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Ministry of International Trade and Industry
January 18, 2000
The "Three-year Program for Promoting Administrative
Deregulation" (as revised by Cabinet resolution on March 30, 1999)
stipulates that when establishing a new regulation, the necessity of
the regulation, its expected effects, and the projected burden on the
public must be examined, and the conclusions drawn from those examinations
must be promptly and publicly released to the citizenry in an easily
understandable manner after the closing of each ordinary Diet session,
together with a list of bills with review clauses and the results of
reviews made pursuant to those review clauses.
The conclusions drawn from examinations of the newly
established "Law Concerning Reporting, etc. of Releases to the
Environment of Specific Chemical Substances and Promoting Improvements
in Their Management," which was passed by the 145th
ordinary Diet session, are hereby publicly released as specified in
the attached report.
For inquiries regarding the above, please contact Haruhito
Fujita or Reiko Eda of the Chemicals Management Policy Division, Basic
Industries Bureau, Ministry of International Trade and Industry.
Telephone numbers:
Switchboard: (03) 3501-1511 (ext.
3231)
Direct: (03) 3501-0080
For inquiries regarding items concerning
Cabinet resolutions aside from the abovementioned law, please contact
Takeshi Nagasawa of the Policy Evaluation and Public Relations Division,
Minister's Secretariat, Ministry of International Trade and Industry.
Telephone numbers:
Switchboard: (03) 3501-1511 (ext.
2352)
Direct: (03) 3501-1042
1. Name of the
Law
The Law Concerning Reporting, etc. of Releases to
the Environment of Specific Chemical Substances and Promoting Improvements
in Their Management
2. Necessity of the Law
Chemical substances are useful materials that are
utilized in diverse forms, not only in industrial fields but also
in daily life, and they are indispensable for our modern-day economy
and society. At present, an estimated 50,000 to 100,000 different
types of chemical substances are being traded; in Japan alone, approximately
300 new chemical substances are developed and placed on the market
each year.
A substantial number of chemical substances manifest
certain harmful properties due to their specific characteristics,
and when enterprises conduct activities that emphasize only economic
factors, certain "external diseconomies" may arise, such
as environmental pollution and the possibility of harming the health
of human beings.
The "Law Concerning the Examination and Regulation
of Manufacture, etc. of Chemical Substances" and other laws and
regulations regulate the manufacture, import, use, and handling of
chemical substances for which a cause-effect relationship has been
scientifically verified in terms of their impact on human health,
and for which the danger in terms of their impact on human health
(and other areas) is deemed to be beyond permissible levels.
However, there are numerous chemical substances that
are not subject to these laws and regulations and whose harmful properties
have been confirmed, but for which a cause-effect relationship has
not been verified in terms of their harmful impact on human health,
animals, and plants; and these substances are being utilized in diverse
fields.
Accordingly, for chemical substances whose harmful
properties have been confirmed, regardless of the establishment of
a verified cause-effect relationship in terms of their harmful impact
on humans (and in other areas), as a preliminary-stage measure prior
to full regulation — that is, at a stage before impediments to
environmental protection have arisen — there is a need to work
toward preventing the emergence of impediments to environmental protection
by improving and strengthening businesses' voluntary management activities
covering each and every aspect of the handling of such substances,
including their manufacture, use, distribution, and storage.
3. Objectives
of the Law
The objectives of the "Law Concerning Reporting,
etc. of Releases to the Environment of Specific Chemical Substances
and Promoting Improvements in Their Management" are (i) to improve
and strengthen the management activities of businesses covering the
manufacture, use, and handling of chemical substances by utilizing
the data that businesses obtain under the PRTR system and the MSDS
system and by having businesses heed the chemical substance management
guidelines set by the national government, and (ii) to prevent any
impediment of environmental protection before they occur.
Q Regarding the PRTR System
A PRTR (Pollutant Release and Transfer Register)
is a catalogue or register of potentially harmful pollutant releases
or transfers to the environment from a variety of sources (OECD definition).
Under the "Law Concerning Reporting, etc. of Releases to the
Environment of Specific Chemical Substances and Promoting Improvements
in Their Management":
(i) businesses are required to
estimate the volume of each of the chemical substances regulated
by this Law that they release to the environment or transfer in
the waste, and to report these estimated volumes to the national
government, and
(ii) the national government is
required to somehow aggregate these estimation results and to release
those aggregate figures to the public [refer to Section 4(2)].
