The basic principles of Hazard Analysis and Critical Control Points (HACCP) have been recognized since the 1970s, and more formal programs have been continually evolving since then. Regulatory agencies in the United States [U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA)] and Canada (Canadian Food Inspection Agency) have each issued their own set of HACCP regulations. Each system follows the concepts of the standard seven principles of HACCP, at times with the use of different terms.

At the heart of any HACCP or food safety plan are the documented control measures, which are based on the Hazard Analysis. Control Measure Concepts in North America The USDA Food Safety Inspection Service HACCP regulation1 was the first rule published on HACCP in the United States and requires the use of CCPs to control hazards reasonably likely to occur that were identified during the Hazard Analysis.

Prerequisite programs (PRPs) are defined as written procedures that describe specific activities of a plant that can be used to support decisions made in the Hazard Analysis. PRPs do not control food safety hazards. Good Manufacturing Practices (GMPs) or Sanitation Standard Operating Procedures (SSOPs) are examples of PRPs. While PRPs are not considered a sufficient control measure for an identified food safety hazard, these programs are considered support for hazards being considered not reasonably likely to occur, and as a justification for not adding a potential hazard to an HACCP plan. FDA has promulgated three regulations relating to HACCP and food safety, commonly referred to as Juice HACCP,4 Seafood HACCP5 and the Preventive Controls rule.6

Under Juice HACCP, the regulated facility is required to implement control measures for all hazards deemed reasonably likely to occur that were identified during the Hazard Analysis. Control measures can be CCPs or SSOPs. Good Agricultural Practices (GAPs) and Current GMPs (CGMPs) are not considered to be control measures.

Seafood HACCP provisions are nearly identical to those in Juice HACCP, except that instead of “control measure,” the term “preventive measure” is used. CCPs and SSOPs are the required preventive measures for all hazards deemed reasonably likely to occur that were identified during Hazard Analysis. The Preventive Controls rule is the first regulation that introduces the concept of “preventive controls,” which are defined as “(i) Controls at CCPs, if there are any CCPs, or (ii) Controls, other than those at CCPs, that are also appropriate for food safety.” This rule does not require use of the terms CCPs, operational PRPs (OPRPs) or PRPs, but rather any control that is appropriate for food safety is considered a preventive control.

Decisions on how to choose, verify and validate controls other than CCPs can be difficult, especially for smaller companies. Various terms have been coined to describe controls other than CCPs, such as OPRPs, “specific PRPs” and the more traditional terms PRPs and “universal PRPs.” The Safe Food for Canadians Act7 refers to the use of the Canadian Food.

Safety Enhancement Program Manual 2014-07-01. Prior to the publication of this act, HACCP systems in Canada were similar to those in the U.S., and Canadian HACCP systems were early adopters of the use of PRPs as control measures in the first edition of the Canadian Food Safety Enhancement Program Manual.

Using Decision Trees to Determine the Type of Preventive Control An Internet search for “HACCP decision trees” will result in a hundred types of decision trees, but all of them have common elements, and many relate back to the decision tree listed by Codex Alimentarius.

This is often referred to simply as the Codex Decision Tree (Figure 1). To use this decision tree to decide whether a particular preventive control measure should be a CCP at a process step, there are certain pieces of information needed: the process steps where control measures may be applied, the potential control measures, the effectiveness of the control measures and the contamination potential of the product after control steps have been applied. The output from this tree is either that the process step is a CCP or the process step is not a CCP. If the process step is not a CCP, then the assumption is made that the process step does not need to be a preventive measure at all, or that it may need to become a PRP or SSOP. Figure 2 is a similar decision tree suggested in the Seafood HACCP guidance,10 with fewer questions but similar outputs. Figure 3 is another modified decision tree from Campden BRI11 that starts with the question about whether the identified hazard is managed by PRPs and stops the process immediately if the answer is yes.

This decision tree could possibly be used for USDA, Juice HACCP and Seafood HACCP plans, but would not be practical for facilities regulated under the FDA Preventive Controls rule. While these trees can be very helpful for determining CCPs, they are not as useful when a facility has “preventive controls other than CCPs” in their HACCP system for certain identified hazards. These preventive controls may still be necessary for food safety but will not meet the criteria for a CCP in these other trees. For those situations, modified Codex decision trees could be more helpful. Figure 4 shows modified trees that allow for the possibility of OPRPs in the decision-making process.