APEC Good Regulatory Practice, "Case Study Workshop on the Chemicals Sector- From Principles to Practice" (CTI 10/2009A) March 1 – 2, 2010; Hiroshima, Japan DRAFT Workshop Summary Table of Contents Introduction & Outline Workshop Objective Summary of Day One Presentations & Discussions Mid-Morning Session Afternoon Session I Afternoon Session II Summary of Day Two Presentations & Discussions Keynote Address Chemicals Management / Risk Management & Best Practices Tools & Information sources in the review of chemicals Capacity Building- IOMC Session & Next Steps Next Steps / Wrap-Up Appendix I: Agenda Appendix II: Speaker / Panelist / Moderator Biographies Introduction & Outline Regulatory and industry representatives from seventeen (17) APEC economies, along with four (4) intergovernmental organizations gathered on the sidelines of the first APEC Senior Officials Meetings (SOM 1), 1-2 March, 2010 in Hiroshima, Japan for the Chemical Dialogue’s Good Regulatory Practice, "Case Study Workshop on the Chemicals Sector - From Principles to Practice". The workshop, sponsored by the United States, Japan, Australia and Indonesia, aimed to provide participants with a robust overview of chemicals management, best practices and discussions on the sound management of chemicals within the APEC region. Summaries of presentations and discussion of each Workshop session follow. These summaries endeavor to capture highlights from the agenda, which is also appended to this summary, along with key points and next steps emanating from the Workshop.1 All presentations and other materials, e.g. agenda, participant list, etc., are available on the APEC CD public site.2 Background The Chemical Dialogue (CD) serves as a forum for regulatory officials and industry representatives to find 1 Any errors or omissions contained in this report are those of the drafters alone and not participants in the meeting. 2http://aimp.apec.org/MDDB/Pages/search.aspx?setting=ListMeeting&DateRange=2010/03/01%2C2010/03/end&Name=Case%20Stud y%20Workshop%20on%20the%20Chemicals%20Sector%20-%20From%20Principles%20to%20Practice%202010 1 solutions to challenges facing the chemical industry and users of chemicals in the Asia-Pacific region. The Dialogue has successfully engaged industry and some regulatory officials in discussions on the sound management of chemicals, but a challenge within the forum has been participation of environmental and chemical regulatory representatives from a wider range of APEC economies. An initial step to help round out, address questions and resolve chemicals management issues was the creation of a Regulators’ Forum alongside the CD. However, like the CD, it remained necessary to enhance the participation of APEC economy regulatory officials, so the workshop made possible through the support of APEC was an important step to help enhance a more robust regulatory dialogue. Workshop Objective As such, the workshop’s main objective was to provide a forum that encourages exchange with a range of stakeholders, especially regulators, on approaches for the sound management of industrial chemicals across the APEC economies. The workshop helped highlight good regulatory practices in the sound management of chemicals, as demonstrated by APEC economy and industry case studies, tools and approaches. It also served as a platform to identify and discuss chemical management priorities in the region, capacity building needs and potential opportunities to facilitate collaborative approaches. Possible next steps emanating from the workshop include future project proposals for more focused technical and information exchange seminars that: address specific challenges and priorities for APEC economies in the sound management of chemicals; identify topics for more detailed information exchange, consultations and cooperation in future Regulators’ Forum meetings; and coordinate potential further APEC contributions to the objectives of the Strategic Approach to International Chemicals Management (SAICM). Day One Welcome & Introductory Session Welcome and scene setter Ms. Barbara Norton, Chemical Dialogue (CD) Co-Chair, Deputy Assistant, U.S. Trade Representative of the Office of the U.S. Trade Representative (USTR), provided a welcome address and background for the genesis of the workshop. Ms. Norton noted that the workshop puts into practice Minister and Leader supported and approved “Principles for Best Practice Chemical Regulation” (see Annex Three). Historically, however, the CD has largely been attended by trade, economic or ministries of foreign affairs and while the CD also includes a Regulators’ Forum as a component to further promote information sharing, collaboration with tools and capacity building, sustained involvement by regulatory officials is a critical component. Ms. Norton welcomed all participants to the workshop, in particular regulators new to the CD, and noted that the Workshop adds momentum to the CD and bridges the path forward for best practices chemicals management. Keynote address Mr. Hiroshi Fukushima, Director, Chemical Management Policy Division of Japan Ministry of Economy, Trade and Industry (METI), delivered the keynote address. Mr. Fukushima welcomed participants, noting the importance of sharing experiences and identifying priorities for the APEC region. Chemicals management includes a range of programs, among those the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Pollutant Release and Transfer Registry (PRTR), etc. Sharing actions on a regional basis can promote transparency, allow the recognition of differences and help address impacts to support sustainable development, growth and prosperity in the region. In addition, these efforts contribute to SAICM, which is important to industry and economies, as well as achieving World Summit on Sustainable Development (WSSD) 2020 goals. The Chemical Dialogue serves as a forum for industry and economies to find solutions to chemicals issues in the region. Introductory Overview Overview of Approaches & Lessons from Japanese-hosted International Workshop on Chemicals Management 2 Mr. Taka Hiraishi, Member of the Board of Directors, Senior Consultant at the Institute for Global Environmental Strategies (IGES), provided an overview of approaches and lessons learned from an international workshop on chemicals management in North East Asia. Mr. Hiraishi noted that chemicals management is a combination of assessment, information tools, command and control and voluntary approaches. New trends in chemicals management involve shifts from hazard to risk assessment. Chemical management requires regional and global harmonization, without unnecessary burdens, not only on the chemical industry, but also on governments in terms of implementation or for consumer understanding of risk. Lessons learned from the international workshop on chemicals management, held in 2007, highlight the role of information sharing among economies, which helps not only to speed up, but to also allow national policies to be more effective. In addition, challenges to chemicals assessment and management include multiple factors, such as existing chemicals, substitution, multi-stakeholder involvement and life cycle approaches. Topics included in the past workshop focused on Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, GHS and SAICM, which will most likely remain on the international agenda. Economies need to understand each others systems and continue to broaden their dialogue, e.g., with the EU, U.S. and Asian economies. Industry Challenges Chemical Industry’s upcoming approaches to chemical management Mr. Tetsuo Nishide, Director General of the Japanese Chemical Industry Association (JCIA), presented on the Japanese chemical industry’s approaches to chemicals management. Mr. Nishide outlined the global impact and market share of the chemical industry in Japan and explained initiatives of the International Council of Chemical Associations (ICCA). The Global Product Strategy (GPS), launched in 2006, aims to strengthen product stewardship for the entire supply chain, including downstream users. GPS is an industry contribution to the Strategic Approach to Chemicals Management (SAICM), along with the Japan Initiative of Product Stewardship (JIPS), which helps provide practical risk assessment and product stewardship for small and medium-sized enterprises (SMEs). Mr. Nishide referenced two successful ICCA capacity building workshops, focusing on transitioning from science to practice, held in Bangkok and Tokyo, with more planned throughout 2010. Ultimately, these efforts aim to create an intelligent risk-based strategy for all chemicals in commerce and to restore public confidence in chemicals and their safe use. Recently Enacted or Pending Chemical Legislation & Updates on Regulatory Actions Chemicals management regimes among the APEC economies are at various levels of development, with multiple economies recently enacting chemical legislation, regulatory actions and efforts to align with international commitments. The following sessions focused on updates to chemicals legislation, either recently enacted or pending, along with updates from economies about their chemical management processes and regional collaboration efforts. Mid-Morning Session Japan Mr. Shuji Tamura, Deputy Director of the Chemical Management Policy Division at Japan’s Ministry of Economy, Trade and Industry (METI), discussed Japan’s newly amended Chemical Substances Control Law (or CSCL). The law is being updated to: address increased public interest in safety and security of chemical substances; focus on risk versus hazard, include additional scope to prioritize and evaluate existing chemicals; and to comply with and harmonize domestic practice with international obligations, such as the Stockholm Convention and WSSD 2020 goals. The amendment includes: provisions for some exemptions; an evaluation process that requests exposure information first, e.g. production volume, use, and hazard data if necessary; prioritization based on manufactured/imported quantity and information on uses; and a new emphasis on controlling chemicals through regional supply chains by focusing at the firm-level on standards and labelling. http://www.meti.go.jp/policy/chemical_management/english/index.html 3 China Mr. Nie Jinglei, Division Director (Associate Professor) for the Chemical Registration Center of the Ministry of Environmental Protection (MEP), provided a summary on the “Provisions on the Environmental Administration of New Chemical Substances (MEP Order No. 7)”, a recent amendment to China’s chemical substances law, issued January 19, 2010 to go into effect October 15, 2010. Improvements include a focus on risk versus hazard, parallel registration and control and differentiated administration. The new regulation: addresses international commitments (i.e. WTO accession, etc.); redefines qualifications of notification applicants including restrictions for foreign importers; adds a low-volume exemption for commercial purposes (1 ton per year or less will not need to submit a notification); specifies that notifications for new chemicals will be examined by an expert committee; and states that results of notification should be made available to the public. Korea Mr. Hae Yeop Seo, Deputy Director of the Chemicals Management Division at the Ministry of Environment, discussed Globally Harmonized System of Classification and Labelling of Chemicals (GHS) legislation in Korea. Mr. Seo outlined GHS milestones in Korea, beginning in 2004 to the current implementation status of GHS, which is implemented under the Toxics Chemicals Control Act (Ministry of Environment), Industrial Safety and Health Act (Ministry of Labor) and the Hazardous Materials Act (National Emergency Management Agency). The Ministry of Environment has prepared GHS labeling and classification for more than 1500 toxic chemicals since 2006. GHS implementation under each authority is given a grace period with stepwise enforcement. Each ministry provides a website (see below) with projected goals for classification and labeling specific to its authority. Web http://ghs.nier.go.kr (Aiming C&L for approx 2,500 specified toxic chemicals by Early 2011) http://www.kosha.net/index.jsp (C&L and Safety Data Sheet for approx 6,000 substances (Additional 5,000 substances by the end of 2009)) http://ghs.nema.go.kr/index.jsp (C&L for approx 2,200 substances for physical hazards only) North East Asia-TEMM (Tripartite Environment Ministers Meeting) Mr. Nie Jinglei, Division Director/Associate Professor of the Chemical Registration Center of the Ministry of Environmental Protection (MEP), discussed co-regional initiatives for chemical management among China, Japan and Korea under the auspices of the Tripartite Environment Ministers Meeting (TEMM) and the Policy Dialogue on Chemical Management. The third Tripartite Policy Dialogue on Chemical Management was held September 14-16, 2009 in Beijing, China. Parties continue to include GHS, PRTR, Good Laboratory Practices (GLPs), chemical testing and risk assessment topics and exchange information to promote cooperation and research. The next Dialogue will occur in September 2010 in Japan where all parties will consider cooperation on GLPs, a comparison report on GHS, among other topics. Parties are currently constructing a website to further support the tripartite cooperation and information exchange. The current TEMM site is www.temm.org/. Singapore Mr. Tan Kia Tang, Deputy Director of the Health Risk Control Branch, outlined GHS legislation in Singapore. He presented the organizational structure in Singapore for GHS implementation and coordination, which is maintained by a national GHS taskforce. One important aspect that was stressed and a key starting point for effective chemical safety management is hazard communications. Singapore conducted a five-step strategy for GHS including: 1) promoting GHS, 2) building capacity, 3) engaging stakeholders, 4) regulatory framework, and 5) developing partnerships. Experiences and lessons learned include: close interagency cooperation as a prerequisite; a single body to coordinate/champion the process; engaging stakeholders at all levels (if a 4 supplier understands the process, it will drive the end users); and a national implementation plan to track measurable results and achieve quantifiable objectives. Web Singapore Workplace Safety & Health (WSH) Conference 2010, 15-16 September, 2010: www.singaporewshconference.sg Handouts during workshop, listed on slide ‘Strategy 1-Promoting GHS’: Publications at www.scic.sg/ WSH Bulletin: http://app.wshc.gov.sg/cms/WSHC/Archives/WSHBulletin/tabid/156/Default.aspx Session Discussion The discussion following the first session included: a request for Japan’s new amendment in English and a timeline for updates; availability of Singapore GHS documents, and a request for China’s legislation in English. The China delegate noted that the legislation is not yet available in English, but emphasized that a guidance document will be available before the new legislation comes into force in October 2010. Additionally, China clarified that the new legislation covers new chemicals. China also responded to an additional question stating that its low volume classification was added and is 1 ton/year. Afternoon Session I Chinese Taipei Dr. Jowitt Li, Manager of the National Chemical Substance Register (NCSR) Office, reviewed the development of Chinese Taipei’s national chemical substance inventory and new substances notification scheme. Dr. Li provided a background overview of the multiple authorities and regulations encompassing chemicals management in Chinese Taipei. Chinese Taipei conducted a gap analysis against 36 SAICM possible work areas and determined the need to establish a national chemical substance inventory and develop a new chemical nomination scheme. In addition, the economy developed interagency action plans for GHS implementation and national chemical registry management. The action plans aim to enhance national chemical management in line with international trends, in accordance with SAICM and the WSSD 2020 goal on the sound management of chemicals. National chemical substance nominations commenced November 2, 2009 and will continue until December 31, 2010. Both domestic and foreign entities are eligible to participate in the national chemical substance nomination program. The new substances notification scheme will commence in 2011. Web National Chemical Substance Register (NCSR) Office: http://csnn.cla.gov.tw & ecncla@mail.cla.gov.tw GHS Website: http://ghs.cla.gov.tw Vietnam Dr. Phung Ha, Director General at Vietnam Chemicals Agency (Vinachemia) of the Ministry of Industry and Trade, presented examples of implementation of the chemical management law in Vietnam. Priority sectors in Vietnam include fertilizer, petrochemicals, basic chemicals and pharmaceuticals. Growth of the chemical industry is seen as a key pillar of a long-term economic development vision for the economy. A chemical law was passed on November 21, 2007, which Improved chemical control at the national level. In addition, on January 2, 2009, the Vietnam Chemicals Agency was established under the Ministry of Industry and Trade in order to develop a strategy for chemical management for Vietnam. Since its inception, Vinachemia has become the focal point for SAICM, is developing a chemical database and national chemicals list, establishing REACH/RoHS centers, organizing training courses on chemical safety, participating in international cooperation and promoting GHS implementation, whereby provisions will enter into force by the end of 2010. Malaysia Dr. Ab. Rahman Awang and Ms. Hanili Ghazali of the Hazardous Substances Division at the Department of Environment outlined Malaysia’s Environmentally Hazardous Substances Notification and Registration Scheme. 