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Long-Range Research Initiative
Global Research Strategy
21st Century Approaches to Risk Sciences
LRI Global Research Strategy - Priority Areas
21st Century Approaches to Risk Sciences


Emerging Technologies – Assessing innovative tools, approaches,
and data for robust, timely, and resource-effective evaluations of
chemicals as well as new technologies, such as nanotechnology.


Exposure Science – Improving the tools to quantify everyday
and incidental exposures to chemicals and to guide intelligent
testing and risk assessment.


Translation Relevant to Health and Environment –
Developing approaches and tools to improve understanding
of links between exposures to chemicals and their potential
effects on human health and the environment.
Executive Summary

The innovative research program of the International Council
of Chemical Associations’ Long-Range Research Initiative
(ICCA-LRI) is designed to improve the quality of chemical safety
assessments. This global program and its research strategy
target the science-policy interface to modernize and improve
chemical management. Although societal and political drivers
vary around the world, the three regional LRI programs in Europe,
the United States, and Japan identify common scientific topic
areas that industry regards as important to form the core of
the global ICCA-LRI program and direct its research strategy.
This LRI Global Research Strategy, 21st Century Approaches
to Risk Sciences, comprises three priority areas: emerging           1
technologies, exposure science, and translation relevant to
health and environment. The research funding invested in these
three areas is often leveraged through collaboration with publicly
funded projects that can maximize project value up to five
times. Through a rigorous governance structure involving chief
executive officers (CEOs) and directors general from the three
LRI regions, strategic alignment, complementarity, efficient use
of financial resources, and effective dissemination of research
results are achieved. The ICCA-LRI is recognized as a brand that
demonstrates industry engagement within Responsible Care®,
provides early warning on emerging issues, achieves outreach
to opinion leaders through its network, and supports capacity
building within industry to ensure knowledge-based decision
making by companies and by public policy makers.
Introduction

    Background
    The importance of science to decision making about the safety      The LRI programs at Cefic, ACC, and JCIA sponsor
    of chemicals is more evident today than ever before. Demands       independent third-party research that enhances the credibility
    are increasingly heard for more data, better information, and      of LRI-funded science. A unifying focus for these programs
    science that can drive decisions to improve the quality of         is to improve the way we address the safety of our chemicals,
    public health and the environment. At its core, the business       particularly with regard to everyday exposures of employees,
    of chemistry is all about science – science aimed toward           consumers, and the general public to low levels of chemicals.
    innovations in products and services that can make people’s        Through the perspectives and expert guidance provided
    lives better, healthier, and safer. Science is also an essential   by scientists from industry, academia, and governmental
    part of the process needed to inform good decisions.               agencies, LRI-supported research provides critical information
                                                                       to government and industry regarding risk assessment
2   Since 1999, the ICCA-LRI has supported the science to              decisions about the potential health and environmental impacts
    address these issues and the demands of decision makers and        of chemicals. The LRI also extends the chemical industry’s
    the public to understand the impact of chemicals on human          commitment to Responsible Care, strengthens the basis for
    health and the environment. The LRI is a global program            harmonized regional and international chemical policies,
    implemented through three ICCA member organizations – the          and supports establishment of reliable frameworks for safety
    European Chemical Industry Council (Cefic), the American           evaluation and innovation.
    Chemistry Council (ACC), and the Japan Chemical Industry
    Association (JCIA). Through the ICCA, these regionally
    managed LRI research programs support complementary areas
    of scientific investigation.
LRI Mission

The mission of the LRI is to identify and fill gaps in our understanding about the hazards
posed by chemicals and to improve the methods available for assessing the associated risks.
Its innovative research programs are designed to improve the way we address the safety
of our chemicals, particularly everyday exposures of consumers to low levels of
chemicals and chemical mixtures. The LRI fosters a sustainable and healthy future
through its support of high-quality science that can inform
effective decision making by industry,
regulators, and society.
Purpose of the Strategy
    Developing and implementing an effective LRI research             This Strategy considers the LRI program as a whole,
    program requires guidance from a strategic plan as well as        independent of which regional LRI program manages the
    effective processes designed to achieve coordination among        research. Each regional LRI program is responsible for
    the three regional LRI programs. This LRI Global Research         examining the relationship of its research program to the
    Strategy outlines the direction for the LRI research program in   Strategy’s overall objectives and for ensuring alignment.
    three priority research areas: emerging technologies, exposure    The ICCA-LRI Planning Group (PG), whose composition and
    science, and translation relevant to health and environment,      responsibilities are described on page 15 of this document,
    based on a five-year timeframe. This document also describes      works to ensure coordination among the LRI programs in
    the guidelines and processes used by the LRI to achieve its       Europe, the United States, and Japan within an agreed-upon
    research objectives.                                              set of principles and broad technical issues. The regional LRI
4                                                                     programs share common objectives, but each program is
                                                                      targeted towards industry policy priorities within its region. The
                                                                      PG’s goals include sharing information and experiences and
                                                                      ensuring that the regional LRI programs are complementary
                                                                      and that no unnecessary duplication exists among the research
                                                                      projects in the three programs.
LRI Goals and Principles

