TERS_PWS.docx

Mid-Continent Ecology Division (MED), Duluth, Minnesota.

Toxicological and Ecological Research Support Contract

Performance Work Statement

I. BACKGROUND: The U.S. EPA, Office of Research and Development (ORD), National Health and Environmental Effects Research Laboratory (NHEERL) intends to procure a contract for toxicological and ecological research support services at its Mid-Continent Ecology Division (MED) in Duluth, Minnesota. The mission of MED is to provide scientific information for use in predicting and assessing the effects of pollutants and other stressors on the sustainability of our nation's freshwater resources. The Division accomplishes its mission in partnership with its sister Divisions of NHEERL, other ORD laboratories, and EPA Program and Regional Offices. Partners also include States, Tribes, other federal and international agencies, and research organizations in the private and non-governmental sectors. To meet the information needs of the Agency, ORD's national laboratories and centers strive to integrate "solution-oriented" research with "core" research programs, in a holistic manner consistent with the Agency's ecological risk assessment paradigm. Research at the Division supports ORD Research Programs to contribute to Agency protection of the chemical, physical and biological integrity of the nation’s waters, to provide an understanding of the balance between the three pillars of sustainability – environment, society and economy, and to provide information, methods and tools to make better-informed decisions about chemical risk. To support and complement areas of expertise in other NHEERL and ORD Divisions, the Mid-Continent Ecology Division's research activities are focused within the realms of freshwater ecology and ecotoxicology. Division research derives from a foundation of scientific strengths that are being applied to EPA ORD research programs:

a. Systems and translational toxicology assessment

b. Watersheds and water resources toxicology and modeling

c. Ecosystem analysis, assessment, and forecast modeling

II. PRIMARY AND OPTIONAL TASKS: The Contractor shall furnish the necessary personnel, supplies, and equipment except as otherwise defined, to perform toxicological and ecological research support services for the U.S. EPA, ORD/NHEERL Mid-Continent Ecology Division (MED), Duluth, Minnesota. Task Orders, approved by the Contracting Officer (CO), will be issued in the following general areas of technical support, and the Contractor will be assigned specific tasks described in electronically issued technical directives (TDs) approved by the Task Order Contracting Officer Representative (TOCOR), and the Contract Level, Contracting Officer Representative (COR).

The Contractor will be tasked to:

TASK 1 - Culture organisms for toxicity bioassays.

1. Obtain from sources which have been approved by EPA, transport or arrange for shipping to MED, and hold in the culturing unit, cultures of multiple species of fish and invertebrates. Participate in the planning and preparation for the introduction of new organism cultures or the expansion of existing cultures, and the design and construction of appropriate tanks or enclosures that will have adequate capacity and ensure the maintenance of healthy cultures. The organisms to be held may include, but not necessarily be limited to, the current holdings at MED:

Fish Holding

2. Operate and maintain the Organism Culture Unit 24 hours a day, seven days a week, with the goal of providing the highest quality organisms for MED’s research projects.

This will include food preparation and feeding of animals, routine cleaning of tanks and enclosures, monitoring physical and chemical parameters of life-support systems, and monitoring of the health of animal cultures for evidence of microbial, viral, or parasitic infestations, providing appropriate treatment when necessary.

3. Respond to requests (electronic technical directives) for organisms with the specified numbers of individuals of the appropriate size, age, gender or strain, and prepare them for safe and timely transfer to the site of their intended use within or outside of EPA.

4. Maintain complete and accurate records and documentation of all culture activities conducted under this contract, in accordance with NHEERL and MED QAPPs and SOPs/OPs. All raw and processed electronic data files, logbooks and research notebooks are the property of EPA, and the Contractor shall enter them into the MED archival records system (according to the assigned Record Schedule) upon contract completion.

TASK 2 - Provide electronic scientific equipment support.

1. Maintain and repair scientific electronic equipment used by government personnel. Electronic scientific equipment is defined as the specialized electronic equipment used in the laboratories for physical, chemical or biological analyses, the electronic equipment used in field studies for sampling, analyses or data logging, the electronic equipment designed for the monitoring and control of bioassay systems, and electronic equipment onboard the laboratory’s small boats and research vessel.

