Chevron Case: Re 26 Public Strauss Expert Report (nov 7, 2014)

The Matter of An Arbitration Under the Rules of the United Nations on International Trade law Chevron Corporation and Texaco Petroleum Company v. The Republic of Ecuador PCA Case 2009‐23

Supplemental Opinion of Harlee Strauss, Ph.D. Regarding Human Health Risks and Health Impacts Caused by Crude Oil Contamination in the Former Petroecuador‐Texaco Concession, Oriente Region, Ecuador

In response to the following:

Expert Opinion of Thomas E. McHugh, Ph.D., D.A.B.T., Regarding Lack of Evidence of Health Risks Associated with Petroleum Operations in the Former‐Petroecuador‐ Texaco Concession Area, Oriente Region, Ecuador May 2014 Expert Opinion of Suresh H. Moolgavkar, M.D., Ph.D. May 9, 2014

Expert Opinion Of John A. Connor, P.E., P.G., Bcee, Regarding Remediation Activities And Environmental Conditions In The Former Petroecuador ‐ Texaco Concession, Oriente Region, Ecuador May 7, 2014 Claimants’ Supplemental Memorial on Track 2, May 9, 2014

Prepared at the request of: Winston & Strawn LLP 1700 K Street N.W. Washington DC 20006‐3817 and The Louis Berger Group, Inc. 412 Mount Kemble Avenue Morristown, NJ 07962‐1946

Prepared by: H. Strauss Associates, Inc. 30 Union Avenue Boston, MA 02130

______________________________________ Harlee S. Strauss, PhD. November 7, 2014 November 7, 2014

TABLE OF CONTENTS

1.0 Introduction ....................................................................................................................... 1 1.1 Summary Of Scope Of Retention ................................................................................................. 1 1.2 Summary Of Previous Opinions ................................................................................................... 1 2.0 Response To Claimants’ Critiques Of Risk Assessment .......................................... 3 2.1 Texpet’s Contamination Has Resulted In Both Cancer Risk And Non‐Cancer Health Hazards Regardless Of Whether The Contamination Is Considered “Widespread” ............................................................................................................................................... 5 2.2 There Are Current Exposures To Residues Of Crude Oil Released By Texpet, Although This Is Not A Requirement For A Finding Of Unacceptable Risk ....................... 6 2.3 Exposure Parameters Are Appropriate For The Concession Area ................................ 8 2.3.1 Drinking Water Ingestion ...................................................................................................................... 9 2.3.2 Soil And Sediment Ingestion Rates ................................................................................................. 10 2.3.3 Frequency And Duration Of Bathing .............................................................................................. 13

2.4 TPH Can Be Used To Evaluate Toxicity, Especially Oil Related Toxicity, and Thus To Show Health Risks ............................................................................................................................ 14 2.4.1 Development Of A Non‐Cancer Dose Response Factor (Reference Dose) For Crude Oil From The Concession Area .................................................................................................................... 15 2.4.2 Methods For Analyzing TPH ............................................................................................................. 16 2.4.3 Risk Characterization Based On Crude Oil As A Whole ......................................................... 18 2.5 There Are Substantial Non‐Cancer Health Risks From Exposure To Crude Oil .... 19

2.6. There Are Cancer Risks From Crude Oil Exposure ........................................................... 21 2.6.1 Toxicology Studies Show Crude Oil Components Are Mutagenic And Carcinogenic . 22 2.6.2 Risk Of Cancer In The Concession Area Using HHRA Methodology ................................. 23 2.7 Response To Additional Critiques From Claimants’ Experts ....................................... 24 2.7.1 Barium Toxicity Is Evaluated Appropriately ............................................................................. 24 2.7.2 Surface Water Samples Should Not Be Filtered ........................................................................ 25 2.7.3 Exposure Is Evaluated At Appropriate Locations ..................................................................... 25 2.7.4 Exposure To Sediments And To Surface Water Is Evaluated Appropriately ................ 26 2.7.5 Dr. McHugh’s Citation Of His Personal Experience Is Culturally Inappropriate And An Unreliable Basis To Develop Exposure Parameters In The Concession Area ................... 26

3.0 Supplemental Opinion: Petroleum Contamination Has Reduced Local Food Resources, Including Farm Animals, Crops, And Fish. The Reduced Availability Of Home‐Produced Food Has Had An Adverse Impact On The Health Of The Local Population That Relies On These Resources. .................................................................... 27 3.1 Loss Of Livestock .............................................................................................................................. 27 3.2 Contamination Of Fish Pond At SSF‐13 .................................................................................. 31 3.3 Implications Of Livestock, Fish, Wild Game And Crop Loss .......................................... 31 4.0 Supplemental Opinion: Dr. Moolgavkar Used Highly Flawed Data As The Basis Of His Cancer Study, Making His Results And Conclusions Unreliable And Uninformative .............................................................................................................................. 32 November 7, 2014

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4.1 Cancer Mortality Data From The Oriente Are Unreliable .............................................. 32 4.2 Dr. Moolgavkar Uses An Inappropriate Measure Of Oil Exposure ............................ 34 Technical Appendix 1: Details Of The Risk Calculations ............................................... 36 Technical Appendix 2: Development Of A Reference Dose For Crude Oil ............... 37 References ..................................................................................................................................... 39

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1.0 Introduction This report responds to comments on my rejoinder expert report dated December 16, 2013, offered by Chevron’s experts McHugh, Moolgavkar, and Connor and by Claimants in their Supplemental Memorial of May 2014.

I continue to hold the opinions expressed in my February and December 2013 reports and provide additional evidence to support those opinions in this report, including quantitative risk assessments of additional well sites investigated by LBG in 2014. I also provide opinions regarding the adverse impact of petroleum contamination on local food production and human health, and the unreliability of death certificate data with regard to cancer deaths in the Concession Area.

1.1 Summary Of Scope Of Retention Since providing my expert report in December 2013, I have been further retained to: 1) review additional reports prepared by Chevron’s experts; 2) travel to the Concession Area to personally view locations of additional field studies and to interview residents near well sites studied by LBG and health care providers in the Concession Area; 3) prepare additional baseline human risk assessments using newly collected data; and 4) prepare this report to respond to issues raised by Chevron’s experts regarding my December 2013 report.

My opinions in this expert report are given to a reasonable degree of scientific probability.

They are based on my education, training, experience, information and data available in the scientific literature, and information and data about this lawsuit made available to me at the time these opinions were formulated. They are also based on personal observations during my visits to the Concession Area including my most recent visit of approximately 10 days in June 2014. If additional information becomes available, I reserve the right to supplement my opinion to reflect such information.

1.2 Summary Of Previous Opinions 1) The extraction and transport of crude oil from the Napo Concession Area in Ecuador’s Oriente (“Concession Area”) by Texaco Petroleum (“Texpet”) resulted in the release of contamination into the environment that, with sufficient exposure, is toxic to humans.

This remains my expert opinion. Chevron’s experts McHugh, Moolgavkar, and Connor commented on various aspects of my expert report in their May 2014 rebuttal reports.

None of Chevron’s experts contested the existence of contamination sources related to crude oil or its components. The LBG reports have examined sources and types of contaminants released during oil well installation and operation, including contamination attributable solely to Texpet operations. These additional analyses identify petroleum‐ related contaminants and elevated concentrations of barium, a metal associated with drilling muds.

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2) During Texpet’s operations, adults and children residing in the Concession Area were exposed to crude oil and its residues, produced water, drilling mud, hydrogen sulfide, diesel emissions, and flares via exposure pathways that result in inhalation, ingestion, and/or dermal exposures. Some exposure is ongoing at locations where Texpet released contamination remains in environmental media. Several of the pathways by which Concession Area residents were exposed to contaminants are not generally included in exposure assessments in industrialized countries, but are critical to consider based on the lifestyle and cultural practices in the Oriente. This includes, but is not limited to, domestic use of water visibly contaminated with oil, walking on local roads that were coated with crude oil and its residues, and consumption of fish floating (dead) in oil contaminated water.

This remains my expert opinion. Chevron’s experts McHugh and Moolgavkar did not dispute the specific exposure pathways listed in my February 2013 report, although they did dispute whether there is on‐going exposure from these pathways that is attributable to Texpet and is high enough to constitute a health hazard.

My expert opinion continues to be that exposures originating from Texpet sources pose a risk to the health of residents in the Concession Area. The basis of this opinion is the qualitative assessment provided in my original report, strengthened by the quantitative risk assessment in my December 2013 report, and further strengthened by the additional data collected in field studies conducted in 2014. My analysis of the non‐cancer hazards of the most recent data is discussed in Section 2.5. My analysis of cancer risks from crude oil is set forth in Section 2.6.

3) Adverse effects reported in studies of occupational and community exposures to crude oil include skin irritation and other skin problems, eye irritation, throat irritation, headaches, dizziness, psychological problems, perception of poor health, leukemia and other types of cancer. The adverse effects reported by adults and children in the Concession Area following exposure to crude oil and its residues are completely consistent with effects reported from dermal and air exposures in other settings. Other symptoms, such as stomach problems and diarrhea, are consistent with symptoms of poisoning following ingestion of petroleum products.

This remains my expert opinion. No Chevron expert has disputed the toxicity of crude oil and its components. Although Chevron expert Dr. Moolgavkar states that there are no ‘gold standard’ epidemiological studies proving adverse effects from exposure to crude oil, Dr. McHugh—who (unlike Dr. Moolgavkar) has a toxicology degree—does not dispute the clinical and toxicological evidence for health impacts from exposure to crude oil. Dr. Moolgavkar also claims that his epidemiological study shows there are no excess cancer risks in the Concession Area. As discussed in Section 4, however, his study is based on unreliable data and thus is non‐informative.

In her opinion, Dr. Blanca Laffon describes her studies of the immediate and delayed impacts of exposure to fuel oil from the Prestige oil spill off the coast of Spain on workers and community members. Dr. Philippe Grandjean addresses the epidemiological issues

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raised by Dr. Moolgavkar in his opinion.

4) The patterns, durations, and intensities of exposure in the Concession Area are different from these aspects of exposure in occupational settings and in general populations of the industrialized countries in which most epidemiological studies are conducted. As a result of these differences, comparable emissions or contaminant concentrations will result in higher exposures and doses of the contaminants to children and adults in the Concession Area, which, in turn, results in an increased likelihood and severity of adverse effects in the exposed population.

This remains my expert opinion. My visits to the Oriente region in 2014 further confirmed my opinion.

5) Toxic contaminants released into the environment during Texpet’s exploration and production of crude oil resulted in immediate and delayed adverse health effects in children and adults living in the Concession Area. Some of these exposures are on‐going and continue to create immediate health effects. The delayed health effects are continuing to harm residents from previous exposures as well as on‐going exposures.

