When does a food test have to be done by a LAAF-accredited laboratory?

In the circumstances 21 CFR 1.1107 names: to support removal of a food from an import alert through consecutive testing, to support admission of an imported food detained at the border, where an existing FDA regulation requires testing to address an identified or suspected food safety problem, such as certain tests of shell eggs, sprouts and bottled water, and under a directed food laboratory order. For import testing the requirement applies analyte by analyte, six months after the FDA lists the analyte as having sufficient accredited capacity.

Early access How it works

Laboratory Accreditation for Analyses of Foods

The Laboratory Accreditation for Analyses of Foods rule, 21 CFR part 1 subpart R, established a program under which the FDA recognises accreditation bodies that accredit food testing laboratories, and it requires that testing in certain circumstances, mostly around imports, be done by a laboratory accredited under it.

What it is: FSMA final rule
Where it lives: 21 CFR part 1, subpart R
Final rule: December 2021
Docket: FDA-2019-N-3325
Published by: U.S. Food and Drug Administration

Who it covers

Owners and consignees of food who need a test done in one of the circumstances the rule names, accreditation bodies seeking FDA recognition, and laboratories seeking accreditation under the program. A laboratory is free not to seek accreditation; the effect of the rule is on who may be used for the covered tests.

The circumstances are: testing to support removing a food from an import alert through consecutive compliant results; testing to support admission of an imported food detained at the border; testing that existing FDA regulations already require in response to an identified or suspected food safety problem, which the FDA gives as certain tests of shell eggs, sprouts and bottled water; and testing under a directed food laboratory order.

What it requires

The FDA recognises accreditation bodies, which accredit laboratories to the standards the rule sets. Laboratories apply to a recognised accreditation body, not to the FDA. The program is being implemented in steps: for import-related testing, an analyte is added to a public registry once the FDA finds there is enough accredited capacity for it, and the requirement to use an accredited laboratory for that analyte starts six months later. For the other testing circumstances the FDA has not yet made a capacity determination.

In the FDA’s words

“Owners and consignees of imported food subject to the LAAF regulation must use a LAAF-accredited laboratory to conduct covered import-related food testing starting on the applicable compliance date, which is 6 months from the date a specific analyte is listed on a public registry, based on FDA's determination that sufficient laboratory capacity has been achieved for such analyte.”

U.S. Food and Drug Administration, Laboratory Accreditation for Analyses of Foods (LAAF) Program & Final Rule, updated 2026-03-31. Read 2026-09-16.

The compliance date is per analyte and moves with the FDA's registry, so there is no single date to write down for this rule.

Compliance dates

Who	Date
Import-related testing, per analyte	Six months from the date the analyte is listed on the public registry

The FDA publishes the current table of analytes and dates on its LAAF program dashboard, and will publish further Federal Register notices as capacity for the remaining testing circumstances is reached.

The dates are the FDA’s, as stated on Laboratory Accreditation for Analyses of Foods (LAAF) Program & Final Rule, updated 2026-03-31, read 2026-09-16. Compliance dates have been extended before; check that page before planning against any of them.

Where it is in 21 CFR

The rule is codified at 21 CFR part 1, subpart R, General Enforcement Regulations. Title 21 is a work of the United States government and in the public domain, so the regulation is reproduced in full on this site. These are the sections a reader of this page most often needs.

What goes wrong in practice

A rule describes the controls; the FDA’s recall records are what happened where a control was missing. These are the hazards and the kinds of food whose records this rule is most often written against.

Questions

When does a food test have to be done by a LAAF-accredited laboratory?: In the circumstances 21 CFR 1.1107 names: to support removal of a food from an import alert through consecutive testing, to support admission of an imported food detained at the border, where an existing FDA regulation requires testing to address an identified or suspected food safety problem, such as certain tests of shell eggs, sprouts and bottled water, and under a directed food laboratory order. For import testing the requirement applies analyte by analyte, six months after the FDA lists the analyte as having sufficient accredited capacity.

The other FSMA rules

FSMA is enforced as 10 rules, and a single business frequently sits under several. The Act itself, and how the rules fit together.

An inspection under this rule asks for the records behind each requirement, and finding them is the work. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.