RECORDREFERENCE OUTLINE

EPA FIFRA GLP Compliance Record

Compliance record for pesticide registration studies, which fall under the EPA good laboratory practice standards rather than the FDA ones. Begins with an explicit regime determination, scopes which studies must comply in both directions, prepares the submission statements that have no counterpart in the pharmaceutical regime, and tracks international acceptance before the study runs rather than at submission. Maps to 40 CFR Part 160.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
40 CFR Part 160
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

The United States has more than one good laboratory practice regulation. Studies supporting pesticide registration fall under the EPA standards rather than the FDA ones, and although closely aligned the two are separate legal instruments with their own scope, enforcement and required statements. Deciding which regime a study sits under is your determination, and citing the wrong one survives casual review because both are real and both are called GLP.

What's Inside

✓Regime determination recording why FIFRA study support places this work under the EPA standards
✓Scope established in both directions — what must comply, and what deliberately need not
✓Submission statements prepared deliberately, since they have no counterpart in the pharmaceutical regime
✓Study conduct architecture verified element by element rather than assumed from an existing GLP claim
✓Environmental and residue work treated on its own terms, including field sites outside the laboratory
✓Sponsor, testing facility and testing site responsibilities separated wherever work is subcontracted
✓International acceptance tracked before the study runs, with the receiving authorities named explicitly

How to Use It

1Determine the regime before designing the study; citing 21 CFR Part 58 for a pesticide registration study survives a spot-check and fails a submission.
2Scope in both directions — applying the standard beyond its reach wastes effort, and missing work inside it invalidates the submission.
3Prepare the required submission statements explicitly; teams whose habits formed in the pharmaceutical regime omit them without noticing.
4Name the testing sites, including field sites, and record who holds facility responsibility at each one.
5Track international acceptance up front; a study completed and then found not to travel is a full repeat.
6Re-check the determination if the study’s intended use changes, because a study can move between regimes after it starts.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Regime Determination
2Scope — Which Studies Must Comply
3Required Submission Statements
4Study Conduct Architecture
5Environmental and Residue Work
6International Acceptance
REGULATORY CONTEXT

40 CFR Part 160 sets the EPA good laboratory practice standards governing studies submitted under FIFRA, with its own scope, enforcement provisions and submission-statement requirements. It is a separate legal instrument from 21 CFR Part 58, and alignment between them is not equivalence. Which regime a particular study falls under, and whether a supporting study sits inside or outside the scope, are determinations the sponsor makes and records. The compliance-record structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
40 CFR Part 160
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