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<p> December 17, 2014 Hon. Joseph Martens Commissioner New York State Department of Environmental Conservation 625 Broadway Albany, NY 12207 Dear Commissioner Martens: In September 2012, you asked Dr. Shah, then Commissioner of Health, to initiate a Public Health Review of the Department of Environmental Conservation’s draft Supplemental Generic Environmental Impact Statement for High Volume Hydraulic Fracturing (HVHF). I assumed responsibility for this review when Dr. Shah left. It became clear during this assessment that DOH’s Public Health Review needed to extend beyond the scope of the initial request to consider, more broadly, the current state of science regarding HVHF and public health risks. This required an evaluation of the emerging scientific information on environmental public health and community health effects. This also required an analysis of whether such information was sufficient to determine the extent of potential public health impacts of HVHF activities in New York State (NYS) and whether existing mitigation measures implemented in other states are effectively reducing the risk for adverse public health impacts. As with most complex human activities in modern societies, absolute scientific certainty regarding the relative contributions of positive and negative impacts of HVHF on public health is unlikely to ever be attained. In this instance, however, the overall weight of the evidence from the cumulative body of information contained in this Public Health Review demonstrates that there are significant uncertainties about the kinds of adverse health outcomes that may be associated with HVHF, the likelihood of the occurrence of adverse health outcomes, and the effectiveness of some of the mitigation measures in reducing or preventing environmental impacts which could adversely affect public health. Until the science provides sufficient information to determine the level of risk to public health from HVHF to all New Yorkers and whether the risks can be adequately managed, DOH recommends that HVHF should not proceed in NYS. I appreciate the opportunity to conduct this Public Health Review. It furthers the long history of close collaboration between the two Departments carrying out our shared responsibility to protect human health and the environment. Sincerely, Howard A. Zucker, M.D., J.D. Acting Commissoner of Health 2/13/2015 Errata A Public Health Review of High Volume Hydraulic Fracturing for Shale Gas Development It has come to the attention of the Department of Health (DOH) that the Public Health Review document posted on the DOH web site on December 17, 2014 contained two errors requiring correction: 1. The following text (enclosed in ‘ ‘) was inadvertently omitted from the beginning of page 41 and has been added back to the document to complete the sentence started at the end of page 40: [ODNR] ‘says that it will develop new criteria and permit conditions for new applications in light of this change in policy. The department will also review previously issued permits for wells that have not been drilled.’ As a consequence of the omission, the formatting of the next section heading, beginning on page 41, was also incorrect and has been corrected: Conclusions – Health and Environmental Literature 2. Endnote 4 listed on page 89 referred to a web link that had been removed from the document before it was finalized. That endnote was deleted, and all subsequent endnotes were renumbered accordingly (i.e., original-endnote 5 became new-endnote 4, etc.). In addition, a number of minor typographical errors have been corrected in the amended version of the document. These include the following changes: 1. deletion of an additional blank space character following periods: pages 21, 25, 48, and 56; 2. addition of a missing blank space character: pages 23, 25, 32, and 36; 3. addition of a missing period character: pages 21 and 29; 4. correction of acronyms for US EPA and US DOL: pages 5, 7, 35, 36, 104 and, 105; 5. correction of the date from 2012 to 2014 for reference to an IOM report: page 43; and 6. correction of the date of the reference to an US EPA document and addition of a missing closing parenthesis in endnote 4 (originally numbered 5): page 89. None of these corrections to the Public Health Review document result in any substantive change to the meaning of the document or the document’s conclusions. Table of Contents | Executive Summary ..........................................................................................1 Scope of the Public Health Review ....................................................................2 Public Health Review Process ...........................................................................3 Major Findings ...................................................................................................4 Air Impacts .....................................................................................................5 Water-quality Impacts ....................................................................................5 Seismic Impacts .............................................................................................6 Community Impacts .......................................................................................6 Health Outcomes near HVHF Activity ............................................................7 Substantial Gaps Remain ..............................................................................8 Conclusions ..................................................................................................... 11 | Background ..................................................................................................... 13 Scope of the Review ........................................................................................ 15 Public Health Review Process ......................................................................... 15 | Results Evaluation of Scientific Literature Relevant to the Objectives of the Public Health Review ............................................................................. 17 HVHF Health Outcome Studies ....................................................................... 18 Birth Outcomes ............................................................................................ 19 Case Series and Symptom Reports ............................................................. 22 Local Community Impacts ............................................................................ 24 Cancer Incidence ......................................................................................... 25 Non-peer-reviewed Information .................................................................... 26 HVHF Environmental Studies .......................................................................... 26 Air Quality Impacts ....................................................................................... 26 Water Quality Impacts .................................................................................. 35 Induced Earthquakes ................................................................................... 39 Conclusions – Health and Environmental Literature ........................................ 41 | Results Information Gathered from Outside Authoritative Organizations, Public Health Experts, and Formal Health Impact Assessments .................. 42 Health Impact Assessments ............................................................................ 42 Meetings with Other State Agencies ................................................................ 49 California ...................................................................................................... 