OCCUPATIONAL SAFETY

A N D HEALTH
SERIES
No. 3 3

OCCUPATIONAL CANCER -
PREVENTION A N D CONTROL

I N T E R N A T I O N A L L A B O U R OFFICE - G E N E V A
ISBN 92-2-101827-X

First published 1977

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Printed by the International Labour Office, Geneva. Switzerland.

 CONTENTS

£âSÊ
FOREWORD 1
1. PROBLEMS RELATING TO THE ESTABLISHHENT OF
OCCUPATIONAL STANDARDS FOR CARCINOGENS 3
1.1 Animal experimentation 3
1.2 Extrapolation from animal to man 5
1.3 Epidemiological studies 7
1.4 New chemicals and chemicals in use 8
2. CLASSIFICATION OF CARCINOGENS FOR THE PURPOSE OF
LEGISLATION 10
3. PREVENTIVE MEASURES 13
3.1 General principles 13
3.2 Technical measures 14
3.3 Personal protective measures 16
3.4 Emergencies 17
4. EXPOSURE MONITORING 18
4.1 Workplace monitoring 18
4.2 Biological monitoring 19
5. PERSONNEL ADMINISTRATION 21
5.1 Choice of personnel 21
5.2 informing workers .., 21
5.3 Labour turnover 21
5.4 Lists of workers 22
6. MEDICAL SUPERVISION 23
6.1 Special medical examinations 23
6.2 Information to be supplied to the responsible
physician 23
6.3 Assignment to specified workplaces 24
6.4 Personal work logbook 24
7. REGISTERS AND RECORDINGS 25
7.1 Technical files 25
7.2 Medical files 26
APPENDIX 1 •*• Carcinogenic substances and agents 27
Materials of complex composition whose use
represents a significant carcinogenic risk 28
Industrial processes involving significant.
carcinogenic risk 28

E-2700-lTC:8
 Pa.qe
APPENDIX 2 - ILO international instruments 29
Convention No. 139 concerning prevention and
control of occupational hazards caused by carcino-
genic substances and agents 29
Recoanendation No. 147 concerning prevention and
control of occupational hazards caused by carcino-
genic substances and agents -....<.. 32
 FOREWORD

The question of the prevention of occupational cancer and the

protection of workers against this risk has been under active con-
sideration by the ILO during the past decade, in particular follow-
ing the adoption of a resolution on this subject by the 1967 session
of the International. Labour Conference. It bécane a priority
subject when the ILO Governing Body decided to convene a meeting of
experts to examine possible ILO action with a view to submitting to
the International Labour Conference proposals for international
standards on this question. The Conference discussed at two
successive sessions, in 1973 and 1971», the principles for the
organisation of technical and medical prevention, and finally
adopted two international instruments, a Convention (No. 139) and a
Recommendation (No. 147) concerning the prevention and control of
occupational hazards caused by carcinogenic substances and agents.
The Convention states the most essential principles: replacement of
carcinogenic substances by less dangerous ones; establishment of a
list of carcinogens to be prohibited, or made subject to
authorisation or to control; recording of data concerning exposure
and exposed workers; medical surveillance; information and
education. In the Recommendation, these principles are expanded and
member States are invited, when implementing the provisions of the
instruments, to take into account guides and other technical
publications prepared by the ILO. The intention of the Conference
was therefore to lay down general principles for implementation at
the national level of the specific and detailed measures required
and for the development of adequate control programmes.

Recognising the difficulties of action in this field, the 1975

session of the International Labour Conference also adopted two
resolutions related to the problems of occupational cancer. The
first refers to the adverse social and economic consequences, both
for the workers and for the industry which may follow the
implementation of strict preventive and protective measures
prescribed by national legislation, and methods of meeting the
hardships involved; the second asks for the establishment of an
appropriate consultation mechanism to be used by the ILO in order to
provide up-to-date information on the results of research and on the
most effective methods of preventing occupational cancer. One
important task specified in this connection is to provide guidance
for the implementation of the principles set forth in the ILO
Convention and Recommendation (see Appendix 2).
This publication represents a first step in this direction.
It was originally drawn up with the valuable help of a group of
consultants1 and reviewed by the ILO Panel of Consultants on

1
Participated in this consultation (10-12 November 1975): Dr.
E. Bolinder, Chief, dedicai Department, Swedish Trade Onion Con-
federation, Stockholm (Sweden); Dr. B. Holmberg, Associate Professor
of Toxicology, National Board of Occupational Safety and Health,
Stockholm (Sweden); Dr. A. Munn, Division Medical Officer, Imperial
Chemical Industries Ltd., Manchester (united Kingdom); Dr. V.E.
Rose, Department of Health, Education and Welfare, Houston (USA);
Dr. G. Smagghe, Chef des Services de médecine et de toxicologie,
Société de produits chimiques Dgine-Kuhlmánn, Paris (France); Prof.
R. Truhaut, Directeur du centre de recherches toxicologiques,
Faculté des sciences pharmaceutiques et biologiques, Paris (France).
Occupational Cancer.• The ILO expresses its thanks to these persons
for their valuable collaboration. It is hoped that this publication
«ill serve as a useful aid to all those having responsibilities in
the planning and implementation of measures for the prevention of
occupational cancer.

* Panel of consultants on occupational cancer (1976-1981) .

Titular members: Dr. E. Bolinder, Chief, Medicai Department, Swedish
Trade Onion Confederation, Stockholm (Sweden); Dr. A. Eiras de
Araujo, Director, Instituto Nacional de Cancer, Rio de Janeiro
(Brazil); Dr. C. Eskandari, Chief, Industrial Medical Services,
National Iranian Oil Company, Abadan (Iran); Dr. A. Munn, Medical
Director, Monsanto Europe S.A., Bruxelles (Belgium); Prof. N.P.
Napalkov, Director, Petrov Research Institute of Oncology, Leningrad
(USSR); Dr. J. Paris, Confédération générale du Travail, Paris
(France); Dr. H. Sakabe, Chief, Department of Industrial Physiology,
National Institute of Industrial Health, Kawasaki (Japan); Prof. T.
Schramm, Head, Department of Chemical Cancerogenesis, Central
Institute for Cancer Research, Academy of Sciences of GDR, Berlin
Buch (DDR) ; Dr. 6. Smagghe, Chef des Services de médecine et de
toxicologie, Société de Produits chimiques Ugine-Kuhlmann, Paris
(France); Prof. R. Truhaut, Directeur du Centre de recherches
toxicologiques, Faculté des sciences pharmaceutiques et biologiques,
Paris (France); Dr. J.K. Hagoner, National Institute for
Occupational Safety and Health, Cincinnati (OSA). Substitute
members: Dr. J.W. Charters, Corporate Medical Director, The Steel
Company of Canada Ltd., Hamilton (Canada); Prof. D. Henschler,
Director, Institut für Toxicologie, Wurzburg (Fed. Rep. of Germany) ;
Dr. S. Holmes, Chief Health Physicist, T.B.A. Industrial Products
Ltd., Rochdale (United Kingdom); Dr. J. Lepoutre, Médecin-chef,
Services médicaux, S.A. Eternit, Kapelle-op-den-Bos (Belgium); Prof.
P. Purriel, Subdirector del Instituto de Tisiologia, Montevideo
(Uruguay); Dr. P.V. Thacker, Chief, Department of Industrial Health,
TATA Services Ltd., Bombay (India); Monsieur U. Viviani, Montedison,
S.p.A., Milan (Italy).

2
 1. PROBLEMS RELATING TO THE ESTABLISHMENT
OF OCCtJPATl5NAL~STÏNDÏRDS~POR_CARCÏNOGENS

For the purpose of this document, occupational carcinogens are

chemical substances, physical agents or work processes which nay
cause cancer in man due to conditions of exposure in the workplace.
Occupationally induced tumours are no different in type and nature
from those arising from non-occupational factors. Indeed, they may
cause a significant increase of a particular type of cancer in the
exposed working population.

These considerations extend to the so-called "benign" tumours.

Many benign spontaneous human neoplasms and induced animal neoplasms
may become frankly malignant, so that for the purpose of prevention,
no differentiation is made between "tumourigens" and "carcinogens".

1.1 Animal experimentation

Current approaches to the control of occupational cancer now
rely heavily on animal experimentation usually involving the rat or
mouse. More and more the approach fron the regulatory point of view
is to consider experimental carcinogens as potential human
carcinogens when a significant human exposure exists. In following
this line of reasoning, however, the magnitude of the potential
problem becomes considerable. For example, the National Institute
for Occupational Safety and Health (NIOSH) of the United States has
identified some 1,300 substances which have produced some
tumourogenic or carcinogenic effect in animals.1 However, a number
of these cases need further confirmation because they are inferred
from published studies for which there are insufficient data with
regard to the design of the research or the criteria for evaluation.

