General Protocol for Demonstration of Notes to the Reader The discovery, characterization and remediation of contaminated sites have historically created explosive growth and development of remediation programs in government and industry. As an increasing share of the total expenditure in this field shifts from discovery and characterization to remediation attention has focused on documenting the cost and performance of conventional site cleanup technologies. This activity has demonstrated a broadly recognized need for innovation in the environmental technology field from state and federal government, technology users, technology vendors, tribal government and the public. The collective desire is, through innovation, to develop and demonstrate new environmental technologies that perform as well or better and cost less. This document was developed by members of the Interstate Technology and Regulatory Cooperation (ITRC) Work Group. The membership of the workgroup includes: Representatives of state and Federal environmental regulatory agencies representatives of Federal agencies Public representatives tribal representatives members of industry The ITRC believes that the field of in situ bioremediation has the potential of providing cost-effective cleanups for a variety of waste sites. Therefore, for this and other reasons, in situ bioremediation was deemed of high interest to members of the ITRC. This ITRC product facilitates the demonstration of in situ bioremediation (ISB) technologies through cooperative mechanisms among participating states and stakeholders. It captures not only the technical elements of ISB but also the general thinking and experience of members of many state regulatory agencies. As the format and approach of this document are somewhat unique and different from other publications found in the field of site remediation. ISB technologies have long been recognized to offer efficient, cost effective remedial alternatives. A vast amount of research is being sponsored and conducted in this area by universities, research institutes and private industry. Advances in this field have been observed even during the compilation of this document. While the ITRC fully expects changes to result from new technology and new science, we offer this protocol as a framework which can accept new technologies for demonstration. ISB offers a number of challenges not apparent in other conventional cleanup technologies. Because the active process relies on microorganisms and the natural properties of the subsurface, longer times are often required to observe measurable changes when compared with technologies which employ physical/chemical/thermal processes. The challenges of obtaining meaningful process and performance data are compounded by obtaining representative samples from a heterogeneous system. Lastly, because these technologies are not contained in the formal sense, the flow of mass and energy through the system is far more complicated than with a contained system such as an above ground system. The group recognizes these issues will be apparent in virtually every ISB technique or technology. Therefore we hope the reader will view these issues as challenges for the future rather than obstacles from the past. As a reader of this document, bear in mind the challenges and opportunities in this field. This is not a prescriptive document, but rather a descriptive process which will accommodate site specific and community specific considerations in the demonstration and use of ISB. This binder also carries with it technology specific position papers supporting the appropriate consideration of intrinsic bioremediation and bioventing. These position papers also contain references to other documents which characterize the performance of these techniques. We encourage readers to make this material available to their colleagues as a resource document. Executive Summary In situ technologies rely on the capabilities of indigenous or introduced microorganisms to degrade, destroy or otherwise alter objectionable chemicals in soils or ground water. These technologies can be applied to soils or deep sediments and in arid or wet regions. In situ bioremediation is a class of technologies as variable as the subsurface itself. The In Situ Bioremediation Technology Specific Task Group (ISB Group), a subgroup of the ITRC, recognized that given appropriate conditions, in situ technologies can remediate contaminants more cost effectively than conventional technologies. The ISB Group developed a General- Protocol and Outline for the general class of in situ bioremediation technologies plus conducted detailed literature reviews of technology-specific protocols for "Natural Attenuation" and "Bioventing" of petroleum hydrocarbons. These protocols have been developed by Federal agencies, contractors and industry. The use of this document is intended to offer the proponent of the demonstration multi-state and tribal (regulatory) acceptance of the data generated during the demonstration project. It also offers an early opportunity for tribal and stakeholders to understand the intent of the demonstration and discuss their concerns and sensitivities with the proponent before the demonstration is in its final design. The ISB Group knows, through experience, that acceptance of a technology by multiple states and state agencies, tribes (as regulators or stakeholders), and local communities requires an organized collective process. In the "General Protocol" the ISB