A Health Impact Assessment of Unconventional Oil …...proximity to unconventional gas development, which has raised concerns about the potential for harm both in the short-term and

A Health Impact Assessment of

Unconventional Oil and Gas in Scotland

Peer-Reviewers’ Comments on Initial Draft Report

October 2016

Peer-Reviewers’ Comments on Initial Draft Report Page 2 of 57

Table of Contents

Peer-Reviewer Page

Madelon Finkel 3

Liz Green 22

Institute of Occupational Medicine 29

David McCoy 53


Expert Report Prepared by Professor Madelon Finkel, Ph.D.

Consulting Epidemiologist

New York, NY USA

Prepared At the Direction of Health Protection Scotland

EXECUTIVE SUMMARY

In 2015, the Scottish Government (SG) commissioned Health Protection Scotland (HPS) to

prepare a written Report, a Public Health Impact Assessment (PHIA), of the potential

consequences of developing oil and shale gas and coal bed methane in Scotland (hereafter

referred to as unconventional oil and gas or UOG).The PHIA (hereafter referred to as the

Report) is intended to be an evidenced-based critique of the “best evidence” on the topic, the

results of which “would provide the government with the scientific and technical information

that it required in order to develop an evidence-based policy for UOG development in

Scotland”.

Three questions provide the focus of the Report:

1. What are the potential risks to health associated with exploration for and exploitation

of shale oil and gas and coal bed methane?

2. What are the wider health implications of deploying the technology necessary for the

exploration and exploitation of shale oil and gas and coal bed methane?

3. What options could there be to mitigate any potential adverse impacts that are

identified?

I was informed that other Reports would focus on specific aspects of UOG (e.g., impact to

the environment) and that this Report was to focus specifically and solely on the Public

Health impact of UOG in a generic way. That is, the Report would not focus on one specific

location or one specific defined population nor would the Report issue specific

recommendations on “what the final government policy on the topic should be”. As such, the

Report was meant to serve as a guideline for policy making but within a narrowly conscripted

focus.

The Report and its accompanying Appendices and References represent a tremendous

amount of research and compilation of information. However, as currently written, the Report

needs massive editing. I reviewed the Reports issued by Public Health England (Review of

the Potential Public health Impacts of Exposures to Chemical and Radioactive Pollutants as

a Result of Shale Gas Extraction. 26 June 2014) and the New York State Department of

Health (A Public health Review of High Volume Hydraulic Fracturing for Shale Gas

Development. December 2014). Both of these Reports were well organized, comprehensive

in scope and content, and concisely written. In comparison, the Health Protection Scotland


Report is not. I present what I consider to be the major flaws in the body of this critique, and

offer recommendations for consideration.

Specific questions were commissioned by the GS. The following is an overview summary,

as the body of this critique provides a much more in depth discussion of the issues.

1. What are the potential risks to health associated with exploration for and

exploitation of shale oil and gas and coal bed methane?

The Report’s charge is to present a literature review of the “best evidence” of

epidemiologic studies to answer this question. Unconventional gas development using high-

volume, slickwater hydraulic fracturing from clustered multiwall pads using long, directionally

laterals (known by the popular name of “fracking”) is a relatively new technology (since

2007), with the overwhelming majority of activity taking place in the United States. As such,

long-term effects on the potential for harm to health are not fully known at this writing. In the

short-term, anecdotal adverse effects have been reported among some individuals living in

proximity to unconventional gas development, which has raised concerns about the potential

for harm both in the short-term and in the long-term (e.g., years or even decades).

Over the past 5 years a substantial number of small-scale health outcomes studies

conducted (all within the U.S.) have been published in peer-reviewed Journals. Overall,

these studies are limited in their ability to show that exposure to risk factors caused a health

outcome. The published studies are ecological and descriptive in design, which do not test

hypotheses. Rather, findings from such studies can be used to generate hypotheses for

testing in observational case-control or cohort studies. The published findings, both

suggestive and compelling, highlight the complexity of empirically showing the chain of

causation between risk factors and health outcomes. The cumulative body of information

from ecological and epidemiologic studies demonstrates that there are substantial

uncertainties regarding the relationship between short-term and long-term adverse health

outcomes and risk factors that may be associated with unconventional gas development. Of

course, the potential for harm will vary by proximity to drilling sites, the nature of the

exposure, exposure pathways, route of exposure, and length of time exposed. There needs

to be particular attention paid to when the drilling starts, for how long individuals have lived in

proximity to the well site, and the health status of the individuals prior to drilling and

extraction of oil or gas.

2. What are the wider health implications of deploying the technology necessary

for the exploration and exploitation of shale oil and gas and coal bed methane?

I am not entirely sure what this question is supposed to address. What does “wider health

implications of deploying the technology…” mean? The Report correctly presents an

analysis and discussion of related issues such as noise, odor, and community impact. If this


was the intent, then the Report did indeed include these “wider health implications” in the

text.

3. What options could there be to mitigate any potential adverse impacts that are

identified?

I failed to see a discussion addressing options to mitigate potential adverse impacts from

drilling, extracting, and transporting gas through populated areas of Scotland. Perhaps the

discussion on regulatory agencies was supposed to address this? If so, please make this

much clearer in the text. Some discussion is provided in the subsections, Limitations of the

Evidence on Mitigation Options as well as Recommendations on Mitigation Options, in the

Overall Conclusion section; however, the material is buried here. This is a very important

topic/issue that needs to be discussed more fully, and not placed at the end of the Report.

With respect to the above three questions, general and specific aspects were posed for

comment.

General aspects:

Regarding the content of the Report in terms of appropriateness and relevance to

answering the question, my overall impression is that while an apparently exhaustive

literature search was conducted (including grey literature), the Report repeatedly cites a few

studies at the exclusion of others. That is, the Report relies on a few references when indeed

there are many more high-quality studies that should have been cited in the text. Further,

and perhaps most damaging, in many instances the conclusions drawn are not fully

supported by the evidence presented. The tone of the Report is often apologetic (in my

opinion), tentative (perhaps unnecessarily so), and so watered-down to be of limited value to

the SG (again, my opinion).

The SG requested a Report on the Public Health impact on shale oil and gas, as well as

on coal bed methane. There is no discussion of the latter in the text. Either include

information on coal bed methane, or delete it from the title and focus of the Report.

Regarding the appropriateness of the Health Impact Assessment (HIA) process, the

Report goes to unusual lengths to make a distinction between an Health Impact

Assessment (HIA) and a Public Health Impact Assessment (PHIA), and tries to justify why a

PHIA was “more appropriate” than an HIA or an Environmental Health Impact Assessment

(EHIA), both established and recognized processes. I am puzzled by this and wonder why

this course of action was chosen given that there is no body of literature that I could find on a

PHIA. Further, even thought the Report makes a big deal about not being a HIA, throughout

the text the term HIA is used, not PHIA. I am confused by this. The key questions delineated

by the SG could easily have been addressed using an HIA or an EHIA and would have

obviated the need to question why an amorphous concept of a PHIA was employed.


The Report presents an excessive amount of information about the Scottish regulatory

process in an effort to explain how potential adverse impacts would be mitigated. The

experience from the U.S., while not entirely comparable, provides a wealth of information

about the contamination of water sources, air pollution, well casing failures, fugitive

methane, and so forth. The mitigation of environmental and health impacts must rely on

stringent regulatory mechanisms.

My most severe criticism of the Report focuses on its readability and suitability for a non-

expert audience. Clearly a tremendous amount of work (time and effort) went into preparing

this Report. However, massive editing of the text would do much to improve the Report’s

readability. In its current form, the Report falls short in so many ways. It is ponderous in tone,

there is an unacceptable amount of duplication and repetition of material, and questionable

conclusions are drawn from the literature. It is far too long in length. The topic is a hugely

important and contentious issue. The Report should be viewed as a guide for decision-

making and it should not require that the reader spend hours reading it. Hopefully my

detailed comments and recommendations will guide the authors as they rewrite the text.

Specific aspects:

The sections delineating the search strategy was too diffuse, long, and incomplete. There

needs to be a concise, complete presentation of the search strategy. I did not see MeSH

terms listed in the text; I didn’t see an inclusion/exclusion criteria delineated; I didn’t see the

included years of publication (e.g., 2000-2016). There is reference to Appendix 6 and 7, but

this material is central to the understanding of how the literature search was conducted and

must be made more clear in the body of the text. It is perfectly acceptable to include details

in an Appendix, but this material must be spelled out clearly and concisely in the text. The

Report states that only evidence showing that exposure to the agent(s) is directly related

(italics mine) to unconventional gas development would be included. This is a much too

narrowly focused perspective and one that is nearly impossible to achieve in epidemiology.

There was a much more comprehensive discussion of the search strategy in the Grey

literature section compared to that for the non-Grey literature. As Table 6 illustrates, the

search strategy is too open-ended resulting in tens, even hundreds of thousands, of “hits”.

This implies that the search terms were too broad. I seriously doubt that anyone preparing

this Report actually read all of the 206,000 hits listed under “public health”. In my opinion,

this illustrates a poor search strategy and raises questions about the material actually

selected. Table 6 just looks silly as presented. “Water” produced 310,000 hits. There is a

need for a much more effective use of MeSH terms to convince the reader that an intelligent

search of the literature was conducted.


This important section must be reworked to give the reader a better understanding of how

the search was conducted. The reader should not have to flip from text to Appendix to figure

out how the search was conducted.

My Concluding Thoughts and Recommendations:

HPS was charged with producing an evidence-based assessment of the literature to

answer the three questions posed by the SG. While a tremendous amount of work (time and

effort) went into preparing this Report, it falls short in many ways because of its ponderous

tone, duplication and repetition of material, and questionable conclusions drawn from the

literature. Massive editing of the text would do much to improve the readability of the Report.

The Report must make clear the limitations of epidemiology and the difficulty in showing

strength of association between a risk factor(s) and health outcome. A short section on

epidemiological study design, association and causation, and Hill’s Criteria would be

important to include. The Report must make clear that the potential for harm will vary by

proximity to drilling sites, the nature of the exposure, exposure pathways, route of exposure,

and length of time exposed. There also must be an understanding of confounding factors

that could contribute to adverse health outcomes, especially behavioural factors such as

tobacco smoking diet and such. Baseline health status must be obtained prior to drilling.

Baseline water samples should be taken to determine if the water source is polluted prior to

drilling. Lay people reading the Report may not fully understand the limitations of

epidemiology.

It probably is beyond the scope of this Report to comment on the economics of UOG.

Hopefully other Reports will focus on this issue. There is a global glut of natural gas and oil,

as if reflected in the market price of each. Does the cost of drilling make economic sense?

Also, there must be consideration of where the millions of gallons of water needed for the

drilling and extraction process will come from, and how the produced and wastewater will be

managed (stored; treated). Health aspects of the UOG are only one part of the issue.

UOG is a hugely important and contentious issue. The Report should be viewed as a

guide for decision-making and should not require that the reader spend hours reading it.

Recommendations for Consideration:

The Report is unnecessarily long. Much of the material could be stated in more

succinct manner, which would improve the readability of the Report considerably.

There is duplication of content and repetition among the different sections of the

Report.

There are obvious differences in the style of writing from section to section, which

needs to be corrected by careful editing.


There are portions of the text that clearly do not (indeed should not) be included in

the text; they should be placed in an Appendix.

There needs to be a better description of the search strategy, including a clearly

defined inclusion and exclusion criteria and a definition of the years from which

published articles are considered eligible for inclusion in the review.

The tone of the Report is hesitant, tentative, and overly cautious. At times the text is

disjointed in style and content. I noted contradictions among different sections of the

Report.

In some sections there is a poor discussion of the literature to the point that the

Report is unhelpful. Some of the statements go against what the literature shows!

Important topics are not discussed despite their Public Health impact (e.g., from

where will the millions of gallons of water needed for the drilling and extraction of

natural gas be found? Where and how will the wastewater be managed? How and

where will the gas be transported?). Perhaps other Reports will address these

issues. If so, it should be stated in this Report.

There should be a section to discuss epidemiologic study design, Hill’s Criteria as

well as the notion of cause and association. This, in my opinion, is a serious

omission.

The Report would benefit greatly by a Table of Contents, an Executive

Summary, and a concise delineation of recommendations. Inclusion of Appendices

is encouraged. I strongly recommend that the Report should be reformatted to allow for a

more logical flow of information and Content. Specifically, there should be a tight

organizational structure similar to that presented in the Public Health England and the

New York State Department of Health reports. The Report as written is not reader-

friendly in its current form.

CRITIQUE OF REPORT BY SECTION

The following critique follows the structure of the Report. My recommendations are

offered after each section as a summary. Since I offer a line-by-line critique, there will be

repetition in my review. It is my strong recommendation that the Report be reorganized.

It is too disjointed and repetitive as presently written.

Section 1: Introduction

In the Introduction, the Report goes to unusual lengths to make a distinction between

an Health Impact Assessment (HIA) and a Public Health Impact Assessment (PHIA). It

tries to justify why a PHIA was “more appropriate” than an HIA or an Environmental

Health Impact Assessment (EHIA), both established and recognized processes. I am


puzzled by this and wonder why this course of action was chosen given that there is no

body of literature that I could find on a PHIA, per se. Indeed, in lines 56 and 57 of the

Report, it is stated that a PHIA does not have a recognized distinct meaning! There are

accepted options that could have been used instead. Further, even thought the Report

makes a big deal about not being a HIA, throughout the text HIA is used, not PHIA. I am

confused by this.

An HIA is an accepted process that considers to what extent the health and well-

being of a population may be affected by a proposed action (e.g., policy, program, plan

or project). It is a systematic process that uses an array of data sources and analytic

methods, and considers input from stakeholders to determine the potential effects of a

proposed policy, plan, program, or project on the health of a population and the

distribution of those effects within the population. HIA provides recommendations on

monitoring and managing those effects. The European Centre for Health Policy defines

an HIA as a combination of procedures, methods, and tools through which a policy

program or project may be judged as to its potential effects on the health of a population,

and the distribution of those effects within the population. The U.S. National Academy of

Sciences as well as Public Health England endorsed the use of HIAs.

Health Impact Assessment methodology evolved from environmental impact

assessment (EIA) tools. Similar to HIA, an EIA is the process by which the anticipated

effects on the environment of a proposed development or project are measured.

