Setting Environmental Standards, Guidelines For Decision Making

Setting
environmental
standards
Guidelines for
decision-making
Edited by
H. W. de Koning
Published by the World Health Organization,

in collaboration with the United Nations
Environment Programme and the lnternational
Union for Conservation of Nature and Natural
Resources .
. . ~J
•
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~~ WORLD HEALTH ORGANIZATION - GENEVA
The World Health Organization is a specialized agency of the
United Nations with primary responsibility for international health
matters and public health. Through this organization, which was
created in 1948, the health professions of sorne 165 countries exchange
their knowledge and experience with the aim of making possible the
attainment by all citizens of the world by the year 2000 of a level of
health that will permit them to lead a socially and economically
productive life.
By means of direct technical cooperation with its Member States,
and by stimulating such cooperation among them, WHO promotes the
development of comprehensive health services, the prevention and
control of diseases, the improvement of environmental conditions, the
development of health manpower, the coordination and development of
biomedical and health services research, and the planning and
implementation of health programmes.
These broad fields of endeavour encompass a wide variety of
activities, such as developing systems of primary health care that reach
the whole population of Member countries; promoting the health of
mothers and children; combating malnutrition; controlling malaria and
other communicable diseases, including tuberculosis and leprosy;
having achieved the eradication of smallpox, promoting mass immuniz-
ation against a number of other preventable diseases; improving mental
health; providing safe water supplies; and training health personnel of
all categories.
Progress towards better health throughout the world also demands
international cooperation in such matters as establishing international
standards for biological substances, pesticides, and pharmaceuticals;
formulating environmental health criteria; recommending international
nonproprietary names for drugs; administering the International
Health Regulations; revising the International Classification of
Diseases, Injuries, and Causes of Death; and collecting and disseminat-
ing health statistical information.
Further information on many aspects of WHO's work is presented in
the Organization's publications.
SETTING ENVIRONMENTAL
STANDARDS
SETTING ENVIRONMENTAL
STANDARDS
GUIDELINES FOR
DECISION-MAKING
Edited by
H. W. de Koning
Division of Environmental Health
World Health Organizat10n
Geneva, Switzerland
WORLD HEALTH ORGANIZATION

GEN EVA
1987
ISBN 92 4 154214 4
© World Health Organization 1987

Publications of the World Health Organization enjoy copyright protection in
accordance with the provisions of Protocol 2 of the Universal Copyright
Convention. For rights of reproduction or translation of WHO publications, in
part or in toto, application should be made to the Office of Publications, World
Health Organization, Geneva, Switzerland. The World Health Organization
welcomes such applications.
The designations employed and the presentation of the material in this
publication do not imply the expression of any opinion whatsoever on the part
of the Secretariat of the World Health Organization concerning the legal status
of any country, territory, city or area or of its authorities, or concerning the
delimitation of its frontiers or boundaries.
The mention of specific companies or of certain manufacturers' products
does not imply that they are endorsed or recommended by the World Health
Organization in preference to others of a similar nature that are not mentioned.
Errors and omissions excepted, the names of proprietary products are
distinguished by initial capital letters.
The editor alone is responsible for the views expressed in this publication.
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Contents
Preface . . . . . . V
Contributors and reviewers vi
l. Introduction . 1
2. Identification of priority pollution issues . 5
Selection of pollutants for control . . . 6
Advantages of international cooperation 8
3. Information on health effects 13
Studies of health effects . 13
Dose-effect relationships . 17
4. Assessment of exposure. . . 28
High-risk groups . . . . . 28
Definition of adverse health effects . 30
5. Strategies for prevention and control . 33
Source-oriented measures. 33
Medium-related measures 41
6. Legal framework. . . . . . . 43
Nature of the decision .. 43
Scope and development of environmental legislation . 44
Content and structure of regulations . . . . . . . . . 46
Institutional considerations. . . . . . . . . . . . . . . 48
Geographical dimension of environmental problems 50
Supporting measures for regulatory strategies . . . . 51
7. Consequences of different approaches to environmental
health protection . . . 57
Risks and benefits. . . 57
Cross-media concerns . 58
Acceptable risks . . . . 59
Cost and effectiveness of control measures 59
Other types of analysis . 60
8. Decision-making process . . . . . . 65
Interactions between science and policy 67
Constraints affecting developing countries . 68
Characteristics of an effective standard-setting process. 70
References . . . . . . . . . . . . . . 71
¡¡¡
Contents
Annex l. WHO Environmental Health Criteria documents (as of

September 1986). . . . . . . . . . . . . . . . . . . . . . 77
Annex 2. Example from the legal file of the International Register
of Potentially Toxic Chemicals. . . . . . . . . . . . . . 79
Annex 3. IARC Monographs on the evaluation of the carcino-
genic risk of chemicals to man (as of September 1986) 81
Annex 4. Pesticides for which evaluations of residues in food
have been carried out (as of September 1986). . . . . 83
Annex 5. Compounds for which evaluations have been carried
out by the Joint FAO/WHO Expert Committee on
Food Additives (as of September 1986). . . . . . . 85
Annex 6. Summary of WHO water quality guideline values. . . 93
Annex 7. Summary of air quality guidelines , developed by the
WHO Regional Office for Europe . . . . . . . . . . . . 96
iv
Preface
Awareness about environmental pollution has increased during

recent years so that there is now widespread appreciation of the serious
health risks and the need for preventive measures. Such measures,
implemented voluntarily or through legislation, have many technical
and economic ramifications, as well as social and public health
implications.
The various aspects of the decision-making process for the
development of environmental standards are discussed in this
publication from the standpoint of health. Several sections deal with
the definition of appropriate health objectives or norms while other
sections discuss the strategies and legislative instruments available to
achieve these norms. In practice, of course, the decision-making
process must be adapted to the overall economic, social, public health,
and planning policies of each country. An attempt has been made
throughout the text to provide examples and illustrations of how
individual countries have done this.
Various procedures related to the decision-making process are
described to provide the reader with an insight into and an
understanding of what is involved and what uncertainties may
surround the information that is being used. More detailed information
on these procedures can be obtained from the references cited.
Many experts in different fields have contributed to the preparation
of this publication. Sorne have prepared whole sections, while others
have provided comments and suggestions for improvement, par-
ticipated in meetings or acted as consultants. A list of contributors is
given on pp. vi-vii and the contribution of all those involved is
gratefully acknowledged. Special mention should be made of the work of
Dr W. Muir, Hampshire Research Associates Inc., Alexandria, VA,
USA, who, particularly in the early stages of the project, played a
significant role in its coordination.
This book is the result of cooperation between the World Health
Organization (WHO) and the Environmental Law Centre, which is
located in Bonn, Federal Republic of Germany, and forms part of the
Secretariat of the International Union for Conservation of Nature and
Natural Resources (IUCN) . .The Centre provided support in the
preparation of this publication and technical advice throughout the
project. The United Nations Environment Programme provided
financial support for the publication of this book.
Comments and queries regarding this publication should be
addressed to the Division of Environmental Health, W orld Health
Organization, 1211 Geneva 27, Switzerland.
The views expressed in this book should not be construed as
representing either decisions or policies of the lnternational Union for
Conservation of Nature and Natural Resources, the United Nations
Environment Programme, or the World Health Organization.
V
Contributors and reviewers
V. Aalto, World Health Organization, Brazzaville, Congo

M. Baram, Franklin Pierce Law Center, Concord, MA, USA
C. Bartone, Pan American Center for Sanitary Engineering, Lima,
Peru
M. Bothe, University of Hanover, Hanover, Federal Republic of
Germany
W. Burhenne, IUCN Commission on Environmental Policy, Law and
Administration, Bonn, Federal Republic of Germany
F. Burhenne-Guilmin, Environmental Law Centre, Bonn, Federal
Republic of Germany
K. Bustueva, Central Institute for Advanced Medica! Training,
Moscow, USSR
J. Butler, Environmental Protection Agency, Washington, DC, USA
J. Carmichael, United Nations Industrial Development Organization,
Vienna, Austria
E. Clark II, The Conservation Foundation, Washington, DC, USA
C. Cochrane, International Centre for Industry and Environment,
Villeneuve de Berg, France
G. Davila, World Health Organization, Washington, DC, USA
B. Dieterich, World Health Organization, Geneva, Switzerland
E. Engstrom, National Food Administration, Uppsala, Sweden
S. Epstein, University of Illinois, Chicago, IL, USA
S. Fluss, World Health Organization, Geneva, Switzerland
M. Forster, Environmental Law Centre, Bonn, Federal Republic of
Germany
M. Gilbert, United Nations Environment Programme, Geneva,
Switzerland
B. Gillespie, Organization for Economic Cooperation and
Development, París, France
D. Gushee, Congressional Research Service, The Library of Congress,
Washington, DC, USA
R. Harcourt, Department of Health, Wellington, New Zealand
J. Huismans, United Nations Environment Programme, Geneva,
Switzerland
O. Ikeda, Environment Agency, Tokyo, Japan
F. Irwin, The Conservation Foundation, Washington, DC, USA
D. Jayasuriya, World Health Organization, Geneva, Switzerland
F. Kaloyanova, Institute of Hygiene and Occupational Health, Sofía,
Bulgaria
S. Kato, Ministry of Health and Welfare, Tokyo, Japan
M. Key, University of Texas, Houston, TX, USA
V. Kodat, Ministry of Health, Prague, Czechoslovakia
O. Kolbasov, Institute of State and Law, Moscow, USSR
W. Kreisel, World Health Organization, Manila, Philippines
vi
Contributors and rev1ewers
R. Luken, Environmental Protection Agency, Washington, DC, USA

Z. Madar, Institute of State and Law, Prague, Czechoslovakia
U. Marinov, Environmental Protection Service, Jerusalem, Israel
H. Mattos de Lemos, United Nations Environment Programme,
Nairobi, Kenya
C. Millar, International Atomic Energy Agency, Vienna, Austria
W. Muir, Hampshire Research Associates Inc., Alexandria, VA, USA
M. Nakamura, WHO Western Pacific Regional Centre for Promotion
of Environmental Planning and Applied Studies, Kuala Lumpur,
Malaysia
S. Niu, Institute of Health, Beijing, China
G. Ozolins, World Health Organization, Geneva, Switzerland
D. Popescu, University of Bucharest, Bucharest, Romanía
P. Recht, Brussels, Belgium
E. Rehbinder, J. W. Goethe University, Frankfurt am Main, Federal
Republic of Germany
W. Rowe, American University, Washington, DC, USA
P. Royabhorn, National Environment Board, Bangkok, Thailand
H. Salas, Pan American Center for Sanitary Engineering, Lima, Peru
M. Saric, Institute for Medica! Research and Occupational Health,
Zagreb, Yugoslavia
M. Sheikh, World Health Organization, Alexandria, Egypt
E. Smith, World Health Organization, Geneva, Switzerland
R. Smith, Department of Health, Canberra, Australia
K. Snidvongs, National Environment Board, Bangkok, Thailand
M. Sommers, Department of National Health and Welfare, Ottawa,
Canada
M. Stephenson, Economic Commission for Europe, Geneva,
Switzerland
P. Stief-Tauch, European Economic Commission, Brussels, Belgium
K. Symon, Charles University, Prague, Czechoslovakia
S. Tabacova, Institute of Hygiene and Occupational Health, Sofia,
Bulgaria
R. Tardiff, Environ Corporation, Washington, DC, USA
G. Vettorazzi, World Health Organization, Geneva, Switzerland
P. Waight, World Health Organization, Geneva, Switzerland
R. Waller, Department of Health and Social Security, London,
England
R. Zielhuis, University of Amsterdam, Amsterdam, The Netherlands
vii
Chapter 1
lntroduction
For this publication, environmental pollution is defined as energy or

waste materials that are discharged into the environment where they
can cause damage to human health (Holdgate, 1979). This definition
excludes potentially hazardous materials used by individuals on
themselves, for example, cosmetics, food additives, pharmaceuticals, or
tobacco. The toxicity of environmental pollutants depends on their
formulation and concentration. For example, the organic combinations
of mercury, especially methylmercury, pose a greater hazard than the
inorganic mercury salts. Similarly, high concentrations of sulfur
dioxide (S0 2 ) in urban areas can undoubtedly harm both plants and
people, even though sulfur is an essential component of all living
organisms.
Pollutants may reach man through different pathways, e.g., via
water, air, food, or consumer products, but one source usually
contributes the major proportion of the pollutant. This pathway is
called the "critica! pathway". If the environmental health effects of a
substance are to be monitored and controlled in the most efficient and
economic way, this critica! pathway must be identified. If this is not
possible, the quality and quantity of total exposure via multiple
pathways must be carefully assessed. The absence of such knowledge
is one of the principal obstacles to the control or prevention of the
adverse health effects associated with environmental pollutants. For
example, a child suffering from lead poisoning may have been ingesting
lead in drinking-water that flows through lead pipes, in paint or soil
containing lead, or in food contaminated by lead through the air,
water, soil, or via the food chain. When setting ambient air standards
or permissible industrial effluent standards for lead, therefore, it is
necessary to consider whether the amounts of lead reaching the child
from all other sources should be taken into account.
An additional problem is that sorne pollutants are chemically very
stable and degrade only very slowly. This stability means that the
pollutant persists in the environment resulting in its gradual
accumulation, for example, in the soil. A well known example of this
type of pollutant is the insecticide DDT, but there are many other
examples.
For sorne years there has been a considerable development of
environmental policies at the national, regional, and internationallevels
( Schaefer, 1981). The scope of these policies in eludes both the
reduction of pollution and the preservation of natural resources, as well
Setting environmental standards
as the promotion of an improved quality of life. The control of

environmental pollution, and in particular the setting of standards,
raises difficult problems for governments, because different people,
or groups of people, have different views of the extent to which
a government should protect its citizens from risk and at what cost.
Often it is a question of distribution: who is bearing the risk 1 and who
the cost? (Technical Information Project, 1979).
For example, the people living near a waste dump are more likely to
suffer the consequences of an accident at the site than people from
another area who use its services as a treatment or disposal facility. On
the other hand, the immediate neighbours of a chemical manufacturing
plant may not oppose its installation, even if the risk involved in the
factory siting is similar to that of the waste dump, because they will
benefit economically from its presence through the creation of jobs.
It is particularly important to encourage broad participation in the
decision-making process since the risk involved is often not evenly
distributed; different groups may be particularly affected by environ-
mental pollution for various reasons such as age or nutritional status,
as well as for geographical reasons. In addition, the way in which
people balance costs and benefits will differ. A major challenge of
environmental standard-setting for governments and Cltlzens is
learning to communicate with each other about risks and to make
decisions on the basis of information that is often incomplete.
Toxicity is the capacity of a substance to cause injury to a living
organism. Hazard refers to the potential of a pollutant to induce harm
(World Health Organization, 1977). The purpose of environmental
health standards is to reduce or eliminate health or environmental
hazards.
The assessment of the pollution hazard should be a strictly scientific
process-a matter of evaluating probabilities using the best available
information about the dispersion of a pollutant and the associated
effect on the health of man or other targets. Once the likelihood of a
particular level of effect under particular circumstances of emission and
dispersa! has been determined, value judgements become important;
the effects on the socioeconomic system must be considered. The
socioeconomic system in turn determines the types of effect that are
acceptable, and the measures that may be taken to control the
pollution. In practica! terms, this control will involve limitation of
effiuents or emissions of pollutants, of radiation to the environment, or
of the exposure of individuals. Another important consideration is
prevention of hazard; this is a fundamental factor in the organization of
a system of protection for man.
lt is becoming increasingly evident that both prevention and control
of environmental pollution involve a number of complex societal
1
RHk 1s the probability of unfavourable or undesuable effects appeanng as a result of a given
exposure.
2
lntroduction
systems and must be analysed within a framework that is sufficiently

broad to include all intrinsic and extrinsic factors that might affect
human health and other targets (Davos & Nienberg, 1980). Each
society will have a particular legal and procedural framework for
making decisions about control measures and for determining whether
these should be advisory or mandatory.
The main steps in the formulation of public policy decisions to
protect health and welfare from environmental hazards usually occur in
two stages, as follows.
1. Scientific stage
(a) Knowledge of the hazard-involves identification and character-

ization.
(b) Eva/uation of the risk-establishes the probability and severity of
potential adverse effects on health and safety.
(e) Assessment of hazard --determines routes of exposure and es-
timates the number of people exposed.
At the conclusion of this stage it should be possible to determine the
levels of pollutants that do not produce adverse effects and to establish
necessary safety margins, thus establishing goals or norms for national
environmental pollution prevention and control programmes.
2. Political and administrativa stage
(a) Determination of acceptable risk-views problem not as a scientific

matter, but rather one of opinion.
(b) Determínation of public to be protected--considers not only healthy
individuals but also population groups whose particular physio-
logical make-up or state of health need to be taken into account.
(e) Consideration of human ecology-sees man in balance with his
environment.
(d) Choice of control technology-requires both formulation of strategy
and selection of appropriate control techniques.
(e) Legislationjstandards --considers existing national legal framework
and identifies necessary legal strategies.
(f) Economics -strikes a balance between costs and benefits.
This stage requires knowledge of the technical, social, financial,
legal, and institutional implications of the solutions to be adopted. This
knowledge promotes the examination of links between environmental
problems, the solutions, and society (Rodricks & Tardiff, 1984; Males,
1985). At this stage, consideration is given to the means of achieving
the environmental health goals.
3
The framework outlined above is somewhat schematic and in most

cases it will only be followed in a generalized way. lt puts forward a
logical progression in decision-making that, in "real life" situations,
might not always be followed. Also, it proposes a decision-making
process that is "science-driven". In practice, the decision-maker might
have to find solutions for existing environmental problems, in which
case the process might work in reverse: from the political to the
scientific stage (see also Chapter 2). Lastly, although the process
outlined above is linear, in practice it is cyclical, as constant
improvements in information are likely to result in adjustments and
changes being made to strategies, standards, and methods. However, no
matter how the process operates, the elements described remain valid;
they are discussed further in the other chapters of this book.
This approach to decision-making is not without its critics.
Criticisms stem in part from the inadequacy of the data on which the
assessment is based. For example, uncertainties concerning the effects
of chronic exposure to environmental pollution make it almost
impossible to quantify the associated risks. Further criticism stems
from the concept of risk acceptability-acceptable to whom?
Faced with such uncertainties sorne would suggest that it might be
better to take all practicable steps to eliminate avoidable risk,
irrespective of precise quantification. However, the prevailing approach
to pollution control is based on the principie that with scarce
resources, attempts should be made to relate the control imposed to the
hazards of exposure, and this approach is followed in this publication.
4
Chapter 2
ldentification of priority pollution issues
There are generally insufficient resources available to deal with all the
pollution problems in a country, and it will be necessary to establish
priorities. Two general criteria should be considered in doing so (Whyte
& Burton, 1980):
l. The boundaries of the problem must be defined. For example, a
decision has to be made as to whether the risk to human health is the
sole or major criterion for control. In the past, priority ratings have
tended to focus on human health a ion e but increasingly, hazards to
animals, plants, and natural areas have prompted environmental action
in their own right.
Within human health and well-being, a hierarchy of effects can be
identified from minor temporary ailments through acute illness to
chronic diseases. Particular problems arise with chronic diseases, which
are often difficult to relate to specific hazards or sources of risk. For
others the significance of effects is uncertain. For example, it is known
that at levels of less than 100 ~g of lead per 100 mi of whole blood,
anaemia does not usually occur. However, these low concentrations of
lead in the blood affect the activity of an enzyme, porphobilinogen
synthase (EC 4.2.1.24) (see Fig. 1 and 2, pages 18 and 19). Can this be
considered to be a significant effect on human health? The question of
what constitutes a health effect is discussed further in Chapter 4.
2. The problem in question must be put into a wider context by
consideration of other risks and/or benefíts. Risks can be evaluated in
terms of the additional hazard they present over:
-what occurs naturally in the environment;
-what has been tolerated for long periods of time with no apparent ill
effects;
-the leve! that is accepted as beneficia! (e.g., in the case of pesticides).
For example, natural background levels have been used as a
yardstick in measuring the risk associated with nuclear power
production, the potential risk of adding fluoride to the domestic water
supply as a public health measure, and the assessment of elevated noise
levels near airports and traffic routes.
The question arises as to how national agencies should choose which
pollutants must be controlled from among the thousands introduced
into the environment. Traditionally, this decision has been based on a
5
subjective consideration of a number of factors such as immediate

hazard, public concern, feasibility of control, etc.; formal procedures
have not generally been used. However, most developed countries and
international organizations have now adopted systems for setting
priorities in order to provide more rigorous guidance. Five criteria
(World Health Organization, 1976) are usually applied in determining
the extent to which a pollutant may pose an environmental hazard.
These are:
-Severity and frequency of observed or suspected adverse effects on

human health. Of importance are irreversible or chronic effects, such
as genetic, neurotoxic, carcinogenic, and embryotoxic effects includ-
ing teratogenicity. Continuous or repeated exposure generally merits
a higher priority than isolated or accidental exposure.
-Ubiquity and abundance of the pollutant in the environment. Of
special concern are inadvertently produced chemicals and substances
that add to a natural hazard.
-Persistence in the environment. Pollutants that resist environmental
degradation and accumulate in man, in the environment, or in food
chains, deserve attention.
-Environmental transformation or metabolic alterations. Since alter-
ations may produce chemical substances that have greater toxic
potential, it may be more important to ascertain the distribution of
the derivatives than that of the original pollutant.
-Population exposed. Attention should be paid to exposure involving
a large proportion of the general population, or occupational groups,
and to selective exposures of highly vulnerable groups such as
pregnant women, newborn children, the infirm or the elderly.
Selection of pollutants for control
In practice, hazard identification begins with one component of the

problem, usually the source of the effect, and does not consider the
system as a whole at the outset. Sorne methods of identification are
systematic while others appear to be more or less ad hoc. This is a
pragmatic response to the different ways in which hazards are
discovered. In the following paragraphs the different reasons for which
pollutants may be selected for attention by environmental decision-
makers are discussed.
Systematic evaluations
In the United States of America, efforts have been made to identify
priority chemical pollutants systematically by using a scoring system to
rank each substance (Environmental Protection Agency, 1977). Severa!
other efforts in different parts of the world rely upon the knowledge and
opinions of groups of experts.
6
ldentification of priority pollution issues
At the international level, the Council for Mutual Economic

Assistance (CMEA) and the Organization for Economic Cooperation
and Development (OECD) both have programmes on methods of
setting priorities for testing of new and existing chemicals. As a result
of cooperation among CMEA countries during recent years, a number
of documents have been published including a reference book on
problems of industrial toxicology (GKNT, 1986). This publication
contains guidelines and recommendations for studying various aspects
of the biological effects of chemical compounds as well as procedures
for establishing sanitary standards in CMEA countries. OECD recently
published a guidance document, in two volumes, for the selection for
further testing of chemicals on which data are inadequate. The second
volume of the report includes nearly 700 citations that are useful in
setting prionues (Organization for Economic Cooperation and
Development, 1984).
Local or foreign public health crises