5 Malaysia recognized its need for a comprehensive chemical system and developed the newly implemented voluntary notification and registration scheme. The scheme aims to collect information from the chemical industry about environmentally hazardous substances in Malaysia and is an initial effort to obtain information and enable prioritization, risk assessment, risk reduction and action, to be taken in the future. The notification and registration is scheduled to take place in phases, with an introductory voluntary phase in 2009 and 2010. The final legislation is expected sometime in 2010 and subsequent implementation will commence in phases based on tonnage and toxicity. An online notification tool is available and in response to confidentiality concerns, the government is implementing a new system whereby industry can notify government directly. The module is already uploaded to the system for this purpose. Web www.doe.gov.my http://www.e-ehs.doe.gov.my/ Indonesia Mr. Rasio Ridho Sani, Assistant Deputy Minister for Hazardous Substances and Wastes Management of the Ministry of Environment, discussed Indonesian challenges on implementing hazardous substance and waste management. Mr. Sani explained that Indonesia is at an early stage of developing a chemical management system and is currently looking at formalizing a longer-term strategic approach given challenges (i.e. illegal importing, lack of international standards, high levels of pollutants). The Environmental Protection and Management Act (2009) is a first step in developing a framework and entails more protection and consistency in policy for companies doing business in Indonesia. Its chemical management plan will deal with waste from households and industry; implement extended producer responsibility; and host a national single window for registration of substances, which is a good prerequisite for the development of a notification scheme. Remaining challenges include governance and institutional arrangements, capacity and public disclosure. Session Discussion Discussion focused on Chinese Taipei’s notification scheme, confidential business information and mercury regulations. The Chinese Taipei delegate confirmed that with the new notification scheme, ingredients in Research and Development (R&D) samples qualify for notification and that companies will still have an opportunity to supplement information at a later date for ingredients that might have been missed at this stage. In addition, next year Chinese Taipei will finalize plans for a proposed inventory for existing chemicals based on health and environmental hazards. With regard to confidential business information, an industry representative thanked Malaysia for allowing companies to submit information directly and through its online notification system. In response to a discussion question on each economy’s experiences regulating mercury, Japan pointed out that their law excludes elemental substances like mercury, and Chinese Taipei noted that mercury is regulated in different ways depending upon whether the concern is the workplace, the environment, etc. The next key step involves improving management in accordance with international control mechanisms. The Malaysia delegate noted that their approach is similar to Chinese Taipei and controls already in place include: provisions under occupational and health law; emissions standards; required licenses to import mercury for pharmaceutical use; and production and import/export flows controlled under a pesticides act. Afternoon Session II Australia Ms. Hana Hamdan of Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and Ms. Dusanka Sabic of the Australian Center for Cooperative Research and Development (ACCORD) Australasia provided a case study example of Australia’s experience with implementation of Low Regulatory Concern Chemicals (LRCC) reforms. The case study highlighted effective stakeholder engagement (2002-2004) of a policy package that aimed to: introduce flexibility for more efficient and effective ways of introducing low 6 risk chemicals (i.e. chemicals of low hazard and low or controlled exposure and has regulatory input from elsewhere) on the Australian market; preserve current human health and environmental standards; provide chemical safety information to the public; and optimize the risk-resource allocation in NICNAS assessment processes. New concepts with the reforms included: audited and modular self assessments, with a focus on non-hazardous substances; exemptions for transshipment and export only; and a multi-pronged approach to engage stakeholders with an LRCC taskforce (industry, government and community). The reform and legislation passed in two years and the process is recommended by industry as a model. Please see the Final Report and Recommendations for NICNAS LRCC Reform Initiative here. New Zealand Ms. Andrea Eng, General Manager Hazardous Substances of Environmental Risk Management Authority (ERMA) New Zealand, provided a case study on the development and implementation of group standard approvals for chemical products. Ms. Eng provided a brief background and introduction of ERMA and the Hazardous Substances and New Organisms (HSNO) Act (1996), which covers the life cycle of hazardous substances from manufacture or import through to disposal. All hazardous substances, under the HSNO Act, require an approval and group standards act as a way to effectively manage products, since substances can be grouped around primary hazards or a combination of primary hazards. The approvals for groups of substances include products similar in nature, type or that have similar circumstances of use. In such a manner the risk of the grouped substances can be effectively managed by one set of conditions. Examples include cleaning products, aerosols, compressed gases, cosmetic products and food additives and fragrances. Over 100,000 hazardous substances are now managed under group standard approvals in New Zealand. Advantages to the program include product development, innovation and cost savings, as companies are not required to seek separate approvals. Please also see an information sheet on the group standards program included in New Zealand’s presentation posted on the APEC website. Web Group Standards web page: http://www.ermanz.govt.nz/hs/groupstandards/index.html List of Group Standards: http://www.ermanz.govt.nz/hs/groupstandards/list.html Labelling – Hazard & Precautionary Information: http://www.ermanz.govt.nz/hs/groupstandards/standards/ss/hplabelling.pdf Assigning a substance to a Group Standard: http://www.ermanz.govt.nz/resources/publications/pdfs/Assigning%20a%2 Canada Mr. Bernard Madé of Environment Canada presented an overview of Canada’s Chemical Management Plan (CMP), which by 2020, establishes that the government of Canada will address the legacy of un-assessed chemical substances in Canada so as to significantly reduce their potential risks to human health and the environment. Government of Canada scientists, in co-operation with industry and health and environmental groups, completed the categorization of 23,000 substances on Canada’s Domestic Substances List (DSL) in September 2006. The criteria for a chemical to be “categorized in” (identified as a priority for further work) are: that it may present the greatest potential for exposure to individuals in Canada; or are persistent (P) and/or bioaccumulative (B); and “inherently toxic” to humans or to non-human organisms. The results of this initiative include the identification of 195 high level substances, with 29 substances identified for risk management. Lessons learned from the CMP include information gathering challenges, monitoring and research opportunities, international collaboration and robust engagement with stakeholders. Workshop participants expressed great interest in Canada’s prioritization process and potential opportunities to build capacity among economies for similar approaches. 7 Web Information on the Chemicals Management Plan: www.chemicalsubstances.gc.ca Information on CEPA 1999 and associated instruments: www.ec.gc.ca/ceparegistry Information on substances managed under CEPA 1999: www.ec.gc.ca/toxics Challenge documentation: http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/indexeng.php Other Environment Canada websites on risk management instruments : o www.ec.gc.ca/epr (extended producer responsibility) o www.ec.gc.ca/cepap2 (pollution prevention planning) o www.ec.gc.ca/ceparegistry/guidelines (codes of practice & guidelines) Risk Management, Policies & Publications: http://www.tbs-sct.gc.ca/pubs_pol/dcgpubs/RiskManagement/siglist-eng.asp Chile Mr. Marcelo Gamboa, Pollution Prevention and Control Department of the Comisión Nacional del Medio Ambiente (CONAMA), presented an overview of Chile’s national policy on chemical safety. Mr. Gamboa outlined the institutional context for chemicals management in Chile, highlighting national policies, international commitments and associated ministries for chemical substances management, which also focuses on Chile’s most dominant sectors -- agriculture, forestry and mining. Current actions in Chile’s chemical management system reform process include strengthening the institutional structure for a more sufficient national and regional system, which includes sixteen (16) regions undergoing decentralization. Other actions included in this reform involve: strengthening regulatory frameworks; control and inspections throughout the chemical lifecycle; promoting risk analysis and the use of existing instruments; the dissemination of information; and a commitment to an international chemicals agenda, among other actions. The Comisión is scheduled to transition to a Ministry of Environment as well. Session Discussion Discussion focused on New Zealand’s group standards, various screening and prioritization methods for chemicals among the economies and Canada’s prioritization scheme and inventory. New Zealand confirmed that certain restrictions apply to carcinogens, mutagens and reproductive toxicants or CMRs in cleaning ingredients with regard to its group standards and inventory. Each economy provided a short description of its screening methods or prioritization for regulation of new chemicals. The Chile delegate noted that it usually prioritizes chemicals related to international obligations. The New Zealand delegate commented that there is an approval process in place, although it deals mostly with pesticides instead of new chemicals. Canada has a series of review processes for new chemicals and certain products. In addition, Canada’s system requires companies to notify the government, which then conducts a health and ecological/environmental assessment. Furthermore, the Canada delegate confirmed that Canada is in the process of updating their inventory. Additional discussion included Canada’s bilateral cooperation with the EU, which aims to facilitate information exchange on chemicals and cooperation on assessments with substances of mutual interest. Summary comments from the moderator of the last session on day one highlighted that all of the programs and schemes covered throughout the day sound different, but basic objectives are similar among all the economies. Jurisdictions are looking for pragmatic solutions, in order to maximize efficiencies and allow regulators and industry alike to focus on what is most important in each economy. Key messages included working with stakeholders, engaging in work that makes the most sense and an ability to focus on what’s most important, as well as mechanisms to also rely on the work of others. 