2. Equipment items will include, but not necessarily be limited to, those listed below.

· Thermo Fisher DFS high resolution mass spectrometer (EPA#C00811)

· (2) Hewlett Packard MSD GC/MS (EPA#s 802275,929649)

· Agilent 1100 series LC/MSD(EPA#929658)

· Agilent 7500ce LC/ICP-mass spectrometer(C00901)

· Agilent 6410 TSQ LC/mass spectrometer(EPA#C00915)

· Agilent 5975C GC/mass spectrometer(EPA#C00812)

· Thermo-Finnigan SIR-mass spectrometer(EPA#929666)

· Bio-Rad Radiance 2000 Laser Scanning microscope (EPA#929640)

· Packard Oxidizer/Scintillation Counter (EPA#801923)

· Packard 2550 Liquid Scintillation Counter (EPA#929122)

· Packard Minaxi 5000 Gamma Counter (EPA#802425)

· Gas, liquid, and ion chromatographic instrumentation

· Infrared, UV/visible, fluorescence, and AA spectrophotometers

· pH, specific ion, and dissolved oxygen meters

· Electronic equipment and instrumentation aboard research vessels/boats.

3. Maintenance and repair of electronic monitoring and control systems equipment supporting, (but not necessarily limited to).

· Amphibian UV exposure facility.

· Fish physiological monitoring units.

· High hazard exposure/effluent treatment facility.

· Toxicant dilution systems for aquatic bioassay testing.

· Automated sampling and sample processing equipment.

Note: Equipment comprising these systems is described in specific research Task Orders available from the COR.

4. Install or relocate electronic scientific equipment and instrumentation. This includes the installation of new equipment or the moving of existing equipment. The Contractor may be asked to participate in the planning and preparation for movement and installation of equipment, as well as assist during the movement, installation and startup of equipment.

5. Design and assemble electronic equipment. The Contractor may be asked to work with government scientific staff to design, construct, and install, specialized electronic devices to meet specific research project needs. This may include, for example, apparatus for computerized electronic control and monitoring of aquatic bioassay systems, or shipboard systems to provide centralized computer control of sensory devices, data logging, and interconnectivity of shipboard scientific equipment and navigational systems. This task may include the writing of software and firmware.

6. Maintain complete and accurate records and documentation of maintenance of electronic equipment and instrumentation conducted under this contract, in accordance with NHEERL and MED QAPPs and SOPs/OPs. All raw and processed electronic data files and research notebooks are the property of EPA, and the Contractor shall enter them into the MED archival records system (according to the assigned Record Schedule) upon contract completion.

Considerations and Limitations for Task 1 and Task 2:

Culture unit support

1. Although the Contractor will have 24hr/7day responsibility for operation and maintenance of the culture unit, the full contract staff need only be present during MED’s normal working hours, Monday through Friday. A reduced staff shall be required on weekends and holidays to perform the minimum tasks necessary to maintain healthy organism cultures.

2. The Contractor shall rely on the MED electronic facilities monitoring system (Metasys) and MED security guard personnel, to monitor culture unit operation during the non-staffed, after-hours periods. MED security guard personnel are tasked with general observation of the culture facility during off-hours and will report any unusual observations or alarm indications to designated contract personnel. The Contractor shall, at all times, have at least one person, equipped with a pager or other communication device, available to respond to alarms or other after-hours indications of problems. EPA will provide training on the Metasys system to the Contractor.

Scientific equipment support

1. Maintenance and repair is limited to electronic scientific equipment or instrumentation being used in support of MED research projects. Non-scientific equipment will be the responsibility of the Division’s Operation and Maintenance (O&M) Contractor. For further clarification of this issue, see Procurement Operations Division memo on “Guidance for Equipment Maintenance under MED Contracts” below. Likewise, only computers which are interfaced with, or are integral components of, scientific equipment will be the responsibility of this Contract. The Division’s O&M Contractor personnel will perform any modifications to the facility required for equipment connections to utilities in the laboratories, and similarly, the Information Technology (IT) Contractor will make any necessary computer connections to internet or Laboratory Automation Network (LAN) systems to insure conformance with EPA and MED standards.

