Standard 9: Program Assessment
Public Health Metric and Risk Factor Study
The goal of both the NEHA-FDA Retail Flexible Funding Model (“RFFM”) Grant Program and the Voluntary National Retail Food Regulatory Program Standards (“Retail Program Standards”) is to reduce the incidence of foodborne illness factors in food establishments so that foodborne illness occurs less frequently. Completing Standard 9: Program Assessment (“Standard 9”) which serves as a Public Health Metric, with the required Risk Factor Study, is one key component of achieving this goal.The NEHA-FDA RFFM Grant Program provides funding to jurisdictions to comply with Standard 9, which includes:
- completing a Risk Factor Study
- implementing intervention strategies to address out of compliance risk factors
Completing a Risk Factor Study
A Risk Factor Study includes data collection, analysis of the data, and written report on your jurisdiction’s occurrence of foodborne illness risk factors.
Risk Factor Study Cycle
- Baseline Study: The first study is considered the baseline study.
- The data collection instrument pertaining to the 5 foodborne illness risk factors must be included, using the IN/OUT/NA/NO convention.
- Only the facility types that jurisdictions have regulatory authority over need to be included.
- Intervention: After the baseline study is complete, jurisdictions implement intervention strategies to address the most common risk factors out of compliance identified in the study.
- 5-Year Intervals: Further studies are repeated at 5-year intervals to evaluate the efficacy of the implemented intervention strategies
Scope of Work
First, determine what can be accomplished during the grant period and only request funding for an appropriate scope of work. However, a strategy that includes full completion of a five-year Risk Factor Study cycle is highly recommended to include in your Comprehensive Strategic Improvement Plan (CSIP).
Track 2 Development Base Grant: Work on Elements of Standard 9 in Pursuit of a Public Health Metric
These one year grants can be used to begin or continue work on elements of Standard 9 such as a Risk Factor Study. Each of the following options works toward meeting at least one of the elements of Standard 9 and can be selected in the application process:
- implement a Risk Factor Study or equivalent protocol to develop a baseline survey
- develop and implement one or more intervention strategies aimed at mitigating the occurrence of out-of-control risk factors
- continue to use the results of collected inspectional data to improve the survey instrument
- statistically measure the outcomes of new information compared to the baseline
Track 3 Maintenance and Advancement Base Grant
No new Maintenance and Advancement (M&A) awards will be given in 2023. If your jurisdiction has already been awarded a Track 3 M&A Base Grant, you would have been awarded funding for one these:
- Work on Elements of Standard 9 in Pursuit of a Public Health Metric
- Track 3 Maintenance and Advancement Base Grant: This three year grant enables grantees to make significant progress through the Retail Program Standards.
- Incorporating a Risk Factor Study into the proposed project is a requirement for any jurisdiction that has not already achieved Standard 9 (with audit passed and required paperwork approved by FDA) due to the importance of the work encompassed by Standard 9.
- Jurisdictions who have not already met Standard 9 must include either routine inspection data or a separate data collection Risk Factor Study in their proposed projects and be prepared to work on the metric for the full three-year cycle of the grant.
Protocols for establishing a Risk Factor Study based on the FDA model can be found on FoodSHIELD, at Retail Food Risk Factor Study (FDA), and the Standard 9 Information document.
Refer to Guidance for Completing a Risk Factor Study for additional information.
Example Risk Factor Study 5-Year Cycle
An example of a full, five-year Risk Factor Study cycle appropriate for a Track 2 Development Base Grant or a Track 3 Maintenance and Advancement Base Grant would be:
- Establish a baseline survey through data collection using random sample of food establishments
- OR establish a baseline survey using routine inspectional data.
- OR update inspection forms if they do not include IN, OUT, NA, and NO and begin baseline study.
- Develop intervention strategies aimed at mitigating the occurrence of out-of-control risk factors and begin implementing them.
- OR if the intervention strategies have already been developed, continue to add data to the survey instrument using expectations found in Standard 9 of the Retail Program Standards.
Year 3 & 4
- Continue to use the results of collected inspectional data to improve the survey instrument.
- Statistically measure the outcomes of newly collected data compared to the outcomes from the baseline survey.
Sample Intervention Strategies
Examples of possible interventions could include:
- Sharing educational materials, such as posters and videos, that are available for download. In these examples, the posters are available in nine languages.
- Providing on-site training.
- Assisting food establishments in developing their Food Safety Management System, such as assisting them in developing Prerequisite Programs.
- Assisting in the development/teaching of Process HACCP for menus.
- Reviewing type and placement of food equipment, with the goal of incorporating control of risk factors to minimize out-of-control occurrences.
Additional FDA information pertaining to Standard 9: Program Assessment can be found at Voluntary National Retail Food Regulatory Program Standards.