Document XOv7BkYg90E5obXvbK3wmzQjB

American Water Works Association Government Affairs Office i 300 Eye Street NW Suite 70 W Washington, DC 20005-3314 T 202.628.8303 F 202.628.2846 August 1, 2018 Office of the Science Advisor Environmental Protection Agency 1200 Pennsylvania Ave NW Washington, DC 20460 Re: Comments on Strengthening Transparency in Regulatory Science (EPA-HQ-OA-2018-0259) Dear Mr. Sinks: The American Water Works Association (AWWA) appreciates the opportunity to comment on the advanced notice of proposed rulemaking titled "Strengthening Transparency in Regulatory Science," published in the Federal Register on April 30, 2018. AWWA supports transparency in all Environmental Protection Agency actions (both regulatory and non-regulatory), including the data and information used to inform EPA decision-making. In taking steps to improve the transparency of current EPA rulemaking processes, it is important that the Agency address the following: EPA's statutory obligations, transparency of influential (pivotal) decision-making processes, and the public and business communities' right to privacy. EPA must meet statutory requirements The Safe Drinking Water Act requires that regulatory decisions be based upon "(i) the best available, peerreviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature o f the decision justifies use of the data)." (Sec. 1412 (b)(3)(A)). Other environmental statues have similar provisions. Should EPA finalize the "Strengthening Transparency in Regulatory Science" rule, the Agency must meet this statutory obligation with respect to setting regulatory requirements under SDWA, and EPA must assure that the rule does not interfere with the use of the best available science. EPA is required to utilize the best available science whenever the Agency makes a regulatory decision. EPA clearly contemplated using the "best available science" even when the underlying data was not publicly available (i.e., proposed 30.9). This provision may be used extensively as the research community transitions to meet new expectations for data access and transparency from scientific journals, funding organizations, and government agencies. How determinations under this section would be made warrants an extensive discussion with stakeholders so that the Agency has a full understanding of how to best utilize this embedded discretionary authority. Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00001 August 1, 2018 EPA-HQ-OA-2018-0259 Page 2 of 4 AWWA has long requested transparency in EPA decisions AWWA has commented previously on numerous regulatory actions and policy decisions, requesting greater transparency in EPA's decision-making process. Plow EPA decides which studies and models to utilize, what assumptions or safety factors to incorporate, and which data is of adequate quality to support decision-making is critical to science-based decision-making. Section 30.1 of the proposed rule clearly speaks to this need, "... ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation." To illustrate the importance of transparency within EPA's process, we have reviewed prior comments for examples. Attachment A includes a partial list of instances where greater transparency in EPA's decision making process would have informed interested stakeholders and facilitated more effective information exchange. AWWA recommends that EPA refocus the proposal on transparency in decision-making broadly, as openness and reproducibility of key influential decision points in a regulatory analysis can be much more significant than the availability of individual data points. Again, the experience of the engaged stakeholder community in a discussion of how to best focus efforts to improve transparency in Agency decision making would be most effectively gathered through a collaborative stakeholder process. EPA's own research One way EPA could increase transparency in its decisions would be to focus on setting standards for the public disclosure of its own research and models. Currently, Agency staff seek to verify the quality of their work through publication in peer-reviewed journals and through small-group, peer-review processes. What is often lacking is the reproduction of model decision logic and external user testing of Agency models. By setting an appropriate 'high bar' for transparency in its own data and processes, EPA can be an example to others whose research is conducted elsewhere. Evolving open data access policies Open data access principles are increasingly an expected element of modern research. Investigators, whether funded by federal agencies or by private philanthropic organizations, such as the Bill and Melinda Gates Foundation, have clear expectations for open access to final data from the research they fund.1"There is likewise a growing expectation for open data access in the peer-review, scientific publication process. However, open access policy is still maturing. In 2013, the federal emphasis was on simple public access to published research results. Today, open access repositories for actual data from research studies are becoming more common. Importantly, practices are evolving at different speeds in different research disciplines. Different fields of study face different data constraints, that is, the form (e.g., numeric, image, etc.), volume (e.g. megabytes, terabytes, etc.), utility, and protected status (e.g., personal or business confidential information) of the data researchers generate. Not unimportant is the level of funding available to support research; some fields are lucky to have funding to support essential work, while other topics receive a continuous and substantial funding stream that can support ancillary research infrastructure, such as data systems to support open access to data. Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00002 August 1, 2018 EPA-HQ-OA-2018-0259 Page 3 of 4 As open access principles will take years to fully integrate into practice, EPA will need to (1) apply reasonable expectations for data availability from historical studies given accepted practice at the time, (2) determine how it will assess research from projects that are underway now as EPA itself is changing its policies, and (3) set achievable expectations appropriate to different fields of research given unique constraints during the transition process. Given past Office of Management and Budget guidelines and the historic focus on peer-review not only at EPA but in scientific research broadly, EPA will need to rely heavily on peer-review rather than public access to underlying datasets for many key science-policy decisions for the immediately foreseeable future. As mentioned above, this emphasizes the need for EPA to engage stakeholders in a productive dialogue on how to implement this policy, including how to transition from current practice to the new policy. Stakeholder engagement AWWA sought an extension to the comment period for this notice in order to provide useful insights on the proposed rule. Providing recommendations on this proposal was difficult. The proposal, is worded in very broad terms and is not accompanied by any supporting guidelines to inform detailed evaluation. For example, proposed 30.9 provides for EPA Administrator authority to exempt research studies from the public data requirements on a case-by-case basis. The docket does not include documentation describing the protocol EPA would follow or factors that are critical for making such a decision under this section. AWWA strongly supports using the best science to support regulatory decisions. Decisions intended to assure public health and safety require a high standard of care. It is also prudent to be sure that limited Agency and stakeholder resources are applied effectively. Toward that end, the proposed rule was not accompanied by an analysis of the costs and associated benefits of the proposed policy change. Preparing a clear description of how the new policy would be implemented would provide a basis for evaluation of implementation costs and hurdles both for EPA and those effected by the rule requirements. With this assessment in hand, it would be possible on at least a qualitative basis to describe the associated cost-benefit. AWWA strongly recommends that EPA engage stakeholders to discuss how to best implement, and as necessary, refine this proposed rule prior to publishing a final rule. The quality of the science used to support EPA decisions is one of the most important organizational principles underpinning the soundness of Agency rules and the Agency's credibility. At present, AWWA, and likely many other stakeholders, do not understand how the proposed rule would in fact be implemented. This lack of clarity is best resolved before EPA finalizes the rule. We appreciate the opportunity to provide comment on this matter. Please feel free to contact myself or Adam Carpenter at AWWA (202-628-8303, acarpenter@awwa.org) if you have any questions regarding these comments. Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00003 August 1, 2018 EPA-HQ-OA-2018-0259 Page 4 of 4 Respectfully, G. Tracy Meran, Executive Director of Government Affairs American Water Works Association cc: David Ross, OW Peter Grevatt, OW/OGWDW Andrew Sawyers, OW/OWM Jennifer Orme-Zavaleta, ORD Eric Burneson, OW/OGWDW Attachments: 1 About AWWA: AWWA is an international, nonprofit, scientific and educational society dedicated to providing total water solutions assuring the effective management of water. Founding 1881, the Association is the largest organization of water supply professionals in the world. Our membership includes nearly 4,200 utilities that supply roughly 80 percent of the nation's drinking water and treat almost half of the nation's wastewater. Our over 50,000 total memberships represent the full spectrum of the water community: public water and wastewater systems, environmental advocates, scientists, academicians, and others who hold a genuine interest in water, our most important resource. AWWA unites the diverse water community to advance public health, safety, the economy, and the environment. 