Often, national authorities are forced into the decision-making
process by the discovery of a major local problem. For example, the
Japanese government in the 1960s had to react quickly to deal with the
mercury poisonings at Minamata (Katsuma, 1968). After the ex-
perience at Minamata, other countries around the world attempted to
assess their own local situation with regard to mercury, and to take
appropriate action.
Environmental problems are rarely confined to one country and in
most instances sooner or later a particular problem will occur in severa!
locations. As a result, the setting of standards and priorities for
environmental control in one country may be influenced by the action
of others. For example, when scientists in the Netherlands in the early
1970s discovered that certain harmful organic substances were present
in drinking-water as a result of chlorination, many countries took
appropriate control action.
Research
In sorne cases, environmental health issues appear on the decision-
making agenda as suspected problems. For example, severa! countries
have taken action since 1975 either to limit their production capacity of
chloroftuorocarbons (CFC) or to ban (or severely restrict) their use as
aerosol propellants. These actions were taken on the basis of a theory
that the release of chlorofluorocarbons into the atmosphere will
eventually significantly reduce the amount of ozone in the stratosphere
that shields the earth's surface from harmful solar ultraviolet radiation
(Council on Environmental Quality, 1975). While supporting
evidence for this theory has been presented, the restrictions have been
implemented before there has been any direct observation of a decrease
in the ozone layer.
7
Outsíde opíníon
Often, the press or local political figures will focus attention upon an
issue to such an extent that priorities for action must be changed. In
Canada, for example, press and politicians have drawn attention to the
existence of several hundred miles of railroad bed made from asbestos
tailings. As a result, environmental health officials have been obliged to
consider the associated risks and possible remedial action.
Chemícal símí/aríty
Problems may often be suspected on the basis of the chemical
similarity between one substance and another that is known to be
hazardous. For example, polybrominated biphenyls quickly received
regulatory scrutiny around the world after the chemically similar
polychlorinated biphenyls were shown to constitute a major enviran-
mental hazard.
The factors discussed above may influence local and national author-
ities in their efforts to set priorities for action. Alternatively, such
authorities may wish to devote their full effort to controlling hazards
and may therefore rely upon various international programmes to
establish priority lists. These lists may be supplemented by local and
national surveys to pinpoint specific local problems.
Advantages of international cooperation
The advantages of international cooperation include the availability

to decision-makers of expert reviews of information from many
countries at low cost. Generally, su eh reviews provide not only
internationally relevant suggestions for priority action but also
associated information on evaluation of health effects, suggested safe
levels for human, plant, and animal exposure, production or emission
data, and concentrations in different environmental media, etc. Further
information on relevant documentation produced by different inter-
national programmes is given in the following paragraphs.
WHO Envíronmental Health Crítería programme

Established in 1973, the main objective of this programme is to
assess existing information on the relationship between exposure to
environmental pollutants, or other physical factors, and human health,
as well as to provide guidelines for setting exposure limits that are
consistent with health protection. This programme was later in-
8
ldent1fication of priority pollution issues
corporated into the newly established International Programme on

Chemical Safety (IPCS). 1
In view of the large number of environmental agents and factors that
may adversely influence human health, the preparation of criteria
documents must be based on clearly defined priorities. Each criteria
document comprises an extensive scientific review of a specific
environmental pollutant, group of pollutants, or physical factor(s); the
information provided ranges from sources and exposure levels to a
detailed account of the available evidence concerning effects on human
health. Over fifty documents have been published to date. A list of
Environmental Health Criteria publications is given in Annex l.
lnternational Register of Potentially Toxic Chemicals

The International Register of Potentially Toxic Chemicals (IRPTC)
is part of the United Nations Environment Programme. The Register
serves as an international data bank and information service on possible
chemical hazards. 2 lts activities involve the development of data profiles
on chemicals, the operation of a query-response service, and the regular
publication of the IRPTC bulletin which contains up-to-date informa-
tion on chemicals. The main objective of this programme is to facilitate
access by countries to existing data on the effects of chemicals on man
and the environment, and thus to contribute to a more efficient use of
national and international resources. The programme also helps to
identify the potential hazards of chemicals and pollutants, and to
improve awareness of such hazards.
At the present time, the IRPTC has data profiles on more than 500
chemical substances; a list of these is available from IRPTC. Two
specific files from the Register have been published separately: the
IRPTC legal file (also accessible on-line) and Treatment and disposal
methods for waste chemicals. Examples of pertinent records are given in
Annex 2.
/nternationa/ Agency for Research on Cancer

In 1965, the World Health Assembly established the International
Agency for Research on Cancer (IARC) in Lyon, France. One major
activity of IARC over the last decade has been the publication of
monographs evaluating the possible carcinogenic hazards from chemi-
cal substances and complex mixtures. U p to September 1986, 38
volumes had been issued, concerning approximately 700 chemicals,
groups of chemicals, and industrial processes. Of these, 30 chemical
substances, mixtures, or groups of products, and 9 industrial processes
' MERCIER, M. The International Programme on Chemical Safety. Unpublished WHO document,
EHE/80.14, Rev. l.
' Summary of the Second Meeung of E:x:perts on Listing of Erwironmentally Dangerous Chem1cal
Substances and Processes of Global S~gnificance, 21-25 NO!Jember 1983. Geneva United Nations
Environment Programme, 1983.
9
have been found to be causally associated with cancer in man. In

addition, 63 chemical substances or mixtures of chemicals and 5
industrial processes are considered to be probably carcinogenic to man.
There are another 115 chemicals for which evidence of carcinogenicity
has been found in animals, but for which no studies or data are available
on their effects in man (Vainio et al., 1985). A listing of the IARC
monographs is given in Annex 3.
FAO¡WHO pesticide reviews

J oint meetings of the F AO W orking Party of Experts on Pesticide
Residues and the WHO Expert Committee on Pesticide Residues have
been held regularly since 1965. Proceedings of the meetings are
published in reports that summarize the conclusions reached, including
values of recommended acceptable daily intake (ADI) and maximum
residue limit (MRL), as well as the recommendations for further work
on the evaluation of pesticide chemicals. The reports are supplemented
by accompanying volumes containing summaries of toxicological and
residue studies for each of the individual pesticides considered at the
meeting (Vettorazzi & Radaelli-Benvenuti, 1982). A listing of com-
pounds discussed, many of which have been reviewed severa! times
during past years, is given in Annex 4.
FAOfWHO food additive reviews

Since 1957, toxicological evaluations of food additives and contamin-
ants have been carried out by the Joint FAO/WHO Expert Committee
on Food Additives (JECFA); the 29th repon of this Committee was
issued in 1986 (WHO, 1986b). These reviews provide guidance to the
authorities that are responsible for setting standards and for organizing
the control of foods. For each chemical substance evaluated, the
relevant report recommends an acceptable daily intake (ADI). A list of
additives and contaminants reviewed to date is given in Annex 5.
Guidelines for drinking-water quality

Since 1971, WHO has coordinated international reviews of scientific
and epidemiological information on different pollutants to provide
guidelines for drinking-water quality. The la test revision of these
guidelines was published in two volumes in 1984 and 1985 (World
Health Organization, 1984, 1985). These two publications provide
detailed and comprehensive data for each pollutant, upon which the
guideline values are based. A table summarizing the WHO water quality
guidelines is given in Annex 6.
Air qua/ity guidelines

The WHO Regional Office for Europe has developed guidelines for
air quality (Annex 7). The primary aim of these guidelines is to provide
10
ldentificat1on of priority pollut1on issues
a basis for protection of public health from adverse effects of air

pollution and for elimination or reduction of pollutants that are known
or likely to be hazardous.
The guidelines are intended to provide background information and
guidance to governments for making risk-management decisions-in
particular, for planning control strategies and setting national or local
standards. The guidelines should, however, be considered in the context
of prevailing exposure and environmental, social, economic, and cultural
conditions. Under certain circumstances, there may be valid reasons to
pursue strategies that will result in pollutant concentrations above or
below the guideline value. In this regard, a recent publication of the
WHO Regional Office (World Health Organization, 1987) provides
further information that would be of assistance in making the
appropriate decision.
Workp/ace standards
Literally thousands of chemical substances are used in the
workplace. Many countries have adopted occupational exposure limits
for numerous airborne contaminants found in the workplace. The
lnternational Labour Office has prepared a compilation of these
regulations (lnternational Labour Office, 1980). Within the WHO
programme on recommended health-based limits for occupational
exposure to airborne contaminants (El Batawi & Goelzer, 1985), reports
have been published on heavy metals (World Health Organization,
1980), selected organic solvents (World Health Organization, 1981 ),
pesticides (World Health Organization, 1982), vegetable dusts (World
Health Organization, 1983a), respiratory irritants (World Health
Organization, 1984a), and mineral dusts (World Health Organization,
1986a). The limits set out in these reports are health-based, which
means that only scientific and not economic evidence is considered
concerning exposure levels and associated health effects. An overview of
the methods used to calculate tentative safe exposure levels in the
workplace in countries bdonging to the Council for Mutual Economic
Assistance (CMEA) was published recently (GKNT, 1986).
United Nations Environment Programme

The United Nations Environment Programme (UNEP) has prepared
a list of environmentally dangerous pollutants and processes that are
harmful at the global leve!, in an attempt to stimulate awareness among
governments and the public of the hazardous effects of environmental
pollutants on man and the environment (United Nations Environment
Programme, 1982). This list will be revised periodically. Pollutants of
global significance are defined as those that occur widely in the
environment in significant quantities as a result of their transport
through air, water, and food chains, or because they are present in
commodities traded internationally on a large scale. The selection of
11
dangerous pollutants for the UNEP list is also based on the persistence
and transformation of a substance in the environment, rates of
bioaccumulation and biomagnification, the exposed populations, toxicity,
exposure level, and effects on the physical and chemical environment.
The wide variety of external influences on the process of priority
setting, and the pressure to deal with recently discovered problems as
they arise, before others have been resolved, pose a dilemma for
environmental decision-makers. On the one hand, they must be
responsive to current needs, and, on the other hand, they must
maintain sufficient consistency to allow the typically lengthy analytical
and decision-making processes to be completed for as many pollutants
as possible.
12
Chapter 3
lnformation on health effects
The toxic effects of pollutants found in the environment are

commonly divided into broad classes, such as acute toxicity, chronic
toxicity, carcinogenicity, teratogenicity, and mutagenicity. A substance
may be capable of causing a range of toxic effects, including cancer.
The main distinguishing characteristic between these categories of
effects is the assumption that dose-thresholds exist for the acute and
chronic toxic effects, but that such thresholds do not exist (or have not
been demonstrated) for carcinogenic effects. In the former case,
standard-setting aims to achieve a total dose of the substance that is
below the level at which any injury would result to any individual in
the population. For pollutants assumed not to have a threshold level, it
follows that sorne finite risk may exist at any dose level above zero;
thus, standard-setting may aim to reduce exposure to zero (a level that
is often neither measurable nor achievable in practice) or to specify a
dose level that will contribute only a negligible increase in the lifetime
risk to the individuals and/or the population exposed.
Studies of health effects
The first step in establishing environmental standards for a pollutant

is to determine the nature of any hazards associated with it. Whether
the national or local authority chooses to conduct appropriate studies
itself, or decides to rely upon the expert opinion of others, it is
important that the strengths and limitations of the data and
information available are known.
Epidemiologyl
Epidemiological studies on human populations can in principie
provide definitive evidence of the health risks associated with
a particular pollutant. However, for the study of environmental
pollutants, their main weakness is that they are relatively
ineffective in proving that observed health effects are the direct
result of exposure to a particular substance. In practice, the
1
Epidemiology is the study of the various factors that determine the occurrence and d1stribution
of diseases and other physiological and pathologlcal effects in human populauons.
13
requirement for a pollutant to be present for a long time before

discernible differences appear in a population militates against the use
of epidemiology as a basis for regulatory decisions on environmental
health issues. Unless the effect of the pollutant is unusual, highly
specific, and recognizable by a physician-as in the case of
angiosarcoma of the liver caused by exposure to vinyl chloride-it will
pass unnoticed during a normal survey. For example, in order to detect
a twofold increase in congenital malformations over a background rate
of 2%, a total of 3000 births would have to be studied (Kline et al.,
1977).
Different types of epidemiological study may differ considerably in
their time-frames. In simple terms, cross-sectional or prevalence
epidemiological studies refer to the present, retrospective or case-
control studies to the past, while cohort and prospective intervention
studies follow groups into the future. The limitations of such studies
have recently been considered (World Health Organization, 1983). Sorne
of the salient features of each type of epidemiological study are
presented in Table l.
Sorne examples where the setting of environmental health standards
has been largely based on epidemiological studies are the fluoridation
of drinking-water, air quality objectives for oxides of nitrogen, and the
control of emissions of arsenic, asbestos, and vinyl chloride. In sorne
instances, epidemiological studies can be used to confirm the upper
limit of a risk estímate, e.g., in occupational exposure to ionizing
radiation.
Clinical studies
Certain types of information about the effects of environmental
pollutants can only be obtained by direct observations in man. For
example, carefully controlled experiments on sorne types of effect, such
as subtle changes in reaction time, behavioural functions, and sensory
responses, can be carried out using low doses otherwise considered to
be safe.
Animal studies
Acute animal studies are most commonly used to predict human
response to short-term, high-level exposures, such as may occur
following an accident; they can also provide a measure of the toxic
potential of different compounds. Metabolic and pharmacokinetic
studies are used to determine the absorption, distribution, and
elimination of the test compound, its biotransformation and the rates at
which these processes occur. The toxic effects of longer-term, low-level
exposure are obtained from chronic or lifetime studies, as well as from
subchronic studies of 28 days or longer. The rationale of such tests has
been described in detail elsewhere (World Health Organization, 1982a).
14
Table 1. Majar features of various study designs in environmental epidemiology
Study Population Exposure Health Confounders Problems Advantages

design effect are:
Descríptíve study Vanous sub- Records of past Mortallty and Doffocult to sort out Hard to establlsh Cheap, useful on
populatoons measurements morbodoty statostocs, cause-result and formulatong hypothesos
case regostnes, etc. exposure-effect
relatoonshíps
Cross-sectoonal study Communoty or spe- Current Current Usually easy to measure Hard to establlsh Can be done quockly;
coal groups; exposed cause-result can use large populatoons,
vs. non-exposed relatíonshop, can estímate extent of
groups current exposure problem (prevalence)
may be orrelevant to
current dísease
Prospectove study Communoty or spe- Defoned at outset of To be determoned Usually easy to measure Expensove and tome Can estomate íncodence
cíal groups, exposed study (may change dunng course of consumíng; expo- and relatove nsk; can
vs. non -exposed duríng course of study sure categones can study many doseases, can
groups study) change, hogh drop- mfer cause-result
out rate relatíonshop
Retrospectiva cohort Specoal groups such Occurred m past- Occurred m past- Often doffícult to meas- Changes on Less expensove and
study as occupatoonal need records of need records of ure because of retro- exposure¡effect over qu ocker than prospecto ve
groups, patoents, past measurements past doagnosos spectíve nature (e.g, tome of study; need cohort study, govong
and onsured persons and measure- past smokmg habíts) to rely on records somolar response, of
ments that may not be suffocoent past records are
accurate avaolable
Tome-senes study Large communoty Current, e g., daoly Current. e g , daoly Often doffocult to sort Many confoundíng Useful for studoes on acute
woth severa! molllon changes m expo- vanat1ons m mor- out factors, often díffo- effects
people; susceptoble su re taloty cult to measure
groups such as asth-
matícs
Case-control study Usually small groups, Occurred ín past Known at start of Possoble to ellmmate Doffícult to gener- Relatovely cheap and
díseased (cases) vs. and determoned by study by matchíng for them allze due to small quock, useful for studyong
non-doseased records or íntervoew study group, sorne rare díseases
(conrols) oncorporated boases
Expenmental Communoty or spe- Controlled¡known To be measured Can be measured; can Expensove; ethícal Well accepted results;
(onterventoon) coal groups dunng course of be controlled by ran- consíderatíon, study strong evodence for
study study domízatoon of subjects sub¡ects' complíance causalíty
requored; dropouts
...
U1
A methodology has been proposed for assessment of chronic toxicity

on the basis of the dose-time relationship (Pinigan, 1976; Pinigan &
Grigorevskaya, 1978). This method, widely used in the USSR for
setting maximum permissible concentrations (MPC) for air pollutants,
is based on the determination of dose-time relationships in one-month
animal studies using relatively high concentrations. The established
threshold concentration is subsequently extrapolated for longer
period(s) of exposure, e.g., up to 4 months.
Most regulatory decisions on the toxicity of pollutants are based on
the results of animal tests using mammalian species. Experiments with
animals raise the fundamental question: how valid is the comparison
between man and animals? Although the basic biological processes of
molecular, cellular, and organ function are similar from one mam-
malian species to another, there are marked differences between the
standard animal models and man.
Extrapolation from animals to man has been most successful for
certain effects such as carcinogenicity, acute toxicity, and metabolic
interference, as well as for deafness, behavioural changes, and influence
on the immune system. The greater our understanding of the basic
mechanisms of toxicity and interspecies differences, the more accurate
will be predictions based on animal toxicology studies.
Short-term tests
The time, expense, and logistic difficulties involved in the conduct
of animal tests have stimulated the search for short-term test methods
to detect toxicity (World Health Organization, 1978). Further moti-
vation for such research has also been provided by a growing concem for
animal welfare. Mutational effects (induction of changes in genetic
material) have been widely used as an index of toxicity. Such screening
will not only detect substances that may induce birth defects, but will
also give an indication of possible carcinogenicity, although the extent of
the association between mutagenicity and carcinogenicity appears to
depend greatly on the class of pollutant as well as on the properties of
the test system used to assay mutagenic potential (Ashby, 1983).
There are over 50 mutagenicity tests in existence (National Research
Council, 1983), of which the Salmonella assays first developed by
Ames et al. (1973) are the best known, most widely used, and most
thoroughly validated. In spite of their imperfections, these tests do
provide a valuable tool for the detection of potential mammalian
genotoxic carcinogens and mutagens. However, it should be borne in
mind that, with the possible exception of the action of electrophilic
agents, the multistage nature of carcinogenesis is too complex to be
reduced to simple systems.
Structure-activity re/ationships
From the early days of pharmaceutical research, it has always been
hoped that knowledge of the physicochemical characteristics of a
16
substance could be used to predict its biological activity. Much

information has been collected for various classes of compounds on the
correlation between chemical structure, in terms of functional groups
and spatial orientation, and parameters of toxicity (Birge, 1983). Short-
term methods for predicting toxicity and maximum permissible
concentrations for occupational and ambient air pollutants have been
developed on the basis of such studies (Zaeva, 1964; W orld Health
Organization, 1975; Nikiforov et al., 1979).
Dose-effect relationships
The dose received can either be expressed as the total dose,

integrated over time, or as the actual dose, that is the amount present
in the target organ at a point in time. The actual dose in the critical
organ, which is often correlated with daily absorbed dose, is usually
the most relevant measure with regard to graded effects, i.e., effects
that can be measured on a graded scale of intensity; the magnitude of
such an effect is directly related to the dose.
The total dose is more important with regard to quantal effects, i.e.,
those for which the occurrence of an effect depends on the absorbed
dose. The term quantal means that the effects permit no gradation and
can be expressed only as "occurring" or "non-occurring", i.e., there is
no dose-threshold below which the effect will not appear, but the
probability of experiencing the effect increases with increasing dose
(World Health Organization, 1978). Hereditary effects and cancer
caused by certain chemicals are considered to be quantal effects.
Observed effects are evidence of biological changes in an organism.
A dose-effect 1 relationship can be seen in terms of either the
increasing severity of one effect with increasing dose (e.g., eye
irritation versus oxidant concentration in the atmosphere) or a series of
effects, from the less severe to the more severe, with increasing dose.
The latter case is illustrated in Fig. 1 and 2, which show the
relationship between lead concentration in blood and various health
effects in adults and children.
The terms effect and response are often considered to be
interchangeable, but the latter refers more specifically to the
proportion of a group of individuals that demonstrates a defined effect.
:This section considers the different approaches to the development
of standards for both carcinogens and substances thought to be
noncarcinogens, with threshold (graded) or non-threshold (quantal)
dose-effect relationships. One of the problems inherent in the
establishment of a dose-effect relationship is that of extrapolating from
the results of high doses observed during experimental studies to those
of the low dose levels that are more typical of human exposure.
1
The term exposure may be used m preference to dose; 1t is the amount of the agent taken up by
the body per unit time over a penod of time (World Health Organization, 1980).
1200
1100
1000
900
800 )(
~
'3
O'> 700
"O
o 600
o
:o
e
500 )(
.,"'
"O
__j
400 )(
l
)(
u
:E ...,
;;; E
c. o
-o - c.
~E
~;:-
u,
<= <=
w~
Fig. 1. Lowest observed levels for lead-mduced health effects in adults
Threshold effects
Different types of dose-effect curve are shown in Fig. 3. Curve 1
represents the simplest case, where there is no risk until a certain level
of exposure is reached, at which point curve 1 leaves the abscissa
A more complex and more common situation is illustrated by curve
2. Here there are sorne effects at low doses, and these effects increase
relatively slowly with increasing exposure, until a take-off point is
reached after which the effects increase dramatically. This example
illustrates the case where a few susceptible members of a population
are affected by low-level exposure but the mass of the population
remains unaffected until a certain threshold exposure or take-off point
is reached.
Both curves 1 and 2 may be directly linked to policy options. In the
case of curve 1, it would be appropriate to keep exposure of the
18
1000.-----------------------------------------~
900-
800-
)(
700 r-
~
~ 600 r-
3
"O
g 500 r-
::0
400 1-- )(
I l I
e:
"0
5 3001--
I
2001--
I
100 1-- )( ~
~
o
~
o 1 1 1 1 1 1 1 _¡_
E
.
-~
u
:se
S
g.~
¡;¡ ca-g
-"'
¡;¡ ~=
u e::
u: e::"'
w·;;
Fig. 2. Lowest observed levels for lead-induced health effects in children
population below the threshold leve!. For curve 2, it may not be

practicable to reduce exposure to zero in order to protect the relatively
small number of susceptible people affected at low doses. In this case,
the standards may be set at or somewhat below the take-off point, and
additional steps taken to safeguard or reduce the exposure of the
susceptible persons.
A more complicated situation is illustrated by curve 3 where the
effects of exposure are impossible to separate from similar effects that
occur from background exposure. In other words, there are sorne
"effects" at zero dose and any dose above zero will increase those
effects.
In sorne instances, a gradual increase in the intensity of the effect
can be observed with increasing exposure (dose); an example is the
effect of lead on enzyme systems connected with haem biosynthesis.
One of the enzymes affected is porphobilinogen synthase (PS), the
activity of which is known to decrease with increasing dose of lead.
Using the blood lead levels as a measure of the dose, a negative linear
relationship can be established between the dose and the logarithm of
PS activity in the erythrocytes. Almost complete inhibition of the
19
2
.....
(.)
Cl)
......
......
w
WHO 86990
Dose or exposure ------11.,._
Fig. 3. lllustration of different types of dose-effect curve showing a threshold
enzyme can be observed at blood lead levels that exceed 600 ~g per
litre. Demonstrable PS inhibition can often be observed at blood lead
levels below 100 ~g per litre.
In practice, it is not always possible to specify with confidence the
slope of the dose-effect curve or to state exactly where any threshold
level is. A number of factors account for this lack of precision. The
vulnerability of individuals varies and physiological diversity in human
populations is such that effects may vary according to the section of
the population exposed. Measuring techniques have their limits of
detection and monitoring of levels can be carried out in only a few
selected samples or sites. At very low exposures, the effects may not be
easily detectable; equally, data relating to the upper end of the curve
are difficult to obtain because massive exposures are relatively rare.
The principal use of dose-effect curves is, therefore, to predict the
consequences of very high and very low exposures.
Fig. 4 is a generalized exposure-effect curve showing how effects at
the lower levels of exposure may be estimated by extrapolation from
"middle range" observations.
The solid line to point A is the dose-effect curve, determined by a
multiple-dosing experiment. Point A is the "no observed effect" level
(NOEL) in mg per kg of body weight per day for the most sensitive
adverse end point, as determined from a chronic multiple-dose animal
20
....
-
(.)
Q)
E D C B WHO 86991
Oose
Fig. 4. Exposure--effect curve showing the different possible estimates at lower
dose levels
study. Curves AB, AD, and AE are possible dose-response curves at

lower doses, with points B, D, and E the respective thresholds for the
adverse effect in the human population. In setting an acceptable daily
intake (ADI) concentration (point C), a selected safety (uncertainty)
factor is applied to the dose at point A. If the curve AB is the true
dose-response curve, then the calculated AD 1 val u e will be lower than
the threshold dose, thus indicating that the safety factor was
appropriate. However, if AD or AE is the true dose-effect curve then
the calculated AD 1 will be too high, and the safety factor too small; in
this case, sorne individuals in the population will suffer adverse effects.
The size of the gap between points C and B is also of interest, because
if it is large, expenditure on control methods could be greatly in excess
of what is needed.
Safety factors and extrapolations

