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| Study Design         for Evaluating of Impacts to Underground Sources of Drinking Water by         Hydraulic Fracturing of Coalbed Methane Reservoirs 1.0 INTRODUCTION 
 1.1 Study Background 

 Coalbed gas production through wells began in the 1970's as a safety         measure in underground coal mines to reduce the explosion hazard posed         by methane (Elder and Deul, 1974). In 1980, the U.S. Congress enacted         a tax credit for non-conventional fuels production, including coalbed         methane, as part of the Crude Oil Windfall Profit Act. In 1984, there         were fewer than 100 coalbed wells in the U.S. By 1990, however, with the         anticipated expiration of the tax credit almost 8,000 coalbed wells had         been drilled nationwide (Pashin and Hinkle, 1997). In 1996, coalbed methane         production in 12 states totaled about 1,252 billion cubic feet, accounting         for approximately seven percent of U.S. gas production (U.S. Department         of Energy, 1999). According to the U.S. Department of Energy, natural         gas demand is expected to increase at least 45% in the next 20 years (U.S.         Department of Energy, 1999a). The rate of coalbed methane production is         also expected to increase in response to the growing demand. 

 Although the use of natural gas has many environmental benefits over         traditional energy sources, concerns have been raised regarding the environmental         impacts of coalbed methane production. Coalbed methane production in certain         areas has led to alleged ground water depletion and produced water discharge         issues. Citizens, state agencies, producers, and the regional EPA offices         in those areas are working in concert to understand and mitigate potential         problems. Separate from ground water depletion and water discharge issues         are allegations that hydraulic fracturing of coalbed methane wells has         affected the quality of ground water. State oil and gas agencies receiving         citizen complaints have stated that, based on their investigations, hydraulic         fracturing did not contribute to water quality degradation. 

 The State of Alabama recently adopted hydraulic fracturing regulations         into its Underground Injection Control (UIC) program in response to an         11th Circuit Court of Appeals (hereafter, "the Court") decision (LEAF         v. EPA, 118F.3d 1467). Prior to the Court's decision, EPA had not considered         hydraulic fracturing as underground injection because it did not regard         production well stimulation as an activity subject to regulation under         SDWA's UIC program. However, the Court held that the injection of fluids         for the purpose of hydraulic fracturing constitutes underground injection         as defined in the Safe Drinking Water Act (SDWA); that all underground         injection must be regulated; and that hydraulic fracturing of coalbed         methane wells in Alabama was not regulated under Alabama's UIC program.         Stakeholders are interested as to whether or not and to what extent hydraulic         fracturing in coalbed methane could be a national issue. 

 Given that coalbed methane production will likely increase and given         that EPA has received reports from citizens in different states alleging         hydraulic fracturing resulted in ground water degradation, EPA believes         further investigation is necessary to evaluate the potential risks. 

 1.2 Purpose 

 The purpose of the fact-finding study described herein is to assist         EPA in determining if hydraulic fracturing of coalbed methane wells poses         a threat to underground sources of drinking water. EPA intends to complete         this study before making regulatory or policy decisions regarding hydraulic         fracturing. 

 In July, 2000 EPA published a Federal Register notice (Volume 65, Number         143, [Page 45774-45775]) requesting comment on a conceptual study design         in order to receive stakeholder input on how an EPA study should be structured.         EPA received more than 80 sets of comments from industry, state oil and         gas agencies, environmental groups and individual citizens. A summary         of comments can be viewed on EPA's web site at 		http://www.epa.gov/safewater/uic/cbmstudy.html. Hard copies can be ordered         by contacting EPA's Water Resource Center by phone at (202) 260-7786,         or by e-mail to 		[email protected]         or by conventional mail to EPA Water Resource Center, RC-4100, Ariel Rios         Building, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. 

 1.2 What is Hydraulic Fracturing? 

 Hydraulic fracturing is the initiation and propagation of a fracture         in a rock matrix by means of hydraulic pressure. The hydraulic fracturing         process uses very high pressures to initiate a fracture at a specific         depth in the coal formation. The length and height of this fracture is         dependent upon a number of geological properties of the rock in which         the fracture is initiated and the rock types that bound that interval.         Due to the loading forces contributed by the rock above the injection         zone, hydraulic fractures that are initiated at depths greater than 1,500         feet below the surface are typically vertical fractures. Hydraulic fracturing         operations initiated at shallower depths may create horizontal fractures         under ideal situations. Rather than a branched network of major and minor         fractures, hydraulic fracturing creates fractures with vertical, two-dimensional         fan-shaped, planar features, having two "lobes" centered on the wellbore         perforations (Diamond, 1987; Morales et al, 1990). 

