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1. Goals for the Research Center for
Chemical Risk Management (CRM)
1-1. Mission
The Research Center for Chemical Risk Management (CRM) was established
in April 2001 with a mission to develop theories in risk assessment
and risk management which are indispensable for maintaining
compatibility between environmental safety and effective use
of chemical substances, and to facilitate rational and science-based
decision-making in chemical risk management of regulatory, industry
and public through presenting specific examples of its research
outcomes.
Three specific targets were set to accomplish the mission of
CRM:
＜Methodology Development＞
CRM is to develop methodologies in risk assessment, risk-benefit
analysis, and quantification of risk.
＜Risk Assessment Documents＞
As specific examples of chemical risk assessment, CRM is to
conduct risk assessments of thirty chemical substances and release
the results.
(Through the process to assess risks of specific chemical substances,
CRM is to develop risk assessment methodologies, as well as
to promote that the outcomes of its risk assessments are reflected
in regulatory policies.)
＜Basic Tools for Risk Assessment＞
To facilitate decision-making in chemical risk management based
on risk-benefit analysis among regulatory, industry, and public,
CRM is to develop and release basic tools of risk assessment,
as well as databases of fundamental data relative to chemical
risk assessment.
Four years passed since the establishment of CRM. During the
initial phase of CRM’s research activities there were a lot
of confusions, as the concept of risk assessment was not always
clear even within CRM.
These confusions have been resolved through continuous and steady
efforts of research staff at CRM. From April 2005 the second
phase of the medium term plan was initiated. CRM’s mission stays
the same as it was established in 2001, however, the specific
targets are expanded.
1-2. From a Specific Chemical to Chemical Substances as a Whole
For the last four years, one of the biggest difficulties that
CRM has been facing is risk assessment of specific chemical
substances. Starting from scratch, CRM has completed and released
its risk assessment documents for six chemical substances (
as of April 2005).
The process to complete each risk assessment document took more
than originally planned. During the process CRM faced various
criticisms on its assessment of specific chemical risks for
their political implications.
More risk assessment documents are to be released from CRM this
year. Although it will take another 3 years to complete all
the risk assessments for 30 chemical substances originally planned,
CRM is starting to realize what can be achieved through the
process to develop these risk assessments.
CRM could and will be able to establish its own methodologies
for the risk assessment of each specific chemical substance.
The next target of CRM is to develop a theory and a principle
of risk assessment based on its experiences; based on the knowledge
obtained and the methods developed through the risk assessment
of specific chemical substances,
CRM is to derive general principles of risk assessment which
eventually would be applicable to overall management of existing
chemical substances which are said to be more than 20,000.
Further, CRM has a wish to develop risk assessment which is
applicable in the process of production and/or of new product
development. It is not possible for CRM to start this new challenge
before completing the original targets set for the seven years
after its establishment.
CRM, however, will continue its research efforts with this new
perspective in mind.
These targets also represent the science to support “Evaluation”
of the policies which was presented by AIST in the second phase
of the medium term plan, and to judge its directions.
1-3. Target in the Second Phase of the Medium Term Plan: Multiple
Risk Management
The research target in the second phase of the medium term plan
is “development of methodologies in multiple risk assessment
for optimal management of chemical risks; with a target to achieve
optimal management of multiple risk management, to develop methods
and techniques for risk assessment and risk-benefit assessment
for chemical use, release the outcome of assessment utilizing
those methods and techniques, and to promote the application
of risk assessment tools.”
CRM adheres fundamentally to its original mission, but with
an emphasis on the concept of multiple risks, i.e. the needs
of risk assessment and risk management considering the co-existence
of various chemical substances and further of the risks other
than those from chemical substances.
The specific research activities include:
· Development
of evaluation indices [e.g., QOL (Quality of Life)] and/or methods
to appropriately handle issues in risk trade-off;
·
Completion of risk assessments for 30 chemical substances and
the release of the resulted documents and the tools used;
· Development of overall and comprehensive assessment
methods applicable to a multiple number of chemical substances
[e.g., application of QSAR (Quantitative Structure Activity
Relationship) with consideration to combined effects];
· Development of risk assessment method applicable in
the process of developing alternative substances;
·
Development of a framework of risk assessment and risk management
for new technologies including nanotechnologies.
CRM’s direction in the second phase is to strengthen the fundamentals
of risk assessment, to have a comprehensive view in risk management
and to expand its insights more into the actual fields of industries.
1-4. Research Focus in the Fiscal Year 2005
The focus of the CRM’s research activities in the Fiscal Year
(FY) 2005 are as follows:
1) Risk assessment and risk management applicable in the process
of production and/or technology development:
· Initiation
of a research project in risk assessment of nanotechnology
· Development of strategies for selection of alternatives
in risk assessment and risk management (e.g., flame retardants)
· Global competitiveness of industry and risk assessment
2) Multiple Risk:
· Comprehensive assessment of multiple
chemical substances
· Research in indices including
QOL
· Research in in-door air pollution
3) Qualitative and quantitative expansion of the continued research
activities:
· Release of additional risk assessment
documents (seven chemical substances targeted) and their application
· Improvement of risk assessment tools and their
further dissemination
· Initiation of developing
the ADMER second-generation model
· Development
of ecological risk assessment methods
4) Structured Hazard Assessment
1-5. Risk Assessment and Full Research
One of the missions of AIST is to actively promote Type-II Basic
Research and successfully achieve the objectives of Full Research
thereon. The Full Research defined by AIST encompasses three
phases, i.e., Type-I Basic Research, Type-II Basic Research,
and Development Process, and aims to create new services or
goods to meet society’s needs. In some occasions, the process
of the Full Research is not simple and straightforward, and
requires going back and forth among these three phases.