Q Regarding the MSDS System
An MSDS (Material Safety Data Sheet) is a document
with a specified format that stipulates, among other things, the names
of chemical substances, their physical and chemical properties, information
on their harmful properties, and the precautions that need to be exercised
when handling the substances. Distributing an MSDS whenever chemical
substances are traded among businesses provides the recipient of the
substances with information about their harmful properties and appropriate
handling methods [refer to Section 4(3)].
4. Contents of
the Law
(1) Substances Subject to the Law
(i) Class I Designated Chemical
Substances (Subject to both PRTR and MSDS regulations)
These are chemical substances which
may be hazardous to human health and/or may impair the life and
growth of flora and fauna, and which are recognized to continuously
exist in the environment over considerably wide areas judging from
their physical-chemical properties, manufacturing conditions, and
other factors (as specified by government ordinance).
(ii) Class II Designated Chemical
Substances (Subject to MSDS regulations)
These are chemical substances with
harmful properties similar to those of Class I Designated Chemical
Substances, and which are anticipated to continuously exist in the
environment over considerably wide areas judging from their physical-chemical
properties, manufacturing conditions, and other factors (as specified
by government ordinance).
(2) Requirement of Reporting Environmental
Releases of Chemical Substances (PRTR System)
(i) Businesses quantify the volumes
of the chemical substances that they release to the environment
or transfer in the waste and report these volumes to the national
government (to the Competent Ministers overseeing the businesses)
via the prefectural governments (confidential business information
is reported directly to the national government, that is, to the
Competent Ministers overseeing the businesses); the Environment
Agency and the Ministry of International Trade and Industry jointly
aggregate the reported data for each substance by types of industry
and by geographic regions, publicly release the aggregated data,
and provide it to the prefectural governments.
(ii) The Environment Agency and the Ministry of International
Trade and Industry will cooperate with each other in estimating
the quantity of releases of chemical substances which are not included
in the quantity reported under 1) above (such as chemical substances
released from houses, farmland, automobiles, etc.) and publish the
result with (i) above.
(iii) When requested by a citizen, the national government
shall disclose data of individual businesses while keeping trade
secrets. Businesses are required to improve and enhance management
of chemical substances while paying attention to the Technical Guidelines
set by the national government and striving to increase interested
parties' understanding about their releases and management of chemical
substances.
(iv) Based on the aggregated results
of the PRTR and other information, the national government shall
conduct the environment monitoring survey and study the effects
requirement of distributing on human health and ecosystems.
(3)Material Safety Data Sheet (MSDS)
When transferring or supplying designated
chemical substances to other businesses, the transferring business
shall provide the transferee with information on properties and handling
of the chemical substances concerned.
(4) Supportive activities by the
National and Local Governments
(i) Increase the scientific knowledge
on the hazardous properties of chemical substances.
(ii) Compile a database on
the properties of chemical substances.
(iii) Give technical advice
to businesses.
(iv) Assist in increasing
public understanding about management, etc. of chemical substances.
(v) Train persons to carry
out the tasks described in (iii) and (iv) above.
5. Projected Burden
on the Public
(1)Burden Incurred in Implementing
the PRTR System
(i) Estimating the quantities
of chemical substances released and transferred
It is assumed that businesses handling
Class I Designated Chemicals, etc. (estimated to total tens of thousands
of businesses under the present Bill) will incur expenses when estimating
the quantities of chemical substances released and transferred subject
to PRTR regulations.
The national government is not
requesting that these businesses introduce new facilities to quantify
their emission volumes and transport volumes. Rather, as a means
of reducing the burden placed on businesses, the Environment Agency
and Ministry of International Trade and Industry will jointly prepare
manuals that present simple calculation methods that can be used
to prepare volume estimates for each main process, such as the cleaning
and reaction processes.
Consequently, the main expense
incurred by businesses that already have sufficient management in
place to quantify the volumes of raw materials that they use will
be personnel expenses; businesses with insufficient management will
have to incur the costs required to manage the volumes of raw materials
that they use. (While there will be some range in the expense burden
incurred, considering the personnel costs, it is estimated that
the average burden per business establishment will be on the order
of ･100,000-･ 200,000).