 One or more stimulation fluids is used in each hydraulic fracturing         event. The composition of these fluids include water, hydrochloric acid,         "slick" water (which includes a viscosity reducer), gels, and nitrogen         foam (Palmer et al, 1993). Included with most stimulation fluids are "proppants"         which are sand grains or glass, plastic or ceramic beads that serve to         hold the hydraulic fracture open after the initiating pressure is released.         The most common proppant used in coalbed methane treatments is sand. The         amount of proppant injected for each fracture treatment ranges from 10,000         to 120,000 pounds (Holditch et al, 1989; Palmer et al, 1991a, 1993). Fracture         widths in the formation vary from 0.5 inches to closed (i.e., no proppant         used), depending on the distance from the wellbore and the efficiency         of the proppant displacement into the fracture (Palmer and Sparks, 1990;         Palmer et al, 1993; Steidl, 1993). 

 1.3 Summary of EPA's Study Approach 

 EPA will perform an investigation of the potential impacts on underground         sources of drinking water (USDWs) from hydraulic fracturing of coalbed         methane wells. Given the enormous variation in geology among and within         coalbed basins in the U.S., any evaluation of potential impacts at a national         level will necessarily be broad and general in scope. In order to best         utilize resources in investigating this issue, EPA will conduct the study         in three phases, narrowing its focus from general to more specific as         needed. At the completion of each phase, EPA will decide if findings warrant         continuation into the next phase 

 Phase I of the study will be a limited-scope assessment designed to         enable the Agency to determine if hydraulic fracturing of coalbed methane         wells clearly poses little or no threat to USDWs, or if the practice may         pose a threat and require further investigation. In Phase I, EPA will       
-  Gather existing information to review hydraulic fracturing processes,           practices, and settings; 
-  Request public comment to identify incidents that have not been reported           to EPA; and, 
-  Review reported incidents of ground water contamination and any follow-up           actions or investigations by other parties (State or local agencies,           industry, academia, etc.). Phase I will include a review of the results           of the GSA study described above. Once the information gathered through           the Phase I effort is analyzed, EPA will make a determination regarding           whether further investigation is needed. 

 The decision to continue with Phase II will be based on the results         of the Phase I study and consideration of other priorities within the         Office of Ground Water and Drinking Water. EPA will not continue into         Phase II of the study if the investigation finds no hazardous constituents         are used in fracturing fluids, hydraulic fracturing does not increase         the hydraulic communication between previously isolated formations, and         reported incidents of water quality degradation can be attributed to other,         more plausible causes. 

 If OGWDW moves to Phase II, it would likely include site investigation(s)         of proposed physical or chemical mechanisms that potentially lead to USDW         endangerment and an estimate of national risk. If OGWDW believes Phase         II findings indicate significant risk exists, EPA would move to Phase         III of the study. Phase III would consist of an evaluation of existing         regulations and a policy determination. EPA will not draft a detailed         approach for conducting Phases II and III unless and until the Agency         makes decisions to continue the study into each subsequent phase. 

 EPA will take several steps to involve the public during the course         of the study. Those steps include publishing Federal Register Notices         requesting comments on study plans and draft work products; providing         periodic updates for stakeholders in the form of written communication;         and maintaining a web site where stakeholders can view the project documents         and provide information to EPA. 

 In addition to efforts to review hydraulic fracturing at a national         level, EPA has jointly funded a site-specific study, which will be conducted         by the Geological Survey of Alabama (GSA). This study will attempt to         address a concern that is central to contamination and drawdown issues         - the degree to which flow is confined within coal beds in coalbed methane         fields (GSA, June, 2000). Additional information is available on the GSA's         web site at http://www.gsa.state.al.us/gsa/3DFracpage/3Dfracstudy.htm.         

 2.0 PHASE I STUDY OBJECTIVES - MECHANISMS         THAT MAY IMPACT USDWs 

 The first step in investigating the potential for hydraulic fracturing         to endanger USDWs is to define mechanisms by which endangerment could         occur. EPA defined two hypothetical mechanisms by which hydraulic fracturing         of coalbed methane wells could potentially impact USDWs: 
 1. The intentional direct         injection of fracturing fluids into a USDW; and,        2. Creation of a hydraulic communication between the target coalbed formation         and adjacent USDWs. 
 The objective of the Phase I study is to consider these two mechanisms,         based on existing literature and data, when evaluating whether hydraulic         fracturing endangers USDWs. 

