Project Title

Harmonization of Maximum Residue Limit (MRL) Setting Process in the Asian Region through Training on Pesticide Residue Evaluation 

Project Year

2016   

Project Number

CTI 32 2016T 

Project Session

Session 2   

Project Type

Standard 

Project Status

Project in Implementation   
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Project No.

CTI 32 2016T 

Project Title

Harmonization of Maximum Residue Limit (MRL) Setting Process in the Asian Region through Training on Pesticide Residue Evaluation 

Project Status

Project in Implementation 

Publication (if any)

 

Fund Account

TILF Special Account 

Sub-fund

None 

Project Year

2016 

Project Session

Session 2 

APEC Funding

91,000 

Co-funding Amount

143,139 

Total Project Value

234,139 

Sponsoring Forum

Sub-Committee on Standards and Conformance (SCSC) 

Topics

Conformance; Standards 

Committee

Committee on Trade and Investment (CTI) 

Other Fora Involved

 

Other Non-APEC Stakeholders Involved

 

Proposing Economy(ies)

Japan 

Co-Sponsoring Economies

Malaysia; Singapore; Thailand 

Expected Start Date

15/12/2016 

Expected Completion Date

15/03/2017 

Project Proponent Name 1

Dr Yukiko Yamada (new PO wef 19 July 2017) 

Job Title 1

Advisor to Vice-Minister 

Organization 1

Ministry of Agriculture, Forestry and Fisheries 

Postal Address 1

1-2-1 Kasumigaseki, Tokyo, 100-8950 Japan 

Telephone 1

81-3 35025969 

Fax 1

Not Applicable 

Email 1

yukiko_yamada530@maff.go.jp 

Project Proponent Name 2

Not Applicable 

Job Title 2

Not Applicable 

Organization 2

Not Applicable 

Postal Address 2

Not Applicable 

Telephone 2

Not Applicable 

Fax 2

Not Applicable 

Email 2

Not Applicable 

Declaration

Dr Yukiko Yamada 

Project Summary

Safe and efficacious pesticides are indispensable for ensuring stable supply of foods of plant origin. Such pesticides are also useful for improving the quality of food commodities.

For better access to new and safer pesticides, one of the best ways is to participate in the Global Joint Review (GJR), developed in relation to the OECD Pesticide Programme. A limited number of economies have so far participated in GJR due to the limited availability of evaluation capabilities. It is therefore necessary to build the capacity to evaluate pesticide residues using scientific and globally harmonized methodology.

This project, through three seminars conducted in Southeast Asia and Japan during the first quarter of 2017, provides training, targeting regulatory officials, on residue evaluation. Expedited registration of new pesticide and establishment of comparable Maximum Residue Limits (MRLs) would promote the public health, agricultural production and trade and economy of the region.

Relevance

In view of the growingly tight food supply situation, it is clear that safe and efficacious pesticides are becoming more and more important for the global food security. In response to the development of pesticide resistance in plant pests and in order to address concerns over adverse effects on human health and the environment, new pesticides are constantly developed. In order for farmers to enjoy the benefits of such new pesticides, the pesticides need to be registered in each economy.

In order to gain access to markets of as many economies as possible with minimum time and costs, pesticide manufactures are increasingly expressing preference for work sharing activities, such as the “Global Joint Review (GJR)”, which has been developed in relation to the OECD Pesticide Programme, with a view to internationally harmonized and synchronized registration of pesticides. However, due to the limited availability of evaluation capabilities, participation in GJR has so far been limited to a small number of developed economies.

In order to improve such situations, this project provides training on the evaluation of pesticide residues in foods, targeting regulatory officials in Southeast Asian economies. Prompt registration of new pesticides and establishment of comparable MRLs, through the introduction of scientific and globally harmonized pesticide residue evaluation, will have positive impacts on the public health, agricultural production and global trade, within the region and with other regions. New and safer pesticides would reduce the occupational health risks of farmers. Participation of ASEAN economies in GJR would lead to the establishment of MRLs on important commodities not only for the region but also for the global trade.

