EPA Stakeholder Meeting on Development of Primary Drinking Water Regulation for Radon

The U.S. Environmental Protection Agency (EPA) Office of Ground Water and Drinking Water (OGWDW) held the fifth in a series of stakeholder meetings regarding the development of the primary drinking water regulation for radon on March 16, 1999 in Washington DC.⁽¹⁾ The promulgation of this rule is required by the Safe Drinking Water Act (SDWA) Amendments of 1996, Section 109(b)(13) (SDWA Section 1412(b)). The purpose the meeting was to present information and receive feedback from interested and affected parties on two specific topics:

Participants at the meeting included representatives of public water utilities, state drinking water and indoor air programs, public health and environmental groups, and industries related to radon testing and treatment, as well as U.S. EPA and other federal agencies. A list of participants is included as Attachment B. Transcribed facilitator's flip chart notes can be found at Attachment C. The HRRCA was released for public comment prior to the meeting and was provided to all participants, either by direct mail or by download from Office of Ground Water and Drinking Water website.⁽²⁾

Jim Taft (Chief of the Targeting and Analysis Branch of OGWDW) thanked participants for their ongoing meaningful participation in the dialogue regarding development of the new radon rule. He explained that this is the first rule EPA has developed that triggers all of the requirements of the Safe Drinking Water Act (SDWA) Amendments of 1996 - most notably the development of the Health Risk Reduction and Cost Analysis. He acknowledged that the tight time frames dictated by the statute are somewhat constraining for all involved, but encouraged participants to continue to take advantage of these opportunities to comment on the HRRCA and on the proposed rule when it is released.

Mr. Taft reminded participants that the maximum contaminant level (MCL) for radon in drinking water had not yet been set, and that the day's discussion could help to illuminate how the HRRCA should inform this question. He acknowledged that concerns have been raised about the viability of the new approach using an alternative MCL (AMCL) in conjunction with a multi-media mitigation program to reduce risks from radon exposure. He noted EPA's interest in understanding the nature of the potential burdens and constraints on states and public water systems (PWSs) associated with this option, while also emphasizing EPA's belief that this new and unique statutory requirement can work. Mr. Taft noted that the AMCL will be set at 4,000 pCi/L, based on the transfer factor (from radon in drinking water to air) of 10,000 pCi/L, and an average national ambient radon level of 0.4 pCi/L, as established by the National Academy of Sciences.⁽³⁾

Sylvia Malm (EPA/OGWDW) provided an update on the overall development of the rule and the context for the HRRCA and the multi-media mitigation (MMM) approach. She reviewed the 1991 efforts to establish a standard for radon in drinking water, and the specific requirements of the 1996 SDWA regarding radon, including the requirements for EPA to develop the HRRCA and the multimedia risk reduction guidelines. She reviewed the time line for the rule development, noting in particular the following milestones:

Proposed HRRCA released Deadline for comments on HRRCA Internal Agency review and revision OMB review (90 days) Proposed rule and MMM Guidelines Final Rule and MMM Guidelines Effective date of rule Effective date if MMM option chosen	2/99 4/12/99 4/99 5/99-8/99 8/99 8/00 8/03 2/05
(if state states intent within 90 days of final rule)

Ms. Malm briefly reviewed the two-option approach that is unique to this rule: allowing states to choose between regulating radon in drinking water at an established MCL for radon or, regulating drinking water at the higher AMCL in conjunction with developing and implementing a multimedia mitigation program designed to reduce exposure to radon in indoor air by an amount at least equal to the reduction that would have been achieved by meeting the MCL. With regard to setting the MCL for radon, Ms. Malm emphasized that this is a risk management decision that is still being examined. Setting the MCL for radon will follow the requirements of the 1996 SDWA amendments under which EPA is to first to set a health-based maximum contaminant level goal (MCLG), and then set the MCL as close to the MCLG as "feasible", taking technology and costs into account. The SDWA radon provision contains language directing EPA to also take into account the costs and benefits of controlling radon from other sources. Ms. Malm reviewed the technical, risk and cost/benefit factors that will inform the Administrators decision on the MCL, noting that the HRRCA contribute to this process. The SDWA also requires the EPA Administrator to determine whether the benefits justify the costs. For radon, there is effective available treatment technology and a proven analytical method so technology is not expected to be a limiting factor in determining the MCL.

