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Michael D. Klein, P.E., CHMM
         06/26/2012
 Topics that will be covered include
   Specialty experts.
   Experts and the science of exposure to chemical
    hazardous materials.
   What steps an expert takes to evaluate a chemical
    exposure
   Sample case study
 You have located, screened, and selected an expert
 whose credentials are:
   above reproach
   has the education, training, and experience
   who can withstand a Daubert challenge
   whose particular skills are what are needed for the
    case
   who has communication skills
 Before signing that engagement letter, you the
  litigator should think through what will be required for
  the case.
 Does the case require a
   workhorse?
   a show horse?
   or a racehorse?
 Is the case dependent largely on the quality and
  sophistication of calculations and analysis?
 Does counsel need a polished courtroom
  appearance?
 Does the expert need to be capable of translating
 arcane formulae and calculations into opinions that
 will not put a jury panel of mere mortals to sleep?

 Does the case demand someone with expertise in a
 highly specialized area?

 Does the expert need to be capable of hitting top
 speed when emergencies arise or timelines are
 tight?
 The litigator and the expert must define the facts and
  assumptions — the “givens” — on which the expert
  will base the evaluation of a chemical exposure.
 These facts and assumptions represent the
  foundation of the expert’s opinion.
 An expert who undertakes an evaluation of a
  chemical exposure without having facts and
  assumptions clearly defined and articulated is on a
  very slippery slope.
 Litigation involving the chemicals said to pose
 excessive risks to health requires litigants to present
 evidence regarding exposure.
   Exceeding regulatory standards
 Understanding the exposure is essential to
 understanding whether the toxic properties of
 chemicals have been or will be expressed in humans
 or the animal population.
   Exceeding levels that lead to adverse health effects
 Claims of toxic tort or product liability generally
  require expert testimony in
   Medicine
   The sciences of epidemiology and toxicology
   The nature and magnitude of the exposures incurred
    by those alleging harm
 Litigation involving the chemicals said to pose
 excessive risks to health requires litigants to present
 evidence regarding exposure.

 Where the magnitude of exposure is an important
 component of the needed evidence, and if that
 magnitude is not a simple question of fact, then
 expert testimony will be important.
 Exposure science is not yet a distinct academic
 discipline.

 Initially, exposure assessment was typically practiced
 by toxicologists and epidemiologists.

 As the breadth and complexity of the subject began
 to be recognized scientists and engineers are now
 necessary to provide scientifically defensible
 assessments.
 The engineer and scientist is a grouping of experts
 who can provide expertise as to the properties of
 chemicals
   How they behave and undergo change in different
    environments
   The methods available to identify and measure
    chemicals in products and in the environment
 Their training, education and experience.
 The necessary foundation of an expert to provide
 scientifically defensible assessments.
 The expert’s job goes beyond merely stating
  conclusions.
 He or she must be comfortable articulating the basis
  for calculations and conclusions.
 This will require the ability to “deconstruct and
  reconstruct” the big picture into all its component
  parts and computations.
 The expert will not simply be called on to opine
  based on a static set of facts. He or she must be
  able to master the event chronology in the case.
 Exposure science is the study of how people can
 come into contact with (are exposed to) chemicals
 that may be present in various environmental media
   Air
   Water
   Food
   Soil
   Consumer products of all types
 They evaluate the amounts of those chemicals that
 enter the body as a result of these contacts.
 Human beings are exposed to natural and industrial
 chemicals from conception to death.

 Almost all chemicals can become harmful if
 exposures exceed certain levels.