In qualitative terms, the toxic action of environmental pollutants in
man can usually be inferred, with a reasonable degree of certainty,
from animal studies. On the other hand, the accuracy and reliability of
the quantitative prediction of toxicity in man depend on a number of
conditions, such as the animal species, design of the experiment, and
methods of extrapolation used (World Health Organization, 1982a).
21
There are two fundamental problems of extrapolating animal data to

man: (1) the problem of extrapolating projected response from one
species to another, and (2) the problem of extrapolating from a tested
dose-response range to a different dose range of practica! importance.
The safety (or uncertainty) factor reflects the degree of uncertainty
that must be incorporated in the extrapolation from experimental data
to the human population. When the quality and quantity of dose-
response data are high, the safety factor is low; when the data are
inadequate or equivoca!, the safety factor must be higher. However, it
should be noted that when permitted doses of carcinogens are the
practica! equivalent of zero, safety factors are not especially relevant.
In the case of carcinogens, the term safety factor should be replaced by
the term "acceptable risk" (see pp. 24-27).
The following general guidelines have been adopted by the National
Academy of Sciences (NAS) Safe Drinking-Water Committee and are
also used by the Environmental Protection Agency in the USA in the
development of drinking-water standards (National Academy of
Sciences, 1977):
10 factor-Applied to data from valid experimental studies on
prolonged human intake, with no indication of carcino-
genicity. This 10-fold factor protects the sensitive
members of the population.
100 factor-Applied when experimental results from studies of
human intake are not available, or are scanty; valid
results of long-term intake studies on one or more
species of experimental animals; no indication of
carcinogenicity.
1000 factor-Applied when there are no long-term or acute human
data; scanty results on experimental animals; no
indication of carcinogenicity.
These are not rigid rules and should be applied using scientific
judgement in each particular situation.
In the USSR the term "reserve coefficient" is used to represent the
difference between the maximum permissible concentration (MPC) and
the threshold level for physiological responses. The "reserve coef-
ficient" may be viewed as the safety factor that is incorporated in each
standard. Severa! approaches have been proposed in the USSR for
the derivation of safety factors. According to Izmerov (1973), the
maximum permissible concentration should include a safety factor of
30% in all cases. This means that if a presumed threshold is found, the
next level tested is 30 % lower. If there is no pollutant-induced activity
at that level, the experimentation can stop, with that final concentra-
tion tested becoming the maximum permissible concentration. This
may seem a very small safety factor when compared to the traditional
factors of 10 or 100 adopted in the United States, but it must be
remembered that the USSR uses this method to prevent the
occurrence of the most sensitive indicator of exposure and not
necessarily the pathological response (see also pp. 28-29).
22
Example of a threshold effect: para-dích/orobenzene

An example of a calculation of acceptable daily intake showing the
use of exposure-effect data and safety factors is described below for
para-dichlorobenzene. 1 Animal studies with various doses of para-
dichlorobenzene have shown effects including liver and kidney damage,
porphyria, pulmonary oedema, and changes in spleen weight. Human
exposure to high concentrations of the chemical has been reported to
result in pulmonary damage and haemolytic anaemia. A one-year
gavage study in the rabbit using groups of 5 animals dosed with
between O and 1000 mg of para-dichlorobenzene per kg of body weight
per day resulted in weight loss, tremors, and liver pathology. The
highest no-observed-adverse-effect level (NOAEL) was 357 mg of para-
dichlorobenzene per kg per da y. A subchronic study indicated a no-
observed-adverse-effect level of 150 mg of para-dichlorobenzene per kg
of body weight in the rat exposed by gavage. Animals received doses of
37.5, 75, 150, 300 or 600 mg of para-dichlorobenzene per kg per day in
corn oil, 5 days per week for 13 weeks. No significant differences were
observed in food consumption or gain in body weight compared with
controls for either sex at any dose. At the two highest doses, an
increase in the incidence and severity of renal cortical degeneration was
detected microscopically.
U sing this last experiment as the basis for calculations with an
additional factor reflecting that the exposure in the experiment
occurred for only 5 days each week, the provisional AD I was computed
as follows:
150 mg¡'kg of body weight/day x 70 kg/person x 2
ADI = 100 x10 7
= 7.5 mg per person per day

where 100 is the safety factor appropriate for use with a no-
observed-adverse-effect level from animal studies with no comparable
human data; and 10 is an additional safety factor because the duration of
exposure in the experiment was significantly less than a lifetime.
Minimal data were available on the contributions of food and air to
exposure, so an arbitrary designation of 20% was chosen as the
maximum allocation from drinking-water. If the daily water intake per
person is assumed to be 2 litres per day, then the allocated ADI for
water (AADI) is:
ADI xwater allocation
AADI = - - - - - - - -
2 litresjday
7.5mgjdayx 20% /l
= = 0.75 mg
2 1/day
1
Conmvo, J. A. Risk assessment and control decisions for protecting drinking-water quality. In:
Evaluanon of methods for assessing human health hazards from drinklng-water. Lyon, France,
lntemational Agency for Research on Cancer, 1986 (Interna! Technical Repon No. 86/001).
23
Non-threshold effects
The curves shown in Fig. 5 all represent possible non-threshold
relationships. Curve 1 is the classical linear exposure-effect relation-
ship when no threshold exists. Zero risk occurs only at zero exposure.
Curve 2 is a variant showing reduced sensitivity to risk at lower levels,
and curve 3 is the reverse showing increased sensitivity at lower levels
of exposure (Whyte & Burton, 1980).
2
+-'
-
(.)
QJ
LLJ
WHO 86992 Dose or exposure ~

- - - - - i....
Fig. 5. lllustration of different types of dose--effect curve showing zero threshold
The existence of a threshold for cancer is a subject of contention

among risk assessors. The argument against a threshold assumes that a
single point mutation of the DNA can lead to the uncontrolled growth
of a somatic cell that eventually produces cancer. A probabilistic
argument can be made that, while an individual may have a threshold,
different individuals may have different thresholds or may have none at
all. The arguments for a threshold are based on the existence of gene
repair mechanisms, immune defences, and epigenetic mechanisms.
The US National Academy of Sciences Safe Drinking-Water
Committee has outlint:d fou;: principies that it believed should be
useful in dealing with the assessment of hazards involving chronic
24
irreversible toxtclty or the effects of long-term exposure (National

Academy of Sciences, 1977). These were intended to apply primarily to
cancer risk from pollutants that cause somatic mutation. These
principies, discussed below, may also be applicable to mutagenesis and
teratogenesis.
1. Effects in anima/s, properly qualified, are applicable toman. This
premise underlies all of experimental biology, but it is often questioned
with regard to human cancer. Virtually every form of human cancer
has an experimental counterpart, and every form of multicellular
organism is susceptible to cancer. There are differences in suscep-
tibility among animal species, different strains of the same species, and
individuals of the same strain. However, extensive data indicate that
substances that are carcinogenic to animals are likely to be carcinogenic
to man, and vice versa.
2. Methods do not exist, at present, to establish a threshold for the long-
term effects of toxic agents. It is not possible to establish experimentally
carcinogenesis thresholds that would be applicable to a total
population. There is no scientific basis for the estimation of "safe" doses
of carcinogens using classical exposure assessment techniques. Even
experimental bioassays involving a large number of animals are likely
to detect only powerful carcinogens. Negative results in such bioassays
do not prove that the agent is unequivocally safe for man.
3. The exposure of experimental anima/s to high doses of toxic agents is a
necessary and va/id method of assessing possib/e carcinogenic effects in man.
There is no choice but to use a small number of animals relative to
the size of the exposed human population, and then to use biological
models to extrapolate the results in order to estimate risk at low doses.
An incidence as low as 0.01% would represent a risk to 20000 people
in a population of 200 million, whereas the lower limit of
reproducibility in common animal studies would be an incidence of
10%. The best method available, at present, is to assume a direct
proportionality between dose and tumour incidence, with no threshold.
It is possible that the actual risk to man is greater than predicted by
small animal studies because of the longer human lifetime and hence
exposure period.
4. Material should be assessed in terms of human risk rather than as "safe"
or "unsafe". Decisions must take account of possible benefits as well as
risks, and should consider the nature, extent, and recipient of these
benefits. It is often necessary to accept risks when there are sub-
stantial benefits, but risks imposed on persons who gain no benefit
are generally not acceptable. Also, in view of the nature of cancer, the
long latent period of its development, and the irreversibility of
chemical carcinogenesis, it would be highly improper to expose the
general population to an increased risk if the benefits were small,
questionable or restricted to particular segments of the population.
Such benefit-risk considerations not only must be based on hard
25
scientific evidence but also must be ethical, with as broad a population

base as possible being used in the decision-making process.
Quantitative assessment of cancer risk relies on dose-response

functions to establish the likelihood that cancer will occur in
individuals exposed to low doses of pollutants (Ricci & Molton, 1985).
The process of cancer formation provides biologically plausible bases
for sorne of the functions. Quantal functions describe whether the
adverse effect is present or not. Time-to-response functions account
for the differences in longevity among exposed individuals. Such
models as the one-hit, the probit, the logistic, the multihit, and the
multistage do not explicitly model those dependencies.
The one-hit model assumes that a single hit causes irreversible
damage to the DNA (point mutation) and leads to cancer. In the
multistage model, a cell-line must pass through severa! (k) stages
before a tumour is irreversibly initiated. The rate at which cell-lines
pass through these stages is a function of the dose rate. In the multihit
model, k dose-related hits to the sensitive tissue are required to initiate
a cancer. The Weibull model includes the more reasonable assumption
that these hits must occur in a single cell-line and that different cell-
lines compete independently in producing a tumour.
In all of these models it is assumed that the rate at which dose-
related hits occur is a linear function of the dose rate. The most
important difference between the multistage and the Weibull and
multihit models is that in the Weibull and multihit models all hits
must result from the dose, whereas in the multistage model, passage
through sorne of the stages can occur spontaneously. The practica!
implication of this is that the Weibull and multihit models predict a
lower risk at low doses than does the multistage model.
The remaining models-probit and logistic-are not derived from
mechanistic assumptions about the cancer process. They may be
thought of as representing the distribution of tolerance to the
carcinogenic insult in a large population. There is no evidence to
support these particular distributions over others and, in sorne
respects, all the models discussed may be interpreted as tolerance
distributions.
Similar principies for assessment of carcinogenic hazards are used in
member countries of the Council for Mutual Economic Assistance.
Setting of maximum permissible concentrations for carcinogens in the
ambient air is based on the experimental determination of the
probability of occurrence of carcinogenic effect for a period exceeding
the normal lifespan in laboratory animals and subsequent extrapolation
to man using a reserve coefficient (Yanyseva, 1972).
Example of a non-threshold effect: determínatíon of water

qualíty guídelines for carcinogenic substances
In 1984, the World Health Organization established guidelines for
biological quality, aesthetic quality, and levels of radioactivity,
26
1nformation on health effects
inorganic chemicals, and organic chemicals in drinking-water (World

Health Organization, 1984). Of the 20 organic substances for which
guideline values were set, 10 were considered as potential carcinogens
(Table 2).
Table 2. Water quality guidelines for substances considered to

be potential carcinogens
Constituent Guidel~ne val ue ( ll9/l)
benzene 10
benzo[a]pyrene 0.01
carbon tetrachlonde 3
chloroform 30
1,2-dichloroethane 10
1, 1-dichloroethene 0.3
hexachlorobenzene 0.01
tetrachloroethene 10
trichloroethene 30
2,4,6-trichlorophenol 10
Guidelines for carcinogens were set where reliable data were

available from two animal species, preferably supported by muta-
genicity data or population studies. Tentative guideline values were
recommended for three pollutants--carbon tetrachloride, tetrachloro-
ethene, and trichloroethene--where it was felt that the carcinogenicity
data available did not justify definitive guidance.
It was assumed that thresholds for carcinogenicity were either non-
existent or non-measurable. A multistage model was used in many
cases with a data base similar to the one used for the US Water Quality
Criteria (Environmental Protection Agency, 1976) and calculated
values were generally rounded off to the nearest digit. The guidelines
state: "The model is designed to estimate the highest possible upper
limit of incremental (excess over background) risk from a lifetime of
exposure to a particular daily amount of substance." An "acceptable"
risk of 1 in 100 000 per lifetime was arbitrarily selected as the criterion.
Since the guideline values for the carcinogens were computed from a
conservative, hypothetical, mathematical model that could not be
experimentally verified, they should be interpreted with caution. The
uncertainties involved are considerable and a variation of about two
orders of magnitude (i.e., from 0.1 to 1O times the value) could exist.
27
Chapter 4
Assessment of exposu re
Assessment of exposure to a given environmental pollutant involves,

in the first instance, a consideration of the probable sources of the
substance. Such sources may be industrial, domestic, consumer
products or any number of others. These sources are not mutually
exclusive; for example, asbestos fibres may be introduced into the
environment from mining and the production of asbestos products, and
from the use of asbestos in brake linings, water pipes, etc. A good
inventory of sources will provide much information on critical
pathways, possible environmental concentrations, and the hazard posed
to the general population or subgroups at particular risk (World Health
Organization, 1982b ).
Assessment of exposure also involves making environmental meas-
urements to determine the average and peak concentrations of the
pollutant in the relevant media-air, water, and food. The aim of these
measurements is to establish the levels in the different media and to
study how these vary with time and place. This information should
permit an estímate to be made of the exposure of the general
population and subpopulations at particular risk.
Data obtained from monitoring together with information on lifestyle
factors can be used in models to estímate exposure. These models may
be very simple, indicating, for example, that 10% of the population is
exposed to concentrations over a certain value. More complex models
might identify people living in a certain geographical area as being
exposed above a certain preset limit. The ultimate objective here is to
establish the relative number of people who will react to the pollutant
by manifesting a certain effect.
High-risk groups
Once the toxic dose for the "normal healthy" population has been
determined, consideration must be given to high-risk groups such as
infants and young children, the elderly, pregnant women and their
fetuses, the nutritionally deprived, the physically debilitated, in-
dividuals with genetic disorders, and those exposed to excessive
amounts of the pollutant. These groups must be quantified to
determine the proportion of the population at greater risk from a
certain pollutant than the so-called "normal" population.
28
Assessment of exposure
Because of their physical vulnerability and immaturity, fetuses,

infants (especially premature infants), and young children are at greater
risk than adults. For example, severa! Japanese children born to
mothers exposed to methylmercury in fish in Minamata suffered
congenital malformations even though the mothers showed few or no
symptoms of mercury poisoning (World Health Organization, 1976).
Nutritional deficiency may also increase susceptibility to the adverse
health effects of sorne pollutants. Inadequate protein in the diet of rats
increases the toxic effects of most pesticides, but decreases, or fails to
alter, the toxicity of other agents. Vitamin E deficiency increases ozone
toxicity, whereas vitamin E supplementation decreases ozone toxicity in
rats. Dietary deficiencies of calcium and iron, quite common in the
United States of America, significantly potentiate the toxicity of lead.
Individuals who are suffering from sorne disease may also show
increased susceptibility to pollutants. Impairment of the functional
capacity of the excretory systems, e.g., a renal disorder, can change the
rate of clearance of pollutants and their toxic metabolites from the
organism, and thus modify its effects. Impaired liver function can
change rates of metabolic conversion, particularly detoxification of
certain pollutants or their excretion in bile. Also, those suffering from
cardiovascular or respiratory disease are at greater risk from the effects
of carbon monoxide (CO) or sulfur dioxide (S0 2 ) than are healthy
individuals.
It is very important to know which individuals are at high risk with
respect to pollutants, because they will be the first to experience
morbidity and mortality as the leve! of the pollutant increases. A
standard that protects the high-risk sections of the population will also
protect the rest of the population. Consequently, information concern-
ing both the number and distribution of high-risk groups should play
an integral role in the derivation of standards for pollutants in both
ambient and industrial air as well as in drinking-water and food.
A theoretical comparison between normal and high-risk segments of
the population with regard to the onset of toxic effects is shown in
Fig. 6. As pollutant levels increase, adverse health effects will be seen
first in the high-risk group. The precise difference in sensitivity be-
tween a statistically "normal" individual and one in the high-risk subpopu-
lation varíes with the specific cause of the high-risk condition. In any
case, it is probably not entirely correct to assume that a well-defined
threshold for an adverse effect exists within the highly diverse human
population, although such an assumption may be of practica!
significance in many cost-benefit analyses. Neither can it be said that
there are distinct thresholds for the normal and the high-risk groups.
If sufficient data are available on the levels at which particular
effects occur in high-risk groups, an acceptable standard may be the
leve! that does not result in subclinical physiological changes of a
potentially damaging nature. Alternatively, it may be necessary to
apply a safety factor to the dose that is toxic to the general population,
in an effort to protect susceptible groups.
29
Sening environmental standards
Death
1
1
1
1
1High
1 risk
lnjury 1
1
1
1
/
__ ...... / /
/
Health 1...---------------------------- WHO 86994

-----1~ lncreasing pollutant levels
Fig. 6. Comparison of the response of high-risk and normal individuals to

increasing pollutant levels
Definition of adverse health effects
In setting a standard for the control of an environmental pollutant,

the effect that the population is to be protected against must be defined
(World Health Organization, 1977). A hierarchy of effects on health can
be identified, ranging from acute illness and death through chronic and
lingering diseases, minor and temporary ailments, to temporary
emotional or behavioural changes (Table 3). Should the first evidence of
a biochemical or physiological change in an individual be considered
Table 3. Range of effects on

human health of exposure to en-
vironmental pollutants
Prematura death of many individuals

Prematura death of an individual
Severe acute illness or major disability
Chronic debilitating disease
Minor disability
Temporary minor illness
Discomfort
Behavioural changes
Temporary emotional effects
Minar physiological changa
30
Assessment of exposure
adverse? Or is the appearance of clinical symptoms necessary for the

response to be defined as adverse?
One school of thought considers a biological response, of whatever
level of intensity, as evidence either of an impending detrimental effect
on health, or as a direct expression of injury (W orld Health
Organization, 1975). Consistent with this is the idea that any measurable
concentration of the pollutant in body tissues, however low, is evidence
of excessive exposure, since the body is stressed in its attempt to
metabolize, store, or excrete it. In contrast, others assume that the
homoeostatic and compensatory mechanisms in the body make it
possible to offset such insults so that many toxic pollutants can be dealt
with by the body without any threat to health.
Fundamentally, the approach to standard-setting depends largely on
the accepted concept of the term "state of health". In the case of most
environmental and industrial standards in the USA, for example, it is
assumed that there is no threat to health as long as the exposure does
not induce a disturbance of a kind and degree that overloads the normal
protective mechanisms of the body. In marked contrast, in the USSR, a
potential for ill health is said to exist as soon as the organism undergoes
a detectable change, of whatever kind, from its normal state. In the
USSR, maximum permissible concentrations for environmental pol-
lutants are set below the level that causes physiological and other
changes of uncertain significance, i.e., below the level that produces
adaptive and compensatory changes in the most vulnerable groups
(Bustueva, 1976). Thus, the concepts of tolerance limits or thresholds
of response are markedly different in these two countries, at least with
respect to what indicates an effect (see Table 4). Other countries
generally follow one of these two approaches.
Table 4. Contrasts in approaches to standard-setting in the USA and the USSR•
USA USSR
1. Minor physiological adaptive changes 1. Maximum allowable concentration will
are permitted not permit the development of any dis-
ease or deviation from normal
2. Economic and technological feasibility 2. The principie is that standards should be
are important considerations in the de- based entirely on health and not on
velopment of standards technological and economic feasibility
3. Values are time-weighted averages 3. Concentrations are maximum values
4. Research emphasis 1s on pathology 4. Research emphasis is on nervous system
testing
5. Except for carcinogens, goals of near 5. The goal is a level of exposure that
zero exposure are not widely adopted does not strain the adaptive and com·
pensatory mechanisms of the body
(Ryazanov, 1961; Bustueva. 1976)
• Adapted from Calabresa, 1978.
31
In spite of these differences in approach, the trend in standard-

setting in many countries, including the USA, has been to lower the
permissible levels as a result of the development of increasingly more
sensitive indicators of preclinical, physiological, biochemical, and other
indices of functional disturbance. One example of this relates to lead;
there is now agreement and concern among scientists that relatively
low blood lead levels (in the range of 400-600 Jlg of lead per litre) in
children may increase the risk of learning impairment very soon
thereafter.
32
Chapter 5
Strategies for prevention and control
Once it has been decided that exposure to an environmental

pollutant needs to be prevented or reduced in order to protect human
health, the next step is to select appropriate measures to achieve this
goal. Exposure can be avoided if the pollutant is prevented from being
released or if it is degraded naturally or treated before it reaches its
target. Reduction or control measures may be taken at various points
on the path between the source of the contaminant and its target-a
person or resource (see Fig. 7).
Frequently, measures will be taken against a pollutant at more than
one point. For sorne contaminants, such as heavy metals, control
actions may be introduced in nearly every area. For example, the
European Economic Community has at least 17 directives that apply to
cadmium, including limit values for the discharge of cadmium into
water from six manufacturing processes (von Moltke et al., 1985).
The decisions made concerning the points of intervention and the
type and level of control to be used must take into account many
factors, including the chemical and physical characteristics of the
pollutant, its transport through the environment, and possible related
exposure. Such decisions are also influenced by the technology
available and the financial resources of both the government and
industry. The legal and cultural traditions of the country also play a
role. Control at each stage has its own advantages and disadvantages.
The opportunities and constraints faced, particularly by developing
countries, are discussed in Chapter 8. The discussion below outlines
different possible control strategies, using cadmium as an example
where possible. 1
Source-oriented measures
Product design, marketing, and use

