EVH: Risk and Risk assessment
body, skin, ingested, inhaled
Dose can be influenced by many factors, such as how the substance enters the ______, whether absorbed through the _____, _______ with food, or ________.
clean up levels, permit levels, contamination
EPA risk assessments are used in risk management decisions to establish _________________ To set __________ for discharge, storage or transport of hazardous wastes To determine allowable levels of _________________, such as drinking water standards
ED50
Effective dose that produces a defined or specific effect to 50% of the test organisms
cross-sectional, cohort, case control
Epidemiology Study types
Epidemiology
Epidemiology is the study of the distribution and determinants of disease frequency in the human population.
HQ=E/RfD
Hazard Quotient (non-carcinogen) formula
step 5, Determine public health implications
In Risk Assessment step 2 is Dose-response assessment toxicity assessment In Health Assessment this is ___________ __________________________________________________
step 4, Identifying and evaluating exposure pathways
In Risk Assessment step 3 is Exposure assessment In Health Assessment this is ________ _______________________________
step 6, conclusions and recommendations
In Risk Assessment step 4 is Risk Characterization In Health Assessment this is _________ ________________________________________________
ecological, human health
In __________________ risk assessment the potential and actual impact on all exposed or potentially exposed plants and animals is calculated In ___________________ assessment the potential impact on the target population is calculated
extrapolation
In risk analysis, the term _______________ refers to the use of animal data to predict human response to chemical exposure.
exposure defaults
In risk assessment, values recommended by regulators as representative of average population exposure levels for defined environmental pathways.
the data you collect how you interpret the data to whom you will communicate this information
It is important to understand these differences (Risk assessment vs. health assessment) because they will affect
Comprehensive Environmental Response, Compensation, and Liability Act of 1980, Superfund
Legislative Rationale for Risk Assessment _____________________________________ CERCLA PL 96-510 ____________ national program designed to control hazardous substances in the environment administered by EPA
LD50
Lethal Dose that kill 50% of the testorganisms
uncertainty, variability, and effect of multiple exposures
Limitations of risk analysis include _____________________________________________. Despite these limitations, risk assessment is still a valuable tool for exploring and understanding the risks of the modern world.
lowest, adverse, increases
Lowest-observed-adverse-effect-level (LOAEL) -In dose-response experiments -_________ exposure level -With _________ effects -Statistically or biologically significant ____________ in frequency or severity of adverse effects -between the exposed population and its appropriate control group
information is used, perceived outcome vs. actual outcome
Main difference between Health Assessment and Risk Assessment is how the _______________________- different data requirements In health assessment community concerns and health outcomes are considered- ________________________________________
identifying community concerns
Main difference between risk assessment process and health assessment process is step 2. While public comment is required and solicited, complete process of _____________________________________ is not carried out.
NOAEL, no, increases,
NO-Observed-Effect-Level (NOEL) -In dose-response experiments - Similar to ________ - There are __ statistically or biologically significant ___________ in the frequency or severity of any effect -Between the exposed population and its appropriate control
highest one, Highest, without adverse effect
No-Observed-Adverse-Effect-Level(NOAEL) -with more than one NOAEL -regulatory focus is primarily on the ____________ - leading to the term NOAEL to mean the ______exposure level _____________
adverse, no, increases
No-Observed-Adverse-Effect-Level(NOAEL) in dose-response experiments -and exposure level -no ___________ effects _____ statistically or biolofgically significant ____________ in the frequency or severity of adverse effects -between the exposed population and its appropriate contol
information for site evaluation
Physical/geographic description location in community Land use Presence of water and use Fishing and hunting activities - especially if consumption of fish and game occurs - how much consumption Site History Related off site activities
site evaluation, contaminant identification, evaluating site information, identify community concerns, identifying contaminants
Risk Assessment step 1 is the Hazard Identification _____________ ___________________________ In Health Assessment this step is broken into three steps ________________________________ ______________________________________ _______________________________
risks and benefits
Risk analysis allows public groups to make informed decisions and weigh the _______________________ in their community.