8 Day Two United States (Keynote Address) Mr. Greg Schweer, New Chemicals Management Branch Chief, Chemical Control Division, Office of Pollution, Prevention and Toxics of the United States Environmental Protection Agency (EPA) provided a summary of recent chemical priority actions and outlined possible next steps in the United State’s revision of the Toxic Substances Control Act (TSCA). Administrator Jackson advanced six principles for reform of chemicals management legislation in order to increase confidence that chemicals used in commerce are safe and do not endanger public health and welfare of consumers, workers or sub-populations such as children, or the environment. EPA is also undertaking a comprehensive effort to enhance its chemical management program by taking specific risk management actions; developing action plans that outline risk management efforts on chemicals of concern; requiring information to better understand chemical risks; and increasing public access to information about chemicals. A first set of action plans, released Dec. 30, 2009 included phthalates, polybrominated diphenyl ethers (PBDEs), long-chain perfluorinated chemicals (PFCs) and short-chain chlorinated paraffins. Additional initiatives include a regulatory review of nanoscale materials (NMs), updates to TSCA Inventory Update Reporting (IUR) and the endocrine disruptor screening program. Please see an information package accompanying this presentation located here3. Web Essential Principles for Reform of Chemicals Management Legislation: http://www.epa.gov/oppt/existingchemicals/pubs/principles.html Enhanced Chemical Management Program: http://www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html Control of Nanoscale Materials under TSCA: http://www.epa.gov/oppt/nano Inventory Update Rule (IUR) Reporting: www.epa.gov/iur EDSP Program: http://www.epa.gov/endo/ Chemicals Management / Risk Management & Best Practices While economies develop chemical and risk management processes specific to their needs and priorities, this session offered an opportunity for economies to present and discuss their approaches and share information on best practices, e.g., specific programs, systems and considerations economies and industry utilize in industrial chemical management. Global Harmonized System for Labeling & Classification (GHS) Ms. Catherine Oh, Australian Center for Cooperative Research and Development (ACCORD) Australasia, presented an Australian case study on industry and government collaboration in GHS implementation for consumer products. Ms. Oh outlined existing regulatory frameworks for consumer products and the differences between them and GHS. Considerations in Australia for a path forward included four options for GHS adoption, which underwent an extensive public consultation, and was guided from the perspective of public health as a priority. As a result of the process, lessons learned included: the need for a ‘whole of government’ approach, including states and territories; respectful early and continuous engagement with stakeholders; a clear understanding of all stakeholder positions and practices; and a focus on integration with the existing system and outcomes. Web Existing Regulations National Coordinating Committee on Therapeutic Goods (NCCTG): http://www.tga.gov.au/docs/html/ncctg.htm 3 http://aimp.apec.org/Documents/2010/CDSG/WKSP1/10_cd_wksp1_017b.pdf 9 Risk-based decision making-- National Drugs and Poisons Schedule Committee (NDPSC): http://www.tga.gov.au/ndpsc/index.htm Compendium of decisions-- Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP): http://www.tga.gov.au/ndpsc/susdp.htm Public Discussion Paper: http://www.health.gov.au/internet/main/publishing.nsf/Content/7FE108F56018FC1DCA2575910011D11E/$Fil e/GHS%20Discussion%20Paper_Final%20Draft%20for%20Approval_16%20March%202009.pdf Global Harmonized System for Labeling & Classification (GHS) Dr. Shuh Woei Yu, Board Member of the Taiwan Chemical Industry Association (TCIA), and Dr. Jowitt Li, Manager of the National Chemical Substance Register (NCSR) Office, outlined the context and current updates to the GHS Reference Exchange and Tool (G.R.E.A.T) website. The tool acts as a clearinghouse to aid in GHS implementation in the region; reduce burdens for competent authorities and industries while providing access to GHS standardized elements across APEC economies of different local languages; and facilitates international trade by using correct and updated GHS labeling elements in local languages. Currently six (6) member economies have input their data and the tool also provides the latest news on GHS implementation by economy and individual economy web links for GHS information has been requested. Web G.R.E.A.T. website: http://great.cla.gov.tw APEC member economies are encouraged to provide information to the webmaster at apec‐great@mail.cla.gov.tw for updating If you have any inquiry, please feel free to contact Project Manager at CCChen@sahtech.org Update on the OECD Clearinghouse on New Chemicals (CHNC) & The Parallel Process and Mutual Acceptance of Notification (MAN) Dr. Marion Healy, Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and current Chair of the OECD Clearinghouse on New Chemicals (CHNC), provided an overview of the Parallel Process and case study of how it can be used with specific chemicals. Members of the Clearinghouse include governments, stakeholders, experts and observers from other international organizations. The goal of the clearinghouse is to act as a mechanism to promote international harmonization of the principles and procedures for the notification and assessment of new chemicals. The overall vision is that countries can see, understand and accept each others’ decisions aimed at protecting human health and the environment; companies can submit one notification and then market globally; and governments can be more efficient and effective in their activities related to new chemicals. Work areas include mutual acceptance of notifications, exemptions from notification and electronic notification templates. Economies are encouraged to actively participate in the Clearinghouse. Further information on the mandate of the CHNC, a description of its work items and a description of the pilot phase of the OECD Parallel Process for the Notification of New Chemicals is available at the websites below. Web OEC D website: www.oecd.org For more information, please contact: international@health.gov.au Mandate of the Clearing House on New Chemicals: http://aimp.apec.org/Documents/2010/CDSG/WKSP1/10_cd_wksp1_020b.pdf Description of Work Items: http://aimp.apec.org/Documents/2010/CDSG/WKSP1/10_cd_wksp1_020c.pdf Pilot Phase of the OECD Parallel Process for the Notification of New Chemicals: http://aimp.apec.org/Documents/2010/CDSG/WKSP1/10_cd_wksp1_020d.pdf 10 Session Discussion The discussion session focused on the OECD Clearinghouse inclusion of nanomaterials and notification, Australia’s GHS implementation and the U.S.’ list of chemicals of concern, updates on nanomaterials and to its inventory reporting. Dr. Healy, Chair of the OECD Clearinghouse, noted that it is still premature to say if nanomaterials will fall within the its scope which depends largely on whether nanomaterials will be considered new or existing chemicals. This also varies by economy. An example of work done on a relatedarea includes polymers of low concern, where a number of countries have similar definitions and others have been influenced to adjust their regulations. In the longer term, there is a level of alignment that occurs across countries, including notification and assessment, but overall there’s a need to determine how/whether governments can adopt regulatory decisions of other jurisdictions. This will get easier over the long term and that is the vision of the Clearinghouse, but it is an incremental process. Queried about the costs and benefits of Australia’s recent GHS implementation and potential effects on trade, Ms. Oh responded that an independent organization determined that the GHS implementation in Australia is efficient and works. The key is alignment of classifications, while supporting risk assessment, protecting human health and the environment, and promoting trade and harmonization through a gradual process. With regard to precautionary statements, Ms. Oh noted that the risk assessment will deem if the statement is necessary, otherwise it will be taken off and the option is for the regulator. She also noted that the language is not definitive per the GHS guidelines and the regulation in Australia will be flexible in terms of verbiage. Regarding the chemicals of concern list, U.S. EPA has established a first list of action plans on chemicals of concern, with plans for future action plans. On the endocrine program, the Office is collaborating its work with the pesticides program and drinking water. An Australia delegate noted its recent public consult on nanomaterials and queried the U.S. about its own experience. The U.S. delegate noted that its pre-manufacture notice (PMN) process has provided additional information on nanomaterials. With regard to U.S. EPA’s chemical inventory update, the U.S. delegate noted that EPA considered a re-set of the inventory as a mechanism to take out chemicals no longer in commerce from the inventory, but that idea is currently on hold due to other priorities. However, a non-CBI form of the inventory is now available on the following website and will be updated twice a year: http://www.epa.gov/opptintr/newchems/pubs/invntory.htm Responsible Care / Product Stewardship Dr. Fumiaki Shono of the Japan Chemical Industry Association (JCIA) outlined the implementation of the Global Product Strategy (GPS)/Industry Product Stewardship and the framework for gathering and sharing a base set of information and risk characterization on chemicals. The GPS, launched in 2006, is an International Council of Chemical Associations (ICCA) initiative aimed to improve government and public confidence in the industry’s management of chemicals and serve as a foundation for industry participation and advocacy. Activities are focused on chemicals in commerce that exceed a production threshold of one ton per year per company or have high toxic/eco-toxic profiles. The initiative establishes a base-set of hazard and exposure information to conduct and share safety assessments for chemicals in commerce. The program is unique in its ability to work with industry in the exchange of information, while maintaining confidentiality. An IT portal with a central global source of information will be completed by May 2010. The benefits of the program include an opportunity for international conformity with OECD assessment tools, an enhanced confidence in the management and use of chemicals, as well as a contribution to SAICM’s goals. Web GPS IT-portal: http://www.icca-chem.org GPS information: http://www.icca-chem.org/en/Home/ICCA-initiatives/Global-product-strategy/ 11 Informed Substitution, Pollution Prevention, e.g., Design for Environment (DfE) Dr. Scott Mobley, Ph.D., Research Fellow, Research and Development of the Clorox Services Company, offered a case study of its Greenworks product line in collaboration with U.S. EPA’s Design for the Environment (DfE) program highlighting an example of chemical management implementation and business best practices in the chemicals sector. Since 2005-2006, Clorox witnessed a growing consumer base, the “chemical avoiding naturalist” and decided to develop a new line of green cleaning products. The line benefits from informed substitution whereby its products: minimize the likelihood of unintended consequences; use alternatives that are technologically feasible; deliver the same or better value in cost and performance; provide an improved profile for health and environmental issues; account for economic and social considerations; and have potential to result in lasting change. The DfE process involves third party screening and additional testing by the DfE program in partnership with the company. The DfE criteria are based on internationally agreed toxicological endpoints and thresholds. The Greenworks brand has been so successful, capturing the largest share of natural home care cleaners in its market, that the line has been expanded to ten products. In addition, through the DfE program, industry partners reduced more than 500 million pounds of chemicals of concern in 2009. Web www.TheCloroxCompany.com http://www.epa.gov/dfe Supply Chains – Downstream Users Dr. Noriaki Santo, Deputy Director, Chemical Management and Information Office Center of the Japan Environmental Management Association for Industry (JEMAI), presented on the Joint Article Management Promotion-consortium (JAMP) programs. Mr. Santo provided background on JEMAI, which includes 900 companies as members. The JAMP program, established in 2006, aims to promote international competitiveness for industry through the appropriate management and information communication on chemicals contained in products within the supply chain. The program offers guidance for chemicals management in products, minimum data set and database design, a declarable substances list and an information infrastructure with confidential business information (CBI) protection. Mr. Santo outlined workshops and demonstration programs held throughout 2008, 2009 and future opportunities. Activities for the program are global in scope and tools located on its website are free of charge. Included in Dr. Santo’s presentation posted on the APEC website, please also see additional information listed in the latter half of the presentation. https://www.japm-info.com & santo@jemai.or.jp Session Discussion The session discussion focused on the Clorox Greenworks products, Design for the Environment (DfE) program and the JAMP program. Dr. Mobley confirmed that Clorox is a member of ICCA and Responsible Care and through this program demonstrates a commitment to safe chemistry, addresses concerns on the environment and benefits from a good framework for business growth and development. Queried if Greenworks products are superior to its standard line, Dr. Mobley clarified that all Clorox products are safe for the consumer and the environment and the products address broader concerns of the consumer naturalist that also include the environment. In addition, Greenworks is a hazard based program, so its intention is to protect both upstream and downstream. Responding to procedural questions about the DfE program, a third party review is conducted by NSF International and a second company for a few thousand dollars. There are additional product lines certified through DfE and information is available on the website: http://www.epa.gov/dfe. With regard to the JAMP program, Dr. Santo noted that REACH is driving more information needs and demands across the supply chain. 12 Tools & Information sources in the review of chemicals Ensuring consistent approaches and access to tools and information relevant and useful in the review of chemicals remains a challenge among the APEC economies. This session highlighted economy and industry case studies and perspectives in the use of OECD and other similar organizations’ tools and information sources for the review of chemicals. OECD Tools Mr. Bob Diderich, Principal Administrator, ENV/EHS OECD provided an overview of the OECD tool suite for chemicals management, including High Production Volume (HPV) programs, (Quantitative) Structure Activity Relationships (QSAR) Toolbox, eChemPortal, Hazard Assessment Task Force, and the Exposure Assessment Task Force. Mr. Diderich outlined hazard assessment tools, including the high production volume chemicals program (produced at more than 100 tons/year), QSAR application toolbox, eChemPortal, exposure assessment with emission scenario documents and OECD overall persistence (Pov) and long-range transport potential (LRTP) screening toolkit. The HPV program aims to elaborate initial hazard assessments for OECD HPV chemicals with an initial focus on the 4638 substances listed as a priority on the list. Currently, 1000 substances have been reviewed, in large part due to an ICCA-HPV initiative. Revisions to the program include developing integrated approaches to testing and assessment, avoiding duplication of work and continuing with full initial hazard assessments, among others. In addition, Mr. Diderich detailed the QSAR toolbox and noted a second version of the QSAR toolbox is scheduled for the end of 2010. An additional hazard assessment tool outlined in the presentation included the eChemPortal, an internet portal that provides public access to information on properties of chemicals. Additionally, the presentation included exposure assessment tools and Emission Scenario Documents (ESD), which describe the sources, production, processes, pathways and use patterns to quantify emissions of a chemical in water, air, soil and/or solid waste. It is particularly useful for new chemicals, persistent organic pollutants (POPs), persistent, bioaccumulative and toxic chemicals (PBTs) and has been used in the Stockholm Convention and to help estimate long-range transport. Web http://www.oecd.org/env/existingchemicals OECD Guidance on Grouping of Substances: http://www.oecd.org/dataoecd/53/62/39850072.pdf QSAR: www.oecd.org/env/existingchemicals/qsar eChemPortal: http://www.oecd.org/ehs/eChemPortal http://www.oecd.org/env/riskassessment Guidance Document on Reporting Summary Information on Environmental & Occupational Exposure: http://www.olis.oecd.org/olis/2003doc.nsf/LinkTo/env-jm-mono(2003)16 OECD Good Laboratory Practice Labs & Test Guidelines in APEC regions Ms. Kwei Fern CHANG, Director of Accreditation at SPRING Singapore, provided an update of Singapore’s progress on Good Laboratory Practices (GLP) and the Mutual Acceptance of Data (MAD) Agreement. During the early 1990’s Singapore determined that a GLP program was a key infrastructure support for the growing biomedical sciences and chemicals sectors. High value-added products in these sectors required that overseas recognition of Singapore’s data was paramount. In addition, the benefits for a GLP program included elimination of non-tariff trade barriers; increases in international market access; regulatory confidence in data; avoidance of duplication; reduction in time to market for products; and saved resources. Singapore developed a ‘whole of government’ approach to identify its regulatory framework, engage stakeholders, and establish an advisory committee along with participating in an OECD working group. The GLP program was established in 2006 and Singapore has been a full member of the OECD’s MAD Agreement for GLP since January 2010. In conclusion, Ms. Fern outlined its GLP journey and roadmap to MAD, along with capacity building activities and the countries with which it will now share mutual acceptance of data. 13 OECD Good Laboratory Practice Labs & Test Guidelines in APEC regions Mr. Bob Diderich, Principal Administrator, ENV/EHS OECD discussed Mutual Acceptance of Data (MAD), Good Laboratory Practices (GLP) and Compliance Monitoring, as well as possibilities for APEC economies. A 1981 MAD decision stated that data generated in the testing of chemicals in an OECD member country in accordance with OECD test guidelines and principles of good laboratory practice will be accepted in other member countries for purposes of assessment and other uses. The purpose has been to ensure that every test only needs to be done once, to minimize costs and contribute to the reduction of non-tariff barriers. Mr. Diderich outlined the flow of data and acceptance between countries and a pilot project which aimed to strengthen the system of compliance. The project, Mutual Joint Visit (MJV), examined the extent of implementation of national GLP compliance monitoring authorities, which has been integrated into the GRP program since 2006. Mr. Diderich underscored the technical support available from the OECD Secretariat for countries that are interested in the programs. Web http://www.oecd.org/env/glp MAD: http://www.oecd.org/document/41/0,3343,en_2649_34365_1890473_1_1_1_1,00.html World Health Organization (WHO) Risk Assessment Toolkit Ms. Carolyn Vickers, Team Leader, Chemical Safety of the World Health Organization (WHO), outlined the World Health Organization (WHO) Risk Assessment Toolkit. The purpose of the toolkit is to help people make decisions about chemicals by assessing the magnitude of potential risks to human health. It helps users identify and acquire international information (i.e. OECD, WHO) to assess chemical hazards and use the information to estimate potential chemical exposure and the corresponding health risks. The toolkit provides road maps and lists, identifies information necessary for an assessment, describes and provides URLs for international resources and provides case studies to illustrate how the toolkit can be used to address a health risk assessment question. The target audience for the document includes scientific and lay professionals. The toolkit will be available during the first quarter of 2010 and a web-based toolkit available later in 2010. A companion toolkit, Environmental Risk Assessment Toolkit, is being developed by the OECD, but a projected completion date is not yet available. http://www.who.int/ipcs/en/ & contact ipcsmail@who.int Session Discussion The session discussion focused on OECD tool accessibility, data quality and information sharing, along with details of the WHO risk assessment toolkit and Singapore’s accreditation program. Mr. Diderich confirmed that all OECD tools are publicly available from the OECD website and free of charge. The potential for data quality problems (e.g. different samples not controlled, etc.) was discussed and Mr. Diderich noted that the OECD addresses this issue in a manual with a section on data quality and national assessments are asked to take this into account. While this does not always guard against occasional issues, the OECD requires information provided on what was tested. In response to the timeline for sharing information on assessments, Mr. Diderich noted that a specific timeline is not yet available, although the OECD has sent a questionnaire to member countries to gather information on how they document and share information. Once that information is received, the OECD can begin to develop a plan for giving access to other countries in a condensed form, with results hopefully by the end of the year. In addition, the Mutual Acceptance of Data (MAD) system is open to any country, the OECD is encouraging countries to adhere to the MAD system and the OECD is actively engaged in outreach programs to countries that could benefit. In response to queries about the WHO risk assessment toolkit, Ms. Vickers noted it has been presented to participants at a SAICM regional meeting in Africa and plans underway include a meeting in Latin America and Asia as well as feedback opportunities for further development of the toolkit with case studies. In addition, the toolkit will be web-based, but since the web is not always the most practical means for an economy, hard copies will also be available. The benefit of 14 the web-based version is that links are accessible immediately, e.g. WHO INCHEM, OECD eChemPortal. With regard to the methodology for the toolkit, it draws on international and nationally-accepted methods of assessment. It is not a system for assessment, but a toolkit to help competent authorities conduct their own assessments. In tandem, the environmental risk assessment toolkit, being developed by the OECD, is in initial stages of development with the hope of being completed within the next two years. During a last query to Singapore regarding its accreditation programs and GLP, Ms. Chang noted that SPRING, as a national accreditation body, is based on ISO standards, which is different from the GLP program. The GLP program is linked to safety test studies and pre-clinical analysis, which has a different focus and therefore different criteria and purposes. Capacity Building- IOMC Session & Next Steps Capacity building opportunities are available to economies through the inter-organization programme for the sound management of chemicals (IOMC), chemical-related Convention Secretariats and other organizations and programs. This session focused on different capacity building opportunities for APEC economies and encouraged dialogue for more developed-developing economy trainings. This session also outlined next steps and topics for future Train-the-Trainer sessions and Regulator Forum meetings that focus on identified challenges and priorities for APEC economies in the sound management of chemicals. Capacity Building Opportunities Ms. Catalina Marulanda, Ph.D., Senior Environmental Specialist of the World Bank’s Montreal Protocol / POPs Unit outlined potential capacity building opportunities and collaboration efforts available between the World Bank and APEC. Ms. Marulanda outlined the cross-cutting nature of chemical management and highlighted the importance of chemical management to sector and national development. With competing country priorities and limited resources, countries need to build capacity and integrate chemicals management at all levels of government. The World Bank’s approach to mainstreaming chemicals management includes knowledge development and capacity building through analytic data and demonstrating the value and cost savings of integrating chemicals management in development planning, along with consultation, stakeholder involvement and capacity building. In addition, mainstreaming chemicals management requires strategic planning, priority setting and investment options, such as blending funds or leveraging other resources. Ms. Marulanda cited numerous case study examples to illustrate these approaches, including a Canada POPs Trust fund, an Africa Stockpiles Programme, South Asia ship recycling, Chile Pollutant Release and Transfer Register (PRTR), among others. Suggested ways forward include sharing information, handling chemicals management within a hazardous waste management framework, mainstreaming and a focus on a risk-based approach. www.worldbank.org/pops Capacity Building Opportunities Mr. Craig Boljkovac, Inter-organization Programme for the Sound Management of Chemicals (IOMC) Chair and Manager, Chemicals and Waste Management Programme of United Nations Institute for Training and Research (UNITAR) presented an overview of the structure and function of the IOMC and provided examples of its collaborative work in the past with economies. Mr. Boljkovac also discussed possibilities for the Chemical Dialogue and APEC to work together for the sound management of chemicals in the coming years. The IOMC is comprised of nine (9) inter-governmental Organizations (IGOs) working together to achieve the sound management of chemicals in relation to human health and the environment. Each IGO is active on chemical safety issues and the IOMC provides a mechanism for each organization to cooperate more effectively, avoid duplication in countries, and share information. An IOMC Strategy for Strengthening National Chemicals Management capacities assists countries to effectively implement SAICM and achieve the 2020 goal for the sound management of chemicals. Priority areas include effective national level coordination, mainstreaming of chemicals management into national priorities and the integration of chemicals with other issues (e.g. climate change, biodiversity), among others. 15 Web IOMC Strategy for Strengthening National Chemicals Management Capacities (in six different languages): www.iomc.info/publications/publications/en/index.html IOMC Brochure, Public reports of meetings, IOMC Publications: www.iomc.info IOMC Brochure: http://aimp.apec.org/Documents/2010/CDSG/WKSP1/10_cd_wksp1_029b.pdf For further information: infoIOMC@who.int Session Discussion The session discussion focused on current work or requests from economies for POPs reductions or alternatives, IOMC activities on SAICM and emerging policy issues. A workshop participant noted that coordination enhances efficiencies; an idea that resonated throughout the workshop, and questioned the prevalence of requests for newly listed POPs and how that work might relate to existing work of the World Bank and IOMC, especially in regard to finding alternatives. In response, Ms. Marulanda noted increased interest in the new POPs and concerns on how the listing will affect industry. Currently, the Stockholm Convention is organizing workshops and attempting to build capacity to include these chemicals in national implementation plans, but limited Global Environment Fund (GEF) funding makes it difficult. Mr. Boljkovac noted that the Stockholm Convention Secretariat is taking steps to draft guidance on POPs and UNITAR is developing decision trees on how to work through these new chemicals. Overall, engagement on the issue is being strengthened. In regard to specific IOMC activities related to SAICM emerging policy issues, Mr. Boljkovac confirmed the IOMC website has a section on SAICM and emerging policy issues, and at least one IOMC organization has taken a lead or co-lead role for each of them. For example, e-waste is led by UNIDO and the Basel Secretariat and nanomaterials is led by OECD with UNITAR helping to raise awareness with developing economies. Along these lines it should be noted that the OECD work is also open to non-Member countries. . In general, demand for capacity building outmatches resources for the IOMC, but efficiencies can be made in delivering in the gaps that remain. Next Steps / Wrap-Up Overview of Best Chemicals Practice Economy Assessment Questionnaire: Status, Common Challenges & Priorities in the APEC Region Ms. Heather Page, Workshop Project Overseer, International Team, Office of Pollution, Prevention and Toxics, of the U.S. Environmental Protection Agency (EPA), provided an overview of regional priorities & topics for potential future technical and information exchange seminars based on a questionnaire distributed to economies prior to the workshop. The questionnaire aimed to identify the overall status of chemicals management among the APEC economies, while also pinpointing specific themes and topics for future collaboration. Topic areas included regulatory development and transparency procedures; science-based risk assessment in support of regulation; risk management; information and risk communication; and enforcement and monitoring. Answers for the questionnaire were based on a SAICM reporting format. Thirteen (13) economies completed the questionnaire prior to the workshop. Included in the presentation were highlighted summaries from each topic area, along with possible next steps and collaboration areas based on the results. Common areas of collaboration pinpointed by responses include: possible resources for training on new approaches for risk management and sustainable management of chemicals; the development of mechanisms to prioritize and take action on chemical risks; and information shareing on assessment activities. In general, the questionnaire demonstrated that there continues to be widespread support to share information and build capacity on chemicals management across APEC economies. Good Regulatory Practices Workshop: Best Chemicals Practice Economy Assessment Questionnaire: web address off APEC site: doc 30b [to add] 16 Panel Discussion on Challenges, Priorities & Future Work in the Sound Management of Chemicals in the APEC region: Economies, Industry & IGO Perspectives Moderator: Lee Eeles, Department of the Environment, Australia Panelists: Mr. Bernard Made, Environment Canada Mr. Rasio Ridho Sani, Ministry of Environment, Indonesia Ms. Teresita Torres, Secretaría de Medio Ambiente y Recursos Naturales (SEMARNAT), Mexico Mr. Mike Walls, American Chemistry Council (ACC) Dr. Fumiaki Shono, Japan Chemical Industry Association (JCIA) Mr. Craig Boljkovac, IOMC Chair The moderator and panel participants, along with workshop participants, discussed their economy, industry and IGO perspectives in relation to the challenges, priorities and future work opportunities in the sound management of chemicals in the APEC region. The panel discussion reviewed cross-cutting themes for chemicals management, coordination with industry and stakeholders, SAICM and the integration of chemicals management work with an international chemicals agenda as well as strategic challenges and potential solutions. Cross-Cutting Themes Panelists noted the importance of recognizing key cross-cutting issues; since it is evident economies and industry are pursuing the same objectives which require pragmatic solutions, with stakeholder engagement, and prioritization of work, information and data sharing. In addition, panelists were