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Good Laboratory Practices: Questions and Answers - Definitions
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
- Will EPA issue separate GLP standards for field testing as opposed to laboratory testing?
- Can an experiment be divided into more than one study, based on where or when the work is performed, or the phase of the experimental work?
- What is EPA’s formal policy on certifying copies of raw data? Must each page be signed and dated?
- Is it permissible to discard original raw data worksheets after exact copies have been made?
- What type of sponsor-testing facility communication is considered to be raw data which must be archived at the end of the study?
Study Director
Quality Assurance Unit (QAU)
Facilities
Test Control and Reference Substance Characterization
Test Substance Storage Containers
Protocols
Reporting
Archives
GLP Violations
1. Will EPA issue separate GLP standards for field testing as opposed to laboratory testing?
The expansion of GLPS to cover field studies was based on the need to assure identical standards for all data submitted to EPA under FIFRA and on the determination that the GLPS are technically general enough to cover virtually any type of research environment. EPA does not intend to issue separate standards.
2. Can an experiment be divided into more than one study, based on where or when the work is performed, or the phase of the experimental work?
Under GLPS, the term "study" refers to an experiment to determine or predict the effects or characteristics of a test substance. EPA considers a study to be composed of all of the necessary elements of research which are performed in order to obtain the reported results. If the elements of research consist of several phases of work which must be taken in the context of each other to get meaningful results, they are all considered to be elements of the same study. An example of this would be where one laboratory treats a test system with a test substance and sends the treated test system to another laboratory for analysis. Another example is if the experiment involves treatment of test systems in several different locations.
3. What is EPA’s formal policy on certifying copies of raw data? Must each page be signed and dated?
EPA stated in the preamble to the August 17, 1989 rule (54 FR 34066) that acceptable alternatives to signing and dating each page may be devised and incorporated into standard operating procedures. EPA did not further elaborate in order to allow each testing facility flexibility in implementing Standard Operating Procedures (SOPs) that would provide adequate assurances within its facilities. Note that EPA may inspect the original records, which must be maintained by the registrant as provided at 40 CFR 169.2(k), to assure that they have been kept and that the copies are correct.
4. Is it permissible to discard original raw data worksheets after exact copies have been made? Destruction of original raw data is prohibited. The registrant is responsible for maintaining all original raw data as specified at 40 CFR 169.2(k). Copies of data may be used to assure compliance with GLPS at the level of the testing facility, but EPA requires that the registrant maintain all original data that support a study.
5. What type of sponsor-testing facility communication is considered to be raw data which must be archived at the end of the study?
All records of sponsor-testing facility communication which occur as part of the activities of a study are considered to be raw data, as defined at 40 CFR 160.3. This includes memoranda, letters, and records of telephone conversations which occur during the course of the study. Communication conducted prior to the study (i.e., before the protocol is signed) or following the completion of the study (i.e., after the report is signed) would not normally be considered to be raw data. Note that certain records not specific to a particular study which are generated when the study is not in progress still need to be retained to prove that study's compliance with GLPS. Examples include records of a sponsor's notifying a facility of the need to comply with GLPS as required at 40 CFR 160.10, and records of facility documents such as standard operating procedures.