The actual extent of occupational exposure to many of these

chemicals may be minimal. Nevertheless, there can be no doubt that
some, if not many, of these substances are capable of* producing
cancer in humans. In addition, the number of chemicals to which
workers are exposed and which lack adeguate evaluation is unknown.
In evaluating experimental animal data, it must be recognised
that this is not a perfect tool. There are substances, such as the
inorganic compounds of arsenic, which are highly suspected of
producing an increased incidence of cancer in workers, but for which
animal experimentation has to date been unsuccessful.2 Just as
"false negative" results exist, so do "false positives". There is
some evidence to indicate that while certain substances, such as o-
toluidine and diethyleneglycol, are carcinogenic in test animals,
their hazard potential in the workplace is not significant.
Another factor of concern involves the evaluation of trace
impurities especially as more sophisticated analytical techniques

» National Institute for Occupational Safety and Health (1975)

SusEêçtgd_çarçinogensi A_subfile of the__NI0SH Toxic Substances
LÏit7~NIOSH7~ROckvïïïë~7iâryïând77~P~3'»2T
2
International Agency for Research on Cancer (1973) I£RÇ.
Monographs on the Evaluation of Carcinogenic Risk of Chemicals to
fias" I?

3
become available. Serious concerns exist as to whether the basic
chemical or the impurity is the aetiological agent. The best
example of this probably involves 1- and 2-naphthylanines. Here the
2-isomer is without doubt a carcinogen. Some researchers have
attributed the increased incidence of bladder cancer among workers
involved in the manufacture of 1-naphthylamine to the 2-impurities.
However, lacking definitive data, certain countries which regulate
carcinogens have chosen to include 1-naphthylamine as a carcinogenic
substance.

another area of current controversy involves the concept of

dose-effect relationship and the existence of a "no effect" dose
level. The problem of "no effect" levels of «xposure to carcinogens
has been much debated over many years. Our knowledge about dose-
effect relationships and cancer is mainly based on animal
experimental work. The dose-frequency curve obtained with, for
instance, methylcholanthrene after a single subcutaneous injection
has the S shape known fron classical toxicology.1 The shape of the
curve implies the existence of a zero-effect level of the
carcinogen. In a probit diagram the S shape curve can be
transformed to a linean curve.* It should be remembered, however,
that an increase in the number of experimental animals per dose
group increases the probability of obtaining an animal with a tumour
at a low dose level. The zero-effect dose seems thus to be a
phenomenon closely related to the number of animals, the species and
the route and type of administration, which cannot be extrapolated
to other population sizes, nor to other species, absorption routes
or exposure- times.
The fractioning of a single dose of a potent carcinogen into
small doses administered over a long period seems to increase the
response.2 Thus, twelve subcutaneous injections of 0.042 mg each of
benzo(a)pyrene in mice induce tumours in 70 per cent of the animals.
The same total dose (0.5 mg) administered at one single injection
induces tumours in about 20 per cent of the animals. If any
generalisation can be made from one experiment with one substance,
then it would appear to be more dangerous to be exposed to small
amounts of a carcinogen repeatedly and for a long time than to have
one single peak exposure.
Dose-latency studies seem to indicate that low single doses
induce tumours with long latent periods, while high singlé doses
induce tumours with short latent periods.» It should therefore be
theoretically possible to derive a dose for a given animal species,
number of animals, route and type of administration, which does not
induce a tumour within the life expectancy of that particular
species. However, even if this were possible for one substance and
one test species, it is not possible to extrapolate such a zero-
effect dose level to any other species.

1
Bryan, H.R. and Shimkin, S.B. (1943) Journal_of_the_National
Cancer .Institute. 3, 503. - - -
2
Payne, W.U. and Heuper, U.C. (1960) American Industrial
Hygiene association Journal. 21, 3S0. ~

4
1.2 Extrapolation from aninal to nan
The sane problems arise in the extrapolation of laboratory
tests to industrial exposures because of variations in response in
different aninal species and in nan, in respect of both tusour
induction and target organ. The problem is enhanced in so far as in
nost experinents it has not been possible to reproduce industrial
exposure in respect of either dose level or route of entry into the
body.

The following arguments are adduced against an extrapolation

of dose-response data from laboratory aniñáis in an attempt to es-
tablish linits of occupational exposure:
Han is genetically more heterogeneous than test animal
strains. It is thus more likely that a highly sensitive or
highly resistant individual will be found in any human
population than that such an individual will be detected among
a limited number of animals.
There are reasons to believe that a number of endogenous
and/or exogenous factors interfere with the response towards
a carcinogen, either strengthening or antagonising the
carcinogenic action of a substance. Some of these factors,
such as nutrition or physical stress are standardised for
laboratory animals, but not for man.
The age of the individual at the start of the exposure may be
an important parameter in determining the response. Young
animals are more sensitive than old animals. Laboratory
animals are selected according to age, weight or both at the
start of the experiment and are thus more biologically
homogeneous. Human populations are not standardised in any
respect when occupational exposure starts.

Fractioned exposure, i.e. low doses over a long time, is a

common feature in human populations which may increase the
risk of cancer. ,
Human populations are likely to be exposed to more than one
potential carcinogen at one time during life. Synergistic
effects may therefore be expected. Horeover, carcinogens are
metabolised by different species in a different manner and at
different rates into biologically active or inactive
metabolites. There are differences in the metabolic
mechanisms of man and animals. Extrapolation of "safe" doses
from animal experiments to man is therefore at present still
not possible, and in any case it would not ensure safety when
the total exposure panorama is considered.
The size of an animal test population as compared to man is a
considerable problem when discussing zero-effect levels of
carcinogens. Table 1, taken from Zbinden, illustrates the
relation between test group sizes and the predictability of
animal tests in guantitative terms for human populations.
Within 59 animals in each dose group one can, for instance,
detect at least one animal responding to a carcinogen which
will lead to 5 per cent tumour-bearing individuals in an
exposed human population, if one accepts a confidence level of
0.95. In order to detect a low potent carcinogen, causing say
one tumour per thousand workmen, it is necessary to use at

5
 least 2,995 test animals in each dose group. Such a
comparison is based upon the assumption that human populations
and test animal populations respond identically, an assumption
which may well be false.

!afeiÊ_i' fiSfber_of_anina1s_in_toxiçit£
experiments

Probability of toxic Animals in experiments*

effects in man
Probability Probability
(«) 0.95 0.99

100 1 1
80 2 3
60 4 6
50 5 7
40 6 10
20 1« 21
10 29 44
5 59 90
2 149 228
1 299 459
0.1 2 995 4 603
0.01 29 956 46 050
Source: Zbinden G. (1973) Progress in Toxicology. 1, Springer, New
ïork.

«Number of animals to be included in an experiment in order to

find at least one subject with the toxic effect (assuming identical
incidence of toxic effect in animals and man). (Calculated by T.
Harthaler, Biostatistics Centre, University of Zurich.)

It is clear from the above points that the study of the

response to low doses of carcinogens is extreoely difficult.
Extrapolation from high dose levels down to low dose levels might be
regarded as a possibility. Such an extrapolation can be done from
a linear dose-response curve in a probit diagram. Our' knowledge
about the shape of dose-response curves at low dose levels is,
however, limited. & study on chemical carcinogenesis referred to
above, indicates that the dose latency curve has a flatter slope at
low dose levels than at high levels, though a linear curve at all
dose levels studied is suggested for tobacco carcinogenesis and for
radiation-induced cancer in human populations. A simple
extrapolation of a linear part of a dose curve obtained by
epidemiological studies may thus be hazardous even when a safety
factor is introduced.

The conclusion is, in summary, that experimental studies on

chemical carcinogenesis, although providing very useful information,
are insufficient for establishing a risk estimate for human exposure
in the work environment. The best way to establish a true risk
estimate for human exposure is by means of an integrated evaluation

6
of epidemiological studies and proper animal experiments. In the
absence of an adequate dose-response curve for a human population as
obtained by epidemiological studies, animal data should essentially
be used to establish carcinogenicity as such, and possibly for
comparing the risk potential from one substance to another.
Experimental animal testing remains indeed necessary in the case of
new substances for which epidemiological studies are obviously not
applicable. From a practical point of view, exposure to an
experimental carcinogen should be kept as close to zero as possible
in the occupational environment, irrespective of dose level in the
test system, animal species, tumour site, type or frequency.

