SOLICITATION NOTICE
R -- IRIS SUPPORT
- Notice Date
- 2/23/2009
- Notice Type
- Presolicitation
- Contracting Office
- Environmental Protection Agency, Office of Acquisition Management, EPA/Headquarters, Environmental Protection Agency, National Procurement Contract Service Center, 1200 Pennsylvania Avenue, Nw 3803r, Washington, DC 20460
- ZIP Code
- 20460
- Solicitation Number
- RFQ-DC-09-00133
- Response Due
- 3/6/2009
- Archive Date
- 4/6/2009
- Point of Contact
- Point of Contact, Paul Dawson, Purchasing Agent, Phone (202) 564-4473<br />
- Small Business Set-Aside
- N/A
- Description
- NAICS Code: 541620 The EPA intends to award a sole source purchase order, under FAR Part 12, to Science International, Inc. of Alexandria, VA., for Integrated Risk Information System (IRIS) Technical Support for Human Health Risk Assessment and Related Activities for the Development of anIssue Paper Evaluating Published Re-analyses of Data from the Taiwanese Epidemiological Studies (Wu et al., 1992; Chen et al., 1989) on Inorganic Arsenic. This Issue Paper will be in Support of the Inorganic Arsenic Toxicological Review (Cancer Assessment). The Statement of Work and sole source justification are attached. No contract will be awarded on the basis of offers received in response to this notice. Any firm who believes it is capable of meeting EPA's requirement as stated herein may submit a response, which if received within 10 calendar days of the date of this announcement, will be considered. Responses to this posting must be in writing. A determination not to compete the proposed Purchase Order based upon the responses to this notice is solely within the discretion of the Government. All questions should be directed to Paul Dawson via email at dawson.paul@epa.gov. Telephone inquiries will not be accepted. PART I - BACKGROUND U.S. EPA's Integrated Risk Information System (IRIS) Program is developing 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. has completed substantial work on this project as a subcontractor to Oak Ridge Institute for Science and Education (ORISE) through interagency agreement No. DW-89939822-01-0. PART II - JUSTIFICATION Sciences International Inc. is considered the only source to provide the expertise required to perform the work described in this purchase order because of the following: (1) Sciences International Inc has completed substantial work on this project as a subcontractor to 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 Sciences International Inc highly experienced in chemical hazard assessment. Sciences International Inc has provided data collection and evaluation services in the environmental sciences for more than 16 years. (4) Sciences International 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. STATEMENT OF WORKNCEA TECHNICAL SUPPORT FOR PROFESSIONAL SERVICES I. Background Integrated Risk Information System (IRIS) Technical Support for Human Health Risk Assessment and Related Activities for the Development of an Issue Paper evaluating Re-analyses of the Taiwanese Datasets for Inorganic Arsenic II. Scope of Work 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 evaluates recent epidemiological data and commentary/analyses with respect to conclusions of the NRC report of 2001. 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 will also be included. This effort would also include a literature search to for relevant information to support the conclusions of the issue paper. The work plan shall include the following: a. Description of the overall technical approach b. Level of effort c. Staffing d. Schedule for completion of tasks EPA will review the work plan and will clarify any questions with the contractor. The contractor shall develop a JQM/QAPP for this project for the Technical Project Officer's 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. (See Appendix A: Requirements for Use of Secondary Data.) Task 2: The contractor will participate in conference call to discuss any clarification to the scope of work described within the workplan. 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 epidemiology studies since 2001 b. Review of meta-analyses conducted since 2001 c. Review of the available cancer datasets from Taiwan populations, mainly focusing on Chen et al. (1988, 1992) and Wu et al. (1989)d. Review of all analyses existing for the Taiwanese 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 analysise. A detailed rationale of the most logical approach for analyzing the Taiwanese cancer datasets as well as presenting logical explanations of alternative analysis not chosen are inappropriate. This detailed rationale should include a detailed account of the evidence (i.e., supporting data) supporting the conclusionsf. Comparison of Taiwan data to other populations, including Chile and Bangladesh g. Discussion of the increased strength of human evidence in multiple populations since 2001 See Appendix B for a more detailed outline of the paper. Upon completion of the draft document the contractor will submit 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.
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