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Page 1 of 31 REPORT OF A CONSULTANTSMEETING HELD AT THE IAEA HEADQUARTERS IN VIENNA AUSTIA, 23-27, JUNE 2014 ON: A planned Coordinated Research Project (CRP) 2084: “Development and Strengthening of Radio-Analytical and Complementary Techniques to Control Residues of Veterinary Drugs and Related Chemicals in Aquaculture Products” 2015-2020.

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REPORT OF A CONSULTANTS’ MEETING HELD AT THE IAEA HEADQUARTERS IN VIENNA AUSTIA, 23-27, JUNE 2014 ON:

A planned Coordinated Research Project (CRP) 2084:

“Development and Strengthening of Radio-Analytical and Complementary Techniques to Control Residues of Veterinary Drugs and

Related Chemicals in Aquaculture Products” 2015-2020.

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Table of Contents 1. Purpose of the meeting ...................................................................................................... 3 2. Background........................................................................................................................ 3 3. Objectives .......................................................................................................................... 4 4. Presentations and Discussions ........................................................................................... 4 5. Detailed discussions and conclusions. ............................................................................... 7 6. Recommendations ............................................................................................................. 8 7. Potential CRP contract and agreement holders. ................................................................ 9 8. List of Participants. ............................................................................................................ 9 9. Annex 1. AGENDA ......................................................................................................... 11 10. ANNEX 2. CRP PRPOSAL ........................................................................................ 15

Proposal for a Coordinated Research Project (CRP) ........................................................... 15 Title: .................................................................................................................................... 15 CRP Code: ........................................................................................................................... 15 Budget Cycle: ...................................................................................................................... 15 Project: ................................................................................................................................. 15 Division: .............................................................................................................................. 15 Responsible officer: ............................................................................................................. 15 Alternate Project Officer: .................................................................................................... 15 Funding Choice: .................................................................................................................. 15 Summary: ............................................................................................................................ 15 Background Situation Analysis: .......................................................................................... 16 Selected References: ............................................................................................................ 17 Overall objective: ................................................................................................................ 18 Specific Objectives: ............................................................................................................. 18 Nuclear Component: ............................................................................................................ 18 Financial Resources Inputs: ................................................................................................. 19 Explanation/Justification: .................................................................................................... 19 Other resources required: .................................................................................................... 20 Participation of Agency’s laboratories: ............................................................................... 20 Assumptions: ....................................................................................................................... 20 Related TC Projects: ............................................................................................................ 21 Expected Research Outputs: ................................................................................................ 21

Potential collateral output ................................................................................................ 21

Expected Research Outcomes: ............................................................................................ 21 Additional benefits .......................................................................................................... 21

Relationship to Sub-programme objective and other Agency Programmes and Sub-programmes: ........................................................................................................................ 22 Logical Framework: ............................................................................................................ 22 Summary of management and coordination activities ........................................................ 28

11. ANNEX 3: SOME POTENTIAL PARTICIPANTS ................................................... 30

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1. Purpose of the meeting The purpose of the meeting was to advise the Food and Environmental Protection Subprogramme (FEP) of the Joint FAO/IAEA Programme for Nuclear Techniques in Food and Agriculture (NAFA) on the proposed Coordinated Research Project (CRP), Development and Strengthening of Radio-Analytical and Complementary Techniques to Control Residues of Veterinary Drugs and Related Chemicals in Aquaculture Products.

2.Background Rapid demographic changes and rising incomes in developing countries combined with changing dietary habits in all countries has boosted the demand for fish and fish protein. The fastest growing food production industry is intensive aquaculture, in which the fish are fed with external food supply. In the period 2000–2012 world food fish intensive aquaculture production expanded at an average annual rate of 6.2% from 32.4 million to 66.6 million tonnes. In the same period, growth was relatively faster in Africa (11.7%) and Latin America and the Caribbean (10%). Global aquaculture production in 2012 was at an all-time high of 90.4 million tonnes (live weight equivalent) worth US$144.4 billion, comprising of 66.6 million tonnes of food fish and 23.8 million tonnes of aquatic algae. China alone produced 43.5 million tonnes of food fish and 13.5 million tonnes of aquatic algae. Global production of food fish and aquatic algae for 2013 was estimated at 70.5 million and 26.1 million tonnes, respectively1.