2. Maintenance of equipment shall be performed according to technical directives issued by the COR. Detailed descriptions of work performed shall be entered into the service and maintenance logs of equipment items for which such logs are maintained. Generally, “maintenance” of electronic equipment, for the purpose of this Contract, refers to the type of maintenance that would be considered “preventative maintenance” by equipment manufacturers and would normally be performed by the manufacturer’s service personnel; and thus does not mean the type of work that would be considered “routine operator maintenance”.

3. The Government recognizes that in some instances the repair of equipment may not be practicable, or may require the services of the manufacturer's trained service personnel. In these instances, the Contractor shall notify the COR so that other arrangements can be made for the repair. Obtaining the services of specialized service personnel will not be the responsibility of the Contractor.

4. Unless otherwise indicated in the technical directive, the Contractor shall acquire the electronic supplies, repair parts, and fabrication materials required for the performance of the Task Order(s). However, if any single supply or replacement part costs in excess of $500.00, approval to purchase must be received in advance from the COR.

Additional Tasks The Contractor may be tasked to:

1. Perform toxicity testing and bioassays, including ecological test systems, of ambient waters, spiked water (toxicity bioassays), leachates and sediments, using fish, amphibians and aquatic invertebrates as test organisms. Expose aquatic organisms in flow-through static exposure systems to pure chemicals, chemical mixtures, or environmental samples to evaluate their toxicity and toxicokinetics. Collect data on organism responses including mortality, growth, reproduction, and biochemical, physiological and behavioral endpoints. Method protocols will be provided by EPA when available, but the task may involve the development of new methods, or the refinement of existing methods, to meet specific research goals.

2. Maintain bioassay systems, monitoring and controlling test water conditions (e.g., temperature, water chemistry and test chemical concentration time series). Participate in the modification of existing systems or the design and construction of new systems.

3. Perform chemical analyses of laboratory and environmental samples. Analyses include qualitative and quantitative analyses of water, air, soil, sediment and biota samples. Analyses shall be performed according to EPA method protocols or alternative methods approved by EPA. Analyses will involve the use of a variety of analytical instrumentation which may include techniques such as gas chromatography, liquid chromatography, and mass spectrometry. Instrumentation will be provided by EPA.

4. Perform taxonomic analysis of aquatic vertebrates and invertebrates in water or sediment and specimen samples collected from field and laboratory studies. The Contractor may be asked to pick, sort, count and/or identify aquatic organisms (plant, vertebrates and invertebrates) found in environmental samples (water, sediment various trap samples).

5. Conduct scientific field studies as solely Contractor operations, or in conjunction with EPA staff. Contractor support may include the areas of planning and logistics, collection of physical, chemical and biological data, collection of water, soil, sediment, and biological samples, and chemical and biological analyses of field samples. The Contractor shall be required to maintain detailed records of field operations and prepare reports of study results and conclusions. Logistical support may include maintenance and minor repair of boats, ATVs, and other field-study equipment.

6. Provide shipboard operations support for MED's research vessel Lake Explorer II and other smaller vessels. The Contractor may be asked to provide qualified, and in some cases licensed, personnel to perform shipboard scientific, operational and maintenance functions. Maintenance functions may include general, mechanical or electrical, ship maintenance, maintenance of shipboard scientific equipment and maintenance or modification of equipment platforms.

7. Conduct and coordinate scientific workshops, meetings or seminars. Provide administrative and logistical support which may include planning, choice of location and presenters, perform scheduling, printing, mailing and registration. Record and transcribe workshop discussions, documenting points of consideration and subsequent determination. Note: The Contractor shall be responsible for expenses of consultants (non-federal government employees). Federal government employees participating by invitation will not be compensated. (See Clause RTP-H-4, "EPA Sponsored Meetings, Workshops, and Conferences).

8. Conduct literature searches using EPA approved search strategies. Review and analyze scientific literature and perform data entry to toxicological and ecological databases.

9. Conduct quality assurance review of EPA test data which may be suitable for model or benchmark development. Provide quality assurance review of original EPA data books and data sheets against electronic data files, identifying errors and missing information within data records. For data not already incorporated into electronic data files, abstract information onto data entry coding sheets for entry into an electronic data file.

