Work Statement - PFAS Hazard Assessment Svcs.docx

Performance Work Statement – PFAS Hazard Assessments Peer Review Services

1.0 INTRODUCTION

The Department of Veterans Affairs Office of Patient Care Services’ Health Outcomes Military Exposures (HOME), in partnership with U.S. Defense Centers for Public Health – Aberdeen Toxicology Directorate (DCPH-A/TOX), requires services for a critical project focusing on the hazard assessments of per- and polyfluoroalkyl substances (PFAS). This project is dedicated to developing predictive models for adverse health effects associated with PFAS exposure, a response to the increased need for improved healthcare for Veterans exposed to these substances during military service. By enhancing methods for measuring and monitoring PFAS exposure, this initiative underscores the commitment to identifying potential health outcomes experienced by Service Members exposed to these chemicals.

2.0 BACKGROUND

HOME, in response to the PACT Act, is focusing on addressing health concerns related to PFAS exposure among Veterans. This initiative arises from the recognition of PFAS's wide range of toxicity concerns, especially for Veterans exposed to these substances in military contexts. Current methods of monitoring exposure are insufficient, prompting the need for innovative approaches like dried blood spot analysis to better identify and understand potential adverse health outcomes. This effort is critical in advancing the care and monitoring of Veterans' health in relation to environmental and occupational exposures during military service.

3.0 SCOPE

3.1 Description of Work: HOME, in collaboration with DCPH-A/TOX, is initiating a comprehensive project to assess the long-term health impacts of PFAS exposure on veterans. HOME will oversee the effort, leveraging DCPH-A/TOX’s provision of critical exposure data. The selected contractor will conduct an extensive review of various data streams, including toxicological, epidemiological, and environmental information. This review will be integral to developing robust serum concentration models for PFAS compounds, delineating their relationship to potential adverse health effects in the veteran population. The contractor's responsibilities encompass expert peer review of hazard assessments conducted by the DCPH-A/TOX, as well as the development of additional hazard assessments as indicated by the available data, identification and refinement of serum/blood points of departure (PODs) for each toxic endpoint where sufficient evidence of an adverse effect exists, and the employment of advanced PBPK modeling to predict serum/blood concentrations at these PODs. In scenarios where data is insufficient for PBPK modeling, the contractor is expected to use contemporary, scientifically defensible extrapolation methods to estimate serum/blood concentrations, aligning these findings with available human evidence from hazard assessments. This project is particularly focused on a subset of 22 PFAS compounds, out of which it is estimated that only ten may possess adequate toxicological information to determine PODs. These ten compounds are anticipated to have 6-8 toxicity endpoints each, necessitating the development of serum/blood PODs. If the existing data allows, a single PFAS-specific PBPK model could be used to calculate human equivalent concentrations (HECs) for these endpoints. The remaining PFAS, lacking in sufficient data for model development, will require the contractor to apply conventional assumptions for extrapolation to human equivalent sera/blood PODs. Since PFAS occur as mixtures in environmental contexts, relevant models for mixtures should also be considered/employed. The contractor must have a documented track record in evaluating the toxicology of PFAS compounds, including experience in developing toxicity-based benchmarks, risk assessment, and the creation and refinement of physiologically based toxicokinetic models. This detailed effort aims to significantly enhance HOME’s capabilities to safeguard the health of veterans against the backdrop of PFAS exposure.

3.2 Period of Performance: 12 months

3.3 Place of Performance: Work will be performed at the Contractor’s home office or remotely at the Contractor’s discretion.

4.0 REQUIREMENTS

4.1 Participate in a Post-Award Conference. This virtual meeting shall provide an introduction between the Contractor personnel and Government personnel who will be involved with the contract. The meeting shall provide the opportunity to discuss technical, management and security issues. The Post Award Conference will aid both the Government and Contractor in achieving a clear and mutual understanding of all requirements and identify and resolve any potential issues. The Contractor shall be prepared to discuss any items requiring clarification and gather information as necessary to support each deliverable.

4.2 Provide a Project Management Plan outlining milestones and timelines for the performance period no later than 30 days after the start of the period of performance. This plan may be altered, as necessary, throughout the period of performance with the approval of the Government.

4.3 Create an archive or database of all articles and documents included in the assessments/modelling. This collection of resources will contain published works and official documentation, such as assessments, that were reviewed and included in the hazard assessments. The collection should be stored in a manner such that it can be made available to the Government and key stakeholders in justification of the findings of the assessments and data generated from all modelling. Secure channels will not be needed as no sensitive information should be included.

