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Preface
The Industrial
Structure Council Chemicals and Bio-industry Committee's Subcommittee
on planning of Chemical Management began its study on future policy
direction concerning evaluation and regulation of chemical substances
in October 2002 and put its findings together in a report in January
2003. That is a joint report with the Subcommittee consulted and met
with the Health Sciences Council Committee on Chemical Substance Control
Regulation's Subcommittee on Amendment of the Chemical Substance Control
Regulation and the Central Environment Council Environmental Health
Panel's Subcommittee on the System for the Evaluation and Regulation
of Chemical Substances. This paper provides the highlights of the
report.
Back grounds
Environmental
pollution caused by polychlorinated biphenyl (PCBs) in the late 1960s
alerted people to the realization that very useful chemical substances
can also pose a threat to their health. Accordingly, the Law Concerning
Examination and Regulation of Manufacture, etc. of Chemical Substances
(the Chemical Substances Control Law) was enacted in 1973 to prevent
environmental pollution by chemical substances that possess resist
degradation (i.e. persistent), accumulate in high concentrations (i.e.
highly bioaccumulative), and long-term toxicity. This new law introduced
pre-market evaluation system for new chemical substances and regulation
of the manufacture, use of persistent, highly bioaccumulative chemical
substances with long-term toxicity to human. The law was amended in
1986 to expand regulatory coverage to chemical substances (such as
trichloroethylene) that are persistent and possesses long-term toxicity,
even if they are not highly bioaccumulative.
Similar efforts
to ensure new chemical substances to be safe have also been made in
Europe and North America, and efforts are being made in the OECD,
the United Nations, and elsewhere to encourage international policy
coordination and cooperation in this area. The Plan of Implementation
adopted by the World Summit on Sustainable Development in August 2002
recently provided international confirmation of the basic thinking
as regards chemical substances, including (a) committing to the protection
of human health and the environment as the primary objective, (b)
using transparent science-based risk assessment and risk management
procedures, and (c) taking into account the precautionary approach
to the management of chemical substances.
In January 2002,
the Environmental Performance Review conducted by the OECD on Japanese
chemical management policy recommended, among other things, further
expanding the scope of regulation to include ecosystem protection
and further enhancing the effectiveness and efficiency of chemical
management and to strengthen voluntary initiatives in the chemicals
industry and grant more active role to chemical producers in safety
investigation of existing chemicals . It is in light of these developments
that Japan is reviewing its chemical substance evaluation and regulation
system.
Evaluation and
regulation of chemical substances focused on their impact on the environmental
organisms
It cannot be
denied that some chemical substances have adverse effect on environmental
organisms and that they might well have adverse effect on the ecosystem
to some extent. At the same time, given the intrinsic diversity of
life and ecosystems, there has been considerable discussion of what
life and ecosystems should be protected and to what extent, such that
it has proved impossible so far to establish a clear methodology for
assessing the adverse effects of chemical substances on the environment
as a whole. The method used at present is to infer the likely impact
on the environment as much as possible from toxicity test data on
specific in vitro organisms.
As well as promoting
policies to deal with chemical substances, Japan's Basic Environmental
Law and Basic Environmental Plan require consideration be given to
properly assessing and controlling chemical substance impact on the
ecosystem, such that the national government conducts toxicity tests
to evaluate the impact on environmental organisms. This is in addition
to reviewing the assessment methodology for agricultural chemicals
so as to protect fisher life and promoting efforts such as those to
set target values for water quality to preserve useful plant and animal,
aquatic organisms, including the life forms lower on the food chain,
with a view to preserving the human living environment as mandated
by the Basic Environmental Law. The government is also designating
those chemical substances considered possible threats to the habitation
or growth of animals and plants so that such chemical substances can
be properly regulated by the 1999 Law Concerning Reporting, etc. of
Releases to the Environment of Specific Chemical Substances and Promoting
Improvements in Their Management.
