United States: New traceability requirements for high-risk foods

  • Legal update

    22 October 2025

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New United States food traceability rules are set to impact New Zealand exporters. If you handle high-risk foods destined for the United States market, new recordkeeping obligations under the Food and Drug Administration’s (FDA) Food Traceability Final Rule may apply to your operations.

This alert summarises the key changes, offers practical recommendations for New Zealand exporters, and provides links to further information.

Who needs to read this and why?

New Zealand food exporters and shippers to the United States, especially those handling high-risk foods like fresh produce, seafood, dairy, and nut butters. 

Background

The United States Food Safety Modernisation Act (FSMA), first signed into law in 2011, aims to prevent foodborne illnesses in the United States food supply chain. 

One of its key components, the Food Traceability Final Rule, introduces enhanced recordkeeping obligations for entities handling high-risk foods listed on the Food and Drug Administration’s (FDA) Food Traceability List (FTL). The Food Traceability List includes products frequently linked to outbreaks due to perishability or processing methods. 

The rule applies to both domestic and foreign businesses, including New Zealand exporters. It mandates extensive record keeping and is designed to help the FDA quickly identify and remove contaminated food from the market. 

Key dates
  • Original introduction date: 20 January 2026
  • Proposed extension: 20 July 2028
  • Deadline for extension comments: 8 September 2025

As of the latest updates available, the FDA has not officially confirmed whether the compliance date will be extended to 2028. We recommend monitoring FDA updates closely for confirmation.

Who must comply?

The rule applies to all entities that manufacture, process, pack, or hold foods on the FTL, including New Zealand businesses exporting to the United States. The FTL covers products frequently linked to outbreaks, such as:

  • Dairy products: Eggs, cheese 
  • Fresh produce: Cucumbers, herbs, leafy greens, fruits
  • Refrigerated deli salads 
  • Seafood: Finfish, crustaceans, molluscan shellfish and bivalves (fresh, frozen, and previously frozen)
  • Nut butters
What will be required?

Businesses subject to the Food Traceability Final Rule must record key data elements (KDEs) at critical tracking events (CTEs). CTEs include:

  • Harvesting
  • Cooling
  • Initial packing
  • First land-based receiving
  • Shipping
  • Receiving
  • Transformation (including packaging, repacking, relabelling, processing)

KDEs may include product origin, production date, quantity, and traceability lot codes (TLCs). 

Records must be maintained in either original paper or electronic format. The records must be retained for at least two years and made available to the FDA within 24 hours upon request.

Exemptions may apply – see FDA guidance for more details.

How to prepare

New Zealand food producers should:

  • Identify which products are on the FTL and which parts of your operations are subject to the rule (e.g. harvesting, packing, shipping, transformation). 
  • Develop a traceability plan including procedures for assigning TLCs, maintaining records, identifying FTL foods, and responding to FDA requests.
  • Coordinate with United States partners to ensure data sharing and compliance.
Need help?

Our international trade and regulatory team can assist with interpreting the rule, assessing its impact, and preparing traceability plans or compliance strategies.