  Through its commitment to the LRI, the global chemical
  industry is recognized as an informed and knowledgeable
  partner in worldwide efforts to improve scientific
  understanding of the potential impacts of chemicals
  on human health and the environment.                                LRI Principles
  The goals of the LRI are:
                                                                      Chemical Industry Relevance. Research
• Extend knowledge worldwide on the health, safety, and               needs and priorities will be determined based
  environmental impacts of the chemical industry’s products           on the relevance of the research to the chemical
                                                                      industry and the overall goal to fund research
  and processes.
                                                                      that increases scientific understanding about
• Support informed decision making and risk management                the potential health and environmental impacts       5
  decisions by increasing scientific understanding                    of chemicals.
  through research.
                                                                      Scientific Excellence. Research will focus on
• Develop new tools to assess chemicals, especially as                scientific excellence by identifying and engaging
  new questions emerge about potential health and                     the best scientists and having as its primary
  environmental impacts.                                              goal advancement of scientific understanding.
• Coordinate research among ICCA member associations to
                                                                      Transparency and Action. The research
  achieve international scientific participation in the research
                                                                      process will be transparent, the results
  process and create synergy among the research projects.             will be publicly available, and industry will
• Improve public confidence in decisions based on a scientific        act on the results in a timely fashion.
  understanding of risk.
                                                                      Fair and Unbiased Conduct. Review of
  To achieve significant scientific advances in its funded research   proposed research will identify possible conflicts
  projects, the LRI developed principles to govern its conduct;       of interest and the potential for bias in decision
  these principles are consistent with Responsible Care goals.        making will be monitored continuously.
LRI Program Drivers

    Implementation of Registration, Evaluation, Authorisation and        A variety of current issues underscore the critical need by
    Restriction of Chemicals (REACH) in the EU … reform of the           society and industry to advance the science of risk assessment
    Toxic Substances Control Act (TSCA) in the United States             for chemicals and corroborate the value of the chemical
    … revision of the Chemical Substances Control Law (CSCL)             industry’s investment in the LRI. They include:
    in Japan ... the industry’s obligations under the Strategic
                                                                       • Advancing Approaches for Risk Assessment and
    Approach to International Chemicals Management (SAICM ) …
                                                                         Risk Management. Improving risk assessment methods,
    de-selection pressures. Globally, these drivers have motivated
                                                                         including innovative approaches to improve understanding of
    the industry’s product stewards and those in governmental and
                                                                         human exposures and advance evaluation of aggregate and
    regulatory agencies to seek high-quality scientific information
                                                                         cumulative risks, will enable more accurate interpretations of
    about chemical risks to better inform these current issues. This
                                                                         information derived from both existing and new studies. Such
    information is crucial to risk assessment, risk management,
6                                                                        improvements will also provide key information to industry
    and risk mitigation and, ultimately, is the basis for making
                                                                         and regulators about the most effective and efficient risk
    good decisions about chemical management strategies.
                                                                         assessment and management strategies.
    Similarly, the general public is demanding better information
    about the safe use of chemicals, an essential element for          • Emerging Technologies for Toxicity Testing. New biological
    improving its confidence in our products.                            research tools, such as genomics, high-throughput assays,
                                                                         computational models, and bioinformatics to analyze extensive
                                                                         data sets, have the potential to revolutionize risk assessment.
                                                                         These tools also have an important role in the design of
                                                                         intelligent testing strategies, which are integrated knowledge-
                                                                         based approaches aimed toward reducing costs and animal
                                                                         use and accelerating risk assessment. A critical element for
                                                                         successful integration of the data from these tools into risk
                                                                         assessment practice will be developing approaches
                                                                         to effectively interpret the data and to identify actual human
                                                                         health risks.
• Improving Exposure Science. Information about exposures           • Public Demands That Industry “Know Its Products.”
  to chemicals is as important as hazard information to               Through Responsible Care, the chemical industry is committed
  appropriately assess human health risks. This particularly          to understanding the potential health and environmental
  applies to everyday exposures to chemicals. Meaningful              risks associated with the production, use, and disposal of its
  exposure data are needed to understand the health implications      products. Through its research support, the LRI is advancing
  of data from biomonitoring studies, the ecological impacts          use of state-of-the-art methods and technologies in health
  of chemical exposures, and the effects of indoor air quality        and environmental science to address these risk concerns so
  on human health. Innovative tools to characterize and predict       that industry can meet its product stewardship commitments
  environmentally relevant exposures are essential to address all     effectively and efficiently.
  of these issues.
                                                                    • Alternatives to Animal Testing. The LRI supports
• Demands for Increased Knowledge about Health Risks                  development of testing and research methods that reduce           7
  to Susceptible Populations. Children are a susceptible              the unnecessary use of animals. This goal may be realized
  population because they have the potential for higher               through (1) developing or improving animal tests so that they
  exposures compared to adults for some chemicals and                 provide high-quality data using fewer animals; (2) devising
  have increased biological sensitivity due to their developing       new methods, such as those that utilize cell lines, including
  physiological systems (e.g., nervous system, reproductive           human cell lines, that avoid the use of animals while providing
  system). Other populations at increased risk for health effects     meaningful results; and (3) improving methods that use
  from chemicals include workers, the elderly, and those with         genomic technologies and have the potential to reduce reliance
  compromised health status. Through the LRI, the chemical            on animal testing over the long term.
  industry is innovating improved screening and testing methods
  as well as advancing exposure assessment approaches
  to better understand health risks for children and other
  susceptible populations.
LRI Global Research Strategy
     21st Century Approaches to Risk Sciences
      The LRI Global Research Strategy is designed to directly         These priority areas, which by design are interrelated and
      address many of the complex challenges faced by the industry     interdisciplinary, provide an overall structure for the global LRI
      as it advocates for sound chemicals management policies.         program. However, the focus on different topics within these
      The current Strategy, 21st Century Approaches to Risk            priority areas may vary from year to year and from region to
      Sciences, targets the science-policy interface to modernize      region depending on budget and other drivers. On balance, the
      and improve chemical management. The Strategy incorporates       regional diversity adds both depth and texture to the ICCA-LRI
      three priority areas:                                            research program. The text that follows and the accompanying
                                                                       table provide an overview of the 2010 research topic areas.
    • Emerging Technologies – Assessing innovative tools,
      approaches, and data for robust evaluations of chemicals as      In the area of emerging technologies, JCIA leads in the
8     well as new technologies, such as nanotechnology.                application of technologies to understand how chemicals act
                                                                       on biological systems; ACC’s focus is on developing new
    • Exposure Science – Improving the tools to quantify everyday      bioinformatic tools to interpret the data and apply it to risk
      and incidental exposures to chemicals and to guide intelligent   assessment; and Cefic leads in the development of predictive
      testing and risk assessment.                                     models and decision frameworks as well as in acceptance
    • Translation Relevant to Health and Environment –                 of new product areas, such as nanotechnology, to guide
      Developing approaches and tools to improve understanding         intelligent testing strategies.
      of links between exposures to chemicals and their effects on     With regard to exposure science, ACC has a program to link
      human health and the environment.                                exposure to hazard assessment and improve chemical safety
                                                                       and risk assessments; JCIA’s research program has a focus on
                                                                       ecological impacts of chemical exposures and on exposure-
                                                                       dose relationships for risk assessment; and Cefic has a strong
                                                                       program in real-life exposures and modeling and developing
                                                                       assessment frameworks for exposures from multiple sources,
                                                                       including chemical mixtures.
For translation relevant to health and environment, Cefic
has a focus on children’s health, including relevance of clinical
indicators and improved assessment methods to reduce
uncertainty, as well as on emerging issues, such as animal
welfare and endocrine disruptors; ACC’s research program
addresses methods and models for improving human health
risk assessment; and JCIA’s research program addresses
sick building syndrome and immune responses as well as
assessment and application of human health risk assessment.


