SOW_for_SOL-DC-14-00002.docx

STATISTICAL & TECHNICAL SUPPORT FOR THE ASSESSMENT OF TOXIC SUBSTANCES

BACKGROUND

The Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) of the Office of Chemical Safety and Pollution Prevention Washington, D.C., under the auspices of the Toxic Substances Control Act (TSCA), (Sections 4, 5, 6 and 8 (Title IV) and Goal 4 - of the OPPT Mission; Healthy Communities and Ecosystems; Sub-objective 4.1.1: Reduce Chemical Risks; has the responsibility to collect data for chemical assessments and to support the regulatory and pollution prevention activities of the Office. These studies relate to organic and inorganic substances under the jurisdiction of TSCA.

OBJECTIVE

The purpose of this procurement is to provide statistical, mathematical, field data collection, and technical analysis support and planning for OPPT programs. This capability is needed to identify long and short term program objectives, develop well formulated data collection programs, provide the means to track progress made toward meeting stated program objectives and to conduct those statistical, technical and scientific studies that will provide for technically feasible, fiscally sound and effective programs. OPPT also provides support for programs in the areas of economics, chemistry, engineering, and exposure assessment. OPPT’s economic analysis supports rulemaking and helps the Agency determine promising non-regulatory approaches. OPPT also manages the Risk -Screening Environmental Indicators Model, which provides information on the relative risk impacts of chemical releases from industrial facilities, and leads the Design for the Environment and Green Chemistry Programs, which focus on voluntary pollution prevention.

The work performed under this solicitation will include EPA’s lead-based paint (LBP) program, which has a goal of eliminating childhood lead poisoning as a major public health concern. The LBP program provides technical and program development assistance to the U.S. Department of Housing and Urban Development (HUD) in the areas of detection, measurement, and abatement/management of lead-based paint hazards in housing. This support was formalized in a Memorandum of Understanding between EPA and HUD signed in the spring of 1989. The Residential Lead-Based Paint Hazard Reduction Act of 1992 (Title X) gives EPA a strong role in addressing the national problems of lead-based paint in housing and the broader problem of childhood lead poisoning. EPA’s lead strategy recognizes lead-based paint in housing as an important contributor to elevated blood lead levels in children. More specific program goals and objectives will be identified in work assignments.

EPA’s budget and individual projects are tied to the Government Performance and Results Act (GPRA) goals. The agency is required to report to the Congress on its progress towards meeting those goals. This procurement may be used to evaluate EPA’s progress under specific GPRA goals.

SCOPE OF WORK

The contractor shall develop reasonable and cost-effective approaches to accomplish the objectives of each work assignment. Various financial and time constraints specified in work assignments will limit the extent of any project and the contractor shall deliver optimum value in light of these constraints. As specified in work assignments, the contractor shall develop the required data in a format (specifications to be provided in work assignments or by written technical direction) which is compatible and consistent with existing data and databases. The contractor shall comply with the agency’s Quality Program Policy Standards and Procedures, per EPA Orders CIO 2106.0 and CIO 2105.0 in the performance of the work under this contract. During performance of the contract, the contractor shall immediately inform the Project Officer by telephone and in writing of any problems that impede performance, suggest corrective actions necessary to solve the problems, and implement these actions as specified by the contracting officer.

The contractor shall perform tasks, as specified by work assignments, in the following five areas: (1) Collection of Data; (2) Analysis of Data; (3) Technical Program Support- General; (4) Technical Support-Specific and (5) Physical Testing. All activities will be accomplished using level of effort contracting and performance-based contracting.

The contractor is required to comply with all Section 508 requirements in work areas that are held to such requirements under EPA Order 2100.

All contractor, subcontractor, and consultant personnel shall wear prominently displayed identification badges at all times when performing tasks under this contract when interaction with EPA officials, federal agencies, state, tribal and local governments, businesses, industry and the general public. The badge shall contain the individuals name and the company’s name and logo. When participating in any event, meeting or discussion, contractor staff shall verbally identify themselves as contractor personnel, so that there is not a possible appearance of being EPA officials.