likelihood, unwanted, uncertainty
Risk can be defined as the ___________ of an ___________ occurrence coupled with an element of __________ about when the risk might occur.
risk perceptions, biases, scientific knowledge, educational backgrounds, race, gender
Risk communication can be challenging, as it requires addressing people's different ________________________, ________, __________________, ___________________________, even ____ and _________.
comparing the risk
Risk management generally involves _______________________ to some other factor such as the cost, or reducing the risk or the benefit gained from the risk.
risk analysis, social factors
Risk management involves merging the results of _________________ with various ___________________, such as socioeconomic conditions, political pressures, and economic concerns.
Health Assessment Format
Specific format to be followed: 1. Summary 2. Background 3. Community Health Concerns 4. Environmental Contamination and Other Hazards 5. Pathways(s) Analyses 6. Public Health Implications 7. Conclusions 8. Recommendations 9. Authors of Report 10. References 11. Appendices
dollar spent
The "best" course of action is not always the one that reduces the most risk, but rather, is the most economically feasible option, reducing the greatest amount of risk per ___________.
10-4 to 10-6
The USEPA states that the acceptable risk for cancer is:
risk communication, risk information
The goal of____________________________ is to effectively relay _________________________ developed through risk analysis to various interested groups
Hazard Identification
The health assessment step "Identifying community concerns" is part what step in the EPA risk assessment?
hazard identification
The initial step in risk assessment, ___________________________, involves identifying chemicals that present a risk to human health. This step entails performing a qualitative assessment of a chemical's potential for negative health impacts on humans.
Provide information on health implications of a site
The primary goal of a Health Assessment performed by ATSDR is to:
Conduct the RI/FS process on a site
The primary goal of a Risk Assessment performed by the USEPA is to:
Hazard identification Dose-response evaluation Exposure assessment Risk characterization
The process of risk assessment has four steps:
Acceptable Daily Intake (ADI)
The purpose of toxicology studies is often to establish an acceptable level of exposure or dose of a substance that is considered "safe". This level, which poses little risk, is termed the ___________________________________.
Hazard Index (HI)
The ratio between measured population exposure and the calculated reference dose. A smaller number typically indicates that the population exposure is sufficiently below the level of concern.
Hazard Quotient (non-carcinogen)
The ratio of a single substance exposure level over a specified time period (e.g. subchronic) to a reference dose for that substance derived from a similar exposure period.
HQ
The ratio of a single substance exposure level over a specified time period to a reference dose for that substance is _______.
EPA and ATSDR, same
The reason for the difference in Risk Assessment and Health Assessment is the different roles of ____________________ Generally the process is the _____
high-dose, short duration , longer term, lower level
The results from _____________,______________animal studies are used to predict (extrapolate) human response to the _________________, ___________________ exposures we generally receive
false
The risk management decision implemented is always the method that reduces the risk the most.
dose-response evaluation
The second step in risk assessment, _________________________, provides a quantitative view of the risk. This step also involves a review of scientific studies and data. In this case, the magnitude of response is correlated with the dose.
exposure assessment
The third step is risk assessment. The purpose of the ____________________ is to measure or estimate a person's level of exposure.
Educational Economic Regulatory
Three avenues of risk management are:
doses, threshold
Toxicologists use different _______ to elicit different animal responses. Animals receiving doses above the _____________ amount will begin to show adverse effects and some animals will die.
increase
Translating technical terminology into comprehensible terminology can ______________ risk communication.