For pollutants that are produced or used in the manufacture of a
product, the first point on the pathway between the source and the
target individual or population is the design and marketing of the
' Thc cxamplcs involving cadmium, unlcss othcrwisc rcfcrcnccd, are takcn from von Moltkc et al.,
1985, Anncx 3 (Measures to control cadmium in selected countries).
33
w
.,..
THE ENVIRONMENT THE TARGET
Product
standards
Biological _ _ _ _ _ _ _--,
standards
Residue
T ransformation standards i n - - - - - - - + - - ,
tissue
Metabolism
Environmental quality
W"T"dT
Process Emission
standards standards
Surface
Exposure
(primary V ~
protection) Excretion ~
standard ~
"'
Fig. 7. The pollutant pathway showing possible points at wh1ch standards may be set (from Holdgate, 1979).
product itself. If the substance does not have a known threshold level
and there is thus no safe level of exposure, it makes sense to start at
this stage to see if it is possible to prevent completely its release, e.g.,
by redesigning the product, or searching for a substitute.
Governments can influence product design in a number of ways.
One way is to ban the product or the use of a substance for certain
purposes. Sweden has banned the use of cadmium except in certain
areas-electroplating, pigments, and stabilizers for plastics. It may also
be used in soldering if the product is appropriately marked, but not on
products that could come into contact with drinking-water or food.
Another possibility is for the government to encourage the use of
substitutes. In Finland, for example, the use of organic compounds
instead of cadmium-based pigments is recommended. Research is being
carried out in the Federal Republic of Germany on possible
alternatives to the use of cadmium in plastics and paints, as well as on
the possibility of recycling certain products, i.e., returning them to the
manufacturer for safe disposal. These types of provision do not involve
the setting of any levels for cadmium. The approach of setting levels
has been taken by sorne countries for paint; the United Kingdom, for
example, sets a maximum concentration of 100 mg/kg (100 ppm) in dry
film for paints on toys and the same concentration of soluble cadmium
for crayons, brushes, and similar articles.
Another approach that can be used at this stage is the imposition of
labelling and other handling requirements. In the European Economic
Community, paints, inks, varnishes, adhesives, and similar products
containing cadmium concentrations higher than 0.1% by weight (1 g per
kg) must comply with special requirements on type and strength of
packaging material and on labelling identifying the product distributor.
This is also the approach being used for cadmium batteries in a number
of countries. In this case, in combination with recycling, such measures
reduce exposure to a minimum since release of cadmium is unlikely
during routine use.
Process of manufacture
Like the product design stage, the process stage offers an
opportunity for reduction of the amount of a pollutant that enters
the environment through the use of different methods of production.
Control at this stage is likely to require an investment in research and
development, but it may also reduce production costs. Control may
affect individual companies differently because of variations in their
needs and circumstances. Sorne companies fear that their competitive
advantage will be reduced if they reveal details of process changes.
However, changes that reduce the quantity of waste products generated
are being increasingly publicized (Huisingh & Bailey, 1982). Much
work on production changes has been carried out under the heading of
residuals management at the research institution, Resources for the
Future, in the USA (Kneese & Bower, 1979).
35
Manufacturing process changes have been proposed in the Federal

Republic of Germany to reduce the amount of cadmium used and
released during electroplating. These include changing the amount of
cadmium in the electrolytes and improving the rinsing technology, by
recirculating the rinse-water and also by treating it separately from
other wastes. Recirculation of wastewater with concomitant removal of
toxic substances is also mandatory in Czechoslov:akia. The substitution
of other materials for cadmium in electroplating, such as zinc and
aluminium, is also being tried in sorne countries.
To encourage changes in manufacturing processes, governments can
provide tax incentives and support information exchange programmes.
They can indirectly promote changes by enacting and enforcing
regulations concerning emission standards and waste management
programmes. Process changes may also be mandated directly. Japan
required the replacement of mercury cells by diaphragm cells for the
production of chlorine and caustic alkali after first requiring a process
change, i.e., the recycling of all water containing mercury.
Operating practices
The modification of operating practices focuses primarily on the
handling of materials in ways that prevent accidental or continuing
release and that deal with them when they occur. These procedures
include maintenance measures to avoid spills and to clean them up,
careful storage and segregation of different types of waste so that they
can be more easily recycled or treated, and thorough cleaning of
equipment. Training is essential to ensure that operating practices are
strictly adhered to. Recent accidents in the chemical industry in
Bhopal, India, and West Virginia, USA, have highlighted the
importance of such basic procedures in avoiding or mitigating serious
exposure to chemicals and pollutants.
Methods for taking emergency containment and clean-up action and
warning the surrounding community must be well developed to handle
any accidents that do occur. Until recently, the development of these
practices has been entirely the responsibility of the company,
occasionally with assistance from trade associations. Under a European
Economic Community Directive on industrial accidents (European
Economic Community, 1982), companies using certain hazardous
substances are now required to inform the appropriate government
authority about their accident prevention and control plans. These plans
must describe how substances are stored, used, and produced and the
various risks involved. The responsible government agency reviews the
company's plans and the adequacy of emergency off-site planning. The
Environmental Protection Agency has developed guidance on emergency
planning for communities (Environmental Protection Agency, 1985).
This guidance includes a list of about 400 chemicals that are capable of
producing serious health effects immediately upon or shortly after
exposure.
36
Many countries have regulations concerned with the packaging,

storage, handling, and disposal of toxic substances. In Romania, for
example, pesticides may be used only by trained personnel, and may
not be handled by persons under 18 years of age or by pregnant
women.
Limits on re/eases into the air and water

Much of the effort in the environmental control of pollutants has
been concentrated on the development of emission limits on industrial
discharges to air and effluent limits on those to water. Recently,
increased attention has also been paid to releases into the soil.
Emission or effluent standards may be expressed in terms of the
permissible concentration of a pollutant in units of air emitted or
wastewater discharged by a source, or in terms of the total load of
pollutant per time unit, unit of production, or unit of energy or
materials input. The prescription of number of samples to be tested,
measurement methods, and statistical assessment procedures forms an
integral part of the standard.
Emission or effluent standards may also be expressed in a more
general way, e.g., in terms of significant danger to health or to the
environment, or in terms of the possibility or feasibility of control
measures. In this case, the emission or effluent standard is related to
the preferred method of control. The great advantage of such a
standard is its direct relevance to the polluting activity. Furthermore, it
is a comparatively easy standard to implement, as far as the regulatory
aspect is concerned.
A European Economic Community directive prescribing limits on
cadmium discharges to water illustrates how such standards may be set
(European Economic Community, 1983). Limits have been set for six
industrial sectors at two levels, the first of which must be complied
with by 1986, and the second by 1989. The limits are given in terms of
milligrams of cadmium per litre of discharge water and grams of
cadmium discharged per kilogram of cadmium handled. The standards
cover: zinc mining; lead and zinc refining; the production of cadmium
metal; manufacture of cadmium compounds; manufacture of pigments;
manufacture of stabilizers; manufacture of batteries; and electroplating.
Member states are required to set emission standards that are no less
stringent than the most nearly comparable limit value, taking into
account the best technical means available for control. Depending on
the experience obtained with the directive, the Commission of the
European Communities may propose more restrictive limit values in
the future.
The directive also covers the manufacture of phosphoric acid andjor
phosphatic fertilizer from phosphatic rock, but does not set limit values
because no economically feasible technology exists for extracting
cadmium from this rock. Member states are still expected to set
emission standards for this process, however. A proposed strategy for
37
the control of cadmium recommends that the Commission fund

research on the development of processes to remove cadmium from
phosphatic rock in the manufacture of fertilizer, and that a permissible
level of cadmium content in fertilizer be specified. Thus emission
levels need to be closely tied to process and product controls.
The European Economic Community directive controlling cadmium
discharges into water also links emission standards to environmental
quality objectives. Permitted concentrations in water bodies are those
judged to be the maxima compatible with the protection of aquatic life.
The concentration in sediments and shellfish is not to increase
significantly over time. Methods to be used in monitoring cadmium
levels are also specified.
In the USA, cadmium and its compounds are among 129 priority
pollutants to be controlled in water. This is accomplished through
limitations on effluents or setting of pretreatment standards according
to industrial category. The industries covered include electroplating
and metal finishing, production of non-ferrous metals, ore mining and
dressing, porcelain enamelling, and manufacture of electrical and
electronic components. The limits are enforced through a permit system.
Air emission standards have been set primarily in relation to energy
production and incineration since these processes may release
respirable particles containing cadmium. The Netherlands has a dust
emission limit for coal-fired power plants, while the United Kingdom
uses the "best practicable means" approach (see page 40). Numerous
countries are looking at controls on various types of incinerator; the
Netherlands requires wet scrubbers or semi-dry filtering with
electrostatic precipitation.
Discharge standards for air and water have been a first step towards
pollution control in many countries, often for particular industries, but
in sorne cases, applied generally. Sometimes standards are more
stringent for new plants than existing ones. The standards may be
legally enforceable or they may be issued as guidelines, as is the case in
India and Sweden. The United Kingdom operates on a case-by-case
approach; although there is a list of presumptive limits for air
pollutants, each case is judged individually. In the USSR, norms are
set for maximum allowable emissions from every fixed source and
every mode of transpon. For fixed sources, a special permit is issued
by the authorized state body, specifying the maximum allowable
emission and detailing other conditions and requirements. Financia!
incentives can also play a role. In Hungary, air pollution emitters must
pay fines if their level of emissions is above that considered
acceptable. 1
Emission levels, whether as guides or enforceable standards, are
important in controlling pollution from industrial and combustion
' Compendium of environmental guidelines and standards for industrial discharges. Unpublished WHO
document, EFP/83.49.
38
sources. ,They give both government and industry clear goals to aim
for. Their development can, however, be extremely time-consuming
and expensive for many industries. In addition, while they may
encourage companies to change their products or processes, such
standards have often led to the use of add-on pollution control
equipment, such as filters, scrubbers or settling ponds. This equipment
collects the pollutant rather than releasing it into the air or water in the
immediate vicinity. The trapped pollutants are then often moved to
another location and dumped on land. From this new location the
pollutants that do not rapidly degrade move into the air or water at a
later date. In the USA, cadmium was the tenth most frequently
reported substance at 546 waste sites on the list for clean-up; it was
detected at 82 sites (Environmental Protection Agency, 1984). It was
found in the air at 31 sites and in the surface water and groundwater at
28 sites each. A number of cadmium waste streams that are now
designated hazardous and thus require special handling may be the
source of sorne of this cadmium. They include dust recovered from
electric furnace production of steel and secondary lead-smelting control
devices and wastewater treatment sludges from electroplating.
Because sludge from wastewater treatment plants is often applied to
soil, there is now a need for the development of emission limits to the
soil. The cadmium in this sludge usually comes both from industrial
discharges to the treatment plant and non-point sources, and may
cause a problem by accumulating at high levels in sorne foods. Sweden
has set maximum concentrations in sludge used for agricultura!
purposes at 15 mg of cadmium per kg (dry weight). The Netherlands
has imposed a limit for the amount of sewage sludge that can be
applied to croplands of 2 tonnes per hectare per year and for grasslands
of 1 tonne per hectare per year. The cadmium content must be below
10 mg/kg.
Treatment and disposa/

Once a pollutant has been produced, it must either be degraded into
forms that will not cause adverse health effects or be contained and
isolated from the population. Sorne pollutants, including metals such as
cadmium, do not degrade; once released into the environment, they
continue to circulate in the air, water, and soil. Cadmium accumulates
in the soil, from where it may move into the food chain, leach into the
groundwater, erode into surface water, or be blown on the wind as
dust. In order to prevent its build-up in the environment it needs to be
contained as far as is possible by such measures as recycling of rinse-
waters used during manufacturing processes involving cadmium. In
Finland, 50-70% of wastewater from mines is recycled and the
remaining cadmium is chemically precipitated. Closed water cycles are
also used in basic metal and sulfuric acid industries. Other non-
degradable pollutants need to be handled in a similar way.
39
Sorne contaminants can be treated by a wide range of biological and

chemical methods that destroy their toxicity. Polychlorinated bi-
phenyls, for example, can be destroyed chemically using sodium-based
compounds that remove their chlorine atoms, or by high-temperature
incineration. These processes are more expensive than landfill
techniques, but they ensure that the compounds do not enter the
environment at a later date. In the waters of the Great Lakes region of
the USA and Canada, deposition from the air is apparently the largest
source of polychlorinated biphenyls and sorne metals (Eisenreich et al.,
1980). Other sources include rivers that are contaminated from landfills
and then flow into the lakes. Thus the most important sources are no
longer direct, but indirect discharges resulting from the lack of
degradation or failure of containment processes.
Many countries have regulations that require careful handling of
hazardous wastes. In the USA, land disposal of sorne wastes may be
prohibited, giving further impetus to the use of treatment methods that
destroy or contain the pollutant. A more direct approach is to require
particular methods of treatment for specific materials. In the USA
there are special requirements for the disposal of polychlorinated
biphenyls and, under the Toxic Substances Control Act of 1976, the
authorities can specify the type of disposal and containment to be used
for a compound. There are also recommended procedures for the
disposal of pesticides containing cadmium, and their containers (USA,
1984).
Best practicable means

This approach implies the use of the best available and economically
feasible control technology. It is inherent in the term "feasible" that
the cost will be within the reach of industrial plants. What will be
considered a feasible cost of control will depend on the effects of the
pollutant on human health and the environment in general; indirectly,
therefore, environmental quality is taken into consideration.
Emission/effluent standards are often used to define the "best
practicable means" for single sources. Emission standards based upon
"best practicable means" should in principie be uniform for the whole
country, if the technical and economic conditions are essentially the
same. With uniform emission standards, however, the environmental
quality will vary with such factors as density of population and sources
of environmental pollution, as well as with meteorological and
hydrological conditions. Therefore, it seems reasonable that these be
taken into account when choosing the "best practicable means" to be
enforced. An advantage of the "best practicable means" approach is
that different plants within an industry are treated alike so that no one
company has an undue advantage. In addition, it serves to preserve
environmental quality in non-polluted areas, since there is no incentive
for industries to relocate to clean areas.
40
The disadvantages of this approach are that it does not guarantee a

satisfactory environmental quality and that it does not greatly
encourage the development of new or modified processes that produce
less pollution or new abatement technology. Another criticism of the
"best practicable means" approach is that in certain cases it may
constitute control for control's sake, since it is not related to actual
health effects.
Medium-related measures
Environmental quality or ambient standards

Environmental quality may be expressed in terms of one or more of
a number of aspects. Among these are included health (of human,
aquatic, andjor wildlife populations), economic considerations (for
example, the environment has an economic quality if it facilitares the
provision of agriculture andjor industrial goods and services), and
recreational and aesthetic factors. At present, human health and
economic considerations are viewed as the most important of these by
society.
An environmental quality standard designed to attain or maintain the
human "health" quality is a measurable concentration of a contaminant
or other parameter of human stress, derived from known relationships
between it and its effects. It may be expressed in terms of the mean of
a number of samples collected during one or more periods of time,
together with a maximum allowable deviation of an individual sample
from the mean that will confer a predicted degree of health protection
for the human population(s) involved.
An environmental quality standard may range from (1) a stated
concentration value for a contaminant or other parameter of quality in
an environmental medium designed to provide a degree of health or
other protection for man or other species to (2) a regulatory standard,
complete with statements of scope and purpose, definitions, specifi-
cation of permissible concentration for the contaminant, compliance
requirements, prescription of sampling methods and frequency, and
acceptable analytical methods.
Environmental quality standards are often related to emission
standards. In the United Kingdom, emission standards are set
individually to achieve standards of water quality that are determined
by the intended use of the water. The emission standards may thus be
tightened if the monitoring of water content shows that quality levels
are not being attained.
Exposure standards
Exposure standards are commonly set for the workplace and for
food, but are also used for drinking-water quality control. The
41
acceptable daily intake (ADI) (see pp. 20~23) is the most usual form of
exposure standard; it specifies a daily level of chemical intake that is
considered safe over a lifetime of exposure.
Exposure levels have been set for cadmium in drinking-water and
bottled water in sorne countries. In 1972, an FAO/WHO Joint Expert
Committee on Food Additives (see Annex 5) set a provisional
maximum tolerable weekly intake from all sources of 400~500 ¡.tg of
cadmium. Acceptable levels of exposure via the air have also been set
for the workplace in many countries.
Biological standards
These are standards that relate to the concentration of pollutants in
biological fluids and tissues, for example, lead in blood or mercury in
human hair. The advantage of biological standards is that they include
contamination from all sources, which may vary from person to person,
thus their use provides an accurate picture of exposure. One
disadvantage is that it is difficult to implement biological standards
because this may require compulsory sampling. However, such
standards can be useful for screening on the basis of volunteer samples.
For example, the European Economic Community set three reference
blood levels of lead for a screening survey. After this survey, in the
United Kingdom, it was decided that when a child was found to have a
blood level of more than 250 ¡.tg of lead per litre, his or her
environment should be investigated for lead contamination (Haig,
1984a, 1984b ).
Environmental quality management

This approach is based on environmental quality standards. From
emission inventaries and monitoring data, a dispersion model for the
area concerned can be developed. Using this model, it is possible to
calculate the reductions in emissionsjeffiuents necessary to meet the
standards adopted.
Environmental quality management is a logical approach. lt permits
long-term planning to avoid environmental pollution. It is possible to
incorporate various factors such as city planning and energy and
transport policies into programmes designed to achieve or maintain
desired environmental quality. The approach has a built-in alert
system to prevent environmental pollution from reaching concentra-
tions that are in excess of those stipulated by the environmental quality
standard.
One of the drawbacks of this approach is that there are serious gaps
in the techniques for making emission inventaries and developing
dispersion models. There is also a need for continuous reappraisal of
the adequacy of the predictions made in the planning stages as
additional information becomes available on the performance of the
controls.
42
Chapter 6
Legal framework
Environmental control policies define not only the responsibilities of

industry, but also the limits on the government's power to intervene.
The decision to undertake or forego regulation is usually controlled by
an evaluation of risk to establish the circumstances justifying interven-
tion. For example, regulatory action may be authorized whenever there
is a substantial hazard to human life or health or the environment. In
sorne instances a broader approach may be adopted, that requires the
implementing agencies to weigh economic and social considerations
together with public health aspects in reaching a decision concerning
regulation.
Nature of the decision
The control options discussed in this book all seek to achieve one
final result: to ensure that levels of pollutants in a given medium-air,
water, soil, food-do not exceed specified quantities. In general, this
may be achieved through either legislation or voluntary cooperation
between industry and government, together with public information
and education.
These two contrasting approaches towards improving the quality of
the physical environment and safeguarding the health of the population
are well illustrated by the methods adopted in the USA and the United
Kingdom. On the whole, environmental regulation in the United
Kingdom is relatively informal and flexible while regulations in the
USA tend to be more formal and fixed. The United Kingdom makes
extensive use of self-regulation and encourages clase cooperation
between government officials and representatives of industry, while in
the USA the legislature and courts play a more active role in making
and enforcing environmental policy (Vogel, 1986; Brickman et al.,
1985).
The advantages of the cooperative approach can include effective
collaboration among all parties involved and a shared commitment to
improve steadily the quality of the environment. One disadvantage is
the lack of accountability. In this case, the success of the regulating
procedure depends on the sincerity with which the process is
conducted and whether independent analyses are available. In short,
both the regulators and the regulated must be committed to achieving
socially acceptable levels of protection against risk.
43
Generally speaking, the choice of measures and strategies for

regulation depends to a large extent on the existing legal and social
framework in the country (Magat, 1982). In countries where there is a
history of close cooperation between government and industry and of
industrial compliance with government "suggestions", and a positive
public attitude towards environmental quality, standards will tend to
be applied through voluntary agreements. On the other hand, countries
that possess a long history of state control of polluting activities
through licensing, and a well developed administrative apparatus for
the supervision of such activities, will generally use regulatory options
that fit into this particular system.
Legislation is particularly advantageous in countries where the
national constitution has provisions regarding the priority to be
accorded to environmental protection measures and the rights and
duties of the citizens with regard to the environment in which they live
and work. In this sense, environmental law should not be understood
as just another system of rules and agencies (Mayda, 1985). Rather, it
must be viewed as part of a comprehensive process of resource
management, supported by scientific data and assessment, and
integrated with economic development planning.
Scope and development of environmental

legislation
While the enactment of legislation is a political process, in many

countries statutes and regulations are often drafted initially by
technical and legal experts within government departments. In
countries where severa! statutes dealing with a particular issue have
been passed over a period of time, two evolutionary trends can be seen:
development of more comprehensive laws and an increasingly creative
and forward-looking role of government in environmental management.
For example, pollution control in many countries has evolved from
common law, dealing with nuisances, into legislative control of
emissions (or effluents) of particular pollutants at specific locations
(e.g., chimney stacks or river outflow pipes) on a case-by-case basis.
Other legislation involves the setting of ambient air and water quality
standards that then determine what emission concentrations are
permissible. Current legislation often attempts to anticípate and
prevent potential environmental problems, e.g., through environmental
impact assessment.
Over the years, the legislative framework has moved from a
responsive role that facilitated particular decisions towards a guiding
role that places decisions regarding pollution within a wider context of
social and economic development (Whyte & Burton, 1980). Legislation
in many countries now covers:
-protection and conservation of natural resources essential for survival
of people, animals, and vegetation alike;
44
Legal framework
-national and international rules and regulations controlling the

discharge and distribution of pollutants and chemical substances;
-approaches to planning and other behavioural controls to reduce the
impact of man-made pollution and natural hazards; and
-the establishment of investigatory bodies to appraise, review, and
quantify risks in relation to associated benefits.
The constitutional framework of a country determines, to a great
extent, the permissible areas of regulation and the assignment and
delegation of executive and administrative powers and responsibilities.
Even in countries that do not have a constitution, public health and
social policy considerations normally provide sufficient justification for
the framing of environmental regulatory measures, provided these
come within the permissible limits, e.g., concerning division of power.
Countries with a federal structure must recognize the need to divide
both jurisdictional and operational power and responsibility between
the central (or federal) government and provincial (or state)
governmen ts.
The development of a legal framework comprises two regulatory
actions. The first is the enactment of a formal legal instrument, such as
an act, ordinance or decree. The second is the development of
regulations, by-laws, rules, and orders, which may embody subsidiary
legal changes, by the authority designated in the formal legal
instrument. The development of these subsidiary instruments involves
the determination and acceptance of a standard or norm, representing
the pollutant level that is considered acceptable for protection of
human health and the environment. In common speech, however, the
words "regulation" and "standard" are often used interchangeably.
There are three possible approaches to effecting legal changes
(J ayasuriya, 1985):
(a) the revision or updating of existing laws by amending legislation;
(b) the replacement of existing laws by an entirely new piece of
legislation; and
(e) the enactment of comprehensive legislation, where none existed
previously, by the consolidation and revision of sections from severa!
existing laws, supplemented by new or additional provisions.
Approaches (a) and (b) are closely interlinked. It is often difficult to
decide which of these two approaches is preferable in a particular
situation. An assessment of the nature and magnitude of the
contemplated changes and the ease with which they can be
accommodated within the existing legislative framework may provide
an indication of which approach is preferable.
Approach (e) is generally more cumbersome and time-consuming,
particularly if substantial changes have to be effected in a number of
statutes. Moreover, since the new provisions will be embodied in
severa! different statutory instruments, the process of identifying the
changes and new legislative structures and linking up the different
substantive and procedural provisions is likely to prove tedious. In
45
addition, if the various statutes to be amended come within the scope

