Safe Drinking Water Act:

EPA Should Improve Implementation of Requirements on Whether to Regulate Additional Contaminants

GAO-11-254: Published: May 27, 2011. Publicly Released: Jul 12, 2011.

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Under 1996 amendments to the Safe Drinking Water Act, every 5 years the Environmental Protection Agency (EPA) is to determine for at least five contaminants, such as chemicals, whether regulation is warranted, considering those that present the greatest public health concern. Since 1996, EPA had not recommended any new contaminants for regulation until February 2011, when it reversed its controversial 2008 preliminary decision to not regulate perchlorate, an ingredient in rocket fuel and other products. GAO was asked to (1) evaluate the extent to which EPA's implementation of the 1996 amendments has helped assure the public of safe drinking water and (2) review the process and scientific analyses used to develop the 2008 preliminary regulatory determination on perchlorate. GAO analyzed relevant statutory provisions and regulatory determination documents and interviewed EPA officials.

Systemic limitations in EPA's implementation of requirements for determining whether additional drinking water contaminants warrant regulation have impeded the agency's progress in assuring the public of safe drinking water. EPA's selection of contaminants for regulatory determination in 2003 and 2008 was driven by data availability--not consideration of public health concern. EPA does not have criteria for identifying contaminants of greatest public health concern and based most of its final determinations to not regulate 20 contaminants on the rationale of little or no occurrence of the contaminants in public water systems. Moreover, EPA's testing program for unregulated contaminants--which can provide key data to inform regulatory determinations--has fallen short in both the number of contaminants tested and the utility of the data provided because of management decisions and program delays. In addition, EPA has not developed policies or guidance for interpreting the amendments' broad statutory criteria for selecting contaminants and making regulatory determinations, increasing the potential for inconsistent decision making. Also, the credibility of some of EPA's regulatory determinations is limited by a lack of transparency, clarity, and consistency of key documents. For example, EPA made decisions on nine contaminants relying on tests that were not sensitive enough to detect them at the agency's health risk benchmarks. Furthermore, EPA did not clearly and consistently disclose this limitation and its effect on EPA's analysis. In making its preliminary regulatory determination on perchlorate in 2008, EPA used a process and scientific analyses that were atypical, lacked transparency, and limited the agency's independence in developing and communicating scientific findings. First, while an intra-agency workgroup typically makes recommendations to the Assistant Administrator for Water on whether to regulate evaluated contaminants, in this case, the Assistant Administrator directed the staff to develop a determination to not regulate and to support a specified exposure level as protective of all populations. This direction was outlined in an agreement between high-level officials at EPA and other federal agencies that is not part of the perchlorate regulatory determination record. Moreover, EPA adopted the National Academies' 2005 perchlorate health assessment--a foundation for EPA's regulatory determination--without using EPA's standard internal scientific review process. This assessment is controversial, especially its sufficiency to protect infants. Also, the credibility of EPA's exposure estimate for perchlorate, which is based on a novel analysis, is reduced by the lack of a comprehensive explanation of the methodology's limitations and uncertainties in the preliminary determination notice. Finally, according to key EPA scientists, the agency mischaracterized important scientific findings on the sensitivity of various age groups to perchlorate exposure. EPA scientists who managed the sensitivity analysis did not agree that it supported the conclusion that the selected exposure level was protective of all populations, which was one component of the aforementioned agreement between EPA and other federal agencies. GAO's 17 recommendations include that the EPA Administrator require (1) development of criteria to identify contaminants that pose the greatest health risk, (2) improvements in its unregulated contaminants testing program, and (3) development of policies or guidance to interpret the broad statutory criteria. EPA agreed with 2 recommendations but took the position that developing guidance and taking the other recommended actions are not needed. GAO believes EPA needs to adopt all of the recommendations to better assure the public of safe drinking water.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: EPA improved the process it used to identify contaminants for the third and fourth contaminant candidate lists (CCL 3 and CCL 4), using a more rigorous scientific process to assess whether the contaminants on the list are the highest priority for public health protection. In addition, EPA consulted with an independent panel of scientists in October 2011 on the regulatory determination process and whether it focuses on the greatest public health risk. The panel of scientists noted that while EPA is not actually developing a prioritization of contaminants, but more of a binning approach to narrow the list of contaminants for further evaluation and regulatory consideration due to its data limitations, it believes the process has led to positive results regarding EPA's identification of potential drinking water contaminants.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to systematically implement the statutory requirement to consider for regulation the contaminants that present the greatest public health concern, the EPA Administrator should require that the Office of Water to develop criteria and a process for identifying those contaminants on its candidate list that present the greatest public health concern.

