Improving the recipe for food safety
06/01/2001
WHILE MUCH OF THE FOOD-PROCESSING INDUSTRY EMBRACES HACCP, REGULATORS PONDER A FEW MID-COURSE REFINEMENTS
By Sheila Galatowitsch
When Doug Bradley was learning the right consistency of sauces at The Culinary Institute of America, he never dreamed his career as a chef would lead to supervising a Hazard Analysis and Critical Control Point (HACCP) program. But if you regularly attend trade shows or sporting events, you should be glad it did.
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Bradley is the director of culinary standards for convention centers and tourism accounts at Aramark (Philadelphia), the $7.3-billion managed-services company that each year is responsible for feeding 50 million visitors at 27 convention centers, 14 conference centers, 70 stadiums and arenas and 15 nationals parks, resorts and tourist attractions.
The company voluntarily implemented HACCP plans in all its sports and entertainment accounts three years ago. So when Bradley urges you to relax over lunch, go ahead. He's got the documents that prove Aramark is hitting its critical control points (CCPs) for food safety before, during and after the production process.
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"It's not the crack in the floor that will get people sick," says Bradley. "It's how you handle food from the time it comes in until it goes out to the guests. HACCP pays attention to the most critical pieces."
All across the food processing and food service industries, HACCP is becoming a fact of life. [See "Contamination control in a food processing environment—Having HACCP helps," CleanRooms, May 2000, p. 23.]
The food safety approach has been mandatory for seafood processors since late 1997 and for all meat and poultry processors since January 2000. It will become a regulatory requirement for large juice processors in January 2002 and for small juice processors by the following year.
Even in segments of the food processing industry where it is not mandated, HACCP is taking hold—driven mostly by the giant processors who want their suppliers to be HACCP-compliant. And like Aramark, many large restaurants and food service establishments are voluntarily adopting HACCP. It's also evolving into a global standard for food safety as foreign companies shipping food into the U.S. launch HACCP programs.
But does the science-based system actually work to improve food safety and reduce the incidence of food-borne illness? Yes, say federal regulators, food processors, academics and industry consultants.
"Does HACCP help avoid all food safety problems? No. However, it's better than the inspection systems we have had in the past—absolutely. It's a quantum leap," says Charles Cook, Ph.D., managing partner of Cook & Thurber, L.L.C. (Madison, WI), a company that performs food safety audits and HACCP development and validation. "HACCP forces a facility to be disciplined, to do the documentation and apply the seven HACCP principles in a uniform way."
Not the total solution
To Dean Cliver, Ph.D., a professor of food safety at the University of California at Davis, HACCP is the most significant development in food safety he's seen in his 39-year career. "We get more assurance of minimal safety defects by HACCP than by alternative procedures, but it's not a one-size-fits-all solution to the food safety problem."
Cook agrees. "If a facility myopically concentrates on HACCP alone without concern for prerequisite programs, it is doomed for failure." The recipe for food safety is a "holistic" approach that includes HACCP, Sanitation
Standard Operating Procedures (SSOPs) and good manufacturing practices (GMPs). While HACCP covers only the most critical hazards related to food safety and human health, the prerequisite programs must also be operating as designed to ensure such fundamentals as proper sanitation, waste disposal, pest control and employee hygiene.
SSOPs and GMPs are the foundation of any good food safety program, says Joseph Iwan, a HACCP trainer and consultant with Professional Food Safety Ltd. (Chicago) and former Illinois Dept. of Agriculture regulator. They actually work to reduce the number of potential hazards. For example, before companies start a HACCP program, they should have in place an effective pest control program that will nullify any hazard that would otherwise result from the lack of one.
"The first part of a hazard analysis includes evaluating all prerequisite programs. Then, when all else fails, those things that are essential for food safety are the ones to monitor and document in a HACCP plan," says Iwan.
Critics say some government regulators responsible for food safety fail to take these important prerequisite programs into consideration in their HACCP rulemaking. This charge is specifically launched at the USDA's Food Safety and Inspection Service (FSIS), which oversees meat and poultry processors. Several trade groups have petitioned the FSIS to make certain "mid-course corrections" in its HACCP regulations.
Key among the corrections is recognizing the role of these prerequisite programs and better defining what constitutes a food safety hazard.
"We have long believed that HACCP is the very best method for systematic control of food safety hazards, at least those hazards that we know of at this point in time," says Lloyd Hontz, senior director of regulatory affairs in the Office of Food Safety at the National Food Processors Association (NFPA; Washington, DC). One of the petitioning trade groups, NFPA represents the $460-billion food processing industry on such scientific and public policy issues as food safety, technology and regulatory matters.
Room for improvement
HACCP is working, says Hontz of NFPA, "but that's not to say that it can't be done better. Even where HACCP is mandatory for seafood operations and meat and poultry operations, there is room for improvement."