However, an EIA does not typically include an assessment of the health effects, and

when it does, it is often narrowly focused. That being said, an Environmental Health

Impact Assessment (EHIA) is an EIA with a health component included in the appraisal

process. An EHIA includes health, but only as one component in the assessment; the

analysis of health issues is not as focused as with HIA. Often, health assessment in

EHIA includes health issues that can be measured – such as chemical and pollution

exposure – while focusing less on qualitative information such as community perceptions

of health issues.

The key questions as delineated by the SG could easily have been addressed using

an HIA or an EHIA and would have obviated the need to question why an amorphous

concept of a PHIA was employed.

Recommendation: Condense this section into a few paragraphs in which definitions of

HIAs, PHIAs, EHIAs are presented. Explain the similarities and differences of the

concepts. This should be a concise, brief section of the Report.

Structure of the Report


While the outline presented in this Section is clearly defined, the body of the report

tends to wander from the proposed structure of the Report. There is too much duplication

and repetition in Sections, which must be addressed and corrected.

UOG, Public Risk Perception and Risk Communication Section

This section seems to be mistitled and misplaced in the body of the Report. This

material should be in a dedicated section of the Report, not in this section, in my opinion.

This Section is a weak, almost apologetically written, and unnecessarily repetitive in

parts. It is much too long in its current form. Too much is made about what the Report

was not supposed to focus on (e.g., climate change); this material need not be included

in the final Report. The SG clearly stated what it wanted the Report to focus on.

The subsection titled, Hazard, Risk and Health Impact Assessment of UOG, is

diffuse in content and the material probably should be integrated with that in the Section

talking about risk. There should be a concise presentation of risk in the beginning of the

Report and combined with the material in the subsection titled, Risk Perception and

Risk Communication. As presently written, there is no clear discussion of the potential

benefits and risks. Risk is never defined, leaving it up to the reader to decide how to

interpret what “risk” means. The section reads like a existential thesis, which is not very

useful for the purposes of the Report, in my opinion.

The subsection, Public Attitudes to Unconventional Oil and Gas Development,

speaks of public opinion polls. It is important to include this information in the Report, but

it should be incorporated into a Background/Overview section. This subsection, as

written, is too wordy. I think that lines 375-379 are disingenuous and should be deleted.

Of course public opinion polls have limitations, but they give a snapshot indication of

what people are thinking at a specific time.

The subsection, Credibility and Trustworthiness of Public Information on UOG,

should be placed in a newly created Purpose of Report section. This is an important

issue to present in a clear, concise manner. Lines 402-403 (assurances of objectivity)

must include how objectivity was assured and by whom. Who constitutes the

independent external peer review panel? Many sentences need further qualification in

order for the reader to understand how impartiality and objectivity were ensured. Further,

it would be important to delineate who was in the Working Group (affiliations etc) and so

list in an Appendix. Lines 400-401 state that stakeholder representatives were not invited

to take part in the HIA beyond the initial scoping sessions events. Why? This needs to be

clarified/justified to the reader. I have problems with lines 396-399 as written. In my

opinion, it seems as if the Working Group was afraid of being inclusive. From my

standpoint, such action may introduce bias into the review process and perhaps the

Reports fidings/recommenations.


Recommendation: This Section includes too many disparate pieces and needs to be

revised. There are too many subheadings that don’t necessarily meld together well.

There needs to be a Background/Overview section at the beginning of the report that

includes a clear, concise and comprehensive overview of the subject of hydraulic

fracturing that should be presented in several paragraphs, not pages. A distinction

between conventional and unconventional drilling should be presented as well as a very

brief overview of unconventional oil and gas in Scotland. No mention is made about coal

bed methane. This material lays the foundation for the content that follows. Public

opinion poll results should be included as well. Risk needs to be defined and discussed

briefly because other sections of the Report will elaborate on the potential benefits and

risks of drilling, extracting, and transporting gas to market. There should be a separate

Section focusing on risk. A separate Section (probably under Purpose of Report) needs

to talk about the composition of the Working Group.

In sum, this Section, as presently written, combines disparate material in an

unsatisfying way.

Section 2: Methods

In my opinion, the material presented here focuses on HIAs, not Methods, per se.

There should be a discussion of what HIAs are and how they are designed, but the

content should not duplicate what might be presented earlier in the text. “Methods”, to

me at least, implies how the study was conducted. For purposes of this Report, you do

need a Methods section to delineate how the literature search was conducted. This has

to be clearly spelled out for the reader.

Specific comments of the material included in this Section are offered. In the

Background section (pp 2-4), definition and purpose of an HIA is presented. The material

conforms to that included in published literature. But, in the beginning of the Report, the

case was made that this was a PHIA, not an HIA. You need to correct this

discrepancy in the text.

The material presented in the section Coordination of the HIA Process (lines 77-111)

doesn’t belong here. You need a dedicated section providing this information to the

reader and it should be placed in the beginning of the Report with an accompanying

Appendix listing who comprised the Working Group. A total number of members would

be good to provide. How big was this group? What is the background of the members

(e.g., Epidemiologists? Biostatisticians? Other health professionals? Policy makers?

Public sector? etc). The Report states that there were no external stakeholders or

representatives from industry. But, then in lines 109-111 it is stated that other

stakeholder groups were invited to attend the scoping workshops. Why? What is the

purpose of this? I disagree that having a broadly based steering group would not be


practical (lines103-104). It seems to me that this Working Group was narrowly and

selectively formed, which could introduce bias. It seems as if the Working Group was

deliberately restricted, which may cast doubt on the Report’s findings because of

selection bias. (See previous comments above on this issue).

Recommendation: Consolidate the information on HIAs into one section. The material

in lines 112-245 should be in a separate section under a discussion of HIAs. As placed,

the material is disjointed. Based on what is written, I found lines 137-139 to be absurd.

The Report is trying to be so generic in scope that it almost becomes meaningless. An

HIA, by definition is designed to assess impacts to a population. The Report so states

this in many places in the text. But here you are saying we are not going to address this

point at all. You don’t have to profile a community, but you should present some

information on the population that would be affected should hydraulic fracturing be

approved.

Description of the Working Group and workshops needs to be placed in a dedicated

section. It is an important component of the Report and should not be buried within other

sections. Inherent in this Section should be a discussion of the Peer Review process

(lines 238-245) and how the working group reached a consensus.

There must be a separate section delineating the methodology used in searching the

literature. Liens 205-222 are out of place. There needs to be a consolidation of this

material in a dedicated section of the Report. Line 220 says that the methodology and

protocol for the literature review is described in Section 6. So why even place this

material where is it?

In sum, this Section screams for better consolidation, reorganization, and elimination

of duplication/repetition of material. As written, it is a jumble of diffuse points, each

important but need to be organized in a more logical way.

Section 3: Background to UOG in Scotland

Will the material presented in this Section be included in other Reports? If so, it

should be either eliminated from this Report or presented in a very succinct manner in a

few paragraphs. This Section is too dense in content and style. Since this Report was

commissioned to present an overview of the health impacts of UOG, why include so

much on how oil and gas are extracted from shale or coal? This contracts what was

stated in the Introduction of the Report—that the report will be narrowly focused. I did not

get that impression at all after reading the full Report.

The Regulatory framework for UOG in Scotland (lines 178-467) does not belong in

the main body of the Report. Present a concise (yes, concise please) listing in an

Appendix. This Section is impossibly wordy. It absolutely must be edited to include the

salient points but not burden the reader with minutia, in my opinion.


Recommendation: Sections 3.1 and 3.2 need to be condensed and much of the

material should be listed in Appendices, not in the text.

Section 3.3: The Role of HSE (Health and Safety Executive)

While it is important to delineate and discuss the role of the HSE in relation to shale

oil and gas, the content included in this Section must be edited in a more parsimonious

manner. Some of the material should be included in the Section on oil and gas

exploration in Scotland (e.g., lines 472-473). The purpose of this Section is to inform the

reader of existing regulatory and legislative modalities in Scotland, but should be done in

a more concise manner.

Recommendation: The material in Section 3 is important but should be imparted in a

much more parsimonious way. Use of Appendices would remove much of the text (a

good thing, in my opinion) yet provide the reader with an understanding of how the

regulatory framework is designed and what regulator roles and responsibilities are.

Section 4: Hazards and Environmental Impacts Potentially Associated with UOG

and Current Regulatory Controls

This should be the crux of the Report and should not include material already

presented in previous Sections. I have the feeling that many people contributed to the

writing of the Report, which may explain the frequent duplication and repetition of

material. This must be rectified before submission to the SG.

There needs to be a much more robust literature review that is synchronized with the

material is presented in Section 6. Consolidate the material please in one dedicated

Section. The topics discussed are relevant and important but need to be presented in a

more parsimonious way and without so many qualifiers. That is, the use of the

conditional tense is not helpful. The data are quite clear about the impact on air quality.

Saying “…there may be releases to the air…”, or “pollution may arise…” or “air

emissions (intended or fugitive) may arise…” sends an incorrect message. The studies

done in the U.S. clearly convincingly show the effect of unconventional gas development

on air and water quality. The language in this section must be revised to state clearly the

effect at all stages of gas drilling, extraction, and transport on air quality.

Similar comments pertain to the subsection on water quality issues. That being said,

in my opinion lines 176-177 are disingenuous. What are “normal circumstances”? Every

well that is drilled is different and the likelihood of water contamination is unfortunately

high (at least in the U.S.). Also, lines 322-324 are dangerously ominous in my opinion.

“Appropriate treatment” means what? Scotland would run the risk of allowing produced

and flowback water to be discharged into the local water/marine environment even

cognizant of the U.S. experience?


Recommendation: The Report must have an integrated, unified Section on Air, Water,

and other subject headings so listed in the Report. I understand why the authors decided

to list each potential hazard and the relevant Regulatory Agency, but it makes for tedious

reading. Material presented in this Section on potential hazards must be integrated with

that in Section 6. Further, the subsections on Regulatory Controls should be placed in an

Appendix. This material should not be included in the body of the text, or it should be in a

separate, dedicated Section of the Report. It does not belong where is it currently placed.

Section 5: Stakeholder Scoping Events

This is an important Section, as it delineates the purpose of the stakeholder

workshops and summary of workshop findings. Minor suggestion: line 70—state who the

vulnerable groups may be; e.g., infants, young children, elderly).

Section 6: Evidence/Literature Review

There must be a concise, complete presentation of the search strategy. In the text,

didn’t see MeSH words, I didn’t see an inclusion/exclusion criteria clearly stated; I didn’t

see the years of publication (e.g., 2000 – 2016) included in the search. There is a

reference to Appendix 6, but this material is central to the understanding of how the

literature search was conducted and should not be buried in an Appendix. Providing

detailed information on the search strategies is fine to include in Appendix 7. Perhaps

consideration of merging the two Appendices would be helpful.

In line 93 the Report states that only evidence showing that exposure to the agent is

directly related (italics mine) to UOG development would be included. In epidemiology,

this is nearly impossible. If you wish to keep this sentence in the text, then provide some

qualifications or explanations.

In line 111, make a third bullet “To explore how UOG…”

Lines 137-142 are odd. By conducting an evidence-based search, one is seeking to

find the “best evidence”. Why even mention that you may have missed some

publications due to time constraints? This raises doubts in the reader’s mind that you

might be consciously or unconsciously leaving out important studies for unknown

reasons. The nature of conducting a systematic review is to identify the “best” studies

based on a preset criterion. (See my comments forthcoming about the search strategy

and getting tens and thousands of “hits”).

Section 6.2: UOG and Health Impacts of Physical Hazards

I think that the Report would be strengthened by a short overview of epidemiology,

study design, association and causation, bias, and confounding. I suggest that a brief

overview of Hill’s Criteria be presented. Those in government, for example, may not have

the knowledge of how epidemiological studies are conducted and why it is so difficult to

show association and causation from valid and reliable data. The material/studies


presented in the Report will be better understood if the reader understands the principles

of epidemiology and strength of association.

The Report must stress that unconventional gas development essentially began in

earnest after 2007 in the U.S., which is too short a period of time to establish strength of

association between exposure(s) and health outcomes. That being said, the body of

evidence does show harm especially to those living in close proximity to drilling sites. It is

important to stress that drilling in the U.S. occurs in rural areas with small populations

usually quite distant from urban population centers. Will this be the case in Scotland?

This must be made very clear in the Report. Also, exposure to the toxic chemicals will

not necessarily result in immediate outcomes. There is a long latency period between

exposure and disease (e.g., cardiovascular, endocrine, respiratory, neurological,

cancers). We are only seeing the tip of the iceberg at this point in time, but this

does not mean that there is no harm to health. We just don’t know what the future

holds for individuals living in proximity of well sites. To whitewash this in any way is

to do a disservice to the SG who has to make policy decisions.

The Report is much too cautious in its conclusions about potential for harm. The fact

that so many chemicals (many toxic and carcinogenic—at least based on those that

have been identified) are used in the process (most of which in the U.S. are not

disclosed), the fact that VOCs are elevated in regions with active drilling wells, the fact

that endocrine disrupting chemicals are evident, suggests that one should proceed

cautiously. To say that there is no or limited potential for harm based on the evidence at

this time is misleading. Too many unknowns exist to say otherwise.

As written, this important Section needs to be edited. Cite pertinent findings and then

give the reference (e.g., the long discussion of the Esswein et al studies found in lines

1006-1054 is unnecessary to include in such detail).

In line 187, consider saying that at this time there are limited number of population-

based epidemiological studies conducted and that several epidemiological studies are

currently underway in the U.S. (e.g., The Marcellus Shale Initiative Study, a National

Institute of Health funded project focusing on asthma control and pregnancy outcomes

among patients at the Geisinger Health System in Pennsylvania; the University of

Colorado at Boulder Sustainability Research Network, a National Science Foundation

funded study that focuses on the impact of high-volume hydraulic fracturing on air and

water).

The Report states that there are “very few” studies, but this is a judgment call and the

Report does not define its meaning. Also, the Report must explain why this is so. For

example, the difficulty in doing such studies, including the cost; in the U.S. individuals

who sell land to industry must sign a confidentiality agreement that prevents them from


sharing any health information!!! Since most of the UOG activity has occurred in the U.S.

it is logical that studies would be based on U.S. cohorts, but legal restrictions make

conducting such studies very difficult.

I do not understand what is meant in lines 201-203.

The comments made in lines 969-973 and are probably not true. The literature in the

U.S. has shown convincing evidence that but for the injection of wastewater into injection

wells, there would not have been earthquakes! There are relevant citations to show this

relationship and these should be cited.