                                                                    9
LRI Global Research Strategy: 2010 Research Topic Areas

                ACC Portfolio                       JCIA Portfolio                          Cefic Portfolio

               • Bioinformatics and Data           • Alternatives to Animal Testing       • Intelligent Testing Strategies
Technologies
  Emerging




                 Interpretation                    • Genomics Approaches to               • Acceptance of New Products
               • High-Throughput Testing and         Understanding Disease                  and Technologies
                 Application to Risk Assessment


               • Application of Biomonitoring to   • Ecological Impacts of Chemical       • Indoor Air Assessment Framework
                 Exposure Assessment                 Exposures
Exposure




                                                                                          • Aggregate Exposures
 Science




               • Improving Frameworks for          • Relating Exposure to Dose for Risk
                 Linking Exposure and Human          Assessment
                 Health Effects


               • Advancing Human Health Risk       • Sick Building Syndrome and           • Children’s Health
                 Assessment Methods                  Immune Responses                     • Endocrine Disruptors and
Environment
 Health and




               • New Tools for Interpreting        • Assessment and Application of          Human Health
                 Biomonitoring Data                  Human Health Risk Assessment         • Real-Life Exposure, Cumulative
                                                                                            Exposure, and Modeling
Translation for Decision Making

Outreach and communication, elements that are integral to       ICCA-LRI workshops, another element of the translation
the ICCA-LRI program, are essential for translating research    component, showcase the global impact of ICCA-LRI
findings into information that can be used for science-based    supported science. Since 2005, these workshops have
decision making. All results from the scientific research       addressed a range of key issues relevant to the chemical
supported by the LRI are openly communicated to the public,     industry, such as human biomonitoring, 21st century methods
the scientific community, and government regulators through     for risk assessment, and emerging issues in exposure science.
a variety of media approaches, including peer-reviewed          They provide important, dynamic forums that foster interactions
publications, workshops, conferences, and the Internet.         among industry and academic researchers, governmental
However, these communication outlets are only one aspect of     agencies, non-governmental organizations, and regulatory
LRI’s approach to deliver impact and demonstrate the overall    decision makers regarding areas of mutual interest in chemical
value of the program. The goals for the translation component   management. Discussions among the diverse participant
of the LRI Global Research Strategy are to facilitate use of    groups promote improvements in the scientific basis for           11
scientific innovations as part of the decision making process   pragmatic policy making and support consensus building
regarding the safety of our products, extend LRI’s network of   that can advance risk and safety assessments for chemicals.
science advocates through public dialogue and workshops,        The following illustration provides a chrononology and brief
and communicate a vision for new policy approaches for          summaries of previous ICCA-LRI workshops.
chemical management.
12



     ICCA-LRI
     Workshops
                                                                                  Public Health
                                                                                  Applications of
     Workshop on                            Making Sense of Human                 Human Biomonitoring
     Human Biomonitoring                    Biomonitoring Data                    Provided a venue for discussions
     Examined biomonitoring from the        Fostered consensus on                 about the strengths and weaknesses
     perspectives of product stewardship,   priorities for future research in     of biomonitoring for the purposes
     policy/advocacy, communication, and    biomonitoring for ICCA-LRI and        of public health tracking,
     existing scientific knowledge gaps.    other research organizations.         intervention, and protection.