In their petition, the trade groups say that FSIS has implemented policies that tend to force companies to adopt CCPs even if the processors don't agree that the issue addressed by that CCP constitutes a true food safety hazard. The groups argue that unnecessary CCPs complicate a HACCP plan and make it more difficult for processors to carry out; strain the agency's inspection resources; and raise food costs for consumers.
For example, FSIS expects processors to treat the receiving temperature of certain perishable ingredients as a CCP. Depending on a company's hazard analysis, receiving temperatures could indeed be CCPs, but in many cases, slight variations in receiving temperatures of ingredients pose no threat to food safety. The trade groups contend that failure to meet a CCP should result in a significant risk to human health and require corrective action. Non-critical issues justly deserve attention and corrective action as "control points," but are more appropriately handled by SSOPs and various GMPs.
The trade groups want FSIS to change its definition of a hazard to align with the definition of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), which developed the current HACCP principles. While the FSIS defines a food safety hazard as any "biological, chemical or physical property that may cause a food to be unsafe for human consumption," the NACMCF definition is narrower. It regards a hazard as a "biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control."
The industry position conflicts with a report issued last summer from the USDA's Office of Inspector General (OIG). In its review of food safety under HACCP, the OIG audited 15 meat and poultry plants and determined that hazard analyses were incomplete and CCPs were not established. OIG recommends that FSIS strengthen its management controls to provide greater oversight over HACCP implementation, pathogen testing and independent reviews of plant and inspection activities. For HACCP to realize its full potential, FSIS must "command a more aggressive presence in the inspection and verification process," said Inspector General Roger Viadero in the report.
Next steps from FSIS
FSIS says it will consider both the OIG report along with the industry petition as it weighs making changes to the HACCP regulations.
In the interim, the agency late last year announced plans to address certain details of HACCP implementation that were put aside while industry and government made the monumental shift to the new food safety method. Among the agency's next steps are addressing control of chemical residues at slaughter and extending awareness of food safety issues to producers.
In addition, FSIS is exploring how to implement HACCP at slaughter. The HACCP Inspection Models Project (HIMP), a pilot program underway in 11 young chicken plants and three market hog plants, is collecting data to compare results of a HACCP-based inspection approach with results of traditional inspection. So far, the data show that the products produced under the new inspection model more consistently meet the agency's safety standards and have fewer non-food safety defects than products produced in plants under traditional inspection, according to Philip Derfler, deputy administrator of the FSIS's Office of Policy, Program Development and Evaluation.
The agency continues to collect data while awaiting the outcome of a lawsuit against HIMP by the inspectors' union, the National Joint Council of Food Inspection Locals. Inspectors say that HIMP violates directives contained in federal meat and poultry inspection statutes and weakens their authority to take corrective action against contaminated meat. HACCP was meant to be an industry process control, but it has turned into an inspection process, says David Kroeger, president of the Midwest Council of Food Inspection Locals. "We see [HACCP] as chaos," says Kroeger. "Our role has to be more clearly defined. There's too much of a gray area."
Meanwhile, the U.S. Food and Drug Administration (FDA) is instituting its own mid-course corrections to strengthen the HACCP program for seafood. Earlier this year, the General Accounting Office released a report evaluating the program, concluding that the FDA has made progress in ensuring the safety of seafood through HACCP, but that the program needs improvements to reach its full objective. In February the FDA said it would intensify its focus on firms that need to control pathogens; firms that need to control histamines, which can cause allergic reactions; and firms that do not have HACCP plans.
These three categories represent the highest risk to consumers, according to the FDA, so the agency plans to increase inspection frequency, expand laboratory testing for pathogens and histamines, and take enforcement action where necessary. The agency also said it will develop an inspector certification program that emphasizes pathogen and histamine control and create a National Seafood HACCP Inspection Database that collects information on the details of seafood processors' preventive controls for safety.
Improving industry HACCP plans
The FSIS and FDA mid-course corrections come in the wake of an E. coli O157:H7 outbreak in Milwaukee last summer that killed one child and sickened many others. In April, The Washington Post and Dateline NBC ran stories questioning the safety of the nation's meat supply and criticizing HACCP, industry and government for failure to prevent the outbreak, which occurred after raw contaminated meat and raw fruit were prepared on the same counter top of a restaurant. The child who died had eaten contaminated watermelon.
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The media placed much of the blame for the outbreak on the meatpacker and FSIS, but Cliver of UC-Davis says the restaurant was also responsible. "In a restaurant, nothing that comes in on beef should wind up on a melon. [The outbreak] is not a failure of HACCP. We need to go back to the idea that HACCP won't solve all of the food safety problems of the country."
"In most cases, HACCP will prevent and control food safety hazards so they don't reach the public, but HACCP will not assure 100 percent reliability," says Juan Silva, Ph.D., a Mississippi State University professor in the Department of Food Science and Technology and a member of the Institute of Food Technologists (Chicago).
Still, there is room for improvement in the HACCP plans currently operational.
