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Good Laboratory Practices: Questions and Answers - Protocols
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
Protocols
- Can a "generic protocol" be used for obtaining sponsor approval?
- What records of seeds or transplants of crops or plants used in field studies must be maintained?
Reporting
Archives
GLP Violations
1. Can a "generic protocol" be used for obtaining sponsor approval?
The GLPS require that the protocol be approved by the sponsor, and the date of approval must be included with the protocol; however the GLPS also provide flexibility in how this approval is obtained. A "generic protocol" approach may be acceptable for obtaining sponsor approval of certain protocol elements. In such a case, the testing facility which is drafting the protocol for a study would only need to obtain approval of those elements which were not included in the generic protocol. Please note that since the GLPS require protocols to include certain information that would not be included in a generic protocol, such as the test substance or the proposed start and termination dates, it would still be necessary to obtain sponsor approval for such information in addition to the approval of the generic protocol.
2. What records of seeds or transplants of crops or plants used in field studies must be maintained?
Where crops or plants are the test system or a component of the test system, all GLP standards relating to test system records are applicable. These include protocol provisions given at 40 CFR 160.120(a)(6) and (7), as applicable. Included, for example, would be the source of the test system supply, species, method of identification, etc. Lot numbers of seeds, brand names, and other information uniquely identifying the test system would be relevant.