Dec,2006 : Citizen’s Proposal on Chemical Management

Mar 17, 2012

Citizen’s Proposal on Chemical Management
(Preliminary translation)
NGO Forum for a New Chemical Policy
Toxic Watch Network
People’s Association on Countermeasures of Dioxin & Endocrine Disruptors
Citizens Against Chemicals Pollution
WWF Japan
Japan Occupational Safety and Health Resource Center (JOSHRC)
Asbestos Center
Address:c/o Toxic Watch Network
4F, Z Building, 7-10-1 Kameido, Kotoku, Tokyo, Japan
Phone & Fax: (+813) 5836-4359
Citizen’s groups and NGOs concerned about chemical substances had worked separately on specific
issues including dioxin, endocrine disruptors, chemical sensitivity syndrome, environmental
contamination, wastes and occupational health and safety. However in April 2002, they formed the
“ Toxic Watch Network,” a loose network of citizen and NGOs focused on the government chemical
management policy. It was a response to the “Law on the promotion of the grasp of the discharge of
the specified chemical substance to the environment and the improvement of the management”
established in 2001 based on PRTR and MSDS systems.
In November 2004 and September 2005, NGOs and civil society groups joined to organize and
sponsor two international seminars focused on REACH (Registration, Evaluation and Authorization of
Chemicals) that is to be implemented in the EU in the near future. At the first REACH seminar,
“Tokyo Declaration on Toxics-Free Earth” was adopted and publicized on November 23, 2004.
The declaration expressed strong expectation for the REACH to be finalized “without compromising
its original purpose of ensuring a high level of safety with respect to both human health and the natural
environment,” while highly valued the REACH initiatives as the “first step” towards the earth free
from man-made chemical contamination.

Their declaration strongly asked some segments of the Japanese government and industry to
immediately halt their actions in intervening in the REACH process in pursuit of their short-term
profits at the cost of human and ecological health. It demanded the Japanese government to begin without delay, comprehensive reviewing of the existing chemical management system in Japan
incorporating the following considerations.
1) Promotion of the use of safer alternatives to existing chemicals, based on precautionary
2) Termination of the use of chemicals whose safety has not been proven
3) Shifting of burden of proof that a substance is harmless from government authorities to
producers, and strengthening of the principle of producer liability
4) Assurance of citizen’s rights of access to information, including full disclosure of chemicals
contained in products
5) Institutionalization of public participation in the drafting of regulations and other aspects of
policy making.

Initiatives and activities of the NGO Forum for a New Chemical Policy in Japan

The Japanese government plans to review the “Pollutant Release and Transfer Register” system or
PRTR in 2007 and the “Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc.” in 2009. The process has already Started from the spring of this year (2006). The
Ministry of Economy, Trade and Industry set up a sub-committee on basic policy issues on chemical
substances under the Industrial Structure Council, and the Ministry of Environment established a
sub-committee on environmental measures relating to chemical substances under the Central
Environmental Council. To monitor the government process, a new network of concerned citizens,
“NGO Forum for a New Chemical Policy, Japan” was formed around the groups and organizations
that had organized the above mentioned international seminars and endorsed the Tokyo Declaration.
Our major objectives include:

To demand the government to ensure full participation of citizens in the policy
making process relating to chemical substances identified in the Agenda 21 and
SAICUM, and;
To develop and advocate policy proposals/agendas on chemical management
from citizen’s point of views, that reflect the experiences of member
organizations’ activities

The NGO Forum for a New Chemical Policy committed has worked on policy analysis and proposals
focusing on the government process of reviewing and revising the above mentioned two laws, i.e. the
PRTR and the “Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture,
etc.” particularly on creating a possible new basic law on chemical substances. As the members of the
Forum, we are calling for further understanding and support from the public in Japan.

