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Water: Microbial

Thesaurus of Terms Used in Microbial Risk Assessment: 5.10 Risk Characterization, Risk Management, and Policy Terms

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acceptable daily intake          (ACRONYM: ADI)
  1. The amount of a chemical a person can be exposed to on a daily basis over an extended period of time (usually a lifetime) without suffering deleterious effects.  (EPA 2003)
  2. The ADI of a chemical is the estimate of the amount of a substance in food and/or drinking water, expressed on a bodyweight basis, that can be ingested daily over a lifetime without appreciable health risk to the consumer on the basis of all the known facts at the time of the evaluation. It is usually expressed in milligrams of the chemical per kilogram of body weight.  (FAO/WHO 1997)
  3. The estimated amount of a substance that can be consumed every day for a lifetime by humans without presenting a significant risk to their health, based on current scientific evidence.  (FSA 2005)
  4. Estimated maximum amount of an agent, expressed on a body mass basis, to which an individual in a (sub) population may be exposed daily over its lifetime without appreciable health risk.  (IPCS/OECD 2004)
  5. Estimate of the amount of a substance in food or drinking water, expressed on a body mass basis (e.g., mg or μg/kg body weight), which can be ingested daily over a lifetime by humans without appreciable health risk.  (ILSI 2001)
  6. An estimate of the daily exposure dose that is likely to be without deleterious effect even if continued exposure occurs over a lifetime.  (RAIS 2004)
    RELATED TERMS:reference dose, tolerable daily intake

May also be known as “allowable daily intake.”  Note, “allowable” does not imply that the level is “acceptable.”

acceptable risk
  1. The likelihood of suffering disease or injury that will be tolerated by an individual, group, or society.  The level of risk that is determined to be acceptable may depend on a variety of issues, including scientific data, social, economic, legal, and political factors, and on the perceived benefits arising from a chemical or process.  (EPA 2004)
  2. This is a risk management term.  The acceptability of the risk depends on scientific data, social, economic, and political factors, and on the perceived benefits arising from exposure to an agent.  (IPCS/OECD 2004)
actual risk

The damage to life, health, property, and/or the environment that may occur as a result of exposure to a given hazard.  Risk assessment attempts to estimate the likelihood of actual risk.  (EPA 2004)

added risk

The difference between the cancer incidence under the exposure condition and the background incidence in the absence of exposure.  (RAIS 2004)

additional risk          (ACRONYM: AR)

The calculated difference in risk of a particular condition between those who are exposed and those who are not.  This measure is derived by subtracting the rate (usually incidence or mortality) of the disease among the unexposed persons (Pu) from the corresponding rate among the exposed (Pe), i.e., AR= Pe-Pu.  The AR is an absolute measure of the excess risk attributed to exposure.  (EPA 2003)
RELATED TERMS: excess lifetime risk, attributable risk, risk difference

aggregate risk

The risk resulting from aggregate exposure to a single agent or stressor.  (EPA 2004)

appropriate level of protection          (ACRONYM: ALOP)

Level of protection deemed appropriate by the member (country) establishing a sanitary or phytosanitary measure to protect human, animal, or plant life or health within its territory.  (CAC 2002)

attributable risk

The rate of a disease in exposed individuals that can be attributed to the exposure.  This measure is derived by subtracting the rate (usually incidence or mortality) of the disease among non-exposed persons from the corresponding rate among exposed individuals.  (RAIS 2004, SRA 2004)
RELATED TERMS: additional risk, odds ratio

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cancer risk

A theoretical risk for getting cancer if exposed to a substance every day for 70 years (a lifetime exposure).  The true risk might be lower.  (ATSDR 2004)

comparison value          (ACRONYM: CV)

Calculated concentration of a substance in air, water, food, or soil that is unlikely to cause harmful (adverse) health effects in exposed people. The CV is used as a screening level during the public health assessment process. Substances found in amounts greater than their CVs might be selected for further evaluation in the public health assessment process.  (ATSDR 2004)

confounder
  1. A condition or variable that is both a risk factor for disease and associated with an exposure of interest.  This association between the exposure of interest and the confounder (a true risk factor for disease) may make it falsely appear that the exposure of interest is associated with disease.  (EPA 2003)
  2. A variable that introduces bias into an association between a causal factor and an effect.  (A bias resulting from an unbalanced distribution of other causal factors, or markers for such factors, among people in different exposure categories.)  (NZ 2002)
  3. Variables that may introduce differences between cases and controls which do not reflect differences in the variables of primary interest.  (RAIS 2004, SRA 2004)
    RELATED TERMS: matching
confounding factor

SEE: confounder

control point          (ACRONYM: CP)

