Although EMDs have been used over the past 25 years in various scientific fields, particularly medical research and diagnostic fields, their application to environmental remediation management is relatively new and rapidly developing. One of the expected challenges in implementing EMDs for environmental remediation is acceptance by the regulatory community. The ITRC EMD team surveyed regulators, consultants, and stakeholders to determine the following:
Based on the survey results (see Appendix B), most regulators are not familiar with EMDs. Of the 54 regulators who responded, 65% were not familiar with or had not applied EMDs. Only four were identified as having applied EMDs in the field of environmental remediation. In the course of the survey, when provided with a description of each EMD, regulators identified key areas in environmental remediation where they thought EMDs could be used. Some thought different EMDs could be used as: a forensic tool; a way to evaluate remediation alternatives or feasibility studies; a monitoring tool for site management; a tool for site investigation/characterization; or a tool to expedite site closure. Although most regulators may currently be unfamiliar with EMDs and how to apply them in environmental remediation management, once the benefits of EMDs are better understood, acceptance is expected to increase.
In November 2011, ITRC published a series of EMD Fact Sheets (EMD-1) to provide introductory information about and promote awareness of a selection of EMDs applicable to environmental remediation management (including site characterization, remediation, monitoring, and closure). The EMD Fact Sheets, in conjunction with this document, should significantly improve EMD awareness not only among regulators, but also in the environmental community at large. This section provides guidance on involving regulatory agencies in the approval process for using EMDs and also describes regulatory permitting considerations.
If EMDs will be proposed for a site, the regulator must be involved as early as possible in the EMD selection process. During the initial meeting, it is best to have a draft work plan for the EMD sampling, analysis and data use already prepared for discussion. The work plan can easily be adjusted to reflect all agreements reached during the meeting and can be submitted later as a final document. The work plan at a minimum should:
All permitting requirements that are necessary for the use of the EMD must be identified to facilitate regulatory and stakeholder acceptance.
The ITRC EMD team used survey results and results from a questionnaire completed by the states’ POCs to identify permitting/regulatory concerns that may be raised when the use of EMDs is proposed. As expected, the responses varied from state to state. However, at a minimum, approval must be obtained for one or more of the following: notification, a work plan, a discharge permit or a Underground Injection Control (UIC) Permit. The use of amended EMD sampling devices, such as stable isotope probing (SIP) and in situ enzyme activity probes (EAPs) involve the introduction of contaminant-bearing materials into the subsurface. Although the introduced contaminants are small in quantity and are intended to stay in place, these in situ evaluations may require additional regulatory review and approval, or a UIC Permit. In cases where groundwater discharges to surface water, a discharge permit may be required. In cases where drinking water wells could potentially be impacted, it may be necessary to notify drinking water regulatory programs or even end-users or well owners. A thorough review of permitting requirements and regulatory approval is encouraged on a site-specific basis whenever the use of EMDs is proposed.
Not all EMDs involve contaminant-bearing materials being introduced into the subsurface. Most are laboratory analyses only and therefore do not require permitting. These include CSIA, qPCR, microbial fingerprinting, microarrays, and FISH, but may also include all SIP and EAPs that are not conducted in situ. Although permits may not be required for laboratory analyses, prior approval from the regulatory agency may be needed. Therefore, at a minimum, a work plan as described above should describe the intended use and expected outcome.
Team members and most of those surveyed agree that education is the key to more widespread use of EMDs in the environmental remediation field. As regulators become better educated and more comfortable with their use, guidance and regulations specific to EMD use will be developed. Until state documents are developed, this ITRC document and ITRC's EMD Fact Sheets (EMD-1) serve as the most comprehensive resources available for regulators, consultants, and the general public.