I. Background and basis of the citizen’s proposal

1. Fundamental revision of laws and regulation on chemical substances is needed.
In the latter half of the 20th century, human society witnessed ever faster and higher levels of a
“chemical civilization.” Countless number and variety of synthetic chemicals were developed and
invented to be used in every aspect of our lives
While it is true that chemical substances can be utilized for variety of benefits, it is widely known that
some of them can negatively impact human health and ecology. Unfortunately, the negative aspects of
chemicals have not been sufficiently managed. Minamata disease, Kanemi oil poisoning case and
other incidents caused by hazardous chemical contamination that Japan experienced were typical
examples of poor chemical control.
Learning from those bitter incidents, regulations and laws on chemical management have been
enforced though quite slowly including the above-mentioned laws. However, it is estimated that there
are nearly 100,000 chemical products in the present market and the majority of them are manufactured
and used without any data on their negative impact. Thus, our chemical substance management system
is still very insufficient. In addition, in recent years, there are hazardous or toxic sub-products
generated during the process of chemical products, such as dioxin.
They are unintentionally produced substances that we know very little about. In other words, what
are their causes? What mechanism is creating such by-products ? What are their levels of toxicity?
Nor, do we hardly know about the present conditions and impacts of multi-chemical exposure, though
we all are exposed to numerous chemical substances in our everyday life.
With this reality, it is significantly critical for us to effectively use chemical products by controlling
their negative impact that can be identified as a black shadow over use. Foolishly, humans have
jumped on the bright side of chemical substances and mass-produced them for the commercial market
without thoroughly examining their dark side. It is very clear now that we cannot continue this
business if we want to prevent the hazardous impact on human health and ecology. In other words, it
is clear for us now that we need to conduct a thorough review, and drastically revise the present
chemical management system, if we want to continue enjoying the benefits of chemical substances.

In EU, REACH, a drastic new system of chemical management, has been developed and soon to be
enforced as a result of many years of in-depth discussions and consultations on sustainable chemical
management system. It is also time for Japan to fundamentally review the present system for
establishment of a new system of chemical management.

2. Problems in the present system
Comprehensive or integrated management perspectives are not incorporated into the present system
in Japan that categorizes chemical substances by its usage or application such as drugs and medicine,
agricultural application, general chemical products and occupational health. Thus, the laws and
regulations are enforced category by category by the different government offices, in the so-called
“vertically divided administration system.” Naturally, some unavoidable inconsistencies between
sectors occur. For example, chlordane was prohibited to register as agricultural pesticide, but
continues to be allowed to use as a repellent for ants in the consumer market. Another case is asbestos.
Even after the hazard of asbestos was recognized, insufficient communication and cooperation among
government authorities resulted in significant danger to workers and the public that could have been
prevented. There were many other similar cases of serious damage due to the “vertically divided
administration system.”

Because of this ministry-by-ministry administration system, there are no common or harmonious
strategies nor management rules. For one chemical substance, there are different rules for acquiring
manufacturing and sales approval, and different labeling regulations, depending on the applications.
This is very confusing for the public.
Considering how large the number and quantity of the entire chemical products now being
manufactured and used, some strict controlling rules shall be in place to ensure safe management. At
the same time, an efficient and effective information disclosure and communication system is
important so that all stakeholders including consumers, manufacturers and other users of chemical
products are able to practice appropriate risk management for themselves. In the present system where
there is no mandatory rules to provide MSDS for general consumers, the information disclosure for
the public is not good enough. There is no foundation of communication between users, companies
and manufactures.

The life cycle management from production to disposal is needed for chemical substance management.
But, the present laws and regulations do not clearly stipulate manufacturer’s responsibility at the end
of the product’s life. Needless to say, the effective life cycle management is not possible under the
existing vertically divided administrative system.
There are no provisions on newly developed technologies such as nanotechnology in the present laws
and regulations. There is no foundation for applying precautionary principles or precautionary
measures that are very important for chemical substance management.

3. Limitations of the risk approach
The risk approach is a method used in the present law enforcement system that is based on the
quantitative risk assessment of chemical substances. We recognize the following problems with it.
First, quantification and numerical conversion of the risk itself is a problem. There are a variety of
negative impacts on human health and ecology. It is quite unreasonable to determine the levels of risks
of different qualities by standardized numbers. For example, how can we assess risks of death and
infertility by the same standards?

Second, even quantitative risk assessment is not possible on the predominant number of chemicals
because their data is far below the required level. It would take a great amount of budget and time to
get the data necessary for risk assessment. Thus, risk approach will not be done in time to implement
the effective measures to decrease environmental risks that are increasingly becoming serious every

Third, quantitative risk assessment methods for complex or multi-chemical exposure, and low-level
exposure have not been established yet. This is not very realistic. Because people are exposed to
hundreds of chemicals every day. So, the risk approach can be totally unrealistic to the actual risks.