4.4 Provide the following after internal quality assurance/quality control of the data:

4.4.1 Review of existing PFAS hazard assessments.

4.4.2 Development of additional, new PFAS hazard assessments.

4.4.3 Derived Points of Departure, where data are sufficient.

4.4.4 Results of advanced modelling efforts.

4.5 Regular communication with DCPH-A/TOX and HOME staff to discuss the current state of the project and ways forward. These communications shall include:

4.5.1 Bi-weekly teleconferences with DCPH-A/TOX and HOME. The Contractor shall provide written summary minutes following each meeting.

4.5.2 Monthly written progress reports to HOME highlighting the state of the project and issues/concerns.

5.0 DELIVERABLES

6.0 KEY PERSONNEL

3.0 4.0 5.0

6.1 Certain skilled, experienced professionals and/or technical personnel are essential for accomplishing the work to be performed. Key personnel for the purposes of this requirement are as follows:

6.1.1 Senior Toxicologist(s). Qualifications: PhD or equivalent in Toxicology or related field and at least 10 years of relevant work experience (board certification in Toxicology required). Description: Oversees qualitative and quantitative projects. Possesses extensive background in area of expertise. Reviews the work of staff involved with digesting and summarizing research papers or analytical reports, conducting technically focused literature and internet searches. Resolves complex problems, which requires mastery and an in-depth knowledge of subject matter related to toxicology. Demonstrated mastery of the assessment of the effects of complex mixtures on human health as it relates to environmental and human health risk assessment, such as those conducted by the Environmental Protection Agency/National Toxicology Program, is required. Demonstrated ability to use advanced computational modelling techniques to derive benchmark points of departure. Specific experience in interpreting data resulting from applying modelling techniques and toxicological concepts to understand the impact of PFAS exposures is required. Oversees the development of technical reports, presentations, and all final deliverables. Provides guidance to staff and the Government concerning task or project strategic direction and outcomes.

6.1.2 Toxicologist(s). Qualifications: MS or equivalent in Toxicology or related field and at least 10 years of relevant work experience (PhD and 5 years of experience highly desired). Description: Works under very minimal supervision and with a focus on qualitative and quantitative projects. Possesses excellent background in area of expertise. Performs tasks that involve digesting and summarizing research papers or analytical reports, conducting technically focused literature and internet searches. Resolves complex problems, which requires mastery and an in-depth knowledge of subject matter related to toxicology. Knowledge of and experience in the assessment of the effects of complex mixtures on human health as it relates to environmental and human health risk assessment, such as those conducted by the Environmental Protection Agency/National Toxicology Program, is preferred. Has an understanding of various analytical tools and is able to interpret and apply the results of analyses prepared by others who use those tools. Experience using advanced computational modelling techniques to derive benchmark points of departure required. Specific experience in applying modelling techniques and toxicological concepts to understand the impact of PFAS exposures is preferred. Prepares draft technical reports and presentations. Incorporates review comments into draft and final deliverables. Coordinates progress with other work team members. Provides insight and advice concerning task or project strategic direction and outcomes.

7.0 QUALITY CONTROL

The Contractor shall implement and maintain a Quality Control Plan (QCP) to ensure work performed conforms to the scope of work and meets the requirements under this PWS. The QCP shall, at a minimum provide a process by which assessments/modelling will be reviewed by qualified individuals to ensure that conclusions are scientifically sound prior to delivery to the Government. Also, all written content should be reviewed to ensure clarity and grammatical accuracy prior to delivery to the Government.

8.0 QUALITY ASSURANCE

8.1 The Government reserves the right to perform inspections and surveillance to evaluate the Contractor’s compliance to the contract terms and performance of the requirements in the PWS. The Government will make every effort to ensure that the surveillance methods described below are conducted in an objective, fair, and consistent manner.

8.1.1 Periodic Surveillance. This action occurs when the COR or other Government official observes a deficiency. Examples include evidence from accidents, incidents, or delays. Regardless of where in the line-of-duty the COR observes contractual procedures not being followed, he/she has an obligation to document and report the deficiency to the Contracting Officer.

8.2 Contract Discrepancy Report (CDR). In the event of unsatisfactory performance, the COR will request the CO to issue a CDR that will explain the circumstances and findings concerning the incomplete or unsatisfactory service. The Contractor shall acknowledge receipt of the CDR and respond in writing as to how he/she shall correct the unacceptable performance and avoid a recurrence. The Government will review the Contractor's corrective action response to determine acceptability and will use any completed CDR as part of an overall evaluation of Contractor performance when determining present or future contractual actions.