APEC Project Proposal |
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| Project No. | CD 01 2020T | ||||||||||||||||||||||||||||||||||||||||||||||||
| Project Title | Facilitating Trade by Improving Risk Assessment Capacity | ||||||||||||||||||||||||||||||||||||||||||||||||
| Project Status | Project in Implementation | ||||||||||||||||||||||||||||||||||||||||||||||||
| Publication (if any) | |||||||||||||||||||||||||||||||||||||||||||||||||
| Fund Account | TILF Special Account | ||||||||||||||||||||||||||||||||||||||||||||||||
| Sub-fund | None | ||||||||||||||||||||||||||||||||||||||||||||||||
| Project Year | 2020 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Project Session | Session 1 | ||||||||||||||||||||||||||||||||||||||||||||||||
| APEC Funding | 28,432 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Co-funding Amount | 39,989 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Total Project Value | 68,421 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Sponsoring Forum | Chemical Dialogue (CD) | ||||||||||||||||||||||||||||||||||||||||||||||||
| Topics | Chemicals | ||||||||||||||||||||||||||||||||||||||||||||||||
| Committee | Committee on Trade and Investment (CTI) | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other Fora Involved | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Non-APEC Stakeholders Involved | |||||||||||||||||||||||||||||||||||||||||||||||||
| Proposing Economy(ies) | United States | ||||||||||||||||||||||||||||||||||||||||||||||||
| Co-Sponsoring Economies | Japan;Malaysia;Philippines;Singapore;Chinese Taipei | ||||||||||||||||||||||||||||||||||||||||||||||||
| Expected Start Date | 01/02/2021 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Expected Completion Date | 31/12/2021 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Project Proponent Name 1 | Kent Shigetomi | ||||||||||||||||||||||||||||||||||||||||||||||||
| Job Title 1 | Not Applicable | ||||||||||||||||||||||||||||||||||||||||||||||||
| Organization 1 | Office of the US Trade Representative | ||||||||||||||||||||||||||||||||||||||||||||||||
| Postal Address 1 | Not Applicable | ||||||||||||||||||||||||||||||||||||||||||||||||
| Telephone 1 | (1-202) 3956843 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Fax 1 | Not Applicable | ||||||||||||||||||||||||||||||||||||||||||||||||
| Email 1 | kent_shigetomi@ustr.eop.gov | ||||||||||||||||||||||||||||||||||||||||||||||||
| Project Proponent Name 2 | Edward Brzytwa | ||||||||||||||||||||||||||||||||||||||||||||||||
| Job Title 2 | Director, International Trade | ||||||||||||||||||||||||||||||||||||||||||||||||
| Organization 2 | American Chemistry Council | ||||||||||||||||||||||||||||||||||||||||||||||||
| Postal Address 2 | Not Applicable | ||||||||||||||||||||||||||||||||||||||||||||||||
| Telephone 2 | (1-202) 2496420 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Fax 2 | Not Applicable | ||||||||||||||||||||||||||||||||||||||||||||||||
| Email 2 | Edward_Brzytwa@americanchemistry.com | ||||||||||||||||||||||||||||||||||||||||||||||||
| Declaration | Kent Shigetomi and Edward Brzytwa | ||||||||||||||||||||||||||||||||||||||||||||||||
| Project Summary | Lack of capacity and inefficiencies in risk assessment procedures can act as barriers to trade; drive up costs; delay introduction of innovative products; and impair health and environmental protection. As chemicals are found in more than 85% of manufacturing supply chains, the social, health, environmental, and economic cost of delay is felt economy-wide. This project aims to address this gap, by engaging officials through an interactive, "tabletop exercise” workshop, which allows participants to work through real-world challenges and discuss practical approaches to risk assessment decision-making in a resource-limited, multi-stakeholder environment. The exercise will be conducted virtually during Q1 of 2021 and if necessary again in 2021. It will advance the results of work in 2019, 2015, and 2012, and lay the foundation for: (1) a risk assessment "toolbox" for chemical regulators and stakeholders; (2) APEC Guidelines for Risk Assessment in the Chemical Industry; and (3) a compendium of risk assessment/risk management resources. |
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| Relevance | Relevance – Region: APEC accounts for a 69% share of the $5.2 trillion USD global chemical industry, which directly employs 11.7 million people in APEC economies. APEC economies are increasingly assessing the risks of organic and inorganic chemicals, including metals, to human health, safety, and the environment. This project seeks to build the capacity of APEC regulators, officials and stakeholders to employ the principles and best practices of efficient chemical risk assessment and risk management, under realistic, resource-constrained conditions, particularly as economies are combatting COVID-19. Lack of capacity and inefficiencies in risk assessment procedures act as barriers to trade, drive up costs, and delay introduction of innovative products by the chemical industry, which serves a foundational role for the region’s economy. All APEC economies will