-------
LIFETIME HA CALCULATION:
NON-CARCINOGENS
• Determine RfD (Reference Dose) in mg/kg/day
- NOAEL or LOAEL In mg/kg/day
Uncertainty Factor
• Determine DWEL (Drinking Water Equivalent Level) in
mg/L assuming 100% drinking water contribution
(Rfd) (70kg person)
(2 L/day)
• Determine Lifetime HA in mg/L
Lifetime HA = (DWEL) (% drinking water
contribution)
MCLG = Non-enforceable health goal
for a chemical to be regulated
(set MCL)
Lifetime HA = Non-enforceable guidance level
used in an emergency situation
(accidents/ spills)
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF DRINKING WATER
SAFE DRINKING WATER HOTLINE
1-800-426-4791 (TOLL-FREE)
202-382-5533 (WASHINGTON, D.C.)
MONDAY THRU FRIDAY, 8:30 A.M. TO 4:30 P.M. E.S.T.
NATIONAL PESTICIDE TELECOMMUNICATION NETWORK
ANY QUESTIONS ABOUT PESTICIDES?
CALL
1-800-858-7378
24 HOURS - 7 DAYS A WEEK
9-
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GLOSSARY OF TERMS
Risk Assessment and Management
Absorbed dose. The amount of a chemical that enters the body of an
exposed organism.
Absorption. The uptake of water or dissolved chemicals by a cell or an
organism.
Absorption factor. The fraction of a chemical making contact with an
organism that is absorbed by the organism.
Acceptable daily intake (ADI). Estimate of the largest amount of
chemical to which a person can be exposed on a daily basis that is
not anticipated to result in adverse effects (usually expressed in
(Synonymous with RfD)
Active transport. An energy-expending mechaniism by which a cell ooves
a chemical across the cell membrane from a point of lower concen-
tration to a point of higher concentration, against the diffusion
gradient.
Acute. Occurring over a short period of ti«e; used to describe brief
exposures and effects which appear promptly after exposure.
Additive Effect. Combined effect of two or more chemical* «qual to the
SUB of their individual effects.
Adsorption. The process by which chemicals are held on the surface of
a mineral or soil particle. Compare with absorption.
Ambient. Environmental or surrounding conditions.
Animal studies. Investigations using animals as surrogates for humans,
on the expectation that results in animals are pertinent to humans.
Antagonism. Interference or inhibition of the effect of one chemical
by the action of another chemical.
Assay. A test for a particular chemical or effect.
Bias. An inadequacy in experimental design that leads to results or
conclusions not representative of the population under study.
Bioaccumulation. The retention and concentration of a substance by an
organism.
Bioassay. Test which determines the effect of a chemical on a living
organism.
-10-
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Bioconeentration. The accumulation of a chemical in tissues of an
organism (such as fish) to levels that are greater than the level
in the medium (such as water) in which the organism resides (see
bioaccumulation).
Biodegradation. Decomposition of a substance into more elementary
compounds by the action of microorganisms such as bacteria.
Biotransformation. Conversion of a substance into other compounds by
organisms; includes biodegradation.
by. Body weight.
CAG. Carcinogen Assessment Group.
Cancer. A disease characterized by the rapid and uncontrolled growth
of aberrent cells into malignant tumors.
Carcinogen. A chemical which causes or induces cancer.
CAS registration number. A number assigned by the Chemical Abstracts
Service to identify a chemical.
Central nervous system. Portion of the nervous system which consists
of the brain and spinal cord; CHS.
Chronic. Occurring over a long period of time, either continuously or
intermittently} used to describe ongoing exposures and effects
that develop only after a long exposure.
Chronic exposure. Long-term, low level exposure to a toxic chemical.
Clinical studies. Studies of humans suffering from symptoms induced by
chemical exposure.
Confounding factors. Variables other than chemical exposure level
which can affect the incidence or degree of a parameter being
measured.
Coat/benefit analysis. A quantitative evaluation of the costs which
would be incurred versus the overall benefits to society of a
proposed action such as the establishment of an acceptable dose of
a toxic chemical.
Cumulative exposure. The summation of exposures of an organism to a
chemical over a period of time.
Degradation. Chemical or biological breakdown of a complex compond
into simpler compounds.
Dermal exposure. Contact between a chemical and the skin.
-11-
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Diffusion. The movement of suspended or dissolved particles from a ^^
more concentrated to a less concentrated region as a result of the
random movement of individual particles; the process tends to
distribute them uniformly throughout the available volume.
Dosage. The quantity of a chemical administered to an organism.
Pose. The actual quantity of a chemical to which an organism is exposed.
(See absorbed dose)
Dose-response. X quantitative relationship between the dose of a
chemical and an effect caused by the chemical.
Dose-response curve. A graphical presentation of the relationship
between degree of exposure to a chemical (dose) and observed
biological effect or response.
Dose-response evaluation. A component of risk assessment that describes
the quantitative relationship between the amount of exposure"to a
substance and the extent of toxic injury or disease.
i
Dose-response relationship. The quantitative relationship between the
amount of exposure to a substance and the extant of toxic injury
produced.
DWEL. Drinking Water Equivalent Level — estimated exposure (in mg/L)
which is interpreted to be protetective for noncarcinogenic
endpoints of toxicity over a lifetime of exposure. DWEL was
developed for chemicals that have a significant carcinogenic
potential (Group B). Provides risk manager with evaluation on
non-cancer endpoints, but infers that carcinogenicity should be
considered the toxic effect of greatest concern.
Sndangerment assessment. \ site-specific risk assessment of the actual
or potential danger to human health or welfare and the environment
froa the release of hazardous substances or waste. The endangerment
assessment document is prepared in support of enforcement actions
under CERCLA or RC8A.
Endpoint. A biological effect used as an index of the effect of a
chesdcal oa an organism.
Spidemiologic study. Study of human populations to identify causes of
disease. Such studies often compare the health status of a group
of persons who have been exposed to a suspect agent with that of a
comparable non-exposed group.
Exposure, contact with a chemical or physical agent.
Exposure assessment. The determination or estimation (qualitative or
quantitative) of the magnitude, frequency, duration, route, and
extent (number of people) of exposure to a chemical.
-12-
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Exposure coefficient. Term which combines information on the frequency,
mode, and magnitude of contact with contaminated medium to yield a
quantitative value of the amount of contaminated medium contacted
per day.
Exposure level, chemical. Th« amount (concentration) of a chemical at
the absorptive surfaces of an organism.
Exposure scenario. A set of conditions or assumptions about sources,
exposure pathways, concentrations of toxic chemicals and populations
(numbers, characteristics and habits) which aid the investigator in
evaluating and quantifying exposure in a given situation.
Extrapolation. Estimation of unknown values by extending or projecting
from known values.
Savage. Type of exposure in which a substance is administered to an
anir**1 through a stomach tube.
Gran. 1/454 of a pound.
Half-life. The length of time required for the BASS, concentration, or
activity of a chemical or physical agent to be reduced by one-half.
Hazard evaluation. A component of risk assessment that involves
gathering and evaluating data on the types of health injury or
disease (e.g., cancer) that nay be produced by a chemical and on
the conditions of exposure under which injury or disease is
produced.
Henatopoiesis. The production of blood and blood cells; hemopoiesis.
Hepatic. Pertaining to the liver.
Hepatoma. A malignant tumor occurring in the liver.
High-to-lowdese extrapolation. The process of prediction of low
exposure risks to rodents from the measured high exposure-high
risk data.
Histology. The study of the structure of calls and tissues; usually
involves microscopic examination of tissue slices.
Human equivalent dose. A dose which, when administered to humans,
produces an effect equal to that produced by a dose in animals.
Human exposure evaluation. A component of risk assessment that involves
describing the nature and size of the population exposed to a
substance and the magnitude and duration of their exposure. The
evaluation could concern past exposures, current exposures, or
anticipated exposures.
-13-
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Human health risk. The likelihood (or probability) that a given exposure
or series of exposures may have or will damage the health)of indi-
viduals experiencing the exposures.
Incidence of tumors. Percentage of animals with tumors.
Ingestion. Type of exposure through the mouth.
Inhalation. Type of exposure through the lungs.
Integrated exposure assessment. A summation over time, in all media,
of the magnitude of exposure to a toxic chemical.
Interapecies extrapolation model. Model used to extrapolate from
results observed in laboratory animals to humans.
In vitro studies. Studies of chemical effects conducted in tissues,
cells or subcellular extracts from an organism (i.e., not in the
living organism).
In vivo studies. Studies of. chemical effects conducted in intact living
organisms.
Irreversible effect. Effect characterized by the inability of the body
to partially or fully repair injury caused by a toxic agent.
Latency. Time from the first exposure to a'chemical until the appearance
of a toxic effect.
, The concentration of a chemical In air or water which is expected
to cause death in 50 percent of test animals living in that air or
water.
LDgQ. The dose of a chemical taken by mouth or absorbed by the skin
which is expected to cause death in SO percent of the test animals
so treated.
Lesion. A pathological or traumatic discontinuity of tissue or loss of
function of a part.
Lethal. Deadly; fatal.
Lifetime exposure. Total amount of exposure to a substance that a
human would receive in a lifetime (usually assumed to be seventy
years).
Linearized multistage model. Derivation of the multistage model, where
the data are assumed to be linear at low doses.
LOAEL. Lowest-Observed-Adverse-Effect Level; the lowest dose in an
experiment which produced an observable adverse effect.
-14-
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Malignant, very dangerous or virulent, causing or likely to cause
death.
Margin of safety (MOS). Maximum amount of exposure producing no
measurable effect in animals (or studied humans) divided by the
actual amount of human exposure in a population.
Mathematical model. Model used during risk assessment to perform
extrapolations.
Metabolism. The sum of the chemical reactions occurring within a cell
or a whole organism; includes the energy-releasing breakdown of
molecules (catabolism) and the synthesis of new molecules (anabolism).
Metabolite. Any product of metabolism, especially a transformed chemical.
Metastatie. Pertaining to the transfer of disease from one organ or
part to another not directly connected with it.
Microgram (ug). One-millionth of a gram (3.5 x 10~8 oz. • 0.000000035 oz.).
Milligram (mg). One-thousandth of a gram (3.5 x 10~8 oz. « 0.000035 oz.).
Modeling. Use of mathematical equations to simulate and predict real
events and processes.
Monitoring. Measuring concentrations of substances in environmental
media or in human or other biological tissues.
Mortality. Death.
MOS. See Margin of safety.
MTD. Ma*!"*"1" tolerated dose, the dose that an animal stfecies can
tolerate for a major portion of its lifetime without significant
impairment or toxic effect other than carcinogenic!ty.
Multistage model. Mathematical model based on the multistage theory of
the carcinogenic process, which yields risk estimates either equal
to or less than the one-hit model.
Mutagen. An agent that causes a permanent genetic change in a cell
other than that which occurs during normal genetic recombination.
Mutagenieity. The capacity of a chemical or physical agent to cause
permanent alteration of the genetic material within living cells.
Necrosis. Death of cells or tissue.
Neoplasm. An abnormal growth or tissue, as a tumor.
Neurotoxieity. Exerting a destructive or poisonous effect on nerve
tissue.
-15-
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NOAEL. No-Observed-Adverse-Effect Level; the highest dose in an
experiment which did not produce an observable adverse effect.
NOEL. No-Observed-Effect Level; dose level at which no effects are
noted.
NTP. National Toxicology Program.
Oncology. Study of cancer.
One-hit model. Mathematical model based on the biological theory that
a single "hit" of some minimum critical amount of a carcinogen at
a cellular target -- namely DNA — can initiate an irreversible series
of events, eventually leading to a tumor.
Oral. Of the mouth? through or by the mouth.
Pathogen. Any disease-causing agent, usually applied to living agents.
Pathology. The study of disease.
Permissible dose. The dose of a chemical that may be received by an
individual without the expectation of a significantly harmful
result.
Pharmaeokineties. The dynamic behavior of chemicals inside biological
systems; it includes the processes of uptake, distribution,
metabolism, and excretion.
Population at risk. A population subgroup that is more likely to be
exposed to a chemical, or is more sensitive to a chemical, than is
the general population.
Potency. Amount of material necessary to produce a given level of a
deleterious effect.
Potentiation. The effect of one chemical to increase the effect of
another chemical.
ppb. Part* p*r billion.
ppa. Parts par million.
Prevalence study. An epidemiological study which examines the
relationships between diseases and exposures as they exist in a
defined population at a particular point in time.
Prospective study. An epidemiological study which examines the
development of disease in a group of persons determined to be
presently free of the disease.
Qualitative. Descriptive of kind, type or direction, as opposed to
size, magnitude or degree.
-16-
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Quantitative. Descriptive of size, magnitude or degree.
Receptor. (1) In biochemistry: a specialized molecule in a cell that
binds a specific chemical with high specificity and high affinity,-
(2) In exposure assessment: an organism that receives, may receive,
or has received environmental exposure to a chemical.
Renal. Pertaining to the kidney.
Reservoir. A tissue in an organism or a place in the environment where
a chemical accumulates, from which it may be released at a later
time.
Retrospective study. An epidemiclogical study which compares diseased
persons with non-diseased persons and works back in time to
determine exposures.
Reversible effect. An effect which is not permanent, especially adverse
effects which diminish when exposure to a toxic chemical is "Ceased.
RfD. Reference dose; the daily exposure level which, during an entire
lifetime of a human, appears to be without appreciable risk on the
basis of all facts known at the time. (Synonymous with ADD
Risk. The potential for realization of unwanted adverse consequences
or events.
Risk assessment.. A qualitative or quantitative evaluation of the
environmental and/or health risk resulting from exposure to a
chemical or physical agent (pollutant); combines exposure assessment
results with toxicity assessment results to estimate risk.
Risk characterization. Final component of risk assessment that involves
integration of the data and analysis Involved in hazard evaluation,
dose-response evaluation, and human exposure evaluation to determine
the likelihood that humans will experience any of the various
forms of toxicity associated with a substance.
Risk estimate. A description of the probability that organisms exposed
to a specified dose of chemical will develop an adverse response
(e.g., cancer).
Risk factor. Characteristic (e.g., race, sex, age, obesity) or variable
(e.g., smoking, occupational exposure level) associated with
increased probability of a toxic effect.
Risk management. Decisions about whether an assessed risk is sufficiently
high to present a public health concern and about the appropriate
means for control of a risk judged to be significant.
Risk specific dose. The dose associated with a specified risk level.
-17-
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Route of exposure. The avenue by which a chemical cornea into contact
with an organism (e.g., inhalation, ingestion, dermal contact,
injection).
Safe. Condition of exposure under which there is a "practical certainty"
that no harm will result in exposed individuals.
Sink. A place in the environment where a compound or material collects
(see reservoir).
Sorption. a surface phenomenon which may be either absorption or
adsorption, or a combination of the two; often used when the
specific mechanism is not known.
Stochastic. Based on the assumption that the actions of a chemical
~substance results from probabilistic events.
Stratification. (1) The division of a population into subpopulations
for sampling purposes; (2) the separation of environmental media
into layers, as in lakes.
Subchronic. Of intermediate duration, usually used to describe studies
or levels of exposure between five and 90 days.
Synergism. An interaction of two or more chemicals that results in
an effect that is greater than the sum of their effects taken
independently.
Systemic. Relating to whole body/ rather than its Individual parts.
Systemic effects. Effects observed at sites distant from the entry
point of a chemical due to its absorption and distribution into
She body.
Teratogenesis. The induction of structural or functional development
abnormalities by exogenous factors acting during gestation;
interference with normal embryonic development.
Teratogenieity. The capacity of a physical or chemical agent to cause
non-hereditary congenital malformations (birth defects) in offspring.
Therapeutic Index. The ratio of the dose required to produce toxic or
lethal effect to dose required to produce non-adverse or therapeutic
response.
Threshold. The lowest dose of a chemical at which a specified measurable
effect is observed and below which it is not observed.
Time-Weighted Average. The average value of a parameter (e.g., concen-
tration of a chemical in air) that varies over time.
Tissue. A group of similar cells.
-18-
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Toxicant. A harmful substance or agent that may injure an exposed
organism.
Toxieity- The quality or degree of being poisonous or harmful to plant,
animal or human life.
Toxieity assessment. Characterization of the toxicological properties
and effects of a chemical, including all aspects of its absorption,
metabolism, excretion and mechanism of action, with special emphasis
on establishment of dose-response characteristics.
Transformation. Acquisition by a cell of the property of uncontrolled
growth.
Tumor incidence. Fraction of animals having a tumor of a certain type.
Uncertainty factor. A number (equal to or greater than one) used to
divide NOAEL or tOAEL values derived from measurements in animals
or small groups of humans, in order to estimate a NOAEL value for
the whole human population.
Onit cancer risk. Estimate of the lifetime risk caused by each unit of
exposure in the low exposure region.
Upper bound estimate. Estimate not likely to be lower than the true risk.
volatile. Readily vaporizable at a relatively low temperature.
-19-
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GENERAL PRINCIPLES OF RISK ASSESSMENT. MANAGEMENT AND COMMUNICATION
AND
TOXICOLOGICAL APPROACHES FOR DEVELOPING ENVIRONMENTAL
STANDARDS AND GUIDANCE
BY
EDWARD V. OHANIAN
BIBLIOGRAPHY
Calabrese, E.J., Gilbert, C.E., Pastides, H. (eds.). Safe Drinking Water Act:
Amendments, Regulations and Standards, Lewis Publishers, Inc., 1989.
Cothern, R., Mehlman, M., Marcus, W. (eds.). Risk Assessment and Risk Management
of Industrial and Environmental Chemicals. In: Advances in Modern Environmental
Toxicology (Volume XV), Princeton Scientific Publishing Co., Inc., 1988.
Finkel, A.M., Confronting Uncertainty in Risk Management: A Guide for
Decision-Makers. Center for Risk Management, Resources for the Future,
Washington, D.C., 1990.
Hance, B.J., Chess, C., Sandman, P.M. Improving Dialogue with Communities: A Risk
Communication Manual for Government. New Jersey Department of Environmental
Protection, 1988.
Ram, N., Christman, R., Cantor, K. Significance and Treatment of Volatile Organic
Compounds in Water Supplies, Lewis Publishers, Inc., 1990.
Tardiff, R., Rodricks, J. (eds.). Toxic Substances and Human Risk: Principles of
Data Interpretation. Plenum Press, 1987.
U.S. Environmental Protection Agency, 1989. Risk Assessment Guidance for
Superfund: Volume 1 - Human Health Evaluation Manual (Part A). Office of
Emergency and Remedial Response, Washington, D.C. EPA/540/4-89/002.
U.S. Environmental Protection Agency, 1989. Risk Assessment, Management,
Communication: A Guide to Selected Sources. Office of Information Resources
Management, Washington, D.C. EPA/MSD/89-004.
U.S. Environmental Protection Agency, 1990. Seminar Publication: Workshops on Risk
Assessment, Management, and Communication. Office of Drinking Water,
Washington, D.C. and Center for Environmental Research Information,
Cincinnati, Ohio. EPA/625/4-89/024.
Vanderslice, R.R., Orme, J., Ohanian, E.V., Sonich-Mullin, C. Using Synergistic Effects
in Risk Assessment of Drinking Water Contaminants. Toxicol. Indust. Hlth. 5:747-755
1989.
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DOCUMENT 4
SESSION 1 - GENERAL TECHNOLOGY AND APPLICATION
U.S. ENVIRONMENTAL PROTECTION AGENCY - DEPARTMENT OF THE ARMY
MEMORANDUM OF UNDERSTANDING:
RISK ASSESSMENT AND MUNITIONS CHEMICALS
-------
U.S. ENVIRONMENTAL PROTECTION AGENCY -- DEPARTMENT OF THE ARMY
MEMORANDUM OF UNDERSTANDING: RISK ASSESSMENT AND MUNITIONS CHEMICALS
Welford C. Roberts
I. USEPA -- DOA MOU
A. Authority
B. Purposes
1. MOU
2. Health Advisories
C. Implementation
D. Status of Munition Health Advisories
II. Risk Assessment and Munitions Chemicals
A, Risk Assessment Methodology ~ A Brief Review
B. Published Health Advisories .-- Summary
C. Human Health Effects
D. Animal Health Effects
E. Health Advisory Values
1. Nitrocellolose
2. Trinitroglycerol
3. Trinitrotoluene
4. RDX
5. HMX
6. DIMP
-------
HEALTH EFFECTS AND RISK
ASSESSMENT OF MUNITIONS
WELFORD C. ROBERTS
MAJOR, US ARMY
DETAILED TO THE USEPA
I OFFICE OF DRINKING WATER J
U.S. ARMY-EPA MOU TO PROVIDE THE ARMY
LEADERSHIP WITH DW HEALTH ADVISORIES
• Authonty-EPA Assistani Administrator for Water and Army Deputy for
Environment, Safety and Occupational Health.
• Describes the Responsibilities and Procedures Under Which the EPA and DA
will Cooperate in Developing Health Advisories on Chemicals Associated with
Munitions that May Be Found as Drinking Water Contaminants.
• Promotes Maximum Use of Federal Resources in the Establishment and Use of
lexicological Data Bases and Methodologies.
• Reflects Army Leadership's Desire to Protect the Public Health Where the Army
is the Manufacturer or User of Toxic Materials.
1 Supports the Army Pollution Abatement Program, the Installation Restoration
Program, Regulatory Agencies and Others Involved in Determination of Adverse
Health Impact.
Serves as a Highly Credible Basis for Corrective Actions such as Treatment,
Clean-up, and Negotiation.
Implementation-Army Surgeon General (Supported by the Army Research and
Development Command) and the EPA Director of the Criteria and Standards
Division (Supported by the Health Effects Branch).
-1-
-------
STATUS OF MUNITIONS HEALTH
ADVISORIES
COMPLETED
• Nitrocellulose
• Trinitroclycerol (TNG)
• 2.4,6-Trinitrotoluene (TNT)
• Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)
• Octahydro-1.3,5,7-tetranitro-1,3,5,7-tetrazocine (HMX)
• Diisopropyi Methylphosphonate (DIMP)
DRAFT
• Dimethyl Methylphosphonate (DMMP)
• 1,3-Dinitrobenzene (DNB)
• Nitrcguanidtne (NG)
• 2,4-Dinitrotoluene/2,6-Dinitrotoluene (DNT)
• White Phosphorus (WP)
• Zinc Chloride
• Hexachloroethane
PUBLISHED MUNITIONS HEALTH ADVISORIES SUMMARY
Advisory Value (PPB) ng/L
Chemical
Target Pop.
NC
TNG
DIMP
TNT'"
RDX"'
HMX
One-
Day
Child
NT"
5
8,000
20
100
5,000
Ten-
Days
Child
NT
5
8,000
20
100
5,000
Longer-
Term
Child
NT
5
8,000
20
100
5,000
Adult
NT
5
30,000
20
400
20,000
Lifetime
20% RSC
General
NT
600
2
2
Lifetime"
100% RSC
General
NT
5
3,000 !
10
10
400 | 2.000
' Monitoring data should be available to support use of a RSC greater than 20%.
"Not toxic
"'Classified EPA Group C. Possible Human Carcinogen.
-2-
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HEALTH ADVISORIES
All Chemicals Have a DWEL (Drinking Water Equivalent Level)
FUD x 70 Kg
DWEL= ------ -
2 L/Day
Group A and B Carcinogens (Human and Probable Human Carcinogens)
No Lifetime Health Advisory Value Since by Law the MCLG is Zero
Quantitative Cancer Risk Assessment is Provided Using the Linearized
Multistage Model
Usually 10"5 - 10 6 Risk Range is Acceptable if Zero is Not an Option
ng/L
ug/L
Risk Predictions are Provided Using Other Models for Comparison
HEALTH ADVISORIES
Group C Carcinogens (Possible Human Carcinogen)
LIFETIME HA = -DWELxRSC
UF
Drinking Water Office Policy Requires Extra Uncertainty
Factor (2-10) to Account for Equivocal Evidence of
Carcinogenicity.
RSC = 20% or Use Monitoring Data
IV. Group D and E (Non-Carcinogens)
LIFETIME HA = DWEL x RSC
RSC = 20% or Use Monitoring Data to Support Another
RSC Value.
-3-
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HUMAN SYSTEMIC HEALTH EFFECTS
Chemical
TMT
HMX
iRDX
Acute
Subchromc or
Chronic
Reduced Red Discoloration of
Hematocnt. Urine
Hemoglobin. Red Hepatitis
Blood Cells i Aplastic Anemia
Skin and Respiratory t Death
Tract Irritation
Gastrointestinal
Tract Disoraers-
Limited Research
Data
Skin Irritation from
Paten Testing
Limited Research
Data
Dermatitis
Nausea. Vomiting
Central Nervous
System Toxicity -
Convulsions and
Unconsciousness
Insomnia. Rest-
lessness Amnesia
Renal Damage
(Oliguna.
Hematuna.