50 Texas ........................................................................................................... 51 Illinois ........................................................................................................... 53 Public Health Expert Consultation ................................................................... 55 | Overall Conclusions ........................................................................................ 85 | Endnotes .......................................................................................................... 89 | References ....................................................................................................... 92 | Appendix 1 ..................................................................................................... 109 Supplemental Literature Considered for the Public Health Review ............... 109 | Appendix 2 Radon Screening Analysis ..................................................... 172 Radon from Natural Gas ............................................................................ 173 1 | Executive Summary The New York State Department of Health (DOH) is charged with protecting the public health of New Yorkers. In assessing whether public health would be adequately protected from a complex activity such as high volume hydraulic fracturing (HVHF), a guarantee of absolute safety is not required. However, at a minimum, there must be sufficient information to understand what the likely public health risks will be. Currently, that information is insufficient. In 2012, the New York State Department of Environmental Conservation (DEC) requested that DOH review and assess DEC’s analysis of potential health impacts contained in DEC’s draft supplemental generic environmental impact statement (SGEIS) for HVHF. In response to the original request from DEC, DOH initiated an HVHF Public Health Review process. In conducting this public health review DOH: (i) reviewed and evaluated scientific literature to determine whether the current scientific research is sufficient to inform questions regarding public health impacts of HVHF; (ii) sought input from three outside public health expert consultants; (iii) engaged in field visits and discussions with health and environmental authorities in states with HVHF activity; and (iv) communicated with multiple local, state, federal, international, academic, environmental, and public health stakeholders. The evaluation considered the available information on potential pathways that connect HVHF activities and environmental impacts to human exposure and the risk for adverse public health impacts. Based on this review, it is apparent that the science surrounding HVHF activity is limited, only just beginning to emerge, and largely suggests only hypotheses about potential public health impacts that need further evaluation. That is, many of the 2 published reports investigating both environmental impacts that could result in human exposures and health implications of HVHF activities are preliminary or exploratory in nature. However, the existing studies also raise substantial questions about whether the risks of HVHF activities are sufficiently understood so that they can be adequately managed. Furthermore, the public health impacts from HVHF activities could be significantly broader than just those geographic locations where the activity actually occurs, thus expanding the potential risk to a large population of New Yorkers. As with most complex human activities in modern societies, absolute scientific certainty regarding the relative contributions of positive and negative impacts of HVHF on public health is unlikely to ever be attained. In this instance, however, the overall weight of the evidence from the cumulative body of information contained in this Public Health Review demonstrates that there are significant uncertainties about the kinds of adverse health outcomes that may be associated with HVHF, the likelihood of the occurrence of adverse health outcomes, and the effectiveness of some of the mitigation measures in reducing or preventing environmental impacts which could adversely affect public health. Until the science provides sufficient information to determine the level of risk to public health from HVHF to all New Yorkers and whether the risks can be adequately managed, DOH recommends that HVHF should not proceed in New York State. Scope of the Public Health Review DOH evaluated whether the available scientific and technical information provides an adequate basis to understand the likelihood and magnitude of risks for adverse public health impacts from HVHF activities in New York State. DOH reviewed how HVHF activities could result in human exposure to: (i) contaminants in air or water; (ii) naturally occurring radiological materials that result from HVHF activities; and (iii) the effects of 3 HVHF operations such as truck traffic, noise, and social changes on communities. DOH also reviewed whether those exposures may result in adverse public health outcomes. Public Health Review Process The initial component of the Public Health Review focused on understanding how public health concerns were addressed in the draft SGEIS. Three nationally recognized experts participated as consultants to the initial phase of the review process. The expert consultants reviewed elements of the draft SGEIS and documentation developed by DOH, and provided extensive input through multiple rounds of communication. As a result of this input, as well as broader consideration, it became clear that DOH’s Public Health Review needed to extend beyond this initial assessment to consider, more broadly, the current state of science regarding HVHF and public health risks. This required an evaluation of the emerging scientific information on environmental public health and community health effects. This also required an analysis of whether such information was sufficient to determine the extent of potential public health impact of HVHF activities in NYS and whether existing mitigation measures implemented in other states are effectively reducing the risk for adverse public health impacts. In addition to evaluating published scientific literature, former Commissioner Shah, Acting Commissioner Zucker, and DOH staff consulted with state public health and environmental authorities to understand their experience with HVHF. Former Commissioner Shah, Acting Commissioner Zucker, and DOH staff also engaged in a number of discussions and meetings with researchers from academic institutions and government agencies to learn more about planned and ongoing studies and assessments of the public health implications of HVHF. In total, more than 20 DOH 4 senior Research Scientists, Public Health Specialists, and Radiological Health Specialists spent approximately 4500 hours on this Review. Major Findings Summarized below are some of the environmental impacts and health outcomes potentially associated with HVHF activities: • Air impacts that could affect respiratory health due to increased levels of particulate matter, diesel exhaust, or volatile organic chemicals. • Climate change impacts due to methane and other volatile organic chemical releases to the atmosphere. • Drinking water impacts from underground migration of methane and/or fracking chemicals associated with faulty well construction. • Surface spills potentially resulting in soil and water contamination. • Surface-water contamination resulting from inadequate wastewater treatment. • Earthquakes induced during fracturing. • Community impacts associated with boom-town economic effects such as increased vehicle traffic, road damage, noise, odor complaints, increased demand for housing and medical care, and stress. Additionally, an evaluation of the studies reveals critical information gaps. These need to be filled to more fully understand the connections between risk factors, such as air and water pollution, and public health outcomes among populations living in proximity to HVHF shale gas operations (Penning, 2014; Shonkoff, 2014; Werner, 2015). 