This project falls under Rank1 in the APEC Funding Criteria in 2016. The participation in the GJR of pesticides, to be achieved through this project, in itself the “regulatory cooperation” related to “standards, technical regulations and conformity assessment”. The prompt access to new pesticides as a result of GJR and the strengthened capacity of pesticide residue evaluation would contribute to the improvement of “food safety” in the region. Establishment of harmonized MRLs for important commodities for the region would contribute to “regional economic integration”, removing the chances of non-tariff barriers to trade of these commodities.

Objectives

1) to enable the trainees to derive MRLs compatible with good agricultural practice and to confirm the safety of the MRLs through dietary exposure assessment, resulting in positive impacts on the public health and farm income through increased productivity and trade.

2) to familiarize the trainees with the process and benefits of GJR.

(3) to share the experiences of economies that have participated in GJR, which will help other economies prepare for future participation in GJR.

Alignment

At the First APEC Ministerial Meeting on Food Security in Niigata, Japan, 16-17 October 2010, APEC Ministers responsible for food security recognized that:

”APEC economies should work together to facilitate improved agricultural trade … and ensure food safety in the region in cooperation with key stakeholders.”

and, in this regard, agreed on

“the need to sustain the benefits of globalization and open markets, highlighting the crucial importance of encouraging science-based standards, rejecting protectionism and the development of regionally integrated markets.”

Consequently, it was also agreed that:

“Building the capacity of economies to produce, access, and distribute safe food, as well as developing appropriate food safety regulation, is an integral element of food security.”

(Niigata Declaration on APEC Food Security, paras 13, 15 and 18)

The key activity of this project is the capacity building concerning the evaluation of pesticide residues with a view to introduce science-based and internationally harmonized methodologies. Namely, the project will enhance “skills and human resource capacities to enable the development of national food safety regulatory frameworks that are harmonised to the extent possible, with international standards”, one of the strategic goals of the FSCF agreed in 2007.  Enhanced participation of Southeast Asian economies in GJR will contribute to the prompt access to new pesticides and establishment of globally harmonized MRLs, which will lead to the elimination of non-tariff barriers to trade and improvement of food safety and security.

TILF/ASF Justification

The project will help APEC economies follow-up the trade liberalization and facilitation goals in the Osaka Action Agenda, in particular in the areas of “Standards and Conformance” (Part 1, Section C 5.) and “Deregulation/Regulatory Review and Reform” (Part 1, Section C 10.).

Although the establishment of pesticides MRLs will continue to be in the hands of individual economies, the internationally harmonized methodologies for the evaluation of pesticide residues, which is to be introduced through this project, will promote the establishment of domestic MRLs substantially aligned with Codex MRLs, provided that the same set of data are submitted. As the capacity of residue evaluation builds up in the economies through this project, these economies will become able to actively participate in standard setting activities in the Codex Committee on Pesticide Residues and send experts to the Joint FAO/WHO Meeting on Pesticide Residues (JMPR).

The internationally harmonized methodologies for pesticide residue evaluation, such as those adopted by the JMPR, have been developed during the last several decades since the introduction of synthetic pesticides. In several developing economies, while systems to monitor pesticide residues in foods have been introduced, evaluation of pesticide residues to register pesticide products and establish MRLs has not yet modernized and streamlined. These situations have led to frequent shipping back or destruction of agricultural products which have found to contain new pesticides that are not yet registered in the importing economies. This project, through the training of officers involved in pesticide registration, is expected to bring about reforms in the pesticide regulation of participating economies, which may in the long run enable their participation in GJRs, thus reducing the possibilities of pesticide-related trade restrictions.

Beneficiaries and Outputs

Outputs: The outputs of the project are three series of seminars, providing training on the evaluation of pesticide residues, with particular focus on dietary exposure assessment. The training would comprise both lectures and practical exercises.

At the end of the seminar, participants are expected to;

-  understand the process of toxicological evaluation;

-  identify supervised residue trials that can be used to support pesticide registration;

-  estimate the amount of pesticide ingested as residues in foods and compare it with relevant toxicological reference values;

-  propose pesticide MRLs; and

-  understand the process of GJR and modes of participation.