Lastly, this approach cannot be applied to the risks whose quantitative risk approach are not yet
established such as endocrine disrupter substances. Needless to say, it is not applicable to unknown
risks. In the past history of chemical management, we saw the emergence of new risks one after
another along with scientific development. Considering the unpredictability of risks, there is the
limitation in the present risk approach that can only be applied to known risks.

As described above, there are significant problems in the present risk approach. However, it does not
mean we shall totally deny the risk approach, but we need to fully recognize its limitation. With that
recognition, we shall implement as much as and as quickly as possible the appropriate management
practices based on precautionary principles.

4. Based on the above recognition and perspectives, we drafted the following proposals for the ideal
management of chemical substances. We hope those who are in the relevant industries and in the
policy-making levels of government will examine them carefully, and immediately began working on
a new comprehensive and integrated management system based on thorough review of the present
chemical management system.

II. Our Proposals

1. Proposals on essential policy direction for the management of chemical substances

1) A comprehensive integrated management system
Under the present management system, chemical substances are categorized by their applications and
usages. Thus, the laws and regulations on management are separately enforced by relevant
government authorities. As we have experienced with the asbestos cases, there are inevitable
inconsistencies and gaps among the administrative practices that are inherent in the vertically divided
administrative system. The environment cannot be divided into administrative segments. Thus, it is
essential to establish a comprehensive law enforcement system by consolidating administrative tasks
into a certain central government authority.
Therefore, in order to realize a truly comprehensive integrated management system, we propose the
government to establish a new agency that exclusively engages in safe management of chemical
substances, or to set up the committee on chemical safety issues within the cabinet office while
initiating the process to establish the basic law on safety of chemical substances.