(ii) Reporting Quantities of
Chemical Substances released and Transferred to the Competent Minister
It is assumed that businesses handling
Class I Designated Chemicals, etc. will incur expenses for reporting
the quantities released and transferred to the government. The national
government will work to reduce this burden on the businesses required
to submit reports, including small and medium-size enterprises,
by facilitating the submission of reports via the Internet and other
electronic information methods, in accordance with the needs of
the particular businesses.
Q Regarding
Businesses Handling Class I Designated Chemicals, etc.
The national government is currently considering subjecting
those businesses handling Class I Designated Chemical Substances —
those with at least 21 full-time employees and handling at least one
ton per year of any Class I Designated Chemical Substance, as stipulated
by government ordinance — to the PRTR system regulations (the period
for public comment on this issue has already ended). However, the national
government is also considering subjecting the following businesses to
the PRTR system regulations as special requirements for handling specified
volumes of certain substances.
- Businesses with establishments handling at least 0.5 tons per year
of substances that are carcinogenic to human beings
- Businesses with facilities that require licenses from or notification
to the national government under laws related to facilities for the
final treatment of sewage, the treatment of waste products, or sanitation
- Businesses with facilities that require licenses or the submission
of reports to the national government under laws related to the regulating
of environmental emissions of chemical substances contained in natural
resources that are used as raw materials
- Businesses that are obligated by laws or regulations to report dioxin
emission concentrations
(iii)
Requests for Public Disclosure
It is assumed that citizens requesting
public disclosure of information will incur expenses related to
this public disclosure, such as postage and envelope costs.
(2) Burden Incurred in Making Obligatory
the Distribution of a Material Safety Data Sheet (MSDS)
(i) The Provision of Information
Regarding the Properties and Handling of Designated Chemicals, etc.
It is assumed that businesses handling
Designated Chemicals, etc. (estimated to total tens of thousands
of businesses under the present Bill) will incur expenses for the
preparation and distribution of an MSDS (the costs incurred in the
initial preparation of an MSDS, including the costs incurred in
searching various databases, are estimated to be on the order of
several hundreds of thousands of yen; the costs incurred in the
delivery of an MSDS are estimated to be limited to postage and facsimile
costs). The national government will work to reduce this burden
on businesses by preparing a database on the harmful properties
and other information related to chemical substances that must be
entered on an MSDS and releasing this database via the Internet
and other means so that it can be widely accessed and used by the
general public. The national government will also work to reduce
the burden on businesses by permitting the provision of an MSDS
by means that can be easily used by businesses engaged in MSDS transactions,
such as via the delivery of written documents or magnetic disks.
6. Expected Effects
(1) Effects from the Implementation of the PRTR System
The introduction of the PRTR system is expected to
promote the improvement and strengthening of businesses' management
of chemical substances, and to prevent the emergence of impediments
to environmental protection. Moreover, businesses' chemical substance
management activities are expected to be improved and strengthened
due to the following factors.
(i) Because the introduction of
the PRTR system will ensure that businesses quantify the volume
of the chemical substances subject to PRTR regulations that they
are releasing into the environment from their business establishments
or transferring in the waste, it will provide an opportunity for
businesses to recognize and evaluate their own chemical substance
management and emissions conditions.
(ii) Because the reported data
on quantities of chemical substances released and transferred will
be aggregated and summarized according to substance, industry, region,
business scale, and other factors and then publicly released, businesses
will be able to use this information as a reference for recognizing
the status of their own quantities of chemical substances released
and transferred; this will also facilitate the evaluation and review
of their own chemical substance management methods.
(iii) Because businesses will work
to provide information regarding their own chemical substance management
and releases conditions to related parties, this will help to enhance
the understanding of the related parties concerning the chemical
substance management efforts that are being implemented.
(2) Effects from Making Obligatory the Distribution of MSDS
MSDS information is useful for chemical substance
manufacturers because it allows them to have their own products handled
properly by users; it is useful for users because it provides germane
information regarding the selection and ideal handling of raw materials.
Accordingly, the Japan Chemical Industry Association initiated activities
for the introduction and spread of the MSDS system on a voluntary
basis beginning in 1991.
In 1992 and 1993, the Ministry of Labor, the Ministry
of International Trade and Industry, and the Ministry of Health and
Welfare promoted the spread of the MSDS system via administrative
applications (public notices).
