By William H. Sperber and Richard F. Stier
On October 4, 1957, the Soviet Union put Sputnik, the world’s first satellite, into orbit. The launch of this satellite, a package weighing less than 200 pounds that carried no military or scientific equipment, propelled America into the space race. President Eisenhower responded by committing America to the space program. He signed the National Aeronautics and Space Act into law on July 29, 1958. The first step was to get an American satellite into orbit; the second was to get a person into space.
The pressure on scientists involved with the space program to “get it right” was intense. This was a matter of national pride, and those involved took all possible steps to ensure that the program was successful. Failure was not an option.
A Little History
Food was an integral part of putting a man into space; food that would not only provide concentrated nutrition, but would not create any health issues. Above all, the food had to be safe. Take a trip to Cape Canaveral or the Smithsonian and look at one of the early space capsules. An astronaut who became sick would be a danger to himself and the mission. The group involved with creating foods for manned space flight initially consisted of Herbert Hollender, Mary Klicka and Hamed El-Bisi from the United States Army Laboratories in Natick, MA, and Dr. Paul Lachance from NASA’s Manned Spacecraft Center in Houston, TX.
In 1959, Pillsbury joined the program as a contractor and began working on cube-sized foods for space flight. Producing foods that would not crumble in zero gravity and provide adequate nutrition was only one of the problems; food safety was another. Dr. Howard Bauman, a microbiologist by training, was Pillsbury’s lead scientist on the project. NASA’s Dr. Lachance imposed strict microbiological requirements, including pathogen limits, on all foods destined for space travel. He and Dr. Bauman, along with the Natick scientists, soon realized that traditional quality control methods would be inadequate to guarantee the food’s safety, as testing and analysis alone would not suffice. In fact, to ensure that the food was safe, manufacturers had to test so much product that there was little left for actual use.
The search for a better way came in part from NASA’s own requirements. NASA had mandated the use of critical control points (CCPs) in engineering management, so it was a logical step to apply this same process to food manufacturing. The CCP approach adopted by NASA apparently had first been practiced in the munitions industry as a means to ensure the reliability of shells. Similarly, the Army Laboratories used Failure Modes and Effects Analysis (FMEA) to test the reliability of weapons and engineering systems. Extrapolating from those examples, Pillsbury and NASA required contractors to identify “critical failure areas” and eliminate them from the system. Applying this concept to a food system was new. It was a NASA requirement, but Pillsbury was the company that “grabbed the bull by the horns” and made it work for space foods. In fact, Dr. Bauman was so pleased with Pillsbury’s experience with the space program that he advocated for his company to adopt the approach in its own manufacturing.
The Birth of HACCP
Shortly thereafter, The Pillsbury Company was confronted with a serious food safety matter in one of its commercial food products—glass contamination in farina, which was commonly used as an infant food. Under the leadership of Dr. Bauman, Pillsbury immediately began to promote the HACCP system for the production of commercial foods and to apply it to the production of its own foods. A panel discussion at the 1971 National Conference on Food Protection featured an examination of the importance of CCPs and Good Manufacturing Practices (GMPs) in the production of safe foods.
Because of several cases of botulism and numerous incidents of Clostridium botulinum contamination that were attributed to under-processed, low-acid canned foods around 1970 to 1971, the U. S. Food and Drug Administration (FDA) asked Pillsbury to organize and conduct a training program for its inspectors so that the new system of food safety based on CCPs could serve as the basis for regulating the production of canned foods. Held in September 1972, the training program consisted of 11 days of classroom lectures and discussion, and 10 days of canning plant evaluations. The FDA inspectors returned to Washington, DC and published the canned foods regulations in 1973. This training program, “Food Safety through the Hazard Analysis and Critical Control Point System,” appears to be the first published use of the term “HACCP.” This training program is a good example of how industry and government can successfully collaborate.
During 1972, Pillsbury also established new internal specifications systems and training programs, and hired one of us (WHS) as a research microbiologist to conduct the first hazard analyses and validations for the production of consumer products. The new systems and HACCP-based ingredient and product specifications were computerized and completed in 1975. Recognizing the advantages of HACCP over traditional quality control procedures in food safety management, progressive food companies, led by the canners, began to adopt the HACCP system of food safety management.
The initial HACCP system was based on three principles:
1. Conduct a hazard analysis.
2. Determine critical control points.
3. Establish monitoring procedures.
Through experience with its new management system, Pillsbury quickly adopted two additional principles:
– Establish corrective actions to take when deviations occur at a CCP.
