EPA GLP (40 CFR 160) Readiness for Pesticide Study Facilities
Separate the QAU, approve the protocol, follow written SOPs and archive the study for as long as the permit relies on it.
In Short
- The QAU stays independent.
- Protocol approved before work.
- Archive for the longest period.
The Chemical Manufacturing Guide
Approved formulas. Tested batches. Correct labels out the door.
- Which rules reach your plant
- Raw material to store
- Charge, watch, adjust, release
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Chemical Manufacturing Guide
Approved formulas. Tested batches. Correct labels out the door.
40 CFR Part 160 sets good laboratory practice for studies that support, or are intended to support, EPA research or marketing permits for pesticide products under FIFRA and data under FFDCA sections 408 and 409. It covers people, the quality assurance unit, procedures, protocols, reports and archives. This guide is for testing facilities and sponsors. It is orientation, not regulatory advice. Sources checked 4 Oct 2026.
Which studies are in scope
Section 160.1 applies the part to studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by EPA, with the FIFRA and FFDCA sections it lists. That reaches field and laboratory studies alike.
More on which studies are in scope
Start with a list of every current and planned study, its sponsor and the permit it is meant to support, so the scope decision is written down rather than assumed.
People and the quality assurance unit
Under 160.29, everyone conducting or supervising a study needs suitable education, training and experience, and the facility keeps a current summary of training, experience and job description for each person. Section 160.35 requires a quality assurance unit entirely separate from the people directing and conducting the study.
QAU inspection record (160.35)
More on people and the quality assurance unit
The QAU keeps the master schedule and protocols, inspects each study at adequate intervals, reports problems that could affect integrity to the study director and management immediately, and gives written status reports.
Standard Operating Procedures
Section 160.81 requires written SOPs that management is satisfied are adequate, covering items such as test system care, handling of test, control and reference substances, laboratory tests, data handling and equipment maintenance and calibration. Deviations from SOPs in a study are authorised by the study director and documented in the raw data.
More on standard Operating Procedures
Significant SOP changes are authorised in writing by management, and a historical file of every revision with its date is kept.
Protocol and Final Report
Each study has an approved written protocol under 160.120, stating objectives and methods and the items listed there, such as test substance identity by name or CAS number, sponsor and facility, test system, experimental design and dosage. Changes are documented and approved.
More on protocol and Final Report
Section 160.185 lists what the final report contains, including the protocol objectives and changes, statistical methods, circumstances that may have affected data quality, and signed reports from the scientists involved.
Archives and Retention
Section 160.195 sets retention for documentation, raw data and specimens at the longest of: the time the sponsor holds a permit the study supports; at least 5 years after results are submitted to EPA; or, where the study is not submitted, at least 2 years after it ends. Fragile specimens are kept only as long as they can still be evaluated.
Worked Example: Archive Periods for Study ST-2207
| Situation | Keep at least |
|---|---|
| Submitted, permit granted | While the permit is held |
| Submitted to EPA | 5 years after submission |
| Never submitted | 2 years after study end |
- Submitted, permit granted
- Keep at least
- While the permit is held
- Submitted to EPA
- Keep at least
- 5 years after submission
- Never submitted
- Keep at least
- 2 years after study end
More on archives and Retention
Give the archive a named custodian and an index that a study director and an auditor can both search.
Questions
Is GLP the same as GMP?
No. Part 160 covers studies that generate data for EPA permits, not routine manufacture of products.
Can the study director also be in the QAU?
No. For a given study the QAU must be entirely separate from the people directing and conducting it, under 160.35.
How long are study records kept?
The longest of the periods in 160.195, which can mean the life of the permit the study supports.
Where does V5 fit?
V5 keeps SOPs with revision history, training records, equipment calibration and reference material lots. Your study director and QAU run the study and sign the report.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
10 CFR Part 35 Medical Use: Written Directives, Dosage Records and Medical Events
21 CFR 111 Readiness: Identity, Master and Batch Records
21 CFR Part 211 Guide: Scope, Batch Controls and QCU Review
21 CFR 212 PET Drug cGMP Readiness: Production Evidence Guide
BSE Feed Rule Readiness: 21 CFR 589.2000 and 589.2001 for Feed and Pet Food
21 CFR 820 to ISO 13485 Crosswalk: Re-citing Procedures Under the QMSR