Thomas J. Hughes and Elaina Kenyon QA and Records Manager, and Research Scientist Experimental Toxicology Division (ETD) U.S. EPA, ORD, NHEERL, RTP, NC U.S. EPA Annual QA Meeting San Antonio, TX May 14, 2009 The Use of Secondary Data in Modeling of Biological Data
PURPOSE • Discuss the two different types of secondary data for modeling • Discuss secondary data checklist for modeling 3. Discuss other types of checklists (surveillance and QC) 4. Case studies
High Profile Research Studies in ETD • Human Health – Asthma/Food/Mold • Particulate Matter (Libby Asbestos, UCAPS, Diesel and bio-fuels) • Drinking Water (OW – DBPs) • Risk Assessment (OPP – Pyrethroids) • RARE Projects (PIN, Old Town, Maine in Region 1, and Huntington, WV in Region 3) • National Homeland Security Research Center (NHSRC) projects (chlorine, toluene, enzyme inhibitor studies) and development of PALs
Types of Secondary Data • Primary – secondary data used for models when model data will be used for regulations, laws, criteria documents or PALs levels (NHSRC). 2. Supportive – secondary data used for models when data will be used for initial assessment or the data are from in vitro experiments.
Definition of Secondary Data Types Primary – data are supplied for individuals, and a comprehensive discussion of results and all supporting data necessary for complete reanalysis of data are provided (e.g., controls and dose response data. Supportive – data are pooled, means and standard deviations are supplied, but supporting data are not comprehensive and all data for reanalysis are not available.
Secondary Data Checklist for Modeling ETD Secondary Data Checklist (Handout) • ETD Checklist is divided into three sections: human, animal and in vitro studies. • Checklist is based on my experience with bacteria, toxicology testing in animals, human monitoring, and • ATSDR Toxicology Profile assessment of chemicals from peer-reviewed literature data. 4. Other checklists for secondary exist.
Other Types of Checklists for QA Assessment of Laboratories ETD Surveillance Checklist (Handout) • ETD QAM uses this checklist for a once a year talk (in June) with the division PIs to assess the QA status of their laboratory. • Checklist could be used to conduct remote QA assessment of labs that get grants. • Checklist can used by the QAM and for self-assessment of labs by the scientist before internal and external audits.
Other Types of Checklists for QA Assessment ETD Quality Control Checklist (Handout) • QA (quality assurance) is what the auditor or QAM conducts (external to the lab). • QC (quality control) is what the scientist does to insure the accuracy and defensibility of their data (internal to the lab). • QA is only as good as the QC conducted by the scientist. 4. Checklist assists scientists with the QC section of the research protocol.
Summary • Models are being used much more frequently, especially with overall available dollars decreasing at the US EPA. • Models are a very useful tool when data has to be quantitatively analyzed. • Models have been used to quantitatively rank-order large databases (Ames testing of water and chemicals)
Case Studies 1. Human liver P450 cytochrome iso-enzymes and BDCM metabolism (Zhao and Allis, 2002). • BDCM metabolism (Ross and Pegram, 2004) 3. Case Studies (UF, DDEF)
Contact Information Hughes.Thomas@EPA.Gov QAM, NHEERL, ORD, USEPA, RTP, NC (919) 541-7644 Kenyon.Elaina@EPA.Gov Research Scientist, NHEERL, ORD, USEPA, RTP, NC (919) 541-0043