Drinking Water Guidelines and Standards
Drinking Water Guidelines and Standards
Drinking Water Guidelines and Standards
Chapter 5:
By
Sombo Yamamura
In collaboration with
5.1 Introduction 3
5.6 Surveillance 14
Box 5-5: Application of national arsenic drinking water guidelines / standards in Hungary
References
2
Chapter summary
The primary aim of the WHO Guidelines for Drinking-water Quality (GDWQ) is the
protection of public health. The Guidelines are intended to be used as a basis for the
development of national standards that, if properly implemented, will ensure the safety of
drinking water supplies through the elimination, or reduction to a minimum concentration,
of constituents in drinking water that are known to be hazardous to health. The guideline
values recommended are not mandatory limits. They are intended to be used in the
development of risk management strategies which may include national or regional
standards in the context of local or national environmental, social, economic and cultural
conditions.
The main reason for not promoting the adoption of international standards for drinking
water quality is the advantage provided by the use of a risk-benefit approach (qualitative
or quantitative) to the establishment of national standards or regulations. This approach
should lead to standards and regulations that can be readily implemented and enforced
and which ensure the use of available national financial, technical and institutional
resources for maximum public health benefit.
WHO has had a public position on arsenic in drinking water since 1958. The last edition
of WHO GDWQ (1993) established 0.01 mg/L as a provisional guideline value for arsenic
in drinking water with a view to reducing the concentration of arsenic in drinking-water,
because lower levels preferred for health protection are not reliably measurable.
In a number of countries, the WHO provisional guidelines of 0.01 mg/L has been adopted
as the standard. However, many countries have kept 0.05 mg/L, established in an earlier
edition of the guidelines, as the national standard or as an interim target before tackling
populations exposed to lower but still significant concentrations in the 0.01-0.05 range.
In developing national drinking water standards based on the guideline values, it will be
necessary to take account of a variety of geographical, socio-economic, dietary and other
conditions affecting potential exposure.
5.1 Introduction
The primary aim of the Guidelines for Drinking Water Quality is the protection of
public health. In 1984 and 1985, WHO published the first edition in three volumes.
The development of these Guidelines was organized and carried out jointly by WHO
HQ and WHO EURO. In 1988, WHO (HQ & EURO) decided to initiate the revision
of the Guidelines. The revised Guidelines have again been published in three volumes.
They have been widely used as a basis for setting national standards to ensure the
safety of public water supplies.
The guideline values recommended are not mandatory limits. Such limits should be set
by national authorities, using a risk-benefit approach and taking into consideration local
environmental, social, economic and cultural conditions.
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Volume 1 Recommendations (published in 1993)
This volume sets out guideline values for a large number of water contaminants
relevant to the quality of drinking-water. The book also provides an explanation of how
the guideline values should be applied, the criteria used in selecting the various
chemical, physical, microbiological, and radiological contaminants considered, a
description of the approaches used to derive the guideline values, and brief summary
statements supporting the values recommended or explaining why no health-based
guideline value is necessary at present.
The book has 17 chapters presented in three parts. The first, on microbiological
aspects, addresses the common and widespread health risks associated with the direct
or indirect contamination of drinking-water with human or animal excreta, particularly
faeces. The second and most extensive part, which contains almost 800 pages, provides
evaluations, supported by toxicological monographs, for each of 36 inorganic
constituents and physical parameters, 27 industrial chemicals, 36 pesticides, four
disinfectants, and some 23 disinfectant by-products. The final part explains application
of the reference level of dose for radiological contaminants in drinking-water. The
volume concludes with a list of the hundreds of experts who collaborated in the
evaluations, a convenient tabular presentation of the guideline values, and a
comprehensive index.
The book has eight chapter organized to reflect the key stages in the development of
surveillance. Chapter one explains how the basic principles of surveillance and control
apply to small-community supplies and alerts readers to several unique problems that
need to be overcome. Planning and implementation are discussed in the second
chapter, which gives particular attention to the distinct yet complementary
responsibilities of the water supply agency and the public health protection agency.