2) Life-cycle management system
Chemical substances must be managed through the entire life cycle including production, distribution,
consumption (application), and disposal. Though its necessity is recognized, the present system does
not cover the entire life cycle. In the area of food, the integrated system covering production,
distribution and consumption has been developed in recent years. For the chemical substances as well,
we propose a life-cycle base risk assessment and management system through IT technology.
3) Pre-examination system for chemical substances including those in the market at present
The government shall adopt a management method in which only a chemical substance whose safety
is confirmed based on sufficient data gathered, shall be permitted to be manufactured and used. In
order to bring it to the public, a pre-examination system shall be developed like the Chemical
Substances Control Law that is now only applied to new chemical substances. But, we believe it shall
be applied to existing chemicals as well.
4) Full implementation of measures based on precautionary principles
As mentioned above, the present risk approach has limitations. But, there is no effective methods
being developed at present. Thus, it is expected to always take precautionary principles into full
consideration to implement the management system based on the risk approach. Therefore, we
propose development of the precautionary principle application guideline as soon as possible.
5) Formulation of the principles for promotion of alternative materials
We propose to establish the principles on alternative materials that actively promote conversion to
safer production or manufacturing processes and materials. Sufficient safety examination shall be
required on alternative production methods, processes and substances.
6) Participatory process shall be ensured.
Application and implementation of the precautionary principles require not only approval reached by
administrative officials and experts, but also wider social acceptance. We propose fully ensured
participatory decision-making process on management of chemicals, open to all stakeholders
including citizens and NGOs.
2. Proposals on information gathering and communication relating to chemical substances
Considering the countless numbers of chemical substances and commercial products existing today,
usage of information is particularly important in their management. We propose the following matters
regarding information gathering and communication.
1) Who shall be responsible to gather information, and what information shall be gathered.
From the perspectives of international harmonization, the information to be gathered shall be in line
with GHS and OECD guidelines. The scope of safety examination shall not be set by uniformed
criteria, but some variation shall be used according to the volume of production and applications.
In principle, upstream manufactures are responsible for gathering data and information. However,
downstream manufacturers shall be imposed mandatory responsibility to gather information when they
use chemical substances in ways different from the specified application instructed by upstream
manufacturers. To implement this, a new system shall be introduced that requires downstream
manufacturers to report how they apply chemicals to upstream manufacturers. Further, another system
shall be established that requires both upstream and downstream manufacturers to submit the
government the volume of production and applied conditions of chemical substances as well as
gathered data on toxicity.
2) Assessment, registration and management of data
The examination of data shall be conducted by a third party institution. Ideally, the evaluation system
shall be incorporated into the above-proposed new government agency on chemical safety or the
committee on chemical safety. This institution or organization shall be responsible for data registration
and management system.
Active data gathering in the industry shall be encouraged, even after the first set of the date is
submitted to the government. For the newly found hazardous information, mandatory submission with
certain penalties shall be imposed on the industry.
3) Information disclosure and communication
In principle, the submitted data shall be disclosed to the public while paying careful consideration on
industrial secret issues. As stated in the Overreaching Policy Strategy Annex IVB, 15 (c) of SAICM,
we need to keep in mind that “— information on chemicals relating to the health and safety of humans
and the environment should not be regarded as confidential—.”
The government shall collect information on chemicals over a wider scope, develop an integrated data
system of the data subjected to mandatory submission and PRTR data, and provide it to the public in
accessible and useful ways. For example, in case of PRTR data, people shall be able to have easy
access to a website where you can click on the regional grid square and find not only the amount of
emissions but also the relating links for information on toxicity, the ranking of danger or toxicity, the
production volume and application/usage information (on particular products), records of detected
levels in human body and environment in and out of the country, regulatory conditions and other
relevant information.
As for the chemicals used in consumer products or home appliances in particular, an information
system is needed in which detailed information (on components, toxicity, application, disposal and
environmental impact among others) shall be explained in easy-to-understand ways. For this purpose,
it is necessary to implement measures including mandatory disclosure or the supplying of the risk
assessment documents made by manufacturers and MSDS (Material Safety Data Sheet) to the end
users, implementation of labeling system on GHS (Globally Harmonized System of Classification and
Labeling of Chemicals,) and environmental labeling regulations.
3. Proposals on full introduction of GHS system
1) The major objective of the GHS recommendations drafted by United Nations is “to classify and
label all substances and mixtures of chemicals based on their hazards.” GHS will be implemented in
Japan in December 2006, but limited only to the occupational safety sector. The revised Occupational
Safety and Health Law is not yet sufficient as its mandatory labeling covers only 93 substances and
mandatory submission of MSDS covers only 634 substances.
In order to fully implement GHS recommendations, an overreaching comprehensive GHS system is
needed that covers not only occupational safety and health but more sectors including environment
and consumer while mandatory labeling and MSDS shall also be expanded to many more substances.
Therefore, we propose the integrated “Chemical Substance Labeling Law” (GHS Law) in Japan to