 Fluids can be injected into a USDW (mechanism #1 above) directly or         indirectly depending on the location of the coalbed relative to a USDW.         In many coalbed-methane producing regions, the target coalbeds occur within         USDWs, and the fracturing process injects stimulation fluids directly         into the USDWs (see Figure 1). In other production regions, target coalbeds         are adjacent to the USDWs that exist either higher or lower in the geologic         section. 

 Once the fluids are injected, local geologic conditions may interfere         with their complete recovery. This may result in fracturing fluids being         "stranded" in a USDW. If hazardous materials are included in the stimulation         fluids, they could potentially endanger a USDW and any drinking water         supplies relying on the USDW. 

 The second hypothetical mechanism is the creation of hydraulic communication,         or a pathway, between the target coalbed and an adjacent USDW that may         cause associated water quality and quantity impacts within the USDW, separate         from the injection of fluids as described above. Hydraulic fracturing         in coalbed methane formations typically creates fractures that are taller         than they are wide (Morales et al, 1990; Zuber, 1990; Holditch et al,         1989; Palmer et al, 1991, 1991a, 1993), and the potential exists for fractures         to extend through the stratigraphic layers that separate coalbeds and         USDWs. Some stakeholders have theorized that either stimulation fluids         containing hazardous materials or more saline ground water may enter a         USDW through newly-formed pathways created from hydraulic fracturing (see         Figure 2) and water quality may be affected from this hydraulic communication         between coalbeds and adjacent USDWs. 

 It will be difficult to properly evaluate the potential for hydraulic         fracturing to create hydraulic communication between coalbeds and adjacent         stratigraphic layers as a Phase I study element. In order to make a defensible         determination that hydraulic fracturing has impacted an aquifer, it would         be necessary to have site-specific data concerning: 
-  Water quantity and quality conditions in a USDW (or a well) both           before and after a fracturing event; 
-  Location, dimensions, and conductivity of fractures created during           the coalbed stimulation event; 
-  Measured changes in ground water flow between the USDW and coalbeds           or other aquifers; and 
-  Impacts of other, unrelated, hydrologic and water quality processes           that could also be affecting the USDW. 

 The extent to which these data are available to properly support an         analysis of national scope is unknown, but the effort necessary to collect         and evaluate them fully is beyond the scope of Phase I. EPA believes the         first mechanism described in this section, fluid injection directly into         a USDW, presents the more plausible scenario of the two endangerment scenarios         presented. However, the data that are collected as part of Phase I will         be analyzed to determine if information exists to draw conclusions regarding         the impacts of creating a hydraulic connection between a coalbed and a         USDW, and if so, this information will be included in the Phase I report.       

 3.0 STUDY COMPONENTS 

 EPA will research the topic areas described below to evaluate the impacts         of hydraulic fracturing on USDWs. Information will be collected regarding         the geology and hydrogeology of the coalbed methane production regions         (Section 3.1), the processes used to hydraulically fracture coalbed methane         production wells (Section 3.2), the fluids used in the fracturing process         (Section 3.3) and the techniques that may be used to monitor the effects         of fracturing (Section 3.4). EPA will also evaluate water supply incidents         possibly related to hydraulic fracturing of coalbed methane production         wells (Section 3.5). EPA will rely on currently available literature and         data as the primary source of information for Phase I efforts. 

 3.1 Hydrogeology of Coalbed Methane Production         Regions 

 The study will evaluate, on a regional basis, the hydrogeologic setting         of each coalbed methane production region. Local hydrogeologic conditions         vary in each coalbed methane production region in the country, and, as         a result, the potential impacts of the hydraulic fracturing process may         also vary. 

 The basic geology of each region will be evaluated, including the location         and extent of the coalbed formations. The study will also identify the         depth and hydrologic relationships between USDWs and coalbed methane wells         by identifying where coalbed formations are located within or directly         adjacent to currently mapped USDWs. This information will be used to evaluate         if hydraulic fracturing of methane production wells could result in the         injection of fluids into USDWs as described in Section 2.0 above. 

 3.2 Processes Used to Hydraulically Fracture         Coalbed Methane Formations 

 Information will be obtained to describe the basic processes used in         coalbed methane production, including well construction information, water         and methane withdrawal data. The ways in which methane production practices         vary by region will be evaluated and described. 

 If coalbed formations are identified in proximity to mapped USDWs as         determined in the hydrogeologic analysis (Section 3.1), the potential         to create a hydraulic communication between the target coalbeds into the         USDW will be evaluated considering: 
-  The depth of separation between coalbed formations and USDWs; 
-  The petro-physical characteristics and susceptibility (e.g., the           in-situ vertical stress distribution) within intervening rock layers           to fracturing; and 
-  The general characteristics and dimensions of fracturing techniques           utilized in the particular region or field from readily available data.         