– Establish critical limits to be enforced at CCPs.
The food industry’s early efforts to deploy the HACCP system were given an intellectual boost by a National Academy of Sciences report that recommended government inspectors replace infrequent and brief plant inspections with evaluations of plant records to verify compliance with its HACCP system. Had this concept been followed, government “inspections,” which covered periods of hours or days, would have been replaced with government “audits,” which could have verified compliance over periods of days, months, and even years. However, in the following 25 years, there has been no significant regulatory shift from inspection to audit procedures, and few effective food safety regulations have been promulgated in the U.S.
A second recommendation from the above report was more successful. It advocated the formation of a National Advisory Committee on Microbiological Criteria for Foods (NACMCF). One of the first NACMCF efforts was the definition of a HACCP system and guidelines for its application. Its efforts were coordinated with those of the Codex Committee for Food Hygiene (permanently chaired by the U.S.), leading to reports from each group in 1992, which were further harmonized in 1997. The reports added two more principles to HACCP, giving us the seven principles that are in effect today:
1. Conduct a hazard analysis.
2. Determine the CCPs.
3. Establish critical limit(s).
4. Establish a system to monitor control of the CCPs.
5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
6. Establish procedures for verification to confirm that the HACCP system is working effectively.
7. Establish documentation concerning all procedures and records appropriate to these principles and their application.
This Codex document, having the effect of law between member nations of the World Trade Organization, has assisted global food corporations in their efforts to ensure food safety throughout the global supply chain. Despite the widespread application of HACCP by the food industry, food safety failures occasionally occur. Most of these failures are attributable not to defects in the HACCP system, but to failures of GMPs, especially those for sanitary design and cleaning and sanitation procedures. The food industry quickly recognized that “food safety” and “HACCP” were not synonymous terms. Rather, food safety could be better defined as an integrated system of HACCP plus GMPs, which are now often called prerequisite programs —programs that have been incorporated into government regulations throughout the world, including Codex and ISO 22000.
The success of HACCP in controlling hazards in food processing establishments led to consumer and regulator clamor to apply HACCP from “farm to table,” and eventually gave rise to expectations that unprocessed foods, such as fresh produce and raw meat and poultry products, could be rendered pathogen-free. Of course, such expectations cannot be fulfilled because the definitive process controls that can be applied by food processors—for example, the pasteurization of raw milk—cannot be applied at the “farm” and “table” ends of the food supply chain. Instead, we need to think in terms of improving food safety from farm to table by using prerequisite programs, including good agricultural practices, when definitive HACCP-based controls can not be used.
To a very large extent, global food corporations have implemented HACCP around the world without significant assistance (other than the Codex document described above) from governmental and intergovernmental food regulatory and health agencies. That is, HACCP reached its current state of preeminence as a voluntary industry program, not as a government mandate. It would be a great help if federal agencies, without being prescriptive, would require the appropriate use of HACCP and/or prerequisite programs in food operations from farm to table. We can expect that a much greater and more effective collaboration can be reached among all agencies, including the prospective formation of a “Food Protection Organization” within the United Nations or the World Trade Organization.
Since its birth in 1959 and formalization in 1972, the HACCP system has grown from three to seven principles. The future may see the addition of more principles, perhaps related to training, validation, prerequisite programs, etc. Whatever the ultimate configuration of HACCP system details, it is comforting to note that the HACCP pioneers, beginning 50 years ago, established features of HACCP that have not changed. These are the following:
– HACCP is a preventive system to control significant, identified hazards.
– It functions by designing food safety into a product and controlling the process by which that product is produced.
– It does not rely on product testing or lot acceptance criteria.
These features are the timeless essence of HACCP, serving as a permanent testament to the vision of the HACCP pioneers.
We dedicate this editorial to two HACCP pioneers, Dr. Howard E. Bauman (1925–2001), a long-time leader of research, food safety and regulatory affairs at The Pillsbury Company, and Dr. Paul A. Lachance, former NASA Flight and Food Coordinator and retired professor of nutrition and department chair at Rutgers University.
Source: Food Safety Magazine
William H. Sperber, Ph. D., has led microbiology and food safety programs in global corporations for more than 40 years. He is Global Ambassador for Food Protection at Cargill, Inc., Minnetonka, MN.
Richard F. Stier has been involved in food safety and HACCP since 1981. He currently consults on food safety, sanitation and quality systems and has worked with companies throughout the world.