A step in the water supply at which contamination is prevented reduced or eliminated or minimized and which, if collectively in compliance, would ensure that water quality targets are met.  CPs are points in the water supply where it is possible to set operational and/or critical limits, monitor those limits and take corrective action in response to a detected deviation before the water becomes unsafe.  Often these points are control measures that are specifically designed to control a hazard.  (KIWA 2004)
Control points are part of Hazard Analysis Critical Control Points (HACCP) and are used in a broader context than just water, for example HACCP was originally created for food and beverage production.

control processes

Control processes are measures that are in place or new options under evaluation that are part of the risk mitigation strategy.  Examples of control processes are wastewater treatment plants and pasteurization.  Alternative control processes may be evaluated using risk assessment.  (ILSI 2000 text)

criteria

Descriptive factors taken into account by EPA in setting standards for pollutants. For example, water quality criteria describe the concentration of pollutants that most fish can be exposed to for an hour without showing acute effects.  (EPA 2005e)

critical limits

A criterion which measures performance of the control point to ensure that the control point will deliver water of a quality consistent that meets the water quality targets.  Exceeding the Critical Limit implies that the Control point is no longer in compliance with the Water Safety Plan and there is an increased risk of water quality failing to meet the Health Target.  (KIWA 2004)

decontamination
  1. Removal of harmful substances such as noxious chemicals, harmful bacteria or other organisms, or radioactive material from exposed individuals, rooms and furnishings in buildings, or the exterior environment.  (EPA 2005b, RAIS 2004)
  2. The reduction or removal of a chemical, biological, or radiological material from the surface of a structure, area, object, or person.  (MERREA 2005)

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disinfection
  1. disinfectant - A chemical that destroys vegetative forms of harmful microorganisms, but does not ordinarily kill bacterial spores.  (EPA 2005e)
  2. Killing of infectious agents outside the body by direct exposure to chemical or physical agents.  (MERREA 2005)
  3. The process designed to kill most microorganisms in water, including essentially all pathogens.  (CRCWQT 2002)
excess death

The excess over statistically expected deaths in a population within a given time interval.  Attempts are made to relate excess deaths to specific causes.  Note that since every person can (and must) die only once, there can be no excess deaths over all time.  (SRA 2004)

excess lifetime risk

The additional or extra risk of developing cancer due to exposure to a toxic substance incurred over the lifetime of an individual.  (EPA 2003)

expected deaths

The number of deaths statistically expected in a population in a given time interval obtained by summing the product of age-, sex-, and race-specific mortality rates from a standard population and person-years in each age, sex, and race category in the study population.  (RAIS 2004, SRA 2004)

expected loss

The quantity obtained by multiplying the magnitude of health or environmental effect loss by the probability (or risk) of that loss and adding the products.  The expected loss is the average loss over a large number of trials; one must reflect on the appropriateness of its use in cases for which there will be only one, or a few, trials.  (RAIS 2004, SRA 2004)

guidance value

Value, such as concentration in air or water, which is derived after allocation of the reference dose among the different possible media (routes) of exposure.  The aim of the guidance value is to provide quantitative information from risk assessment to the risk managers to enable them to make decisions.  (IPCS/OECD 2004)
RELATED TERMS: reference dose

individual risk
  1. The probability that an individual will experience an adverse effect.  (EPA 2003)
  2. The risk or hazard to an individual in a population rather than to the population as a whole.  (EPA 2004)
  3. The risk to an individual rather than to a population.  (MERREA 2005, RAIS 2004, SRA 2004)
level of concern          (ACRONYM: LOC)

The concentration in air of an extremely hazardous substance above which there may be serious immediate health effects to anyone exposed to it for short periods.  (EPA 2005b)
Phrases that have specific definitions in one context may also have common vernacular meanings.  For example, “level of concern” could easily have a general meaning that encompasses a variety of possible “levels.”  However, LOC is a specific jargon term used for air toxics that has not been adopted for water contaminants or pathogens.

management goal

A goal is a general statement of the desired outcome for the overall decision that would solve the problem or take maximum advantage of the opportunity, etc., for example, “Reestablish and maintain water quality and habitat conditions in Waquoit Bay and associated wetlands, freshwater rivers, and ponds.”  (EPA 1998a)

management objective

An objective is a more specific statement of the desired outcome.  It should be specific enough to allow scientists to develop measures from them for a risk assessment.  Objectives for Waquoit Bay included: “Restore and maintain self-sustaining native fish populations and their habitat.”  Objectives include an entity (native fish in this case), some attribute (population), and a desired state or direction of change (self-sustainability).  Note that assessments endpoints are similar in that they include an entity and an attribute, but do not include a desired state or direction of change.  (EPA 1998a)

margin of safety
  1. Maximum amount of exposure producing no measurable effect in animals (or studied humans) divided by the actual amount of human exposure in a population.  (EPA 2005b)
  2. For some experts the Margin of Safety has the same meaning as the Margin of Exposure, while for others, the Margin of Safety means the margin between the reference dose and the actual exposure dose or concentration.  (IPCS/OECD 2004)
    RELATED TERMS: margin of exposure