benefit from the collaboration and regulatory cooperation proposed under this project, with particular benefit to developing APEC economies via the capacity building aspects of the program. Relevance – Eligibility and Fund Priorities: As required for TILF projects, this project would contribute to achieving trade and investment liberalization and facilitation objectives by reducing trade barriers that arise due to inconsistent and inefficient risk assessments (please see relevant objectives under Alignment – APEC). The project is also aligned with several reporting areas under Part 1 of the Osaka Action Agenda, including non-tariff measures, standards and conformance, regulatory review, information gathering and analysis, RTAs/FTAs, and transparency. Relevance – Capacity Building: This project will build the capacity of APEC member economies, particularly developing economies and those with more resource-constrained regulatory oversight regimes, by building awareness and proficiency among officials to implement best practices for chemical risk management under realistic conditions. The workshop will illustrate the steps in risk assessment that chemical and environmental regulators need to deploy in real-world scenarios, including problem-formulation, developing a data generation strategy, resource management, and making scientifically sound decisions in an open, collaborative manner. The workshop would also build greater awareness of risk assessment, emphasizing that it is a vital component in crafting chemical regulations and identifying chemicals that could be subject to regulations. This project will also better equip economies to respond to COVID-19, as participants could apply the skills and knowledge gained to assessing the risks of innovative new products or substance that could help combat the pandemic. |
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| Objectives | To build capacity in APEC member economy chemical regulators by increasing awareness of objective, scientifically sound risk assessment principles, and facilitate their use in decision-making across the public and private sectors. Chemical regulators will gain "hands-on" experience employing risk assessment/risk management procedures under realistic conditions, and will share recommendations, approaches, and insights with officials from other APEC economies. The project will also support efforts to help APEC economies use risk assessments conducted by competent authorities in other economies. |
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| Alignment | Alignment - APEC: The proposed project supports the Committee on Trade and Investment (CTI) and Economic Committee (EC) priorities on Good Regulatory Practices (GRP) in regional trade agreements and International Regulatory Cooperation (IRC) to avoid non-tariff barriers. This project would also contribute to achieving numerous trade facilitation instructions from APEC Leaders and Ministers, including to (1) “undertake initiatives in the areas of transparency, alignment of standards and conformity assessment systems… as well as promoting good regulatory practices in the preparation, adoption and application of standards, technical regulations and conformity assessment procedures,” (2) “encourage economies to share successful practices that have been used to improve their regulatory frameworks…,” and (3) “call for closer cooperation between government and the private sector in developing regulatory and policy processes to create a conducive environment for doing business[.] ” Alignment – Forum: This project will carry forward the Chemical Dialogue's overall focus on international regulatory cooperation – which remains the CD's top substantive priority for 2020. Risk assessments are a key component of the CD’s Best Practice Principles (2008/SOM2/CD/002rev1) and associated Checklist for Chemical Regulations (2016/MRT/007) and the principle that chemical regulators should adopt a risk management approach to developing and administering regulation. This project also supports two of the three ‘shared goals’ from the Dialogue’s Strategic Framework: (1) to facilitate trade by expanding and supporting cooperation and mutual recognition among chemical regulators in the region, and (2) to enable effective cooperation between industry and governments to improve chemical product stewardship and safe use. |
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| TILF/ASF Justification | Not Applicable. |