1.3 Epidemiological studies

The most effective contribution to the establishment of a
reliable risk estimate for human exposure in the working environment
is by means of epidemiological studies. &n epidemiological study is
a statistical means of comparing the frequency of a particular
effect in one group of people with that of another group or with the
population as a whole. Ideally, it should be possible in such a
study to measure the level of exposure and the incidence of effects
so as to establish a dose-response relationship. This is however,
seldom possible in studying the incidence of occupational cancer
because of the small populations at various risk levels and of
inadequate or even complete absence of relevant analytical data on
the contaminants. when these data are available, then valid
information is obtained. Some recent studies have confirmed the
validity of this method for assessing the relationship between the
incidence of certain types of cancer and an occupational exposure.
This was the case, for example, for pleural mesothelioma in asbestos
workers and for hemoangioma of the liver in vinyl chloride workers.
Many uncontrolled factors can contribute to making an
epidemiological study on occupational cancer less informative or
even to making it non-valid. Thus, the size of exposed populations
may be small or the exposure time shorter than the time period
necessary for tumour induction;, information on past exposure levels
may be semi-quantitative or even absent, the technological process
may have changed quantitatively or qualitatively during the actual
induction period, etc., all factors negatively influencing the risk
assessment. In some occupations a multiplicity of chemical products
is used making it impossible to correlate exposure to a given agent
with an increased risk of cancer.
The problems of establishing a dòse-response relationship at
low dose levels are of the sane magnitude in human populations as in
test animal populations. This means, among other things, that for
practical purposes the concept of a safe level of exposure for human
populations is closely connected to the size of the exposed
population and any increase in population size may increase the
probability of observing a cancer due to occupational exposure.
Moreover, epidemiological studies are naturally based upon
comparisons with control populations which are themselves changing.
The cancer incidence in the population of industrial societies is
increasing even over a relatively short-time perspective. For
certain cancer sites, for instance lung cancer, the incidence in
some countries has increased considerably over a ten-year period.
Any risk estimate obtained in an occupationally-exposed population
is thus based on a comparison with a population having a con-
tinuously increasing "background noise", and it might be argued that

7
this mere fact involves an acceptance that an increase in cancer
incidence is reasonable. The conclusion is that a risk estimate
based on an epidemiological study should be corrected by a "safety
factor", the size of which could be 2 or higher. Even if an
occupational standard could tentatively be established according to
such estimations, the exposure should be kept as close to zero as
possible because a zero-effect level might not exist or at least
would be most difficult to validate.
This is the concept which led, for certain carcinogens, to the
establishment of "technical reference concentrations". These were
laid down for practical purposes in order to provide guidance for
the planning and implementation of the technical control of the
working environment. Where these concentration limits were
established they have been primarily based, in a nueber of cases, on
the concept of "least feasibly detectable" or attainable
concentration using existing technology. However, the setting of
occupational standards according to technological criteria must be
made with an understanding of technology's potential for change when
specifically directed towards improving work hygiene. Tbe story of
vinyl chloride exemplifies this situation. The Swedish occupational
exposure limit of vinyl chloride was temporarily lowered in the
spring of 1974 to 20 ppm time-weighted average. This level was
merely an adjustment to the practical level already maintained in
the polymerisation industry at that time. A limit below 10 ppm was
considered technologically not possible by the industry. Animal
data indicated, however, that 50 ppm, which was the lowest dose
tested, induced tumours in mice and rats, a fact which strengthened
the demand for a zero exposure. In the autumn of 1974, 1 ppm was
adopted as the time-weighted standard. Today the Swedish companies
are able to maintain that limit of exposure. The technologically
impossible task of today might thus be feasible tomorrow.

l.i» New_çhemiçals_and_çhemiçals_in_use
A prevention programme for new chemicals could include an
obligatory adeguate testing of chemicals for their possible
carcinogenic potential.
For chemicals already in industrial use, testing for
carcinogenicity and mutagenicity may be required by national
authorities, especially for suspect substances where no
epidemiological data exist or can be obtained.
Although testing would be desirable for all new chemicals and
for a large proportion of chemicals already in use, this is
obviously a most difficult task considering the number of new
substances introduced each year onto the market as well as those
already in use. Moreover, taking into account the relatively long
duration and the complexity of animal experiments, it becomes
necessary to evolve criteria for selecting substances to be
submitted to further animal experiments. Promising avenues in this
connection seem to be provided by testing substances for
mutagenicity in bacteria or other inferior organisms, for malignant
cell transformation in vitro or for unscheduled DNA synthesis.
These methods are more rapid than experimental testing in laboratory
animals and, although they still present considerable difficulties
in their interpretation, substances found to be active in these
tests may also be suspected for carcinogenicity. In spite of
certain differences of opinion in the assessment of the screening

8
tests, the present approach is therefore to carry out tests in
animal systems on chemicals which (a) are found to be active by
screening tests for mutagenicity; and (b) are structurally related
to known experimental or human carcinogens. Other important factors
to be considered when establishing priorities are the physical,
chemical and biochemical properties, especially as they relate to
potential routes of exposure; the quantity of material produced or
the anticipated potential: the number of workers exposed and the
level of exposure; the ultimate community involvement, whether for
instance exposure is limited to industrial settings or a wider
contamination is possible. These problems have been actively
studied in recent years.»
fts a consequence it has been felt necessary to develop
practical guidelines for the conduct of these experimental studies.
it the international level such guidelines have been developed by
the International Agency for Research on Cancer (IARC) and, in
essence, these require: exposure to dose levels lending to
measurable effects; appropriate length of testing; presentation of
a satisfactory protocol involving appropriate exposure routes; use
of an adequate control group; interpretation of results in
relationship to a control group.
In addition to experimental studies and animal testing, epi-
demiological studies should be performed in order to establish a
risk estimate for chemicals in use.
The final evaluation, especially as regards the establishment
of preventive regulatory measures, should consider the carcinogenic
hazard to working populations. Consequently, several factors should
be taken into consideration, among which are: evaluation, both
qualitative and quantitative, of experimental data; critical
evaluation of epidemiological data when available; consideration of
physical, chemical and bio-chemical factors; the nature of the
technology where exposures may result; and other possible
influencing factors, such as synergistic/antagonistic potential, the
potential for personal factors such as diet and smoking to have a
contributory effect and the possibility of mutagenic and/or
teratogenic effects to be manifested, especially where exposure of
females of childbearing age is possible.

» See also:
world Health Organisation (1971) Principles for the testing and
evaluation of drugs for carcinogenicity. Technical Report Series No.
«82, WHO, Geneva.
World Health Organisation (1971) Evaluation and testing of drugs for
mutagenicity: principles and problems. Technical Eeport Series No.
U82, WHO, Geneva.
World Health Organisation (1974) Assessment of the carcinogenicity
and mutagenicity of chemicals. Technical Report Series No. 546, WHO,
Geneva.

9
 2. CLASSIFICATION OF CARCINOGENS FQR THE
£2iIös|_ö?_LECllLÄ2I9ä

In the field of occupational carcinogenesis, as in other

scientific fields, very little is known in comparison with what is
not known. The resources available to cope with the entire spectrum
of occupational safety and health problems are finite, and
occupational carcinogenesis is just one part of this spectrum.
Hence the need to classify carcinogens by some rationale, in order
that governmental authorities, employers and employees can put the
problem into a proper perspective.

While every classification system is arbitrary, it is accepted

that some form of classification is useful. For practical purposes
a list of carcinogens can, for instance, be structured according to
one or more of the following criteria:

(a) human carcinogens/animal carcinogens;

(b) highly/moderately/low potent carcinogens;

(c) prohibited/permitted carcinogens according either to

"necessity" (cost-benefit assessment), or technological
feasibility, or to potential hazard, i.e., degree of risk, as
regards occupational exposures.

A listing according to principle (ay would for instance

include 2-naphthylamine, bis-chloromethyl ether, benzene and vinyl
chloride as human carcinogens. The most satisfactory criterion for
listing a substance as a human carcinogen is an increased cancer
risk (adjusted for age, sex and other compounding factors) in
occupationally exposed groups (at best with different dose levels)
compared to control groups. This is derived from epidemiological
studies which are unfortunately only available in a minority of
cases for the establishment of the carcinogenic activity of
chemicals.