Line 999 needs to be edited. Do you mean that there is a dearth of research studies

on health hazards of workers in the oil and gas industry? I believe that there are cancer

studies that have been done in the U.S. on this topic.

Lines 1205-1230 are misplaced A discussion of epidemiological studies must be

placed in the beginning of the Section (as I suggested previously).

Lines 1233-1256 must be qualified by saying that cancers (and chronic diseases)

take years to develop and manifest themselves. To expect to see an elevation of cancer

after a few short years would be probably related to some factor other than UOG. My

suggestion is to qualify this subsection accordingly. There are, however, some recent

studies that showed increased hospitalization rates among those living in areas

proximate to drilling well sites and of an increase in birth defects among pregnant women

living in proximity to drilling sites. These references must be cited in the Report.

My overall impression is that the Report repeatedly cites a few studies at the

exclusion of others. The Report relies on a few references when indeed there are many

more studies that could/should be cited. There is a large body of literature on each of the

topics and this Report should provide as many citations as possible. For example,

Shonkoff et al (2014) provide an excellent overview of the issues. Also, Finkel and Hays

(2015) provide a rationale for why epidemiological studies are necessary. The Report

should cite the U.S. EPA study on water contamination.

The Report should make the case that available science raises substantial questions

about the potential for harm to health; this Report is much too tentative in tone. The

evidence just doesn’t warrant the cautionary tone, in my opinion. For example, line 304-

305 says that water may contain toxic elements. This is patently false, as Colburn and

others have shown. There is no “may” about it. Cite McKenzie et al when talking about

air particles. And, there was no mention of the U.S. EPA studies on Pavillion Wyoming

and Dimock Pennsylvania in the water contamination section. Vidic et al also needs to

be cited.


I think that the material presented in lines 1476-1552 should be placed in another

Section. The material pertains to well site placement and well integrity. While important

to include, it does not belong in the Health Section.

Material in lines 1773-1783 is misplaced. Integrate with material in a more relevant

section.

Recommendation: Condense and integrate the material in the Discussion and Findings

subsection (lines 1555-1639) with that in the Summary (beginning of line 1641). As written, it

is too wordy. Please consult the Public Heath England Report and the New York State

Department of Health Report as a guide for presenting your findings.

It is my opinion that the summary is too cautious in tone and perhaps is misleading.

There are too many qualifiers that, in my opinion, may lead to an incorrect impression by

some reading the Report. Whilst it must be made clear that it takes time to conduct an

epidemiological study, it also must be stated quite clearly that unconventional gas

development is still at an early stage, beginning in earnest after 2007 in the U.S. To be able

to state “definitively” that exposure from UOG activities leads to adverse health outcomes is

naïve.

Based on the evidence presented, there is cause for concern in the short-term. Long-term

effects will not be known for years. Specifically, the sentence in lines 1655-1666 is

unnecessarily obtuse. Just say that there is evidence to show that airborne hazards have led

to increased health risks among some individuals living near well sites in the U.S. Regarding

water contamination, the evidence is strong that there are issues with well casing failures;

contamination of wells, aquifers and streams in the U.S. To say otherwise would not be

based on the evidence. Saying “may be impacted” goes against the evidence. Of course not

every well or water source has been contaminated, but far too many have, which should be

of concern to Scotland as it debates the issue.

The Report does not discuss where the millions of gallons of water needed in the drilling

and extraction processes in Scotland will come from. It does not discuss how the produced

and wastewater will be treated and stored. It does not discuss the impact of drilling,

extracting, and transporting gas on a semi-urban population. Drilling in rural Pennsylvania or

Colorado is not the same as drilling at Edinburgh or Glasgow’s doorstep. The population that

is exposed to the potentially harmful effects of UOG in the U.S. is probably different from that

in Scotland. This distinction must be made, in my opinion.

Section 3: UOG and Potential Wider Health Impacts

This Section is important. My only recommendation is to edit the text more concisely if

possible. An excellent discussion of these issues can be found in the book I edited, The

Environmental and Health Impact of Fracking (Praeger Press 2015). I sent a copy to Dr

Ramsey.


Grey Literature

Ironically, in this Section, there is a fairly comprehensive discussion of searching terms

and results. This was not evident in the earlier Section delineating the search strategy for the

non-Grey literature! Also, line 2986 clearly states the time period from which grey literature

reports would be considered, which was not presented in the Section for non-Grey literature.

This should be corrected. As Table 6 illustrates, the search strategy was very open-ended

resulting in tens and even hundreds of thousands of “hits”. This implies that the search terms

were too broad. I seriously doubt that anyone preparing this report actually read the 206,000

hits listed under “public health”. In my opinion, this illustrates a poor search strategy and

raises questions about the material actually selected. I would redo the search to produce a

more parsimonious listing. Table 6 looks silly as presented. “Water” produced 310,000 hits.

You need a much better use of MeSH terms to convince the reader that you did an intelligent

search of the grey literature. As such, the text from lines 2325 on seems suspect to me. Why

not refine this Section by stating that only valid and reliable government reports (and this has

to be defined) were reviewed. Personally, I would not even consider including material that

was not peer reviewed (most government documents are reviewed by experts and the public

for comment).

Community-based surveys are potentially useful but there must be clearly stated criteria

regarding the validity and reliability of such surveys. Non-generalizable and/or non-

representative surveys are not helpful and should not be included in this Report.

I take issue with the report’s conclusion (lines 2596-2605). As written, the conclusion

seems to “white-wash” or sanitize the findings from the studies (grey and non-grey

literature). The Report contradicts itself, which is not a good thing!

Regarding water quality and resources, you must include the U.S. EPA study on the

issue. To leave this material out of the Report is a big omission. It is mind-boggling to me

that the Report states that there is limited evidence showing contaminated groundwater at

exposure levels that could pose concerns to health. The tone of the text seems almost

apologetic and it is as if the authors are desperately trying to reach a conclusion that the

“best evidence” does not fully support. There is so much waffling in this Section.

Regarding noise, studies in the U.S. have found that the noise from the compressor

stations, truck traffic, well site, etc can lead to mental health issues, especially stress.

Regarding earthquake and seismicity, my suggestion is to rethink this issue and find

more current citations because injecting wastewater into injection wells has been shown to

lead to seismic activity. It is my opinion that your cautious stance is not reflecting

reality, and, as such, the Report will convey a misleading message to the SG. The

Report must be objective and its conclusions evidence-based. Waffling hedging,

misinterpreting the evidence weakens the Report.


The Report specifically states that climate change would not be addressed, yet in this

Section pages are dedicated to the issue. Please correct this inconsistency. And, if you

decide to include material on climate change, you must not limiteit to the Grey Literature

Section.

Several countries have issued bans on hydraulic fracturing (please include this in the

Report) as well as states (other than New York) and municipalities. They did so because of

the concern for the health of the population and the environment. Please provide a little more

information on the difference between a “ban” and a “moratorium”. This is a potentially

important section to present to the SG. A Table listing places with bans or moratoriums

in place should be prepared.

Section 7: Findings and Conclusions

This Section and the one that follows (Overall Conclusions on the Evidence Reviewed) is

in need of massive editing. Why is there an inclusion of multiple summary/conclusion

sections? The Summary/Conclusion must be clear, concise, comprehensive, and as

presented in this Report, it is not. Most people will not read the entire Report, rather they will

read the Summary/Conclusion to obtain the gist of the Report. In order for this Report to

have any value to the SG and others reading it, this Section above all others MUST be better

presented. The salient points (to be determined by the authors) should be presented

concisely (I suggest bullet points). A summary is supposed to be just that: a summary review

of the important points.

Whilst the Report states that it would consider potential harm from coal bed methane, I

did not see any literature cited on this issue/topic. Either delete coal bed methane from the

text or provide a Section on its impact on health.

Regarding specific Question #1 (potential risks to health associated with exploration for

and exploitation of shale oil and gas and coal bed methane), the Report provided a review of

what it judged to be the “best evidence” from a wide range of sources. The potential for harm

from various aspects of the process (drilling, extraction, transportation) were discussed; yet,

in some instances the conclusions drawn are not fully supported by the evidence. The tone

of the Report in addressing this Question was often apologetic (in my opinion), tentative

(perhaps unnecessarily so), and so watered-down to be of limited value to the SG. The

Report focused exclusively on gas with little mention of oil and coal bed methane. Either

include material on these two topics or state that the review focuses on natural gas

exclusively.

I am not entirely sure what Question #2 is supposed to address. What does “wider health

implications of deploying the technology…” mean? The Report correctly presents an

analysis and discussion of related issues such as noise, odor, community impact.

Clarification of what this question is to address would be helpful.


I failed to see a Section addressing options to mitigate potential adverse impacts

identified, as stipulated in Question #3. Perhaps the discussion on regulatory agencies was

supposed to address this? If so, please make it clearer in the text. Some discussion is

provided in the subsection Limitations of the Evidence on Mitigation Options (beginning line

203) and in line 344 Recommendations on Mitigation Options in the Overall Conclusion

Section. However, lines 344-365 actually do not answer the question posed! Essentially

what is written is fairly useless.

The Overall Conclusion on the Evidence Reviewed Section is totally unnecessary as

a stand-alone subsection, as it repeats what was stated in the Findings and Conclusion

Section. Actually, it contradicts what is said in various parts of the Report and is much too

long in length. Summary and Conclusion sections should be crisp in tone, concise, yet

comprehensive. I counted no less than 15 pages of summary/conclusion text, including a

third Section, Summary of Findings and Concluding Comments!!! How many summary and

conclusion sections are needed? Please, it is imperative that these sections be

streamlined to have any value. I was exhausted after reading the first Summary and

Conclusion section and then realized that there are two more Summary/Conclusion sections

to wade through.

Finally in lines 266-268 the Report concludes That “…the literature does indicate that

overall, if UOG activities were permitted in Scotland, there would be a possibility that

exposure to certain hazards, might pose a risk to public health”. Why burry this at the very

end of the Report? This is an important conclusion, and one that was not conveyed very

convincingly in the body of the Report.

UOG in Scotland is a very important issue. The Report should be viewed as a guide for

decision-making and should be prepared in a way that is reader-friendly, informative, and

presents recommendations based on the “best evidence”. It should be made clear that there

at this point in time there are substantial uncertainties about the long-term potential for

adverse health effects associated with UOG. It must be made clear that a guarantee of

absolute safety is not possible. That being said, based on evidence predominantly from the

U.S. (and I understand that Scotland’s experience could be different), there are causes for

concern that the SG must acknowledge and address before changing its policy.

BACKGROUND AND QUALIFICATIONS

I am a Professor of Healthcare Policy & Research and Director of the Office of Global

Health Education at Weill Cornell Medicine, the medical college of Cornell University. I hold

a Ph.D. in Epidemiology from New York University. In addition to my faculty appointment at

Weill Cornell, I was an invited Visiting Professor at the School of Public Health, University of


Sydney (Australia). I was named a Fulbright Senior Specialist awarded by The Fulbright

Program, sponsored by the U.S. Department of State’s Bureau of Educational and Cultural

Affairs, and appointed by the Director General of the WHO to the WHO Expert Advisory

Panel on Drug Evaluation. I was elected to the American College of Epidemiology in 1980.

I have served as consultant to numerous organizations, including law firms and

pharmaceutical companies, in the areas of epidemiology, pharmaco-epidemiology, and

health care policy. I serve as a Board member of PSE (Physicians, Scientists, and

Engineers for Healthy Energy, and is Secretary of the Board of the Christian Medical College

Vellore Foundation (USA).

My articles have appeared in numerous peer-reviewed professional journals. I am the

author of 12 books, including Understanding the Mammogram Controversy, Truth, Lies, and

Public Health: How We Are Affected when Science and Politics Collide, and I served as

Editor of a three-volume text on public health, Public Health in the 21st Century. My 12th

book, The Human and Environmental Impact of Fracking, was released in 2015. I also write

for the lay press, translating the epidemiological science into language that the public can

comprehend. My pieces have appeared in many newspapers in the US and in Europe.

I was engaged to prepare this expert report at the request of Health Protection Scotland

and will be compensated for my time researching and preparing this report.

Respectfully submitted,

Madelon L. Finkel, Ph.D.

July 5 , 2016


Annex A - Health Protection Scotland (HPS)

Unconventional Oil and Gas Public Health Impact Assessment

(UOG PHIA)

Peer Review Proforma

Name: Liz Green

Contact details: [email protected]

Date of Review: August 2nd 2016

Introduction

The following table sets out specific questions on the content of the draft PHIA on UOG in Scotland. Please complete these are far as you are able. If

you are unable to complete a cell, please state “unable to complete” in the cell and if possible state reasons. The questions are intended to assist the

reviewer in identifying the key issues that HPS needs to address when revising the report. Both general and specific aspects relevant to the review are

listed. In addition to the items specified in the table, the reviewer is also invited to use their professional expertise to make suggestions regarding other

aspects of the report. However, when making any comments, please bear in mind the limitations of the PHIA remit specified by the Scottish

Government, as listed in the commissioning statement.

mailto:[email protected]


The Scottish Government posed these questions for this HIA:

1. What are the potential risks to health associated with exploration for and exploitation of shale oil and gas and coal bed methane?

2. What are the wider health implications of deploying the technology necessary for the exploration and exploitation of shale oil and gas and coal bed methane?

3. What options could there be to mitigate any potential adverse impacts that are identified?

General aspects for comment: Reviewer’s comments

With respect to the three key questions posed by SG, please comment on the points numbered below (or mark ‘unable to comment’ and provide reasons):

1. The content of the report in terms of appropriateness and

relevance to answering above questions 1, 2 and 3.

The content was appropriate and relevant in respect of answering the questions set by Scottish Government’s (SG) scope. It is a thorough independent interrogation of the evidence available and a comprehensive review – particularly of the environmental health related data and published evidence. A high quality, robust HIA will consider positive impacts and opportunities to improve and protect health and wellbeing as well as risks and potential detrimental impacts and unintended consequences. I understand that the authors had to work within the constraints of the scope set by SG, however, I do think that the report reads very negatively and although some positive impacts are identified, particularly for question 2, there is an emphasis on negative impacts throughout the report and in the conclusions and findings. If there have been no positives identified then this should be explicitly stated – at least the reader will know that they have been considered and it also ensures that the process is a HIA and not a Health Risk Assessment. In respect of the risk assessment review in the literature review, it is helpful that the evidence reviewed is summarised as ‘might be harmful to health’ and ‘not likely to be harmful to health’ - perhaps these should refer to ‘physical health’? The content related to question 3 is based on the evidence reviewed and is sensible and straightforward. Again, I know that the scope set did not refer to maximisation of any positive implications for communities but it may be worth referring to these within Section 7.


