SOLICITATION NOTICE
C -- Drinking Water Exposures and Internal Doses of Trihalomethanes in Humans
- Notice Date
- 12/8/2005
- Notice Type
- Solicitation Notice
- Contracting Office
- Environmental Protection Agency, Ow Service Center, 26 West Martin Luther King Drive, Cincinnati, OH 45268
- ZIP Code
- 45268
- Solicitation Number
- RFQ-OH-06-00040
- Response Due
- 12/23/2005
- Point of Contact
- Point of Contact, Scott Fogle, Purchasing Agent, Phone (513) 487-2049
- E-Mail Address
-
U.S. Environmental Protection Agency
(FOGLE.SCOTT@EPA.GOV)
- Description
- NAICS Code: 541330 The US Environmental Protection Agency (EPA), Office of Research and Development (ORD), National Center for Environmental Assessment (NCEA), intends to negotiate, on a sole source basis, under the authority of FAR 13.106-1(b), with Wilkes Technologies Inc. This sole source award will address highly technical review comments on the structure and operation of the Total Exposure Model and physiologically based pharmacokinetic models employed in the NCEA-C-1691 report; to translate concentrations of trihalomethanes disinfection byproducts into human internal doses and target tissue concentrations; and develop three draft manuscripts for submission to peer reviewed journals; provide textual, graphic and tabular input to the three manuscripts. Based on the EPA's knowledge of this requirement, there are features covered in the statement of work that may have unique capabilities to particular vendors. Statement of Work Drinking Water Exposures and Internal Doses of Trihalomethanes in Humans Background: While most human health chemical risk assessments are based on laboratory findings in animals which were exposed only to the chemical of interest (a single-chemical exposure), humans are not so uniquely exposed. Human exposures to chemical mixtures are the norm, in both therapeutic treatment (solvent, diluent, formulating agents, and active ingredients), environmental exposures to pesticides (active pesticide agents, synergists, surfactants), and through the consumption of drinking water, which may contain more than one hundred disinfectant by-products, as well as pesticides and breakdown products, and other contaminants of ground- and surface water sources not fully removed by treatment. Given the differences in exposure scenarios (acute versus chronic; daily versus seasonal), and in anticipated exposure route (oral, dermal and inhalation), exposures may vary by several orders of magnitude. In addition, chemical specific differences in metabolism and solubility in blood and tissues modify the internal dosimetry of these agents such that organs and tissues will be exposed to quantitatively different amounts (concentrations) and qualitatively different chemical moieties (parent chemical versus a metabolite). These factors are the determinants of chemical-specific pharmacokinetics (PK) among and within animal species. NCEA and research partners have demonstrated the feasibility of using complex modeling approaches to characterize the oral, dermal and inhalation exposure to trihalomethanes drinking water disinfection byproducts based on the concentration of the contaminants in tap water, the physicochemical properties of the chemicals, and information on household airflow and human water use and activity patterns. These exposures have been successfully translated into measures of internal and target tissue doses through physiologically based pharmacokinetic (PBPK) modeling. Recently the EPA report on this work was subjected to internal and external review in accord with Agency peer review standards. The work received laudatory comments from each review, but some of the comments will require an appreciable amount of additional work in order to refine the report to its most valuable stage. Further, dissemination of the report's findings in the open, peer-reviewed literature through the publication of a series of journal articles was highly recommended by the external peer panel review. For the present work, NCEA-Cincinnati project 6485a is concerned with refining the report to address external reviewer comments and developing a series of journal articles on the work. Objective: The purpose of this acquisition is to obtain contractor support in addressing highly technical review comments (Attachment 1) on the structure and operation of the Total Exposure Model and physiologically based pharmacokinetic models employed in the report (NCEA-C-1691) (Attachment 2); to translate concentrations of trihalomethanes disinfection byproducts into human internal doses and target tissue concentrations. Further, this acquisition will obtain contractor support for the development of three draft manuscripts for submission to peer reviewed journals. A brief summary of the three manuscripts, specifically indicating contractor contributions, can be found in Attachment 3. Description of Tasks Government Provided Data: The Government will provide external panel review comments on the NCEA report, a copy of the draft report, outlines of three draft manuscripts for contractor contributions, and a copy of the NCEA Instruction Manual for Contractors, August 2005. Task 1: Address the review comments on NCEA Report. In a telephone conversation initiated by the Project Officer (PO) the Contractor shall discuss with the PO each of the comments. The contractor shall develop a specific response to each of the comments; that response shall identify the pages, sections, and/or paragraphs of the draft report revised to address the reviewer comments. Task 2: Revise the NCEA Report to reflect changes. The contractor shall revise the report to reflect the changes made, and shall clearly indicate the modified text. Task 3: Develop contributions to three draft manuscripts. The Contractor shall develop specific text that addresses the points in the summaries of the three draft manuscripts. Such text shall be free from grammatical errors and be constructed in an information-dissemination style consistent with such found in top-quality professional journals devoted to toxicology and human health risk assessment. Pending a choice for journal submission, formatting of the draft contributions should not be a priority. Task 4: Address journal review comments. Once submitted to the journal and the editor's reviews returned, the Contractor shall participate in addressing journal review comments that pertain to the manuscript contributions developed by the Contractor. The Contractor shall revise the returned draft manuscripts to address journal reviewer comments and develop a "response to comments" document for return with resubmission of the revised journal article. Task 5: Address Quality Assurance in a Narrative Statement. The Contractor must warrant this report contains, and the conclusions are based upon, the most scientifically-defensible data and methods available. All data that serve as the basis for computations must be obtained from the peer-reviewed literature, and referenced as such. When data necessary for computations are required, but not available in the peer-reviewed literature, they are to be estimated using peer-reviewed procedures developed for that purpose. Those methods must be properly cited. The pharmacokinetic models must have either been developed specifically to address the chemicals of concern and the tissue doses of interest in this acquisition, or have been adapted using properly referenced and peer-reviewed procedures in their adjustment. Concentrations of contaminants in drinking water, which were provided by