Further, the number of factors already mentioned which can

influence negatively a correct risk assessment, and the multiplicity
of exposure to chemicals inside and outside the work site, may
invalidate the conclusions of such inquiries or call for caution in
their interpretation. There is thus a tendency to underestimate the
true number of human carcinogens. This means that a listing of
human carcinogens apart from experimental carcinogens, in so far as
the listing implies separate levels of restriction of the
occupational exposure, does not necessarily reflect the true risk
situation. A rather widely accepted pragmatic approach from the
regulatory point of view is to consider experimental carcinogens as
potential human carcinogens when a significant human exposure
exists. This point is illustrated by the findings concerning, for
instance, vinyl chloride, bis-chloromethyl ether, diethylstil-
boestrol, which, having shown carcinogenic action in animal
experimentation, were subsequently found to be carcinogenic also for
man.

A listing of carcinogens according to potency is the second

possibility. This, however, is not accepted by a number of
scientific workers, because of the difficulty of defining criteria
of potency. Generally speaking, potency may be defined as being the
amount of carcinogen required for the production of a given

10
proportion of malignancies and the ^steepness of the slope of the
dose-response curve. However, the carcinogenic potency of a
chemical is not a characteristic independent of the «xperimental
condition nor of biological parameters. Animal species, strain of
animals, sex, age at start of exposure, nutritional factors,
enzymatic pattern, immunological factors, routes or types of
administration are among those factors influencing the dose-
response. Thus, 2-nap'hthylamine seems, for instance, to be a
carcinogen of lower potency for rats and rabbits than for dogs and
humans. Some experimental highly active carcinogens, like
methylnitrosourea and dietbylnitrosourea, occur in environments
where the establishment of their risk in occupational handling is
difficult. The listing of carcinogens as high potent/low potent
carcinogens, implying different levels of legislative action
according to potency, may thus lead either to workers being exposed
to potential carcinogenic hazards or to unnecessary stringent
legislation.
A listing of carcinogens occurring in the occupational
environment could be structured according to technological criteria.
This may refer either to the technical necessity of using a specific
substance having a carcinogenic action for a given technological
process, or to the degree of exposure to a carcinogen under normal
operating conditions. Both approaches may result in a list of
prohibited substances. There is no doubt that some potential
carcinogens used by industry could be dispensed with, although the
economic impact of the withdrawal of such potential carcinogens
varies from country to country. There is also no doubt that many
carcinogenic substances can be substituted by other non-carcinogenic
compounds or by compounds known to present less risk in a carefully
controlled work environment, as estimated in reliable epidemio-
logical studies.
In the recommendations which follow, carcinogenic chemicals,
physical agents and processes are classified on the basis of their
estimated potential for inducing cancer in working populations.
Therefore, a number of factors are combined in the assessment. It
is not proposed that the listings as shown in Appendix 1 are all-
inclusive, but they are rather an attempt to identify the risks for
which, in the view of the ILO Panel of Consultants, sufficient
information is available at the present time. It is anticipated
that as more information becomes available on these and other
problems, the listings will be modified and appropriate additions
and/or deletions made.
Specific recommendations have not been made as to the
appropriate course of action to be taken by governments or
industries to arrive at the degree of control recommended for each
category. Depending on a number of complex individual factors,
these may include banning the use of certain chemicals, the need to
obtain special authorisation for use and/or the establishment of
levels of exposure based on current control technology.
In cases where the competent authority has power to deliver
special authorisation for the production or use of specified
carcinogenic substances, such authorisation should stipulate the
obligation to apply strict preventive measures. These should
include such appropriate technical, hygiene and personal protective
measures that would ensure a satisfactory protection; the medical
supervision, biological tests or other investigations to be carried
out; the records to be maintained and the professional
qualifications of those dealing with the supervision of exposure to
the substances in question.

11
 Due to the paucity of epidemiological data, uncertainties in
extrapolating animal data to human exposures, and the conceptual
difficulty in formulating acceptable degrees of risk, it would
appear particularly difficult to recommend "safe" levels of exposure
for carcinogenic substances at this time. There is, however, from
a practical point of view* a clear need to provide guidance for
cases in which the production or use of carcinogenic substances
cannot be dispensed with, in particular where they also present
other types of risks, such as intoxication, explosion, etc. One way
to cope with this need at the present time is to prescribe for
certain carcinogens the "technical reference concentrations"
referred to above, whose role is to give guidance in the
implementation of technical preventive measures designed to reduce
to a minimum the exposure to these substance's. This has been done
in certain national lists, where provisional limit values have been
assigned to less dangerous carcinogens.

12
 3. PREVENTIVE MEASURES

3.1 Ggneral_ErincÍEles

Safety and health measures should be applied to ensure that

work involving the use of one or more carcinogens does not endanger
the health of workers or of persons living in the neighbourhood of
the plant, by giving due consideration to all the various possible
modes of contamination and to the circumstances under which this
contamination might occur. Carcinogens may enter the body by:
inhalation (vapours, mists, dusts), skin absorption (splashes,
soiled work clothes) or ingestion (eating with soiled hands,
smoking, etc.). The nature and scope of these measures may
therefore vary depending on the situation; they «ay also vary
depending on the evolution of scientific or technical knowledge.

The material set out in this section is intended to be used as

a guide to enable each case to be studied individually and at the
same time enable consideration to be given to the different points
listed herein.

Each carcinogen encountered in a plant should be the subject

of a document which indicates the practical measures to be taken in
relation to the agent's characteristics and to the type of occu-
pational exposure.

Where appropriate, workers or their representatives should be

involved in the development of specific procedures and should have
the reasons for these procedures explained to them.

The installations (areas, buildings) or workplaces for which

special measures should be drawn up and applied should be
designated. If necessary, "controlled areas" or "supervised zones"
should be marked out.

These measures should be related to the health hazard as it

may arise through inhalation, skin absorption, or ingestion, for:

(a) workers involved directly in the process in question or doing

jobs close by; production workers and maintenance workers;
direct employees and indirect employees (external
contractors);

(b) persons living in the neighbourhood who may be exposed to:

airborne effluents (gases, dusts, mists); liquid effluents;
and solid wastes.

All aspects of the industrial process should be covered,

including:

sources of hazard (raw materials, intermediates, by-products,

finished products, impurities);

all stages of manufacture, packaging, transport and use;

production;

laboratory operations;

normal operating conditions;

13
 repairs and preventive maintenance;
incidents.

3.2 Technical measures

Sasic_Hrinci£le
Technical preventive measures should form an integral part of
all work in which carcinogens are encountered or night be
encountered, and before commencing or continuing operations it
should be ensured that these measures are effectively implemented.
Their implementation should be such as to render other measures
unnecessary and taken only on precautionary grounds.

Substitution
Wherever possible, products known to be carcinogenic in man or
likely to be carcinogenic in man should be replaced by other
products. Nevertheless, it must be proved that these substitution
products constitute a significantly lower health hazard from all
toxicological points of view.
Where information is lacking on the health hazards of a given
product, for example with new products, literature studies and
experimental research should be carried out at the appropriate time
with particular reference to potential carcinogenic action.

Special studies
A decision to utilise a process in which a carcinogen is
employed or during which a carcinogen- may occur, entails a "special
study". Such special studies are aimed at minimising the duration
of the dangerous operations and clearly identifying these operations
for the information of those in charge of the plant. They also
provide the necessary detail regarding the physical nature of the
hazard, and a complete range of technical data for different stages:
temperatures, pressures, etc.

Consideration should be given to research laboratories, pilot-

operations and future full-scale production operations, and include:
the study and recording of the operations of the process in
which the carcinogen is present;
carrying out process technology research in order to minimise
the duration of these phases;
consideration of waste products and any possible impurities;
the forecast of any possible technical incidents or
breakdowns;
the development of analytical procedures for determining
hazardous substances in the intermediate and final products,
waste substances and environment.

1U
 Technological study
The installation is then designed on the basis of the specific
data provided by the above special study in such a way that the
eguipnent gives rise to no external contaoination. The over-all and
detailed phases of the technological study should deal in particular
with:
the plant location (prenises with permanent ventilation
equipment or open-air installations) ;
the design of the plant itself, its equipment, the choice of
materials, etc., making allowance for any subsequent
maintenance or repair work which might entail a substantial
hazard (for example, foresee the likelihood of the workers
being involved in such operations having to wear complete
airtight "divers" suits with maybe bulky, self-contained
respirators), special gaseous, liquid or solid effluent
circuits sealed off from the environment, and the special
processing of effluents to ensure purification prior to waste
disposal, and the development of decontamination procedures
for spillage;
safety and rescue procedures to minimise the risk of
contamination and to deal with possible breakdowns or
failures;
suitable washing facilities (washbasins with a regular soap
supply, disposable drying materials or hot-air dryers) and
immediate decontamination facilities (emergency showers).