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microbiological criteria

A microbiological criteria for food defines the acceptability of a product or a food lot, based on the absence or presence, or number of microorganisms including parasites, and/or quantity of their toxins/metabolites, per unit(s) of mass, volume, area, or lot.  (CAC 2002)

mitigation

Measures taken to reduce adverse impacts on the environment.  (EPA 2005b)

kmultipathway risk

The risk resulting from exposure to pollutants through more than one pathway.  (EPA 2004)
RELATED TERMS: multipathway exposure, multipathway assessment

peer review
  1. The process by which manuscripts submitted to health, biomedical, and other scientifically oriented journals and other publications are evaluated by experts in appropriate fields (usually anonymous to the authors) to determine if the manuscripts are of adequate quality for publication.  (NLM/NICHSR 2004)
  2. A process whereby scientific and technical research and analysis is subject to outside review and comments by individuals or a panel qualified to review and comment upon the material.  Many scientific and technical journals conduct peer reviews before studies are published.  Governmental agencies involved in scientific and technical missions and programs also often use peer reviews to guide research agendas, evaluate research proposals and studies, and evaluate proposed health-based environment standards.  (NYS 1998) 
performance criteria

The required microbiological outcome of one or more control measures at a step or combination of steps that contribute to assuring the safety of a food.  (CAC 2002)

performance standard

The requirement for certain results or outcomes.  Usually used to describe results-based regulations, performance standards shy away from prescribing practices or specifications, and do not stipulate the type of technology or other requirements to be used when complying with the regulations.  (NYS 1998)

permissible dose

The dose of a chemical that may be received by an individual without the expectation of a significantly harmful result.  (EPA 2005b)

permissible exposure limit          (ACRONYM: PEL)
  1. An occupational health standard to safeguard employees against dangerous chemicals or contaminants in the workplace.  (Last 1983)
  2. The legal limit for occupational exposure to airborne concentrations of several hundred agents.  Established by OSHA (U.S. Occupational Safety and Health Administration  (REAP 1995)
population attributable risk

SEE: attributable risk

potential risk

Estimated likelihood, or probability, of injury, disease, or death resulting from exposure to a potential environmental hazard.  (EPA 2004)

public health approach

Regulatory and voluntary focus on effective and feasible risk management actions at the national and community level to reduce human exposures and risks, with priority given to reducing exposures with the biggest impacts in terms of the number affected and severity of effect.  (EPA 2005b)

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public health context

The incidence, prevalence, and severity of diseases in communities or populations and the factors that account for them, including infections, exposure to pollutants, and other exposures or activities.  (EPA 2005b)

qualitative uncertainty estimate

A detailed examination, using qualitative information, of the systematic and random errors of a measurement or estimate.  (EPA 2004)

quality assurance
  1. An integrated system of activities involving planning, quality control, quality assessment, reporting and quality improvement to ensure that a product or service meets defined standards of quality with a stated level of confidence.  (EPA 2004)
  2. Quality Assurance/Quality Control: A system of procedures, checks, audits, and corrective actions to ensure that all EPA research design and performance, environmental monitoring and sampling, and other technical and reporting activities are of the highest achievable quality. (EPA 2005b, RAIS 2004)
    RELATED TERMS: quality control
quality assurance project plan

A document describing in comprehensive detail the necessary quality assurance, quality control, and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance criteria.  (EPA 2004)

quality control

The overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the needs of its users.  The aim is to provide data quality that is satisfactory, adequate, and dependable.  (EPA 2004)
RELATED TERMS: quality assurance

relative risk          (ACRONYM: RR)
  1. The relative measure of the difference in risk between the exposed and unexposed populations in a cohort study.  The relative risk is defined as the rate of disease among the exposed divided by the rate of the disease among the unexposed.  A relative risk of 2 means that the exposed group has twice the disease risk as the unexposed group.  (EPA 2003)
  2. A comparison of the risk of some health-related event such as disease or death in two groups.  (CDC 2005)
  3. The ratio of two incidence rates (strictly, rate ratio for person-time data); or the ratio of two cumulative incidences (strictly, risk ratio for count data).  For “rare” diseases these ratios are approximately equal (hence, in common usage, both are referred to as relative risk).  Loosely used to mean odds ratio in case-control studies since, for “rare” diseases, they may approximate one another.  (NZ 2002)
  4. The ratio of the rate of the disease (usually incidence or mortality) among those exposed to the rate among those not exposed.  (RAIS 2004, SRA 2004)
    RELATED TERMS: risk ratio
relative risk assessment