Intensive production practices and exacerbating factors such as polluted water supplies and climate change have resulted in a rise in disease outbreaks and increased use of pharmacologically active substances including licenced and prohibited veterinary medicines and compounds such as malachite green. This has a significant public health impact as a result of development of microbial and parasitic resistance to these compounds and the presence of toxic residues in food. As a result many countries, including developing ones, have implemented food control regulations to guarantee the quality and safety of foods for their consumers. However, they find it difficult to access the required know-how and skills, thus hindering their ability to access international markets. One significant constraint is the lack of laboratory services using analytical methods validated to internationally acceptable standards to implement surveillance programs and make appropriate risk assessments.

Methods for the detection of residues of pharmacologically active substances include microbiological, immunochemical, chromatographic and spectrometric techniques. While these may fulfil suitability performance criteria, such as method sensitivity, they require multiple time-consuming steps for extraction, sample clean-up or pre-concentration prior to measurement. These measurement techniques also often lack the robustness necessary for their successful application in developing countries. This CRP aims to address these issues by developing methods utilising nuclear and related technologies. The methods would also meet the need for robust analytical methods required by other international bodies such as the Joint FAO/WHO Codex Alimentarius Commission during the standards setting process.

1 FAO: The State of World Fisheries and Aquaculture: opportunities and challenges. 2014. http://www.fao.org/3/a-i3720e.pdf

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3.Objectives The objectives of the meeting were to:

i. critically review the draft Contract Research Project Proposal,

ii. identify robust nuclear and related technologies suitable for the screening and confirmatory analysis of residues of veterinary medicines in aquaculture products,

iii. identify compounds of importance in aquaculture and to propose a suitable research program to develop methods development to detect them,

iv. assist with identifying competent agreement and contract holders with suitable laboratories and resources.

4.Presentations and Discussions The provisional agenda for the meeting was adopted as proposed (Annex 1). Ms Uzma Maqbool (Pakistan) chaired the meeting with Mr Rajendra Patel (UK) as the rapporteur and Mr James Sasanya (IAEA) as the Scientific Secretary.

Mr Carl Blackburn (IAEA) Acting Head, Food and Environmental Protection Section opened the meeting. He provided information on the Joint FAO/IAEA Division and stressed the role consultants were expected to play in developing the CRP.

Mr Bashur Bashur (IAEA) from the IAEA Research Contracts Section, Nuclear Sciences and Applications, provided valuable background information and guidance on IAEA’s Coordinated Research Activities (CRA).

Mr James Sasanya (IAEA) highlighted the activities of the IAEA laboratory in Seibersdorf and its links with Member State laboratories to assist them meet the increasing demand for robust, rapid and affordable analytical methods.

Mr Philip Kijak (USA) provided an insight into the USA regulatory system for aquaculture products. He explained how the responsibilities are split between the Department of Health and Human Services, Food and Drug Administration (FDA), the Department of Commerce National Oceanic and Atmospheric Administration (NOAA) and the Department of Agriculture, Food Safety and Inspection Service (FSIS). FDA has responsibility for the approval of all aquaculture drug products. In the US because of the low sales potential, there are very few veterinary products approved for aquaculture use. Currently, the Office of Minor Use Minor Species in FDA Centre for Veterinary Medicine (CVM) helps to provide the data needed for the approval of these minor uses veterinary drug products by working with industry, States and other Federal agencies. FDA also coordinates and prioritizes aquaculture research including methods development at three research facilities. It also has an aquaculture facility at the CVM Office of Research where incurred residues samples are produced for internal US FDA method validation studies. Species handled include salmon, tilapia, hybrid bass and catfish. Use of incurred materials is key to developing robust methods and the meeting recommended that the possibility of utilising FDA skills for this CRP should be explored.

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Mr Wim Reybroeck (Belgium) provided an overview of the nuclear/isotopic technologies available for screening of pharmacologically active compounds in aquaculture products and the challenges faced by laboratories to develop an effective strategy for surveillance programs for these contaminants. His focus on radio-receptor assays has provided the CRP a framework for developing screening assays for a number of important antibiotic families including β-lactams, tetracyclines, sulfonamides, aminoglycosides, macrolides, amphenicols (including chloramphenicol) and nitrofurans. Many laboratories supported by IAEA TC programs already have scintillation counters and the meeting recommended that radio-receptor assays should be set up and optimized for use on such equipment. This could be done through awarding a technical contract to an appropriate expert laboratory. The contract can also incorporate a primary validation study to characterize the performance criteria of the assays. Mr Reybroeck also provided valuable information on other relevant screening technologies that can be utilised in combination with radio-receptor assays to develop an integrated analytical strategy.