Subsequent chapters offer advice on the nature, scope, and timing of sanitary
inspections, describe the most appropriate methods for sampling water and assessing
its hygienic quality, and explain how the resulting data can be used to improve the
quality, coverage, quantity, cost, and continuity of the water supply.
The most extensive chapter describes and illustrates numerous technical interventions
for preventing or correcting hazards associated with water from different sources,
procedures for water treatment, and methods used to treat and store water in
households. Additional strategies for improvement are covered in the remaining
5
chapters, which outline methods of hygiene education in communities and discuss the
important role of legislation and regulation.
The origin of WHO Guidelines for Drinking-Water Quality (GDWQ) goes back to the
1950s. At that time the requirements for safe and potable water supplies became
particularly pertinent with the great increase in travel, especially global air travel. It became
apparent that the traveler must be provided with potable drinking-water. In 1953,WHO
distributed a questionnaire to all member states to assess the status of water treatment
plants and their production of acceptable water quality. The replies to the questionnaire
clearly indicated the magnitude of the problem and the need for WHO to establish
drinking water standards.(WHO 1958)
In addition to being cited in the International Sanitary Regulations for deciding what
constitutes pure and acceptable water supply at ports and airports, the 1958 International
Standards became to be widely used as a reference in the development of local national
standards and as a basis for improved water treatment practices.
Some countries adopted the International Standards as the official and legal standards of
water quality while other countries developed national standards based in part or in whole
on the International Standards. Increasing knowledge of the nature and effect of various
contaminants, and improved techniques for identifying and determining their
concentrations, have led to a demand for further revision of the recommendations.
Accordingly the International Standards for Drinking-Water were revised in 1963 and
1971.(WHO 1958, 1963, 1971)
The International Standards had been in existence for over a decade until they were
superseded by the WHO Guidelines for Drinking-Water Quality (GDWQ) in 1984.
While it was recognized that it might not be possible by a number of member states to
attain all of the recommended guideline levels, it was anticipated that member states would
develop water quality standards as close as possible to these guidelines in the endeavour
to protect public health.
The change from Standards to Guidelines meant that the guidelines were intended for use
by member states as a basis for the development of national standards which, if properly
implemented, would ensure the safety of drinking-water supplies both in the urban and
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rural settings. The philosophy and content of the WHO Guidelines constituted a drastic
departure from the previous International Standards. The revised guidelines were
published in three volumes including criteria monographs prepared for each substance
or contaminant listed in the guidelines.(WHO 1984, 1985).
The second edition of the GDWQ Volume 1 was published in 1993 followed by Volume
2 in 1996 and Volume 3 in 1997. The work involved numerous institutions, over 200
experts from nearly 40 different developing and developed countries and 18 meetings of
the various coordination and review groups. The International Programme on Chemical
Safety (IPCS) provided major input to the health risk assessments of chemicals in
drinking-water.
In GDWQ, it is often emphasized that the guideline values recommended are not
mandatory limits. In order to define such limits, it is necessary to consider the guideline
values in the context of local or national environmental, social, economic, and cultural
conditions. The main reason for not promoting the adoption of international standards for
drinking-water quality is the advantage provided by the use of a risk-benefit approach
(qualitative and quantitative) to the establishment of national standards and regulations.
This approach should lead to standards and regulations that can be readily implemented
and enforced. For example, the adoption of drinking-water standards that are too stringent
could limit the availability of water supplies that meet those standards a significant
consideration in regions of water shortage. However, considerations of policy and
convenience must never be allowed to endanger public health. The judgement of safety
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or what is an acceptable level of risk in particular circumstances B is a matter in which
society as a whole has a role to play. The final judgement as to whether the benefit
resulting from the adoption of any of the guideline values given here as standards justifies
the cost is for each country to decide (WHO 1993).