Risk assessment is not a substance but a marketable good, which
is an indispensable tool for a society to function efficiently
and to guide rules for distributing resources and/or negative
influences.
Therefore, the ultimate goals of CRM include:
1) wide and frequent applications of specific risk assessments
developed by CRM;
2) resource-saving operations achieved with application of risk
assessment;
3) society with reduced risks realized through application of
risk assessment; and
4) consensus –building more easily achieved by sharing
methods of risk assessment. CRM is to promote the Full Research
with emphasis on Type-II Basic Research, in order to provide
society its good of risk assessment methods.
Risk assessment, however, is not an ordinary good whose value
can be recognized easily, but a good for which highly specialized
and sophisticated knowledge is required for full appreciation.
Thus, it is also the mission of CRM to constantly communicate
the needs of risk assessment and increase the awareness of risk
assessment in society.
2.
Directions of Research and Development at CRM
2-1. Researches and Practical Research Activities Expected at
CRM
Each researcher is required to carry out both the vertical and
horizontal researches (No change has been made in this requirement).
The vertical research includes the studies in each element required
in environmental risk management, which are the basic researches
including innovative research activities.
The horizontal research is a risk assessment of a specific chemical
substance assigned to each researcher, and thus, is defined
as practical research activities.
To carry out the horizontal research, it is necessary for each
researcher to have a good understanding of most of the elements
of the vertical research.
Through the process to pursue both the vertical and horizontal
researches, each researcher is required to develop a comprehensive
understanding of environmental risk assessment as well as to
improve one’s own expertise.
The horizontal research is one of the examples of the processes
to achieve Full Research through Type-II Basic Research described
in the section 1.
2-2. Emphasis on Social Application of the Research Outcomes
CRM puts emphasis on social application of its research outcomes.
It is important to realize that the risk assessment documents
developed by CRM are applied in the decision-making by regulatory,
industry and public, and that the risk assessment tools developed
by CRM are widely used.
In FY 2004, CRM could maximize the opportunity of presenting
its research outcomes in the form of a document submitted to
Industrial Structure Council under the Ministry of Economy,
Trade and Industry.
CRM is to pursue similar opportunities in FY 2005, to increase
more social application of its risk assessment, and to reflect
the needs from society found in such opportunities into the
next step of research activities.
2-3. Commercial Publication of Risk Assessment Documents
With an intention to realize application of CRM’s risk assessment
documents on specific chemical substances in various purposes,
CRM continues their commercial publications.
The names of those who involved in the development of each risk
assessment document are to be included in the publication to
verify the ownership of each deliverable.
2-4. Emphasis on Subjects with Integrated Fields
The research project in risk assessment of nanotechnology is
CRM’s first attempt to develop risk assessment of a subject
with integrated fields.
The success of this project is critical to increase the value
of CRM and to expand its future research activities in other
subjects with integrated fields.
2-5. Improvement and Emphasis on Study Group
In the process to expand risk assessment of specific chemical
substances into a comprehensive assessment of multiple chemicals,
the importance of theories and concepts increases.
To supplement the situation, CRM is to make efforts to improve
the quality of its study groups and to put more emphasis on
their activities. The study groups are to be open to the researchers
outside of CRM.
3. Management
Policy within CRM
3-1. Ethics of CRM
1) CRM is to be aware and responsible for the fact that the
facility is operated with public fund.
2) CRM, as a research facility specialized in environment and
safety, is to be responsible and give consideration to environmental
protection and safety controls (including control of chemicals
used within CRM).
3-2. Evaluation of Research Staff
Evaluation of each research staff for his/her short-term achievement
is made with consideration to the three aspects as follows:
1) Deliverables (those elements including one’s ability, future
potentials, and attitudes are not considered)
2) Quality of the deliverables (e.g., level of social influence,
uniqueness of analysis, innovative perspective)
3) Level of achievement against the target set by each researcher
(Annual target is set through discussions with Team Leaders
or CRM Director at the beginning of each FY)
Deliverables defined here are actual outcomes of research activities
which can enhance the value of CRM in society.
CRM’s evaluation on long-term achievement in principle is not
merely an accumulation of short-term evaluations, but considers
the aspects as follows:
1) Research capability (*), future potentials, and leadership
(*Administrative and/or management capabilities are also considered
as the important elements of research capability.) (Levels required
differ according to the grade of each researcher, i.e., Grade
2 to 3, Grade 3 to 4)
2) Research direction (Ability of persuasive communication is
required to present the research needs and directions)
3) Achievement in the past
Evidences are required in evaluation of each aspect described
above.
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