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2016/SOM1/CD/005 Agenda Item: 3A.i

APEC Risk Assessment Training on Metals and Metal Compounds (CD012014S) – Post-Workshop

Report and Proposed Next Steps

Purpose: Information Submitted by: Australia

16th Chemical DialogueLima, Peru

23 February 2016

APEC Risk Assessment Training on Metals and Metal Compounds (CD012014S) – Post-Workshop report

and proposed next steps

Objectives

To:

• inform the Chemical Dialogue of next steps regarding the design and delivery of on-going training materials throughout in early 2016, as well as other actions, following the successful holding of the APEC Metals Risk Assessment (MRA) Workshop in August 2015.

Background

Australia provided the Chemical Dialogue with an out-of-session, interim report (main text of interim report at Attachment A) on the outcomes of Phase 1 (the MRA Workshop) of this capacity building project and intended next steps (Phase 2 of the project) on 5 January 2016. A Summary Report on the Workshop outcomes was attached. No comments were received.

• The Summary Workshop Report is reattached here (Attachment B, separate file) as a final document. Australia has submitted this Summary Workshop Report, along with a brief description of the Workshop, to the APEC Secretariat for publication on the Chemical Dialogue webpage at xxx.

• It provides an overview of the various key outcomes from the Workshop, which Australia reported upon in the interim update – refer Attachment A.

• To reiterate, the three key messages from the Workshop were:

o the different physicochemical properties of metals and metal compounds intimately affect their toxicity and bioavailability to organism – hence these properties must be well characterized by the assessor;

o the specific physicochemical properties of environmental media in turn impact on the physicochemical properties of metals and metal compounds – hence, the local chemistry of environmental media needs to be profiled when determining the toxicity and bioavailability of metals and metal compounds; and

• as many metals are essential for life, the different sensitivities of local environmental organisms need to be profiled in order to accurately determine the toxicity of metals and metal compounds under local conditions.

• The successful completion of the APEC metals risk assessment workshop was also noted at paragraph 78 of the 2015 APEC Ministerial Meeting Joint Ministers Statement, Manila, Philippines, 17 November 2015 – Priority 1 Enhancing the Regional Economic Integration Agenda – Industry Dialogues1:

78.We welcome the research undertaken by the Chemical Dialogue to better understand divergences in the implementation of the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) and look forward to a report from the Chemical Dialogue in 2016 on the implementation of measures to reduce these divergences. We welcome the work of the APEC regulatory community to strengthen capacity in the scientific assessment of metals and metal compounds, as well as the work of the Chemical Dialogue with EC on Good Regulatory Practices.

Next steps

The original, approved, project proposal, for the APEC self-funded project CD012014S at Attachment C refers.

1. The interim report circulated by Australia on 5 January (Attachment A) asked the Chemical Dialogue to note that Phase 2 of the project, on the development and delivery of on-going training tools, will be progressed as follows:

• MRA Workshop participants expressed an equal desire for webinars and fact/technical sheets to be developed as on-going training tools on topics arising from the Workshop;

• the Organising Committee has therefore determined that 3-4 seminars will be run between January and March 2016.

• The latest timing for these webinars is now March 2016, as follows:

o Webinar 1: March 3rd Practical models for determining environmental risks posed by soil from metals/use of simple extraction tests to help assess health risks from metal contaminated sites. Yvette Lowney, Senior Managing Scientist, Exponent, US.

o Webinar 2: March 8th, Practical tools for dealing with bioavailability in soil standard setting. Mike McLaughlin - Science Fellow, CSIRO and Professorial Research Fellow, University of Adelaide, Australia.

1 http://www.apec.org/Meeting-Papers/Ministerial-Statements/Annual/2015/2015_amm/

o Webinar 3: March 17th, Practical bioavailability tools for aquatic assessment, Graham Merrington, Managing Director of WCA, UK.

2. Final surveying of participants, in May 2016:

The Project will conduct an e-survey, following the last of the webinars, to review:

• The extent to which the learnings from the 28-29 August Workshop and the webinars have been used by participants in their everyday work, as well as the extent to which participant have extended these learnings to their colleagues.

3. Completion report:

It is intended that a completion report will be lodged with the APEC Secretariat in June 2016.

Note that this timing is three months later than original envisaged, but this will not impact the project

Dr Matthew Gredley, NICNAS, Australian Department of Health, matthew.gredley@nicnas.gov.au

February 2016

ATTACHMENT A

Main text of interim report circulated to CD members 5 January 2016 – no comments

received

APEC Risk Assessment Training on Metals and Metal Compounds (CD012014S) – Post-Workshop report

and proposed next steps

Objectives

To:

• update the Chemical Dialogue on the outcomes of the training Workshop held under the APEC self-funded project CD012014S at SOMIII, 28-29 August 2015; and

• inform the Chemical Dialogue of next steps regarding the design and delivery of on-going training materials throughout in early 2016, as well as other actions.

Background

The project (2014 approved proposal at Attachment A):

• is fully self-funded, sponsored by Australia, and co-sponsored by Japan, New Zealand and Chinese Taipei;

• supported by Chile, China, Peru, Philippines and Russia;

• is driven by industry partners (consortium of metals industry associations coordinated by the International Council for Mining and Metals) to build, with facilitation from governments, the capacity of the APEC regulatory community in the scientifically sound risk assessment of metals and metal compounds at the intermediate-advanced level by delivering:

o a 1.5 day workshop, organized by the contractor Exponent, was held on 28-29 (half day) at SOM 111 and related meetings, Cebu, Philippines (venue provided by the Philippines Government), that documented and discussed risk assessment approaches develop by APEC economies and non-APEC entities, illustrated by case studies; and

o on-going training materials over the remainder of 2015 through to early 2016, to maintain the sustainability of capacity building beyond the training workshop.

