SOLICITATION NOTICE
R -- Evaluation of Carcinogenicity
- Notice Date
- 4/11/2007
- Notice Type
- Solicitation Notice
- Contracting Office
- Environmental Protection Agency, Program Contract Service Center, 1200 Pennsylvania Avenue, Nw, Washington, DC 20460
- ZIP Code
- 20460
- Solicitation Number
- RFQ-DC-07-00150
- Response Due
- 4/27/2007
- Archive Date
- 5/27/2007
- Description
- NAICS Code: 541620 NAICS code 541620: The U.S. Environmental Protection Agency (EPA) plans to negotiate on a sole source basis with Dr. Kyle Streeland at Emory University. Negotiations shall be conducted pursuant to the authority of 41 U.S.C. 253 (c)(1), which allows for negotiations without full and open competition if there is only one responsible source PART II - SOLE SOURCE JUSTIFICATION Dr. Kyle Steenland, Professor of Environmental and Occupational Health at Emory University, is recommended to conduct the work described in this purchase order. Dr. Steenland has unique qualifications to provide assistance to the Agency in the evaluation of the carcinogenicity of ethylene oxide. He has devoted a significant part of his career to the study and evaluation of the effects of ethylene oxide on humans and has published extensively on the epidemiology of ethylene oxide related effects and methodology for analyzing data that relate to these effects. He is the principal investigator of the study that is the major source of information on mortality in a cohort of people exposed to ethylene oxide [Steenland et al, "Mortality analyses in a cohort of 18, 235 ethylene oxide exposed workers: follow up extended from 1987 to 1998", Occupational and Environmental Medicine (2004), 61:2-7.] The Agency relied heavily on the work of Dr. Steenland and his colleagues in preparing the draft Ethylene Oxide Carcinogenicity Assessment (2006). Dr. Steenland has also published other papers on ethylene oxide epidemiology and papers that deal with general methodology for analyzing epidemiology data that are directly relevant to the evaluation of ethylene oxide. EPA is seeking further analysis and modeling of the data from the ethylene oxide epidemiological studies conducted by Steenland. Dr. Steenland is in possession of these data and computer routines developed to analyze these data for the prior publications. Dr Steenland is thus uniquely placed having both the specialized expertise and the specific data and computer routines required to perform this work assignment. Dr. Steenland is editor for the American Journal of Industrial Medicine and Epidemiology, a member of the American College of Epidemiology and the International Congress on Occupational Health and an editor of 2 books on occupational and environmental epidemiology. Publications authored or co-authored by Dr. Steenland that are relevant to the evaluation of ethylene oxide include the following: Steenland K, Stayner L, Deddens J, Mortality analyses in a cohort of 18 235 ethylene oxide exposed workers: follow up extended from 1987 to 1998 Occup Environ Med 61: 2-7, 2004 Steenland K, Whelan E, Deddens J, Stayner L, Ward E, Ethylene oxide and breast cancer incidence in a cohort study of 7576 women, Cancer Causes Control 14: 531-539, 2003 Stayner L, Steenland K, Greife A, Hornung R, Hayes R, Nowlin S, Morawetz J, Ringenburg V, Elliot L, and Halperin H, Exposure-response analyses of cancer mortality in a cohort of workers exposed to ethylene oxide, Am J Epidemiol 138, 787-798, 1993 Steenland K, Stayner L, Griefe A, Halperin B, Hayes R, Hornung R, Nowlin S, A cohort mortality study of workers exposed to ethylene oxide, New Eng J Med 324,20: 1402-1407, 1991 Greife A, Hornung R, Stayner L, Steenland K, Development of a model for use in estimating exposure to ethylene oxide in a retrospective cohort mortality study, Scand J Work Environ Health 14, suppl 1: 29 30, 1988 Hornung R, Greife A, Stayner L, Steenland K, et al., Statistical model for prediction of retrospective exposure to ethylene oxide in an occupational mortality study, Am J Industrial Med 25:825-836, 1994. Steenland K, Deddens J, Salvan A, Stayner L, Negative Bias in Exposure-Response Trends in Occupational Studies: Modeling the Healthy Worker Survivor Effect, Am J Epidemiol, Vol. 143, No. 2: 202-210, 1996. Steenland K and Deddens J A, Practical guide to exposure-response analyses and risk assessment in occupational epidemiology, Epidemiology 15: 63-70, 2004 Richardson D, Wing S, Steenland K, McKelvey W, Time-related aspects of the healthy worker survivor effect, Ann Epidemiol 14: 633-639, 2004 NCEA TECHNICAL SUPPORT FOR PROFESSIONAL SERVICES STATEMENT OF WORK I. Background The U.S. Environmental Protection Agency's (EPA) Office of Research and Development (ORD) has requested that the EPA Science Advisory Board (SAB) review its draft assessment entitled "Evaluation of the Carcinogenicity of Ethylene Oxide". Ethylene oxide (EtO) is manufactured from ethylene and used primarily as a chemical intermediate in the manufacture of ethylene glycol. It is also used as a sterilizing agent for medical equipment and as a fumigating agent for spices. The focus of the ORD draft assessment is on lifetime cancer risk from inhalation exposure. The SAB Ethylene Oxide Panel met in Washington, DC on January 18-19, 2007 to discuss their review of the draft document and develop a plan of action for writing a panel report documenting the Panel's review. EPA will evaluate the Panel's report, respond to comments from the Panel and issue a revised document that takes into consideration the comments and recommendations from the panel. EPA will also evaluate and respond to comments from the public on the draft assessment. II. Scope of Work The contractor shall perform a number of tasks to support the Agency's evaluation and response to comments on the draft assessment from the SAB panel and the public. The contractor will use his unique, in-depth knowledge of the epidemiological data dealing with effects of ethylene oxide exposure on humans and risk assessment methodology in the performance of these tasks. This contract involves the analysis of secondary data. Secondary data are defined in this context as environmental or health data that exist and are available for analysis. That is, epidemiological data on the carcinogenic effects of exposure to ethylene oxide that were collected prior to the issuance of this contract. This includes data from the NIOSH study of workers exposed to ethylene oxide and may include other relevant data