10. Conduct searches of MED-Duluth and EPA electronic data files, including but not limited to ECOTOX, TOXICITY/RESIDUE, and various chronic and acute databases, for data associated with chemicals of concern. Using Standard Operating Procedures (SOPs) and guidelines provided by EPA, evaluate data quality of test results provided in publications. Provide ancillary documentation summarizing the use of EPA's data quality checklists, meanings of abbreviations, and short phrases used in the documents. Maintain the "data quality checklists" and all supporting operating procedures and documentation. Conduct assessments of peer-reviewed and non-peer-reviewed literature, using the "data quality checklist," evaluate whether or not a specific data point has met minimum qualifications for use in setting water quality criteria, or other Agency or predefined ecological benchmarks.

11. Perform statistical analysis and interpretation of laboratory and field-study data. Evaluate test data using EPA approved criteria to determine its acceptability for deriving criteria or other benchmarks and developing state-of-the-art models. Provide statistical expertise for experimental design and the development of sampling protocols.

12. Provide histological support for tissue studies. Prepare tissues, cells and whole organisms for histological analysis to allow evaluation of morphological effects of exposure to chemicals. Evaluation of biological materials to localize gene expression and pathological effects may be required.

13. Present contract-generated data at scientific meetings and seminars.

14. Provide technical and logistical support to environmental education and outreach activities including, but not limited to:

· Scientific demonstrations

· Training workshops

· Environmental communications

· Scientific seminars

· Coordination of laboratory tours/visitors

In addition to the specialized personnel required to perform the optional tasks described above, the Contractor may also be tasked to provide unique expertise in scientific and technical fields such as:

· Bioinformatics

· Social Science

· Economics

· Decision Support

· Toxicology

· Microbiology

III. RELATED SERVICES: The Contractor performs the following as required in approved Task Orders:

1. Attend meetings with EPA researchers to discuss technical or logistical issues relating to project planning, implementation, progress, problems, results, etc.

2. Serve on ad hoc committees formed on a temporary basis, to deal with specific issues relating to Health and Safety or Quality Assurance, and communicate recommendations to standing MED committee chairs.

3. Present contract-generated data at MED seminars.

IV. GENERAL REQUIREMENTS AND UNDERSTANDINGS:

1. The Contractor's on-site Project Manager shall supervise and manage all activities conducted by the Contractor under this contract and shall be responsible for ensuring that all activities are conducted in accordance with EPA and MED policies and guidelines.

2. The Contractor shall keep complete and accurate records of all work performed under this contract and shall be required to prepare reports of work progress and results. The Contractor may be tasked to participate in the preparation or review of scientific journal articles and other scientific documents, present findings at scientific meetings and workshops, and prepare seminar presentations as assigned in Task Orders. The Contractor shall obtain approval from the COR and CO prior to submitting any articles or data, resulting from work performed under this contract, for publication or presentation.

3. Quality Assurance (QA)/Quality Control (QC) on Scientific Tasks:

· The Contractor shall follow the QA procedures documented in the NHEERL Quality Management Plan (QMP) in all work performed under this contract. In addition, the Contractor shall be required to develop and submit its own QMP for the proposed work under this contract, which delineates management and employee responsibilities in producing quality work products. The Contractor may also be required to conduct, or participate in, periodic quality assurance audits. The Contractor’s QMP will be reviewed and approved by the QAM. The guidance for developing a QMP is called EPA QA/R-2, EPA Requirements for Quality Management Plans, found at: https://www.epa.gov/quality/epa-qar-2-epa-requirements-quality-management-plans

· Research conducted by the Contractor is directed by Task Orders (TO’s). The Contractor will be required to write Quality Assurance Project Plans (QAPPs) applicable to individual TOs. A TOCOR may assign work on one or many projects. The QAPPs must be approved by the TOCOR and MED QAM or their designee, prior to the initiation of work. Implement specific technical quality assurance and quality control guidance when supplied by the EPA COR to collect, format, process and provide quality control of samples as well as experimental and observational information from the field and laboratory. The guidance for developing a QAPP is called EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans, found at: https://www.epa.gov/quality/epa-qar-5-epa-requirements-quality-assurance-project-plans

· The Contractor may develop/draft QAPPs and SOPs as directed by TOs. The form and content of these documents shall follow the guidance found in the NHEERL QMP. The QAM will provide a copy of the QMP upon request.