 The exposure expert brings understanding as to the
 magnitude and duration of exposures to chemicals
   This is critical to understanding their health impacts.
 Exposure scientists also study whether and how
 those amounts change over time.
   The goal of exposure science is to quantify those
    amounts and time periods.
   The quantitative expression of those amounts is
    referred to as a dose.
 Ultimately the dose incurred by individuals or
  populations is the measure needed by health experts
  to quantify risk of toxicity.
 Exposure science does not typically deal with the
  health consequences of those exposures.
 Exposure assessments can be directed at past,
  present, or even future exposure
 They can be narrowly focused
   One chemical
   One environmental medium
   One population group
 They can also be very broad in scope
   Many chemicals
   Several environmental media
   Several different population groups
 Oil and gas recovery operations utilize the process
 of Hydraulic Fracturing.
   Perform a chemical exposure evaluation of the
    operations.
   Information that is required to perform it.
   Results obtained from a chemical exposure
    evaluation.
   How the results are used.
 The method used to make hard shale rock more porous.
 Allows gas shale to flow through the fine grained, organic-rich,
  sedimentary rock formations to the wellbore.
 Shale gas is present across much of North America in basins of both
  extreme and moderate size. Some of the major shale reserves
  include:
      Marcellus (Pennsylvania, New York,
       Ohio, West Virginia, Kentucky)
      Bakken (North Dakota, Wyoming)
      Haynesville (Texas, Louisiana)
      Barnett (Texas)
      Eagleford (Texas)
      Fayetteville (Arkansas)
      Antrim (Michigan, Illinois, Ohio)
      Woodford (Oklahoma)
 The Marcellus Shale
 is known as the
 Saudi Arabia of
 Natural Gas.

 The US Geological
 Survey estimates
 500 trillion cu ft of
 natural gas in
 Marcellus alone.
 Until recently shale gas could not be cost
 effectively extracted.

 Two factors came together in
  recent years to make shale gas
  production economically viable:
  • Advances in horizontal drilling
  • Advances in hydraulic fracturing
By drilling and casing a well for the extraction of the
natural gas
   producers drill into the earth several thousand feet
    until they reach the natural gas reservoir
   steel casings are inserted to a depth of 1,000 to
    3,000 feet
   the space between the casing and the drilled hole
    is filled with cement to stabilize the well and prevent
    any leakage
   the cement sets
   this process is repeated, using a series of s
    successively smaller casings until the reservoir
    is reached
   depths reach distances of 6,000 to 10,000 feet
Once drilling and casing is complete
   3 to 5 million gallons of
    water, mixed with sand and
    chemical additives, are
    pumped into the wellhead
    at high pressure, creating
    cracks in the rock beds

   the hydraulic fracturing
    mixture is 95% water,
    4.5% proppant, and
    0.5% chemical additives
Once drilling and casing is complete
 Proppant is a material, such as grains of sand, ceramic,
  or other particulates, that prevent the fractures from
  closing when the injection is stopped.

 Fracturing fluid formulas vary slightly among production
  sites in accordance with the unique requirements of each
  site’s geology.

 The fracture width is typically maintained after the
  injection by introducing a proppant into the injected fluid.
 Shale gas extraction using the process of
 hydraulic fracturing environmental and human
 health concerns possibly may include the
   Potential mishandling of solid or liquid toxic waste
   Potential risks to air quality
   Potential contamination of ground water
   The unintended migration of gases and hydraulic
    fracturing chemicals to the surface within a given
    radius of drilling operations
 Exposure assessment is generally intended to
 answer the following questions:
   Who has been or could become exposed to a specific
    chemical(s) arising from one or more specific sources?
   Is it the entire general population, or is it a specific
    subpopulation?
   What specific chemicals comprise the exposures?
   What are the pathways from the source of the
    chemical to the exposed population?
 Pathways include direct product use.
 Indirect pathways where the chemical moves
 through one or more environmental media to reach
 the media to which people are exposed.
   Air
   Water
   Food
   Soil and dust
 Understanding pathways is necessary to
 understanding exposure routes and quantifying
 exposures.
 By what routes are people exposed?
   Routes include ingestion, inhalation, and dermal
    contact.
 Identifying exposure routes is important because
  those routes affect the magnitude of ultimate
  exposures and because they often affect health
  outcomes.
 What is the magnitude and duration of exposure
  incurred by the population of interest?
 Dose: the amount of chemical entering the body or
 contacting the surface of the body, usually over
 some specified period of time (often over 24 hours).

 Duration refers to the number of days over which
 exposure occurs.
   Exposures can be intermittent or continuous and can
    be highly variable, especially for some air
    contaminants.
 The ultimate goal of exposure assessment is to
 identify dose and duration.

 After a chemical enters or contacts the body, it can
 be absorbed (into the bloodstream), distributed to
 many organs of the body, metabolized (chemically
 altered by certain enzymes in cells of the liver and
 other organs), and then excreted.
 Understanding these processes is important to
  determining whether and how a chemical may cause
  adverse health effects.
 These processes mark the interface between
  exposure science and toxicology, epidemiology, and
  medicine.
 Understanding the dose is the necessary first step in
  understanding these processes.
Questions?
Thank you for having
        me!