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| Beneficiaries and Outputs | Outputs: 1) Virtual Risk Assessment Workshop (February 2021; as necessary again in 2021) a) Up to 24 participants (at least one government or industry representative from each economy) and 4 expert facilitators. i) Speakers will be workshop organizers and facilitators of breakout groups in the virtual workshop. The facilitators will be risk assessment experts in companies or governments in the region. The virtual workshop will take place over Webex’s Training Modules platform. The workshop functions optimally with a smaller number of participants, which may require hosting a second risk assessment workshop later in 2021 if there is sufficient demand. b) PO to identify participants, including breakout group leaders, through nominations by APEC economies (November 2020 – January 2021). Participants should include chemical regulators, particularly those from developing APEC economies. c) PO to draft agenda and extend invitations to participants and experts (January 2021) d) Workshop Plan: i) Project proponents will preview the webinar at the virtual CD meeting November 4 – 5 and encourage participation. ii) Informational email to be sent to APEC CD in November 2020. iii) One hour, introductory webinar in December 202 (for participants and other interested experts/officials). iv) Two hour workshop in February 2021: virtual, interactive, breakout group experience, employing risk assessment/risk management procedures under realistic conditions. v) Review of workshop at first CD meeting in 2021 (date TBD). vi) Incorporate shared recommendations, approaches, and insights into project outputs and future versions of the virtual workshop. 2) In Person Risk Assessment Workshop (by October 2021 if conditions allow) a) 35 participants (including from 11 travel eligible economies and up to 6 experts). Participants include chemical regulators, particularly those from developing APEC economies b) PO to identify participants and up to 6 experts/speakers for workshop c) PO to draft agenda and extend invitations to participants and speakers d) Workshop Plan: i) In person workshop will build off previous virtual engagements. ii) "Hands on” interactive experience employing risk assessment/risk management procedures under realistic conditions iii) Sharing recommendations, approaches, and insights with officials from other APEC economies iv) Incorporate shared recommendations, approaches, and insights into project outputs a) Summary of Report of Virtual Workshop(s) b) PO and stakeholders to commence draft of outputs (November 2020 – November 2021) i) Risk Assessment “Toolbox” – a set of practical tools that economies can use in their conduct of risk assessments, drawing from the experiences of the workshops and existing literature on the “how to” of risk assessments ii) APEC Guidelines for Risk Assessment in the Chemical Industry – The workshops can help the Chemical Dialogue understand whether the development of guidelines regarding risk assessments in the chemical industry would be useful and what information they should contain. iii) Compendium of Risk Assessment/Management Resources c) Initial outlines presented at Chemical Dialogue meeting in Q3 2021 during New Zealand host year 4) Dissemination of Workshop Outputs and Policy Tools a) Summary report of workshop circulated to APEC Chemical Dialogue for approval (February 2021). Workshop summary report will be 5-10 pages in length. The report will include a summary of both virtual workshops, survey results of participants regarding their experiences with the workshop, and recommendations for developing the outputs below. The PO will use an electronic survey of participants to document participant’s experiences, insights, and recommendations. b) Policy tools circulated to APEC Chemical Dialogue for Approval (September 2021): i) Risk Assessment “Toolbox”: This output will outline practical tools available to economies that are seeking to undertake risk assessments on existing and new chemical substances. The PO will develop this output in coordination with the VWG on Regulatory Cooperation and Coherence. This document will be 5-10 pages in length. ii) APEC Guidelines for Risk Assessment in the Chemical Industry: This output will provide greater definition around how economies should undertake risk assessments for chemical substances, thereby promoting greater regulatory alignment and enhanced regulatory cooperation. The PO will develop this output in coordination with the VWG on Regulatory Cooperation and Coherence. This document will be 1-2 pages in length. iii) Compendium of Risk Assessment/Management Resources: This output will be a “literature review” of existing resources for risk assessment/management practitioners. The PO will develop this output in coordination with the VWG on Regulatory Cooperation and Coherence. This document will be 5-10 pages in length. The PO will combine all the policy tools in one document for the purposes of APEC publication and dissemination of the outputs within and outside of APEC. Outcomes: Key project outcomes will likely include the following – which would be overseen by the APEC Chemical Dialogue's Virtual Working Group on Regulatory Cooperation and Convergence (VWG RCC): 1) Workshop participants’ knowledge growth and understanding of best practices of chemical risk assessment/risk management is established through an electronic survey issued to participants immediately after the virtual and if possible in-person workshops. The PO will issue another survey to all participants six months after the final workshop to assess whether the participants are using the knowledge and understanding gained from the workshops. 