Elevated BUN)
HUMAN SYSTEMIC HEALTH EFFECTS
i Chemical
Acute
Subchronic or
Chronic
Nitrocellulose No Toxic Effects
No Toxic Effects
TNG
OIMP
Hypotension, Dizzi-
ness, Fainting,
Headache, Flush-
ing of Face and
Neck
1 Rapid Pulse Rate
Respiratory Failure
i Leading to Death
No Data Reported
! Unsubstantiated
Skin Irritation
Chronic Exposure
Leads to Devel-
oping Tolerance
Chest Pains
Ischemic Heart
Disease
Death
No Data Reported
-4-
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ANIMAL SYSTEMIC HEALTH EFFECTS
Chemical
Acute
Nitrocellulose • Low Acute Toxicity -
1 LD. > 5 000
mg'/kg
TNG
DIMP
Subchromc or
Chronic
intestinal Impaction
Weight Loss Due to
Physical-Mechan-
ical Effects of
Chemical
Decreased Food
Intake - De-
creased Weight
Increased Erythro-
cytes, Hematocnt,
Hemoglobin and
Alkaline Phos-
phatase
Decreased Blodd
Glucose
Hemosiderosis of
Spleen
Testicular Atrophy
Methemoglobmemia
Liver Lesions
Behavioral Altera-
tions
1 Central Nervous
! System Com-
1 plications
Gastroenteritis
Increased Blood
Clotting Time
Skin/Eye Irritation
Death
None Noted in 90
Day Feeding
Studies
ANIMAL SYSTEMIC HEALTH EFFECTS
Chemical
TNT
HMX
RDX
Acute
Hemolytic Anemia
; fleticulocytosis and
< Macrocytosis
' Methemoglobmeinia
Increased Spleen
Weight
' Anemia
Subcnramc
or Chronic
Hematopoiesis
Increased Liver Weight
Decreased Food Intake
Weight
Myelofibrosis of Bone
Marrow
Spleen Enlargement
Liver Iniun/
Hepatomegaly '
Skin Irritation
Central Nervous
System Toxicity -
Convulsions
Histologic Changes in
Liver
Tubular Kidney
Changes
Increased Mortality
Liver and Renal Effects
i Central Nervous
System Toxicty -
: Convulsions
Ultrastructural
Changes in Liver
and Kidney
Decreased Food
Intake
Anemia
Dermatitis
Death
-5-
\ Central Nervous I
! System Toxicity - i
Convulsions i
Increased Liver Weight
i Anemia
) Vomiting
Weight Loss
Liver and Kidney '
Toxicity
Testicular Atrophy
Inflammation of
Prostate
-------
EPA HEALTH ADVISORY VALUES
TRINITROCLYCEROL
CH2 - ONO2 One-Day (Child) 0.005 mg/L
Ten-Day (Child) 0.005 mg/L
~ 2 Longer-Term (Child) 0.005 mg/L
CH2 - ON02
Lifetime 0.005 mg/L
Basis of Lifetime HA
Human No Effect Level for Vasodilation. Animals were Generally Less Sensitive to
the Effects of TNG
TRINITROGLYCEROL (TNG)
GENOTOXICITY
Salmonella: Negative to Weak
In vivo Bone Marrow and Kidney Cell (Rat): Negative
Dominant Lethal (Rat): Negative
In vivo Kidney Cells and Lymphocytes (Dog, Rat): Negative
In vitro Chinese Hamster Ovary: Negative
TWO YEAR BIOASSAYS
Dogs: Negative
Mice: Negative
Rats: Positive for Hepatocellular Carcinoma (Males and Females)
POTENCY: SF » 1.66 x 10-' (mg/kg/day)-'
CANCER MODEL for 1Q-* Risk
Models ng/L
Linearized Multistage 2
One-Hit 2
Probit 120
Logit .4
Weibull 1
-6-
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EPA HEALTH ADVISORY VALUES
TRINITROTOLUENE
o2N /V XN02 One-Day (Child) 20 ng/L
Ten-Day (Child) 20 \ig/L
Longer-Term (Child) 20 ng/L
(Adult) 20 ug/L
N02 Lifetime 2.0 ^g/L
Basis of Lifetime HA
Levine et al (1983) Adverse Liver Effect (Hepatocytomegalia) in Dogs Exposed for
26 Weeks Via Diet.
Group C, Possible Human Carcinogen
2,4,6-TRINITROTOLUENE (TNT)
GENOTOXICITY
Salmonella: Positive
In vivo Bone Marrow (Rat): Negative
in vitro UDS Human Diploid Fibroblasts: Negative
Bone Marrow Micronucleus Assay: Negative
in vivo/In vitro UDS Hepatocytes (Rat): Negative
TWO YEAR BIOASSAYS
Mice: Negative
Rats: Positive for Urinary Bladder Papillomas and Carcinomas in Females
POTENCY: SF = 3 x 1CH (mg/kg/day)-'
CANCER MODEL for 1Q-* Risk
Models MQ'L
Linearized Multistage 1
One-Hit 7
Probit 700
Logit 20
Weibull 10
CLASSIFICATION: EPA Group C, Possible Human Carcinogen
-7-
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EPA HEALTH ADVISORY VALUES
HYXAHYDRO-1,3,5-TRINITRO-1,3,5-TRIAZINE(RDX)
One-Day (Child)
Ten-Day (Child)
Longer-Term (Child)
(Adult)
Lifetime
0.1 mg/L*
0.1 mg/L*
0.1 mg/L
0.40 mg/L
0.002 mg/L
Basis ol Lifetime HA
Levins et al. (1983) Adverse Prostate Effects (Suppurative Inflammation) in Rats
Exposed Via Diet for 24 Months.
Group C Possible Human Carcinogen
'No data available to develop shon-term HA values Value shown is an estimate
based on longer-term HA for 10kg child.
HEXAHYDRO-1,3,5-TRlNITRO-1,3,5-TRIAZINE (RDX)
GENOTOXICITY
Salmonella: Negative
Dominant Lethal (Rats): Negative
In vitro UDS Human Fibroblasts: Negative
TWO YEAR BIOASSAYS
Rats (Two Strains): Negative
Mice: Positive for Hepatocellular Carcinomas and Adenomas in Females
POTENCY: SF » 1.1 x 1Q-' (mg/kg/day)-'
CANCER MODEL for 1Q-« Risk
Models
Linearized Multistage
Probit
Logit
Weibull
.3
<.002
<.002
<.002
CLASSIFICATION: EPA Group C, Possible Human Carcinogen
-8-
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EPA HEALTH ADVISORY VALUES
OCTAHYDRO-1,3,5,7-TETRANITRO-1,3,5,7-TETRAZOCINE (HMX)
N02
! One-Day (Child) 5.0 mg/L*
/~~\i.Noz Ten-Day (Child) 5.0 mg/L*
o2N—N I Longer-Term (Child) 5.0 mg/L
\_*/ (Adult) 20 mg/L
NOZ Lifetime 0.4 mg/L
Basis of Lifetime HA
Everett et al. (1985) No-Adverse-Effect Level (50 mg/kg/day) for Liver Lesions in
Male Rats Fed HMX in the Diet.
'No data available to adequately develop short-term HA values. Value shown is an
estimate based on longer-term HA for 10kg child.
EPA HEALTH ADVISORY VALUES
DIIDOPROPYL METHYLPHOSPHONATE (DIMP)
CH> °\ ^ One-Day (Child) 8.0 mg/L*
CH-o-p-o-CH Ten-Day (Child) 8.0 mg/L*
x\ Longer-Term (Child) 8.0 mg/L
CH3 CH3 CHO (AdlJlt) 30.0 mg/L
Lifetime 0.6 mg/L
Basis of Lifetime HA
Hart. 1980. Developed NQAEL of 75 mg/kg/day Based on 90-Day Dietary Study in
Dogs.
'No data available for developing short-term HA values. Value shown is an
estimate based on longer-term HA for 10kg child.
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DOCUMENT 5
SESSION 1 - GENERAL TECHNOLOGY AND APPLICATION
PRINCIPLES OF RISK ASSESSMENT: A NONTECHNICAL REVIEW
-------
Principles of Risk Assessment: A Nontechnical Review
I. INTRODUCTION
This report provides general background information for
understanding the types of scientific data and methods currently
used to assess the human health risks of environmental chemicals.
Human health risk is the likelihood (or probability) that a given
chemical exposure or series of exposures may damage the health of
exposed individuals. Chemical risk assessment involves the anal-
ysis of exposures that have taken place in the past, the adverse
health effects of which may or may not have already occurred. It
also involves prediction of the likely consequences of exposures
that have not yet occurred. This document is by -no means a com-
plete survey of the complex subject of risk assessment, but it is
sufficiently comprehensive to assist conference participants in
dealing with the specific sets of data relevant to the case
study.
The report begins with a discussion of the four major compon-
ents of risk assessment and their interrelationships. This sec-
tion is followed by extensive discussion of these four major com-
ponents. Generally, each section focuses on the methods and
tests used to gather data, the principles used for data interpre-
tation, and the uncertainties in both the data and inferences
drawn from them. Throughout these discussions, key concepts
(e.g., exposure, dose, thresholds, and extrapolation) are defined
and extended descriptions provided.
Many of the principles discussed in this report are widely
accepted in the scientific community. Others (e.g., thresholds
for carcinogens, the utility of negative epidemiology data) are
controversial. In such cases we have attempted to describe the
various points of view and the reasons for them and have also
identified the viewpoint that seems to have been broadly adopted
by public health and regulatory officials.
Finally, the concepts and principles we describe here, al-
though broadly applicable, may not apply in specific cases. In
•one instances, the data available on a specific chemical may
reveal aspects of its behavior in biological systems that suggest
a general principle (e.g., that data obtained in rodent studies
are generally applicable to humans) may not hold. In such in-
stances, the usual approach is to aodify the risk assessment
process to conform to the scientific finding.
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XI. RISK AMD RISK ASSESSMENT
BASIC CONCEPTS AND DEFINITIONS
Risk is the probability of injury, disease, or death under
specific circumstances. It may be expressed in quantitative
terms, taking values from sero (certainty that harm will not
occur) to one (certainty that it will). In many cases risk can
only be described qualitatively, as •high," "low," "trivial."
All human activities carry come degree of risk. Many risks
are known with a relatively high degree of accuracy, because we
have collected data on their historical occurrence. Table 1
lists the risks of some common activities.
ANNUAL
RISK Or OCATH
Nuaber
Table 1
rROM SELECTED
of Deatha
COMMON HUMAN
ACTIVITIES1
in Rapreaentativa
Coal Mining
Accident
Blade lung
Motor Vehicle
Truck Driving
ralla
HOM Accident a
1 Selected fro*
katiaated baa*
4
diaaaae 1
44
- U
25
Year
180
,135
,000
400
,3»
,000
1
8
2
Individual
.30 * 1(T3
• 10-3
.2
K 10-4
10-*
7
1
.7
.2
i 10-3
x 10-3
Hutt (1978) rood, DruQ, Coetnetle Lew J.
d upon 70-year
Uretuee and
45-year «rfc
Riak/Year
or 1/770
or 1/125
or
or
or
1/4,500
1/10,000
1/13,000
or 1/83,000
33:558-589.
e^oaura.
t
Llfetuw
Riak2
1/17
1/3
1/65
1/222
1/186
1/130
The risks associated with many other activities, including
the exposure to various chemical substances, can not be readily
assessed and quantified. Although there are considerable histor-
ical data on the risks of some types of chemical exposures (e.g./
the annual risk of death from intentional overdoses or accidental
exposures to drugs, pesticides, and industrial chemicals), such
data are generally restricted to those situations in which a
single, very high exposure resulted in an immediately observable
form of injury, thus leaving little doubt about causation.
Assessment of the risks of levels of chemical exposure that do
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not cause immediately observable forms of injury or disease (or
only minor forms such as transient eye or skin irritation) is far
more complex, irrespective of whether the exposure may have been
brief, extended but intermittent, or extended and continuous. It
is the latter type of risk assessment activity that is reviewed
in this report (although some review of acute poisoning is also
included).
As recently defined by the National Academy of Sciences, risk
assessment is the scientific activity of evaluating the toxic
properties of a chemical and the conditions of human exposure to
it in order both to ascertain the likelihood that exposed humans
will be adversely affected, and to characterize the nature of the
effects they may experience.1
The Academy distinguishes risk assessment from risk manage-
ment; the latter activity concerns decisions about whether an
assessed risk is sufficiently high to present a public health
concern and about the appropriate means for control of a risk
judged to be significant.
The term "safe," in its common usage, means 'without risk."
In technical terms,, however, this common usage is misleading
because science can not ascertain the conditions under which a
given chemical exposure is likely to be absolutely without a risk
of any type. The latter condition—sero risk—is simply immea-
surable. Science can, however, describe the conditions under
which risks are so I6w that they would generally be considered to
be of no practical consequence to persons in a population. As a
technical matter, the safety of chemical substances—whether in
food, drinking water, air, or the workplace—has always been
defined as a condition of exposure under which there is a "prac-
tical certainty* that no harm will result in exposed individuals.
(As described later-, these conditions usually incorporate large
safety factors, so that even more intense exposures than those
defined as safe may also carry extremely low risks). We note
that most "safe" exposure levels established in the way we have
described are probably risk-free, but science simply has no tools
to prove the existence of what is essentially a negative condi-
tion.
Another preliminary concept concerns classification of chemi-
cal substances as either 'safe* or unsafe* (or as "toxic" and
•nontoxic"). This type of classification, while common (even
among scientists who should know better), is highly problematic
1Risk Assessment in the Federal Government; Managing the Process
(Washington, O.C.sNation*! Academy Press,
-3-
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and misleading. All substances, even those which we consume inj
high amounts every day, can be made to produce a toxic response!
under some conditions of exposure. In this sense, all substance^
are toxic. The important question is not simply that of toxici-
ty/ but rather that of risk—i.e./ what is the probability that
the toxic properties of a chemical will be realized under actual
or anticipated conditions of human exposure? To answer the lat-
ter question requires far more extensive data and evaluation than
the characterization of toxicity.2
THE COMPONENTS OF RISK ASSESSMENT
There are four components to every (complete) risk assess-
ment:
A. Hazard Identification—Involves gathering and evaluating
data on the types of health injury or disease that may
be produced by a chemical and on the conditions of expo-
sure under which injury or disease is produced. It may
also involve characterization of the behavior of a chem-
ical within the body and the interactions it undergoes
with organs, cells, or even parts of cells. Data of the
latter types may be of value in answering the ultimate
question of, whether the forms of toxicity known to be
produced by a substance in one population group or in
experimental settings are also likely to be produced
humans. Hazard identification is not risk assessment;
we are simply determining whether it is scientifically
correct to infer that toxic effects observed in one
setting will occur in other settings (e.g., are sub-
stances found to be carcinogenic or teratogenic in ex-
perimental animals likelv to have the same result in
humans?).
B. Dose-Response Evaluation--Involves describing the quan-
titative relationship between the amount of exposure to
a substance and the extent of toxic injury or disease.
Data derive from animal studies or, less frequently,
from studies in exposed human populations. There may b-
many different dose-response relationships for a sub-
stance if it produces different toxic effects under
2Soae scientists will claim that carcinogens display their toxic
properties under all conditions of exposure/ and that there is
ao "safe" level of exposure to such agents. This special prob-
lem receives extensive treatment in later sections.
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different conditions of- exposure. The risks of a sub-
stance can not be ascertained vith any degree of confi-
dence unless dose-response relations are quantified,
even if the substance is known to be "toxic."
C. Human Exposure Evaluation—-Involves describing the
nature and fixe of the population exposed to a substance
and the magnitude and duration of their exposure. The
•valuation could concern past or current exposures, or
•xposures anticipated in the future.
0. Risk Characterization—generally involves the integra-
tion of the data and analysis of the first three compo-
nents to determine the likelihood that humans will
experience any of the various forms of toxicity associ-
ated with a substance. (In cases where.exposure data
are not available, hypothetical risk can be character-
ized by the integration of hazard identification and
does-response evaluation data alone.)
The next four sections elaborate on each of these components
of risk assessment. However, the concept of "dose," which under-
lies all the discussions to follow of both experimental animals
and human populations, is reviewed first.
DOSE
Human exposures to substances in the environment may occur
because of their presence in air, water, or food. Other circum-
stances may provide the opportunity for exposure, such as direct
contact with a sample of the substance or contact with contami-
nated soil. Experiments for studying the toxicity of a substance
usually involve intentional administration to subjects through
the diet, air to be inhaled, or direct application to skin.
Experimental studies may include other routes of administration:
injection under the skin (subcutaneous), into the blood (usually
intravenous), or into body cavities (intraperitoneal).
In both human and animal exposures, two types of measurement
must be distinguished:
1. Measurement of the amount of the substance in the
medium (air, diet, etc.) in which it is present or
administered.
2. Measurement of the amount received by the subject,
whether human or animal.
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It is critically important to distinguish these two types of
measures. The second measure, which is usually expressed as a
dose, ia the critical factor in assessing risk. The first mea-
sure, along with other information, usually is essential if the
dose is to be established. It may be substituted or supple-
mented, however, in cases where environmental modeling or bicmon-
itoring data are available.
The difference between these two measures is best described
by example. Suppose a substance is present in drinking watar to
be consumed by an individual. To determine the individual's dose
of this substance, it is first necessary to know the amount
present in a given volume of water. For many environmental sub-
stances, the amounts present fall in the milligram (mg, ore-
thousandth of a gram » 1/28571 ounce) or microgram (,ug, one-
millionth of A gram « 1/28,571,429 ounce) range. The analyst
will usually report the number of mg or ug of the substance
present in one liter of water, i.e., mg/1 or pg/1. These two
units are sometimes expressed as parts per Billion (ppm) or parts
per billion (ppb), respectively.3
Given the concentration of a substance in water (say in ppm),
it is possible to estimate the amount an individual will consume
by knowing the amount of water he drinks. Time is another im-
portant factor in determining risk, so the amount of water con-
sumed per unit time is of interest. Zn most public health evalu-
ations, it is assumed that an individual consumes 2 liters of
water each day through all uses. Thus, if a substance is present
at 10 ppm in water, the average daily individual intake of the
substance is obtained as follows:
10 ag/liter x 2 liter/day - 20 mg/day
For toxicity comparisons among different species, it is nacassary
to take into account size differences, usually by dividing daily
intake by the weight of the individual. Thus, for a man of aver-
age weight (usually assumed to be 70 kilograms (kg) or 154
pounds), the daily dose of our hypothetical substance is:
20 mg/day r 70 kg - 0.29 mg/kg/day
3A liter of water weighs 1,000 g. One mg is thus one-millionth
the weight of a liter of water; and one ug is one-billionth the
weight of a liter.
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For a person of lower weight (e.g., a female or child), the daily
dose at the same intake rate would be larger. For example, a 50"
kg woman ingesting the hypothetical substance would receive a
dose of:
20 ng/day r 50 kg « 0.40 mg/kg/day
& child of 10 kg could receive a dose of 2.0 mg/kg/day, although
it must be remembered that such a child would drink less water
each day (say, 1 liter), so that the child's dose would be:
10 mg/liter x 1 liter/day » 10 kg • 1.0 mg/kg/day
XIso, laboratory animals, usually rats or mice, receive a much
higher dose than humans at the same daily intake rate because of
their much smaller body weights (of course, rats and mice do not
drink 2 liters of water each day!).
These sample calculations point out the difference between
measurement of environmental concentrations and dose/ at least
for drinking water. The relationships between measured environ-
mental concentrations and dose are more complex for air and other
media. Table 2 lists the data necessary to obtain dose from data
on the concentration of a substance in water. Each medium of
exposure must be treated separately and some calculations are
more complex than in the dose per liter of water example.
-7-
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Table 2
DATA AND ASSERTIONS NCCCSSARY TO ESTIMATE
MMAM OOSC Of A WTCK CONTAMINANT HUM WOW.EDCE Of ITS CONCO4TRATION
Total Oooe la Equal to the SUM of DBMS fro* Five Routea
1. Direct Ingoation Through Drinking
Amount of vater consumed each day (generally aaaumed to be 2 liters for
adults and 1 liter for 10 kg child).
Fraction of contaminant abaorbed through wall of gmatrointemtlnal tract.
Avaraga human body Might.
2. Inhalation of Contaminants
Air concentrations reaulting from showering, bathing, and other uaes of
Variation in air concentration over time.
Amount of contaminated air breathed during thoae activities that may lead
to volatilization.
Fraction of inhaled contaminant abaorbed through lunge.
Average human body Might.
3. Skin Absorption from Hater
Period of time spent weeding and bathing.
Fraction of eontaminmnt abaorbed through the akin during washing and
bathing.
Average human body weight.
4. Ingestion of Contaminated Food
Concentrationa of contaminant in edible portions of various plants and
animals exposed to contaminated groundwatar.
Amount of contaminated food ingested emeh oar.
Fraction of contaminant abaorbed through wall of gastrointestinal tract.
Average human body weight.
S. Skin Absorption for Contaminated Soil
Concentrationa of contaminant in soil aipoaed to contaminated
groundwatar.
Amount of daily akin contact with moil.
Amount of moil ingested par day (by children).
Abeorotion ratae.
Average human body Might.
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It is important always to consider that a human may be
simultaneously exposed to the same substance through several
media. That is/ a dose may be received through more than one
route of exposure (inhalation, ingestion, dermal contact). The
"total dose" received by an individual is the sum of doses re-
ceived by each individual route (see the example in Table 2).
In some cases, it may not be appropriate to add doses in
this fashion. In these cases, the toxic effects of a substance
may depend on the route of exposure. For example, inhaled chrom-
ium is carcinogenic to the lung, but it appears that ingested
chromium is not. In most cases, however, as long as a substance
acts at an internal body site (i.e., acts svstemieally rather
than only at the point of initial contact), it is usually con-
sidered appropriate to add doses received fron several routes.
Two additional factors concerning dose require special atten-
tion. The first is the concept of absorption (or absorbed dcse) .
The second concerns inferences to be drawn from toxicities ob-
served under one route of exposure for purposes of predicting the
likelihood of toxicity under other routes.
Absorption
When a substance is ingested in the diet or in drinking
water, it enters the gastrointestinal tract. When it is present
in air (as a gas, aerosol, particle, dust, fume, etc.) it enters
the upper airways and lungs. A substance may also come into
contact with the skin and other body surfaces as a liquid or
solid. Some substances may cause toxic injury at the point of
initial contact (skin, gastrointestinal tract/ upper airways,
lungs, eyes). Indeed, at high concentrations, most substances
will cause at least irritation at these points of contact. But
for many substances, toxicity occurs after they pass through
certain barriers (e.g., the wall of the gastrointestinal tract or
the skin itself), enter blood or lymph, and gain access to the
various organs or systems of the body. Figure 1 is a diagram of
some of the important routes of absorption. This figure also
shows that chemicals may be distributed in the body in various
ways and then excreted. (However* some chemical types—usually
substances with high solubility in fat, such as DDT—are stored
for long periods of time, usually in fat.)
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Figurt 1
KEY ROUTES OF CHEMICAL ABSORPTION, DISTRIBUTION, AND EXCRETION
tomt chemicals undergo chemical change (metabolism) within tht etllt of tht body before ixerction.
Toxicity may bt produced by th« chemical •» introduead, or by ona or men maubolitis.
Ingastion
Inhalation
Tract
Otrmal
Contact
Lung
*- Abwrption- *
Livtr
Bila
Blood and Lymph
Kidneys
Extracellular
Fluids
Lung
•Udder
Urine
Secretion
Glands
Expired
Air
Organs of
the Body
Soft
or Bones
n
3
a
o
rn
Secretiont
EXCRETION
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Substances vary widely in extent of absorption. The frac-
tion of a dose that passes through the wall of the gastrointes-
tinal tract may be very small (e.g., 1 to 10% for some metals) to
substantial (close to 100% for certain types of organic mole-
cules). Absorption rates also depend upon the medium in which a
chemical is present (e.g., a substance present in water might be
absorbed differently from the saae substance present in a fatty
diet). These rates also vary among animal species and among
individuals within a species.
Ideally, estimating systemic dose should include considera-
tion of absorption rates. Unfortunately, data on absorption are
limited for most substances, especially in humans. As a result,
absorption is not always included in dose estimation (i.e., by
default, it is frequently considered to be complete). Sometimes
crude adjustments are made based on some general -principles con-
cerning expected rates based on the molecular characteristics of
a substance.
Interspeeies Differences in Exposure Route
As described later, a critical feature of risk characteriza-
tion is a comparison of doses that are toxic in experimental
animals and the doses received by exposed humans. Zf humans are
exposed by the same route as the experimental animals, it is
frequently assumed (in the absence of data) that the extent of
absorption in animals and humans is approximately the same; under
such an assumption, it is unnecessary to estimate the absorbed
dose by taking absorption rate into account. However, humans are
often exposed by a different route than that used to obtain tox-
icity data in experimental animals. Zf the observed toxic effect
is a systemic one, it may be appropriate to infer the possibility
of human toxicity even under the different exposure route. Be-
fore doing so, however, it is critical to consider the relative
degrees of absorption by different exposure routes. For example,
if a substance is administered orally to a test animal but human
exposure is usually by inhalation, knowledge of the percentage
absorbed orally by the animal and by inhalation in humans is
necessary to properly compare human and animal doses. These
calculations and underlying assumptions are too complex for dis-
cussion here, but they should be kept in Bind when risks are
being described.
Zn the following discussion of the components of risk assess-
ment, we shall use the term dose only as described. Many risk
assessors use the terms exposure and dose synonomously. In this
document, however, the term exposure describes contact with a
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substance (e.g., we say that animals are exposed to air contain-
ing 10 mg/m3, of a compound), as well as the size of the dose,
the duration of exposure, and tne nature and size of the exposed
population. In our usage, exposure is a broader term than dose.
Although our usages of those terms are technically correct, it
should be recognized that some assessors use the term exposure to
mean dose (although the reverse is not true).
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ft
III. HAZARD IDENTIFICATION
INTRODUCTION
Information on the toxic properties of chemical substances is
obtained from animal studies, controlled epidemiological investi-
gations of exposed human populations, and clinical studies or
case reports of exposed humans. Other information bearing on
toxicity derives from experimental studies in systems other than
whole animals (e.g., in isolated organs/ cells, subcellular com-
ponents) and from analysis of the molecular structures of the
substances of interest. These last two sources of information
are generally considered less certain indicators 'of toxic poten-
tial, and accordingly, they receive limited treatment here.
Similarly, clinical studies or case reports, while sometimes
very important (e.g., the earliest signs that benzene was a human
leukemogen came from a series of case reports), seldom provide
the central body of information for risk assessment. For this
reason, and because they usually present no unusual problems of
interpretation, they are not further reviewed here. Rather, our
attention is devoted to the two principal sources of toxicity
data: animal tests and epidemiology studies. These two types of
investigation are not only principal sources of data, but also
present Interpretative difficulties, some rather subtle, some
highly controversial.
TOXICITY INFORMATION PROM ANIMAL STUDIES
The Use of Animal Toxicity Data
Animal toxicity studies are conducted based primarily on the
longstanding assumption that effects in humans can be inferred
from effects in animals. In fact, this assumption has been shown
to be generally correct. Thus, all the chemicals that have been
demonstrated to be carcinogenic in humans, with the possible
exception of arsenic, are carcinogenic in some although not all,
experimental animal species. In addition, the acutely toxic
doses of many chemicals are similar in humans and a variety of
experimental animals. This principle of extrapolation of animal.
data to humans has been widely accepted in the scientific and
regulatory communities. The foundation of our ability to infer
effects in humans from effects in animals has been attributed to
the evolutionary relationships and the phylogenetic continuity of
animal species including man. Thus, at least among manunals, the
basic anatomical, physiological, and biochemical parameters are
similar across species.
-------
However, although the general principle of inferring effects in
humans from effects in experimental animals is veil founded,
there have been a number of exceptions. Many of these exceptions
relate to differences in the way various species handle a chemi-
cal to vhich they are exposed and to differences in metabolism,
distribution and pharaacoxinetics of the chemical. Because of
these potential differences/ it is essential to evaluate all
interspecies differences carefully in inferring human toxicity
from animal toxicologic study results.