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Systematic HACCP failures have been the cause of other food contamination cases. Sun Orchard and Bil Mar Foods had good HACCP plans, but both companies experienced food contamination episodes when changes occurred in their production processes but not in their HACCP plans, says Peter J. Slade, Ph.D., director of research and technical services at the National Center for Food Safety and Technology/Illinois Institute of Technology-Moffett Campus (Summit-Argo, IL).
"When some unusual event happens, companies need to revisit their HACCP plan. You can't put it on the shelf and let it collect dust. You must revisit and revise it as part of a biannual or annual review."
In addition, FSIS's Derfler made it clear last December that a small, but "unacceptable," number of very small meat and poultry plants do not really understand what is required of them under HACCP. FSIS intends to reach out to these firms with training and assistance to help them improve their HACCP plans.
Companies interested in learning more about how to implement HACCP can get information from professional HACCP planners, from companies selling off-the-shelf HACCP planning software and from the extension services of land-grant colleges.
Mississippi State University, for example, provides formal HACCP training classes and one-on-one support to the state's many small seafood, meat and poultry processors.
Later this year the University of Arkansas (Fayetteville, AR) will launch an online HACCP educational program for food processors and service providers as well as FSIS inspectors. The Web-based program grew out of the university's HACCP workshops for meat and poultry processors.
FSIS is coming to the realization that it needs a comprehensive educational program for the thousands of food safety inspectors dispersed across the U.S., says James Denton, Ph.D., director of the Center of Excellence for Poultry Science located on the university campus. Implementing a scientific approach over traditional "sight, touch and smell" food safety inspection has proved to be a significant challenge for the industry, in part because it requires a huge cultural shift.
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HACCP in brief
HACCP is a scientific, systematic approach to food safety originally developed by The Pillsbury Co. and the National Aeronautic and Space Administration (NASA) in the 1960s to assure the quality and safety of food products consumed on space flights.
Adopted by federal food safety agencies over the past decade, it relies on a strategy of preventing contamination problems during food production with science-based controls, rather than detecting contamination after the fact with random sampling of final products. Under HACCP, food processors must monitor various production stages for food-borne pathogens and document compliance.
HACCP has five preliminary steps, which include describing the food and developing a process flow diagram, and seven principles, which range from identifying hazards to determining CCPs and appropriate corrective actions.
For more information on HACCP, check out http://www.cfsan.fda.gov/~lrd/haccp.html and http://www.fsis.usda.gov/oa/haccp/imphaccp.htm and http://www.cleanrooms.com search by keyword "HACCP".
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Toward auditing uniformity
Growing in tandem with industry adoption of HACCP is the need for HACCP plan auditing. Processors in industries where HACCP is mandatory want their plans audited against a regulatory standard, while others adopting the approach voluntarily want their plans audited against their customers'—the likes of General Mills Inc. and McDonald's Corp.—expectations.
Faced with a growing need for uniformity among auditors, the American Society for Quality (ASQ; Milwaukee), has developed an add-on certification to the Certified Quality Auditor (CQA) exam—the HACCP Quality Auditor Certification. Standardizing auditors will take HACCP to the next level, says Phil Ventresca, chairman of the ASQ committee that developed the program and president of ESI Qual International (Stoughton, MA), a quality control consulting firm.
The CQA HACCP exam, which was first offered last fall, targets an auditor's knowledge of auditing principles and techniques and fundamental HACCP concepts. The exam applies to any industry with an "anticipatory and preventive" methodology to product safety, including the biomedical and medical device industries.
Previously, audits were conducted by multi-disciplined individuals with various interpretations of HACCP, says Vantresca. "The general feeling in the industry was that individuals had their own perception of what a hazard analysis should contain and how it should be conducted and what constituted a CCP. People recognized a growing need for uniformity among auditors with interpretations similar to the way ISO standards are interpreted."
Auditing uniformity is also behind a National Food Processors Association program called Supplier Audits for Food Excellence (SAFE). In this program the trade group is working with 26 processors to develop a common set of standards that can be used to audit suppliers to processors. Every year each major processor uses third-party auditors to audit suppliers. Some of these suppliers get audited as many as 20 times annually, costing thousands of dollars in lost time and productivity. The uniform audit standard, which includes HACCP as one of five major elements, will significantly reduce the number of audits at each supplier. The program will begin testing and certifying auditors this year and complete its first supplier audits this summer.
Certifying HACCP personnel
While these programs target HACCP auditors, NSF International (Ann Arbor, MI) has developed a certification program for managers who develop, implement and oversee HACCP plans in their companies. The one-year-old program has attracted traditional food processors as well as food safety managers from state and federal correctional facilities, grocery stores, hospital and university food service systems, and restaurant chains. Moreover, the program has attracted a lot of interest outside the U.S. as companies that do business here seek official credentials, says James Lewis, senior administrator of the Center for Public Health Education at NSF International.
NSF also offers a two-day training course for the certification exam where students learn the five preliminary steps to HACCP and the seven HACCP principles. Students select a product or process they are familiar with and use the training exercises to develop mini-HACCP plans. People taking the course must have a basic understanding of food safety, contamination control and prerequisite programs.—SG