encouraged to see APEC best practice principles fully embedded (or actively being pursued) in APEC member economies, even if members are at different stages of development. One panelist cautioned discussion on data gaps, concerned that it may foster duplication, and suggested thinking more about data needs and how to identify those needs, particularly those driven by exposure and use issues. All agreed that APEC can play a role in determining the use of data needs and how to leverage industry and government to achieve this. However, one panelist noted that when an economy is asking for data, it needs to have some mechanism or tool to utilize and store the data effectively and have an established system framework. Another panelist noted that from a government perspective, important issues included policy formulation and global cooperation, along with implementation methods, which key stakeholder engagement can help achieve. In addition, like data, putting into place compliance methods helps ensure an economy’s policy and regulations are compiled in a supportive system. A panelist noted a list of common themes, emanating from discussions and presentations from the workshop, for future information exchange: GHS implementation; chemical registration/notification programs; prioritization of chemicals for risk assessment; best practices in terms of risk management; and noted challenges in governance and coordination at the country level to achieve results. As the next year includes a very active chemicals agenda (e.g. OECD, Commission on Sustainable Development (CSD) and the International Year of Chemistry (2011)), it also presents an important opportunity for APEC. One way of prioritizing themes for action includes a strategic framework for the CD (under discussion following the workshop) and possible contributions to international deliberations, with a focus on achievable objectives and reasonable outcomes. A panelist also noted that the UN system can coordinate more with APEC and was pleased to hear the focus on GHS implementation. One suggested task for the CD included compiling a paper on what IGOs are doing to help economies in the APEC region with chemicals management. In turn, this could help identify and develop coordinated efforts between the economies and the IGOs. 17 Coordination with Industry A panelist noted that industry-government relationships must have effective information exchange across all stages of the supply chain, while also acknowledging challenges due to the complexity of the chemical industry supply chain. While this may be needed for chemical suppliers and in order to help conduct risk assessments, another focus in the chemical management system should be a drive for efficiency and effectiveness. Overall, industry continues to have a significant role, with a lot of data and information development and is at the beginning stages of better outreach and communication across the supply chain. One panelist noted a fundamental best practice to take back to their economy is to involve the full spectrum of actors in the process of developing the chemical management system. SAICM Panelists discussed the perception of SAICM as a “basket full of everything” and how it suffers from trying to be as comprehensive as possible. A panelist noted that international organizations respond to mandates and have little flexibility when mandates are not given, emphasizing that a more strategic approach is needed. The focus needs to be on activities that result in real risk reduction, e.g. Canada as an example of how to focus SAICM. In addition, others noted that SAICM needs to provide more details on guidelines for 2020 implementation targets, since there are so many action plans to work with. However, it was noted to keep in mind that SAICM is still a workable framework and has continued to be a key reference, which evidently has some utility. There is a need to incorporate concepts from SAICM into APEC and that some economies take that ‘basket’ as the ultimate goal. Ideas emanating from the discussion included APEC serving as a clearinghouse for SAICM information; serving as a forum to promote voluntary approaches like DfE, JAMP, etc., and to make use of these mechanisms to support progress at the national level. Strategic Challenges One participant noted that economies have systems in place to manage chemicals, but need to recognize that developing the framework is only the first step in setting the boundaries. The underlying issue is how to make all that work in practice, deal with existing chemicals and manage new chemicals. In addition, another panelist noted the importance of economies’ strengthening their legal framework, as evidenced in the presentations on the first day, but the opportunity to identify or group substances for risk assessment and then share information, since assessments chemical-by-chemical is an extremely slow and laborious process. Another participant noted the stark divide between programs – those that have identified problem areas and are conducting work to fix those problem areas and those that are looking for problems. The participant emphasized Canada as an example for economies, since it conducted an assessment of its inventory, developed it further and focused resources on potential problem substances. It was noted that this example is useful for developing economies, to implement screening processes amidst limited resources and deal comprehensively with big risks. Since the workshop covered the full range of chemical issues, it is important for key priorities, e.g. work over the next 3-5-10 years, to be established. In general, APEC is an opportunity to share information and transfer knowledge, but the key is to find the most effective niche for economies, to not overlap with other initiatives, and to expand on the opportunities of APEC since all share a common market. The key is to find the niche and how to exchange information. Conclusion/Wrap-Up Mr. John Shoaff, APEC CD Regulators’ Forum Chair and International Team Leader, Office of Pollution, Prevention and Toxics at the U.S. Environmental Protection Agency (EPA), provided summary remarks and thanked Japan for their leadership and assistance as the host economy and also as a co-sponsor of the 18 workshop, along with Indonesia and Australia. In addition to also thanking presenters, panelists and participants, Mr. Shoaff noted the wealth of information exchanged during the workshop, hope that this provided an impetus for continued cooperation in the region and briefly outlined plans for future engagement in APEC through the Chemical Dialogue and its Regulators’ Forum. Appendix I. Agenda Appendix II. Speaker Biographies 19 Appendix I APEC Good Regulatory Practice, "Case Study Workshop on the Chemicals Sector- From Principles to Practice" (CTI 10/2009A) March 1 – 2, 2010; Hiroshima, Japan Grand Prince Hotel Hiroshima AGENDA APEC SOM I Meeting Schedule March 1-2: Good Regulatory Practices Workshop March 3 PM: Regulators Forum Mtng (1/2 day) March 3 AM: Industry Pre-Mtng (1/2 day) March 4: Chemical Dialogue Steering Group Mtng Workshop OBJECTIVE To provide a forum that encourages exchange with a range of stakeholders, especially regulators, on approaches for the sound management of industrial chemicals across the APEC economies. The workshop is intended to demonstrate good regulatory practices in the sound management of chemicals, as demonstrated by APEC economy and industry case studies, tools and approaches. The workshop will include a broad overview of current and upcoming approaches to chemical management among the APEC economies, including new legislation and regulatory actions and current available tools and best practices in the sound management of chemicals. It will also identify and offer an opportunity to discuss chemical management priorities in the region, capacity building needs and potential opportunities to facilitate collaborative approaches. Possible next steps emanating from the workshop include future project proposals for more focused Train-the-Trainer seminars that: address specific challenges and priorities for APEC economies in the sound management of chemicals; identify topics for more detailed information exchange, consultations and cooperation in future Regulators’ Forum meetings; and coordinate potential further APEC contributions to the objectives of SAICM. DAY ONE 9:00 - 10:00 Welcome & Introductory AM Session Moderator: Mr. Shuji Tamura, METI, Japan WELCOME & SCENE SETTER Speaker: Ms. Barbara Norton, Chemical Dialogue Co-Chair, Deputy Assistant, U.S. Trade Representative, Office of the U.S. Trade Representative (USTR) KEYNOTE ADDRESS Speaker: Mr. Hiroshi Fukushima, Director, Chemical Management Policy Division, Japan Ministry of Economy, Trade and Industry (METI) INTRODUCTORY OVERVIEW Overview of Approaches and Lessons from Japanese-hosted International Workshop on Chemicals Management Speaker: Mr. Taka Hiraishi, Member of Board of Directors, Senior Consultant, 20 Institute for Global Environmental Strategies (IGES) INDUSTRY CHALLENGES Topic: Chemical Industry’s upcoming approaches to chemical management Speaker: Mr. Tetsuo Nishide, Director General, Japanese Chemical Industry Association (JCIA) 10:00 – 10:15 Tea Break 10:15 – 12:15 Mid-Morning Session Moderator: Mr. Marcelo Gamboa, CONAMA, Chile RECENTLY ENACTED OR PENDING CHEMICAL LEGISLATION & UPDATES ON REGULATORY ACTIONS Q & A / Discussion DESCRIPTION: Chemicals management regimes among the APEC economies are at various levels of development, with multiple economies recently enacting chemical legislation, regulatory actions and efforts to align with international commitments. The following sessions will focus on updates to chemical legislation, either recently enacted or pending, along with updates from economies about their chemical management processes and regional collaboration and efforts. Topic: Chemical Substances Control Law Speaker: Mr. Shuji Tamura, Deputy Director, Chemical Management Policy Division, Japan Ministry of Economy, Trade and Industry (METI) Topic: New Chemical & New Regulation, “Provisions on the Environmental Administration of New Chemical Substances” (MEP Order No. 7) Speaker: Mr. Nie Jinglei, Division Director/Associate Professor, Chemical Registration Center of the Ministry of Environmental Protection (MEP) Topic: GHS legislation Speaker: Mr. Hae Yeop Seo, Deputy Director, Chemicals Management Division, Ministry of Environment Topic: Co-regional Initiatives for Chemical Management among CJK (TEMM) Speaker: Mr. Nie Jinglei, Division Director/Associate Professor, Chemical Registration Center of the Ministry of Environmental Protection (MEP) Topic: Implementation of GHS in Singapore Speaker: Mr. Tan Kia Tang , Deputy Director, Health Risk Control Branch 20 min. Discussion 12:15 – 14:00 Lunch 14:00 – 15:40 Afternoon Session I Japan China Korea North East Asia-TEMM (Tripartite Environment Ministers Meeting) Singapore Chinese Taipei Vietnam Malaysia Moderator: Mr. Terence Koh, SCIC, Singapore Topic: Development of National Chemical Substance Inventory & Notification Scheme Speaker: Dr. Jowitt Li, Manager, National Chemical Substance Register (NCSR) Office Topic: Implementation of Chemical Law in Vietnam Speaker: Dr. Phung Ha, General Director, Vietnam Chemicals Agency (Vinachemia), Ministry of Industry and Trade Topic: Environmentally Hazardous Substances Notification and Registration Scheme Speakers: Dr. Ab. Rahman Awang & Ms. Hanili Ghazali, Hazardous Substances Division, Department of Environment 21 Indonesia Q & A / Discussion Topic: Indonesian Challenges on Implementing Hazardous Substance and Waste Management Speaker: Mr. Rasio Ridho Sani, Assistant Deputy Minister for Hazardous Substances and Wastes Management, Ministry of Environment 20 min. Discussion 15:40 – 15:55 15:55 – 17:40 Tea Break Afternoon Session II Moderator: Ms. Marianne Heinrich, BP, U.S. industry Topic: Case study on Low Regulatory Concern Chemicals (LRCC) reforms Speaker: Ms. Hana Hamdan, Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS) & Ms. Dusanka Sabic, ACCORD Australasia Topic: Case Study on the Development and Implementation of Group Standard Approvals for Chemical Products Speaker: Ms. Andrea Eng, General Manager Hazardous Substances, ERMA New Zealand Topic: Canada’s Chemical Management Plan (CMP) – An Overview Speaker: Mr. Bernard Made, Environment Canada Topic: Chile National Policy on Chemical Safety Speaker: Mr. Marcelo Gamboa, Pollution Prevention and Control Department, CONAMA 20 min. Discussion Australia New Zealand Canada Chile Q & A / Discussion 18:30 Cocktail Reception for all Workshop Participants Venue: Top of Hiroshima Lounge, 23rd floor of Grand Prince Hotel Hiroshima DAY TWO Welcome & Introductory AM Session 9:00 – 9:10 9:10 – 9:30 WELCOME & SUMMARY OF DAY ONE Speaker: Mr. John Shoaff, Regulators’ Forum Chair, International Team Leader, Office of Pollution, Prevention and Toxics, U.S. Environmental Protection Agency KEYNOTE ADDRESS Speaker: Mr. Greg Schweer, New Chemicals Management Branch Chief, Chemical Control Division, Office of Pollution, Prevention and Toxics, U.S. Environmental Protection Agency 9:30 – 10:45 Introductory AM Session Moderator: Ms. Andrea Eng, ERMA, New Zealand CHEMICALS MANAGEMENT/RISK MANAGEMENT & BEST PRACTICES Global Harmonized System for Labeling & Classification (GHS) DESCRIPTION: While economies develop chemical and risk management processes specific to their needs and priorities, this session offers an opportunity for economies to present and discuss their approaches and share information in best practices. The session is envisaged to share information regarding specific programs, systems and considerations economies and industry utilize in industrial chemical management. (1) Topic: Australian Case study presentation on its review of GHS implementation on consumer products Speaker: Ms. Catherine Oh, ACCORD Australasia 22 (2) Topic: G.R.E.A.T GHS tool update Speakers: Dr. Shuh Woei Yu, Board Member, Taiwan Chemical Industry Association (TCIA) & Dr. Jowitt Li, Manager, National Chemical Substance Register (NCSR) Office Update on the OECD Topic: Overview of the Parallel Process & Case Study of how used, e.g. specific Clearinghouse on New chemicals Chemicals (CHNC) & The Parallel Speaker: Dr. Marion Healy, Australia National Industrial Chemicals Notification and Process and Mutual Acceptance Assessment Scheme (NICNAS) of Notification (MAN) Q & A / Discussion 15 min. Discussion 10:45 – 11:00 Tea Break 11:00 – 12:15 Mid-Morning Session Responsible Care/ Product Stewardship Informed Substitution, Pollution Prevention, e.g., Design for Environment (DfE) Supply Chains – Downstream Users Moderator: Mr. John Shoaff, EPA, United States Topic: Implementation of GPS/Industry Product Stewardship; The framework of information gathering and sharing, base set of information & risk characterization Speaker: Dr. Fumiaki Shono, Japan Chemical Industry Association Topic: Informed Substitution, e.g. Design for Environment (DfE) program Speaker: Mr. Scott Mobley, Ph.D., Research Fellow, R&D, Clorox Services Company Q & A / Discussion Topic: The Joint Article Management Promotion-consortium (JAMP) programs Speaker: Dr. Noriaki Santo, Deputy Director, Chemical Management and Information Office Center, Japan Environmental Management Association for Industry 15 min. Discussion 12:15 – 14:00 Lunch 14:00 – 15:35 Afternoon Session I Moderator: Dr. Marion Healy, NICNAS, Australia TOOLS & INFORMATION SOURCES OECD Tools OECD Good Laboratory Practice Labs & Test Guidelines in APEC regions IN