PWS_-_Draft.doc

SOL-CI-15-00018

Attachment 1

PERFORMANCE WORK STATEMENT

TECHNICAL AND REGULATORY SUPPORT FOR THE DEVELOPMENT

OF CRITERIA/LIMITS FOR WATER MEDIA

(HUMAN HEALTH – MICROBIOLOGY AND TOXICOLOGY EMPHASIS)

INTRODUCTION

1. 1 Background

The mission of the United States Environmental Protection Agency's Office of Water (OW) under the Safe Drinking Water Act (SDWA) and the Clean Water Act (CWA) includes protecting the public health from the adverse effects of pollutants (e.g., natural and anthropogenic chemicals, pathogens and their toxins) in media such as ground and surface waters, drinking water, wastewater, biosolids/sewage sludge, and sediments. In fulfillment of this mission, OW's Office of Science and Technology (OST) conducts ecological and human health risk assessments to support decision-making and develops effluent guidelines, human health criteria, health advisories, screening level benchmarks, maximum contaminant level goals, standards for use or disposal of sewage sludge and other products to support evaluation and control of pollutants in various water media.

1.2 Purpose of Contract

This contract will combine both toxicological and microbial support under one contract vehicle to provide technical and regulatory support services to the Health and Ecological Criteria Division (HECD) in OST. The services will include collecting and evaluating the state-of-the-science for specific microbial and toxicological pollutants; assisting HECD in all aspects of the assessment of human health risks from specific microbial and toxicological pollutants; and, providing support for the development of human health water quality criteria, health advisories, screening level benchmarks, maximum contaminant level goals for pollutants in drinking water, implementation guidance support for ambient water quality criteria, and standards for use or disposal of biosolids and other media to support evaluation and control of pollutants. This support includes specific activities such as conducting literature search and performing systematic reviews; synthesizing evidence from peer reviewed literature and guideline studies to support hazard identification and dose response modeling for specific pollutants and groups of pollutants; synthesizing evidence from peer reviewed literature, reports and databases to support exposure assessment, including occurrence and prevalence of pollutants and routes of exposure; providing technical support in computational modeling (e.g., dose response, exposure, fate and transport, infectivity, etc.) for risk prediction, assessment and prioritization; providing statistical analyses of exposure, toxicity and human health data to derive reference values; assessing the potential impact of pollutants on sensitive populations/life-stages or disadvantaged communities; preparing human health risk assessment documents, technical guidance documents, technical support documents for regulatory activities; white papers on scientific issues, responding to Agency and external reviewers’ comments; assisting and conducting webinars/workshops; and developing communication materials and Federal Register notices in supporting OST/HECD’s mission in evaluating pollutants to protect public health.

2.0 GENERAL TASKS

2.1 The Contractor shall furnish all facilities, materials, equipment, and necessary professional, technical, and support personnel to fulfill the purposes of the contract listed in Section 1.0 and in support of the general and specific efforts delineated in Sections 2 and 3.

2.2 The Contractor shall perform the specific tasks in the PWS in accordance with the appropriate EPA risk assessment guidance and science policy guidance (e.g., guidance on the development of a risk reference dose for a non-carcinogen, 2005 cancer guidelines, microbial risk assessment guidance, etc.), as indicated in a work assignment.

2.3 The Contractor shall submit the initial deliverable to EPA in draft form for review and comment. EPA will make all final regulatory, policy and interpretive decisions resulting from Contractor provided recommendations and technical documents. Required revisions will be provided to the Contractor by EPA for incorporation into the final documents.

2.4 The Contractor shall possess or have access to appropriate equipment/software to perform mathematical and computational modeling and statistical analyses to conduct all aspects of risk assessment for microbial and toxicological pollutants in support of criteria development, advisories, screening level benchmarks, maximum contaminant level goals, standards for use or disposal of sewage sludge and other products to support evaluation and control of pollutants. The Contractor shall document the modeling efforts, activities and runs, provide source codes and appropriate tools/software to EPA Contracting Officer’s Representative (COR) and other persons authorized by the EPA Project Officer (PO).

2.5 The Contractor shall develop documents and data bases using EPA standard software (e.g. Word, Excel, Access, and Power Point), as specified in a work assignment. The Contractor may cite the references in the document using standard EPA accepted reference manager software/database. Software documentation shall be accessible to the EPA Work Assignment Contracting Officer Representative (WACOR) and other persons authorized by the EPA Project Officer (PO).

2.6 The Contractor shall provide logistical and technical support to EPA during meetings/workshops/webinars/ conference calls either internal to EPA or with other federal, state, non-Federal potential responsible party or facility. The Contractor shall be required to submit meeting minutes and/or summaries of discussions.