Ms Uzma Maqbool (Pakistan) gave a good example of how IAEA CRP and TC activities can have a significant impact on the implementation of food safety and quality programs in Member States. The Pakistan Atomic Energy Commission (PAEC) National Institute of Agriculture and Biotechnology (NIAB) has collaborated with IAEA for a number of years and through TC and CRP activities has established radiometric-screening technologies for food and environment analysis. To ensure sustainability, NIAB has been providing analytical services on a cost-recovery basis. Currently NIAB has a TC project to extend their analytical capability to include veterinary drug residues.

Mr Mathew Nindi (South Africa) emphasized that for successful determination of residues in complex aquaculture matrices, good sample preparation clean-up techniques are essential. Liquid–liquid extraction (LLE) and solid-phase extraction (SPE) are commonly used for this. However, these methods are time consuming and require large amounts of expensive solvents and they generate a considerable amount of organic waste. The trend nowadays is to substitute these conventional techniques with miniaturized alternatives that have high potential to pre-concentrate target analytes with minimum quantities of organic solvents and are rapid and easy to use. Mr Nindi presented work done in his group using liquid-liquid micro-extraction (DLLME), hollow fibre liquid phase micro-extraction (HF-LPME), hollow fibre-supported liquid membrane (HF-SLM) and dispersive solid phase extraction (dSPE). His work has also demonstrated that substituting organic solvents with hot water, ionic liquids or surfactants for homogenization of solid biological matrices prior to clean-up is cheaper and environmental friendly. The incorporation of these newer greener sample preparation methods to high performance liquid chromatography (HPLC) using conversional detectors and/or LCMS/MS would empower laboratories with limited resources. Such approaches should be encouraged in this CRP.

Mr Rajendra Patel (UK) summarised the current state of aquaculture industry quoting recently published FAO statistics on aquaculture production2. Production of fish and crustaceans make up the bulk of aquaculture industry. Others include molluscs, aquatic plants, crocodiles, alligators, turtles and amphibians. Currently over 80% of the production comes from Asia although rapid growth in Africa and Latin

2 FAO Coordinating Working Party on Fishery Statistics (CWP), http://www.fao.org/fishery/cwp/handbook/j/en

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America will change the statistics. Global aquatic algae production has also increased significantly to 26.1 million tonnes in 2012 with China alone producing 13.5 million tonnes.

Increased aquaculture production has also had a huge negative environmental impact. A video clip on environmental impact of aquaculture in China illustrated this3. For sustainable future growth of the industry to provide safe aquaculture food, these issues have to be addressed in ways that do not damage the ecosystem and erode natural biodiversity.

Feed costs make up 40 to 50% of total operating costs and with depleting supplies and increasing costs, the aquaculture industry is turning to the use of alternative feeds such as algae or insect protein. These changes also have additional benefits. For example fish fed from algae based food present a better ratio of Omega 3/Omega 6 oils in its flesh, thus improving public health. However, the use of algae as a feed source for aquaculture could also have potential negative public health impact. Marine and fresh water environments are filled with bacteria and viruses that can attack fish and shellfish, and can devastate aquaculture farms. Bacteria and viruses can also attack algae, and these microorganisms have biochemical mechanisms for self-defence; such mechanisms involve production of compounds that inhibit bacterial growth or viral attachment. For instance, extracts of Scenedesmus costatum exhibit anti-bacterial activity, these compounds have not yet been characterised4. The possibility of these antibacterial compounds accumulating in algae fed aquaculture may raise concerns from a human health perspective.

