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Public Health Metrics, Risk Factor Studies, and Intervention Strategies

One of the cornerstones of the Retail Program Standards, and in turn, the NEHA-FDA Retail Flexible Funding Model (RFFM) Grant Program, is the goal of reducing the occurrence of foodborne illness risk factors with the expected outcome of reducing foodborne illnesses. To this end, funding for the achievement of Elements that lead to compliance with Standard 9, including completion of a risk factor study and implementation of intervention strategies, is a key part of this grant program. Meeting and maintaining Standard 9 (and particularly developing a baseline risk factor study or equivalent protocol) serves as a Public Health Metric, which according to the National Institutes of Health (NIH) is a yardstick by which assumptions in a model will be tested, used to measure evidence of actual inputs, outputs, and outcomes.

State, Local, Tribal, or Territorial (SLTT) jurisdictions who choose the Track 2 Development Base Grant to work on continuous improvement through Standards and Elements for Standards 1-8 also have the opportunity to request additional funds to work on the Elements that lead to the achievement of Standard 9. As achieving Standard 9 is a multiyear process, several options are offered in the one-year Track 2 Development Base Grant, to enable jurisdictions to either begin or continue work on Standard 9.

No new Track 3 grants are expected to be awarded for CY 2023 or CY 2024, but for SLTT jurisdictions who already have a Track 3 Maintenance and Advancement Base Grant, working on Standard 9 and completing a Public Health Metric is a required component of proposed projects, unless a jurisdiction has already met Standard 9 (with audit passed and required paperwork approved by FDA). Applicants were able to request funding to begin or continue a risk factor study or equivalent Public Health Metric that is based on establishing a baseline survey of the existing status of control of foodborne illness risk factors, develop and implement effective intervention strategies, and then measure the effectiveness (and hopefully reduce out-of-compliance risk factors) over a defined period of time – usually a five-year cycle. This baseline survey can be done using the jurisdiction's existing inspectional data, or the jurisdiction can participate in the collection of data that is the basis for the FDA Risk Factor Study survey.

Listed below are details for the two types of base grants that support work on the Elements of Standard 9 in Pursuit of a Public Health Metric. Explanations are included with examples for project ideas. Please note, these are only examples, and the jurisdiction usually knows best what it needs. For questions about developing a risk factor study specifically for your jurisdiction, reach out to your FDA Retail Food Specialist.

Track 2 Development Base Grant

Work on Elements of Standard 9 in Pursuit of a Public Health Metric: Up to $5,000/year/grantee.

Track 2 Development Base Grants are one-year grants to begin or continue work on Elements of Standard 9 such as a risk factor study or an equivalent public health metric. (An equivalent public health metric would be a parallel process of data collection and analysis, completed in the same fashion that FDA analyzes data from their data collections.) In their application, a jurisdiction can choose to work on one or more of the following options, each of which works toward meeting at least one of the Elements of Standard 9:

  • 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 add inspectional data to the survey instrument

  • Statistically measure the outcomes of new information compared to the baseline

The jurisdiction should determine the scope of work that can be accomplished during the one-year timeframe of the grant and only request funding for that scope of work; however, it is highly recommended that the jurisdiction develop a strategy that Includes a plan for full completion of a five-year risk factor study cycle (included in your Comprehensive Strategic Improvement Plan/CSIP).

An example of a full, five-year risk factor study cycle, appropriate for a Track 2 Development Base Grant, can be outlined as follows:

  • Year 1 – Implement the FDA Risk Factor Study protocol to develop a baseline survey;
    • Or - Develop a baseline survey of the five CDC risk factors based on inspectional data;
    • Or - If the jurisdiction's inspection forms do not include IN, OUT, NA, and NO, update inspection forms to include this data and begin a baseline study.
  • Year 2 – Develop intervention strategies aimed at mitigating the occurrence of out-of-control risk factors and begin implementing.
    • Or - If intervention strategies have already been developed and implemented, continue to add data to the survey instrument using expectations found in Standard 9 of the Retail Program Standards.
  • Year 3 – Continue to add inspectional data to the survey instrument.
  • Year 4 – Continue to add inspectional data to the survey instrument.
  • Year 5 – Statistically measure the outcomes of new information compared to the baseline survey.

Successful intervention strategies are developed and implemented to reduce the out-of-compliance rates for risk factors that have been previously identified in baseline or risk factor studies. They can include:

  • Sharing the educational materials, such as posters and videos, that are available for download. The posters are available in eight 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 building in control of risk factors to minimize out-of-control occurrences.
  • Developing Voluntary Risk Control Plans to impact behavior and encourage process changes that need to be implemented to control certain risk factors.