Operating instructions
Procedures should be established in relation to the potential
hazards. They should be. expressed clearly in language readily
understandable so as to exclude all improvisation. They should be
designed in such a way tha.t, during potentially hazardous
operational phases, the workers are not burdened by time limits.
Possible incidents should be foreseen and simple precautionary
measures indicated; if necessary, provision should be made for
interruption of the process which can then be recommenced after a
break.

Emergency exits and emergency protective equipment should be

clearly marked and their location pointed out to each worker
individually.
Foreseeable repair procedures should be drawn up, specifying
the individual operations involved and the responsibility of each
department in the total process.
These procedures should include the technical data and also
specify personal protective measures such, as special clothing,
respiratory protection, and the rules for any possible personal
decontamination that might prove necessary.
Depending on the severity of the potential hazard, maintenance
and repairs should be carried out under the effective control of a
supervisor or line manager with a special knowledge of the hazard
and the necessary safety measures.

15
 As far as possible, maintenance and repair work should always
be entrusted tò the same workers who will, consequently, acquire
intimate knowledge of the plant and the work itself, become well
aware of the hazards and the safety measures and, moreover, be
subject to specific medical supervision.

3.3 Personal protective measures

Working_çlothes
Working clothes specially suited to the potential hazard
should be given to workers engaged in operations involving potential
exposure to carcinogenic substances. The type of clothing will
depend on the nature of the product, its physical properties, its
consistency, etc. Workers may receive complete sets of clothing
including underclothes and footwear or may, for example, receive
only overalls. The intervals at which this clothing is changed will
depend on the foregoing properties.
An adequate stock of clean replacement clothing should be
available to ensure correct laundering and immediate replacement in
the event of soiling. The intervals at which this clothing is
washed will depend on the severity of the potential hazard and the
properties of the product. Special provision should be made for
collecting and laundering contaminated clothing. If necessary the
clothing may undergo special pre-treatment and then be washed
separately from the rest of the working clothes in the plant.
Before evacuation into the general sewage system, the effluents from
this treatment may be required to undergo a purification process to
remove the product in question.

Changing rooms
The changing rooms for these employees should be separate from
the general changing rooms and their design related to the potential
hazard. In general, they should be divided into three consecutive
sections: town-clothing changing rooms, showers, work-clothing
changing rooms, so that, at the end of the shift, there is no
contact between the working clothes, which are all left in the work
changing room in special containers where necessary, and the town-
clothing; employees put on their town-clothes only after compulsory
showers. Each employee should systematically be provided with
suitable washing materials with clean towels daily.

These premises should be lined with materials which can be

cleaned completely each day. The changing room cabinets should be
designed so that nothing but clothes can be stored in them. Working
clothes that have been worn should not be taken into the town-
clothing changing room or into the showers. Only clean working
clothes can be taken through the town-clothes changing rooms.
Workers should be informed of the best personal procedures for
avoiding possible contamination, for example: precautions to be
taken to avoid soiling the inside of gloves, contamination of tools,
removal of clothing after any unusual contaminating operation, etc.
It should be forbidden to bring food and drink into the work
area. Mess rooms for personnel working in the areas in question

16
should be located at a suitable distance from the workplace. Before
enterin-g these mess rooms, workers should be required to wash their
hands carefully and to put on an overall to cover their working
clothes. Should the nature of the carcinogen make it necessary,
steps should be taken to prevent other possible causes of
contamination (prohibition of smoking in the plant for example).

3. <J Emergencies
Detailed instructions should be laid down describing the
action to be taken in the event of an incident such as a plant
breakdown or other failure which may lead to contamination with
potent carcinogens. These instructions should specify, in
particular, the evacuation of all non-essential workers who night be
subject to contamination.
Wherever possible, after arresting the escape of the
contaminant, subsequent operations should be carried out under
strict control, applying all the necessary safety measures. Such
precautions should be of the highest order and may require the use
of special equipment and clothing.
Following accidental contamination or work on an apparatus
which may have caused contamination, systematic decontamination
should be immediately carried out on:
workers)
) where necessary even before clothing is removed
clothes)
equipment
premises.
In such circumstances, special checks should also be carried out
(see section Hf.

Haste material, contaminated water and decontamination liquids

resulting from such events should be held in special bunds or
containers until they can be decontaminated.

17
 4. EXPOSURE HONITORING

4.1 «2 r k E l a,çe_moji i tori nq.

A£§â§_to_b,e_monitored

It is necessary to monitor all areas of potential exposure

through

(a) fixed point monitoring (valves, gaskets, etc., where leaks may
develop) ;

(b) spot sample monitoring;

(c) personal exposure monitoring.

Samples should be taken in sufficient number to ensure adequate

characterisation of the work environment and individual exposures.

The samples should be taken in accordance with the most

important mode of entry into the body for the carcinogen in question
(for example, in the case of gaseous contaminants, samples are
collected in the breathing zone of the worker).

In appropriate cases monitoring should be extended to:

equipment surfaces, floors, etc. in the case of contaminants which,
by their physical nature, would be readily deposited on them; solid,
liquid or gaseous wastes; products of intermediate phases when they
are isolated; unreacted residues in subseguent products; and working
clothes (in the case of contaminants which do not vaporise rapidly).

Analytical techniques

The analytical measurement techniques should be developed or

laid down by the competent laboratories using the most sensitive
methods. The techniques should be suited to the areas in which
monitoring is necessary.

Intervals between monitoring

The intervals at which each category of monitoring is

systematically carried out should be presented. This shall include
the number and type (fixed, spot or personal) of samples to be
collected. Checks should be carried out at particularly short
intervals when plant is started up and after incidents and repairs.
Subsequently, repeated negative findings will make it possible to
adopt longer intervals between sampling; nevertheless, on no account
should these intervals exceed a specified maximum duration.

Special checks should be carried out immediately following a

technical incident or work operation which may have led to
contamination. If the findings should be above the prescribed
level, checks should be repeated until negative findings are
confirmed by repeated negative samples taken at significant
intervals. Such checks should furthermore be carried out when
processes are modified or new processes are introduced. Similarly,
if during normal working conditions, any monitoring sample proves

18
positive, sampling should be regularly repeated in the manner
specified in the preceding paragraph, whilst at the same time the
cause of the contamination should be sought.

Responsibility for carrying out monitoring

The employer is directly responsible for ensuring that this
monitoring is carried out in accordance with the procedures laid
down (in particular concerning the technigue, media, dates) as well
as the special procedures.'

with_regard_to_açtion
Within a minimum lapse of time as reguired for carrying out
the analyses, the results of the workplace checks should be sent to
those responsible for information and, as necessary, for
implementation of corrective action.

Reçordin2_of_monitorin2_results
These results should be kept in one or more registers or card
indexes by both the head of service in question and by the works'
medical officer. Extracts may be transferred to other special
documents such as personal exposure records, work operations records
or medical records. Should a department terminate its activities,
these registers or monitoring records should be kept by the plant
management. Should the plant terminate its activities, these
registers or records should be kept by the corresponding management
offices of the company. If the company should go out of business,
the records should be transmitted to the appropriate agency of the
competent government authority.

Results shall be made available to the competent authority as

required.

Information of workers
The results of monitoring checks should be made available to
the workers directly concerned; they should also be informed
directly of any results indicating abnormal contamination and of
measures taken or to be taken to prevent recurrences. Such
information should also be made available to members of the safety
and health committee of the enterprise.

i». 2 Biologiçal_monitorina
Where carcinogenic agents are used, working conditions should
be evaluated in regard to hazards and decisions made as to the best
techniques available for evaluating personal contamination. This
may be done through the determination of the carcinogenic substances
in question or their metabolites, as the case may be, in samples of
urine, blood, stools and expired air.

19
 Biological, procedures
It should be ascertained whether suitable procedures have been
published in the literature. If not, information should be sought
fron the laboratories mentioned above that carry out the workplace
monitoring, or from appropriate authorities,. international
organisations or universities in order to find out if techniques are
available.
Examinations shoul'd be carried out by a qualified laboratory
to be designated with the agreement of the industrial medical
officer, and which may or may not form part of the plant or the
company.

