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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?
- How does one obtain such permission?
- What types of conditions may be stipulated by EPA in accepting an alternative approach?
- 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.
However, requests to use alternative approaches that achieve an equivalent level of integrity for situations involving large numbers of containers or safety concerns may be made to the Director, Agriculture Division, Office of Compliance. The request must identify the study for which permission is requested, the testing facility, the nature and quantity of containers involved, and the time and location(s) of the study. The request should also identify any special storage burdens or safety hazards which retention of the containers may pose.
2. How does one obtain such permission?
A request for permission must be submitted in writing to the Director, Agriculture Division, Office of Compliance (2225A), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460.
3. What types of conditions may be stipulated by EPA in accepting an alternative approach?EPA may request that sufficient documentation be available to assure that any containers which have been used for test substance storage during the course of a study are thoroughly accounted for from the time of receipt to disposal. This documentation would generally include such items as bills of lading, inventory records, receipts, use logs, and any other supportive records. In addition, the letter may stipulate that the Director of the Agriculture Division be notified of the location of such records in order that they may be available for inspection.
4. 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.