2) In cooperation with the private sector, successful and practical tools to implement best practices for objective, scientifically sound risk assessments are identified and compiled for chemical regulators, promoting trade, investment, and public-private cooperation in the region. 3) Good regulatory practices for chemical regulatory cooperation in the APEC region are identified and compiled, specifically for chemical regulators from developing economies. 4) An APEC Chemical Dialogue Publication on Risk Assessment, which will be an APEC publication and supported by an agreed dissemination plan. This publication will include: · Risk assessment "toolbox”; · APEC Guidelines for Risk Assessment in the Chemical Industry; and · Compendium of risk assessment/risk management resources. These specific outputs are designed to ultimately help APEC economies work towards a commitment to use risk assessments on chemical substances conducted by other competent authorities in other economies, taking into account of exposure scenarios in their own jurisdictions. Beneficiaries: The program’s main beneficiaries would be chemical regulators, particularly those from developing APEC economies. In particular, the target group of nominated participants for the virtual and in person workshop includes risk assessors or toxicologists working for regulators in developing economies. The Chemical Dialogue will work with its subsidiary forum, the Regulators’ Forum as well as the Sub-Committee on Standards and Conformance (SCSC), to identify the technical experts responsible for risk assessments for chemical substances in individual economies. Secondarily, the program would also benefit other APEC government officials involved in regulatory affairs – including review, promulgation, and oversight. Policy experts involved in capacity building for GRP from other multilateral institutions, such as the World Bank, who have already participated in other related sessions organized by the Chemical Dialogue – would be invited to the introductory webinars and the in person workshop, as they would benefit from hearing the experiences and best practices of economies. The OECD Chemicals Programme Secretariat would also be a key participant in the introductory webinars and in person workshop, having already joined a 2015 metals risk assessment workshop and published guidance on environmental risk assessment for metals in 2017, and would share resources/best practices on risk assessment developed jointly by OECD members – which would particularly benefit the participants from non-OECD APEC economies. |
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| Dissemination | Following the conclusion of the last Risk Assessment Workshop in February 2021, the following outputs will be distributed electronically to the participants of the Workshop, including: a) Workshop summary report, which will be 5-10 pages in length. The report will include a summary of both virtual workshops, survey results of participants regarding their experiences with the workshop, and recommendations for developing the outputs below. The PO will use an electronic survey of participants to document participant’s experiences, insights, and recommendations. b) An APEC Chemical Dialogue Publication on Risk Assessment, which will be an APEC publication and supported be an agreed dissemination plan. This publication will include: i) Risk assessment "toolbox" ii) APEC Guidelines for Risk Assessment in the Chemical Industry iii) Compendium of risk assessment/risk management resources The target audience includes: APEC chemical regulators, particularly those from developing APEC economies; additional APEC government officials involved in regulatory affairs and trade policy; policy experts involved in capacity building for GRP from other multilateral institutions, such as the World Bank; and the OECD Chemicals Programme Secretariat. There is no intention to sell outputs arising from this project. |
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| Gender | The PO will proactively seek balanced representation by women in both the project’s agenda and among workshop attendees. This project will support APEC’s commitment to promote women’s economic empowerment, including with respect to building the capacity of women engaged in risk assessment, facilitating access to markets for women-owned enterprises through streamlined approaches to risk assessment, providing leadership opportunities for women engaged in risk assessment and/or toxicology, and providing access to new information and resources for women engaged in risk assessment and/or toxicology. Increased cooperation will have economy-wide benefits including for government regulators, industry, and consumers, reducing barriers to trade and corresponding costs and spurring economic growth. The PO will encourage broad participation in the workshop, including from women in both government and industry across APEC. Any agreed upon final products from the Workshop will also be broadly disseminated to the widest audience of relevant stakeholders. PO is committed to collecting sex disaggregated data for all speakers and participants (not only those funded by APEC) at the project event. This data will be included when submitting a Completion Report to the Secretariat upon completion of the project, as well as providing guidance to future POs on their own gender parity targets. The PO is also committed to including a gender perspective in the preparatory webinars, the readouts at the APEC Chemical Dialogue, and in the development of the outputs, drawing from existing information on gender and the chemical industry where appropriate (e.g., from the United Nations, the OECD, or the WTO). |