2. The appropriateness of the HIA process used to carry out

an adapted form of health impact assessment (within the

constraints of the remit set by Scottish Government) as a

means of answering questions 1, 2 and 3

The adapted HIA process was appropriate to answer the questions. HIA is a flexible and scalable tool based on evidence of all kinds (qualitative and quantitative, robust academic research and community knowledge for example) and aims to support decision making and inform decision makers. This it does for all the questions set and answers the questions well. The methodology followed all the principals of HIA – it is robust, contains an ethical use of evidence; is equitable and democratic (considers which population will be affected), open and transparent; and participative in nature (stakeholder workshops). A HIA considers positive and negative impacts on health and wellbeing. Whilst some positive implications for health are identified this reports does at times veer into a Health Risk Assessment – which focuses on risk and negative impacts on health. I recognise that this is because of the constraints of the scope set by SG and the need to directly answer the SG’s questions. It needs to demonstrate that positive impacts have either not been identified in the literature or that it is not an aim of that section ie the evidence review of the risks to health which will either could be harmful or will be unlikely to be harmful/not harmful. One final comment - should it be called a Public Health Impact Assessment – this is likely to confuse people in an already crowded impact assessment landscape? I suggest that HIA is much more straightforward.

3. The appropriateness and completeness of the options

identified in the report to mitigate any potential adverse

impacts, identified via the health impact assessment and

review of the evidence (this refers to question 3 only):

The options to mitigate for potential adverse impacts are sensible but are buried in Section 7 and could be more prominent with a larger heading for example. As a suggestion, it may be more helpful to divide them further into groups ie HIA; regulation; policy levers and mechanisms; local level actions so that the options are explicit and detail any specific actions which could be implemented. The suggested need for HIAs at a local level – the wording could be more explicit – in Wales Minerals Technical Advice Note 2: Minerals and Coal states that mandatory HIAs should be undertaken at a local level as part of any Environmental Impact Assessment and that they must involve the community and consider broad health and wellbeing and not simply risk and environmental health determinants.


4. With respect to the report as a whole:

The general quality of the report in terms of readability

and suitability for a non-expert but informed audience.

The quality of the report is good, clearly laid out and well written but it is not suitable for a non-expert audience who may struggle to read it. Even as an informed expert in HIA (who works regularly with Environmental Health Officers and assesses highly technical energy HIAs and other types of proposed waste, transport etc developments) it is a long document to read and an informed audience may not have the time to read it in any depth. There is a good use of tables and diagrams – particularly in Section 3. The document needs to have an Executive Summary and/or a Non-technical Summary for informed audiences, communities or other lay people (elected members such as local councillors) who may be interested in its findings or not have the time to read it in full. It has a high number of acronyms (the abbreviations list is therefore helpful) and there is no glossary. The document definitely requires a glossary to explain some of the terms used. There is no consistent use of terms to describe impacts – impacts/effects/consequences/implications are used interchangeably throughout the document. I know that they can have slightly different definitions ie an effect is a change which is a result or consequence of an action or other cause. If this wording remains then a Glossary needs to define each of the terms. There are no clear links to the other work streams and their findings in relation to health and wellbeing. I recognise the limitations of including these into the draft report (as do the authors themselves who state that they have had no visibility to the other streams work) but the document would be substantially strengthened if it could explicitly signpost to the other completed assessments in relation to economic impacts, transport etc once all the assessments have been completed. These are key determinants of health and wellbeing. General comments on the sections/appendices: Section 3: Well explained and described. Excellent use of tables and diagrams. Section 4: Excellent overview and clear descriptions of regulatory context. Well laid out. Section 6: Well laid out, good use of bold headings. Long paragraphs and sections at times to wade through. Section 7: could a table or box be included in this to break up the text? Can the mitigation options be highlighted in boxes or be more explicit for the reader? Appendices: All are very clearly laid out and easy to read. Appendix 11 for example, is very thorough and I like the structure – it states explicitly who commissioned and conducted the work and I like the structure of all the appendices. Excellent use of tables.

In addition to the above general aspects, the reviewer is asked to assess the following specific aspects relating to methodology used in the report.

Please make clear which part of the evidence review, peer-reviewed published literature, grey literature or other evidence comments refer to.

Specific aspects: Reviewer’s comments


1. The process of determining which evidence to include

in the evidence review.

Very thorough and systematic. A clear focus on answering the questions posed by the SG and the stakeholders

identified themes.

2. The scoping process used to identify the search terms

used for evidence and literature searching.

Inclusive and participatory approach used to widen the scope of the evidence review and literature search. This

ensured that the review was not simply narrowly focussed on risk and physical health impacts. There is no

reference (that I can find) as to how the stakeholder workshop participants were chosen. This could be made

clearer.

3. The methods and criteria used in the evidence search,

screening and selection for further assessment.

Very thorough.

4. The methods and process of the evidence

assessment, including the appropriateness of the

different methods adopted for appraisal of each

category of evidence (peer reviewed literature,

systematic reviews, grey literature, etc.).

Very thorough and tailored to the differing type of literature. CASPs tools and criteria were applied with which to

assess the evidence and make the assessment as robust as possible.

5. The appropriateness of the methods of evidence

analysis and the quality of the review of the evidence.

As above. Quality of the review is excellent and it is obvious that a substantial amount of time has been

dedicated to devising the search terms, sifting through the results and reviewing the papers and documents in

order to draw informed conclusions from them.

6. The processes used to synthesise the conclusions

drawn from the evidence presented

Thorough and impartial.

7. The relevance and appropriateness of the findings and

conclusions drawn from the evidence presented.

Highly relevant and appropriate in order to answer the questions set by the SG.

Any positive impacts are buried in the text and could be more explicit in the findings and conclusions. There are

opportunities to not only protect community health and wellbeing but maximise any positive impacts of UGE too.


Please provide any additional comments on the report not covered under the previous headings. Where these relate to specific content in the report,

reviewers may use tracked changes on the Word Document version, or alternatively may use the following table. For specific comments, please list the

section and line number of the relevant sentence:

Insert

Section

number

Insert

Line

number

Reviewers’ additional comments HPS Use

1, page 3 66 Include physical and mental before ‘ill health’

2, page 2 28 The Barton and Grant diagram could also be inserted here.

2, page 2 22 Is independent a stronger word than impartial? Is HPS an independent organisation or service like Public Health Wales is?

2, Page 4 97 - 111 It is excellent that this is explained but as long as key stakeholders are included within the process and consulted on further (as per

democratic processes) then it is not always feasible or appropriate to include them in Steering Groups dependent on context and

subject. Perhaps condense this section or rephrase?

3, Page

13

303 What are RW02 and RW03? Not clarified in the text.

3, Page

16

413 Should this be highlighted in the document earlier?? A moratorium is important context and information.

4, Page

12

357 Some examples of NORMs would be very useful here – not everyone knows what these are.


7, Page

11

381 Agree. Include the word broad ...Integrate a ‘broad’ health impact assessment into EIA

7, Page

13

437 Include the words ‘broad participatory’ before health impact assessments?

7, Page

11

534 Include the word Independent and impartial??




(UOG PHIA)


Name: Institute of Occupational Medicine Authors: Joanne Crawford, Fintan Hurley, Damien

McElvenny

Contact details: Joanne Crawford, 0131 449 8037 or joanne.crawford@iom-world .org

Date of Review: 12th August 2016

Introduction








The Scottish Government posed these questions for this PHIA:




General aspects for comment: Reviewer’s comments With respect to the three key questions posed by SG, please comment on the points numbered below (or mark ‘unable to comment’ and provide reasons):

1. The content of the

report in terms of

appropriateness

and relevance to

answering above

questions 1, 2 and

3.

Relevance of the content of the main report: The report has a wide remit in that it is not just a literature review (systematic or otherwise) but does feed into a generic HIA. All, or at least almost all, of the content is relevant to the HIA and within the terms of what the report was asked to consider

The terms of reference of the report require that the PHIA is a generic health impact assessment (HIA). There are issues about the extent to which a

generic HIA can fully answer questions 1, 2 and 3, in a way that meets the stated needs of the report, i.e. (i) to inform the Scottish Government in its

policy making now; (ii) to be a resource for any specific local HIAs that may be needed in future in relation to specific proposed UOG developments

in Scotland. These are considered below (Q2) and in more detail, separately, in SN 3. However (to answer the question), the content presented is

relevant to the HIA, and the HIA is relevant to questions 1, 2 and 3; so the short answer is yes, it is relevant. Appropriateness of the content of the main report: At overview level the content is also appropriate, both to the conduct of a HIA, and to the diverse intended readership. Specifically, it is necessary and useful to set the context in different ways (Sections 1-3), to enable a diverse readership to understand the body of the report. It is necessary and useful to identify the environmental (Sections 4 and 5) and other (Section 5) determinants of human health that are potentially affected by exploration for and exploitation of UOG in Scotland; and to do so in a way that is informed by stakeholders and in turn informs the literature review. Section 6, the literature/evidence review, is clearly necessary and appropriate, as is Section 7, where the work as a whole is assessed and conclusions drawn. It is also helpful to any reader to have all of this material collated in a single report. Within this overall framework, we have many detailed comments on the relevance and appropriateness of some detailed sub-sections of the report and of some underlying methodological choices. These are not developed here but are included in the more detailed answers, below. For relevance and appropriateness of the content of the Appendices, see SN 1


2. The appropriateness of the PHIA process used to carry out an adapted form of health impact assessment (within the constraints of the remit set by Scottish Government) as a means of answering questions 1, 2 and 3

The report is of a generic PHIA. This was required by the terms of reference. What this means is discussed in Section 2. We agree with the interpretation that the terms of reference require a generic HIA and not a specific local one, linked with the particular circumstances of a particular development, and that SG questions 1 and 2 be considered together. For detailed comments on the requirement of a Public HIA, see SN 3 still to be completed. While there is wide agreement in the HIA community about how to conduct a specific, local, HIA (and this is summarised well in Section 2), a ‘generic HIA’ is not a well-established concept and there is no agreed methodology for it. In practice it means doing a HIA but leaving out lots of what is essential to doing a specific one, i.e. all the specific details about UOG process, environmental impacts, population affected etc. etc. that would normally be required. This is what the present report does and we agree that this was necessary, in accordance with the remit. However, it does have consequences for the PHIA as means of answering questions 1, 2 and 3. In particular, the assessment of potential health impacts is focussed on a very narrow (though very important) question, something like: “If UOG operations are carried out in Scotland, is a particular exposure or health determinant potentially / possibly / likely to be affected to the extent that there is a potential for, some effect on human health?”. Or: “How strong is the evidence that, if UOG operations are carried out in Scotland, these may cause some exposures to exceed limits above which there is potential for health effects?”. The exact form of the question isn’t stated (it is implicit in the Table of Appendix 5 of the report) and we recommend that it is stated clearly. What is clear is that it doesn’t include any assessment of how big any effect might be for individuals or how many people might be affected or what groups of people in particular might be affected). The report is very wide-ranging in terms of the range of health determinants potentially affected by UOG which it assesses; but the assessment of health impact of any determinant is nevertheless very narrow. This limits the usefulness of the report, as a means towards answering SG questions 1, 2 and 3 in relation to the intended uses. This is discussed in Section 7 of the report. We recommend that Section 2 (in effect, Methods), be extended (including by incorporating much of the material in Section 7) to clarify how the report interprets a generic HIA, and why; and what are the implications of this for an ability in principle to answer SG questions 1, 2 and 3. Our own views on this in relation to questions 1 and 2 are given in a more detailed supplementary commentary (SN 3 of this review; still to be appended). Section 7 can then focus on how well the (necessarily limited) ambition of the PHIA was in practice achieved. Our views on that are given in the specific comments that follow. It may be possible to mitigate the limitations of a generic HIA by developing a number of “what if” scenarios including attempts to estimate the likely size of selected impacts. This possibility should be considered (e.g. by including at least one example of how much additional exposure might occur from UOG and what that would imply for risks to health) and at least discussed. There are more details in SN3. The HIA has two different approaches to identifying potential health effects. One is by assessment of the (limited) epidemiology studies of populations near or affected by UOG operations. The other is via assessment of the ‘Impact Pathway’ from UOG operations through (i) emissions to air, soil and water through (ii) changes in the environmental concentrations through (iii) changes in human exposures (and, if needs be, consequent changes in dose) to (iv) changes in relative or absolute risk of various health outcomes. It would be helpful if these two approaches, and the relationship between them, were distinguished and related to standard approaches such as (modified) DPSEEA. See SN3. That note also comments on other aspects of the HIA process, which generally is good, but we make several recommendations to clarify the reporting of what was done, and some comments on its strengths and limitations. Finally, it includes some commentary on the HIA process and SG question 3, mitigation.

3. The appropriateness and completeness

Process / General comments:

All of these statements relate to Section 7 of the report. We agree that mitigation options are usual in a HIA and that within this report they relate to


of the options identified in the report to mitigate any potential adverse impacts, identified via the health impact assessment and review of the evidence (this refers to question 3 only):

what might be done if UOG operations did go ahead in Scotland, something that is unknown currently. (The mitigation option of not going ahead is

identified and is, properly, not discussed as it is out of remit.) We agree that, if UOG Operations do go ahead, the purpose any mitigations are to

“minimise potential health hazards, to interrupt exposure pathways, and to prevent human health impacts” (Section 7, lines 102-3). It would be good

to spell out illustrative options for how to prevent human health impacts other than via minimising potential health hazards and interrupting exposure

pathways – there are none in the Report. Logically, it could be done by improving population health resilience to various exposures (how?), or by

reducing background rates of mortality and morbidity (so that a % increase in risk from UOG operations has smaller impact being based on lower

background rates), or by improved health services, or…? But are any of these realistic options?

The sub-section on “Limitations of the evidence on mitigation options” (Section 7, p7) is very important and covers many important topics. In

particular it highlights the lack of evidence underlying assumptions that “the extent of the regulatory regime and the rigour of its enforcement” will

provide sufficient protection (however sufficient may be defined), given that there is no evidence about the effectiveness, or not, of the current

regulatory regime in Scotland. It seems logical therefore that if UOG operations were to go ahead in Scotland, this should be done “in a controlled

situation, in a manner and time frame that permitted an adequate evaluation of the effectiveness [of the additional measures]” (Section 7, lines 352-4).