Mike Osinski (EPA/OGWDW) reviewed the overall inputs to and results of the HRRCA. He described the specific requirements for the analysis stipulated in the 1996 SDWA amendments, EPA's goals in the analysis, key inputs and assumptions used in conducting the analysis, and highlights of the results

Rebecca Allen (EPA/OGWDW) reviewed the benefits side of the analysis in greater detail. She reviewed the framework for its preparation, noting the types and sources of inputs used. Ms. Allen explained the consultation process with and recommendations of the Benefits Working Group of the National Drinking Water Advisory Council (NDWAC) on benefits issues on which EPA sought assistance. She noted that several types of non-quantifiable benefits were identified, and the degree of uncertainty associated with them is high but not specified. Further, there is no way of knowing their true significance relative to the monetized, quantifiable benefits.

Ms. Allen highlighted several issues that EPA has identified as of potential concern to some stakeholders. These include: how to account for the treatment of monetized benefits over time to reflect the latency period between the reduction in exposure, diagnosis, and illness or potential death from cancer; and the use of alternative valuation techniques, e.g., value of statistical life year (VSLY) and quality adjusted life year (QALY). Ms. Allen concluded by explaining that EPA is currently working to address these issues to improve procedures for estimating benefits and reduce their uncertainty.

Bill Labiosa (EPA/OGWDW) discussed the procedure used to estimate costs of compliance - both in terms of unit treatment and monitoring costs as well as the characterization of public water systems nationwide - in the HRRCA. He highlighted the framework used to model these costs, including consideration of key inputs and assumption. Mr. Labiosa noted that for most systems size categories, costs were assumed to be distributed as follows: 40% for process, 40% for construction, and 20% for maintenance. He explained that the decision tree for modeling compliance pathways assumes that, given a choice, systems will pursue the least-cost option. He noted, however, that due to specific circumstances, some systems will not have a choice. Mr. Labiosa presented estimates of national compliance costs (capital and O&M) for a variety of MCLs; they ranged from $25 million at an MCL of 4,000 pCi/L to greater than $500 million at an MCL of 100 pCi/L. He noted that, prior to the publication of the proposed rule, EPA plans to test several assumptions used in the analysis to verify these assumptions as well as increase the confidence levels of the uncertainties, and refine the ranges of cost estimates.

The following issues, questions and concerns were raised by stakeholders in response to the HRRCA:

Ommission of the NTNCWSs in the HRRCA. The fact that NTNCWSs are not included in the HRRCA was an issue of significant concern to many stakeholders. Most expect that the costs to NTNCWSs is likely to be considerable, accompanied by little contribution to the benefits side of the equation. Their exclusion skews the estimate of national costs and therefore the overall analysis. Participants emphasized that the costs to NTNCWSs need to be considered in the deliberation over where the MCL should be set. EPA is currently examining ways to incorporate costs to NTNCWSs and hopes to make this information available in connection with the proposed rule.

Discounting benefits. Several participants expressed concern over the lack of comparability of the modeled costs and benefits in the HRRCA. All benefits are treated as if they are experienced in the same year - immediately and are not discounted into the future. The estimated costs, however, have been discounted, yielding an apples and oranges issue, whereby the two are not comparable. EPA representatives indicated that this is a broader policy issue under discussion at the Agency.

Greater burden on small systems. More detail on the costs and benefits by system size would help to get a better picture of the differential burdens. Since regulation is historically set based on costs to large systems, this issue needs to be given sufficient attention here. It was further suggested that since EPA cannot set different MCLs for different system sizes, it should consider the possibility of establishing a variance for a whole category of system sizes.

Additional costs for consideration. Participants noted the several costs that they felt should be reflected in the HRRCA. These included a number of more or less quantifiable costs that some participants believe to be more complicated than the HRRCA currently accounts for, such as:

Radon off-gassing from aeration towers. Questions were raised regarding how the HRRCA addresses the potential risk and costs associated with radon off-gassing from aeration towers. EPA noted that while reliable studies have shown that rapid dilution reduces the risk to insignificant levels, this issue has the potential to be a real risk communication issue. EPA is consulting with air boards in California regarding their reaction to radon regulation and the likelihood that they will view this as an issue for air quality regulation.

Capital costs as a function of design flow. It was suggested that it would be instructive and potentially influential in the interpretation of the results of the HRRCA to graph capital costs as a function of design flow, instead of by system size (a function of population served).

Need for statistical analyses. The need for statistical analysis of health studies and of costs and benefits to provide better information to the EPA Administrator for decision making was emphasized by some participants.

