industry regarding food defense issues. To that end, ALERT identifies five key points industry can use to decrease the risk of intentional contamination at their facility: assure, look, employees, reports, and threat.

The initiative has been expanded into a Web-based training module. “This training module will provide stakeholders with the information they need to begin or enhance their thinking about ways to prevent intentional food contamination within their span of control and facilities,” Garcia says. More information can be found at

HACCP Emphasis Needed

Food security measures are a good thing, but regulatory bodies need to place more emphasis on hazard analysis and critical control points (HACCP) programs in the retail and food service sectors, says O. Peter Snyder Jr., PhD, president of the Hospitality Institute of Technology and Management (St. Paul, Minn.). Dr. Snyder is also a spokesperson for the Retail Food Alliance (RFA; Florence, Ore.), an organization whose members implement HACCP and strive to protect public health while developing new products and processes.

“We have federally mandated seafood and meat HACCP alliances, but nothing in the retail sector,” Dr. Snyder points out. “The U.S. Food Code identifies controls but not the specific hazard, the levels of the hazards, and the Food Safety Objective or tolerable level of the hazard. We clearly need a certifiable program for contamination control in food service that is based on science, not inspectors’ personal opinions.”

Dr. Snyder believes that USDA processor HACCP regulations (9CFR417) are the direction to go in retail. The FDA and USDA have different process performance standards, he observes, which is confusing to the food industry. For example, the USDA requires a processor to cook ground beef for a 6.5 log reduction of Salmonella, while the FDA requires a 5 log reduction. The USDA requires that chicken be cooked to 160°F, while the FDA requires that it be cooked to 165°F for 15 seconds.

“Today the retail chef innovates new processes and products but must adhere to FDA-dictated process controls whereby specified hazards associated with a process are not always identified, critical levels for safety are not identified, the food safety objective is zero illnesses rather than a tolerable level, and equipment selection is often limited to National Sanitation Foundation certified,” Dr. Snyder says. “The FDA says if a retail food operation implements HACCP and does its own scientifically correct process development, it can do any federal process. Unfortunately, the FDA HACCP literature gives no specific food science guidance for validating a process as meeting a food safety objective.”

New HACCP Programs

The RFA has developed its own science-based HACCP process controls program, based on the HACCP template of the National Advisory Committee on Microbiological Criteria for Foods. “HACCP does not provide actual process controls,” Dr. Snyder says. “It only outlines the steps for developing the controls. USDA has based its processor rules on the level of the hazard in the food, the tolerable level the consumer can eat and still meet a food safety objective. FDA provides no information on the basis for the controls. They really should be the same as USDA.”

According to Dr. Snyder, HACCP can be a self-regulating food safety program customized for individual operations or kitchens, especially if they can purchase food with certified lower levels of hazards. “In such applications, HACCP focuses on keeping food in proper time and temperature zones and on reducing or eliminating contamination,” he says. “HACCP identifies and controls potential food safety problems in food handling before they can occur, while it evaluates and monitors each step in the entire food preparation process. The benefits include lower levels of risk and very consistent products served to the customer.”

Process HACCP is not just seven principles, Dr. Snyder adds. “It is the scientific application of the principles to the design of a process, based on the level of hazard that comes from the supplier and reduces the hazards to a tolerable level of risk, such as less than one ill person in 100,000 consuming that food with that hazard, or only one person in 1,000,000 dying because of the hazard in the food,” he says. “Baseline criteria for biological, chemical, and physical contamination are taken into consideration in a food service kitchen HACCP program.”

Food security and defenses against food sabotage are definitely part of a complete and viable active managerial control (AMC) HACCP plan in food service, Dr. Snyder says. “There is no purpose in having food security and food safety separate,” he adds. “Our current food is contaminated on the farm just as it could be by a terrorist. Cooks know food from the farm needs to be made safe, and that level of intervention will make sabotaged food safe. Using HACCP to control hazards will take care of food security, and all the food security resources can be added to our current food safety control plans.”

The RFA is proving, Snyder says, that using AMC to identify the significant hazards in processes, choose validated controls, train people to mastery of the controls, and then coach and reward good performance, ensures a very low risk of customer illness. It also guarantees a consistent product and customer satisfaction. “The regulatory inspector doesn’t control the hazards in the food, the cooks do,” he adds. “The regulator assures the manager has a complete hazard inventory and that the cooks are using the manager’s validated controls to assure safety.”

Process control based on HACCP works for processors and will work in retail operations to control the hazards that contaminate the food from land farms and water farms, Dr. Snyder says. “It is the manager and the cooks who must know and control the hazards with validated controls,” he says. “When we do this we can eliminate the need for a special program for food security and strive for zero defects in our food products and processes.”

Leake is a food safety consultant and writer based in Wilmington, N.C. Reach her at or (910) 799-4881.



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