Notwithstanding that effort, according to the results
of the Ministry of International Trade and Industry survey consigned
to the Japan Chemical Industry Association in 1997, 36% of the respondents
were unable to obtain an MSDS even when they asked for one, and only
a mere 2% of the respondents obtained an MSDS when they did not specifically
request one. Thus, while the drafting of an MSDS has advanced considerably,
the subsequent distribution of the MSDS is still far from complete.
Making the distribution of an MSDS obligatory under
this Law is expected to ensure complete distribution of the MSDS,
and to promote the appropriate management of chemical substances from
the manufacturers or importers through to the final users. Moreover,
for businesses that are obliged to report PRTR, an MSDS will provide
information on the chemical substances contained in the products that
they handle themselves, and that will be helpful in estimating the
quantities released.
(3) Effects of Presenting Chemical
Management Guidelines
Considering the actual handling conditions
of the chemical substances subject to PRTR and MSDS regulations, the
national government will, under the provisions of this Law, prepare
Chemical Management Guidelines indicating methods for utilizing information
regarding the properties of chemical substances and their management
methods — for example, technical guidelines on management methods
and on the improvement of facilities for each main process, such as
cleaning and reaction processes, and means of increasing public understanding
regarding items requiring special consideration, recovery and re-use
methods, management methods, and other matters.
Presenting these guidelines to businesses
is expected to efficiently and effectively promote improvements in
businesses' voluntary chemical substance management efforts.
7. Possible Regulatory Options
(1) Voluntary Response by Industry (Maintaining the
Present Situation)
Under this option, the standards and reporting systems
for the concerned chemical substances would be entirely left up to
the discretion of the chemical industry, as voluntary activities.
(2) Regulatory Measure Response Similar to That Under
Existing Regulatory Laws
Under this option, businesses would be obligated
not only to report the quantities of the concerned chemical substances
released; the manufacture, import, and use of these substances would
also be regulated based on the volumes of these substances present
in the environment, similar to the approach adopted under the "Law
Concerning the Examination and Regulation of the Manufacture, etc.
of Chemical Substances."
(3) Implementation of the PRTR System and Making
the Distribution of an MSDS Obligatory (Response Adopted under the
"Law Concerning Reporting, etc. of Releases to the Environment
of Specific Chemical Substances and Promoting Improvements in Their
Management")
Under this option, businesses are
obligated to report quantities of chemical substances released whose
harmful properties have been confirmed, regardless of the cause-effect
relationship in terms of their harmful impact on human beings. Additionally,
when businesses transfer the concerned chemical substances to other
parties, they are obligated to provide information to those parties
regarding the properties of the chemical substances being transferred
and the precautions that need to be exercised when handling the substances.
8. Comparison of Each Regulatory
Option
(1) Voluntary Response by Industry
(Maintaining the Present Situation)
The PRTR and MSDS systems have advanced under the
voluntary approach of the chemical industry.
However, there are various problems with a voluntary
approach to the PRTR system, including parties that choose not to
participate and the necessity of raising the transparency of the contents
and results of the businesses’ management activities. Similarly,
for the MSDS system, while the drafting of an MSDS by chemical substance
manufacturers is advancing, the distribution of the MSDS is incomplete,
and it is currently difficult for the users, when they are small and
medium-size enterprises, to request the attachment of an MSDS from
upstream and mid-stream businesses.
(2) Regulatory Measure Response Similar to That Under
Existing Regulatory Laws
The existing regulatory laws are
implemented in response to accidents and problems that actually occur
due to the harmful properties of individual chemical substances; they
also regulate chemical substances for which a cause-effect relationship
has been scientifically verified in terms of their impact on human
health and for which the danger in terms of their impact on human
health is deemed to be beyond permissible levels, in accordance with
the types and the extent of the substances' effects.
However, for chemical substances
whose harmful properties have been confirmed but whose effect on human
beings has not been clarified, quantitative emissions standards and
environmental standards cannot be set based on the cause-effect relationship
in terms of their impact on human health. For such substances, the
enforcement of compulsory management methods under regulatory laws,
including orders to decrease production volumes, would constitute
an excessive obligation.
(3) Implementation of the PRTR System
and Making an MSDS Obligatory (Response Adopted under the "Law
Concerning Reporting, etc. of Releases to the Environment of Specific
Chemical Substances and Promoting Improvements in Their Management")
The following problems exist in regard
to the chemical substances regulated under the provisions of this
Law:
(i) These chemical substances are
utilized in various formats and the releases of these substances
also involve various formats, so diverse management methods are
required in accordance with the properties of the chemical substances
and the formats in which they are handled, and it would be difficult
to implement binding regulatory measures for each individual substance
and format.