Zn the particular case of evaluation of long-term animal
studies conducted primarily to assess the carcinogenic potential
of a. compound, certain general observations increase the overall
strength of the evidence that the compound is carcinogenic. With
an increase in the number of tissue sites affected by the agent,
there is an increase in the strength of the evidence. Similarly/
an increase in the number of animal species, strains, and sexes
showing a carcinogenic response will increase the strength of the
evidence of carcinogenicity. Other aspects of importance are the
occurrence of clear-cut dose-response relationships in the data
evaluated; the achievement of a high level of statistical signif-
icance of the increase of tumor incidence in treated versus con-
trol animals; dose-related shortening of the time-to-tumor occur-
rence or time-to-death with tumor; and a dose-related increase in
the proportion of tumors that are malignant. The following sec-
tions describe the general nature of animal toxicity studies,
including major areas of importance in their design, conduct, and
interpretation. Particular consideration will be given to the
uncertainties involved in the evaluation of their results.
General Nature of Animal Toxicity Studies
Toxicity studies are conducted to identify the nature of
health damage produced by a substance4 and the range of doses
over which damage is produced. The usual starting point for such
investigations is a study of the acute (single-dose) toxicity of
a chemical in experimental animals. Acute toxicity studies are
necessary to calculate doses that will not be lethal to animals
used in toxicity studies of longer durations. Moreover, such
*We use the term substance to refer to a pure chemical, to a
chemical containing impurities, or to a mixture of chemicals.
It is clearly important to know the identity and composition of
a tested substance before drawing inferences about the toxicity
of other samples of the same substance that might have a some-
what different composition.
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•tudies will give one estimate of the compound's comparative
toxicity and may indicate the target organ system for chronic
toxicity <«.g., kidney, lung, or heart). Toxicologists examine
the lethal properties of a substance and estimate its 105Q
(lethal dose, on average, for 50% of an exposed population). In
a group of chemicals, those exhibiting lover LD5QS are more
acutely toxic than those with higher values. A group of well-
known substances and their LDso values are listed in Table 3.
TMlt 3
AfMOXIMATE ORAL UD5(j« IN HATS FOR A
(••rum nr wri i-jrwrMu pMTMTrn c1 *Z
CROUP Or MELL-XNONN
Sucre** (toblt augir)
Ethyl •leofcol
Sodii* chloridt (connon Mlt)
Vitamin A
Vanillin
Oilarafom
Copper
C«ff»in«
fh«nob«rbittl,
DOT
SoditM nitrite
Nieotin*
Afliteiin SI
Sediui cyanide
Stryehntrw
Mlt
29,700
U.OQO
3,000
2,000
1,580
1,000
800
300
1»2
1*2
113
85
53
7
4.4
2.5
1S«l»et«d fro« NIOSH, Ktqiitry of Tp«ie Eff«ctt of Chamicil
Subitme>j, 1979. R«sult« r*port«l tl»««^«p» ««y rtiffir.
•CompoundiTir* U«t«d in ord«r of inertMinfl twicity—i.«.,
•uetM* is the Itttt to«ic «nd •tryc^nin* is tto *Mt toxic.
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LD5Q studies reveal one of the basic principles of toxi-
cology: not all individuals exposed to the same dose of a sub-
stance will respond in the same way. Thus, at a dose of a sub-
stance that leads to the death of some experimental animals,
other animals dosed in the same way will get sick but will re-
cover/ and still others will not appear to be affected at all.
Me shall return to this point after a fuller discussion of other
forms of toxicity.
Each of the many different types of toxicology studies has a
different purpose. Animals may be exposed repeatedly or contin-
uously for several weeks or months (subchronic toxicity studies)
or for close to their full lifetimes (chronic toxicity studies)
to learn how the period of exposure affects toxic response. In
general, the reasons to conduct toxicity studies can be summar-
ized as follows:
e Identify the specific organs or systems of the body
that may be damaged by a substance.
e Identify specific abnormalities or diseases that a
substance may produce, such as cancer, birth defects,
nervous disorders, or behavioral problems.
e Establish the conditions of exposure and dose that give
rise to specific forms of damage or disease.
e Identify the specific nature and course of the injury
or disease produced by a substance.
e Identify the biological processes that underlie the
production of observable damage or disease.
The laboratory methods needed to accomplish many of these
goals have been in use for many years, although some methods are
still being developed. Before describing some of the tests, it
is useful to say more about the various manifestations of toxi-
city.
Manifestations of Toxicity
Toxic responses, regardless of the organ or system in which
they occur, can be of several types. For some, the severity of
the injury increases as the dose increases. Thus, for example,
some chemicals affect the liver. At high doses they may kill
liver cells, perhaps so many as to destroy the liver and thus
cause the deaths of some or all experimental subjects. As the
dose is lowered, fewer cells may be killed, but they may exhibit
other forma of damage, causing imperfections in their function-
ing. At lower doses still, no cell deaths may occur and there
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may be only slight alterations in cell function or structure.
Finally, a dose may be achieved at which no effect is observed,
or at which there are only biochemical alterations that have no
known adverse effects on the health of the animal (although some
toxicologists consider any such alteration, even if its long-terr,
consequences are unknown, to be "adverse," there is no clear
consensus on this issue.) One of the goals of toxicity studies
is to determine the "no observed effect level" (NOEL), which is
the dose at which no effect it seen; the role of the NOEL in risk
assessment is discussed later.
Zn other cases, the severity of an effect nay not increase
with dose, but the incidence of the effect will increase with
increasing dose. In such cases, the number of animals experienc-
ing an adverse effect at a given dose is less than the total
number, and, as the dose increases, the fraction experiencing
adverse effects (i.e., the incidence of disease or injury) in-
creases; at sufficiently high dose, all experimental subjects
will experience the effect. The latter responses are properly
characterized as probabilistic. Increasing the dose increases
the probability (i.e., risk) that the -abnormality trill develop in
an exposed population. Often with toxic effects, including can-
cer, both the severity and the incidence increase as the level of
exposure is raised. The increase in severity is a result of
increased damage at higher doses, while the increase in incidence
is a result of differences in individual sensitivity. In addi-
tion, th«- site at which a substance acts (e.g., liver, kidney)
may change as the dose changes.
Generally, as the duration of exposure increases, both the
NOEL and the doses at which effects appear decrease; in some
cases, new effects not apparent upon exposures of short duration
become manifest.
Toxic responses also vary in degree of reversibility. In
some cases, an effect will disappear almost immediately following
cessation of exposure. At the other extreme, some exposures will
result in a permanent injury--for example, a severe birth defect
resulting from a substance that irreversibly damages a fetus at a
critical moment of its development. Most toxic responses fall
somewhere between these extremes. In many experiments, however,
the degree of reversibility cannot be ascertained by the investi-
gator .
Seriousness is another characteristic of a toxic response.
Certain types of toxic damage are clearly adverse and are a def-
inite threat to health. However, other types of effects observed
during toxicity studies are not clearly of health significance.
For example, at a given dose a chemical may produce a slight
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increase in red blood cell count. If no other effects are ob-
served at this dose, it will not be at all clear that a true
adverse response has occurred. Determining whether such sligh
changes are significant to health is one of the critical issues
in assessing safety that has not b«en fully clarified.
Design and Conduct of Toxieity Tests
Toxicity experiments vary widely in design and conduct.
Although there are relatively well standardized tests for various
types of toxicity (e.g., National Cancer Institute carcinogen-
icity bioassays) developed by regulatory and public agencies ir.
connection with the premarket testing requirements imposed on
certain classes of chemicals, large numbers of other tests and
research-oriented investigations are conducted using specialized
study designs (e.g., carcinogenicity assays in fish). In this
section, we present a few of the critical considerations that
enter into the design of toxicity experiments. However, there
are numerous variations on the general themes we describe.
Selection of Animal Species
Rodents, usually rats or mice, are the most commonly used
laboratory animals for toxicity testing. Other rodents (e.g.,
hamsters and guinea pigs) are sometimes used, and many experi-
ments are conducted using rabbits, dogs, and such non human pri
mate* »« monkeys or baboons. For example, although nonhuman
primates may be chosen for some reproductive studies because
their reproductive systems are similar to that of humans, rabbits
are often used for testing dermal toxicity because their shaved
skin is more sensitive.
Rats and mice are the most common choice because they are
inexpensive and can be handled relatively easily. Furthermore,
such factors as genetic background and disease susceptibility are
well established for these species. The full lifespans of these
smaller rodents are complete in two to three years/ so that the
effects of lifetime exposure to a substance can be measured rela-
tively quickly (as compared to the much longer-lived dog or
monkey ) .
Dose and Duration
An LDsn using high doses of the substance is frequently the
first toxicity experiment performed. After completing these*
experiments, investigators study the effects of lower doses
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administered over longer periods. The purpose is to find the
range of doses over which adverse effects occur and to identify
the NOEL for these effects (although the latter is ot always
sought or achieved). A toxicity experiment is of l.mited value
i.nless a dose of sufficient magnitude to cause some type of
idverse effect within the durition of the experiment is achieved.
3f no effects are seen at all doses adminiftered, the toxic
properties of the substances 'ill not have been characterized,
and the investigator will usually repeat the experiment at higher
doses or will extend its duration.s
Studies are frequently characterized according to the dura-
tion of exposure. Acute toxirity studies involve a single dose,
or exposures of very short duration (e.g., 8 hours of inhala-
tion). Chronic studies involve exposures for near the full life-
times of the experimental aninals. Experiments of -arying dura-
tion between these extremes are referred to as subc ronic stud-
ies.
Number of Dose Levels
Although it is desirable that many different dose levels be-
used to develop a well characterized dose-response relationship,
practical considerations usually limit the number to two or
three, especially in chronic studies. Experiments involving a
single dose are frequently reported and leave great uncertainty
about the full range of doses over which effects are expected.
Controls
No toxicity experiment is interpretable if control animals
are omitted. Control animals must be of the same species,
strain, sex, age, and state of health as the treated animals, and
must be held under identical conditions throughout the experi-
ment. (Indeed, allocation of aninals to control and treatment
groups should be performed on a completely random basis.) Of
course, the control animals are not exposed to the substance
under test.
5Some substances with extremely low toxicity must be administered
at extremely high levels to produce effects; in many cases, such
high levels will cause dietary maladjustments leading to an
adverse nutritional effect that confounds interpretation. As a
practical matter/ the highest level of a compound fed to an
animal in toxicity studies is 5% of the diet, even if no toxic
effect is seen at this level.
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Route of Exposure
Animals are usually exposed by a route that is as close as
possible to that through which humans will be exposed, because
the purpose of most such tests is to produce the data upon which
human safety decisions will be based. In some cases, however,
the investigator may have to use other routes or conditions of
dosing to achieve the desired experimental dose. For example,
some chemicals are administered by stomach tube (gavage) because
they are too volatile or unpalatable to be placed in the animals'
diets at the high levels needed for toxicity studies.
Specialized Designs
Generally/ the toxicologist exposes test animals and simply
records whatever effects happen to occur under the conditions of
the experiment. If, however/ it is decided that certain highly
specific hypotheses about a substance are to be tested (e.g./
does the substance cause birth defects or does it affect the
immune system?), certain specialised designs must be used. Thus,
for example/ the hypothesis that a chemical is teratogenic
(causes birth defects) can be tested only if pregnant females are
exposed at certain critical times during pregnancy.
One of the most complex of the specialized tests is the
earcinogenesis bioas»ay. These experiments are used to test the
hypothesis of carcinogenic!ty—that is/ the capacity of a sub-
stance to* produce tumors. Because of the importance of the ear-
cinogenesis bioassay/ a full section is devoted to it. We shall
then.discuss/ in turn/ controversial issues in the design of
animal tests and interpretation of test results.
Design of Tests for Careinogenieity
Zn a National Cancer Institute (MCI) carcinogenicity bioas-
say, the test substance is administered over most of the adult
life of the animal, and the animal is observed for formation of
tumors. The general principles of test design previously dis-
cussed apply to carcinogenicity testing/ but one critical design
issue that has been highly controversial requires extensive dis-
cussion. The issue is the concept of maximum tolerated dose
(MTD)/ which is defined as the maximum dose that an animal spe-
cies can tolerate for a major portion of its lifetime without
significant impairment of growth or observable toxic effect other
than carcinogenicity. Cancer can take most of a lifetime to
develop, and it is thus widely agreed that studies should be
designed so that the animals survive in relatively good health
for a normal lifetime. It is not so widely agreed, however/ that
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the MTD, as currently used, is the best way to achieve this
objective. The MTD and half the MTD are the usual doses used in
the NCI carcinogenicity bioassay.
The main reason cited for using the MTD as the highest dose
in the bioassay is that experimental studies are conducted on a
small scale, making them 'statistically insensitive," and that
very high doses overcome this problem. For practical reasons,
experimental studies are carried out with relatively small groups
of animals. Typically, 50 or 60 animals of each species and sex
will be used at each dose level, including the control group. At
the end of such an experiment, the incidence of cancer as a func-
tion of dose (including control animal incidence) is tabulated by
the examining pathologists . Statisticians then analyze the data
to determine whether any observed differences in tumor incidence
(fraction of animals having a tumor of a certain type) are due to
random variations in tumor incidence or to treatment with the
substance.
Zn an experiment of about this size, assuming none of the
control animals develop tumors, the lowest incidence of cancer
that is detectable with statistical reliability is in the range
of 5%, or 3 animals with tumors in a test group of 60 animals. '
If control animals develop tumors (as they frequently do), the
lowest range of cancer incidence detectability is even higher. A
cancer incidence of 51 is very high, yet ordinary experimental
studies are not capable of detecting lower rates and most are
even le<* -sensitive.
MTD advocates argue that inclusion of high doses will com-
pensate for the weak detection power of these experiments. By
using the MTD, the toxicologist hopes to elicit any important
toxic effects of a substance and ensure that even weak carcin-
ogenic effects of the chemical will be detected by the study.
MTD critics do not reject the notion that animal experiments may
be statistically insensitive, but rather are concerned about the
biological implications of such high doses.
Concerns about use of MTD a can be summarized: (1) the
underlying biological mechanisms that lead to the production of
cancer may change as the dose of the carcinogen changes; (2) cur-
rent methods for estimating an MTD for use in an experiment do
not usually take these mechanisms into account; (3) the biologi-
cal mechanisms at work under conditions of actual human exposure
may be quite different from those at work at or near the MTD; and
(4) therefore, observations at or near an MTD (as determined by
current methods) may not be qualitatively relevant to conditions
of actual human exposure.
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Many agree that greater attention should be paid to develop
ing data on the underlying mechanisms of carcinogenicity and
their relation to dose. Also, a range of doses should be includ-
ed in carcinogenicity testing to assess whether physiological
mechanisms that would normally detoxify the chemical are over-
whelmed at an MTD. These biological considerations have consid-
erable merit, but they are frequently disregarded in designing
studies and interpreting data. Although there are occasional
attempts to develop a more biologically relevant definition of
MTD, aost current tests (e.g., those carried out by the National
Toxicology Program) use a definition of MTD that does not take
biological mechanisms into account.
This state of affairs is not likely to change. Those who
promote the use of MTD/ as currently defined, frequently argue
that if the highest dose used was not the MTD, failure to observe
a carcinogenic effect in a given experiment does not permit the
conclusion that the tested substance is not carcinogenic. A
similar argument is made if the survival of the test animals did
not approximate their full lifetimes.
Conduct and Interpretation of Toxicitv Tests
Many factors must be considered in the conduct of toxicity
tests to ensure their success and the utility of their results.
Zn evaluating the result* of such tests, certain questions must
be asked~about the design and conduct of a test to ensure criti-
cal appraisal. The major questions include the following:
1. Has the experimental design adequate to test the hypo-
thesis under examination?
2. Was the general conduct of the test in compliance with
standards of good laboratory practice?
3. Mas the dose of test compound correctly determined by
chemical analysis?
4. Was the test compound adequately characterized with
regard to the nature and extant of impurities?
S. Did the animals actually receive the test compound?
6. Were animals that died during the test adequately exam-
ined?
7. How carefully were test animals observed during the
conduct of the test?
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8. What tests were performed on the animals (e.g., blood
tests, clinical chemistry tests) and were they ade-
quately performed?
9. If the animals were examined histopathologically (i.e.,
detailed pathological examination based on sections
taken from individual tissues), was the examination
performed by a qualified pathologist?
10. Was the extent of animal and animal tissue examination
adequate?
11. Were the various sets of clinical and pathology data
properly tabulated?
12. Were the statistical tests used appropriate and were
they adequately performed?
13. Was the report of the test sufficiently detailed so
that these questions can be answered?
t
A proper evaluation would ensure that these and other types
of quest-ions were examined and would include a list of qualifica-
tions on. test results in areas where answers were missing or
unsatisfactory.
Categorization of Toxic Effects
Toxicity tests may reveal that a substance produces a wide
variety of adverse effects on different organs or systems of the
body or that the range of effects is narrow. Some effects may
occur only at the higher doses used, and only the most sensitive
indicators of a substance's toxicity may be manifest at the lower
doses .
The toxic characteristics of a substance are usually catego-
rised according to the organs or systems they affect (e.g., liv-
er, kidney, nervous system) or the diseases they cause (e.g.,
cancer, birth defects). The most commonly used categorizations
of toxicity are briefly described in Appendix X.
Although there are uncertainties associated with most evalu-
ations of animal toxicity data, there are some special problems
associated with interpretation of carcinogenicity data. Because
these problems are the source of much controversy, we afford their.
special attention in the next section.
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Uncertainties in Evaluation
of Animal Carcinogenicity
Test Results
One area of uncertainty and controversy concerns the occur-
rence of certain types of tumors in control animals. In most
animal experiments, control animals will also develop tumors, and
interpretation of such experiments depends on comparing the inci-
dence of tumors in control animals with that observed in treated
animals. In some instances, this is not as straightforward as it
Bay seem. For example, the lifetime incidence of lung tumors in
a certain strain of male mice, untreated with any substance, may
vary from a low of about 2% to a high of about 40%; the average
rate is about 14%. Suppose that, in a particular experiment,
sale Bice treated with a substance exhibited a 35% incidence of
lung tumors, and control animals exhibited an incidence of 8%.
Statistical analysis of such data would show that the treated
animals experienced a statistically significant increase in tumor
incidence, and the substance producing this effect might be la-
beled a lung carcinogen.
Further analysis of the incidence data suggests that such a
statistical analysis may b« misleading. The 35% incidence ob-
served in treated animals is within the range of tumor incidence
that is normally experienced by Bale mice, although the particu-
lar group of male mice used as controls in this experiment exhib-
ited an incidence in,the low end of the normal range. Onder sue
circumstances, use of the simple statistical test of significanc
Bight^e .misleading and result in the erroneous labeling of a
substance as a carcinogen.
Another major area of uncertainty arises in the interpreta-
tion of experimental observations of b«nign tumors. Some types
of tumors are clearly malignant? that is, they are groups of
cells that grow in uncontrolled ways, invade other tissues, and
are frequently fatal. There is usually no significant contro-
versy about such tumors, and pathologists generally agree that
their presence is a clear sign that a carcinogenic process has
occurred. Other tumors are benign at the time they are observed
by pathologists, and it is not always clear they should be con-
sidered indicators of a carcinogenic process. Soae tumors will
remain benign for the lifetime of the animal, but in some cases
they have been observed to progress to malignancy. Generally,
the numbers of animals with benign tumors that are thought to be
part of the carcinogenic process are combined with those having
malignancies to establish the total tumor incidence. Many path-
ologists disagree with such combining, and there appears to be no
end to the controversy in this area. The issue has been espe-
cially controversial in connection with tumors found in rodent
livers.
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Short-Term Tests, for Carcinogens
The lifetime animal study is the primary method used for
detecting the carcinogenic properties of a substance. In recent
years, other experimental techniques have become available and,
although none is yet considered definitive, they may provide
important information.
Short-term tests for carcinogenicity measure effects that
empirically or theoretically appear to be correlated with carcin-
ogenic activity. These tests include assays for gene mutations
in bacteria, yeast, fungi, insects, and mammalian cells; mamma-
lian cell transformation assays; assays for DNA damage and re-
pair; and i,n vitro (outside the animal—e.g., bacterial cells as
in the Ames mutagenicity assay) and in vivo (within the animal)
assays for chromosomal mutations in animals' cells. In addition
to these rapid (test-tube) tests, several tests of intermediate
duration involving whole animals have been used. These include
the induction of skin and lung tumors in mice, breast cancer in
female certain species of rats, and anatomical changes in the
livers of rodents.
Other tests are used to determine whether a substance will
interact with the genetic apparatus of the cell, as some well-
known eafcinogens apparently do. However, not all substances
that interact with DMA have been found to be carcinogenic in
animal systems. Furthermore, not all animal carcinogens interact
directly with genetic material.
These short-term tests are playing increasingly important
roles in helping to identify suspected carcinogens. They provide
useful information in a relatively short period, and may become
critical screening tools, particularly for selecting chemicals
for long-term animal tests. They may also assist in understand-
ing the biological processes underlying the production of tumors.
They have not been definitively correlated with results in animal
models, however, and regulatory agencies and other public health
institutions do not consider positive or negative results in
these systems as definitive indicators of carcinogenicity or the
lack thereof, but only as ancillary evidence.
DATA ?ROM HUMAN STUDIES
Information on adverse health effects in human populations
is obtained from four sources: (1) summaries of self-reported
symptoms in exposed persons; (2) case reports prepared by medical
personnel; (3) correlational studies (in which differences in
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disease rates in human populations are associated with differ-
•noes in environmental conditions); and (4) epidemiological st
ies. The first three types of study can be characterized as
descriptive epidemiology and are often useful in drawing atten-
tion to previously unsuspected problems. Although they cannot.
identify a cause-and-effect relationship, they have value in
generating hypotheses that can be further tested. Epidemiologic
studies involve comparing the health status of a group of persons
who have been exposed to a suspected agent with that of a compar-
able nonexposed group.
Most epidemiology studies are either case-control studies or
cohort studies. In case-control studies, a group of individuals
with a specific disease is identified and an attempt is made to
ascertain commonalities in exposures they may have experienced in
the past. The carcinogenic properties of OES were discovered
through such studies. In cohort studies, the health status of
individuals known to have had a common exposure is examined to
determine whether any specific condition or cause of death is
revealed to be excessive, compared to an appropriately matched
control population. Benzene leuxemogenesis was established with
studies of these types. Generally, epidemiologists have turned
to occupational settings or to patients treated with certain
drugs to conduct their studies.
When epidemiological investigations yield convincing re-
sults? they are enormously beneficial because they provide info
mation about humans under actual conditions of exposure to a
specific agent. Therefore, results from well-designed, properly
controlled studies are usually given more weight than results
from animal studies in the evaluation of the total database.
Although no study can provide complete assurance that no risk
exists, negative data from epidemiological studies of sufficient
size can be used to establish the lev«l of risk that exposure to
an agent almost assuredly will not exceed.
Although epidemiology studies are powerful when clearest
differences exist, several points must be considered when their
results are interpreted:
• Appropriately matched control groups are difficult to
identify, because the factors that lead to the exposure
of the study group (e.g., occupation or residence) are
often associated with other factors that affect health
status (e.g., lifestyle and socioeconomic status).
e Zt is difficult to control for related risk factors
(e.g., cigarette smoking) that have strong effects
on health.
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• ?ew types of health effects (other than death) are
recorded systematically in human populations (and even
the information on cause of death is of limited relia-
bility). For example, infertility, miscarriages, and
mental illnesses are not as a rule systematically re-
corded by public health agencies.
• Accurate data on the degree of exposure to potentially
hazardous substances are rarely available, especially
when exposures have taken place in the past. Estab-
lishing dose-response relations is thus frequently
impossible.
• For investigation of diseases that take many years
to develop, such as cancer, it is necessary to wait
many years to ascertain the absence of an effect.
Of course, exposure to suspect agents could continue '
during these extended periods of time and thereby
further increase risk.
• The statistical detection power of epidemiological
.studies is limited, unless very large populations are
'studied.
For these reasons, epidemiological studies are subject to
sometimes extreme uncertainties. ' It is usually necessary to have
independent confirmatory evidence, such as a concordant result in
a second epidemiological study, or supporting data from experi-
mental studies in animals. Because of the limitations of epi-
demiology, negative findings must also be interpreted with cau-
tion.6
*Xt is important to recognize the limitations of negative epide-
mioldgical findings. A simple example reveals why this is so.
Suppose a drug that causes cancer in one out of every 100 people
exposed to 10 units is released for use (no one is aware of the
risks). Moreover, the average time required for cancer to
develop from 10 units' exposure is 30 years (not uncommon for a
carcinogen). After the drug has been in use for 15 years, an
epidemiologist decides to study its effects. Re locates the
death certificates of 20 people who took the drug, but finds
little information on their dosage. Some took the drug when it
was first released, others not for several years after its
release. The health records, which are incomplete, reveal no
excess cancer in the 20 people when compared to an appropriate
control group. Is it correct to conclude that the drug is not
carcinogenic?
-------
HA2ASD IDENTIFICATION: A SUMMARY
For some substances the available database may include sub-
stantial information on effects in humans and experimental
animals, and may also include information on the biological mech-
anisms underlying the production of one or more forms of toxi-
city. In other cases, the database may be highly limited and may
include only a few studies in experimental animals.
In some cases, all the available data may point clearly in a
single direction, leaving little ambiguity about the nature of
toxicity associated with a given compound; in others, the data
may include apparently conflicting sets of experimental or epide-
niological findings. It is not unusual for a well-studied con-
pound to have conflicting results from toxicity tests. If the
tests are performed properly, positive tests results usually
outweigh negative test results. Confusion may be compounded by
the observation that the type, severity, or site of toxicity may
vary with the species of animal exposed. Although it is gen-
erally accepted that results in animals are and have been useful
in predicting effects in humans, such notable exceptions as
thalidomide have occurred. This complex issue, briefly mentioned
here, must be considered for each compound exaained.
The foregoing discussion of hazard evaluation was derived
for exposures to a single toxic agent. Humans are rarely expose
to only'one substance': commercial chemicals contain impurities,
chemicals are used in combinations, and lifestyle choices (e.g.,
smoking, drinXing) may increase exposure to mixtures of chemi-
cals. When humans are exposed to two or more chemicals, several
results may occur. The compounds may act independently; that is,
exposure to the additional chemical(s) has no observable effect
on the toxic properties of the substance. Toxic effects of chem-
icals may be additive; that is, if chemical A produces 1 unit of
disease and chemical B produces 2 units of disease, then exposure
to chemicals A and B produces 3 units of disease. Exposure to
combinations of chemicals may produce a greater than additive
(synergistic) effect; that is, exposure to chemicals A and B
produces more than 3 units of disease. Finally, chemicals may
reduce the degree of toxicity of each other (antagonism); that
is, exposure to chemicals A and B produces less than 3 units of
disease. Hazard evaluation of mixtures of chemicals is complex
and not standardized.
