LIMITED_Source_Justification_for_posting.docx

Limited Source Justification (Reference FAR 8.405-6(c))

1. Agency: US EPA, Office of Research and Development (ORD), National Exposure Research Laboratory (NERL)

Requisition Number: PR-ORD-15-01207

2. Nature and/or description of the action: The Cincinnati Procurement Operations Division intends to award a GSA delivery order for the supplies detailed in Paragraph 3.

3. Description of Supplies or Services: The USEPA Office of Research and Development, National Exposure Research Laboratory (NERL), Ecosystems Research Division, Processes and Modeling Branch requires an ultra-High Performance Liquid Chromatograph (uHPLC) interfaced with a Time of Flight Mass Spectrometer (ToF-MS) complete with computerized software systems for instrument operation and data analysis and reporting from Waters Corporation, to perform state-of-the-science experiments on the transformation and fate of chemicals in environmental and biological systems.

These efforts require the capability to identify and quantify trace levels of compounds in a wide array of complex sample matrices. Because many of these compounds will be unknown, the analyses will be untargeted, i.e., unknown analyte mass to charge ratios. Considering these two factors (dirty matrices and untargeted analyses), success of this research depends upon access to high-resolution, accurate-mass instrumentation. In pursuit of high-resolution capabilities, ultra-performance, high-performance liquid chromatography (UHPLC) is at the forefront of laboratory instrumentation. Among accurate-mass technologies quadrupole time-of-flight (Q-TOF) instruments stand alone in mass resolution; Q-TOFs are able to resolve ppb-range mass-to-charge ratios, about ten-fold more sensitive than the next-most sensitive “orbitrap” instruments.

4. Estimated Value: $330,000 – most of all system components are on the GSA Schedule (required open market items are addressed in a separate sole source justification)

5. An identification of the LSJ rationale, and if applicable, a demonstration of the contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(B) – Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized

The U.S. EPA Office of Research and Development, NERL/PMB requires the specified UHPLC/Q-TOF instrument with consisting of a) an ultra-performance liquid chromatograph (UPLC) capable of binary flows, from 50 µL/min to 2 mL/min via software control; b) an autosampler capable of holding small (2mL) sample vials in cool temperature-controlled setting; and c) a "next generation" a Quadrupole - time-of-flight mass spectrometer (Q-TOFMS) capable of high resolution/accurate mass (HR/AM) and MS/MS.

This instrument is necessary further ongoing research projects described below, as well as complement them with novel, proteomics based research efforts.

(a) ERD has invested several years of research into a major effort to develop the Chemical Transformation Simulator (CTS), a tool intended to aid EPA Program Offices in their mission to evaluate the safety of proposed commercial chemicals. A central ongoing challenge is how to estimate the magnitude of uncertainty in properties estimated by the CTS. To address this challenge, the CTS development team is planning to identify specific chemicals, representing each of several classes of commercial agrochemicals and pharmaceuticals, to subject to chemical testing. These chemical tests will include hydrolytic- and reductive-degradation studies in which unknown products of reaction will be sought using mass-spectral technology.

(b) ERD has invested considerable effort in identification of the role of pesticides, their unknown degradation products and other chemicals identified as endocrine disruptors in amphibian and mouse models. While our progress has been substantial we have run into multiple analytical challenges that only can be resolved by access to UHPLC/Q-TOF instrumentation.

(c) ERD has invested considerable research efforts into the application of ‘omics technologies in elucidating the consequence of exposure to xenobiotics in ecologically relevant species.

Following substantial internet research and contact with several major vendors of high resolution analytical scientific equipment, it has been determined that only the XEVO G2-XS system sold by Waters Technologies Corporation can fulfill the Agency’s minimum analytical research needs.

This instrument is the only one available on the current market that can provide the level of chemical separation, resolution, accuracy, sensitivity, throughput, and dynamic range needed to fulfill the research needs of EPA’s Research Program Offices. For example, this research project requires a mass resolution greater than 40,000 FWHM and it requires a mass range at least to 10,000 m/z with a mass accuracy <1 ppm (external calibration). The only UHPLC/Q-TOF instrument on GSA schedule that has these capabilities is the Waters XEVO G2-XS system.

6. A determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

The EPA Contracting Officer intends to award a delivery order no higher than the GSA Schedule price. The Contracting Officer will request and anticipates receiving a discount from the GSA Schedule price.

7. A description of the market research conducted among schedule holders, and the results of the research, or a statement why market research was not conducted. A statement must be made that the supplies and services are available from the FSS.

Market research was conducted through internet searches and contact the major manufacturers of these types of highly specialized instruments. Based upon those exchanges, it was determined that only the specified system can meet the agency’s analytical needs.

8. Any other facts supporting the limited source justification.

None

9. A statement of the actions, if any, the agency will take to remove or overcome any barriers that led to restricted consideration before any subsequent acquisition for supplies and services is made.

At this point, EPA knows of no other source that could provide this system. EPA will continue to monitor the market place for these highly specialized systems and will be attentive that its required specifications are necessary to care out its analytical research needs.

Certification

Technical Officer’s Certification:

I certify that the facts and representations under my cognizance, which are included in this justification and which form a basis for this justification, are complete and accurate.

Contracting Officer:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Level Above Contracting Officer:

I certify that the facts and representations under my cognizance, which are included in this LSJ and which form a basis for it, are complete and accurate.