FBO_SOW.doc

Statement of Work

Industrial Hygiene Support

For Occupational Epidemiology Studies

A. Background

The Occupational and Environmental Epidemiology Branch (OEEB) within the National Cancer Institute (NCI) carries out studies of occupation and environment-related risk. These studies include retrospective assessment of historical exposures through industry and questionnaire-based evaluations; on-site evaluation of exposures through air, dermal and biological monitoring; and evaluation of early biologic effects and genetic susceptibility.

The OEEB has lost four industrial hygienists over the last several years, and has managed to replace only one person with a new, tenure-track investigator after multiple and extensive international recruitment efforts. As a consequence, the OEEB established a contract with the Institute of Risk Assessment Sciences at the University of Utrecht in the Netherlands (MQ607973/ HHSN261200800353P, May 22, 2006 – May 21, 2009) to provide industrial hygiene support for its occupational epidemiology studies, which has been critical to the progress and success of several key projects carried out by its investigators. A second contract providing continuous industrial hygiene support was established with the Institute of Risk Assessment Sciences at the University of Utrecht (HHSN261200900680P, September 28, 2009 – September 27, 2012). There is still a need for substantially greater industrial hygiene support of OEEB projects than can be provided by current OEEB staff. Therefore, an urgent need exists for continued senior level industrial hygiene support with specific expertise in epidemiologic applications of industrial hygiene to meet critical needs on five major research areas: 1)-studies of workers exposed to diesel exhaust (Diesel Studies), 2)-studies of benzene exposed workers in China (Chinese Benzene), 3) studies on formaldehyde exposed workers in China, 4)-a study on indoor air pollution and lung cancer (Qujing Lung Cancer Study) and 5) a study on risk factors for lymphoma (Asialymph).

Diesel Studies

Diesel exposed miners study (DEMS)

The NCI, in collaboration with the National Institute for Occupational Safety and Health (NIOSH), is conducting a study to evaluate the mortality of roughly 12,400 mine workers exposed to diesel exhaust since the late 1940s in eight mines across the United States. Exposure to diesel exhaust has been estimated based on measurements collected from facility based 1998-2001 personal respirable elemental carbon (REC) data, which were back-extrapolated using regression models of historical carbon monoxide (CO) measurements and diesel exhaust (DE) determinants such as engine horsepower and mine ventilation rates. In addition, to account for lower emissions from newer cleaner engines, the horsepower of engines purchased after 1990 was accounted for in the regression analyses. The exposure assessment and epidemiological results have been published. New analyses involve uncertainty analysis to evaluate the potential impact of assumptions in exposure assessment on study results. Furthermore, additional exposure analyses are foreseen that will require continuous industrial hygiene support.

Diesel biomarker study

Epidemiology studies have provided evidence that diesel exhaust causes lung cancer. However, the biological mechanism of this association remains unclear. Several mechanisms have been proposed including direct genotoxic effects by nitro- and methylated polycyclic aromatic hydrocarbons (PAHs), oxidative damage, changes in gene expression patterns and DNA methylation, and inflammatory effects from particulate deposition, all of which will be investigated in a cross-sectional molecular epidemiology study of workers exposed to diesel exhaust. An important component of this study is the exposure assessment component, which must be conducted in such a way as to be scientifically comparable to the methods and analysis used in the aforementioned DEMS study and to the Quijing lung cancer study (see below), all of which require comprehensive assessment of exposure to toxic elements in air.

Chinese Benzene

The NCI, in collaboration with the Beijing Center of Disease Control (CDC), China is conducting a case-cohort study evaluating the occurrence of hematopoietic malignancies and related disorders of about 3,000 benzene exposed workers. The goal of the exposure assessment is to develop quantitative estimates of benzene and toluene for all subjects from the late 1940’s to 1998. Exposure models are built using a novel Bayesian framework and include information on historical exposure measurements of benzene and toluene, historical information on potential exposure determinants, and individual work characteristics. Models are currently expanded to cover jobs outside the cohort factories as well as to include other exposures such as xylene and other co-exposures. Expertise is needed to combine all information for assignment of life-time benzene exposure estimates and important co-exposures, to be used for assessing benzene-related risks in the case-cohort study. As there are many implicit and explicit steps in the reconstruction of the historical benzene exposure, uncertainty analysis to evaluate the potential impact of critical assumptions in exposure assessment on study results are planned.

