Project Title

Update of the APEC Baseline Study: Regulations of Products Derived from Innovative Agricultural Technologies and Identification of Ways to Promote Greater Efficiencies and Alignment 

Project Year

2017   

Project Number

HLPDAB 01 2017T 

Project Session

Session 2   

Project Type

Standard 

Project Status

Project in Implementation   
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Project No.

HLPDAB 01 2017T 

Project Title

Update of the APEC Baseline Study: Regulations of Products Derived from Innovative Agricultural Technologies and Identification of Ways to Promote Greater Efficiencies and Alignment 

Project Status

Project in Implementation 

Publication (if any)

 

Fund Account

TILF Special Account 

Sub-fund

None 

Project Year

2017 

Project Session

Session 2 

APEC Funding

25,000 

Co-funding Amount

25,000 

Total Project Value

50,000 

Sponsoring Forum

High Level Policy Dialogue on Agricultural Biotechnology (HLPDAB) 

Topics

Agriculture 

Committee

SOM Steering Committee on Economic and Technical Cooperation (SCE) 

Other Fora Involved

 

Other Non-APEC Stakeholders Involved

 

Proposing Economy(ies)

United States 

Co-Sponsoring Economies

Canada; Peru; Philippines 

Expected Start Date

01/12/2017 

Expected Completion Date

31/10/2018 

Project Proponent Name 1

Stacey Peckins 

Job Title 1

Senior Trade Advisor 

Organization 1

Foreign Agricultural Service, USDA 

Postal Address 1

1400 Independence Avenue, SW, Washington, DC 20233, USA 

Telephone 1

1-202 7208053 

Fax 1

Not Applicable 

Email 1

Stacey.Peckins@fas.usda.gov 

Project Proponent Name 2

Ann Katsiak 

Job Title 2

Chief of Party 

Organization 2

US-ATAARI 

Postal Address 2

Nathan Associates, 1777 N Kent Street, Suite 1400, Arlington, Va 22201, USA 

Telephone 2

1-202 7208053 

Fax 2

Not Applicable 

Email 2

akatsiaknathaninc.com 

Declaration

Stacey Peckins and Ann Katsiak 

Project Summary

This project arises from the APEC HLPDAB Terms of Reference along with an agreement made by economies at the APEC HLPDAB Meeting in Piura, Peru and concurred with in Can Tho. This project is to hire a consultant to update the Regulations of Products Derived from Innovative Agricultural Technologies: Baseline Review of APEC Member Economies; identify best practices among APEC economies and develop some tools to build upon the work of international fora and standards; finally, they will work with the forum to develop a roadmap detailing how economies can implement the best practices and tools identified. The ultimate goal is to promote greater alignment of APEC economies while making regulatory processes more efficient. The consultant would update and review the study, report on tools and best practices and work with the forum to incorporate the suggestions into a road map or work plan as a way to move forward.

Relevance

Based on many years of discussions within the forum and an agreement at the 2016 APEC HLPDAB Piura, Peru meeting, economies voted unanimously to develop a working group forum with the ultimate goal of creating more regulatory alignment and identification of best practices to decrease the regulatory burden of getting products from the developer to the farmer and ultimately in the hands of the consumer. All economies will have lasting benefits from the knowledge.

As background, as we enter the 3rd decade of the safe cultivation, consumption and use of agricultural biotechnology, APEC economies can draw on the collective experiences of over 26 countries and 18 million farmers.  As a forum the HLPDAB recognizes that innovation in agricultural through biotechnology can be revolutionary for APEC farmers and ranchers in providing them choices in production practices that can grow trade, increase farm incomes and build resiliency to resource constraints. From the Can Tho Food Security Statement: “We acknowledge that agricultural biotechnologies can be used as tools to enhance agricultural productivity, raise farm income, protect the environment, strengthen food security and mitigate against the impact of climate change. We will work together toward the promotion of transparent, science-based and functioning regulatory systems that allow the development, application and safe trade of innovative agricultural biotechnologies for the benefit of APEC member economies. We encourage the management of regulatory differences through the development of transparent and science-based solutions to global challenges.” Further, according to Crop Life International, in the last 20 years, advances in agricultural biotechnology for agricultural has allowed 16.5 million farmers to escape poverty and saved 132 million hectares of farm land of being over-cultivated. To further these advancements and implement the Can Tho Statement above, we propose hiring a consultant to gather information that will allow economies to document their regulatory experiences with agricultural biotechnology, identify opportunities for regulation harmonization while highlighting best practices and opportunities to where APEC economies might share resources.