This remains my expert opinion. This opinion was based, in part, on my quantitative risk assessment for four sites, as described in my December 2013 report, and is further confirmed by the additional quantitative assessment provided in this report and the opinions of Drs. Laffon and Grandjean.

6) Ecuadorian and World Health Organization drinking water standards are exceeded in the Concession Area

This remains my expert opinion. The basis for this opinion was provided in my December 2013 report.

2.0 Response To Claimants’ Critiques Of Risk Assessment Claimants and their consultants confuse the concepts of human health risk assessment (“HHRA”) for regulatory purposes such as cleanup decisions with whether a substance causes an adverse effect in a specific individual (causation). While exposure assessment methodology can be used to estimate exposures for regulatory HHRAs and to estimate a dose to a specified individual to evaluate causation, the evaluations have different objectives and the details of the calculations differ. HHRAs, such as the ones I have prepared for this and previous reports, incorporate conservative (health protective) exposure parameters to evaluate exposure to a hypothetical “reasonably maximally exposed” (“RME”) individual, defined as “the highest exposure that is reasonably expected to occur at a site” (US EPA 1989, p. 6‐4). Regulatory HHRAs include evaluations of exposures due to current and reasonably foreseeable future uses to evaluate whether remediation is necessary. This was the objective of my December 2013 HHRA: to determine whether remediation is necessary, examining each well site individually.

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My HHRAs are based on a conceptual site model of the Concession Area as shown in the diagram below.

The current conditions scenario, so‐called because it is currently available to the hypothetical RME being evaluated, is based on residential exposure to groundwater (where sites have dug wells), soil, and surface water, which includes drinking, cooking, bathing, and laundry. Residential use of surface water includes exposure to both water and sediment, with intake of contaminants by ingestion and dermal contact. There is further exposure from residues on the laundered clothing.

The future use scenario is based on the same exposures, plus the use of a dug well as a domestic water supply at sites where there is not currently a dug well. Similar to the current conditions scenario, this could result in ingestion and dermal exposure to groundwater.1 Consistent with United States Environmental Protection Agency (“US EPA”) risk assessment methodology, the evaluation is conducted assuming the same usage pattern as would occur absent any contamination. For this reason, the reduction in surface or groundwater use due to rainwater usage (collection barrels shown near the house) is not included in the evaluation.

The diagram also shows many animals present in the vicinity of the house — e.g., chickens, ducks, cattle, and dogs. These animals (and children) get into the contaminated sediment and surface soil, which is very muddy especially during the rainy season, and then track the soil and sediments onto other surface soils. All but the cattle also enter the residence, again tracking in soil and sediment where it becomes indoor dust.

Claimants criticize my December 2013 HHRA showing that crude oil residues at four well sites pose significant risks of adverse health effects to residents under current and future

1 In some groundwater samples, there are volatile compounds at high enough concentrations that inhalation exposure could also pose a risk, but this has not been quantified.

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conditions. Claimants contend that: 1) contamination is not “widespread” and thus poses no risk to the population; 2) there are no “actual” exposures; 3) I used exposure parameters that are too high, and thus grossly overestimate exposure and risk; and 4) there are no health risks from TPH.

These critiques are all baseless, and each is addressed in turn in sections 2.1 through 2.4.

In section 2.5, I address the non‐cancer health risks of exposure to oil. In section 2.6, I address the cancer risk from exposure to oil. And in section 2.7, I address miscellaneous other criticisms from Claimants’ experts.

2.1 Texpet’s Contamination Has Resulted In Both Cancer Risk And Non‐Cancer Health Hazards Regardless Of Whether The Contamination Is Considered “Widespread” In a regulatory HHRA, human health risks are evaluated on an individual, not a population, basis. Thus, whether or not contamination is widespread is irrelevant to my assessment of whether cancer risks and non‐cancer hazards exist at the locations examined. An HHRA, identifies whether people can potentially come into contact with the contamination under present or future conditions, and then evaluates health risks based on that contact. Of course, the more “widespread” the contamination, the higher the number of children and adults who may be at risk.

There are significant risks to human health for current and/or future exposures, as evaluated by accepted HHRA methodology, at all four locations evaluated in my December 2013 rejoinder report. The additional sites evaluated in this report also pose significant risks of adverse health effects under current and/or future conditions. For example, additional sampling at LA02, a previously evaluated site, shows oil contamination in the surface soil that serves as the front patio where the family spends much of its time, on the floors of the living area and kitchen, and on a plastic toy used by young children.

Weathered residues of crude oil are also visible adjacent to the back of the house, and additional residues continue to surface due to erosion and land use. These new data provide a definitive link between environmental contamination in sediments and/or pit soils, and everyday locations of human exposure. Section 2.2 includes additional information regarding these exposures.

While not evaluated in my HHRA, there is ample evidence of past exposures to Texpet‐ released petroleum related contaminants at these and other sites. The evidence includes: 1) Chevron interviews, audit reports and aerial photography showing the existence of open pits2 and people living in close proximity to them under living conditions similar to those evaluated in the current HHRA; 2) the decision by residents to purchase water for all domestic uses due to past contamination (e.g., AG06, SSF 25, SSF43); and 3) interview information and signed affidavits regarding lost farm animals at many of the sites evaluated (e.g., AG02, SSF13, SSF34, SSF43).

2 Clickable database; LBG November 2014 Expert Report, section 2; LBG 2013 Expert Report, p. 23.

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2.2 There Are Current Exposures To Residues Of Crude Oil Released By Texpet, Although This Is Not A Requirement For A Finding Of Unacceptable Risk The Claimants’ critique that there are no actual exposures in the Concession Area and thus no risk is wrong for two reasons: 1) there are residents who have current exposure to petroleum residues, including from petroleum residues that could have originated only from Texpet activities, and 2) the determinant for whether remediation is necessary is based on the highest exposure reasonably expected to occur given the current and future exposure pathways to an individual, referred to in an HHRA as an RME individual.3 In fact, under ASTM guidance4 cited by Claimants’ experts, current exposure would be identified as an immediate threat and trigger response actions to abate the exposure.

Based on data from the 2013 and 2014 site investigations conducted by LBG, my personal observations and those of LBG field personnel, and witness interviews, there are current, on‐going daily exposures of children and/or adults to petroleum contaminants at multiple well sites including:

 AG02 – Children and adults from approximately 6 residences use the contaminated stream for drinking, cooking, bathing, and washing5 (see photo section 2.3.3).  AG06 – The farmer/landowner reports that his family uses rainwater and purchases municipal water for all domestic uses, but he uses the contaminated stream for drinking water while working in the field. He estimates that he drinks 4‐5 liters of stream water on hot days when he is working in his fields near the stream. His cows also drink from this stream, come into contact with sediments, and become ill.  LA02 –The adults and children living in the house adjacent to the platform come into contact with petroleum contamination throughout the day, every day.

Sampling conducted in June 2014 detected crude‐oil related contamination on the floors in the kitchen area and living area (separate buildings), and on a child’s plastic sit‐on pony. The surface soil of the front patio has crude oil residues as does the soil in the back of the house where asphalt chunks are embedded. Sampling in the summer of 2013 identified contaminated sediment and surface water in the wetlands area immediately downhill from the house. The surface water is an abandoned water supply that continues to be used by farm animals such as mature chickens and ducks and that has no barrier to access by young children.

3 US EPA, 1989. Risk Assessment Guidance for Superfund; US EPA 1991. Role of Baseline HHRA in

Remediation Decisions. US EPA 1989 p. 6‐4: “Actions at Superfund sites should be based on an estimate of the reasonable maximum exposure (RME) expected to occur under both current and future land‐use conditions.

The reasonable maximum exposure is defined here as the highest exposure that is reasonably expected to occur at a site. RMEs are estimated for individual pathways. If a population is exposed via more than one pathway, the combination of exposures across pathways also must represent an RME.” 4 ASTM E1739‐95 Standard Guide for Risk‐Based Corrective Action Applied at Petroleum Release Sites., p. 7

(Table 1). ASTM International develops voluntary standards used globally.

5 See also Jose Guamán witness statement.

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LA16 – An extended family living in two houses uses petroleum‐contaminated water from a shallow dug well for drinking, cooking, bathing, and laundry. The family pours water over their young children several times a day, and more frequently when it is hot (see photo section 2.3.3). A house completed in the summer of 2014 has a new shallow dug well that appears to be their water supply.

This well is also contaminated with petroleum.  SSF13 – The residents of this farm obtain their drinking water from a stream catchment area. A sample collected in the same stream immediately downstream from the drinking water area revealed petroleum contamination. This water is used for drinking, cooking, bathing, laundry, and water for farm animals such as chickens and ducks. The chickens and ducks are caged to prevent them from coming into contact with contaminated sediments and highly contaminated surface soil in a former pit, although both the sediments and soil are freely accessible to children (and adults) and cattle raised on the property. A tilapia pond on the farm which no longer supports fish has crude oil related contaminants in the water sample tested by LBG.  SSF25 – There are two sets of residents living near this well site. One residence, apparently a rental facility, is a house on stilts adjacent to a contaminated stream.

There is evidence that the occupants of this residence used the contaminated stream in the past.6 While there is now a metered water supply piped in from the dug well in LaVictoria, it is not always available. As of June 2014, the stream continues to remain readily available for use by the occupants, two children and two adults, when the municipal water is unavailable. The owner of the land lives in a house adjacent to the road with his wife and three children (with another on the way as of June 2014). This household also relies on water piped in from LaVictoria.

It is not clear what they use when this water is unavailable. The landowner reports that in the Spring of 2014 chickens, ducks, and at least one cow died after wandering into a contaminated swampy area behind his house.  SSF34 – Agricultural workers were observed in and near an area of contaminated soil. Crops are not growing well in the contaminated area; the owner said they were cutting down the poorly growing papayas to try cacao.

In addition to these current exposures, there is ample evidence, based on interviews and observations, that residents in the Concession Area try to avoid exposure to contaminated soil, water, and sediment and have had to abandon previously used resources to do so.

Examples include:

 AG06 – A family at this site replaced previously used surface water resources with rainwater and a dug well, supplemented with purchased municipal water delivered by tanker truck every one to four weeks. The family no longer uses the stream for drinking, cooking, bathing, swimming, or laundry. The family also provides water for their chickens and pets, which they reported were harmed by drinking and standing in the stream water.

6 This use was described and documented in my December 2013 report.

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  

LA02 – This family uses rainwater and a well some distance away from their home to avoid using the contaminated stream adjacent to their house that had been a drinking water source (and that the mother had used while growing up at this location). The mother washes the laundry in the stream down the road near her parents’ house instead of the more convenient, but highly contaminated, area of the stream adjacent to her house. The father reports that he teaches his children not to play in the contaminated sediment, and he has built a cage to prevent very young chickens and ducks from getting into the contaminated sediments where many have died. The father covered a petroleum contaminated pit on his property so that his adult chickens, ducks and geese would stop falling into it and dying.