Preliminary, petitioned
Types of Health Assessment ____________ Health Assessment incomplete information ____________ Health Assessment requested by concerned parties or individuals
Toxicology Epidemiology Cellular studies
Which of the following is not a tool of risk analysis?
uncertainty, know control, measure
__________ is a result of things that we can't ______, _______, or ________.
risk assessment, health assessment
______________________ used by EPA in the remedial investigation/feasibility study (RI/FS) to select remedial actions at a site ______________________ used by ATSDR to provide information on health implications of a specific site
availability heuristic
a mental shortcut people use to make decisions that relies on the immediate examples that come to mind when evaluating a specific topic, concept, method, or decision. Events that can be more easily brought to mind or imagined are judged to be more likely than events that are less easily imagined.
risk management
a process that builds on the results of risk assessments to decide on policy options to reduce risk. Involves economic, political, and institutional considerations and consultation with stakeholders.
negative dominance
a risk communication theory describing people's tendency to focus far more on negative information than on positive information when they are concerned, stressed, or upset.
social amplification and attenuation of risk
a risk communication theory that describes how hazards interact with psychological, social, institutional, and cultural processes in ways that either increase (amplify) or decrease (attenuate) public responses to the risk or risk event. These public responses then generate secondary social and economic impact.
Benchmark response (BMR)
a selected from effects measured in the background exposure group, used as a point of departure from the observed data.
risk characterization
fourth step in risk assessment. ______________________________ provides a picture of the risk that addresses its severity, likelihood, and consequences. Includes an estimate of the negative effects to exposed individuals, such as the number of cases of cancer or deaths per 100,000 people.
conformity
holding attitudes, beliefs, or behaviors similar to those of most other people in one's society or group.
right to know
in the context of work place and environmental law, the legal principle that people have the right to know the risks to which they may be exposed in their workplace and general environment. It is embodied in US and other national laws as well as in local laws in several states.
Weight of evidence analysis
in the hazard identification step of risk assessment, a judgement regarding the adequacy of the entire body of available evidence to support a conclusion that the substance poses a hazard to humans.
clinical drug trials
individuals volunteer to be exposed to a substance or to ingest a drug, and are assessed for their health response.
LC50
lethal concentration that kill 50% of the test organisms
highest, carcinogens
maximum tolerated dose (MTD) the _______ dose that does not cause toxicity in test organisms. Important in test of suspected _________________. We often want to use the highest dose possible without causing other non carcinogenic toxicity.
heuristics
mental shortcuts that allow people to solve problems and make judgments quickly and efficiently. Even though helpful in solving complex problems or making difficult judgments, they can also lead to biases.
cost-benefit analysis
"Risk Assessment and Cost-Benefit Act of 1995" Division D of H.R. 9 Ultimately this Act was unsuccessful but it demonstrates the desire to include some sort of ________________________________ in the risk assessment process.
the process of risk analysis
1 A review of scientific studies 2 An understanding of the properties of a risk 3 An assessment of levels of human exposure and dose 4 A conclusion about the likelihood, impact and extent of a risk.
Six steps in every health assessment
1. Evaluating site information 2. Identify community concerns 3. Identifying contaminants 4. Identifying and evaluating exposure pathways 5. Determining public health implications 6. Conclusions and recommendations
central factor
A _____________ of environmental risk is that it is usually involuntary
involuntary
A central factor of environmental risk is that it is usually __________________
Reference Dose (RfD)
A dose of a chemical that is without risk of substantial adverse effects when the chemical exposure occurs over a lifetime.
Benchmark dose-lower bound (BMDL)
A lower confidence limit on the dose at the benchmark dose
examples of things that contribute to uncertainty
Cumulative lifetime exposure to a chemical Spatial and temporal variability in exposure Impact of unmeasured events on sensitivity to exposure
toxicologists
study chemicals to determine their physiological and health impacts on humans.
maximum tolerated dose (MTD)
the highest dose that does not cause toxicity in test organisms. Important in test of suspected carcinogens. We often want to use the highest dose possible without causing other non carcinogenic toxicity.
No Observed Adverse Effect Level (NOAEL)
the highest dose, among doses tested in a study, that demonstrates no significant difference from effects measured in control animals.
Red Book
the informal name for Risk Assessment in the Federal Government: Managing the Process, the 1983 National Academy of Sciences report that established a framework for risk assessment.
silver book
the informal name for Science and Decisions: Advancing Risk Assessment, a 2009 National Academy of Sciences report that updated the 1983 NAS framework for risk assessment.