WHO has had a public position on arsenic in drinking water since 1958. The first version
of International Standards for Drinking-Water in 1958 included arsenic in the category of
toxic substances which, if present in drinking-water supplies at concentrations above
certain levels, may give rise to actual danger to health. It established 0.20 mg/L as an
allowable concentration (WHO 1958). The updated standards in 1963 kept arsenic in the
same category and established a stricter concentration of 0.05 mg/L, although no specific
reason for this reduction was disclosed (WHO 1963).
An update in 1971, kept arsenic in the toxic substances category and reaffirmed the value
of 0.05 mg/L. Its explanatory notes referred to the fact that figures higher than that quoted
are found in a number of Latin American countries and levels up to 0.2 mg/L were not
known to have caused difficulties in drinking water. It also referred to some
epidemiological studies which have suggested that arsenic is carcinogenic but mentioned
that no real proof of its carcinogenicity to man had been established. It concluded that it
would seem wise to keep the level of arsenic in drinking-water as low as possible (WHO
1971).
The WHO Guidelines for Drinking-water Quality in 1984 were intended as a basis for the
development of national standards in the context of national environmental, social,
economic and cultural conditions. It introduced new categories in the drinking-water
guidelines. The categories of toxic and specific substances in the preceding publications
were abolished and arsenic was categorized among the inorganic constituents of
significance to health. It recommended 0.05 mg/L as a guideline value with the explanation
that, based on available human health data, a concentration of 0.05 mg of arsenic per litre
in drinking water is not associated with any adverse health effects. Supporting evidence
in the relevant criteria monograph included the case in Chile and China (Province of
Taiwan). ( WHO 1984 )
The last edition of WHO GDWQ (1993) established 0.01 mg/L as a provisional guideline
value for arsenic in drinking water. The fact that inorganic arsenic compounds are
classified by IARC in Group 1 (carcinogenic to humans) on the basis of sufficient
evidence for carcinogenicity in humans and limited evidence for carcinogenicity in animals
was taken into consideration. Based on the increased incidence of skin cancer observed
in the population in China (Province of Taiwan), the lifetime risk of skin cancer was
estimated using a multistage model.
There are at least two reasons why 0.01 mg/L was selected as a provisional guideline value.
These are: (1) On the basis of observations in a population ingesting arsenic-contaminated
drinking-water, the concentration associated with an excess life-time skin cancer risk of
10-5 was calculated to be 0.00017mg/L. However, this value may overestimate the actual
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risk of skin cancer owing to the possible dose-dependent variations in metabolism that
could not be taken into consideration. (2) This value is below the practical quantification
limit of 0.01mg/L. The estimated excess lifetime skin cancer risk associated with exposure
to this concentration is 6 x 10-4 (WHO 1993).
IPCS Environmental Health Criteria on Arsenic was published in 1981 and provided the
first consensus on international health risk assessments regarding arsenic in drinking
water. The updated version is now under preparation and is to be completed in 2000.
Data on the association between internal cancers and ingestion of arsenic in drinking-
water are limited and insufficient for quantitative assessment of an exposure-response
relationship (USEPA 1988). However, based on the increased incidence of skin cancer
observed in the population in China (Province of Taiwan), the US Environmental
Protection Agency has used a multistage model that is both linear and quadratic in
dose to estimate the lifetime skin cancer risk associated with the ingestion of arsenic in
drinking-water. With this model and data on males (USEPA 1988), the concentrations
of arsenic in drinking-water associated with estimated excess lifetime skin cancer risks
of 10-4, 10-5, and 10-6 are 0.0017, 0.00017 and 0.000017 mg/L, respectively.
It should be noted, however, that these values may overestimate the actual risk of skin
cancer because of possible simultaneous exposure to other compounds in the water
and possible dose-dependent variations in metabolism that could not be taken into
consideration. In addition, the concentration of arsenic in drinking-water at an
estimated skin cancer risk of 10-5 is below the practical quantification limit of
0.01mg/L.
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BOX 5-2: Arsenic health effects data in China (Province of Taiwan)
In a study in which cancer mortality was examined in relation to the arsenic content of
contaminated drinking-water in the same villages of China (Province of Taiwan) and at
the same three levels, there were significant dose-response relationships for age-
adjusted rates for cancers of the bladder, kidney, skin, and lung in both sexes and
cancers of the prostate and liver in males (Wu 1989).