· The Contractor shall maintain complete and accurate records and documentation of all laboratory and field activities conducted under this contract, in accordance with NHEERL and MED QAPPs and SOPs/OPs. All raw and processed electronic data files and research notebooks are the property of EPA, and the Contractor shall enter them into the MED archival records system (according to the assigned Record Schedule) upon contract completion.

· Calibration and Operation of Instrumentation/Analytical Equipment. All GFE and/or “shared” analytical equipment shall be correctly operated using standards, QA samples, calibration procedures, proper application of quality control measures outlined in SOPs/OPs for the instrumentation, and appropriate maintenance procedures.

5. Performance of Additional Tasks 5 and 6 above involving "field studies" and "shipboard operations" may require Contractor use of government vehicles.

If Contractor use of government vehicles is required, the CO will issue the Contractor authorization to use Government Services Administration (GSA) Fleet vehicles in the performance of this contract. The use of GSA Fleet vehicles by the Contractor shall be in accordance with FAR Subpart 51.2 Contractor Use of GSA Fleet Vehicles - Federal Property Management Regulations (FPMR) 41 CFR 101-39.202 and 41 CFR 101-38.301.

6. Health & Safety/Environmental Compliance Program. The contractor shall maintain and manage an employee occupational safety, health and environmental management (SHEM) program to meet EPA’s requirements for on-site work performed at EPA administered facilities and when performing field work. The contractor’s SHEM program shall meet all Federal, State and local regulations. The contractor’s SHEM program shall include personnel training, environmental compliance emphasizing adherence to operating permits and licenses, and occupational safety and health management for all administrative and research tasks performed under the terms of the contract.

Laboratory and Field Safety Requirements. The contractor shall conduct a safety program that is at least as protective as the EPA’s and complies with the State of Minnesota and/or OSHA requirements, whichever are the most protective. The contractor shall support the development of EPA’s Safety Plans. The EPA will provide Safety Plans to the contractor for the work required by this contract. All safety plans will be submitted to the contractor as an integral part of the Task Order, and the contractor shall comply with the EPA Safety Plans. If the contractor cannot comply with the EPA Safety Plans, the contractor shall notify the CO in writing as to the reason(s). The contractor shall maintain a safety program that complies with the MED’s Employee Health and Safety Manual.

Hazardous Waste Management. The contractor shall provide technical support to the hazardous waste program. This support will include the collection, placement and maintenance of a current inventory of hazardous waste in government-provided laboratory space. The contractor shall notify EPA’s Environmental Compliance Manager to request collections from the laboratory on an as-needed basis. EPA’s Environmental Compliance Manager will deposit the waste safely in the on-site hazardous waste storage building, and maintain a current hazardous waste inventory.

Environmental Management Systems Conformance. The Contractor shall perform work under this contract consistent with the relevant policy and objectives identified in the agency, organizational, or facility environmental management system (EMS). The Contractor shall perform work in a manner that conforms to all appropriate Environmental Management Programs and Operational Controls identified by the agency, organizational, or facility EMS, and provide monitoring and measurement information as necessary for the organization to address environmental performance relative to the environmental, energy, and transportation management goals. In the event an environmental nonconformance or noncompliance associated with the contracted services is identified, the Contracting Officer (CO) shall notify the contractor in writing with the appropriate corrective and/or preventative actions. In the case of noncompliance, the contractor, upon written notification from the CO shall respond and take corrective action immediately. In the case of a nonconformance, the contractor, upon written notification from the CO, shall respond and take corrective action based on the time schedule established by the EMS Site Coordinator. In addition, the contractor shall ensure that their employees are aware of the roles and responsibilities identified by the environmental management system and how these requirements affect their work performed under this contract.

All on-site contractor personnel shall complete yearly EPA-sponsored environmental training specified for the type of work conducted on-site. Upon inclusion in the contract Statement of Work, the CO will verify that all contractor personnel have acquired EMS Awareness Training at their appropriate site or location.