    Agency Affected: Environmental Protection Agency

  2. Status: Open

    Comments: EPA has not demonstrated that it has developed a coordinated process for obtaining both occurrence and health effects data to make informed determinations on priority contaminants. EPA's response to this recommendation is that it will continue the status quo of obtaining occurrence data through UCMRs and work with the Office of Research and Development. As we reported, the approach EPA currently uses does not provide the agency with all of the data it needs in a timely manner to support determinations for some priority contaminants.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to systematically implement the statutory requirement to consider for regulation the contaminants that present the greatest public health concern, the EPA Administrator should require that the Office of Water to develop a coordinated process for obtaining both the occurrence and health effects data that may be needed for the agency to make informed regulatory determinations on these priority contaminants.

    Agency Affected: Environmental Protection Agency

  3. Status: Closed - Implemented

    Comments: In May 2012, EPA finalized the rule for UCMR3, which required public water systems to monitor for 29 unregulated contaminants under the UCMR authority and one additional regulated contaminant under a separate authority, for a total of 30 contaminants.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to take full advantage of the opportunities provided by the testing program mandated by the statute and thereby obtain high-quality occurrence data on the authorized number of unregulated contaminants, the EPA Administrator should require the Office of Water to use its full statutory authority to test for the 30 contaminants allowed under each 5-year testing cycle.

    Agency Affected: Environmental Protection Agency

  4. Status: Closed - Implemented

    Comments: In May 2012, EPA published its final rule for UCMR 3, in which it required the more robust assessment monitoring for 21 of the 30 contaminants under the UCMR.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to take full advantage of the opportunities provided by the testing program mandated by the statute and thereby obtain high-quality occurrence data on the authorized number of unregulated contaminants, the EPA Administrator should require the Office of Water to conduct testing for most or all of the selected contaminants using the assessment monitoring program, rather than the more limited screening surveys, to obtain robust occurrence data, from which national estimates with high confidence levels can be derived.

    Agency Affected: Environmental Protection Agency

  5. Status: Closed - Implemented

    Comments: In May 2012, EPA finalized the rule for UCMR3, in which EPA set the minimum reporting levels based on how low the analytical method could reliably measure each contaminant. In January 2014, GAO reported on EPA?s improvement in the monitoring program, stating that by monitoring for contaminants at the lowest concentrations feasible, UCMR3 is more likely to detect contamination at levels of public health concern.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to take full advantage of the opportunities provided by the testing program mandated by the statute and thereby obtain high-quality occurrence data on the authorized number of unregulated contaminants, the EPA Administrator should require the Office of Water to select minimum reporting levels for testing selected unregulated contaminants that are sufficiently sensitive to reliably (1) detect the known and likely occurrence of contaminants in public water systems at levels of public health concern and (2) provide useful and credible information on the occurrence of the contaminants in public drinking water systems.