The Seminar also provides, as appropriate, opportunities for learning from experiences of economies that have already participated in GJRs, including actions taken to enable participation, such as amendments of regulations and guidelines concerning pesticide registration and capacity building. This will help other economies prepare similar action plans.

Outcomes: It is expected that seminar participants would act as proponents of globally harmonized methodologies of pesticide residue evaluation in respective economies. Although training in a one-week seminar would not be sufficient to achieve a comprehensive understanding of the topic, seminar participants will certainly realize the logic and processes of pesticide residue evaluation adopted by the JMPR and developed economies, as well as their advantage and importance for the protection of consumer health and the stable agricultural production. Reference materials introduced during the seminar, as well as relevant regulations and guidelines available on the websites of international organizations and regulatory agencies of developed economies, would serve as good models when considering the reform of evaluation methodologies for pesticide registration in respective economies.

Although reforms of pesticide registration systems requiring changes in legislation might not be achievable even in the medium-term, recent few years of experience of cooperation with ASEAN economies in related areas has indicated that the overall framework for pesticide registration has been well established in several economies in the region. It is therefore expected that the globally harmonized methodologies of pesticide residue evaluation could be taken up by the economies within the medium-term through the revisions and amendments of relevant regulations and guidelines, provided that a sufficient number of competent staffs are secured in time.

Even before the reform of pesticide registration systems, economies may choose to participate in GJRs as observers, once its benefit is understood by the management of regulatory agencies. Participation as observers would provide a great opportunity for close observation of the evaluation processes adopted by other economies and on-the-job training of evaluation officers. The experiences and information gained through the participation in the GJR as observers would in the long run contribute to the adoption of globally harmonized evaluation methodologies and full participation in GJRs.

At least, it would not be overly optimistic to expect that the participation in the seminars or reports by the participants would bring impetus for further learning in respective regulatory agencies. Concrete actions could include planning/requests for the conduct of a similar training course or formation of an inner study group to examine assessment reports of JMPR or developed economies or to investigate the regulations of other economies that have introduced globally harmonized methodologies for pesticide evaluation.

Beneficiaries: Direct project participants would be experts currently involved in governmental activities for MRL setting and pesticide registration or closely related areas, who are expected to use the knowledge and experiences gained from the projects to improve the quality and efficiency of pesticide evaluation. In order to ensure active participation in the training seminars and best use of the outputs, participants should have working-level proficiency in English and more than eight years of work experience.

 In principle, experts shall be nominated by economies with hot and humid climates and widespread rice production in paddy fields, for example, Southeast Asian economies.  Such agro-climatic conditions create specific needs for pesticides, different from those in developed economies in the temperate to cold climate zones producing mainly wheat as the staple foods, where most of new pesticides are developed and introduced. In order to address the specific needs, it is required to register pesticides and establish MRLs based on the studies conducted in appropriate regions.

Other beneficiaries of the project would be farmers and consumers, with faster access to efficacious and low-risk pesticides and stable supply of safe foods, to be aided by the introduction of globally harmonized methodologies of pesticide evaluation. Enhanced productivity and export of regionally important crops and farm income will have positive impacts on the economy of the region as a whole.

Dissemination

The major outputs of the project are training seminars, critical components of which are practical exercises, where participants can deepen the understanding of evaluation methodologies by testing how they work with real examples and by listening to various issues experienced by the lecturer during recent JMPR evaluations. Therefore, the outputs cannot be reproduced by means of electronic or paper publications.

On the other hand, as an outcome of this project, seminar participants are expected to disseminate the importance and merits of introducing globally harmonized evaluation procedures within respective regulatory agencies. When detailed information becomes necessary during such activities, JMPR Training Manual can be referenced. While the contents of the training seminars by this project would be chosen to fit into the duration of five days, the Training Manual (available from the FAO website) covers all the steps of pesticide residue evaluation.

Summaries of each seminar and the entire project, as well as any lessons learned, shall be prepared in English and can be shared with interested economies upon request.