Mr Daniel Wonderlin (Argentina) gave an overview on research carried out in the Suquía River basin (Córdoba, Argentina) in the last twelve years, focusing on the presence of different toxics and natural toxins along the basin and their bioaccumulation in fish inhabiting the basin. Results show that there are different groups of contaminants and natural toxins along the basin. As a consequence of eutrophication attributed to untreated sewage in the touristic area surrounding the lakes in the basin (e.g. Lake San Rogue), the upper basin has presence of cyanotoxins, namely microcystins, nodularin and anatoxin-a. Cyanotoxins were found in the edible tissues of both fish and shrimps captured in this eutrophic lake posing health risks to both fish and consumers. The middle basin shows the influence of wastewater treatment plant (WWTP) from Córdoba city with 1.5 million inhabitants, releasing several toxic compounds into the river, including pharmaceutical and personal care products (PCPs). Several such compounds were detected in tissues of two fish species inhabiting the low basin (downstream from the WWTP), providing evidence on the bioaccumulation of pharmacologically active compounds and their metabolites in fish. Pesticides associated with agricultural practices were also detected in water, suspended material and sediment in the lower basin. For instance, residues of endosulfan and its metabolite, endosulfan sulphate were found in tissues of edible fish, including muscle, posing a health risk to consumers.

Mr Thomas Kuhn (Austria) from the Austrian Agency for Health and Food Safety (AGES) participated in the meeting as a “cost-free” expert. AGES have been a good partner with IAEA in providing facilities for scientific visits and fellowships to

3 New York Times, http://tinyurl.com/kpv8fuh 4 Amaro, HM, et al. 2011. Antimicrobial activities of microalgae: an invited review. In: A Méndez-Vilas (Ed.). Science against Microbial Pathogens: Communicating Current Research and Technological Advances. Formatex Microbiology Book Series, Nova Science Publisher, Volume 3, pp. 1272-1284.

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Member States. Mr Kuhn and other experts from AGES have also been involved in IAEA expert missions and training programs. With his experience in setting up a EU NRL responsible for a range of chemical contaminants in Food of Animal Origin and work in third countries to assist them with their residues programs, Mr Kuhn was able to help the meeting formulate a robust project proposal. He also presented a list of pharmacologically active substances that may be found in fish and are of concern to the EU. Ms Brit Maesteroni (IAEA) described the work of Red Analitica de Latino America y el Caribe (RALACA5) network of laboratories in Latin America. The network is supported by the IAEA project on “sustainability of capacity building activities to improve food safety and quality through nuclear technology and networking” funded by the USA under the Peaceful Uses Initiative (PUI). The initial membership that includes laboratories in 16 countries will be expanded in the future. Members of the network are applying proven technical solutions and efficient information and communication technologies to allow countries without any existing capacity to quickly enhance their capabilities through training utilizing regional capacities.

5.Detailed discussions and conclusions. Based on the FEP proposal and the activities needed to meet the objectives of the CRP, the consultants concluded that:

i. In the context of the rapid growth in the aquaculture sector because of global demographic and dietary changes, the CRP proposal developed during this meeting (Annex 2) addresses a number of issues of importance for global food safety and security and should be implemented.

ii. For the benefit of the countries with limited resources, the CRP should include development of screening methods that do not require purchase of sophisticated equipment. Availability of such methods would empower these countries to establish national monitoring programs for veterinary drugs and other contaminants like mycotoxins in aquaculture products.

iii. Issues relating to extraction of residues from complex aquaculture feed and product matrices, in particular the lack of rapid and effective sample handling, clean-up and pre-concentration should be addressed by this CRP.

iv. The use of radio-labelled and stable isotope labelled internal standards is vital for successful development of robust analytical methods.

v. The methods developed during the CRP should be validated using relevant guidelines and detailed SOPs written and made available for use in Member State laboratories. In this regard inclusion of the developed methods in the IAEA database will be important. The meeting also recognises that the protocols and data generated can support implementation of Codex guidelines and contribute to setting guidelines on respective contaminants through risk assessments carried out by various Codex Committees (e.g. JECFA).

vi. Workshops should be organised and appropriate experts and stakeholders be invited to the RCMs to present up to date developments in the

5 Red Analitica de Latino America y el Caribe, http://red-ralaca.net

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residues field to all participants. The consultants emphasized that in a rapidly developing field of residues chemistry this component is important for the success of the project.

vii. Up to 20 research contracts should be awarded to Member States submitting appropriate research proposals. Each Chief Scientific Investigator (CSI) will have to submit his/her project highlighting current equipment and experience levels in their laboratory together with an indication of availability of adequate funds for relevant research activities. Research Agreement holders (6 to 8) will be invited to support the CRP with their expertise.

viii. Technical contracts should be awarded to selected institutions to provide radioactive and stable isotope labelled reagents and internal standards as well as incurred materials. In order to maximise the use of scintillation counters already existing in many laboratories, the meeting also recommended that radio-receptor assays should be set up and optimized through awarding a technical contract to an appropriate expert laboratory. The contract can also incorporate a primary validation study to characterize the performance criteria of the assays.