SSF13 – The family on this farm cages its ducks and chickens to prevent them from dying as a result of contact with contaminated sediment and water.

SSF25 – The residents of both houses at this site purchase municipal water to replace previously used surface water. However, because the municipal water is not always available, they may continue to use surface water as well.

SSF43 – The residents no longer use their drinking water well, which is contaminated with petroleum, because they said the odor of petroleum was noticeable.7 The loss of this resource has forced this family to pay for tanker trucks to deliver community water. This family also prohibits their children from having pets because it is too sad when the animals die after entering the contaminated wetlands area. The family no longer maintains livestock because of their inability to keep them out of the contaminated area.

2.3 Exposure Parameters Are Appropriate For The Concession Area In a regulatory HHRA, exposure is calculated for a hypothetical person, and is intended to represent an RME. The calculation incorporates several parameters such as: how frequently people are exposed, how long they are exposed, how much water people drink, and how much soil/sediment they ingest, among others. The exposure parameters I used in my December 2013 HHRA are appropriate for the rural areas of the Concession Area, with the intention of calculating an RME under current or future conditions. In several cases, the exposure parameters are higher than are used by the US EPA because of the differences in climate and in the daily activities of the subsistence lifestyle maintained by the rural residents living near Concession Area well sites. The exposure parameters are therefore not overly conservative and they do not overestimate risk, as Claimants’ consultants allege. In fact, as I pointed out in my December 2013 opinion, many exposure pathways were not evaluated due to lack of data. As a result, my HHRA more likely reflects an underestimate, rather than an overestimate, of the risk of harm to the residents.

The use of site‐specific data over standardized assumptions (default values) has been part of US EPA and other agency risk assessment policies for decades. For example, a widely used US EPA document states:

7 This well was tested by LBG in June 2014. The results can be found in the LBG November 2014 Expert

Report, Appendix A Site Investigation and Data Summary Report.

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“EPA has made a policy decision to use, wherever appropriate, standardized assumptions, equations, and values in the human health evaluation to achieve the goal of streamlined assessment. This approach has the added benefit of making human health evaluation easier to review, easier to understand, and more consistent from site to site. Developing unique exposure assumptions or non‐standard methods of risk assessment should not be necessary for most sites. Where justified by site‐ specific data or by changes in knowledge over time, however, non‐ standard methods and assumptions may be used.”8

The hot and humid climate and subsistence lifestyle of residents exposed to contamination at the well sites being evaluated provide clear justification for the use of non‐standard exposure parameters. The sections below explain what site‐specific exposure parameters were used and why they are appropriate to evaluate risk in the Concession Area.

2.3.1 Drinking Water Ingestion The drinking water ingestion rate used in my HHRAs is appropriate for the climate in the Oriente and the daily activities of the rural residents in this area. The basis for the use of 7.5 liters/day in the Concession Area was provided in Appendix A of my December 2013 Rejoinder Report. This drinking water intake rate is far more appropriate for the Concession Area residents evaluated than the 2 liters/day consumed by an office worker in the US, as advocated by the Claimants and their consultants.9

Additional support for this water intake level is provided by US guidance for agricultural workers working in hot weather, conditions consistent with those of the rural residents of the Concession Area. The US Occupational Safety and Health Administration (“OSHA”) recommends 1 liter/hour fluid consumption during working hours when the heat index is greater than 91oF. 10 The heat index frequently reaches this level in the Oriente . The State of California also requires that employers provide at least 1 L/hour potable water for each outdoor worker to prevent heat stress.11

These drinking water rates for outdoor and agricultural workers are consistent with, or even suggest an underestimation of, the 7.5 liters/day intake used in my HHRAs, which was based on, among other things, US Army guidance for water intake for refugees in a hot

8 US EPA 1989, pp. 3‐1 to 3‐2.

9 US EPA increased the default drinking water rate for adults from 2 to 2.5 L/day in February 2014. US EPA

Feb 2014 a, b OSWER Directive 9200.1‐120.

10 OSHA (Occupational Safety and Administration) Heat Index and Protective Measures (accessed on OSHA

website Oct 2014). The heat index is a combination of temperature and humidity and reflects the “felt temperature.”

11 California Department of Industrial Relations Heat Illness Prevention Standard Title8 CCR3395: http://www.dir.ca.gov/Title8/3395.html.

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climate. Higher activity levels, such as those involved in farming, require higher water consumption (separate from, and in addition to, hot climate considerations). Interviews conducted with Concession Area residents in June 2014 support water intake levels of at least 7.5 liters each day. For example, the owner of the farm near AG06 said he drinks 4‐5 liters of water (from the stream) while in the field on sunny days, less on days that are not sunny. This intake does not include water consumption while at home or water used in food preparation.

I am aware of no data or occupation recommendations for drinking water intake for children in a hot and humid climate. My HHRA used a valid methodology based on physiology to estimate a child’s water consumption rate compared to an adult’s consumption rate. To discredit this evaluation, Dr. McHugh referenced an irrelevant case report by Bruce and Kleigman (1997) that describes two infants in a temperate/chilly climate (Wisconsin, US) whose very poor, young mothers fed them bottled drinking water to supplement their infant formula. The result was an electrolyte imbalance. As noted in my earlier reports, living in a hot climate requires a higher fluid intake to offset the loss of water through sweat to remain cool. Dr. McHugh's citation provides no information regarding appropriate drinking water intake for infants and young children in the Concession Area. In addition, Dr. McHugh provides no evidence to support his contention that breastfeeding is the source of fluids for infants and young children. UNICEF data from 2004 show that about 40% of Ecuadorian women breastfeed exclusively for 6 months, an increase from 1999.12 The Ministry of Public Health (Ecuador) summarizes data from 2008 showing that, in rural zones, the average duration of exclusive breastfeeding is 3.6 months for the 53.9% of women who breastfeed exclusively.13 Moreover, even for breastfed infants, hydrophobic components of oil such as PAHs and other polycyclic aromatic compounds are excreted in breast milk and thus passed on to breastfeeding infants leading to higher exposure than estimated in the HHRAs.14

2.3.2 Soil And Sediment Ingestion Rates There have been many studies of how much soil is ingested during daily activities in the US, Europe, and elsewhere.15 Soil is typically ingested when it gets on hands or other objects and the objects get put into the mouth. In most cases, soil ingestion is higher in young children than adults because children have more hand‐to‐mouth and object‐to‐mouth activities. Both children and adults ingest soil that gets into the house and becomes part of indoor dust, settling on food or indoor objects such as toys or glasses. Soil can also be ingested on fruits or vegetables that are not thoroughly washed.

12 UNICEF data http://www.indexmundi.com/facts/ecuador/exclusive‐breastfeeding.

13 Ministerio de Salud Pública del Ecuador Funbbasic/Ibfan. May 2009. World Breastfeeding Trends Initiative.

National Report.

14 Del Bubba et al 2005. PAHs and fat content in breast milk. Annal di Chimica 95: 629‐642. OEHHA 2014.

Table 5.5 p. 5‐22.

15 US EPA 2011. Exposure Factors Handbook. EPA/600/R‐09/052F.

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The amount of soil ingested each day (i.e., the ingestion rate) depends on, among other things, the frequency of hand to mouth activity, and the amount of dirt on hands when these activities occur. The amount of indoor dust also plays a role.

Sediment ingestion occurs for the same reasons as soil ingestion, although it has been less well studied.16 The Concession Area residents are exposed to sediment in a similar way as soil, including tracking in and becoming part of indoor dust. The common practice in US EPA‐type HHRAs is to set the sediment ingestion rate to the same value as the residential soil ingestion rate.

Examples at LA02 of why soil and sediment ingestion occurs

Patio LA02

Living Space LA02 play with dog, dog tracks soil and sediment into house

chicken tracks in soil and sediment

Kitchen LA02 dust from soil and sediment on food (potatos in chair)

Soil and sediment ingestion rates are no doubt higher in the rural parts of the Concession Area than is typical in the US for several reasons including: 1) wet and oil‐contaminated soil17 adheres to hands and other objects more than dry soil, 2) people spend most of their day outdoors (resulting in a higher ingestion rate),18 and 3) soil and sediment are regularly tracked into homes on a daily basis due to the outdoor lifestyle and the presence of farm animals indoors.

16 From the point of view of an exposure assessment, the difference between soil and sediment is the location

(i.e., sediment is located in waterways or wetlands) and that sediment is wet, which means it adheres to skin in a thicker layer than dry soil.

17 US EPA 2011, Exposure Factors Handbook EPA/600/R‐09/052F at pp. 7‐20.

18 Van Wijnen et al. 1990. Cited in US EPA 2011 ibid at pp. 5‐10.

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My 2013 HHRA evaluated sediment ingestion but not soil ingestion because surface soil sampling was not included in LBG’s 2013 sampling program. For the reasons just described, I used soil ingestion rates to analyze the sediment ingestion. For young children, I used a rate of 200 mg/day, which is the USEPA high end ingestion default rate.19 For adults, I used an ingestion rate of 100 mg/day, based on the USEPA high end default rate for adult residential exposure to soil.20

Dr. McHugh claimed that my 2013 HHRA overstated the ingestion rate for sediments. But the methodology applied in my HHRA is identical to that which would be applied at a hazardous waste site in the US where soil ingestion rates are often substituted for sediment ingestion rates. Moreover, in the Concession Area, the indoor dust component of the ingestion rate is likely to be derived, in part, from sediment tracked into the house by people and animals. Thus, because the conditions in the Concession Area result in a higher ingestion of soil and sediment than is anticipated and/or provided for in the US‐based studies on which this ingestion rate is based, 200 mg/day for children and 100 mg/day for adults should be considered to be a moderate estimate of soil and sediment ingestion in the Concession, not an overestimate.

LBG’s 2014 sampling program included both sediment and surface (or shallow) soil. In my current HHRA, I evaluated sediment data in the same manner as my 2013 report (200 mg/day for children and 100 mg/day for adults) using the same HHRA methodology described in my 2013 report. For soil, I used the same 200 mg/day for children and 100 mg/day for adults for residential exposure. For certain sites, I used a 200 mg/day exposure rate for adults because their exposure is agricultural in nature.

The amount of soil ingested by adults in agricultural and other high soil contact settings is higher than in residential areas, which is well known and acknowledged by US industry.

For example, General Electric suggested a soil ingestion rate of 136 mg/day for utility workers and agricultural workers in comments on a 2004 HHRA prepared by the US EPA.21 More recently, the California Environmental Protection Agency published a high end soil ingestion estimate for adults of 210 mg/day.22

Like their children, adults in the Concession Area will ingest more soil than an adult office or factory worker in the US, and a high end soil ingestion rate based on data collected in the US and Europe will be closer to a central tendency ingestion rate in the Concession Area residences and farms near well sites.