 3.3 Hydraulic Fracturing Fluids and Proppants       

 EPA will collect the types of information listed below to address the         potential effects of injecting fracturing fluids directly into a USDW:       
-  The composition of hydraulic fracturing fluids, including potentially           hazardous materials; 
-  The types of proppant materials injected with the hydraulic fracturing           fluids; 
-  Quantities of materials injected; 
-  Data on the extent of fractures, specifically in coalbed formations;           and 
-  Recovery of fluids during methane production following a fracturing           event, and the corresponding loss of stranded fluids in the rock matrix.         

 Because practices may vary from one region to another based on the nature         of the coal seams being produced, the study will describe the variation         in fluids used for hydraulic fracturing throughout the country. 

 3.4 Techniques Used to Monitor and Model the         Hydraulic Fracturing Process 

 The project team will document how the hydraulic fracturing process         and its effects are modeled and monitored. The study will evaluate what         types of instruments are used to document a fracturing event, and what         types of models are used to predict the extent of fracturing. A review         of modeling and monitoring information will help document how accurately         the extent of fracturing in coalbed formations can be predicted, and how         useful these data may be in evaluating the issues associated with this         study. 

 3.5 Reports of Alleged Contamination Cases       

 In 1998, the Ground Water Protection Council conducted a survey of state         oil and gas agencies to determine if those agencies were aware of any         cases in which hydraulic fracturing (CBM) adversely impacted water wells.         Of those 25 states that responded to the survey, thirteen state oil and         gas agencies reported coalbed methane wells. Each of those thirteen State         agencies reported they were not aware of any case in which hydraulic fracturing         impacted water wells (Ground Water Protection Council, 1998). In an effort         to be thorough, EPA believes it should offer other drinking water agencies         and the public at large an opportunity to provide information to EPA on         any impacts to ground water believed to be associated with hydraulic fracturing.         EPA intends to offer this opportunity through a request for public comment.       

 Reports of alleged ground water impacts due to hydraulic fracturing         of coalbed methane wells that are received through the request for public         comment will be reviewed in conjunction with the appropriate State agency.         EPA will evaluate reports based on State agency responses and available         data to determine if sufficient information exists to understand the source         of water quality issues, or if additional data should be collected. The         most pertinent information to evaluate in these reviews will be: 
-  basic construction details of allegedly impacted wells, 
-  the timing of the alleged impact relative to fracturing events at           nearby methane production wells; 
-  nature of the alleged water quality problems; 
-  baseline and subsequent water quality data; previous industrial activity           in the area of concern; and 
-  climate data. 

 To the extent possible, based on the available incident data, EPA will         evaluate where or when USDW degradation has occurred specifically from         hydraulic fracturing of coalbed methane production wells. 

 4.0 DATA COLLECTION 

 The study of potential impacts associated with hydraulic fracturing         will be based on existing information on hydraulic fracturing as utilized         in coalbed methane production. The ability to evaluate the study objectives         is based on the amount of information available from existing literature         sources, academic institutions, industry organizations, federal, state         and local agencies, and individuals' reports. 

 Data collection for the study will follow a four-tiered approach. First,         EPA will review existing industry, academic, and government agency resources         and collect pertinent information. Second, contacts will be made with         State and federal agencies involved in coalbed methane production. These         will include the U.S. Geological Survey, the U.S. Department of Energy,         State water supply agencies, State oil and gas boards, and the Groundwater         Protection Council. Third, EPA will contact State agencies to discuss         the history and nature of complaints received from citizens and any follow-up         conducted in relation to those complaints. Fourth, to the extent possible         within this project, visits will be made to targeted coalbed methane production         areas to collect site-specific data on methane production and hydraulic         fracturing practices. Depending on the information available from State         agencies, EPA may review locations and construction details of subject         water wells, timing and locations of fracturing events, and other data         detailing conditions that may have contributed to problems in water wells.       

 Quality Assurance (QA) procedures for data collection are included in         Appendix A, Section 3.1. Section 3.2 of the QA protocol addresses procedures         for data logging. 

 5.0 DATA ANALYSIS 

 Once data have been collected, EPA will evaluate the information to         determine if hydraulic fracturing of coalbed methane wells clearly poses         little or no threat to USDWs, or if the practice may pose a threat and         require further investigation. EPA will decide if Phase II is warranted         based on Phase I results, resources available to EPA to conduct further         investigation, priorities of the Agency at that time, and whether the         scope of the issue is national or localized. 