2.7 The Contractor shall prepare a Quality Assurance Project Plan (QAPP) for work assignments that require environmental measurements, including the use of secondary data. See Section 3.8 for more discussion on quality system requirements.

The Data Quality Act (also known as the Information Quality Act) requires EPA to ensure that influential information disseminated by the Agency is sufficiently transparent in terms of data and methods of analysis that the information is capable of being substantially reproduced. To support compliance with these data transparency/ data reproducibility requirements, EPA may include QAPPs and deliverables prepared by the Contractor as part of any rulemaking record documentation to be made available to the public. The Contractor may claim information in QAPPs as confidential; if the Contractor chooses to do so, the Contractor shall submit a sanitized (i.e., public) version and an unsanitized (i.e., confidential) version at the time the QAPP is submitted for approval by EPA. If Agency is required to release the QAPP to public, the sanitized version shall be included in the public docket for the applicable rulemaking (or other docket record), and the unsanitized version shall be included in a non-public (i.e., confidential) portion of the docket (or record).

Information contained in the approved QAPP and other documents prepared by the Contractor for dissemination by EPA shall be transparent and reproducible and meet the requirements of the Data Quality Act for influential information. EPA’s Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity, of Information Disseminated by the Environmental Protection Agency (EPA/260R-02-008, October 2002), referred to as “EPA’s Information Quality Guidelines,” describe EPA procedures for meeting Data Quality Act requirements. Section 6.3 of EPA’s Information Quality Guidelines indicate that “especially rigorous robustness checks” should be applied in circumstances where quality-related information cannot be disclosed due to confidentiality issues. Where applicable, the Contractors should indicate which results were obtained using the tools (SOPs, checklists, and guidelines) that the Contractor designates as confidential so that the EPA WACOR can easily identify the areas that shall require rigorous robustness checks and document that those checks have been performed. At the discretion of the EPA Work Assignment Contracting Officer Representative (WACOR) the Contractors may be requested to prepare pre-dissemination review checklist as described in Section 5.5 of the Office of Water Quality Management Plan, February 2009 (or as updated). If this is required, the EPA WACOR shall notify the Contractor through written technical direction.

2.8 The Contractor shall comply with the security requirements to access CBI data in accordance with the clauses in Section H of this contract.

2.9 The Contractor shall provide information that will be used by EPA for quick responses and analyses of options, issues, and policy decisions as they relate to the tasks in this Performance Work Statement (PWS). Quick responses are those that require completion in one to seven days, or as specified in a work assignment. EPA will review results of all Contractor analyses, and make a final determination with regard to program objectives and policy decisions.

2.10 The Contractor shall be able to address and meet the administrative requirements of the Clean Water Act (CWA, aka the Federal Water Pollution Control Act), the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA, aka the Superfund), the Resource Conservation and Recovery Act (RCRA), the Safe Drinking Water Act (SDWA), and the Toxic Substances Control Act (TSCA). Where appropriate and required by statute, the Contractor shall possess the necessary business controls to comply with Confidential Business Information (CBI) requirements.

2.11 The Contractor shall comply with the requirements for studies and rulemaking records contained in authorities such as the Administrative Procedures Act, the Paperwork Reduction Act, the Safe Drinking Water Act, the Clean Water Act, and OMB Circular A-1 30 for management of Federal Information Resources, and the Federal Rules of Appellate Procedure (Rules 16 and 17, 28 U.S.C. Appendix).

2.12 Environmental Justice Requirements. Executive Order 12898 (Environmental Justice) directs Federal agencies to focus on minority and low-income populations in implementing their programs, policies and activities. Consistent with the Agency’s continuing commitment to environmental justice and fair treatment of all people, the contractor shall notify the EPA Project Officer of minority and low-income population, as well as populations with different patterns of subsistence consumption of fish and wildlife, likely to be affected by a program, policy or activity associated with work done under the contract and, when requested by EPA, shall identify any disproportionately high and adverse human health or environmental effects of the program, policy or activity of concern on theses populations.

3.0 SPECIFIC TASKS

3.1 Risk Assessment

3.1.1 The Contractor shall conduct hazard identification, dose response analysis, exposure assessment and risk characterization for microbial and toxicological pollutants according to EPA guidance. The guidance for performing risk assessment and associated activities can be found at the EPA websites . The Contractor shall be familiar with the methodological similarities and differences when considering the assessment of human health risks from microbes and chemicals. The Contractor shall possess the technical expertise to perform risk assessments, including problem formulation, hazard identification, exposure analysis, risk characterization and risk communication, for both types of pollutants. The Contractor shall possess technical experience to conduct Quantitative Microbial Risk Assessments (QMRA). Additionally, some pollutants, such as toxins resulting from Harmful Algal Blooms (HABs) are toxicological pollutants from a microbial source. The Contractor shall be knowledgeable of the state of the science concerning HABs. The Contractor shall be familiar with emerging technologies, such as the direct and indirect potable reuse of wastewater and treatment of various water sources (e.g., stormwater and greywater), for supplementing and enhancing traditional water uses. The Contractor shall be familiar with characterizing risk for sensitive subpopulations. The Contractor shall be familiar with environmental justice concepts used by EPA, how those concepts apply in risk characterization and requirements under Executive order 12898 (including corresponding Agency policies).