19 In the US, studies of soil ingestion rates – which are usually conducted in urban and suburban settings

where much time is spent indoors – show that rates vary among the participating individuals. EPA summarizes high end and central tendency estimates of these exposures c.f. EPA 2011 op. cit. Table 5‐1. p. 5‐ 5, and generally recommends the use of the high end rates in HHRA calculations for the RME. 20 US EPA 2014b.

21 Excerpt from a response by General Electric to a US EPA risk assessment for the Housatonic River in

Massachusetts.

22 CA EPA (OEHHA) Draft Hot Spots Program Guidance Manual) September 2014.

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Finally, Dr. McHugh's unsupported assertion that stream sediments are constantly covered with water shows his unfamiliarity with the seasonality of the water levels in the Concession Area, and the extent of sediment contamination. The contention that the contaminated sediments are always buried under clean sediments is also false. All of the sediment samples collected in the 2014 sampling program and most of the sediments collected in 2013 (including all the samples included in the risk calculation) are surface and shallow sediments. These sediments are or easily could be encountered by residents, e.g., as they stand in the streams to wash clothing, or by animals drinking stream water, and then tracked into houses — and they are contaminated with petroleum.23

2.3.3 Frequency And Duration Of Bathing I used US EPA default values for bathing frequency and duration in my 2013 HHRA. Additional information was collected in June 2014 from observation and interview data in the Concession Area. Bathing is used for both cleaning and heat relief. Mothers in rural areas relevant to the HHRA reported bathing their children at least once each day; several reported bathing their children multiple times per day, including the mother of young children at LA16. As shown below, bathing at LA16 means using a bucket to pour water over the child. This process is repeated many times per bathing event adding to the total amount of time the water remains on the skin. In other locations, children are immersed in water. For example, at AG02 (shown below), children and adults bathe and wash laundry while immersed in a stream.

bathing and washing at LA16 bathing and washing at AG02

The duration of bathing is variable and less well known. My HHRA relied on US EPA guidance in effect when the risk assessment was prepared, one hour for young children and 35 minutes for adults and children over 6. In February 2014, the US EPA changed its recommendation for default values based on more recent data.24 The young child bathing

23 LBG December 2013 Rejoinder Report, Appendix B Site Investigation and Data Summary Report and LBG

November 2014 Expert Report, Appendix A Site Investigation and Data Summary Report.

24 US EPA 2014 a, b OSWER Directive 9200.1‐120 dated February 6, 2014.

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duration was reduced to 32 minutes and the older child and adult bathing duration was increased to 43 minutes. Use of US data may underestimate the typical length of dermal contact with water because Concession Area residents use the same surface water for bathing, swimming, and laundry, and the climate is hotter and more humid than typical in the US.

In response to Chevron’s criticisms, I calculated cancer risk and non‐cancer hazards based on both 30 minute and 60 minute duration bathing for young children. The duration of the bathing made little to no difference in the risk calculations, and no difference in conclusions based on exceedance of a benchmark because dermal exposure to water is just one of several contributors to the overall risk at most of the well sites. For the risk calculations reported below, I used the revised US EPA recommendations.

2.4 TPH Can Be Used To Evaluate Toxicity, Especially Oil Related Toxicity, and Thus To Show Health Risks It is undisputed that Dr. McHugh did not evaluate health risks from TPH in his risk assessments. In part, he argued that it was impossible to evaluate risks from TPH. In this section, I provide a methodology, explained below, to evaluate health risks associated with exposure to crude oil and its residues using TPH as a measure of concentration and petroleum industry generated toxicity data for crude oil. I further show that TPH measured by total extractable material (TEM) method provides the most appropriate measure of TPH concentration to use in this evaluation.

The four step methodology for conducting an HHRA, applied here, was described in both of my previous expert reports: 1) hazard identification; 2) dose‐response assessment; 3) exposure assessment; and 4) risk characterization.25

The goal is to characterize the risk of health effects to determine if cleanup is warranted.

The first step to achieving this goal is to identify the hazard. In the Concession Area, the hazard is crude oil and its residues, hazards that have been described based on clinical studies, toxicology studies, and epidemiological studies. The dose response assessment is usually based on toxicity (animal) testing. The American Petroleum Institute (“API”) (2011) has summarized toxicity tests of crude oil for a number of adverse effects. API has also developed models to predict the adverse responses at particular doses (benchmark doses) of different crude oils; these are necessary for a quantitative dose‐response assessment. The exposure assessment is the estimation of the dose that reaches a hypothetical RME person. The exposure assessment includes the analytical data collected at the location being evaluated (in this case measures of TPH at the various well sites) and various exposure parameters such as those discussed in earlier sections of this report.

Information from the dose‐response assessment and exposure assessment are combined to characterize risk.

25 Strauss, Feb 2013 Section 2.3.2 pp. 12‐17 and Strauss Dec 2013 Appendix A.

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The non‐cancer and cancer assessments are conducted separately. The results are called the hazard index (HI) and excess lifetime cancer risk (ELCR), respectively. These results are compared with regulatory benchmarks, which are often an HI of 1 and an ELCR in the range of 10‐4 to 10‐6 (one in ten thousand to one in a million). If the HI is higher than one, and the ELCR within or higher than the cancer risk range, further evaluation and often remediation are required.

2.4.1 Development Of A Non‐Cancer Dose Response Factor (Reference Dose) For Crude Oil From The Concession Area The API, as part of its submission to the US EPA High Production Volume program for crude oil, provided the results of its toxicity testing program for various crude oils.26 The testing included skin painting studies in which two crude oils, one heavy and one light, were applied to the backs of rats for 90 days, and the adverse effects evaluated. Both crude oils caused skin changes (hyperplasia and hyperkeratosis) associated with skin cell proliferation (pre‐cancer), irritation, and inflammation. Adverse effects on internal organs were also observed, which shows that toxic components of the oils were absorbed through the skin and reached internal organs. The immune system (thymus), the endocrine system (thyroid), the liver, and bone marrow (manifesting as aberrant hematology including reduced red blood cells and platelet counts) were all adversely affected. Reduced body weight gain, a reflection of slower growth of the young animals used in the experiment and a general indicator of toxicity, was also observed. Skin irritation and thyroid effects (hypertrophy and hyperplasia, potentially a precancerous condition) were observed even at the lowest dose tested.27 Similar skin painting studies were conducted using pregnant rats to determine the impact of crude oil on the developing fetus and young offspring. Crude oil was painted on the backs of pregnant rats from zero to 19 days of pregnancy. Even this short dosing period (20 days vs. 90 days, above) resulted in the adverse effects just described – skin irritation, immune system effects, liver changes – on the pregnant rats. Observed pre‐natal and post‐ natal effects included increased in utero death, delayed ossification (skeleton formation), decreased pup body weight, and decreased pup survival.28 As discussed in both of my previous reports, different crude oils have different toxic potencies, and API has summarized data showing that crude oil’s (and that of other petroleum products) potency for cancer, birth defects, thyroid effects, blood effects and immune effects can be predicted by the quantity of the fraction of crude oil known as 3‐7

26 API 2011. Cited and provided in my previous opinions.

27 API 2011. p. 45. These studies were also discussed in my February 2013 expert opinion (p. 41‐42). The expert report of Dr. Blanca Laffon, submitted concurrently with this one, discusses health effects experienced by oil cleanup workers. Many are similar to those observed in the toxicity tests.

28 API 2011 pp. 51‐54. These studies were also discussed in my February 2013 expert opinion (p. 42) and my

December 2013 rejoinder opinion (pp. 51‐52).

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ring PACs,29 although these are not the only toxic components of crude oil. Skin irritation is primarily due to an entirely different component of crude oil; and some aromatic compounds in crude oil, such as benzene, isopropyl benzene (cumene), naphthalene, and 2‐ methylnaphthalene are carcinogenic even though they have 1 or 2 aromatic rings.

Based on the toxicity data from skin painting tests, API calculated doses at which 10% of the animals are predicted to suffer adverse effects.30 These are known as benchmark doses or BMD10. API also developed a method for extrapolating the toxicity of known crude oils to untested crude oils based on the amount of 3‐7 ring PACs in crude oils of untested toxicity. To quantify the toxicity of the untested oils, API calculated predicted benchmark doses, denoted PDR10, using the 3‐7 ring PAC concentration of each crude oil as the basis of the prediction. The PDR10s of more than 40 untested crude oils, along with their API gravity were in their submission to the US EPA.

Benchmark doses such as the PDR10 calculated by API can be converted to reference doses (RfDs), which are the toxicity factor used in the dose response assessment. The conversion is the application of numerical factors to adjust for the uncertainty, variability, and inadequacies of the benchmark dose. These factors include:  variability in responses (e.g., one human to another),  uncertainty of predicting toxicity in humans based on animal data,  conditions of the test vs. applicable conditions (e.g., 90 day vs. lifetime exposure, oral vs. dermal exposure),  whether the benchmark dose is a no observed effect level, and  quality and completeness of available toxicity data.

Following US EPA guidance for development of reference doses31, I used a factor of 3000 to convert the PDR10 to a dermal reference dose. The dermal reference dose was the basis of an oral reference dose. I calculated a dermal reference dose of 0.03 mg/kg‐day and an oral reference dose of 0.004 mg/kg‐day for crude oil of similar API gravity to that in the Concession Area. Technical Appendix 2 provides details of my derivation of these doses.

2.4.2 Methods For Analyzing TPH Measuring the concentration of oil in the environment is a difficult task as crude oil is a complex mixture with many different compounds with different chemical and toxicological properties. Sensory approaches such as observation of floating oil or sheen, odor, and taste are indicative of the presence of oil, and the API and ASTM recommend cleanup when observed to protect animal and human health.32

29 PACs are polycyclic aromatic compounds. This fraction includes polycyclic aromatic hydrocarbons (PAHs)

as well as toxic compounds that also contain nitrogen, sulfur and oxygen in their rings or attached to the rings.

30 API 2011 p. 46.

31 US EPA 2002. A review of the reference dose and reference concentration processes. EPA/630/P‐02/002F. 32 API 2004 (Livestock); ASTM E1739‐95 (human health, sensitive ecological receptors).

