A. GENERAL PRINCIPLES AND PROCEDURES
The objective of the programme is to prepare, with the help of international Working Groups of experts, and to publish in the form of Monographs, critical reviews and evaluations of evidence on the carcinogenicity of a wide range of human exposures. The Monographs represent the first step in carcinogen risk assessment, which involves examination of all relevant information in order to assess the strength of the available evidence that an agent could alter the age-specific incidence of cancer in humans. The Monographs may also indicate where additional research efforts are needed, specifically when data immediately relevant to an evaluation are not available.
In this Preamble, the term ‘agent’ refers to any entity or circumstance that is subject to evaluation in a Monograph. As the scope of the programme has broadened, categories of agents now include specific chemicals, groups of related chemicals, complex mixtures, occupational or environmental exposures, cultural or behavioural practices, biological organisms and physical agents. This list of categories may expand as causation of, and susceptibility to, malignant disease become more fully understood.
A cancer ‘hazard’ is an agent that is capable of causing cancer under some circumstances, while a cancer ‘risk’ is an estimate of the carcinogenic effects expected from exposure to a cancer hazard. The Monographs are an exercise in evaluating cancer hazards, despite the historical presence of the word ‘risks’ in the title. The distinction between hazard and risk is important, and the Monographs identify cancer hazards even when risks are very low at current exposure levels, because new uses or unforeseen exposures could engender risks that are significantly higher.
In the Monographs, an agent is termed ‘carcinogenic’ if it is capable of increasing the incidence of malignant neoplasms, reducing their latency, or increasing their severity or multiplicity. The induction of benign neoplasms may in some circumstances (see Part B, Section 3a) contribute to the judgement that the agent is carcinogenic. The terms ‘neoplasm’ and ‘tumour’ are used interchangeably.
The Preamble continues the previous usage of the phrase
‘strength of evidence’ as a matter of historical continuity,
although it should be understood that Monographs
evaluations consider studies that support a finding of
a cancer hazard as well as studies that do not.
Some epidemiological and experimental studies indicate
that different agents may act at different stages in the
carcinogenic process, and several different mechanisms
may be involved. The aim of the Monographs has
been, from their inception, to evaluate evidence of carcinogenicity
at any stage in the carcinogenesis process, independently
of the underlying mechanisms. Information on mechanisms
may, however, be used in making the overall evaluation
(IARC, 1991; Vainio et al., 1992; IARC, 2005, 2006;
see also Part B, Sections
4 and 6).
As mechanisms of carcinogenesis are elucidated, IARC convenes
international scientific conferences to determine whether
a broad-based consensus has emerged on how specific mechanistic
data can be used in an evaluation of human carcinogenicity.
The results of such conferences are reported in IARC Scientific
Publications, which, as long as they still reflect the
current state of scientific knowledge, may guide subsequent
Although the Monographs have emphasized hazard
identification, important issues may also involve dose-response
assessment. In many cases, the same epidemiological and
experimental studies used to evaluate a cancer hazard
can also be used to estimate a dose-response relationship.
A Monograph may undertake to estimate dose-response
relationships within the range of the available epidemiological
data, or it may compare the dose-response information
from experimental and epidemiological studies. In some
cases, a subsequent publication may be prepared by a separate
Working Group with expertise in quantitative dose-response
The Monographs are used by national and international authorities to make risk assessments, formulate decisions concerning preventive measures, provide effective cancer control programmes and decide among alternative options for public health decisions. The evaluations of IARC Working Groups are scientific, qualitative judgements on the evidence for or against carcinogenicity provided by the available data. These evaluations represent only one part of the body of information on which public health decisions may be based. Public health options vary from one situation to another and from country to country and relate to many factors, including different socioeconomic and national priorities. Therefore, no recommendation is given with regard to regulation or legislation, which are the responsibility of individual governments or other international organizations.
Posted 23 January 2006