Examples of documents the Contractor shall prepare include: supporting documentation for Contaminant Candidate Lists (CCL) Regulatory Determinations and Six-year Review regulations, health advisories and screening-level benchmarks supporting drinking water regulations, human health criteria for ambient water and criteria supporting documentation, and technical support documents for ambient water quality criteria implementation. Document type, scope and purpose will be specified by the EPA COR. Standard EPA formats for these documents will be provided by the EPA COR.

3.1.2 The Contractor shall prepare summaries of peer-reviewed literature on specific microbial and toxicological pollutants, including occurrence and prevalence, clinical and epidemiological endpoints, virulence and pathogenicity, acute and chronic toxicity, fate and transport in various water media, treatment and attenuation from control processes, etc. The scope of these summaries will be specified in the work assignment.

3.1.2.1 Toxicological emphasis: Each summary shall discuss the test protocol (e.g., endpoints measured; test animal; the number, sex, and species of animals in the control group and dosing groups; the method, frequency, and duration of dosing; and sacrifice and pathology data), and shall evaluate the test protocol with respect to EPA guidance as above. Similarly, for epidemiological studies, the Contractor shall evaluate the protocol, type of study (e.g., case-control, ecological, cross-sectional, prospective cohort, or retrospective cohort), analyses and conclusions according to Bradford-Hill criteria. The Contractor shall have familiarity with the types of analyses performed using epidemiological data and with analysis of epidemiologic study designs. The Contractor shall consider the guidance of utilizing open literature for supporting human health risk assessment . Additional information shall be included as needed and specified in the works assignment.

3.1.2.2 Microbial emphasis: Each summary shall discuss, as specified by the EPA WACOR, the characterization of the fecal indicator organism, pathogen or pathogen indicator, including their various sources (i.e., human, zoonotic, and environmental); enumeration methodologies; morbidity, mortality and sequelae of illness; and, available dose-response information. This effort may also include toxic substances of microbial origin, such as cyanotoxins, and genetic material, such as transferrable genes that confer antibiotic resistance. The Contractor shall include information about environmental fate and transport of microbes, including base flow characteristics and wet weather mobilization. Also, information about treatment attenuation in water matrices shall be included when available. The Contractor shall include a synopsis of other empirical or modelled risk estimates.

3.1.3 The Contractor shall prepare a systematic review of the available literature [e.g., epidemiological, microbial, and toxicological information from public databases (e.g., Pub Med)] using standard methodology (e.g., OHAT, GRADIENT or equivalent as specified in the work assignment) to support the risk assessment of contaminants in water, sediments and biosolids. The Contractor shall evaluate the weight of evidence from human, animal and mechanistic data for identification of critical studies, endpoints and effects and support the dose response assessment modeling.

3.1.4 The Contractor shall be able to develop figures, tables or other graphics to display the array of available data for a chemical or microbial pollutant to assist in risk communication, facilitate the dose-response assessments and improve the transparency of health effects support documents

3.1.5 The Contractor shall be able to evaluate water quality and health effects data generated from an epidemiology study. The Contractor shall be familiar with the types of data analyses and approaches used with epidemiological data and be able to explain both the approaches and results to technical and nontechnical audiences. Specific to microbes, the Contractor shall be able to evaluate data generated from human- and animal-based dose response studies. This information may include endpoints for infection or illness. The evaluation shall include a complete description of the protocol used to gather the data; analyses of effects observed, including tabulation of all observations; evaluation of biological significance of endpoints according to EPA published guidelines or other technical documents; statistical analyses of the significance of observations; and characterization of exposure-related effects and their implications for human health. The data used for this task will come from environmental measures identified during literature reviews or provided by the EPA PO/COR.

3.1.6 The Contractor shall collate data, prepare screening analyses on hazard identification, exposure and human health risk for chemical and microbial contaminants that will be used to inform decision making and resource prioritization, such as the development of future Contaminant Candidate Lists (CCLs), Six-year Review of the existing national primary drinking water standards, ambient water quality criteria, biennial review of the existing biosolids standards, and in identifying endocrine disrupting compounds and other emerging contaminants (e.g., pharmaceuticals and personal care products).

3.1.7 The Contractor shall be knowledgeable of the various sources of information to inform the exposure analysis within a risk assessment for both microbes and toxics.