THE REVIEW OF CHEMICALS DESCRIPTION: Ensuring consistent approaches and access to tools and information relevant and useful in the review of chemicals remains a challenge among the APEC economies. This session will highlight economy and industry case studies and perspectives in the use of OECD, other programs, tools and information sources for the review of chemicals. Overview of Tool Suite: (1) Topic: High Production Volume (HPV) programs (2) Topic: (Quantitative) Structure Activity Relationships (QSAR) Toolbox (3) Topic: eChemPortal (OECD) (4) Topic: Hazard Assessment Task Force (OECD) (5) Topic: Exposure Assessment Task Force (OECD) Speaker: Mr. Bob Diderich, Principal Administrator, ENV/EHS OECD (1) Topic: Singapore progress on Good Laboratory Practices (GLP) and Mutual Acceptance of Data (MAD) Agreement Speaker: Ms. Kwei Fern CHANG, Director, Accreditation at SPRING Singapore 23 Q & A / Discussion (2) Topic: MAD, GLP and Compliance Monitoring Speaker: Mr. Bob Diderich, Principal Administrator, ENV/EHS OECD Topic: World Health Organization (WHO) Risk Assessment Toolkit Speaker: Ms. Carolyn Vickers,Team Leader, Chemical Safety, World Health Organization (WHO) 15 min. Discussion 15:35 – 15:50 15:50 – 18:00 Tea Break Afternoon Session II Risk Assessment Toolbox Moderator: Mr. Takashi Fukushima, METI, Japan CAPACITY BUILDING- IOMC SESSION & NEXT STEPS/WRAP UP DESCRIPTION: Capacity building opportunities are available to economies through the inter-organization programme for the sound management of chemicals, chemical related Secretariats and other organizations and programs. This session will focus on different capacity building opportunities for APEC economies and encourage dialogue for more developed-developing economy trainings. Capacity Building Opportunities Q & A / Discussion This session will also outline next steps and topics for future Train-the-Trainer sessions and Regulator Forum meetings that focus on identified challenges and priorities for APEC economies in the sound management of chemicals. (1) World Bank Speaker: Ms. Catalina Marulanda, Ph.D., Senior Environmental Specialist, Montreal Protocol / POPs Unit (2) Inter-organization Programme for the Sound Management of Chemicals (IOMC) Speaker: Mr. Craig Boljkovac, IOMC Chair 15 min. Discussion Next Steps/ Wrap-Up Overview of Best Chemicals Practice Economy Assessment Questionnaire: Status, Common Challenges & Priorities in the APEC Region Panel Discussion on Challenges, Priorities & Future Work in the Sound Management of Chemicals in the APEC region: Economies, Industry & IGO Perspectives Conclusion/Wrap-Up Topic: Identified regional priorities & topics for future Train-the-Trainer sessions Speaker: Ms. Heather Page, Workshop Project Overseer, International Team, Office of Pollution, Prevention and Toxics, U.S. Environmental Protection Agency Moderator: Lee Eeles, Department of the Environment, Australia 1) Canada- Mr. Bernard Made, Environment Canada 2) Indonesia- Mr. Rasio Ridho Sani, Ministry of Environment 3) Mexico- Ms. Teresita Torres, SEMARNAT 4) Industry- Mr. Mike Walls, ACC, U.S. industry 5) Industry- Dr. Fumiaki Shono, JCIA, Japan industry 6) IGO- Mr. Craig Boljkovac, IOMC Chair Speaker: Mr. John Shoaff, Regulators’ Forum Chair, International Team Leader, Office of Pollution, Prevention and Toxics, U.S. Environmental Protection Agency 24 Appendix II (CTI 10/2009A) APEC Good Regulatory Practice, "Case Study Workshop on the Chemicals Sector- From Principles to Practice" March 1 – 2, 2010; Hiroshima, Japan Grand Prince Hotel Hiroshima SPEAKER / PANELIST / MODERATOR BIOGRAPHIES Dr. Abdul Rahman Awang, Director of the Hazardous Substances Division of the Department of Environment, Malaysia Abdul Rahman Awang is currently the Director of the Hazardous Substances Division of the Department of Environment, Malaysia (DOE). His is tasked to look after the overall management of toxic and hazardous wastes and the environmentally hazardous substances (EHS) in Malaysia involving the formulation of policy, strategy and programmes for the management of EHS as well as the coordination and monitoring on enforcement activities for toxic and hazardous wastes in Malaysia. He has been serving for the Department of Environment since 1981, with his first 16 years in the management of toxic and hazardous waste management, followed with 7 years experience as the Director of DOE at State level. He has a PhD in Chemical Engineering from the Loughborough University and a Masters of Engineering in Chemical Engineering from the New South Wales University. Mr. Craig W. Boljkovac, Manager, Chemicals and Waste Management Programme, United Nations Institute for Training and Research (UNITAR) Mr. Boljkovac is the Manager of Chemicals and Waste Management Programme at the United Nations Institute for Training and Research (UNITAR) and the current Chair of the Inter-Organization Programme for the Sound Management of Chemicals (IOMC). Mr. Boljkovac has twenty years’ experience in environmental public policy analysis, management and strategic planning and is trained in environmental policy, with particu lar experience in chemicals issues. He received a Masters in Environmental Studies from the University of Toronto, Toronto, Canada and a Bachelor of Science in Biology from the University of Toronto, Toronto, Canada. Ms. Kwei Fern CHANG, Director, Accreditation, SPRING Singapore Ms. CHANG Kwei Fern is the Director for Accreditation of the Standards, Productivity and Innovation Board (SPRING Singapore). She oversees the operation of the Singapore GLP Compliance Monitoring Programme as well as the national Accreditation Programmes for Laboratories, Certification and Inspection bodies. She was a key driver in the development of the Singapore GLP Programme and represented Singapore in the OECD GLP Working Group. She helps to coordinate efforts with domestic and international stakeholders in achieving the OECD’s Mutual Acceptance of Data (MAD) status for GLP. In accreditation, she has more than 15 years of experience and has participated in international development of standards relating to conformity assessment and accreditation, such as ISO/IEC 17025 and ISO/IEC 17011. Ms. Chang is also the Singapore representative for the regional and international co-operations for laboratory, certification and inspection accreditation including establishing mutual recognition arrangements (MRAs) with the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Pacific Accreditation Cooperation (PAC), European Cooperation for Accreditation (EA), International Laboratory Accreditation (ILAC) and International Accreditation Forum (IAF), to facilitate acceptance of reports and certificates across border. She served as a member of the APLAC Board of Management from 2003 to 2006 and is currently serving in the Board for the term from 2010 to 2011. She is an APLAC Lead Evaluator and has been actively involved in the evaluations of 25 peers’ accreditation systems for MRA purposes. Ms. Chang has an Executive MBA and a Bachelor of Science from the National University of Singapore. Mr. Bob Diderich, Principal Administrator, Environment Directorate, Organisation for Economic Cooperation and Development (OECD) Bob Diderich has been involved in environmental hazard and risk assessment of chemical substances since 1992, when he joined the German Federal Environmental Agency. He was working in France between 1995 and 2002, first for the French Ministry of the Environment and then the French National Institute for Industrial Environment and Risks, where he was assessing the environmental risks of industrial chemicals and biocides. In 2002 he joined the Organisation for Economic Co-operation and Development where he is now in charge of the OECD Existing Chemicals Programme and the OECD Project on (Quantitative) Structure Activity Relationships. Mr. Lee Eeles, Director of the Chemical Partnerships Section, Australian Department of the Environment, Water, Heritage and the Arts Lee Eeles is the Director of the Chemical Partnerships Section in the Australian Department of the Environment, Water, Heritage and the Arts. In this role, he is coordinating Australia's participation in negotiations on a new United Nations legally binding instrument on mercury, as well as Australia's engagement with the APEC Chemical Dialogue. Since 2005, he previously managed Australia's participation in and implementation of the Stockholm and Rotterdam Conventions, as well as the Strategic Approach to International Chemicals Management (SAICM). Before working with chemical related issues, Mr. Eeles worked in the Australian Greenhouse Office for six years. He studied English literature and journalism at the University of Queensland and has an Honours degree in English. Ms. Andrea Eng, General Manager Hazardous Substances, ERMA New Zealand The Environmental Risk Management Authority (ERMA New Zealand) is the New Zealand Government Agency responsible for the implementation of the Hazardous Substances and New Organisms (HSNO) Act. The hazardous substances part of this legislation covers the regulation of all hazardous substances – explosives, dangerous goods, pesticides, veterinary medicines, toxic substances and consumer products – from import or manufacture through to their disposal. Andrea joined ERMA New Zealand in 1998 to lead the project to transfer hazardous substances from coverage under old legislation to the framework of the HSNO Act. On successful completion of the project in 2006, Andrea took on the role as General Manager of the Hazardous Substances Group. In this current role she manages a team of people with responsibility for the evaluation and assessment of hazardous substances (new and existing) and coordinating compliance and enforcement activities. Andrea holds a Bachelor’s Degree in Chemistry, a Postgraduate Diploma in Occupational Safety and Health, and an MBA. Mr. Hiroshi Fukushima, Director, Chemical Management Policy Division, Ministry of Economy, Trade and Industry (METI), Japan Hiroshi Fukushima is the Director of Chemical Management Policy Division at METI. In this role, he has the responsibility for various aspects of chemical managements, including the safety of industrial chemicals, the prohibition of chemical weapons, and the control of the ozone depleting substances. In these fields, he manages the Japanese legislative systems such as the Chemical Substances Control Law (amended in 2009), promotes the selfmanagement practices among industrial manufacturers and users, actively participates in plans for international efforts, and gathers scientific knowledge and information. Mr. Fukushima is the head of the Japanese delegation to OECD's EHS programme aiming to promote the international cooperation, for example, in the development of testing methods as well as in the activities toward emerging issues such as the safety of nanomaterials. Mr. Fukushima previously worked on environmental issues including the climate change. He has a Master’s degree in applied chemistry from Tohoku University. Mr. Takashi Fukushima, Director for Chemical Management Policy, Chemical Management Policy Division, Ministry of Economy Trade and Industry (METI) of Japan 26 Takashi Fukushima is Director for Chemical Management Policy in charge of chemical substance evaluation under Chemical Substance Control Law (CSCL) and international affaires. In this role, he supervises evaluation process of new chemical notification under CSCL and coordination with other Ministries on chemicals evaluation, and also supervises international coordination and cooperation. He previously worked on international negotiation and coordination, cooperation such as SAICM, OECD, and POPRC as a deputy director of the division. He has a Bachelor’s decree in chemistry from the Science University of Tokyo. Mr. Marcelo Gamboa, Specialist, Contamination Prevention & Control Department of the National Environment Commission (CONAMA), Chile Marcelo Gamboa is representing the Contamination Prevention & Control Department of the National Environment Commission (CONAMA), which is about to be converted to an Environment Ministry. His main duties are related to chemical substances and contaminated sites management, specially the implementation of the National Policy on Chemical Safety, the Stockholm Convention National Implementation Plan, the Mercury national agenda, and land and water regulation development. Mr. Gamboa has been CONAMA´s Regional Director of the Coquimbo Region, Chief of the International Affairs Department of the Regional Government of Coquimbo, as well as Regional Director of the General Directorate for Water (Tarapacá and Arica & Parinacota Regions). He has been consultant of the United Nation Food and Agriculture Organization (FAO) and the International Water Management Institute (IMWI). Agronomist Engineer of the University of Chile, he has also a Master on Human Settlements and Environment (Catholic University of Chile). Ms. Hanili Ghazali, Principal Assistant Director, Hazardous Substances Division of the Department of Environment, Malaysia Hanili Ghazali is the Principal Assistant Director of the Hazardous Substances Division of the Department of Environment, Malaysia (DOE). She is currently responsible to develop a framework for managing contaminated sites in Malaysia and developing an effective and sustainable system for the management of Environmentally Hazardous Substances (EHS) in the country. Ms. Ghazali has previously worked as the DOE representative in the Malaysian Industrial Development Authority (MIDA), as the Head of Water Quality Division in the National Hydraulic Research Institute of Malaysia (NAHRIM) and as the Head of Enforcement Division at the DOE State office. She has served the DOE Malaysia for 24 years and has a Masters Degree in Pollution Control from Manchester University. Mr. Phung Ha, General Director, Vietnam Chemicals Agency (Vinachemia), Ministry of Industry and Trade Phung Ha is the General Director of Vietnam Chemicals Agency (Vinachemia) under Ministry of Industry and Trade of Vietnam. Vinachemia was established one year ago, the function of Vinachemia is to set up the strategy, master plan, long-term development of the chemical industry and industrial explosive materials of Vietnam and to manage the chemical safety. Mr. Phung Ha previously worked as a vice director general of Department of heavy industry, he was in charge of chemical sector of Ministry of Industry and Trade. He has a Master Degree in the organic chemistry from Charles University in Prague (Czech Republic) and Ph.D Degree in biomaterial chemistry from Ghent University (Belgium). Ms. Hana Hamdan, Team Leader, Notification and Assessments, National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Australia Hana Hamdan leads the Australian delegation for the OECD Clearing House on New Chemicals. Since 2005 to current she is responsibile for managing the notification and assessment function of new chemicals at the Australian Government National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Prior to this Hana managed the compliance function of the agency. She holds a Bachelor of Science degree and Masters in Occupational Health and Safety, at New South Wales University and Sydney University respectively. Hana has over 10 years regulatory experience in chemical safety risk assessment and management. Prior to NICNAS, Hana worked as a toxicologist and has published at least 8 papers and abstracts in scientific journals. Dr. Marion Healy, Director, National Industrial Chemicals Notification and Assessment Scheme, Department