1 2011, Bill & Melinda Gates Foundation's Data Access Principles. https://docs.gatesfoundation.org/documents/faq.pdf. 1 2013, Increasing Access to the Results of Federally Funded Scientific Research, https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp public access memo 2013.pdf. Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00004 Attachment A. Prior AWWA Comments Noting the Importance ofTransparency Date Docket or Comment Link Subject 12/08/2017 EPA-HQ-OW-2015-0714-0010 Verbal comment to National Drinking Water Advisory Council 11/20/2017 EPA-HQ-OW-2016-0438 Perchlorate Maximum Contaminant Level Goal 10/31/2017 EPA-HO.-OA-2017-0533 10/06/2017 EPA-HQ-0 W-2016-0439 EPA 2018-2022 Strategic plan Perchlorate peer-review 03/14/2017 bPA-HQ-OW-2016- /lb 02/09/2016 EPA-HQ-0 W-2015-0? . 18 08/18/2014 EPA-HCTOPFT-2011-1019 07/10/2012 Letter to SAB (no docket) Water Quality Criteria for Microcystins and Cylindrospermopsin Unregulated Contaminant Monitoring Rule 4 ANPR on Hydraulic Fracturing Chemicals and Mixtures in TSCA SAB Panel on Perchlorate 03/09/2012 Letter to Administrator (no docket) 01/27/2012 /PA:hiaORD:2gil,g895 09/06/2011 Letter to Office of Science Advisory (no docket) Release of Non-OCA data Ground Water Investigation, Pavilion WY Scientific Integrity Policy Description States that health advisories should be developed to meet transparency and other requirements of "economically significant guidance documents" Noted that the instructions for running the model referenced in this process were insufficient to reproduce and lacked rationale on the parameter values used Welcomes EPA's commitment to transparency in Objective 2.2 Requests that peer-reviewers for perchlorate peer review panel be provided with all comments on charge questions for adequate transparency References 2015 AWWA letter to EPA Office of Policy on the need for transparency in health advisories by using "significant guidance" methodology Indicated that important portions of rule scope lacked transparency by being in footnotes Requests a transparent database of hydraulic fracturing chemicals and mixtures in response to ANPR States that EPA limited time for public input at past perchlorate meetings prevented appropriate transparency with the public and among SAB members States that EPA's current practice (as of writing) strikes an appropriate balance between transparency and security in non-OCA data, and discourages publication online Requests transparency in EPA study results and transparency in hydraulic fracturing chemicals States that the EPA should explain how it will promote public access to EPA information and that EPA should not Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00005 Date Docket or Comment Link Subject Description use draft status as a reason to withhold data and information 05/02/2011 EPA-HQ,-0 W--2009-0090-0080 UCMR3 Notice Summarized lack of transparency in the "Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator," used to set UCMR3 MRLs; References prior AWWA comment on the lack of transparency in why groups of compounds were included in the UCMR3 over others that were on the CCL3 11/09/2010 EPA--HQ--OVV-~2.Q:10--068 07/07/2009 Letter to Administrator (no docket) 06/09/2009 Letter to SAB Committee (no docket) 06/01/2009 Letter to SAB Committee (no docket) 04/17/2009 Letter to Assistant Administrator ORD (no docket) 03/16/2009 Letter to OIRA OMB (no docket) 2011 Drinking Water Infrastructure Needs Survey Agency Collection Guidelines for Preparing Economic Analyses Revised Total Coliform Rule Science Integration for Decision Making IRIS Evaluation of Inorganic Arsenic Federal Regulatory Review States that more transparency in use of information was needed to justify certain information EPA requested in the survey to utilities Summarizes issues with past EPA Economic Analyses, including lack of both key citations and listing results from intermediate steps States that transparency in the cost-benefit analysis of the RTCR should include describing underlying and simplifying assumptions Summarizes issues with past EPA Economic Analyses, including lack of both key citations and listing results from intermediate steps Requests that the EPA provide opportunity for public comment, engage the Science Advisory Board, and allow for internal review of the arsenic risk assessment to increase transparency States support for EPA's use of transparency and reproducibility in the regulatory process, including transparency in methods, stakeholder communication, and cost-benefit analyses A- 2 Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00006 Date Docket or Comment Link 05/21/2008 EPA-HQ.