This proposed study is focused around Rank 1 priorities. More specifically, the study aims to further the Rank 1 priority to advance “food production, processing, supply chain and trade, including food safety and security, sustainable agriculture, sustainability of these activities and rural development, technical cooperation and new technologies, as well as implementation of the Food Security Roadmap Towards 2020 and the Food Security Business Plan.” The study and consultant findings will assist APEC economies to work towards the Rank 1 priority of “standards, conformity assessment, technical regulations, regulatory cooperation, and regulatory coherence, including good regulatory practices.” Through the study, a consultant would review economies regulations and identify those that can promote greater efficiencies and alignment.  The work plan developed by the consultant would allow the forum working to focus its efforts and improve the collective understanding while more quickly develop practical solution to be used b APEC economies as they see fit.

Objectives

Update the APEC HLPDAB Study (completed in 2016 started in 2011): APEC Baseline Study: Regulations of Products Derived from Innovative Agricultural Technologies; 2) Identify ways (and tools) to promote greater efficiencies and alignment by exploring APEC economy’s’ policies, regulations, best practices, and trade of agricultural biotechnology along with other international for a and standards; and 3) Develop a work plan for the APEC HLPDAB forum incorporating 1) and 2) listed above including specific actions economies may take to implement the best practices and tools. The goal is to improve regulatory efficiencies which will increase the use of the technology to reap production, environmental and economic benefits for APEC economies. More broadly, the outcome is to promote transparent, science-based regulations in order to advance science and reap the benefits of agricultural innovation in the context of global trade with an emphasis on trade among APEC economies.

Alignment

From the Can Tho HLPDAB Statement: We acknowledge that agricultural biotechnologies can be used as tools to enhance agricultural productivity, raise farm income, protect the environment, strengthen food security and mitigate against the impact of climate change. We will work together toward the promotion of transparent, science-based and functioning regulatory systems that allow the development, application and safe trade of innovative agricultural biotechnologies for the benefit of APEC member economies.  We encourage the management of regulatory differences through the development of transparent and science-based solutions to global challenges, and the benefits of agricultural innovation in the context of global trade. In this endeavor, we recognize the need to build upon the work of international fora and existing international standards. In addition, APEC Leaders have noted the challenge of food security in their annual statements since 2010, including the acknowledgement of the role innovative agricultural technologies, including biotechnology, can play in efforts to ensure food security in member economies and around the globe. APEC Senior Officials continue to highlight the growing importance of technological development and dissemination to increase agricultural output, improve food distribution, decrease cost and help sustain output in the face of environmental and population growth challenges. This project falls under the Outreach and Capacity Building to Support the APEC Innovative Agricultural Technologies Initiative.  Aiming to advance products derived from innovative agricultural technologies as an important means to strengthen food security, raise farm income, foster innovation, spur economic growth, raise agricultural productivity, and protect the environment.

This project will support HLPDAB efforts toward fulfilling its objectives found in the APEC HLPDAB Terms of Reference:  Exchange information and promote capacity building regarding the responsible use, development and informed adoption of agricultural biotechnology as a tool to increase agricultural productivity, raise farm income, spur economic growth, protect the environment, mitigate and adjust to impacts of climate change, and to strengthen food security in the Asia-Pacific region. Promote transparent, science-based, and functioning regulatory systems to ensure safety and to facilitate investment in and the development and application of innovative biotechnologies. Build upon the work of international fora and existing international standards, such as the Codex Alimentarius Commission, to promote greater alignment of national standards with relevant international standards among APEC economies and public confidence in those systems. Support outreach and capacity building activities to help achieve above objectives.