Group defined categories of responsiblities for participants in a multi-state demonstration. These participants might include the state or tribal regulatory agency hosting the demonstration, other states interested in the technology, the proponent, other tribal governments and stakeholders. Each have identified responsibilities during three phases of the technology demonstration process. Phase One identifies the specific parties by name, Phase Two designs the demonstration and Phase Three implements the demonstration and reports the results. These responsibilities are clearly defined in Table 1 of the General Protocol. The "General Outline" to the General Protocol contains the essential elements of an in situ bioremediation (ISB) demonstration. It provides guidance to the proponent during the development of the initial demonstration proposal. While following this guidance, the proponent of the demonstration project should include enough detail that the states or tribal regulatory agency (host and participating) can identify; the applicable regulatory requirements for the project, the innovative nature of the project, and the advantage this project might have over other conventional technologies. It should also contain enough information so that stakeholders, tribal governments and states can identify any sensitivities they may have with this technology. The ISB Group is comprised of representatives from 15 states, the Federal government, industry, and representatives from an environmental and other non-profit groups. Members of the larger ITRC working group, which include community and tribal representatives, offered comments and guidance throughout the development of the General Protocol. Thus, the "Protocol Binder and Resource Document" reflects the input of many sectors of our society interested in site cleanup. Through its collective experience, and depth of representation, the ISB Group found several issues pertinent to in situ bioremediation. These issues, as summarized by the ISB Group, are as follows. Cleanup levels, and the approaches used by various jurisdictions to derive those numerical criteria, vary among state and federal agencies. Although a single set of concentration based cleanup levels cannot be developed to apply to all jurisdictions, it is recommended that a work group be established to formulate policy recommendations for changes that encourage consistency in approach, if not numerical criteria. Factors beyond the jurisdiction of the state regulatory agencies often dictate the type of remedial technology that is deployed. These factors include addressing the concerns of participants in real estate transactions and the financial institutions lending on such transactions and the public's opposition and fear of a technology. These pressures often discourage the deployment of cost-effective techniques and technologies, particularly natural attenuation and bioventing, and thus reduce the potential market for affordable remedial measures. The governors need to consider means of addressing the concerns of these non-regulatory entities in order to broaden market acceptance of many affordable remedial options, as well as encourage the free market to continue to develop remediation techniques and technologies. Natural attenuation for petroleum hydrocarbons, particularly benzene, toluene, ethyl benzene and xylene, is well demonstrated as a remedial option for groundwater. Governors should require that for all sites where remediation is deemed necessary, particularly fuel tank sites, the appropriate agencies should evaluate natural attenuation as a remedy, referencing their agencies to consider the ITRC work-product concerning this topic and the various technical guidance documents and references now available in the literature. Bioventing is a cost-effective in situ technology which reduces petroleum hydrocarbon contamination by accelerating natural biological conversion processes. Where remediation of soils is deemed necessary, particularly for leaking underground fuel sites overseen by state agencies, the use of bioventing should be encouraged as a remedial measure. Introduction In February of 1995 the Interstate Technology and Regulatory Cooperation (ITRC) Work Group chose to focus on in situ bioremediation (ISB) technologies. The purpose was to review the existing use of ISB technologies, identify barriers to their effective use and recommend actions which, if implemented, will promote multi-state acceptance of data obtained during the demonstration. By promoting state agency, federal agency, industry, user, tribal and stakeholder cooperation, the ISB group set out to develop products, processes and recommendations which would accelerate the safe and effective development and deployment of site cleanup technologies using ISB techniques which are as good or better and cost less than conventional technologies. Purpose and Scope of this Document The purpose of the General Protocol is to provide guiding principles and a standard approach for conducting safe and appropriate demonstrations of in-situ bioremediation techniques to foster interstate acceptance of the test results from a variety of in-situ bio demonstrations. This document emphasizes the establishment of objectives, criteria and measures so that work plans can be designed consistent with those measures, and results can be verified. This document presents an outline containing the essential elements the proponent of an in situ demonstration must address