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There are many methods to quantify how much oil, or which components of oil, are present. Each gives a different result from the same initial sample, depending on factors that include the portion of the oil mixture targeted for analysis, sample preparation, detection methodology, potential interferences, and many others. LBG utilized several methods to quantify oil residues, commonly referred to as TPH (total petroleum hydrocarbons), in the June 2014 field program:33

 Method 8015M: This method yields fractions labeled as Gasoline Range Organics (GRO), Diesel Range Organics (DRO), extended DRO, and heavy DRO. Each fraction has a characteristic carbon range, and aromatic and aliphatic hydrocarbons are measured together. The DRO and extended DRO fractions include the toxic 3‐7 ring PAC fraction, although some would be lost due to the solvent used in sample preparation. The GRO fraction has the 1‐2 ring compounds and is appropriately evaluated by comparison to gasoline.  Massachusetts Method VPH/EPH: This method yields fractions with specified carbon ranges; aromatic and aliphatic hydrocarbons are reported separately. The aromatic fractions C11‐C22 include the toxic 3‐7 ring PAC fraction, although some would be lost due to the solvent used for sample preparation. The VPH aromatic fraction contains the carcinogenic 1‐2 ring compounds.  Texas Method TX1005: This method yields various fractions of characteristic carbon range with the aromatic and aliphatic combined. Some of the toxic 3‐7 ring PAC fraction would be lost due to the solvent used for sample preparation.  Total Extractable Material (TEM) Method: This method measures the entire mass of materials using a solvent (dichloromethane) that dissolves the toxic 3‐7 ring PAC fraction, allowing it to be measured. The results combine all carbon ranges and aromatic and aliphatic hydrocarbons.

The following chart shows graphically the ranges of crude oil captured by each analytical method. As can be seen, the TEM method is the most complete, capturing the most fractions of oil.

33 LBG November 2014 Expert Report. Short November 7 2014, Supplementary Memorial Expert Report.

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The fractions detected by the first three methods can be summed to give a single TPH number for each sample analyzed, although as noted above, these summations still miss part of the oil components in the original mixture including some of the toxic 3‐7 ring PACs and heavier components. Most of the crude oil components missed in the summation are captured in the TEM Method. As a result, TPH measured by the TEM method always gives a more complete, and thus higher, result than the other three. Detailed comparisons of TPH concentrations from TEM and Method 8015 show that TEM concentrations are approximately five times higher.34

2.4.3 Risk Characterization Based On Crude Oil As A Whole The health risk from crude oil can be evaluated several ways. US EPA guidance for the evaluation of mixtures35 presents a hierarchy of approaches, with the preferred approaches being evaluated based on the mixture itself or a sufficiently similar mixture. The oil and gas industry also recommends this approach.36 Because toxicity data for whole mixtures are usually lacking, a less preferred but more commonly used approach is to evaluate fractions of the mixture separately using a toxicity value for each fraction based on one individual component of that fraction. This method was used in my previous HHRA based on Method 8015M data and Massachusetts VPH/EPH data.

34 Short Expert Report November 2014 section 4.1; LBG Expert Report November 2014 Appendix C2.

35 US EPA 1986. Guidelines for the Health Risk Assessment of Chemical Mixtures. EPA/630/R‐98/002.; US EPA 2000. Supplementary Guidance for Conducting Health Risk Assessment of Chemical Mixtures.

EPA/630/R‐00/002.

36 c.f., IPIECA 2010 Globally Harmonized System for Petroleum Substances. Version 1.

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For crude oil, the non‐cancer hazard can be evaluated using the more preferred whole mixtures approach based on the quantitative dose response factor described in Section 2.1.4 and an analysis of TPH. In my opinion, the TEM method is the best basis for this whole oil TPH analysis because it includes almost all of the components in crude oil, and most closely approximates the measurement used in the toxicity tests (mass of crude oil).

In other words, TEM is the best measure for an “apples to apples” comparison of the dose.

2.5 There Are Substantial Non‐Cancer Health Risks From Exposure To Crude Oil For this HHRA, I calculated non‐cancer hazard indices (HIs) using both the fraction approach used in my December 2013 HHRA and the whole mixture approach described above (section 2.4). I calculated exposure using the same equations as in my previous HHRA, although the duration of bathing was changed, as described in section 2.3.3 above.

In addition, my new HHRA includes exposures to surface soil, as these data are available from LBG’s 2014 testing but were not available from LBG’s 2013 testing. Soil ingestion rates were described in section 2.3.2. Additional details of the exposure calculations are provided in Technical Appendix 1. The calculation of a reference dose from the API derived benchmark doses is provided in Technical Appendix 2.

The chart below summarizes the non‐cancer hazards (HIs) at six of the well sites investigated by LBG in 2014: AG06, LA02, LA16, SSF13, SSF34, and SSF43. I evaluated several exposure pathways at five of the sites and only a former use pathway at the sixth (SSF43). The second column lists the type of exposure pathway and whether the exposure is a past, current, or future use. The columns labeled VPH/EPH fraction and 8015M fraction give the HIs based on an evaluation of the toxicity of each fraction, the method used in my December 2013 HHRA. The next three columns provide the HIs using the whole mixture approach, namely the concentrations in all the fractions obtained using VPH/EPH, 8015M, or TX1005 are summed to obtain the concentration of petroleum hydrocarbons for that specific method. This total is then used in conjunction with the RfD for Oriente crude oil described in Section 2.4.1 and Technical Appendix 2. The final column of the chart below provides the HI calculated by what is, in my opinion, the most appropriate method for evaluating the risk, namely using oil concentrations measured by TEM and the RfD for Oriente crude.

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The chart highlights the HIs above 1, the point at which harm may occur. HIs above 1 but less than 10 are highlighted in pink, those between 10 and 99 are highlighted in orange, and those above 100 in red.

The TEM�based whole mixture analysis results in the highest HIs, as expected. All methods result in an HI above 1 for at least three well sites. Non�cancer hazard was identified at all six site examined. Exposure pathways at AG06, LA02, and SSF34 had HIs greater than 100,

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which means that the doses are approaching the range in which adverse effects were observed in the toxicology studies.

2.6. There Are Cancer Risks From Crude Oil Exposure Dr. Moolgavkar continues to state that there is no evidence that exposure to oil has caused any harm, including specifically, cancer. However, Dr. Blanca Laffon has filed concurrently with this report a report detailing her findings regarding oil’s genotoxic effects, which show the cancer risk of oil. In addition, Dr. Moolgavkar’s opinion contradicts petroleum industry findings and reports that indicate that dermal contact with crude oil is associated with, among other things, skin cancer, and immune dysfunction.

The worldwide petroleum industry has compiled toxicity data on crude oil to provide to US and European regulatory programs, such as the High Production Volume program in the US and the REACH program in the EU. The focus of industry studies is on dermal exposure.

The diagram below, taken from a report published by CONCAWE37, an industry organization, shows that repeated exposures, such as those experienced by people in the Concession Area, can result in dermatitis, and skin tumors (cancer), and other health effects that require quantitative risk assessment, such as that presented in section 2.5.

Figure 6

Health risk assessment of dermal exposure to petroleum hydrocarbons

37 CONCAWE (Conservation of Clean Air and Water in Europe,) is the oil and gas companies’ European

association for environment, health and safety 2010. Review of dermal effects and uptake of petroleum hydrocarbons. Report no. 5/10.

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Source: CONCAWE 2010, p. 60

CONCAWE38 2010 (p. 59) also points out one reason why the harm increases with repeated exposures and may produce skin cancer:

“In addition to the irritation effects of petroleum hydrocarbons, the skin barrier function may be affected following repeated contact, making the skin more susceptible to other irritants, sensitizing agents, and bacteria and also enhance the dermal penetration of other substances.

Furthermore, there is increasing evidence that severe, dermal irritation induced by long‐term or repeated exposure to certain hydrocarbons can contribute to the progression‐promotion effect and the development of skin tumours.”

2.6.1 Toxicology Studies Show Crude Oil Components Are Mutagenic And Carcinogenic The PAC fraction of oil (which includes PAHs) is mutagenic in standard toxicity tests including the well‐known Ames assay; crude oils are carcinogenic after dermal application to skin (mouse bioassays).

As summarized by the API39: “A number of crude oil samples, representing a range of compositions, have been investigated for their potential to cause skin cancer in mouse skin‐painting studies of 104‐110 week duration. All four crude oils including some distillation fractions of API Crude C and D (See below), produced skin tumors in 33‐100% of mice with latency periods of 40‐76 weeks, and were considered dermal carcinogens. Tumor incidence and latency depended on crude oil source and dose (Table 18). Numerous studies have shown that the mutagenic and carcinogenic potential of complex petroleum‐related substances, all of which are derived from crude oil, correlates with the presence of 3‐7 ring PAC. Further studies have shown these PAC can be absorbed through the skin and enter the general circulation.” (references deleted, emphasis added) This assessment of the potential carcinogenicity of crude oil is supported by the International Petroleum Industry Environmental Conservation Association (IPIECA):40

“For petroleum substances containing PAHs, the skin carcinogenic potential is related to the level of specific 3‐7 fused‐ring PAHs. While

38 ibid. p. 59.

39 API 2011. p. 58.

40 IPIECA, June 17, 2010. Version 1. Guidance on the application of Gloabally Harmonized System (GHS) critera to petroleum substances, at p. 10.

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concentrations of specific PAHs can be determined, and certain PAHs are classified as carcinogenic (e.g., by IARC), the skin carcinogenic potential of petroleum substances should normally be assessed based on the whole substance, taking into account the total PAH content. This is because individual PAHs may occur at toxicologically insignificant concentrations, but the total PAH‐content may be toxicologically important.” [emphasis added] For most people exposed to crude oil in developed countries, dermal contact and inhalation of volatile components are considered the primary routes of exposure. However, in the Concession Area, ingestion exposure – via drinking water, soils, and sediments – is also an important consideration. Oral exposure was relegated to Appendix 5 in the API submission to the US EPA because it was deemed an “unrealistic” route of exposure.

However, the API summary and the underlying data41 show that dermal and oral exposure result in the same health effects, strongly suggesting that ingestion of crude oil also results in cancer, including in particular, cancers in the gastrointestinal system. Moreover, because the carcinogenic 3‐7 ring PACs are absorbed into the body, they may cause cancer wherever they become located in the body.

2.6.2 Risk Of Cancer In The Concession Area Using HHRA Methodology Like the risk assessment for non‐cancer hazards described in sections 2.4 and 2.5, cancer risk from crude oil is most appropriately evaluated using a whole mixture approach with carcinogenicity data based on tests using crude oil and exposure measured by the TEM method. API and other industry groups have reported the results of cancer bioassays of crude oil, but, unlike for the non‐cancer benchmark dose, have not quantified a cancer potency factor.

In my December 2013 HHRA, the cancer risk calculation incorporated the published cancer slope factors for six PAHs which comprise a very small portion of 3‐7 ring PACs, plus 1‐ methylnaphthalene, a 2 ring compound. However, many more 3‐7 ring PACs are known to be carcinogenic based on toxicity testing, as discussed in section 2.6.1. Some of the alkylated PAHs, such as 5‐methyl chrysene, are 100 times more carcinogenic than their parent compound, in this case chrysene,42 yet only chrysene is currently included in US EPA’s risk assessment methodology. Both are included in methodology recently proposed by the State of California.43

Carcinogens that are not part of the 3‐7 ring PAC fraction have also been left out of the cancer risk estimate. For example, carcinogens with fewer than 3 rings, such as

41 API 2011 and API 2003 High Production Volume Chemical Challenge Program. Test plan crude oil category.

Submitted to US EPA by API petroleum HPV testing group. November 21, 2003.