Formaldehyde Study

The NCI, in collaboration with investigators at the Guangzhou National Poison Control Center (GNPCC) in Guangdong, China, conducted a pilot cross-sectional biomarker study of individuals exposed to formaldehyde. The industrial hygiene evaluation played a key role in this study, and included evaluation of current and past air exposures, and relevant co-exposures. NCI will conduct a large follow-up study of early biologic effect biomarkers in workers exposed to formaldehyde in collaboration with the GNPCC. This study requires intensive exposure assessment support to ensure a high-quality study, which must be conducted in such a way as to be scientifically comparable to the methods and analysis used in the previous pilot study.

Qujing Lung Cancer Study

The NCI is conducting a hospital-based case-control study of lung cancer among women in China in the Qujing district of Yunnan Province, where lung cancer is caused in great part by exposure to the indoor combustion products of smoky coal, and a cross-sectional exposure assessment survey of 150 homes to develop exposure models for integration into the analysis of the case-control study. Industrial hygiene expertise is needed to assist the NIC in processing and analyzing exposure data collected as part of the cross-sectional survey, and to assist in develop empirical exposure models based on measurements of toxic components in air and in coal samples to estimate exposure to known and suspected lung carcinogens for each case and control in the case-control study of lung cancer.

Asialymph

The multi-center international hospital based case-control study of lymphoma in Asia (Asialymph) is being conducted by NCI in four study centers in Eastern Asia: Hong Kong, Chengdu, Tianjin, and Taiwan. The primary scientific objectives of Asialymph are to evaluate the etiology of lymphoma in Asia with a main focus on chemical, viral, and lifestyle exposures and genetic susceptibility. In particular, studying the relationship between occupational exposure to benzene, trichloroethylene (TCE), and formaldehyde and risk of lymphoma is a major goal of the study. To assess exposure to these agents for the subjects in the study, detailed occupational information are collected from study individuals. NCI has previously conducted cross-sectional studies exposed to benzene, formaldehyde and TCE and one occupational cohort study of workers exposed to benzene in China, and it is important that the data and expertise from the exposure assessment of these previous studies are applied to the exposure assessment component of Asialymph. Exposure to these chemicals in Asialymph will be estimated using a combination of computer-aided expert assessment and linkage with exposure databases. Industrial hygiene support is needed to work with local industrial hygienists in each center to collect and assist in developing occupational exposure databases, and for the development of historical quantitative estimates to these chemicals using combined approached of expert assessment and quantitative historical data.

B. Purpose and Objectives of the Procurement

The purpose of this procurement is to obtain the services of a contractor experienced in the area of industrial hygiene applications to epidemiologic research on environmental and occupational determinants of cancer with a specific expertise in exposure assessment of benzene, trichloroethylene, formaldehyde, indoor air pollution, diesel exhaust and particulate exposure in particular in occupational circumstances in Asia. The Contractor shall provide services to support OEEB research activities in the areas of workers exposed to diesel exhaust in the United States and China, of workers exposed to benzene in China, of workers exposed to formaldehyde in Asia, of nonsmoking women exposed to indoor air pollution in China, and of subjects exposed to chemicals in the Asialymph study. Services of the Contractor shall include leadership in providing the following to the above studies: a) provide technical support on approaches for environmental and occupational exposure assessment, b) provide comprehensive oversight in the assessment of current and historical environmental and industrial exposures in support of OEEB epidemiologic studies, and c) provide technical support to statistical data analysis for relating these exposures to disease risk.

C. Contractor Requirements

The Contractor shall perform the following tasks.

Base Year

Period of Performance: One year from Date of Award and two (2) One-year option years.