5 Some of the most significant environmental and health-outcome studies are briefly summarized here. Air Impacts Studies provide evidence of uncontrolled methane leakage, emissions of other volatile organic chemicals, and particulate matter from well pads and natural-gas infrastructure. State authorities in both Texas and Pennsylvania have documented methane leakage from natural gas infrastructure by the use of infrared cameras. A recent West Virginia study also determined that heavy vehicle traffic and trucks idling at well pads were the likely sources of intermittently high dust and benzene concentrations, sometimes observed at distances of at least 625 feet from the center of the well pad (McCawley, 2012, 2013; WVDEP, 2013). These emissions have the potential to contribute to community odor problems, respiratory health impacts such as asthma exacerbations, and longer-term climate change impacts from methane accumulation in the atmosphere (Allen, 2013; Bunch, 2014; CDPHE, 2010; Macey, 2014; Miller, 2013; Petron, 2012; Weisel, 2010). Water-quality Impacts Studies have found evidence for underground migration of methane associated with faulty well construction (Darrah, 2014; US EPA, 2011). For example, a recent study identified groundwater contamination clusters that the authors determined were due to gas leakage from intermediate-depth strata through failures of annulus cement, faulty production casings, and underground gas well failure (Darrah, 2014). Shallow methane- migration has the potential to impact private drinking water wells, creating safety concerns due to explosions. 6 Other studies suggest additional sources of potential water contamination, including surface spills and inadequate treatment and disposal of radioactive wastes (Warner, 2013). A recent review paper presented published data revealing evidence for stray gas contamination, surface water impacts, and the accumulation of radium isotopes in some disposal and spill sites (Vengosh, 2014). One recent study also suggests that chemical signals of brine from deep shale formations can potentially be detected in overlying groundwater aquifers (Warner, 2012). These contaminants have the potential to affect drinking water quality. Seismic Impacts Recent evidence from studies in Ohio and Oklahoma suggest that HVHF can contribute to the induction of earthquakes during fracturing (Holland, 2014; Maxwell, 2013). Although the potential public health consequence of these relatively mild earthquakes is unknown, this evidence raises new concerns about this potential HVHF impact. Community Impacts There are numerous historical examples of the negative impact of rapid and concentrated increases in extractive resource development (e.g., energy, precious metals) resulting in indirect community impacts such as interference with quality-of-life (e.g., noise, odors), overburdened transportation and health infrastructure, and disproportionate increases in social problems, particularly in small isolated rural communities where local governments and infrastructure tend to be unprepared for rapid changes (Headwaters, 2013). Similar concerns have been raised in some communities where HVHF activity has increased rapidly (Stedman, 2012; Texas DSHS, 2010; Witter, 2010; WVDEP, 2013). 7 A recent study from Pennsylvania also reports that automobile and truck accident rates in 2010–2012 from counties with heavy HVHF activity were between 15% and 65% higher than accident rates in counties without HVHF. Rates of traffic fatalities and major injuries were higher in 2012 in heavy drilling counties in southwestern Pennsylvania compared to non-drilling counties (Graham, 2015). Health Outcomes near HVHF Activity Although well-designed, long-term health studies assessing the effect of HVHF activity on health outcomes have not been completed, there is published health literature that examines health outcomes in relation to residential proximity to HVHF well pads. One peer-reviewed study and one university report have presented data indicating statistical associations between some birth outcomes (low birth weight and some congenital defects) and residential proximity of the mother to well pads during pregnancy (Hill, 2012; McKenzie, 2014). Proximity to higher-density HVHF well pad development was associated with increased incidence of congenital heart defects and neural-tube defects in one of the studies (McKenzie, 2014). Several published reports present data from surveys of health complaints among residents living near HVHF activities. Commonly reported symptoms include skin rash or irritation, nausea or vomiting, abdominal pain, breathing difficulties or cough, nosebleeds, anxiety/stress, headache, dizziness, eye irritation, and throat irritation in people and farm animals within proximity to HVHF natural gas development (Bamberger, 2012; Finkel, 2013; Steinzor, 2012). Federal investigators have also reported that sub-standard work practices and deficient operational controls at well pads contributed to elevated crystalline silica exposures among workers during HVHF operations (US DOL, 2012). While this report focused on worker exposures, it highlights 8 a possible exposure concern for residents living close to HVHF operations if silica emissions from onsite operations are not properly controlled. Substantial Gaps Remain Systematic investigations studying the effects of HVHF activity on groundwater resources, local-community air quality, radon exposure, noise exposure, wastewater treatment, induced seismicity, traffic, psychosocial stress, and injuries would help reduce scientific uncertainties. While some of the on-going or proposed major study initiatives may help close those existing data gaps, each of these alone would not adequately address the array of complex concerns related to HVHF activities. For example: Marcellus Shale Initiative Study Geisinger Health System, the lead organization in the collaborative Marcellus Shale Initiative, cares for many patients in areas where shale gas is being developed in Pennsylvania. They began pilot studies in 2013 using well and infrastructure data to estimate exposures to all aspects of Marcellus shale development in Pennsylvania. According to the National Institutes of Health (NIH) abstract, they will use these exposure estimates to evaluate whether asthma control and pregnancy outcomes are affected by Marcellus shale development by studying 30,000 asthma patients and 22,000 pregnancies in the Geisinger Health System from 2006-13. Results from this study are not expected to be available for several years. 