MODIFICATION
A -- Consultation for Air Quality Science Assessment for Sulfur Oxides: Toxicology Studies
- Notice Date
- 10/25/2006
- Notice Type
- Modification
- Contracting Office
- Environmental Protection Agency, Specialized Service Center/Cin. Proc. Operations Div., 26 West Martin Luther King Drive, Cincinnati, OH 45268
- ZIP Code
- 45268
- Solicitation Number
- RFQ-OH-07-00007
- Response Due
- 11/1/2006
- Archive Date
- 12/1/2006
- Description
- NAICS Code: 541620 Amendment #1 TECHNICAL QUESTIONS Question #1: Can the proposal be submitted electronically? Answer: Yes, as stated in the Fed Biz Ops Announcement, "Offers shall submit 1 copy of their quotation that references RFQ-OH-07-00007, no later than October 27, 2006 at 3:00 PM (EST) to Scott A. Fogle, at fogle.scott@epa.gov or via fax at 513 487-2107". The preferred method is email (electronically), but fax is also acceptable. Question #2: The announcement mentions a "quotation". Is a budget break-down required? Answer: Yes, a price estimate shall include a break-down of costs for each task, including the Optional Tasks and travel costs as identified in the SOW. Question #3: Are there limits to the format of the proposal - length, print size, etc.? Answer: The Technical Proposal shall be no more than 10 pages in length, with a 12 point font. Question #4: The project is titled "Toxicological Effects of Sulfur in Experimental Animals and In vitro Test Systems" but in several places in the Statement of Work, it indicates that expertise other than that of toxicologists is required. For example, page 2 of the SOW indicates that: "Under this order, the EPA seeks the professional services of an expert scientist(s) to accomplish the tasks described in the statement of work, with respect to assessing human health risks from SOx exposure." Answer: The above mentioned statement which is the concluding paragraph of the introduction to the statement of work, is a generic one reflecting the over all expectations of the EPA for this scientific requirement. The EPA would like to again state that, the statement of work is for the critical evaluation of toxicological evidence from laboratory animals and invitro test systems only. However, where ever there are parallels and possible extrapolations to exposure and health risk in humans, as the EPA PO sees pertinent to the critical evaluation or support to a particular toxicological study, the EPA would request that every effort be made, to address the evaluation along those lines. Question #5: In Attachment 2, it describes several areas which the document is to address - "Air Quality and Atmospheric Chemistry, Exposure, and Health Effects". The Attachment goes on to indicate that a number of questions will be considered. Included are questions such as: "What is the nature of health effects in individuals/animals exposed to multi-pollutant mixtures?..? (See answer below under question #6) Questions #6: In "Uncertainties" on page 18 (Attachment 2), it mentions "uncertainties due to confounding by meteorological factors", "uncertainties due to other confounding factors in epidemiologic studies (e.g., demographic and lifestyle attributes, genetic susceptibility factors, occupational exposure, and medical care)" Under "Susceptible Populations", there are questions regarding susceptible populations such as the elderly, individuals with pre-existing cardiac or respiratory diseases, and children. Thus the question is, "Should the proposal describe expertise other than toxicology (e.g., chemists, epidemiologists)? Answer: To sum up the answers for all the questions listed here on attachment 2; --- Attachment 2 describes the EPA's overall goals and vision of how the science assessment document should be. The EPA is looking at a global integration of information that will aid us understand the health risk from sulfur dioxide exposure from all spheres as pertinent to human health risk assessment. Additionally, if optional task 7B is exercised by the EPA it would be reasonably expected that overall integration of toxicological evidence with relevant epidemiological data from the angles such as cofounders, mixtures, genetic variances, exposure as relevant, be thoroughly evaluated. If the EPA PO identifies there is a need for such integration of toxicology data with meteorological/atmospheric findings, the EPA may decide the expertise from those angles are needed for the satisfactory production of the Science Assessment (SA) document. Finally, there are other SOx requirements which have been awarded and are making a more thorough integration of meteorological data and exposures to human exposures. Question #7: What is the required level and type of documentation needed for the cost proposal? See the answer to question #2. Questions #8: Please provide an example of the SASD or SA, for the depth of analysis. If there is no document that can be provided, is it reasonable to assume that the depth of writing is comparable to that in Air Quality Criteria Documents (AQCD)? Answer: The EPA requests you to view the recent AQCD on lead and ozone from the EPA website for an estimate of the depth of analysis. However, the EPA is trying to keep the present Science Assessment (SA) and support document much more concise and are expecting all the toxicology evidence to come in 75- 100 pages. The SA is the new format that is being introduced and hence has no template as such. However, integrated synthesis chapters from the documents referred above should provide some basis and understanding of how the EPA will integrate the information from all sources of evidence. The EPA expects the SA documents will be around 150- 200 pages. The toxicology aspect of the SA may be 30-40 pages. Question #9: Is human data (epidemiology data, clinical studies) included in the SOW at all Answer: Under this SOW, the EPA is only expecting the critical evaluation of toxicological evidence from laboratory animals and in vitro test systems. However, in the introduction where a summary of events from