In the first year of the contract the Contractor shall provide support on the following studies: 1) Diesel studies, 2) Chinese Benzene, 3) Formaldehyde, 4) Qujing Lung Cancer Study, and 5) Asialymph. The specific tasks to be accomplished and time allocated for each study follows:

Diesel Studies In relation to DEMS, the Contractor shall:

· Provide technical support for analyses extending the DEMS exposure-response analyses to the general environment

· Provide technical support for additional exposure analyses based on issues raised by stakeholders and other reviewers of the DEMS

· Participate in discussions regarding the publication of the results of the DEMS

· Attend public review meetings on this study and be prepared to make presentations on the models used in the exposure assessment and their development

In relation to the Diesel Biomarker Study, the Contractor shall:

· Maintain and update the exposure database on diesel surrogates and other exposure information collected as part of the study

· Provide data management in relation to the development of an analytical dataset of the exposure data, using approaches agreed upon with NCI for handling any missing data and logical discrepancies

· Support the development of individual and group-based estimates of measured air contaminant exposures (REC and concomitant exposure) that can be used in the epidemiological analyses

Chinese Benzene In relation to the Chinese Benzene Study the Contractor shall:

· Maintain and update the exposure database on benzene and other exposure information collected as part of the study

· Provide technical support for the conduct of uncertainty analyses by preparing assessments of the uncertainties in key steps of the exposure assessment.

· Provide support to the government on questions arising from the public release of study results

Formaldehyde Study

In relation to the Formaldehyde Study the Contractor shall:

· Maintain and update the exposure database on formaldehyde and other exposure information collected as part of the study

· Provide data management in relation to the development of individual and group-based estimates of measured air formaldehyde exposures that can be used in the epidemiological analyses

· Provide support to the government on questions arising from the public release of study results

Qujing Lung Cancer Study In relation to the Qujing Lung Cancer Study the Contractor shall:

· Maintain and update the exposure database on indoor air pollutants and other exposure information collected as part of the study

· Provide technical support for the development of quantitative empirical exposure models for quartz, fine particulate matter (PM2.5) and soot to predict exposures for all subjects in the Quijing case-control and biomarker study

Asialymph In relation to the Asialymph Study the Contractor shall:

· Maintain and update the exposure database on benzene, TCE and formaldehyde measurements and other exposure information collected as part of the study

· Provide comprehensive oversight of the local industrial hygienists to review local exposure databases developed for the collection of historical benzene, TCE and formaldehyde measurements collected in the geographical regions included in Asialymph

· Participate in NCI lead site-visits to study centers to meet with study center managers and interviewers to review the occupational component of Asialymph including data collection, CAPI-system

· Provide technical support to the industrial hygienists in the different centers in filling the exposure databases with historical benzene, TCE and formaldehyde measurements

· Provide training and auditing on expert review of obtained occupational information to assess the probability, intensity and frequency of exposure to benzene, TCE and formaldehyde.

First Option Year

Period of Performance: Twelve Months If exercised by NCI, during the second year of the contract the Contractor shall work on the following studies: 1) Diesel studies, 2) Chinese Benzene, 3) Qujing Lung Cancer Study, and 4) Asialymph. The specific tasks to be accomplished and time allocated for each study follow.

Diesel Studies In relation to the DEMS Study, the Contractor shall:

· Provide technical support for analyses extending the DEMS exposure-response analyses to the general environment

· Provide technical support for additional exposure analyses based on issues raised by stakeholders and other reviewers of the DEMS

· Participate in discussions regarding the publication of the results of the DEMS study

· Attend public review meetings on this study and be prepared to make presentations on the models used in the exposure assessment and their development

In relation to the Diesel Biomarker Study, the Contractor shall:

· Maintain and update the exposure database on diesel surrogates and other exposure information collected as part of the study

· Provide IH support to the government on questions arising from the public release of the benzene study results

· Provide data management in relation to exposure analyses based on concerns raised by stakeholders and other reviewers of the diesel biomarker study

Chinese Benzene In relation to the Chinese Benzene Study the Contractor shall:

· Maintain and update the exposure database on benzene and other exposure information collected as part of the study

· Provide IH support to the government on questions arising from the public release of study results

· Attend public review meeting on this study and be prepared to make a presentation on the models and their development

Qujing Lung Cancer Study In relation to the Qujing Lung Study the Contractor shall:

· Maintain and update the exposure database on indoor air pollutants and other exposure information collected as part of the study

