FSMA Section 204: Traceability and Tracking in the Food Industry

Using Digitalization to Track and Trace Foods in the Food Value Chain

In response to the FDA’s New Food Traceability Rule, digitalization and traceability will play a crucial role in increasing the effectiveness of identifying and recalling foods.

FSMA Section 204 – Accelerating food industry shifts

In response to the growing food safety challenges occurring within the food system, the Obama administration signed into law the Food Safety Modernization Act (FSMA) in 2011.1 On November 15, 2022, the Food and Drug Administration (FDA) published the highly anticipated and long-awaited finalized Food Traceability Rule, implementing Section 204 of FSMA (FSMA Section 204).2

A component of the FDA’s “New Era of Smarter Food Safety” blueprint, the rule encourages more investment in digital technology and traceability.3 By creating a “digital twin” of their supply chain, combining traceability and digitalization, companies can play a crucial role in increasing the effectiveness of recalls through the swift identification and removal of contaminated foods from the market.

FSMA Section 204 requires the FDA to:

  1. Establish and publish a Food Traceability List (FTL) identifying high-risk foods to human health. 
  2. Set additional traceability recordkeeping requirements for “persons” who manufacture, process, pack, or hold foods on the FTL.4
Food Safety Modernization Act Section 204: Leveraging compliance to unlock value

Common questions

Challenges for companies in the food value chain

When complying with the FDA’s Food Traceability Rule, companies may face four types of challenges across the following areas: data, processes, stakeholders, and technology.

How to get started

To understand the impact from the FDA’s Food Traceability Rule, companies should consider taking four deliberate steps toward compliance:

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1. Data readiness:

Unlocking value with traceability should start with a systemwide focus on standardization, digitization, and unique identification. Since data becomes less reliable and more expensive to maintain the further it moves from its source, standardization practices should begin in the first mile. Consider:

  • Do you currently use standards or frameworks to manage your supply chain data?
  • Do you understand the source of existing data and where it is stored? Is it in a central repository or scattered across multiple source systems?
  • Which KDEs are not captured to date? How will you begin capturing this data?

2. Processes readiness:

The physical-to-digital link established by the unique lot code should be maintained for each product as it moves through the value chain. Companies should assess current processes to identify areas where traceability may be compromised. Consider:

  • Do you currently capture lot codes for food products?
  • Where is the traceability of products lost within physical processes (e.g., transformation)?
  • Where are the gaps within your existing physical-to-digital link? Maintaining labeling at the most granular product level of handling (e.g., case, item) is a helpful tool for maintaining traceability in many instances.

3. Stakeholder readiness:

Compliance with the FDA’s Food Traceability Rule requires widespread effort and coordination across a company’s supply chain. Mechanisms to share traceability data may likely need to be agreed upon between supply chain partners to promote the digitalization of traceability data. Consider:

  • How will you promote supplier and customer compliance with traceability requirements?
  • How will you manage exempt suppliers?
  • How will you send traceability data to customers?

4. Technology readiness:

The FDA’s Food Traceability Rule does not stipulate the use of any particular digital technologies.10 However, the sheer volume of data required to maintain the needed granular level of traceability will be challenging to manage without digital records. While implementing digital systems to achieve lot-level traceability might seem costly, improving current recall processes can have a significant upside. Consider:

  • Which supply chain technologies require changes or enhancements to support data capture?
  • How will you account for the growing volume of traceability data required to be retained?
  • Will you manage the traceability data yourself or outsource to third parties?

Using the cost to comply to unlock additional value across the supply chain

While the FDA’s Food Traceability Rule primarily focuses on preventing illness from foodborne pathogens to facilitate proactive food safety recalls, establishing traceability is an essential step to digitizing the food system and addressing growing concerns around environmental impact and supply chain logistics. Through the Food Traceability Rule, and the digitization of the food system, companies can be better positioned to unlock additional value in three specific areas:

The time for action is now

Consumers demand more transparency about the safety, quality, and sustainability of the food they eat. One survey found 71% of consumers feel traceability is important and may likely even pay a premium for traceable products.11 Food companies have responded by proactively offering more information and making claims on their labels and packaging. Still, in the absence of adequate traceability, the industry has been unable to demonstrate real progress, leading consumers to question the authenticity of these claims. While not all misleading claims are intentional, they equally contribute to the continued deterioration of public trust in the food system.

The creation of a digital twin of the supply chain, combining traceability and digitalization, is an effective strategy that can expose and help correct the imbalances perpetuated by pervasive gaps in information, if implemented correctly. A lack of preparation may expose companies to significant risks, including noncompliance, loss of consumer trust, and limited supply chain visibility that hinders product quality and safety.

1. Food and Drug Administration (FDA), “Full text of the Food Safety Modernization Act (FSMA),” Pub. L. No. 353, 111th Cong., 2017.
2. FDA and Department of Health and Human Services (HHS), “Requirements for Additional Traceability Records for Certain Foods,” 21 C.F.R. Part 1, 2022.   
3. FDA, “New era of smarter food safety: FDA’s blueprint for the future,” July 2020.
4. FDA and HHS, “Requirements for Additional Traceability Records for Certain Foods.”
5. Ibid.
6. Ibid. 
7. Ibid. 
8. Ibid.
9. Ibid. 
10. Ibid.
11. International Food Information Council, 2022 Food and Health Survey, May 18, 2021.

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