TILF/ASF Justification

Advances in technology and widening use of agricultural biotechnology provide the opportunity for APEC economies to address worldwide challenges of food security, climate change, and sustainable agriculture. The success of these tools, are often limited by misinformed public communication and regulatory barriers. This workshop would bring together the policymakers and the private sector to discuss how to best facilitate regulatory reviews and reforms related to agricultural biotechnology. Relating to the Osaka Action Agenda, Part 1, Section C (10), the workshop will aim to enhance the transparency of regulatory regimes limiting access to, or research on, agricultural biotechnology. After the workshop, attendees would have a better understanding of how to ensure their policy and regulatory frameworks support the trade and development of innovative technologies and identify areas where biosafety regulations can support one another. This will further trade relationships for agricultural biotechnology and new plant breeding technologies to achieve broader APEC goals.

Beneficiaries and Outputs

Outputs: Describe products or services that the project will create. This may include workshop, reports, tools, research papers, recommendations, best practices, action plans etc.

The workshop will culminate in three outputs. An updated study, some tools and best practices and a HLPDAB workplan. The first output will be the  updated APEC Baseline Study: Regulations of Products Derived from Innovative Agricultural Technologies which was started in 2012 and completed in June of 2016. The study will be completed by a review of economy websites and a survey of economy regulators/policymakers to confirm the information. The content will be the same as the existing study which can be found on the APEC website through a link. The Table of Contents is as follows: Executive Summary;  Introduction;  Agricultural Biotechnology Regulatory Approach Matrices, by Member Economy; Conclusions & Next Steps; General References Illustrations/Figures: Elements of National Regulatory Approaches, Summary of Regulatory Reform Criteria; Tables: Global Cultivation of Biotech Crops by Area and by Country, Participation by APEC Member Economies in Relevant International Bodies, GMO Regulatory Index for  APEC Member Economies, Key Agricultural Biotechnology Guidelines, Regulations, Laws, and Directives in APEC Member Economies. The second output will be the identification of best practices or tools. We imagine that there will be less than a handful. that economies can use. These will be described in a second document.   Finally a draft work plan or road map will be drafted on how an economycan  implement these best practices and tools, if they desire.  APEC economies can use these tools/best practices to increase regulatory alignment, increase the number of products that are approved, and ultimately increase food security and trade while decreasing the use of scarce resources. The information will be reported at the HLPDAB meeting and if possible through a hands on workshop in 2018 and shared on the APEC HLPDAB website and through electronic messages.

Outcomes: Describe the specific changes the outputs are expected to achieve in the medium-term. What changes in policy, processes or behavior will the project lead to? 

Through this project we expect that the following would take place:

-       Promotion of transparent, science-based regulations to advance agricultural innovation in the context of global trade.

-       Enhance understanding of regulations of products derived from innovative agricultural technologies through the update of baseline review.

-       Improve information sharing and communication among members. Providing APEC economies with an updated study of each other’s regulations will increase understanding and knowledge.

-       Identify and provided opportunities for regulatory alignment (if more than one economy adopts a best practice or tool, this will lead to greater regulatory alignment).

-       Provide tools for saving resources and explore areas where data can be transported among APEC economies, decision-making documents can be standardized among APEC economies.  

-       Improve knowledge of where new agricultural and plant breeding techniques and products may fit into regulatory systems.

-       Improve the review process for new products.

-       Increase the linkage between APEC economies and their agricultural biotechnology industries (bothe public and private) and other international forums by providing examples of best practices/tools that other forums are using.

-       Increase the knowledge of APEC economies of international standards.

-       Surveys will be used to assess the use of the updated study and the best practices document. In addition, meeting (and possible workshop) sessions will be devoted to the implementation of the best practices and use of the study.

In the medium term we hope that all APEC economies will use some of the tools and or best practices (if not all of them) to make policy recommendations that will improve their regulatory systems. Further, if this is the result then improved regulatory alignment would take place among APEC economies along with the promotion of transparent, science-based regulations. In this endeavor, we recognize the need to build upon the work of international fora and existing international standards by implementing best practices and tools that are in current use. Finally, we would hope that actually producing some tools and best practices where there use would be explored through the APEC HLPDAB work plan would be a draw to attract greater and more robust participation in the forum.

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?

The direct project beneficiaries will include regulators, policy makers, industry (including exporters, importers, and private sector developers or producers of biotechnology)and/or public sector technology developers from APEC economies who will be able to apply the best practices and tools to their regulatory review process. Most of the regulators and public sector developers hold PHDs and policymakers are typically well established officials in their government ministries and/or regulatory agencies. They are responsible for developing and implementing regulations and policy related to emerging innovative agricultural technologies in their economy.  As appropriate, economies may wish to consider nomination of representatives from their private sector and/or academia who are active in innovative technologies.