when initiating a demonstration. The outline represents a compilation of concerns gathered by the ITRC states. A process is also presented which defines the parties responsible for verifying demonstration results and transferring those results to other states for acceptance. In addition, as a guide to the proponent, ITRC has included examples of recommended technology-specific protocols which have been developed by industry and tested in field applications. These Technology-Specific Protocols (appendices B & C) have been evaluated by members of the ISB Group. Use of these protocols will increase the likelihood that the essential information required by the states has been included in the design of the demonstration and test plan. General Outline The essential elements of a ISB demonstration proposal are contained in the General Outline section of this document. This provides guidance to the proponent during development of the initial proposal for a demonstration. The proposal should contain enough detail so that the other parties can identify the applicable regulatory requirements for the project, the innovative nature and scope of the project, the advantage this technology might have over conventional technologies and the sensitivities the participants might have with this technology. Responsibilities of the Parties Many "parties" need to voluntarily accept responsibility during the implementation of a General Protocol based demonstration. These include Host States, Participating States, Proponents, Tribes and Community/Other Public Stakeholders. In some cases, Tribes with regulatory authority may act as host or participating states in this process. The responsibilities of each party are discussed below in phases of a demonstration program. The responsibilities of each of the parties is discussed in the following sections and summarized in Table 1. What follows is not a prescription, rather it describes a process to fulfill individual responsibilities in a collective manner. Phase 1: Identification of the Parties The first phase in the process describes the opportunity for the proponent to identify a host state in which to conduct a demonstration, and select those states where the technology could be transferred following successful demonstration. The host state will coordinate the activities of the participating states. Each participating state must identify and be responsible for any intra-state coordination steps necessary to fully evaluate a demonstration proposal. The proponent, with the assistance of the host state, should also identify other stakeholders who may be impacted or have a stake in the outcome of the demonstration. Participating states should also identify interested community/public stakeholders to include in the review technology demonstration proposals. Phase 2: Demonstration Design The second phase of the process is the submission of the demonstration proposal, prepared by the proponent consistent with the General Outline. Upon receipt each state or tribal environmental agency will identify the applicable regulatory requirements for the technology demonstration. These will be compiled into a single document and provided to the proponent for use in developing the demonstration plan. Community/public stakeholders in turn should identify any concerns or sensitivities they have with the demonstration proposal or technology and deliver these to the proponent. This phase validates the common concerns and regulatory requirements among participating states as well as identifying unique concerns of one or more participating states or other stakeholders that may be incorporated in the demonstration in the host state. This will guide the development of the performance objectives for the demonstration Once the performance objectives are established, the proponent and the states must establish verification criteria (see footnote in table 1) and the verification measures for this demonstration. These are the elements which the host state will use to verify the performance of the technology and report that success to the other participating states. Phase 3: Implementation and Reporting Results Phase three of this process is the actual implementation of the demonstration plan. During this phase the host state is responsible for issuing any applicable permits or approvals from their agency(ies) and overseeing the demonstration. The proponent must collect and validate the results of the demonstration and submit those results to the host state for verification of the demonstration according to the predefined verification criteria and measures, and report those results to the other participating states. The host state, in collaboration with participating states, will develop a summary evaluation describing the level of acceptance of the demonstrated technology based on the predefined verification criteria and measures. Table 1 "X" indicates party responsible for activity