A study in which the ecological correlations between the arsenic level of well-water
and mortality from various malignant neoplasms in China (Province of Taiwan) were
examined demonstrated a significant association with the arsenic level in well-water for
cancers of the liver, nasal cavity, lung, skin, bladder, and kidney in both males and
females and for prostate cancer in males (Chen 1990).
In a case-control study of 204 subjects who died of cancer (69 of bladder, 76 of lung,
and 59 of liver cancer) and 368 community controls matched for age and sex, the odds
ratios of developing these cancers for those who had used artesian well-water for 40 or
more years were 3.90, 3.39, and 2.67, respectively. Dose-response relationships were
observed for all three cancer types by duration of exposure, and the odds ratios were
not changed significantly when several other risk factors were taken into consideration
in logistic regression analysis (Chen 1986). A technical Panel on Arsenic established by
the US Environmental Protection Agency concluded that, although these studies
demonstrated a qualitative relationship between the ingestion of arsenic-contaminated
water and internal cancers, the data were not sufficient to enable the dose-response
relationship to be assessed (USEPA 1988).
WHO Guidelines for drinking-water quality, volume 2, 1996
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Clear evidence of health effects are usually available at high level of exposure.
Extrapolation from high to lower levels of exposure becomes critical for regulatory
setting. Numerous mathematical models have been developed for estimating the effects
of exposure levels well below levels for which cancer data are available. This is based
on two fundamental assumptions: (a) There is no threshold dose for the caicinogenic
effect; and (b) carcinogenic effects of chemicals are directly proportional to dose at
low-dose levels, i.e., the dose response is linear at low doses.
Multistage model is one of the mathematical models, which is most frequently used in
the regulatory process. It was also applied in the 1988 risk assessment for arsenic in
drinking water done by USEPA using the data of an epidemiological study by Tseng et
al. in 1968. This model is based on the concept that a tumour develops from a single
cell in an organ as a result of a number of biological events or stages (e.g. mutation)
that occur in a prescribed order. According to this model, the probability of developing
tumours, P(d) , is
Where the parameter m is the number of stages, a is the background tumour rate and
the q? s are the values that maximize the likelihood of observing the experimental
results. In practice the a, the q? s and the m are estimated from the data. Some of the
q? s may be zero but none can be negative. When the unknown values of the
multistage model parameters are replaced by their maximum likelihood estimates
(MLEs), the resulting model estimates what the risk is most likely to be in the
experimental situation. At low doses the dose-response relationship is thus
approximately linear. This model will fit almost any observed data set as long as the
dose-response curve is not markedly concave downward at low responses.
Although the mathematical models are useful as one tool in the regulatory process,
they are oversimplifications of complex systems. It is important to note that
quantitative risk estimates may give an impression of accuracy which in fact they do
not have. In general, the risk assessment values for carcinogens are at best, “order of
magnitude” estimates.
It should be emphasized that the guideline values for carcinogenic substances have
been computed from hypothetical mathematical models that cannot be verified
experimentally and that the values should be interpreted differently than TDI-based
values because of the lack of precision of the models. At best, these values must be
regarded as rough estimates of cancer risk. However, the models used are conservative
and probably err on the side of caution. Moderate short-term exposure to levels
exceeding the guideline value for carcinogens does not significantly affect the risk.
References:
WHO, 1993
In a number of countries, the WHO provisional guidelines of 0.01 mg/L has been adopted
as the standard. However, many countries have retained the earlier WHO guideline of 0.05
mg/L as the national standard or as an interim target.
A number of European countries have adopted the WHO provisional guideline of 0.01
mg/L as their standard. In the United States of America, the Safe Drinking Water Act
(SDWA) directs the U.S. Environmental Protection Agency (EPA) to establish national
standards for public drinking-water supplies. EPA’s interim maximum contaminant level
(MCL) for arsenic in drinking water is 0.05 mg/L. Under the 1996 SDWA amendments,
EPA has proposed a new standard (an MCL) for arsenic in drinking water in June 2000
and will finalize it by January 2001. New standard value currently proposed is 0.005 mg/L
(see BOX 5-4).