Monitoring periodicity
Based on the nature of the work done by each person in
question, a decision should be taken by, or in consultation with,
the industrial medical officer as to frequency of testing. This
should be reconsidered in case of any modification of processes or
introduction of new processes. In the event of abnormal
contamination revealed by environmental samples or in the event of
a technical accident or incident, special personal measurements
should be carried out systematically. In addition, the medical
officer should decide on any personal checks he deems useful.

Interpretation of results
with .regard to action
The data concerning the results of the medical examinations
and the biological tests should be normally covered by medical
secrecy. However, the detection of abnormal exposure or
contamination should lead to a prompt search for the causative
factors, and to the implementation of technical modifications or
other measures, such as improved personal hygiene, needed to rectify
the situation.

Recording, the results

of personal monitoring checks
Monitoring results should be maintained in two forms:
collectively; since the results when grouped together make it
possible to study environmental or workplace contamination and
the trend in this contamination; and,
individually; together with all the other personal records
resulting from the medical supervision of the workers,
These documents should be kept in the same manner as all other
personal medical supervision records (see section 5).

The medical officer should personally inform the individual

worker of the results of these examinations and environmental
monitoring. When the results are not satisfactory, he should enter
into any appropriate discussions with the person concerned.

20
 5. PERSOHHEL ADMINISTRATION

5.1 Choice of personnel

In order to organise effectively , the appropriate preventive
measures a list of workplaces covered by the measures laid down in
this guide should be established. A special selection procedure
should be applied for all categories of workers to be assigned to
these places, including heads of service, engineers and line
management, supervisors and workers. Whenever possible workers
employed by external contractors should not be assigned at these
workplaces. Also, work of this type should not be allocated to a
worker as his first job in the plant.
Depending on the severity of the hazards involved, workers
allocated to these workplaces should be selected for their personal
gualities, which should include technical competence,
conscientiousness, well-balanced personality, team spirit, good
personal hygiene and a perfect command of the language.

5.2 Informing_workers
Personnel assigned directly or occasionally to this kind of
work should be adeguately informed as to the nature of specific
hazard, the reasons for the safety measures applied, the effects of
work procedures and the form of medical supervision. This
information shall include, but not be limited to, the carcinogenic
risk. Other hazardous properties such as explqsiveness,
flammability, acute, chronic and other toxic effects should also be
adeguately identified.
A briefing should take place before assignment and regularly
thereafter. It should include essential basic data on signing-on;
a regular repetition of the initial brief and presentation of any
newly available information; the results of measurements of group
contamination and, individually, the results of measurements of
personal exposure (where these measurements are possible), together
with • any comments necessary to draw relevant conclusions; and
details of any incidents that may have occurred.

5. 3 La bour_t ur_nover
The competence needed for normal operations and for handling
incidents can be best achieved if the workforce is stable; this is
also a prereguisite of adeguate medical supervision. To comply with
the provisions of the ILO Recommendation concerning prevention and
control of occupational hazards caused by carcinogenic substances
and agents regarding the reduction of a number of workers exposed to
carcinogens, it is desirable to have as low a labour turnover as
possible. These considerations refer egually to intermittent
workers-such as maintenance personnel, as well as to workers
employed by external contractors where these are necessary. It is
to be noted that the availability of a sufficient number of
competent and well-trained workers has a bearing on the safe
operation of an installation. The same considerations apply to
workers employed by external contractors.

21
5. 4 Lists of workers
Lists of workers directly assigned to this type of work or
employed occasionally on such jobs should be drawn up and kept as
indicated under section 7.1.

22
 6
• fiIEi£*L_SöPERVISiON

6.1 Sjjecia l_med iça.l_ex agination s

Special medical supervision comprises a number of individual
examinations intended to:
determine suitability for the work;
monitor, individually, the level of exposure (see section
4.2) ; and
provide detection of any early deviation from normal health or
biological changes.
It covers workers employed on or assigned to a specific
workplace and it is an essential factor in helping the medical
officer to decide on a worker's suitability for a specified job
prior to assignment and regularly thereafter.
The nature of the examinations required for each of the
objectives indicated above and the intervals between them should be
decided upon by a physician. The examination procedure will depend
on the product in question and, if necessary, on the type of work
involved. Moreover, examinations may be modified to suit the
worker's individual characteristics. The physician should also
determine such examinations as may be desirable after a worker has
left one of these assignments, and all possible measures should be
taken to facilitate the implementation of these examinations.
In deciding the examinations to be carried out, consideration
should be given to the latest trends and available knowledge con-
cerning this type of medical supervision.
Considerations of medical secrecy should be taken into
account.
Interpretation of these results is the responsibility of the
medical officer, checks being made where necessary.
Decisions concerning fitness for work resulting from the
interpretation of these results should also be a medical
responsibility. Any technical defects that may he highlighted
following these medical examinations (for example, individual over-
exposure) should be immediately brought to the attention of those
having technical responsibility for the plant. Correction of
defects is the responsibility of the technical personnel.

6.2 Infor§ation_to_be_su££lied_to
the responsible physician

Basic technical information

The medical officer should be kept informed systematically of
any plans for start-up or modification of a process or the
introduction of new chemicals into the workplace.

23
 QEÊ£âÎi2fiâi_iSf2£SâU2û
The medical officer should be immediately informed of any
incident, breakdown or failure or any unusual operation that might
result in abnormal exposure in order that such information may be
recorded for the individual worker.

Information on monitoring results

The results of monitoring of the environment, of waste and of
products, etc., should be sent in writing to the medical officer.

Ifi£°£lâtion_ço^ç.exnin3_th^_worjçers
The medical officer should receive routine information on
absences from work due to illness amongst workers in these work-
places. workers should also have access to the medical officer to
report symptoms or signs of ill-health. The medical officer should
also attempt to record information as to employee's use of tobacco,
alcohol and prolonged medication. workers should not return to
these posts after illness until they have undergone a medical
examination and the approval of the medical officer has been
obtained.

6. 3 âssig_nœent_to_s£eçif ied_work£iâçes
No worker should be assigned to a new post nor continue to
work in a specified workplace, nor resume his work in such places
after an absence due to illness, unless he produces a fitness
certificate delivered by the industrial medical officer.

6.4 Personal work logbook

Any person having worked in one of the specified workplaces
should receive, when he finishes work at the plant, a document which
contains:
the dates on which he started work and left the plant;
the dates on which he was assigned to and finished work at the
workplaces under consideration, together with a definition of
the work involved and a statement as to the carcinogenic agent
involved (chemical as well as trade name);
recommendations as to future medical surveillance including
special bioassay measurements where appropriate.

2H
 7. REGISTERS AND RECORDING

The registers and documents referred to below are intended to

provide information on the magnitude of the exposed industrial
population and on the technological process involving a risk of
occupational cancer; to keep under surveillance the various aspects
of preventive and protective action taken in this connection; and to
improve knowledge on occupational cancer.
These registers and documents should be kept up to date in a
special file in the personnel department of the enterprise. A copy
should be made available to the medical service in order to permit
the degree of biological protection provided by the preventive
measures to be assessed and to discover any untoward health effect
in the exposed workers.
Additionally, it would be useful for national authorities to
have some system of national register with the object of recording
the name of exposed persons, the results of technical monitoring,
medical examinations and laboratory tests performed on these
workers. This would allow for both the competent authority and
selected scientific workers to keep a close watch on the magnitude
of the problem of occupational cancer in the country, on the level
of risk involved in the various types of exposure, the dose-response
relationship and the effectiveness of preventive action. In this
way, increased knowledge of the various aspects of occupational
cancer epidemiology can be gained.

7.1 Technical files

A list of all workers employed on processes using carcinogenic
agents should be drawn up, kept up to date and held indefinitely.
This list should cover workers of all categories; if appropriate, it
may also cover persons working regularly in the immediate
neighbourhood who might be subject to contamination due to
atmospheric pollution.
The list should at least indicate:
the identity of each worker;
the dates of the beginning and end of his assignment;
the workplace (s) held and the nature of his job;
specific substances used or formed in the process.
An appended document should contain:
the results of group exposure measurements;
technical incidents; and
- technical modifications that may have a relationship with the
level of exposure.

25
7.2 Sedical_fîles
The following personal data should be systematically attached
to the normal medical records of each person on the lists drawn up
in accordance with the previous paragraph; they may either be added
to the normal medical record or be contained in a special medical
record appended to the normal file:
data about assignment, and workplace;
dates, duration and causes of absences;
dates and results of personal exposure measurements;
dates and results of specific medical supervision and
detection examinations.
A document should collate the results of the specific
individual examinations to provide material for an over-all study.
The results of various group measurements should be filed by
the medical officer and kept in a fora in which they can be used for
each individual case or for an over-all study.
These documents should be drawn up under the responsibility of
the medical officer and kept for at least 30 years. Should the
plant close down, they should be sent to the company's central
medical service, due consideration being paid to normal medical
secrecy. In the event of the company ceasing to trade, the records
should be sent to the appropriate agency of the competent authority.
A copy of these various personal medical documents should be given
to the workers in question on request.