& proper hazard evaluation should include a critical review
of each pertinent data set and of the total database bearing on
toxicity. It should also include an evaluation of the inferences
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about toxicity in human populations who might be exposed. At
this stage of risk assessment/ however, there is no attempt to
project human risk. For the latter/ at least two additional sets
of analyses must be conducted.
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IV. DOSE-RESPONSE EVALUATION
INTRODUCTION
The next step in risk assessment is to estimate the dose-
response relationships for the various forms of toxicity exhib-
ited by the substance under review. Even where good epidemiolo-
gical studies have been conducted/ there are rarely reliable
quantitative data on exposure. Hence/ in most cases dose-
response relationships must be estimated from studies in animals
which immediately raises three serious problems: (1) animals are
usually exposed at high doses, and effects at low doses must be
predicted, using theories about the form of the dose-response
relationship; (2) animals and humans often differ in suspectibil-
ity, if only because of differences in size and metabolism; and
(3) the human population is very heterogeneous, so that some
individuals are likely to be more susceptible than average.
Toxicologists conventionally make two general assumptions
about the form of dose-response relationships at low doses. For
effects that involve alteration of genetic material (including
the initiation of cancer), there are theoretical reasons to be-
lieve that effects ma.y take place at very low dose levels; sever-
al spec-lfi-c mathematical models of dose-reponse relationships
have been proposed. For most other biological effects, it is
usually assumed that "threshold* levels exist. However, it is
very difficult to use such measures to predict "safe" levels in
humans. Even if it is assumed that humans and animals are, on
the average, similar in intrinsic susceptibility, humans are
expected to have more variable responses to toxic agents. We
discuss these and other issues at length in the following subsec-
tions .
THRESHOLD BPPBCTS
It is widely accepted on theoretical grounds, if not defini-
tively proved empirically/ that most biological effects of chemi-
cal substances occur only after a threshold dose is achieved. In
the experimental systems described here/ the threshold dose is
approximated by the no-observable-effect level or NOEL.
It has also been widely accepted, at least in the process of
setting public health standards/ that the human population is
likely to have much more variable responses to toxic agents than
are the small groups of well-controlled/ genetically homogeneous
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animals ordinarily used in experiments. Moreover, the NOEL is
itself subject to some uncertainty (e.g., how can it be known
that the most serious effects of a substance have been identi-
fied?). Por these reasons, standard-setting and public health
agencies protect populations from substances displaying threshold
effects by dividing experimental NOELs by large "safety factors."
The magnitude of safety factors varies according to the nature
and quality of the data from which the NOEL is derived; the seri-
ousness of the toxic effects; the type of protection being sou.;-•
(e.g./ are we protecting against acute, subchronic, or chronic
exposures?); and the nature of the population to be protected
(e.g., the general population, or populations—such as workers—
expected to exhibit a narrower range of susceptibilities). Safa-
ty factors of 10; 100; 1,000; and 10,000 have been used in vari-
ous circumstances.
NOELs are used to calculate the Acceptable Daily Intake
(ADZ) for humans (which goes by other names in some circum-
stances) for chemical exposures. The ADI is derived by dividing
the experimental NOEL, in mg/kg/day, for the toxic effect appear-
ing at lowest dose, by one of the safety factors listed above.
The ADI (or its equivalent) is thus expressed in mg/kg/day. For
example,-a substance with a NOEL from a chronic toxicity study of
100 ag/fcg/day may be assigned an ADI of 1 mg/kg/day, for chronic
human exposure. The concentration of the substance—be it pesti-
cide, foctd additive, or drinking water contaminant—permitted in
various media must'b« determined by taking into account the vari-
ous uses to which the material has been or will be put, the pos-
sible routes of exposure, and the degree of human contact. Ths
permitted concentrations, sometimes called tolerances or crite-
ria, are assigned to ensure the ADI is not exceeded.
This approach has been used for several decades by such
federal regulatory agencies as FDA and EPA, as well as by such
international bodies as the World Health Organization and by
various committees of the National Academy of Sciences,
Although there may be some biological justification for
assuming the need for safety factors to protect the more sensi-
tive members of the human population, there is very little scien-
tific support for the specific safety factors used. They are
arbitrarily chosen to compensate for uncertainty and, in fact,
could be seen as policy rather than scientific choices.
There is no way to determine that exposures at ADIs esti-
mated in this fashion are without risk. The ADI represents an
acceptable, low level of risk but not a guarantee of safety.
Conversely, there may be a range of exposures well above the ADI,
perhaps including the experimental NOEL itself, that bears no
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risk to humans. The "NOEL-safety factor" approach includes no ^^
attempt to ascertain how risk changes below the range of experi-
mentally-observed dose-response relations.
The assessment of low dose "risks" from threshold agents are
discussed in Section VI on Risk Characterization.
THAT MAY KOT EXHIBIT THRESHOLDS
At present, only agents displaying carcinogenic properties
are treated as if they do not display thresholds (although a few
scientists suggest that some teratogens and mutagens may behave
similarly). In somewhat more technical terms, the dose-response
carve for carcinogens in the human population achieves zero risk
only at zero dose; as the dose increases above zero, the risk
immediately becomes finite and thereafter increases as a function
of dose. Risk is the probability of cancer, and at very low
doses the risk can be extremely email (this will vary according
to the potency of the carcinogen). In this respect, carcinogens
are not much different from agents for which ADIs are established
(i.e., the most that can be said about an ADI is that it repre-
sents a very low risk, not that it represents the condition of
absolute safety).
The Carcinogenic Process
If a particular type of damage occurs to the genetic mate-
rial (DNA) of even a single cell, that cell may undergo a series
of changes that eventually result in - the production of a tumor;
however, the time required for all the necessary transitions that
culminate in cancer may be a substantial portion of an animal's
or human's lifetime. Carcinogens may also affect any number of
the transitions from one stage of cancer development to the next.
Some carcinogens appear capable only of initiating the process
(theae are termed "initiators"). Still others act only at later
stages, the natures of which are not well known (so-called promo-
tors aay act at one or more of these later stages). And some
carcinogens may act at several stages. Some scientists postulate
that an arbitrarily small amount of a carcinogen, even a single
molecule, could affect the transition of normal cells to cancer-
ous cells at one or more of the various stages, and that a great-
er amount of the carcinogen merely increases the probability that
a given transition would occur. Under these circumstances there
is little likelihood of an absolute threshold below which there
is no effect on the process (even though the effect may be ex-
ceedingly small).
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This description of the carcinogenic process is still under
extensive scientific scrutiny and is by no means established.
However, it is by far the dominant model and it has substantial
support. This multistage model has influenced the development of
some of the models used for dose-response evaluation. Before
discussing these models further, it is useful to review the ex-
perimental dose-response information obtained from bioassays and
to discuss why models of the doser-response relation are needed.
Potency and Hiqh~to-Low Dose Extrapolation
The following example, drawn from Rodricks and Taylor,7
illustrates the need for high-to-low dose extrapolation. ASSUT.S
that a substance has been tested in mice and rats of both sexas
and been found to produce liver cancer in male rats. A typical
summary of the data from such an experiment might be as follow.?:
Lifetime Incidence Lifetime
Lifetime Daily of Liver Cancer Probability of
Pose in Rats Liver Cancer
0-mg/kg/day 0/50 0.0
12S mgAg/day 0/50 0.0
250 mgAg/day 10/50 0.20
SOP. mg/kg/day 25/50 0.50
1000 mg/kg/day 40/50 0.80
The incidence of liver cancer is expressed as a fraction,
and is the number of animals found to have liver tumors divider1
by the total number of animals at risk. The probability (P) of
cancer is simply the fraction expressed as a decimal (e.g., 25/50
• 0.50).
Although there is "no-effect" at 125 mg/kg/day, the response
is nevertheless compatible with a risk of about 0.05 (5%) because
of the statistical uncertainties associated with the small num-
bers of animals used.
This experiment reveals that if humans and rats are about
equally susceptible to the agent, an exposure of 250 mg/kg/day in
humans will increase their lifetime risk by 20%; if 1,000 people
were to be exposed to this substance at this dose for a lifetime,
then 200 of these people will be expected to contract cancer from
this substance. This is an extremely high risk and obviously one
^"Application of Risk Assessment to Pood Safety Decision-Making,
Regulatory Toxicology t Pharmacology (1983)r 3:275-307.
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that no one would sanction. However, it is near the low end of ^^
the range of rislcs that can be detected in animal experiments.
To continue with the illustration, assume that it is possi-
ble to estimate the daily dose of the chemical in the human popu-
lation. For the present example/ assume that the exposed human
population receives a dose of 1.0 mg/kg/day. It thus becomes of
interest to know the risk to male rats at 1.0 mg/kg/day.
There is a great difference between the doses used experi-
mentally and the dose of interest. The risks that would likely
exist at a dose of 1.0 ag/kg/day are quite small and to determine
whether they exist at all would require enormous numbers of ani-
mals (perhaps hundreds of thousands). It is thus necessary under
these circumstances to rely on means other than experimentation
to estimate potential risk.
Scientists have developed several mathematical models to
estimate low dose risks from high dose risks. Such models de-
scribe the expected quantitative relationship between risk (F)
and dose (d), and are used to estimate a value for P (the risk)
at the dose of interest (in our example, the dose of 1.0 mg/kg/
day). The accuracy of the projected P at the dose of interest,
d, is .a function of how accurately the mathematical model de-
scribes the true, but. immeasurable, relationship between dose
risk -*t the low dose levels.
These mathematical models are too complex for detailed expo-
sition in this document. Various models may lead to very differ-
ent estimations of risk. None is chemical-specific; that is,
each is based on general theories of carcinogenesis rather than
on data for a specific chemical. None can be proved or disproved
by current scientific data, although future results of research
may increase our understanding of carcinogenesis and help in
refining these models. Regulatory agencies currently use one-
hit, multistage, and probit models, although regulatory decisions
are usually based on results of the one-hit or multistage models.
They also use multihit, Weibull, and logit models for risk
assessment.
If these models are applied to the data recorded earlier for
the hypothetical chemical, the following estimates of lifetime
risk for male rats8 at the dose of 1.0 mg/kg/day are derived:
*A11 rislcs are for a full lifetime of daily exposure. The life-
time is the unit of risk measurement because the experimental
data reflect the risk experienced by animals over their full
lifetimes. The values shown are upper confidence limits on risk
(data drawn from Rodricks and Taylor, 1983).
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Model Applied Lifetime Risk at 1.0 ag/fcg/day
One-hit 6.0 x 10"* (One in 17,000)
Multistage 6.0 x 10"6 (one in 167,000)
Multihit 4.4 x 10-' (one in 230,000)
Weibull 1.7 x 10-« (Onc in 59 million)
Probit 1.9 x 10~10(one in 5.2 billion)
Ther-2 may be no experimental basis for deciding which esti-
mate is closest to the truth. Nevertheless, it is possible tc
show that the true risk, at least to animals, is very unlikely tc
be higher than the highest risk predicted by the various models.
Zn cas&s where relevant data exist on biological mechanisms
of action, the selection of a model should be consistent with
the data. In many cases, however, such data are very limited,
resulting in great uncertainty in the selection of a model for
low dosa extrapolation. At present, understanding of the mecha-
nism of the process of carcinogenesis is still quite limited.
Biological evidence, however, does indicate the linearity of
tumor initiation, and consequently linear models are frequently
used by regulatory agencies.
The one-hit model always yields the highest estimate of low
dose risk. This model is based on the biological theory that a
single "hit" of some minimum critical amount of a carcinogen at a
cellular target—namely, DNA—can initiate an irreversible series
of events that eventually lead to a tumor.
The multistage model, which yields risk estimates either
equal to or less than the one-hit model, is based on the same
theory .of cancer initiation. However, this model can be more
flexible, allowing consideration of the data in the observable
range to influence the extrapolated risk at low dose. Zt is also
based on the multistage theory of the carcinogenic process and
thus has a plausible scientific basis. EPA generally uses the
linearixad multistage model for low dose extrapolation because
its scientific basis, although limited, is considered the strong-
eat of the currently available extrapolation models. This model
yields estimates of risk that are conservative, representing a
plausible upper limit for the risk. Zn other words, it is un-
likely that the "actual* risk is higher than the risk predicted
under this model.
The probit model incorporates the assumption that each indi-
vidual in a population has a 'tolerance* dose and that these
doses are distributed in the population in a specified certain
way. The other models have more complex bases; because none is
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widely used we shall not discuss then. None of the models, as
currently used, incorporates a threshold dose for an exposed
population.
Interspecies Extrapolation
for the majority of agents, dose-response evaluation primar-
ily involves the analysis of tests that were performed on labor-
atory animals, because useful human data are generally not avail-
able. In extrapolating the results of these animal tests to
humans, the doses administered to animals must be adjusted to
account for differences in size and metabolic rates. Differences
in metabolism may influence the validity of extrapolating from
animals to man if, for example, the actual material producing the
carcinogenic effect is a metabolite of the tested chemical, and
the animal species tested and humans differ significantly in
their metabolism of the material.
Several methods have been developed to adjust the doses used
in animal tests to allow for differences in size and metabolism.
They assume that human and animal risks are equivalent when doses
are measured in:
o Milligrams per kilogram body weight per day
o Milligrams per square meter of body surface area per
day
o Parts per million in the air, water, or diet
o Milligrams per kilogram per lifetime.
Currently, a scientific basis for using one extrapolation method
over another has not been established.
DOSE-RESPONSE EVALUATION; A SUMMARY
For substances that do not display carcinogenic properties,
or for the noncarcinogenic effects of carcinogens, dose-response
evaluation consists of describing observed dose-response rela-
tions and identifying experimental NOELs. NOELs can be used to
establish ADIs, or can be used for the type of risk character-
ization described in Section VI.
For carcinogens, various models are applied to project the
dose-response curve from the range of observed dose-responses to
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the range of expected human doses. After the known or expected
human dose is estimated (Section V) carcinogenic risk can be
characterized (Section VI). Although the models in use yield a
range of dose-response relations, it is highly likely that the
projections of the more protective models will not underestimate
risk, at least to experimental animals, and they may strongly
overestimate it. None of the models includes a threshold. In a
•few cases, dose-response data are available from human epidemi-
ology studies and may be used in lieu of animal data for low dose
extrapolation.
It appears that certain classes of carcinogens do not possess
the capacity to damage DMA (they are not genotoxic); in our ear-
lier discussion of the carcinogenic process, such substances
would affect only late stages in the process. Some scientists
maintain that such (nongenotoxic) carcinogens must operate under
threshold mechanisms. Many of the reasons for such a hypothesis
are sound, but no general consensus has yet emerged on this mat-
ter. It is nevertheless possible that some classes of carcino-
gens could be treated in the same way noncarcinogens are treated
for purposes of establishing ADIs.
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V. HUMAN EXPOSURE EVALUATION
Assessment of human exposure involves estimation of the num-
ber of people exposed and the magnitude, duration, and timing of
their exposure. In some cases, it is fairly straightforward to
measure human exposure directly, either by measuring levels of
the hazardous agents in the ambient environment or by using per-
sonal monitors. In most cases, however, detailed knowledge is
required of the factors that control human exposure, including
•those factors which determine the behavior of the agent after its
release into the environment. The following types of information
are required for this type of exposure assessment:
e Information on the factors controlling the production
of the hazardous agent and its release into the envi-
ronment.
e Information on the quantities of the agent that are
released, and the location and timing of release.
e Information on the factors controlling the fate of the
agent in the environment after release, including fac-
tors controlling its movement, persistence, and degra
ation. (The degradation products may be more or less
toxic than the original agent.)
e Information on factors controlling human contact with
the agent, including the size and distribution of vul-
nerable human populations, and activities that facili-
tate or prevent contact.
e Information on human intakes.
The amount of information of these types that is available
varies greatly from case to case and is difficult to discuss in
general terms. For some agents, there is fairly detailed infor-
mation on the sources of release into the environment and on the
factors controlling the quantities released. However, for many
agents there is very limited knowledge of the factors controlling
dispersion and fate after release. Measurements of transport and
degradation in the complex natural environment are often diffi-
cult to conduct, so it is more common to rely on mathematical
models of the key physical and chemical processes, supplemented
with experimental studies conducted under simplified conditions.
Such models have been developed in considerable detail for radio-
isotopes, but have not yet been developed in comparable detail
for other physical and chemical agents.
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In comparison with toxicology and epidemiology, the science
of exposure assessment is still at a very early stage of develop-
ment. Except in fortunate circumstances, in which the behavior
of an agent in the environment is unusually simple, uncertainties
arising in exposure assessments are often at least as large as
those arising in assessments of inherent toxicity.
Once these various factors are known human data can be esti-
mated, as described earlier. The dose, its duration and timing,
and the nature and size of the population receiving it are the
critical measures of exposure for risk characterization.
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VI. RISK CHARACTERIZATION
The final step in risk assessment involves bringing together
the information and analysis of the first three steps. Risk is
generally characterized as follows:
1. For noncarcinogens, and for the noncarcinogenic effects
of carcinogens, the margin-of-safety (MOS) is estimated
by dividing the experimental NOEL by the estimated
daily human dose.
2. For carcinogens, risk is estimated at the human dose by
multiplying the actual human dose by the risk per unit
of dose projected from the dose-response modelling. A
range of risks might be produced, using different mod-
els and assumptions about dose-response curves and the
relative susceptibilities of humans and animals.
Although this step can be far more complex than is indicated
here; especially if problems of timing and duration of exposure
are introduced (as they-no doubt need to be in the present case),
the MOS and the carcinogenic risk are the ultimate measures of
the likelihood of human injury or disease from a given exposure
or r»f*j« of exposures.
The AOIs described earlier are not measures of risk; they
are derived by imposing a specified safety factor (or, in the
above language, a specified MOS). Our purpose here is not to
specify an ADI, but to ascertain risk. There is no means availa-
ble to accomplish this for noncarcinogens. The MOS is used as a
surrogate for risk: as the MOS becomes larger, the risk becomes
smaller. At some point, most scientists agree that the MOS is so
large that human health is almost certainly not jeopardized. The
magnitude of the MOS needed to achieve this condition will vary
among different substances, but its selection would be based on
factors similar to those used to select safety factors to estab-
lish ADIs.
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APPENDIX
TOXIC EFFECTS ON ORGANS AND OTHER TARGET SYSTEMS
INTRODUCTION
To understand the potential toxic effects of chemicals, it is
useful to understand the toxic effects (i.e./ measurable effects)
on endpoints that are commonly observed in animals, including
humans. While the following discussion is presented by organ or
system, chemicals frequently affect more than one organ and can
produce a variety of endpoints. Concentration of the chemical,
duration of exposure, and route of exposure are three of the
factors that can influence the potential toxic effect.
LIVER
A major function of the liver is metabolism--i.e., the bio-
chemical conversion of one substance into another for purposes of
nutrition, storage, detoxification, or excretion. The liver has
multiple mechanisms for each of these processes, and interference
with any of the processes can lead to a toxic effect. Chemicals
that dama-ge the liver are termed "hepatotoxic.* Toxic endpoints
of the liver can include lipid (e.g., fat) accumulation, jaun-
dice, cell death (necrosis), cirrhosis, and cancer. In addition,
chemrfcAls that increase the level of metabolic enzymes, i.e.,
enzyme inducers, can dramatically affect the toxicity of other
compounds.
The accumulation of lipids, primarily triglycerides, is re-
lated to the liver's conversion of sugars and carbohydrates into
fat for storage (or vice versa for energy production during star-
vation}. Chemicals that increase the rate of triglyceride syn-
thesis, decrease the rate of triglyceride excretion, or both can
lead to an accumulation of lipids in the liver and a concomitant
decrease of triglycerides in the blood. While the effects of
lipid accumulation in the liver are not known, a fatty liver is
generally regarded as an indication of an injury to the organ.
Jaundice is a frequent endpoint when the excretory functions
of the liver are impaired; the yellow cast of the skin is caused
by the retention in the blood of the yellow bile pigments that
would normally be excreted. Since blood that has absorbed com-
pounds from the gastrointestinal tract passes through the liver
before the rest of the body, the liver is a major site for the
removal of nutrients and toxicants. Elimination of the absorbed
toxicants can occur in the feces via the bile. In addition to
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bile acting as a mechanism of excretion, bile salts aid in the
absorption of nutrients that are not water soluble. Thus, im-
pairing liver function can affect absorption of compounds. Fi-
nally, the liver is also a site of the destruction of aged red
blood cells. Jaundice is an indicator of liver malfunction.
Necrosis, or cell death, can occur from multiple causes.
There are many mechanisms by which toxicants can directly or
indirectly inhibit required cell functions. The liver has a
limited ability to regenerate destroyed cells. Chronic destruc-
tion of cells, however, may lead to cirrhosis of the liver in
which the normal liver cells (hepatocytes) are replaced by al-
tered cells and connective tissue such as collagen.
A wide variety of chemicals have been shown to cause liver
cancers in laboratory animals. Exposure to vinyl chloride has
been associated with liver cancers in humans. The theories and
uncertainties of carcinogenesis are discussed in the main text.
As a major site of metabolism and and detoxification, the
liver contains enzyme systems that biochemically alter compounds.
Many of these processes facilitate excretion by making the com-
pound more polar, i.e., highly charged (e.g., cytochrome P-450 ,
systems) or attaching polar groups to the compound (e.g., gluta-
thione, glycuronyl, or sulfo-transferases). The speed at which
this occurs depends on the amount of enzyme present; the amount
of enzyme-can be increased by exposure to certain chemicals
called rn&tcvrs. If a nonmetabolized compound is toxic, exposure
to an inducer Bay decrease the toxic effect by increasing the
rate at which the compound is metabolized. If the compound needs
to be metabolized to be toxic, however, exposure to an inducer
may increase the toxic effect by increasing the rate of its meta-
bolism.
KIDNEY
AA an organ whose major function is the elimination of toxi-
cants and other waste products, the kidney can be considered
a complex, elaborate filter. The kidney concentrates wastes for
elimination and retains nutrients and water that are useful to
the body. The kidney can metabolize and detoxify some of the
same compounds as the liver, although the rate of metabolism is
usually slower. Compounds that injure the kidney are called
renal toxicants. Some renal toxicants may cause cell death
(necrosis) or cancer. In addition, the kidney produces chemicals
necessary for homeostasis (maintenance of the body's balance of
functions) and responds to the sympathetic nervous system. To
efficiently remove the body's waste, the kidneys must process
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large volumes of blood. Thus, the first level of susceptibility
of the kidney is that which changes the flow of fluids. This
change can be mechanical--e.g., kidney stones or puncturing
vesicles—or chemicals that dilate or constrict the passages.
The complexity of the kidney's filtering function makes it
susceptible to a number of toxicants. Although some of the fil-
tering requires no energy or special enzymes since the flow is
from high to low concentrations, much of the selection is to a
higher concentration than in the blood and is performed by en-
zymes that may be affected by chemicals. Excessive elimination
of water, salts, or other nutrients can be as harmful as failure
to eliminate wastes. Furthermore, because the kidneys concen-
trate some toxicants, the effective dose of toxicants to the
kidneys may be higher than that for the rest of the body. Toxi-
cants that cause necrosis can also impair renal function. Fail-
ure of the kidneys to filter properly is frequently detected by
an increase in wastes in the blood or an increase in nutrients in
the urine.
The ability of-the kidney to metabolize compounds has not
been studied as extensively as has metabolism in the liver. ' The
presence of inducible metabolic enzyme systems is known. Other
specific metabolic functions occur in the kidney. Finally, be-
cause, the kidney produces compounds that are necessary for other
body functions, damage to the kidney may affect other organ sys-
tems..
REPRODUCTIVE SYSTE.M
Reproductive toxicology involves at least three organisms
(both male and female parents and their offspring) and consists
of many steps and stages. Toxic effects to the reproductive
system can be classified into three general endpoints: impaired
ability to conceive, failure of the conceptus to survive, and
production of abnormal offspring.
Problems with conception usually result from impaired produc-
tion of the sperm or egg. The- formation of sperm (speraatogene-
sis) is continuous in the male and requires a series of steps.
Chemicals that interfere with these steps may prevent sperm pro-
duction and cause sterility, reduce sperm production, or result
in abnormal sperm that have reduced capacity to fertilize. Al-
though in mammals all eggs are formed before birth, their final
maturation occurs in cycles after puberty. Chemicals, e.g.,
contraceptives, can impede this process. Mature sperm and egg/
as well as proper biochemical and physiological conditions within
the body, are required for fertilization.
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Viability of the conceptus depends on a series of steps, in-
eluding implantation and development of the asmiotic sac and
placenta. Death of the conceptus, whether at the early embryonic
stage or later fetal stage, can be caused by a variety of factors
including chemicals. Such chemicals are labeled •embryotoxic"
and "fetotoxic," respectively.
Chemicals that cause defects in development and result in
abnormal offspring are called "teratogens.• Defects range from
abnormal skeletal or muscle structure and mental retardation, to
metabolic malfunctions, to subtle malfunctions that may cot be
noticed during a normal life.
Functionally, for the developing mammal to be exposed, the
chemical must pass through two barriers: the mother and the
placenta. If a given dose of a compound is sufficiently toxic to
kill the mother, resultant toxic effects on the offspring will
not be observed. Although this statement may seem trivial, its
converse is an important principle in teratogenesis. The more
dangerous teratogens are those which affect the, developing organ-
ism at concentrations that are significantly lower than those
that affect the adult mother.
Although.the placenta was once"thought to be a rather strong
barrier?- many chemicals have been found to cross to the con-
ceptus. -Depending on the compound, the final concentration may
be higher-,iff the mother, higher in the conceptus, or equal in
mother and conceptus. Moreover, the placenta is not inert but is
capable of metabolizing some chemicals into either more or less
toxic substances. Metabolism may also affect the flow of com-
pound across the placenta.
Timing has two critical aspects in teratogenesis: timing of
the dose during development and parallel timing of developing
systems. Time of exposure to the potential teratogen may not
only determine which developing system is affected but also
whether the compound will have any effect at all. Tor each de-
veloping system there is a critical period, usually between three
and twelve weeks in the human, during which the system is parti-
cularly sensitive to chemically induced abnormal development.
Although terata may form after this period, the abnormalities are
usually less severe.
The secdnd aspect of timing involves the relative rate of
development of each of the organ systems. To produce a well-
formed offspring, development must be well orchestrated. As with
a symphony, the pace must be parallel in all sections. Nerves
cannot attach to muscles that are not present; cleft palate in
laboratory animals is frequently caused by events occurring out
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of sequence. If all the developing systems were equally re-
tarded, the result might be an immature, but not malformed fetus.