42 CA EPA (OHHEA) 2009. Appendix B (updated 2011) p B‐91.

43 CA EPA (OHHEA) 2014 op cit.

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naphthalene and cumene (isopropylbenzene) have been detected in many Concession Area samples, but are not included in the cancer risk calculation because US EPA has not published a cancer toxicity factor. Cumene was first listed as a carcinogen this year (2014) and more carcinogens may be identified as toxicity testing continues.44 Obviously, the US EPA methodology based on only a few parent PAH (a subset of PAC) compounds substantially underestimates carcinogenic risk of crude oil.

The carcinogenic 3‐7 ring PAC fraction is obtained using an analytical methodology that was not used in any of the field samples in the Concession Area. However, the LBG dataset provides the mass of alkyl substituted and parent PAHs for specified 3‐5 ring PAHs and a few sulfur containing PACs (dibenzothiophenes). These are a portion of the 3‐7 ring PAC fraction. Thus, while still an underestimate, the sum of the total amount of identified 3‐5 ring PAHs plus sulfur containing dibenzothiophenes, which ranges from 0.2‐5%, provides a minimum measure of how small a fraction of potential carcinogenicity is evaluated by currently available cancer slope factors.

Despite the substantial underestimate of cancer risk, my December 2013 HHRA resulted in significant cancer risks for several well site/exposure pathway combinations. At LA02, use of the nearby stream as a domestic water supply (a known former use) resulted in an excess lifetime cancer risk of 1x10‐3 (one in a thousand). This estimate evaluates 0.5% and 4% of the 3‐7 ring PAC fraction for sediment and surface water, respectively. While this is a former use, samples collected in 2014 from inside the house shows ongoing contamination.45

2.7 Response To Additional Critiques From Claimants’ Experts 2.7.1 Barium Toxicity Is Evaluated Appropriately Dr. McHugh suggests that I used an inappropriate measure for the toxicity of barium.46 According to him, I should have used toxicity based on barium sulfate because the elevated barium concentrations are from Texpet’s use of barite‐containing drilling muds. His argument assumes that: 1) barium sulfate is less toxic than other barium salts because it is insoluble and therefore not well absorbed, and 2) barium sulfate is not converted to more soluble barium salts while in the environment. Neither assumption is true.

According to the US EPA toxicological profile for barium,47 some studies show that barium originating from both soluble and relatively insoluble barium salts is absorbed from the

44 US National Toxicology Program October 2014. Report on Carcinogens, 13th edition, Monograph on

Cumene, (monograph dated September 25, 2013).

45 The interior samples were wipe samples. They were collected using individually packaged alcohol wipes

rubbed against the surface. One wipe was used for the children’s toy. For the floor samples, each sample was composed of 5 individual wipes. Each wipe was rubbed inside a 200 cm2 template.

46 Expert opinion of Thomas E. McHugh, May 2014. pp. 3 and 4.

47 US EPA 2005. Toxicological review of barium and compounds. EPA/635/R‐05/001.

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gastrointestinal tract to a similar extent, likely due to the acidic environment of the stomach. In addition, Chevron has not provided any data showing that barium sulfate is the form found in the environmental samples. In fact, LBG has conducted an analysis of barium concentrations in water and has concluded that, in certain samples, the barium is no longer part of barium sulfate; it has been converted into a soluble salt.48

In my opinion, the US EPA reference dose is the most appropriate measure of toxicity of barium in the waters, soils, and sediments in the Concession Area. I also note, however, that barium, even using the US EPA reference dose, does not meaningfully contribute to the non‐cancer hazards in the Concession Area. The vast majority of the estimated hazard is from the crude oil, measured as TPH. 2.7.2 Surface Water Samples Should Not Be Filtered Drinking water exposure should be based on unfiltered water samples (i.e., including sediment to the extent it is suspended in the water) because that is what residents consume and bathe in.49 Dr. McHugh’s statement that "the users would minimize the amount of sediment in their drinking water to the extent possible" is yet another culturally inappropriate and unfounded assertion. HHRAs assess exposure as a site would be used if it were not contaminated. In the former Concession Area, water generally is consumed as collected, sometimes in plastic bottles from streams near a farmer’s field (c.f., the farmer at AG06), sometimes from buckets at wells or from bridges (c.f., LA16, SSF25), sometimes in collection boxes (SSF13). In 2013, the LBG sampling team collected water samples in a manner similar to that used by the residents. In the 2014 sampling program, LBG collected surface water samples by peristaltic pump which had the consequence of minimizing the inclusion of sediments. Data from samples collected in this manner may lead to an underestimate of risk from water consumption.

2.7.3 Exposure Is Evaluated At Appropriate Locations My December 2013 HHRA (as well as the HHRA included in this report) evaluated locations where there was both visible and analytically measured contamination. Real, live people live in these areas, although the sites were evaluated using risk assessment methodology and exposure parameters appropriate for an RME receptor. Dr. McHugh, like the rest of Claimants’ consultants, is trying to average the petroleum contamination over both clean and dirty areas, thus diluting the exposure and subsequent risk that is experienced by individuals living near contaminated well sites.

48 LBG Expert report November 2014 Section 3.4.3.1.

49 US EPA 1989, p. 6‐34.

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The population in these rural areas is increasing,50 which means that even more people will live near contaminated well sites and abandoned pits in the future. Risk assessment methodology requires evaluating risk at future potential drinking water sources and other exposure media. Both current and future exposure locations were sampled and evaluated, and they are appropriate.

2.7.4 Exposure To Sediments And To Surface Water Is Evaluated Appropriately Claimants contend that I evaluated the dermal uptake of contaminants in sediment inappropriately. According to Dr. McHugh: “TPH measured in the surface water samples was not dissolved, but rather was associated with sediment present in the water samples, assuming uptake from both sediment and surface water double‐counts the exposure resulting in an over estimation of risk from dermal uptake.”51 Dr. McHugh’s premise that the TPH measured in water is associated with sediment is not substantiated. LBG has shown that oil (measured as TPH) in water samples can be in the form of an emulsion, i.e., a mixture of water and oil, like shaken up salad dressing. In other cases, it is a sheen, a separate phase in the water, or as oil droplets as shown in photographs in the LBG opinion.52 Thus, the TPH measured in water is not necessarily sediment associated. And even if the TPH were sediment‐associated, exposure to sediment occurs via two different and independent exposure pathways (dermal exposure to water and dermal exposure to sediment). US EPA methodology calls for evaluating these exposure pathways separately and combining the results to calculate the cumulative risks of exposure from all pathways.53 2.7.5 Dr. McHugh’s Citation Of His Personal Experience Is Culturally Inappropriate And An Unreliable Basis To Develop Exposure Parameters In The Concession Area Claimants and their consultants claim that my use of data collected using valid social science methodology is “anecdotal” and thus unreliable. Yet Dr. McHugh offers opinions based on his personal experience in a different climate, lifestyle, and culture. For example, Dr. McHugh’s statement – “In my experience, parents try to minimize the time required to bathe their infants” – does not provide a basis for assessing bathing habits in the Concession Area. As I determined from my interviews with people living near the contaminated well sites, bathing is for both cleaning and relief from the heat.

50 Observations of new housing construction, conversion of forested land to farm use, and rapid growth of

smaller towns (such as Shushufindi) reported by LBG, and INEC data for Concession Area cantons show that both urban and rural populations are growing.

51 Expert opinion of Thomas E. McHugh, May 2014. p. 5.

52 LBG Expert Report November 2014. Section 3.4.1.

53 US EPA 1989, pp. 8‐15 ff.

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Dr. McHugh suggests that I had not addressed his previous criticism regarding my use of “anecdotal data”54 principally the Beristain et al. study with the English title “Words from the Rainforest.”55 On the contrary, I did address his criticism in my December 2013 opinion.

In any event, the information in the Beristain report is consistent with the interview reports prepared by Claimants’ consultants of the residents surrounding wells during their Pre‐inspection Investigations, interviews with some of the same residents whom I spoke with, observations of health effects of oil spills outside of the Concession Area (and outside of Ecuador)56, and information on indigenous culture documented by anthropology and other studies.57

3.0 Supplemental Opinion: Petroleum Contamination Has Reduced Local Food Resources, Including Farm Animals, Crops, And Fish. The Reduced Availability Of Home‐Produced Food Has Had An Adverse Impact On The Health Of The Local Population That Relies On These Resources.

Farm animals intended for food use, including cows, chickens, ducks, and pigs come into contact with soil, sediment, and surface water. Terrestrial wildlife that are hunted for game as well as domestic animals such as horses and pets also come into contact with soil, sediment, and surface water. Both wild fish and those raised in farm ponds come into contact with sediment and surface water. Crude oil‐related contamination has been detected above concentrations known to affect farm animals and fish at many of the well sites.

3.1 Loss Of Livestock The API developed guidance for cleaning up crude oil to protect livestock on contaminated lands, specifically including land contaminated by closed oil pits that were dug as part of the well installation.58 The API guidance assumes that there are no open pits or other free oil accumulations on the ground, consistent with industry and regulatory guidance dating back to at least the 1990s.

54 Expert opinion of Thomas E. McHugh, May 2014. p. 6. (in section 3).

55 Beristain, CM, DP Rovira, and I Fernadez. 2009. Words from the Rainforest. A psychosocial study of the impact of Texaco’s petroleum operations on the communities of Ecuador’s Amazon. English translation of Las Palabras de la Selva.

56 Laffon Expert Report 2014; Strauss Rejoinder Report December 2013; Strauss expert opinion February

2013.

57 c.f. Martínez et al. 2007 Impacts of Petroleum Activities for the Achuar People. of the Peruvian Amazon:

Summary of Existing Evidence and Research Gaps. Env. Res. Lett. 2:1‐10. Sirén, A.; J. Machoa 2008. Fish, wildlife and human nutrition in tropical forests: A fat gap? Interciencia 33(3) pp. 186‐193.

58 API 2004. Risk Based Screening Levels for the Protection of Livestock Exposed to Petroleum Hydrocarbons. Publication no. 4733.

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Guidance was needed because: “Consumption of petroleum hydrocarbons by livestock has been found to lead to a range of health problems, including neurotoxicity, fetal toxicity, damage to the gastrointestinal tract, respiratory system, kidney, and liver.

Petroleum ingestion has also been linked to anorexia, lethargy, and fatal poisoning in cattle.”59 (references deleted).