9 University of Colorado at Boulder, Sustainability Research Network A five-year cooperative agreement funded by the National Science Foundation (NSF) under NSF’s Sustainability Research Network competition, this program involves a multidisciplinary team of investigators and is intended to address: “the conflict between natural gas extraction and water and air resources protection with the development of a social-ecological system framework with which to assess the conflict and to identify needs for scientific information. Scientific investigations will be conducted to assess and mitigate the problems. Outreach and education efforts will focus on citizen science, public involvement, and awareness of the science and policy issues” (Univ. Colorado, 2012; Shonkoff, 2014). Published research has been produced from this program investigating associations between HVHF activity and birth outcomes and potential for methane leakage from natural gas infrastructure. The cooperative agreement extends to 2017. EPA's Study of Hydraulic Fracturing and Its Potential Impact on Drinking Water Resources Begun in 2011, the purpose of the study is to assess the potential impacts of hydraulic fracturing on drinking water resources, if any, and to identify the driving factors that may affect the severity and frequency of such impacts. The research approach includes: analyses of existing data, scenario evaluations, laboratory studies, toxicity studies, and case studies. US EPA released a progress report on December 21, 2012 and stated that preliminary results of the study are expected to be released as a draft for public and 10 peer review as soon as the end of 2014, although the full study is not expected to be completed before 2016. Pennsylvania Department of Environmental Protection (PA DEP) Comprehensive Oil and Gas Development Radiation Study Started in early 2013, PA DEP is analyzing the radioactivity levels in produced and flowback waters, wastewater recycling, treatment sludges, and drill cuttings, as well as issues with transportation, storage, and disposal of drilling wastes, the levels of radon in natural gas, and potential exposures to workers and the public. According to a July 2014 update from the PA DEP, publication of a report could occur as soon as the end of 2014. University of Pennsylvania Study A proposed study of HVHF health impacts was announced several months ago. The study is led by researchers from the University of Pennsylvania in collaboration with scientists from Columbia University, Johns Hopkins University, and the University of North Carolina. Pennsylvania Department of Environmental Protection Recently proposed community air monitoring will determine concentrations of fine and coarse (silica-sized) particles near a transfer facility that handles hydraulic fracturing silica sand. These major study initiatives may eventually reduce uncertainties regarding health impacts of HVHF and could contribute to a much more complete knowledge base for 11 managing HVHF risks. However, it will be years before most of these major initiatives are completed. Other governmental and research institutes have also recently conducted health impact assessments of HVHF (Institute of Medicine, 2014). These include: the European Commission; University of Michigan, Graham Sustainability Institute; Research Triangle Environmental Health Collaborative; Nova Scotia Independent Panel on Hydraulic Fracturing; Inter-Environmental Health Sciences Core Center Working Group on Unconventional Natural Gas Drilling Operations funded by the National Institute of Environmental Health Sciences; and the Maryland Institute for Applied Environmental Health, School of Public Health, University of Maryland. While these assessments identify many of the same potential environmental impacts mentioned above, more importantly, they reiterate that significant gaps exist in the knowledge of potential public health impacts from HVHF and of the effectiveness of some mitigation measures. Conclusions HVHF is a complex activity that could affect many communities in New York State. The number of well pads and associated HVHF activities could be vast and spread out over wide geographic areas where environmental conditions and populations vary. The dispersed nature of the activity magnifies the possibility of process and equipment failures, leading to the potential for cumulative risks for exposures and associated adverse health outcomes. Additionally, the relationships between HVHF environmental impacts and public health are complex and not fully understood. Comprehensive, long- term studies, and in particular longitudinal studies, that could contribute to the understanding of those relationships are either not yet completed or have yet to be initiated. In this instance, however, the overall weight of the evidence from the 12 cumulative body of information contained in this Public Health Review demonstrates that there are significant uncertainties about the kinds of adverse health outcomes that may be associated with HVHF, the likelihood of the occurrence of adverse health outcomes, and the effectiveness of some of the mitigation measures in reducing or preventing environmental impacts which could adversely affect public health. While a guarantee of absolute safety is not possible, an assessment of the risk to public health must be supported by adequate scientific information to determine with confidence that the overall risk is sufficiently low to justify proceeding with HVHF in New York. The current scientific information is insufficient. Furthermore, it is clear from the existing literature and experience that HVHF activity has resulted in environmental impacts that are potentially adverse to public health. Until the science provides sufficient information to determine the level of risk to public health from HVHF and whether the risks can be adequately managed, HVHF should not proceed in New York State. 13 | Background In 1992, the NYS Department of Environmental Conservation (DEC) finalized the Generic Environmental Impact Statement (1992 GEIS) on the Oil, Gas and Solution Mining Regulatory Program.1,2 Conventional natural gas development in NYS – including the use of low-volume hydraulic fracturing – has been permitted by DEC under the GEIS since that time. High-volume hydraulic fracturing (HVHF), which is often used in conjunction with horizontal drilling and multi-well pad development, is an approach to extracting natural gas that raises new, potentially significant, adverse impacts that were not studied in the 1992 GEIS. Therefore, in 2008 DEC began the process of developing a supplement to the GEIS (hereafter the draft SGEIS) specifically addressing natural gas development using HVHF and directional drilling in unconventional formations such as the Marcellus and Utica Shales (collectively referred to here as HVHF shale-gas development). In 2012, DEC requested that the New York State Department of Health (DOH) review and assess DEC’s analysis of potential health impacts contained in DEC’s draft supplemental generic environmental impact statement (draft SGEIS3) for HVHF. In response to the original request from DEC, DOH initiated an HVHF Public Health Review process. DOH has a long history of working closely with DEC on all DEC programs that have public health components. DOH has extensive expertise in environmental health, including protecting drinking water supplies, environmental radiation protection, toxicology, environmental exposure assessment, occupational health, and environmental epidemiology. DOH also collects, manages, and analyzes extensive public health surveillance data for all of New York State. 