In the absence
of legal provisions under the Chemical Substances Control Law for
conducting pre-market evaluation of new chemical substances or assessing
their adverse effects on the ecosystem or environmental organisms,
there is a need to implement policies focused on the adverse effects
of chemical substances on environmental organisms in consideration
of efforts being made to implement other chemical substance policies
elsewhere in the government for environmental protection and in a
manner consistent with the various systems that exist, while not forgetting
the scientific uncertainties involved in linking chemical substance
cause adverse effects on the ecosystem.
I. Basic Thinking
and Framework on Evaluation and Regulation
(1) Introducing
pre-market evaluation of ecotoxicity
Although it is
at present difficult to objectively and quantitatively evaluate the
adverse effects of individual chemical substances on the ecosystem,
it is thought possible to identify those chemical substances that
seem likely to have an adverse effect on the ecosystem by means of
ecotoxicity test using specific test organisms to assess the impact
that chemical substances have on the survival, growth, reproduction,
and other aspects of specific organisms at the population level(eco-toxicity).
Accordingly, it would seem appropriate to use these ecotoxicity test
results to assess to a degree the impact on environmental organisms
as part of the pre-markteing evaluation of new chemical substances
under the Chemical Substances Control Law. The methodology for evaluating
ecotoxicity should be determined based upon how feasible the tests
are, how easy they are, and how internationally harmonized they are,
and it would be appropriate to determine this with some flexibility
so that it can be reviewed and revised in light of scientific advances
and international developments.
(2) Introducing
regulations for ecotoxic chemical substances
Because persistent
ecotoxic chemical substances tend to be residually present in the
environment for long periods, it is impossible to eliminate the possibility
that they might generate irreversible environmental pollution and
might impact organisms. Accordingly, it would be appropriate to introduce
the following measures in consideration of, inter alia, the scientific
uncertainty on evaluating of the effects on the ecosystem and environmental
organisms.
(a) Persistent
and ecotoxic chemical substances
Reporting
manufacturing volume, import volume, and usage of the substances should
be required and information on ecotoxicity should be provided on persistent
ecotoxic chemical substances . In addition, seeking to set rational
target levels and the like for risk management, management guidelines
should be strictly enforced, labeling required, and manufacturing
and import levels held to plan should the situation develop such that
it is feared these substances may have an adverse effect on animals
and plants related to the human living environment.
(b) Persistent
and highly bioaccumulative chemical substances with ecotoxicty
The manufacture, import, and use of substances that are toxic for
top predatory animals (birds or mammals) in the human living environment
should be regulated in so far as is feasible, as is now done with
Class-I Specified Chemical Substances.
II. Related matters
Efforts need
to be made to establish the necessary structures for better enabling
laboratories to conduct ecotoxicity tests and for facilitating evaluation
and regulation. Along with promoting research and investigation on
how chemical substances impact the ecosystem and the habitation and
growth of a diversity of environmental organisms, efforts need to
be made to understand the causal relationships between chemical substances
and the habitation and growth of organisms in the real-world environment.
Because readily
degradable chemical substances, unlike persistent chemical substances,
are essentially easy to break down and eliminate from the environment,
it would be basically appropriate, along with conducting risk assessment,
to deal with them with voluntary initiatives for improved management,
such as making them subject to the Pollutant Release and Transfer
Register (PRTR), and with emission and other regulations at the point
of release under other laws and regulations as necessary.
Reforming the
current evaluation and regulation system from the view point of improving
risk management
Measures and
systems structured under Japan's Chemical Substances Control Law have
focused mainly upon chemical substances' characteristics, but the
North American and European systems provide for risk assessment and
control with consideration not only to the specific substances' characteristics
but also to the danger of exposure to them.
In addition to
risk assessment by the national government, manufacturers and other
players are also engaged in voluntary efforts on existing chemical
substances, and the OECD is promoting international cooperation on
risk assessment of high production volume (HPV) chemical substances.
In light of these
and other developments, Japanese provisions for assessing and regulating
chemical substances should be reviewed from the perspective of risk
assessment and management taking exposure to hazardous substances
into account, and the framework should be strengthened based upon
the progress made in voluntary initiatives by the chemicals industry
and other players so as to derive maximum benefit from such initiatives.
