U.S. Environmental Protection Agency
US environmental regulator; runs the non-FDA GLP regime — 40 CFR Part 160 under FIFRA (and its TSCA twin, Part 792) — for the safety studies behind pesticide and chemical registrations.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT EPA COVERS
The U.S. Environmental Protection Agency regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and industrial chemicals under the Toxic Substances Control Act (TSCA) — and for the GxP world its significance is the good laboratory practice regime those statutes carry: 40 CFR Part 160 for studies supporting pesticide registrations, and its near-identical twin 40 CFR Part 792 for TSCA submissions. This is the non-FDA US GLP: the health-effects, environmental-fate, and ecotoxicology studies behind pesticide and chemical registrations run under EPA's rules, not FDA's 21 CFR Part 58, however similar the two look.
WHAT EPA PUBLISHES
- 0140 CFR Part 160 — GLP standards for FIFRA pesticide studies
- 0240 CFR Part 792 — the parallel GLP standards for TSCA submissions
- 03GLP compliance-monitoring guidance and enforcement policies for test facilities
- 04Data requirements for pesticide registration (40 CFR Part 158), which determine the studies GLP then governs
HOW ITS REQUIREMENTS BITE
Submission-driven data review backed by inspection. Registrants must support FIFRA and TSCA submissions with studies conducted under the applicable GLP standards, each accompanied by a signed compliance statement describing any departures. EPA's GLP compliance-monitoring programme inspects test facilities and audits studies against Part 160/792 — reconstructing substance accountability, protocol adherence, and raw-data integrity — and unreliable or falsely certified data expose the registrant and the facility to enforcement under the statutes' data-integrity provisions, up to rejection of the studies and the registrations built on them.
What practitioners get wrong
- "US GLP" is not one regime: FDA-regulated products run under 21 CFR Part 58, pesticides under Part 160, TSCA chemicals under Part 792 — the submission destination picks the rule.
- Part 160's test-, control-, and reference-substance provisions are more explicit than Part 58 practice; facilities running both should map the deltas rather than assume identity.
- The GLP compliance statement is per-study and signed: honestly described departures are the design, while a clean statement over an unexamined study is the liability.
- Contract facilities abroad conducting studies for EPA submissions are within reach of the regime — the data's destination, not the bench's location, is what matters.
What an inspection under this authority actually probes
WHERE IT SITS INTERNATIONALLY
The United States participates in the OECD Mutual Acceptance of Data system, and EPA's GLP standards are consistent with the OECD Principles of GLP — which is what lets a compliant ecotoxicology study travel between member jurisdictions without repetition. Within the US, the EPA and FDA regimes share the study-director/quality-assurance-unit architecture, and the OECD's GLP advisory documents (computerised systems, data integrity) speak to the same records EPA audits demand.
EPA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN EPA’S REMIT
EPA: frequently asked questions
Reference answers on U.S. Environmental Protection Agency’s mandate, what it publishes, and how its requirements acquire force.
What is EPA GLP?
The good laboratory practice standards EPA applies to studies supporting its regulatory submissions: 40 CFR Part 160 for pesticide registrations under FIFRA and 40 CFR Part 792 for chemical submissions under TSCA — the non-FDA US GLP regime, structurally mirroring 21 CFR Part 58.
When does Part 160 apply instead of FDA's Part 58?
The submission decides: studies supporting pesticide registrations to EPA run under Part 160, studies for FDA-regulated products under Part 58, and TSCA chemical studies under Part 792. A facility may operate under more than one regime for different sponsors.
Does EPA inspect laboratories?
Yes. EPA runs its own GLP compliance-monitoring programme: facility inspections and study audits against Parts 160/792, with submitted studies carrying signed GLP compliance statements that must accurately describe any departures.