LONGS
The major function of the lungs is to exchange oxygen and
carbon dioxide between blood and air. This same mechanism can
facilitate entry and exit of other compounds from the body. In
addition, the lungs have the ability to alter some chemicals
metabolically. Damage to the lung can range from irritation and
constriction, to cell death (necrosis), edema, or fibrosis, to
cancer.
The air not only contains a variety of gases but also small
suspended particulates and liquid aerosols. The fate and, there-
fore, potential to cause damage, for each physical state depends
on the size and composition of the inhaled substance. An analogy
is often drawn between the airways of the respiratory passages
and the structure of a tree. Zn both, the starting point has a
large diameter and branches into more numerous but increasingly
smaller appendages. Given the size of the passage and the fact
that large particles fall out of suspension faster, larger in-
baled particulates and droplets will generally deposit in the
upper .respiratory tract. Deposition is also affected by the
breathing pattern—for example, how fast and how deep.
The lung contains other mechanisms for handling inhaled sub-
stances including secretions, the mucociliary escalator, and
macrophages. Secretions, including mucus, can facilitate trans-
port of compounds across the lungs, between the air and blood.
The mucociliary escalator consists of mucus and hairlixe projec-
tions in the upper respiratory passages. The latter move so that.
particles that have been deposited are transported up the passage
until they can be swallowed. Substances that either affect the*
nucus or inhibit the cilia movement can impair this process.
Macrophages are a type of mobile cell that can engulf particles .
Lungs facilitate exchange in both directions between air and
blood} thus, they can be equally efficient in absorption or ex*
cretion from the body. Whether a given substance is concentrated
in the blood or in the lung air or is at equal concentrations on
both sides depends on several factors, including its solubility
in water and ability to be bound to proteins in the blood. Fur-
thermore, lungs are able to metabolize some chemicals. These
changes may alter the chemical properties and, therefore, the
transport of the chemical.
-45-
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Chemicals that irritate the lung can lead to discomfort.
Although the effects of exposure to irritants are usually revers-
ible, chronic exposure nay lead to permanent cell damage. The
normal, necessary exchange of gases across the lung can be im-
paired by compounds that constrict the respiratory passages,
affect secretions or other normal functions, or physically remain
in the lung. Substances that cause necrosis, edema (excessive
fluid retention), or fibrosis (a change in cell type and composi-
tion) will impair lung function. Exposure to some substances,
such as cigarette smoke, asbestos, and arsenic, can lead to im-
paired lung function and cancer.
SKIN
Skin is a barrier between the internal organism and the ex-
ternal environment. It prevents loss of body fluids, regulates
body temperature, and prevents entry of many substances. How-
ever, the skin is a route of entry for some toxicants. Dermal
toxicants can cause irritation, senaitiiation, pigmentation
changes, chloracne, ulcerations, and cancer.
<
The skin can also be a major route of entry for other sub-
stances—for example, some pesticides and solvents. Moreover,
abrasions or cuts on the skin can compromise the barrier. Com-
pounds that are absosbed through the skin may affect other
systems~-rfcdr;example, organophosphate pesticides that affect the
nervous system. Similarly, compounds that enter by other routes
may affect the skin—for example, the oral ingestion of arsenic
causes dermal changes.
Irritation, rashes, and itching are common toxic reactions to
dermal exposures. Chemical sensitizers may cause an allergic
reaction that becomes more severe with continued exposure to
light. Polliculitis (damage to the hair follicles) and acne are
other common akin disorders. Chloracne is a particular form of
acne that is often caused by exposure to chlorinated hydrocar-
bons. Compounds can change skin pigmentation. Skin keratoses
(hardening or scaling) or ulcers are additional toxic responses.
Skin cancer may be caused by dermal contact with some agents or
systemic administration of others.
CENTRAL NERVOUS SYSTEM
The major function of the central nervous system (CNS) is
communication. Control of reflexes, movement, sensory informa-
tion, autonomic functions (e.g., breathing), and intelligence are
-46-
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controlled by the CNS. These functions can be impaired by toxi-
cants. Damage to the nervoua system can occur in the brain or
other nerve cell bodies, to nerve processes that extend through
the body, to the myelin sheaths that cover these processes, and
at the nerve-nerve or nerve-muscle junctions. Damage to nerve
cell functions are often called "neuropathies."
As in other cells, damage to the cell body of a neuron (nerve
cell) can result in impaired function or death. The brain is
partially protected by the blood-brain barrier. Like other phy-
siological barriers, this one has proven more permeable than
originally thought, although it does blocJc or reduce the passage
of some substances to the brain. Zn contrast, certain substan-
ces, such as organic mercury, have been shown to concentrate in
the CNS.
Axons are long processes that conduct impulses from the nerve
cell body; they can span much of the length of an animal. Sever-
ing the axon can destroy transmission of signals along the nerve.
Because electrical signals are transmitted by charged elements
(ions), chemicals that change the permeability of the cell mem-
brane to ions can also impair transmission of the signal.
Sty el in is the insulating cover of axons. Special cells,
called Schwann cells, form myelin by wrapping themselves in many
layoff* around the axpns. Chemicals can either destroy the myelin
or decrease its amount, both of which decrease the insulation and
impatf signal transmission. Furthermore, demyelination of nerves
can cause a degeneration of the axon. These effects take time to
occur, even if damage is caused by a single exposure. Thus, the
effect may be delayed and not immediately associated with the
exposure.
Transmission of signals between nerves or from a nerve to a
muscle occurs across a space or junction. Chemical compounds
that are stored in vesicles at the nerve endings carry the signal
across the junctions. Exposure to chemicals may accelerate or
inhibit release of these vesicles, mimic the compounds that are
released from the vesicles, or block the receptors that react to
release of the compounds. Any of these responses will distort
the signal.
Subjective or behavior neurological toxicology may be the
•ost difficult toxicological effects to assess. While generally
accepted that exposure to some chemicals can cause headaches,
fatigue, or irritability, it is difficult to determine whether
such symptoms are caused by chemical exposure/ laex of sleep,
depression, or other factors. Although these symptoms may be
•ild and difficult to assess, they are frequently an early warn-
ing of exposure to a toxicant.
-47-
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Behavioral changes are often caused by damage to the nervous
system. Zn laboratory animals, such damage may be as precise and
fatal as failure of pups to nurse. Mental retardation and learn-
ing disabilities are other measurable behavioral changes. Chemi-
cal alteration of behavior is the basis for psychological drug
therapy. Thus, although they are difficult to assess, behavioral
changes should not be ignored.
BLOOD
Transport of oxygen, carbon dioxide, and other materials is
'the major function of blood. The hematopoietic system, which
includes organs and tissues that produce, transport, and filter
blood, interacts with the cells of all other systems. Toxicity
can occur to developing blood cells, existing cells, or the hema-
topoietic organs.
Zn the human being and other mammals, blood cells are formed
in bone marrow; the three major types of blood dells are formed
by branches from a common precursor cell. Red blood cells con-<
tain hempglobin and transport oxygen and carbon dioxide, white
blood cells function as part of the immune system. Platelets are
necessary tor blood clotting. Chemicals toxic to bone marrow can
affect blood formation. Depending on the stage and cell affect-
ed, any_ or all of the major blood cells may be decreased in num-
ber. Abirbrmal increases in production of certain blood cells are
also possible, as in leukemia (excess white cells).
Blood plasma contains a number of proteins, ions, and other
compounds. Changes in the chemical composition of blood may
indicate a toxic response. Furthermore, some chemicals bind to
plasma proteins. Changes in plasma protein composition could
affect the effective concentration of a toxicant.
The normal function of the hemoglobin in circulating red
blood cells is critical to the transport of oxygen to and carbon
dioxide from all cells in the body. Reduced oxygen supply can be
very detrimentali the effects resulting from oxygen deprivation
vary with the site of action. Chemicals can affect hemoglobin by
chemically oxidizing the heme group (causing methemoglobin) or by
denaturing the hemoglobin (which may lead to the formation of
Beinz bodies).
Two other hematopoietic organs that may be affected are the
spleen and heart. The former removes old or damaged red blood '
cells from circulation. The rate and efficiency of the heart's
pumping action can be altered by many causes. Chemicals that
-48-
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constrict or dilate the blood vesicles can also affect circu-
latory function.
IMMUNE SYSTEM
Recognition and protection against foreign substances in the
body is handled by the immune system. Rapid advances are being
made in immunology research; therefore, current knowledge may
soon be obsolete. Three types of cells (macrophages, B lympho-
cytes, and T lymphocytes) are part of the body's immune response
These cells interact at the peripheral lymphoid organs (lymph
nodes, spleen, and tonsils). Exposure to chemicals may activate
or supress the immune system.
The cells involved in the immune system are formed in bone
marrow; hence, chemicals that affect bone marrow may impair im-
mune function. One type of cell engulfs foreign matter, especi-
ally bacterial and viruses, by phagocytosis. Another type pro-
duces the five classes of antibodies. A third type produces
polypeptides, such as interferon, that are important for some
immune responses; this type of cell is also involved in cell*
mediated immunity, such as contact dermatitis, and may partially
regulate the function of antibody-producing cells.
Cfiemicals may stimulate immune responses by several mecha-
nisms 'Including acting as allergens or by stimulating production
of iofcerftron. Chemicals may also suppress immune response; im-
•unosuppressants result in an increased susceptibility to infec-
tion and may result in an increased susceptibility to some forms
of cancer.
GENETIC TOXICOLOGY
The integrity of genetic material (DKA) in all cells is crit-
ical to cell function and may be affected by some toxic agents.
Damage may take several forms: alteration in the chemical compo-
sition of DNA, change in the physical structure of DNA, or addi-
tion or deletion of chromosomes. Effects of genetic toxicity can
range from no observable effect to cancer. Genetic toxicity has
become a popular endpoint for toxicity testing because test re-
sults can be obtained relatively rapidly and inexpensively.
Genetic damage can occur by many mechanisms; the results are
generally classified in three groups: mutations, clastogenic
events, and aneuploidy. Mutagens are substances that change the
-49-
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chemical structure of ONA. Since DNA is "read" to provide infor-
mation necessary for cell function and proliferation, mutations
may cause a misreading, leading to cell damage. Clastogens cause
a break in one or more strands of DNA and a physical rearrange-
ment of its parts. Depending on where the break occurs, clasto-
gens may affect cell proliferation or the production of cell
proteins. Aneuploidy is an addition or deletion of the number of
chromosomes; a commonly known aneuploidy is Down's syndrome
(Mongolism) in which there is an extra chromosome. Aneuploidy is
often caused by chemicals that Affect cell division.
Genetic toxicology is often considered with carcinogenic!ty
since many carcinogens are mutagens and testing for mutagenicity
is easier than testing for carcinogenicity. Genetic toxicants,
however, can have many effects. Much of the DNA in cells is
quiescent. Since skin cells do not produce hemoglobin, there
will be little damage if instructions for producing hemoglobin
are damaged in a skin cell. Such events are called silent muta-
tions. Genetic damage can alter cell proteins and, therefore,
normal functioning of cells. Improper cell function may lead to
cell death or cancer. Finally, if the damage is ia the reproduc-
tive system, genetic toxicants can cause reproductive failure or
abnormal offspring.
A variety of genetic toxicology tests have been developed in
recent years. Many are performed in vitro (outside the whole
animal—e^g., the Ames mutagenicity assay) and use cells grown in
liquidst some are performed in vivo (within the animal). These
tests are-of ten referred to as short-term testing and require
less time, and therefore, less money. Typically, short-term
tests take days to months as contrasted with several years re-
quired for carcinogenicity testing.
-50-
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DOCUMENT 6
SESSION 1 - GENERAL TECHNOLOGY AND APPLICATION
ENVIRONMENTAL ASSESSMENTS PER SUBPART X
-------
ENVIRONMENTAL
ASSESSMENTS
PER SUBPART X
C. J. OSZMAN JR.
USEPA (OS-343)
OFFICE OF SOLID WASTE
WASHINGTON, D.C.
52 FR 46946 (12-10-87)
54 FB 26198 (6-23-89)
SUBPART X UNITS
GEOLOGIC REPOSITORIES
THERMAL TREATMENT OF PEP
DRUM SHREDDERS
CARBON REGENERATION UNITS
OTHERS
-1-
-------
REGULATORY
REQUIREMENTS
40 CFR 270.13
THROUGH
270.23
MUST:
PROTECT H. H. & E.
DOES NOT SPECIFY:
MINIMUM TECHNOLOGY
MINIMUM MONITORING
PREVENTION OF RELEASES
SUBSURFACE
SURFACE WATER AND SOILS
AIR
FOR EACH MEDIUM MUST CONSIDER FACTORS LISTED IN 40 CFR 264.601
-2-
-------
EXISTING VS. NEW UNITS
EXISTING:
NEW:
VISUAL INSPECTION
OFFICIAL REPORTS OF PRIOR RELEASES
MONITORING AND SAMPLING RESULTS
MODELING DATA
INFO FROM SIMILAR UNITS
DESIGN EVALUATIONS
BENCH-SCALE TESTS
IN ALL CASES:
QA/QC REPRESENTATIVENESS
ACCURACY
PRECISION
COMPLETENESS
COMPARABILITY
GENERAL INFORMATION REQUIREMENTS
SCREENING OR PRELIMINARY
ASSESSMENT
RELEASE CHARACTERIZATION-
DETAILED ASSESSMENT
HEALTH AND ENVIRONMENTAL
ASSESSMENT
TERMS AND PROVISIONS FOR
PROTECTION OF H & E
-3-
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GENERAL INFORMATION
REQUIREMENTS
WASTE CHARACTERIZATION
UNIT CHARACTERIZATION
ENVIRONMENTAL SETTING
CHARACTERIZATION
AVAILABLE MONITORING AND OTHER DATA
EVALUATION OF SIMILAR UNITS
VISUAL SITE INSPECTION
WASTE CHARACTERIZATION
IDENTIFICATION AND GENERATION
PHYSICAL AND CHEMICAL
CHARACTERIZATION
CONSTITUTE CONTENT
UNIT CHARACTERIZATION
TYPE AND PURPOSE
LOCATION AND AGE
DESIGN, STRUCTURE AND
DIMENSIONS
OPERATION AND MAINTENANCE
OPERATING HISTORY
-4-
-------
ENVIRONMENTAL SETTING
CHARACTERIZATION
CLIMATE AND METEOROLOGY
TOPOGRAPHY
GEOLOGY
HYDROGEOLOGY
LAND USE
SURFACE-WATER HYDROLOGY
SCREENING ASSESSMENT
PURPOSE
REASONABLE WORST CASE
ASSUMPTIONS
POTENTIAL CONSTITUENT MIGRATION
PATHWAYS
GROUND WATER OR SUBSURFACE
SURFACE WATER, WETLANDS OR
SOIL SURFACE
AIR
-5-
-------
RELEASE
CHARACTERIZATION
DETAILED ASSESSMENT
CONSIDERATIONS
GENERIC APPROACH
RELEASES TO GROUND WATER
OR SUBSURFACE
RELEASES TO SURFACE STRUCTURES
RELEASES TO AIR
HEALTH AND
ENVIRONMENTAL
ASSESSMENT
OVERVIEW
HEALTH AND ENVIRONMENTAL
ASSESSMENT PROCESS
EXPOSURE ROUTES
EXPOSURE LEVELS
HEALTH AND ENVIRONMENTAL
CRITERIA
-6-
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EVALUATION OF .MIXTURES
EVALUATION OF DEEP
SOIL CONTAMINATION
EVALUATION OF SEDIMENT
CONTAMINATION
STATISTICAL PROCEDURES
FOR EVALUATING GROUND WATER
QUALITATIVE ASSESSMENT AND
CRITERIA
REFERENCES
RFA AND RFI
OTHERS
-7-
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DOCUMENT 7
SESSION 2 - ENVIRONMENTAL ASSESSMENT - AIR
AN OVERVIEW OF ITEMS TO CONSIDER IN AIR ASSESSMENT
-------
AN OVERVIEW OF ITEMS TO CONSIDER IN AIR ASSESSMENT
James L. Dicke
I. Introduction
A. Regulatory Background: 40 CFR Part 264.601, Environmental
Performance Standards, Paragraph (c), and Part 270.23
B. Objectives: Listed in Seminar Brochure
II. PEP Volume, Characteristics and Emissions
A. Quantities of Wastes to be Treated and Residues
B. Explosive Reactivity/Ignitability, Toxicity (metals),
Hazardous Constituents
C. Physical State of Air Emissions and Quantities Released/
Unit Operation
III. Potential Magnitude of Air Exposure to Hazardous Waste or
Hazardous Constituents from the Subpart X Unit
A Location of the Unit and Manner of Operations
B. Preliminary Assessment -- Conservative Screening
C. Detailed Assessment -- Appropriate Dispersion Model(s)
IV. Atmospheric Dispersion Modeling for Subpart X Unit Impacts
A. Data Input Requirements
B. Appropriate Models
C. Interpretation of Results
V. Additional Items for Assessment
A. Meteorological/Climatological Summary Including a Windrose
B. Topographic Influences on Atmospheric Dispersion
C. Land Use Maps
D. Existing Air Quality Concentrations -- National Ambient Air
Quality Standards (NAAQS)
E. Sources of Monitoring Data and Representativeness, Including
Meteorological Data
F. Potential for Damage to Other Than Humans by This Operation
VI. Summary — Discussion
-------
AN OVERVIEW OF ITEMS TO
CONSIDER IN AIR ASSESSMENT
I. INTRODUCTION
REGULATORY BACKGROUND
• Federal Register, Thursday, December 10,1987
- 40 CFR Part 264.601, Environmental
Performance Standards
- 40 CFR Part 270.23, Specific Part B
Information Requirements for
Miscellaneous Units
SESSION OBJECTIVES
• PEP Volume, Characteristics and Emissions
• Potential Magnitude of Air Exposure to
Hazardous Waste or Constituents
• Atmospheric Dispersion Modeling
• Additional Items for Assessment
-l-
-------
II. PEP VOLUME, CHARACTERISTICS ^
AND EMISSIONS
QUANTITIES OF WASTES TO BE TREATED
AND THEIR RESIDUES
• Section 270.14 - Physical and Chemical
Analyses Containing Information to Assure
Proper Waste Management, e.g. OB/OD
Waste Analysis Plan under Section 264.13
-Waste Analysis Plans: A Guidance Manual
- Test Methods
- Sampling Methods
- Frequency - Review/Update
- Off-site Facilities
Additional Information on Hazardous Constituents
Prior to Treatment and Residues
WASTE/RESIDUE CHARACTERISTICS
• Hazards - Reactivity, Ignitability, Toxic Metals
• Concentration of Hazardous Constituents
• Quantity of Waste Placed in the Unit and
Quantity of Residues
-------
Residence Time in the Unit
Toxicity of Constituents - Exposure Levels
Volatility, Water Solubility and Mobility of
Constituents - Soils and Water Considerations
Special Considerations
PHYSICAL STATE OF AIR EMISSIONS AND
QUANTITIES RELEASED
• GASES
• PARTICLES
- Size Distribution
- Density/Specific Gravity
- Entrainment
Emission Rates of Constituents
- Frequency of Operations
- Duration of Operations
-Time-Varying Emissions
--Average
--Maximum
- Puff/Instantaneous
-Continuous
-3-
-------
Type of Release
-Point
-Line
-Area/Volume
Special Consideration
III. POTENTIAL MAGNITUDE OF AIR EXPOSURE TO
HAZARDOUS WASTE OR HAZARDOUS
CONSTITUENTS FROM THE SUBPART X UNIT
LOCATION OF THE UNIT AND MANNER OF OPERATIONS
• Description of the Unit
- Dimensions for Dispersion Modeling
-Topography
Operating Procedures
- Characteristics of the Source for Dispersion Modeling
- Air Emission of Constituents from the Unit
Meteorological Conditions
-Acceptable
-Restrictions
Meteorological and Air Quality Monitoring
-4-
-------
PRELIMINARY ASSESSMENT
• Demonstration That There is No Violation of
Environmental Performance Standards in
Section 264.601, i.e. No Adverse Effects on
Human Health or the Environment
• Characteristics of the Source and Unit
Operations
• Emission Rates of OB/OD Constituents
• Critical Receptors
Conservative Screening Model Analysis
- Worst Case Operations and Meteorology
-Comparisons with Exposure/Dosage
Criteria/Limits, i.e. Potential for Risk
Contributions of Air Emissions to Impacts in
Other Media
Continuing Compliance to Ensure Prevention
of Adverse Effects
DETAILED ASSESSMENT
• Source Characteristics and Operating Parameters
• Emission Rates During Unit Operations
*
• Site-Specific Meteorological Data
• Critical Receptors
• Refined Dispersion Model Analysis
-5-
-------
Interpretation of Model Results to Determine the
Potential for Risk Caused by Exposure to Air
Contributions of Air Emissions to Impacts in
Other Media
Continuing Compliance to Ensure Prevention of
Adverse Effects
IV. ATMOSPHERIC DISPERSION MODELING FOR
SUBPART X UNIT IMPACTS
DATA INPUT REQUIREMENTS
• Source Characteristics
• Waste Constituents
• Meteorological Data
• Receptor Locations
• Model Output Instruction - Format, Reports,
Graphs, Tables, Files for Post-Processing
APPROPRIATE MODELS
• Source/Emissions Models
- Source Characteristics - Dimensions, Type
- Emission (Burn) Rates for All Constituents
- Heats of Formation
- Products of Combustion
- Size Distribution of Particles
-Outputs to Dispersion Model
-6-
-------
ATMOSPHERIC DISPERSION MODELS
• Components
- Representative Meteorological Data
- Plume/Cloud Rise - Buoyancy
- Inversion Penetration/Reflection
- Lateral and Vertical Dispersion
-Atmospheric Transformations/Chemical Reactions
in the Cloud
-Temporal Changes in the Wind Field
-Settling/Deposition of Particles - Dry Processes
- Precipitation Scavenging - Rainout and Washout
-Terrain Interaction
- Receptor Grid - Fixed and User Input
Calculations for Source Types
- Instantaneous - Puff/Detonation
- Quasi-continuous-burn
Model Outputs
- Peak Concentration
-Time-averaged Concentration
- Time-integrated Concentration-Dosage
-7-
-------
ft
- Concentration/Dosage/Deposition Isopleths
- Surface Deposition of Particles
- Culpability Tables
- Files for Subsequent Analyses, e.g. Input to
Other Models for Ground Water, Soils, etc.
EXAMPLES
• Screening Techniques - Dispersion
- SCREEN - EPA-450/4-88-010
- PUFF - EPA-600/3-82-078
- Screening Techniques for Air Toxics -
EPA-450/4-88-009
Refined Models
-REEDM -INPUFF-2.0
-POLU10 -RTVSM
-ISCST -PCAD
- BLP - OB/OD Dispersion Model
Proposal by U.S. Army
-------
INTERPRETATION OF MODEL RESULTS
• Potential for Health Risks from Estimated
Exposure Levels
- National Ambient Air Quality Standards
- Health-based Criteria for Carcinogens
- Health-based Criteria for Systemic Toxicants
-Threshold Limit Values
-Other Short-term Exposure Limits
Potential for Damage to Animals, Crops,
Vegetation, Structures from Estimated
Exposure Levels
V. ADDITIONAL ITEMS FOR ASSESSMENT |
Meteorological/Climatological Summary Including a
Wind Rose
Topographic Influences on Atmospheric Dispersion
Land Use Maps
Existing Air Quality Concentrations-National Ambient
Air Quality Standards (NAAQS)
-9-
-------
ft
• Sources of Monitoring Data and Representativeness,
Including Meteorological Data
• Potential for Damage to Other than Humans by This
Operation
• Monitoring, Analysis, Inspection, Response and
Reporting
VI. SUMMARY - DISCUSSION |
-10-
-------
DOCUMENT 9
SESSION 3 - ENVIRONMENTAL ASSESSMENT - WATER AND SOIL
WATER AND SOIL OUTLINE AND SLIDE HARDCOPY
-------
ENVIRONMENTAL ASSESSMENT -- WATER AND SOIL
David K. Kreamer
I. Introduction - Field Uncertainties and Establishing Mass Balance
A. PEP Volume in the Subsurface, Characteristics, and Emissions
B. Frequency of Emissions
C. Monitoring and Control of Emissions
II. Fate and Transport of PEP in the Subsurface - Leak Detection, Characterization
and Remediation
A, Subsurface Fluid Movement - Introduction
1. Liquid Movement - Vadose and Groundwater Zones
a. Miscible Contaminants
b. Immiscible Contaminants
2. Gaseous Migration
B. Physiochemical Properties
1. Partitioning - Sorption
2. Chemical Equilibrium - Redox
3. Cosolvency
4. Facilitated Transport
5. Other
C. Site Assessment
1. Geology, Subsurface Structure and Geohydrology
a. Porous Media
b. Fractured Media
c. Vadose Zones
2. Sampling - Safety
a. Saturated Zone Sampling
b. Vadose
1. Soil Cores
2. Liquids
3. Gases
D. Data Evaluation
1. Geographical Information Systems
2. Modeling
a. Transport
b. Chemical
3. Statistical Approaches
4. Case Study - Hypothesis Testing, Kriging
-------
ENVIRONMENTAL ASSESSMENT « WATER AND SOIL
David K. Kreamer
Page Two
E. Remediation
1. Pump & Treat
2. Excavation
3. Barriers - Fixation
4. Soil Washing
5.VES
6. Bioremediation
ACKNOWLEDGMENTS
This work relied heavily on the efforts of others. References and content for many parts of this
presentation were assembled by several individuals.
Particular thanks is given to:
James W. Mercer
Michael J. Barcelona
Carl Palmer
J. Michael Henson
Ronald C Sims
Lome Everett
Robert Hlnchee
Richard Johnson
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BATCH TESTS
SOLUTION WtTH SOIL WITH SHAKE AND
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MATTER
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SAMPLE AND
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RETARDATION FACTORS
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CARBON TETRACHLORIOE
TETRACHLOROETHYUNE .
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TIME (DAYS)
Afttr HacKav ft jl., 1936.