    Agency Affected: Environmental Protection Agency

  6. Status: Closed - Implemented

    Comments: EPA has improved the transparency, clarity and consistency of its documentation for the third regulatory determination process, although the agency has not developed policies or guidance that specify thresholds or parameters that it requires to be met to support a positive finding for each criterion. Specifically, EPA developed a "Protocol for the Regulatory Determination 3," which was reviewed by an independent scientific panel, and a Federal Register notice and supporting documentation that lists the primary occurrence and health effects data and more explicitly explains the agency's approach for regulatory determinations. The Protocol includes an appendix that transparently and succinctly presents the health effect and occurrence information that supports EPA's proposed regulatory determination for each contaminant. While the Agency does not have a threshold for making a positive finding, EPA's explanation of the factors and information it used to make its regulatory determinations is more transparent and accessible to external parties, including the public, increasing the agency's accountability for the consistency of its determinations. Further, EPA committed to reviewing the process every five years as it conducts each regulatory determination cycle.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should specify any thresholds or parameters that the agency requires to be met to support a positive finding for each criterion to ensure their consistent application.

    Agency Affected: Environmental Protection Agency

  7. Status: Closed - Implemented

    Comments: In the Federal Register notice announcing its 2014 Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3), EPA more clearly and transparently explained the factors it considered in making its preliminary regulatory determinations, including elaborating on the health effects and occurrence data that the agency considers sufficient for making regulatory determinations. While EPA has not developed policies or guidance as GAO recommended, GAO considers the record of greater clarity and transparency EPA has established in the published Federal Register notice to meet the intent of the recommendation for this cycle of regulatory determinations. Therefore, GAO is closing the recommendation as implemented with the expectation that EPA will continue this established practice in future regulatory determination cycles.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should include factors for determining when the occurrence and health effects data the agency identifies are adequate to support a regulatory determination.

    Agency Affected: Environmental Protection Agency

  8. Status: Closed - Implemented

    Comments: In the Federal Register notice announcing its 2014 Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3) and its Protocol for the Regulatory Determination 3, which underwent review by an independent panel of scientists, EPA included clear explanations of key information, such as whether and how EPA used various data throughout the regulatory determination process. In addition, EPA improved its overall presentation of information in the public documents, making them more comprehensive, consistent, informative, and understandable. While EPA has not developed policies or guidance as GAO recommended, GAO considers the record of greater clarity and transparency EPA has established in these public documents to meet the intent of the recommendation for this cycle of regulatory determinations. In addition, EPA has committed to reviewing the process every 5 years as it conducts the regulatory determination cycle. Therefore, GAO is closing the recommendation as implemented with the expectation that EPA will continue this established practice in future regulatory determination cycles.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should establish a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable and that it includes clear explanations of key information, such as whether and how EPA used various data.

    Agency Affected: Environmental Protection Agency

  9. Status: Closed - Implemented

    Comments: In the Federal Register notice announcing its 2014 Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3) and its Protocol for the Regulatory Determination 3, which underwent review by an independent panel of scientists, EPA included clear explanations of key information, such as how the agency derived health reference levels for both cancer and non-cancer endpoints (including the relative source contribution for non-cancer endpoints). In addition, EPA improved its overall presentation of information in the public documents, making them more comprehensive, consistent, informative, and understandable. While EPA has not developed policies or guidance as GAO recommended, GAO considers the record of greater clarity and transparency EPA has established in these public documents to meet the intent of the recommendation for this cycle of regulatory determinations. In addition, EPA has committed to reviewing the process every 5 years as it conducts the regulatory determination cycle. Therefore, GAO is closing the recommendation as implemented with the expectation that EPA will continue this established practice in future regulatory determination cycles.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should establish a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable and that it includes clear explanations of key information, such as the relative source contribution method the agency used to calculate the health reference level.