Lowest observed adverse effect level (LOAEL)
the lowest does, among doses tested in a study, that demonstrates a statistically or biologically significant difference from effects measured in control animals.
risk
the probability that some adverse event will occur
a review of scientific studies
the process of risk analysis step 1
an understanding of the properties of a risk
the process of risk analysis step 2
an assessment of levels of human exposure and dose
the process of risk analysis step 3
a conclusion about the likelihood, impact and extent of a risk
the process of risk analysis step 4
margin of exposure (MOE)
the ratio between the calculated no observed adverse effect level (NOAEL) or Benchmark Dose (BMD) and the measured population exposure. A larger number (ie >100) typically indicates that the population exposure is sufficiently less than the level of concern.
Point of Departure (POD)
the starting point for extrapolating to lower doses; it can be the lower bound of a BMD or it canbe a NOAEL or LOAEL
Risk perception
the subjective judgement that people make about the characteristics and severity of a risk
loss aversion
the tendency for people to strongly prefer avoiding losses over acquiring gains. Most studies suggest that losses are two to times as powerful, psychologically, as gains.
confirmatory bias (also called confirmation bias)
the tendency to seek, interpret, or recall information that confirms one's existing beliefs. Is typically displayed when people gather or remember information selectively. The effect is stronger for emotionally charged issues and for deeply entrenched beliefs.
social marketing
the use of marketing concepts, including product (or service) development, price and distribution channel management, and promotion, to influence behaviors that benefit individuals and communities and contribute to the greater social good.
Toxicology, Cellular Studies, Clinical Trials, Epidemiology
tools of risk analysis (disciplines)
Regulatory Toxicology
toxicology aims at guarding the public from dangerous chemical exposures.
lower and upper limits
toxicology studies can delineate both the _________________________________ of a chemical's potency
Hazard Communication Standard
An OSHA standard (29 CFR Parts 1910, 1915, and 1926) that entitles workers to know the hazards to which they are exposed. The standard requires employers to inform and train workers accordingly.
uncertainty
An important issue in risk assessment is the concept of ___________. is a result of things that we can't know, control or measure.
unit cancer risk (UCR)
An upper bound, approximating a 95% confidence limit, on the increased cancer risk from lifetime exposure (also called cancer slope factor)
EPA acceptable risks
Cancer 10-4 to 10-6 excess lifetime cancer risk Non-carcinogens HI < 1.0 HI= Hazard Index -Sum of Hazard quotients
environment, taken in
Exposure is different from dose in that exposure refers to the amount of a substance in the _____________, while dose is the level of a substance actually ___________ by an organism.
two weeks, 5-90 days, up to two years
Exposure studies convoy in length: Acute:_______________ Subchronic:___________________ Long term or chronic:_______________
Emergency Planning & Community Right-To-Know Act (EPCRA)
a statute administered by the EPA and designed to facilitate the development of chemical emergency response plans by state, tribal, and local governments, and to improve community access to information about chemical hazards. Under EPCRA, companies with hazardous chemicals on their premises above a threshold amount must inform state and local authorities of this fact, and manufacturing firms aboce a certain size must submit a toxic chemical release report to EPA. (This act is TItile III of the Superfund Amendments and Reauthorization ACT [SARA], and is thus also knows as SARA Title III.)
risk assessment
a stepwise process of organizing information about a hazard or agent of concern. The steps are problem formulation, hazard identification, exposure assessment, dose-response assessment, and risk characterization.
message map
a visual display of an organization's messages regarding high-concern or controversial issues. Typically a one-page roadmap for displaying detailed, hierarchically organized responses to anticipated questions or concerns.
Benchmark Dose (BMD)
an estimate of the dose at which a specified increase in adverse effects is apparent
risk communication
an interactive process of exchange of information and opinion among individuals, groups, and institutions, involving multiple messages about the nature of risk.
Consumer confidence reports (CCRs)
annual reports issued by community water systems pursuant to the EPA's National Primary Drinking Water Regulations; these reports provide information to consumers about drinking-water quality.
