Risk-based Targeting of Food Safety Resources

Undertaking a greater number of inspections is a significant part of the Food Safety Modernization Act (FSMA), which requires FDA to meet an inspection frequency mandate targeting resources to high-risk facilities. As food companies begin to ask themselves “Will I be inspected more frequently?” part of that answer may gain clarity as we begin to understand how FDA classifies “high-risk”. This process will have a significant impact on how frequently a facility may see FDA inspectors. In addition, FSMA requires FDA to develop additional record keeping requirements for high-risk food. Under the new FSMA import provisions, the Agency can also require import certificates for food based on risk and inherent product risk will also be taken into account in the eligibility requirements of the Voluntary Qualified Importer Program. Again, the Agency’s criteria and subsequent classification of risk will be the underpinning of their risk based approach to inspections, new record keeping requirements and play a role in decision-making tied to the import provisions.

FDA asked the National Research Council (NRC) at the National Academy of Sciences, an independent, nonprofit institution that provides science, technology and health policy under a congressional charter, to develop a “conceptual model that could evaluate products or product categories that FDA regulates.” A prepublication copy of the report was published last week that details the NRC’s risk framework and a case study of using the model to evaluate several food categories. Understanding the framework and the criteria used in the NRC model may provide insight into how FDA will determine high risk designations for allocating inspection resources, requiring additional record keeping, and certification requirements for imported products.

The NRC framework focuses on defining outcomes or impacts of decisions to enable systematic evaluation of mitigation-selection decisions (potential actions to address risk), targeting decisions (priority setting and resource allocation), and strategic investment decisions (long-term priority setting). The framework consists of three steps:

Identify and define the decision context.

Estimate or characterize the public-health consequences of each option.

Compare the options.

The NRC identified the risk attributes that should be used in Step 2 to determine the public health impact of a decision. They suggest exposed population, mortality and morbidity should be used to determine the number, type, and rate of occurrence of adverse health effects from a decision. The NRC concluded that risk perception and public attitudes have been shown to have an impact on risk of FDA-regulated products. For this reason, they also include personal controllability, ability to detect adverse health effects, and ability to mitigate or reduce adverse health effects as attributes that should be considered as a component of the model.

As part of the report, the committee conducted a case study using the risk framework to evaluate three food categories. The information gained from conducting the analysis under the framework could help drive Agency decisions around resource allocation, inspection prioritization, certification or indentifying products for which additional recordkeeping requirements may be required. For the case study, the committee looked at domestic leafy greens, shrimp, and canned food. To determine values for all of the risk categories, the committee utilized several data sources, including CDC Outbreak Net data, the estimates of foodborne illness released earlier this year by Scallan et.al, and information gained from expert elicitations, among other sources. Personal controllability was calculated based on the percent of time the food was prepared at home and the percent of consumers who have control over the risks in the home. The ability to detect adverse health effects was based largely on estimates of under-reporting in the 1999 Mead et.al article on the Burden of Foodborne Illness. The ability to mitigate adverse health effects is based on the extent to which risk can be mitigated during the production process and the ability to remove product from commerce when a problem is detected.

Based on their analysis, the committee determined that mortality and morbidity were significantly higher for domestic leafy greens, compared to shrimp and canned food. Canned food had the lowest mortality and morbidity rates of the three product classes. Personal controllability was estimated to be greatest for leafy greens (40-50% of cases) and canned food (45-60% of cases) and lowest for shrimp (10-15% of cases). Ability to mitigate adverse health effects was greatest for canned foods (50-70% of cases) and lowest for domestic leafy greens (<10% of cases).

While the risk characterization framework does not provide any definitive answers on which products will be considered high risk, it does provide insight into how the Agency may utilize available information in a way that facilitates cross-product comparisons. It will be important for industry to be aware of how FDA is approaching risk-based thinking to ensure they mitigate risk where possible and anticipate any additional oversight they may receive based risk categorization. As the process continues to unfold in the coming months we will provide further updates on how FDA is approaching risk determinations and how this translates into the Agency meeting new FSMA mandates.

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