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Green Light And Red Flag Avoiding Case Preparation Pitfalls 06 26 2012

  • 1. Michael D. Klein, P.E., CHMM 06/26/2012
  • 2.  Topics that will be covered include  Specialty experts.  Experts and the science of exposure to chemical hazardous materials.  What steps an expert takes to evaluate a chemical exposure  Sample case study
  • 3.  You have located, screened, and selected an expert whose credentials are:  above reproach  has the education, training, and experience  who can withstand a Daubert challenge  whose particular skills are what are needed for the case  who has communication skills
  • 4.  Before signing that engagement letter, you the litigator should think through what will be required for the case.  Does the case require a  workhorse?  a show horse?  or a racehorse?  Is the case dependent largely on the quality and sophistication of calculations and analysis?  Does counsel need a polished courtroom appearance?
  • 5.  Does the expert need to be capable of translating arcane formulae and calculations into opinions that will not put a jury panel of mere mortals to sleep?  Does the case demand someone with expertise in a highly specialized area?  Does the expert need to be capable of hitting top speed when emergencies arise or timelines are tight?
  • 6.  The litigator and the expert must define the facts and assumptions — the “givens” — on which the expert will base the evaluation of a chemical exposure.  These facts and assumptions represent the foundation of the expert’s opinion.  An expert who undertakes an evaluation of a chemical exposure without having facts and assumptions clearly defined and articulated is on a very slippery slope.
  • 7.  Litigation involving the chemicals said to pose excessive risks to health requires litigants to present evidence regarding exposure.  Exceeding regulatory standards  Understanding the exposure is essential to understanding whether the toxic properties of chemicals have been or will be expressed in humans or the animal population.  Exceeding levels that lead to adverse health effects
  • 8.  Claims of toxic tort or product liability generally require expert testimony in  Medicine  The sciences of epidemiology and toxicology  The nature and magnitude of the exposures incurred by those alleging harm
  • 9.  Litigation involving the chemicals said to pose excessive risks to health requires litigants to present evidence regarding exposure.  Where the magnitude of exposure is an important component of the needed evidence, and if that magnitude is not a simple question of fact, then expert testimony will be important.
  • 10.  Exposure science is not yet a distinct academic discipline.  Initially, exposure assessment was typically practiced by toxicologists and epidemiologists.  As the breadth and complexity of the subject began to be recognized scientists and engineers are now necessary to provide scientifically defensible assessments.
  • 11.  The engineer and scientist is a grouping of experts who can provide expertise as to the properties of chemicals  How they behave and undergo change in different environments  The methods available to identify and measure chemicals in products and in the environment  Their training, education and experience.  The necessary foundation of an expert to provide scientifically defensible assessments.
  • 12.  The expert’s job goes beyond merely stating conclusions.  He or she must be comfortable articulating the basis for calculations and conclusions.  This will require the ability to “deconstruct and reconstruct” the big picture into all its component parts and computations.  The expert will not simply be called on to opine based on a static set of facts. He or she must be able to master the event chronology in the case.
  • 13.  Exposure science is the study of how people can come into contact with (are exposed to) chemicals that may be present in various environmental media  Air  Water  Food  Soil  Consumer products of all types  They evaluate the amounts of those chemicals that enter the body as a result of these contacts.
  • 14.  Human beings are exposed to natural and industrial chemicals from conception to death.  Almost all chemicals can become harmful if exposures exceed certain levels.  The exposure expert brings understanding as to the magnitude and duration of exposures to chemicals  This is critical to understanding their health impacts.
  • 15.  Exposure scientists also study whether and how those amounts change over time.  The goal of exposure science is to quantify those amounts and time periods.  The quantitative expression of those amounts is referred to as a dose.  Ultimately the dose incurred by individuals or populations is the measure needed by health experts to quantify risk of toxicity.  Exposure science does not typically deal with the health consequences of those exposures.