The Project Overseer lodged an interim report2 on planning for the project with the APEC Secretariat (through the Chemical Dialogue) on 13 July – the report noted that the project was progressing on time and to budget, and that various identified potential risks to the project had not eventuated.

Outcomes of workshop held 28-29 August 2015

A Summary Report on the Workshop outcomes is attached separately. Key parameters are:

• Attendance

o 69 participants (58 trainees, 9 speakers and 2 Observers from the APEC Mining Task Force) attended

o 15 APEC economies represented, as well as industry from Belgium and India

o Speakers included a member of the OECD Chemicals Assessment Programme

o Australian Government funding supported the attendance of 11 participants, with additional support from the US Government

• Key topics covered by the workshop were:

o plenary sessions on the unique physicochemical properties of metals and metal compounds, human health hazards and exposures, environmental hazards and exposures, regulatory issues and standards – these were documented via presentations

o five case study sessions in two streams (human health and environment) illustrated the theory presented in the plenaries;

o all workshop presentations and case studies are available on the Meeting Document Database in the APEC Information Management Portal, 2015/8/28 Workshop on Metals Risk Assessment 2015 (Official’s login required), and technical information sheets were provided as background reading materials – all documents were made available prior to the Workshop and on USBs during the Workshop.

• Three key messages from the Workshop were:

o the different physicochemical properties of metals and metal compounds intimately affect their toxicity and bioavailability to

2 https://aimp2.apec.org/sites/PDB/Lists/Proposals/DispForm.aspx?ID=1566 – see supporting documents tab

organism – hence these properties must be well characterized by the assessor;

o the specific physicochemical properties of environmental media in turn impact on the physicochemical properties of metals and metal compounds – hence, the local chemistry of environmental media needs to be profiled when determining the toxicity and bioavailability of metals and metal compounds; and

o as many metals are essential for life, the different sensitivities of local environmental organisms need to be profiled in order to accurately determine the toxicity of metals and metal compounds under local conditions.

• An immediate post-workshop survey found that the Workshop was very useful and well-run, but too much information was presented in the 1.5 days with not enough discussion time:

o the organisers note the Workshop was originally designed for two days, but APEC timetabling changes reduced the time available for the Workshop at a point where the Agenda could not be revised;

o in the event, the Workshop venue was available for two days, but by then, participants had already made their logistical arrangements.

The successful completion of the APEC metals risk assessment workshop was also noted at paragraph 78 of the 2015 APEC Ministerial Meeting Joint Ministers Statement, Manila, Philippines, 17 November 2015 – Priority 1 Enhancing the Regional Economic Integration Agenda – Industry Dialogues3:

78.We welcome the research undertaken by the Chemical Dialogue to better understand divergences in the implementation of the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) and look forward to a report from the Chemical Dialogue in 2016 on the implementation of measures to reduce these divergences. We welcome the work of the APEC regulatory community to strengthen capacity in the scientific assessment of metals and metal compounds, as well as the work of the Chemical Dialogue with EC on Good Regulatory Practices

3 http://www.apec.org/Meeting-Papers/Ministerial-Statements/Annual/2015/2015_amm/

Next steps

The Chemical Dialogue is asked to note:

4. Phase 2 of the project:

Based on participant feedback and a subsequent Planning Committee meeting, the second phase of the project on the development and delivery of on-going training tools, will be progressed:

• Participants expressed an equal desire for webinars and fact/technical sheets to be developed as on-going training tools on topics arising from the Workshop;

• the Organising Committee has therefore determined that 3-4 seminars will be run between January and March 2016, with associated fact sheets circulated prior to each webinar – speakers have been engaged, topics almost finalized, and potential times are being consulted upon as follows:

o Webinar 1: Tuesday January 19th (TBC), Bioavailability tools for aquatic assessment, Graham Merrington, Managing Director of WCA, UK.

o Webinar 2: Tuesday February: 2nd (TBC), Practical models for determining environmental risks posed by soil contamination from metals contamination / use of bioelution in assessing health risks from metal contaminated sites, Yvette Lowney, Senior Managing Scientist, Exponent, USA

o Webinar 3: Tuesday February: 16th (TBC), Mike McLaughlin - Science Fellow, CSIRO and Professorial Research Fellow, University of Adelaide, Australia, Topic TBC.

5. Final surveying of participants, in May 2016:

The Project will conduct an e-survey, following the last of the webinars, to review:

• The extent to which the learnings from the 28-29 August Workshop have been used by the Workshop participants in their everyday work, as well as the extent to which participant have extended these learnings to other participants

6. Completion report:

It is intended that a completion report will be lodged with the APEC Secretariat in June 2016.

Note that this timing is three months later than original envisaged, but this will not impact the project

Dr Matthew Gredley, NICNAS, Australian Department of Health, matthew.gredley@nicnas.gov.au

4 December 2015

ATTACHMENT B

SUMMARY WORKSHOP REPORT – FINAL

Refer separate file

ATTACHMENT C

APEC Self-Funded Project Proposal Coversheet

Project Title: APEC Risk Assessment Training on Metals and Metal Compounds

Project Number (Assigned by Secretariat):

CD 01 2014S

Committee / WG / Sub-fora / Task-force:

Committee on Trade and Investment, Chemical Dialogue, Regulators’ Forum

Proposing APEC economy: Australia

Co-sponsoring economies: Japan; New Zealand; Chinese Taipei Supporting economies: Chile, China, Peru, Philippines, Russia

Date approved by fora:

Expected start date: January 2015

Expected completion date: December 2015

Project summary:

Briefly describe the project. Your summary should

include the project topic, planned activities,

timing and location:

The project builds on the November 2012 workshop on Regulatory Cooperation - Introductory Level Training on Risk Assessment and Risk Management by providing intermediate-to-advanced training on the risk assessment of metals and metal compounds, covering such topics as key characteristics unique to metals and metal compounds (bioavailability, human and environmental chemistry, fate and transport) and risk assessment methodologies. A largely industry funded, 1.5 day workshop is proposed, documenting and discussing risk assessment approaches developed by APEC economies and non-APEC entities, illustrated by case studies. The workshop outcomes will be incorporated into key training outputs in the form of a workshop report, webinars, technical documents, fact sheets etc as needed. The workshop, also supported by the APEC MTF, will be scheduled for August 2015 to be held back-to-back with the Regulators’ Forum meeting during SOMIII in Cebu, Philippines. The various outputs would then be designed and delivered by December 2015.