(ii) Drafting regulatory measures
requires the compilation of scientific knowledge regarding the cause-effect
relationship of chemical substances in terms of their harmful effects,
but this requires considerable time and expense.
(iii) Because adopting strong regulatory
measures governing the manufacture, releases, and handling of chemical
substances at a stage prior to the establishment of solid scientific
knowledge would constitute an unjust infringement on free business
activities, it would be excessive to adopt measures regulating the
manufacture, use, releases, and handling of chemical substances
whose harmful properties have been confirmed but whose harmful effect
on human beings has not yet been verified.
The enforcement of binding management
methods for these types of chemical substances would be unacceptable.
Rather, it is appropriate, with the understanding of businesses and
the public, to work toward preventing the emergence of impediments
to environmental protection by improving and strengthening businesses'
voluntary management activities covering each and every aspect of
the handling of such substances, including their manufacture and use,
by implementing the PRTR system and making the distribution of an
MSDS obligatory in a manner whereby data on the harmful properties
of chemical substances and on their quantities released are collected
and aggregated and the scientific knowledge required for the management
of chemical substances is accumulated.
9. Reference Opinions and Ideas
The Chemical Products Council's Safety Measures Committee
and the Risk Management Committee jointly established the Comprehensive
Management Subcommittee, which met 10 times between November 1997
and April 1999 for specific deliberations on the following items concerning
the introduction of the "Law Concerning Reporting, etc. of Releases
to the Environment of Specific Chemical Substances and Promoting Improvements
in Their Management" (the committees themselves met five times
during this period for deliberations on these same items):
(i) the establishment of a knowledge
base regarding hazard data within an international framework,
(ii) the complete distribution
of hazard information in conformity with international practices,
and
(iii) the establishment of a risk-management
foundation and risk-management rules for businesses based on the
hazard information.
The Comprehensive Management Subcommittee of the
Chemical Products Council’s Safety Countermeasures Committee
and the Risk Management Committee sought public comments twice during
the course of its deliberations, as specified below. The opinions
heard during this public-comment process were utilized as reference
opinions for examinations by the subcommittee and by the two committees.
<Opinions
Concerning Chemical Substance Comprehensive Management Policies >
Period for submitting opinions:
August 3-16, 1998
Media used for soliciting opinions:
Ministry of International Trade
and Industry Website
Number of opinions submitted:
31 (12 from enterprises, 14 from
organizations, and five from individuals)
<Opinions
Concerning the Outline of the Comprehensive Management Subcommittee’s
Interim Report>
Period for submitting opinions:
August 20-September 2, 1998
Media used for soliciting opinions:
Ministry of International Trade
and Industry Website, newspapers, mailing related documents to 29
consumer organizations
Number of opinions submitted:
40 (two from enterprises, 28 from
organizations, one from a local government body, and nine from individuals)
10. Implementation and Revisions
(1) In implementing the PRTR system,
the national government will clearly specify the calculation methods
to be used for estimating quantities released and other calculations,
prepare easily understandable manuals for businesses, and provide
technical guidance as necessary. Also, the accuracy of the figures
will be verified through comparisons with data from the same industry
or the same scale enterprises, or by comparisons between the reported
data and prior data.
(2) For making the distribution of
an MSDS obligatory, the national government is compiling a database
by collecting information on the targeted chemical substances, and
this database is scheduled to be completed before the obligation to
deliver an MSDS comes into force.
(3) Article 3 of the "Supplementary
Provisions to the Law Concerning Reporting, etc. of Releases to the
Environment of Specific Chemical Substances and Promoting Improvements
in Their Management" states: "The national government shall
review the circumstances of this Law being enforced when seven years
have passed after enforcement, and shall take appropriate measures
depending upon the outcome of the review." However, if systematic
problems or difficulties with this Law are discovered, the national
government will conduct an examination review even if seven years
have not yet passed (including punitive regulations). In the review
examination process, the examinations conducted will be released publicly,
and public comments will be solicited, so that the opinions of a wide
range of citizens, NGOs, industry representatives, and academic experts
will be considered; in addition, the review examination will be conducted
in conformity with the OECD advisory. The addition or deletion of
target substances will take place as appropriate in accordance with
advances in scientific knowledge.
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