FSMA Proposed Rule for Food Traceability

Section 204 of the FDA Food Safety Modernization Act (FSMA) requires the FDA to designate foods for which additional recordkeeping requirements are appropriate and necessary to protect public health, and to establish those recordkeeping requirements. The additional recordkeeping requirements that the FDA proposes to establish are outlined in the Requirements for Additional Traceability Records for Certain Foods (Food Traceability) proposed rule and are intended to make it easier to rapidly and effectively track the movement of a food to prevent or mitigate a foodborne illness outbreak.

The Food Traceability List (FTL) identifies the foods for which the additional traceability records described in the proposed rule would be required. As noted in the proposed rule, the additional recordkeeping requirements would apply not only to foods specifically listed on the FTL, but also to foods that contain foods on the list as ingredients.

To determine which foods should be included on the FTL, the FDA developed a risk-ranking model for food tracing (“the Model”) based on the factors that Congress identified in Section 204 of FSMA. The Model scores commodity-hazard pairs (e.g., Shiga toxin-producing E.coli O157 (E.coli O157) in Leafy Greens) according to data and information relevant to seven criteria described in the report Methodological Approach to developing a Risk-Ranking Model for Food Tracing FSMA Section 204:

  • Frequency of outbreaks and occurrences of illnesses
  • Severity of illnesses
  • Likelihood of contamination
  • The potential for pathogen growth, with consideration of shelf life
  • Manufacturing process contamination probability and industry-wide intervention
  • Consumption rate and amount consumed
  • Cost of illness

The Model was designed to be flexible and to consider a wide range of contaminants in FDA-regulated human foods. To identify commodities for the Food Traceability List, the commodities and associated commodity-hazard pairs produced by the Model were ranked. Commodities with associated commodity-hazard pairs with criteria scores in the moderate to strong range were considered for inclusion on the List.

For additional information, see Designation of the Food Traceability List Using the Risk-Ranking Model for Food Tracing Memo.

Development of the Food Traceability List

In February 2014 the FDA issued a Federal Register notice to solicit comments on our draft approach for developing a list of high risk foods. Taking into consideration the comments and other information submitted, we developed a draft risk-ranking model and collected data to populate the model for chemical and microbiological hazards associated with specific foods, with technical assistance from external expert panels. Two separate peer-review panels of independent external experts reviewed the draft model and the types of data used to generate risk scores with the model, respectively. We then refined the model and updated the data, taking into consideration comments from the peer reviews.

The Model was developed in conjunction with an FDA Project Advisory Group (PAG) consisting of members from the FDA and the Centers for Disease Control and Prevention. Through contracts the FDA also consulted with external subject matter experts.

Based on data in the Model, we tentatively identified foods for inclusion on the FTL. The list was announced with the Food Traceability Proposed Rule. When the FDA issues a final rule, we will also publish the FTL.  

The proposed rule sets forth a process for the FDA to update the FTL if the agency concludes that updates are appropriate. That process would involve the FDA publishing a notice in the Federal Register stating any proposed changes to the list and the reasons for the changes and requesting information and views on the proposal. After considering any information or views submitted, the FDA would publish a second notice in the Federal Register, stating whether any changes are being made, and the reason for the decision. Any additions to the list would become effective one year after the date of the second Federal Register notice, unless otherwise stated.

Proposed Food Traceability List

Foods Description
Cheeses, other than hard cheeses Includes all soft ripened or semi-soft cheeses, and fresh soft cheeses that are made with pasteurized or unpasteurized milk
Shell eggs Shell egg means the egg of the domesticated chicken
Nut butter Includes all types of tree nut and peanut butters; does not include soy or seed butters
Cucumbers Includes all varieties of cucumbers
Herbs (fresh) Includes all types of herbs, such as parsley, cilantro, basil
Leafy greens, including fresh-cut leafy greens Includes all types of leafy greens, such as lettuce, (e.g., iceberg, leaf and Romaine lettuces), kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, collards, and endive
Melons Includes all types of melons, such as cantaloupe, honeydew, and watermelon
Peppers Includes all varieties of peppers
Sprouts Includes all varieties of sprouts
Tomatoes Includes all varieties of tomatoes
Tropical tree fruits Includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, and starfruit
Fruits and Vegetables (fresh-cut) Includes all types of fresh-cut fruits and vegetables
Finfish, including smoked finfish Includes all finfish species, such as cod, haddock, Alaska pollack, tuna, mahi mahi, mackerel, grouper, barracuda, and salmon; except does not include siluriformes fish, such as catfish [1]
Crustaceans Includes all crustacean species, such as shrimp, crab, lobster, and crayfish
Mollusks, bivalves Includes all species of bivalve mollusks, such as oysters, clams, and mussels; does not include scallop adductor muscle.
Ready-to-eat deli salads Includes all types of ready-to-eat deli salads, such as egg salad, potato salad, pasta salad, and seafood salad; does not include meat salads

[1] Data for catfish were excluded from the Risk-Ranking Model because siluriformes fish (such as catfish) are primarily regulated by the U.S. Department of Agriculture.

Additional Information