Total cost of project (USD): Approx. USD164,600 (includes Australian Government funding of AUD53,700)

Project Overseer Information and Declaration: Name: Dr Matthew Gredley

Title: Principal Scientist

Organization: National industrial Chemicals Notification and Assessment Scheme, Australian Department of Health

Postal address: GPO Box 58, Sydney, NSW,2001, Australia

Tel: 61 2 8577 8873 E-mail: matthew.gredley@nicnas.gov.au

As Project Overseer and on behalf of the above said Organization, I will ensure that all Project outputs (Project reports, proceedings, slides, presentations, CDs, etc.), will comply with the APEC Publications, APEC Logo and Copyrights Guidelines before being published. The guidelines are at: http://www.apec.org/About-Us/About-APEC/Policies-and-Procedures.aspx [signed M Gredley and submitted 10 Nov 2014] Name of Project Overseer

Project Details

SECTION A: Relevance to APEC [Answers to questions 1–3 may be taken or adapted from the Concept Note]

1. Relevance: What problem or opportunity will the project address and why is it important? How will the project benefit APEC members and the region? Which Rank on this year’s APEC Funding Criteria does this project fall under? Briefly explain why. Is it also linked to other Ranks? If so, which topics and how? [½ page]

The Chemical Dialogue (CD) serves as a forum for APEC economies to seek solutions to challenges facing the chemical industry and users of chemicals in the Asia-Pacific region. In general, metals are considered part of chemicals management schemes. The APEC region accounts for 70% of the production of metals and consumes 60% of the world’s mineral resources which are used in many critical applications that bring widespread benefits to society, from the fundamental human rights of clean air, clean water, safe food preparation, and health care, to everyday items in the home such as kitchen utensils and computers.

The APEC Mining Task Force’s 2012 Socio-Economic Study of Impact of EU Nickel Compounds Classification on APEC Economies4 concluded that regulation (the 2009 decisions of the European Commission to classify 138 nickel-containing chemicals as hazardous) not based on scientific decision-making can lead to adverse economic impact. This can arise when regulators, schooled in the traditional risk assessment of organic compounds, do not recognise the specific properties of metals and alloys, including speciation and valency, bioavailability, essentiality for mammals and plants, toxicokinetics, etc. As a result, inappropriate environmental and human health risk assessment methodologies might be used. This adversely impacts the mining and metals industry when seeking to implement assessments by establishing inappropriate identification and control measures, and influencing markets by either encouraging or discouraging substitution, elimination etc.

2. Objectives: Describe the 2-3 key objectives of the project. (e.g. to ensure workshop participants will be able to...; to create a framework...; to develop recommendations...; to build support...; to revise strategies...; to create an action plan; …improve capacity in; etc.) [¼ page] The project seeks to build capacity of the APEC chemical regulatory community (both government and industry) through shared training and resulting regulatory coherence and cooperation to enhance the sound scientific risk assessment of a key APEC economic commodity – metals and metal compounds. The two key objectives of the project, informed by a survey of Chemical Dialogue members undertaken in December 2013 - January 2014, are to build capacity by: • build participants’ knowledge and understanding of the risk assessment of metals and

metal compounds by holding an intermediate-to-advanced two day training workshop for regulators that will document and discuss current approaches used by APEC economies informed by work undertaken by non-APEC entities;

• share that knowledge and understanding through the broader regulatory community (ie beyond workshop participants) by developing the materials from, and the conclusions of the workshop into training tools, such as webinars, technical documents, fact sheets and case studies.

3. Alignment: Describe specific APEC priorities, goals, strategies, workplans and

statements that the project supports, and explain how the project will help achieve them. Explain how it is aligned with your forum’s workplan / strategic plan. [less than ½ page]

4 http://publications.apec.org/publication-detail.php?pub_id=1288

The project contributes to the promotion of regional economic integration as noted by the 2012 APEC Ministerial Meeting Statement5 at Item 17:

Taking into account that APEC economies are among the main producers and consumers of metals, we believe that recognition of metal characteristics in global and regional chemicals management must …be transparent, based on sound science, should be no more trade restrictive than necessary, and …failure to do so may have an unnecessarily negative impact on economic growth, living standards, the environment and the protection of human health and development. …….. Consequently, the APEC 2013 Tasking Statement for 2014 includes a work program on Advancing Regulatory Coherence and Cooperation, including the strengthened implementation of good regulatory practices. This priority has, in turn, been incorporated into the APEC Chemical Dialogue’s Chemical Strategic Framework 2011-2013, which was endorsed by APEC Ministers in 2011, as Shared Goal 1, namely to expand and support cooperation and mutual recognition among chemical regulators in the region to facilitate trade. In accordance with the Strategic Framework, the Regulators’ Forum included in its Action Plan 2014-2015 the assessment of the need for capacity building of APEC regulators in the risk assessment of metals and metals compounds. This Plan was endorsed by the June 2013 meeting of the Chemical Dialogue and by the 2013 APEC Ministerial Meeting Statement6 at item 30. The proposed metals risk assessment training workshop also presents an opportunity for utilizing the Outcomes document and Best Practice Principles that are to be developed by the project Advancing Chemical Regulatory Cooperation in APEC Member Economies workshop (CTI 12 20147) which was held on 11 August 2014.

