Background And Historical Significance

The language surrounding the term "hazard characterization" has referred to the food products themselves, as well as to the hazards that might be present in the food. Hazard characterization has been used in the development of Hazard Analysis and Critical Control Point (HACCP) plans and regulatory policies, as well as for risk assessments. In 1969, the National Academy of Sciences issued a report evaluating the Salmonella problem (NAS, 1969). This report described three hazard characteristics associated with food and Salmonella-.

1. Products containing ingredients identified as significant potential factors in salmonellosis,

2. Manufacturing processes that do not include a control step that would destroy Salmonellae, and

3. Substantial likelihood of microbiological growth if mishandled or abused in distribution or consumer usage.

With the various combinations of these three hazard characteristics, five categories were created that reflected the potential risk to the consumer. Category I included food products intended for use by infants, the aged, and the infirm, that is, the restricted population of high risk. Category II included processed foods that were subject to all three hazard characteristics (ABC) listed above. Category III included those products subject to two of the three general hazard characteristics. These would include such products as custard-filled bakery goods (AC), cake mixes and chocolate candy (AB), and sauce mixes that do not contain a sensitive ingredient ( BC). Category IV included products of relatively minor microbiological health hazard level, subject to only one of the hazard characteristics. Examples include retail baked cakes (A) and some frosting mixes (B). Category V includes foods that are subject to none of the microbiological hazard characteristics and therefore of minimal hazard potential, for example, canned foods sterilized after packaging in the final container.

The Pillsbury Company is recognized as the first company to have developed HACCP plans. The Pillsbury approach to HACCP systems also used three hazard characteristics to categorize food products. In this instance, the hazard characteristics were generalized to include all potential microbial, physical, and chemical hazards, not only Salmonella (Sperber, 1991). As in the NAS report, the permutations of the hazard characteristics resulted in five product hazard classes.

The use of the three hazard characteristics to assess risks was standard in the 1970s (Bauman, 1974). In 1989, the NACMCF presented a HACCP document that used six hazard characteristics to rank microbial hazards for risk assessments (NACMCF, 1989). Chemical and physical hazards were included subsequently (Corlett and Stier, 1991). Hazard characterization at this time was made on the basis of criteria such as:

The consumers' risks associated with factors such as age and health, The risk associated with the ingredients used to make the food product, The production process and its impact on the hazard, The likelihood of recontamination after processing, The potential for abuse during distribution and consumer handling, and The ability of the consumer to detect, remove, or destroy the hazard during the final preparatory steps.

The hazard classification scheme (Hazard Categories A-F) described in the 1989 NACMCF document was updated in 1992 (NACMCF, 1992) and again in 1997 (NACMCF, 1998a). These revisions aligned U.S. HACCP concepts with those published by the internationally recognized Codex Alimentarius Commission (CAC) (1997). The most recent HACCP documents characterize hazards as part of the hazard analysis. The hazard characterization, or evaluation, is done after the hazards have been identified. The criteria for characterizing the hazard include:

The severity of the hazard, to include the seriousness of the consequences of exposure, or the magnitude and duration of the illness or injury, The likelihood that the hazard will occur, based on published information and epidemiological data, The potential for both short-term and long-term effects from exposure, and Available risk assessment data, as well as many of the criteria stated in earlier documents.

Ultimately, according to William H. Sperber (personal communication), "the hazard characteristics were discarded in favor of an open-ended hazard analysis in which an unlimited number of relevant questions could be asked about the product and the process by which it is produced. The product hazard categories fell into disfavor as we recognized that a relatively large percentage of consumers are immunocompromised. All foods must be safe for all consumers. The emergence of new foodborne pathogens in relatively narrow niches, e.g., Listeria monocytogenes in some perishable ready-to-eat foods, further rendered the concept of product hazards categories moot."

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