The contractor shall submit all analyses, options, recommendations, reports and training materials required under this contract in draft for critical review by the contracting officer or contracting officer’s representative (COR). The Government will make all final regulatory, policy and interpretive decisions resulting from contractor-provided recommendations. The contractor shall not publish or otherwise release, distribute or disclose any work product generated under this contract without obtaining EPA’s express written approval. When submitting materials or reports that contain recommendations, the contract shall: explain or rank policy or action alternatives, describe procedures used to arrive at recommendations, summarize the substance of deliberations, report any dissenting views, list the sources replied upon, and detail the methods and considerations upon which the recommendations are based.

The contractor shall prepare a Quality Assurance Project Plan (QAPP) and obtain EPA approval of the QAPP before the conduct of environmental data activities.

DELINEATION OF TASKS

Task I. Collection of Data

1. Develop and implement statistically-valid experimental and survey designs for field monitoring, laboratory studies or other data collection efforts, including the design of data collection forms. A particular study to be performed by the contractor may involve one or more environmental media and the detection and quantification of residue levels of one or more chemicals. The contractor shall determine probable biases and sources of error due to sampling and analytical methods employed and recommend design and/or analysis modifications to minimize error. The contractor shall recommend the proper sample collection program. The contractor shall assess the method of sample collection and the chemical analytical procedure in the design of collection routine. The contractor shall evaluate the basic design issues concerning the method of specimen collection, time period of collection, and duration of the collection effort to ensure statistically-valid and reproducible results.

2. As specified in individual work assignments, the contractor shall:

a. Develop the statistical design for a national or local probability survey where data collection involves the gathering of information, such as information on consumer habits or the work practices of various subgroups exposed to a particular chemical or group of chemicals. The contractor shall develop a sampling frame using available resources to target and access the desired population. The survey developed by the contractor may use telephone or mail procedures for data collection and the contractor shall design and test a questionnaire for obtaining the necessary information.

b. Collect and/or measure environmental and biological samples and administer questionnaires and perform visual inspections or visual assessments, and provide appropriate training for personnel who perform such tasks.

c. Prepare sufficient documentation for administering a questionnaire or similar device to persons participating in a data collection effort. The documentation prepared by the contractor shall adhere to OMB approval requirements, and shall comply with OPPT objectives as specified in work assignments.

d. Perform probabilistic modeling to test proposed sampling protocols in order to optimize study design.

e. Provide expertise and perform tasks related to preparation of information collection packages under the Paperwork Reduction Act for purposes of EPA obtaining Office of Management and Budget (OMB) approval for data collection activities. The contractor shall perform in accordance with EPA Guidance on completing information collection packages.

f. Provide expert technical or peer review of statistical studies, including review and comment upon various monitoring protocols and studies.

g. Develop statistically-valid options for study and experimental design including sample size, schedule and cost options. The contractor shall include the pros and cons for each option.

h. Develop and implement results and performance evaluation studies, to evaluate federal, state, or local government programs, regulations, and guidance. This includes the development of plans, designs, objectives, sampling frames, questionnaires, and other survey instruments. This also includes training survey staff with appropriate training materials, contacting survey participants and administering questionnaires and collecting samples as necessary.

Task II. Data Analysis

1. The contractor shall provide the statistical and other technical expertise necessary to support ongoing OPPT programs including: analyzing data, interpreting results, writing reports for publication, providing briefing materials and carrying out briefings on status and results, performing all necessary quality assurance, (including validation) studies, conducting pilot studies as necessary prior to implementation of full studies, and tracking the status of the studies.

2. The contractor shall perform the following tasks: determine the reliability of the data; extrapolate results for exposure assessment studies and exposure projections, conduct model development validation and prediction verifications from previous studies, and apply the data to programs other than the program which initiated the specimen collection and chemical analysis effort as needed.