COMPARISON OF METHODS
FOR RETARDATION FACTORS
SOLUTE
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OFFICE
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-36-
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HYUHOGEULUuy
• RELATIONSHIP OF MOVEMENT OF SUB-
SURFACE WATERS TO GEOLOGY
• DIRECTIONS AND RATES OF
GROUNDWATER FLOW
• TIES STRATIGRAPHY, LITHOLOGY,
STRUCTURAL GEOLOGY TO THEORY OF
GROUNDWATER HYDRAULICS
• ESSENTIAL TO ANY GROUNDWATER
REMEDIATION, GROUNDWATER MONITOR-
ING OF SURFACE CLEANUP (I.E., EXCAVA-
TION, VACUUM EXTRACT/ON)
DOWUW.U Mtup lor th* G#o Flowmat.r
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dlrectloni during tht jt*r (t) lite fill wtttr-tiblt with no
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polarization
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FORMATION
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-38-
-------
DATA PERTINENT TO THE PREDICTION
OF GROUNDWATER FLOW
• PHYSICAL FRAMEWORK
- Hydrogeologic map showing areal
extent and boundaries of aquifer
- Topographic map showing surface-
water bodies
- Water-table, bedrock-configuration,
and saturated-thickness maps
- Hydraulic conductivity map showing
aquifer and boundaries
- Hydraulic conductivity and specific
storage map of confining bed
- Map showing variation in storage
coefficient of aquifer
- Relation of stream and aquifer
(hydraulic connection)
• STRESSES ON SYSTEM
- Type and extent of recharge areas
(Irrigated areas, recharge basins,
recharge wells, impoundments,
•pills, tank leaks, etc.)
- Surface-water diversions
- Groundwater pumpage (distributed
In time and space)
- Stream flow (distributed in time and
space)
- Precipitation and evapotranspiration
• OBSERVABLE RESPONSES
- Water levels as a function of time
and position
• OTHER FACTORS
- Economic information about water
supply
- Legal and administrative rules
- Environmental factors
- Planned changes In water and land use
-39-
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• OBSERVABLE RESPONSES
- Water levels as a function of time
and position
• OTHER FACTORS
- Economic information about water
supply
- Legal and administrative rules
- Environmental factors
- Planned changes in water and land use
\
\
Flow Otf«ctlonx
\ \ \
\ \ \
\ \ \
\ \ \ \
\ \ \ \
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\ \ \ \ y
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W
MAP VIEW
Hltcilculaclon of |roundw»t«r-(lov dlrtccion* cau><4
by unnco|nlltd h«c«co(in«lCT <
SATURATED ZONE SUMMARY
• no subsurface characterization technique provides
perfect Information; use several techniques In
combination
• determine data thresholds (phased approach) for
remedial decisions; decisions will have
uncertainty; importance of monitoring
• presented general data requirements and
characterization techniques; each application of
techniques Is unique and stte specific
• data Interpretation Is just as importnat as data
collection; need to understand data analysis and
why data are collected
cross SECTION
Groundwat«r Flow Afftctwd by • Pumped Well
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•an, S.W., 1972. GroundMater
Professional Paper 708, U.S
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ch, F. and K. Denny. 1966. Gi
on the permeability of uncoi
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nutrient management in hiana
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REGION (Parti)
(0)
ttl 795-9557
Conceptual model for overlapping contlnua, curve (a) Is
we plot of i property * measured for different volume (REV) L
of porous media; curve (b) 1s,the plot of a property * measured
for different volumes (REV) L3 of fractured porous media. The
region (c) 1$ the coimon region where both the porous medium and
fracture iwdlu* physic* can be represented as though each were
a cont1nuu».
30
10
I inlroductioni Ij
5
Marcn 26 ?7 28 29 30 3' Apr,i 2 j
Model of i nttwork ai punfti
FRACTURED MEDIA SUMMARY
heterogeneity is important to characterize, but Is
especially important In karst and fractured media
characterization techniques are somewhat limited:
coring, aquifer tests, tracer tests, geophysical
tools, and fracture trace analysis
difficult to characterize and predict behavior:
equivalent porous media, discrete fractures, dual
porosity, and stochastic approach
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Water Movement In the Vgdose Zone
DETERMINATION OF
WATER MOVEMENT
IN THE
VADOSE ZONE
Water Storage
Water Movement
Contaminant Storage
Contaminant Movement
Vapor Movement
Impacts on Remediation
for T*itm« «nd Mrt*n*l§
of Stat* Hi^iwvy OHicwU
US. D*e«nm>nt
of Ayicultur*
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Soil-^urat» tin limits of ASTM, AASHO, USD A. FAA, Corps of Enginwn. and USSR.
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SIWHARY OF METHODS TO HEASURE UNSATURATED HYDRAULIC-CONDUCTIVITY
VALUES IN THE FIELD AND LABORATORY
Method
Constant-Hetd
Borehole
Infi1tration
Application
Field nethod in open or
partially cased borehole.
Most cannonly used method.
Includes a relatively large
volume of porous media in
test.
Reference
Bouwer (1978);
Stephens and Neunan
(19824,b.c);
Amoozegar and
WarricK (1986)
Guelph Field method in open,
Permeameter small-diameter borehole (>5
cm). Relatively fast
method (5 to 60 unutes)
requiring small volume of
•ater. K,, K(*) and
sorptivity are measured
simultaneously. Many
boreholes and tests may be
required to fully represent
heterogeneities of porous
media.
Reynolds and El rick
(1986)
Air-Entry Field method. Test per-
Peraeameter formed in cylinder which is
driven into porous media.
Small volume of material
tested; hence, many tests
may be needed. Fast,
simple method requiring
little water (-10 L).
Bouwer (1966)
Instantaneous
Profile
Field or lab method. Field
method measures vertical
*(»,») during drainage.
Measurement of moisture
content and hydraulic held
needs to be rapid and non-
destructive to sample.
Commonly used method,
reasonably accurate.
Boumi, Baker, and
Veneman (1974);
Klute and Oirksen,
(1986)
Crust-Imposed
Steady Flux
Field method. Measures
vertical K(*) during
wetting portion of
hysteresis loop. Labor and
time intensive.
Green. Ahuja, and
Chong (1986)
Sprinkler-
Imposed Steady
Flux
Field method. Larger
sample area than for crust
method. Useful only for
relatively high moisture
contents.
Green. Ahuja, and
Chong (1986)
Parameter
Identification
Results of one field or lab
test ire used by a
numerical approximation
method to develop K(f),
K(»), and »(») over a wide
range of » and ».
Relatively fast method;
however, unique solutions
ire not usually attained.
Zachmann et al.
(198U.6. 1982);
Kool et al. (1985)
Empirical
Equations
Each empirical equation has
Its own application based
upon the assumptions of the
equation. Relatively fast
technique.
Brooks-Corey
(1964);
van Genuchten
(1980);
Nualem (1986)
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SUMMARY OF METHODS TC » -SURE OR ESTIMATE EVAPOTRANS?::
Method
WATER BALANCE
METHODS
Pan
Lysimeter
Aoplication
Reference
Direct field method,
accurate, moderate to low
cost.
Veihmeyer (1964),
Shjrma 11985!
Soil
Moisture
Sampiing
Direct field method.
accurate, moderate to
cost.
low
Veihmeyer (1964)
Potential Direct field method of PET. Thornthwaite and
Evapotrans- Moderately accurate and low Mather (1955;
pirometers cost.
CV Tracer Indirect combined field and Sharma (1985)
laboratory method; moderate
to high cost.
yater-Budget Indirect field estimate of Davis i Dewiest
Analysis ET, manageable to (1966)
difficult; moderate to low
cost.
Ground-water
Fluctuation
MICROMETEORO-
LOG1C METHODS
Profile
Method
Energy
Budget/
Bowen Ratio
Indirect fitld method;
moderate to low cost.
Indirect field method.
Indirect field method;
difficult, costly, requires
data which is often
unobtainable, research
oriented.
Davis I Dewiest
(1966)
Shama (19B5)
Veihmeyer ( 1964) ;
Shanna (1985)
Eddy
Covariance
Method
Indirect field method;
costly; measures water-
vapor flux directly; highly
accurate; well accepted;
research oriented.
Veihmeyer (1964),
Shanna (1985)
Penman
Equation
Indirect field method.
difficult, costly, very
accurate; eliminates need
for surface temperature
measurements: research
oriented.
Veihmeyer (196*);
Sharma (1985)
Thornwaite
Equation
Blaney-
Criddle
Equation
Empirical equation; most
accepted for calculating
PET; uses average monthly
sunlight, moderate to low
cost.
Empirical equation; widely
used; moderate to high
accuracy; low cost; adjusts
for certain crops and
vegetation.
-60-
Veihmeyer (1964);
Shama (1985)
Stephens I Stewart
(1964)
-------
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-61-
-------
Catalog of Methods for Monitoring Water Content in the Vadose Zone
Method
Principle
Advantages
Disadvantages
Refi
1 Gravimetric
a. Oven drying
b. Carbide method
Core samples are obtained
from (he vadoae zone us-
ing tube samplers for shal-
low depths and hollow
stem auger plus core sam-
pling for greater depths. A
core sample ts weighed.
oven dried at 105 C for 24
hours, and reweighed. The
water content is deter-
mined by difference in
weight Results expressed
on a dry weight or volume
basis. The difference in
water content values of
successive samples repre-
sents change in storage.
A field method. Solids sam-
ples are placed in a con-
tainer with calcium car-
bide. The calcium carbide
reacts with water, rrteas-
Ingagas. The gas pressure.
registered on a gage, ts
converted Into water con-
tent on a dry weight bails.
1 A direct method.
2. The most accurate
of available methods.
a Simple.
1 More rapid than
oven drying.
Z Initial capital invest-
ment ts lower than for
oven drying.
I. A large number of repli-
cate samples are required
for each depth Increment
(necessitating several
holes) to account for spa-
tial variability of water
holding properties.
Z Expensive if large num-
bers of samples are re-
quired.
3. Adestructive method—
i.e.. additional measure-
ments cannot be obtained
at the same sites.
1. May not be as accurate
as oven drying
2. Other disadvantages
are the same as for oven
drying.
Gardner II9651.
HUldll97U
Schmugge. Jackson
and McKJm I1980L
Reynolds (1970a.
1970b I. Brakensiek.
Osbom and Rawls
119791.
2. Neutron moisture
logging (neutron
scatter met hod I
A source of high energy
neutrons leg-amereclum-
bervUluml in a down-hole
tool Is lowered Into an
access well. Water In the
vadose zone slows down
the fast neutrons, which
are eapt ured by a detector
In the tool. Counts are
measured by a surface
sealer, ratemeter. or re-
corder. Counts are con-
verted into volumetric
water content by an appro-
priate calibration relation-
ship. Successive readings
show temporal changes in
water storage at successive
depths.
1. Rapid.
Z An in-sltu method.
3. Can be conducted in
cased or uncased holes
(for safety in unstable
material should Install
casing).
4. Can be Interfaced
with portable data col-
lection system.
& Successive readings
are obtained in the
same profile at the
same field location.
6. Can be used to locate
perched ground-water
zones. I*, valuable for
positioning monitoring
wells for sampling
perched ground water.
1. Expensive, requiring
the purchase or lease of
equipment.
2. Water content is mea-
sured In a sphere. Cannot
relate results exactly to a
specific depth.
3. Fast neutrons are
moderated by other con-
stituents besides hydro-
gen In water, eg,, chlorine
or boron. Accuracy may be
affected.
4. During Installing of
access wells, cracks or eavi-
ties may be formed caus-
ing leakage along the cas-
ing wall.
5. An indirect method re-
quiring calibration. Cali-
bration is a difficult pro-
cedure.
& Accurate readings an?
not possible within 6 la of
soil surface.
7. Cannot be used to Infer
water movement in re-
gions where storage
changes do not occur.
Holmes. Taylor and
Richards 11967L van
Save) II963). Keys
andMacCaryll971).
McGowan and
WIDUms(1980L
Schmugge. Jackson
and McKlmllSeOL
Wilson (1980 L Hllld
(197 U Brakensiek.
Osbomand Rawls
119791. Visvaiingum
and Tandy 119721.
-62-
-------
Method
Gamma rav
attenuation.
i. Transmission
metnod-
tx Scattering
methon.
4. Tensiomeiers
Two parallel wrils installed
at precise distances aoan
are rea uired. A prooe with
a gamma photon source
ie4. cesium 13711s lowered
tnoneweil A second prooe
with a detector lex sodium
iodide scintillation crystal I
ts lowered at the same rate
In the second well Acces-
sories include a high-volt-
age supply, amplifier.
acaler. timer, spectrum
analyzer pulse height
analyzer and phoiomuln-
plier tube The degiet to
which a beam of monoen-
ergettc gamma ravs is
attenuated depends on the
bulk densirv and water
content. Assuming that
the bulk densirv remains
constant, changes be-
tween readings reflects
changes in water content
A single probe is used, con-
taining a gamma source
and a detector separated
by a tead shield- Comma
ray* beamed Into the sur-
rounding media are ab-
sorbed by the soixl media
and water Back-scattered
rays are detected and mea-
sured Knowing the dry
bulk density of the media.
the water content can be
calculated. Requires
empirical calibration
curves.
A tenstometer consists of
a porous ceramic cup ce-
mented to ngid plastic
tube, containing small
diameter tubing leading
to a surface reservoir of
mercury. Alternate njsiuri
uses strain gage trans-
ducer in lieu of mercury
manometer. The body tub-
Ing kt fined with water.
Rjies in cup form contin-
uum with pores in exterior
medium. Water moves into
or out of body tube until
equilibrium is reached.
Measured water pressure
reflects corresponding
water pressure in medium.
By using appropriate soil
water characteristic curve.
pressure can be related to
water content
1 A rapid, in-snu
method.
Z Water content is ob-
tained in s narrow
beam —depth-wise
measurement can be
obtained as ooat a» one
inch apart.
1 Measurements can
be obtained within one
Inch of surtace.
4 Nondestructive and
successive measure-
ments are obtained at
same locations.
5 Can be interfaced
with portable data cot-
lecuon system.
1 Limited to mallow
depths because of difHcuJ
ues In installing precisely
parallel weUa. parucularrv
In roocv material
2. Instabilities in count
rate mav occur.
a. Expensive.
4 ChangesinbuUi densirv
In shrinkine-swelling
material afTects acruracv
of water content readings.
5. Variations in water con-
lent and bulk density
occur in stratified soils.
6. Care muat be taken in
handling radioactive
source.
BraXensieK. Osbom
and Rawis 11979)
Gardner U 9651
Bouwer and JacHson
(1974L Regmatoand
vanBaveM1964l.
Rejonato and Jacfcaon
U97HSchmugf!e-
j^-kson and McKim
(19801.
1 Rapid.
1 Nondestrucuve.wlth
successive measure-
ments obtained at
mame depth.
3. in conu*»» to tne
iju^smtsskon method
onry one access wett ta
required. Reading can
be obtained at great
depth in vadoae tone.
1. Requires a sourer of
higher strength than
uangmisajon method.
1 r« as accurate as trans-
mininn method because
water content measured
in sphere and not • beam.
a Expensrve.
4. Changes in bulk densirv
in ahnnking. swelling
maienaJ changes cali-
brations.
Krvs and MacCarv
II 97 H BraXensieK
1. Provide continuous.
in ptaoe 11» •' 111 11 • i it»
of water content.
2. Successrve meaaure-
ments are obtained.
3. Inexpensive and
atmpse.
4, Transducerxiniui re-
spond falrty rapidry to
water content changes.
1 units fall ai the air entry
vatue of the ceramic cup.
t -Q£ atmo-
(1979LPaeta*d
119791.
spheres.
Z Results are subject to
hysteresis, that is. differ-
ent results are obtained
for wetting vs. drying
media.
a If proper contact is not
made between cup and
media units wUl not oper-
ate property.
4 Sensitive to tempera-
ture changes.
5. Difficult to install at
great depth in vadose rone.
BraXensjek. Osoom
and Bawls ll 979 L
Holmes. Tavtor and
Richards 11967 L
Btancnt 11967L
Gairon and Hadas
U973lSchmugge.
jackson and McKim
(1980L WUson 1198OL
Oaksford I1978L
-63-
-------
Method
Principle
Advantages
Disadvantages
-ft
5. Elecincal resistance
blacks
6. Thermocouple
psychrometers/
Blocks consist of elec-
trodes embedded in por-
ous material (plaster of
pans, nylon, doth, fiber-
glass). Water content of
blocks change with water
content of soil Electrical
properties ofbtocks change
with changing water con-
tent. Electrical properties
are measured using a
meter. Calibration curves
must be obtained.
A psychrometer unit con-
sists of a porous bulb with
a chamber In which the
relative humidity of the
exterior media is sampled:
a sensitive thermocouple.
a heat sink, reference elec-
trode, and electrical cir-.
cuitry. The unit operates
on the principle thai a rela-
tionship exists between
soti water potential and
relative humidity. Two
types are available, the wet
bulb type and the dew
point type. Both types rely
on cooling of the thermo-
couple junction by the ra-
tter effect In the wet bulb
type, when the tempera-
ture at the junction is re-
duced below the dew point.
cooling is discontinued. As
cnnrtrnsfd water evapor-
ates, the temperature in-
creases to ambient. Signal
from the junction at the
porttonsi to relative humid-
ity. In the dew point type.
the temperature at Junc-
tion la held constant at
dew point. The tnermo*
couple signal <
lo dew point
and thus to the relative
humidity. Different meth-
ods are required far the
two types-The dew point
method is more accurate.
Calibration curves relating
relative humidity to water
potential are required.
Water potential and water
content are related
through a charactensuc
curve for each material
1. Can be Interfaced
with portable data col-
lection system.
Z Can be used at soil
water pressures less
than -0.8 atmospheres.
3. Gypsum blocks are
inexpensive.
4. Precision is good.
1. In-situ pressure
m aniiiMM iiti arrpos
si bie down to - 5O atmo-
spheres, permitting the
determination of water
contents In the very dry
range
Z Permits continuous
recording of pressures
(and water contents! at
the same depth.
3. Can be Interfaced
with portable or remote
data coUectlon systems.
4. Some units have
been installed to great
depth (down to 30O
feetl
I. Subject to hysteresis.
2 Mav be difficult to in-
stall at great depth in
vadose zone and maintain
good contact.
3. Requires calibration for
each textural type in
profile.
4. Lack of Insensltlvtty In
wet range.
5. Sensitivity to soil salin-
ity (except gypsum bkxksL
6. Gypsum blocks deteri-
orate badly in certain
media.
7. Calibration curves of
some units shift with time.
& Time lag In response.
1. Results are subject to
hysteresis.
Z Good contact between
bulb and surrounding
media may be difficult to
obtain.
3. Provide point measure-
ments only.
4. May be difficult to ob-
tain accurate calibration
curves for deep regions of
the vadose zone.
5. Fragile, requiring great
care in installation.
Brakensiek. Osbom
and Rawt3ll979l.
Holmes. Tavlor and
Richards (1967).
Phene. Hoffman and
Rawllns 1197 U
Schmugge. Jackson
and McKJmll980L
Citron ana Hadas
(19731.
Rawllns and Dalton
(1967). Memll and
Rawllns (19721
Enfldd. Hsleh and
Wamck(1973L
Schmugge, Jackson
andMcKlm(1960L
Hanks and Ashcroft
(1960l.Bnscoe(l979L
CampoeU. Campbell
and Bariow I1973L
-64-
-------
Heal dissioation
sensor
Heat dissipation
operate on the principle
that thr temperature era-
dicnt to dissipate a eivrn
amoumoi heat ma porous
medium ol low conauctiv-
itv is related lo water con-
tent In practice tne water
content ol a soil can be
measured bv apprvine a
neat sourer at a central
point within the sensor
and measuring tne tem-
perature nse at that point
Calibration curves of
matnc potential vs. tem-
perature difference are
obtained using a pressure
plate apparatus with soils
from the site The matnc
potential ii mated to water
content by preparing a
wmier cruractenstic curv*.
Commercial tensors con-
sist of a miniature heater.
urmprrature sensors and
circuitry embedded in a
cyl i ndncal porous cmrruc
btock within a smalt-diam-
eter PVC tube, and • lead
1 Simp*.
2 Mav be interiaccd
with a Oau acquisition
svstem lor remote coi-
*cnon ol data.
3 Measurements are
inoeDenoeni 01 salt con-
tent of soil
4 Calibration appears
10 remain constant
5 Can be used to mea-
sure soil temperature
as well as mainc poten-
tial
6. Useful for meaaur-
irve water contents in
the dry range.
1, Subtect to hv^jtereats in
the water characteristic.
2. Calibration is required
foreachcnanaem texture
3. Mav be dlfflnolt to in
suit at Orpin in the vaooae
zone and maintain eood
contact berwren the sen
sor and medium.
Phene. MofTman and
Rawlins Il971al
Phene. Rawtins and
Hoffman I I971bi
Schmusgt. Jacitson
and McKjm 119801
-65-
-------
Catalog of Methods for Monitoring or Estimating Flux of Wastewater in the
Vadose Zone
Method
Principles
Advantages
Disadvantages
References
l.lnllJtrauonat land
surface
a. Impoundments
ID Water budget
method
Entails solving for the
water budget equation.
That is:
Inflow - Outflow « ± AS
SL=II*P)-(D+EI±AS
Where SL = seepage toss
1 = inflow from all
1. Averages intake rate
for the en ore surface
ares of the pond
(sides and bottom L
2. Measurements do
not interfere with
normal pit operation.
l.Tlme consuming and
expensrve.
2. Errors in measurements
of auxiliary parameters
affect accuracy in esti-
mating seepage.
Bouwer 11 9781
(U) Instantaneous
rate method
P = precipitation
D = discharge
E = evaporation
S 'storage
Measurements of L P. O. E.
AS are required: requiring
flumes, raingages. evapor-
atlon pan. and staff gages
or water stage leuurdtia.
Calibration curve or table
of head vs. surface ana is
required
By shutting down aO In-
flows to a pond and afl
discharges m^n a puil
the water lewd wtl node
primarily as a result of
Infiltration That is. al the
components of the water
budget equation are set
Infiltration, evaporation
and change in storage.
Measuring AS for a short
time provides a value for
Infiltration rate (r
(Ul)
1 meters are cyttn*
dera> rapprd at one did
and open at the other end.
The open end of the cylin-
der Is (breed Into the pond
surface and seepage Is
equated to the outflow
from the cylinder when
pressure heads Inside and
outside the cylinder are
equal Types include: the
SCS seepage meter, the
USSR seepage meter and
the Bouwer-Rte
I.May cause Inconveni-
ence to pond operator.
2. The measured Instan-
taneous rate does not
account for rate fluctua-
tions caused by fluctua-
tions in inflow and out-
flow components.
1 . Simple and inexpen-
sive.
2. Errors In measuring
auxiliary compon-
ents do not enter
Into calculations.
3. Estimates average
surface area of pond.
X Simple to operate.
a Uses only one piece
of equipment. l.e-
reduces the overall
error compared to
using several mea-
suring device* as
with water budget.
1. Measures seepage at
discrete points and a
large number of mea-
surements are required
to obtain "average* In-
take rates (Including
both sides and bottom
potntsl
2. Operator will need to
swim underwater to in-
stall units In bottom
of pood.
Bouwer(1978L
Bouwer and Rkse
(1963LKraaa(1977.
b. Land treatment
areas and
Irrigated Adds
(I) Water budget
method
See Impoundments: Water
budget method. Inflow and
outflow from fields are
measured by flumes, weirs.
etc Evaporation equaled
to that from a free surface.
See Impoundments:
water budget method.
-66-
See Impoundments: water
budget method.
-------
(II) InfUtromriers
An tnftltrometer ts an open
rnoed cylinder anven into
the around. The amount ol
water aaoed to maintain
a constant head in the
cvtinoer is equated to in-
filtration rate. Types m-
dude siruoe-rina and dou-
bie-rtng inAltrometers. In
doubte-nru? type both the
outer and inner annular
areas are Qooaed. oatens-
lory UD minimize diverg-
ence in flow from inner
are*. Intake measurements
are taken in the inner area.
1 Stmwe
Z Inexpensive
3. PortaMe
point measure-
ments oruv
Z Because ot spatial van
abtlltv in sou properues
a large numDer 01 read-
ings reauirea u> estimate
'xvtnge' inAlirauon.
3-Shattow fknv impeOing
layer* affect results.
4 Oivcrtence in subsur-
face Sow occurs because
of un»aturated flow
(Bower recommenQs
using antfte. iaree min-
der (o minimize this
Bouweril978l Dunne
and Leopold 119781
Bureevand Lutrun
119561 US.
Environmental Pro-
teen on Aaencv US.
Armv Corps ot £ngl-
neersanfl US.
Qenu uiicnt of Agncu>-
ture (19771.
S Leakage along side walls
mav cause anomaiousiv
high raxes.
;tll) T«l basins
Larse basins lei 20 feet
by- 20 feet i arc constructed
at several locations in a
flekt The basins are flood-
ed and intake rates are
measured Results arc re-
lated to 'average intake
rate (or the ftekt iThe water
source to be used for fteld-
sued operations snouid be
used during testing.)
1 Provides more rroir-
sentauve mtaxe rates
than inftltrometerv
rrsults can be used
to design fuU-scale
protects.
Z Simple.
1 Expensive
Z Time consuming,
1 Mav be difficult to trans-
port water to sites.
4 ShaUow tenses of fine
material will aflect rr
suits by causing diver-
gence of flow
S. Spatial variability in soli
properues aflects results.
L' S Environmencal
Protection Aflencv.
L'S Corps ol Engi-
neers- and L'S. Depart-
ment ol Agriculture
,1977!
Z Flux in the vadoae
zone.
a. Water budget with
soil moisture
accounting.
The w«ter budget method
of Thornthwaite and
Mather 11957) is appOed
to • given soil Orpin lej^
root zone of an irrigated
Reid: final toil cover on a
LandflUL Inflow compon-
ents include rainfall and
irrigation. Outflow com-
ponents include runoff.
evapouanapt ration, drain-
age, and deep percatauon
(Ouxl. Change in iiinagi
equals water content
cnange in depth of interest.
Flux equaled to known in-
flow and outflow compon-
ents and AS Evapoiran-
•piration mav be most dif-
ficult component to mea-
sure (see Jensen. 1973 for
alternative method* 1.
1 Estimates flux for
enure area and not
onry pointa.
2. Computer programs
are available to sun-
pUfy calculations itg.
WATBUG. WUlmotL
19771.
. Errors in measurement
or estimation of com-
ponents accumulate in
esoaaues of Dux.
Thomthwaite and
Mather 11957L
WUlmon (19771
Mather and
Rodnquez 11978L
Fenn. riaruey and
DeGearet 19731.
Jensen 11973L
-67-
-------
_
MetbrxJ
t Methods reiving
on water content
measurements
*t-S.. draining pro-
file metnoos).
j = - /' 2 a6 A
\J J _, ^li
O 01
c. Method requiring
measurements of
Prtnowes
Flux is related to water
oomen t c nances in a eiven
depth of tne vaaose tone
The reiationsnip oerwn.ii
flux ana water content is
expressed as touow&
Where J = flux 8 = water
content, z = depth and I =
time (This method is
actuallv a protlie-specilir
water oudeet witn all terms
except flux and storage
chance set eauai to reroi.