cover all substances and of chemical mixtures.
2) As short-term measures until the above mentioned GHS Law is established, we propose two
measures in relation to the MSDS institutionalized by the present Occupational Safety and Health Law,the Chemical Management Law and the Poisonous and Deleterious Substances Control Law. First, to
revise the format and requirements of MSDS to harmonize with those of GHS, and second, to
immediately implement mandatory illustrated labeling requirements.
Reviewing of substances to be covered by MSDS and GHS is needed as well. The review process
shall include and refer to the 1500 substances to be listed and announced by the government through
the Chemical Management Center of NITE (National Institute of Technology and Evaluation), and
500 substances classified as hazards in the European Council directive on classification, packaging
and labeling of dangerous substances (67/548/EEC).
3) Labeling of hazardous consumer products is very crucial for citizen.
We recommend the government to immediately begin reviewing all regulations and laws related to
consumer products, prior to the final establishment of the GHS Law. From the perspective of
consumer protection, we propose hazard classification of consumer products and mandatory labeling
with illustrations.
4. Proposals on chemical management methods
1) Establishment of the pre-marketing examination system
It is important for the chemical management to develop pre-marketing examination system. The
examination system shall include PBT (Persistent Bioaccumulative Toxic) substances, vPvB (very
persistent and very bioaccumulating) substances, CRM (Certified Reference Material), and endocrine
disturbance materials as well as mass-produced chemical substances and those used in wider open
2) Post-marketing management system
Chemical substances and products in the market shall be managed under the comprehensive system
that implements regulations by their domain and usage or application.
Effective management is needed through effective and optimal combination and/or integration of
available methods in various aspects including restrictions, framework regulations, economic methods,
information regulations, and voluntary management. If a substance may cause serious impact on
human health and environment, restrictions shall be taken. The voluntary management methods shall
be combined with the framework restrictions as much as possible. If it is not possible, mandatory
information disclosure shall be jointly implemented. More aggressive introduction of economic
methods such as environmental tax shall be further encouraged. Recommendations on the information
methods are as described above.
When implementing restrictive measures, restrictions or control on the total volume and classified
base regulations shall be enforced with the substance base restrictions.
When developing a management system, cautious consideration shall be taken into account on
high-risk groups such as children and the ecology. The existing level of standards shall be reviewed
from their point of view and a special risk level shall be set for such groups if necessary.
5. Proposals on risk assessment and risk management
At present the chemical management is implemented based on the risk approach that has inherent
limitation and problems as mentioned above. Therefore, we propose the followings as matters to be
considered in adopting the risk approach measures.
1) The main implementation body
First, a manufacturer shall conduct an individual risk assessment on each product and clarify its
management method. The information shall be available to the end users.
However, the government shall conduct risk assessment as well and enforce risk management
measures through control and restrictions. In this case, risk assessment shall be conducted by the
Chemical Safety Agency or the chemical safety committee, or other independent government bodies
different from the ministers and agencies that oversee subject industries.
2) Application of precautionary principles
Recognizing the limitation inherent to the risk approach measures, application of precautionary
principles is crucial for risk assessment and risk management. As already mentioned, the relevant
guideline shall be formulated without any delay.
3) Implementation of risk assessment focused on highly concerned risks
Risk assessment shall be done not entirely based on figures or numbers at the average level, but focus
on areas and groups in the population that may have potentially high risk of exposure.
4) Assessment and management based on mixed or multiple chemical exposures and compound
Risk assessment and management shall take into account not only single chemical exposure and its
impact, but also as much as possible, mixed or multiple chemical exposures and their compounded impact. At the same time, research and studies on mixed chemical exposures and their complex impact
shall be encouraged and promoted.
5)Ensured citizen’s participation
A participatory system for citizen shall be ensured. The system shall be consistent with the provision
of the Annex VI, C (g) of SAICM stating “To promote and support meaningful and active
participation by all sectors of civil society, particularly women, workers and indigenous communities,
in regulatory and other decision-making processes that relate to chemical safety” and with the
provisions of the Aarhus Convention or the Convention on Access to Information, Public Participation
in Decision-making and Access to Justice in Environmental Matters that was adopted by the UN
Economic Commission for Europe.
6. Proposals on a relief system for victims of new types of health damages
In recent years, we have witnessed increasing cases of new types of health impacts by chemical
substances such as sick-house, sick-school and chemical sensitivity syndromes that are essentially
different from the conventional chemical contamination impacts. There is an absolute lack of
experiences, studies and information on their mechanisms, source materials and medical treatment. As
a result, there are no relief measures for the victims. We propose a positive promotion of research and
study in order to build up sufficient knowledge and information on them, and set forth the following
proposals to establish such a relief system.
1) Medical system
(i) Thorough education and training of medical personnel
We often see the cases that even doctors, nurses and other medical personnel do not sufficiently
understand sick-house, sick-school and chemical sensitivity syndromes. Thus, it is essential to
conduct a thorough dissemination of information, training, and educational activities on pathogenic
mechanisms and the actual status of damages and countermeasures, in order to ensure a wider scope
of medical personnel understood and recognized such conditions.

