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The FDA Food Safety Modernization Act (FSMA) section 204 (21 U.S. Code § 2223), requires the Food and Drug Administration to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
The FDA developed a Risk-Ranking Model for Food Tracing (RRM-FT) as a data-driven science-based decision support tool to assist the Agency in the process of designating a Food Traceability List (FTL) as required by FSMA Section 204.
This website is designed for users to view the RRM-FT results as well as the risk-ranking methodology. Users can navigate the RRM-FT website through the following tabs:
The methods document “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S. Code § 2223))” is downloadable here:
The full list of references evaluated and used to obtain data for the scoring of the seven criteria for commodity-hazard pairs in the RRM-FT is downloadable here:
The results for the food commodities on the FTL can be downloaded at the Commodity level for FTL foods or at the Commodity-Hazard pair level for FTL foods . The results for all food commodities and the associated commodity-hazard pairs can be downloaded here.
Last update: April 2023.
The RRM-FT is a semi-quantitative risk-ranking model that scores commodity-hazard pairs according to data and seven criteria. Click on a Criterion to obtain a highlight of the scoring definition, the data sources and an example.
These criteria are consistent with the requirements in section 204(d)(2)(A) (21 U.S. Code § 2223(d)(2)(A)).
The methods document “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S. Code § 2223))” is downloadable here.
The full list of references evaluated and used to obtain data for the scoring of the seven criteria for commodity-hazard pairs in the RRM-FT is downloadable here.
To calculate a risk score for a commodity (fictitious example: “Commodity A”), we first obtain the risk score(s) for the commodity-hazard pair(s) (e.g. “Commodity A - Hazard 1”, “Commodity A - Hazard 2”, “Commodity A - Hazard 3”, etc.) and then aggregate the commodity-hazard pair risk score(s) into a commodity risk score.
A risk score for a commodity-hazard pair is calculated by summing weighted criteria scores across all seven criteria. Equal weighting (criteria weight = 10) was used for each criterion (see § 5.4 of the method document). For example, say that the pair “Commodity A - Hazard 1” has criterion scores as follows:
Commodity | Hazard | Criterion 1: Frequency of outbreaks and occurrence of illnesses | Criterion 2: Severity of illness | Criterion 3: Likelihood of contamination | Criterion 4: Growth potential, with consideration of shelf life | Criterion 5: Manufacturing process contamination probability and industry-wide intervention | Criterion 6: Consumption | Criterion 7: Cost of illness |
---|---|---|---|---|---|---|---|---|
Commodity A | Hazard 1 | 9 | 9 | 1 | 3 | 3 | 9 | 9 |
The Risk Score for “Commodity A - Hazard 1” is then:
Commodity-Hazard Pair Risk Score = (10 × 9) + (10 × 9) + (10 × 1) + (10 × 3) + (10 × 3) + (10 × 9) + (10 × 9) = 430
For a commodity associated with multiple hazards, i.e., multiple commodity-hazard pairs are identified, a Commodity Risk Score is calculated through an aggregation method according to the following formula:
$$RS_i\_C=10\times\log_{10}(\sum_{j=1}^{n_i}10^{RS_{i,j}/10})$$
where,
RSi_C is the aggregated risk score associated with commodity i;
RSi,j is the risk score for commodity i and the jth hazard;
ni is the number of hazards associated with commodity i.
(The division of the individual risk scores by 10 is for computational reasons. To return to the original scale, the result is then multiplied by 10.)
For example, say that the commodity “Commodity A” is associated with the following commodity-hazard pairs:
Commodity | Hazard | Criterion 1: Frequency of outbreaks and occurrence of illnesses | Criterion 2: Severity of illness | Criterion 3: Likelihood of contamination | Criterion 4: Growth potential, with consideration of shelf life | Criterion 5: Manufacturing process contamination probability and industry-wide intervention | Criterion 6: Consumption | Criterion 7: Cost of illness | Commodity-Hazard Pair Risk Score |
---|---|---|---|---|---|---|---|---|---|
Commodity A | Hazard 1 | 9 | 9 | 1 | 3 | 3 | 9 | 9 | 430 |
Commodity A | Hazard 2 | 1 | 9 | 3 | 9 | 3 | 9 | 1 | 350 |
Commodity A | Hazard 3 | 0 | 9 | 3 | 9 | 3 | 9 | 0 | 330 |
Commodity A | Hazard 4 | 0 | 9 | 1 | 0 | 1 | 9 | 0 | 200 |
The Commodity Risk Score is then:
Commodity Risk Score = 10 × [log10 (1043+1035+1033+1020)] = 430.
The Commodity Risk Score is driven by the risk score for the highest-ranking commodity-hazard pair.
Click on a row to open a sub-table that shows the commodity-hazard pairs evaluated in that commodity including their model criteria scores. Users can search for a commodity category or commodity of interest by typing the name in the search box. Users can visualize the results in alphabetical order by commodity category and by commodity, and in numerical order by commodity risk score by clicking the corresponding column name.
The results for the food commodities on the Food Traceability List can be downloaded at the Commodity level for FTL foods or at the Commodity-Hazard pair level for FTL foods.
a Abbreviations: RAC: Raw Agricultural Commodity; RTE: Ready-to-Eat.
b Abbreviations: STEC: Shiga-toxin producing E. coli.
For food commodities on the Food Traceability List, click on a bar to obtain a graph showing the corresponding commodity-hazard pairs.
Click on a row to open a sub-table that shows the commodity-hazard pairs evaluated in that commodity including their model criteria scores. Users can search for a commodity category or commodity of interest by typing the name in the search box. Users can visualize the results in alphabetical order by commodity category and by commodity, and in numerical order by commodity risk score by clicking the corresponding column name.
The results for all food commodities and the associated commodity-hazard pairs can be downloaded here.
Note: Commodities noted with an asterisk “
a Abbreviations: LACF: Low-Acid Canned Food; N.E.C: Not Elsewhere Classified; RAC: Raw Agricultural Commodity; RTE: Ready-to-Eat.
b Abbreviations: Afl DON Fum OTA: Aflatoxins, Deoxynivalenol, Fumonisins, and Ochratoxin A; STEC: Shiga-toxin producing E. coli; PSP: Paralytic shellfish poisoning; ETEC: Enterotoxigenic E. coli.