Down the road, improving the efficiency in regulatory approval will allow more products to be cultivated that will lead to increase food security; decrease use of scarce resources used and increase in trade for APEC Economies. The International Service for the Acquisition of Agri-Biotech Applications (ISAAA) recently announced that, since 1996, over 2 billion hectares of arable land have been planted using biotech crops. This is a dramatic increase from 1996 and this growth suggests that the technology is effective and the world’s farmers are witnessing results.  Over the last two decades, farmers in 28 countries have seen $150 billion dollars in benefits from biotech crops and the technology has played a large role in alleviating poverty for 16.5 million small-scale farmers.  Of the 28 countries who plant biotech crops, 20 of them are considered developing countries. (ISAAA 2015 Report, 4/27/2016)  GE crops can make farming more profitable by increasing crop quality and may in some cases increase yields. The use of some of these crops can simplify work and improve safety for farmers. This allows farmers to spend less of their time managing their crops and more time on other profitable activities.

GE technology provides farmers with tools that can make production cheaper and more manageable.  For example, some GE crops can be engineered to tolerate specific herbicides, which make weed control simpler and more efficient. Herbicide-tolerant crops are particularly compatible with no-till or reduced tillage agriculture systems that help preserve topsoil from erosion. Other crops have been engineered to be resistant to specific plant diseases and insect pests, which can make pest control more reliable and effective, and/or can decrease the use of synthetic pesticides. These crop production options can help countries keep pace with demands for food while reducing production costs.

Many other types of GE crops are now in the research and development stages. While it is not possible to know exactly which will come to fruition, certainly GE technology will have highly varied uses for agriculture in the future.  Advances in GE technology may provide consumers with foods that are nutritionally-enriched or longer-lasting, or that contain lower levels of certain naturally occurring toxicants present in some food plants. Developers are using GE technology to try to reduce saturated fats in cooking oils, reduce allergens in foods, and increase disease-fighting nutrients in foods.

Dissemination

The updated study, the report on the identification of best practices and tools to share resources along with the work plan will be shared through the APEC Secretariat’s HLPDAB email list and on the APEC HLPDAB website. In addition, project overseers will have the consultant attend the APEC HLPDAB next meeting or workshop to present the results of their work. The APEC HLPDAB contact list individuals will be encouraged to share the information received through email, on the website and gained at the workshop with their colleagues. Ultimately, the information gained at the HLPDAB workshop will assist attendees with developing policies and programs that will benefit their farmers and consumers. The target audience is policy makers and regulators in APEC economies.

Further, as part of the work plan, HLPDAB members could be encouraged to further share the information contained in the final report as an advocacy tool in their discussions with other economies on biotechnology, including in forums like ASEAN and other regional trade forums, along with FAO, OECD, and GLI.

Gender

The consultant will encourage economies to provide at least one-half of their interviewees be female. As a result, the expected percentage gender breakdown is 50/50 for input to the study/report. If there is a workshop to roll out the updated study, best practices and tools for regulatory alignment economies will be strongly encouraged to consider qualified female participants in their nominations. The consultant will also aim to explicitly discuss gender implications for topics where relevant, such as discussing farming technologies. We will also make the consultant aware and  appreciate that, in APEC economies, women make up a large percentage of the farmer and consumer population, so in the long-term, advancements made through increased trade of innovative technologies to help food security will have a multiplied benefit for women and their communities.

Work Plan

This project seeks funding to hire a consultant to update the APEC Baseline Study: Regulations of Products Derived from Innovative Agricultural Technologies and then to identify ways to promote greater efficiencies and alignment within APEC economies as well as determine best practices and tools that can be shared with APEC economies. 

Time

Tasks

Deliverables

Dec-17

The Project Overseers will work to finalize the Statement of Work for the consultant.

Statement of Work

Feb-18

Consultant Hired; Consultant contact information shared with forum members and vice versa.

Background information provided to consultant by HLPDAB forum members and project overseers. Public and Private Sector Developers and Industry contacts collected from forum members by consultant.