Countries where the national standard for arsenic in drinking water remains at 0.05 mg/L
include Bangladesh, China and India. The Table 5-1 shows the currently accepted national
standards for arsenic in drinking water in some selected countries.
Table 5-1 The currently accepted national standards for arsenic in drinking water
Standard Countries
Countries whose standard is lower than Australia (0.007 mg/L, 1996)
0.01 mg/L
Countries whose standard is 0.01 mg/L European Union (1998), Japan (1993),
Jordan (1991), Laos (1999), Laos,
Mongolia (1998), Namibia, Syria(1994)
Countries whose standard is lower than Canada (1999) 0.025 mg/l
0.05 mg/l but higher than 0.01 mg/l
Countries considering to lower the United States (1986*) , Mexico(1994)
standard from 0.05 mg/L
Countries whose standard is 0.05 mg/l Bahrain, Bangladesh (unknown), Bolivia
(1997), China (unknown), Egypt(1995),
India (unknown), Indonesia (1990), Oman,
Philippines (1978), Saudi Arabia,
Sri Lanka (1983), Viet Nam(1989),
Zimbabwe
( ) shows the year standard was established
* new standard value 0.005 mg/L is being proposed
In developing national drinking water standards based on the guideline values, it will be
necessary to take account of a variety of geographical, socio-economic, dietary and other
12
conditions affecting potential exposure. This may lead to national standards that differ
appreciably from the guideline values.
The current standard of 50 ppb (0.05 mg/L) was set by EPA in 1975, based on a Public
Health Service standard originally established in 1942. A March 1999, report by the
National Academy of Sciences concluded that the current standard does not achieve
EPA? s goal of protecting public health and should be lowered as soon as possible.
Under the Safe Drinking Water Act Amendments of 1996, EPA is required to
promulgate a final rule by January 1, 2001.
EPA is proposing to change the arsenic standard in drinking water to 5 ppb (0.005
mg/L) to more adequately protect public health. The proposed arsenic standard is
intended to protect consumers against the effects of long-term, chronic exposure to
arsenic in drinking water. The new standard will apply to all 54,000 community water
systems, serving approximately 254 million people.
EPA is taking comment on other proposed levels for arsenic [namely, 0.003 mg/L,
0.010 mg/L, and 0.020 mg/L]. EPA is for the first time proposing a drinking water
standard (5 ppb) that is higher than the technically feasible level (3 ppb). The Safe
Drinking Water Act (SDWA) requires EPA to determine the health goal, then to set the
standard as close to the goal as technically feasible.
EPA is also proposing a public health goal of zero for arsenic. The health goal is the
level below which no known or anticipated health effects would occur. EPA sets
public health goals at zero for all known carcinogens for which there is no dose
considered safe.
While many systems may not have detected arsenic in their drinking water above 5
ppb, there may be ? hot spots? with systems higher than the predicted occurrence for
an area. More water systems in western states that depend on underground sources of
drinking water have naturally-occurring levels of arsenic at levels greater than 10 ppb
(0.01 mg/L) than in other parts of the U.S.. Parts of the Midwest and New England
have some systems whose current arsenic levels range from 2-10 ppb.
For systems that require corrective action to meet a standard of 5 ppb, annual
household costs will average $28 for Americans served by large systems and $85 for
those served by small systems (those serving fewer than 10,000 people). Over 98
percent of the cost to water systems comes from adding treatment equipment,
chemicals, and oversight of the new treatment.
USEPA, 2000
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Hungary has made a great effort to decrease the arsenic (As) in drinking water
concentrations in 80 waterworks systems (supplying about 400,000 people) to below the
50 µg/L guideline. WHO and the EU however, decreased this guideline (1993 and 1998,
respectively) to 10 µg/L. To comply with this new guideline or standard will be a very
costly proposition.
