Health & Chemicals

Strategic Programs on Environmental Endocrine Disruptors '98 (SPEED '98) - Chapter II

II. The Environment Agency's Basic Policy on Environmental Endocrine Disruptors

1. Basic position

A scientific study of the problem of endocrine disrupting chemicals has just got under way and many aspects have yet to be scientifically elucidated. But we can tell from current scientific knowledge that it is a serious problem that has the potential to cause major harm to the reproductive processes of humans and animal species.
Our basic approach to the problem will be to conduct a comprehensive assessment of risks that may result from a contaminated environment and adopt effective countermeasures to ensure a safe environment for future generations. It is therefore important to accelerate scientific study under interdisciplinary forums and establish a framework so that administrative measures based on newly acquired scientific knowledge can be taken without delay. The following points are particularly important.

To promote study and research in close cooperation with other administrative bodies, academic research institutes and private organizations

It is important to promote investigations to collect data on endocrine disrupting chemicals and their sources and concentrations in the environment, and to have the outcome of such investigations and research reflected in administrative measures, while, at the same time, supporting the smooth operation of basic and applied studies at laboratories and universities. To this end, the Environment Agency is to establish and reinforce personnel and organizational networks between research groups (including those in the private sector) and administrative bodies in cooperation with local government. The Agency is also to request private businesses and organizations to provide useful data and information in their possession concerning chemicals and pollution sources.

To strengthen the international research cooperation and information network

In view of the importance of strengthening and improving investigations and research activities in relevant fields and the importance of international cooperation, the Agency is to strengthen cooperation through international organizations, as well as through bilateral and multilateral cooperative arrangements.
As some developing countries still use the kind of agricultural chemicals known to be endocrine disruptors even though production and use of these chemicals have been prohibited in developed countries, the possibility of Japan's environment being contaminated cannot be discounted. The Agency intends to provide such countries with information and assist in their efforts to conserve and improve their environment.

To promote the reexamination of preventive measures against chemical pollution

In view of the special characteristics of the endocrine disrupting chemical problem, the Agency and environmental departments of local governments are to reexamine and improve conventional pollution prevention measures and environment monitoring systems that have been implemented from the standpoint of preventing environmental pollution, and take appropriate steps on matters which cannot be adequately dealt with within the framework of current anti-pollution measures.

To secure close cooperation with other Ministries and Agencies

The Agency is responsible for taking the leading role in dealing with the problems of endocrine disrupting chemicals from the standpoint of managing environmental risks to humans and ecological systems. But it is also important for the Agency to strengthen cooperation with other Ministries and Agencies engaged in environmental risk management, such as those ensuring the safety of foods and drinking water and the safe use of chemicals. It is also important to promote exchanges of information and make further efforts to coordinate policies.

2. Specific approaches to problem

(1) Promotion of field investigations into the present state of environmental pollution and adverse effects on wildlife of endocrine disrupting chemicals

  • A) The Agency will study the actual state of environmental pollution caused by endocrine disrupting chemicals, their sources and amounts, and will estimate the degree of environmental exposure to humans and wildlife by such chemicals to acquire basic data and information for use in practical environmental risk assessment.
  • B) The Agency will investigate abnormal reproductive function and behavior of wildlife (particularly, aquatic animals and those living along the water's edge) resident in or migrant to Japan, study the contamination of their tissues and the concentrations of vitellogenin in their blood in order to determine if there is a causal relationship between the occurrence of abnormalities and environmental pollution.
  • C) The Agency will continually study adverse effects on human health by employing the 'Health Effect Surveillance Method' on a regular basis using several selected indicators. In conducting these investigations and studies, the Agency seeks the cooperation of medical institutions, wildlife protection organizations and environmental NGOs having highly-specialized knowledge, as well as the environmental departments of local governments.

A)Collection of information on environmental pollution with endocrine disruptors and their sources

  • (1) Environmental pollution investigation: the Agency will compile a list of substances that have priority (prioritized substances) from among the substances suspected of having endocrine disrupting properties and investigate the pollution situation of the general environment (air, water quality, biota, etc.) on a national level.
  • (2) Investigation of sources of endocrine disruptors and their burden on the environment: the Agency will investigate the amount of prioritized substances produced and their level of usage, their sources to the environment and burden on the environment, and their decomposition and synthesis in the environment.
  • (3) Investigation of exposure routes: the Agency will study the behavior of the prioritized substances in the environment and consider them along with the outcome of the investigations listed under (1) and (2) to understand the route and degree of exposure to humans and to wildlife.

B) Promotion of study on adverse effects on wildlife

  • (1) Investigation of the current situation with regard to possible adverse effects on wildlife: the Agency will investigate the concentrations of prioritized substances in wildlife on a Japan-wide basis, and study in various ways the possible occurrence of reproductive abnormalities.
  • (2) Investigation of wildlife contamination pathways: investigation of transfer routes to wildlife of contamination caused by prioritized substances will be conducted in tandem with the investigation listed under A) (3).
  • (3) Establishment of a wildlife monitoring system: the Agency will set up a monitoring system to investigate chronological changes in the reproductive abnormalities of selected wildlife.

C)Implementation of surveillance of possible adverse effects on human health

  • (1) Sperm investigation: the Agency will investigate the sperm count for adult men, and sperm formation in testes (data obtained from corpses), and analyze and assess their relationship with the degree of exposure to the prioritized substances.
  • (2) Umbilical cord investigation: the concentrations of prioritized substances in umbilical cords will be measured to use as an index of exposure during fetal development (with cooperation of university laboratories).
  • (3) Surveillance: the Agency will seek the cooperation of medical institutions to obtain useful information on a continual basis to understand the effects of endocrine disrupting chemicals. Such information will be tallied and analyzed.