Though consider (a) that what could be evaluated is the effectiveness of the (enhanced) regulatory regime as a whole, and not of the additional

measures only; and that (b) (see line 355) as well as environmental data what may be most informative is exposure data rather than health impact

data, given that exposure is a necessary part of the impact pathway and that health impacts may take a long time to develop (there are some more-or-

less immediate potential impacts and some delayed ones).

Against this background, the proposed mitigation measures seem feasible and comprehensive; but we are less expert than the WG on these issues.

However, we offer a few detailed comments on the discussion of mitigation measures, including the bulleted list in Section 7, p13-14: i. In the section on limitation of evidence for mitigation options, mention is made of “expert technical reports” without clarifying which reports are

being referred to. ii. The statement “elimination of all risk is not practical” should be rephrased. All human actions carry a risk; it’s whether these risks are

tolerable or acceptable. However that raises the question: tolerable and acceptable to whom, by what criteria? And, as noted above, the HIA gives us no benchmark on magnitude of risk.

iii. In the same section, it is stated “new technologies similar to UOG” have been permitted. It would be useful to remind the reader what these are and who has permitted them. If it is meant that EMFs and mobile phone technology are an example of this, then we respectfully disagree, as RF radiation has not been confirmed to be carcinogenic to humans (IARC classified RF radiation as a 2B possibly carcinogenic to humans), yet some of the exposures associated with UOG are already known hazards e.g. category I carcinogens.

iv. To say that mitigation measures will depend on the regulatory regime and level of enforcement, could be better expressed as say that these should be configured to ensure that risks to human health are properly controlled – though this once again raises the question of what this means in practice.

v. The statement “could apply measures identified in other jurisdictions” is too vague. Which measures and in what circumstances? vi. Any developments should be done in such a way as to enable generation of health impact data. This is laudable, but should not be at the

expense of a HIA being done before construction is allowed to go ahead. A clearer statement should be made as to what these data might be.

vii. Involvement of the local community in HIA is laudable; however, this costs money and should be paid for by the developers. viii. The list of mitigation measures re planning and regulatory frameworks seems thorough.


In summary, apart from those related to planning, the list of mitigation measures is too vaguely expressed and should be made more explicit with clear linkages to the different phases of operations as outlines in Figure 4. There should be a clearer statement of relevance of existing mitigation measures e.g. in the USA for Scotland.

4. With respect to the report as a whole: The general quality of the report in terms of accessibility, readability and suitability for a non-expert but informed audience.

A PHIA necessarily draws on knowledge from a very wide range of sources and disciplines. Many readers will be expert in some aspects of what informs or is included in the PHIA but will in effect be ‘lay’ readers on other aspects. It is appropriate and relevant therefore to include essentially background Sections such as Sections 2 and 3. These are written well for a non-expert but informed audience, in terms of content, structuring and use of language; though (see Q2 above, about HIA process), we recommend that Section 2 be expanded to include methods currently in Section 7. Because the intended readership is non-expert (and it is difficult for anyone to be expert across all of this wide field on knowledge) it is particularly important that the report is clear throughout: in describing its remit, its interpretation of that remit, its detailed methods, its results and its conclusions; and that the reader can find these easily in expected places. A substantial amount of this is in place; but the report itself, while it is appreciated it is a draft report, has become complex in its reporting style as it includes a review, the policy and legislative control measures and the public health impacts. While much is explained, we have found several places where better explanation is needed, and we refer to these in our comments on other questions as well as here. We would make the following suggestions to improve the readability of the report:

A simple process diagram to give the reader a map of the report

Statements of evidence (or findings) at the end of each section

A clearer separation of methods, discussion and conclusions – especially Sections 7 and 2 (see specific recommendation in Q2, above)

Bringing into the body of the report some material currently in the Appendices; specifically, the definitions of sufficient, limited, inadequate etc. evidence that is currently in Appendix 6.

A glossary for terms such as proppant, cohort study, etc.

In addition to the above general aspects, the reviewer is asked to assess the following specific aspects relating to methodology used in the report,

including the review of peer reviewed published evidence, grey literature and other evidence.

Specific Aspects: Reviewer’s comments 5. The process of

determining which evidence to include in the evidence review.

These comments refer not only to the process but also to the outcome of the process, in respect of what was included and what wasn’t. This leads into the next question about search terms. By way of context: A conventional HIA would identify the many pathways by which UOG operations could potentially affect human health and then, for each of these, would work through the stages of the Impact Pathway to identify relevant evidence. For environmental exposures the main stages would typically be (i) from UOG operations (exploration and exploitation) through (ii) emissions to air, soil and water through (iii) changes in the environmental concentrations through (iv) changes in human exposures (and, if needs be, consequent changes in dose) to changes in relative or absolute risk of various health outcomes. Similar, possibly less detailed, impact pathways can be constructed for those non-environmental determinants of health that might be affected by UOG. In principle, all of these stages of the Impact Pathway are relevant to a literature review for a PHIA of UOG. In practice, the present report focuses mainly on what health determinants / exposures are potentially affected by UOG operations; and in particular, are affected sufficiently that there is potential to affect human health.


A strength of the work is that it is wide-ranging in terms of the health determinants that it includes – both environmental and other determinants of health are considered. The environmental determinants were identified largely from the earlier SG review (Section 4); environmental and other determinants proposed by stakeholders (Section 5) were included also; and the authors and the Advisory Group exercised judgement on what determinants would be the focus of the literature review. This seems a good and comprehensive process, though for transparency please be clear about whether Advisory Group members took part in a personal capacity or whether they were representing some organisational interest. We welcome that stakeholders were involved, thereby increasing the chances that all potentially relevant health determinants were considered. And we think it right that the final decisions were made by the authors and their Advisory Group. This focus on literature review of how UOG affects exposures to health determinants is understandable and necessary – as the report says, without exposure there are no health effects. But is it sufficient? There is very little in the Section 6 literature review about the relationship between health determinants and health effects. Initially it was surprising to find a literature review for a (P)HIA that was focused so little on health. On reflection, this is mostly okay, i.e. mostly sufficient for answering the limited PHIA question as understood/ defined by the report – see earlier. There are however two ways in which review (of the evidence linking particular health determinants with particular health effects) may be needed.

i. The report seems to accept uncritically that when an exposure is above designated ‘accepted’ or regulatory levels of exposure, there is a potential or adverse health effects; and that there isn’t such a potential if exposures are below those levels. While this may sometimes or often be true, there isn’t such a clear relationship between ‘accepted’ or regulatory levels of exposure and risks to health. There is a case for at least limited review of the extent to which relevant exposure levels are really protective of health.

ii. The relationships between health determinants affected by UOG and health effects also need to be reviewed, at least to some degree, for later local specific HIAs or for a generic one that includes ‘what-if’ scenarios – in these circumstances, there is a need to select risk functions (and identify background rates in the populations).

Such reviews should not only include focus on studies conducted in or near UOG operations; the wider literature about these determinants and health in other contexts is also relevant. It is arguable that this is an unnecessary additional workload in what is already a wide-ranging and complex project. However, at least, the report should say clearly that this element of review was not done, explain why, and explain the implications. It’s unclear to what extent the authors also used results from earlier reports, by other groups, to help identify the long list of health determinants potentially affected by UOG operations.

6. The scoping process used to identify the search terms used for evidence and literature searching.

The scoping process used was good especially the involvement of stakeholders at this stage. One question would be whether the stakeholders were chosen to represent their organisations or because of the skills that they had. It would be useful to clarify this within the report. While the stakeholders suggested a number of different topic areas within the report it is clear that some topics were not examined. At a much later stage within the report it is stated that some topics were not included because there was no evidence related to them. Could this actually be provided earlier on as wellbeing is mentioned at one part but is not covered anywhere else? This is part of identifying evidence gaps so an important part of the review process.


A second question on this is, how did the list of social determinants of health get narrowed down so much? Again please help the reader – if there is no evidence and that was how things were narrowed down please state that. Furthermore it is not clear whether the searches were used to determine exposure arising from or related to UOG or were health effects of the identified exposures searched for; if not, how were the health effects identified? While it is appreciated that the aim here was to carry out a PHIA rather than an HIA, it would be helpful to give some indication of the size of the population near potential sites. There were no scenario explorations within the report. If this is not the point of a PHIA, I think the reader should be told this. However, some scenario exploration may help to give context to the report. The risks of accidents and explosions (non-transport) were not covered in the review – was there a reason for this or is it thought the mitigation through legislation as a means of prevention covers this? One suggestion might be to have more of an emphasis on occupational effects that could inform the environmental assessment.

7. The methods and criteria used in the evidence search, screening and selection for further assessment.

The methods used to find the evidence including the listing of the databases was extremely helpful and these represent a comprehensive list. The search terms are clear and again well presented. The search protocol did highlight the language limitations within the report. Within Appendix 6 it is stated that a third of publications were double screened. What was the reason for double screening only one third? What would also help is with regard to inclusion and exclusion criteria for publications – were any dates used? The language limitations are presented but were any other criteria used. With regard to grey literature, the searches used were less clear and some further explanation on the process would be helpful. Some of the grey literature may have identified other factors that were important, e.g., risk of explosion. In relation to screening for grey literature, there is some question about only looking at the first 100 on the Google search list. Is this a recognised methodology and if so please reference the source. The difficulty is that the first 100 might be different on different computers. In summary the methods of searching, screening and data extraction are acceptable but with regard to grey literature further information should be provided of the methods used.

8. The methods and process of the evidence assessment, including the appropriateness of the different methods adopted for appraisal of each category of evidence (peer reviewed literature,

The methods outlined in Appendix 6 in terms of the identification of the relevant peer-reviewed literature appear very thorough, with the appropriate databases and search terms having been used. However, the status of grey literature (especially pre-existing HIAs or other related reviews) appears to have been dealt with in a different way, despite acknowledging that many of these reports will have been subject to some form of peer-review. With regard to data extraction, only one third were extracted by two people. Some clarity on why a particular third (or was it random) would be helpful, as well as any data on agreement / disagreement between the two people, as knowledge of consistency in methods would help in building the reader’s trust in the included papers. The methods used for data extraction all seem to be valid for the different types of research included. However, what is not clear is how


systematic reviews, grey literature, etc.). The appropriateness of the methods of evidence analysis and the quality of the review of the evidence.

the papers were assessed for quality – Appendix 9 lists the papers included as well as some limitations within the paper. The included papers are all listed within the documents in a number of tables. However, the quality of the papers included which would have been part of the data extraction using methodologies including SIGN. This helps the reader with some knowledge to actually view the papers and be able to weight some of the evidence when reading. It also helps in the synthesis of the findings of the review into limited, strong or other type of evidence. This may have been a decision made in relation to completing a narrative review rather than a systematic review. In which case the quality assessment tools may be redundant. If quality has been assessed inclusion of it in the body of the report would be helpful. The use of the assessment tool for exposure assessment is an interesting development and we have appended some comments in relation to this in SN 2. Whilst there is nothing inherently wrong with undertaking a qualitative review, the following statement: “Quantification of the potential health risks would require details of the exposed population and further details about the probability, frequency and duration of exposure. However, this was outside the remit of this review.” appears odd. To us it seems that the authors have chosen to exclude highly relevant information. If none exists, then clearly it can’t be included, but it should not have been excluded at this point of the PHIA. Whilst it is good that the authors’ own conclusions from papers are presented, there is rarely a critique of the paper with the authors of this reports’ views as to whether or not the papers’ authors’ views can be relied upon or how reliable and robust a piece of evidence is. Although some strengths and weaknesses of e.g. the epidemiological evidence are pointed out, there is no indication to the reader as to what effect these might have on the sizes of risks in the studies. Rather than stating that the lack of a risk cannot be ruled out (which is true for all epidemiological studies) it would be more useful to state what epidemiological studies would be required to plug any knowledge gaps. Some of the hazards identified have very well-known health effects. This needs better acknowledgement for the agents/substances involved, because further studies should be aimed at charactering risk, rather hazard determination. It’s likely that, among all the groups potentially exposed, the highest exposures will occur among workers and yet this is barely mentioned in the report. If the risks to the workers can be demonstrated to be controlled to an acceptable level, then it follows, unless there are exceptions e.g. aerial dispersion of fumes, that environmental exposures to local residents and nearby workers/passers-by will be even lower. It doesn’t necessarily follow that these lower exposures imply no risks to the general public because the general public includes sub-groups (e.g. very young people, older people, people with chronic disease) who would not appear in, or would be under-represented in, the workforce. The same will be true of catastrophic incidents as well as routine exposures. The main limitation of the epidemiological evidence is that there are so few direct studies of workers in the industry. However, for many of the relevant agents/substances identified, there may be a lot of epidemiologically relevant data which could be drawn into this report. While a number of different health impacts from fracking are identified, including chemical or dust exposures, the impact of such exposures in contexts other than UOG are not really considered. This could have informed the review better in relation to different exposures.


