Registry insights

October 9, 2026

FDA Offers Enforcement Discretion on Food Traceability Records: What Changes and What Does Not

Published: October 9, 2026 | Comments close: November 23, 2026

US food business manager and compliance colleague reviewing traceability records and shipping paperwork in a naturally lit warehouse office

October 9, 2026

FDA has announced draft enforcement discretion for certain retail food establishments and restaurants under the Food Traceability Rule. Enforcement discretion is not an exemption. It does not repeal, waive, or withdraw the rule. The underlying regulatory requirements remain in place. The practical effect is a change in current enforcement posture for a defined group of entities. Businesses should document the calculation, the applicable status, and the evidence supporting the decision.

This article provides general compliance information, not legal advice.

What FDA Announced

FDA announced the draft guidance on October 8, 2026. The Federal Register published the notification of availability on October 9, 2026.

The draft guidance is titled Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants. It is associated with Docket No. FDA-2025-D-6952, Document No. 2026-20721, and citation 91 FR 64629.

FDA states that it does not intend to enforce certain regulatory requirements for specified entities based on its current understanding of the risk. The draft guidance applies to all requirements in the Food Traceability Rule for qualifying retail food establishments and restaurants within the stated monetary band.

The policy is not final. When finalized, the guidance will represent FDA’s current thinking. It will not bind FDA or the public. An alternate approach may be used if it satisfies the applicable statutes and regulations.

The Food Traceability Rule was published as a final rule on November 21, 2022. It appears in 21 CFR Part 1, Subpart S. The draft guidance addresses a gap between the existing small-business exemption and larger operations.

The central operational result is clear. Enforcement pressure changes for a defined group. The need for accurate classification, compliance evidence, and defensible records does not disappear.

Who the Draft Policy Covers and Who It Does Not

The draft policy covers:

Retail food establishments.
Restaurants.
Entities with an average annual monetary value of food sold or provided during the previous three-year period greater than $250,000.
Entities with an average annual monetary value of food sold or provided during that period no more than $1,000,000.
Calculations made on a rolling basis.
Monetary thresholds adjusted for inflation using 2020 as the baseline year.

The existing rule already provides a full exemption for small retail food establishments and restaurants at or below $250,000 in average annual food sales or food provided during the previous three-year period. That calculation also uses a rolling basis and an inflation adjustment based on 2020.

The draft guidance addresses entities above that existing exemption threshold and up to the proposed $1,000,000 band.

The draft policy does not establish a general relief category for every food business. It is directed to qualifying retail food establishments and restaurants. An entity outside the stated category should not treat the draft policy as a basis for noncompliance.

The classification must be supported by source data. A business should identify the entity covered by the calculation, define the three-year period used, preserve the underlying records, and assign ownership for the determination.

Labeled produce crates and lot tags being checked by workers on a US commercial loading dock

Enforcement Discretion Is Not an Exemption

An exemption is part of the regulatory structure. It identifies circumstances in which a requirement does not apply under the rule.

Enforcement discretion is an agency position about whether and how the agency intends to enforce an applicable requirement. The requirement remains in the rule. The agency’s position can be revised, finalized differently, or replaced.

This distinction affects compliance registration and record design.

A business that qualifies for an exemption should retain evidence showing why the exemption applies. A business relying on the draft enforcement policy should retain evidence showing why the current enforcement position is relevant. The two decisions should not be labeled or stored as the same control.

A defensible record should identify:

The applicable rule or guidance.
The entity classification.
The monetary calculation.
The period used for the calculation.
The inflation adjustment applied.
The date of the determination.
The responsible owner.
The scheduled review date.
The decision reached.

The policy does not convert an enforcement position into a permanent legal status. The record should therefore show the basis for the position and the condition that would trigger a new review.

This approach also supports broader compliance evidence controls. The same discipline used for notice record retention, regulatory notice requirements, and a notice of compliance should be applied to the food traceability determination. The record should show what was reviewed, who approved the conclusion, and when the conclusion must be tested again.

The Threshold You Have to Test Every Year

The relevant test uses a rolling three-year period. It is not a one-time business-size determination.

The base monetary bands are:

At or below $250,000. The Food Traceability Rule contains a full exemption for qualifying small retail food establishments and restaurants.
Greater than $250,000 and no more than $1,000,000. FDA intends to exercise enforcement discretion for all requirements in the Food Traceability Rule under the draft policy.
Outside the stated band. The draft policy does not provide the same enforcement position.