4. For TILF Special Account applications: Briefly describe how the project will contribute to APEC trade and investment liberalization and facilitation with reference to specific parts of the Osaka Action Agenda (Part 1, Section C and, where appropriate, Part 2). For APEC Support Fund applications: Briefly describe how the project will support the capacity building needs of APEC developing economies, and how they will be engaged. [¼ page] Not applicable.

SECTION B: Project Impact

5. Outputs: Describe products or services that the project will create. This may include workshop, reports, tools, research papers, recommendations, best practices, action plans etc. [½ to ¾ page] The project design is informed by the results of a December 2013 survey on the need of economies for capacity building in the risk assessment of metals and metal compounds. The survey found that a number of respondents use risk assessment as a tool, and that challenges in the risk assessment of metals include a lack of data on bioavailability, bioaccessibility, and exposure, as well as a lack of environmental monitoring studies. The project outputs are therefore: • an intermediate-to-advanced 1.5 day training workshop on the risk assessment of

metals and metal compounds, held back-to-back with the Regulators Forum during SOM III, Cebu, Philippines, August 2015, that will document and discuss risk assessment approaches developed by APEC economies, and will be informed by the

5 http://apec.org/Meeting-Papers/Ministerial-Statements/Annual/2012/2012_amm.aspx

6 http://www.apec.org/Meeting-Papers/Ministerial-Statements/Annual/2013/2013_amm.aspx

7 http://aimp2.apec.org/sites/PDB/Lists/Proposals/DispForm.aspx?ID=1533

work of non-APEC entities and illustrated by case studies. These will potentially covering such topics as key characteristics unique to metals and metal compounds (such as bioavailability, human and environmental chemistry, fate and transport), risk assessment methods, exposure assessment, risk characterization, and modeling; post-workshop survey of attendees;

• training materials: incorporating workshop outcomes into key training tools in the form of a workshop report, webinars, technical documents, fact sheets and case studies as required;

• final project report incorporating learnings from post-implementation surveys.

6. Outcomes: Describe the specific changes the outputs are expected to achieve in the medium-term. What changes in policy, processes or behaviour will the project lead to? [½ to ¾ page]

The project seeks to influence change by requiring workshop participants to be technically qualified and senior enough to influence the culture and processes in their organisations/economies. The project outputs are expected to directly lead to the following:

• increased knowledge of the unique characteristics of metals and metal compounds and

of various approaches to the scientifically sound assessment of their human and environmental risks;

• increased regulatory cooperation as a means to effectively utilise/adapt these risk assessment methodologies.

More systemic changes are the initiative of individual economies (government regulators) and corporate frameworks (industry regulatory affairs officers) and are outside the scope of this project to directly influence. However, in order to translate this increased knowledge and cooperation into increased capacity to appropriately assess the risks from these chemicals, the following changes could be envisaged, as underpinned by the APEC Chemical Dialogue Best Practice Principles for Chemical Regulation:

• regulators and regulatory affairs officers would need to put in place methods and

systems to collect or create toxicological and exposure data on these compounds, and then develop risk assessments;

• economy risk management organisations would also need to develop the capacity to design and implement appropriate risk mitigation measures to address those risks;

• economy governments would also need to have in place appropriate systems to predict and measure regulatory impacts on industry to ensure any regulatory interventions arising from the scientifically sound risk assessment of metals and metal compounds are no more than the absolute minimum necessary to achieve appropriate protection of human and environmental protection.

Depending on the regulatory and legislative structure of each economy, new/updated technical guidance documents, assessment frameworks, regulations and legislation may also be required to implement specific risk assessment methodologies.

7. Beneficiaries: Who are the direct project participants and users of the outputs? Describe their qualifications, level of expertise, roles/level of responsibility, gender, economies represented, government departments, APEC fora involvement etc.. Explain how they will use and benefit from the outputs. Who else will benefit from the project and how? [½ to ¾ page] The main beneficiaries of the workshop and training materials will be the APEC chemical regulatory community (government regulators and industry regulatory affairs staff) in a broad range of APEC economies, both developed and developing. The workshop will focus on senior technical regulatory staff of particular influence in their organisations, who are then able to facilitate the dissemination of/access to the training materials to their colleagues in their sectors. In this way, broader capacity building will occur, not only indirectly by communication of workshop results by attendees to non-attendees, but also directly to non-attendees through their use of the training tools. These tools will benefit participants and

users by building their capacity to undertake sound, scientific risk assessment of a key APEC economic commodity – metals and metal compounds.

8. Dissemination: Describe plans to disseminate results and/or outputs of the project, including: • The number, form and content of any publications. (Note: APEC will not fund

publications that are only presentation slides, or website maintenance. Electronic publication encouraged.)

• The target audience. • Any intention to sell outputs arising from this project. [less than

½ page]

Participants will receive all materials needed for the workshop in electronic format prior to the workshop so as to enable prior preparation by participants. This will maximize time in the workshop actively learning and contributing to the discussion, rather than spending valuable workshop time familiarizing themselves with the material. These materials, as well as the learnings from the workshop, will then be developed into key training tools in the form of a workshop report, technical documents, fact sheets and case studies, which will then be disseminated in electronic form through workshop participants to end users in regulatory agencies and business. Webinars will be directly accessible by end users, and all these tools will also be available through the APEC website project database. As the materials will be technical in nature and the project focuses on the capacity building of regulators, there is no intention at this stage to circulate the material to the public at large. However, individual economies may wish to modify the materials for circulation to their citizens as part of domestic risk communication programs. There is no intention to sell outputs arising from this project.