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| Work Plan |
This workshop is intended to build off previous efforts at SOM3 2019 in Chile (2019/SOM3/CD/020). |
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| Risks | Risk #1: Lack of participation by appropriate officials, namely chemical regulators, particularly from developing economies. Management Strategy: The PO will dedicate substantial effort to recruiting appropriate representation. The PO will seek support from the Regulators’ Forum as well as the Sub-Committee on Standards and Conformance (SCSC) to seek appropriate technical experts responsible for risk assessments for chemical substances in individual economies. Additionally, APEC funds will go almost exclusively to funding participation by APEC travel eligible regulators. Risk #2: Schedule conflicts, particularly due to August scheduling date, from sought speakers and experts Management Strategy: There are numerous international experts on regulatory cooperation and the PO will have a large pool from which to recruit. Because lessons can be learned from regulatory cooperation successes in other sectors, if there is unanticipated difficulty in recruiting from the chemical sector, then additional speakers with broader expertise can be sought. Risk #3: Limited access of project results (project reports and resources) in developing economies. Management Strategy: The PO will work closely with participants and industry to ensure that the project results get to the right people in developing economies and the knowledge, understanding, best practices are applied. The PO will organize an information sharing sessions at future Chemical Dialogue meetings regarding dissemination and application of the project outputs. Risk #4 Inability for participants to travel to an international meeting due to COVID-19. Management Strategy: Upon approval of this project proposal the PO will request a one year extension so that the date of the in person workshop can be delayed until 2022 and held on the margins of an APEC meeting cluster. |
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| Monitoring and Evaluation |
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| Linkages | Within APEC, the risk assessment workshop will support cross-fora collaboration by complementing the work – and demonstrating industry-specific best practices – of the broader GRP workstreams of the Economic Committee (EC) and the SCSC and their joint initiative to convene an annual conference on GRPs. The work will also build upon the CD’s “APEC Risk Assessment Training on Metals and Metal Compounds” (CD012014S) and “Regulatory Cooperation – Introductory Level Training on Risk Assessment to Provide Tools for the Development of Sound Chemical Regulations” (CTI052012). Should permission be granted, non-APEC ASEAN member economies will be invited to participate and share their experiences and best practices. |
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| Sustainability | Beneficiaries of the project will be supported by receiving the workshop outputs, including the Risk Assessment “Toolkit”, the APEC Guidelines for Risk Assessment in the Chemical Industry; and the Compendium of Risk Assessment Resources. Progress and next steps will be tracked through surveys conducted by the APEC Chemical Dialogue to understand knowledge growth and understanding of best practices and principles of risk assessment/management. The Chemical Dialogue could consider future capacity building projects on implementing the Guidelines in individual APEC developing economies and using risk assessments conducted by competent authorities in other economies. |
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| Project Overseers | The Project Overseers include: · Kent Shigetomi, Office of WTO and Multilateral Affairs, Office of the U.S. Trade Representative · Ed Brzytwa, Director, International Trade, American Chemistry Council The Project Overseers have considerable experience on Good Regulatory Practices, standards and conformance, and regulatory cooperation issues. They rely on the support of company representatives with expertise in risk assessments to implement the project and develop the outputs. |
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| Cost Efficiency | Not Applicable. |
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| Drawdown Timetable | Not Applicable. |
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| Direct Labour | Not Applicable. |
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| Waivers | Not Applicable. |
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| Are there any supporting document attached? | No | ||||||||||||||||||||||||||||||||||||||||||||||||