NAICS Code: 541620 The United States Environmental Protection Agency (EPA), Office of Acquisition Management, intends to award a sole source purchase order to Sciences International Inc., for the development of an issue paper evaluating published re-analyses of data from the TaiwaneseEpidemiological studies on inorganic arsenic.

The primary purpose of this data is for the U.S. EPA's Integrated Risk Information System (IRIS) Program to develop a Human Health Risk Assessment to estimate cancer risk from exposure to inorganic arsenic (iAs). This Human Health Risk Assessment has undergone multiple review processes including Agency Review, Interagency Review, and External Peer Review by the U.S. EPA's Science Advisory Board (SAB). Each of these reviews consistently recommended the use of epidemiological data from the Taiwanese population as reported in Chen et al. (1988, 1992) and Wu et al. (1989). Overall these reviews have recommended the same approach for quantitative dose-response analysis as outlined by the National Research Council (2001). These epidemiological studies have been the focus of numerous re-analyses since their publication (Lamm et al., 2006; U.S. EPA, 2005; Kayajanian et al., 2003; Lamm et al., 2003; NRC, 2001; Morales et al., 2000). Some of these re-analyses (Lamm et al., 2006; Kayajanian et al., 2003; Lamm et al., 2003) challenge the qualitative and quantitative conclusions of the NRC (2001) and the SAB (2007). An issue paper evaluating the strengths and weaknesses of these re-analyses (Lamm et al., 2006; Kayajanian et al., 2003; Lamm et al., 2003) with emphasis on evaluation and application of their methodologies, qualitative and quantitative assumptions, and soundness of conclusions would provide useful information with respect to the current cancer assessment for iAs. Sciences International Inc. is considered the only source to provide the expertise required to perform the work described in this purchase order based on the following reasons:

(1) Sciences International Inc. has completed substantial work on this project for Oak Ridge Institute for Science and Education (ORISE) through interagency agreement No. DW-89939822-01-0, entitled Review of Arsenic Related Documents.

(2) Sciences International Inc. is uniquely qualified to perform this work because it is a continuation of work that has been previously performed on an extremely complex data base with which they are intimately familiar.

(3) Sciences International Inc. has extensive experience in the preparation of technical reviews on numerous chemicals and chemical classes making them highly experienced in chemical hazard assessment. They have also provided data collection and evaluation services in the environmental sciences for more than 16 years.

(4) Sciences International Inc scientists have performed hazard evaluations exposure assessments, dose response analyses and risk characterizations of environmental chemicals.

(5) It would require substantially more resources (i.e. time and money) to bring another contractor to the level of expertise and experience required to conduct the precise analysis and work specified by this work assignment. No other contractors were identified with the in-depth experience and knowledge of the previous work on the critical evaluation of recent analyses of the Taiwanese epidemiological data.

The scope of work related to this issue paper will involve four tasks, as outlined below:

Task 1: Preparation of Work Plan and Joint Quality Management/Quality Assurance Project Plan (JQM/QAPP). The contractor shall submit a work plan for the completion of an issue paper that provides a sound evaluation of the strengths and weaknesses of re-analyses (Lamm et al., 2006; Kayajanian et al., 2003; Lamm et al., 2003) performed on the epidemiological data from Taiwanese populations exposed to iAs with an emphasis on evaluation and application of their methodologies, qualitative and quantitative assumptions, and soundness of conclusions with respect to the current cancer assessment for iAs. This effort would also include a literature search for relevant information to support the conclusions of the issue paper. The work plan shall include a description of the overall technical approach, level of effort, staffing, and a schedule for completion of tasks.

EPA will review the work plan and clarify any questions with the contractor. The contractor shall develop a JQM/QAPP for this project for the Technical Project Officer's (TPO) and Quality Assurance staff's approval. The work plan and quality assurance statement shall be submitted simultaneously for approval. The contractor shall not perform any work under this project until the JQM/QAPP is reviewed and approved by the TPO. The contractor must address in the JQM/QAPP how secondary data will be evaluated for use in the project. Secondary data is environmental or health data that was developed for a different purpose.

Task 2: The contractor will participate in a conference call to discuss any clarification to the scope of work described within the work plan. After this conference call, the contractor will proceed to develop a draft issue paper that will include, but not limited to the following:

a. Review of the available cancer datasets from Taiwan populations, mainly focusing on Chen et al. (1988, 1992) and Wu et al. (1989).b. Review of all analyses existing for these datasets (including, but not limited to Lamm et al., 2006; NRC, 2001; Kayajanian et al., 2003; Lamm et al., 2003; Morales et al., 2000; etc.) including a comparison of the strengths and weaknesses for each analysis.c. A detailed rationale of the most logical approach for analyzing the Taiwanese cancer datasets as well as presenting logical explanations of alternative analysis for why those not chosen are inappropriate. This detailed rationale should include a detailed account of the evidence (i.e., supporting data) supporting the conclusions.

Upon completion of the draft document, the contractor will then submit it to the EPA for review.

Task 3: Upon receipt of comments on the draft version of the issue paper, the contractor will participate in a conference call to address any necessary clarification to the comments submitted by the EPA to the contractor. Based upon written comments and discussions during the conference call the contractor will revise the draft issue paper.

Task 4: The final revised draft will then be resubmitted to the EPA within 30 days of the conference call at which time there will be an option to hold an additional conference call. If further revisions are unnecessary, this conference call can be cancelled by the EPA PO.





















As stated above, EPA intends to award this procurement on a sole source basis. Nevertheless, if any firm feels they are capable of performing this work, they must submit evidence of such capability within 15 days of this posting.Telephone calls and/or requests for a solicitation will not be accepted or acknowledged. All responses should be sent via email to honegger.harold@epa.gov