API developed risk based soil and water screening values for livestock such as cows and horses that are pastured, but not chickens and ducks, which it assumed are raised in enclosed areas. However, in the Concession Area, chicken and ducks generally roam freely, and thus are also subject to injury by oil.

Because it assumed there are no open pits, API’s livestock guidance is based on the conceptual model depicted below in which a closed pit releases petroleum contamination to soil and to surface water (either by overland flow or through groundwater). In this model, livestock are exposed when consuming soil along with plant materials during grazing, and by ingestion of contaminated drinking water.

Source (API, 2006)60

59 Ibid. p. 2‐1.

60 American Petroleum Institute (API) 2006. Livestock Exposure Brochure. API Creative Services | 2006‐059 |

06.06 | 300.

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Chevron employees Sara McMillen and Renae Magaw were members of the workgroup and review committee that developed the API livestock guidance. GSI has used livestock risk based screening levels in the past,61 and prepared an issue paper on livestock exposure in the Oriente, including development of risk�based screening levels for pigs, ducks, and chickens.62 Unfortunately, documentation of how these levels were derived was not provided in the paper.

The chart below highlights the six well sites that violate the industry standard of no surface accumulations of oil in agricultural areas. It also compares risk based screening levels protective of farm animals such as cows, horses, goats, and sheep with TPH concentrations found in certain surface soils near the well sites investigated by LBG in 2014.63 Surface and shallow sediment data were compared with API’s risk based screening levels at all well sites from which data were collected. The sites where at least one soil or sediment sample exceeded the API screening levels are marked with a red oval (soil) or triangle (sediment).

The chart also summarizes reports of harm to crops or animals based on interviews in the clickable database or by interviews conducted with landowners/tenants during my site visit in June 2014.

61 GSI 0520535.

62 GSI0769161.

63 No surface soil samples were collected in the 2013 site investigation.

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Eleven of the 13 well sites examined had observable surface accumulations of petroleum, or at least one exceedance of a risk based livestock screening level or crop screening level.

LBG conducted only limited site investigations at the various well sites. No surface soil samples were collected in the crop area at LA16 nor in the wetlands area at SSF43 where animals reportedly contacted contamination and died. Thus, absence of an exceedance should not be interpreted as absence of contamination.

As seen in the final column, the petroleum contamination causes observable harms to farm animals, often resulting in the loss of the animal and the food or cash income it would provide.

3.2 Contamination Of Fish Pond At SSF‐13 The farm at SSF13 has a fish pond similar to many in the region, where fish such as tilapia are raised for personal consumption and possibly also for sale. However, no fish were observed in this pond during the LBG field work in June 2014. A sediment sample collected from the pond had a TPHTEM concentration of 320 mg/kg. The surface water had TPH8015 of 153 ug/L; naphthenic acids, which could only have come from crude oil, were present at 3.7 ug/L.64 In other words, residues of crude oil have reached and contaminated the surface water and sediment of this fish pond.

3.3 Implications Of Livestock, Fish, Wild Game And Crop Loss The loss of livestock and crops, chickens, ducks, eggs, and tilapia ponds, represents the loss of both food for residents and cash income. The loss of fish in streams and wild game65 also represents a loss of food for the subsistence farmers and indigenous people.66 The loss of food has important effects on nutrition, including loss of both calories and a balanced diet including fat and protein.67 These losses are particularly important in the Concession Area because the children are already nutritionally deficient as evidenced by an approximately 50% rate of anemia in children under 5.68 Most, but not all, of the anemia responds to treatment with supplemental vitamins and iron, which means that the anemia is due to undernourishment. This local estimate of nutrition‐related anemia is consistent with the World Health Organization’s statistics on chronic malnutrition in rural areas of Ecuador.69

64 LBG Expert Report 2014. Section 3.4.3.2.

65 Beristain et al. 2009 op cit; José Guamán witness statement (also interview July 2013).

66 Martínez et al. 2007 op. cit.

67 Sirén and Machoa 2008 op cit.

68 Estimate based on interview with Dr. Angel Jara Pinto, Sub Centro de Salud La Victoria on 6/13/14.

69 The World Health Organization (WHO) 2013 reports that chronic malnutrition in rural areas of Ecuador

decreased from 42.8% in 1999 to 35.5% in 2006, although the rate is twice that among indigenous populations.

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The health impacts of undernourishment and malnutrition are well known. The World Bank70, in its summary of Ecuador, provides a general, lay summary of the health impact of undernourishment:

 Undernourished children have an increased risk of falling sick and greater severity of disease.  Undernourished children who fall sick are much more likely to die from illness than well‐nourished children.

In the language of risk assessment, the loss of food animals and crops makes the residents of the Concession Area a susceptible population and thus more sensitive to the toxic effects of the oil pollution.

4.0 Supplemental Opinion: Dr. Moolgavkar Used Highly Flawed Data As The Basis Of His Cancer Study, Making His Results And Conclusions Unreliable And Uninformative Dr. Moolgavkar cited an opinion piece by J. P. A. Ioannidis titled “Why Most Published Research Findings are False”71 in his May 2014 expert opinion. Ironically, his recently published paper titled “Cancer mortality and quantitative oil production in the Amazon region of Ecuador, 1990‐2010”72 most certainly falls into the category of false research findings.

4.1 Cancer Mortality Data From The Oriente Are Unreliable Dr. Moolgavkar’s analysis has a fundamental flaw: the mortality data on which he bases his analysis, death certificate data from the Amazon region, are unreliable with respect to cancer deaths. Obviously, the use of unreliable data yields results that are non‐informative at best, and it can lead to false and misleading conclusions.

Dr. Moolgavkar and colleagues obtained all of their underlying cancer mortality data from the Instituto Nacional de Estadistica y Censos (INEC), which in turn derives its data from death certificate data submitted by health care workers throughout Ecuador. Interviews with several health care providers in the Concession Area, including physicians who write death certificates, revealed several reasons why death certificate data from the Concession Area are unreliable and may substantially underreport the existence of cancer.

70 World Bank (undated). Ecuador Nutrition at a Glance. (downloaded from the World Bank website in

October 2014). The World Bank goes on to provide its summary of the economic impact of undernourishment, but that is beyond the scope of my opinion.

71 Ioannidis, John P.A. 2005. Why Most Published Research Findings are False. PLoS Medicine, 2(8) e124.

72 Moolgavkar, SH, Change, ET, Watson, H, Lau, EC. 2014. Cancer Causes Control 25:59‐72.

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The director of Hospital Provincial Marco Vinicio Iza Lago Agrio told me that death certificates are notoriously inaccurate in terms of actual cause of death. He noted that they often cite the immediate cause of death (e.g., cardiac arrest or multi‐organ failure) rather than the underlying cause of death (e.g., cancer, heart disease, diabetes). Similarly, a doctor at Shushufindi Hospital told me that everyone gets a death certificate and confirmed that cancer would rarely if ever be listed as a cause of death on a death certificate.

Further, an unknown but potentially large percentage of cancers in the Concession Area are not diagnosed formally,73 which can be done only at certain hospitals run by the Sociedad de Lucha Contra el Cáncer (SOLCA hospitals) that specialize in cancer.74 Residents in the Concession Area are usually referred to the SOLCA hospital in Quito. Many health care providers in the Concession Area pointed out that poor people rarely seek formal diagnosis or treatment because of the many barriers they face in getting to Quito. The residents living nearest to the well sites, those most exposed to oil, are among the poorest of the Concession Area (based on housing type, access to clean water, electricity, sanitary waste disposal, and other measures). They are most at risk of cancer from oil exposures and yet least likely to be counted in cancer incidence and cancer mortality studies.

One doctor estimated that 90% of the children referred to Quito for treatment don’t go.

Significantly, his estimate is based on only those residents who visit Shushufindi Hospital; there may be a large number of sick people who do not even make the initial visit to the local hospital. The health care workers interviewed at a primary care clinic, 18th de Noviembre Centro de Salud, which refers patients to Shushufindi Hospital, reported barriers to access, such as lack of transportation, to even this local hospital. Another doctor at the Provincial Hospital in Lago Agrio also reported that not all patients go to Quito for diagnosis and treatment, and his patients include those who have the means to get to the main provincial hospital.

The inadequacy of death certificate data from the Oriente is well‐known and taken into account in economic development plans for provinces. For example, the 2011 Development Plan for Orellana, referring to the two national registries for the principal causes of death, points out that “[i]t is important to take into account that the information from both sources is not always complete given that, in many cases, deaths take place in remote places in the region without obtaining medical assistance or evaluation.”75 It is unknowable how many of these deaths may have been due to cancer.

73 They are strongly suspected to have cancer based on clinical indications, which is why they are referred to

Quito.

74 The exception to this may be cervical cancer that can be diagnosed at the hospital in Lago Agrio. However,

this capability only became available 4 years ago (2010); at the very end of the time period studied by Moolgavkar et al.

75 Gobierno Autónomo Provincial de Orellana 2011. Plan de Desarrollo de la Provincia de Orellana.

Caracterización Provincial. P. 177. The original Spanish is: “es importante tener en cuenta que la información de ambas fuentes no siempre es completa ya que, en muchos casos, las muertes suceden en lugares apartados de la región sin que se logre contar con asistencia o evaluación médica.”

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Because the mortality data underlying Moolgavkar’s cancer study are inaccurate, the only possible conclusion is that the study is non‐informative regarding cancer deaths in oil producing areas; any conclusions drawn from the study are unsubstantiated.

4.2 Dr. Moolgavkar Uses An Inappropriate Measure Of Oil Exposure Dr. Moolgavkar claims that his new study improves upon the exposure component (and other components) of the study published in 2009 by Kelsh and co‐workers.76 By doing so, he also implicitly claims that it is better than the exposure metric used by Hurtig and San Sebastian in their publication.77 I disagree that Moolgavkar’s measure of exposure is better than prior studies, and I continue to hold the opinion that the exposure metric used by Hurtig and San Sebastian is more appropriate for two important reasons:

 Hurtig and San Sebastian focused their study on the Concession Area where Texpet operated. In contrast, Moolgavkar and Kelsh included all oil‐producing areas (Cascales, Cuyabeno) where other oil companies were the operators. Only Texpet’s practices are relevant to the question of health effects caused by Texpet.

 Hurtig and San Sebastian required that exposure take place over a long period of time (20 years), consistent with the common understanding that cancer develops (in adults) following prolonged exposure. In contrast, Moolgavkar quantified oil exposure by “well‐year”, the cumulative number of oil wells and total years of their existence, modified by oil production volume as if it were equally distributed for each well. Moolgavker does not require an extended period of exposure. In the Moolgavkar (and Kelsh) exposure system, a newly installed high producing well can count as much as an older, lower producing well, although the older well could easily pose more risk. Moreover, exposure from abandoned wells, several of which were evaluated in my HHRA in the previous section, are not included in the Moolgavkar/Kelsh exposure system. Given that exposure in the Oriente is largely through unremediated pits and spills, neither of which go away when a well is abandoned, it is unreasonable to exclude them.