Disproportionate benefit to smokers. Concern was expressed over the fact that the radon rule provides disproportionate benefit to smokers. Some indicated that since the lives of smokers are shorter, some means of discounting should be incorporated, as is done and accepted in other contexts in medicine. EPA OGWDW representatives responded by pointing out that this is an Agency-wide issue. However, comments on the Agency guidelines would be welcome.

Value of Statistical Life (VSL). Participants expressed interest in EPA's determination of the value of a statistical life (VSL) . It was noted that other agencies use different values, e.g., the U.S. Department of Transportation uses a lower value in analyses of airline safety. An EPA representative explained that the value used by EPA was developed for the Agency from the current literature. Some participants also urged that the VSL approach be explained or applied in a way that lends itself to improved communicability so that people (consumers) can understand it. One suggestion was that it be translated into rate-payer cost per life saved.

Private Wells. It was noted that the costs and benefits associated with private well users were not considered in the HRRCA. Although the rule will not apply to private wells, it was pointed out that many private well users opt to treat their water to compliance levels and that where the MCL is set will have implications for private well owners and may be influential in real estate transactions. This will pose additional risk communication challenges at the state and local levels.

Anita Schmidt (of EPA's Office of Radiation and Indoor Air (ORIA) and lead staff person on the development of the EPA multimedia mitigation program guidelines) explained EPA's current thinking on criteria for multi-media mitigation (MMM) program plans. She reminded stakeholders that the EPA MMM guidelines will be published in conjunction with the proposed rule in August 1999.

Through consultation with stakeholders, EPA has iteratively refined its goals in designing the criteria and guidelines for MMM programs to reduce health risk from radon in indoor air. EPA's current goals are to achieve risk reduction through:

Ms. Schmidt emphasized it is clear that each state represents a unique situation, and the MMM approach will appropriately play out differently in each state. Therefore, EPA is emphasizing the need to provide flexibility to the states in developing the criteria and guidelines for the MMM programs.

Ms. Schmidt highlighted the key ideas on which the conceptual framework for MMM plan criteria are based and then presented the draft criteria that would be required for inclusion in MMM plans submitted for EPA approval. The conceptual framework for the MMM Plan criteria is based on three key elements:

Hence, the criteria EPA will use in considering MMM program plans for approval will be to assess whether the plan contains the following four required components:

Ms. Schmidt concluded by presenting the draft timeline for reporting and review of the effectiveness of MMM programs, suggesting that states might be required to report on results and progress to date every 2 years - a sort of performance evaluation. The statute requires a review by EPA at least every five years, at which the 2-year progress reports can help EPA, in consultation with the state, to assess the results against the state's MMM program goals. She referred to this process as one of consultative assistance to improve programs that fall short of their goals to improve future results. EPA does not envision automatic withdrawal of MMM plan approval if a program has not achieved its goals within five years. However, it is possible that states that continually show no progress risk losing their MMM approval.

Key Issues from Stakeholder Discussion of EPA MMM Program Criteria and Guidelines

Stakeholders raised the following issues, questions and concerns regarding the MMM program plan criteria and guidelines as currently envisioned by EPA:

Establishing baselines and measuring progress. Several participants asked about a requirement to identify or somehow quantify the starting point for states selecting the MMM/AMCL option. Questions focused on how much of existing programs should be in the baseline and how much can receive credit towards the MMM Program. It was noted that states with very active indoor radon programs have a de facto high "baseline." Related questions were raised regarding what EPA will require in the way of measuring or quantifying progress. Ms. Schmidt emphasized that EPA is not determining quantitative goals for individual states, nor is it prescribing the way in which states should measure or track progress. Rather, it will be up to each state opting for the MMM/AMCL approach to describe to EPA what efforts they will pursue to achieve their goals, how they will track and measure progress, and how they have "vetted" this - and the overall MMM program plan - with their public. She noted that in many cases a baseline would not be possible for a state to quantify now, but a means of tracking efforts and progress needs to be established for prospective results achieved. Over the first few years of an MMM program, establishing a more quantifiable baseline and tracking system could be part of the overall effort.

Funding. Participants raised concerns about funding for MMM program activities. In particular, they cited the cost of monitoring progress on MMM plans and stated the need for additional funding. They expressed particular concern that the additional monitoring and administrative costs of the MMM programs will be a drain on the funds now used for state indoor radon programs. While no new funds have been identified for this purpose, existing sources will be available for use in the MMM programs. Existing sources on the drinking water side include the State Program Assistance Grants, and Administrative Set-Asides from the State Revolving Fund. On the air side, EPA will be looking at the State Indoor Radon Grants (SIRG) guidelines to ensure that activities that implement the MMM program elements and that meet current SIRG eligibility requirements can be carried out with SIRG funds. However, expenditure of SIRG will not be permitted to fund strictly water-related activities, such as testing or monitoring of water at PWSs. Rather they might be used to fund activities to increase awareness of the health hazard posed by radon and actions that can be taken by the public to reduce exposure. It was further suggested that there may be a funding role for the PWSs which may experience significant cost savings as a result of not having to meet the more stringent MCL.

