PATHOLOGY PEER REVIEW AND PATHOLOGY SUPPORT FOR THE DNTP AND DIR AT NIEHS" CHARLES RIVER LABORATORIES (CRL)

Charles River Laboratories Intntl, Inc., Wilmington MA

Investigators

Abstract

The subject contract was established to provide a broad range of routine and specialized pathology services in support of studies conducted under contract by the National Toxicology Program (NTP) and for supplemental studies on pathology specimens generated through these studies. The contract also provides critical pathology (including molecular pathology) support for studies conducted by in-house investigators at NIEHS and other NIEHS contract studies. Specifically, the following services are supported by this contract: 1) necropsy and in-house necropsy assistance; 2) histology (tissue trimming and processing, slide preparation, and staining); 3) histopathological evaluation/interpretation; 4) application of specialized qualitative and quantitative morphological procedures (immunohistochemistry, morphometrics, cell proliferation, apoptosis, electron microscopy); 5) adaptation, development, refinement, application of new techniques in cellular and molecular biology including (but not limited to) genotyping, DNA sequencing, in situ hybridization, DNA and RNA isolation and amplification, and real time, quantitative, and in situ PCR, as well as training in the application of these techniques; 6) Pathology Peer Review (including Pathology Data Review [PDR], Audit of Pathology Specimens [APS], Quality Assessment of pathology evaluations and Pathology Working Group Coordination [QA/PWG]) and technical support for these activities; 7) pathology data entry; 8) presentation or publication of pathology data or techniques, or support for these activities; 9) oversight of the peer review process and preparation of the technical/toxicity reports, and 10) administrative support for the laboratory animal medicine group. The following work was completed for the Division of Translational Toxicology (DTT) and the NIEHS on this contract in the past year: four PWGs; 8 histology projects, primary pathology evaluations for 3 immunotoxicity studies, pathological evaluation of 10 studies for in-house NIEHS projects, and preparation of 5 posters, journal publications, or other publications. In addition, there are many other projects for the NTP and NIEHS that are in progress. Specific Aims (at least 250 words): The goal of this contract is to provide support to Division of Translational Toxicology (DTT) hazard identification activities targeted toward the prevention of diseases or adverse effects caused by environmental exposure to chemical or physical agents. The services provided under this pathology support contract are an integral component of the evaluation of pathology data generated by DTT studies and in ensuring the consistency and accuracy of that data. The majority of the studies are toxicity studies aimed at elucidating the cancer-causing potential or other potential toxic effects of chemicals or agents. Other types of studies are also conducted, including immunotoxicity studies and reproductive and developmental toxicity studies. These studies are used to evaluate the effects of various chemicals or physical agents of public health concern. Pathology data generated in these studies are used by the DTT to prepare final technical and toxicity reports. These reports provide a direct benefit to the public inasmuch as government regulatory agencies consult these reports when making regulatory decisions concerning the use of or exposure to chemicals or agents. Therefore, it is imperative that the data be complete and accurate, which underscores the importance of the pathology peer review services provided by this contract. The services provided by the Pathology Support Contract are also utilized to generate pathology data for NIEHS investigators at various stages during the conduct of laboratory-based research studies. This data is often used in the preparation of manuscripts and reports for publication in peer-reviewed scientific journals. Therefore, the specific aim of this contract is to continue to provide quality, professional pathology, histology, necropsy, and molecular biology/pathology services to the NTP and to NIEHS investigators.