B. SCIENTIFIC REVIEW AND EVALUATION
Each Monograph includes general information on
the agent: this information may vary substantially between
agents and must be adapted accordingly. Also included
is information on production and use (when appropriate),
methods of analysis and detection, occurrence, and sources
and routes of human occupational and environmental exposures.
Depending on the agent, regulations and guidelines for
use may be presented.
(a) General information on the agent
For chemical agents, sections on chemical and physical
data are included: the Chemical Abstracts Service Registry
Number, the latest primary name and the IUPAC systematic
name are recorded; other synonyms are given, but the list
is not necessarily comprehensive. Information on chemical
and physical properties that are relevant to identification,
occurrence and biological activity is included. A description
of technical products of chemicals includes trade names,
relevant specifications and available information on composition
and impurities. Some of the trade names given may be those
of mixtures in which the agent being evaluated is only
one of the ingredients.
For biological agents, taxonomy, structure and biology
are described, and the degree of variability is indicated.
Mode of replication, life cycle, target cells, persistence,
latency, host response and clinical disease other than
cancer are also presented.
For physical agents that are forms of radiation, energy
and range of the radiation are included. For foreign bodies,
fibres and respirable particles, size range and relative
dimensions are indicated.
For agents such as mixtures, drugs or lifestyle factors,
a description of the agent, including its composition,
Whenever appropriate, other information, such as historical
perspectives or the description of an industry or habit,
may be included.
(b) Analysis and detection
An overview of methods of analysis and detection of the
agent is presented, including their sensitivity, specificity
and reproducibility. Methods widely used for regulatory
purposes are emphasized. Methods for monitoring human
exposure are also given. No critical evaluation or recommendation
of any method is meant or implied.
(c) Production and use
The dates of first synthesis and of first commercial
production of a chemical, mixture or other agent are provided
when available; for agents that do not occur naturally,
this information may allow a reasonable estimate to be
made of the date before which no human exposure to the
agent could have occurred. The dates of first reported
occurrence of an exposure are also provided when available.
In addition, methods of synthesis used in past and present
commercial production and different methods of production,
which may give rise to different impurities, are described.
The countries where companies report production of the
agent, and the number of companies in each country, are
identified. Available data on production, international
trade and uses are obtained for representative regions.
It should not, however, be inferred that those areas or
nations are necessarily the sole or major sources or users
of the agent. Some identified uses may not be current
or major applications, and the coverage is not necessarily
comprehensive. In the case of drugs, mention of their
therapeutic uses does not necessarily represent current
practice nor does it imply judgement as to their therapeutic
(d) Occurrence and exposure
Information on the occurrence of an agent in the environment
is obtained from data derived from the monitoring and
surveillance of levels in occupational environments, air,
water, soil, plants, foods and animal and human tissues.
When available, data on the generation, persistence and
bioaccumulation of the agent are also included. Such data
may be available from national databases.
Data that indicate the extent of past and present human
exposure, the sources of exposure, the people most likely
to be exposed and the factors that contribute to the exposure
are reported. Information is presented on the range of
human exposure, including occupational and environmental
exposures. This includes relevant findings from both developed
and developing countries. Some of these data are not distributed
widely and may be available from government reports and
other sources. In the case of mixtures, industries, occupations
or processes, information is given about all agents known
to be present. For processes, industries and occupations,
a historical description is also given, noting variations
in chemical composition, physical properties and levels
of occupational exposure with date and place. For biological
agents, the epidemiology of infection is described.
(e) Regulations and guidelines
Statements concerning regulations and guidelines (e.g. occupational exposure limits, maximal levels permitted in foods and water, pesticide registrations) are included, but they may not reflect the most recent situation, since such limits are continuously reviewed and modified. The absence of information on regulatory status for a country should not be taken to imply that that country does not have regulations with regard to the exposure. For biological agents, legislation and control, including vaccination and therapy, are described.
Posted 23 January 2006