26
 APPENDIX 1»

Carcinogenic substances* and agents

GRODP 1 - Contact should" be avoided

2-naphthylamine
nitrosamines (dialkyl)
benzidine
4-aminodiphenyl
2-acetylaminofluorene
2-nitronaphthylamine
U-dimethylaminoazobenzene.
4-nitrodiphenyl
aethylnitrosourea (MNÜ)
bis (chloromethyl) ether
*0se caution concerning any derivatives of substances pos-
sessing a carcinogenic risk. Although some are considered to be
non-carcinogenic, such as the sulfonated derivatives of aromatic
amines, extreme care should be exercised until results are
demonstrated.

GB0UP_2 - Exposures should be limited through the application of

stringent protective measures
1-naphthylamine**
propane sultone
asbestos
vinyl chloride
ionising radition and radioactive substances
methylcbloromethyl ether**
diazomethane
1,1-dimettoylhydrazine
benzene
ß-propiolactone
**Hith these compounds, as with many others, there is
difficulty in determining whether the basic chemical or its
impurities (or both) is the active agent(s). Datil such information
is available, both the chemical and its contaminant (s), i.e., the
mixture, must be considered to possess carcinogenic risk.

» The indicative lists given above have been drawn up by the ILO
Panel of Consultants as a guide to implementation of the preventive
measures referred to in the present document. A number of national
lists of toxic substances for which exposure limits are prescribed
make reference to carcinogenic substances. The lists will be found
together with complementary information in "Occupational exposure
limits for airborne toxic substances" (ILO, Occupational Safety and
Health_Series No.37).

27
GRODP 3 - Exposure should be kept to a mininun through the use of the
most feasible and applicable controls
inorganic arsenic
nickel carbonyl
4,4*-methylene-bis-o-chloraniline (HOCA)
dimethyl sulfate
3,3'-dichlorobenzidine
o-tolidine
dianisidine
ethylenimine
ethylene thiourea

Materials of complex composition* whose use

represents a significant carcinogenic risk

Exposure to be kept at a minimum through the use of technical

and personal protective measures.
coal tar
high boiling petroleum residues
cutting Dineral oils
shale oil
creosote oil
coal pitch
soot
«Using common terminology. All of these materials are known
to have caused cancer in nan.

Industrial processes involving significant

carcinogenic risk

Exposure should be kept to a minimum through the use of the

most feasible and applicable controls.
treatment of chromium ores
treatment of nickel ores
auramine manufacture
magenta manufacture
hematite mining
coke-oven operations
manufacture of isopropyl alcohol
pressing of paraffin wax from petroleum
use of antioxidants and accelerators in the rubber an,d
cablemaking industry

28
 APPENDIX 2

lLP_international instruments
Convention 139

CONVENTION CONCERNING PREVENTION AND CONTROL

OF OCCUPATIONAL HAZARDS CAUSED BY CARCINOGENIC
SUBSTANCES AND AGENTS

The General Conference of the International Labour Organisation,

Having been convened at Geneva by the Governing Body of the International
Labour Office, and having met in its Fifty-ninth Session on 5 June 1974, and
Noting the terms of the Radiation Protection Convention and Recommendation,
1960, and of the Benzene Convention and Recommendation, 1971, and
Considering that it is desirable to establish international standards concerning
protection against carcinogenic substances or agents, and
Taking account of the relevant work of other international organisations, and in
particular of the World Health Organisation and the International Agency
for Research on Cancer, with which the International Labour Organisation
collaborates, and
Having decided upon the adoption of certain proposals regarding control and
prevention of occupational hazards caused by carcinogenic substances and
agents, which is the fifth item on the agenda of the session, and
Having determined that these proposals shall take the form of an international
Convention,
adopts this twenty-fourth day of June of the year one thousand nine hundred and
seventy-four the following Convention, which may be cited as the Occupational
Cancer Convention, 1974:
Article 1
1. Each Member which ratifies this Convention shallperiodically determine the
carcinogenic substances and agents to which occupational exposure shall be pro-
hibited or made subject to authorisation or control, and those to which other provi-
sions of this Convention shall apply.
2. Exemptions from prohibition may only be granted by issue of a certificate
specifying in each case the conditions to be met.
3. In making the determinations required by paragraph 1 of this Article, con-
sideration shall be given to the latest information contained in the codes of practice
or guides which may be established by the International Labour Office, as well as to
information from other competent bodies.

Article 2
1. Each Member which ratifies this Convention shall make every effort to have
carcinogenic substances and agents to which workers may be exposed in the course of
their work replaced by non-carcinogenic substances or agents or by less harmful

29
substances or agents; in the choice of substitute substances or agents account shall be
taken of their carcinogenic, toxic and other properties.
2. The number of workers exposed to carcinogenic substances or agents and the
duration and degree of such exposure shall be reduced to the minimum compatible
with safety.
Article 3
Each Member which ratifies this Convention shall prescribe the measures to be
taken to protect workers against the risks of exposure to carcinogenic substances or
agents and shall ensure the establishment of an appropriate system of records.

Article 4
Each Member which ratifies this Convention shall take steps so that workers who
have been, are, or are likely to be exposed to carcinogenic substances or agents are
provided with all the available information on the dangers involved and on the
measures to be taken.
Article 5
Each Member which ratifies this Convention shall take measures to ensure that
workers are provided with such medical examinations or biological or other tests or
investigations during the period of employment and thereafter as are necessary to
evaluate their exposure and supervise their state of health in relation to the occupa-
tional hazards.
Article 6
Each Member which ratifies this Convention—
(a) shall, by laws or regulations or any other method consistent with national
practice and conditions and in consultation with the most representative organisa-
tions of employers and workers concerned, take such steps as may be necessary
to give effect to the provisions of this Convention;
(b) shall, in accordance with national practice, specify the persons or bodies on
whom the obligation of compliance with the provisions of this Convention rests;
(c) undertakes to provide appropriate inspection services for the purpose of super-
vising the application of this Convention, or to satisfy itself that appropriate
inspection is carried out.
Article 7
The formal ratifications of this Convention shall be communicated to the Director-
General of the International Labour Office for registration.

Article 8
1. This Convention shall be binding only upon those Members of the Interna-
tional Labour Organisation whose ratifications have been registered with the Director-
General.
2. It shall come into force twelve months after the date on which the ratifications
of two Members have been registered with the Director-General.
3. Thereafter, this Convention shall come into force for any Member twelve
months after the date on which its ratification has been registered.

30
 Artide 9
1. A Member which has ratified this Convention may denounce it after the
expiration of ten years from the date on which the Convention first comes into force,
by an act communicated to the Director-General of the International Labour Office
for registration. Such denunciation shall not take effect until one year after the date
on which it is registered.
2. Each Member which has ratified this Convention and which does not, within
the year following the expiration of the period of ten years mentioned in the preceding
paragraph, exercise the right of denunciation provided for in this Article, will be
bound for another period of ten years and, thereafter, may denounce this Convention
at the expiration of each period of ten years under the terms provided for in this
Article.
Article 10
1. The Director-General of the International Labour Office shall notify all
Members of the International Labour Organisation of the registration of all ratifica-
tions and denunciations communicated to him by the Members of the Organisation.
2. When notifying the Members of the Organisation of the registration of the
second ratification communicated to him, the Director-General shall draw the
attention of the Members of the Organisation to the date upon which the Convention
will come into force.
Article 11
The Director-General of the International Labour Office shall communicate to
the Secretary-General of the United Nations for registration in accordance with
Article 102 of the Charter of the United Nations full particulars of all ratifications
and acts of denunciation registered by him in accordance with the provisions of the
preceding Articles.
Article 12
At such times as it may consider necessary the Governing Body of the Interna-
tional Labour Office shall present to the General Conference a report on the working
of this Convention and shall examine the desirability of placing on the agenda of
the Conference the question of its revision in whole or in part.

