Introduction: Food Associated Disease Outbreaks

Food safety in the United States is something that most consumers take for granted. However, there are instances where illness, usually attributed to bacterial infections, can be traced to a contaminated food. The Centers for Disease Control and Prevention (CDC) keeps a list of selected multistate foodborne outbreak infections, by year, going back to 2006.

For example, so far this year, the CDC's list contains six investigations for multistate bacterial illness outbreaks (caused by pathogens such as E.coli O103, Salmonella, and Listeria monocytogens) transmitted by contaminated produce. Because these food-associated infections can result in people becoming sick or dying, it is important to be able identify the origin of any foodborne illness and to remove the offending food from grocery store shelves as quickly as possible.

The FDA's Announcement

With this as background, the U.S. Food and Drug Administration (FDA) recently issued an announcement, a food traceability list, and a proposed new rule. In its announcement, the agency characterizes the proposed new rule as laying "the foundation for the end-to-end food traceability across the food industry … over the next decade." The FDA defines traceability as the "ability to track a food at every step of the supply chain." The agency notes the proposed rule would "create a first-of-its-kind standardized approach to traceability recordkeeping."

As the announcement notes, the proposed end-to-end food traceability:

has the potential to help [the FDA] pinpoint the exact sources of foods involved in outbreaks. Not only does this help us [the FDA] to remove potentially unsafe products from the market more quickly, preventing additional illness or death, but it also helps [the FDA] to conduct root cause investigations to figure out what went wrong leading to the outbreak.

So which foods would the proposed rule apply to? What are some key provisions of the proposed rule? What is the implementation schedule? How much of a recordkeeping burden would be imposed? Are there exemptions? And what about submitting comments? We address these questions, and others, below.

Food Traceability List

The proposed food traceability list contains more than 15 categories of foods ranging from vegetables (herbs; leafy greens; peppers; sprouts; cucumbers; all types of fresh-cut vegetables; and ready-to-eat salads), to nut butters, to fruits (all fresh cut fruits; tropical tree fruits such as mangos; melons; and tomatoes), to cheeses other than hard cheeses, eggs of the domesticated chicken, to crustaceans, mollusks (e.g., oysters and claims), and to finfish. These are foods the FDA, based on historical data, considers to be "high risk."

The agency notes that when it issues a final Food Traceability Rule, it will also issue a final Food Traceability List. Importantly, the agency notes that the proposed rule's "additional record keeping requirements would apply not only to foods listed on the Food Traceability List, but also to foods that contain foods on the list as ingredients."

FDA's Proposed Rule: Key Data Elements and Critical Tracking Events

The FDA notes that at the core of its proposed rule "is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs)." The CTEs for which records containing KDEs would be required include: growing, receiving, transforming, creating, and shipping.

Growing

The proposed rule notes that growing is generally the "first step in the food supply chain." The rule also notes, in addition to general KDE for growing, "sprout growers would be required to establish and maintain additional growing KDEs that are specific to sprouts."

Receiving

Receiving is "an event in a food's supply chain in which the food is received by a customer (other than a consumer) at a defined location after being transported … from another defined location." In essence, any receiving CTE necessarily contains a food transfer. The proposed rule notes that in addition to the general KDEs, first receivers would "need to establish and maintain additional KDEs."

Creating

Creating is defined as the "making or producing of a food on the Food Traceability List (e.g., through manufacturing or processing) using only ingredient(s) that are not on the Food Traceability List." Understanding the definition of creating can be aided by an example.

Remember that nut butters are included in the Food Traceability List. Peanut butter is a nut butter. Peanut butter is not found in nature. Rather, peanut butter is created from peanuts, and additional ingredients such as salt, sweeteners, and emulsifiers. Thus, peanut butter (a nut butter) is created.

Transforming

Transformation involves "changing a food on the Food Traceability List, its package, or its label." Transforming can be effected, for example, by cooking, commingling, repacking, or repackaging. Again, an example may be helpful. As described above, peanut butter is a created food. If the peanut butter is placed between two crackers to form a peanut butter sandwich cracker, this act transforms peanut butter.

Shipping

Shipping is "an event in a food's supply chain in which a food is arranged for transport (e.g., by truck or ship) from a defined location to another defined location …"

Recordkeeping

The "records required at each CTE would need to contain and link the traceability lot code of the food to the relevant KDE." Further, in addition to requiring records of KDE's, the proposed rule also requires establishment and maintaining of traceability program records. These include: A description of the relevant reference records; a list of foods on the Food Traceability List that are shipped; a description of how traceability lot codes are assigned; and other information needed to understand data provided within the required records.

Additionally, the proposed rule would require that records be maintained as original paper records, electronic records, or true copies; that the records be legible; and that the records be stored to prevent deterioration or loss. Further, traceability records must be provided to the FDA within 24 hours of being requested by the agency; and an electronic sortable spreadsheet containing relevant traceability information be provided to the FDA within 24 hours of a request when necessary to assist FDA during an outbreak, recall, or other threat to public health.

Exemptions to the Proposed Rule

The proposed rule exempts different parties including: farms having no more than $25,000 in average annual produce sales; shell egg producers with fewer than 3,000 laying hens at a particular farm; as well as food grown on farms to the extent that the food is sold directly to consumers through, e.g., farmer's markets and roadside stands. Beyond these examples, there are further exemptions contemplated in the proposed rule.

Implementation

The FDA proposes that any final rule on additional traceability recordkeeping requirements for foods on the Food Traceability List would become effective 60 days after publication of the final rule in the Federal Register. Also, the agency believes that "all person[s] subject to the rule should come into compliance by the same date." Further, the FDA proposes a compliance date for all persons subject to recordkeeping requirements under the final rule of "two years after the effective date of the final regulation."

Conclusion, Analysis, and Comments Period Information

The proposed rule would, if enacted, impose significant recordkeeping requirement burdens on food: manufacturers, processors, packers, and holders relating to foods on the Food Traceability List, and foods which contain one or more of these foods. The proposed rule would also create significant record organizational safeguarding and production burdens.

Further, while the rule only applies to certain parties and certain foods on the Food Traceability List, or foods containing a food on this list, the reach of the proposed rule may end up being broader. The agency notes, for example, that the proposed rule requirements "were designed to be suitable for all FDA-regulated food products" and that the agency "would encourage the voluntary adoption of these practices industry wide." Thus, the rule may, over time, expand to encompass other foods and their manufacturers, processors, packers, and holders.

Interested parties are therefore encouraged to submit comments on the proposed rule to the FDA. The period for submitting comments ends January 21, 2021.

For questions relating to the proposed rule, the Food Traceability List, help preparing and submitting comments to the FDA, or any FDA related question, please contact any member of Wilson Sonsini's FDA Regulatory, Healthcare, and Consumer Products practice.