‘05                                     ‘06                                     ‘07
            paRis,                                  Minneapolis,                         ReseaRch tRiangle paRk,
            FRance                                  Minnesota, Usa                       noRth caRolina, Usa
Connecting Innovations
                                          in Biological, Exposure,                                                      13
  Twenty-First Century                    and Risk Sciences:
  Approaches to Toxicity                  Better Information for               Integrating New Advances
  Testing, Biomonitoring,                 Better Decisions                     in Exposure Science and
  and Risk Assessment                     Stimulated discussions about
                                                                               Toxicity Testing: Next Steps
  Addressed advances in the new           interpreting the data from new       Focused on the application of
  technologies for toxicity testing       technologies and advancing risk-     integrated approaches in exposure
  and biomonitoring; considered           based decision making; reviewed      science and toxicology to the
  approaches for effective                innovative tools to characterize     design, evaluation, and health
  communication of the deluge of data     exposure and their implications      risk management of chemicals;
  from these new technologies; and        for health risk assessment;          considered what research is needed
  promoted exchange of views on how       and addressed the key role of        to improve communication among
  these technological advancements        communication to effectively         scientists, stakeholders, and decision
  can be used to improve the science      explain the emerging research        makers to develop better chemical
  of human health risk assessment.        outcomes to diverse audiences.       management policies and practices.




‘08                                     ‘09                                  ‘10
         aMsteRdaM,                              chaRleston,                          stResa,
         the netheRlands                         soUth caRolina, Usa                  italy
LRI Global Management and Governance

      Global Management
      Under the ICCA umbrella, Cefic, ACC, and JCIA have forged a        • Link these global activities to ICCA priorities:
      virtual management and coordination structure that facilitates         • Establish rapport and dialogue with global agencies (e.g.,
      implementation of the LRI program with common goals                      World Health Organization, Organisation for Economic
      and principles. At the same time, this structure recognizes              Co-Operation and Development, and United Nations
      the diversity among the scientific communities, regulatory               Environment Programme) to ensure the industry is
      structures, and societal issues of the three geographical                effectively addressing global concerns.
      regions of Europe, the United States, and Japan.
                                                                             • Provide a framework for participation and contribution by
      This management structure was initially established in October           other organizations, including governments, industries, and
      2004 to ensure trans-regional coordination for critical science-         non-governmental organizations.
14    based issues that are best addressed through implementation
                                                                           LRI continues its focus on innovations to advance the science
      of long-range research programs. This LRI Global Research
                                                                           of chemical risk assessment. A primary aim is to provide a
      Strategy extends the concepts and principles previously
                                                                           scientific foundation for the chemical industry, as part of the
      described in the 2005 version of this document. Recognizing
                                                                           larger global society, to make responsible product stewardship
      the growing global complexity of the many issues the chemical
                                                                           and regulatory decisions concerning the production, marketing,
      industry faces, this updated Strategy extends coordination of
                                                                           and use of its products. Substantial progress towards this aim
      regional activities to:
                                                                           has been realized through the strong commitment of each
     • Plan LRI activities with a global view that supports                of the ICCA regional programs to the greater LRI vision. The
       coordination among the research programs while retaining            success of the LRI Global Research Strategy has been and
       independent management by each region.                              continues to be based upon implementation of processes
                                                                           that increase transparency and integration among the regional
     • Design and implement a global program that addresses                programs and create a venue for a comprehensive “one
       those issues for which consensus and endorsement from the           industry” approach.
       ICCA-LRI Steering Committee exist.
Governance
ICCA-LRI is a framework for coordination and collaboration            The SC keeps abreast of emerging scientific issues that could
among the three regional LRI programs that are funded and             affect the global chemical industry, while maintaining a focus
governed by their respective boards at Cefic, ACC, and                on science-based decision making. The SC informs the ICCA
JCIA. The ICCA-LRI Steering Committee (SC) oversees                   board about relevant issues and provides the industry with
implementation of this global framework. Through a rigorous           an opportunity to establish a leadership role and to respond
governance structure of the SC involving CEOs and directors           proactively. The SC includes two CEO-level representatives
general from the three LRI regions, strategic alignment,              from each of the three regional associations. The SC chair is
research programs that support complementary areas of                 selected from the membership and rotates between Cefic and
scientific investigation, efficient use of financial resources, and   ACC every two to three years.
effective dissemination of research results are achieved.
                                                                      The SC is supported by an ICCA-LRI Planning Group (PG) that          15
                                                                      includes senior managers from each of the three LRI regions
                                                                      and is responsible for program management, efficient delivery
                                                                      of content, and dissemination of research results. Typically, the
    Governance of the LRI                                             secretariat of the SC and PG rotates with the chair of the SC, but
                                                                      this rotation depends on staff availability. The SC meets once
    ICCA-LRI Steering Committee                                       a year to coincide with the fall ICCA board meeting. The PG
    Six executive contacts, two each from the                         meets more frequently to ensure appropriate coordination and
    Cefic, ACC, and JCIA, who oversee the                             communication among the LRI regional programs.
    LRI and report to the ICCA board.

    ICCA-LRI Planning Group
    Senior company and association managers
    from the Cefic, ACC, and JCIA regional LRI
    programs, who provide support to the Steering
    Committee and feedback to their associations.
LRI - Science in Action