Gender

Seminar participants shall be nominated by regulatory agencies of participating economies on the basis of working experiences in related areas and proficiencies in English. Participating economies are encouraged to ensure that the genders of the nominated persons are in proportion to the gender ratios of experts working in related areas, provided that there are enough numbers of eligible persons of each gender. Please also note that one of the staffs supporting the PO is female and that she would be in charge of the practical operation of the project.

Women of child-bearing age are particularly vulnerable in terms of risks posed by pesticide residues in foods. The introduction of globally harmonized evaluation methodologies and participation in GJRs would have positive impacts on the registration of newly developed pesticides, which tend to be less toxic to humans than currently used old ones, and contribute to the protection of the health of consumers, particularly women of child-bearing age.

It should also be noted that female labor is relatively important in the agricultural production in Asia. According to a working paper prepared by FAO, shares of female labor are relatively high in weeding and harvesting, while plowing is largely dominated by male labor. This means that women in rural areas in Asia might be at higher risk of intoxication by pesticides through dermal or inhalational exposure on fields and would benefit from new and safer pesticides more than men.

Work Plan

It is proposed to conduct three series of seminars in two cities in Southeast Asia and in Tokyo, programs of which are in principle the same. Agricultural Chemicals Office, Plant Production Safety Division, Food Safety and Consumer Affairs Bureau of MAFF itself conducts the preparation stage of the project, namely, tentative decision on venues and schedules of the seminars and request for the nomination of participants. No expenditure is foreseen before the notification of BMC Decision and subsequent conclusion of a contract. Should this project fail to obtain approval, the seminars will still be held but on a smaller scale.

1. Confirmation of willingness to hold the training seminar (by the end of October)

Letters to confirm the willingness to hold the training seminar in cooperation with the proposing economy are sent to relevant economies. Financial and/or in-kind contributions expected from these economies are clarified in these letters. These economies are in reply requested to indicate possible dates of seminars. (So far, Malaysia and Thailand have expressed willingness. Venues will be selected considering accessibility from international airports.) 

2. Tendering process to decide the contractor to conduct the seminars (by the end of November)

The contractor to conduct the seminars is selected through a tendering system. In response to the request for proposal, bidders should indicate the program of the seminars and candidates for lecturers. Since the success of the seminars is for the most part dependent on the lecturers, there are a few requirements for their qualifications: an expert in pesticide residue evaluation listed on the “JMPR Roaster of Experts” or with equivalent expertize and proficiency in English to allow stress-free communication on highly technical and complicated matters. As the case may be, additional lecturer(s) may be assigned to cover specific areas such as toxicological evaluation. 

3. Tentative decision on venues and schedules for the seminars (by the end of November)

Venues and schedules of the seminars are tentatively decided based on the availability of the venues proposed by the relevant economies and availability of the lecturer(s) proposed by the contractor. Tentative decision is made at this stage in order to allow participating economies to nominate participants having regard to their job schedules. (The decision becomes final after the conclusion of contract and when invitations are sent out by the contractor.) 

4. Nomination of Participants (by the end of December)

In accordance with the criteria explained above, regulatory agencies of participating economies nominate seminar participants. Curricula vitae of nominated persons are submitted to the Project Overseer. 

5. Conclusion of a contract for the conduct of seminars (by the end of December)

In accordance with the administrative procedures of Ministry of Agriculture, Forestry and Fisheries of Japan (MAFF), contract documents are prepared for acceptance by both sides. 

6. Invitation and agenda for the seminars (by mid-January)

After consultation with the lecturer(s) and upon confirmation of venue availability by the economies hosting the seminars, the contractor finalizes the agenda for the seminars and send it to the nominated persons along with an invitation letter. 

7. Arrangement for travel of participants and lecturer(s) (by the end of January)

Participants prepare passports and visas necessary to attend the seminar. The economies hosting the seminars provide, as appropriate, any assistance to streamline the visa application processes. The contractor purchases flight tickets for participants travelling from other economies and lecturer(s) and reserve hotel accommodations for them. 

8. Conduct of Seminars (February)

With the logistical supports of the contractor and the hosting economies, the lecturer runs the seminars. 

