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Good Laboratory Practices: Questions and Answers - Test Substance and Storage Containers
FIFRA Topics
- Good Laboratory Practices
- FIFRA Grants
- Inspections
- Worker Protection Safety
- Pesticide Producing Establishments
- Pesticide Imports and Exports
EPA has prepared responses to several questions in order to help clarify the Good Laboratory Practices Standards (GLPS) rule. The Questions and Answers are grouped into eleven different categories listed below. The following Questions and Answers serve as official written policy.
Applicability
Definitions
Study Director
Quality Assurance Unit (QAU)
Facilities
Test Control and Reference Substance Characterization
Test Substance Storage Containers
- Is it necessary to retain test substance storage containers for the duration of a field study?
- Will EPA accept a “generic” alternative approach to cover multiple studies and/or test substances?
Protocols
Reporting
Archives
GLP Violations
1. Is it necessary to retain test substance storage containers for the duration of a field study?
Yes, as provided at 40 CFR 160.105(c), storage containers for test substances shall be assigned for the duration of a study. This requirement is necessary to assure that test substances are stored in proper containers, and that the containers that are used can be accounted for during the study. At any time during the study, it must be possible to examine the containers to assure that this standard is met.
2. Will EPA accept a “generic” alternative approach to cover multiple studies and/or test substances?
More than one study and/or test substance may be included in given request, as long as each study and test substance is specifically identified. EPA’s response will address only those studies covered in the request.