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Good Laboratory Practices: Questions and Answers
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
- Current reregistration procedures involve submission of data that resulted from studies performed prior to the effective date of GLPS. Do GLPS apply to such data, and if so, how?
- Do GLPS apply to data used to support tolerance petitions?
- Do GLPS apply to weather data and soil analysis data?
- What applicability do GLPS have when state, federal, or independent laboratories are used to provide soil or weather data for GLP studies?
Definitions
Study Director
Quality Assurance Unit (QAU)
Facilities
Test Control and Reference Substance Characterization
Test Substance Storage Containers
Protocols
Reporting
Archives
GLP Violations
1. Current reregistration procedures involve submission of data that resulted from studies performed prior to the effective date of GLPS. Do GLPS apply to such data, and if so, how? Any data presently submitted in support of a pesticide research or marketing permit must be accompanied by a true and correct compliance statement as described at 40 CFR 160.12 regardless of when the study was performed. Therefore, data submitted to meet reregistration requirements are required to be accompanied with a true and correct compliance statement informing EPA in detail of all differences between the practices used in the study and those required by GLPS. It is not unlawful to truthfully admit that studies supporting such submissions did not comply with GLPS, nor would such an admission necessarily lead to rejection of the data. The compliance statement will help the Agency to determine the reliability of the data based on current data requirements. Note that such an admission may nevertheless result in an enforcement action if they indicate that an unlawful act has occurred. For example, other regulations, i.e., books and records as stated at 40 CFR 169.2(k), require retention of raw data generated in support of registered pesticides prior to the effective date of GLPS. Admitting to destruction of records would not exclude the Agency from taking enforcement actions for the books and records violation.
2. Do GLPS apply to data used to support tolerance petitions?
Yes. The scope of the regulations as stated at 40 CFR 160.1 require that studies conducted to develop data pursuant to sections 408 and 409 of the Federal Food, Drug, and Cosmetic Act be performed in accordance with GLPS.
3. Do GLPS apply to weather data and soil analysis data?
Any data which are collected as part of a study listed in 40 CFR 160.1 must be collected according to GLPS. This includes weather data and soil analyses which are collected as part of a larger study which must comply with GLPS. If non-study data such as local weather data are cited in a study report, and the study report clearly indicates that such data were not gathered as part of the study, GLPS would not apply to such data.
4. What applicability do GLPS have when state, federal, or independent laboratories are used to provide soil or weather data for GLP studies?
GLPS are applicable in such circumstances if such data are gathered as part of a FIFRA study. Only where such data are gathered independently of the study, and the study report clearly indicates that such data were not gathered as part of the study, would GLPS not apply.