(2) Promotion of research and screening and testing method development

The Agency intends to improve the research arrangements at the National Institute for Environmental Studies, including the establishment of related research facilities and the promotion of laboratory studies and technological developments by using the environment-related budgets allocated to state-run laboratories. The outcome of such efforts will be, for example, incorporated into the various investigation methods mentioned in (1) or used as data in deciding administrative measures. The Agency also intends to support research efforts by universities and other academic research institutions.

A) Promotion of laboratory studies

Among many laboratory studies, the following projects should be given priority.

  • 1) Elucidation of mechanisms by experiments utilizing in vivo and in vitro assays
  • 2) Elucidation of how exposure during fetal development exert its effects
  • 3) Development of a biomarker to measure the level of exposure and effects on wildlife and its practical application
  • 4) Development of a biomarker to measure the level of exposure and effects on humans and its practical application
  • 5) Elucidation of the compound effects of endocrine disrupting chemicals
  • 6) Elucidation of the mode of action of phytoestrogens
  • 7) Development of technology to improve and restore polluted environments

B) Development of examination and inspection methods and their practical application

The development, with international cooperation, of examination methods to determine whether chemical substances have endocrine disrupting properties and their practical application.

  • 1) Development of an analytical method using structure-activity relationships
  • 2) Development of a screening method to determine endocrine disrupting properties by experimentation on animals (in vivo assays) and its practical application
  • 3) Development of a biomarker to measure the level of exposure and effects on wildlife and its practical application
  • 4) Development of an examination method to understand the multi-generational effects of endocrine disrupting chemicals and its practical application
  • 5) Development of a simple method to measure concentrations of endocrine disrupting chemicals in the environment and their practical application
  • 6) Development of a technology to sensitively measure endocrine disrupting chemicals and its practical application

Promotion of environmental risk assessment and risk management, and information dissemination

  • A) On the basis of the results of studies and research listed under (1) and (2) above, environmental risk assessment will be conducted on endocrine disrupting chemicals in a predetermined order of priority.
  • B) Measures necessary for environmental risk management will be promoted based on the above assessment.
  • C) New scientific knowledge and the results of environmental risk assessment, etc. will be made available to help the general public understand the problem.

A) Promotion of environmental risk assessment

The Agency will promote environmental risk assessment based on the level of environmental contamination, information on the source of such chemicals, estimates of exposure level and pathways to humans and wildlife, as well as on scientific knowledge concerning endocrine disruptive effects.

B) Promotion of environmental risk management

  • 1) Re-examination of measures based on current laws and ordinances: while thoroughly controlling chemicals whose use has been restricted under current anti-pollution laws and ordinances, the Agency will re-examine whether the laws and ordinances can fully cope with endocrine disrupting chemicals. In addition, on the basis of the results of environmental risk assessment, the Agency will consider and implement necessary measures, including socioeconomic ones, to reduce the burden on the environment by business activity and consumption.
  • 2) Promotion of the disposal of PCBs and measures against dioxins: the Agency will promote the proper disposal of PCBs that are in safe keeping after their use was prohibited. It will also strive to ensure a steady progress of the anti-dioxin five-year plan.
  • 3) Introduction of the Pollutant Release and Transfer Register (PRTR): The Agency will strive for the introduction of the PRTR, a system under which the amount of pollutants released into the environment or their quantity transferred as waste are registered and published.

C) Promotion of continual publication and dissemination of information

While publishing new information obtained through studies and research from time to time, the Agency will also release leaflets and hold lecture meetings and symposia for the proper understanding of the problem in cooperation with local governments, university laboratories, related academic societies and environmental NGOs.

About PRTR

PRTR (Pollutant Release and Transfer Register) is a system to register, on the basis of reports by business operators, the amount of pollutants released into the environment or their quantity transferred as waste and to publish them. The PRTR is a necessary tool for environmental policy administration in the conducting environmental risk management of chemicals. It also prompts business operators producing or using chemicals to restrict the discharge of the chemicals and helps raise awareness of the problem. The United States, Canada, the United Kingdom and the Netherlands have already introduced legally-binding PRTRs. In 1996, the Organization for Economic Cooperation and Development (OECD) agreed on recommendations that member countries take steps to establish a PRTR system. The Environment Agency began pilot projects in some areas of Kanagawa and Aichi prefectures in June 1997 and published an interim report. The Agency intends to continue discussions on the introduction of a PRTR system after summarizing the final assessment of the pilot projects and reviewing comments from the public in August this year. The PRTR is indispensable in estimating accurate amounts of endocrine disrupting chemicals in the environment and in taking appropriate administrative steps against their changes.

(4) Strengthening of international networks

The Agency will positively support activities of the OECD and other international organizations, promote joint studies and research with other countries, hold international symposia, and provide developing countries with relevant information.

On the basis of the 1997 Declaration of Environmental Leaders on Children's Environmental Health, and with a test guideline now being prepared by the OECD, the Agency intends to promote investigations and research in cooperation with international organizations and other countries. It will promote joint investigations and studies and hold international symposia with countries tackling the problem to compare assessments of data and to deepen personnel interchanges. It will strive to provide developing countries with relevant information. The Agency will also strive for the adoption of the international agreement on persistent organic pollutants (POPs) and the convention on prior informed consent (PIC) for international trade in harmful chemicals and pesticides. It intends to contribute positively to global-scale monitoring activities.

The Environmental Agency's approach to the problem of endocrine disrupting chemicals outlined above is based on scientific knowledge and information currently available. As new knowledge is obtained, the Agency will review its approach on a continual basis to ensure that the most effective measures are implemented.

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