Estimating the risks associated with different stressors or management actions.  (EPA 2005b)

risk-based decision-making

An approach to regulatory decision-making in which such decisions are made solely based on the results of a probabilistic risk analysis.  (USNRC 2005)

risk-based targeting

The direction of resources to those areas that have been identified as having the highest potential or actual adverse effect on human health and/or the environment.  (EPA 2005b)

risk management policy

Guidance provided for value judgment or policy choices, and provision for apportionment of adequate resources and peer review.  (CAC 2002)

risk monitoring

Process of following up the decisions and actions within risk management in order to ascertain that risk containment or reduction with respect to a particular hazard is assured.  Risk monitoring is an element of risk management.  (IPCS/OECD 2004)

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risk profile
  1. A description of a food safety problem and its context so as to guide further risk management action.  (CAC 2002)
  2. The description of the food safety problem and its context.  (CAC 2003)
  3. An overall summary of the context in which a risk is being analyzed, including: a description of the risk(s) considered, values threatened by the risk, social perception of the risk, who benefits from producing the risk, who benefits from managing the risk, and characteristics of the risk, the risk-producer and the risk-bearer, which are pertinent to successful management of the risk.  (OMAF 1997)
  4. A description of the food safety problem and its context.  Risk profiling is the process of describing a food safety problem and its context, in order to identify those elements of the hazard or risk relevant to various risk management decisions.  The risk profile would include identifying aspects of hazards relevant to prioritizing and setting the risk assessment policy and aspects of the risk relevant to the choice of safety standards and management options.  (USDA 2004)
risk ratio

SEE: relative risk

risk reduction

Actions that can decrease the likelihood that individuals, groups, or communities will experience disease or other health conditions.  (ATSDR 2004)

subjective judgment

SEE: expert judgment

tolerable daily intake

Analogous to acceptable daily intake.  The term “tolerable” is used for agents that are not deliberately added such as contaminants in food.  (IPCS/OECD 2004)

tolerable intake

Estimated maximum amount of an agent, expressed on a body mass basis, to which each individual in a (sub) population may be exposed over a specified period without appreciable risk.  (IPCS/OECD 2004)

unit risk
  1. The upper-bound excess lifetime cancer risk estimated to result from continuous exposure to an agent at a concentration of 1 g/L in water, or 1 g/m3 in air.  The interpretation of unit risk would be as follows: if unit risk = 1.5 x 10-6 g/L, 1.5 excess tumors are expected to develop per 1,000,000 people if exposed daily for a lifetime to 1 g of the chemical in 1 liter of drinking water.  (EPA 2003)
  2. The unit risk factors (URFs) provide estimates of the risks due to a unit inventory of contaminant (i.e., risk/gram or risk/curie).  URFs can be calculated for water, soil, air, and radiation.  URFs can be used to calculate risk for quantities greater than unity only if the relationship is linear.  (RAIS 2004)
unit risk estimate          (ACRONYM: URE)

The upper-bound excess lifetime cancer risk estimated to result from continuous exposure to an agent at a concentration of 1μ g/L in water, or 1 μg/m3 in air.  The interpretation of unit risk would be as follows: if the water unit risk = 2 x 10-6 μg/L, 2 excess tumors may develop per 1,000,000 people if exposed daily for a lifetime to 1 μg of the chemical in 1 liter of drinking water.  (EPA 2004)

water quality target

The maximum levels of microbiological hazards in drinking water, which are considered acceptable for human consumption, preferably in a quantitative and verifiable manner as described by official state authorities.  (KIWA 2004)

water safety plan          (ACRONYM: WSP)

A management plan developed to address all aspects of water supply that are under the direct control of the water supplier focused on the control of water production, treatment and distribution to deliver drinking water.  (KIWA 2004)

weight-of-evidence          (ACRONYM: WOE)

In determining carcinogencity, a system for characterizing the extent to which the available data support the hypothesis that an agent causes an adverse health effect in humans.  For example, under EPA’s 1986 cancer risk assessment guidelines, the WOE was described by categories “A through E,” Group A for known human carcinogens through Group E for agents with evidence of noncarcinogenicity.  The approach outlined in EPA’s proposed guidelines for carcinogen risk assessment (1996 and updates) considers all scientific information in determining whether and under what conditions an agent may cause cancer in humans, and provides a narrative approach to characterize carcinogenicity rather than categories.  (EPA 2003, 2004)

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