One-Year Scope of Work

As a reminder, as part of a Track 2 Development Base Grant application, jurisdictions should only apply for funds for the scope of work that will be accomplished during the one-year performance period of a proposed project (i.e., the work for a single year of a five-year risk factor study cycle). As outlined in the NEHA-FDA RFFM Grant Guidance and built into the Grant Portal, your application must include a detailed Project Implementation Plan that includes Action Steps / Tasks Required related to your proposed one-year scope of work.

Track 3 Maintenance and Advancement Base Grant (no new awards will be given in 2023)

The Track 3 Maintenance and Advancement Base Grant is a three-year grant, intended to enable grantees to make significant progress through the Retail Program Standards. Because of the importance of the work encompassed by Standard 9, incorporating a Public Health Metric 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). Applicants who have not already met Standard 9 are required to include one of the two Public Health Metrics in their proposed projects, and they must be prepared to work on the metric for the full three-year cycle of the awarded grant.

If your jurisdiction has already been awarded a Track 3 M&A Base Grant, the following information is a reminder of the two funding types that have been awarded.

Work on Elements of Standard 9 in Pursuit of a Public Health Metric: Up to $5,000/year/applicant

This Public Health Metric project will begin with a study based on inspectional data derived from an inspection report form that has the IN, OUT, NA and NO convention. Failure to use this convention skews the data toward either IN or OUT of compliance. Jurisdictions that have developed an inspection form using the IN, OUT, NA, and NO convention may use that inspection form as a survey instrument (see Description of Requirement, Standard 9, Program Assessment). In addition, to meet the requirements of Standard 9, the inspectional data must include all the facility types the jurisdiction has regulatory authority over. The four (4) facility categories are:

  1. Health Care
  2. Schools (K-12)
  3. Restaurants
  4. Retail Food Stores

Not every jurisdiction has regulatory authority over all four categories, however, they must include any of the four for which they do have regulatory authority.

The jurisdiction should determine the work that can be accomplished during the three-year timeframe of the grant, only requesting funding for this three-year scope of work; however, it is recommended that the jurisdiction develop a strategy to allow for full completion of a risk factor study cycle which may extend past the grant period.

Three-Year Scope of Work

As a reminder, as part of a Track 3 Maintenance and Advancement Base Grant application, jurisdictions should only apply for funds for the scope of work that will be accomplished during the three-year performance period of a proposed project (i.e., the work for three years of a five-year risk factor study cycle). As outlined in the NEHA-FDA RFFM Grant Guidance and built into the grant program portal, your application must include detailed action steps related to your proposed three-year scope of work.

Work on Elements of Standard 9 in Pursuit of a Public Health Metric: Up to $10,000/year/applicant

This Public Health Metric project allows grantees to participate in the FDA Risk Factor Study, helping to continue to standardize data that is collected across the country. For forms and guidance please reach out to your FDA Retail Food Specialist.

A risk factor study based on the FDA Risk Factor Study model uses data from inspection report forms that use the IN, OUT, NA, and NO convention. In addition, the study will capture any additional collection data that has become part of the FDA Risk Factor Study. The jurisdiction must include all the facility types they have regulatory authority over. The four (4) facility categories are:

  1. Health Care
  2. Schools (K-12)
  3. Restaurants
  4. Retail Food Stores

Not every jurisdiction has regulatory authority over all four categories, however, they must include any of the four categories for which they do have regulatory authority.

An example of a full, five-year risk factor study cycle, appropriate for a Track 3 Maintenance and Advancement Base Grant, can be outlined as follows:

  • Year 1 – Implement the FDA Risk Factor Study to develop a baseline survey;
    • Or - Develop a baseline survey of the five CDC risk factors based on inspectional data;
    • Or - If the jurisdiction's inspection forms do not include IN, OUT, NA, and NO, update inspection forms to include data and begin baseline study.
  • Year 2 – Develop intervention strategies aimed at mitigating the occurrence of out-of-control risk factors and begin implementing;
    • 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 – Continue to add inspectional data to the survey instrument.
  • Year 4 – Continue to add inspectional data to the survey instrument.
  • Year 5 – Statistically measure the outcomes of new information compared on the baseline survey.

Protocols for establishing a risk factor study based on the FDA model can be found on FoodSHIELD and at www.fda.gov/media/98224/download.