3.1.7.1 Toxicological emphasis: The Contractor shall be familiar with the EPA Toxics Release Inventory data base, and other Federal and private release, occurrence and exposure data bases (e.g., USGS, NHANES, FDA TDS, NCOD and Exposure Factors Handbook). The Contractor shall be familiar with the available information from EPA, USDA, USGS, other governmental agencies and in the scientific literature documenting microbial occurrence, prevalence, and distribution. The Contractor shall document the methodology, assumptions, and rationales used in the analyses to support relative source allocation for chemical and microbial pollutants to generate relative source contribution and developing source apportionment. EPA will make the final decision concerning a finding based on the appropriate technical information and Agency policy.

3.1.7.2 Microbiological emphasis: The Contractor shall be familiar with and be able to provide analyses of food and water consumption patterns and associated exposure to infectious agents through food and water consumption for the U.S. population. These analyses shall include frequency and amount of water ingested by sex, age, activity and geographical locations. Data to be analyzed shall include data from the published scientific literature, Federal data collection efforts, State collection efforts, and special studies. The contractor shall provide analyses of exposure data from the Center for Disease Control National Health and Nutrition Examination Survey data base and the EPA National Human Exposure Assessment Survey data base, water quality data from U.S. Geological Survey and morbidity and mortality data on food and waterborne illnesses from available databases and other sources as deemed appropriate.

3.1.8 The Contractor shall prepare, evaluate, and revise health effects support documents or health advisories. These documents provide information on the criteria that protect human health from exposure to a chemical or a microbial pollutant in water media, sediments, and biosolids. The Contractor shall document the methodology, assumptions, and rationales used for this task. EPA will make the final decision concerning a health effects support document or health advisory document or other risk assessment documents based on the appropriate technical information and Agency policy.

A health effects support document or health advisory document for a pollutant shall address, as specified in a work assignment: (1) physical, biological and chemical properties of the pollutant; (2) occurrence in water and other media, (3) environmental fate and transport; (4) toxicokinetics or pathogenicity; (5) human exposure to the pollutant; (6) health effects in animals and humans; (7) mechanisms of toxicity or virulence and pathogenicity; (8) magnitude of carcinogenic and non- carcinogenic effects including the relative source contribution or morbidity, mortality and sequelae of illness; (9) risk characterization, and (10) any other areas set forth in the work assignment. Information from other governmental bodies regarding health effects from the pollutant shall be included when available.

3.1.9 The Contractor shall provide state of the art technical support in the preparation, evaluation of critical/controversial issues and shall prepare white paper or regulatory support documents. The paper may include hazard identification, metabolism, exposure assessment, mode of action analysis, dose-response modeling, susceptibility/sensitivity and uncertainty analysis and risk characterization of contaminants to develop human health criteria for various water media (e.g., surface water and drinking water) and biosolids. Additionally, the Contractor shall identify and include information on effective risk management practices and risk reduction approaches when available. The Contractor shall apply the state-of the-art tools and document the methodology, assumptions, and rationale used for this task. EPA will make the final decision concerning a technique or methodology based on the appropriate technical information and Agency policy.

3.1.10 The Contractor shall provide rapid-response analyses of human health risk assessment guidelines, results of human health risk assessments, analytical and treatment technology practices and procedures. This includes, among other things, analysis of the impact of criteria on sensitive populations, and analyses of dose response data, pharmacokinetics data, exposure data, and bioaccumulation data.

3.1.11 The Contractor shall prepare, evaluate, and revise technical guidance documents for microbes or chemicals. These documents provide information on the principles for criteria development (e.g., minimum data requirements, assumptions for exposure and occurrence, dose response, and health effects). The Contractor shall document the methodology, assumptions, and rationale used for this task. EPA will make the final decision concerning a technical guidance document based on the appropriate technical information and Agency policy.

3.1.12 The Contractor shall conduct Monte Carlo or similar statistical uncertainty analyses of pathogenicity data (microbial emphasis), toxicity (toxicological emphasis) or epidemiological endpoint (incidence of adverse health endpoint outcomes) or exposure data, as specified in a work assignment. These analyses shall be completed in accordance with EPA published guidance.

3.1.13 The Contractor shall model the dose response data from humans and animal models for infection and illness (microbiological) and cancer and noncancer (toxicological) endpoints quantification using benchmark dose modeling, Physiologically Based Pharmacokinetic/ Biologically Based Dose Response (PBPK/BBDR) modeling, categorical regression or other similar methodologies developed by the Agency as specified in a work assignment. These analyses shall be completed in accordance with EPA published guidance for the methodology used.

3.1.14 The Contractor shall be knowledgeable about and able to conduct evaluations of the recent advances in microbiology and toxicology.