9. Reporting

The contractor submits the completion report by early March to MAFF. Subsequently, the APEC project report is prepared and submitted by the proposing economy. 

10. Post-training survey

In order to assess the impacts of the seminars, questionnaire surveys will be conducted approximately one year after the seminars, where participating economies will be asked to report any activities to disseminate the knowledge and information acquired through the seminar and to hold a similar training course in respective regulatory agencies.

Risks

Although there is no identifiable significant risk to this project, there is a possibility that three seminars may not fit into the short period of the above-mentioned project schedule. If one of the seminars cannot be arranged by the end of February 2017, it should be rescheduled after April and before November 2017 in order to allow expenditure by the MAFF budget for the Fiscal Year 2017 (starting from 1 April 2017). If this is the case, relevant changes are immediately reported to the APEC Secretariat.

In case one lecturer cannot cover the entire seminars to be held by this project, another lecturer with a similar level of knowledge and experiences in dietary exposure assessment of pesticides will be appointed. This will not affect the total project budget because the honorarium of USD 20,000 is to cover the work of the lecturer for three series of seminars including preparations.

Monitoring and Evaluation

Progress of the project: The planning stage of the project is run by a unit under the direct supervision by the Project Overseer. After the project is contracted out, its progress is monitored through regular reporting and consultation by the contactor. It will be checked if the preparations for the seminars are as scheduled. In case of any delay, its impact on the conduct of seminars will be assessed to see if any additional action is necessary.

Impacts of the project: The direct impact of the project is the improvement of the capacity of experts in Southeast Asian economies to conduct pesticide residue evaluation. Degrees of impacts in this respect will be monitored through the answers to the evaluation forms to be submitted by seminar participants, who will be asked if the seminar has added to their knowledge and understanding of the topics.

The long-term impact of the project is the introduction of globally harmonized methodologies for pesticide residue evaluation by the regulatory agencies of participating economies. Since such changes may not be easily observable, instead, any activities to disseminate the knowledge and information in the regulatory agencies of the participating economies, including debriefing or back-to-office report by seminar participants, will be monitored. Participating economies will be asked to report such activities one year after the seminar.

Indicators: Through three series of seminars, approximately 30 participants representing at least five developing economies will receive training concerning the globally harmonized methodologies of pesticide residue evaluation.

Linkages

This project will add to the ongoing efforts under the FSCF Action Plan to Implement the APEC Regulatory Cooperation Plan, aiming at the alignment of national and international pesticide MRLs, through enhanced participation of the APEC economies in work sharing in MRL setting. In particular, this project will build on the Guideline for the Harmonisation of Pesticide MRLs for Imported Foods within APEC Economies. While exposure to pesticides used outside the economy will be evaluated for the establishment of import tolerances, evaluation processes after the level of pesticide residues are determined for each commodity is basically the same with the evaluation of pesticides for registration in the economy. The relation of this project with the recent activities of the Wine Regulatory Forum is similar, in that pesticide residues in wine grapes will be for the most part regulated as import tolerances in ASEAN economies, without significant production of wine grapes. Concerning the second pilot project on pesticide MRLs for mangoes after those for wine grapes, ASEAN economies are expected to take on more active roles, including proposing MRLs on the basis of supervised residue trials consistent with the economy’s GAP, Those involved in the pilot project in ASEAN economies may be nominated as the trainee of this project. Progress of this project will be reported during the FSCF meeting to be held at the margins of SOM2 in order to seek possibilities for better coordination with these related activities.

ASEAN economies are currently involved in the establishment of ASEAN MRLs in order to promote the harmonization of pesticide MRLs applied in each economy. While the ASEAN MRLs tend to be established for relatively old pesticides that are widely used among different ASEAN economies, this project intends to strengthen the capacities of ASEAN economies in evaluating new pesticides, which may improve the productivities of agricultural sectors in the Region.ASEAN shares and supports the APEC objectives and its Secretariat is the official observer of the APEC. Conduct of the training seminars as an APEC project not only financially enables broader participation from ASEAN economies but also sends a strong signal to these economies to consider active participation.