  • 16.  Exposure assessments can be directed at past, present, or even future exposure  They can be narrowly focused  One chemical  One environmental medium  One population group  They can also be very broad in scope  Many chemicals  Several environmental media  Several different population groups
  • 17.  Oil and gas recovery operations utilize the process of Hydraulic Fracturing.  Perform a chemical exposure evaluation of the operations.  Information that is required to perform it.  Results obtained from a chemical exposure evaluation.  How the results are used.
  • 18.  The method used to make hard shale rock more porous.  Allows gas shale to flow through the fine grained, organic-rich, sedimentary rock formations to the wellbore.
  • 19.  Shale gas is present across much of North America in basins of both extreme and moderate size. Some of the major shale reserves include:  Marcellus (Pennsylvania, New York, Ohio, West Virginia, Kentucky)  Bakken (North Dakota, Wyoming)  Haynesville (Texas, Louisiana)  Barnett (Texas)  Eagleford (Texas)  Fayetteville (Arkansas)  Antrim (Michigan, Illinois, Ohio)  Woodford (Oklahoma)
  • 20.  The Marcellus Shale is known as the Saudi Arabia of Natural Gas.  The US Geological Survey estimates 500 trillion cu ft of natural gas in Marcellus alone.
  • 21.  Until recently shale gas could not be cost effectively extracted.  Two factors came together in recent years to make shale gas production economically viable: • Advances in horizontal drilling • Advances in hydraulic fracturing
  • 22. By drilling and casing a well for the extraction of the natural gas  producers drill into the earth several thousand feet until they reach the natural gas reservoir  steel casings are inserted to a depth of 1,000 to 3,000 feet  the space between the casing and the drilled hole is filled with cement to stabilize the well and prevent any leakage  the cement sets  this process is repeated, using a series of s successively smaller casings until the reservoir is reached  depths reach distances of 6,000 to 10,000 feet
  • 23. Once drilling and casing is complete  3 to 5 million gallons of water, mixed with sand and chemical additives, are pumped into the wellhead at high pressure, creating cracks in the rock beds  the hydraulic fracturing mixture is 95% water, 4.5% proppant, and 0.5% chemical additives
  • 24. Once drilling and casing is complete  Proppant is a material, such as grains of sand, ceramic, or other particulates, that prevent the fractures from closing when the injection is stopped.  Fracturing fluid formulas vary slightly among production sites in accordance with the unique requirements of each site’s geology.  The fracture width is typically maintained after the injection by introducing a proppant into the injected fluid.
  • 25.  Shale gas extraction using the process of hydraulic fracturing environmental and human health concerns possibly may include the  Potential mishandling of solid or liquid toxic waste  Potential risks to air quality  Potential contamination of ground water  The unintended migration of gases and hydraulic fracturing chemicals to the surface within a given radius of drilling operations
  • 26.  Exposure assessment is generally intended to answer the following questions:  Who has been or could become exposed to a specific chemical(s) arising from one or more specific sources?  Is it the entire general population, or is it a specific subpopulation?  What specific chemicals comprise the exposures?  What are the pathways from the source of the chemical to the exposed population?
  • 27.  Pathways include direct product use.  Indirect pathways where the chemical moves through one or more environmental media to reach the media to which people are exposed.  Air  Water  Food  Soil and dust  Understanding pathways is necessary to understanding exposure routes and quantifying exposures.
  • 28.  By what routes are people exposed?  Routes include ingestion, inhalation, and dermal contact.  Identifying exposure routes is important because those routes affect the magnitude of ultimate exposures and because they often affect health outcomes.  What is the magnitude and duration of exposure incurred by the population of interest?
  • 29.  Dose: the amount of chemical entering the body or contacting the surface of the body, usually over some specified period of time (often over 24 hours).  Duration refers to the number of days over which exposure occurs.  Exposures can be intermittent or continuous and can be highly variable, especially for some air contaminants.
  • 30.  The ultimate goal of exposure assessment is to identify dose and duration.  After a chemical enters or contacts the body, it can be absorbed (into the bloodstream), distributed to many organs of the body, metabolized (chemically altered by certain enzymes in cells of the liver and other organs), and then excreted.
  • 31.  Understanding these processes is important to determining whether and how a chemical may cause adverse health effects.  These processes mark the interface between exposure science and toxicology, epidemiology, and medicine.  Understanding the dose is the necessary first step in understanding these processes.