Water content chances are
measured uv neutron log-
ging, tensiometers. resist-
ance blocKs and psycnro-
meteiv
The method Is based on
soMng Darcvs eouanon
•|i1mn»<> •
I Slmpfc
2. Compared to meth-
ods reiving on data
for hydraulic gradi-
ents, a larse numoer
of measurements can
be obtained with
minimal cost and
Labor needs.
3 A larse number of
measurements using
simple methods is
more amenable to
statistical analyses.
I . A very precise
method.
Disaovantaeea
1. Errors in measuring
devices affect rou/Ls.
2. Spauaj vanabilirv m soh
hvdrauJic propenies re-
quires mat a larse num-
ber ol measurements De
obtained to obtain an
"average value.
3 Cosu\-"
4 Mav not be suitable for
measuring flux oeiow
impoundments of land-
fills because of difficul-
ties in installing measur-
ing units.
l.More complex than
methods using water
Reierences
Ubardiet ai 119601.
Nielsen. Biggar and
Err. i 1973! Uarncx
and Amoozecar-fart
:98O' Bouwer ana
JacKSon I !974i
Wilson 1 198OI
LaRue. Nielsen and
Hajzan 1 19681. Bouwer
hydraulic
gradients.
d Method basea on
assumption thai
hydraulic gradi-
enis are unity.
Tor unsarurated flow.
J= Kl»)l
where KJ 9) designates tha t
hydraulic conductivity is
a function of water cement
ft I = hydraulic gradient.
Hydraulic gradients are
measured by installing
tenaiometen. block* or
pmctirameten. CfJOnoon
curves are required to
relate negative pressure
measurements to water
content, and water content
to unsaturated hydraulic
conductivity. Separate
curves are required for
each texiural change.
Same as above except that
unit hydraulic gradient is
assumed so that J=KI»L
Only one pressure meas-
uring unit is required
at c*cn depth of tntoest
to permit estimating f
from a pressure vs, water
con tent curve. rU»)t* esti-
mated from a separate
curve. (For a more cu i Mr i
ver*Jon of this method aee
Ntetaen. Blggar and Erh.
1973.) An altemaovc ap-
proach is to use the rda-
donshipJ* Kl*.!. which
requires a curve showing
the change* in hydraubc
oonducoviry with DBDIC
potential I*.). Bouma.
Baker and VenananUS74)
described the •o-cafled
"cruet test" (or pteyamig
• Kit] va. *. curve. This
ficsd procedure la earned
out on cytlnoj tual ooluan
content values.
2. Results are subject to
hysteresis in the calibra-
tion curves.
3. Expensive to install the
requisite number of
units for statistical
anaryses.
4. May not be suitable for
pond* or landfills.
S-Oneralrv restricted to
•hallow depths in the
vadoae zone.
and JacKSon (19741.
WUson(19SOL
1. Simpler and less
expensive than meth-
od* requiring grad-
ients.
1. Assumption of unit hv-
draulic gradients may
fall, parucularry in lay-
ered media.
2. Results are *ubiect to
hysteresis in calibration
curves.
3. May not be suitable for
pond* or landfllb.
4. More complex than
methods requiring sod
motature evaluation.
5. Large number of units
required to oflset spaoal
variability in aotl prop-
Medsen. Blggar and
Erh (19731. Bouutr
and Jacxson (1974L
Warrick and Amooxe-
gar-Fard 11980 Land
Bouma, Baker and
Venneman(1974L
-68-
-------
Principles
Advantage*
e. Flowmeters
f Methods baaed on
estimating or
measuring hy-
draulic conductiv-
ity. K.
(1) Laboratory
methods.
(aa)Permea-
meters
(bb) Rdatlon-
shtps be-
tween
hydraulic
conduct-
ivity and
grain-sue.
(cc) Cata-
log of
hydraulic
proper-
ties.
constructed In a tot pit
Each column is instrument-
ed with a tenslometer. a
ring inflJtrometer. and
gypsum-sand crusts. A
series of crusts are used
during different runs 10
linpose varying resistances
to flow During each run.
Infiltration rates and ten-
slometer values are mon-
itored.
Flux Is measured directly
using flowmeters. Princi-
ples of two available types
are as follows' 11) direct
flow measurement using
a sensitive Qow transducer.
and 12) flow is related to
movement of a heat pulse
In water moving In a por-
ous cup buned i n the SOIL
Calibration curves are re-
quired for second type.
The premise of these
methods is that if K values
are available the flux can
be estimated by assuming
hydraulic gradients are
unity, and that Darcy s law
Is valid.
Cylindrical cores of vadose
rone sediments arc placed
in tight fining metal or
plastic cylinders. Water Is
applied to the cores and
outflow is metered. The
head of water applied to
cores may be either con-
stant head or falling.
Appropriate equations are
solved to determine K.
knowing head values, ap-
plication rates and dimen-
sions of the container.
Primarily for saturated K.
Grain-size distribution
curves are obtained for
samples of vadose zone
material. The hydraulic
conductivity is calculated
from equations which ac-
count for a representative
grain-size diameter or from
the spread in the gradation
curve. Primarily for satur-
ated K.
A catalog of hydraulic pro-
perties of soils, prepared
by Mualem 11976) Is con-
sulted for soil rypes sim-
ilar to vadose zone sedi-
ments. Both saturated and
unsaturated K values are
imported.
l.Do not require In-
formation on hy-
draulic conductivity
or hydraulic gradi-
ents.
1. Simple
2. May be used to deter-
mine variations In K
values because of
stratifications.
1. A "first cut" method
if other data are un-
available.
2. May be used to esti-
mate relative varia-
tions, in K because of
stratification.
1. Simple.
2. A quick method.
a May be used to esum-
mate relative varia-
tions in K because of
stratification.
4. Inexpensive—provi-
ded that grain-size
data are available.
-69-
I. Disturbance of soil dur-
ing installation may af-
fect results.
2. Convergence/divergence
problems anae in the
flow field.
3. Limited range of soil
types and fluxes.
4 Calibration procedures
are tedious.
5. Applicability to deeper
regions of the vadose
zone is questionable.
1. Expensive if a large
number of samples are
required.
XAccuncy of method Is
questionable because of
win effects.
3. Not an in-sltu method-
results will be affected
by spatial variability of
hydraulic properties in
vadose zone.
1. Accuracy Is question-
able.
2. A disturbed method-
results may not be repre-
sentative of In-sltu
values.
3. Expensive if grain-size
values are unavailable.
4. Requires trained per-
sonnel.
1. Problems arise because
of hysteresis in unsatu-
rated K.
2. Because of errors In
measuring K (t\. values
for a particular soil type
may not be transferable
to similar types. To ob-
tain a closer estimate
KI0) must be evaluated
far each soil I Evan* and
Wamc*. 19701
Gary (1973). Dlrksen
(1974al. Dlrksen
(1974bl.
Bouwer 11978L Freeze
and Cherry (19791
Freeze and Cherry
(1979) and references
therein.
Mualem 11976L
-------
Method
Principles
Disadvantages
(III Field methods.
(aal Shallow
methods.
(aa II Methods
for meas-
uring sat-
urated K
in the
absence
of a water
table.
A portion of the soil zone
is brought to saturation
and saturated K is esti-
mated Tor the flow system
thus created. Appropriate
measurements and equa-
tions are used to solve for
K- Alternative methods
include-111 pump-in meth-
od. 12) alr-enuy permea-
meters. 13) Infiltration
gradient method, and (41
double tube method.
1 Each method has Its
own advantages—see
Bouwer and Jackson
(1974).
1 Each method has its
own disadvantages—see
Bouwer and Jackson
(1974).
2. Because of air entrap-
ment during tests com-
plete saturation is not
possible. Measured K
values may be 1/2 actual
values (Bouwer. 19781.
3. Several of the methods
are based on the assump-
tion that flow is entirely
vertical—a false premise.
Bouwer and Jackson
(1974).
(aa2) Instantan-
eous profile
method.
as/at
(bb) Deeper
(bbl)USBR single
wefl method.
The basis of this method
is the Richards equation.
rewritten as follows.
In practice, a soil plot in
the region of interest is
Instrumented with a bat-
tery of tensiometers. with
individual units terminat-
ing at depths of interest.
for measuring water pres-
sures; and with an access
tube for moisture logging.
The soil is wetted to su-
urauon throughout UK
study depth. Wetting is
stopped and the surface is
covered to prevent evapor-
ation. Water pressure and
water content measure-
menu are obtained during
drainage. Curves of *, vs. z
and • vs. t are prepared.
Slopes of the curve* at the
depths of interest are used
to solve for Klfl. Values of
Klf I at varying times can
be used to prepare KIM vs.
• and KU.) vs. *. cuncs:
(far a detailed description
of the method. Including
step by step procedures.
see Bauma. Baker and
Veneman. 1974k.
Water is pumped Into a
borehole at a steady rue
such that a uniform water
level is maintained to a
basal test section. Satu-
rated K is estimated from
appropriate curves and
equations, knowing dimen-
sions of the hoie and Inlet
pipes, length in contact
with formation, height of
water above base of bore-
hole, depth to water table.
and Intake rate at steady
state. Two types of (cats:
(1) open-end casing tests.
In which water flows only
out of the end of the casing,
and (2) open-hole teats. n
tout of
and
1. Method can be used
In stratified soils.
2. Simple.
3. Reasonably accurate.
at least at each mea-
suring site.
I.May be used to esti-
mate K at great
depths in vadose
2.A pronJe of K
may be obtained.
-70-
1. Provides hydraulic con-
ductivity values only for
draining profiles. Be-
cause of hysteresis, these
values are not represent-
atlve of the hydraulic
conductivity during wet-
ting cycles.
2. Because of spatial van-
abilities in soil hydraulic
properties, a Urge num-
ber of sites must be used
to obtain mean values of
hydraulic conductivity.
3. Time consuming and
relatively expensive.
Bouma. Baker and
Veneman 119741.
1. Solution methods are
baaed on assumption
that flow region Is en-
tirely saturated (free sur-
fisoe theory t—this is not
X Aa a consequence of I. K
to underestimated.
3, Expensive and Qme con-
suming.
4. Requires sklfled person-
nel to conduct tests.
US. Bureau of
Reclamation 1197TL
-------
(bb2)USBR
muluote well
method.
Ibb3l Stephens-
Neuman
sirufie wdl
method.
Used u> estimate K in vvin-
trv of widesoread kenses of
siowtv permeaMe material.
An intaxe well and acnes
of piezometers are in-
staUed Water is pumped
into well at • steady rat*
and water rves are mea-
sured in piezometers. Ap-
propriate curves and equa-
Uoru are used ID deter-
mine K.
Stephens and Nruman
(1980) developed an cm
pineal formula baaed on
numerical simulations
using the unsaturated
charactenstlcs of four
sous. That is. this approach
accounts for unsaturaied
Qorw
1. Result* can be uaed
to estimate Lateral
flow rates m percned
ground-waierregxina.
1 The formula can be
used to estimate the
saturated hydraulic
conductivity of an
unauuraied soli with
improved accuracy
2. No need to wait for
steady state condi-
tions—ir»e final How
rate can DC estimated
from data dunng
transient stage.
1 Expensive and u me con-
suming,
2 Requires trained per-
sonnel.
U.S. Bureau of
Reclamation (1977V
1 Seeds Held testing.
Stephens and
Neuman 119SOL
:bb4l Air per-
meacuirv
metnod.
3. Veocirv in the
vaooae zone.
a. Tracers
tx Calciiiauon using
Gox vajues.
Air prrssure chana« art
measured in speciaUv con-
structed piezometers dur-
ing barometric changes ai
the land surface. Pressure
response data are counted
with inlormauon on air-
flUed porositv to solve
equations leading to air
permeawlitv. U the KUnken-
berg effect is small, air
permeaDOirv is comwied
u> hvdrauUc connucavifv
A suitable tracer ICA tn-
num. iodide. Qrorrude. Suor-
ocartxansi is introductrd
into the liquid souce LAI-
temauvetv, a tracer sucn
as cnlonOe. aire*3v present
in the source could be
incd. 1 Samples are obtain-
ed from suction cups at
successive depths and
tracer break-through
curves are prepared.
Flux values ofctairvd bv
methods described anove
are used, together with
estimated or measured
water content valuer in
the following reiauortsnip-
wtiert v = veJocirv. J =
Dux and 6 = water content.
Assumes that 111 hydraulic
gradients are ururv, 12) an
average water con tent can
be determined, 13) How i»
vertical, and (4) homogen-
eouk media.
1 Can be used to esti-
mate nvdraulic con-
ductivirv values of
Uvercd materials in
the vadoae zone.
1 A direct meinod.
2. Simple.
3 Accounts for Qow in
actual pores — aoos-
er measure ol the true
4 More accurate than
method* requmng
kr»ow>ea« of compo-
nents of Darcy s
equation.
1 Inexpensive when
coupied with otncr
methods.
ZSlmpte.
3. A "quick and dirty"
method for estimat-
ing the travel ume
of pollutants in the
zone.
-71-
I An indirect method.
2. Presence of ejtcessive
water limits the utility
of the method.
3. Expensive
4.Time consuming,
S.Comc*»—requires train-
ed personnel.
Weeks 119781
1. Analyses of tracers may
be expensive.
2. Operation of suction
samplers mav affect na-
tural Qow field, leading
to incorrect values.
3. In structured media the
actual veiociry may be
higher than measured
because at flow in craoes,
4. If velocities are slow.
excessiveiv long time
periods will be required
for tests.
1 Vekx-irvwiUbehienerm
structured media than
thai calculated.
X Method assumes vertical
flow only—perching
layers cause lateral Cow.
3. For multUayered media
an iverase 8 and v value
may be difficult to obtain.
Freeze and Cherry
119791. Pnsaa.« al
11974)
Bouwcr I1980L
WUson 119801
-------
Mexnod
c CaJcuJanon usme
tone tern mni
tranon aaia.
\ — ' = w'
9 »
Pnnaoiea
The lone-term infiltration
rait 1 ol the lacilin. is
assumed to eaual the
sveaav state flux j m the
vaoose rone. ConseoucntA-
*Jso assumes the 1 1 ) hv-
arauiic sraoieTnaareururv'.
AfJvmnLaaca
I Simoie
2 ProDaoK sansiacton,
is firs: esdmale ol
'.riocin.
3 Inexpensive
IhiacrvmniAaes
! V'eiocirv will be hieher
:" siructurec mesia
•nan cajcuiated
2 Meihoa assumes venica-
flcrwonr. Pcrrninfiia-vrrs
cause taterai Ooi*
3 For muJtilavcred meaia
an iveraae 6 and \ mav
be difficult to oouja
Rcierences
Bnuxirr 1 !9«OI
'AAmcK i 198 i i
- 8. OlQowuvmicaland
i-»i homoeeneoijs media.
-------
Catalog of Methods for Monitoring Pollutant Movement
in the Vadose Zone
Method
Principles
Advantage*
Disadvantages
1 Indirect method*
a. Four probe
electrical
method
b. EC probe.
c Salinity
sensors.
2. Direct methods.
a. Solids sampling
followed by
laboratory ex-
traction of pore
waier. Inorganic
constituents.
Used for measuring soil
salinity in situ. Basically
the method consists of
measuring soil electrical
conductivity using the
Wenner four probe array
The apparent bulk soil
conductivity is related to
the conductivity of the
saturated extract using
calibration relationships.
The EC (electncaJ conduc-
tivity! probe consists of a
cylindrical probe contain-
ing electrodes at fixed spac-
ing apart The probe is
positioned In a cavttv and
resistivity Is measured at
successive depths. Calibra-
tion required. PrtmanJv
used for land treatment
areas and Irrigated fields.
An alternative version con-
sists of Inexpensive probes
which can be permanently
implanted for periodic
measuremen ts.
Sensors consist of elec-
trodes embedded In porous
ceramic. When placed In
soil the ceramic comes in
hydraulic equilibrium with
soil water Electrodes
measure the specific con-
ductance of the soil solu-
tion. This method is most
suitable for land treatment
areas and irrigated fields.
ajihough sensors could be
Installed beJow ponds be-
fore ponds are put in opera-
tion. Call bration curves are
required.
Soilds samples are obtain-
ed by hand or power auger
and transported to a labor-
atory Normally samples are
taken in depth-wise incre-
ments. Samples are used
to prepare saturated ex-
tracts I see Rhoades. 1979a.
for method L Extracts are
analyzed to determine the
concentrations of specific
constituents.
1 An m-piace method.
2. Readings are ob-
tained quickly and
inexpensively
3. Can be used to de-
lect the presence of
shallow saline
ground water.
4 Can be used to de-
termine lateral tran-
sects of satlnltv
5 By varying electrode.
spacing can be used
to determine verti-
cal changes in salin-
ity.
6. The sallrtitv in larger
volumes of soli are
Measured compared
to other methods.
1. Changes in salinltv
are measured at dis-
crete depths in stra-
tified soils
2. Measurements are
obtained at greater
depth than four etec-
trode method.
3. The m-piace units
permit determining
changes In salinity
with Orne.
1. Simple, easily read
and sufficiently ac-
curate for salinity
monitoring.
2. Readings are taken
at same depths each
time.
3. By Installing units
at different depths
chronological salin-
ity profiles can be
determined.
4. Output can be inter-
faced with data
acquisition systems.
1. Depth-wise profiles
of specific pollutants
can be prepared.
2. Variations in ionic
concentrations with
changes in layering
are possible.
3. Soilds samples can
be used for addi-
tional analyses such
as grain size, cation
exchange capacity.
etc.
-73-
1 Obtaining calibration
relationships may be
tedious.
2. Accuracy decreases In
layered soils.
3. Chronological In situ
changes cannot be
measured except by
taking sequential trav-
4. PnmarUv used for shal-
low depths of the vadose
zone.
5. Does not provide data
on specific pollutants.
1. Individual calibration
relationships are re-
quired for each strata—
time consuming and
expensive
2. Variations in water con-
tent may affect results.
3. Primarily used for shal-
low depths of the vadose
zone.
4. Does not provide data
on apenflc pollutants.
1. More subject to calibra-
tion changes than four
electrode method,
2. More expensive and less
durable than four elec-
trode method.
a Time lag in response to
changing salinity.
4. Cannot be used at soil
water pressures less
than -2 atmospheres.
5. SoU disturbance during
installation may affect
results.
6. Does not provide data
on specific pollutants.
1. Became of the spatial
variability of soil prop-
erties an inordinate
number of samples are
required to ensure rep-
resentauvenesm.
2. Expensive, if deep
sampling Is under-
3. Changes in soil water
composition occur
during preparation and
extraction.
4. Samples should be ex-
tracted at prevailing
water con tent Le_ Ionic
composition changes
during saturation.
Rhoades and Halvorson
(19771 Rhoades I1979al.
Rhoades 11979bL
Rhoades and Halvorson
11977) Rhoades ana van
Schllfgaarde (1976).
Rhoades I1979al.
Rhoades U979cl.
Rhoades (1979a). Oster
and Ingvalson (1967).
Richards 119661. Oster
and WUlardson (1971).
Rhoades 11979aL Rlble et
al 119761. Pratt. Warneke
and Nash 119761
5. Aorstructiwe method— variability in sedimena
samples cannot be re- preclude* comparing
taken in exactly the successive result*.
same location *nanal
-------
Method
Principles
Advantages
Disadvantage*
References
b Sotlds sampling
for organic and
microtoial con-
stituents— drv
tube coring pro-
cedure.
A hole is augered to above
(he desired sampling
depth A drv-tube core
sampler of special design
is forced into the sampling
region. Separate sub-
samples are obtained for
analyses of organics and
microorganisms. Extreme
care must be exercised to
avoid contamination.
1 Contamination of
samples is mini-
mized of. other core
sampling methods.
Z Additional sub-
samples could be
taken for chemical
analyses.
1 Expensive and time Dunlap et al (1977)
consuming.
Z Difficult to obtain sam-
ples at great depth in
vadosezone.
3. Samples cannot be ob-
tained directly bdow
Impoundments.
4. A destructive method.
5. Results are affected by
spatial variabilities in
properties of the vadoae
zone.
c Ceramic type
samplers I suc-
tion Ivsi meters).
(I) Vacuum
operated
type.
(II) Vacuum-
pressure
type.
A ceramic cup is mounted
on the end of a small
diameter PVC tube. A one-
hole rubber stopper is
pushed into opening In
tube. A small diameter tube
is forced through stopper.
terminating at base of
ceramic cup. Unit Is placed
in shallow soil depth. A
vacuum is applied to the
small tube and soil water
moves through the cer-
amic cup. Sample Is
sucked out the small tub-
Ing into a collection flask.
Samples are analyzed In
the laboratory. When using
such samplers extreme
auv must be exercised to
prepare cups to remove
sorted ions. An add treat-
ment Is letxMitmended for
this purpose. A variation
of this type uses a filter
candle In lieu of a suction
cup.
A ceramic body tube con-
tains a two hole rubber
stopper. A small diameter
tube is pushed into one
opening, terminating at the
base of the cup. A second
tube pushed into the other
opening terminates below
the rubber stopper. The
long line is connected to a
sample bottle. The snort
line is connected to a pres-
sure-vacuum source. When
the unit Is In place, a
vacuum la appbed to draw
In exterior solution. Pres-
sure ts then applied to blow
the sample Into a f
1 A direct method for
determining the
chemical character-
istics of soil water.
Z Samples can be ob-
tained repeatedly at
the same depths.
3. Inexpensive and
simple.
4. Can be installed
below shallow im-
poundments and
landfill* prior to con-
struction, for later
monitoring of seep-
1. Can be used at
depths below the
suction lift of water.
Z Several units can be
Installed In a com-
mon borehole to de-
termine depth-wise
changes in quality.
Also: See advantages
1. Generally limited to soil
depths less than 6 feet.
Z Limited to soil water
pressures less than air
entry value of the cups
(-1 atmosphere).
3. Point samplers—be-
cause of the small vol-
ume of sample obtained
representativeness of
results Is question-
ruble.
4. Pore water in the soil
blocks is sampled. In
structured soils, water
moving through cracks
may have different ionic
oornpoaioon than water
In bkxka,
& Suction may aflect soil-
water flow patterns.
TensJonmeteriinustbe
Installed to ensure that
the proper vacuum is
& Samples may not be
representative of pore
water because tech-
nique does not account
for relationships be-
tween pore sequences.
water quality and
drainage rates (Hansen
and Hams. 19751
1. When air pressure is
applied some of the
solution is forced
through the wails of the
cup.
Also: See disadvantages
2 through 6. vacuum
operated type.
Rhoades 11979al. England
(1974). Hoffman
et ail 19781.
Rhoades (1979aL England
(19741 Partzefc and Lane
(1970). Apgar and Lang-
raulr (1971L Johnson and
Cartwnght(1960L
-74-
-------
Method
HID High
Pr
vacuum
type.
Principle*
d Sampling
perched
ground water.
The sampler is divided into
two chamDers. The tower
chamber is a ceramic cup.
Upper and tower chamber*
are connected via tubing
with one-wwv varve A piug
In the upper cnamoer has
rwooornings. One opening
la connected bvtuotng to a
pressu re-vacuum source.
The second opening is con-
nected to a line within the
upper chamber This line
contains a one-wav vaive.
The line also extends to
the surface, terminating in
a collection flask. When
vacuum is applied to one
tube, solution is drawn into
the upper chamber When
pressure is applied the one-
wav valve in base orevents
sample from being forced
out of cup. Sample is forced
up the outlet line into col-
lection flask.
Perched ground-water re-
gions frequenuv are oo-
agrvtd in vadose zones, for
example. In alluvial vallevs
in the west. Water samples
may be extracted from
perched ground-water
regions for analvses. For
shallow perched ground
water, samples can be
obtained bv installing
wells, piezometer nests or
multilevel samplers. For
deeper perched ground
water, two possibilities
ejosuill sampling cascad-
ing water in existing wells.
or!2) constructing special
weiis.
; Prrvrnis ajr P''*'
sure irom b*owing
sample out ol cup
Z Can be usea at great
deptns.
a Se%rral units can be
installed in a com-
mon oorenoie-
*o: S« advajitaees
for vacu um operated
tvpe
as for vacuum-
pressure rvpe except tor
No 1
Reference*
Wood (1973). Wood and
Signer U975L
Laroe sample vol-
umes are obtain-
abie paruculartv fle-
sirabie when sam-
pling for organics
and viruses-
Samples reflect the
integrated quailtvof
water draining from
an esciensi ve pomon
oi overtvtng vadoae
zone^•-more leure-
sentanve tnan point
samptes,
. Cheaper tnan instafl-
ing deep wells with
battenes of sucuon
samplers.
, Can be located near
ponds and landfills
without concern
about causing leaKs.
i Nested piezometers
and multilevel
samplers can be
used to delineate
vertical and lateral
extent o< plumes and
hydraulic gradients.
1 Perched zones mav not
be present in source
area,
2. Detection of perched
ground water mav be
expensive, requiring
test wHls or geophysical
metnods.
3. Some perched ground
water rapons are epnem-
erml and mav dry up
4 The method is most
suitable for diffuse
sources, such as land
spreading areas or irri-
gated fields.
5. Multilevel sampling ts
restricted to regions
with shallow water
tables permitting
vacuum pumping.
Wilson and Schmidt
119791 Schmidt 119801.
Graf (19801 Ptctena « aL
119811. Hansen and Hama
11974 1980).
-75-
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-80-
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Auq«r, rotary and ca*le-tool drilling techniques advantages ind disadvantages for
construct'Of Of monitoring Mils
T»oe Advantages
Auger • Ninlmal damage to aquifer
• No drilling fluids required
• Auger flights act as temporary
casing, stabilizing hole for
well construction
• Good technique for unconsoll-
dated deposits
• Continuous core can b« collected
by wlre-1 Ine method
Rotary • Quick and efficient method •
t Excellent for large and small
diameter holes •
• No depth limitations
• Can be used In consolidated
and unconsolldated deposits
<
• Continuous core can be
collected by wire-line method
Cable Tool • No limitation en veil depth
• Limited amount ef drilling
fluid required
• Can be used In both consoli-
dated and unconsolldated
deposits
• Can be used In areas where
lost circulation Is a problem
• Good llthologtc control
• Effective technique In boulder
environments
• Cannot be used In consolidated
deposits
• Lieited to mils less than ISO feet
In depth
• Nay have to abandon holes If
boulders are encountered
Requires drilling fluids which
alter water cheitstry
Results In i aud cake on the
borehole «jlI, requiring
additional well development, and
potentially causing changes In
chemistry
loss of circulation can develop
In fractured and high-permeability
material
May have to abandon holes If
boulders are encountered
Limited rigs and experienced
personnel available
Slow and inefficient
Difficult to collect core
Air.