from published literature, from hard copies and computer data bases. Task1: Perform a preliminary evaluation of comments from public commentators on the draft document that address epidemiological issues, carcinogenic risk estimation and related topics. Submit a brief written summary (a minimum of three typewritten pages) of this preliminary evaluation. Task 2: Perform a preliminary evaluation of the epidemiology and risk assessment sections of the draft document titled "Evaluation of the Carcinogenicity of Ethylene Oxide". Submit a brief written summary (a minimum of three typewritten pages) of this preliminary evaluation. Task 3: Identify and perform analyses to further investigate the data on ethylene oxide exposed workers analyzed in the work described in: Steenland K, Stayner L, Deddens J, Mortality analyses in a cohort of 18 235 ethylene oxide exposed workers: follow up extended from 1987 to 1998 Occup Environ Med 61: 2-7, 2004, and Steenland K, Whelan E, Deddens J, Stayner L, Ward E, Ethylene oxide and breast cancer incidence in a cohort study of 7576 women, Cancer Causes Control 14: 531-539, 2003. In particular, further investigation should include evaluation of the use of Poisson regression with various dose-response models as appropriate, e.g., K-power, and segmented linear regression to model the relationship between haematopoetic cancer (and possible subcategories, e.g., lymphoid) and exposure and between breast cancer mortality and incidence and exposure. Also, evaluate the possible use of alternative cut-points for exposure categorization. In addition, identify alternative statistical methods for relating ethylene oxide exposure and cancer effects that employ individual worker data rather than summary or categorical data. Also, evaluate whether the available data will support analysis of: (1) healthy worker survivor effects and (2) an assessment of the effects of uncertainty in exposure estimates. Document analyses performed. The contractor shall provide a detailed descriptive summary of the exposure data for the cohort. A goal of this effort is to assist EPA in making judgments for the EtO assessment regarding the best approach to dose-response modeling of the EtO data set in order to estimate points of departure (PODs) and the associated uncertainties. Additionally, this work should support consideration of alternative statistical 0approaches to this problem that may warrant presentation in EPA's EtO risk assessment. Where appropriate, per EPA technical guidance, the contractor may perform analyses of available results from other EtO epidemiological studies to provide comparison with these results. Task 4: Review all comments received from the American Chemical Council (ACC) on the draft document titled "Evaluation of the Carcinogenicity of Ethylene Oxide" that pertain to epidemiological and related statistical issues. Provide a draft written summary evaluation of all comments reviewed. The summary shall include a response to each significant comment that indicates where commentators have valid issues and where they do not; the technical basis for this finding; and recommendations on what further analyses, if any, should be done to support the response to the comment. Task 5: Review all comments received from the EPA Science Advisory Board Panel on the draft document titled "Evaluation of the Carcinogenicity of Ethylene Oxide" that pertain to epidemiological and related statistical issues. Provide a draft written summary evaluation of the Panel's comments. The summary shall include an assessment of each significant comment and a suggested response. The summary shall indicate the technical basis for the contractor's findings and recommend what further analyses, if any, should be performed to support the contractor's positions. Task 6: In consultation with the Technical Project Officer, determine what, if any, additional analyses should be performed to provide technical support for comment responses to the ACC and /or the Science Advisory Board Panel. Task 7: Perform and document analyses identified in Task 6. III. Deliverables and Professional Services All products by the Contractor must be of high quality, written in a clear concise style, with a logical organization and presentation. Descriptions of analyses performed must: 1. Identify and summarize data employed; 2. Clearly specify models, methodology and assumptions underlying the analyses; 3. Describe results obtained including interpretation of findings that emphasize epidemiological and risk assessment issues and discussion of uncertainties; 4. Describe the quality of the studies, data, and models used, specifically, how the data and the models were determined to be appropriate. 5. Include graphic plots of data and results where appropriate. Products not adhering to these standards, or substantially lacking scientific quality, will not be accepted. The Contractor shall provide all written materials and responses in both hard copy and electronic format. Estimated Delivery and Task Completion Schedule The Contractor shall be responsible for delivering all written materials and professional services accordance with the following time schedule. Deliverables/Meetings Anticipated Completion Dates Tasks 1 and 2 reports 30 days after award Task 3 report 90 days after award Task 4 report 120 days after award Task 5 report 150 days after award* Task 7 report 180 days after award* The Contractor shall report to the NCEA Technical Project Officer (TPO) on a weekly or daily basis as needed. Quality assurance items will be addressed in progress reports and in the draft and final deliverable documents. The Contractor shall not release any of the data collected in this study nor publish any of the results of this work without the written consent of the TPO. *Completion dates for Tasks 5 through 7 may be adjusted pending receipt of SAB Panel comments. This notice of intent is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to the requiring by submitting documentation, to Thomas Martinez at the office identified above, by e-mail (Thomas.Martinez@epa.gov) , which establishes that their specifications meet EPA's requirement. Documentation must be received within fifteen (15) days after the date of publication of this synopsis to be considered by EPA. A determination not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
- Record
- SN01271396-W 20070413/070411221736 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |