Good Laboratory Practice Standards (FIFRA)
The EPA's GLP standards for studies supporting pesticide registrations under FIFRA — the non-FDA US GLP regime. Structurally a sibling of FDA's 21 CFR Part 58, it governs organisation and personnel (including the quality assurance unit and study director), facilities, equipment, test, control, and reference substances, protocols and study conduct, and records and reports, with GLP compliance statements required on submitted studies. A near-identical twin, 40 CFR Part 792, covers TSCA chemical studies.
What this does not cover
stated in the document's own scope- Covers studies supporting FIFRA pesticide submissions; FDA-regulated product studies follow 21 CFR Part 58, and TSCA chemical studies follow the twin regulation 40 CFR Part 792.
- A GLP regime for study conduct and data reliability; the substantive data requirements for registration (which studies to run) sit in EPA's data-requirement regulations, not Part 160.
- US law: studies for other jurisdictions run under the OECD Principles of GLP as implemented nationally, with MAD providing mutual acceptance among members.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
40 CFR Part 160 is the EPA's good laboratory practice regulation — the GLP regime for studies submitted in support of pesticide registrations under FIFRA, and the reason "US GLP" does not simply mean FDA. Structurally it mirrors 21 CFR Part 58: a study director with single-point responsibility for study conduct, an independent quality assurance unit auditing against the protocol and SOPs, requirements for facilities, equipment, and standard operating procedures, characterisation and handling of test, control, and reference substances, an approved protocol governing study conduct, and retention of raw data, specimens, and reports that lets the study be reconstructed. Studies submitted to EPA carry GLP compliance statements, and the agency runs its own inspection and data-audit programme.
Scope & applicability
Laboratories and sponsors conducting studies submitted to EPA in support of pesticide registrations under FIFRA — health effects, environmental fate, and ecotoxicology studies among them. FDA-regulated product studies follow 21 CFR Part 58; OECD-member submissions abroad run under the OECD GLP Principles.
Legal basis & how it acquires force
Issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which requires the safety and efficacy data behind pesticide registrations to be reliable. First promulgated in 1983 and comprehensively revised by the final rule of 17 August 1989, Part 160 applies to studies intended to support FIFRA submissions; its near-identical twin, 40 CFR Part 792, covers studies under the Toxic Substances Control Act. False or non-compliant data expose registrants to enforcement under FIFRA's data-integrity provisions.
Document structure
| Part | Covers |
|---|---|
| General provisions | Scope, definitions, and the applicability of GLP to FIFRA studies |
| Organization and personnel | Management, the study director, personnel, and the quality assurance unit |
| Facilities and equipment | Design, maintenance, and calibration requirements for test facilities |
| Test, control, and reference substances | Characterisation, stability, handling, and accountability of the substances a study runs on |
| Protocol and conduct of a study | The approved protocol, its amendments, and study execution requirements |
| Records and reports | Final reports, raw-data retention, specimen archiving, and retrieval |
Key requirements
- A study director with single-point responsibility and an independent quality assurance unit
- Characterised test, control, and reference substances with documented stability and storage
- An approved protocol and conduct of the study in accordance with it
- Raw data, specimens, and reports retained and retrievable for the required period
- GLP compliance statements accompanying submitted studies
Implementation tips
- Facilities running both FDA and EPA studies should map the deltas rather than assume identity — Part 160's reference-substance provisions and EPA's inspection programme differ in detail from Part 58 practice
Revision notes
First promulgated in 1983 and comprehensively revised effective 1989 (final rule of 17 August 1989), aligning with the parallel TSCA GLP standards in 40 CFR Part 792.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 160 completes the trio of GLP regimes a US nonclinical laboratory may face: FDA's 21 CFR Part 58 for FDA-regulated products, EPA's Parts 160/792 for pesticides and industrial chemicals, and the OECD Principles of GLP — the framework the Mutual Acceptance of Data system runs on — for studies travelling internationally. The frameworks share the study-director/QAU architecture, and the OECD data-integrity advisory (No. 22) speaks to the same records the EPA regime demands, but each regime's submissions must satisfy its own rule.
40 CFR Part 160: frequently asked questions
Quick answers to common questions about 40 CFR Part 160.
How does EPA GLP differ from FDA GLP?
In jurisdiction more than architecture. Part 160 (FIFRA) mirrors 21 CFR Part 58's study-director/QAU model, with differences of detail such as its explicit reference-substance provisions. Which rule applies follows the submission: pesticide registrations to EPA run under Part 160; FDA-regulated products under Part 58; TSCA chemicals under Part 792.
What studies does 40 CFR Part 160 cover?
Studies conducted to support FIFRA pesticide registrations and related submissions — health effects, environmental fate, and ecotoxicology among them — wherever conducted, including outside the US when the data are destined for EPA.
Does EPA inspect GLP facilities?
Yes. EPA operates its own GLP compliance-monitoring programme, inspecting facilities and auditing studies against Part 160, and submitted studies must carry GLP compliance statements describing any departures.
How do the EPA regimes relate to OECD GLP?
The US participates in the OECD Mutual Acceptance of Data system, and EPA's GLP standards are consistent with the OECD Principles — which is what lets compliant studies travel between member jurisdictions without repetition. The legal hooks remain national: Part 160 for FIFRA, Part 792 for TSCA.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.