(ii) Application of health insurance
Chemical sensitivity syndrome is not officially recognized as a disease to be diagnosed, thus, no
health insurance is applicable. However, as the number of patients is increasing, we propose to
immediately establish diagnostic criteria so that health insurance can be applied.
(iii) Development and creation of specialized clinics/hospitals and facilities for health resort
therapies, as well as a support system for private sector organizations
One of the major treatments for the patients of these diseases is to transfer them to a clean
environment where they can avoid further exposure that would only worsens their symptoms. For
this purpose, facilities for health resort therapies and temporary shelter type facilities are needed.
Thus, we propose development and creation of specialized clinics/hospitals, facilities for health
resort therapies and temporary shelters while providing support to private sector organizations that
manage such facilities.
2) Creation of a relief system
In quite a few cases, patients of sick-house, sick-school and chemical sensitivity syndromes have
difficulties to continue working. In many cases, it takes quite a long time to reduce their symptoms.
Therefore, they and their families have to manage the acutely heavy burden of both medical and health
resort therapies expenses as well their daily expenses.
Legal relief for them is also quite difficult because they have to satisfy very rigid criteria to prove
causes and results of their sicknesses, as well as problems related to their occupations. Therefore, we
propose setting up a new support system funded by the government and industry to cover their
medical care including health resort therapies, and daily expenses.
3) Consultation system, publicity and education
We need to develop as soon as possible a consultation system that the victims can access easily. Such
system shall provide sufficient consultation and information on such considerations as information on
sick-house, sick-school and chemical sensitivity syndromes, introduction to medical clinics/hospitals,
implementation of a chemical contamination survey, introduction to the survey/research organizations
and how to negotiate with manufacturers and sales entities.
It is also essential to implement PR measures to educate more widely the public on potential
possibilities of damages and countermeasures.
7. Proposals on new challenges
1) Establishment of a comprehensive assessment system when a new technology is introduced
For new technologies such as nanotechnology and genetic engineering, a comprehensive pre-market
assessment system on technological safety and socio-economic rationality shall be established through
guaranteed participation by citizens. When any scientific uncertainty is recognized, the precautionary
principles shall be applied. Criteria to decide its introduction shall not be decided by limited number of
experts, scientists, administrative officials and industrial representatives, but by a wider segment of society. In this regard, we propose the creation of a new citizen participatory system that may refer to
the model of a consensus meeting established directly by the national parliament in Denmark.
2) Proposals on nanotechnology
There are huge expectations for nanotechnology as a new technology that can make revolutionary
progress in all industries. Japan is among the countless number of countries that have invested a huge
amount of capital to aggressively compete with others in championing the nanotechnology market.
The application of nanotechnology has already been commercialized in all industrial sectors including
drug and cosmetics such as sunscreen products, sports items like tennis rackets, IT equipments like PC
memory chips, foods, medicines, environmental restoration, energy, chemistry and agriculture.
However, there is no single country that has any laws or regulations on nanotechnology. Without any
national safety standards, numerous nanotech-products are being marketed globally.
Contrary to its rapid progress, research and studies on the risks and impacts of the technology on
human health, environment, and society are at a very insufficient level. Naturally, funding to the safety
research is far below the amount allocated for technological development. This is the present reality.
Because of their micro sizes, it is assumed that a nano-substance often has chemical and biological
characteristics that are very different from conventional chemical substances even though their
chemical components are the same. A lot of scientific evidence has already been reported that
indicates serious implications of nano-substances on human health and environment.
In the United States and Europe, the governments publicized their policy initiatives on safety of
nanotechnology and they are calling for public comments. But in Japan, there is no announcement
from the government on the safety policy of nanotechnology. On top of that, they do not even clarify a
government ministry or agency that is responsible for the safety of nanotechnology. We believe, if we
want to develop nanotechnology, appropriate risk assessment on human health and environment is
essential, so that its safety can be ensured. Therefore, we propose the following.
(i) Basic policy
The government shall develop a basic policy on nanotechnology to ensure its safety and protect
human health and environmental safety from the potential risks of nanotechnology, and shall
immediately publicize a general timetable on implementing the policy. The government must
also immediately begin to work on new laws for managing nanotechnology.

(ii) Safety
The government and industry shall carry out research programs quickly under international
cooperation to establish standards and criteria on nanotechnology including the standards to test nano-substances, hazards, exposure and risk assessment criteria/standards and nano-product
safety standards. These research and study shall be jointly funded by the government and
(iii) Moratorium till safety is confirmed
The government shall enforce a moratorium on the environmental release of nano-substances,
and manufacture and importation of nano-products till the safety of nanotechnology is fully
confirmed. The government shall try its best to gain international approval and agreement on
such a moratorium.