 6.0 STAKEHOLDER INVOLVEMENT 

 Maximizing stakeholder input to the study process is a priority of EPA.         To that end, efforts will be made to identify all stakeholders to the         greatest extent possible. Stakeholder input has been solicited on this         study methodology and will be solicited on the draft summary report. Postings         on relevant web sites, mailings, public meetings, public notices, and         other means, will be used to involve industry, environmental groups, citizen         groups, academia, drinking water agencies, and other governmental and         non-governmental agencies. EPA will obtain input from experts (industry,         academia, and government agencies) on the issues of coalbed methane production         and hydraulic fracturing, in order to peer-review data sources, analytical         approaches, and conclusions. The review process will include: 
-  EPA internal review conducted by Offices outside the Office of Ground           Water and Drinking Water; 
-  Inter-agency review requested from Department of Energy, U. S. Geologic           Survey, Bureau of Land Management, and appropriate state agencies; 
-  Independent scientific peer review conducted by an EPA-convened panel;           and 
-  Stakeholder review. 

 Further discussion of the quality assurance aspects of the review process         is included in Section 4.0 of the QA protocol. This review process will         result in an official record of comments on study methods and results,         and a determination of whether the study conclusions can be supported         by the data. 

 7.0 REPORTING 

 Reporting of study methods, data sources, data analysis, and conclusions         will be made in a clear, accurate, and complete manner. The body of technical         information considered during the study will be recorded and available         for review by stakeholders. In addition, the manner for evaluating, analyzing,         and drawing conclusions from the collected data will be communicated in         order that reviewers may observe and validate methods. Limitations on         where a conclusion may apply, and alternative interpretations of data,         will be documented. Overall, the conclusions that address the objectives         of the study will be supported by the results of peer-reviewed data evaluation         and analysis. EPA will post materials to the internet periodically to         inform stakeholders of progress on the study. The stakeholders will have         an additional opportunity for input when the draft study is released.         Notice of availability will be made through mailings to individual stakeholders.       

 8.0 SCHEDULE AND DELIVERABLES 

 EPA estimates the study as described herein will be completed by February         2002. EPA expects to complete the literature search by April 2001; a request         for public comment in May, 2001; and follow-up of reported incidents in         August, 2001. A draft report is expected to be completed and available         for comment three months after data collection. 

 Deliverables for Phase I of the study will include a study methodology         and draft and final reports. 

 9.0 REFERENCES 

 Diamond, W.P. 1987. Characterization of fracture geometry and roof penetrations         associated with stimulation treatments in coalbeds, Proceedings of the         1987 Coalbed Methane Symposium, U. of Alabama, p. 243. 

 Elder, C. and M. Deul. 1974. Degasification of the Mary Lee coalbed         near Oak Grove, Jefferson County, Alabama, by vertical borehole in advance         of mining, U.S. Bur. Of Mines Report 7968. 

 Holditch, S., J. Ely and R. Carter. 1989. Development of a coal seam         fracture design manual, Proceedings 1989 Coalbed Methane Symposium, Tuscaloosa,         Alabama, pp. 299-320. 

 Hansen, C. 2000. Interstate Oil and Gas Conservation Commission August         15, 2000 Comments in Response to FRL6839-8, Oklahoma City, OK, pp. 1-3.       

 Geological Survey of Alabama. 2000. Grant Application for 3-D Characterization         of Natural and Induced Fractures in Coalbed Methane Reservoirs of the         Black Warrior Basin in Alabama, Tuscaloosa, AL. 

 Ground Water Protection Council. 1998. Survey Results on Inventory and         Extent of Hydraulic Fracturing in Coalbed Methane Wells in the Producing         States, Oklahoma, City, OK. 

 Morales, R., J. McLennan, A. Jones and R. Schraufnagel. 1990. Classification         of treating pressures in coal fracturing, Proceedings of the 31st U.S.         Symposium on Rock Mechanics, 31, pp. 687-694. 

 Palmer, I., N. King and D. Sparks. 1993. The character of coal fracture         treatments in the Oak Grove Field, Black Warrior Basin, In Situ, J. of         Coal Research, v. 17(3), pp. 273-309. 

 Palmer, I., N. King and D. Sparks. 1991. The character of coal fracture         treatments in Oak Grove Field, Black Warrior Basin, SPE Paper 22914, Proceedings,         1991 Society of Petroleum Engineering Annual Technical Conference and         Exhibition, pp. 277-286. 