3.1.14.1 Toxicological emphasis: The Contractor shall provide technical support using validated high throughput toxicity data, adverse outcome pathways and 21st century toxicity tools (e.g., Toxcast, Expocast, reverse pharmacokinetics tools) for toxicity/exposure/risk prediction to support rapid screening, prioritization and grouping of contaminants in various water matrices, sediments, and biosolids to support the regulatory risk assessment documents. The Contractor shall provide expertise in the cheminformatics, bioinformatics in addition to toxicology, biochemistry, molecular biology, epidemiology, physiology, pharmacology, pathology, statistics and quantitative dose response modeling.

3.1.14.2 Microbiological emphasis: The Contractor shall provide technical support for conducting QMRA-related analyses, such as dose-response modeling, uncertainty and variability analyses, statistical constructs for microbial distributions, etc. The Contractor shall be knowledgeable of the latest advances in the detection and enumeration, including molecular and other rapid methodologies, of fecal indicator organisms, microbial sources markers, pathogens, and pathogen indicators and be able to provide technical support for the interpretation of the results from each type of method. The Contractor shall be knowledgeable about microbial community analysis approaches and be able to provide technical support for characterizing published results to help inform decision-making. The Contractor shall provide technical support in the area of Harmful Algal Blooms (HABs) and be knowledgeable about the various genera of algae that produce toxins, such as microcystins, and their related adverse health effects. The Contractor shall provide expertise in microbiology, molecular microbial ecology, biostatistics, aquatic biology (cyanobacteria and phytoplankton), epidemiology and public health. The Contractor shall be knowledgeable of current environmental molecular biological techniques, including environmental gene tracking and those being developed by governmental and academic researchers. The contractor shall provide soil- and sediment science expertise in addition to the abovementioned microbiological and toxicological capabilities.

3.1.15 Tasks and deliverables described above shall be completed in accordance with EPA published guidelines as specified in 3.1.1 (e.g., carcinogenic risk assessment guidelines, reproductive risk assessment guidelines, developmental risk assessment guidelines, neurotoxicity guidelines, exposure assessment guidelines, risk characterization policy guidelines, benchmark dose guidelines or Monte Carlo guidelines). Links to these guidance materials for assessing and managing environmental risks can be found on EPA’s risk assessment portal: http://www.epa.gov/risk/guidance.htm

3.1.16 The Contractor shall use the standard software (e.g., Microsoft Office Suite) in preparing the documents and ensure that the risk assessment documents are technically accurate, and adhere to the standard technical editing guidelines and all the references are properly cited and included (The Chicago Manual of Style and the Scientific Style and Format CSE (Council of Science Editors)).

3.1.17 The Contractor shall prepare deliverables that are compliant with section 508 of the Rehabilitation Act.

3.2 Biosolids and manures

3.2.1 The Contractor shall provide technical support during the preparation, evaluation, and revision of procedures for selecting microbial or chemical pollutants-of-concern in biosolids and manures that is used for fertilizer, land applied or disposed of, and shall provide technical support during the evaluation of those pollutants. The Contractor shall document the methodology, assumptions, and rationale used for this task. EPA will make the final decision concerning the procedure used to select pollutants-of-concern and the evaluation of those pollutants based on the appropriate technical information and Agency policy.

3.2.2 The Contractor shall have expertise covering the following areas: the occurrence and prevalence of human and zoonotic pathogens, pathogen surrogates or indicators, and other microbial hazards (e.g., toxins, antibiotic resistance genes) in biosolids and manures; the various options of treatment that reduce pathogens or other microbial hazards in biosolids and their treatment efficacy parameters; and, tools related to conducting exposure pathway risk assessments for pollutants in biosolids and manures applied to the land, placed on a surface disposal site, or fired in a sewage sludge incinerator. The pathways evaluated for each use or disposal practice shall be the pathways evaluated for each practice when the Standards for the Use or Disposal of Sewage Sludge (40 CFR Part 503) were developed, and other pathways specified in a work assignment. Results of the risk assessments will be used by EPA to develop standards for use or disposal of sewage sludge.

3.2.3 The Contractor shall prepare, evaluate, and revise technical support documents related to the standards for the use or disposal of biosolids and manures. These documents contain the rationales for the requirements (i.e., risk evaluations, general requirements; standards for use or disposal of biosolids; management practices; operational standards; and frequency of monitoring, record keeping, and reporting requirements) in a sewage sludge use or disposal standard (see 40 CFR Part 503). The Contractor shall document the methodology, assumptions, and rationale used for this task. EPA will make the final decision concerning a technical support document based on the appropriate technical information and Agency policy.