It should be noted that the Secretariat of the WTO/SPS organized a workshop on pesticide MRLs on 24-25 October 2016, which highlighted the role of Codex as the single international food standard setting body recognized by the SPS agreement and challenges and efforts concerning the implementation of Codex MRLs in developing economies. The SPS agreement requires WTO Members to “play a full part, within the limits of their resources”, in the relevant international organizations in order to promote the development of international standards, guideline and recommendations. This project, through the capacity building of expert involved in pesticide registration and MRL setting in each economy, may contribute to enhanced participation of relevant economies in the international MRL setting process in the Codex.

Sustainability

In order to ensure that the project has long-lasting impacts on the capacity of relevant regulatory agencies, participating economies are encouraged, in nominating candidates for seminar participants, to consider the period each candidate can serve as an evaluator. Namely, instead of high-ranking officials in charge of management, relatively young staffs actually evaluating study reports submitted by pesticide manufacturer will be preferred.

Seminar participants, the direct beneficiaries of this project, are expected to disseminate the knowledge and information acquired through the seminars, for example in the form of debriefing and back-to-office reports. When the advantages and necessities of the globally harmonized methodologies for pesticide residue evaluation become understood by the management of regulatory agencies of participating economies, relevant actions should follow, including but not limited to reforms of pesticide registration systems and participation in GJRs as an observer.

Although follow-up actions taken are up to each economy and out of control of the proposing economy, in order to ensure that efforts are made by seminar participants to share the knowledge and information within each organization, participating economies will be asked to report such actions one year after the seminars. Ideally, seminar participants should serve as trainers, but it would not be possible in a short term. In order to be able to give lectures and oversee exercises, experiences in pesticide residue evaluation using globally harmonized methodologies will be essential. Training of trainers could be considered in a second phase of this project in the future.

Project Overseers

Mr Toru FURUHATA, the Project Overseer, is the Director of the Agricultural Chemicals Office, Plant Production Safety Division, Food Safety and Consumer Affairs Bureau of the Ministry of Agriculture, Forestry and Fisheries of Japan and responsible for the overall management of the project.

Mr Masashi KUSUKAWA (masashi_kusukawa470@maff.go.jp), Deputy Director of the Agricultural Chemicals Office, is in charge of liaison with APEC Secretariat and project implementation under the supervision of PO.

Ms Maki TERAWAKI (maki_terawaki870@maff.go.jp), staff of the same office, is in charge of supervision of the contractor and daily communication with seminar participants for the smooth operation of the project.

Cost Efficiency

Not Applicable.

Drawdown Timetable

Not Applicable.

Direct Labour

Not Applicable.

Waivers

Group exercises are an integral part of the proposed seminar. In order to maximize the effectiveness, the exercises need to be interactive, where the lecturer will check the progress of each group and provide advice upon requests and the result of group work will be presented at the end of each session. This design naturally limits the number of participants manageable by a single lecturer. Taking the example of the similar seminar we held last year, there were 12 participants from 6 economies.

This is why we have set the size of seminar to approximately 10 participants each. Since the number of participants per economy and the number of participating economies are not decided at this stage, no breakdowns of participants are indicated in the Notes. Tentative decision on venues and schedules for the seminars by the end of November and nomination of Participants are planned by the end of December (see p5). 

Please note that this project focuses on the Southeast Asia Region because of the geographic proximity to minimize the travel costs of participants, similarity in agricultural production involving paddy rice cultivation and existing efforts of intra-regional regulatory cooperation. Although direct beneficiaries are experts working in related areas in Southeast Asian economies, accelerated introduction of new and safe pesticides in these economies, which is expected as the outcome of this project, will contribute the improved global food safety. In the long run, establishment of MRLs by Southeast Asia economies with internationally harmonized methodologies for pesticide evaluation will have positive impacts on the global trade, as explained under “Relevance” of the Project Proposal.

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Total Project Value

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Topics

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Project Summary

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Objectives

Alignment

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Beneficiaries and Outputs

Dissemination

Gender

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Monitoring and Evaluation

Linkages

Sustainability

Project Overseers

Cost Efficiency

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Direct Labour

Waivers

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