Both thresholds are adjusted for inflation using 2020 as the baseline year. The calculation must therefore use the applicable adjusted values rather than treating the unadjusted figures as permanently fixed.

A yearly review should use the most recent available rolling three-year period. It should preserve:

The dates covered by the three-year period.
The monetary source data.
The calculation method.
The applicable inflation adjustment.
The resulting classification.
The decision and approval date.
The next scheduled review date.

The annual retest protects against relying on an outdated classification. A change in the rolling period or the underlying monetary value can change the position. Threshold documentation should remain available with the organization’s compliance records.

Clean exterior of a US federal building in a civic district under natural daylight

What the Record Should Show Either Way

For entities inside the enforcement-discretion band, the record should show the calculation supporting the position. It should also identify the dates of the three-year period, the source data, the owner, and the review cadence.

The file should include a documented decision stating that the entity falls within the described category and that the current FDA draft policy was reviewed. The record should state that the position is based on enforcement discretion rather than an exemption.

For entities outside the enforcement-discretion band, the record should identify the traceability records required by the Food Traceability Rule. The organization should maintain evidence that the applicable records were identified, assigned, and retained.

A structured evidence file should use access controls and version history. It should preserve the source used for the calculation and the approval record for the conclusion. A controlled compliance registration process can help assign accountability across locations, entities, and responsible managers. Available compliance registration support is described on the services page.

The evidence file should not rely on a short statement such as “FDA discretion applies.” That statement does not establish the monetary calculation, the covered entity, or the review date.

A related audit trail framework for legal notices and compliance evidence provides a useful record-control model. The subject matter differs, but the control principles remain applicable. Evidence should be complete, attributable, dated, and retrievable.

The Comment and Meeting Dates to Add to the Register

The draft guidance has a comment deadline of November 23, 2026. Comments submitted by that date can be considered before FDA begins work on the final version of the guidance.

FDA will also hold a public meeting on November 6, 2026 concerning challenges and solutions in lot-level food traceability.

The meeting is connected to a congressional directive under the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, P.L. 119-37.

Important meeting dates include:

October 26, 2026. Deadline for individuals who want to speak during the public comment period.
November 5, 2026. General registration deadline.
November 6, 2026. Public meeting.
November 23, 2026. Deadline for comments on the draft guidance.

These dates should be entered into the organization’s compliance register with an assigned owner and status field. A calendar entry alone does not create sufficient compliance evidence. The register should also retain the source notice, submission status, and any internal decision connected to the event.

Frequently Asked Questions

Does the FDA announcement eliminate the Food Traceability Rule?

No. The Food Traceability Rule remains in 21 CFR Part 1, Subpart S. The draft guidance describes current enforcement discretion for qualifying entities.

Is enforcement discretion the same as an exemption?

No. The rule contains a full exemption for qualifying entities at or below the applicable $250,000 threshold. The draft policy addresses entities above that level and up to $1,000,000 through an enforcement position. Enforcement discretion is not an exemption.

Which businesses are covered by the draft policy?

The draft policy covers retail food establishments and restaurants with an average annual monetary value of food sold or provided during the previous three-year period greater than $250,000 but no more than $1,000,000, calculated on a rolling basis and adjusted for inflation using 2020 as the baseline.

Does the business need to retain the threshold calculation?

Yes. The calculation supports the organization’s position. It should include the three-year period, source data, inflation adjustment, responsible owner, decision, and review cadence.

When should the threshold be reviewed?

The threshold should be re-tested annually using the applicable rolling three-year period. The review should also account for changes to the FDA guidance or the underlying rule.

Next Step

Establish a controlled review sequence:

Identify each retail food establishment or restaurant covered by the analysis.
Define the applicable rolling three-year period.
Gather and preserve the source data.
Apply the inflation adjustment using 2020 as the baseline year.
Classify the entity under the exemption, enforcement-discretion band, or neither.
Document the decision and responsible owner.
Calendar the annual review and the FDA comment and meeting dates.
Update the record when the agency position or business facts change.

The notice record retention guide provides additional guidance on preserving dated, attributable, and retrievable evidence. Organizations requiring structured support for compliance registration and evidence controls can use the contact page.