An additional problem with Dr. Moolgavkar’s methodology is that he sorted oil‐exposed and unexposed cantons based on oil activity as of 1990. However, some of his unexposed cantons have had substantial oil development post‐1990, as indicated in his Table 1. This poses a problem because he evaluated this exposed/non‐exposed grouping using mortality data from 1990‐2010. Thus, some of the populations he designates as unexposed have actually been exposed during the period he is evaluating. He also ignores completely the time period between 1970‐1990.

76 I opined on Kelsh’s work in my first Expert Opinion dated 2‐18‐13 at pp. 39‐40.

77 Hurtig AK, San Sebastian M. 2002. Geographical differences in cancer incidence in the Amazon basin of

Ecuador in relation to residence near oil fields. Int J Epidemiol, 31:1021‐7.

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The many inadequacies related to epidemiological aspects of Dr. Moolgavkar’s methodologies were addressed in Dr. Grandjean’s expert opinion of December 2013.

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Technical Appendix 1: Details Of The Risk Calculations

I evaluated the data collected in LBG’s June/July 2014 field sampling program to evaluate the risk of potential adverse health effects to current and future residents of the Concession Area who might be exposed to the oil contamination. I used the same exposure assessment methodology and parameters described in my December 2013 Rejoinder report for exposure to surface water, groundwater, and sediment, with the exception of the modified bathing times described in Section 2.3.3. Additional explanation for the exposure parameters appears in section 2 of this report. I added exposure scenarios to surface soil (child residential and adult farmer exposures) because surface and shallow soil data were collected in the sampling 2014 program. In addition, as described in section 2.4.1 of my report, I evaluated non‐cancer hazard using the preferred whole mixture approach in addition to the commonly used fraction approach.

The surface soil exposure scenario is very similar to the sediment exposure scenario: it includes soil ingestion and dermal contact, and requires exposure parameters for the evaluation. For a child, surface soil non‐cancer hazard is based on daily exposure for children who ingest 200 mg of soil, and who get dirt on their heads, hands, feet, forearms, and lower legs. The average adherence factor (AF) for the dirt on their bodies is 0.2 mg/cm2. These child exposure parameters are the ‘default’ values used in a residential soil scenario in a US EPA risk assessment.78

For adult farmers, the exposure scenario is based on daily contact with soil in an agricultural setting, but without machines and the dust generated by them. The scenario incorporates a soil ingestion rate of 200 mg/day based on the upper bound estimates of soil ingestion from the State of California as described in section 2.3.2. It assumes the same area covered with dirt as the sediment scenario, namely face, hands, forearms, lower legs, and feet with a total exposed surface area (SA) of 6275 cm2. The adherence factor (AF) is 0.13 mg/cm2‐event. It is a weighted average of the measured AFs for these body parts in the archeologist activity provided in the US EPA’s exposure factors handbook, as these are the most similar to the Concession Area farmer.79 These exposure scenarios represent a high end, but not extreme, exposure under conditions in the US. For residents living near well sites in the Concession Area, it is more likely to be closer to a central tendency or average exposure.

78 US EPA February 2014a, b op. cit.

79 US EPA 2011 (Exposure Factors Handbook) op. cit.

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Technical Appendix 2: Development Of A Reference Dose For Crude Oil

An RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure to the human population (including sensitive groups, such as asthmatics, or life stages, such as children or the elderly) that is likely to be without an appreciable risk of deleterious effects during a lifetime. An RfD is generally expressed in units of milligrams per kilogram of bodyweight per day: mg/kg/day.

An RfD is determined by use of the following equation:

RfD = (experimental or benchmark dose)/uncertainty factors

The dose can be an experimentally determined no observed adverse effect level (NOAEL) or lowest observed adverse effect level (LOAEL), or a benchmark dose that is calculated from the experimental data and provides an estimate of the population that would be affected (e.g., 10%) at a specified dose.

Uncertainty factors (UFs) take into account the variability and uncertainty that are reflected in possible differences between test animals and humans (generally 10‐fold or 10x) and variability within the human population (generally another 10x); the UFs are multiplied together: 10 x 10 = 100x. If a LOAEL is used, another uncertainty factor, generally 10x, is also used. In the absence of key toxicity data (duration or key effects), an extra uncertainty factor(s) may also be employed. Sometimes a partial UF is applied instead of the default value of 10x, and this value can be less than or greater than the default. Often the partial value is ½ log unit (the square root of 10) or 3.16 (rounded to 3‐ fold in risk assessment). Note, that when two UFs derived from ½ log units are multiplied together (3 x 3) the result is a 10 (equal to the full UF from which the two partial factors were derived).

I used a predicted benchmark dose, specifically a PDR10 from a repeated dose experiment, as the basis for the reference dose calculation.80 Because different crude oils have different toxicities, I used the lower end of the doses of the four crude oils with API gravities within 1o of Concession Area crude (the nearest PDR10s are: 93, 202, 130, 305), specifically a PDR10 of 100 mg/kg‐d.

I applied a total uncertainty factor of 3000, which was a combination of the following factors: 10x variability in the human population 10x differences between test animals and humans 10x use of a LOAEL rather than a NOAEL. A factor of 10 was used for two reasons: 1) the benchmark dose is for an effect of 10% of the population and 2) the benchmark dose (or the predicted benchmark dose, or PDR10) is the best estimate, not the lower bound

80 The PDR

10 is similar to a BMD10 except it is a predicted dose based on API’s peer reviewed model.

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estimate (BMDL10) that US EPA would typically use.

3x use of a repeated dose (90 day) rather than lifetime test.

RfD (dermal) = 100/3000 = 0.03 mg/kg‐day

I converted the RfD (dermal) to an RfD(oral) using a dermal absorption factor of 0.13, US EPA’s default dermal absorption factor for all PAHs. In other words, only 13% of the PACs applied dermally reach target organs inside the body compared to those taken in orally.

Accounting for this reduction in toxicity by the dermal route leads to an RfD(oral) of 0.004 mg/kg‐d.

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References Already In The Record

United States Environmental Protection Agency (EPA). 1989. Risk Assessment Guidance for Superfund Part A.

United States Environmental Protection Agency (EPA). 1991. Role of the Baseline Risk Assessment in Superfund Remedy Selection Decisions. OSWER Directive 9355.0‐30.

USEPA. 1986. Guidelines for the Health Risk Assessment of Chemical Mixtures. EPA/630/R‐ 98/002.

USEPA. 2000. Supplementary Guidance for Conducting Health Risk Assessment of Chemical Mixtures. EPA/630/R‐00/002.

ASTM 1739‐95 Standard Guide for Risk‐Based Corrective Action Applied at Petroleum Release Sites.

Jose Guamán Witness Statement.

American Petroleum Institute (API), “High Production Volume (HPV) Chemical Challenge Program Crude Oil Category Assessment Document,” submitted to the USEPA by American Petroleum Institute Petroleum HPV Testing Group, January 14, 2011.

Beristain, CM, DP Rovira, and I Fernadez. 2009. Words from the Rainforest. A psychosocial study of the impact of Texaco’s petroleum operations on the communities of Ecuador’s Amazon. English translation of Las Palabras de la Selva.

Ioannidis, John P.A. 2005. Why Most Published Research Findings are False. PLoS Medicine, 2(8) e124.

Moolgavkar, SH, Change, ET, Watson, H, Lau, EC. 2014. Cancer Causes Control 25:59‐72.

Hurtig AK, San Sebastian M. Geographical differences in cancer incidence in the Amazon basin of Ecuador in relation to residence near oil fields. Int J Epidemiol 2002;31:1021‐7.

Expert reports of LBG, Short, Grandjean and Laffon, 2014.

New References

EPA. Feb 2014 a, b OSWER Directive 9200.1‐120.

EPA. 2011. Exposure Factors Handbook. EPA/600/R‐09/052F.

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OSHA (Occupational Safety and Health Administration) Heat Index and Protective Measures (accessed on OSHA website Oct 2014).

California Department of Industrial Relations Heat Illness Prevention Standard Title 8 CCR3395: http://www.dir.ca.gov/Title8/3395.html.

UNICEF data http://www.indexmundi.com/facts/ecuador/exclusive‐breastfeeding Ministerio de Salud Pública del Ecuador Funbbasic/Ibfan. May 2009. Iniciativa mundial sobre tendencias en lactancia materna informe nacional.

Del Bubba et al 2005. PAHs and fat content in breast milk. Annal di Chimica 95: 629‐642.

General Electric. 2004. Response to a USEPA risk assessment for the Housatonic River in Massachusetts. Attachment E. Selection of Soil Ingestion Rates.

CA EPA (OEHHA). Draft Hot Spots Program Guidance Manual. September 2014.

CA EPA (OHHEA). 2009. Appendix B (updated 2011).

EPA 2002. A review of the reference dose and reference concentration processes.

EPA/630/P‐02/002F.

API. 2004. Risk Based Screening Levels for the Protection of Livestock Exposed to Petroleum Hydrocarbons. Publication no. 4733.

EPA. 2005. Toxicological review of barium and compounds. EPA/635/R‐05/001.

IPIECA. 2010. Globally Harmonized System for Petroleum Substances. Version 1.

CONCAWE (Conservation of Clean Air and Water in Europe) is the oil and gas companies’ European association for environment, health and safety. 2010. Review of dermal effects and uptake of petroleum hydrocarbons. Report no. 5/10.

API. 2003. High Production Volume Chemical Challenge Program. Test plan crude oil category. Submitted to USEPA by API petroleum HPV testing group. November 21, 2003.

US National Toxicology Program. October 2014. Report on Carcinogens, 13th edition, Monograph on Cumene (monograph dated September 25, 2013).

Sirén, A.; J. Machoa. 2008. Fish, wildlife and human nutrition in tropical forests: A fat gap?

Interciencia 33(3) pp. 186‐193.

Martinez et al. 2007. Impacts of Petroleum Activities for the Achuar People of the Peruvian Amazon: Summary of Existing Evidence and Research Gaps. Env. Res. Lett. 2:1‐10.

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World Health Organization (WHO). 2013. Country Cooperation Strategy at a Glance. http://www.who.int/countryfocus.

World Bank (undated). Ecuador Nutrition at a Glance. (downloaded from the World Bank website in October 2014).

Gobierno Autónomo Provincial de Orellana 2011. Plan de Desarrollo de la Provincia de Orellana. Caracterización Provincial.

American Petroleum Institute (API). 2006. Livestock Exposure Brochure. API Creative Services | 2006‐059 | 06.06 | 300.

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