Article 13
1. Should the Conference adopt a new Convention revising this Convention in
whole or in part, then, unless the new Convention otherwise provides—
(a) the ratification by a Member of the new revising Convention shall ipso jure
involve the immediate denunciation of this Convention, notwithstanding the
provisions of Article 9 above, if and when the new revising Convention shall
have come into force;
(b) as from the date when the new revising Convention comes into force this Con-
vention shall cease to be open to ratification by the Members.
2. This Convention shall in any case remain in force in its actual form and content
for those Members which have ratified it but have not ratified the revising Convention.

Article 14
The English and French versions of the text of this Convention are equally
authoritative.

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Recommendation 147

RECOMMENDATION CONCERNING PREVENTION AND CONTROL

OF OCCUPATIONAL HAZARDS CAUSED BY CARCINOGENIC
SUBSTANCES AND AGENTS

The General Conference of the International Labour Organisation,

Having been convened at Geneva by the Governing Body of the International
Labour Office, and having met in its Fifty-ninth Session on 5 June 1974, and
Noting the terms of the Radiation Protection Convention and Recommendation,
1960, and of the Benzene Convention and Recommendation, 1971, and
Considering that it is desirable to establish international standards concerning
protection against carcinogenic substances or agents, and
Taking account of the relevant work of other international organisations, and in
particular of the World Health Organisation and the International Agency for
Research on Cancer, with which the International Labour Organisation
collaborates, and
Having decided upon the adoption of certain proposals regarding control and
prevention of occupational hazards caused by carcinogenic substances and
agents, which is the fifth item on the agenda of the session, and
Having determined that these proposals shall take the form of a Recommendation,
adopts this twenty-fourth day of June of the year one thousand nine hundred and
severity-four the following Recommendation, which may be cited as the Occupational
Cancer Recommendation, 1974:

I. GENERAL PROVISIONS

1. Every effort should be made to replace carcinogenic substances and agents to

which workers may be exposed in the course of their work by non-carcinogenic
substances or agents or by less harmful substances or agents; in the choice of substitute
substances or agents account should be taken of their carcinogenic, toxic and other
properties.
2. The number of workers exposed to carcinogenic substances or agents and the
duration and degree of such exposure should be reduced to the minimum compatible
with safety.
3. (1) The competent authority should prescribe the measures to be taken to
protect workers against the risks of exposure to carcinogenic substances or agents.
(2) The competent authority should keep the measures prescribed up to date,
taking into account the codes of practices or guides which may be established by the
International Labour Office and the conclusions of meetings of experts which may be
convened by the International Labour Office, as well as information from other
competent bodies.

33
 4. (1) Employers should make every effort to use work processes which do not
cause the formation, and particularly the emission in the working environment,
of carcinogenic substances or agents, as main products, intermediates, by-products,
waste products or otherwise.
(2) Where complete elimination of a carcinogenic substance or agent is not pos-
sible, employers should use all appropriate measures, in consultation with the
workers and their organisations and in the light of advice from competent sources,
including occupational health services, to eliminate exposure or reduce it to a mini-
mum in terms of numbers exposed, duration of exposure and degree of exposure.
(3) In cases to be determined by the competent authority, the employer should
make arrangements for the systematic surveillance of the duration and degree of
exposure to carcinogenic substances or agents in the working environment.
(4) Where carcinogenic substances or agents are transported or stored, all appro-
priate measures should be taken to prevent leakage or contamination.
5. Workers and others involved in occupational situations in which the risk of
exposure to carcinogenic substances or agents may occur should conform to the
safety procedures laid down and make proper use of all equipment furnished for
their protection or the protection of others.

II. PREVENTIVE MEASURES

6. The competent authority should periodically determine the carcinogenic sub-

stances and agents to which occupational exposure should be prohibited or made
subject to authorisation or control, and those to which other provisions of this
Recommendation apply.
7. In making such determinations the competent authority should give consider-
ation to the latest information contained in the codes of practice or guides which
may be established by the International Labour Office, and in the conclusions of
meetings of experts which may be convened by the International Labour Office,
as well as to information from other competent bodies.
8. The competent authority may permit exemptions from prohibition by issue of
a certificate specifying in each case—
(a) the technical, hygiene and personal protection measures to be applied;
(b) the medical supervision or other tests or investigations to be carried out;
(c) the records to be maintained; and
(d) the professional qualifications required of those dealing with the supervision of
exposure to the substance or agent in question.
9. (1) For substances and agents subject to authorisation or control, the com-
petent authority should—
(a) secure the necessary advice, particularly as regards the existence of substitute
products or methods and the technical, hygiene and personal protection meas-
ures to be applied, as well as the medical supervision or other tests or investi-
gations to be carried out before, during and after assignment to work involving
exposure to the substances or agents in question;
(b) require the institution of such measures as are appropriate.

34
 (2) The competent authority should further establish the criteria for determin-
ing the degree of exposure to the substances or agents in question, and where appro-
priate should specify levels as indicators for surveillance of the working environment
in connection with the technical preventive measures required.
10. The competent authority should keep the determination of carcinogenic sub-
stances and agents made in pursuance of this Part of this Recommendation up
to date.

III. SUPERVISION OF HEALTH OF WORKERS

11. Provision should be made, by laws or regulations or any other method

consistent with national practice and conditions, for all workers assigned to work
involving exposure to specified carcinogenic substances or agents to undergo as
appropriate—
(a) a pre-assignment medical examination;
(b) periodic medical examinations at suitable intervals;
(c) biological or other tests and investigations which may be necessary to evaluate
their exposure and supervise their state of health in relation to the occupational
hazards.
12. The competent authority should ensure that provision is made for appro-
priate medical examinations or biological or other tests or investigations to con-
tinue to be available to the worker after cessation of the assignment referred to in
Paragraph 11 of this Recommendation.
13. The examinations, tests and investigations provided for in Paragraphs 11 and
12 of this Recommendation should be carried out as far as possible in working hours
and should be free of cost to the workers.
14. If as the result of any action taken in pursuance of this Recommendation it is
inadvisable to subject a worker to further exposure to carcinogenic substances or
agents in that worker's normal employment, every reasonable effort should be made
to provide such a worker with suitable alternative employment.
15. (1) The competent authority should establish and maintain, where practicable
and as soon as possible, in association with individual employers and representatives
of workers, a system for the prevention and control of occupational cancer including—
(a) the institution, maintenance, preservation and transfer of records ; and
(b) exchange of information.
(2) In establishing such a system of records and exchange of information, account
should be taken of the assistance which may be provided by international and national
organisations, including organisations of employers and workers, and by individual
employers.
(3) In the case of closure of an undertaking, records and information held in
compliance with this Paragraph should be dealt with in accordance with the directions
of the competent authority.
(4) In any country in which the competent authority does not establish such a
system of records and information, the employer, in consultation with representatives
of workers, should make every effort to attain the objectives of this Paragraph.

35
 IV. INFORMATION AND EDUCATION

16. (1) The competent authority should promote epidemiological and other
studies and collect and disseminate information relevant to occupational cancer
risks, with the assistance as appropriate of international and national organisations,
including organisations of employers and workers.
(2) It should endeavour to establish the criteria for determining the carcino-
genicity of substances and agents.
17. The competent authority should draw up suitable educational guides for both
employers and workers on substances and agents liable to give rise to occupational
cancer.
18. Employers should seek information, especially from the competent authority,
on carcinogenic hazards which may arise with regard to any substance or agent
introduced or to be introduced into the undertaking; when a carcinogenic potential
is suspected, they should decide in consultation with the competent authority on the
additional studies to be carried out.
19. Employers should ensure that in the case of any substance or agent which
is carcinogenic there is at the workplace an appropriate indication to any worker
who may be liable to exposure of the danger which may arise.
20. Employers should instruct their workers before assignment and regularly
thereafter, as well as on introduction of a new carcinogenic substance or agent,
on the dangers of exposure to carcinogenic substances and agents and on the
measures to be taken.
21. Employers' and workers' organisations should take positive action to carry
out programmes of information and education with regard to the hazards of occupa-
tional cancer, and should encourage their members to participate fully in programmes
of prevention and control.

V. MEASURES OF APPLICATION

22. Each Member should—

(a) by laws or regulations or any other method consistent with national practice
and conditions, take such steps, including the provision of appropriate penal-
ties, as may be necessary to give effect to the provisions of this Recommen-
dation;
(b) in accordance with national practice, specify the bodies or persons on whom
the obligation of compliance with the provisions of this Recommendation rests;
(c) provide appropriate inspection services for the purpose of supervising the appli-
cation of the provisions of this Recommendation, or satisfy itself that appro-
priate inspection is carried out.
23. In applying the provisions of this Recommendation, the competent authority
should consult with the most representative organisations of employers and workers
concerned.

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