3.3 Statistical and Computational Modeling Support

3.3.1 The Contractor shall have statistical analyses capabilities to perform analyses of environmental data for microbial and toxicological pollutants to derive descriptive or interpretative statistics.

3.3.2 The Contractor shall provide statistical and computational modeling support in evaluating environmental measures for the development of water quality criteria, maximum contaminant level goals, standards for use or disposal of biosolids and manures, and other program requirements, as specified in a work assignment. Modeling expertise should include PBPK modeling.

3.3.3 The Contractor shall have statistical analysis capability for supporting the cumulative risk assessment of microbial and chemical contaminants in water media and sewage sludge/biosolids.

3.3.4 The contractor shall have the capacity to develop multi-level (i.e., hierarchical) occurrence models for these contaminants, while properly accounting for measurement limitations that may include censored values (below reporting limits), imprecise measurement methods, and discrete or continuous data.

3.3.5 The Contractor shall have experience with EPA’s Benchmark Dose software and shall be capable of using the software to model dose-response relationships for chemical pollutants.

3.3.6 The Contractor shall have expertise in tools related to Cheminformatics and Bioinformatics for toxicity prediction for water contaminants with limited animal, human or epidemiological data.

3.4 Administrative Record Support

The Contractor shall provide data and documentation to be used by EPA in the analysis of technical issues and options for proposed and final regulations, as specified in a work assignment. Deliverables under this task include data summaries, technical reports, option papers, issue papers, and public and confidential records and files. The Contractor shall describe and document the data gathering activities; display, characterize, and interpret the data and information collected; obtain copies of any references used; and describe all methodologies used. Written reports and corresponding records and files shall be prepared and organized, indexed, and cross-referenced in an administrative record for a proposed or final regulation so that the analyses and conclusions can be reproduced based on the information in the administrative record for a proposed or final regulation. Deliverables shall be compliant with Section 508 of the Rehabilitation Act.

3.5 Rule Making Support

The Contractor shall index and summarize public comments on proposed regulations. Using information provided by EPA (i.e., typically public comments submitted in response to a proposed regulation, policy document or information collection request), the Contractor shall prepare an index of issues in the information provided by EPA, and cross reference those issues to the public comments. For technical issues assigned by the EPA COR, the Contractor shall, based on knowledge of the appropriate rule making, prepare draft technical responses to the issues in the public comments including all relevant citations to the administrative record. EPA will review the draft technical responses, and prepare the final responses to the comments.

3.6 Risk Communication and Preparation of Outreach Materials

3.6.1 The Contractor shall provide the necessary technical writing expertise when preparing deliverables so that the deliverables consist of good quality writing, can be accessible to a wide audience (i.e., nontechnical and technical readers) and can be used to inform decision-making. The Contractor shall be knowledgeable of the different approaches when conveying information to different types of audience and be able to provide tailored deliverable aimed at specific audience when requested in a work assignment.

3.6.2 The Contractor shall develop outreach materials in support of the tasks in this PWS. These materials include brochures, presentation boards, slide shows, fact sheets, pamphlets, posters, videos, web layouts, and models. The materials shall be developed for use in media events (e.g., press releases). In addition, the Contractor shall provide materials for distribution at presentations. All materials shall be provided in accordance with the limitations set for in the Section H clause titled "PRINTING (EPAAR 1552.208-70)." The Contractor shall provide a draft of all materials for approval by the EPA COR, and shall prepare the final materials based on the EPA COR's comments on the draft materials. For print products, the Contractor shall provide a camera-ready copy (or digital equivalent) and Section 508 compliant electronic format that enables the material to be loaded onto the internet. This task only shall be done in direct support of the technical requirements in this PWS.

3.6.3 The Contractor shall provide, when included in a work assignment, a complete and accurate translation of foreign language articles cited in a criteria document, a health advisory, health effects support document, whitepaper or a technical guidance document. Translations shall be performed by experienced scientific translators well versed in chemical, toxicological, statistical, biomedical, or epidemiological terminology. The Contractor shall insure that there are no terminology or language usage ambiguities that make interpretation and analysis of the findings difficult. No translations shall be made without the written approval of the Project Officer.

3.7 Arranging and Conducting Workshops

The Contractor shall provide support in arranging workshops, conferences, training sessions, webinars, and public meetings, and obtaining appropriate individuals to address various issues. Meeting support shall be limited in scope, and shall cover only those meetings required to address the requirements in this PWS. The Contractor shall arrange travel only in accordance with the authority and limitations in the Section H clause titled "APPROVAL OF CONTRACTOR TRAVEL" (i.e., use of contract funds to reimburse travel is strictly limited to logistical support for speakers, scientists, and experts who contribute directly to the requirements of a task in this PWS). The Contractor shall support EPA by: (1) providing information for meeting agendas, including typing the agendas; (2) preparing drafts of technical information for use in preparing briefing materials; (3) identifying and inviting speakers and experts to participate in a workshop; (4) arranging for meeting space when Government space is not available; (5) arranging for the appropriate audio-visual equipment; (6) providing advance announcements, registration support, visual aid preparation, logistical support, case study preparation, interactive and role-playing activity development; and (7) preparing the minutes of the meeting, including the meeting results and report, for approval by the EPA COR.

