What the completed inspection establishes
ARE Labs completed an on-site U.S. EPA FIFRA Good Laboratory Practice facility inspection and selected-study audit on August 25–26, 2026 under 40 CFR Part 160. As of September 2, 2026, the final written EPA report is pending. The completed event therefore establishes that EPA inspectors conducted the on-site review; it does not establish the conclusions that the Agency may state in its report.1
- GLP inspection and data audit
- EPA describes these as compliance-monitoring work focused on GLP compliance and the quality and integrity of test data submitted by a registrant. For a completed study, the data-audit component examines raw data and other study records and compares them with results in the final report submitted to the Agency.3
Part 160 requires a testing facility to permit authorized EPA or FDA representatives to inspect the facility and inspect or copy required records and specimens for covered studies. From a sponsor's perspective, an on-site inspection is evidence that the laboratory's written systems and retained study materials were available for regulatory examination, not merely described in a proposal or quality questionnaire.2
The systems an EPA GLP review puts in view
The regulation connects organizational responsibility, equipment control, written procedures, protocol execution, source records, quality assurance, reporting, and retention. EPA's GLP inspection manual turns those provisions into facility-review and study-audit questions. The regulation remains controlling; the manual is inspector guidance and notes that newer EPA procedures can supersede it.2,4
| Control area | What Part 160 requires | Why it matters to a sponsor |
|---|---|---|
| Data integrity | Original observations and activities needed to reconstruct and evaluate the study report are treated as raw data; the study director must assure accurate recording and verification. | Reported values should trace to attributable source records, documented changes, calculations, and reviewed data rather than an isolated results table. |
| Equipment and calibration | Data-generating equipment must be inspected, maintained, tested, calibrated or standardized as appropriate, with written procedures and dated records, including malfunction and remedial-action records. | A result is easier to defend when instrument status, calibration history, method timing, and any equipment exception can be matched to the study period. |
| Quality assurance | An independent quality assurance unit monitors covered studies, performs documented inspections, reports problems, checks unauthorized deviations, and reviews the final report against methods and raw data. | Sponsors can distinguish independent QA oversight from routine technical review and ask how findings and corrective actions entered the study record. |
| Protocols and conduct | Each covered study has an approved written protocol describing objectives and methods; the study director is the single point of study control and must assure the protocol is followed. | The intended claim, test system, acceptance logic, responsibilities, and authorized changes should be fixed before execution and visible in the final record. |
| Archives | Raw data, documentation, protocols, specimens, and reports are retained in indexed archives with controlled access and conditions suited to retrieval and preservation. | Future questions from a regulator or sponsor depend on being able to retrieve the evidence needed to reconstruct the study after report issuance. |
| Final reports | A final report documents the facility, dates, protocol objectives and procedures, methods, results, deviations, and required QA statement, and is signed and dated by the study director. | The report should be read as the endpoint of a controlled record chain, not as a standalone certificate detached from source data and protocol history. |
Why the selected-study audit matters
A facility review asks whether the quality system exists and is being operated. A selected-study audit adds a vertical test through one study record. EPA's compliance strategy describes the audit as comparing raw data and other generated records with the results in the submitted final report. This makes traceability across the study, rather than possession of individual documents, the practical issue for sponsors.3,4
- Protocol traceability: the approved objective and methods should connect to the work performed, with changes approved and deviations authorized and documented.2
- Measurement traceability: equipment identity, service status, calibration or standardization, and remedial actions should align with the dates and methods used to generate data.2
- Data traceability: observations, worksheets, instrument outputs, calculations, corrections, and derived results should permit reconstruction of what occurred and how the reported value was obtained.2,4
- QA traceability: inspection dates, phases reviewed, reported findings, corrective actions, final-report review, and the signed QA statement should form a consistent oversight record.2
- Archive traceability: the index and custody controls should lead reviewers to the retained raw data, protocol, specimens where applicable, correspondence, and final report.2
A selected-study audit should not be generalized into a conclusion about every study, method, or product program at the facility. Its value is narrower and still important: it gives EPA a concrete record through which to evaluate whether stated GLP practices operated in an actual study and whether reported results connect back to retained evidence.3,4
What sponsors remain responsible for
Part 160 defines a sponsor as a person who initiates and supports a study, submits it to EPA, or in some cases both initiates and conducts it. When a sponsor uses a contract laboratory for covered work, the sponsor must notify the laboratory that the service is or forms part of a study required to comply with Part 160. An inspection of the laboratory does not remove that scoping responsibility.2
The submission interface also matters. For data from a covered study, Part 160 requires a true and correct compliance or non-compliance statement signed by the applicant, sponsor, and study director. A sponsor therefore needs enough study-specific evidence to understand the statement it will sign, including disclosed departures from the regulation when applicable.2
- Define intended regulatory use before protocol approval, including whether the work is a covered FIFRA study, a non-GLP development exercise, or one part of a larger submission package.2
- Ask for the approved protocol, amendments and deviations, study-director identity, applicable SOP references, equipment and calibration records, QA statement, final report, and archive arrangements for the specific study.2
- Confirm which work was conducted under Part 160 and keep that boundary separate from screening, method development, or other work that was not represented as a GLP study.2
- Record the inspection status accurately: the August 25–26, 2026 on-site review and selected-study audit are complete, while ARE Labs' final written EPA report remains pending.1