the past documents is given and also in the brief statements that are made in the beginning of each section on the over all progress in the scientific work covering that area, brief statements on epidemiological and clinical evidence that is relevant to toxicology are normally covered. In addition, all along the critique of the scientific evidence pertaining to the toxicology, where ever, relevant parallels and extrapolations to the human exposures, from both clinical and epidemiological work is found most appropriate, the EPA expects that every effort shall be made to bring the discussion along those lines. Question #10: Is the document covered by the SOW intended to include the data addressed in earlier documents, or to be an update from those documents? If the former, will an electronic copy of those earlier documents be provided? Answer: A brief summary of the scientific eveidence at the begining of each section as an introduction to the toxicology chapter covering the scientific evidence as presented in the previous document (that includes the latest addendum) is required for this requirement. Either electronic versions or the hard copies of the past SO2 document will be provided once the order is placed. Question #11: What is the time frame that the literature survey and study summary should cover? The 1994 supplement to the Second Addendum, the 1986 Second Addendum, or from the 1982 SOx AQCD? Answer: Although, the main focus of attention would be a thorough critique of the pertinant literature from 1994 onwards, the introductory summary statements can build historic perspective from the 1986 addendum as well. Question #12: The SOW states under item 10, that the detailed critical analysis of all toxicological studies on SOx health effects is beyond the scope of this document. However, it also states that of most importance for present purposes are those studies which provide useful qualitative or quantitative information on exposure-effect or exposure-response relationships for health effects. Is there any guidance on distinguishing these two types of studies? Answer: Note: Any toxicological evidence without serious methodological flaws from 1994 onwards is inclusive in this evaluation. Limitations in the methodologies, if any perceived, would be discussed in the critique. While, not excluding any relevant evidence, the EPA is expecting that studies reflective of ambient levels, exposure routes that are appropriate to human exposure scenarios, studies of animal disease models and clinical end points, shall be given their due weightage. Question #13: Which of the scientific issues listed in Attachment 2 are covered by this SOW? How do the issues listed in Attachment 2 relate to the proposed outline (Attachment 3). For example, uncertainties, biological mechanisms of action, and susceptible populations are not explicitly included in the outline, although issues related to them could be worked into the outline. Are these topics covered in the SOW and chapter 5? Answer: Attachement #2 describes the EPA's overall goals and vision of how the SA shall be completed. The EPA is looking at a global integration of information that will aid in understanding the overall health effects from ambient sulfur dioxide exposure. If, optional task 7B is exercised, the contractor shall include the overall integration of toxicological evidence with relevant epidemiological data from the angles such as cofounders, mixtures, genetic variences, exposure as pertinant to be thoroughly evaluated and integrated. To sum up, while, the statement of work as described, covers all the toxicological evidence from 1994, the SA document will focus on studies that are more relevant for integration of evidence with human exposure, clinical, controlled and other human studies, that can be extrapolated to human exposure scenarios. The outline in attachment 3 strictly limits to toxicological evidence with the extrapolations to human studies at the most appropriate instances. Question #14: What are the criteria for including a study in the main text under chapter 5 vs. including it in the Annex tables? Answer: Annex tables will have the details of every single original research study reported under the statement of work. It shall cover the study details such as species/cell type ( in case of invitro studies) dose, duration, type of compound, exposure route, and the salient study findings etc. For the format please refer to the EPA's recent AQCD on lead. Question #15: Task 4 includes review of "the entire" Toxicology chapter. Please provide information on the content of the Toxicology chapter that is not being written under this SOW. Answer: All the areas of toxicology are covered under the present SOW. Question #16: How many people, from the author team for the work under this SOW, should attend the peer review meetings Answer: Only the author(s) that significantly contribute and act as an internal reviewer of the document in the team, should attend the meeting. Question #17: Task 7a is entitled preparation of the SA, but the text under the title refers to revising and finalizing the SA. How many drafts will there be for the SA, and under what task is the first draft written? Answer: Task 7a is an optional task for the preparation of the Science Assessment document and is an optional task. An initial and revised draft will be needed under this task if exercised. Additionally, the initial and revised draft will be written under Optional Task 7a. Question #18: Based on the specified level of effort and the complexity of the database for this chemical, judgments will be needed regarding the data that are included. Is it appropriate to caveat the proposal with clearly laid out assumptions to further define the scope of work? Answer: Yes, provide all assumptions upfront with your quote. The detailing on technical direction of the SOW will be addressed during the 1st teleconference when the expanded outline is received, (Task 2) under the SOW. NOTE: Due to the delay in answering