· Provide data management in relation to the development of a framework for multiple exposure analyses and endpoints

· Provide technical support on exposure assessment to the government on questions arising from the public release of the study results Asialymph In relation to the Asialymph Study the Contractor shall:

· Maintain and update the exposure database on benzene, TCE and formaldehyde measurements and other exposure information collected as part of the study

· Provide comprehensive oversight of the local industrial hygienists to review local exposure databases developed for the collection of historical benzene, TCE and formaldehyde measurements collected in the geographical regions included in Asialymph

· Participate in NCI lead site-visits to study centers to meet with study center managers and interviewers to review the occupational component of Asialymph including data collection, CAPI-system

· Provide technical support to the industrial hygienists in the different centers in filling the exposure databases with historical benzene, TCE and formaldehyde measurements

· Provide services to enhance and refine further development on CAPI-system, job-modules and associated keywords to ensure optimal functionality in the field.

Second Option Year

Period of Performance: Twelve Months If exercised by NCI, during the third year of the contract the Contractor shall work on the following studies: 1) Diesel studies, 2) Chinese Benzene, 3) Qujing Lung Cancer Study, and 4) Asialymph. The specific tasks to be accomplished and time allocated for each study follow.

Diesel Studies In relation to DEMS, the Contractor shall:

· Provide technical support for additional exposure analyses based on issues raised by stakeholders and other reviewers of the DEMS

· Participate in discussions regarding the publication of the results of the DEMS study

· Attend public review meetings on this study and be prepared to make presentations on the models used in the exposure assessment and their development In relation to the Diesel Biomarker Study, the Contractor shall:

· Maintain and update the exposure database on diesel surrogates and other exposure information collected as part of the study

· Provide IH support to the government on questions arising from the public release of the benzene study results

· Support refinements of the exposure analyses based on concerns raised by stakeholders and other reviewers of the diesel biomarker study

Chinese Benzene In relation to the Chinese Benzene Study the Contractor shall:

· Maintain and update the exposure database on benzene and other exposure information collected as part of the study

· Provide IH support to the government on questions arising from the public release of study results

· Attend public review meeting on this study and be prepared to make a presentation on the models and their development

Qujing Lung Cancer Study In relation to the Qujing Lung Study the Contractor shall:

· Maintain and update the exposure database on indoor air pollutants and other exposure information collected as part of the study

· Provide exposure assessment support to the government on questions arising from the public release of the study results Asialymph In relation to the Asialymph Study the Contractor shall:

· Maintain and update the exposure database on benzene, TCE and formaldehyde measurements and other exposure information collected as part of the study

· Provide comprehensive oversight of the local industrial hygienists to review local exposure databases developed for the collection of historical benzene, TCE and formaldehyde measurements collected in the geographical regions included in Asialymph

· Participate in NCI lead site-visits to study centers to meet with study center managers and interviewers to review the occupational component of Asialymph including data collection, CAPI-system

· Provide technical support to the industrial hygienists in the different centers in filling the exposure databases with historical benzene, TCE and formaldehyde measurements

· Provide services to enhance and refine further development on CAPI-system, job-modules and associated keywords to ensure optimal functionality in the field.

· Provide service to enable exposure modeling of the quantitative historical exposure data on benzene, TCE and formaldehyde to models for quantitative population based exposure assessment in the Asialymph study D. Government Responsibilities

The NCI will provide suitable office space, as well as usual and necessary resources (including computer, software, peripherals, and common office supplies) to accommodate the Contractor during visits to the OEEB office in Montgomery County, MD.

Diesel Studies

The government will provide electronic databases of all measurement data, job information, work histories, and determinants data available in the study. These databases will be generated in Excel or Access.

Chinese Benzene The government will provide all collected data to the Contractor in pdf format and as data files in Excel or Access.

Formaldehyde Study

The government will provide all collected data to the Contractor in pdf format and as data files in Excel or Access.

Qujing Lung Cancer Study The government will provide all collected data to the Contractor in pdf format and as data files in Excel or Access.

Asialymph The government will provide all collected data to the Contractor in pdf format and as data files in Excel or Access.

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