of different authorities or agencies, the new provisions may not be
enforced uniformly unless there is an effective coordinating and
monitoring mechanism.
Content and structure of regulations
As explained in the previous section, the fundamental decisions

relating to acceptable risk can be found in the appropriate legislation;
the technical details are usually set out in subsidiary regulations. For
example, the main legislative instrument might empower the issue of
licences to construct, operate, and maintain a certain manufacturing
facility, but the format of such licences and the general conditions
subject to which such licences may be issued might be dealt with in
subordinate legislation.
It is difficult to draw an appropriate dividing line between the
content of parliamentary legislation and subsidiary regulations. In a
number of countries, there are constitutional provisions that require
legislation for certain fundamental matters. There is also a question of
expediency. Legislation, as a rule, is more difficult to amend and to
adapt to changing circumstances, or technical possibilities, than are
regulations. The process of making regulations also facilitates the
participation of public interest groups and associations with expertise
in the particular area concerned. Flexibility in the establishment of
regulations is of particular importance in the field of environmental
control (Bothe, 1980).
As a rule, the determination of quantitative ambient or emission
standards and the prescription of certain known technical procedures
for processes and use standards are relatively easy to handle. However,
there are two problems. Firstly, a pollutant may be reaching the target
through various pathways, which may vary in importance according to
local conditions; in terms of health goals, therefore, it is difficult to
define absolute acceptable concentrations of any specific pollutant in a
given medium (Homburger, 1983). Quite often, this concentration can
only be determined on a case-by-case basis. Secondly, new problems or
dangers may emerge over time, and once recognized, may require that
a stricter standard be set. A standard that has been determined on the
basis of technical feasibility may well prove to be unnecessarily lenient
or obsolete when new technologies are developed that require stricter
standards (Stoel et al., 1980). In view of these two problems,
regulations must be flexible enough to permit amendments to be made
easily as new information and techniques become available.
Standards are generally based on evaluations of scientific data and
information and seek to apply generalized risk assessment to individual
situations. This, in turn, brings about the use of general clauses in the
46
Legal framework
relevant regulation, which may be based on one of two different

approaches. The regulation may take as a point of departure the danger
to a specific target. Then, any pollution that constitutes an
unacceptable danger to that particular target will be illegal. The
alternative point of departure is technical feasibility. In other words,
any pollution that can be avoided is illegal, even if it has not been
proven that this pollution is harmful to a particular target. A number
of countries have followed the latter approach in drawing up
regulations. In this case, the standards used are related in sorne way to
what may be called the "state of the art". This may be framed in terms
of the best technology currenti y in use in a particular industry, the best
technology available, e.g., in pilot projects and the like, or technology
that is not yet developed but which will have to be developed if the
potential polluter wants to start or carry on bis activities.
The reference to the state of the art (however defined) is often
combined with considerations of practica! feasibility and economic
costs. The legal problem related to the underlying economic issue is
proportionality, a principie that, in different forms under different
constitutional systems, limits state interference with private activity, in
particular, economic actlvlty. Thus, if the advantages for the
environment gained by the use of a particularly expensive pollution
abatement device are minimal, it may be a violation of this principie of
proportionality to impose the use of such a device on a particular
polluter.
A particular case in point concerns the "no-risk" or zero exposure
principie. The guiding philosophy of this principie is that there is no
acceptable level of risk for the hazard in question. This is in direct
contrast to standards based on the threshold level approach, which
inherently incorporates a risk-benefit analysis. Zero exposure puts the
emphasis on the "risk" side of the equation.
Zero exposure is required most often when a country is considering
the risks from suspected carcinogens. Experience in the USA with zero
tolerances in legislation has been widely discussed. The best known
legislation is the Delaney clause which regulates additives in food. In
the United Kingdom, the zero exposure principie is the basis of the
Pesticides Safety Precaution Scheme under which British companies
may not sell pesticides that have not been cleared as non-carcinogens.
One difficulty with using a zero-exposure or zero-tolerance approach
in standards is that the definition of "zero" depends on the accuracy of
the measuring techniques available. Moreover, our present ability to
detect amounts as low as one part per trillion for sorne substances far
outstrips our ability to evaluate the significance of such minute
amounts.
The format and structure of standards incorporated in legal
instruments vary from country to country. However, any regulation
will generally contain the following:
47
(a) a statement of the scope of the legal instrument, together with a

definition of the applicable terms and concepts, specification of the
responsible authorities, and of the parties, areas and substances to
whom or to which the instrument will apply;
(b) mention of applicable documents, such as other standards, specifi-
cations, and regulations;
(e) a detailed description of the requirements, including limits on
pollutants, applicable tests, mandatory control methods, reporting
requirements, etc. Where the requirements are to be implemented
over a period of time, a timetable will be included;
(d) a specific statement of the monitoring, reporting, and inspection
systems; and
(e) a statement describing applicable penalties for contraventions.
Sorne legal instruments may be more inclusive, covering such

matters as the operative time period of the instrument and procedures
for review. Where tax incentives or other fiscal benefits are available,
they may be set out in the instrument itself or in other relevant
instruments such as the legislation concerned with taxation.
The authority empowered to enact regulations varies from country to
country. As regards environmental standards, the appropriate authority
may be the Minister of Health or the Environment Agency or Control
Board. In many legal systems, however, the parliament or similar law-
making body has the power to review and approve such instruments.
The requirement that these instruments be published, usually in a
government publication, and that they be tabled in the legislature,
enables control to be exercised over their scope and content.
Experience from most parts of the world suggests that approval of
standards is often nothing more than a procedural formality.
Furthermore, certain legal systems do not require all standards and
their revisions to be tabled in the legislature or other appropriate
forum. For instance, the power to modify lists of hazardous substances
or of scheduled industries can usually be exercised through an order
that requires hardly any follow-up formalities, except perhaps its
publication.
lnstitutional considerations
Different countries have different political and administrative

hierarchies. Decisions, both legislative and administrative, are generally
made at various levels, e.g., national, regional, and local. The
distribution of power within the country determines the leve! at which
particular decisions may be taken. In view of the complexity of many
environmental issues, sorne thought must be given to the political and
administrative organs and structures best suited to environmental
48
Legal framework
decision-making in each country. Administrative considerations also

influence the types of institutional mechanism and appellate procedure
that are to be built into the legislation. For instance, the right to a
hearing, before an application is rejected or refused or a licence is
cancelled or suspended, has been incorporated into many administra-
tive law systems.
One factor in determining the appropriate decision-making leve! for
environmental control is the geographical scope of the problem.
Another is the technical expertise of the various decision-making
bodies. Authorities at the local leve! may not always possess the
necessary knowledge to make decisions that take into account fully all
the technical issues, possibilities, and options involved. They may also
be more subject to local pressure than a central or national authority.
On the other hand, the local conditions of the area affected must also
be considered in the decision-making process.
The decision regarding the appropriate leve! is also related to
whether the contemplated regulations are to be local in operation or
applied on a nationwide basis. In sorne cases uniformity is necessary, in
particular where the environmental problem is widespread or potential
environmental regulations may create barriers to trade. Thus, pollution
created by mobile sources is often regulated on a nationwide basis and,
at least as far as certain basic minimum rules are concerned,
regulations generally extend to the entire area in which these sources
move; for example, pollution from aircraft is regulated on a worldwide
basis. On the other hand, in situations where regional or local
conditions warrant special consideration, the adaptation of general
regulations may be inappropriate.
Another issue that should be considered in the drawing up of laws
governing environmental pollution is that environmental risks are
characteristically multidimensional problems that cut across the normal
jurisdictions of government departments. Decisions that affect the
environment may have to be made by public bodies or agencies that
are not primarily concerned with environmental matters. One way of
ensuring that environmental concerns are included in the decision-
making process is to institute procedures providing for the partici-
pation of the competent government agencies in any decision that may
have an impact on the environment. These procedures may take
different forms, such as providing for representation in drafting or
planning committees, or requiring submission of drafts for prior
approval.
Where different agencies attempt to solve one particular problem
together, severa! administrative problems may arise (Whyte & Burton,
1980):
- There may be uncertainty about exactly which agency should take

overall responsibility and, as a result, action is delayed or not taken at
all.
49
-Interdepartmental rivalries and jealousies may result in the withhold-

ing of information that should be shared, in order for the best
solutions to be found.
-Each agency tends to have its own particular interests and
constituency so that interagency confiict rather than cooperative
problem-solving may ensue.
- Technical expertise may be divided between different agencies so that
no one agency can gather together the necessary scientific and
managerial team.
Countries that have special ministries, departments, or agencies with

responsibility for environmental issues should ensure that all relevant
sectors are adequately represented and that all perspectives are taken
into account during policy- and decision-making (MacAndrews &
Chia, 1979). Environmental issues cannot be treated in isolation; every
effort must be made to take account of all factors that impinge on
environmental problems.
Geographical dimension of environmental problems
The geographical range of environmental problems is essentially

determined by the laws of nature. The spread of pollution in the air is
governed by natural agents such as the wind, temperature distribution,
and humidity. The spread of pollutants in water is determined by the
natural flow of that water. Any meaningful regulatory approach must
take these factors into account (Organization for Economic Cooperation
and Development, 1984). Certain pollutants may find their way from
one medium to another, e.g., from the air into soil and water and thus
into the food chain. Certain areas are particularly vulnerable; others are
particularly valuable because of their influence on climate, their
capacity to produce oxygen, etc.
Natural phenomena, such .as those described above, have nothing to
do with the distribution of powers provided for by particular national
legal systems or political boundaries drawn up by man. Thus, the
jurisdictional scope of an agency competent to make the relevant
decisions may not have the same boundaries as the geographical range
of an environmental problem. This can pose problems within a country
and even greater problems when environmental pollution transcends
national boundaries. Generally, it is not possible to change the
distribution of power in order to extend the territorial jurisdiction of
an agency. In a federal country such a change of distribution of powers
may necessitate constitutional amendments, which are difficult, if not
impossible, to carry through. The solution to this problem, both within
countries and especially in the international sphere, depends on the
establishment of procedures of cooperation to ensure that the problem
is dealt with in a consistent and concerted way, after consultation and
deliberation with all relevant agencies, bodies or institutions.
50
Legal framework
Supporting measures for regulatory strategies
Where regulatory strategies have been adopted, the crucial question

is whether the relevant standards are observed in practice. Various
schemes and procedures, usually with a legislative basis, have been
developed to facilitate the implementation of environmental standards.
Environmenta/ impact assessment

An environmental impact assessment (EIA) is an assessment of the
short-term and long-term effects of any proposed action (or absence of
action), including policies, legislative proposals, programmes, projects,
and operational practices, on the population and the physical,
biological, and socioeconomic environment. It employs a structured
approach to the evaluation of the impact of a development (e.g.,
hydroelectric installation, nuclear power plant, industrial complex),
programme or policy on human health and the environment. Possible
measures to prevent or control the impact of the various associated
forms of environmental pollution are also included for consideration
during the decision-making process. This allows decision-makers to
select the option that results in the least pollution, or to stop the
project entirely. Where standards exist, the persons proposing the
development, programme or policy are required to state how they
intend to comply with such standards. Environmental impact assess-
ment is probably the most comprehensive procedure available today in
which health effects and control strategies are considered (Mayda,
1985).
Licensing strategy
Where a licence is required before a product can be marketed, an
installation built or operated, or a process used, but no rules are
prescribed as to the particular characteristics that the product,
installation, or process should possess, the licensing requirement is
itself a strategy. On the other hand, if licensing is used as a way to
ensure compliance with predetermined standards, it becomes an
instrument for the enforcement of those standards.
The licensing requirement ensures that the proposed actlvities are
not undertaken before the competent authority has approved the
project on the basis of the information provided in the application.
Licensing can also be used as a strategy that combines information
gathering and licensing. Thus, a licence may be considered to have
been granted if the competent authority does not react to information
given within a prescribed period of time. Non-compliance with the
conditions specified in the licence generally entails withdrawal,
cancellation or suspension of the licence by the issuing authority. The
possibility of such a course of action, which could have far-reaching
economic implications, often promotes compliance with standards and
other relevant conditions.
51
Setting env1ronmental standards
Dissemination of information
This aspect of regulation implementation is related to a more general
subject-the shaping of public attitudes. Such attitudes may be
influenced by, among other things, information provided by the state,
or by prívate concerns or individuals in compliance with legislation.
One particular aspect of this subject that is relevant to the control
options discussed earlier is the attitude of consumers to products that
are created by polluters or potential polluters. Thus, the enactment of
regulations requiring that product labels contain information about
possible hazards associated with the particular product may deter
people from buying or using it. In this case, industry may then limit
its production or produce alternatives that are less hazardous.
Conversely, special labels for goods that possess positive qualities for
the environment may preferentially stimulate their sale to the
detriment of other, more harmful, products. Legal provision for
environmental education programmes is useful in sensitizing the target
groups of such programmes to the need to protect the environment and
natural resources, using a variety of methods, including enforcement of
standards.
Economic incentives or disincentives

Fiscal instruments, such as taxes, effluent charges, charges on
particular pollutants, subsidies for desirable activities, and tax-
deduction schemes, are quite often used as part of environmental
policy (International Union for Conservation of Nature and Natural
Resources, 1980a). They may be related to a particular standard and
used to enforce it; for example, a charge may have to be paid by the
polluter if an emission exceeds a certain prescribed concentration level.
At present, the principal instruments used are taxes or other charges
on emissions or other discharges of pollutants into the environment;
charges on particular uses or processes; product charges (e.g., charges
on oil, beverage containers or used tyres); direct subsidies for pollution
abatement measures or for the development of relevant technology; and
increased depreciation or other tax-deduction schemes for desirable
investment, such as in pollution abatement equipment.
Care must be taken to define the purpose of such charges. Sorne may
simply be used as a means of financing a certain activity, in which case
they constitute a device for the redistribution of income. Others may
be used to implement environmental policy by financing measures for
the preservation or amelioration of the environment. Charges may also
be levied against polluters in an attempt to deter potential offenders. In
this case, the effluent or emission charge is one of the most widely
discussed tools of environmental policy. It is said to be more effective
than direct regulation (i.e., setting of binding standards) because it
relies on market forces for protection of natural resources (in particular
the regenerative capacity of air and water). The disincentive effect of
52
Legal framework
effluent charges is only in part a question of market mechanisms, in

that the charge is not based on supply and demand, but is determined
unilaterally by the government.
The basis of the calculation and the determination of the charge,
however, are crucial. The disincentive effect depends to sorne extent on
the economic status of the polluter. The charge levied against the
polluter must be higher than the cost of equivalent pollution
abatement. The charge should be calculated on the basis of the amount
of pollutant emitted into the environment. This poses a difficult
administrative problem as regards measurement or estimation of the
level of pollution. This practica! difficulty appears to be the major
obstacle to the extensive use of pollution charges as part of
environmental policy.
A positive incentive for pollution abatement may often be
appropriate, although such an approach also presents sorne fundamen-
tal problems. It is generally agreed by most industrialized states that it
is the polluter, and not the taxpayer, who should bear the cost of
pollution abatement or prevention. The adoption of this "no-subsidy"
principie internationally means that distortions to trade are minimized.
However, it has always been accepted that there are exceptions to this
principie, for example, where an industry providing essential employ-
ment would be priced out of the market if it had to bear the cost of
controlling its effluents. If strict environmental standards are to be
enforced, sorne kind of financia! assistance or tax subsidy from the
government will often be needed, at least provisionally, so that weaker
enterprises are not forced out of business.
Government subsidies, either in the form of direct subsidies or tax
advantages (tax credits or accelerated depreciation rates), raise certain
questions. It is important that these advantages are not given to finance
investments that would be made even without the externa! financia]
incentive. Such unwarranted financia] advantages merely provide
windfall profits and do not act as an incentive.
It is, however, difficult, if not impossible, to ensure that such fiscal
advantages are given only for investments that otherwise would not be
made. Furthermore, if the provision of subsidies or the contribution of
financia! incentives is made to decrease industry's costs of investment,
the assumption is made that the polluter is prepared to spend his own
resources on pollution control. Any subsidy related to capital
investment stimulates capital-intensive abatement measures (acquisition
of expensive equipment) rather than development of other ways of
reducing pollution (for instance, changes in the production process, in
the material used, or in the product). It seems advisable that assistance
should not be based on the introduction of any particular investment
or technique, but rather on the simple criterion of damage reduction.
In addition, tax advantages, such as accelerated depreciation
allowances, tend to favour highly profitable undertakings (those paying
high taxes), and not the weaker, marginal enterprises, which may need
more assistance and which may in sorne cases be the worst polluters.
53
Setting env1ronmental standards
/nformation gathering
Legal regulations for the protection of the environment often
prescribe information that must be provided to a particular government
body, usually a state agency. Such information may be necessary in
relation to certain control strategies (for example, to ensure that
emission standards are complied with), but information gathering and
inspection may represent a regulatory strategy in itself. The need to
give information, for example, on the possible effects of a product or
on the possible impact of an installation, has the immediate effect of
inducing the providers of such information to consider the potential
consequences. In addition, this information provides the basis for any
necessary feedback and follow-up action by the responsible agency. In
the case of chemicals, a number of laws require the testing of a new
chemical before it can be marketed, without defining any particular
standard. Thus in this case, the obligation to provide information does
not serve as a means of enforcing a particular standard, but rather as
the basis for future action, if the relevant administration believes that
marketing of the substance would be dangerous or would create an
unacceptable risk (Brickman et al., 1985).
Administrative supervision and penalties

Preventive control through licensing requirements is not appropriate
for all activities that may affect the environment. Even where they are
used, licensing requirements have to be supplemented by regular
checks. The supervising administration must not only possess the
necessary information about what is going on, but must also be in a
position to take effective measures on the basis of such information.
Monitoring of ambient quality, as well as of the emissions or
discharges of individual polluters, is essential. Furthermore, rules
facilitating access by the competent agencies to information generated
by the polluter are an important feature of effective supervision. For
example, polluters may be obliged to measure emissions or discharges
on a regular basis and to report the results. The agency will also have
the right to carry out inspections, and to frame requirements for
specific control measures, if, for example, a particular production
process proves to be too harmful to the environment.
Compliance with applicable standards may also be ensured by
administrative penalties or even criminal sanctions. One of the
problems in this context is similar to that discussed in relation to fiscal
disincentives, i.e., the penalties must be more costly than pollution
abatement. Otherwise, the polluter will rather pay the penalties and
continue to pollute. A higher penalty for a second or subsequent
offence, including perhaps an order for closure or similar action, may
improve compliance.
The mere existence of these measures of administrative supervision
and sanctions may serve as a deterrent to potential polluters. In
general, however, there are a certain number of conditions that must
54
Legal framework
be met if the measures are to be effective. It has already been

mentioned that sanctions must be sufficiently severe. Similarly, the
supervisory or prosecuting agencies must be competent to deal with the
problem; in particular, they must possess the necessary technical
expertise and manpower, and they must have a certain amount of
political backing. Polluters may try to exert political or other pressures
on the agencies in an attempt to persuade them not to enforce the
relevant standards or to interpret the regulations more leniently.
Compliance with the applicable rules of environmental law must be
accorded the highest priority, and safeguards must be taken against
attempted interference with the exercise of powers under the law.
It is stressed that rules must be designed to ensure that the
monitoring of compliance does not become too complicated and
cumbersome. Since there are numerous activities that may have
detrimental effects on the environment, regulatory bodies must focus
on the most important aspects. Regulatory interventions should be
introduced only where the chain of events allows for successful control.
For instance, it is not feasible to monitor the emissions of individual
motor vehicles; it is easier to formulate and enforce regulations on the
construction of engines that will result in an overall reduction in
exhaust emissions, although, in any particular case, emissions may be
excessive due to a mechanical defect in an individual vehicle. A scheme
for the periodic inspection of cars is mandatory. Subject to cost-
benefit considerations, the feasibility of requiring owners of motor
vehicles to install devices for the reduction of exhaust emissions may
also be considered as a possible option. Such an option assumes
importance particularly in countries that have a large number of old
motor vehicles. Researchers and manufacturers need to be offered
incentives to develop and manufacture such devices.
Land-use planning
Land-use planning is an important collateral method of protecting
certain targets from pollution. By means of land-use planning, it is
possible to prohibit environmentally harmful activities in certain areas
and to confine polluting activities to clearly demarcated geographical
areas or sites where no particularly vulnerable targets exist. Land-use
planning is thus an important means of singling out and protecting
areas that are vulnerable or particularly important from an ecological
point of view. 1 If polluting activities are systematically confined to
particular regions, the state becomes a planning agency for industrial
siting decisions. Traditionally, it has been industry that has chosen
suitable sites, leaving the state with only retrospective control over the
consequences of a decision that has already been made (i.e., restrictive
1
LAUSCHE, J. D. Selected management too/s for mtegratmg ent)lronmental and health concerns wuh
development. Unpubhshed WHO document, EFP/EC¡WP¡83.13.
55
planning). In a situation where the capacity of the environment to

eliminate pollution is limited, it may be more appropriate for the state
itself to identify and demarcate appropriate sites and to exclude
industrial installations from others (i.e., positive planning).
National conservation strategies

