2. Basic policies
Problems of endocrine disruptors require immediate research and studies and,also necessary measures as occasion demands because there are indications thatthese substances may affect human health, and, in particular, may harm
multiple generations. However, the problems that endocrine disruptors cause are
not easy to solve because they are often beyond conventional understanding andknowledge in the scientific field, and these substances vary in type andcharacteristic. Accordingly, the problems are diverse and complicated. Also, thesechemicals may have various effects in everyday life. Under such circumstances, afundamental policy to solve endocrine-disruptor problems comprehensively andsmoothly should be urgently set up, based on the information in previous sectionsof this report. This section describes a basic policy for coping with endocrine
disruptors which will protect human health.
(1)

Concept of chemical safety

In the past, chemical safety was focused on preventing acute toxicity, due mainly
to unintentional consumption of pesticides. Half the lethal dose obtained fromanimal experiments was used as the index of toxicity. Hazardous chemicals
eventually came to be labeled adequately, and the number of accidents resulting
from these chemicals decreased.
In recent years, carcinogenicity has been used as an important index for chemicalsafety. This approach was taken because cancerous diseases have become highranking causes of human death, and efforts have been made to study relationships
between chemicals and cancers in toxicology and pathology. In addition,
teratogenicity and reproductive toxicity have been used as indexes, consequent to
the occurrence of teratogenicity from a pharmaceutical, thalidomide.
In safety evaluations of food additives, various indexes are used, including oneyear repeated dose toxicity, reproductive toxicity, teratogenicity, carcinogenicity,
antigenicity, and mutagenicity. Guidelines for the safety evaluation of additives
require data obtained from studies using these indexes.
Epidemiological indexes are however not appropriate in evaluating chemical

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safety, except for acute toxicity, such as food poisoning. In evaluating chronic
toxicity, as there are various causes which are mutually acting, it is difficult toevaluate the direct effects of chemicals through epidemiological investigations.
Endocrine disruptors are new types of problems which have occurred recently.
There are many questions which remain to be solved, such as the presence orabsence of endocrine disrupting activities, and the type and extent of activities.
Also, evaluation methods have not been established yet. Therefore, Japan andother countries are working extensively on research to clarify these various points
and to establish safety-evaluation approaches for endocrine disruptors.
If standardized evaluation-methods are established, the adoption of these methods
should be considered for safety evaluation of any food additive and pesticide which
will be developed.
( 2 ) Development of an information management and distribution system, basedon a database
It is expected that scientific research will be promoted globally. To solve problems
effectively, a time- and cost-saving management system must be established,which enables the general management of various types of research, and helps toavoid duplication. Because there are divers target chemicals for research, andinformation on these chemicals also varies, various pieces of information should beintegrated for effective risk assessment and risk management.
At the moment, the WHO is working to produce a database to manage informationworldwide. Japan needs to establish an information management system based onthat database in cooperation with international organizations and other countries.
Compiled information should be widely available not only to the governmental
agencies concerned and foreign countries, but also to Japanese consumers.
Exchange of information should be encouraged among administrative agencies,
academic institutions, and private organizations.

(3) Encouragement of international cooperation
Endocrine disruptors are now recognized as global problems common to manycountries. The WHO and OECD are leading the build-up of a framework for48

tackling these problems. The United States and European countries are discussing
how to proceed with research and how to regulate endocrine disruptors on theirown. Under such circumstances, Japan needs to join the international activities
under this framework, and to encourage cooperation in taking measures against
endocrine disruptors.
Japan heavily depends on importation for many kinds of domestically consumed
products, such as food. There is a high possibility that the use of chemicals inexporting countries may cause health effects in the Japanese population. To
protect the health of the Japanese population, we have to provide exporting
countries, especially developing countries, with necessary information based on
research findings. This also will help to prevent the occurrence of health hazards
in developing countries and to promote environmental conservation.
(4)

Promotion of comprehensive research

It is necessary to thoroughly investigate the adverse effects of chemicals which aresuspected of having endocrine disrupting actions and which are drawing thepublic attention. Unnecessary public concern should be removed by clarifying
questions, such as those concerning the presence or absence of health effects andthe type and extent of these effects, based on these investigations. Also,
appropriate measures should be taken immediately, as occasion demands.
The chemicals currently suspected to be endocrine disruptors have been focusedupon as a result of the investigations of their effects on wildlife and effects on cells
in vitro. The number of chemicals used in Japan is estimated at several tens ofthousands. Therefore, it is necessary to identify the effects of these chemicals andto take action to prevent them because there is the possibility that they may haveendocrine disrupting actions on humans and wildlife, now or in the future. To that
end, it is necessary to promote research on the potential endocrine-disrupting
actions for the chemicals for which observations have not yet been obtained.
There are not enough data to draw conclusions on combined effects of multiple
chemicals and responses to low dosages. It is necessary to explore methods ofevaluation and to carry out sufficient studies under the international framework
for accumulating data.

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In 1996, Japan began research on problems of endocrine disruptors in view of theprevention of health hazards, mainly under the framework of the Health Sciences
Research Program. These activities were promoted in cooperation with theindustrial and academic sectors. In addition, the promotion of comprehensive
research is needed, adding to the voluntary conduct of research in the industrial
sector and the provision of information, such as study data, by foreign countries
and related governmental agencies.

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