 Palmer, I., R. Fryar, K. Tumino and R. Puri. 1991a. Comparison between         gel-fracture and water-fracture stimulations in the Black Warrior Basin,         Proceedings 1991 Coalbed Methane Symposium, University of Alabama, pp.         233-242. 

 Palmer, I. and D. Sparks. 1990. Measurement of induced fractures by         downhole TV camera in coalbeds of the Black Warrior Basin, Soc. Of Petroleum         Engineers Paper 20660, Proceedings, 1990 Soc. Of Petroleum Engineers Annual         Technical Conference and Exhibition, pp. 445-458. 

 Pashin, J. and F. Hinkle. 1997. Coalbed methane in Alabama, Geol. Surv.         Of Alabama, Circular 192, 71pp. 

 Steidl, P. 1993. Evaluation of induced fractures intercepted by mining,         Proceedings 1993 Coalbed Methane Symposium, University of Alabama, pp.675-686.       

 U.S. Department of Energy. 1999. U.S. Crude Oil, Natural Gas, Natural         Gas Liquids Reserves 1999 Annual Report, p. 34. 

 U.S. Department of Energy. 1999a. Environmental Benefits of Advanced         Oil and Gas Exploration and Production Technology, Office of Fossil Energy,         p 8. 

 Zuber, M., V. Kuuskraa and W. Sawyer. 1990. Optimizing well spacing         and hydraulic fracture design for economic recovery of coalbed methane,         SPE Formation Evaluation, v.5(1):98-102. 

 Zuber, M. 1997. Production characteristics and reservoir analysis of         coalbed methane reservoirs, International Journal of Coal Geology (Appalachian         Coalbed Methane), v.38(1-2). 
 APPENDIX A        QUALITY ASSURANCE PROTOCOL       The current strategic plan of the U.S. Environmental Protection Agency (EPA),       published in 1997 in response to the Government Performance and Results       Act, acknowledges that environmental protection efforts need to be "based       on the best available scientific information," and "sound science." Although       this goal sounds straightforward, achieving it in practice is complicated       and challenging. However, the credibility of the resulting policy decision       depends, to a large extent, on the strength of the scientific evidence on       which it is based. This Quality Assurance Process for data collection describes       the procedures to be used for a systematic and well-documented approach       to realizing this goal for the Hydraulic Fracturing Study Design and Methodology.       
 It is imperative that this quality assurance process produces a set         of data and scientific findings that are sound and conclusions that are         supported by the data. "Sound science can be described as organized investigations         and observations conducted by qualified personnel using documented methods         and leading to verifiable results and conclusions (SETAC, 1999)." In order         to ensure that findings are sound, the following quality assurance questions         will be addressed for all sources of data: 
-  What was the purpose of the study? 
-  Whose data is it? 
-  What is their source? 
-  Are the data reliable? 
-  Is the interpretation biased? 

 This quality assurance process establishes a set of guidelines and general         approaches to assess available data and information in a clear, consistent,         and explicit manner. Data collection and review according to this process         will make conclusions more transparent and thus more readily understood         and communicable to stakeholders. In this study, the quality assurance         process will proceed even when the data and scientific information is         insufficient. Areas lacking data will be recorded and discussion will         ensue on the role of scientific uncertainty in the quality assurance process.       

 The objectives of the systematic expert review of data and information         are transparency, avoidance of bias, validity, replicability, and comprehensiveness.         Following a protocol for review of data and information, by everyone involved         in data collection and evaluation, can ensure a common understanding of         the task and adherence to a systematic approach. The components of this         quality assurance protocol are as follows: 
 1. Specification of the         hypotheses to be addressed;        2. Justification of the expertise represented in the expert investigators         team;        3. Specification of the methods to be used for identification of relevant         studies, assessment of evidence of the individual studies, and interpretation         of the entire body of available evidence (WHO, 2000);        4. Review process; and        5. Communication of findings. 
 Revisions of the protocol may be necessary as new aspects of the task         emerge during the study development process. The components of the protocol         are addressed in further detail below. 

 1.0 SPECIFICATION OF THE HYPOTHESES/OBJECTIVES       

 Specification of the hypotheses to be addressed is included in Section         2.0 of the Study Methodology. This quality assurance process will ensure         that all participants in the study understand the scope and purpose of         the study. Definition of the scope and purpose of the study in Section         2.0 of the Study Methodology is the basis for the choices made concerning         data collection and methods for evaluation. 