3. The contractor shall process and analyze existing data sets containing data from previously conducted monitoring studies. The contractor shall interpret existing data in light of EPA information needs and objectives as specified in work assignments and present results in both statistical and non-statistical language. In addition, the contractor shall develop and maintain databases resulting from monitoring and field studies, as well as those data collected via other means, and provide documentation of the databases.

4. The contractor shall: utilize state-of-the-art statistical methodology, such as pattern recognition techniques or measurement error analyses, where appropriate, to analyze data collected by the contractor or to analyze data furnished by EPA; analyze data using appropriate statistical techniques commensurate with the way the data was collected; provide documentation of data sources and data description, and documentation of analysis techniques and methods; conduct simulation studies and perform mathematical or probabilistic modeling to test proposed sampling and data collection protocols in order to evaluate the efficiency of the study design; write reports on data analysis for publication and develop and maintain databases resulting from monitoring and field studies, as well as those data collected via other means, and provide required documentation.

5. The contractor shall provide statistical and analytical quality assurance expertise and perform tasks necessary to support OPPT, and the National Program Chemicals Division. Specifically, the contractor shall support the exposure assessment activities through the collection and analysis of new and existing data, and provide an assessment of their applicability to Agency needs. The contractor shall perform the following tasks: a) determine the quality and reliability of the data; b) extrapolate results for exposure assessment studies and exposure projections; c) conduct model development, validation and prediction activities from previously existing studies; and d) apply the data to other programs as necessary.

6. The contractor shall conduct statistical analysis of chemical assessment data, quantitative risk assessments (QRAs), hazard assessments, and epidemiological studies and reviews.

Task III. Technical Program Support - General Support

1. Provide literature searches of technical studies on technical or scientific topics and provide lists and/or summaries of the studies obtained through the literature search.

2. Provide technical review or peer review of statistical, biostatistical, epidemiologic and other technical studies, or portions of those studies. This includes review of plans, designs, protocols, statistical and chemical analysis methods, questionnaires, data analyses, draft and published reports, brochures, pamphlets, and journal or book articles.

3. Develop guidelines and fact sheets for dissemination to both professionals and to the general public. Conduct focus groups or other review mechanisms by the intended users of the guidelines or fact sheets to obtain feedback and reaction prior to publication.

4. Provide data and accompanying documentation in appropriate paper and computer file formats that can be released to EPA, other federal and state agencies, and to the general public. The format of the data can vary from ASCII files, to Word files, to SAS files.

5. Use or develop statistical analysis and economic/risk assessment procedures to evaluate competing technologies on the basis of their cost effectiveness, their effectiveness toward meeting program objectives and the technological risks associated with the program’s likelihood of success.

6. Plan, design, and implement public seminars or workshops both nationally and internationally on technical issues at which recognized experts would have the opportunity to present state-of-the-art methodologies, results, and emerging issues.

7. Develop and present technical training sessions for EPA staff in statistics, chemistry, biology, epidemiology, and computer science.

8. Develop products or deliverables required under this contract utilizing available technological approaches for information dissemination that are appropriate to the subject matter involved. Existing techniques, information formats and information dissemination approaches can include, but are not limited to: Compact Disc, Video and Audio Recordings, Internet accessible information files, Color graphics, and Local and Wide Area Networks. The use of these technologies shall be identified in the work plan and approved by the work assignment manager.

9. Provide briefing and presentation materials on the analyses and projects conducted under this contract. Conduct briefings when requested on the analyses and projects conducted under this contract.

10. Complete reports for EPA publication on the projects conducted under this contract. This includes responding to all technical and editorial comments on the draft reports so as to produce a final report that meets EPA criteria and standards for publication, developing and producing report cover designs consistent with EPA standards, submitting camera-ready copies of the report and cover design for submission to the EPA print shop, and, if requested in the work assignment, a version of the report suitable for inclusion on an Internet Web Page.