February 2018 to June 2018

Consultant updates study through research and contact with APEC economies. Consultant reaches out to developers/industry for their input. Consultant surveys international organizations and requests from HLPDAB their best practices and existing tools.

Updated study. Best practices/tools document. Draft work plan with best practices to Project Overseers.

Jul-18

The Project Overseers will review the final study, best practices/tools and work plan to ensure that the consultant has successfully completed their work. Consultant works with APEC economies to finalize work plan and seek comments/concerns with the best practices and developed tools.

Final draft study, best practices document and work plan prepared.

Aug-18

Consultant will present updated study, best practices document and the work plan to the APEC HLPDAB meeting/workshop. Pre and post- meeting surveys will be conducted by project overseers.

Forum discusses three final documents. Survey pre and post meeting to compare usefulness, knowledge gained at meeting.

August 2018 to October 2018

Consultant will finalize study, and best practices document. Project overseers will compile and compare pre and post surveys.

Consultant will share final study and best practices document. Forum members, host and chair PNG will finalize work plan. Pre and post meeting surveys distributed to forum members.

Oct-18

Prepare completion report.

The Project Overseers will submit a Project Completion Report to the APEC Secretariat

2/1/2019  to March 31, 2019

6-month survey of forum members conducted to determine use and potential of study and best practices.

Results of survey shared.

Aug-19

Impact of study/best practices discussed at APEC HLPDAB Meeting in Chile

Work plan revised accordingly.

August 2019 to September 2019

One year survey of members conducted to determine use of study and best practices.

Applications shared.

Risks

The risks for this project include:

1) Risk: Hired consultant is not up to task.

Risk mitigation: Thorough vetting of consultant’s credentials will ensure the consultant is up to task.

2)   Risk: Low participation by APEC economies in response to consultant’s inquiries.

3) Risk mitigation: The organizers will conduct outreach to participants to ensure they are actively engaged.

4)  Risk: Consultant abandons the project for one or more reasons.

Risk mitigation: The Statement of Work will be structured to include performance based elements that can be completed independent of each other. This would allow for less disruption if the consultant was unable to complete the entire project.

5) Risk: The work plan is that the survey does not result in any use of best practices by APEC economies. Risk mitigation: The work plan should identify tools and approaches that facilitate the adoption of best practices.

Monitoring and Evaluation

The consultants work will benefit from five different types of survey measures to monitor its effectiveness: 1. a survey of APEC HLPDAB APEC economies to be conducted at the start of the APEC HLPDAB 2018 meeting on the quality of the work plan, best practices and tools, and updated study 2. a knowledge-gained survey to determine attendees’ perceptions of the work plan, best practices and tools, and updated study  after attending the meeting/ (on-site); 3. a questionnaire filled out after six months after the 2018 APEC HLPDAB to determine the use and relevance of the tools, best practices and updated study along with progress made on the work plan; and 4. a follow-up survey one-year after the 2018 APEC HLPDAB  concludes sent via email to understand the level of continued relevance and use; and finally 5. include a session at the following HLPDAB on the results of the project could provide opportunities to further assess the impact. All surveys will be provided to all APEC member economies(with only one response per economy). We expect a completion of 15 for each survey but will target all APEC economies for participation.Results of surveys 3 and 4 will be compiled by project overseers and distributed via email by the APEC Secretariat and highlights shared on the APEC website. For 5. Above the meeting minutes will provide forum members with the results of the discussion along with inputs into future work plans.

The indicators for this project are provided below and will be disaggregated by economy and sex:

·  Percentage of survey participants (we will only count one response per economy) who state that their capacity has increased as a result of the updated study, best practices, and tools while at the meeting/workshop (data source: survey 1 and 2);

·  Percentage survey participants (we will only count one response per economy) responding that they applied trade and investment liberalization practices for new technologies as a result of the updated study, best practices, and tools after six months (data source: survey 3, 4); and

·  Percentage of participants who respond that changes in their home economies’ regulations, laws, or processes were influenced (data source: survey 3 ,4).

Based on the results gathered from the monitoring efforts, project organizers will work with APEC HLPDAB forum to focus the work plan and enact recommendations provided in survey 2, 3 and 4.