14 DOH is charged with defending the public health of New Yorkers. In order to meet this charge with respect to HVHF, DOH reviewed and evaluated relevant emerging scientific literature that investigated the environmental health and community health dimensions of HVHF. The literature was assessed in terms of the adequacy of the current science to inform questions regarding public health impacts of HVHF. As part of this review, DOH also sought input from three outside public health expert consultants, engaged in discussions and field visits with health and environmental authorities in states with HVHF activity, and held numerous meetings with local, state, federal, international, academic, environmental, and public health stakeholders. The evaluation considered the available information on all potential pathways that connect HVHF activities and environmental impacts to human exposure and the risk for adverse public health impacts. HVHF shale-gas development is a large-scale, complex issue that potentially could affect a significant portion of New York State. In order to make an informed assessment of the potential public health consequences of HVHF in New York, the totality of available information from relevant sources has to be evaluated collectively. A single study or isolated piece of information will not provide a complete public health picture for such a complex activity. In assessing whether public health would be adequately protected when allowing a complex activity such as HVHF to go forward, a guarantee of absolute safety is not required, but there must be sufficient information to understand what the likely public health risks will be. Ultimately, in conducting this Public Health Review, DOH evaluated the relevant lines of available evidence collectively, and made a judgment on whether the scientific information was adequate to determine the level of public health risk. 15 Scope of the Review DOH evaluated whether the available scientific and technical information provides an adequate basis to understand the likelihood and magnitude of risks for adverse public health impacts from HVHF activities in New York State. The evaluation reviewed how HVHF activities could result in human exposure to: (i) contaminants in air or water; (ii) naturally occurring radioactive materials that result from HVHF activities; and (iii) the effects of HVHF operations such as truck traffic, noise, and social changes on communities. The evaluation also reviewed whether those exposures may result in adverse public health outcomes. Public Health Review Process The initial component of the Public Health Review focused on understanding how public health concerns were addressed in the draft SGEIS. Three nationally recognized experts also participated as consultants to the initial phase of the review process. The expert consultants reviewed elements of the draft SGEIS and documentation developed by DOH, and provided extensive input through multiple rounds of communication. As a result of this input, as well as broader consideration, it became clear that DOH’s Public Health Review needed to extend beyond this initial assessment to consider, more broadly, the current state of science regarding HVHF and public health risks. This required an evaluation of the emerging scientific information on environmental public health and community health effects. This also required an analysis of whether such information was sufficient to determine the extent of potential public health impact of HVHF activities in NYS and whether existing mitigation measures implemented in other states are effectively reducing the risk for adverse public health impacts. 16 One major component of the Public Health Review was an objective evaluation of the emerging scientific information on environmental impacts and public health effects of HVHF activity. Scientific studies reporting relationships between HVHF and public health outcomes were the main focus of this evaluation, but relevant literature that was only focused on HVHF and effects on environmental media was also reviewed. Additional literature was reviewed and considered supplemental to the main Public Health Review (see Appendix 1). More than 20 DOH senior Research Scientists, Public Health Specialists, and Radiological Health Specialists contributed to the review under the direction of former Commissioner Shah and Acting Commissioner Zucker. The entire Public Health Review process involved more than 4500 hours of combined effort. In addition to evaluating published scientific literature, former Commissioner Shah, Acting Commissioner Zucker, and DOH staff held multiple discussions and meetings with public health and environmental authorities in several states to understand their experience with HVHF. Former Commissioner Shah, Acting Commissioner Zucker, and DOH staff, also engaged in a number of discussions and meetings with researchers from academic institutions and government agencies to learn more about planned and ongoing studies and assessments of the public health implications of HVHF. 17 | Results Evaluation of Scientific Literature Relevant to the Objectives of the Public Health Review In order to evaluate the analysis of health impacts in the draft SGEIS in a broader environmental and public health context, DOH reviewed and evaluated relevant emerging scientific literature investigating the environmental health and community health dimensions of HVHF. This was not intended to be a comprehensive review of all the published scientific literature on HVHF. Rather, the emerging literature was surveyed, and studies with direct environmental health relevance were reviewed to better understand the adequacy of the current science to inform questions regarding public health impacts of HVHF. Two major types of peer-reviewed scientific studies were the focus of the literature review process – studies of impacts to environmental media and studies of health outcomes. As is very often true in environmental health science, both types of studies have limitations that make it difficult to draw firm conclusions about environmental causation of disease from any one study or small group of studies. Strong conclusions about disease causation in environmental health derive from a collective assessment of the weight of evidence from a large body of research that often takes many years to conduct.4 Studies of environmental impacts investigate the effects of HVHF activities on environmental media such as air, water and soil. Contamination of environmental media 18 has the potential to contribute to human health impacts if people experience exposures to those contaminants (for example, through breathing contaminated air or drinking contaminated water) that are large enough to cause a biological effect. However, studies of environmental impacts often do not attempt to directly demonstrate whether contamination of environmental media has resulted in significant human exposure or whether a health effect occurs as a result of an exposure. Other studies report on observed human health outcomes potentially associated with HVHF activity (i.e., environmental epidemiology studies). Health outcome studies related to HVHF activity focus on health effects reported among people living near HVHF drilling sites. Most health outcome studies can only suggest a potential statistical relationship between a source of environmental contamination and the observed health outcomes. These studies are limited in their ability to demonstrate that an actual exposure to the source has occurred or that exposure to an environmental source causes a health outcome. Health outcome studies vary in the complexity of their design and how rapidly they can be carried out. Some health outcome study designs that are relatively simple and quick to conduct are often also limited in their ability to account for other unrelated factors (usually referred to as bias and confounding) that might contribute to the observed health effects. Longitudinal prospective cohort studies are among the strongest study designs, but are very expensive and take years to conduct. HVHF Health Outcome Studies The public health science surrounding HVHF shale-gas development is currently limited and studies are largely exploratory in nature. Peer-reviewed epidemiologic studies were not found that employ robust study designs addressing possible associations between HVHF activities and adverse health outcomes while providing adequate control for confounding and bias. Scientific studies that contain relevant information investigating 19 human health outcomes potentially associated with HVHF activities are briefly summarized below. Birth Outcomes An unpublished 2013 revision to a 2012 working paper by Hill reports results of a study using data on 2,459 natural gas wells completed