9. Gender: What steps will the project take to ensure the participation and engagement of both men and women in project activities? How do project objectives benefit women? [less than ½ page] The main beneficiaries of the training will be the APEC chemical regulatory community (government regulators and industry regulatory affairs staff). As such, the project will offer an equal opportunity for participation regardless of gender; hence it will not be aiming to specifically benefit women. In order to encourage the engagement of both men and women at the end-user stage of the project, Chemical Dialogue members and workshop participants will both be requested to facilitate access to these tools by end users in the regulatory community irrespective of gender. Overall, it is expected that the gender ratio of end users who access these tools will be comparable to the gender ratio of the regulatory community, covering both governments and industry.

SECTION C: Project Effectiveness

10. Work plan: Provide a timeline of actions you will take to reach your objectives. For each, include: • How it will be implemented; how member economies, beneficiaries & others will be

involved • Related outputs for that particular step (e.g. contract, agenda, participant list,

workshop, report) [1-2 pages. Answers may be taken or adapted from the Concept Note]

The project will formally commence from 1 January 2015, although the creation of an organising committee is intended to start informally as soon as possible in 2014. Expected timelines are: Step 1: Establishing core steering committee of supporting APEC economies (governments and industry) and cultivating interest from potential contributors, participants and contractors – November – December 2014 A core steering committee will be convened to guide the planning process for the training project to ensure it responds to the needs and interests of the APEC economies. The

Project Proponent, Industry Coordinator, and co-sponsoring economies are expected to be part of the core steering committee, but invitations will also be extended to other interested economies identified through CD13 in August 2014, including the Philippines as the 2015 APEC Host Economy. At the same time, general interest in the training project will be maintained and grown by specific communication with the Chemical Dialogue and the participants in the November 2012 workshop. Potential contributors of training materials, such as case studies on specific metals/metal compounds, will also be approached, informed by the results of the capacity building survey. Finally, key economies and organisations that could contribute experts to the project, such as Japan, will be informally approached about their interest in the project and their availability. Outputs: Core Steering Committee established, interest in project generated amongst key supporting stakeholders Step 2: Formalise the cross-economy Steering Committee, establish the necessary arrangements for delivering the project, contract technical experts and commence recruitment of workshop participants – January – April 2015 The formal cross-economy Steering Committee will be finalised, based on the core group referred to in Step 1, as well as other interested economies and advisers tentatively identified by December 2014. A detailed planning timeline will be developed to provide certainty to the planning process, ensure accountable and timely use of funds, and ultimately provide for the delivery of the project outputs. Experts will be contracted to deliver the intermediate-to-advanced level training on the risk assessment of metals and metal compounds, with logistics support provided by the 2015 APEC Host Economy, the Philippines, as part of the SOMIII and associated meetings. Working with the steering committee and non-APEC entities, the experts will do an initial identification of topics to be covered and associated materials needed for the training, including topics and materials/case studies nominated by contributing economies. Preference will be given to the identification of existing material where available, with the possibility of customizing the material as appropriate. The cross-economy Steering Committee will consult with the Chemical Dialogue concerning the draft agenda and identification of training materials/case study topics to ensure their relevance before they are developed in detail, as well as identifying potential workshop participants. It will also keep the APEC Host Economy appraised of developing logistical requirements. Finally, informed by the draft training topics and materials/case studies, the cross-economy Steering Committee will scope out the suitability of delivering this material through various training tools (such as a workshop report, webinars, technical documents, fact sheets and case studies). It is envisaged that regulatory agencies of member economies will wish to be closely involved in the generation of these tools, hence the Steering Committee will liaise with the Chemical Dialogue on how best to generate them, and identify the need to contract appropriate specialists to generate training tools. The Chemical Dialogue, as endorsing APEC forum for this Workshop, will be requested to approve these arrangements as they progress. Outputs: Cross-economy Steering Committee finalised, workshop organisers contracted, topics and materials/case studies identified, initial participant list generated, nature of training tools scoped and need to engage specialist assistance identified. Step 3: Finalise program, training materials, workshop participant list and economy interest in creating training tools, and, engage specialist contractor to generate training tools as needed. Finalise logistical arrangements April – July 2015 The experts, with assistance from the cross-economy Steering Committee, and based on comments received from Chemical Dialogue members, will finalise the materials and case studies for the training workshop and finalise the participant list. The Project Overseer will coordinate with the project’s Industry Coordinator, the APEC Host Economy and the Program Director to finalise logistical arrangements needed for the meeting, including travel arrangements for travel-eligible participants. The Steering Committee will also scope options for the development of training tools informed by the training material.