--0W-2007-1189 07/02/2007 EPA-HQ-OW-2007-0068-016 06/11/2007 EPA- EiQ--OW-~2006-0958 06/11/2007 Letter to OIRA OMB (no docket) Subject CCL 3 Draft Regulatory Determinations Regarding Contaminants on CCL 2 Expedited Approval of Test Procedures OMB Cost Benefit Regulations Description Notes that the CCL docket's length relative to the comment period, lack of post-scoring by outside experts, and lack of justification for changing of some scores does not contribute to transparency; suggests all materials used for CCL3 be publicly available in docket and suggests a document in the docket with listed experts will increase transparency States that EPA needs to raise the level of transparency in decision logic for regulatory determinations Recommends the EPA provide for peer-review and comment opportunities in its expedited method approval process Identified transparency issues with LT2 Rule economic analysis, including obscurity of presentation and model assumptions, and with EPA's use and analysis of ICR Data in the Stage 2 DBP Rule 03/12/2007 OMB-2007-0003-0001 06/21/2005 Letter to OIRA OMB (no docket) OMB Report on Costs and Benefits of Federal Regulations Draft 2005 Report to Congress on the Costs and Benefits of Federal Regulations States that EPA should clearly state the intermediate results of a CBA estimation Summarizes issues with past EPA Economic Analyses, including lack of both key citations and listing results from intermediate steps 06/23/2004 06/01/2004 EPA-HQ-ORD-2004- 0004- 0016 F-PA-HQ,-OW-2003-0028-0020 Examination of EPA Risk Assessment Principles and Practices CCL 2 Notice States that EPA should reveal quantitative impacts of its assumptions on risk outcomes to be transparent States that use of expert judgment to automate contaminants should be documented 01/09/2004 EPA-HQ-OVV-2002-0039-0562 LT2 Enhanced Surface Water Treatment Rule Identified transparency issues with LT2 Rule economic analysis, including obscurity of presentation and model assumption and lack of approaches and results for r estimates used in the analysis A- 3 Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00007 Date Docket or Comment Link Subject 07/16/2003 EPA-HQ-OW-2003-0013-0011 Information Collection Request (ICR) 02/03/2003 Letter to OIRA OMB (no docket) 08/02/2002 EPA-HQ-OW-2002-0021 07/03/2002 06/17/2002 EPA-HQ-OPP-2002-00260001 EPA-HQ-OW-2002-0012 Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations Priority Contaminants for CCL Revised Human Health Risk Assessment for Atrazine 2002 Results of EPA's Review of Existing Drinking Water Standards 05/28/2002 Letter to OIRA OMB (no docket) 03/28/2002 Letter to NCEA (no docket) 10/31/2001 EPA-HQ-OW-2001-0001 Draft 2002 Report to Congress on the Costs and Benefits of Federal Regulations Perchlorate Environmental Contamination: Toxicological Review Draft NRDWR: Arsenic 08/15/2001 12/31/2000 Letter to OIRA OMB (no docket) EPA-HQ-OW-2001-0001-0096 2001 Draft Report to Congress on the Costs and Benefits of Federal Regulations NPDRWR: Radon-222 Description States EPA's methods for determining distribution of utilities required to prepare a emergency response plan and for determining how CWS burden costs were offset by grant money lacked transparency Summarizes issues with past EPA Economic Analyses, including lack of both key citations and listing results from intermediate steps States that the EPA decision process and relevant criteria for narrowing the CCL was not transparent Indicated that lack of access to monitoring program data for review by the EPA prevented full public review States that tables essential to understanding the agency's decision logic should be made available in the Federal Register notice and that summary of the Bayesian analysis was inadequate States that data quality reviews are a more transparent avenue to address EPA's analyses than public comments States more transparency in risk characterization required more thorough explanation of diet in toxicological studies Recommends EPA present information in reproducible, transparent methods in Notice of Data Availability on upcoming arsenic regulation States OMB should ensure the EPA follow CBA guidelines, including transparency, full disclosure, and replicability in CBAs Identified transparency issues, including lack of consistency in concepts applied in the CBA of the radon rule A - 4 Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00159918-00008 Date 08/09/2000 06/09/2000 01/31/2000 04/12/1999 09/15/1998 Docket or Comment Link EPA-HQ-OW-2002-0043-0020 EPA-HQ-OW-2002-0008-0001 EPA-HQ-OPP-2000-00625 EPA-HQ-OW-2002-0046-0001 Letter to the Tolerance Reassessment Committee (no docket) Subject NPDWR: Ground Water Rule NPDWR: LT1 Enhanced Surface Water Treatment and Filter Backwash Recycle Rule OPP Policy Issues Papers Related to the Food Quality Protection Act Radon In Drinking Water Health Risk Reduction and Cost Analysis (HRRCA) Tolerance Reassessment Advisory Committee Description States that EPA was not transparent In falling to provide a GWR workshop summary to stakeholders and that the Regulatory Impact Analysis (RIA) was not clear In describing methodologies States that the Regulatory Impact Analysis (RIA) had critical Inconsistencies In approach and methodologies States that the EPA should be transparent by defining strategies and methodologies used for estimating aggregate exposure and risk assessment Requests that the certain support documents be released before the proposed rule so that HRRCA could be reviewed States support for EPA's transparency In EPA's process on tolerance assessment and determining Individual pesticide tolerances Sierra Club v. EPA 18cv3472 NDCA A- 5 Tier 5 ED 002061 00159918-00009