In 1980, the International Union for the Conservation of Nature and
Natural Resources (IUCN) launched the World Conservation Strategy
(International Union for Conservation of Nature and Natural
Resources, 1980). The strategy has been widely endorsed by
international organizations, governments, and non-governmental
organizations throughout the world.
The strategy is now being used as a basis for discussion,
programming, and action in a number of countries concerned with the
ever-increasing pressures on their environmental resources and with
the consequences of these pressures for long-term economic develop-
ment (International Union for Conservation of Nature and Natural
Resources, 1983). Sorne countries have developed National
Conservation Strategies to emphasize the relationship between
development goals that satisfy human needs and those that maintain a
healthy environment. These strategies can form a vital part of the
development planning process of a country; they can indicate patterns
of development that are detrimental to the environment and help focus
policies on alternative development schemes that satisfy human
requirements while maintaining a healthy environment.
56
Chapter 7
Consequences of different approaches to

environmental health protection
For each level of risk and for each means of control or prevention,
there will be not only health-related concerns, but also a range of
economic and social consequences. While an understanding of these
consequences will obviously be very helpful in formulating a decision
on control, it will not be necessary to apply all of the techniques
described in this chapter to each situation. Rather, the analyses used
should be designed to provide useful information on how effectively a
proposal will achieve the desired result and how the proposal will
affect other sectors of the society, such as the enforcing agency, the
enterprises involved, and consumers. A full list of possible analyses is
given in Table 5.
Table 5. Possible types of analysis of proposed control

measures
Concern Type of analysis
Risk Net risk reduction

Comparison of risks
Costs Cost-effectiveness
Industrial impact
Economic impact
Risk--cost comparisons
Benefits {and costs) Benefit--cost analysis
Distributional analysis
Environment, etc. Cross-media analysis
Environmental impact
Social impact
Other impacts
Risks and benefits
The first question to consider is whether the technical analyses have,

in fact, covered all the risks and benefits associated with the proposed
action. Often a decision to deal with one type of risk will affect other
57
risks in society as well. These effects may be either positive (other risks
are reduced) or negative (other risks are increased). For instance,
prohibiting the use of nitrates as a food preservative, because the body
can convert them into possible carcinogens, may actually increase the
total health risk because nitrates in food prevent the development of
Clostridium botulinum, a bacterium that causes food poisoning that is
often fatal (World Health Organization, 1978a).
Such problems are commonly encountered by regulatory agencies in
considering whether to limit the use of particular chemical substances.
Usually, the imposition of such a limitation will result in the substitution
of another substance for the one that is regulated. It then becomes
necessary to consider the risks associated with the use, manufacture,
and disposal of the substitute substance. Sorne possible substitutes may
be more dangerous than the one being considered for control. It is
necessary to determine whether the production process is likely to be
more (or less) risky when these substitutions are made, and whether
there will be more (or less) risk associated with the use of the product
incorporating the substitute.
An industrial chemist familiar with the industrial processes under
investigation may be able to answer many of these questions.
Experience in countries that have already implemented the proposed
controls may also provide useful information. Regulatory agencies in
such countries may also be able to indicate what types of action can be
taken to reduce any associated risks.
Cross-media concerns
It is also important to be sure that the proposed control measures

will really reduce the risks and not just transfer them somewhere else
(Conservation Foundation, 1984; World Resources lnstitute and
lnternational lnstitute for Environment and Development, 1986). For
instance, sorne procedures for removing potentially toxic volatile
chemicals from wastewater result in the release of these chemicals into
the air. If this release occurs in an area with a high population density,
the total risk may actually be increased by the effort to remove the
chemicals from the water. Similarly, placing to2{ic substances in
landfills may result in their being carried into surface water or
groundwater by rainfall.
The procedures for conducting cross-media analyses are not well
developed. Such an analysis requires a good understanding of the
physical, chemical, and biological properties of the chemicals involved
and the control techniques being proposed, as well as substantial
insight and imagination. However, just asking what happens to
the pollutant when a certain control is adopted may well result in the
most serious cross-media problems being identified before they
occur.
58
Consequences of environmental health protection
Acceptable risks
Having established the net risk reduction associated with the

proposed action, the question arises as to whether this is considered
acceptable by society (National Academy of Sciences, 1975). The types
of risk that are considered acceptable can vary substantially from one
society to another. A society's tolerance for risk may also decrease as it
develops economically. This suggests that not only present but
probable future levels of acceptable risk should be considered when
making a decision.
What the public perceives as a significant hazard may be very
different from the objectively assessed risk. For example, when three
groups of people (league of women voters, university students, and
business and professional club members) were asked to rank 30 causes
of death, nuclear power was placed in first position by both the league
of women voters and the university students. However, actuarial
studies of the same 30 causes of death place nuclear power in 20th
place (Upton, 1982). When the public perception of risk is very much
higher, or lower, than the actuarial risk, difficulty may be experienced
in formulating standards. The dilemma arises in deciding how much
weight to give to the public perception of risk and how it can be
reconciled with the computed risk.
Although sorne researchers have attempted to make rigorous analyses
of a society's willingness to accept different types of risk, there is no
accepted methodology for such comparisons, and no country has
adopted such risk comparisons as the basis for regulation of hazards.
Thus, there is likely to be little more than intuition, supported by
public comment, to guide the decision-maker in evaluating the socially
acceptable level of risk.
Cost and effectiveness of control measures
Rarely are regulatory decisions based solely on consideration of level

of risk and available control techniques. The cost of the proposed
action is usually also taken into account. A complete cost estímate
includes both the "investment" cost required initially to bring
facilities into line with the proposed regulations, and the costs required
to maintain compliance thereafter, including any increased manufactur-
ing costs and reduced profits that may result. Cost estimates based on
experience in developed countries may not accurately represent the
costs in less developed countries.
Usually, in addition to knowing the absolute cost of the proposed
control method, the decision-maker wants to be sure that it is cost-
effective, i.e., that it represents the cheapest way of achieving a given
goal (Thompson, 1980).
The first problem in analysing cost-effectiveness is to define
properly the goal to be achieved. Often a goal can be defined in
59
different ways, which can have significant implications for the

strategies to be considered and the resulting costs. For instance, the
goal of a programme to control air pollution may be (a) to reduce air
emissions toa given level, (b) to achieve a given ambient air quality, or
(e) to reduce to an acceptable level the risks from the air pollutant. If
goal (a) is adopted, the alternatives are limited to actions such as the
installation of pollution abatement equipment to reduce the emissions
to the desired level. If alternati ve (b) is chosen, the cost-effectiveness
analysis would include all these techniques, as well as other strategies
such as construction of higher smoke stacks or location of new facilities
in clean areas. If goal (e) is chosen, the available alternatives may be
expanded still further to include such items as improvement in medical
care, location of facilities in remote areas where few people will be
exposed to the pollutant, and requirements for workers to wear safety
equipment.
The identification of all the alternatives is usually a substantial task.
Once they have been identified, it usually becomes clear that they will
not all, in fact, achieve the same goal. Commonly, the less expensive
options will be less effective in reducing risk. For instance, the
cheapest way of reducing the risk of hearing impairment in factories is
usually for everyone working in the facility to wear ear-plugs.
However, the employees often will not comply with such a
regulation. Thus, while this alternative may appear to be the least
expensive, it cannot be depended upon to achieve the desired
reduction in risk.
The decision-maker, therefore, has to trade off the costs and
effectiveness of the various possible control strategies. These trade-offs
are further complicated by the probable sensitivity of the analyses to
two sets of assumptions. The first set includes the assumptions made
about the prices to be used in the cost estimates. Relatively small
changes in interest rates or foreign exchange rates can produce large
variations in the relative cost-effectiveness of alternative control
options. The second set of assumptions includes those made about the
relative prices, total emissions, and acceptable risks that will apply in
the future. Changes in any of these may make it more cost-effective in
the long-term to invest in more stringent controls than would seem to
be necessary under existing conditions.
Other types of analysis
The types of analysis discussed so far, i.e., comparison of risks,

analysis of acceptable risks, cross-media analyses, and cost-
effectiveness analyses, should probably be included in sorne form in
every decision-making process. Other types of impact analysis may be
appropriate, depending on the particular circumstances and concerns.
Many impact analyses can be extremely expensive and time-
consuming if strictly carried out. However, such strictness is often
60
neither necessary nor useful. If a lack of resources, data, or valid

methodology make rigorous analysis difficult or of doubtful value,
there are severa! possible approaches. One is to make sure that
someone familiar with the potentially important issues thinks carefully
about how serious the impact of the proposed action may be. This,
perhaps supplemented by a few discussions with other knowledgeable
parties, may be all that is necessary. Such a quick review may suffice
to eliminate concerns about the possible seriousness of the impact, or
may allow the government or the affected parties to reduce the severity
of any such impact.
A second possibility is to review studies relating to these issues that
have been completed for other purposes. For instance, economic
assessments undertaken to justify a foreign loan may contain enough
information to suggest the likely economic impact of a pollution
abatement requirement on a particular industry. lnferences can also be
drawn from impact analyses carried out in other countries. Such
inferences should only be drawn by someone familar with the theory
and methods used in the study, as well as with the particular types of
problem that the proposed action may create.
A third approach is to conduct the entire decision-making process
openly and publicly, inviting comments from individuals familar with
L•le issues raised.
All these actions may provide much of the information that would
result from a more formal and rigorous analysis. They should at least
help to ensure that the decision-maker is asking the right questions and
examining the correct issues.
Risk-cost comparison
While cost-effectiveness analyses are used to compare alternative
means of accomplishing the same reduction in risk for a particular
pollutant, risk--cost comparisons are used to compare the relative costs
of risk reduction, either by controlling a substance at different levels of
stringency, or by reducing alternative types of risk.
Once estimates of both risk reduction and cost have been made, a
risk--cost comparison is relatively straightforward. The reduction in
risk (expressed in terms of the number of illnesses, accidents, or deaths
avoided for the whole population) is divided into the cost of attaining
that reduction to give a ratio measured in terms of the cost per unit
risk reduction-for instance, dollars per life saved, per accident
avoided, or per asthma attack avoided.
For such risk--cost analyses to be directly comparable with each
other, the risk reduction and the costs must each be expressed in
similár units. This requirement is not usually a problem as regards
costs. 1t is, however, a problem when a proposed action will reduce
more than one type of risk, or when the alternative actions affect
different types of risk. In such cases, it is usually more helpful to carry
out a benefit-cost analysis (see page 62).
61
Industrial impact analysis

An industrial impact analysis assesses the likely economic impact of
the proposed regulations on the profits and viability of the industry
most affected. These analyses are often inaccurate and actual compliance
costs and economic impacts are frequently lower than projected. The
industry's economic situation may also turn out to be much different
from that expected. Any analysis should be reviewed by trained
economists who are familar with the domestic and international
performance of the industry.
A key determinant of the industrial impact is the extent to which
industry can pass on any increased costs to the consumers in the form
of higher prices. If, for instance, the industry is in close competition
with foreign producers, it may be difficult to increase prices and the
economic impact will therefore be significant. Another consideration is
the size and age of individual companies in the industry: newer and
larger companies are often better able to absorb increased costs.
An industrial impact analysis can help to identify actions that the
government might take in order to reduce the severity of the economic
impact. For instance, any economic impact will probably be reduced if
the deadline for complying with the control requirements is delayed
(but such delays may also extend the risks). Similarly, the controls
could be applied immediately to new facilities, but be delayed for older
ones. There are a number of such variations that can help reduce the
economic impact and may be justified if the projected impact is
unusually serious.
Economic impact analysis

Sorne countries undertaking extensive environmental and public
health protection programmes have been concerned that the cost of
these programmes might adversely affect the overall state of the
nation's economy, particularly the rate of inflation, leve! of unemploy-
ment, economic growth, and foreign trade. Such large-scale effects can
only be estimated by using relatively sophisticated macroeconomic
models of the economy (Organization for Economic Cooperation and
Development, 1985). The results of such efforts conducted in countries
such as France, Japan, the Netherlands, and the USA generally show
no significant impact. It is unlikely that similar analyses in developing
countries would demonstrate significantly different results, unless the
proposed expenditure was significan ti y greater than 2% of the
country's gross domestic product. If such an analysis is thought to be
desirable, the decision-maker should enlist the cooperation of the
finance ministry or economic planning commission in conducting the
analysis.
Benefit-cost analysis
When the effects of different types of action are being reviewed,
both benefits and costs should generally be expressed in monetary
62
units, and benefit-cost ratios computed in order to make inter-study

comparisons easy (Organization for Economic Cooperation and
Development, 1981; Thompson, 1980). Estimating these monetary
values may be quite difficult, particularly when potentially fatal health
risks or the stability of ecosystems is considered. Because of these
problems, a sophisticated benefit-cost analysis may not always be a
useful decision-making tool (Swartzman et al., 1982). However, even
where economic values cannot be derived, the benefit-cost framework
can assist in the organization of complex scientific data, by presenting
meaningful quantitative measures of environmental results and provid-
ing a basis for comparison of improvements in health and
the environment with the cost of pollution reduction (Luker,
1985).
Distributiona/ ana/ysis
Distributional analysis addresses such questions as whether any
particular groups are expected to pay an unreasonable share of the
costs of a proposed programme, and whether the benefits are widely
distributed or limited to a small section of the population (Harrison,
1975). The distribution of the benefits of health and environmental
protection programmes should be relatively clear from the risk
assessment. It is also reasonably easy to identify those who are
currently experiencing the risks and, therefore, will benefit when they
are reduced.
Estimating the distribution of the costs, as well as any monetary
benefits, may be more difficult. The costs will often be passed on
through the economy so that they are ultimately met by people quite
different from those who originally pay them. For instance, if the
controls are imposed upon companies producing goods primarily for a
protected domestic market in which there is little competition, the
costs will probably be passed on to the consumer in the form of higher
prices. On the other hand, an industry that exports much of its
production and is in competition with other foreign companies (or with
other substitute products) is essentially a "price taker" and will be
unable to pass on the costs in the form of higher prices. In this case,
the costs will be borne either by the owners of the company, by its
workers (who may receive lower wages), or by the suppliers of the raw
materials.
The question of the direction and the extent to which the costs are
passed on requires analysis by a trained economist who is familar with
the economy's characteristics and with the conditions in the industry
facing the new expenditure. Because of the difficulty of making these
analyses and the uncertainty that is necessarily associated with any
results, distributional analysis might best be restricted to an analysis of
the distribution of the direct benefits and the direct costs. Such
a simplified analysis may well indicate whether or not there are likely
to be any distributional problems associated with the proposed
action.
63
Environmental impact analvsis

An environmental impact analysis is often used to assess the
environmental and social impacts of a proposed development project,
such as a dam or a new power plant (Munn, 1979). Such analyses can
also be undertaken for other types of action, such as the disposal of
sludge from a sewage treatment plant or an air pollution scrubber in
valuable wetland, or the construction of a sewer pipe which may
damage valuable areas and interfere with natural stormwater run-off
thus causing flooding. The purpose of an environmental impact
statement is to identify both the possibility that undesirable events may
occur and ways of avoiding them (see also page 51).
The decision as to which of these additional assessments should be
undertaken for a given proposal will depend upon three considerations.
The first is whether there are any particular national concerns
(environmental, economic, or social) that may be adversely affected by
the proposed action. For instance, certain environmental assets (e.g.,
wetlands, forests), certain "infant industries", or certain social groups
(e.g., tribal people) may be considered particularly important. If any of
these could be adversely affected by a proposed action, an impact
statement may be called for. The second is whether any particular
types of analysis, such as environmental impact assessment, are required
by law, regulation, br national policy. The third is whether the
proposed action is likely to have a major impact on one particular
industrial sector, social group, environmental amenity, or geographical
area of the country. When the impacts are concentrated in this fashion,
it may be useful to evaluate them to ensure that they are not excessive.
64
Chapter 8
Decision- maki ng process
It is not possible to describe in detail the decision-making process

concerning regulation of an environmental problem, since this may
involve a large number of activities and considerations. Nevertheless,
the process does not always need to be extremely complex. Very often,
for example, there are useful precedents, related either to the
environment or other areas, which can serve as examples.
The main objectives in all instances are:
-to agree on a goal (or norm) for control of a particular pollutant,
that will provide adequate protection for health; and
-to establish a suitable regulatory strategy and legislative instrument
to achieve this health goal.
The decision-making process varíes from country to country, even
though from a strictly technical viewpoint the health goals are often
similar. Variations may occur, for example, in developing countries
where there may be a larger group of sensitive persons, thus
necessitating a more stringent health goal. There will be differences in
the strategies used to achieve the goal, depending on numerous factors
including social, economic, and institutional considerations. In de-
veloping countries, for example, it may be suitable to have sorne
form of licensing scheme that can be implemented by relatively few,
well trained staff. In addition, the time-frame for implementing a
certain measure may vary; for example, a country may decide to deal
with new industries first, giving notice to existing older industries that
they will be required to comply with the regulations within a certain
number of years. Examples of this are the various control measures for
cars, which are usually announced years ahead of time to give the
automobile industry time to comply. Finally, however, despite the
large number of individual national approaches to control of a given
pollutant, there are few major differences and countries should not
have much difficulty in finding appropriate examples relevant to their
situation in other areas.
Environmental decision-making is never carried out in isolation. In
recent years, public awareness of environmental hazards has increased
considerably. This trend tends to increase the complexity of the
process at the national leve! since the number of groups involved in
discussions (government departments, politicians, industrialists,
joumalists, consumer groups, etc.) can be formidable (Vaupel, 1982;
Coppock, 1985). In addition, consideration must be given to
65
international implications of action at the national level. There are

questions concerning the common environment (air and water) of
neighbouring countries, and regarding the import and export of
products. Plants and vegetables are often affected in this way when
limits are set for the pesticide residues on (or in) them. These actions
may sometimes be perceived as, or even used as, trade barriers.
International conventions or agreements may also affect the national
decision-making process. For example, countries bordering on the
Mediterranean have signed a treaty that obliges them to limit their
effluent from land-based sources. Certain groups of countries may
decide to take joint action-this was done by the European Economic
Community in the case of cadmium (see page 33), and by the countries
belonging to the United Nations Economic Commission for Europe,
which decided to reduce sulfur dioxide emissions to 70% of the 1980
level by 1993. Finally, citizens in one country may not be willing to
accept a higher risk (i.e., have a more lenient norm or regulation) than
those in other countries and the decision-maker may also have to take
this popular feeling into consideration.
The number of environmental issues in each country requiring
attention and possibly regulation can be large. Such issues may
suddenly become areas of public concern as a result of many different
occurrences, such as an industrial accident, press reports about a
mysterious illness, or pressure for action from well organized and
informed citizen groups. In all countries, the large number of items on
the environmental agenda tends to stretch resources, such that sorne
form of international cooperation or consultation for exchange of
information and results of analysis is almost mandatory. In addition,
the scientific information base will change with time as more data
become available. This may lead to lower thresholds for no-observed-
adverse-effects, and correspondingly stricter standards in sorne
countries. This particular situation may cause problems in developing
countries, since it takes time and it is sometimes difficult to find out
the reasons why changes are made.
The organizational and institutional structures for making environ-
mental decisions will vary from country to country (Schaefer, 1981;
Johnson & Johnson, 1977; Lam, 1982; International Institute for
Environment and Development, 1981 ). In the past, ministries of health
were mainly involved in decision-making when basic sanitary measures
in air, water, and food were the prime concern. With the increasing
contamination of the environment as a result of waste disposal by
industry and the ever-increasing use of chemicals for a multitude of
applications, including agriculture, more and more sectors became
involved in formulating measures for protecting people and the
environment in general. Today, many countries have consolidated the
responsibility for protecting the environment by setting up a separate
department or ministry. Such a department may have mainly a
coordinating function or, at the other extreme, may be a fully fledged
environmental protection agency.
66
Decision-making process
The complexity of the decision-making process will depend on the

organizational and institutional structure. The existence of a depart-
ment of the environment will probably facilitare the process, since it
can establish a permanent mechanism for gathering and processing the
information required for regulating pollutants. It can also ensure that
the administration of the legislation and regulations is carried out in a
well organized manner. Under these circumstances, the role of the
ministry of health would be mainly to identify hazards, derive
acceptable norms for the protection of the population, and carry out
monitoring and health surveillance activities to ensure that the
measures taken are adequate. Through a department of the environ-
ment, consultation with other departments and interested groups can
be streamlined and made efficient.
The alternative to this procedure might be for a sectoral department
(health, water resources, public works, labour, industry, etc.) to
formulate the necessary proposal for environmental legislation or
regulations and see it through until its adoption. This procedure will
probably be more cumbersome and prolonged, but may present an
advantage if the regulation contemplated will affect one particular
sector or group of individuals, such as agriculture or industry.
lnteractions between science and policy
The role of science in public decision-making has increased in

parallel with the involvement of governments in the management of
scientific and technological change. Caught up in a spiral of promotion
and control of new techniques, the governments of all industrializing
societies have to make complex policy choices requiring the regular
input of information and advice from experts.
In order for an environmental protection programme to be
successfully implemented, compromises will undoubtedly have to be
accepted and improvements achieved will be short of the goals
identified in studies of health effects and related analyses. The
question arises, therefore, as to how important are such objective
analyses. How far will they affect the political judgements made in
relation to the proposed initiatives?
Drawing upon an empirical investigation of the way science is used
in the regulation of toxic chemicals, a study in four industrialized
countries (France, Federal Republic of Germany, the United
Kingdom, and the USA) has shown that there is considerable variation
in the extent to which governments rely on expert analysis and in how
they acquire it (Brickman et al., 1985). While each country calls upon
experts to identify and measure hazards and to clarify the available
control options, the institutional means for incorporating these inputs
and the broader purposes served differ considerably, as outlined below.
l. The United States exhibits a much stronger demand for expert
analysis of all kinds in its regulatory processes than do the European
67
countries. Extensive use is made of scientific arguments and formal

analysis in the regulatory process. The agencies involved have large
research and development capabilities of their own, they have sizeable
resources in terms of the expertise of the staff, and they perform the
major part of their chemical risk assessments themselves. An important
complementary source of expertise is outside consultants who are hired
under agency contract.
The European countries provide a sharp contrast to this situation.
The staff of the agencies that issue regulations rarely have the
analytical skills needed to determine scientifically the level of risk.
Unlike in the USA, where rules are accompanied by elaborate
analytical justification and scientific documentation, European agencies
rarely divulge the scientific rationale behind their decisions.
2. The European countries place more emphasis than the USA on
the expertise of pluralistic advisory committees that combine technical
competence with the representation of partisan viewpoints.
Advisory committees are a standard feature of toxic chemical control
programmes in all four countries. However, European committees tend
to be quite different in composition, role, and function from their
American counterparts. They typically include representatives from the
regulated industry and other interests, and their policy influence is
greater than any similar body advising authorities in the USA.
3. Regulatory officials in the USA and the Federal Republic of
Germany make most extensive use of the independent bodies of
scientific and professional opinion. The two most visible and versatile
purveyors of official scientific advice in these two countries are the
National Academy of Sciences (NAS) and the Deutsche
Forschungsgemeinschaft (DFG). These two organizations, which have
no real equivalent in France or the United Kingdom, are frequently
consulted by regulatory agencies for their recommendations and
analyses. Official deference to their opinions appears to be greater in
the Federal Republic of Germany than in the USA.
The decision-maker may be assisted by having a summary of the
relevant information and analyses. When the decision has been made, it
is wise to record the rationale behind the choice of the option selected.
This will facilitate any judicial or administrative reviews of the
decision, and it will enable others to understand the basis for the
decision. It is particularly important when reviews are being carried
out in the light of new data and information that may or may not have
an impact on the decision taken.
Constraints affecting developing countries
Although many people believe that environmental controls in

industrializing nations must be geared to their level of development
and affluence, there is no concrete evidence to suggest that a country
68
Decision-making process
will attract international investment simply by minimizing the

strictness of its environmental regulations. Neither is there any
evidence to suggest that an industrializing country will deter
multinational corporations simply by requiring them to adhere to
environmental codes similar to those in effect in developed countries
(MacAndrews & Chia, 1979).
lndeed, loose environmental constraints can pose a threat to foreign
industries because excessive pollution can provoke strong anti-
government and anti-multinational corporation sentiment among the
population. As many examples demonstrate (Leonard, 1985), pollution
frequently becomes an important local political issue. Citizens often
resent what they perceive as collusion between their government and
foreign companies in undertakings that despoil the environment or
threaten public health. Thus, industrial strategies based on attracting
pollution-creating industries can seldom, if ever, be tenable in the long
term.
There are no fundamental reasons why the process for making
decisions on environmental standards for the protection of the health of
the people in developing countries should be different from that in
developed countries. However, there are sorne specific factors that have
a bearing on the process and may influence it in a particular way
(Mayda, 1985). Sorne of these are outlined below.
Problem assessment
l. There are difficulties in the timely and effective transfer of
information on specific pollutants that will allow national scientists
and others to make evaluations and appropriate recommendations
regarding national environmental issues. lnternational efforts (see
Annexes 1-7) are intended to help overcome this problem by providing
consolidated information for the most important pollutants and
chemicals.
2. Most of the health-related research information on pollutants is
produced in developed countries with temperate climates and is based
on studies of people who do not suffer from the debilitating effects of
climatic stress, malnutrition, diarrhoea, malaria or general extreme
poverty, all of which can impair the natural defence mechanisms of the
body. It may therefore be necessary, until more data from developing
countries become available, to consider with extra care the safety
factors to be used in standard-setting in these countries. Increasing the
safety factor would go sorne way towards ensuring that the relatively
large, sensitive subpopulation is protected.
3. It is well known that, in developing countries, very rapid
industrialization and urbanization are taking place. Both may be
proceeding with very limited planning and without appropriate
safeguards, thus exposing large numbers of people to much higher
levels of environmental pollution within a short space of time (World
Health Organization, 1977, 1985a).
69
The response mechanism

l. In most developing countries there is inevitably competition for
resources between the economic and health development interests.
Most often, a balance will have to be found in the form of a
compromise decision being made on the levels of pollutants allowed for
in the regulations (Bowonder, 1981).
2. Competing, and sometimes conflicting, health values may come to
the fore; for example, attempts to control disease and increase food
supply require the widespread use of hazardous insecticides and
other pesticides that may in turn contaminate air, water, and food.
3. There may be inadequate mechanisms for coordinating the
division of labour required to carry out the decision-making process
leading to adequate legislation and standards. Also of concern in this
regard may be a lack of vertical coordination within sectors (Schaefer,
1981).
Characteristics of an effective standard-setting process
From the points discussed, it can be seen that an effective process

should have the following characteristics.
- l t should involve, at sorne stage, the major parties in the community,
such as politicians, bankers, citizen groups, industrial leaders,
and health officials. Their involvement will stimulate debate
encompassing differing perspectives and values; it will generally lead
to sorne compromises being made in both goals and methods but will
ensure broad support in the society at large.
-It should provide a mechanism through which technical and policy
analyses can be generated, distributed, and criticised.
-It should provide a mechanism whereby the results of analyses can be
presented to the policy-makers and the other centres of interest in the
society, to inform these groups of the costs, benefits, and impact of
the proposals under discussion.
-It should provide a mechanism for conflicting interests to be heard
and discussed in a controlled manner, so that divergent opinions in
the society can be aired and, as far as possible, accommodated in the
implementation of the proposal.
- l t should provide a mechanism whereby the society can reach a
decision and take useful action, even though such action may be less
than what is "objectively" ideal.
70
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76
Annex 1
WHO environmental health criteria documents