Outputs: Final agenda, training materials and case studies, and participant list; plan for generating training tools and contractor engaged as required. Step 4: Training materials delivered to participants, training workshop on risk assessment of metals and metal compounds held, initial survey of outcomes conducted, report to August 2015 Regulators Forum and Chemical Dialogue – August 2015. The training materials will be delivered to participants in electronic form at least two weeks prior to the holding of the two day workshop (specific dates to be determined by 2015 APEC Host Economy). It is intended that the training workshop will be held immediately prior to the Regulators Forum during SOM III, Cebu, Philippines, covering the agreed topics, which are expected to include key characteristics unique to metals and metal compounds (such as bioavailability, human and environmental chemistry, fate and transport) and risk assessment methodologies. It will document and discuss risk assessment approaches developed by APEC economies, informed by the experiences of non-APEC entities, and will be illustrated by case studies. The workshop will also include a session on subsequent dissemination of the workshop results through the intended training tools, such as the workshop report, webinars, technical documents, fact sheets and case studies. An initial, paper-based post-workshop survey instrument of attendees will also be completed at the workshop to ensure a maximum response rate from participants. The Project Overseer will report to that body on initial impressions from the workshop. The Regulators Forum will in turn report to the Chemical Dialogue. Outputs: Workshop delivered, initial survey completed, views on fine-tuning of training tools and commitment to facilitating dissemination of these materials; initial report to Regulators Forum and Chemical Dialogue Step 5: development and dissemination of training tools, completion of final survey on dissemination of workshop outcomes – September – December 2015 The training materials and workshop outcomes from the 1.5 day intermediate-advanced level workshop on the risk assessment of metals and metal compounds will be incorporated into key training tools in the form of a workshop report, webinars, technical documents, fact sheets and case studies. This process will take account of comments provided at the training workshop. It is envisioned that a summary of the workshop, along with the training materials, will be posted on the APEC Project Database for on-going access by participants and end users For the tools that member economies wish to fund and create (envisioned to be technical documents, fact sheets and the like), the timing and specifications of these materials will be at the discretion of the economies concerned. Further tools that economies do not wish to take direct responsibility for will be created by the specialist contractor, funded through this project. Examples could be the creation of webinars that explain the application of risk assessment techniques to metals and metal compounds in more depth, or that expand on case studies provided by interested economies. A final, electronic survey of workshop participants and end users of training tools will be held in December 2015 under the aegis of this project, so as to gain further in-depth impressions of the take-up of the workshop learnings and initial interest in the training tools. Outputs: Summary of workshop outcomes, broader dissemination of training materials, creation of training tools and their dissemination Step 6: Evaluation – January-February 2016 The results of the initial and in-depth surveys, along with copies of all training materials, case studies and training tools, will be incorporated into a project Completion Report as appropriate. This will be lodged with the Program Director within the requisite two months of formal completion of the project.

11. Risks: What risks could impact project implementation and how will they be managed? [⅛ to 1 page, depending on project nature/complexity] The project is technically relatively simple, and from that perspective, risks that are relatively straightforward to mitigate are engagement and procurement-related: • Risk 1: interest from APEC member governments and industry is inadequate and

implementation stalls; • Risk 2: the workshop does not attract enough participants and therefore the workshop

conclusions are not reliable; • Risk 3 – contractors do not undertake work to specified quality or timelines. However, a more significant risk relates to the scientific validity of the training content: • Risk 4: that participants and end-users perceive that the metals risk assessment

methodologies presented at the training workshop and subsequently incorporated into training tools are not scientifically sound.

These risks will be managed through standard consultative, engagement and procurement practices: • Risk 1 and 2 – engagement of a cross-economy Steering Committee to ensure the

project is implemented in a way that reflects the broad interests of APEC economies. The effectiveness of this risk mitigation will be further amplified by early consultations between the Steering Committee and the Chemical Dialogue. Risk 2 will be further minimized through direct engagement with the participants of the November 2012 workshop, whereby the current workshop is positioned as a progression of the basic risk assessment principles presented at the previous workshop, as applied to intermediate-advanced level training to metals risk assessment. On this basis, it expected that a significant number of these participants, or their colleagues, will engage in the current workshop.

• Risk 3 - standard industry and economy government procurement practices will mitigate

against less than optimal delivery of contracted goods and services. • Risk 4 – this risk will be mitigated by including in the selection criteria for contracted

experts the requirement that they demonstrate expert knowledge in the application of scientifically sound risk assessment methodologies, as well as a clear independence from both government and industry stakeholders. This independence is crucial given that the beneficiaries and end users of the project and its outputs are the regulatory community, being government regulators and industry regulatory affairs staff.

12. Monitoring and Evaluation: How will you know whether the project achieved its

objectives? • What information will be collected to assess progress and impact (e.g.

stakeholder feedback, website hits, participant stats)? How will gender impacts be measured?

• How will you collect it (e.g. surveys, meetings, interviews, peer review, records review)?

• What indicators will you use and/or measure to know if the project is on track (monitoring) and successful in meeting its objectives (evaluation)? [½ page]

Monitoring will be conducted on the delivery of the key outputs described in the project Work plan at subsection 8 of this document. The indicators that will be used and methodologies to measure these indicators will be based on feedback from Chemical Dialogue members to the Steering Committee on the: • selection of expert contractors – are they well-regarded in their fields and demonstrably

independent; • the relevance of the draft workshop topics and indicative training materials – do they

address the technical issues that stakeholders have agreed should be included in the training?

• the scientific soundness and technical complexity of the training materials, case studies and training tools subsequently delivered – do these stand up to scientific scrutiny by APEC economies and do they logically build on basic risk assessment and management principles, as well as present the technical issues associated with the risk assessment of metals and metal compounds at the intermediate and advanced level?

Evaluation of the extent to which the objectives have been met will be addressed in relation to whether the project has indeed contributed to building capacity in the scientifically sound risk assessment of metals and metal compounds. This will be measured through: • the number and quality of participants to the training workshop – do they broadly

represent regulators who are able to utilize the materials themselves as well as being influential enough to disseminate them to other end users?;

• feedback from workshop participants through the immediate post-workshop survey - was the quality of the trainers and training material adequate, to what extent were participants able to effectively engage in the training experience?

• subsequent end user feedback on the utility of the training tools developed and disseminated after the workshop - the extent to which materials posted on the APEC Project Database are accessed, the range of fact sheets and technical guidances found to be useful; and

• periodic updates from members of the Chemical Dialogue on the extent of dissemination – for example, the number and nature of end users that have accessed training tools, frequency of participation in, and satisfaction with, training webinars, etc.