of Health and Ageing, Australia 27 Dr. Marion Healy was appointed to the position of Director of NICNAS in April 2007 for a period of 5 years, and leads NICNAS in its scientific and regulatory role. Marion’s research training and background is in the field of molecular genetics and she spent 15 years researching in this field. Since 1996 she has worked in senior positions in regulatory agencies with a focus of her work being the interface between scientific evidence and regulatory decision-making. In the period prior to being appointed as Director of NICNAS, Marion was Chief Scientist at Food Standards Australia and New Zealand (FSANZ) for eight years. Marion has considerable experience in international negotiations on regulatory frameworks. She has also served on numerous national and international committees, including acting as an expert advisor to the World Health Organisation, the World Trade Organisation and the Hong Kong government. She currently Chairs the OECD Clearing on New Chemicals. Ms. Marianne U. Heinrich, Lead Product Regulatory Advisor, BP, United States Marianne U. Heinrich is the Lead Product Regulatory Advisor for BP, a multinational, integrated petroleum and chemical company. In the Global Product Stewardship Group, she provides global regulatory oversight and guidance to the BP businesses. She has worked in the global regulatory area, in chemical control and chemical management activities, for 21 years. She has been active in harmonization initiatives and serves as the BIAC Chair for the OECD Clearinghouse on New Chemicals. Currently, she chairs the International Regulatory and Compliance Network and the China team, associated with SOCMA. She continues to be involved in the development of the parallel process under the OECD New Chemicals Clearinghouse, as well as other mutual recognition activities. She is actively involved in advocacy work, for those countries developing and modifying chemical control legislation, including Korea, China, and Taiwan. Ms. Heinrich has a Bachelors Degree in Biology from the University of Miami, and a Masters of Science in Biochemistry from the University of California, Riverside. She has been employed by BP for the past twenty-five years and has held a variety of scientific and regulatory positions within the company. Mr. Taka HIRAISHI, Board Member and Senior Consultant, Institute for Global Environment Strategies (IGES), Japan Taka HIRAISHI worked since early 1970s in the environmental management field at the Ministry of the Environment, Japan - in various areas, e,g. toxics management, hazardous wastes control, water pollution control and international cooperation. Though his current work is largely in the field of climate change – he is currently an IPCC Bureau member and Co-chair of IPCC GHG Inventory Programme, he worked in the OECD Secretariat (Chemicals Division) and UNEP (Assistant Executive Director, Environmental Assessment and Early Warning). In March 2008 he chaired the International Workshop on Chemical Management in China, Republic of Korea and Japan in the context of global trends. Mr. Nie Jinglei, Division Director/Associate Professor, Chemical Registration Center of the Ministry of Environmental Protection (MEP), People’s Republic of China Mr. Nie is the leader for New Chemical Substance Management Division, Chemical Registration Center of the Ministry of Environmental Protection (MEP). In this role, he coordinate, advise and deal with the new chemical management issues and related activities that span China borders, This may include, for instance: check the new chemical notification document, carry out meeting in order to review the new chemical, inspect the new chemical testing laboratory, research the improvement of new chemical management system, and so on. Mr. Nie work at Chemicals Registration Center of MEP for 14 years, He see the China new chemical notification system born, development and growth. He got BA in organic chemistry at chemical department of Yunnan University in 1993, and got MA in phytochemistry at the Kumming Institute of Botany of Chinese Academy of Sciences in 1996. Tel: 86-01084915287 Fax: 86-010-84913897- 201 Mr. Terence Koh, Executive Director, Singapore Chemical Industry Council (SCIC), Singapore Terence KOH is the Executive Director for the Singapore Chemical Industry Council. Since taking office 5 years ago, Terence has been actively involved in shaping up the industry capabilities on health, safety and environment practices. He is also leading the industry in advocacy issues pertaining to manpower, occupational safety and health, environment, process safety, energy, and trade amongst many others. He initiated and helped in setting up the country’s national taskforce for the Globally Harmonised System on Classification and Labelling of Chemicals (GHS). He has also steered SCIC to be the focal organisation in building capacity for all industries in Singapore impacted by 28 both GHS and the EU REACH regulations. Terence is a member of the SPRING Singapore’s Chemical Standard Committee (CSC), which looks into the formulation of Singapore Standards and Codes of Practices. He is also chairing the working group for supply chain security which monitors the development of ISO 28000 series of standards. He is a member of the National Taskforce for the implementation of the Globally Harmonised System which is co-chaired by the Ministry of Trade & Industry and SCIC. He is also a member of the advisory board for the Nanyang Environment and Water Research Institute (NEWRI). Terence represents the Singapore Chemical Industry in the ASEAN Ministerial Groupings’ meetings (AMEICC), the APEC Chemical Dialogues (APEC CD) and the United Nations Environmental Program (UNEP) meetings on SAICM. He has a Diploma in Business and Communications from the Singapore Polytechnic and a Bachelor in Communications from the Edith Cowan University, Australia. Dr. Jowitt Li, PhD, PEng. Manager, Safety and Health Technology Center (SAHTECH) and National Chemical Substance Register (NCSR) Office, Chinese Taipei Jowitt Li is the senior researcher and manager associated with the Safety and Health Technology Center (SAHTECH). His main area of responsibilities includes hazard communication and chemical management development with the interagency authorities of Chinese Taipei. He is currently involved in interagency GHS implementation programs, and new chemical substance notification (NCN) scheme development. Jowitt is currently the Acting Manager of the National Chemical Substance Register (NCSR) Office responsible for the existing chemical inventory nomination (ECN). He is adjunct assistant professor of the National University of Tainan focusing on sustainable development studies. Dr. Li received his Ph.D. from the University of British Columbia (Canada) in environmental engineering, Master from University of Maryland at College Park (US), and his BA from National Chung Hsing University (Taiwan). Prior to joining SAHTECH in 2007, Jowitt’s previous positions include: researcher of ITRI (Taiwan) and consulting engineer in Canada and the USA. Ms. Shi Lili, Nanjing Institute of Environmental Sciences, Ministry of Environmental Protection of P.R.China Shi Lili is the deputy director of division of argo-chemical pollution prevention and control research, the principal scientist of subject of environmental safety assessment and management of chemicals in NIES. Major in environmental fate and safety of pesticides, ecological impact strategies and assessment of new chemicals. From 2000, having taken charge of and participated in several national and ministerial research projects of new chemicals. Specializing in new chemical’s testing technology, assessment indicators and assessment methodology. Understanding and being familiar with China's chemical management regulation and requirements. Having published more than 30 papers in national and international journals and participated in compiling 4 books. Mr. Bernard Madé, Director, Environment Canada Bernard Madé is the Director of the Chemical Production Division at Environment Canada. This group is responsible for managing the environmental risks related to the Canadian chemical manufacturing and distribution sector. One of the priorities of this Division is the implementation of Canada’s Chemical Management Plan. This includes the development of regulations and other control measures to prevent or limit the releases of chemicals declared toxic under the Canadian Environmental Protection Act. Bernard was born in Percé, Québec, Canada. He received a Bachelor in chemical engineering from Sherbrooke University (Québec) in 1981. He joined Environment Canada in 1982 and has since occupied a number of positions within the air and water pollution control and chemicals risk assessment and management groups of Environment Canada. Ms. Catalina Marulanda, Senior Environmental Specialist, Environment Department, The World Bank Catalina Marulanda is a Senior Environmental Specialist in the Montreal Protocol, POPs and Chemicals Unit of the Environment Department at the World Bank. In this capacity, she provides technical support and advice to World Bank task teams working on various chemicals management issues. This includes, for example, the design and implementation of projects focusing on hazardous waste disposal and remediation, industrial pollution abatement and cleaner production, and institutional strengthening for environmental management. Ms. Marulanda is also the Technical Specialist for Chemicals in the World Bank’s GEF Coordination Unit. Her role is to ensure that technical and quality guidelines of all chemicals-related project submitted by the Bank for financing from the GEF are met. She has a Ph.D. in Geotechnical Engineering from the Massachusetts Institute of Technology and a Bachelor’s Degree in Civil Engineering from Lehigh University. 29 Dr. Scott Mobley, Research Fellow, The Clorox Company, U.S.A. Scott Mobley is a member of the Research & Development organization at The Clorox Company (consumer products manufacturer) based at their primary R&D facility in Pleasanton, California. He has degrees in Zoology (BS, MS) and Pharmacology & Toxicology (PhD), and has split his professional career between the consumer products and agricultural chemicals industries. Scott’s training and experience with biological systems, both ecological and human, has led to his current responsibilities which include helping ensure that sustainable principles, practices and chemistry are incorporated into the development of Clorox products. Scott has extensive experience working with external stakeholders while representing Clorox on matters of product regulations and safety. He works closely with leaders of the U.S. EPA Design for the Environment (DfE) program to advance the use of safer chemistry in household cleaning products. Since its inception in 2005, Scott has also been part of Walmart’s Chemical Intensive Products Network that, which through the development of a product “scorecard”, is driving the use of preferred chemistry in products sold at the world’s largest retailer. In 2009, Scott joined the advisory committee of The Sustainability Consortium, a recently formed partnership between independent scientists and engineers from leading academic research institutions around the world who engage with other leading researchers from the NGO, Governmental, and Industrial sectors to build a scientific foundation that drives innovation to improve consumer product sustainability. Mr. Tetsuo Nishide, Director General, Japan Chemical Industry Association (JCIA) The Japan Chemical Industry Association (JCIA), having 190 member companies and 80 organizations engaged in the manufacturing and handling of chemical products and related services. JCIA participates in the government councils where state regulations are deliberated as a representative of Japanese chemical industries. JCIA also conducts the voluntary action programs of chemical industries as a leading organization with regard to chemicals management and GHG reduction. JCIA proactively extends its support to the activities of the International Council of Chemical Associations (ICCA) in cooperation with ACC and Cefic. Mr. Nishide had worked for the Ministry of Economy Trade and Industry (METI) and the Ministry of the Environment, being engaged in making industrial, technical and environmental policies. He served as Director General of Chugoku Bureau of METI from 2002 to 2004 in Hiroshima. In 1997, he received Stratospheric Ozone Protection Award from US Environment Protection Agency. He has a B.S. and M.S. in chemistry from Tokyo Institute of Technology. Ms. Barbara Norton, Deputy Assistant, U.S. Trade Representative, Office of the U.S. Trade Representative (USTR) Barbara Norton is the Deputy Assistant U.S. Trade Representative in USTR’s Office of Small Business, Market Access and Industrial Competitiveness. She is the USTR lead for the APEC Chemical Dialogue, the APEC Life Sciences Planning Group, the APEC Market Access Group, and the APEC Auto Dialogue. She has worked on APEC issues since 1997, and chairs both the APEC Chemical Dialogue Steering Group and the APEC Life Sciences Planning Group. In addition to APEC, Ms. Norton has been the USTR lead for the WTO Non-Agricultural Market Access (NAMA) negotiations on non-tariff barriers since 2002, as well as to the Government/Authorities Meeting on Semiconductors since 1994. Prior to her current position, Ms. Norton spent 12 years in USTR’s Office of GATT Affairs, working mainly on tariff negotiations, customs valuation and development issues. She has a Master’s degree in Economics from the George Washington University, and a Bachelor’s degree from Brown University. Ms. Catherine Oh, Technical & Scientific Manager, ACCORD Australasia Catherine is the Technical & Scientific Manager for ACCORD Australasia, the peak national industry association representing the manufacturers and marketers of formulated consumer, cosmetic, hygiene and specialty products, their raw material suppliers, and service providers. ACCORD members market fast-moving consumer and commercial goods primarily in Australia and New Zealand. She is responsible for the management of scientific assessment and technical analysis within the group, with key roles in the assessment of regulatory requirements impacting on industry products and operations. Current focus includes GHS implementation in Australia and New Zealand, dangerous goods regulations and risk-based consumer product regulations. Catherine is a regulatory chemist with extensive experience in handling regulatory and technical matters in the fields of industrial chemicals and medical devices. Her past experience includes regulatory compliance role for Nalco Australia and Advanced 30 Medical Optics Australia. Her qualifications include a combined BSc/BA (honours) degree from the University of Sydney. Ms. Heather Page, Workshop Project Overseer, International Team, Office of Pollution, Prevention and Toxics, U.S. Environmental Protection Agency Ms. Page is a member of the International Team for U.S. EPA’s Environmental Assistance Division, Office of Pollution Prevention and Toxics (OPPT). As an Environmental Protection Specialist, she helps coordinate industrial chemical and pollution prevention activities in two primary areas: Latin America and Asia-Pacific. Her work in Latin America focuses primarily on mercury reduction and SAICM projects through trade capacity-building under CAFTA-DR. Ms. Page also assists Office coordination for the Strategic Approach to International