the technical questions received, the due date for quotes has been extended to Wednesday, November 1, 2006 NLT 12:00PM (EST). NCEA TECHNICAL SUPPORT FOR SERVICES This is a combined synopsis/request for quote (RFQ) for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. The identifying RFQ number is RFQ-OH-07-00007. The RFQ and incorporated provisions/clauses are those in effect through Federal Acquisition Circular 05-13. A firm fixed price purchase order is anticipated to result from the award of this RFQ. The NAICS code is 541620. STATEMENT OF WORK I. Project Identification: Consultation for Air Quality Science Assessment for Sulfur Oxides: Toxicological Effects of Oxides of Sulfur in Experimental Animals and In vitro Test Systems II. Period of Performance: 24 months from award date III. Type of Purchase Order: Firm Fixed Price (inclusive of all travel costs and fees) IV. Estimated Level of Effort: 503 hours for Tasks 1-8 (162 hours for Optional Tasks (7a, 9, and 10) Background The Clean Air Act requires periodic review of the National Ambient Air Quality Standards (NAAQS). As part of this process, the National Center for Environmental Assessment (NCEA) of the U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD) reviews and integrates new scientific information on the pollutant in a Science Assessment (SA), historically known as an Air Quality Criteria Document (AQCD). The EPA is now in the process of reviewing the NAAQS for sulfur oxides (SOx). On April 30, 1971, the EPA promulgated primary NAAQS for SO2 at 0.14 parts per million (ppm), averaged over a period of 24 hours and not to be exceeded more than once per year, and 0.030 ppm annual arithmetic mean based on the findings outlined in the original 1970 AQCD, Air Quality Criteria for Sulfur Oxides. In 1982, EPA published the Air Quality Criteria for Particulate Matter and Sulfur Oxides along with an addendum of newly published controlled human exposure studies, which updated the scientific criteria upon which the initial standards were based. A second addendum presenting newly available evidence from epidemiologic and human controlled exposure studies was published in 1986 followed by a supplement to the second addendum in 1994. On April 26, 1988, the EPA announced its proposed decision not to revise the standards for SOx. In that notice, the Administrator also solicited comment on an alternative of adding a 1- hour primary standard of 0.4 ppm. On November 15, 1994, the EPA proposed not to revise the 24 hour and annual standard but solicited comments on adding a new 5-minute standard of 0.60 ppm, with one expected exceedance. The final decision on May 22, 1996 stated that revisions of the NAAQS for SOx was not appropriate at that time. The schedule for the current review of the NAAQS for SOx is the subject of ongoing litigation and will eventually be established as a court-ordered schedule. The EPA's proposed schedule includes a commitment for completion of the SOx SA by September 2008, in order to provide the scientific basis for re-evaluation of the SOx air quality standard. The EPA's proposed schedule also includes a number of target dates for interim steps in the development of the SOx SA, including completion of the first draft of the SOx SA by June 2007. The scientific information on SOx shall be reviewed and summarized in a Science Assessment Support Document (SASD) and the Science Assessment (SA). The first draft of the SASD will be reviewed at an authors review meeting sponsored by the EPA. This draft SASD will be revised to produce a peer review draft that shall be reviewed by peer reviewers at a public meeting. Peer review comments will be incorporated in the draft final SASD. After the peer review comments are incorporated to the draft final SASD, the SA (a focused integrative document) shall be prepared as an external review draft for review by the Clean Air Scientific Advisory Committee (CASAC) of the EPA's Science Advisory Board (SAB), and for public comment. The EPA anticipates preparing two drafts of the SOx SA for public and CASAC review, before completion of the final SOx SA. EPA NCEA is seeking to retain the professional services of scientists to assist with the review, critical evaluation summary and integration of the available scientific database on SOx physical and chemical properties, measurement methods, environmental sources, concentrations, and pathways to human exposure, environmental effects, toxicological and human effects, and an evaluation of health risks to include public health significance. Under this order, the EPA seeks the professional services of an expert scientist(s) to accomplish the tasks described in the statement of work, with respect to assessing human health risks from SOx exposure. ***Note: Due to the length of the SOW, Technical Evaluation Criteria, and Attachments 1-3, the EPA could not post the entire information to the Fed Biz Ops website. If a contractor or consultant is interested in this requirement, please submit a request in writing via email to Scott Fogle at fogle.scott@epa.gov requesting an electronic copy of the SOW, Technical Evaluation Criteria and Attachments. All requests for these documents need to be submitted by close of business October 24, 2006. The following clauses apply to this request for quote: FAR 52.212-1, Instructions to Offerors-Commercial Items; FAR 52.212-2 Evaluation-Commercial Items, and the specific evaluation criteria: (See Technical Evaluation Criteria attachment) Offers shall provide information to demonstrate/substantiate that its quote meets the requirements in the Statement of Work; FAR 52.212-3, Offeror Representations & Certifications-Commercial Items, shall be completed by offeror and submitted with quote, unless the offeror's registered with CCR; FAR 52.212-4, Contract terms & Conditions-Commercial Items; The following FAR clauses in paragraph (b) of FAR clause 52.212-5, Contract Terms & Conditions Required to Implement Statutes
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