(as of September 1986)
l. Mercury (1976) 27. Guidelines on studies in

2. Polychlorinated biphenyls and environmental epidemiology
terphenyls (1976) (1983)
3. Lead (1977) 28. Acrylonitrile (1983)
4. Oxides of nitrogen ( 1977) 29. 2,4-Dichlorophenoxyacetic
5. Nitrates, mtntes, and N- acid (2,4-D) (1984)
nitroso compounds (1978) 30. Principies for evaluating
6. Principies and methods for health risks to progeny as-
evaluating the toxicity of sociated with exposure to
chemicals, Part 1 (1978) chemicals during pregnancy
7. Photochemical oxidants ( 1978) (1984)
8. Sulfur oxides and suspended 31. Tetrachloroethylene (1984)
particulate matter (1979) 32. Methylene chloride (1984)
9. DDT and its derivatives 33. Epichlorohydrin (1984)
(1979) 34. Chlordane (1984)
10. Carbon disulfide ( 1979) 35. Extremely low frequency
11. Mycotoxins (1979) (ELF) fields ( 1984)
12. Noise (1980) 36. Fluorides and fluorine (1984)
13. Carbon monoxide (1979) 37. Aquatic (marine and fresh-
14. Ultraviolet radiation (1979) water) biotoxins (1984)
15. Tin and organotin com- 38. Heptachlor (1984)
pounds ( 1980) 39. Paraquat and diquat (1984)
16. Radiofrequency and micro- 40. Endosulfan (1984)
waves (1981) 41. Quintozene ( 1984)
17. Manganese (1981) 42. Tecnazene (1984)
18. Arsenic (1981) 43. Chlordecone (1984)
19. H ydrogen sulfide ( 1981) 44. Mirex (1984)
20. Selected petroleum products 45. Camphechlor (1984)
(1982) 46. Guidelines for the study of
21. Chlorine and hydrogen chlor- genetic effects in human
ide (1982) populations (1985)
22. Ultrasound (1982) 47. Summary report on the
23. Lasers and optical radiation evaluation of short-term tests
(1982) for carcinogens (collabo-
24. Titanium (1982) rative study on in vitro tests)
25. Selected radionuclides (1983) (1985)
26. Styrene (1983) 48. Dimethyl sulfate (1985)
77
Annex 1
49. Acrylamide (1985) childhood: the need for a

50. Trichloroethylene (1985) special approach (1986)
51. Guide to short-term tests for 60. Principies and methods for
detecting mutagenic and car- the assessment of neurotox-
cinogenic chemicals (1985) icity associated with exposure
52. Toluene (1986) to chemicals (1986)
53. Asbestos and other natural 61. Chromium (1986)
mineral fibres (1986) 62. 1,2-Dichloroethane (1986)
54. Ammonia (1986) 63. Organophosphorus insecti-
55. Ethylene oxide (1985) cides-a general introduction
56. Propylene oxide ( 1985) (1986)
57. Principies of toxico-kinetic 64. Carbamate pesticides-a gen-
studies (1986) eral introduction (1986)
58. Selenium (1986) 65. Butanols-four isomers (1986)
59. Principies for evaluating 66. Kelevan ( 1986)
health risks from chemicals 67. Tetradifon (1986)
during infancy and early 68. Hydrazine (1986)
78
Example from the file of the lnternational Register of Potentially Toxic Chemicals 8
IRPTC RECOMMENDATIONS-LEGAL MECHANISMS
TG0350000 FENITROTHION
AREA TYPE SUBJECT DESCR- LEVELS, REMARKS AND REF-
IPTOR ERENCE
BRA REG FOOD AL PLANT (SPECIFIED): 0.1-().4 MG/KG EFFECTIVE DATE:
FEED AL (SAFETY INTERVAL: 7-30 DAYS); ENTRY DATE IN IRPTC: AUG 1982
PASTURE: 0.5 MGjKG (INTER-
VAL BETWEEN APPLICATION
AND GRAZING: 10 DA YS)
SO URCE: CATALOGO DOS DEFENSIVOS AGRICOLAS, 2, 85, 1980
CSK REG CLASS POISONOUS SUBSTANCE EFFECTIVE DATE: JUL 1967
ENTRY DATE IN IRPTC: MAY 1982
SOURCE: SBIRKA ZAKONU CESKOSLOVENSKE SOCIALISTICKE
REPUBLIKY/COLLECTION OF THE LAW OF CZECHOSLOVAK SOCIALIST
REPUBLIC, 22, 217, -, 1967
CSK REG HUMAN FOOD MRL LIMIT OF RESIDUES PRESENT EFFECTIVE DATE: OCT 1978
DUE TO PLANT PROTECTION: 0.5 ENTRY DATE IN IRPTC: MAY 1982
MG/KG.
SOURCE: HYGIENICKE PREDPISY MINISTERSTVA ZDAVOTNICTVI
CSRjHYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR, 43, -,
1978
......
co
~
Annex 2 (Contd.)
CSK REG USE AGRIC PRMT SUBSTANCE IS APPROVED AS EFFECTIVE DATE: AUG 1981
PESTICIDE. SPECIFIC USES, ENTRY DATE IN IRPTC: MAY 1982
LIMITATIONS AND SAFETY
PRECAUTIONS ARE GIVEN
SO URCE: SEZZAM POVOLENYCH PRIPRAVKU NA OCHRANU
ROSTLIN/LIST OF PERMITTED CHEMICALS FOR PLANT PROTECTION, -,
-, 1981
DEU REG FOOD MRL PLANT (SPECIFIED) 0.5 MGjKG. EFFECTIVE DATE: 1 AUG 1978
ENTRY DATE IN IRPTC: MCH 1982
SOURCE: BUNDESGESETZBLATT, IS. 718, 729, 1978
DEU REG LABEL RQR FOR LABEL AND PACKAGING SEE EFFECTIVE DATE: 1 OCT 1980
PACK RQR EEC (OJEC**, L. 360, 1, 1976). ENTRY DATE IN IRPTC: JUN 1982
USE occ RSTR HANDLING OF SOME GROUPS OF
CHEMICALS (INCL. CARCINO-
GENIC, MUTAGENIC, POISONOUS,
EXPLOSIVE AND EASIL Y INFLAM-
MABLE COMPOUNDS) IS PRO-
HIBITED OR RESTRICTED FOR
PREADULTS AND PREGNANT OR
NURSING WOMEN.
SOURCE: BUNDESGESETZBLATT, IS. 2069, 2069, 1980
a Explanatory notes
BRA-Brazil CLASS-Classification
CSK-Czechoslovakia MRL-Maximum restriction limit
DEU-Federal Republic of Germany PRMT-Permined
REG-Regulation RQR-Requirement(s)
OCC-Occupation hygiene RSTR-Restriction(s)
AL-Acceptable limit(s) SOURCE-Information reference
Annex 3
IARC monographs on the evaluation of the

carcinogenic risk of chemicals to man (as of
September 1986)
l. Sorne inorganic substances, 13. Sorne miscellaneous phar-

chlorinated hydrocarbons, maceutical substances ( 1977)
aromatic amines, N-nitroso 14. Asbestos (1977)
compounds, and natural prod- 15. Sorne fumigants, the herbi-
ucts (1972) cides 2,4-D and 2,4,5-T,
2. Sorne inorganic and organo- chlorinated dibenzodioxins
metallic compounds ( 1973) and miscellaneous industrial
3. Certain polycyclic aromatic chemicals (1977)
hydrocarbons and heterocyclic 16. Sorne aromatic amines and
compounds (1973) related nitro compounds-
4. Sorne aromatic amines, hy- hair dyes, colouring agents
drazine and related sub- and miscellaneous industrial
stances, N-nitroso compounds chemicals (1978)
and miscellaneous alkylating 17. Sorne N-nitroso compounds
agents (1974) (1978)
5. Sorne organochlorine pesti- 18. Polychlorinated biphenyls and
cides (1974) polybrominated biphenyls
6. S ex hormones ( 197 4) (1978)
7. Sorne anti-thyroid and related 19. Sorne monomers, plastics and
substances, nitrofurans and synthetic elastomers, and
industrial chemicals (197 4) acrolein (1979)
8. Sorne aromatic azo com- 20. Sorne halogenated hydrocar-
pounds (1975) bons (1979)
9. Sorne aziridines, N-, S- and 21. Sex hormones (Il) (1979)
0-mustards and selenium 22. Sorne non-nutritive sweeten-
(1975) ing agents (1980)
10. Sorne naturally occurring 23. Sorne metals and metallic
substances (1976) compounds (1980)
11. Cadmium, nickel, sorne epox- 24. Sorne pharmaceutical drugs
ides, miscellaneous industrial (1980)
chemicals and general con- 25. Wood, leather and sorne as-
siderations on volatile anaes- sociated industries (1981)
thetics (1976) 26. Sorne antineoplastic and
12. Sorne carbamates, thiocarba- immunosuppressive agents
mates and carbazides (1976) (1981)
81
Annex 3
27. Sorne aroma tic amines, coal-tars and derived prod-

anthraquinones and nitroso ucts, shale-oils and soots
compounds, and inorganic (1985)
fluorides used in drinking- 36. Sorne allyl compounds, alde-
water and dental preparations hydes, epoxides and peroxides
(1982) (1985)
28. The rubber industry (1982) 37. Tobacco habits other than
29. Sorne industrial chemicals smoking, betel-quid and
and dyestuffs (1982) areca-nut chewing and sorne
30. Miscellaneous pesticides related nitros amines ( 1985)
(1983) 38. Tobacco smoking (1986)
31. Sorne food additives, feed ad-
ditives and naturally occur-
ring substances (1983)
32. Polynuclear aromatic com- Supplements
pounds, Part 1, Chemical, en-
vironmental and experimental 1. Chemicals and industrial pro-
data (1983) cesses associated with cancer in
33. Polynuclear aromatic com- humans (IARC Monographs,
pounds, Part 2, Carbon Volumes 1-20) (1979)
blacks, mineral oils and sorne 2. Long-term and short-term
nitroarenes (1984) screening assays for carcino-
34. Polynuclear aromatic com- gens: a critica! appraisal ( 1980)
pounds, Part 3, Sorne com- 3. Cross index of synonyms and
plex industrial exposures in trade names in Volumes 1 to
aluminium production, coal 26 (1982)
gasification, coke production, 4. Chemicals, industrial processes
and iron and steel founding and industries associated with
(1984) cancer in humans (IARC
35. Polynuclear aromatic com- Monographs, Volumes 1-29)
pounds, Part 4, Bitumens, (1982)
82
Annex 4
Pesticides for which evaluations of residues in

food have been carried out (as of September 1986)
Further information regarding evaluation of specific pesticide

residues is available from Division of Environmental Health, World
Health Organization, 1211 Geneva 27, Switzerland.
Acephate Carbon tetrach!oride Diazinon

Acry lonitrile Carbophenothion 1,2-Dibromoethane (see
Aldicarb Carbosulfan ethylene dibromide)
Aldrin Cartap 1,2-Dichloroethane (see
Aminocarb Chinomethionat ethylene dichloride)
Allethrin Chlorbenside Dichlofluanid
Aluminium phosphide Chlordane Dichloran
(see hydrogen phos-. Chlordimeform Dichlorvos
phide) Chlorfenson Dicofol
Amitraz Chlorfenvinphos Dieldrin
Amitrole Chlormequat Diflubenzuron
Azinphos-ethyl Chlorobenzilate Dimethoate
Azinphos-methyl Chloropicrin Dimethrin
Azocyclotin Chloropropylate Dinocap
Bendiocarb Chlorothalonil Disulfoton
Benomyl Chlorpropham Dioxathion
BHC (technical grade) Chlorpyrifos Diphenyl
gamma-BHC Chlorpyrifos-methyl Diphenylamine
Binapacryl Chlorthion Diquat
Bioresmethrin Coumaphos Disulfotan
Bitertanol Crufomate DNOC
Bromide ion Cyanofenphos Dodine
Bromomethane Cyhalothrin Edifenphos
Bromophos Cyhexatin Endosulfan
Bromophos-ethyl Cypermethrin Endrin
Bromopropylate 2,4-D Ethephon
Butocarboxim Daminozide Ethiofencarb
sec-Butylamine DDT Ethion
Calcium arsenate Deltamethrin Ethoprophos
Camphechlor Demeton Ethoxyquin
Captafol Demeton-S-methyl Ethylene dibromide
Captan Demeton-S-methyl Ethylene dichloride
Carbaryl sulfoxide Ethylene oxide
Carbendazim Demeton-S-methyl Etrimfos
Carbofuran sulfone Fenamiphos
Carbon disulfide Dialifos Fenbutatin oxide
83
Annex 4
Fenchlorphos Methomyl Pirimiphos-methyl

Fenitrothion Methoprehe Prochloraz
Fensulfothion Methoxychlor Procymidone
Fenthion Methyl bromide Propargite
Fentin compounds MGK 264 Propamocarb
Fenvalerate Methyl parathion Propham
Ferbam Mevinphos Propineb
Folpet Monocrotophos Propoxur
Formothion Nabam Pyrethrins
Guazatine Nitrofen Quintozene
HCH, technical Omethoate 2,4,5-T
Heptachlor + heptachlor Organomercury Tecnazene
epoxide compounds Thiabendazole
Hexachlorobenzene Oxamyl Thiofanox
(HCB) Oxydemeton-methyl Thiometon
Hydrogen cyanide Oxythioquinox Thiophanate-methyl
Hydrogen phosphide Paraquat Thiram
(phosphine) Parathion Toxaphene
Imazalil Parathion-methyl Triadimefon
Iprodione Permethrin Triazophos
Isofenphos D-"Phenothrin'' Trichlorfon
Lead arsenate Phenthoate Trichloroethylene
Leptophos Phenylmercuric acetate Trichloronat
Lindan e 2-Phenylphenol and its Tricyclohexyltin hydrox-
Malathion sodium salts ide (see cyhexatin)
Maleic hydrazide Phorate Triforine
Mancozeb Phosalone Triphenyltin
Maneb Phosmet compounds
Mecarbam Phosphamidon V amidothion
Metalaxyl Phosphine (see hydrogen Vinclozolin
Methacrifos phosphide) Zineb
Methamidophos Phoxim Ziram
Methidathion Piperonyl butoxide
Methiocarb P1rimucarb
84
Annex 5
Compounds for which evaluations have been

carried out by the Joint FAOjWHO Expert
Committee on Food Additives (as of
September 1986)
This list includes antioxidants, antibiotics, food colours, contamin-

ants, extraction and carrier solvents, ftavouring agents, sweetening
agents, xenobiotic anabolic agents and multifunctional compounds.
Further information regarding evaluation of specific food additives is
available from Division of Environmental Health, World Health
Organization, 1211 Geneva 27, Switzerland.
Acesulfame potassium Amaranth

Acetic acid, glacial Ammonium acetate
Acetic and fatty acid esters of glycerol Ammonium adipate
Acetone Ammonium alginate
Aceton peroxide Ammonium carbonate
Acetylated distarch adipate Ammonium chloride
Acetylated distarch glycerol Ammonium hydrogen carbonate
Acetylated distarch phosphate Ammonium hydroxide
Acid fuchsine FB Ammonium lactate
Acrylonitrile Ammonium persulfate
Adipic acid Ammonium phosphate, dibasic
Agar Ammonium phosphate, monobasic
Alginic acid Ammonium polyphosphate
Alkali blue Ammonium salts of phosphatidic acid
Alkanet and alkannin Ammonium stearate
Allura red AC Ammonium succinate
Allyl-aipha-ionone Ampicillin
Allyl-3-cyclohexyl propionate Amyl acetate
Allyl hexanoate alpha-Amylase (Aspergillus oryzae)
Allyl tiglate alpha-Amyl cinnamic aldehyde
Aluminium ammonium sulfate alpha-Amyi cinnamic aldehyde di-
Aluminium, calcium, magnesium, methyl aceta!
potassium and sodium salts of ca- alpha-Amyl cinnamyl alcohol
prylic, capric, lauric, and oleic Amylose, amylopectin
acids trans- Anethole
Aluminium potassium sulfate Anisyl acetone
Aluminium powder Annatto extracts (Bixin and Norbixin)
Aluminium silicate Anoxomer
Aluminium sodium sulfate Anthocyanin colour from grape skin
Aluminium sulfate (anhydrous) Anthocyanins
85
Annex 5
Arabic gum Calcium aluminum silicate

Arsenic Calcium ascorbate
beta-Asarone Calcium benzoate
Asbestos Calcium carbonate
Ascorbic acid Calcium chloride
Ascorbyl palmitate Calcium citrate
Ascorbyl stearate Calcium cyclamate
Aspartame Calcium disodium ethylene-diamine-
Azodicarbonamide tetraacetate
Azorubine Calcium ferrocyanide
Bacitracin (Bacillus subtilis) Calcium fumarate
Beet red Calcium gluconate
Benzaldehyde Calcium di-L-glutamate
Benzene Calcium 5'-guanylate
Benzoic acid Calcium hydrogen carbonate
Benzoin gum Calcium hydrogen phosphate
Benzoyl superoxide Calcium hydrogen sulfite
Benzyl acetate Calcium hydroxide
Benzyl alcohol Calcium iodate
Benzyl benzoate Calcium lactate
Benzyl butyl ether Calcium DL-malate
Benzyl isobutyl carbinol Calcium 5' -inosinate
Benzyl isoeugenyl ether Calcium metabisulfite
Benzyl violet 4B Calcium myristate
Bis(2-ethylhexyl) phtalate Calcium oxide
Bixin Calcium palmitate
Black 7984 Calcium peroxide
Blue VRS Calcium phosphate, tribasic
Bone phosphate Calcium polyphosphate
Borax Calcium propionate
Boric acid Calcium pyrophosphate, dibasic
Brazil wood Calcium 5' -ribonucleotides
Brilliant Black BN Calcium saccharin
Brilliant Black PN Calcium silicate
Brilliant Blue FCF Calcium silicoaluminate
Bromelain Calcium sorbate
Brominated vegetable oils Calcium stearoyl lactylate
Brown FK Calcium succinate
Brown HT Calcium sulfate
Bu tan e Canthaxanthin
1,3-Butane diol Capsanthine
1-Butanol Capsorubine
2-Butanol Caramel colour 1 (plain)
Butyl acetate Caramel colour 11
Butyl butyryl lactate Caramel colour 111
tert-Butylhydroquinone Caramel colour IV
Butyl-p-hydroxybenzoate Carbohydrase from Aspergillus awa-
Butylated hydroxyanisole (BHA) mori
Butylated hydroxytoluene (BHT) Carbohydrase from A. niger
Cadmium Carbohydrase from A. oryzae
Calcium acetate Carbohydrase (alpha amylase) from
Calcium adipate Bacillus lycheniformis
Calcium alginate Carbohydrase (pullulanase) from
86
Annex 5
Klebsiella aerogenes Citric and fatty acid esters of