13. Linkages: Describe the involvement of other APEC fora, and other relevant

organizations. Include: • Engagement: How are you engaging other relevant groups within and outside

APEC? • Previous work: How does this project build on, and avoid duplication of, previous

or ongoing APEC initiatives, or those of other organizations working in this area? • APEC’s comparative advantage: Why is APEC the best sources of funds for this

project?

[¼ to 1 page. Answers may be taken or adapted from the Concept Note]

Engagement – this project has its genesis in the APEC Mining Task Force’s Socio-Economic Study of Impact of EU Nickel Compounds Classification on APEC Economies, which concluded that regulation not based on scientific decision-making can lead to adverse economic impact. Moreover, the June 2014 APEC MTF meeting supported the holding of the workshop (under the aegis of the Chemical Dialogue), based on consensus support from Australia, Chile, the People's Republic of China, Japan and Chinese Taipei. As a result, the Project Overseer proposes that the APEC MTF be invited as an Observer to the training workshop. Previous work – The project will build on the November 2012 workshop on Regulatory Cooperation - Introductory Level Training on Risk Assessment and Risk Management (CTI 05 20128), sponsored by the US and co-sponsored by Australia, Chinese Taipei, New Zealand and Peru, and hosted in Thailand. This workshop covered basic risk assessment concepts using case studies involving organic chemicals - these concepts will be taken as a prerequisite for the August 2015 intermediate-advanced workshop. The risk assessment of metals and metal compounds carries its own technical challenges different to those posed by organic chemicals. The design of the proposed workshop also builds upon comments made by/the lessons learned from the 2012 workshop, published in a workshop appraisal report as CT 05 12 CR. These include:

8 http://aimp2.apec.org/sites/PDB/Lists/Proposals/DispForm.aspx?ID=192

• continue the theme of risk assessment training, and provide more advanced training on specific risk assessment topics;

• reiterating to economies the profile of the intended workshop participant (pre-requisite of knowledge basic risk assessment/attendance at the November 2012 workshop, senior technical regulatory staff of particular influence in their organisations, who are then able to facilitate the dissemination of/access to the training materials to their colleagues in their sectors), noting that end-users of training material can then access material on an as-needs basis; and

• providing training materials to participants well before attendance at the workshop, so as to enable participants to become familiar with material beforehand, thereby maximizing effectiveness of their interaction at the workshop.

SECTION D: Project Sustainability

14. Sustainability: Describe how the project will continue to have impact after the APEC funding is finished. • How will beneficiaries be supported to carry forward the results and lessons from

the project? • After project completion, what are the possible next steps to build on its outputs

and outcomes? How will you try to ensure these future actions will take place? How will next steps be tracked?

• How will progress on the outcomes and impacts (Question 6) be measured? [less than 1 page]

The project will continue to have an impact after APEC funding is finished through several mechanisms: • the relationships built between the trainers and individual participants at the training

workshop that will support continued professional development of risk assessors in this area – measured by the quality and extent of on-going communication.

• access to the training tools, such as the workshop report, webinars, technical

documents, fact sheets and case studies, that incorporate the training materials, discussions and learnings from the intermediate-advanced level training workshop on the risk assessment of metals and metals compounds, via APEC Project Database and through the broadcasting of webinars. The training tools were specifically requested by respondents to the survey on the need for capacity building in metals risk assessment, and as such, they are seen by regulators as the most effective way to deliver sustainable training beyond the lifetime of the APEC project – measured by website access and audience statistics.

• senior technical regulatory staff of particular influence in their organisations, who are

target participants for the workshop, can subsequently facilitate: o the dissemination of/access to the training materials to their colleagues in their

sectors (government regulators and industry regulatory affairs staff) as described above.

o access to on-going webinars that will be accessible as required by individual economies;

o on-going regulatory updates at the APEC Chemical Dialogue Regulators Forum meetings, where Regulator Forum members can report on how their economy’s capacity needs are being met and the recent developments in the science of metals risk assessment can be discussed.

• the success of the current workshop, in delivering intermediate-advanced level training

to regulators in a specialized area of chemicals management, can be expected to raise the profile of the Regulators’ Forum in delivering practical capacity building outcomes, and thereby encourage the development of further training workshops in areas of chemicals management that have already been scoped out by members of the Chemical Dialogue, such as chemicals inventory management, etc in accordance with the vision of November 2012 workshop on Regulatory Cooperation - Introductory Level Training on Risk Assessment and Risk Management.

• as was noted in the outcomes of the November 2012 workshop, economies may wish to participate in sub-regional workshops that may address specific issues of interest identified in the 2015 workshop. In such cases, individual economies would be expected to pursue such sub-regional workshops through their own multilateral arrangements, or, where a significant number of APEC economies would benefit, they may wish to propose an APEC project.

Other measures include the publication in technical risk assessment guidance by regulators, the number and quality of risk assessments on metals and metal compounds undertaken, the growth in formal international regulatory cooperation relationships, etc.