9. Dealt with under 4

10. The process used to synthesise the conclusions drawn from the evidence.

We interpret this as the conclusions relevant to individual exposures and health determinants which, for environmental hazards / determinants, are summarised in Section 6, P58-60. Our remarks apply to these. For reasons of time, we have not integrated into these comments a proper consideration of the longer, narrative summaries and discussion earlier in Section 6, e.g. for Airborne hazards, the lengthy discussion and summary Section 6, p23-25; and equivalents elsewhere. It seems that these summaries are based on the assessment of ‘impact pathways’, and not on the limited direct epidemiology near UOG operations. This seems reasonable (the direct epidemiology adds little of value, especially about individual hazards), but if yes, please say so explicitly. Our comments on process assume yes. We consider two aspects: the categories into which conclusions are summarised; and the process used to summarise the evidence into those categories. The categories used (‘sufficient’ evidence, ‘limited’ evidence etc.) are based on the evidence categories used by IARC. It is wise to use internationally well-established categories and associated definitions. The “meanings behind the terms” (Section 6, line 1648) is essential core information, including for a lay reader, and should be in the main report. And we think that these should not only be described but also discussed. For example, ‘sufficient evidence’ is a high standard. The evidence regarding water quality (lines 1659-1668) falls short of this high standard (with “few studies” and “confounding exposures could not be entirely ruled out”) and so is ‘limited’ evidence of a potential health effect. But nevertheless “it is very probable that UOG-related water-related hazards could lead to increased health risks”. The lay reader might reasonably think that very probable means sufficient to place a bet on it, though (accepting the summary as valid), technically it doesn’t amount to ‘sufficient evidence’ in the terms of the present and of the IARC classification. That needs to be explained. Else, the classification as ‘limited evidence’, while technically correct, may be misunderstood. Similarly with the assessment of airborne hazards, as described lines 1651-1658. Within IARC, these evidence categories are applied to two sources, human studies and animal studies; and then an overall classification of carcinogenicity is derived (with clear rules for how evidence across the two sources is combined), i.e. as Group 1, Group 2a, Group 2b etc. There is something similar in the present HIA; that is, that the overall evidence relates to different stages of the ‘impact pathway’ which can perhaps be abbreviated to three questions: (i) What is the strength of evidence that there is an increase in hazard and environmental impact from UOG operations? (ii) What is the strength of evidence that there is an increase in exposure? (iii) What is the strength of evidence that those exposures have the potential to increase risks to health in exposed individuals and consequently, across the exposed population, to cause an increase in health effects? The summary conclusions p58-60 incorporate aspects of all three, but not in a systematic or transparent way, to reach an overall conclusion about the potential of each hazard to cause some kind of health effect (p58-60) and the potential of any exposure, or of exposures in combination, to cause particular kinds of health outcome (p60). More generally, there is not a clear process described – NICE and SIGN describe a process of evidence statements and how the study(ies) support or not. (see e.g. https://www.nice.org.uk/guidance/ph49/evidence/evidence-statements-69192109). This doesn’t necessarily mean that the conclusions are ‘wrong’, an informal process may be adequate, but in the interests of transparency, and so that readers can judge, please describe the process as clearly as possible.

https://www.nice.org.uk/guidance/ph49/evidence/evidence-statements-69192109


As well as the lack of clarity about how strength of evidence within the various parts of the impact pathway gets combined into an overall assessment as ‘sufficient’, ‘limited’, etc., we have two major reservations / suggestions for improvement about the process. It seems that individual studies have been assessed for quality; that is an important strength of the work. However, whilst a systematic approach (aside from the issue with the grey literature) to identifying the relevant literature and assessing its quality is laudable, the quality of the evidence doesn’t then appear to have been taken into account when synthesising the evidence. Why is this? Studies (e.g. Appendix 8) appear to have been synthesised individually and not synthesised across the different sources of evidence. Including quality assessment in synthesising across studies in effect means weighting the evidence according to the quality of the underlying study. Not to do so seems an important limitation, even if it is consistent with a narrative review, and the report is explicitly a narrative review. But does it need to be? Because (as best we can tell) the quality assessments have been done. The second reservation concerns the basis on which the potential for health effects is assessed, given evidence (maybe sufficient, maybe limited) of increase in hazard / impact on the environment and consequent increase in exposure. One option is to base assessment principally on evidence from studies conducted around UOG sites, necessarily in other countries. However, the overwhelming sense from reading this review is that such ‘direct’ evidence on which to base a HIA assessment (and therefore a HIA for a specific proposed site) is very limited / inadequate. (We use the words in a non-technical sense.). There is however an alternative approach, that is, to base assessment on the international literature about the particular hazard or exposure that UOG operations has (maybe/definitely) increased. For example, with noise, “it is established” (there is sufficient evidence that?) there is an increase in hazard; and “there are no empirical studies on the noise resulting from increased traffic volumes caused by UOG operations and specific health effects”. Yes, but… What about the international evidence of health effects from noise, including traffic-related noise, elsewhere and in other contexts (WHO, 2011, http://www.euro.who.int/__data/assets/pdf_file/0008/136466/e94888.pdf)? That evidence seems transferable, with a wide range of potential health effects, from cardiovascular to sleep disturbance / annoyance, all of which are relevant to the wide view of health within the HIA. There may be issues of possible threshold to consider carefully, including the potential for traffic and other noise from UOG operations to exceed any thresholds that may exist. There may be other hazards where the nature of the UOG-related hazard is specific – this may be the case for odours, for example, we don’t know. On the other hand, it seems that the international evidence, and not UOG-specific studies, is used integrally, e.g. for occupational accidents (“oil and gas industry in general”) and, even more clearly, occupational health risks from exposure to crystalline silica. So the general questions are:

To what extent does the assessment of the potential health risk take account of the generic international evidence of health effects of the hazard, in contexts other than for UOG operations, and transfer that knowledge to the UOG context; or

To what extent is the assessment of potential health effects based on the (generally inadequate) evidence base from studies near UOG operations?

And why the difference in how various hazards are dealt with? We think that the international evidence from other contexts is generally relevant and not to include it integrally risks under-estimating the (strength of evidence for) the potential for health effects to occur. While this is a significant issue for conclusions about whether particular hazards from UOG operations have the potential to cause health

http://www.euro.who.int/__data/assets/pdf_file/0008/136466/e94888.pdf


effects, it bears even more strongly on the assessment (Section 6, p60) of the potential for different kinds of adverse health conditions to be affected. We agree that there is very little evidence from UOG-specific studies; but the range of health outcomes potentially affected may be very large indeed, given the many hazards that UOG operations may affect, with associated exposures, and the evidence from other contexts for potential health effects of those exposures.Finally, a reminder that, for reasons for time, we have not looked similarly for conclusions on the health effects of non-environmental determinants; we trust that the authors will consider if any of the issues above apply.

11. The relevance of the conclusions drawn and congruence to the evidence presented.

In terms of the relevance in principle, see comments on overall Q2, about the generic HIA process; and the other related comments about the absence of any information about the size of risks or impacts, even via a “what-if” scenario. The conclusions that are drawn are relevant to answering SG questions 1 and 2 (potential for health impacts), and so to informing answers about SG question (mitigation). Whether they can even in principle give sufficient answers to these question to meet the needs underlying the work (i.e. to help inform policy development in the SG; to be a resource for specific local HIAs, if and when needed) has also been discussed earlier. To what extent are the conclusions congruent with the evidence presented? For reasons of time and indeed, on several aspects, of knowledge without detailed investment of time, we have not tried to assess the ‘congruence to the evidence presented’ of each specific hazard and/or health outcome. However, the methodological issues described in Q6 do affect the conclusions. Some examples have been given, e.g. on noise. There are similar issues with air pollution from increased traffic (not included under airborne hazards) – if there is an established increase in traffic volumes, we can expect some increase in traffic-related air pollution, and some associated potential health effects, in fact a very wide range of cardio-respiratory outcomes. Whether the risks are large or small, and/or affect many people or only a few, are not assessed in this generic HIA which is about potential health impacts. And whether or not these are the kinds of effects (from increased traffic) to be expected of any large-scale industrial development may be relevant to final decision-making but is not a reason for excluding them from the present HIA. It seems that several of the conclusions of Section 6, p58-60, may need to be re-considered.

12. The process used to synthesise overall conclusions from each section of the review.

The overall conclusions are in Section 7. The process by which these are synthesised from each section of the review is not described, other than that “The reviewed material was then used to assess the overall adequacy of the currently available international evidence, as a basis for drawing conclusions on the overall risk of health impacts associated with UOG activities”. More detail is necessary and would be helpful. Looking at the content of Section 7 from the viewpoint of inferring the process, we note: a. Although described as Findings and Conclusions, much of Section 7 is about HIA Methods and associated Discussion. This material

is necessary, but (as described earlier) the HIA Methods are better in Section 2, and arguably the Discussion of HIA Methods is best there also, in terms of discussing what a generic HIA could aim to do. There is a place for additionally discussing in Section 7 the strengths and weakness of what the present generic HIA actually did (which may be more, or less, than what it aimed to do).

b. Limitations of the evidence on the health impacts of UOG: There are five paragraphs. i. The first two are about the weakness of the epidemiological studies in populations near or affected by UOG activities. Much

of this has been said earlier in the Review. There are some new things that are important, e.g. “The relative paucity of published evidence should not be interpreted to mean that adverse impacts do not occur.” Agree with this statement.

ii. The third paragraph is about the feasibility in principle of such studies. The lack of baseline data is identified, correctly, as a barrier. But there are other barriers, notably, the likely power of such a study. Even if UOG-related health effects are occurring, what is the likelihood that a study can be designed with good chances of identifying and attributing them? This


involves, variously, the size of the exposed population, the multitude and complexity of possibly harmful exposures, the time-frames over which increased risk might show through to increased effects, the many other factors which might affect health over the same time periods. These issues need to be examined critically, especially as design to gather new evidence is an intrinsic part of strategies for mitigation, if UOG activities go ahead, even on a limited basis. While not wishing to give up in advance on the possibility that epidemiological studies will be useful, we think that it will probably be more practicable to focus future studies (of environmental hazards) on identifying changes in the environment and in human exposures, rather than changes in human health but with long-term follow-up. Health impacts can then be inferred, from the international evidence about health effects of those hazards.

iii. The 4th paragraph is about transferability of evidence. It seems to be about transfer of epidemiology in populations around

UOG sites. We agree, that’s in principle an important issue (maybe not in practice, the available epidemiological evidence is so limited).

iv. There is, in paras 4 and 5, discussion about transferability (or not) of increases in hazard. Can more be said about the transferability of any evidence about exposures? And can this be extended into discussion of the strengths and limitations of the strategy of estimating environmental changes and/or exposures, and then using the international literature (about exposures of that kind, from sources other than UOG operations) to infer the potential for health impacts. Currently that’s missing, and it seems a major omission. Without it the discussion seems imbalanced, because of how much it focuses on epidemiology near UOG sites, and the evidence base there is weak.

c. This issue, of to what extent assessment of potential risks and health effects of pollutants and exposures needs to be based on studies near UOG sites, or to what extent it can be inferred from linking the potential exposures with the wider international literature about that kind of exposure, runs like a fault-line through the report. It needs to be described in the methods and then discussed here.

d. Limitations of the evidence on mitigation options – see response to Q3, earlier.

13. The appropriateness of the final findings and conclusions, in terms of the evidence presented.

Overall Conclusions: Section 7, p8-11. a. UOG-related hazards and exposure pathways: Once again there is discussion of transferability of evidence, but that is an important

issue. However, “The overall conclusion reached is that the evidence is reasonably sound”. This is specifically for characterisation of hazards (line 248). What about the potential for exposures, in particular exposures at levels that are considered a risk? Lines 267-8 say that “…there would be a possibility that exposure to certain hazards, might pose a risk to public health”. Can this be made more specific, e.g. for environmental factors, by explicit reference to Section 6 p58-60 (and ideally by reference to a revised version of those conclusions)? And what is meant by “a risk to public health”, in the absence of quantification, even illustrative quantification – does it simply mean some potential for some health effects in some people, without guidance on how big or how small these might be?

b. Health Impacts: i. “Compared to the literature on hazards and exposure pathways, the evidence available on UOG related health impacts was

more limited” – lines 270 / 271. Yes, based on the evidence presented, from studies near UOG sites. No, or maybe not, based on the international literature of the health effects of that hazard and exposure (see long answer to Q6, above). For an extreme example, consider noise. No evidence presented for noise, light and odours (Section 6, lines 923-28), because no studies found in or near UOG sites. But extensive international evidence on noise and health, reviewed by WHO and others for quantification purposes – see answer to Q6.

ii. The weakness of the epidemiological evidence from studies near UOG operations is once again discussed (Section 7, p9), with some discussion on non-environmental health impacts. We apologise that we haven’t in the time available been able to give the non-environmental factors proper attention, though we question if their effects are “indirect”. The list (lines 310-314) of factors potentially affecting “the probability of health impacts” indicates the complexity both of this generic HIA and of any


future site-specific one, if needed. iii. “However, the evidence reviewed regarding potential health impacts associated with UOG activity, is judged overall to have

significant gaps, to be of inadequate quality in some cases and unsuitable in others to confirm epidemiological associations between potential UOG-related hazards and health outcomes” – lines 315-318. We assume that this is about UOG-related epidemiology, rather than UOG-related hazard and exposure assessment plus international literature, from other non-UOG contexts, of health effects – clarity is needed (see Q8, earlier). The purpose is to answer SG questions 1 and 2, about potential health effects and risks, and as you now know, we think that for at least many of the health determinants, it is not necessary to “confirm epidemiological associations between potential UOG-related hazards and health outcomes” via studies near UOG operations. Even with the modelling approach, there are surely significant gaps; but has this been evaluated in reaching the conclusion?

c. First overall conclusion (lines 323-326): “There is an adequate amount of reasonably good quality evidence to confirm that there are potential hazards and potential environmental impacts associated with UOG activities, which could have the potential to result in adverse human health impacts, if not effectively mitigated.” We agree

d. Second overall conclusion (lines 327-330): this gives a conclusion (“…it is not possible to provide a definitive conclusion on the likelihood of occurrence of the potential risks to health associated with UOG development”) and then, beforehand, a reason for the conclusion (“Due to the limited quantity and the questionable quality of the epidemiological evidence available at present…”). This needs to be unpicked a little.

i. As would be expected, the conclusion is worded carefully. It is difficult to disagree with it – to do so would mean saying that it is possible to provide a definitive conclusion etc. However,

“providing a definitive conclusion” is setting the bar very high, especially when applied globally, to all health determinants;

The current summary evaluations for environmental factors (e.g. Section 6, p58-60) suggest that for various environmental determinants there is ‘sufficient’ evidence of potential health effects and for others effects are “highly probable” even though the evidence is not definitive; and

If the proposed approach (of linking the potential for exposure from UOG operations with international literature of effects) is adopted, then the range of potential risks for which there is ‘sufficient’ evidence, or where effects are “highly probable”, would grow.

ii. Can a wording be considered which reflects this, more than is already included in the 1st overall conclusion?

e. It is probably useful to recognise again that the study does not give a basis for judging the size of any potential risks, or the number of people affected by them; that, arguably, this is a consequence of the remit, though within the remit to be generic there may in principle be scope for some illustrative examples of the size of the risks and associated health impacts in a hypothetical exposed population.

Detailed additional comments It would be helpful to the reader if the conclusion section (section 7) was just conclusions or conclusions and recommendations. Findings should be elsewhere and there is too much of a reprise of the discussion in earlier sections. It’s not clear how and to what extent the quality of the evidence has been used in the synthesis of the evidence. It needs to be made clearer that health consequences should include occupational as well as environmental and other exposures. It would be useful to the reader to know how the conclusions from this report differed from the earlier reviews (to the extend they were addressing the same or similar questions).


