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Good Laboratory Practices: Questions and Answers - Archives
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
- The GLPS state that the study director must assure that raw data are transferred to archives during or at the close of the study. Is there a "grace" period allowed after the end of the study to allow this to be done?
- How does EPA define "close of study" in regard to archiving?
- Given that data must be transferred to archives at the close of the study, is it possible to use temporary archives prior to transfer to a central archive?
- Must field notebooks be archived during or at the close of a study?
- Must analytical preparations (e.g., scintillation vials and solutions) be archived?
- How long must soil, water and plant specimens be retained?
GLP Violations
1. The GLPS state that the study director must assure that raw data are transferred to archives during or at the close of the study. Is there a "grace" period allowed after the end of the study to allow this to be done?
Under GLPS, the study director is required to assure that all raw data, documentation, the protocol, specimens, and final reports are transferred to the archives during or at the close of the study (40 CFR 160.33(f)). Thus, there is no grace period. The study director must comply with this requirement prior to signing the compliance statement. This ensures that data are fully accounted for at the completion of the study.
2. How does EPA define "close of study" in regard to archiving?
The term "at the close of the study" is strictly interpreted to mean that point of time at which the study director signs the final study report. The act of signing the final report is one of assurance by the study director that the report is a true representation of the data that support the report. At or prior to the time that the study report is signed, the study director must pass control of the raw data to the archives where their integrity will be maintained. Any delay in the transfer of data beyond the close of the study creates a lapse between the time that the study director assures that the raw data support the study report and the time that the data are secured from damage, misuse, or loss.
3. Given that data must be transferred to archives at the close of the study, is it possible to use temporary archives prior to transfer to a central archive?
There is flexibility in the location of the archives of raw data and specimens. At 40 CFR 160.190(b), the GLPS state that retention of records at alternate locations is acceptable, provided that there is specific reference to those locations in the archives. Such off-location archives must still meet the full requirements of 40 CFR 160.190. Whether records are archived at the registrant's facility, at a contractor's central location, or at separate contractors' locations, the study director must assure that all raw data and specimens have been archived before the study report is signed. If the study director cannot assure that records, at a particular location are archived correctly, he should not sign a compliance statement that indicates that this standard has been met. Note that, for the purpose of complying with GLPS, true copies may be archived at the close of the study. The original records will have to be maintained as well but need not be archived at the end of the study if this is impractical, for example where the original data constitutes a facility record shared by other studies still in progress at the close of the study.
4. Must field notebooks be archived during or at the close of a study?If a notebook contains raw data, the notebook or the raw data must be archived at the close of the study. Note that the registrant is responsible for the original records under 40 CFR 169.2(k) and section 8 of FIFRA, so it is inadvisable to enter raw data for studies related to different registrations in the same bound notebooks.
5. Must analytical preparations (e.g., scintillation vials and solutions) be archived?
Such preparations need not be retained beyond the period that they afford evaluation, as stated at 40 CFR 160.195(c). Generally, samples prepared for analysis have limited utility beyond the time of analysis and can be discarded.
6. How long must soil, water and plant specimens be retained?
These need only be retained until the QAU has verified that their disposal will not jeopardize the integrity of the study, as provided at 40 CFR 160.190(a) and 160.195(c). Please note that there may be study-specific sample retention requirements in addition to and independent of GLP requirements. Failure to retain such samples may result in rejection cf data by EPA cr enforcement actions independently of whether a GLP violation has occurred.