 2.0 QUALIFIED INVESTIGATORS 

 To provide authoritative assessments of data and information, it is         important to rely on expert investigators to evaluate the evidence, draw         conclusions on the existence of actual and/or potential hazard, and estimate         the magnitude of the associated risk. The team of expert investigators,         which will evaluate the evidence associated with this study, possesses         the following qualifications: 
-  Formal training and/or on-the-job experience; 
-  Knowledge of the subject and the body of technical information pertaining           to it; 
-  Experience in scientific review of technical data and information;         
-  Ability to use descriptive and analytical tools appropriately; 
-  Ability to design studies to test hypotheses; 
-  Experience in risk assessment of environmental factors; 
-  Ability to communicate results accurately to decision-makers and           stakeholders; 
-  Experience coordinating multiple tasks and disciplines to ensure           timely and accurate delivery of study components; and 
-  Representation of a broad range of abilities. 

 3.0 DOCUMENTED METHODS 

 Processes and methods used to collect and evaluate the data and information         must be clear, explicit, and based on valid practice. It is important         to adhere to a rigorous and thorough approach to the processes of data         collection (Section 3.1), data logging (Section 3.2), evaluation of data         (Section 3.3), data analysis (Section 3.4), and use of data in drawing         conclusions (Section 3.5). 

 3.1 Data Collection 

 Comprehensive identification of relevant studies will be achieved by         use of the following strategy: 
-  Involvement of qualified researchers and trained investigators; 
-  Adherence to an explicit search plan including identification of           key words; 
-  Considered effort to include all available studies; 
-  Search of bibliographic databases and journals; 
-  Inclusion of abstracts and unpublished data; 
-  Contact with authors of published data for further information; 
-  Contact with applicable agencies and associations; 
-  Contact with industry representatives; 
-  Contact with environmental group representatives; 
-  Other stakeholder contacts; and 
-  Other. 

 3.2 Data Logging 

 Verification of data and information will be achieved by adherence to         a rigid data collection protocol involving explicit written documentation         of where, when, and from whom particular data and information is obtained,         including information obtained from personal or telephone contacts. All         sources of data and information, both verbal and written will be recorded         in ink in bound notebooks. 

 All reports, records, etc., potentially providing data for the study,         will initially be included in the inventory (data log) of relevant information.         Strict maintenance of the data log will address the necessity for producing         a record of the comprehensiveness of the study base of information. 

 3.3 Data Evaluation 

 Subsequent to the data logging process, those reports potentially providing         useful information will undergo a selection process to evaluate quality         of the information and usefulness to the study. Systematic evaluation         of the validity of individual studies, data, and information will therefore         include assessment of the following: 
-  Source of the data and information; 
-  Qualitative review of the literature; 
-  Qualitative review of data and information collected; 
-  Scientific strength of the data and information; 
-  Geographical, geological, geochemical, spatial, and temporal relevance;         
-  Relevance to determining baseline conditions; 
-  Validity of extrapolation to the scope of the Study; 
-  Characteristics of associations, plausibility, alternative explanations;         
-  Consistency and specificity of the results; 
-  Scientific uncertainties, limitations, and confounding variables;           and 
-  Other. 

 A scale or rating of the data and information with respect to a level         of proof required to support conclusions is specifically not proposed         as part of this quality assurance process. Establishing a specific level         of scientific evidence required to justify a subsequent conclusion would         generate significant controversy. Instead, expert judgment will be used         to evaluate and weigh available data and information. 

 3.4 Data Analysis 

 A variety of technical methods and tools will be utilized to sort through         the pertinent information and decipher the meaning of the data. These         data analysis methods may include: 
-  Quantitative review of selected data and information collected; 
-  Tabulating valid data and information; 
-  Constructing geologic cross sections; 
-  Evaluating current and historical site operations; 
-  Examining adjacent land uses; 
-  Review of consistencies between studies and information; 
-  Review of sources of discrepancies between studies and information;         
-  Evaluation of heterogeneity among studies; 
-  Development of inclusion and exclusion criteria for data and information           used for hypothesis testing; and, 
-  Other. 

 All assumptions will be explicitly documented, the basis for use of         any models explained, lack of evidence noted, and scientific uncertainties         described as precisely as possible. 