Linkages

This project stems from discussions at the last two APEC HLPDAB meetings and workshops which included discussions with not only government policymakers and regulators but also farmers, developers, industry, academia and other international forums (FAO, OECD) as to how to best improve the regulatory systems to get more products from field to fork. This project builds on five years of previous meetings and workshops in Indonesia (2013), China (2014), and The Philippines (2015), Peru (2016), and Viet Nam (2017) without duplication to advance the use of agricultural biotechnology across the APEC region. The resulting APEC HLPDAB work plan should identify connections with other APEC priorities and groups, such as the Policy Partnership on Food Security, as increased agricultural production through biotechnology can help economies to secure more food and assist in lessening malnutrition.

APEC is the most appropriate forum to implement this project because the proposal responds to APEC’s priorities of utilizing new technologies to advance food security and increase agricultural production. Based on the success of the initiative, the HLPDAB could recommend that this project be shared with other forum within APEC as a best practice.

Sustainability

The project will continue to have an impact through APEC economy use of the best practices, updated study and tools designed by the consultant and used as the basis for developing a robust work plan. After the consultant delivers the results of their work, it will be up to APEC economies to ensure the best practices and tools are shared with their colleagues and put into practice. In addition, the best practices and tools will be shared on the APEC HLPDAB website and the APEC Secretariat will mail them out to the HLPDAB contact list. This will allow economies to more easily share the best practices and tools to disseminate to their home economy stakeholders, extending the reach of the project beyond meeting/workshop attendees.

As discussed in the monitoring and evaluation section the impact will be measured by a six-month and one-year follow-up survey delivered via email to APEC economies. Finally, by incorporating the tools and best practices into the APEC HLPDAB work plan it will ensure that future actions will take place in achieving the projects goals which are the same as the forums goals:  The goal of the HLPDAB is for policy makers in APEC’s 21-member economies to exchange information, encourage capacity building, and promote public policy development to support the responsible use, development and informed adoption of innovative agricultural biotechnology as a tool to increase agricultural productivity, raise farm income and farmer’s welfare, spur economic growth, protect the environment, mitigate and adjust to impacts of climate change, and to strengthen food security in the Asia-Pacific region.

Project Overseers

The two Project Overseers for this project are:

·   Ms. Stacey Peckins is a Senior Trade Advisor for the New Technologies and Production Methods Division, Office of Agreements and Scientific Affairs at the United States Department of Agriculture, Foreign Agricultural Service. In this capacity, Ms. Peckins handles the United States’ participation in APEC under the HLPDAB.

·  Ms. Ann Katsiak is the Chief of Party for the US-APEC Technical Assistance to Advance Regional Integration (US-ATAARI) activity. In this capacity, she serves as the facilitator for US-ATAARI activities across APEC fora and working groups.

Cost Efficiency

Not Applicable.

Drawdown Timetable

Not Applicable.

Direct Labour

Not Applicable.

Waivers

Not Applicable.

Are there any supporting document attached?

No 
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Project No.

Project Title

Project Status

Publication (if any)

Fund Account

Sub-fund

Project Year

Project Session

APEC Funding

Co-funding Amount

Total Project Value

Sponsoring Forum

Topics

Committee

Other Fora Involved

Other Non-APEC Stakeholders Involved

Proposing Economy(ies)

Co-Sponsoring Economies

Expected Start Date

Expected Completion Date

Project Proponent Name 1

Job Title 1

Organization 1

Postal Address 1

Telephone 1

Fax 1

Email 1

Project Proponent Name 2

Job Title 2

Organization 2

Postal Address 2

Telephone 2

Fax 2

Email 2

Declaration

Project Summary

Relevance

Objectives

Alignment

TILF/ASF Justification

Beneficiaries and Outputs

Dissemination

Gender

Work Plan

Risks

Monitoring and Evaluation

Linkages

Sustainability

Project Overseers

Cost Efficiency

Drawdown Timetable

Direct Labour

Waivers

Are there any supporting document attached?

hdFldAdmin

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Secretariat Comments

Reprogramming Notes

Consolidated QAF

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PD Sign Off

Batch

Forum Priority

Committee Ranking Category

Committee Priority

PDM Priority

Priority Within Funding Category

Monitoring Report Received

Completion Report Received

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PMU Field 3

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