Hungarian authorities have examined this issue very carefully and have suggested that
the data for the development of this new guideline/standard be reviewed. For example,
based on Hungarian experience which is supported by many referenced publications,
no significantly elevated frequency of skin cancer was detected below a threshold value
of 200µg/capita of daily exposure.
In Hungary, more than 1.2 million people consume drinking water with an arsenic
concentration in the range 10-30 µg/L. To decrease this concentration below 10 µg/L
within the foreseeable future appears to be very difficult without the development of
appropriate and economically viable water treatment technologies which can be utilised
at the municipal level.
5.6 Surveillance
In most countries the agency responsible for the surveillance of drinking-water supply
supplies (urban and rural) is the ministry of health. In some countries, the ministry of
14
environment or the ministry of local government may have that responsibility. The
surveillance agency should preferably be an established national institution designated by
appropriate legislation and should be able to operate at central, provincial and local levels.
The objective of water quality surveillance is not simply to collect and collate information,
but also to contribute to the protection of public health by promoting the improvement of
water supply with respect to quality, coverage, cost and continuity.
The Guidelines for drinking-water quality cover a large number of possible contaminants
in order to meet the varied needs of countries. However, it is very unlikely that all of the
contaminants mentioned will occur in a water supply. Care should therefore be taken in
selecting substances for which national standards will be developed. Scare resources
should not be wasted on developing standards for, and monitoring, substances of minor
importance.
In countries where economic and human resources are limited, short- and medium-term
targets should be set in establishing national drinking-water standards, water-quality
surveillance, and quality-control programmes so that the most significant risks to human
health are controlled first.
The most common and widespread health risk associated with drinking-water is microbial
contamination, the consequences of which are so serious that its control must always be
of paramount importance. It is therefore necessary to ensure that priority is given to water
supplies presenting the greatest public health risk.
When a guideline values is exceeded, this should be a signal: (1) to investigate the cause
with a view to taking remedial action; and (2) to consult with, and seek advice from, the
authority responsible for public health.
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References
WHO, 1998. Guidelines for drinking-water quality, second edition, Addendum to Volume 1,
WHO, 1998. Guidelines for drinking-water quality, second edition, Addendum to Volume 2
Risk Assessment Forum. Special report on ingested inorganic arsenic. Skin cancer; nutritional
essentiality. Washington, DC, US Environmental Protection Agency, 1988 (EPA-625/3-87/013).
Joint FAO/WHO Expert Committee on Food Additives. Toxicological evaluation of certain food
additives and contaminants. Cambridge, Cambridge University Press, 1989:155-162 (WHO Food
Additives series, No.24)
Tseng WP. Effects of dose-response relationship of skin cancer and blackfoot disease with arsenic.
Environmental health perspectives, 1977, 19:109-119.
USEPA, Proposed Revision to Arsenic Drinking Water Standard, Technical Fact Sheet: Proposed
Rule for Arsenic in Drinking Water and Clarifications to Compliance and New Source
Contaminants Monitoring, http://www.epa.gov/safewater/ars/prop_techfs.html, May 2000
Wu MM et al. Dose-response relation between arsenic concentration in well water and mortality from
cancers and cardiovascular diseases. American journal of epidemiology, 1989, 130:1123-1132.
Chen CJ, Wang CJ. Ecological correlation between arsenic level in well water and age adjusted
mortality from malignant neoplasms. Cancer research, 1990, 50:5470-5474.
Chen CJ et al. Malignant neoplasms among residents of a blackfoot disease-endemic area in Taiwan:
high-arsenic artesian well water and cancers. Cancer research, 1985, 45:5895-5899.
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Chen CJ et al. A retrospective study on malignant neoplasms of bladder, lung and liver in blackfoot
disease endemic area of Taiwan, British journal of cancer, 1986, 53:399-405
WHO Guidelines for Drinking Water Quality Training Pack, March 2000
http://www.who.int/water_sanitation_health/Training_mat/GDWQtraining.htm
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Acronyms used in this chapter
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