in Pennsylvania between 2006 and 2010, along with vital records for the years 2003 through 2010. The study compared birth outcomes for infants born to mothers living within selected fixed distances from spudded Marcellus Shale wells (the "existing well” infant group) with outcomes for infants born to mothers living within the same distances from future wells (the “future well” infant group). The outcomes considered were birth weight, gestation, five-minute APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score (a health indicator assessed immediately following birth), small-for-gestational-age (yes/no), premature (yes/no), congenital anomalies (yes/no) and infant death (yes/no). The investigator reported that after specifying a fixed distance of 2.5 km from an existing or future well, and after controlling for multiple risk factors (e.g., maternal age, race, education, WIC status, marital status, insurance status and smoking), the “existing well” infant group had statistically significantly lower averages for birth weight and 5-minute APGAR score, as well as statistically significantly higher prevalence of low birth weight and small-for-gestational age, compared with the “future wells” infant group. No statistically significant differences were observed for prematurity, congenital anomalies or infant death. Hill’s conclusion that a “causal” relationship between natural gas development and birth outcomes was established may overstate the findings of this single study. The statistical approach used by the investigator, the differences-in-differences method, had in the past been employed primarily by social scientists but is increasingly used in public health studies. In the context of this study, this statistical approach assumed that, in the 20 absence of drilling, average outcomes for the “existing wells” and “future wells” infant groups would have followed parallel paths over time. Because differences may have existed between the two study groups with regard to potential risk factors not incorporated into the statistical analyses (e.g., prenatal care adequacy, maternal lifestyles, pre-existing chronic diseases, perinatal complications) it is possible that this "parallel paths" assumption may not have been appropriate. However, the author was able to demonstrate that, at least with regard to measured characteristics, there were no indications that this key assumption was not met. A similar study by McKenzie et al. (2014) evaluated potential associations between maternal residence near natural gas wells and birth outcomes in a retrospective cohort study of 124,842 births between 1996 and 2009 in rural Colorado. Specifically, the authors investigated associations between natural gas well density and prevalence of congenital heart defects, neural tube defects, oral clefts, preterm birth, and term low birth weight. The least exposed (reference) group had no natural gas wells within a 10- mile radius. After adjustments for maternal and infant covariates, prevalence of congenital heart defects was significantly positively associated with increased exposure to natural gas development, with an increase of 30% (95% CI: 20% to 50%) for the highest exposure tertile when compared with the reference group. Prevalence of neural tube defects was significantly positively associated with exposure to natural gas development for the highest tertile of exposure, with an increase of 100% (95% CI: 0 to 390%) for the most exposed group when compared with the reference group. Exposure was associated with lower odds of preterm birth and lower odds of low birth weight (i.e., the high exposure groups were less likely to be preterm or low birth weight). No association was found between exposure and oral clefts. 21 It is notable that these two birth-outcome studies used similar study designs and observed associations between birth-outcome measures and maternal proximity to HVHF well pads. However, there is a lack of coherence between the observed associations in the two studies. Hill reported associations with low birth weight and APGAR score, but no associations with congenital defects. Conversely, McKenzie et al. reported associations between proximity to well pads and some congenital defects, but the highest exposure group had lower odds of preterm birth or low birth weight than the reference group. Taken together, the relationship between maternal proximity to HVHF well pads during pregnancy and birth outcomes, if any, is unclear. Both birth-outcome studies used proximity to a drilling site as an exposure surrogate, rather than actual environmental contaminant measurements. This was a reasonable approach for an initial exploratory investigation, as it would be difficult and expensive to characterize indoor and outdoor exposures to all potentially relevant environmental agents (e.g., noise, air pollutants, groundwater pollutants, nighttime lighting) at numerous homes and workplaces. However, studies that employ vicinity as a surrogate for exposure cannot identify specific risk factors associated with the observed adverse outcomes or establish how, if at all, these risk factors were related to HVHF. For example, these studies cannot exclude the possibility that another factor unrelated to HVHF also varied by residence proximity to drill pads and contributed to the observed pattern of birth outcomes. The lack of coherent associations between this exposure surrogate and comparable outcomes may reflect weaknesses in the use of this exposure surrogate. The authors noted that greater specificity in exposure estimates would be required to further explore the reported associations. 22 Case Series and Symptom Reports Bamberger and Oswald published a study in 2012, which documents case reports of animal and human health effects potentially resulting from nearby natural gas drilling operations. The summary of reported human health effects lacks specificity, but mentions a variety of symptoms such as upper respiratory, burning eyes, headache, gastrointestinal, dermatological, and neurological. The authors acknowledge the lack of complete testing of water, air, soil, and animal tissues that hampered more thorough analysis of the connection between gas drilling and health. They suggest further investigation is needed, ideally with policy changes that could assist in the collection of more complete data sets. Bamberger and Oswald were also guest editors for a 2013 special issue on shale gas development in the same journal (New Solutions). The articles in that special issue largely expand on potential health concerns raised in the original Bamberger and Oswald paper, although Bamberger and Oswald (2013) note in their introduction to the special issue that firm conclusions about potential health concerns cannot be established given the lack of relevant data. Findings from an investigation done by the Earthworks’ Oil & Gas Accountability Project were published in a non-peer-reviewed report (Steinzor, 2012). The report summarizes the extent and types of health symptoms experienced by 108 people from 55 households from 14 Pennsylvania counties where HVHF is occurring. It also has results of air sampling near 34 of the households and water sampling from nine of the households. It is difficult to interpret the results of this assessment. Participants report experiencing a number of symptoms, and the results suggest that those living closer than ~½ mile from a gas drilling facility may report symptoms in larger proportions than those living farther than ~½ mile. However, the sample is self-selected, and there was no systematic assessment of baseline health status or comparison with a similar population (the report does mention a five person control group that tended to 23 experience fewer symptoms) unaffected by