     LRI’s research and advocacy for science-based decision             In summary, the LRI, its research, and its translation program
     making provide a strong linkage to key ICCA advocacy               facilitate use of scientific innovations in ways that can
     priorities and position the chemical industry as a leader and      advance chemical management, better inform decisions
     knowledge partner in the broader community of science              about safe use of chemicals, and lead to improved public
     and policy experts. Since 2005, LRI has been a global              confidence in our products. The LRI program for innovating
     leader in interpretation of biomonitoring data through             chemical risk assessment positions the chemical industry
     research, consensus-building among different entities, and         as a leader and knowledge partner in the broader community
     communication of the scientific results, as well as other          of science and policy experts. It will further ensure value
     outreach activities to governmental and non-governmental           and relevance to other global programs, such as the ICCA
     agencies. LRI is currently investing in innovations for toxicity   initiatives for high production volume chemicals and global
     testing to advance methods that are faster, more cost-effective,   product strategy, that demand state-of-the-art methods to
16   and responsive to animal welfare issues. Its broader program       understand and communicate environmental risk information.
     in exposure science is also improving our understanding of the     Research in the priority areas described in this LRI Global
     exposures of different populations to multiple chemicals in the    Research Strategy, 21st Century Approaches to Risk Sciences,
     environment. Through the LRI and its research program, the         extends the chemical industry’s commitment to safe
     chemical industry contributes significantly to the science that    chemical management, strengthens the basis for regional
     will shape the future of chemical management policies.             and international policies for chemicals, and facilitates
                                                                        establishment of a responsible framework for innovations in
                                                                        scientific research.
From Data to Decisions: Informing Regulatory Policy

LRI research addresses the gap between new technologies and the science to interpret and
understand the emerging data. Key questions include what research is needed to bridge this
gap; how to harness the data to better inform decisions about public health; and how best to
communicate research outcomes as they evolve.




                        Research          QUESTIONS
                                                                              Informed
LRI                                                             Policy
                                                                              Public Health
               Data




                                       COMMUNICATION
Research                                                       Makers
                      Interpretation     INFORMATION
                                                                              Decisions
21st Century Approaches to Risk Sciences

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21st Century Approaches to Risk Sciences

