HACCP alone is not a food safety silver bullet

by Kerri Harris and Jeff Savell
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On Dec. 29, 1995, the Food Safety and Inspection Service published an advance notice of proposed rulemaking and additional rulemaking proposals describing the agency’s strategy for mandating Hazard Analysis and Critical Control Point (HACCP) systems. The Pathogen Reduction; Hazard Analysis and Critical Control Point Systems; Final Rule was issued on July 25, 1996, and HACCP was implemented in all inspected meat and poultry establishments between January of 1998 and 2000.

The HACCP concept depends on using seven principles to identify and control food-safety hazards throughout a production process. HACCP systems are and should be dynamic to allow for modifications in production and/or changes in the food-safety hazards. So, change should not be a surprise. However, in looking back to 1998, and then thinking about where we are now, it appears the expectations for HACCP may have changed more than the HACCP systems.

A food-safety tool

However, we need to remember that HACCP is a tool that focuses on food safety. It should not be a stand-alone program but rather part of a food-safety system. Unfortunately, it seems that both the industry and regulatory agencies have tried to force HACCP into being more. Maybe the expectations of HACCP are like the saying that “if the only tool you have is a hammer, then everything starts to look like a nail,” and some people forget they have other tools, such as prerequisite programs, that should be part of their food safety systems.

This is not meant to imply that HACCP does not work – it works well. Properly designed HACCP plans in food processing operations that can apply effective controls achieve positive results. Also, technologies, such as irradiation and high-pressure pasteurization, are being used for some finished raw products. Unfortunately, in raw meat and poultry production, HACCP’s capability to prevent, eliminate or reduce pathogens is questionable due to the inherent risks associated with raw products and the lack of a true critical control point in these processes.

When mandatory HACCP was first implemented in raw meat and poultry processes, most people seemed to understand that CCPs were designed to reduce risk (i.e., lower pathogen counts) rather than eliminate the risk altogether. Some processors initially tried to use the term “control points” rather than “critical control points” to distinguish the limitations of the interventions. However, the language in the HACCP regulation did not clearly allow for the incorporation of control measures or other prerequisite programs, and establishments were encouraged to include these process steps in their HACCP plans as CCPs – even though these steps did not truly prevent, eliminate, or reduce the pathogen to an acceptable level.

Over time, FSIS began to acknowledge and accept the use of prerequisite programs. For example, the Oct. 7, 2002, Federal Register Notice (Vol. 67, No. 194) on dealing with E. coli O157:H7 contamination of beef products “…grinders that have purchase specifications that require that all of their suppliers have one or more CCPs in their HACCP plans that are validated to eliminate or reduce E. coli O157:H7 below detectable levels and that ensure these specifications are met may determine that no additional steps to address E. coli O157:H7 are necessary in their production process for ground beef. However, given the nature of the pathogen, FSIS strongly recommends that grinders that have purchase specifications addressing E. coli O157:H7 determine whether CCPs preventing E. coli O157:H7 growth or contamination after product receipt are necessary.”

Addressing Listeria monocytogenes in post-lethality exposed ready-to-eat meat and poultry products is another great example of where HACCP may not be the only tool needed or used by establishments, and the FSIS regulation (9 CFR Part 430) clearly allows for the use of HACCP, sanitation, and other prerequisite programs. In many ready-to-eat establishments, Listeria is not a reasonably likely to occur food safety hazard in the post-lethality steps, so there is no CCP.

In other establishments, post-lethality treatments are applied as CCPs. While prerequisite programs do not have the exact same regulatory requirements for recordkeeping, supporting documentation, decision making, and verification/validation that is required for HACCP, they still are important components of the food safety system.

Today, grinders and producers of non-intact beef often use purchase specifications to support that E. coli O157:H7 is not reasonably likely to occur on incoming raw materials, so antimicrobial interventions, such as organic acids, are applied as processing aids rather than as a CCP. It seems that both industry and agency personnel often struggle with how to make this approach work within the HACCP regulation. So, rather than trying to force everything into a HACCP system, maybe it is time to embrace the total food safety system approach.

Use all tools available

In the end, the safety of raw meat and poultry depends on developing and implementing solid prerequisite programs and sound HACCP plans in order to provide a greater opportunity for establishments to address a full range of food-safety concerns.


Kerri Harris is President/CEO of the International HACCP Alliance and is an Associate Professor in the Department of Animal Science at Texas A&M University. Jeff Savell is Regents Professor and E.M. “Manny” Rosenthal Chairholder in the Department of Animal Science at Texas A&M University.
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