More could usefully presented on the current regulatory regime in Scotland and how that differs from e.g. the USA (where most of the empirical evidence comes from). It’s not clear what is meant by “sound epidemiological data”. It is stated that the paucity of evidence should not be interpreted as that adverse impacts do not occur. The converse is also true that it should not be concluded that they have the potential to occur in the absence of a reasonable amount of robust data. Uncertainty in the transfer of data from the USA to Scotland seems a crucially important point and needs a little more explanation than that provided. How likely are there to be differences and how large might they be? It’s not clear why the probability of impacts is beyond the scope of this report. Elimination of all risk associated with any human activity is not practical, let alone in the context of UOG. The certain hazards might pose a risk needs to be qualified by some statement about the circumstances in which this might happen. Just because a limit might be exceeded, this doesn’t imply that people’s health might be put at risk, as it depends on the safety margin used in deriving the limit. Also, the evidence needs to be based on robust data (preferably from several high quality studies at different UOG sites). It is very hard to prove the absence of a risk and this needs better acknowledgement. It is stated that much of the exposure evidence is inherently weak, but earlier it was stated that it was “sound”. This is confusing to the reader.




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Reviewers additional comments HPS Use


SN 1 Use of Appendices

1) The list of current UOG activities in Scotland is highly relevant and also appropriate. Although it’s stated in the report that this report is not intended to make recommendations for Scottish government policy, it might be useful to state what the current policy is.

2) The checklist is relevant and appropriate. However, it’s not clear how it was derived. It would have been more useful if the right-hand column was completed and therefore the range of impacts considered by the main report summarised.

3) Whilst at first sight this Appendix appears useful, it could be make even more useful by stating who might be affected, how and in what way. It would also be a useful place to state exposure limits. It seems likely that some of the items e.g. light pollution may not be relevant as they may not result (directly or indirectly) in health effects (workforce or local population).

4) The agendas for the consultation workshops are not very informative, but it is important to include them in the report.

5) This appendix is helpful and relevant. However, it’s not clear what is in scope and what is not in scope i.e. where the boundaries are. Also there appears to be a lack of recognition that exposures to workers will be the same and at higher levels than the general public.

6) The literature review protocol is very useful, although it’s unclear how the relative merits of the peer-reviewed and the grey literature are dealt with. It’s also unclear how the quality of a paper will be used in the evidence synthesis.

7) The search terms appear to be relevant and appropriate, but it’s not clear why these can’t be included in the previous appendix. It’s not clear why the Medline search was included, but not the methods for searching the other databases.

8) This appendix would be better served by having the inclusion and exclusion criteria clearly stated.

9) This appendix is relevant and appropriate, although it would normally appear in the main body of a review. Having a preliminary synthesis of individual studies appears to be odd however. It would be more helpful to have a critique of each study and then an overall synthesis (but in the main body of the report).

10) This is useful and relevant, but there is no critical appraisal of each report.

11) It’s not clear why they are included with this level of detail without it. It would also be useful to know what the present report adds to the previous body of evidence.


SN 2 Note on Exposure Assessment

Evaluation of Exposure Assessment studies

Exposure assessment studies can be carried out for a number of reasons, including

- risk analysis (e.g. as part of epidemiological study)

- risk management (e.g. determining compliance with limits)

- intervention studies (e.g. determining the effect of a control measure to reduce exposure in the workplace)

- health impact assessment

The requirements and hence methods and strategies used for estimating exposure will vary between reasons for carrying out the exposure assessment study. Also,

the scope of the study may determine the exposure assessment exercise. For example, epidemiological studies may investigate the effect of exposure in a population

to identify if there is any evidence of a risk using crude markers of exposure (e.g. exposed or not exposed). Other epidemiological studies are designed to investigate

a quantitative exposure response relationship, say between cumulative exposure and chronic disease, to inform development of health-based exposure limits. For

the latter, a detailed quantitative exposure assessment process is required.

In order to evaluate the quality and utility of an exposure assessment study, as was done as part of the UOG health impact review, it is essential to explicitly state

how this information will be used.

We assume that the main reason for the use of the exposure information is twofold:

i) to determine the quality of the epidemiological evidence

ii) to determine the strength of the evidence of risk, as described on Page 9 and 10 of Appendix 6

For the former assessment the protocol described In 6.4.7 ExpoAssesQA – Form for Assessing Quality of Exposure Assessment studies appears appropriate, although

due to the complexity and wide variety of possible studies (occupational, environmental, personal, etc) it may have been useful to design separate criteria for

different studies.

For the second reason mentioned above, not only the quality of the data is of importance, but also how this information matches with the epidemiological evidence.

For example, if there is a strong evidence from various epidemiological studies that the distance between the home and a UOG site is correlated with a health

outcome, but it has not been possible to determine a single underlying causative agent (e.g. due to the complexity of the environmental exposure), than having

results from very detailed and high quality measurement campaign, may not be helpful for determining risk.


In summary, I would recommend that the authors

i) add the specific reasons for use of the information obtained from the exposure studies

ii) provide details how the criteria have been used in the review (e.g. inclusion/excluding)

iii) consider adding a description on how the exposure information was linked with risk estimates to derive conclusions in terms of the level of

evidence for risk / health impact (see page 9 and 10 of Appendix 6).

SN 3 Note on generic HIA

1st draft of Comments on PHIA Strategy

Comments on the appropriateness of the PHIA process used to carry out an adapted form of HIA… as a means of answering questions 1, 2 and 3.

Q1: What are the potential risks to health associated with exploration for and exploitation of shale oil and gas and coal bed methane (UOG)?

Q2: What are the wider health implications of deploying the technology necessary for the exploration and exploitation of UOG?

Q3: What options could there be to mitigate any potential adverse impacts that are identified?

These comments are in relation to the intended uses, i.e. to provide:

a. A review of the relevant scientific evidence for use a Scottish Government level; and

b. A practical resource for use at local level by public health agencies…who may be required to conduct or contribute to a more specific local HIA.

SN3: SUPPLEMENTARY NOTE ON THE (PUBLIC) HEALTH IMPACT ASSESSMENT METHODOLOGY USED

What kind of HIA is to be carried out in the present context? What does it mean to carry out an adapted, generic, Public, Health Impact Assessment?

HIA in general

“Background to Health Impact Assessment” in Section 2 is a very good overview of the definition, purpose and key characteristics of a HIA. We agree with the

definition and purpose of HIA as described in Section 2, p8, lines 12-24. From this, and the rest of the Section, we agree (among other things) that in principle:

a. It includes positive as well as negative effects on health;

b. It includes a wide definition of health;

c. It includes a wide definition of health determinants;


d. It uses a wide definition of the population potentially affected – (i) it is not confined to the ‘local’ population only; and (ii) it is not confined to more-

or-less immediate effects on the current population;

e. It includes not only an assessment of impacts overall, but also an assessment of impacts in sub-populations, with particular focus on the extent to

which health inequalities are affected;

f. It is forward-looking;

g. It aims to inform policy but does not of itself determine policy; and

h. It can be carried out to different levels of detail (though it is important to communicate (i) what degree of rigour and detail is being aimed at, and

why; and (ii) to what extent this was achieved).

We agree also with combining answers to Q1 and Q2 within a single HIA, and for the reasons given (Sec 1, lines 71-72).

The remit was/is to carry out an adapted form of HIA which is (a) a Public Health Impact Assessment (PHIA); and (b) a generic HIA, i.e. it is about general issues, not

about “predicting the health impacts of a specific proposal in a specific location”.

The report discusses what this means in practice, and how does it affect the two purposes of providing (i) a review of the relevant scientific evidence for use at

Scottish Government level; and (ii) a practical resource for use at local level by public health agencies…who may be required to conduct or contribute to a more

specific local HIA. We consider these issues also.

A Public Health Impact Assessment (PHIA)

The significance, or not, of this being Public Health Impact Assessment is considered in Section 1, p3-4. In summary, we agree with the authors that the word ‘Public’

has no operational significance here.

In more detail:

We agree with the authors that this term is not well-defined; and that, in the present context, it should not be interpreted as in principle incorporating other well-

established kinds of impact assessment (Sec 1, lines 57-62) – except insofar as these are needed in order to do a good HIA as usually understood.

a. In the present context this would include some aspects of an Environmental Impact Assessment, because these are necessary to understand

how exploration for and exploitation of UOG might affect the environment and so affect exposures of humans and so affect human health; but

for this the HIA would where practicable collaborate with the EIA so that the HIA can use the EIA results, (i.e. so that the EIA results are of a

form that is useful to the HIA), rather than perform an EIA itself;

b. Arguably it does include a Health Inequalities Impact Assessment (HIIA) – see above

c. Within HIA there is an emerging sub-discipline of Environmental Health Impact Assessment (EHIA), i.e. those health effects of a policy or

measure which are mediated via changes to the environment and environmental exposures. While not specifically named within the current


PHIA report, these ‘environmental health’ effects are included in the report and indeed the work to address them forms a major part of the

literature review.

Another possible interpretation of ‘public’ is to use Public Health as oppositional to Occupational Health, i.e. to interpret public health narrowly as affecting the

general public but not as affecting workers. The review does not do this. It takes the view that the health of workers is one aspect of the overall public health which is

to be considered. We strongly agree.

Against this background the review interprets Public Health as meaning “a high-level, generic form of HIA” (Sec 1, lines 61-62). This interpretation isn’t necessary, in

that a high-level generic form of HIA is separately required – see below. But we think it is reasonable and we agree with it.

An implication is that the word Public has no operational significance - it seems simply to say ‘Public Health’ where normally practitioners would say ‘Health’, and so

uses PHIA and generic HIA inter-changeably. Again, we agree. Though it would be wise to check this interpretation with the SG before finalising the report (we

assume this checking may have been done already).

A Generic HIA

It is explicitly stated in the remit (e.g. Sec 1, lines 43-46) that “the PHIA will differ from a normal Health Impact Assessment (HIA) as it will consider generic issues that

might arise from unconventional oil and gas extraction, rather than predicting the health impacts of a specific proposal in a specific location and who in the defined

population will bear such impacts”. We are told (Sec 7, lines 17-18) that “The Scottish Government indicated that this assessment was to be carried out at a strategic

level”. Is this the authors’ way of interpreting the remit to be generic, or was it additional guidance? Please say.

A generic HIA is unusual and consequently there is no agreed definition. It is important to know (a) how the authors interpret it, and (b) why, and (c) what are the

implications compared with a specific HIA, and (d) what are the implications for the PHIA being able, even in principle, to meet the needs as stated in the report and

reproduced above.

The report does discuss these issues, quite considerably, in Section 7, p2-5. It’s good to have this discussion, but we think that at least some of this c/should be

earlier, in Section 2, where there is a lot of detail about usual HIA methods but very little specifically on what it means to do a generic HIA. If Section 2 includes at

least a clear description of how the authors interpret a generic HIA and, especially, what does this imply compared to a conventional / specific HIA in terms of what

can be done and what actually was done in the present instance, this would inform expectations of what follows. We recommend that this be done. Also that you

consider including in Section 2 rather than in Section 7 the discussion of what the particular interpretation of generic HIA means for the report’s ability even in

principle to meet the meet the needs of the SG for its policy and to inform future HIAs, if needed.

This would leave Section 7 as a place to consider the strengths and limitations of how well the generic HIA was actually implemented (rather than what it is or isn’t in

principle).


So, how did the authors interpret a generic PHIA and what are/were the implications?

The key characteristic of a generic HIA (PHIA), compared to a specific one, is (obviously) the absence of specificity about so many things, e.g. (i) the nature of the UOG

operations, with detailed information about processes, substances etc.; (ii) the specific environment in which they would be conducted; (iii) the size and

characteristics of the population that might be affected – workers, local residents (however defined), people at some greater distance (however defined); (iv) the

social context; (v) sub-populations etc. etc.; i.e. overall, the absence of specificity about so many things that would be part of a conventional HIA.

We think that this absence of specificity is unavoidable but it has numerous disadvantages compared with a specific HIA. In particular it means that the PHIA is

“focussed only on assessing impacts at a generic and strategic level, essentially from a theoretical perspective” (Sec 7, lines 112-3). It seems that the process as a

whole gets focused on answering (for each of the health determinants that are potentially affected by exploration for and/or exploitation of UOG: “Is there (likely to

be) sufficient change in the health determinant that there may also be changes in health effects in the population, i.e. that someone somewhere sometime may

experience an adverse health effect (or may gain a health benefit)? – together with consideration of what aspects of health may be affected?”

We recommend that the authors clarify whether this, or some re-formulation, is a fair representation of what the try to achieve in the PHIA by way of assessment of

health impacts, and if so say this clearly in Section 2, and discuss its implications in Section 2 or 7.

In principle such a generic HIA can still assess health benefits as well as adverse health effects; it can still take a wide view of health and a wide view of health

determinants; it can take a wide view (in space and time) of the population that might be affected; it can be structured in how it sets about answering the particular

generic question that it aims to answer. Much of our (i.e. IOM’s) review of the report is about to what extent it succeeds in its aim of answering the Para 16 question

a comprehensive way. These present comments intentionally do not address this issue – they deal with the nature of the PHIA and what it can even in principle

achieve.

1. What does it mean for providing a review of the scientific evidence for use at Scottish Government level?

a. A reasonable case can be made that answering this generic question is all that is required in order to answer Q1 (“What are the potential

risks to health associated with…UOG”) – it tells us, for each health determinant potentially affected by UOG, whether the likely or possible

size of the change in that determinant is big enough to potentially cause some health impacts also.

b. The main drawback (which the authors acknowledge in Section 7, and to an extent elsewhere) of focusing the PHIA on a generic question

along the lines of that in Para 16, is that the PHIA gives no information about the size of the risks or gains. It doesn’t tell us how big the

impacts are likely to be in the population as a whole, or how big they are for sub-populations and for individuals (and so there is little

indication about inequalities). And it’s hard to see how a list of potential health effects, with no indication of size, can really inform decision-

making.

c. Also, as is clear from the PHIA itself, and from our detailed review comments about it, it is a major effort ‘simply’ to answer this generic

question, for the numerous health determinants that may be affected by UOG exploration and/or exploitation.