  • 1. Long-Range Research Initiative Global Research Strategy 21st Century Approaches to Risk Sciences
  • 2. LRI Global Research Strategy - Priority Areas 21st Century Approaches to Risk Sciences Emerging Technologies – Assessing innovative tools, approaches, and data for robust, timely, and resource-effective evaluations of chemicals as well as new technologies, such as nanotechnology. Exposure Science – Improving the tools to quantify everyday and incidental exposures to chemicals and to guide intelligent testing and risk assessment. Translation Relevant to Health and Environment – Developing approaches and tools to improve understanding of links between exposures to chemicals and their potential effects on human health and the environment.
  • 3. Executive Summary The innovative research program of the International Council of Chemical Associations’ Long-Range Research Initiative (ICCA-LRI) is designed to improve the quality of chemical safety assessments. This global program and its research strategy target the science-policy interface to modernize and improve chemical management. Although societal and political drivers vary around the world, the three regional LRI programs in Europe, the United States, and Japan identify common scientific topic areas that industry regards as important to form the core of the global ICCA-LRI program and direct its research strategy. This LRI Global Research Strategy, 21st Century Approaches to Risk Sciences, comprises three priority areas: emerging 1 technologies, exposure science, and translation relevant to health and environment. The research funding invested in these three areas is often leveraged through collaboration with publicly funded projects that can maximize project value up to five times. Through a rigorous governance structure involving chief executive officers (CEOs) and directors general from the three LRI regions, strategic alignment, complementarity, efficient use of financial resources, and effective dissemination of research results are achieved. The ICCA-LRI is recognized as a brand that demonstrates industry engagement within Responsible Care®, provides early warning on emerging issues, achieves outreach to opinion leaders through its network, and supports capacity building within industry to ensure knowledge-based decision making by companies and by public policy makers.
  • 4. Introduction Background The importance of science to decision making about the safety The LRI programs at Cefic, ACC, and JCIA sponsor of chemicals is more evident today than ever before. Demands independent third-party research that enhances the credibility are increasingly heard for more data, better information, and of LRI-funded science. A unifying focus for these programs science that can drive decisions to improve the quality of is to improve the way we address the safety of our chemicals, public health and the environment. At its core, the business particularly with regard to everyday exposures of employees, of chemistry is all about science – science aimed toward consumers, and the general public to low levels of chemicals. innovations in products and services that can make people’s Through the perspectives and expert guidance provided lives better, healthier, and safer. Science is also an essential by scientists from industry, academia, and governmental part of the process needed to inform good decisions. agencies, LRI-supported research provides critical information to government and industry regarding risk assessment 2 Since 1999, the ICCA-LRI has supported the science to decisions about the potential health and environmental impacts address these issues and the demands of decision makers and of chemicals. The LRI also extends the chemical industry’s the public to understand the impact of chemicals on human commitment to Responsible Care, strengthens the basis for health and the environment. The LRI is a global program harmonized regional and international chemical policies, implemented through three ICCA member organizations – the and supports establishment of reliable frameworks for safety European Chemical Industry Council (Cefic), the American evaluation and innovation. Chemistry Council (ACC), and the Japan Chemical Industry Association (JCIA). Through the ICCA, these regionally managed LRI research programs support complementary areas of scientific investigation.
  • 5. LRI Mission The mission of the LRI is to identify and fill gaps in our understanding about the hazards posed by chemicals and to improve the methods available for assessing the associated risks. Its innovative research programs are designed to improve the way we address the safety of our chemicals, particularly everyday exposures of consumers to low levels of chemicals and chemical mixtures. The LRI fosters a sustainable and healthy future through its support of high-quality science that can inform effective decision making by industry, regulators, and society.
  • 6. Purpose of the Strategy Developing and implementing an effective LRI research This Strategy considers the LRI program as a whole, program requires guidance from a strategic plan as well as independent of which regional LRI program manages the effective processes designed to achieve coordination among research. Each regional LRI program is responsible for the three regional LRI programs. This LRI Global Research examining the relationship of its research program to the Strategy outlines the direction for the LRI research program in Strategy’s overall objectives and for ensuring alignment. three priority research areas: emerging technologies, exposure The ICCA-LRI Planning Group (PG), whose composition and science, and translation relevant to health and environment, responsibilities are described on page 15 of this document, based on a five-year timeframe. This document also describes works to ensure coordination among the LRI programs in the guidelines and processes used by the LRI to achieve its Europe, the United States, and Japan within an agreed-upon research objectives. set of principles and broad technical issues. The regional LRI 4 programs share common objectives, but each program is targeted towards industry policy priorities within its region. The PG’s goals include sharing information and experiences and ensuring that the regional LRI programs are complementary and that no unnecessary duplication exists among the research projects in the three programs.
  • 7. LRI Goals and Principles Through its commitment to the LRI, the global chemical industry is recognized as an informed and knowledgeable partner in worldwide efforts to improve scientific understanding of the potential impacts of chemicals on human health and the environment. LRI Principles The goals of the LRI are: Chemical Industry Relevance. Research • Extend knowledge worldwide on the health, safety, and needs and priorities will be determined based environmental impacts of the chemical industry’s products on the relevance of the research to the chemical industry and the overall goal to fund research and processes. that increases scientific understanding about • Support informed decision making and risk management the potential health and environmental impacts 5 decisions by increasing scientific understanding of chemicals. through research. Scientific Excellence. Research will focus on • Develop new tools to assess chemicals, especially as scientific excellence by identifying and engaging new questions emerge about potential health and the best scientists and having as its primary environmental impacts. goal advancement of scientific understanding. • Coordinate research among ICCA member associations to Transparency and Action. The research achieve international scientific participation in the research process will be transparent, the results process and create synergy among the research projects. will be publicly available, and industry will • Improve public confidence in decisions based on a scientific act on the results in a timely fashion. understanding of risk. Fair and Unbiased Conduct. Review of To achieve significant scientific advances in its funded research proposed research will identify possible conflicts projects, the LRI developed principles to govern its conduct; of interest and the potential for bias in decision these principles are consistent with Responsible Care goals. making will be monitored continuously.
