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Good Laboratory Practices: Questions and Answers - Reporting
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
Reporting
Archives
GLP Violations
1. The GLPS at 40 CFR 160.185(a)(12) require that signed and dated reports of each scientist or other professional in the study be included in the final report. Can these reports be combined into one report, with all of the scientists and professionals dating and signing that report?
This requirement is intended to ensure that all information related to the study is included in the final report. Specifically, when individual scientists findings are part of the study effort, they are required to be included separately. Combined reports may in effect be consensus documents, and that would defeat the purpose of this requirement. Note that this requirement is not intended to require separate reports of all scientists participating in a study if such scientists are not, in fact, providing individual findings or opinions. For example, pathologist-s reports are considered to be separate findings which must be reported separately.