B -- RISK ASSESSMENT METHODOLOGY FOR ASBESTOS

Notice Date

November 27, 2000

Contracting Office

55 Broadway; Cambridge, MA 02142

ZIP Code

02142

Solicitation Number

DTRS57-01-R-20007

Response Due

December 11, 2000

Point of Contact

Point of Contact -- Linda Byrne, Contracting Officer, (617) 494-2172

E-Mail Address

Contracting Officer (byrne@volpe.dot.gov)

Description

The Volpe National Transportation Systems Center intends to negotiate on a non-competitive basis with Aeolus, Inc. for contract support to revise and update the current EPA Methodology for conducting Risk Assessments at Asbestos Superfund Sites, including both the protocol itself and the companion technical background document for peer review. The Contractor will be required to complete the required services by March 31, 2001. The current document is based on available epidemiology data up to 1989, as well as a limited number of documents as recent as 1994. The Contractor will be required to complete the following 6 tasks: (1) revise/reconcile the previous literature review; (2) review separate project specific related risk documentation for consistency with the methodology; (3) obtain an d organize data from new and previously analyzed epidemiology studies; (4) review and develop new mesothelioma and lung cancer risk models; (5) apply new risk models to available exposure and mortality data sets; and (6) complete modifications/revisions to finalize the existing methodology. Aeolus, Inc. has extensive expertise regarding asbestos morphology and mineralogy, risk assessment research and development, statistical support, data analysis, and risk model development and implementation. The Contractor is required to have an in-depth understanding of the history of the methodology s development and the interrelationship and particulars of each of the separate efforts that were part of its development. The Contractor must also possess all of the original raw and model data sets an d documentation that was reviewed and prepared in the development of the original methodology, including electronic versions of all text, tables, and figures associated with the current protocol and background document. The Contractor will also need to posses the modeling and raw data associated with the animal inhalation studies used previously to reconcile the epidemiological dose response factors and will be needed to develop the new recommended exposure indices. It should be noted that not all the required documentation is referenced or identified within the methodology documents (protocol and background document). Due to the potential for this methodology to be used as part of an ongoing DOT/EPA project responding sources must conduct a Conflict of Interest screening and provide th eir opinion as to whether they have a Conflict with W.R Grace and the performance of this work. The following is a summary of the tasks required as part of this effort. The Contractor will be required to search the literature (approximately 300+ documents) published since 1989 to identify relevant studies to be acquired and incorporated into an updated literature review and reconciliation. The purpose of this effort is to both verify that the procedures proposed in the existing protocol agree with updated literature and to identify/address potential conflicts and inconsistencies in the asbestos literature that might otherwise suggest alternate approaches to asbestos risk assessment. The Contractor will identify relevant asbestos studies (primarily those published after 1994) and evalu ate their abstracts. In addition, the Contractor will collect and evaluate epidemiological studies from periods as early as 1989 and related supporting studies for inclusion in analysis. Based on this initial screening, the Contractor will identify and acquire key studies for more formal review, evaluation, and reconciliation with the approximately 1400+ articles/literature already reviewed during development of the risk assessment protocol. The Contractor will be required to obtain, review, and organize data to be modeled for the purpose of deriving new (updates to existing) recommended risk factors and exposure indexes. This will be accomplished by pairing epidemiological studies with studies that characterize exposure in the same or comparable environments. This effort will include t he following activities: (1) updating mortality data from previously analyzed studies, using the full range of available follow-up studies; (2) developing new limited exposure level/mortality matrices, for studies from new relevant environments; (3) securing access to original raw mortality data and exposure samples, for previously considered and follow-up studies; and (4) developing detailed exposure-level mortality matrices using raw data and characterization analysis of exposure samples, from selected key studies. The Contractor will be required to reevaluate the appropriateness of the current mesothelioma model being used to derive recommended risk factors and exposure indexes, as compared to a new alternative biologically-based model. The Contractor will compare results from the two models using data from studies in which follow-up has been extended the longest, to determine which is most consistent with the available data. The Contractor will also develop risk estimates from the alternate model, if it is found to be consistent with the data, to indicate the range of lifetime risks that may be estimated for mesothelioma, given defined exposure. The Contractor will be required to develop a similar model that can account for the time-dependent persistence of fibers in the body as applied to lung cancer and to compare predictions based on this model with predictions from the lung cancer model traditionally employed by EPA to determine which model is most consistent with available data. The Contractor will be required to evaluate the reconciled exposure and mortality d ata using the recommended mesothelioma and lung cancer models, so that exposures that are functions of fiber type and size can be fit to the observed mortality (lung cancer and mesothelioma) incidence in the studies. The Contractor will evaluate the data to reconstruct person-years (and mortality incidence) as a multi-variate function of time since first exposure, duration of exposure, and cumulative exposure. Model fitting will be performed explicitly for a selected subset of epidemiological studies from which the raw data could be obtained. The Contractor will then apply the models to the published data from the remaining epidemiological studies, by incorporating whatever exposure assumptions are required. Once the literature evaluation, sample analysis, model development, evaluation o f exposure and mortality data from selected studies, and updates to the evaluation of the epidemiological database are completed the Contractor will revise Methodology for Conducting Risk Assessment at Asbestos Superfund Sites accordingly. The Methodology revision will address all relevant text, figures, and tables of both the Protocol and companion Technical Background Document, including revisions to referenced appendices. If you feel that you have the capabilities required to perform this contract, please submit no more than three written pages stating your experience with the above mentioned requirements and capability of performing the work within the identified time constraints. This documentation must include information related to your Past Performance on similar projects of the s ame scope and magnitude. See Note 22.

Web Link

Volpe Center Acquisition Division home page (http://www.volpe.dot.gov/procure/index.html)

Record

Loren Data Corp. 20001129/BSOL003.HTM (D-332 SN507499)