GENERAL OUTLINE FOR IN SITU BIOREMEDIATION DEMONSTRATIONS This General Outline contains the essential elements of a ISB demonstration proposal. It is intended to provide guidance to the proponent during development of the initial proposal for a demonstration. A proposal developed according to the outline should contain enough detail that the other parties can identify the applicable regulatory requirements for the project, the nature and scope of the project, the advantage this technology might have over conventional technologies and other sensitivities and concerns the participants might have with this technology. Expansion of the outline creates a site-specific work plan. Technology-specific information, as provided in the technology-specific protocol documents in appendix B and C, forms the basis for section IX, X, XI and XII of the following outline. I. Executive Summary This Section briefly describes the contents of the Test Plan and includes a general overview of the technology to be verified, a clear description of test objectives and their suitability, and a concise description of the test approach. II. Table of Contents III. List of Tables IV. List of Figures V. Acknowledgments/Disclaimers VI. Introduction VII. Background Describe the market need for an alternative technology VIII. Stakeholder (community/tribal) Involvement Plan A. Describe Method(s) for identifying and contacting citizens concerned about technology development and application. 1. Applicable state public participation requirements. 2. Refer to Appendix D, "A Guide to Tribal and Community Involvement in Innovative Technology Assessment" for guidance. B. Describe a process for collecting and addressing community concerns and issues with a demonstration. (e.g. Noise, Odor, Traffic, Dust) IX. Technology Summary A. Basic process description 1. Principles a. Stimulation b. Naturally occurring microorganisms c. Aerobic or anaerobic 2.Implementation a. Air emissions b. Water reinjection c. Amendments-list chemicals and MSDS d. Delivery system e. Process monitoring f. Process containment 3. Site monitoring B. Applicability to chemicals of concern 1. Expected reactions/pathways a. Degradeablity of the compound 2. Expected extent of mineralization/possible end products, by-products, products of incomplete degradation C. History of application or previous testing results This section summarizes any existing data (e.g., microcosm tests or other laboratory scale data) and explains how this data was used in developing test objectives and the test plan. D. Cost and performance information X. Suitability of the Site for ISB A. Description of Site 1. History of the site a. Operations at the site and land use b. Disposal practices and waste types 2. Environmental setting/characteristics a. Soil types, particle size, moisture content b. Ground water c. Surface water d. Air e. Climatic conditions 3. Receptors B. Existing condition(s) of the site 1. Characterization results-nature and extent of contaminants 2. Indigenous microorganism population & activity 3. Targeted chemicals 4. Medium to be treated 5. Source control/removal C. Predicted condition during the test 1. Scope of demonstration 2. Targeted chemicals, amendments, by-products, end products, products of incomplete degradation and expected extend of mineralization 3. Medium treated 4. Other media of interest D. Predicted condition following test 1. Targeted chemicals, amendments, by-products, end products, products of incomplete degradation 2. Medium treated E. Monitoring systems 1. Soil 2. Soil gas 3. Ground water 4. Surface Water 5. Air F. Other considerations 1. Land Ownership Stability 2. Institutional Controls 3. Adjacent Ownership a. Land Use b. Uncontrolled Exposure G. Site Protection 1. Worker Health and Safety 2. Public Health and Safety XI. Demonstration Objectives Determine the specific objectives of the demonstration (e.g. performance under specified conditions, address identified regulatory or stakeholder concerns, ability to meet established site cleanup standards from multiple states). XII. Performance Objectives A. Determining the mass destruction or reduction attributable to the technique or technology B. Define criteria, measures, methods for evaluating performance (e. g. oxygen depletion, CO2 increase, primary metabolite depletion, soil sample analytical confirmation) XIII. Test Design A. Controls and baseline measurements Establish the effect of the technology by comparison of "with project" and "without project" conditions, often including the design and implementation of a suitable control or controls. B. Description of the test region C. Data Quality Assurance/Quality Control D. Introduction of amendments Explanation: Showing that amendments added, or alterations to the test region, reach targeted chemicals and cause an increase in the desired biochemical reactions (demonstrate cause and effect) 1. mode 2. amounts 3. rates E. Process measurements 1. Injection rates a. Electron acceptors (oxygen, etc) b. Nutrients c. Microbes d. Cometabolites 2. Monitoring a. Air emissions b. Ground water c. Fate and effect of amendments and byproducts d. Respiration rates (oxygen and CO2 levels) e. Microbial Levels (Plate counts, Most Probable Number Procedure, other) f. Degradation by-products, end products g. Targeted contaminants & levels F. Engineering controls G. Safety considerations 1. Conditions for shutdown H. Contingency Plan I. Analytic procedures and Data Quality Objectives 1. Published methodologies by recognized organizations 2. Modifications to published methods, provided modifications are completely documented 3.Unpublished methods which are scientifically valid and are fully described and documented in the demonstration plans J. Health and Safety Plan XIV. Final Report This section should describe in detail how the results of the testing will be reported and presented. It should also follow the Federal Remediation Roundtable Guidance on Cost and Performance Reporting |
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Page last updated 10/10/1999 |