3.8 Quality System Requirements

EPA policy requires all organizations conducting EPA-funded environmental programs to establish and implement a quality system. This is accomplished through a Quality Management Plan (QMP) that documents how the organization structures its quality system and describes its quality policies and procedures, criteria for and areas of application, and roles, responsibilities, and authorities. It also describes an organization’s policies and procedures for implementing and assessing the effectiveness of the quality system.

All technical activities performed under this contract must be supported by the Contractor’s quality system and documented by the Contractor in a customized Quality Management Plan that documents how the contractor will integrate quality assurance (QA) and quality control (QC) procedures and plans into the wide variety of technical activities contemplated in the PWS.

In addition, all individual projects under the contract that involve environmental data operations must be supported by a Quality Assurance Project Plan (QAPP) that describes the quality assurance procedures, quality control specifications, and other technical activities that must be implemented to ensure that the results of the project to be performed will meet project specifications.

Requirements governing the customized QMP and QAPPs prepared in support of this contract are described below.

3.8.1 Customized Quality Management Plan

A Quality Management Plan (QMP) documents how an organization will plan, implement, and assess the effectiveness of its quality assurance (QA) and quality control (QC) operations. Specifically, it:

· Describes how an organization structures its quality system, the quality policies and procedures, areas of application, and roles, responsibilities, lines of communication and authorities.

· Documents the elements of the organization or program’s quality system

The QMP is an organization or program-specific document; it describes the general practices of an organization or program.

A customized QMP is a QMP that is tailored to the requirements in the PWS, and explains how the organization’s Quality System will support those specific activities, and is prepared in accordance with EPA Requirements for Quality Management Plans. The contractor shall annually review, and if necessary, revise this customized QMP to ensure it accurately to reflect their organizational structure and quality system throughout the duration of the contract.

3.8.2 Quality Assurance Project Plans

EPA policy requires that an approved QAPP be in place before commencing any work that involves the collection, generation, evaluation, analysis or use of environmental data. The work to be performed by the Contractor under this contract involves such activities.

The Contractor shall prepare and submit a programmatic Quality Assurance Project Plan (p-QAPP) upon the award of the contract. A p-QAPP is used to describe, in a single document, information that is not site or time-specific, but applies throughout the program (i.e., contract). Application-specific information is then added to the approved p-QAPP as that information becomes known or completely defined. This may be accomplished through the use of:

Supplemental QAPPs (s-QAPPs) prepared for individual work assignments, which are designed to supplement the approved p-QAPP with the additional detail needed to describe the specific goals and objectives of the project or tasks supported under the work assignment and the specific QA strategies and technical activities that will be employed to support the objectives of the work assignment project or task

- OR-

Traditional QAPPs (t-QAPPs) prepared for individual work assignments, which are designed to serve as stand-alone documents that focus on the goals, objectives, QA strategies, and technical activities needed to support a single work assignment or project.

Note that while the customized QMP documents an organization's management system for the environmental work to be performed under the contract, the p-QAPP documents the technical QA/QC elements needed to support the environmental work that will be performed under contract. Supplemental and traditional QAPPs also document the technical QA/QC elements needed to support the environmental data operations that will be performed, but they do so at the work assignment or project level, rather than at the contract level. Note: Because the p-QAPP is prepared as a contract-level document, it is understood that the details (e.g., specific objectives, analytical methods, and/or acceptance criteria) of specific projects may not be known. In such instances, the contract-wide p-QAPP should document the Contractor’s procedures for defining and documenting this information for specific projects or work assignments.

To support requirements specified in the EPA Quality Manual for Environmental Programs (CIO 2105-P-01-0), the Contractor's p-QAPP for this contract must specify that (1) all major deliverables (e.g., Technical Support Documents, Study Reports, Study Plans, etc.) produced by the Contractor under this contract will include a discussion of the QA/QC activities that were or will be performed to support the deliverable, and (2) this discussion will provide a sufficient level of detail to support EPA’s use of the data.

EPA policy requires that an approved QAPP must be in place before any environmental data operations begin. Accordingly, the Contractor shall not incur any billable costs for work that involves the collection, generation, evaluation, analysis or use of environmental data under the contract, unless those activities are covered under an approved p-QAPP, s-QAPP, or t-QAPP.