  • 8. LRI Program Drivers Implementation of Registration, Evaluation, Authorisation and A variety of current issues underscore the critical need by Restriction of Chemicals (REACH) in the EU … reform of the society and industry to advance the science of risk assessment Toxic Substances Control Act (TSCA) in the United States for chemicals and corroborate the value of the chemical … revision of the Chemical Substances Control Law (CSCL) industry’s investment in the LRI. They include: in Japan ... the industry’s obligations under the Strategic • Advancing Approaches for Risk Assessment and Approach to International Chemicals Management (SAICM ) … Risk Management. Improving risk assessment methods, de-selection pressures. Globally, these drivers have motivated including innovative approaches to improve understanding of the industry’s product stewards and those in governmental and human exposures and advance evaluation of aggregate and regulatory agencies to seek high-quality scientific information cumulative risks, will enable more accurate interpretations of about chemical risks to better inform these current issues. This information derived from both existing and new studies. Such information is crucial to risk assessment, risk management, 6 improvements will also provide key information to industry and risk mitigation and, ultimately, is the basis for making and regulators about the most effective and efficient risk good decisions about chemical management strategies. assessment and management strategies. Similarly, the general public is demanding better information about the safe use of chemicals, an essential element for • Emerging Technologies for Toxicity Testing. New biological improving its confidence in our products. research tools, such as genomics, high-throughput assays, computational models, and bioinformatics to analyze extensive data sets, have the potential to revolutionize risk assessment. These tools also have an important role in the design of intelligent testing strategies, which are integrated knowledge- based approaches aimed toward reducing costs and animal use and accelerating risk assessment. A critical element for successful integration of the data from these tools into risk assessment practice will be developing approaches to effectively interpret the data and to identify actual human health risks.
  • 9. • Improving Exposure Science. Information about exposures • Public Demands That Industry “Know Its Products.” to chemicals is as important as hazard information to Through Responsible Care, the chemical industry is committed appropriately assess human health risks. This particularly to understanding the potential health and environmental applies to everyday exposures to chemicals. Meaningful risks associated with the production, use, and disposal of its exposure data are needed to understand the health implications products. Through its research support, the LRI is advancing of data from biomonitoring studies, the ecological impacts use of state-of-the-art methods and technologies in health of chemical exposures, and the effects of indoor air quality and environmental science to address these risk concerns so on human health. Innovative tools to characterize and predict that industry can meet its product stewardship commitments environmentally relevant exposures are essential to address all effectively and efficiently. of these issues. • Alternatives to Animal Testing. The LRI supports • Demands for Increased Knowledge about Health Risks development of testing and research methods that reduce 7 to Susceptible Populations. Children are a susceptible the unnecessary use of animals. This goal may be realized population because they have the potential for higher through (1) developing or improving animal tests so that they exposures compared to adults for some chemicals and provide high-quality data using fewer animals; (2) devising have increased biological sensitivity due to their developing new methods, such as those that utilize cell lines, including physiological systems (e.g., nervous system, reproductive human cell lines, that avoid the use of animals while providing system). Other populations at increased risk for health effects meaningful results; and (3) improving methods that use from chemicals include workers, the elderly, and those with genomic technologies and have the potential to reduce reliance compromised health status. Through the LRI, the chemical on animal testing over the long term. industry is innovating improved screening and testing methods as well as advancing exposure assessment approaches to better understand health risks for children and other susceptible populations.
  • 10. LRI Global Research Strategy 21st Century Approaches to Risk Sciences The LRI Global Research Strategy is designed to directly These priority areas, which by design are interrelated and address many of the complex challenges faced by the industry interdisciplinary, provide an overall structure for the global LRI as it advocates for sound chemicals management policies. program. However, the focus on different topics within these The current Strategy, 21st Century Approaches to Risk priority areas may vary from year to year and from region to Sciences, targets the science-policy interface to modernize region depending on budget and other drivers. On balance, the and improve chemical management. The Strategy incorporates regional diversity adds both depth and texture to the ICCA-LRI three priority areas: research program. The text that follows and the accompanying table provide an overview of the 2010 research topic areas. • Emerging Technologies – Assessing innovative tools, approaches, and data for robust evaluations of chemicals as In the area of emerging technologies, JCIA leads in the 8 well as new technologies, such as nanotechnology. application of technologies to understand how chemicals act on biological systems; ACC’s focus is on developing new • Exposure Science – Improving the tools to quantify everyday bioinformatic tools to interpret the data and apply it to risk and incidental exposures to chemicals and to guide intelligent assessment; and Cefic leads in the development of predictive testing and risk assessment. models and decision frameworks as well as in acceptance • Translation Relevant to Health and Environment – of new product areas, such as nanotechnology, to guide Developing approaches and tools to improve understanding intelligent testing strategies. of links between exposures to chemicals and their effects on With regard to exposure science, ACC has a program to link human health and the environment. exposure to hazard assessment and improve chemical safety and risk assessments; JCIA’s research program has a focus on ecological impacts of chemical exposures and on exposure- dose relationships for risk assessment; and Cefic has a strong program in real-life exposures and modeling and developing assessment frameworks for exposures from multiple sources, including chemical mixtures.
  • 11. For translation relevant to health and environment, Cefic has a focus on children’s health, including relevance of clinical indicators and improved assessment methods to reduce uncertainty, as well as on emerging issues, such as animal welfare and endocrine disruptors; ACC’s research program addresses methods and models for improving human health risk assessment; and JCIA’s research program addresses sick building syndrome and immune responses as well as assessment and application of human health risk assessment. 9
  • 12. LRI Global Research Strategy: 2010 Research Topic Areas ACC Portfolio JCIA Portfolio Cefic Portfolio • Bioinformatics and Data • Alternatives to Animal Testing • Intelligent Testing Strategies Technologies Emerging Interpretation • Genomics Approaches to • Acceptance of New Products • High-Throughput Testing and Understanding Disease and Technologies Application to Risk Assessment • Application of Biomonitoring to • Ecological Impacts of Chemical • Indoor Air Assessment Framework Exposure Assessment Exposures Exposure • Aggregate Exposures Science • Improving Frameworks for • Relating Exposure to Dose for Risk Linking Exposure and Human Assessment Health Effects • Advancing Human Health Risk • Sick Building Syndrome and • Children’s Health Assessment Methods Immune Responses • Endocrine Disruptors and Environment Health and • New Tools for Interpreting • Assessment and Application of Human Health Biomonitoring Data Human Health Risk Assessment • Real-Life Exposure, Cumulative Exposure, and Modeling
  • 13. Translation for Decision Making Outreach and communication, elements that are integral to ICCA-LRI workshops, another element of the translation the ICCA-LRI program, are essential for translating research component, showcase the global impact of ICCA-LRI findings into information that can be used for science-based supported science. Since 2005, these workshops have decision making. All results from the scientific research addressed a range of key issues relevant to the chemical supported by the LRI are openly communicated to the public, industry, such as human biomonitoring, 21st century methods the scientific community, and government regulators through for risk assessment, and emerging issues in exposure science. a variety of media approaches, including peer-reviewed They provide important, dynamic forums that foster interactions publications, workshops, conferences, and the Internet. among industry and academic researchers, governmental However, these communication outlets are only one aspect of agencies, non-governmental organizations, and regulatory LRI’s approach to deliver impact and demonstrate the overall decision makers regarding areas of mutual interest in chemical value of the program. The goals for the translation component management. Discussions among the diverse participant of the LRI Global Research Strategy are to facilitate use of groups promote improvements in the scientific basis for 11 scientific innovations as part of the decision making process pragmatic policy making and support consensus building regarding the safety of our products, extend LRI’s network of that can advance risk and safety assessments for chemicals. science advocates through public dialogue and workshops, The following illustration provides a chrononology and brief and communicate a vision for new policy approaches for summaries of previous ICCA-LRI workshops. chemical management.
