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Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices
parameters in its HACCP system. These upper and lower control limits may use prevalence to measure control of a hazard over time. As defined in the 2009 review of FSIS public health riskbased systems by the Institute of Medicine, a process is in control when, within the limits of a stable and predictable process variation, all hazards are controlled to an acceptable level. 5
Data collected initially by the establishment can be used in process mapping for HACCP validation. The establishment can compare pathogen levels on incoming and final product to determine whether the process is achieving the desired reduction in microbial loads. Then, if the pathogen testing results demonstrate that the process is functioning correctly, the establishment can use the testing results for indicator bacteria to set a maximum limit for each indicator at each collection point. FSIS agrees with the commenter, however, that where the Agencys pathogen-reduction performance standards apply, an acceptable level would be one that is at or below the pathogen limit of a standard. Just as in the 2015 guidance, the updated guidance continues to advise an establishment seeking to reduce microbial hazards to consider FSISs applicable Salmonella and Campylobacter performance standards for carcasses, parts, and comminuted poultry.
Comment: The poultry industry association said that, additionally, the guideline frequently instructs establishments to reevaluate their processes if they are resulting in high numbers of Campylobacter or Salmonella subtypes more commonly associated with human illness, without defining what the Agency views as a high level of these serotypes. Further, the poultry industry association argued that serotypes have little or no practical impact on HACCP systems. According to the commenter, a good HACCP
system should work to control all Salmonella serotypes or Campylobacter species regardless of their serotype.
Response: Under HACCP, criteria for additional testing or actions are defined by the establishment. These criteria could be derived from the establishments own baseline data, as well as the frequency at which serotypes of human-health concern are identified in that baseline. While FSIS agrees that HACCP systems should address all 5 IOM Institute of Medicine. 2009. Review of the Use of Process Control Indicators in the FSIS Public Health Risk-Based Inspection System: A Letter Report. Washington, DC: The National Academies Press. P.12.

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pathogens, FSIS uses characterization data, including serotypes of increased human health concern, to prioritize further evaluation and assessment of an establishments HACCP system.
Specifically, if an establishment does not meet FSIS performance standards, as part of the public health review evaluation PHRE, FSIS will assess whether the Agency has found frequent serotypes of public health concern in the establishments product. If so, FSIS
will also likely conduct a food safety assessment FSA at the establishment.
Comment: A poultry industry association noted that the 2015
guidance appears to conflate the terms prevalence and load when referring to recommendations for decreasing Salmonella and Campylobacter.
According to the poultry industry association, the prevalence of a pathogen on raw poultry product is a distinctly different microbial sampling metric than the load, or quantity, of pathogen on a raw poultry product. The prevalence of a pathogen refers to the presence or absence of a pathogen, regardless of quantity and is usually expressed as a percentage or rate of occurrence over time. By contrast, the microbial load of a pathogen refers to the concentration of bacteria for example, in colony-forming units in or on a unit of product. Yet, according to the poultry industry association, the guideline uses the terms prevalence and load interchangeably when recommending practices to decrease the prevalence or load of Salmonella and Campylobacter on raw poultry products. The poultry industry association argued that these two metrics are not, in fact, interchangeable.
Since FSIS had reiterated that the Agency will focus on the presence of Salmonella or Campylobacter rather than on load, the poultry industry association recommended that the Agency revise the guidance for consistency in referring to prevalence rather than load. According to the poultry industry association, the guidance should refer to prevalence rather than load.
Response: FSIS disagrees that it conflated the terms prevalence and load and did not make the poultry associations recommended changes to the guidelines. Establishments are not limited to considering only prevalence, which may be derived from qualitative test results over time, when designing and implementing a HACCP system.
Available tools for enumeration can help inform a prudent establishment so that it can consider the impact of pathogen load, or the actual levels of contamination in positive samples,
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along with the prevalence information in order to improve process-control systems.
Comment: The poultry industry association offered several recommendations intended to improve discussion in the guidance of data analysis techniques. Thus, in the area of process mapping, the poultry industry association recommended that FSIS give establishments the flexibility to use process indicators that reliably reflect their operations and environments. The poultry industry association also suggested edits to make the text more consistent with tables that show median values for indicator organisms on poultry carcasses and parts. The poultry industry association remarked that linking a product with human illness is not necessarily evidence of a loss of control by the establishment that prepared the product. The poultry industry association also stated that the use of microbiological performance standards is not the only way to evaluate process controls. The commenter also stated that the moving window approach to monitoring and assessing whether establishments meet performance standards and use of the category-ranking system has not been evaluated for assessing process control.
Response: Establishments are free to choose appropriate microbiological indicators for determining processcontrol effectiveness. FSIS has removed some of the material about sampling for specific indicator organisms, including the sections regarding median indicator values, as more detail is provided in the FSIS Compliance Guideline:
Modernization of Poultry Slaughter InspectionMicrobiological Sampling of Raw Poultry 6 to assist small and very small establishments that may not have their own baseline information.
While microbiological performance standards may not be the only measures of process control, they do help focus industry attention on the public health aspects of poultry processing and the need to improve processes as necessary to prevent foodborne illnesses. During the past two years, FSIS has been employing the moving window dataframe for microbiological test results on poultry products as a way of determining whether establishments meet performance standards over time.
FSIS has evaluated the technique as a more consistent replacement for sampling sets that can better identify trends, such as seasonality, over time.
Comment: The poultry industry association recommended that FSIS
6 Available at: https www.fsis.usda.gov/
guidelines/2015-0013.

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