FDA Publishes Materials Clarifying Food Traceability Proposed Rule

In September 2020, FDA released its Food Traceability Proposed Rule, which would impose additional traceability recordkeeping requirements on persons who manufacture, process, pack, or hold foods on FDA’s newly-created Food Traceability List (FTL). FDA has since held three public meetings on the proposed rule, during which stakeholders have raised various questions and concerns about the proposed rule’s requirements. Yesterday, FDA issued two updates that address some of these questions and concerns.

Clarifying Updates to the FTL

First, FDA made three clarifying updates to the FTL:

1. FDA clarified which cheeses qualify as “cheeses, other than hard cheeses” for purposes of the FTL. FDA specified that this category includes “soft ripened/semi-soft cheeses” such as brie, camembert, feta, mozzarella, taleggio, blue, brick, fontina, monterey jack, and muenster, and “soft unripened/fresh soft cheeses” such as cottage, chevre/goat, cream, mascarpone, ricotta, queso blanco, queso fresco, queso de crema, and queso de puna. FDA also specified that “hard cheeses” are cheeses with less than 39 percent moisture, such as cheddar, Romano, and parmesan.
2. FDA added the qualifier “(fresh)” to the following FTL items: cucumbers, leafy greens, melons, peppers, sprouts, tomatoes, and tropical tree fruits.

3. FDA eliminated “collards” from the description of “leafy greens.” This was based on FDA’s recognition that collards are listed as “rarely consumed raw” in FDA’s produce safety regulation, and would thus be exempt from the food traceability proposed rule under the proposed rule’s exemption for “produce that is rarely consumed raw.”

These updates address some, but not all, of the questions stakeholders have raised about the FTL. For example, the precise scope of some items on the FTL—such as “tropical tree fruits”—remains unclear. It also remains concerning that the FTL encompasses multiple foods that have not been historically associated with foodborne illness outbreaks, such as cottage cheese and cream cheese

FAQs on the Proposed Rule

Second, FDA issued a set of FAQs that address various questions stakeholders have raised about the proposed rule. These include questions regarding the composition of the FTL, the traceability lot code requirement, the first receiver requirement, and the specific requirements for farms, retail food establishments, and persons who originate, grow, transform, and/or create listed foods. Some of the key issues addressed by these FAQs include the following:

• FDA states that persons who “create” foods on the FTL (i.e., persons who make or produce a listed food using only ingredients that are not on the FTL) are not required to maintain traceability records for the ingredients used to create the listed food since, by definition, those ingredients are not listed foods.
• FDA confirms that restaurants qualify as “retail food establishments” for purposes of the proposed rule. As such, many restaurants will likely be subject to at least some of the rule’s requirements.
• FDA clarifies which entities in the supply chain may qualify as “first receivers.” For example, FDA notes that brokers who purchase a listed food but never take physical possession the food would not qualify as first receivers, since a “first receiver” must purchase and take physical possession of a food. Similarly, third-party coolers who take possession of a listed food without purchasing it would not qualify as “first receivers.”
• FDA clarifies that while the proposed rule generally only permits firms that originate, transform, or create foods to assign “traceability lot codes” to listed foods, other firms may assign their own, separate lot codes to such foods. When doing so, however, firms must link all “key data elements” required by the proposed rule to the listed food’s traceability lot code.

• FDA also answers multiple questions regarding the methodology behind its Preliminary Regulatory Impact Analysis.

What can you do?

FDA recently issued a 60-day extension of the comment period for the proposed rule. Interested stakeholders now have until February 22, 2021 to submit written comments on the proposed rule.

If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Beverage, and Dietary Supplements practice.