Hollow-Stem Auger
Direct Rotary
Cable Tool
A conceptual compirlion of tht hollow-it** *u|tr, tht dlrict-roctry, «nd th« -81-
ctbli-tool drllltrj •ethoji.
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FLUORINATED ET
PROPYLENE (FEP
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-85-
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Hell casing and screen material - advantages and disadvantages in monitoring wells.
Tvoe Advantages
Fluortnated Ethylene
Propylene (FEP)
Polytetrafluoroethylene •
(PTFE) or Teflon
PolyvtnylcMortde (PVC) .
Acrylonitrlle Butadiene •
Styrent (MS)
Polyethylene
Good chemical resistance to
volatile orginlcs
Good chemical resistance to
corrosive environments
lightweight
High-Impact strength
Resistant to awst cheeilcals
lightweight
Resistant to weak alkalis,
alcohols, aliphatic hydro-
carbons and oils
Noderately resistant to strong
adds and alkalis
lightweight
• Lightweight
• lower strength than steel and
Iron
• Weaker than Host plastic •iterul
• weaker than steel and Iron
• More reactive than PTFt
• Deteriorates when In contact
with ketones, esters, and
aromatic hydrocarbons
• Low strength
• less heat resistant than PVC
• Lower strength than steel and
Iron
• Mo I coamnnly available
• low strength
• Here reactive than PTFE, but less
reactive than PVC
• Not commonly available
Polypropylene
Kynar
Stainless Steel
Cist Iron I Low-Carbon
Steel
Galvanized Steel
Lightweight
Resistant to mineral Kids
Noderately resistant to
alkalis, alcohoU, ketonet and
esters
. High strength
• Resistant to awst chemicals
and solvents
. High strength
• Cood cheeitcal resistance to
volatile organic*
• High strength
. High strength
• low strength
• Deteriorates when in contact with
oxidizing acids, aliphatic hydro-
carbons, and aromatic hydrocarbons
. More reactive than PTFE, but less
reactive than PVC
• Not commonly Available
• Poor chemical resistance to ketones,
acetone
• Not commonly available
• May be a source of chromium In low
pH environments
• May catalyze some organic reactions
• Rusts easily, providing highly
sorptive surface for many metals
• Deteriorates In corrosive
environments
• May be a source of zinc
• If coating is scratched, will rust,
providing a highly sorptive surface
for many metals
-86-
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Changes In Plumes and Factors Causing the Changes
Source: U.S. EPA, 1977
—— Form«r boundary
—— Pr«v«nt boundary
• Watl* lit*
J
ENLARGING
HUME
REDUCING
PLUME
L Incrocn* In rait of I Reduction in watt**
ditchargvd wait*t
2. Sorptlon activity
tried up
X Effect* ofchanaof
In wa(*r tabh
2. Ef f«
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-91-
-------
STEP
Hydrologic
Measurements
Well Purging
Sample Collection
Filtration/
Preservation
Reid Determinations
Reid Blanks/
Standards
Sampling Storage/
Transport
GOAL
Establishment of nonpumping
water level.
Removal or isolation of stagnant
HjO which would otherwise bias
representative sample.
Collection of samples at land
surface or in well-bore with
minimal disturbance of sample
chemistry.
Filtration permits determination of
soluble constituents and is a
form of preservation. It should be
done in the field as soon as
possible after collection.
Reid analyses of samples will
effectively avoid bias in
determinations of parameters/
constituents which do not store
well: e.g., gases, alkalinity, pH.
These blanks and standards will
permit the correction of analytical
results for changes which may
occur after sample collection:
preservation, storage, and
transport
Refrigeration and protection of
samples should minimize the
chemical alteration of samples
prior to analysis.
RECOMMENDATIONS
Measure the water level to ±0.3
cm (±0.01 ft).'
Pump water until well purging
parameters (e.g., pH, T, Q-1. Eh)
stabilize to ±10% over at least
two successive well volumes
pumped.
Pumping rates should be limited
to —100 mL/min for volatile
organics and gas-sensitive
parameters.
Filter: Trace metals, inorganic
anions/cations, alkalinity.
Do not filter: TOC, TOX, volatile
organic compound samples. Filter
other organic compound samples
only when required.
Samples for determinations of
gases, alkalinity and pH should
be analyzed in the field if at all
possible.
At least one blank and one
standard for each sensitive
parameter should be made up in
the field on each day of
sampling. Spiked samples are
ateo recommended for good QA/
QC.
Observe maximum sample
holding or storage periods
recommended by the Agency.
Documentation of actual holding
periods should be carefully
performed.
Lit.
-92-
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Tk)
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TABLE 3 2. SUH1ARY OF SOIL-CORE SAMPLING PROTOCOL FOR BACKGROUND AND ACTIVE LAND TREAMENT AREAS
Sampling
Area
Number of
Randomly
Selected
Core Samples
Sampl ing
Depth
Sampl ing
Frequency
Background, in soils with
similar mapping chtracter-
1stlcs In active »re»
Within 6-ip depth
below treatment zone
on active zone
One time
2. Active land treatmnt area
a. Uniform area less than
5 hectares (12 acres)
Within treatment zone
for determination of pH
Semiannual ly
Within 6-irt region below
treatment zone for PHC's
b. Uniform area greater
than 5 hectares
(12 acres)
2 per 1.5 hectares
(4 acres)
6 per 5 hectares
(12 acres)
Within treatment zone
for determination of pH
Semiannual 1y
Within 6-in; region below
treatment ^one for PHC's
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VACUUM PC
ANO 3AU6E
VACUUM TEST HAND PUMP
CCLLiCTS SOIL-WATER SAMPLS
Figure 4-3. Soil-water sampler (Courtesy Soilmoisture
Equipment Corp., 1978)
2 WAY PUMP «-»sT!c mae
^2-WAY PUMP AN(j gjMf
8-tNCH HCt£
MTM T2MPQ
SiL£A SANO
•-Z scrnxi
Figure 4-5. Modified pressure-vacuum lysineter
(Morrison »nd Tsii, 1981)
Figure 4-4. VaccuB-«r«sirc
Lane, 1970)
(Parlzek and
-102-
-------
B CHAM8SS
PVC
1201
Figure 4-6. '
Soilwisxirre
CASING LYSIMCTEtt
INSTALLATION
soil-water sappier" (Courtesy
Corp., 1978)
CERAMIC CUP
CASINO LVtutfTt*
Ground Surtfat
M S«« —3
IMIMMU SH>
fflnciMH TIMM
TUBE CUT ON BEVEL
BOTTOM OF CUP
Figure 4-21. Location of potential dead space in suction lysimete
— Wink PVC.
-103-
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FIGURE 7 Casing Lysimeter
-------
-104-
-------
BACKGROUND
JSOIL PORE LIQUID
MONITORING DEVICES
FOR EACH SOIL SERIES
\ ^7 INITIAL i
•
M
3)0 cm
12 ml
\7 &CASCM>
ACTIVE
6 SOIL PORE LIQUID
MONITORING DEVICES
PER UNIFORM AREA
.OIL SURFACE /
TREATM
ENT 20NE
30cm t
I1J mli
=
1 '.
IS
ATL
1
13
IL HIGH WATER IAQLE
m
III
UNCATl
zo
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m
fil
JRATEO
NE
\\
Figure 4-12. Pore liquid sampling depths
SAMPLING TUBB
INSTALLATION TRENCH
(BACKFILLED AFTER LYSIMETER INSTALLATION!
V
\
SAMPLE LINE
WATER TABLE
-15m
TREATMENT
: ZONE
TRENCH LYSIMETER
OR GLASS BLOCK
10 m-
Figure 4-23. Pan lysimeter installation
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CONCENTRATION OF TOTAL VOCs IN SOIL CORES
IN HUNDREDS OF mg/kg
5-
10-
15-
20-
ESTIMATED HEIGHT OF THE
^ TOP OF CAPILLARY FRINGE - '
X
ESTIMATED WATER TABLE DEPTH
25-
CALCULATED CO-
VALUE BELOW
WATER TABLE
10
15
% CO 2
20
25
C02
TOTAL VOCs
SATURATED
SAMPLE
Figure 4. Comparison of measured gaseous carbon dioxide concentrations versus total
organic compounds in soil cores from a vadose zone in a region of known contamination.
-110-
-------
Rrvu»o*u aod t uocepiuaJ
WO5J
r*
& *.
Lohman, S W . 1972 Definitions of Selected Ground Wat.
Refinements USGS Waler Supply Paper. Washington, C
model to aid to selecting
g Rcvtew 9-124-1)6
analytical
Monilonn,
McKxc. C. and A Bumb. 1988 A three -dimensional
monitoring locations in ibc vndosc zone Ground Walet
Muni and Interim Science
*
1
Miller, E . 1975 Physics of swelling and cracking sous Joi
52<)) 4)4-44)
plcl geometry, and vacuum
§
.f
*
C
MorTison, R . and B Lowcry. 1989» Effect of cup propc
on tbe sampling rale of a porous cup sampler (in prcu)
cup sampler, e«pcrimcDi»l
•
Morrison, R , aod B Lower?. 198% Sampling zone of
reftitlu (tn prcu)
bodiUogy foi sampting and
pp 3842
ic a,/ e, leach aod incubate
ri and met
ua Review.
M
l!
f--
2S
U (
Ij
I"
n
il
ii
method to
Myen, R G , C W Swallow and D E Kissel. I989 A i
undisturbed soil cores Soil Sci Soc Amei 5341,7-471
paths in sous New York i
1
S
j*
Parlange. J , el al . 1988 The Dow of pesticide) through p
Food and Life Sciences Ouartclly 18 2O21
i Hazardous and Industrial
ly for Testing and Materials.
!
1 5
C L Perkel, 1986 Quality Control in Remedial Sue In
Solid Waste Testing. Filth Volume ASTM STP 925 Amcr
Philadelphia. PA
tafysis fan 1 Physical and
can Agronomy Monograph
33
1*
Pelenen. R , and L CaMn, 1986 Sampling Methods
MuKralogtcal Methods (2nd edition) Soil Scsence Sooct)
N 9. pp 3) 52.
> sous Soil Sacnce Soaely
1
Raau, P, 197) Unstable welling (runts in uniform and i
of American Proceedings )76HI-b84
I
1
1
S
I
1
i
\
igsoll wall
Journal 4
Scon, and CJolhstr. 1983 A Iranssenl method lot measuni
bydrauuc conductivity Soil Science Socseiy of American
1
9
1
•5
Simpson. T, and R Cunningham. 1982 The occurrence
Envuonmenlal Quality 1(1) 29 W
lonilormg Design lor Melal
57-66 Amervun Society lor
r?
Slarks. T H . K- W Brown, and N J Fuhcr. 1986 Prcl
Pollution in Palmcrton. PA In ASTM STP 925. C Pcrkcl
Testing and Materials. Philadelphia. PA
w ol wafer and solutes on
s lur Ihc llnsalurilcd Zone
**
1 =
Slcenhuis, T, and 1 Pailangc. IVKR Simulating prefe
hlllslopcs Confcicnce on Validation of Flow and Transp
RuiJuio. New Meuco . May 23 2ti. pg II
=
1
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Slecnhuis. R . J Parlange. M Pallangc. and f Slagciull
hlllsklpcs Agrvculluial Waicr Management 14 ISM il*
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ADAPTION/ACCLIMATION
An observed increase in the rale of biodegradation
after tome period of exposure of the microbial community
to a chemical.
TIME
WAYS TO MAXIMIZE
AVAILABLE SOIL OXYGEN
• Prevent Water Saturation
• Presence ol Sand. Loam (Not Hvy Clay)
• Moderate Tilling
• Avoid Compaction
• Controlled Waste Loading
A - ADAPTATION TIME
EFFECT OF MANURE AND DM AMENDMENTS ON PAH DEGRADATION
IN A COMPLEX WASTEINCOflPORATEO INTO SOIL
PAH Compound
MICROBIAL ADAPTATION
Allowt for m«th«m«iic«l mod.U
Hall-Life In WaiieiSoil Mi«tu>« (Oay«)
Wilrtoul Amendment* With Amenomenii
Acenaphthylene
Anthracene
Phenanthrene
Ruoranthene
8enz(a)antrhaeene
8enz(a)pyrene
Dtbenz(a,h)anthracene
78
28
69
104
123
91
179
14
17
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52
69
70
ADVANTAGES OF
PULSING AMENDMENTS
II mo<« man on* jaiendmeni n lequued to promote lubiuriac*
D 100.000 mg/I'lt')
can remove bloloullng and i«sux* in* «llic«ncy m tO|tcbon
well* or m|«c(ion galleries.
Pu**e* ol hydrogen peiooO* at high concenualion can ilenkl*
tne aquiler and detiroy caiala** Kllvily . pttvenlmg p get Fe (OH),
Add oxygen or hydrogen peroxide to water with
Mg/l ol organics
•> get biofouling
Add phosphate to aquifer with Ca (Mg) CO, matrix
•> Ca (Mg) FO4
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-------
SPEAKERS
Douglass P. Bacon
Douglass P. Bacon received a B.S. in Business Administration from Northeastern University in 1961,
and an M.A. in Political Science from the University of Washington in 1974 at which time he joined
the University faculty as Associate Professor of Military Science. He is a graduate of the United
States Army Command and General Staff College, and Canadian Land Forces Command and Staff
College. Additional professional education includes the Project Management Development Course,
Explosive Ordnance/Special Weapons Disposal Courses, National Security Management (Industrial
College of the Armed Forces), Radiological Safety Course, and Basic and Advanced Chemical Officer
Courses.
Mr. Bacon joined Andrulis Research Corporation as a scientist upon his retirement from the military
service. In this capacity, he is commonly involved with testing of munitions, chemical-biological
defense equipment, new chemical defense procedures, and prototype military hardware.
Gary M. Booth
Gary M. Booth received his B.S. degree in entomology in 1963 and M.S. degree in entomology in
1966, both from Utah State University, and his Ph.D. in toxicology from the University of California
in 1969. Dr. Booth spent 1-1/2 years as an NSF Post-doctoral fellow at the University of Illinois, and
one year as Director of the Environmental Toxicology Research Laboratory for the Illinois Natural
History Survey. He has been a Faculty member at Brigham Young University (BYU) in the
Department of Zoology since 1972 and Director of Research and the Quality Assurance Program for
Environmental Labs Inc. (ELI) since 1972.
Dr. Booth directed the development of a field quality assurance program for II large scale field
Toxicology Assessments for ELI. He has directed quality assurance programs field trials on the
behavior of various xenobiotics in agricultural environments. He now teaches a course in Toxicology
and Quality Assurance at BYU and has directed QA audits in a number of research laboratories. Dr.
Booth currently serves as a toxicology consultant for the Senate Subcommittee on Labor and Human
Resources on the effects of foreign chemicals in the environment.
James F. Bowers
James F. Bowers is presently Chief of the Meteorology Division of Dugway Proving Ground. He
received his B.S. and M.S. degrees in physics from Tulane University and, as an Air Force Officer,
studied meteorology at the graduate level at Texas A&M University. As Chief of the Dugway
Meteorology Division, Mr. Bowers directs all aspects of test meteorological forecasting and
instrumentation, mesoscale wind field modeling, and atmospheric transport and dispersion modeling.
Mr. Bowers' experience in dispersion modeling for OB/OD-type releases dates to the early 1970's
when, as an Assistant Staff Meteorologist at Vandenberg Air Force Base, he developed the
operational procedures used to forecast the transport and dispersion of the large exhaust clouds
produced by the Titan HID missile.
-------
James L. Dicke
James L. Dicke has a B.A. in chemistry from St. Olaf College, a B.S. degree in meteorology from the
University of Utah and a M.S. degree in meteorology from the University of Michigan. He has
worked as a NOAA research meteorologist and supervisory meteorologist assigned to the U.S.
Environmental Protection Agency and its predecessor organizations since 1962. He has extensive
experience in air pollution meteorology, first from the perspective of 13 years in EPA's Air Pollution
Training Institute and, most recently, from over 14 years in developing and implementing regulatory
dispersion model policy and guidance in EPA's Office of Air Quality Planning and Standards.
Mr. Dicke is currently employed by the National Oceanic and Atmospheric Administration, U.S.
Department of Commerce as a supervisory meteorologist and assigned to the U.S. Environmental
Protection Agency in Durham, NC. He plans and supervises his staff in the evaluation, modification
and improvement of atmospheric disperston and related models. He and his staff prepare guidance
on applying and evaluating models and simulation techniques that are used to assess, develop or
revise national, regional and local air pollution control strategies for attainment/maintenance of
ambient air quality standards. He is a member of the Open Burning/Open Detonation (OB/OD)
Technical Steering Committee established by the Department of the Army.
Cecil Eckard
Cecil Eckard has a B.A. in Mathematics from Bridgewater College and an M.E.A. from the University
of Utah. He has worked as a Mathematical Statistician in various positions for the Department of
Defense. He has over 40 years experience in the analysis of test data from the Biological and
Chemical Programs of the Defense Department.
Mr. Eckard is currently employed by the Andrulis Research Corporation as a Group Scientist. He
is presently involved as an OB/OD Team Member with responsibility in the planning and conduct of
the test program, and the analysis and reporting of the results. He has authored and co-authored on
over a 100 test reports.
Wayne Einfeld
Wayne Einfeld earned an M.S. degree in environmental science at the University of Washington and
has also worked as an industrial hygienist. He is board certified in comprehensive practice by the
American Board of Industrial Hygienists.
Mr. Einfeld is currently a senior staff scientist with the Applied Atmospheric Research Group at
Sandia National Laboratories. As an atmospheric scientist, Wayne has been involved in a number of
areas of research relating to air pollution concerns. A primary focus of his recent work has been the
development and implementation of instrumented aircraft sampling techniques for both particulate
and gaseous species. Over the past several years, Wayne and co-workers at Sandia have developed
the Sandia instrumented Twin Otter aircraft into a highly advanced sampling platform for continuous
plume, puff, urban air and clean air sampling and characterization. His most recent efforts have been
associated with the implementation and use of instrumented aircraft sampling and analysis techniques
to fully characterize pollutant emissions from large scale open burning and open detonation of
obsolete military munitions. He is also engaged in the study and characterization of both chemical
and optical properties of smoke from biomass and hydrocarbon fires and how these smoke emissions
contribute to global climatology.
-------
Macdonald B. Johnson
Macdonald B. Johnson graduated from Brigham Young University in 1959, with a B.S. degree in
Chemistry/Chemical Engineering.
Mr. Johnson joined the Electronics industry in 1959 where for the next 15 years he worked as Project
Manager while developing the technology and methodology for the abdication of discrete components
and integrated circuitry for solid state electronics. Mr. Johnson joined the U.S. Government in 1981
in the demilitarization and technology field where he has served as a Program Manager on several
major OB/OD and alternatives to OB/OD studies conducted by Headquarters AMCCOM.
David K. Kreamer
David K. Kreamer has a B.S. in Microbiology, with a minor in Chemistry from the University of
Arizona. He has an M.S. and Ph.D. from that same institution in Hydrology, with a minor in
Geosciences. He has been an Assistant Professor of Civil Engineering at Arizona State University
since 1984.
Dr. Kreamer has performed an extensive amount of research on the fate and transport of
contaminants in subsurface environments. He serves on numerous local, state and national
committees, has authored over 30 publications, and has served as a lecturer for many groups including
the U.S. Environmental Protection Agency, the U.S. Bureau of Reclamation, the National Water
Well Association and the States of Idaho, Alaska and Arizona.
Daniel LaFleur
Daniel LaFleur holds a B.S. in Chemical Engineering from the University of Southwestern Louisiana.
For the past six years, he has worked in the Navy's Ordnance Environmental Support Office, dealing
specifically with ordnance-related environmental matters. For the past two years, Mr. LaFleur has
participated in the DOD Open Burning/Open Detonation Study being conducted by the Army
Demilitarization Office, and has served on the technical steering committee for that study.
Mr. LeFleur is a member of the American Institute of Chemical Engineers and the American
Defense Preparedness Association.
-------
Milton L. Lee
Milton L. Lee received a B.A. degree in chemistry from the University of Utah in 1971 and a Ph.D.
in analytical chemistry from Indiana University in 1975. Dr. Lee spent one year (1975-1976) at the
Massachusetts Institute of Technology as a postdoctoral research associate before taking a faculty
position in the Chemistry Department at Brigham Young University, where he is presently the H.
Tracy Hall Professor of Analytical Chemistry.
Dr. Lee is best known for his research in modern capillary gas and supercritical fluid chromatography
and for the application of these techniques to the analysis of complex mixtures in environmental
samples and coal-derived products. He is the author or co-author of over 250 scientific publications,
and is a co-author of two books, "Analytical Chemistry of Polycyclic Aromatic Compounds" Academic
Press, 1981, and "Open Tubular Column Gas Chromatography", John Wiley, 1984. He has also
recently co-edited a comprehensive text entitled "Analytical Supercritical Fluid Chromatography and
Extraction". He is the founder and editor of the Journal of Microcolumn Separations and is on the
editorial advisory boards of Chromatographia, Journal of Supercritical Fluids, and Polycyclic Aromatic
Compounds.
Edward V. Ohanian
Edward V. Ohanian received his bachelors in Biological Sciences from Columbia University and his
Masters in Physiology from the New York Medical College. His Doctorate in Biomedical Sciences
was obtained from Mount Sinai School of Medicine. His professional affiliations include the Society
of Toxicology, the Society for Environmental Geochemistry and Health (President, 1987-1989) and
the American Association for the Advancement of Science. Dr. Ohanian is the recipient of EPA's
Gold medal for Exceptional Service.
Dr. Ohanian manages the efforts of a multidisciplinary team of professionals responsible for
developing and conducting risk assessment to establish maximum contaminant level goals as required
under the Safe Drinking Water Act and health advisories for drinking water contaminants. He also
serves as an Adjunct Associate Professor with the Department of Environmental Health Sciences of
the School of Public Health and Tropical Medicine at Tulanc University Medical Center.
Chester J.'-Oszman
• ' '-" , ' ' '•'
^Chester J: Oszman received a B.S.C.E. in Engineering with graduate study in geology from the
University of Iowa. He has worked for the U.S. Environmental Protection Agency since June 1977.
In his current position, Mr. Oszman is a staff environmental engineer with responsibility for
controlling and improving solid and hazardous waste practices nationally. Mr. Oszman advises and
assists senior managers permit staff in Headquarters, Regional Offices, state and local governments,
and the regulated community in matters relating to the implementation of the hazardous waste
regulations and Resource, Conservation and Recovery Act permits. Mr. Oszman is considered a
national expert 9,1 the treatment and storage of hazardous waste and is currently managing the
implementation of the Subpart X —miscellaneous unit-permit program.
/- t ~ f ~ '
Mr. Oszman is a member of the American Society of Civil Engineers, two engineering honor
societies, the University of Iowa Alumni Association, and various employee organizations.
-------
Reinhold A. Rasmussen
Reinhold A. Rasmussen is Professor of Air Chemistry and Director of the Institute of Atmospheric
Sciences (IAS) at the Oregon Graduate Center, Beaverton, Oregon. He is also President of
Biospherics Research Corporation.
Dr. Rasmussen has pioneered atmospheric trace gas measurements that are now implicated in the
issues of Global Change. His laboratory has provided the primary atmospheric measurements since
1975 on the year-by-year increase in the ozone layer-destroying chlorine-containing CFC's. Recently
his laboratory demonstrated that man-made CFC's have now exceeded the natural levels of chlorine-
containing gases, which are at 600 pptv. Dr. Rasmussen's first air chemisty work, in 1965, was as a
botanist when he discovered that isoprene was released form certain plants to the atmosphere and,
in conjunction with the terpenes, in quantities that exceeded man-made sources, both within the
U.S.A. and globally. This led to President Reagan's quip in 1980 that trees were th chief culprit in'
the air pollution hydrocarbon emissions.
Raymond C. (Rocky) Rhodes
Raymond C. Rhodes received his B.S. degree in Nautical Science from the U.S. Merchant Marine
Academy. He received his B.S. degree in Chemical Engineering and his M.S. degree in statistics from
the Virginia Polytechnic Institute. Mr. Rhodes is a Fellow Member of the American Society for
Quality Control, and has been Chairman of the Chemical Division and Regional Counselor of the
Biornedical Division. He is a member of the Air and Waste Management Association and the
American Statistical Association.
Mr. Rhodes has over 40 years of experience in Quality Assurance and Statistical Quality Control.
20 Years was spent at Hercules, Inc. as Assistant Technical Director and Quality Assurance Manager
in the states of Virginia and Utah. He has spent 2 years as a Quality Assurance Consultant, and over
18 years with the USEPA in Quality Assurance Statistics. He is currently a Quality Assurance
Specialist for the USEPA at Research Triangle Park, NC.
Major Welford C. Roberts
Welford C. Roberts has B.S. and M.S. degrees in Biology from Hampton University, Virginia and is
currently a Doctoral Candidate at the University of South Carolina, School of Public Health^ His
Doctoral study has been Environmental Health Sciences with an emphasis in Occupational Health
and Industrial Toxicology. He is a Commissioned Officer in the United States A'fmy and forlrie past
12 years has served as an Environmental Science Officer. His assignment histbry'has'pr6Vided him
broad public health experience in the disciplines of environmental and institutional satiita'tiofa^disease
control and epidemiology, hospital safety and sanitation, occupational health'and industrial hygiene
and medical research and development. • • ""-'• '•"> '<•'• "'• ••'-
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Dean 13- Seyey
Dean D. Sevey received a B.S. degree in Mechanical Engineering from Tri-State University in 1959.
Upon graduation, Mr. Sevey worked on the Redstone and Jupiter Missiles at Chrysler Missile
Corporation. In 1961 Mr. Sevey began his work with the U.S. Government in the ammunition field.
In-1968 he became associated with the Demilitarization Field and has been serving as Chief of the
Demilitarization and Technology Branch at Headquarters, AMCCOM, at Rock Island, IL since 1981.
John Woffifiden -._^_.._-_, v-. -
John Wqffinden received his B.S. degree from Utah State University in geology and mathematics.
Mr. Woffinden has. become an expert in geological testing. He has 14 years of experience in the
putili'c and private sectbf, including 4 years of environmental and munitions testing experience at
i DtfgweiyProving Ground (DPG). He is currently the 'project officer for the OB/OD test program at
DPG.
U S. EnvlrTjnrntal Protection Agency
!•--->-:i on 5, LiSrirv (5PL-16)
.iJ'J S, Dearborn Stieet, Room 1670
Chicago, IL 60604
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