    Agency Affected: Environmental Protection Agency

  10. Status: Closed - Implemented

    Comments: In the Federal Register notice announcing its 2014 Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3) and its Protocol for the Regulatory Determination 3, which underwent review by an independent panel of scientists, EPA explicitly identified the cases where the minimum reporting level (MRL) exceeded the health reference level (HRL) (1,3-dinitrobenzene and terbufos) and noted that "some occurrence above the HRL may have gone undetected since reporting levels are not documented." In addition, EPA's overall presentation of information in the public documents, making them more comprehensive, consistent, informative, and understandable. While EPA has not developed policies or guidance as GAO recommended, GAO considers the record of greater clarity and transparency EPA has established in these public documents to meet the intent of the recommendation for this cycle of regulatory determinations. In addition, EPA has committed to reviewing the process every 5 years as it conducts the regulatory determination cycle. Therefore, GAO is closing the recommendation as implemented with the expectation that EPA will continue this established practice in future regulatory determination cycles.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should establish a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable and that it includes clear explanations of key information, such as instances in which the minimum reporting levels for data used in assessing contaminants' occurrence in drinking water are above the health reference level (e.g., are not sufficiently sensitive to detect occurrence at the level of public health concern) and the limitations of using such occurrence data to support regulatory determinations.

    Agency Affected: Environmental Protection Agency

  11. Status: Open

    Comments: EPA's Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3) did not appear to include any cases in which EPA made an exception to existing guidance, negating the need for an explanation. EPA has not developed policies or guidance that establishes a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable, and that it includes clear explanations of key information and the Protocol for Regulatory Determinations 3 does not appear to address this circumstance. Without policies or guidance establishing a process to ensure the comprehensive, consistent, informative, and understandable presentation of its regulatory determinations, there is no guarantee at this time that EPA would include this information in future regulatory determinations.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should establish a process to ensure that the presentation of health effects and occurrence information in regulatory determination notices and support documents is comprehensive, consistent, informative, and understandable and that it includes clear explanations of key information, such as any exceptions to existing guidance reflected in the agency's support for its regulatory determinations.

    Agency Affected: Environmental Protection Agency

  12. Status: Closed - Implemented

    Comments: In the Federal Register notice announcing its 2014 Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3), EPA included clear explanations of key information, such as how it applied Age Dependent Adjustment Factors in its consideration of the mutagenic mode of action. In addition, EPA improved its overall presentation of information in the public documents, making them more comprehensive, consistent, informative, and understandable. While EPA has not developed policies or guidance as GAO recommended, GAO considers the record of greater clarity and transparency EPA has established in these public documents to meet the intent of the recommendation for this cycle of regulatory determinations. In addition, EPA has committed to reviewing the process every 5 years as it conducts the regulatory determination cycle. Therefore, GAO is closing the recommendation as implemented with the expectation that EPA will continue this established practice in future regulatory determination cycles.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should establish the approaches, such as methods and analyses, as appropriate, to evaluate the health effects on sensitive subpopulations, including such groups as infants and children, those with kidney and liver disease, those with compromised immune systems, and the elderly, and to comply with applicable agency policy and guidance for assessing children's health risks.

    Agency Affected: Environmental Protection Agency

  13. Status: Open

    Comments: EPA's response to this recommendation reflects the practice that was in place at the time we issued our report including this recommendation. As a result, it does not appear that EPA has taken any additional action to satisfy this recommendation at this time.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should specify that appropriate stakeholders--that is, EPA offices with relevant expertise such as the Office of Children's Health Protection and regional offices that have known or likely occurrence of the contaminants being evaluated in public water systems within their areas of jurisdiction--be encouraged and have the opportunity to participate in the regulatory determination work groups.

    Agency Affected: Environmental Protection Agency

  14. Status: Closed - Implemented

    Comments: In the Federal Register notice announcing its 2014 Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List (Reg Det 3) and its Protocol for the Regulatory Determination 3, which underwent review by an independent panel of scientists, EPA states that "contaminants that receive negative determinations are evaluated in future Contaminant Candidate List (CCL) development processes to determine if new data are available on health effects and/or occurrence that warrant listing on future CCLs" and has already begun implementing this approach. For example, EPA included manganese--a contaminant for which the agency previously made a negative regulatory determination--on the draft fourth CCL. While EPA has not developed policies or guidance as GAO recommended, GAO considers the record of greater clarity and transparency EPA has established in these public documents to meet the intent of the recommendation for this cycle of regulatory determinations. In addition, EPA has committed to reviewing the process every 5 years as it conducts the regulatory determination cycle. Therefore, GAO is closing the recommendation as implemented with the expectation that EPA will continue this established practice in future regulatory determination cycles.