HVHF. The results also do not adequately account for potential confounders (except smoking). An unpublished presentation of findings from the Southwest Pennsylvania Environmental Health Project (SWPA-EHP) was made available on the organization’s web site. A formal report of these findings was not available; the findings are summarized in a slide presentation.5 Self-reported symptoms were summarized for patients from one county in southwestern Pennsylvania who sought medical care at the SWPA-EHP clinic. Self-reported symptom categories occurring in 21 – 48 percent of individuals seeking medical care included: skin rash or irritation, nausea or vomiting, abdominal pain, breathing difficulties or cough, and nosebleeds. Other complaints mentioned in the presentation include anxiety/stress, headache, dizziness, eye irritation, and throat irritation. The presentation attributes up to 27 cases6 of symptom complaints as plausibly associated with a source of exposure in either air or water. However, there is no environmental exposure assessment presented in support of the claimed associations. No air or water monitoring data are presented. The symptoms reported are common in the general population and can have many causes. As with the Earthworks analysis, the sample is self-selected, and there was no systematic assessment of baseline health status or comparison with a similar non-HVHF population. There is no information presented indicating that the analysis attempted to account for potential confounders or other existing exposure sources. Rabinowitz et al. (2014) conducted a preliminary (hypothesis-generating) study in the same county in southwestern Pennsylvania as the SWPA-EHP report described above. The study found some evidence that residential proximity of natural gas wells may be associated with the prevalence of certain health symptoms, largely acute or self-limiting dermal and upper-respiratory conditions. As the authors noted, follow-up investigations 24 would be required before drawing any conclusions with regard to actual disease incidence or possible causal relationships. Results from a series of patient evaluations or symptom reports as presented above can only be considered hypothesis generating; that is, they can suggest possible relationships between an environmental exposure and health effects that could be investigated systematically in epidemiology studies designed to control for bias, confounding, temporality and chance findings. These types of clinical reports do not allow conclusions to be drawn about causal associations between HVHF exposures and health risks. However, while many of the reported symptoms are common in the general population, these reports indicate current information is not adequate to exclude the possibility that HVHF is contributing to public health impacts. Local Community Impacts There is a broad agreement in the public health community that social factors such as income, education, housing, and access to health care influence health status (i.e., so- called social determinants of health).7 Many historical examples exist of rapid and concentrated increases in extractive resource development (e.g., energy, precious metals) resulting in local community impacts such as interfering with quality-of-life (e.g., noise, odors), overburdened transportation and health infrastructure, and disproportionate increases in social problems, particularly in small isolated rural communities where local governments and infrastructure tend to be unprepared for rapid changes.8 These impacts could indirectly result in increased stress, which, in turn, can be associated with increased prevalence of some health problems (for example, WHO, 2009). Similar concerns have been raised in some communities where HVHF activity has increased rapidly (Texas DSHS, 2010). 25 For example, in some areas of HVHF well pad development nearly all water used for hydraulic fracturing is hauled to the pad by truck. One horizontal well is estimated to require about 1500 to 2000 truck trips over the entire life of the well (NTC Consultants, 2011). A recent study from Pennsylvania reports that automobile and truck accident rates in 2010 - 2012 from counties with heavy HVHF activity were between 15% and 65% higher than accident rates in counties without HVHF. Rates of traffic fatalities and major injuries were higher in heavy drilling counties in southwestern Pennsylvania compared to non-drilling counties in 2012 (Graham, 2015). Major potential adverse impacts from increased truck traffic include increased traffic congestion and accidents; more damage to roads, bridges and other infrastructure; and spills of hazardous materials during transportation.9 Cancer Incidence Fryzek et al. (2013) conducted a retrospective assessment of the potential for an association between childhood cancer incidence and HVHF in Pennsylvania, and reported no increase in childhood cancers after HVHF commenced. Study limitations included the insensitivity of the methods employed, the rarity of childhood cancers, and the absence of adequate lag time between most HVHF activities and most of the study’s childhood cancer diagnoses. These raise some uncertainty about the strength of the study conclusions. 26 Non-peer-reviewed Information In addition to investigating information in the peer-reviewed scientific literature, DOH has maintained an ongoing effort to follow news reports and other non-peer-reviewed sources for emerging information related to HVHF and potential public health impacts.10 Many findings reported through such non-peer-reviewed sources are from informal or anecdotal health evaluations that have significant limitations such as self-selected symptoms reports, non-specific symptoms, lack of exposure data, lack of baseline health information, lack of unexposed comparison groups, and lack of controls for bias and confounding. Reports of this sort cannot be used to draw conclusions about associations between reported health symptoms or complaints and any specific potential environmental exposure source such as HVHF shale-gas development. However, these types of reports suggest hypotheses for associations between health outcomes and shale-gas activities that could be tested with proper environmental epidemiology methods. HVHF Environmental Studies Studies investigating HVHF impacts on environmental media such as air or water were included in the review if they provided information about the potential for human exposures from HVHF activity. Air Quality Impacts Maintaining good air quality is obviously vital for promoting public health; poor air quality can affect large populations of people, and therefore can contribute to significant morbidity and mortality. DOH programs promote clean outdoor air quality by developing health comparison values for use by DEC and by investigating and helping to correct conditions that contribute to poor indoor air quality. NYS was the first state in the 27 country to establish indoor smoking prohibitions in public spaces under the NYS Clean Indoor Air Act. The National Institute for Occupational Safety and Health (NIOSH) has assessed potential risks to workers associated with chemical exposure at natural gas drilling sites (NIOSH, 2012). In field studies conducted at 11 sites, respirable crystalline silica and diesel particulates were measured at levels with the potential to pose health hazards. NIOSH has proposed several controls and recommended proper use of personal protective equipment to minimize exposures. NIOSH has also reported that the occupational fatality rate among oil and gas industry workers is seven times higher than the average rate for all US industries (Retzer, 2011). On August 23, 2013, the federal Occupational Safety and Health Administration (OSHA) announced that