the US EPA from published sources, will be properly referenced. Other quality issues to be addressed within this narrative and throughout the document are detailed in the following two sections on quality assurance and quality requirements. Quality Assurance: This project requires some data to be generated. The Contractor shall demonstrate the application of peer-reviewed techniques and methods, and the application of peer-reviewed values for blood: air partition coefficients in the derivation of tissue:air PC values for THM compounds. All critical steps in the developed approach and information contained in the identification and justification for the chemical mixtures shall be clearly identified as to source, with the Contractor placing an emphasis on information available in the peer-reviewed literature. Any information not found in publicly available EPA sources or in the peer-reviewed literature shall be additionally and uniquely identified (as simple as an asterisk and footnote) as having its origin outside of the peer-reviewed literature. All information shall be accurately referenced. Any adjustments made to existing pharmacokinetic models shall be fully described and justified, whether based on scientific best judgment from experience or based directly on information obtained from the peer-reviewed literature. Quality Requirements: This acquisition will use additional information to refine estimates of the internal doses of trihalomethane DBP chemicals. It will incorporate new empirically-derived values for partition coefficients and will refine exposure to reflect temporal patterns, rather than average daily estimates of exposure. Published and peer-reviewed works on these subjects, developed for this purpose will serve as reference material (see reference section), and the Contractor shall employ only methodology which has previously been peer-evaluated and published in the open, peer-reviewed literature. The final report from this acquisition shall clearly communicate the methods employed, and sources of information and/or data employed as reference material or values for underlying key equations and data serving as the foundation for the work. Specific attention should be given, so that the report adequately demonstrates the advantage in estimating temporally-varying measures of exposure, rather than time- weighted exposures. An example of this justification may be related to the toxicity of peak- versus time-averaged measures of exposures. Additional attention should be devoted to demonstrating the impact of uncertainty in key biological or biochemical parameters of the PBPK model (e.g., blood:air PC values for chemicals whose hepatic metabolism is flow-limited) on risk-related model predictions. In this work, consideration should be given to communicating the importance of assessing metabolic interactions, and presenting the underlying concepts and considerations which guide the determination of the likelihood of metabolic interactions among these mixture components at the anticipated exposure (see Dobrev et al., 2002). To summarize, the final report shall contain a justification (and references) for the water concentrations of trihalomethanes employed, shall clearly identify the physicochemical data and methods used to predict volatility, a description of the pecifics of the inter characteristics of the simulated domicile, the water use patterns for individuals residing in the home, and the activity patterns of the individuals whose internal doses are simulated, and information clearly describing the patterns of exposure to the trihalomethanes during the daily cycle. The PBPK model portion of the report shall present references for PBPK models used with or without adaptation, the values and references for values used for biological and biochemical parameters. A section of the report shall identify and justify (with references) the dose metric (i.e., AUC, area under the concentration-time curve, of parent chemical in kidney) for each of the THM chemicals which will serve as the risk relevant PK outcome employed in determining sensitivity to model parameters. Finally, the report shall contain the results of a sensitivity analysis demonstrating the degree to which the risk-relevant pharmacokinetic outcome for each of the THMs is dependent on these parameters. The report shall be developed and formatted so that minimal changes are required for publication in the peer-reviewed literature. Milestones and Deliverables: Task Deliverable Due Date 1 Response to Review Comments on NCEA Draft Report and Revised Report Text 75 days after award 2 Contractor contributions to the first manuscript 75 days after award 3 Contractor contributions to the second manuscript 150 days after award 4 Contractor contributions to the third manuscript 150 days after award 5 QA Narrative Statement 150 days after award Acceptance Criteria: The contractor shall provide one hard copy of each for the deliverables. The Response to Comments document for the report shall be formatted in the manner supplied to the Contractor, accomplished by filling in the "response" section found in Attachment 1. The contributions to each of the manuscripts shall be formatted in the manner usual for publication in the peer reviewed literature in accordance with the NCEA Instruction Manual for Contractors (excepting the requirement to use Microsoft Word software for word processing), August 2005 (Attachment 4). Conflict of Interest The Contractor warrants that, to the best of the Contractor's knowledge and belief, that there are no relevant facts or circumstances which could give rise to a conflict of interest, as defined in FAR subpart 9.5, or that the Contractor has disclosed all such relevant information. The Contractor agrees to notify the Contracting Officer immediately, that to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the Contractor may have. The Contractor agrees that if an actual or potential conflict of interest is identified during the performance, the Contractor will immediately make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consulting with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Contract Publication Review Procedures (EPAAR 1552.237-70) (ARP 1984) The Contractor may not publish, present briefings or release any material resulting directly or indirectly from work performed under this order in any conference, presentation, forum, publication or other discussions without the prior approval of the EPA Project Officer. However, any firm believing itself capable of meeting the EPA's requirement may submit technical documentation to establish the potential of complying with the specifications. Such documentation must be submitted to the point of contact within 15 days of the posting of this notice. A determination not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered only for the purpose of determining whether to conduct a competitive procurement or to proceed on a sole source basis. The applicable NAICS code is 541330. Please submit your request in writing to Scott A. Fogle at fogle.scott@epa.gov or fax your request to (513) 487-2107. No telephone requests will be honored. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (08-DEC-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 24-JAN-2006, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/EPA/OAM/OH/RFQ-OH-06-00040/listing.html)
- Record
- SN00972545-F 20060126/060124213400 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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