 3.5 Drawing Conclusions 

 Drawing conclusions from evaluated and appropriately analyzed and summarized         data and information will involve expert judgment as to whether observations         are consistent with the study hypotheses/objectives (presented in Section         2.0 of the Study Methodology) or whether some alternative is suggested.         The expert investigators will draw upon all evaluated and appropriately         summarized data and information, however, no checklist or formula will         be applied to arrive at conclusions. Instead, critical scientific reasoning         and judgment will be used to draw conclusions. The process of scientific         reasoning and judgment will be made explicit by describing and documenting         how expert investigators: 
-  Assessed completeness of data and information; 
-  Accounted for lack of evidence and limitations, and impacts on the           conclusions; 
-  Qualified and quantified the degree of scientific uncertainty; 
-  Assessed and accounted for bias in original data and/or information;         
-  Weighed particular information; 
-  Used applicable guidelines and rationales; 
-  Used any ranges of estimates to arrive at conclusions, where appropriate;         
-  Incorporated assumptions into assessments and accounted for the implications           of those assumptions in their conclusions; and 
-  Other. 

 Conclusions will be drawn within the boundaries of the data and the         scope of the study. Lack or absence of evidence will be addressed. The         relative strength or weakness of available information to support conclusions,         limitations on where a conclusion may apply, and alternative interpretations         of data, will be recognized and discussed. Any qualification on the use         of the data and factors that contribute to uncertainty will be conveyed.       

 4.0 REVIEW PROCESS 

 The quality assurance review process will provide a means to examine         if the results and conclusions are verifiable. The review process will         result in a determination of whether the conclusions are directly supported         by the data or evidence and can be independently validated by others.         This quality assurance review process will be hierarchical and will include         four review levels: 
-  EPA internal review, 
-  Inter-agency review, 
-  Independent scientific peer review, and 
-  Stakeholder review. 

 Internal review will be accomplished by using an in-house staff member,         skilled in quality assurance and other EPA offices involved with coalbed         methane or hydraulic fracturing. Other federal agencies will be asked         to review products including the USGS, the BLM and the DOE. Those agencies         may also participate as partners with EPA in conducting the study. Thus,         this level of peer-review will not constitute an independent peer review.         EPA will assemble a peer review panel consisting of experts in hydraulic         fracturing or associated subjects. Finally, EPA will accept comments from         stakeholders. Work products will be available on the internet, or stakeholder         may request hard copies by contacting EPA via electronic mail, telephone,         or in writing. 

 Supporting documentation and data will be easily available for in-depth         consideration by other reviewers. Candid and critical comments will be         sought to assist the investigators in making the study as sound as possible         and to ensure that the study meets Agency standards for objectivity, evidence,         and responsiveness to the study charge. Reviewer comments and objections         will be preserved and made a part of the record for the study. Reasons         for proceeding or not proceeding with the study will be clearly explained.       

 5.0 COMMUNICATION OF FINDINGS 

 This quality assurance process will be reflected in the communication         of scientific findings in a clear, accurate, and complete manner to interested         parties. Investigators will communicate to Agency and stakeholders: 
-  The body of technical information that was considered; 
-  The manner for evaluating, and drawing conclusions from, collected           data and information; and 
-  Conclusions that address the hypotheses/objectives and are supported           by the results of data evaluation and analysis. 

 The use of presentation tools such as charts, diagrams, and computer-generated         displays will be based on sufficient, valid, and defensible data. 

 6.0 REFERENCES 

 Breslin, K., Airing on the Side of Caution or Pulling Standards Out         of Thin Air? Environmental Health Perspectives, 108(4), April 2000.          http://ehpnet1.niehs.nih.gov/members/2000/108-4/spheres.html

 Clay, R., Still Moving Toward Environmental Justice, Environmental Health         Perspectives, 107(6), June 1999.  http://ehpnet1.niehs.nih.gov/members/1999/107-6/spheres.html

 Evaluation and Use of Epidemiological Evidence for Environmental Health         Risk Assessment: WHO Guideline Document. Environmental Health Perspectives,         108(10), October 2000. World Health Organization European Centre for Environment         and Health, Bilthoven Division, A. van Leeuwenhoeklaan 9, Bilthoven, The         Netherlands.          http://ehpnet1.niehs.nih.gov/members/2000/108p997-1002kryzanowski/abstracts.html.         

 Manuel, J., Truth in Numbers, Environmental Health Perspectives, 108(8),         August 2000.  http://ehpnet1.niehs.nih.gov/docs/2000/108-8/niehsnews.html

 Sound Science Technical Issue Paper. Society of Environmental Toxicology         and Chemistry (SETAC), SETAC Press, Pensacola, FL, 1999.  http://www.setac.org/sstip.html

 Strengthening Science at the U.S. Environmental Protection Agency: Research-Management         and Peer-Review Practices. National Academy Press, Washington, D.C. (2000).          http://www.nap.edu/catalog/9882.html

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