Role of PWSs. Questions were raised about the expected role of PWSs in a state MMM program. Ms. Schmidt emphasized that this will not be prescribed by EPA, but that it will be up to the individual states, in consultation with the PWSs and the public. The role of the PWSs could be quite minimal and vary extensively from state to state. It was noted that states should consider involving involving the PWSs, as well as public water customers, in developing the MMM program plan. In most cases it seems reasonable to assume that PWSs would be very supportive of implementing this approach, and might play a role in helping to develop and support it in a variety of ways.

In the event that a state chooses not to pursue the MMM/AMCL option, and one or more individual PWSs choose to do so on their own, the PWS will need to develop and implement a MMM program plans for their service area. State representatives inquired what their role would be in approval of MMM plans submitted by PWSs in states that opt not to develop a MMM program. Ms. Schmidt explained that this has not yet been defined, but that EPA recognizes the State agency role in protecting public health and is considering how to include them in the process.

Public participation requirements. Participants questioned the extent to which appropriate or sufficient public participation will be prescribed by EPA (e.g., with respect to inclusiveness of representation, extent of outreach, adequate funding, etc.). Ms. Schmidt again maintained that it is not EPA's intent to prescribe specific requirements, leaving it up to the state to determine what makes the most sense for their individual circumstances. EPA criteria will require that states provide descriptive information explaining the process, who was solicited, who was involved and how, what issues were raised, and how they were addressed in the MMM plan. It was suggested that the MMM Program Guidelines provide states with examples or elements of credible public participation processes.

Concern was expressed that in some states, the requirement for public "vetting" of the MMM program plan could actually lead to erosion of the goals in current state indoor radon programs.

Equity. Questions about how to address equity issues associated with the MMM provision of this rule were raised by stakeholders. It was noted that equity concerns seem inherent to the concept of MMM and that this is likely to pose important risk communication challenges in some areas. The required public participation element of the MMM Plans was acknowledged to be a potential tool for both assessing and addressing these concerns locally. Consumer Confidence Reports (CCR) were cited as a risk communication and education tool to help address equity concerns. Ms. Schmidt noted that EPA is committed to development of risk communication messages and tools to assist states, PWSs and others with this challenge.

Coordination with other federal agencies. EPA was encouraged to coordinate with other federal agencies (e.g., the U.S. Department of Housing and Urban Development, other public housing construction agencies, and housing loan-making entities, such as the Federal Housing Administration) to develop requirements for radon testing in homes as a condition for loan approval.

In concluding discussion of the multimedia mitigation program elements, Ms. Schmidt noted that EPA is planning a series of conference calls with state representatives of both drinking water and indoor air or radon programs to gather further input on the criteria and guidelines for MMM Plans. She acknowledged the tension, implied by participants' questions and comments, between providing maximum flexibility to states in crafting plans to their specific circumstances, and the need for EPA to provide minimum criteria that are protective of public health. She encouraged stakeholders to contact EPA with further comments or suggestions.

¹ Previous stakeholder meetings took place on June 26, 1997 and October 19-20, 1998 in Washington, DC, September 2, 1997 in San Francisco, California, and October 30, 1997 in Boston, Massachusetts. In addition, a series of three conference calls with representatives from state drinking water and state radon programs to discuss options and issues related to the development of the multimedia mitigation guidelines for radon was held in August 1998. For more information, contact EPA's Drinking Water Hotline at 1-800-426-4791 or visit the EPA OGWDW website at: http://www.epa.gov/safewater/radon.html.

³ National Research Council (Committee on the Risk Assessment of Exposure to Radon in Drinking Water). 1998. Risk Assessment of Radon in Drinking Water. National Academy Press: Washington, DC. Prepublication copy. Available on-line at URL http://www.nap.edu/readingroom/enter2.cgi?0309062926.html

⁴ Never-smokers are defined as individuals who have smoked fewer than 100 cigarettes in their lives.

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Stakeholder Meeting on Development of Primary Drinking Water Regulation for Radon

Meeting Summary