11. As specified in work assignments, coordinate and conduct meetings and briefings at which the contractor shall present results of the research and analyzes performed under this contract. The contractor shall present technical papers at conferences. The contractor shall also conduct focus groups and stakeholder meetings with the objective of obtaining feedback and reaction from interested parties regarding technical products and planning.

12. Develop publication formats using state-of-the-art technology, such as videos, CD-ROMs, computer diskettes, Internet-accessible files, illustrated brochures, and presentation slides, overheads, and graphics to make technical reports, guidelines, fact sheets, and other products available to the widest possible audience.

13. Where required, provide logistical support for technical meetings. This support includes, but is not limited to, providing meeting space when Government space is not available; court reporter services; appropriate meeting presentation equipment; preparation of agendas; meetings information to participants; and proceedings of the meeting.

14. Develop strategy documents for responding to health, environmental, and related issues.

15. Develop technical guidelines and provide support for the development of regulations for TSCA chemicals.

Task IV. Technical Program Support - Program Specific

1. Conduct technical studies on a variety of TSCA program issues. The contractor shall evaluate new and emerging technologies to assess their impact on meeting the objectives of the TSCA program.

2. Evaluate current and proposed technology to measure, detect, or reduce exposure to toxic substances, including lead, mercury, polychlorinated biphenyls, and other chemicals or concern under TSCA.

3. Support programs that evaluate the risks of classes of chemicals by maintaining program information, tracking progress of program chemicals, evaluating correspondence and test plans, providing robust summary submissions and updating the web site as well as analyzing program status.

4. Provide support to the Lead Renovation, Repair, and Painting regulation for Public and Commercial Buildings. This may include research on work practices and maintenance procedures.

5. Provide support to the Mercury Program in the areas of addressing mercury releases, addressing mercury uses in products and processes, managing commodity-grade mercury supplies, communicating to the public about mercury exposure risks, addressing international mercury sources and conducting mercury research.

6. Provide risk exposure assessments relating to PCBs and other potential environmental contaminants such as Mercury and Dioxins. These assessments are performed using easily available information from the open literature, EPA files or other sources and require experience in conducting environmental chemical/compound (PCBs, Dioxins, Mercury) risk investigations. Specifically, this element includes, but is not limited to: (1) maintaining PCB Transformer Registration spreadsheets; (2) developing and formating outreach materials for chemicals of interest; (3) conducting peer reviews of technical guidance, and (4) conducting market surveys.

7. The contractor shall provide support to EPA’s Existing Chemicals Program which addresses pollution prevention, risk assessment, hazard and exposure assessment and characterization, and risk management for chemical substances in commercial use. For the chemicals that EPA identifies as high hazard and risk, EPA will choose from among many actions that it is authorized to take under the Toxic Substances Control Act. The Agency may pursue such regulatory actions as restricting chemical use through banning its manufacture/import, issuing Significant New Use Rules that require manufacturers/importers to alert EPA of any new uses, and publishing test rules that require the chemical industry to supply EPA with additional data. Among other options, the Agency will also analyze safer substitute chemicals and consider voluntary phase-outs from the chemical manufacturers. Specifically the contractor shall assist EPA with managing chemical data under its Chemical Data Reporting (CDR). Work may include supporting Internet communications, preparing webinar and training modules, and producing outreach materials. EPA may ask for help in querying CDR information, and may also require assistance in querying previous chemical data reporting cycles related to the Inventory Update Reporting (IUR) periods of 2006 and earlier. EPA may request CDR/IUR statistics in terms of chemical production volume, companies, industrial processing and use, consumer and commercial use, and other related information.