Chemicals Management (SAICM) and bilateral coordination and agreements with countries such as China and Indonesia. Ms. Page has a dual Master’s degree in Natural Resources/Sustainable Development and International Affairs from American University and the University for Peace, Costa Rica. Ms. Dusanka Sabic, Director, Regulatory Reform, ACCORD Australasia Dusanka is a regulatory policy specialist who leads the development of ACCORD’s strategy for a better, more efficient and cost-effective regulatory system. ACCORD Australasia is the peak national industry association representing the manufacturers and marketers of formulated consumer, cosmetic, hygiene and specialty products, their raw material suppliers, and service providers. As a former Australian Public Servant, she has held senior positions in the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), the National Occupational Health and Safety Commission, the Office of Small Business and the Federal Bureau of Consumer Affairs. Dusanka has developed and implemented policies to assist business, especially in terms of reducing and simplifying the regulatory burden, for example, Dusanka was engaged by the South African Government to assist in its national review of the regulatory burden on small business. Prior to joining ACCORD, she was leader of the NICNAS Low Regulatory Concern Chemicals reform initiative and was awarded the 2003 NICNAS Innovation Award for her work in the design and implementation of this initiative. Dusanka has been with ACCORD since 2005. Mr. Rasio Sani, Assistant Deputy Minister for Management of Hazardous Substances and Wastes (Mining, Energy, Oil & Gas), Ministry of the Environment, Republic of Indonesia Mr. Rasio Ridho Sani is an Assistant Deputy Minister for Management of Hazardous Substances and Wastes (Mining, Energy, Oil & Gas) in The Ministry of the Environment Republic of Indonesia. In addition, he is the Executive Secretary for Indonesia Public Disclosure Program for Environmental Management Performance. In the Ministry of the Environment, Mr. Sani has experienced in many field works, such as, water and air pollution control, disaster management, information and communication. In the recent, he is responsible for development of policy related hazardous substances and wastes management and implementation of the policies including monitoring of policies implementation. He involves actively in International negotiation including Strategic Approach to International Chemical Management (SAICM), the Basel Convention, Global Mercury, and other chemicals related agreements. Furthermore, he is a vice chairman of the Basel Convention Compliance Committee. Mr. Sani has worked with Ministry of the Environment for almost 20 years. He has master degrees from University of Potsdam in Cooperation with InWent (Germany) in Public Management, University of Sydney (Australia) in Economic and Finance, and Degree from University of Indonesia (Indonesia) in Chemistry. He also has attended several advanced training in environmental management and engineering, and strategic management in Indonesia and overseas. Dr. Noriaki Santo, Deputy Director, Chemicals Management and Information Office Center, Japan Environmental Management Association for Industry (JEMAI) Noriaki Santo is Deputy Director for Chemicals Management and Information Office Center (CMIC), and Advisor for Customers Service Center for REACH, Department of Environmental Business and Technology, the Japan Environmental Management Association for Industry (JEMAI). He leads headquarter of the Joint Article Management Promotion-consortium (JAMP) and also helps coordinate and advice on industrial chemical management issues. This includes information exchanges with interested international stakeholders. Mr. Santo has worked on green science, which was a new field of fused biology and chemistry for good health, food and environment for the Research center for Green Science of Fukuyama University. He has also engaged in impact 31 assessment for environment and ecological toxicity issues which included developing OECD TG No.231: Amphibian Metamorphosis Assay for a private company’s institute as a general manager. He has a Ph. D. in environmental systems from the graduate school of geo-environmental science of Rissho University and a Bachelor of Science in Marine Biology from Kyushu University. Mr. Hae-yeop, Seo, deputy director, Ministry of Environment, Korea Seo Hae-yeop is the deputy director for MOE’s chemicals management division. He has been working for that division since 2008.4 and now taking the role of responding for REACH and other international chemical regulations and also tasks related to GHS implementation issues. Mr. Seo previously worked on Chemical Accident issues including prevention, preparation and response for chemical accident in the same division. Mr. John Shoaff, International Team Leader, U.S. Environmental Protection Agency (EPA) John Shoaff is the International Team Leader for U.S. EPA’s Environmental Assistance Division, Office of Pollution Prevention and Toxics (OPPT). In this role, he helps coordinate and advise on industrial chemical issues and pollution prevention activities that span U.S. borders. This may include, for instance: technical and scientific exchanges on domestic efforts with interested international stakeholders; regulatory and regional cooperation toward mutual objectives; and global partnerships on specific substances of common concern. Mr. Shoaff has represented the Office, Agency and U.S. in the negotiation of the Strategic Approach to International Chemicals Management (SAICM), on technical barriers to trade (TBT) matters with Free Trade Agreements and under the WTO, in the development of international environmental management standards (ISO 14000 series) and in the formation of other innovative domestic environmental programs and activities from Performance Track to Environmentally Preferable Purchasing. Mr. Shoaff previously worked on air quality issues for the Governor of California and the California Air Resources Board. He has a J.D. from the University of Maryland School of Law and a Bachelor’s in Business Management from the University of Notre Dame. Mr. Fumiaki Shono, Ph.D., General Manager, Japan Chemical Industry Association Mr. Shono is currently General Manager of the Japan Chemical Industry Association’s Chemicals Management Department as well as Vice Secretary-General of the REACH Task Force. Since joining the Japan Chemical Industry Association in November 2006, he has been working on several issues related to REACH’s support for companies inside Japan and chemical management. In the past, he has focused on the Chemical Policy and Health Information Gathering and Sharing Task Force and has also worked with the Leadership group of the ICCA LRI, and he is the OECD BIAC Chemicals Committee member for Japan. Within Japan, he is a member of the 2009 related ministry Nanomaterial Safety Government Expert Committee and a member of the NEDO Structure-Activity Relationship Committee. F. Shono joined Sumitomo Chemical Co., Ltd. in 1975 and received a Ph.D. in pharmaceutical drug metabolism from the College of Pharmacy, Osaka University in 1996, after which he carried out research into pharmaceutical and pesticides metabolism at the Biology and Environment science laboratory, and was working at the head office on Environment and Chemical safety department in charge of Registration works of Industrial chemicals with Japanese and overseas chemical regulations and on the household use pesticide business within the Biocide division. Throughout these years, he has successively filled various posts: part-time lecturer of subjects related to chemical management at various universities in Japan, and lecturer at JICA’s exchange student development course. Mr. Shuji Tamura, Deputy Director, Chemical Management Policy Division, Ministry of Economy, Trade and Industry (METI) of Japan Shuji Tamura is the Deputy Director responsible for international affairs in METI’s Chemical Management Policy Division, Manufacturing Industries Bureau. In this role, he participates in a variety of international discussions on the chemical management including the Strategic Approach to International Chemicals Management (SAICM), the Stockholm Convention and other international legal framework, chemical management discussion in the Organisation for Economic Co-operation and Development (OECD) where he is designated as one of Vice-Chairs for the Working Party on Manufactured Nanomaterials, and regional activities related to the chemical management such as APEC Chemical Dialogue. Mr. Tamura previously worked in the OECD secretariat on science and technology 32 development issues for three years. He has an MSc from Imperial College London and a Bachelor’s in Science from the University of Tsukuba (Japan). Mr. Tan Kia Tang, Deputy Director, Occupational Safety and Health Specialist Department, Ministry of Manpower, Singapore In his role, he participates in the development of polices, regulations, standards and guidelines related to occupational hygiene (OH). He plans and develops national OH programmes to safeguard employees against health hazards at work. He provides advice to management, field staff, and stakeholders on all OH matters. An industrial hygienist by profession, he has been practicing comprehensive industrial hygiene since joining the Ministry in 1977, focusing on regulatory, standard setting and enforcement work. He has been one of the main contributors in drafting numerous legislation, standards, codes of practice, and guidelines related to OH, as well as in developing various OH programmes, capability building courses, and in promoting OH best practices at the national level. Currently, he co-chairs the National Globally Harmonised System (GHS) Task Force to coordinate the implementation of GHS on chemical hazard communication. He is also an Adjunct Associate Professor at the Department of Epidemiology & Public Health, and the Department of Chemical & Bio-molecular Engineering of the National University of Singapore, lecturing on numerous OH subjects including chemical safety management, industrial noise and ventilation. He holds a First-class Honours Degree in Physics (University of Singapore), a MS Degree each in Health Physics (University of Rochester), and Industrial Hygiene (University of Pittsburgh). Ms. Teresita Romero-Torres, Deputy Director, Direction of Research on Chemicals and Ecotoxicological Risks of the Ministry of Environment and Natural Resources, Mexico Teresita Romero is the Deputy Director of the Direction of Research on Chemicals and Ecotoxicological Risks of the National Institute of Ecology (INE), which is the technical branch of the Ministry of Environment and Natural Resources of Mexico. As part of her duties, she coordinates studies to determine the impact of hazardous substances in the environment and the development of chemicals management tools. Currently, she is coordinating the development of the National Chemicals Inventory of Mexico. She belongs to the chemicals inventory team of the Commission for Environmental Cooperation of North America. She is also in charge of the updating of the National Chemicals Profile, which will be one of the main inputs for the implementation of the Strategic Approach to International Chemicals Management (SAICM) in Mexico. As a consultant she participated in the development of the National Implementation Plan of the Stockholm Convention on Persistent Organic Pollutants of Mexico. In 2007, she got her Ph.D. degree on Environmental Sciences from Imperial College London. Ms. Carolyn Vickers, Team Leader, Chemical Safety, Department of Public Health and Environment, World Health Organization Carolyn Vickers is the Team Leader for Chemical Safety in the World Health Organization Department of Public Health and the Environment. She leads the work of the Chemicals Team, which is responsible for: development of internationally harmonized methods for risk assessment; risk assessment of chemicals of public health importance; poisons prevention, information and management; prevention and response to chemical emergencies; WHO's involvement in international conventions and agreements on chemicals; and advocacy on chemicals of public health concern. Prior to joining WHO, she was responsible for the Existing Chemicals Programme of the Australian National Industrial Chemicals Notification and Assessment Scheme, and earlier in her career had a variety of experience relating to pesticide registration and occupational health standards. She has Master of Toxicology degree from the University of Surrey, United Kingdom and an Honours Science degree in physiology and pharmacology from the University of Queensland, Australia. Dr. Shuh Woei Yu, Board Member, Taiwan Chemical Industry Association (TCIA) Dr. Yu is a full-time professor at the Graduate Institute of Environmental Engineering of the National Central University in Taiwan and he is also chairman of Safety and Health Technology Center, SAHTECH. As a professor, his research activities and lectures primarily focus on occupational safety and health management. SAHTECH, with its staff members highly experienced in industrial safety and health technologies, provides consulting services to government agencies, multinational companies with business interests in Taiwan, and companies in the manufacturing sector. He has been actively promoting GHS and the national chemical inventory and registration 33 scheme since his tenure at Industrial Technology Research Institute as the director general of Environmental, Safety and Health Technology Development Center. He was heavily involved in organizing the APEC sponsored 2003 GHS Capacity Building Workshop held in Taipei. He received his Doctor of engineering degree from Tulane University and a Bachelor’s in Chemical Engineering from National Taiwan University. Dr. Yu worked for Exxon Chemical and Shell Oil Company in the US prior to his first teaching job at the Chemical Engineering Department of the university he currently serves. Mr. Mike Walls, Vice President of Regulatory and Technical Affairs, American Chemistry Council Mr. Walls oversees the issue, regulatory process and agency experts whose work provides a foundation for ACC’s advocacy efforts. Mr. Walls has been with ACC for 22 years and has experience in a wide range of U.S. domestic chemical regulatory issues, including the Toxic Substances Control Act (TSCA), the Emergency Planning and Community Right to Know Act (EPCRA) and the Resource Conservation and Recovery Act (RCRA), among others. His experience also includes work on international chemical regulatory issues, including the European Commission’s proposed regulation for Registration, Evaluation and Authorization of Chemicals (REACH) and the Chemical Weapons Convention. He has represented the industry in several international chemical negotiations, and in support of U.S. ratification and implementation of those agreements. Before joining ACC, Mr. Walls was in private law practice in Washington, D.C., where he represented domestic chemical manufacturers. He also served on the staff of U.S. Sen. Jim Sasser (D-Tenn.). Mr. Walls was an adjunct Professor of Law at the University of Maryland’s School of Law and American University’s Washington College of Law. Mr. Walls received his bachelor’s degree from Georgetown University, his law degree from Syracuse University College of Law and his master’s degree in business administration from the Georgetown University School of Business. 34