  • 14. 12 ICCA-LRI Workshops Public Health Applications of Workshop on Making Sense of Human Human Biomonitoring Human Biomonitoring Biomonitoring Data Provided a venue for discussions Examined biomonitoring from the Fostered consensus on about the strengths and weaknesses perspectives of product stewardship, priorities for future research in of biomonitoring for the purposes policy/advocacy, communication, and biomonitoring for ICCA-LRI and of public health tracking, existing scientific knowledge gaps. other research organizations. intervention, and protection. ‘05 ‘06 ‘07 paRis, Minneapolis, ReseaRch tRiangle paRk, FRance Minnesota, Usa noRth caRolina, Usa
  • 15. Connecting Innovations in Biological, Exposure, 13 Twenty-First Century and Risk Sciences: Approaches to Toxicity Better Information for Integrating New Advances Testing, Biomonitoring, Better Decisions in Exposure Science and and Risk Assessment Stimulated discussions about Toxicity Testing: Next Steps Addressed advances in the new interpreting the data from new Focused on the application of technologies for toxicity testing technologies and advancing risk- integrated approaches in exposure and biomonitoring; considered based decision making; reviewed science and toxicology to the approaches for effective innovative tools to characterize design, evaluation, and health communication of the deluge of data exposure and their implications risk management of chemicals; from these new technologies; and for health risk assessment; considered what research is needed promoted exchange of views on how and addressed the key role of to improve communication among these technological advancements communication to effectively scientists, stakeholders, and decision can be used to improve the science explain the emerging research makers to develop better chemical of human health risk assessment. outcomes to diverse audiences. management policies and practices. ‘08 ‘09 ‘10 aMsteRdaM, chaRleston, stResa, the netheRlands soUth caRolina, Usa italy
  • 16. LRI Global Management and Governance Global Management Under the ICCA umbrella, Cefic, ACC, and JCIA have forged a • Link these global activities to ICCA priorities: virtual management and coordination structure that facilitates • Establish rapport and dialogue with global agencies (e.g., implementation of the LRI program with common goals World Health Organization, Organisation for Economic and principles. At the same time, this structure recognizes Co-Operation and Development, and United Nations the diversity among the scientific communities, regulatory Environment Programme) to ensure the industry is structures, and societal issues of the three geographical effectively addressing global concerns. regions of Europe, the United States, and Japan. • Provide a framework for participation and contribution by This management structure was initially established in October other organizations, including governments, industries, and 2004 to ensure trans-regional coordination for critical science- non-governmental organizations. 14 based issues that are best addressed through implementation LRI continues its focus on innovations to advance the science of long-range research programs. This LRI Global Research of chemical risk assessment. A primary aim is to provide a Strategy extends the concepts and principles previously scientific foundation for the chemical industry, as part of the described in the 2005 version of this document. Recognizing larger global society, to make responsible product stewardship the growing global complexity of the many issues the chemical and regulatory decisions concerning the production, marketing, industry faces, this updated Strategy extends coordination of and use of its products. Substantial progress towards this aim regional activities to: has been realized through the strong commitment of each • Plan LRI activities with a global view that supports of the ICCA regional programs to the greater LRI vision. The coordination among the research programs while retaining success of the LRI Global Research Strategy has been and independent management by each region. continues to be based upon implementation of processes that increase transparency and integration among the regional • Design and implement a global program that addresses programs and create a venue for a comprehensive “one those issues for which consensus and endorsement from the industry” approach. ICCA-LRI Steering Committee exist.
  • 17. Governance ICCA-LRI is a framework for coordination and collaboration The SC keeps abreast of emerging scientific issues that could among the three regional LRI programs that are funded and affect the global chemical industry, while maintaining a focus governed by their respective boards at Cefic, ACC, and on science-based decision making. The SC informs the ICCA JCIA. The ICCA-LRI Steering Committee (SC) oversees board about relevant issues and provides the industry with implementation of this global framework. Through a rigorous an opportunity to establish a leadership role and to respond governance structure of the SC involving CEOs and directors proactively. The SC includes two CEO-level representatives general from the three LRI regions, strategic alignment, from each of the three regional associations. The SC chair is research programs that support complementary areas of selected from the membership and rotates between Cefic and scientific investigation, efficient use of financial resources, and ACC every two to three years. effective dissemination of research results are achieved. The SC is supported by an ICCA-LRI Planning Group (PG) that 15 includes senior managers from each of the three LRI regions and is responsible for program management, efficient delivery of content, and dissemination of research results. Typically, the Governance of the LRI secretariat of the SC and PG rotates with the chair of the SC, but this rotation depends on staff availability. The SC meets once ICCA-LRI Steering Committee a year to coincide with the fall ICCA board meeting. The PG Six executive contacts, two each from the meets more frequently to ensure appropriate coordination and Cefic, ACC, and JCIA, who oversee the communication among the LRI regional programs. LRI and report to the ICCA board. ICCA-LRI Planning Group Senior company and association managers from the Cefic, ACC, and JCIA regional LRI programs, who provide support to the Steering Committee and feedback to their associations.
  • 18. LRI - Science in Action LRI’s research and advocacy for science-based decision In summary, the LRI, its research, and its translation program making provide a strong linkage to key ICCA advocacy facilitate use of scientific innovations in ways that can priorities and position the chemical industry as a leader and advance chemical management, better inform decisions knowledge partner in the broader community of science about safe use of chemicals, and lead to improved public and policy experts. Since 2005, LRI has been a global confidence in our products. The LRI program for innovating leader in interpretation of biomonitoring data through chemical risk assessment positions the chemical industry research, consensus-building among different entities, and as a leader and knowledge partner in the broader community communication of the scientific results, as well as other of science and policy experts. It will further ensure value outreach activities to governmental and non-governmental and relevance to other global programs, such as the ICCA agencies. LRI is currently investing in innovations for toxicity initiatives for high production volume chemicals and global testing to advance methods that are faster, more cost-effective, product strategy, that demand state-of-the-art methods to 16 and responsive to animal welfare issues. Its broader program understand and communicate environmental risk information. in exposure science is also improving our understanding of the Research in the priority areas described in this LRI Global exposures of different populations to multiple chemicals in the Research Strategy, 21st Century Approaches to Risk Sciences, environment. Through the LRI and its research program, the extends the chemical industry’s commitment to safe chemical industry contributes significantly to the science that chemical management, strengthens the basis for regional will shape the future of chemical management policies. and international policies for chemicals, and facilitates establishment of a responsible framework for innovations in scientific research.
  • 19. From Data to Decisions: Informing Regulatory Policy LRI research addresses the gap between new technologies and the science to interpret and understand the emerging data. Key questions include what research is needed to bridge this gap; how to harness the data to better inform decisions about public health; and how best to communicate research outcomes as they evolve. Research QUESTIONS Informed LRI Policy Public Health Data COMMUNICATION Research Makers Interpretation INFORMATION Decisions