2. And what does it mean for providing “a practical resource for use at local level by public health agencies…who may be required to conduct or

contribute to a more specific local HIA”?

a. It certainly has some uses, for example,

i. The descriptions of UOG and its processes, of HIA and its processes, of the regulatory framework, are all very useful.

ii. And all the work done to develop the long list of those health determinants that may be affected by UOG, to the point of having some

impact on populations health, is a very useful starting-point for a specific local HIA. However, this list is of limited value without being

able to provide also some perspective on the size or importance of each determinant and potential health effects.

b. But as a working example of the kind of specific local HIA that will be needed, the PHIA is deficient:

i. Because all local context is omitted, it provides, necessarily, a limited example of what a specific local HIA would look like.

ii. And a specific local HIA would want to estimate, to some degree of accuracy, the likely magnitude of the many potential health

impacts identified in the current report.

There is a lot of material in Section 7 relevant to these two issues (in paras 19 and 20). It is however somewhat dispersed. We recommend that the discussion be

drawn together more clearly, as an assessment of the ability of a generic PHIA to meet the needs identified in the remit. We suggest – see earlier – that this be

included in Section 2 rather than Section 7.

And is there a reasonable alternative way of looking at it?

...i.e. Is there any practicable way of overcoming these limitations while respecting the requirement to do a generic HIA, not a specific one?

The only suggestion we have is to include, at least sometimes, some ‘what if’ examples, e.g., for some ‘typical’ exposure level, as suggested by the literature, and for

some standard population size (with age distribution, mortality and morbidity ‘typical’ of Central Scotland), what would the impact be the impact of UOG operations,

or more exactly what might the impact be of increased exposures on earlier mortality or specific diseases etc.? Or, what might the health benefit be?

We don’t know how feasible something like this is. Technically, it would involve some quantification of key pathways (UOG to health determinants to health), under

various kinds of scenario with ‘typical’ levels of increased exposures and working out, e.g.

i. how big is the risk per person in relative terms, i.e. as % increase in some health outcome per unit exposure; and/or

ii. how big is the risk in absolute terms, i.e. relative risk linked with background rates of morbidity and mortality; and/or

iii. how big is the impact (on a particular health outcome, via a specified determinant of health) in a population of some standard size.

Doing this would doing this involve additional work, and it is clear that a huge amount of good and detailed work has already been done work ‘simply’ to answer the

generic question implied by the HIA in its present form, without quantification (Appendix 3, for example, has a wealth of detailed information with links to

background publicly available documents); and to construct credible illustrative examples of impacts would take additional time and cost. There is also a danger that,

the more realistic the scenario, the more likely it is that the illustrative numbers it produces would be (mis-)quoted in public debate.


It’s difficult to tell to what extent some illustrative quantification along these lines was considered and insofar as it was, whether the reasons that quantification was

not done were principled, i.e. that’s not what a generic HIA is for; or on practical ones. Possibly the latter – Section 7 says that the data would be ‘too vague’ to be

used for quantification.

Nevertheless, can the authors re-consider this possibility and discuss more fully their reasons for whatever option they finally settle on; because it seems to us that, if

feasible, some illustrative quantification would put some of the potential impacts into context (about the size of the risk for individuals and for the population as a

whole), and it would be helpful to future local specific HIAs, if ever these were needed.

Aspects of the implementation of a conventional HIA – and how does a generic HIA differ from this?

It is useful to have the ‘Steps to take in a HIA’ described clearly and in relation to the present review. We agree that the steps of a HIA are usually done iteratively

rather than ‘once-and-for all’. Was this also the case in the present generic HIA?

The ‘Coordination of the HIA process’ was clearly thought through carefully and seems to be very thorough. The core group is very well qualified for its purpose and

the technical members give necessary expertise in what is a very complex interdisciplinary process. The reasons for not including stakeholders (local communities,

industry...) are reasonable. In principle they apply also to specific local HIAs, if ever these were needed. Do the authors have a view on this?

Framework for Environmental HIA

The HIA has two different approaches to identifying the potential of environmental determinants to be affected by UOG operations sufficiently to lead to health

impacts.

a. One is by assessment of the (limited) epidemiology studies of populations near or affected by UOG operations – a ‘measurement’ approach.

b. The other is via assessment of the ‘Impact Pathway’ from UOG operations through (i) emissions to air, soil and water through (ii) changes in the

environmental concentrations through (iii) changes in human exposures (and, if needs be, consequent changes in dose) to (iv) changes in

relative or absolute risk of various health outcomes – a ‘modelling’ approach.

It would be helpful if these two approaches were distinguished more clearly, and their strengths and weaknesses discussed explicitly, as part of reporting more clearly

which approach was being used for which determinants, and why.

For example, while studies near UOG operations have the clear advantage of relevance, they may lack power to detect effects (e.g. if the

exposed population is small), or, even if effects are found related to e.g. distance from the site of operations, it may be difficult or impossible to

attribute these effects to specific causal pollutants. This in turn limits the ability to recommend specific mitigation measures and it limits

transferability of results to other situations, with possible different operational practices.


The issue of transferability (or not) is key to the modelling approach, which draws on the international evidence about the risks from exposure to

particular pollutants and links that with exposure levels and characteristics of the population-at-risk. Whether or not it is workable depends on the

extent to which the particular pollutants have been studied elsewhere and the extent to which those results are transferable to estimating the

effects of UOG operations. And in practice modelling cannot take proper account of interactions between determinants, whereas studies of

populations near UOG operations are essentially studies of pollution mixtures.

Some discussion of general considerations such as these would be helpful n Section 2, in advance of clearer description later of what approach was being taken, and

why. (In practice the epidemiology near UOG sites was found to be weak as yet, and so the modelling approach is the only one viable.)

Framework for Environmental HIA

There is within the HIA report a strong focus on the health impacts of environmental determinants. Health impacts mediated via environmental factors

(‘Environmental HIA or EHIA) is a relatively well-developed sub-discipline of HIA generally. It has its distinctive characteristics, including that the analysis/assessment

phase can be strongly expert-driven, because typically there is a lot of relevant information about the various kinds of environmental determinants being considered

(Hurley and Vohra, 2010).

A number of structured approaches have been developed for estimating health impacts of environmental determinants. All are variants in one form or another of

working through the stages of an ‘impact pathway’ (or, typically, numerous impact pathways, for different health determinants) from UOG to human health,

including:

i. Identifying hazards

ii. And associated changes in the environment

iii. Potentially leading to changes in exposures, i.e. in the interaction between the population and its environments;

iv. Potentially leading to changes in health effects.

For example, in the DPSEEA (Morris et al.) framework, the Pressure P would be UOG operations; S is state of the environment, i.e. (ii) above; E is Exposure (iii), above;

and E is Health Effect. DPSEEA and modified DPSEEA (which takes account of social and contextual factors especially in the stages from environment of exposure and

from exposure to health) are familiar in environmental public health in Scotland as the methodologies underpinning the Scottish Government’s Good Places, Better

Health initiative. The ‘Impact Pathway’ (or full chain) Approach has been used in many European studies, especially those of the ExternE programme and some of its

successors.

The present generic HIA report is aware of the stages of the impact pathway (there is e.g. a diagram of the pathways from operations through air, soil and water to

exposure) but is not really explicit about them in a consistent way. As a consequence, it is sometimes unclear exactly what aspects of the pathway is being focus on.

For example, for any pollutant, to what extent is the literature review focused on (i) the strength of emissions; (ii) the measurement or modelling of how emissions

may travel through air, soil and water; (iii) what this may mean for the potential for people to be exposed (to concentrations at levels which, in conjunction with


background, have the potential to cause harm to health), and (iv) finally, to the risk of health effects in individuals and so, finally, (v) to estimated health impacts in

the population.

Exactly where on a pathway such as this is the analysis focusing, for a particular pollutant, at a particular time? It would help if the report could be clearer about this,

and cross-reference to one of these established frameworks could help. (We think that greater clarity about the stages is needed – else it can be difficult to see why

does a review about health focus so much on hazard and exposure. Whether reference is or isn’t made to any of the more established frameworks depends on

whether the authors find these helpful or not to that underlying need for communication and ‘signposting’ – use them if they are useful.

The HIA process and SG question 3, mitigation

In principle recommendations for mitigation can come from assessment of health impacts and judgement about where interventions (Actions, in the modified

DPSEEA Framework) might be useful. Regarding interventions, it is very helpful if studies of their effectiveness have been carried out, because seemingly reasonable

interventions do not always have the desired or expected effect. It seems that in the present context there is a major lack of evidence about the effectiveness (or not)

of proposed interventions / mitigation methods.

Reference

Hurley, F. and Vohra, S., 2010. Health Impact Assessment. In Eds J.G. Ayres, R.M. Harrison, G.L. Nichols and R.L. Maynard. Environmental Medicine CRC Press, Baton

Rouge, USA.




(UOG PHIA)


Name: David McCoy

Contact details: [email protected]

Date of Review: July 2016

Introduction








The Scottish Government posed these questions for this PHIA:




General aspects for comment: Reviewer’s comments

With respect to the three key questions posed by SG, please comment on the points numbered below (or mark ‘unable to comment’ and provide reasons):

1. The content of the report in terms of appropriateness

and relevance to answering above questions 1, 2 and

3.

The content of the report is generally appropriate and relevant to the questions 1 and 2. However, when it comes to question 3, I would say that while the state of regulation is described in the report, not enough assessment has been made about the ability to effectively implement the regulatory system as it stands. In order to mitigate any potential adverse impacts, there needs to be the capacity (human, technical and economic) to prevent unsafe practices, ensure adequate monitoring and surveillance. The question is whether one can be confident about the potential for mitigation actually being realisable in practice.


2. The appropriateness of the PHIA process used to

carry out an adapted form of health impact

assessment (within the constraints of the remit set by

Scottish Government) as a means of answering

questions 1, 2 and 3

There are aspects of Chapter 6 that felt a bit muddled to me. I think this is more a problem related to the structure and organisation of the material, rather than a conceptual problem. I’ve tried indicate this is the body of the text. Some other broad comments are: First, there are three steps in the risk-impact pathways that are being considered, and there are passages in the report when these three steps are jumbled up. The first step is the risk of hazards being produced by UOG activity. The second is the risk of human exposure to any hazards produced by UOG. The third is the risk that exposure to hazards will produce health impacts. In particular, I think the first two steps have been conflated in the report, and could be separated out. Second, I am concerned about the way the ‘hierarchy of evidence’ is being applied to shale gas. The nature of shale gas and its associated hazards and risks is such that it is simply not possible to generate large amounts of ‘high quality’ epidemiological studies that are generalizable and definitive. In addition, there is clear evidence that the effects /impact of fracking on human populations or the environment will be variable and do not follow a normal distribution. There is considerable geographic and temporal variation such that consistent findings should not be expected. What may appear to be contradictory evidence may in fact simply be evidence of variability. The way in which you have applied this hierarchy of evidence has resulted in one study (Bamberger and Oswald 2012) being excluded – this was a study of 21 detailed case studies which provide, in my opinion, strong case study evidence that demonstrates that UOG can and has produced significant negative health and environmental health impacts. Given the nature of shale gas and the methodological challenges involved in assessing health impact, case study research of this kind should be considered as a legitimate and valid type of evidence, even if it can’t generate a single p-value. Unfortunately, the SIGN designation places case studies at the bottom of the hierarchy – this may be appropriate for some types of RQ, but less so for RQs that are much more complex, in which case, case studies can be the best or most appropriate form research method. Third, there are passages where the distinction between a comment on the strength of the ‘’availability of evidence” and the ‘strength of conclusion from the evidence that is available” is not always clear. I have inserted comments in the main body of the report illustrating this point, which I hope will make this point clearer. Fourth, it was not clear to be if the inclusion and exclusion criteria were spelt out. I could not see this in appendix 6.


3. The appropriateness and completeness of the

options identified in the report to mitigate any

potential adverse impacts, identified via the health

impact assessment and review of the evidence (this

refers to question 3 only):

I thought this was fine. I have no comments to make.

4. With respect to the report as a whole:

The general quality of the report in terms of

accessibility, readability and suitability for a non-

expert but informed audience.

I commend the writers for the large amount of work. But, there is room for improving the structure and organisation of the material in chapter 6. As a general point, there is room for removing some duplication and repetition in the report.

In addition to the above general aspects, the reviewer is asked to assess the following specific aspects relating to methodology used in the report,

including the review of peer reviewed published evidence, grey literature and other evidence.

Specific Aspects: Reviewer’s comments

8. The process of determining which evidence to include

in the evidence review.

This appears to have been systematic and appropriately done.

9. The scoping process used to identify the search terms

used for evidence and literature searching.

Fine

10. The methods and criteria used in the evidence search,

screening and selection for further assessment.

While the potential for bias in the literature was recognised, it would have been good if research that had been

funded or supported by the O&G industry had been flagged as such.

11. The methods and process of the evidence

assessment, including the appropriateness of the

different methods adopted for appraisal of each

category of evidence (peer reviewed literature,

systematic reviews, grey literature, etc.).

I think there is inevitably going to be differences in how one judges and summarises the rigour of a study; and

summarises its key findings. Similarly, how one forms conclusions from the overall body of literature involves a

degree of judgement and subjectivity. In some cases, I would have arrived at different ways of summing up a

paper or summarising my conclusions.

I can see that separating out peer-reviewed publications from grey literature makes sense at one level; however,

some grey literature, especially those that document pollution or the release of potential hazards, can be

12. The appropriateness of the methods of evidence

analysis and the quality of the review of the evidence.


13. The process used to synthesise the conclusions drawn

from the evidence.

considered to be of good quality evidence if they use acceptable means of data collection / measurement, and if

they are based mainly on the presentation of data in a simple, descriptive manner.

In very broad terms, I agree with the overall conclusions, although I have suggested some alternative wording.

14. The relevance of the conclusions drawn and

congruence to the evidence presented.

As noted in the report, the conclusions from this report should really be integrated with the evidence and

conclusions drawn from the other assessments that are being conducted separately and in parallel, including the

impact of shale gas on global warming.

15. The process used to synthesise overall conclusions

from each section of the review.

As noted in the body of the text, I think there ways in which the structure and organisation of the material

presented could be simplified.

16. The appropriateness of the final findings and

conclusions, in terms of the evidence presented.




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Reviewers additional comments HPS Use

Documents

A Health Impact Assessment of Unconventional Oil …...proximity to unconventional gas development, which has raised concerns about the potential for harm both in the short-term and