Task V: Physical Testing

1. The contractor shall apply Quality Assurance (QA) methodology and guidelines, including Quality Assurance Project Plans (QAPPs) and Data Quality Objectives (DQOs), to all physical testing requirements specified in the individual work assignments. Because of the complexity and variety of these requirements, the performance objectives, and performance standards will be defined at the work assignment level. A Quality Assurance Plan (QAPP) shall be submitted by the contractor in accordance with the schedule for each work assignment. Testing will not commence until the EPA Quality Assurance Manager has approved the QAPP. The QAPP shall be the primary evaluative tool for the Project Office when determining successful performance.

2. The contractor shall perform laboratory analysis of environmental and biological samples for the full range of the Office of Chemical Safety and Pollution Prevention chemicals. All testing shall be performed in accordance with the approved QAPP. These tests and analysis include, but are not limited to, inorganic compounds such as lead, mercury and other heavy metals; Persistent, Bioaccumulative and Toxic chemicals such as mercury, cadmium and lead; organic compounds such as dioxin, furans and PCBs; endocrine disruptors such as estrogen and androgens; Voluntary Children’s Chemical Evaluation Program chemicals such as perfluorooctanoic acid (PFOA) and vinylidene chloride; isotopic analysis of compounds such as lead oxide to determine the source of the element or compound; geochemical reactions such as mercury methylation in sulfur cycling; microbial agents and biochemical reactions ; and blood, hair, urine and various types of tissue samples from both humans and animals. This shall be accomplished using state-of-the-art quality control and quality assurance mechanisms to ensure the validity of the laboratory results. Frequently, the analyses will require analytical methods that are commonly available in commercial laboratories.

3. QAPPs shall include the following information: problem definition; quality objectives and criteria for measurement data; experimental design; analytical methods; quality control; data management; assessment/oversight; data review, validation and verification; verification and validation methods; and reconciliation with user objectives. Specific QAPP requirement will be specified in the individuals work assignments.

PERFORMANCE MEASURES

Task I. Collection of Data

Once a year (during each contract period of performance) the Government shall review the promptness of submitting a final report as required in the work assignment. If the contractor is late more than 14 calendar days, from the due date as specified in the work assignment, the Government shall take a 10% reduction in the fee associated in that Work Assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Once a year (during each contract period of performance), the Government shall review the completeness of the report as required in work assignment. If the contractor’s report is incomplete, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Task II. Data Analysis

Once a year (during each contract period of performance), the Government shall review the promptness of submitting the final report as required in work assignment. If the contractor is late more than 14 calendar days, from the due date as specified in the work assignment, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignments.

Once a year (during each contract period of performance), the Government shall review the completeness of the report as required in work assignment. If the contractor’s report is incomplete, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Task III. Technical Program Support - General Support

Once a year (during each contract period of performance), the Government shall review the promptness of submitting the final report as required in the work assignment. If the contractor is late more than 14 calendar days, from the due date as specified in the work assignment, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Once a year (during each contract period of performance), the Government shall review the completeness of the report as required in work assignment. If the contractor’s report is incomplete, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Task IV. Technical Program Support - Program Specific

Once a year (during each contract period of performance), the Government shall review the promptness of submitting the final report as required in the work assignment. If the contractor is late more than 14 calendar days from the due date, as specified in the work assignment, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Once a year (during each contract period of performance), the Government shall review the completeness of the report as required in work assignment. If the contractor’s report is incomplete, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Task V: Physical Testing

Once a year (during each contract period of performance), the Government shall review the promptness of submitting the QAP’s as required in the work assignment. If the contractor is late more than 14 calendar days, from the due date as specified in the work assignment, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Once a year (during each contract period of performance), the Government shall review the completeness of the submitted QAPP’s as required in work assignment. If the contractor’s QAPP is missing one or more of the required elements as listed in number 3 above, the Government shall take a 10% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.

Once a year (during each contract period of performance), the Government shall review the results of the physical testing as required in work assignment. If the contractor has failed to perform the physical testing in accordance with the approved QAPP the Government shall take a 30% reduction in the fee related to the delivered LOE in that work assignment. The reduction will be applied to both the paid fee and unpaid fee for that work assignment.