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Good Laboratory Practices

  1. Applicability
  2. 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?
  3. Do GLPS apply to data used to support tolerance petitions?
  4. Do GLPS apply to weather data and soil analysis data?
  5. What applicability do GLPS have when state, federal, or independent laboratories are used to provide soil or weather data for GLP studies?
  1. Definitions
  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?
  3. What is EPA’s formal policy on certifying copies of raw data? Must each page be signed and dated?
  4. What type of sponsor-testing facility communication is considered to be raw data which must be archived at the end of the study?
  5. Will EPA issue separate GLP standards for field testing as opposed to laboratory testing?
  1. Study Director
  2. If there can only be one study director assigned to a study, is it acceptable to assign “field directors" and "analytical directors" to manage the work which involves different phases and/or locations?
  3. Many field studies involve more than one technical phase, each involving different personnel and different methodologies, often by different contractors. Concern has been raised over the difficulty for a single individual to physically oversee all phases and to be expert in all techniques involved. Within the same study, is it acceptable to assign a different study director to different phases?
  1. Quality Assurance Unit (QAU)
  2. Is it acceptable to inspect study-related procedures at a time other than when the study is ongoing?
  3. What would constitute adequate inspection of the ongoing study? Would an audit of the protocol or of data records be adequate?
  1. Facilities
  2. Is it permissible to store mixed feeds containing the test substance in the same room with the test system during feeding studies?
  1. Test Control and Reference Substance
  2. Can data developed by the supplier of the standard be accepted? If not, can it be used on an "interim" basis until the standard is adequate characterized?
  3. Do characterization requirements at 40 CFR 160.105 apply to analytical standards?
  4. What documentation would apply to standards?
  1. Test Substance Storage Containers
  2. Is it necessary to retain test substance storage containers for the duration of a field study?
  3. Will EPA accept a “generic” alternative approach to cover multiple studies and/or test substances?
  1. Protocols
  2. Can a "generic protocol" be used for obtaining sponsor approval?
  3. What records of seeds or transplants of crops or plants used in field studies must be maintained?
  1. Reporting
  2. 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?
  1. Archives
  2. 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?
  3. How does EPA define "close of study" in regard to archiving?
  4. How long must soil, water and plant specimens be retained?
  5. Must analytical preparations (e.g., scintillation vials and solutions) be archived?
  6. 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?
  1. GLP Violations
  2. Can EPA assess penalties for GLP violations?
  3. Can EPA reject studies not conducted in accordance with GLPS?
  4. What are the maximum penalties that can be imposed?
  5. What are the possible violations under the statute?
  6. Will civil or criminal penalties be imposed for all GLPS violations?

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