Carbohydrase from Rhizopus oryzae glycerol
Carbohydrase from Saccharomyces Citronellol (90% and 98 % alcohol)
spp. Citrus red No. 2
Carbon, activated vegetable (food Cochino) and carminic acid (carmines)
grade) Copper
Carbon black Coumarin
Carbon dioxide Crocin and crocetin
Carboxymethyl cellulose Cupric sulfate
Carmine: aluminium lake and alumin- Curcumin
ium calcium lake of carminic acid Cyclohexane
Carob bean gum Cyclohexylsulfamic acid
beta-apo-8' -Carotenal Dammar gum
Carotenes (natural) Decana!
beta-Carotene (synthetic) Desoxycholic acid
beta-apo-8'-Carotenic acid, methyl or Dextrins, white and yellow
ethyl ester Diacetyl
Carrageenan (refined non-degraded) Diacetyltartaric and fatty acid esters of
Carthamus red glycerol
Carthamus yellow Diatomaceous earth
o-Carvone Dibenzyl ether
L-Carvone Dibutyl sebacate
Castor oil Dichlorodifluoromethane
Catalase (bovine liver) 1, 1-Dichloroethane
Catalase (Aspergillus niger) 1,2-Dichloroethane
Catalase (Micrococcus lysodeikticus) Dichloromethane (methylene chloride)
Cellulose, microcrystalline Diethyl ether
Cellulose, powdered Diethyl pyrocarbonate
Chloramphenicol (Streptomyces vene- Diethyl tartrate
zuelae) Diethylene glycol
Chlorine Diethylene glycol monoethyl ether
Chlorine dioxide Diethylene glycol monopropyl ether
Chloroform Dihydrostreptomycin ( Streptomyces
Chlorophyll griseus, S. bikiniensis, S. mashuensis)
Chlorophyll copper complex Di-isopropyl ether
Chlorophyllin copper complex, Dilauryl thiodipropionate
sodium and potassium salts 2,6-Dimethyl-5-heptenal
Chlortetracycline (Streptomyces aureo- Dioctyl sodium sulfosuccinate
faciens) Diphenyl
Chocolate brown FB Dipotassium hydrogen phosphate
Cholic acid Dipotassium guanylate
Choline acetate Dipropylene glycol
Choline carbonate Dipotassium inosinate
Choline chloride Disodium ethylene-diaminetetraacetate
Choline citrate Disodium 5' -guanylate
Choline lactate Disodium hydrogen phosphate
Choline L( + )-tartrate Disodium 5'-inosinate
Chrysoine Disodium pyrophosphate
Cinnamaldehyde Disodium 5'-ribonucleotides
Cinnamyl anthranilate Distarch phosphate
Citral Distearyl thiodipropionate
Citranaxanthin Dodecyl gallate
Citric acid Dulcin
87
Annex 5
Eosine Glucose isomerase (S. rubiginosus)

Erythorbic acid (isoascorbic acid) Glucose isomerase (Immob.) (S.
Erythrosine rubiginosus)
Erythromycin (Streptomyces erythreus) Glucose isomerase (S. violaceoniger)
Esters of glycerol and thermally oxi- Glucose oxidase and catalase (Asper-
dized soybean fatty acids gillus niger)
Estragole L( + )-Glutamic acid
Ethanol Glycerol
Ethyl acetate Glycerol diacetate
Ethyl butyrate Glycerol ester of wood rosin
Ethyl cellulose Glyceryl monoacetate
Ethylenimine Gold
Ethyl formate Guaiac resin
Ethyl heptanoate Guanylic acid
Ethyl isovalerate Guar gum
Ethyl p-hydroxybenzoate Guinea green B
Ethylhydroxyethyl cellulose Gum ghatti
Ethyl lactate Heptane
Ethyl laurate Hexamethylenetetraamine
Ethyl maltol Hexane
Ethyl methyl ketone alpha-Hexyl cinnamic aldehyde
Ethyl methylphenyl glycidate Hydrochloric acid
Ethyl nonanoate Hydrocyanic acid
Ethyl 3-phenylglycidate Hydrogen peroxide
Ethylene oxide Hydrogenated glucose syrups
Ethyl protocatechuate H ydroxycitronellal
Ethyl vanillin Hydroxycitronellal dimethyl aceta!
Eugenol H ydroxycitronellol
Eugenyl methyl ether Hydroxylated lecithin
Fast green FCF 4-Hydroxymethyl-2,6-di-tert-butyl-
Fast red E phenol
Fast yellow AB Hydroxypropyl cellulose
Ferric ammonium citrate Hydroxypropyl distarch glycerol
Ferrous gluconate Hydroxypropyl distarch phosphate
Ficin Hydroxypropyl methyl cellulose
Food green S Hydroxypropyl starch
Formic acid Indanthrene blue R.S.
Fumaric acid Indigotine
Furcelleran Inorganic mercurials
Furfural Inosinic acid
Gelatin, edible Insoluble polyvinyl pyrrolidone
Geranyl acetate (PVPP)
Geranyl acetoacetate alpha-lonone
G lucono-delta-lactone beta- Ionone
Glucose isomerase (lmmob.) (Actino- Iron
planes missouriensis) Iron (ferric form)
Glucose isomerase (Bacillus coagulans) Iron oxide black
Glucose isomerase (Immob.) (Bacillus Iron oxide red
coagulans) Iron oxide yellow
Glucose isomerase (lmmob.) (Strep- Iron oxides (hydrated and non-
tomyces olivaceus) hydrated)
Glucose isomerase (lmmob.) (S. Iso-alpha-methyi ionone
olivochromogenes) Isoamyl butyrate
88
Annex 5
Isoamyl gallate Methyl p-hydroxybenzoate

lsomalt (isomaltitol) Methylmercury
Isopropyl acetate Methyl N-methylanthranilate
Isopropyl citrate mixture Methyl beta-naphthyl ketone
lsopropyl myristate Methyl phenylacetate
Isoquinoline 2-Methyl-2-propanol
Karaya gum Methyl salicylate
Kanamycin (Streptomyces kanamy- Methyl violet
ceticus) Mineral oil, food grade
DL-Lactic acid Mixed carbohydrase and protease
Lactic and fatty acid esters of (Bacillus sub tilis)
glycerol Mixed tartaric, acetic and fatty acid
Lactitol esters of glycerol
Lead Mixed tocopherol concentrate
Lecithin Monoammonium L-glutamate
Leucomycin (Streptomyces kitasato- Monoammonium orthophosphate
ensis) Mono- and diglycerides
Light green SF yellowish Monocalcium phosphate
Light petroleum Monoglyceride citrate
Linalool, 90 lo and 95 ~~ Monomagnesium phosphate, mono-
Linalyl aceta te, 90 ~·~ and 96 ~,~ basic
Lipase, animal Monopotassium L-glutamate
Lipase (Aspergillus oryzae) Monosodium L-glutamate
Lithol rubine BK Monosodium monophosphate
Magnesium acetate Monostarch phosphate
Magnesium adipate Naphthol yellow S
Magnesium carbonate Natamycin (Streptomyces natalensis)
Magnesium chloride Neomycin (Streptomyces fradiae)
Magnesium citrate Nisin (Streptococcus lactis, Lancefield
Magnesium gluconate group N)
Magnesium di-L-glutamate Nitrogen
Magnesium hydrogen carbonate 2-Nitropropane
Magnesium hydroxide Nitrous oxide
Magnesium lactate (DL-l gamma-Nonalactone
Magnesium lactate (L-) Nonanal
Magnesium oxide Norbixin
Magnesium phosphate, dibasic Nordhydroguaiaretic acid
Magnesium phosphate, monobasic Novobiocin (Streptomyces niveus)
Magnesium phosphate, tribasic Nystatin (Streptomyces noursei)
Magnesium silicate Oat gum
Magnesium succinate Octanal
DL-Malic acid Octyl gallate
Malt carbohydrases Oleandomycin (Streptomyces anti-
Maltol bioticus)
Mannitol Orange 1
Methanol Orange G
Menthol (L-and oL-) Orange GGN
Mercury Orange RN
Methyl anthranilate Orchil and orcein
Methyl cellulose Organomercurial compounds
alpha-Methyl cinnamic aldehyde Organotin compounds
Methyl coumarin Oxidized hydroxypropyl distarch
Methyl ethyl cellulose glycerol
89
Annex 5
Oxidized starch Potassium dihydrogen citrate

Oxystearin Potassium dihydrogen phosphate
Oxytetracycline (Streptomyces rimosus) Potassium ferrocyanide
Papain Potassium fumarate
Paprika, oleoresins Potassium gluconate
Patent blue V Potassium hydrogen carbonate
Pectin (amidated) Potassium hydrogen malate
Pectin (non-amidated) Potassium hydroxide
Penicillins (Streptomyces spp.) Potassium iodate
Pentapotassium triphosphate Potassium lactate
Pentasodium triphosphate DL-Potassium malate solution
Pepsin Potassium metabisulfite
Pepsin, avian Potassium nitrate
Phenylacetaldehyde Potassium nitrite
Phenylmercury Potassium persulfate
o-Phenylphenol Potassium phosphate, tribasic
Phosphated distarch phosphate Potassium polyphosphates
Phosphoric acid Potassium propionate
Pimaricin (Streptomyces natalensis) Potassium saccharin
Piperonal Potassium sodium tartrate
Polydextrose Potassium sorbate
Polydimethylsiloxane Potassium succinate
Polyethylene glycols Potassium sulfate
Polyethylenimine Potassium sulfite
Polyglycerol esters of fatty acids L( + )-Potassium tartrate
Polyglycerol esters of interesterified Propane
ricinoleic acid Propan-1-ol
Polymixin B (Bacillus polymyxa) Propan-2-ol
Polyoxyethylene (20) sorbitan mono- Propionic acid
laurate beta-Propy lanisole
Polyoxyethylene (20) sorbitan mono- p- Propy lanisole
oleate Propyl gallate
Polyoxyethylene (20) sorbitan mono- Propyl p-hydroxybenzoate
palmitate 1,2-Propylene glycol
Polyoxyethylene (20) sorbitan tri- 1,2-Propylene glycol acetate
stearate 1,2-Propylene glycol alginate
Polyoxyethylene (8) stearate Propylene glycol esters of fatty acids
Polyoxyethylene (40) stearate Propylene oxide
Polyvinylpyrrolidone (PVP) Protease (Aspergillus oryzae)
Ponceau 2R Protease (Streptomyces fradiae)
Ponceau 4R Quercetin and quercitron
Ponceau 6R Quillaia extracts
Ponceau SX Quinine hydrochloride
Potassium acetate Quinine sulfate
Potassium adipate Quinoline yellow (methylated and
Potassium alginate non-methylated)
Potassium aluminosilicate Red 10 B
Potassium ascorbate Red 2 G
Potassium benzoate Rennet
Potassium bromate Rennet (bovine)
Potassium carbonate Rennet (Bacillus cereus)
Potassium chlorate Rennet (Endothia parasitica)
Potassium chloride Rennet (Mucor miehet)
90
Annex 5
Rennet (M. pusillus) Sodium sulfite

Rennet (Mucor spp.) L( + )-Sodium tartrate, monobasic
Rhodiamine B DL-Sodium tartrate, monobasic
Riboflavin Sodium thiocyanate
Riboflavin 5' -phosphate sodium Sodium thiosulfate
Saccharin Sorbic acid
Saffron Sorbitan monolaurate
Safrole and isosafrole Sorbitan mono-oleate
Salicylic acid Sorbitan monopalmitate
Salts of myristic, palmitic, and stearic Sorbitan monostearate
acid with bases accepted for food Sorbitan tristearate
use (Al, Ca, Na, Mg, K, am- Sorbitol
monium) Sorbitol syrup
Scarlet GN Sorboyl palmitate
Silicon dioxide Spiramycin (Streptomyces ambofaciens)
Sil ver Stannous chloride
Sodium acetate Starch acetate
Sodium adipate Starch, acid-treated
Sodium alginate Starch, alkali-treated
Sodium aluminium phosphate, acidic Starch, bleached
Sodium aluminium phosphate, basic Starch, sodium octenyl succinate
Sodium aluminium polyphosphate Starch, sodium succinate
Sodium aluminium silicate Starches, enzyme-treated
Sodium ascorbate Stearyoyl monoglyceridyl citrate
Sodium benzoate Stearyl citrate
Sodium carbonate Stearyl tartrate
Sodium carboxymethylcellulose Streptomycin (Streptomyces griseus)
Sodium caseinate Styrene
Sodium cyclamate Succinylated monoglycerides
Sodium diacetate Sucroglycerides
Sodium dihydrogen citrate Sucrose acetate isobutyrate (SAIB)
Sodium erythorbate Sucrose esters of fatty acids
Sodium ferrocyanide Sudan G
Sodium fumarate Sudan red G
Sodium gluconate Sulfur dioxide
Sodium hydrogen carbonate Sulfuric acid
DL-Sodium hydrogen malate Sunset yellow FCF
Sodium hydrogen sulfite Tale (magnesium hydrogen meta-
Sodium hydroxide silicate)
Sodium lactate Tannins, food grade
oL-Sodium malate Tara gum
Sodium metabisulfite DL-Tartaric acid, ammonium, cal-
Sodium nitrate cium, and magnesium salts
Sodium nitrite Tartrazine
Sodium 0-phenylphenol Tetrachloroethy lene
Sodium phosphate, tribasic Tetracycline (Streptomyces spp.)
Sodium polyphosphate, glassy Tetrapotassium pyrophosphate
Sodium potassium polyphosphate Tetrasodium diphosphate
Sodium propionate Thaumatin
Sodium saccharin Thiodipropionic acid
Sodium sesquicarbonate Thujone and isothujone
Sodium sorbate Tin
Sodium stearoyl lactylate Titanium dioxide
91
Annex 5
alpha- Tocopherol Turmeric

Toluene Tylosin (Streptomyces fradiae)
Tragacanth gum Ultramarines
Trenbolone acetate gamma- Undecalactone
Triacetin Vanillin
Triammonium citrate Violet 5 BN
1,1,1-Trichloroethane Vinyl chloride
1, 1,2-Trichloroethy lene Xanthan gum
1,1 ,2-Trichlorotriftuoroethane Xanthophyllis
Triethyl citrate Xylitol
Triglycerides (synthetic) Yellow 2G
Tripotassium citrate Yellow 27175N
Trisodium citrate Zeranol
Trypsin Zinc
92
Annex 6
Summary of WHO water quality guideline

val uesa
Values recommended in these guidelines are for total concentrations

(i.e., all forms of substances present).
l. Bacteriological quality
Number of organisms per 100 ml
piped supplies
(a) treated water entering faecal coliforms: O
the distribution system coliform organisms: O
(b) untreated water entering faecal coliforms: O
the distribution system coliform organisms: O in 98%
of samples over the year; 3 in
an occasional sample, but not
in consecutive samples.
(e) water in the distribution faecal coliforms: O
system coliform organisms: O in 95 %
of samples over the year; 3 in
an occasional sample, but not
in consecutive samples.
unpiped supplies faecal coliforms: O

coliform organisms: 10
bottled drinking-water faecal coliforms: O

coliform organisms: O
emergency supplies of drinking- faecal coliforms: O

water coliform organisms: O
• Further information can be obtained from: WHO. Guidelines for drinking-waur quality. Geneva,
World Health Organization Vol. l-3. 1984/85.
93
Annex 6
2. Inorganic constituents of health significance

Guideline value
(mg/litre)
arsenic 0.05
cadmium 0.005
chromium 0.05
cyanide 0.1
fluoride 1.5
lead 0.05
mercury 0.001
nitrate (as N) 10
selenium 0.01
3. Organic constituents of health significance

Guideline value
(~g/litre)
benzene 10
chlorinated alkanes and alkenes
carbon tetrachloride
1,2-dichloroethane
1, 1-dichloroethene
tetrachloroethene
trichloroethene
chlorophenols
pentachlorophenol 10
2,4,6-trichlorophenol 10
(odour threshold con-
centration, 0.1 ~g/litre)
polynuclear aromatic hydrocarbons
benzo [a] pyrene 0.01
trihalomethanes
chloroform 30
pesticides
aldrin/dieldrin 0.03
chlordane 0.3
2,4-D 100
DDT 1
heptachlor and heptachlor epoxide 0.1
hexachlorobenzene 0.01
lindane 3
methoxychlor 30
a Tentative guidehne values. When available carcinogenicity data could not suppon a guideline
value, but the compounds were judged to be of imponance in drinking-water and guidance was
considered essential, a tentative guideline value was set on the basis of avallable health-related data.
94
Annex 6
4. Radioactive materials
gross alpha activity 0.1 Bqjlitre
gross beta activity 1 Bq/litre
5. Aesthetic quality
Guideline value
(mgjlitre)
aluminium 0.2
chloride 250
copper 1.0
hardness (as CaC0 3 ) 500
iron 0.3
manganese 0.1
sodium 200
sulfate 400
total dissolved solids 1000
zinc 5.0
colour 15 true colour units (TCU)

taste and odour not offensive to most of the
consumers
turbidity 5 nephelometric turbidity
units. Preferably < 1 for ef-
fective disinfection.
pH 6.5-8.5
95
Annex 7
Summary of air quality guidelines,

developed by the WHO Regional Office
for Europe
1. Air quality guideline values for individual substancesa
Substance Guideline value
Time-weighted Averaging time

average concentration
(per m 3 )
Cadmium 1-5 ng (rural areas) 1 year

10-20 ng (urban areas) 1 year
Carbon disulfide 100 Jlg 24 hours
Carbon monoxide 100 mgb 15 minutes
60mgb 30 minutes
30mgb 1 hour
10mg 8 hours
1,2-Dichloroethane 0.7mg 24 hours
Dichloromethane
(methylene chloride) 3mg 24 hours
Formaldehyde 100mg 30 minutes
Hydrogen sulfide 150 Jlg 24 hours
Lead 0.5-1.0 Jlg 1 year
Manganese 1 Jlg 1 yearc
Mercury 1 Jlgd 1 year
(indoor air)
Nitrogen dioxide 400 Jlg 1 hour
150 Jlg 24 hours
Ozone 150-200 Jlg 1 hour
100-120 Jlg 8 hours
Styrene 800 Jlg 24 hours
Sulfur dioxide 500 Jlg 10 minutes
350 Jlg 1 hour
Tetrachloroethene 5mg 24 hours
Toluene 8mg 24 hours
T richloroethene 1 mg 24 hours
Vanadium 1 Jlg 24 hours
96
Annex 7
2. Guideline values for combined exposure to sulfur dioxide and

particulate mattera
Averaging Reftectance assessment Gravimetric assessment

time
so2 Black smokeb Total suspended Thoracic par-
(Jlg/m3) (/lg/m3) particles (TSP)e ticles (TPt
(Jlg/m3) (Jlg/m3)
Short term
24 hours 125 125 120' 70'
Long term
1 year 50 50
a No direct compansons can be made between values for particulate matter in the nght- and left-
hand sections of this table, since both the health mdicators and the measurement methods d1ffer. While
values for total suspended particles and thoracic parncles are generally greater than those of black
smoke, there is no consisten! relationship between them, the rano of one 10 the other varying widely
depending on the nature of the sources.
b Nominal ¡¡g/m 3 units, assessed by reflectance. Application of the black smoke value is
recommended only in areas where coal smoke from domestic tires is the dominant component of the
particulate matter. It 1s not necessarily applicable where diesel smoke 1s an important contributor.
e Measurement by high volume sampler, without size selection.
d Equivalent values for a sampler with ISO-TP charactensncs (having 50~. cut-off point at 10 ¡¡m):
estimated from TSP values using site-specific TSP;ISO-TP ratios.
• This value should be regarded as tentative at this stage, since it is based on a single study
(involving S0 2 exposure also).
Footnote to table on page 96.
a These guideline values were developed by the WHO Regional Oflice for Europe for use in the
European Region. Information from th1s table should not be used without reference to the ranonale
given in the full text (WHO. Air qualicy gu1delmes for che European region. Copenhagen, WHO Regional
Office for Europe, 1987).
b Exposure at this concentration should be for no longer than the indicated time and should not be
repeated within 8 hours.
e In view of the respiratory irritancy of this substance, it would be desirable to have a short-term
guideline; however, the present data base does not permit such an estimation.
d The guideline value is for indoor pollution only: no guideline is given for outdoor concentration
that might be of indirect relevance v1a deposition and entry into the food chain.
97
Annex 7
3. Guideline values based on sensory effects or annoyance

reactions
Substance Detection Recognition Guideline Averaging

threshold threshold val u e time
(per m 3 ) (per m 3 ) (per m 3 ) (minutes)
Carbon disulfide 20 Jlg 30

in viscose
emissions
Hydrogen sulfide 0.2-2.0 Jlg 0.6-6.0 Jlg 7Jlg 30
Styrene 70 Jlg 210-280 Jlg 70 Jlg 30
Tetrachloroethene 8mg 24-32mg 8mg 30
Toluene 1 mg lOmg 1 mg 30
98
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Awareness about the serious health risks
associated with environmental pollution has
increased considerably in recent years. The
subject of pollution control is of interest to
all countries, but particularly to those
undergoing rapid industrialization, where
appropriate action now may prevent the
development of serious problems in the
future.
This book deals with the various aspects
of the decision-making process for the
development and enforcement of enviran-
mental standards, from the standpoint of
health. lt begins by outlining the factors to
be considered when appropriate health
objectives or norms for environmental
pollutants are being defined, and goes
on to discuss the strategies and legislative
approaches that may be adopted to achieve
these norms. lt is recognized that the whole
decision-making process must be adapted
to national economic, social, public health,
and planning policies, and examples are
given throughout the text to show how
individual countries have done this.
Price: Sw. fr. 17.- ISBN 92 4 154214 4

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Setting

Published by the World Health Organization,

WORLD HEALTH ORGANIZATION

© World Health Organization 1987

Contributors and reviewers vi

Annex l. WHO Environmental Health Criteria documents (as of

Awareness about environmental pollution has increased during

V. Aalto, World Health Organization, Brazzaville, Congo

R. Luken, Environmental Protection Agency, Washington, DC, USA

For this publication, environmental pollution is defined as energy or

as the promotion of an improved quality of life. The control of

systems and must be analysed within a framework that is sufficiently

(a) Knowledge of the hazard-involves identification and character-

2. Political and administrativa stage

(a) Determination of acceptable risk-views problem not as a scientific

The framework outlined above is somewhat schematic and in most

ldentification of priority pollution issues

subjective consideration of a number of factors such as immediate

-Severity and frequency of observed or suspected adverse effects on

Selection of pollutants for control

In practice, hazard identification begins with one component of the

At the international level, the Council for Mutual Economic

Local or foreign public health crises

Advantages of international cooperation

The advantages of international cooperation include the availability

WHO Envíronmental Health Crítería programme

corporated into the newly established International Programme on

lnternational Register of Potentially Toxic Chemicals

/nternationa/ Agency for Research on Cancer

have been found to be causally associated with cancer in man. In

FAO¡WHO pesticide reviews

FAOfWHO food additive reviews

Guidelines for drinking-water quality

Air qua/ity guidelines

a basis for protection of public health from adverse effects of air

United Nations Environment Programme

lnformation on health effects

The toxic effects of pollutants found in the environment are

Studies of health effects

The first step in establishing environmental standards for a pollutant

requirement for a pollutant to be present for a long time before

Study Population Exposure Health Confounders Problems Advantages

A methodology has been proposed for assessment of chronic toxicity

substance could be used to predict its biological activity. Much

The dose received can either be expressed as the total dose,

Fig. 1. Lowest observed levels for lead-mduced health effects in adults

Fig. 2. Lowest observed levels for lead-induced health effects in children

population below the threshold leve!. For curve 2, it may not be

study. Curves AB, AD, and AE are possible dose-response curves at

Safety factors and extrapolations

There are two fundamental problems of extrapolating animal data to

Example of a threshold effect: para-dích/orobenzene

= 7.5 mg per person per day

WHO 86992 Dose or exposure ~

Fig. 5. lllustration of different types of dose--effect curve showing zero threshold

The existence of a threshold for cancer is a subject of contention

irreversible toxtclty or the effects of long-term exposure (National

scientific evidence but also must be ethical, with as broad a population

Quantitative assessment of cancer risk relies on dose-response