    Recommendation: To increase EPA's consistency, transparency, and clarity in implementing the Safe Drinking Water Act in a way that better assures the public of safe drinking water, and to support the development of regulatory determinations that are transparent, clear, and consistent and that follow applicable agency policy, the EPA Administrator should require the Office of Water to expeditiously develop, and make available to the public, policies or guidance that clearly articulates the agency's interpretation of the act's broad statutory criteria for making regulatory determinations and provides a protocol for making such determinations. In particular, the guidance should define the circumstances under which, and the process EPA will use, to reconsider whether to regulate a contaminant for which it previously issued a determination not to regulate and, in the context of the recommended guidance, consider whether the agency needs to re-evaluate any of its past determinations to not regulate.

    Agency Affected: Environmental Protection Agency

  15. Status: Closed - Implemented

    Comments: As part of EPA's commitment to improve the transparency of the regulatory determination process, the agency drafted a Protocol for Regulatory Determination 3. The agency assembled an independent panel of scientists to review the Protocol and provide comments, which EPA used to revise the Protocol. In addition, EPA held a public meeting to solicit input on its preliminary regulatory determinations for five CCL3 contaminants. While EPA has not developed policies or guidance as GAO recommended, GAO considers EPA's efforts to develop a protocol and submit it for review by an independent panel of scientists sufficient to meet the intent of the recommendation for this cycle of regulatory determinations. In addition, EPA has committed to reviewing the process every 5 years as it conducts the regulatory determination cycle. Therefore, GAO is closing the recommendation as implemented with the expectation that EPA will continue this established practice in future regulatory determination cycles.

    Recommendation: A draft of the guidance GAO is recommending EPA develop should be reviewed by the Science Advisory Board's Drinking Water Committee or the National Drinking Water Advisory Council and that EPA consider the committee's comments before finalizing the guidance. In addition, the EPA Administrator should develop and implement an internal review mechanism to help ensure that EPA's regulatory determinations are consistent with the guidance.

    Agency Affected: Environmental Protection Agency

  16. Status: Open

    Comments: EPA indicated that it has begun a process of developing concise updates to carry forward into its health advisory table and that the process will be completed gradually over the next year, with updates continuing in the future, but has not yet published any updates for non-microbial contaminants. In addition, EPA has not addressed the call in the recommendation for the documentation of the process to update the advisories. The agency did indicate its plan to update the Drinking Water Standards and Health Advisory table in the fall of 2016, so we will leave this recommendation open and continue to monitor for future actions.

    Recommendation: In light of EPA's decisions to issue health advisories in conjunction with determinations to not regulate certain contaminants that have been detected in some public water systems at levels of public health concern, the EPA Administrator should (1) determine whether the Office of Water's use of health advisories provides sufficient information on these unregulated contaminants to support timely and effective actions by states, localities, public water systems, and the public to ensure the safety of public drinking water, and (2) if not, direct the Office of Water to develop a plan to more effectively communicate such information to these entities.

    Agency Affected: Environmental Protection Agency

  17. Status: Closed - Implemented

    Comments: EPA included OMB's redline strikeout version of its 2014 preliminary regulatory determinations in the public record.

    Recommendation: To improve transparency and help EPA ensure that it maintains the fairness and openness of its operations and thus strengthens public confidence in its decisions, the EPA Administrator should require the Office of Water to include in the public record OMB's and other federal agencies' comments on and revisions to regulatory determination notices and support documents.

    Agency Affected: Environmental Protection Agency

 

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