15. Project Overseers: Who will manage the project? This includes managing of contractors and specialists? Please include brief details of the PO and any other main point(s) of contact responsible for this project. [less than ½ page] The two key contacts for this project are the Project Overseer (Australian Government) and the Industry Coordinator (International Council on Mining and Metals). The PO, Dr Matthew Gredley, is responsible for ensuring the project progresses in accordance with the overall objectives and vision laid out in the Project Proposal, the overall coordination of the Steering Committee and its consultations with the Chemical Dialogue, liaison with supporting economies and the appropriate use of any Australian government funding.. The Industry Coordinator, Mr Ben Davies, will marshall funds from industry, provide resources and expertise to assist the Steering Committee in developing content and delivery, engage and coordinate contracted experts and ensure the delivery of the project outputs. Biographic information An industrial chemist by training, Dr Matthew Gredley, is Principal Scientist, National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Australian Department of Health. He is currently responsible for coordinating NICNAS engagement in the APEC Chemical Dialogue, which he has undertaken since 2008.. Prior to this role, Dr Gredley was Head of the NICNAS Reform Program, which developed and initiated the reform of NICNAS’s Existing Chemicals Program. Before joining NICNAS, Dr Gredley worked in the Australian Department of Industry on international and domestic science policy, and was a member of Australia’s delegation to the APEC Industrial Science and Technology Working Group (now the APEC Policy Partnership on Science, Technology and Innovation) for several years, during which time he managed contracts concerning the creation of the APEC Science and Technology Website (ASTWeb).

Mr Ben Davies has worked with ICMM since 2004 and has a background in physical science having obtained his PhD for research in metallurgy and materials science. Working within ICMM's Materials Stewardship work program, Mr Davies’ primary responsibilities are in the fields of chemicals management and sustainable consumption and production. Mr Davies is actively involved within the industry developing guidance to ensure that companies have the necessary resources to meet their commitments as ICMM members. This has included coordinating collaborative industry projects on metals hazard and risk assessment including the Metals Environmental Risk Assessment Guidance (MERAG) initiative. Mr Davies’ role also requires engagement in the international policy arena where he regularly represents the sector at the United Nations and OECD as well as with national governments, intergovernmental agencies and NGOs. The ICMM brings together 21 mining and metals companies as well as 34 national and regional mining associations and global commodity associations to address core sustainable development challenges ICMM has previously run workshops based on the MERAG guidance in Brazil, Canada, China, Japan and the United States.

SECTION E: Project Efficiency

16. Budget: Complete the budget and budget notes for the project in the template in SECTION F of this form. The budget should include calculation assumptions (e.g., unit costs) and self-funding contributions. Please consult the Guidebook on APEC Projects for eligible expenses.

SECTION F: APEC Project Itemized Budget

Please consult the descriptions of eligible expenses in the Guidebook on APEC Projects

All Figures in USD

# of Units Unit Rate

APEC Fundin

g Self-

Funding Notes

Direct Labour

Speaker’s honorarium (government officials ineligible)

(# of speakers) 2

600/day - 2,400 Rate of

international

expert on risk

assessment

Translator’s fees (# of pages)

Not applicable

Short-term clerical fees (please provide details of scope of work and deliverables in Budget Note 1 - Direct Labour)

(# of hours)

Not applicable

Contractor (including (contractors Secretary’s fees to be included in cost and packaged together) - design and running of workshop - design of training tools – up to 5 webinars for use in 2016

200 5x60hrs

250

100/hr

50,000

30,000

Development of

case studies and

training material

for workshop

(may be

somewhat less

as economies

will provide case

study materials

as well)

Travel (Speaker, Experts, Researchers)

Per diem (incl. accommodation and “75% additional payment”)

(# of persons and days) 2 speakers and 1 researcher

1,000

per

person

3,000 Washington to

Cebu,

Philippines

SOMIII venue

Airfare (# of persons and trips) 3 persons, 3 return trips

2,400 7,200 Program

Director to

manage logistics

Travel for Participants (from travel-eligible economies only. Active participants only)

All Figures in USD

# of Units Unit Rate

APEC Fundin

g Self-

Funding Notes

Per diem (incl. accommodations and “75% additional payment”)

(# of persons and days) 189 participants, 3 days10

3.75 x

$21511

14,50012 (location of

event)

Cebu,

Philippines

SOMIII venue

Airfare (restricted economy class)

(# of persons and trips 1813 participants, 18 return trips

1,67014 30,10015 Program

Director to

manage

bookings

Other items

Publication/distribution of report

(# of copies) USB drives containing workshop materials

500

Material will also

be made

available via

email or Internet

download prior

to workshop.

Specialized equipment or materials (please describe)

(type, #, and # of days)

Not applicable

Photocopying (# of copies)

Not applicable

Communications (telephone, fax, mail, courier)

Not applicable

9 Australian Government support funding defines 10 travel-eligible economies, these being Chile, China, Indonesia, Malaysia, Mexico, Papua New Guinea, The Philippines, Peru, Thailand and Viet Nam. The Philippines does not require travel support.

10 Includes one night’s accommodation in Manila between international (home economy-Manila) and domestic (Manila-Cebu) flights.

11 Based on UN per diem rate of USD179 accessed 5 Nov 2014, plus extra 20% for inflation

12 Funding is sourced from the Australian Government and is confirmed as AUD17,700 – the USD figure is illustrative only.

13 The Philippines does not require travel support.

14 Based on cost of return economy flight accessed from Webjet.com.au 15 Oct 2014and averaged across the capital cities of each eligible economy, plus extra 20% for inflation

15 Funding is sourced from the Australian Government and is confirmed as AUD36,000 – the USD figure is illustrative only

All Figures in USD

# of Units Unit Rate

APEC Fundin

g Self-

Funding Notes

Hosting (provide breakdown, e.g., room rental, stationery)

(units as appropriate) Two day room rental with AV equipment

4,500

Provision

al

To be provided

by 2015 APEC

Host Economy

Total 164,600 16

Budget Note 1: Direct Labour: Provide information for APEC-funded positions including general duties, total hours and who will be contracted, if known. (It is not acceptable to contract staff from your own organization or government employees.)

Not applicable Budget Note 2: Waivers: Provide details of any requests for waivers from the normal APEC financial rules, with justifications in the notes column of the budget table, or below if the waiver requires a detailed explanation. Not applicable

16 Includes USD21,800 for contingencies and inflation not itemized