All QAPPs prepared under the contract, including the p-QAPP, shall be reviewed at least annually to ensure their content continues to be valid and applicable to the program over time. Previously-approved QAPPs that do not specifically address all of the environmental data operations performed under the Work Assignment will require editing and resubmission for approval.

Any QAPP that is approved by EPA for a Work Assignment issued under this contract will be considered by EPA to be available in the public domain and may be distributed by EPA to the public. (See the discussion of “Data Quality Act/Information Quality Guidelines Requirements” Section 3.9 of the PWS) The Prime Contractor shall ensure that all parts of the organization performing work, including subcontractors (including consultants), are responsible for implementing the approved Programmatic QAPP and any other QAPP that has been approved by EPA to support an individual Work Assignment issued under the contract. The Prime Contractor shall also ensure that all personnel involved in the work have access to the latest approved version of the QAPP and all other necessary planning documents applicable to the work they are supporting.

The Prime Contractor shall ensure that all personnel in the organization, including subcontractors (including consultants), who are involved in each individual work assignment and task, understand the technical and QA requirements prior to the initiation of data collection, generation, evaluation, analysis, or use activities.

The Prime Contractor must ensure that all personnel, including subcontractors, who develop and review QAPPs prepared in support of this contract have the experience and educational credentials to understand the relevant issues.

The Contractor shall provide all QAPPs prepared under this contract to the EPA COR in electronic form in both a word processing file and a PDF file. When preparing QAPPs under this contract, the Contractor shall do so in accordance with the following documents:

· U.S. EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans, March 2001 (reissued May 2006). EPA/240/B-01/003. http://www.epa.gov/quality/qs-docs/r5-final.pdf

· U.S. EPA QA/G-5, Guidance for Quality Assurance Project Plans, December 2002, EPA/240/R-02/009. http://www.epa.gov/quality/qs-docs/g5-final.pdf

The contractor also may be asked to comply with other guidance when preparing QAPPs for specific types of activities such as modeling and statistical analyses, environmental surveys, monitoring, generation of GIS data, biological & ecological assessments, etc. Examples of such additional QAPP guidance include:

· U.S. EPA QA/G-5M, Guidance for Quality Assurance Project Plans for Modeling, December 2002, EPA/240/R-02/007 (http://www.epa.gov/QUALITY/qs-docs/g5m-final.pdf)

· U.S. EPA Guidance on the Development, Evaluation, and Application of Environmental Models, March 2009, EPA/100/K-09/003 (http://www.epa.gov/crem/library/cred_guidance_0309.pdf)

· Guidance available in the in New England Regional Library Quality System Documents (http://www.epa.gov/region1/lab/qa/qualsys.html); see Modeling and Use of Secondary Data Guidance)

· U.S. EPA QA/G-5S, Guidance on Choosing a Sampling Design for Environmental Data Collection for Use in Developing a Quality Assurance Project Plan, December 2002, EPA/240/R-02/005 (http://www.epa.gov/QUALITY/qs-docs/g5s-final.pdf)

U.S. EPA QA/G-5G Guidance for Geospatial Data Quality Assurance Project Plans, March 2003, EPA/240/R-03/003 (http://www.epa.gov/QUALITY/qs-docs/g5g-final.pdf ).

3.8.3 Reporting Quality Assurance Progress

When an approved QAPP is in place for any Work Assignment issued under this contract, the contractor shall be required to include Statements of Quality Assurance Progress in the contractor's monthly progress reports from the time of QAPP approval until the final deliverable necessitating the QAPP is accepted by EPA.

The contractor shall also furnish a Quality Assurance Report (QAR) at the time a final technical support document or other final document is provided. The QAR may be a section or chapter of the final document. The QAR will be submitted for review and approval by the Work Assignment Manager to document the contractor's QA/QC of the technical effort to produce a defensible deliverable. The contractor can anticipate including the QAR with other deliverables of the Work Assignment. The Work Assignment Manager will specify the format the contractor must follow for preparing the QAR in the individual task of the Performance Work Statement.

4.0 Compliance with Information Technology Requirements.

All work performed under this contract shall adhere to the clause EPAAR 1552.211-79 “Compliance with EPA Policies for Information Resources Management”, which requires adherence to all Agency directives for performance of any Information Research Management (IRM) related work.

4.1 All contractor work shall be in compliance with pertinent Federal and EPA information processing and telecommunications standard and procedural guidelines. The contractor shall also comply with the Federal Information Processing and Standards (FIPS) and Federal Security Information Management Act (FSIMA), along with its accompanying procedures, published by the National Institute for Standards and Technology (NIST). The contractor shall also comply with the EPA’s technical and operational standards as issued by its technology services organizations. The contractor shall observe the policies, procedures, and formats published as follows:

Federal Policies and Regulations