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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 risk factors in food establishments to help control the spread of foodborne illness. Completing Standard 9: Program Assessment (Standard 9) is a key component of achieving this goal.

Through both Track 2 Development Base and Track 3 Maintenance and Advancement Base Grants, the NEHA-FDA RFFM Grant Program provides funding to jurisdictions to enable them to meet and then maintain Standard 9.

The FDA has built a to help jurisdictions with their work on Standard 9. This is the best source of in-depth information for working to conform with Standard 9. The following information, however, provides an overview of the key steps that must be accomplished in meeting this Standard, and aligning the work needed with your 1-year Track 2, or 3-year Track 3 base grant.

Risk Factor Study Approach

The first step for a jurisdiction requesting funds to begin work on Standard 9 is to determine which Risk Factor Study approach to be used. FDA鈥檚 Retail Food Risk Factor Study Toolkit describes two different approaches and a third, hybrid approach, as paraphrased below. Because both the Level 2 and Hybrid approaches result in more work for a jurisdiction, more annual funding is provided for these steps for both Track 2 and Track 3 grantees.

• A Level 1 Risk Factor Study uses the 鈥淔ile Study鈥� approach which uses routine inspection data from inspections that have already been completed, to retroactively assess the occurrence of risk factors - Fixed Funding of $5,000 per year
• A Level 2 FDA Risk Factor Study uses the 鈥淒ata Collection鈥� approach to estimate the occurrence of risk factors using observational visits to randomly selected retail food establishments. A 鈥淒ata Collection鈥� visit has, as its sole focus, observation of food safety behaviors tied to risk factors and is completed separately from the regulatory inspection - Fixed Funding of $10,000 per year
• A third approach, also considered a Level 2 Risk Factor Study, is the 鈥淗ybrid Approach鈥� which combines elements of the first two, by combining the data collection with a routine inspection. It is suggested that the data collection work occur after the routine inspection has been performed Fixed Funding of $10,000 per year

Scope of Work

Once the Risk Factor Study approach is determined, deciding what can realistically be accomplished during a one-year or three-year grant period is critical for success in achieving conformance with Standard 9. Consider requesting funds for a scope of work that your jurisdiction will be able to realistically achieve in the given time frame of your selected grant. It is recommended that a multi-year scope of work (often 5-years), outlining all steps required for a successful Risk Factor Study cycle, be included in your Comprehensive Strategic Improvement Plan (CSIP). From there, activities that correspond to where you are in your multi-year cycle can be included in your grant request.

Track 2 Development Base Grant: Work on Elements of Standard 9

These one-year grants offer applicants the option to begin, continue, or maintain work on elements of Standard 9.

Track 3 Maintenance and Advancement Base Grant

Work to meet or maintain Standard 9 is a requirement for these three-year grants, which also can be used to begin, continue, or maintain work on elements of Standard 9. Due to their duration, however, they also offer the grantees the opportunity for significant progress including full compliance with Standard 9, if it has not already been met.

Example Risk Factor Study 5-Year Cycle

Following is an example of a full, five-year Baseline (Initial) Risk Factor Study cycle, which could become part of a CSIP, and which could be partially achieved during the project period of a one-year Track 2 Development Base Grant or a three-year Track 3 Maintenance and Advancement Base Grant:

Year 1

• Design (or update) Risk Factor Study, prepare materials, train staff

Year 2

• Collect risk factor data for new (baseline) or ongoing study

Year 3

• Collect risk factor data for new (baseline) or ongoing study

Year 4

• Analyze risk factor data
• Complete data analysis report and determine interventions needed

Year 5

• Implement interventions based on results of data analysis
• Meet and Audit Standard 9

Year 6/1

• Process is repeated every 5 years, with the opportunity to measure the effectiveness of previously implemented interventions

Sample Intervention Strategies

Examples of possible interventions include:

• Sharing food safety educational materials, such as posters and videos.
• Providing on-site training on out of compliance risk factors.
• Assisting operators in developing Prerequisite Programs to control non-compliant risk factors.
• 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.

For significant, additional information pertaining to conforming with and maintaining Standard 9: Program Assessment, be sure to follow the link near the top of this page to the FDA Retail Food Risk Factor Study Toolkit.