it intended to propose a revised standard (called a permissible exposure limit) to protect workers from exposure to respirable crystalline silica.11 OSHA's Notice of Proposed Rulemaking for Occupational Exposure to Respirable Crystalline Silica was published in the Federal Register on September 12, 2013.12 If enacted, the new regulation would reduce the permissible exposure limit for crystalline silica and would establish certain other requirements related to measuring levels of silica in workplace air, controlling dust, providing respiratory protection, training of workers, and offering medical exams. While the NIOSH assessment focused on worksite air quality, this report is suggestive that uncontrolled silica emissions could affect the air quality of residences or businesses near well pads. In 2010, the Texas Department of State Health Services collected blood and urine samples from 28 people, living in and near the town of Dish, to determine whether people there had higher levels of volatile organic compounds (VOCs) in their blood than 95% of the general United States (U.S.) population. Community residents had raised 28 concerns that they were experiencing exposure to air contaminants from nearby gas wells and compressor stations. Measuring the presence of chemicals in biological fluids (i.e., biomonitoring) is a technique that can demonstrate that exposure occurred to those chemicals, but does not necessarily identify the source of the exposure, or when exposure occurred. Based on the pattern of VOC values found in the samples, the information obtained from this investigation did not provide evidence that community- wide exposures from gas wells or compressor stations were occurring in the sample population. Other sources of exposure such as cigarette smoking, disinfectant byproducts in drinking water and consumer or occupational/hobby related products could explain many of the findings. In 2010, the Colorado Department of Public Health and Environment released a public health consultation evaluating the potential public health hazards of ambient air pollution in areas of Garfield County in close proximity to oil and natural gas development activities. This report summarized results from enhanced air quality monitoring implemented following a 2008 public health consultation13 which found air concentrations near the upper end of EPA’s acceptable range for benzene-associated cancer risk at one monitoring site. In this study, air monitoring was used to measure concentrations of chemical contaminants in the air near HVHF activities, and then those measured levels were compared to health-based comparison values for the chemicals. Health comparison values are a risk-assessment tool and are set at levels to be protective of public health. If comparison values are exceeded, it does not imply that adverse health impacts will occur, but it indicates that further investigation of potential exposures is warranted. In the 2010 report, the investigators concluded that it could not be determined if breathing ambient air in those areas of Garfield County that were monitored could harm 29 people’s health. This conclusion was reached because the cancer risks and noncancer hazards for 65 out of 86 contaminants could not be quantitatively estimated due to the unavailability of chronic inhalation toxicity values. Although the evaluation suggests that exposures are not likely to result in significant cancer and noncancer effects (the levels measured are much lower than those known to cause health effects), cumulative health effects from synergistic interactions are unknown. Where quantitative evaluations were possible, increased risks of cancer, long-term (chronic) noncancer hazards and short- term (acute) noncancer hazards (where data were available) were low, although for the latter there is uncertainty because insufficient data are available to evaluate intermittent short-term peak exposures. A similar risk-assessment study of air-quality monitoring in the Barnett Shale region of Texas was published in 2014 by Bunch et al. (2014). The study summarized air- monitoring data for volatile organic chemicals collected at six fixed monitoring locations in Wise, Denton and Tarrant counties in north-central Texas including areas in and around the city of Fort Worth. The monitoring network is operated by the Texas Commission on Environmental Quality (CEQ) and is described in the report as the most extensive air monitoring network in place in any U.S. shale play. The network includes both real-time monitors and 24-hour average samples analyzed in the laboratory, covers regions of the Barnett shale producing both dry and wet gas, and spans areas of urban and suburban development where the potential for community exposure to any shale-gas air emissions could be significant. The analysis of these data included assessing potential health risks of short-term and long-term exposure to all chemicals measured by the monitoring network using existing health comparison values (for example, Texas CEQ air monitoring comparison values or US EPA reference concentrations). Many of the chemicals measured by the existing network are unrelated to shale-gas development. Therefore, the authors also conducted more refined 30 quantitative risk assessments for a subset of volatile organic chemicals thought to be most likely to be associated with shale gas production. The Bunch et al. study summarized the results of over 4.6 million data points collected over more than 10 years for up to 105 different volatile organic chemicals per monitor. Only one observed short-term value exceeded an applicable odor-based comparison value.14 None of the measured short-term (one hour or 24-hour average) air levels for the entire panel of chemicals exceeded an applicable short-term health-based comparison value. Only one chemical (1,2-dibromoethane) had any annual average concentrations that exceeded its applicable long-term health comparison value.15 The authors noted that the analytical detection limit for 1,2-dibromoethane is substantially higher than its chronic comparison value and about 90% of the 1,2-dibromoethane results that contributed to the exceedances were non-detects. This suggests the true annual average concentrations could have been substantially lower than the reported estimates. The authors also did not consider 1,2-dibromoethane to be a chemical reasonably expected to be associated with shale-gas production. According to the authors, it is used as a lead-scavenger in aviation fuel. The two monitoring locations where the 1,2-dibromoethane 2011 annual averages exceeded applicable comparison values are located near airports. More refined deterministic and probabilistic quantitative risk assessments for annual average concentrations found that estimates of cumulative noncancer and cancer health risks were below levels of concern at all monitoring locations. The authors concluded that their analysis demonstrated that shale gas operations in the monitored region of the Barnett play have not resulted in community- wide exposures to the measured volatile organic chemicals at levels that would pose a health concern. 31 Macey et al. (2014) analyzed data from grab and passive air samples that were collected in Arkansas, Colorado, Ohio, Pennsylvania and Wyoming by trained volunteers at locations identified through systematic observation of industrial operations and air impacts over the course of residents’ daily routines. The investigators reported that concentrations of eight volatile chemicals exceeded risk-based comparison values under several operational circumstances. Benzene, formaldehyde, and hydrogen sulfide were the most common compounds to exceed acute and other risk-based values. However, it was not always clear that th</p>