I. Measures for
Existing Chemical Substances that turned out to be persistent and
highly bioaccumulative
For existing
chemical substances that the national government's evaluation has
shown to be clearly persistent and highly bioaccummulative, given
the fear that environmental pollution might continue unabated from
the start of long-term toxicity studies until such time as actual
measures are taken and might adversely affect human health and environmental
organisms , it is imperative that some controls be put in place under
the laws and regulations commensurate with the manufacturing and use
situation until such time as it is clear the substance is or is not
(long-term) toxic to human and top predatory animals.
Specifically,
the following measures should be taken.
- Obligatory
reporting of actual quantities of manufacture and import volumes,
use.
- If a certain
potential for risk is presented according to preliminary toxicity
evaluation by the government, , guidance and advice to businesses
on measures for risk reduction to minimize release into the environment.
- After risk
reduction measures have been taken, the manufacturers and importers
are if necessary instructed to investigate long-term toxicity. If
long-term toxicity is identified, the chemical substance is designated
as a class-1 specified chemical substance.
II. Reforimg
Pre-market evaluation system for New Chemical Substances in Consideration
of Possibilities of Exposure
It should be
possible to deal flexibly with new chemical substances that meet certain
criteria indicating the likelihood of exposure through environmental
pollution is low, such as exempting them from the registration requirement
and doing the hazard evaluation in tiers, premised upon ensuring this
through pre-market evaluation and post-use monitoring.
(1) Measures
by exposure control
Pre-market evaluation should be exempted in the following cases where
there is little or no possibility of exposure, provided the following
handling methods are sure to be used.
a. Chemical substances used as intermediates
b. Chemical substances used for process in which the possibilities
of environmental release is extremely low, such as in closed systems
c. Chemical substances for export only (provided the pre-market evaluation
system is well established in the country of destination)
(2) Tiered evaluation
of chemical substances with small quantities of manufacturing and
import
For new chemical
substances that prior evaluation has shown to be persistent but not
bioaccummulative, when total amount of domestic manufacturing/import
quantities less than about 10 tons per year, it may be assumed that
there is very little possibilities of exposure from residuality in
the environment over a wide area, such that toxicity for human health
or environmental organisms can be inferred from known values, it would
be appropriate to allowed to be manufactured or imported without obligatory
submission of toxicity data.
III. Introducing
obligatory reporting system for Hazard information obtained by businesses
In order to utilize
hazard data for reviewing pre-market evaluation on new chemical substances,
and promoting evaluation of existing chemical substances by the government,
a new system shall be established. That makes it obligatory for the
manufuatures and importers to submit the self-obtained information
indicating a certain hazard listed in the evaluation items under the
Chemical Substances ControlLaw.
IV. Promotion
of evaluating the Hazard and Risk of Existing Chemical Substances
In line with
the efforts to date as they relate to the evaluation of existing chemical
substances, the businesses and the national government, staying in
full two-way communication, should each do what it can to facilitate
the systemic evaluation of hazards.
It is hoped the
businesses, as the party that actually manufactures and handles the
chemical substance, will embark upon this promptly, including using
information gleaned from international practices, setting priorities,
and dividing the work up appropriately among the parties involved.
As well as moving
promptly to conduct safety evaluations of existing chemical substances,
the national government, for its part, should make further efforts
to develop methodologies for evaluating hazards, to strengthen educational
efforts and testing facilities, and otherwise to create a better environment
for evaluation so that the overall effort can proceed smoothly and
effectively, and should do more to promote risk assessment, including
better databasing of the findings and other information.
Related items
In line with
the evaluation of chemical substances and the review of current systems
to date, there is a clear need to integrate the current provisions
more closely and to ensure greater harmonization among them. Study
should also be given to having the national government make the information
obtained in evaluating and regulating chemical substances public so
that everyone concerned can have easier access to accurate information
on chemical substances for enhanced, informed risk awareness.
In closing
In line with
this report, the Ministry of Economy, Trade and Industry, together
with the Ministry of Health, Labour and Welfare and the Ministry of
the Environment submitted a bill to amend the Chemical Substances
Control Law to the current regular session of the National Diet.
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