ix. Research to identify markers as indicators for the production conditions of aquaculture should be carried out through the application of nuclear and related methods for non-targeted analysis and profiling techniques (e.g. metabolomics).

x. Environmental impact studies carried out during this CRP can inform future developments in the design of environmentally friendly aquaculture production units.

xi. The Food and Environment Protection Laboratory (FEPL) of the FAO/IAEA Agriculture and Biotechnology Laboratory at Seibersdorf will provide scientific and technical support to the CRP and assist in the transfer of technology developed in this CRP to Member States.

6.Recommendations Based on the FEP proposal, the discussions during the meeting and in view of the activities needed to meet the objectives of the CRP, it is recommended that:

1. In the context of the rapid growth in the aquaculture sector because of global demographic and dietary changes the CRP proposal developed during this meeting (Annex 2) should be implemented.

2. The meeting recognizes that the CRP is not ideally designed to build CSI laboratory capacity per se, but to formulate and implement a research project to address specific issues of mutual interest to Member States. In this regard this CRP addresses the many challenges faced by Member States in meeting the requirements of aquaculture product safety and quality. For successful implementation the meeting recommends that participants should:

i. Be reliable institutions with recognizable infrastructural and human resource to ensure sustainability

ii. Be involved in on-going food safety programs with reasonable experience in residue analysis of veterinary drugs or biotoxins associated

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with aquaculture feed and/or water (such as mycotoxins and cyanotoxins),

iii. Have a quality system in place (such as ISO/IEC 17025, GLP or equivalent)

iv. Have relevant facilities e.g. functional CHARM-II, Liquid Scintillation, ELISA, microbiological inhibitor tests, HPLC and/or LC-MS/MS.

3. Additionally, participants with the following attributes should be selected preferentially in order to increase the productivity and success of the CRP:

i. Connections with national food safety authorities and be recognized by these authorities.

ii. Linkages with aquaculture farmers/veterinarians.

iii. Capability to conduct fieldwork.

iv. Experience of using labelled drugs or compounds for evaluating method performance, validations and stable isotopes for quality assurance / control

4. Given that there are so many veterinary pharmaceuticals and contaminants impacting the aquaculture industry, the meeting emphasized the need to focus on analytes in aquaculture products (including feed and water) currently of greater concern. The CRP should prioritize these compounds at the first RCM taking into account information provided by the participants.

5. Technical contracts and workshops are critical for the success and eventual impact of this CRP and should form a core part of the CRP activities.

6. In order to ensure that the protocols are robust, repeatable, transferable and suitable for publication, the CRP agreement and research contract holders should adhere to a defined quality system.

7.Potential CRP contract and agreement holders. The importance of selecting technically competent laboratories and contract holders from developing countries was stressed and in this regard, the consultants proposed potential CRP participants and laboratories (Annex 3).

8.List of Participants.

Mr. Bashur Bashur IAEA

Mr. Carl Blackburn IAEA

Mr. Philip Kijak Division of Residue Chemistry, Office of Research/Centre of Veterinary Medicine, US Food and Drug Administration

Tel: 301-210-4589; USA

Email: [email protected]

Ms Viitaniemi Kyoko

(Administrative support)

IAEA

Ms Britt Maestroni IAEA

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Ms. Uzma Maqbool

(Chairperson)

Nuclear Institute for Agriculture and Biology (NIAB), Pakistan Atomic Energy Agency – National Institute for Agriculture and Biology

Faisalabad, Pakistan.

Tel: +92-41-9201751-60; Fax: +92-41-9201776

Tel: +92-41-2656542; Cell: +92-321-6656806

Email: [email protected]

Mr. Mathew Nindi Department of Chemistry, University of South Africa, P. O. Box 392, Muckleneuk Ridge

City of Tshwane, 0003, South Africa, Office: TvW G-18

Phone: (27) 012 429 8559; Fax: (27) 012 429 8549; Cell:(27) 076 442 4888

Email: [email protected]; [email protected]

Ms Ana Maria V. Ojeda IAEA (Administrative support)

Mr. Rajendra Patel

(Rapporteur)

12 Runnemede Road, Egham, Surrey, TW20 9DQ

United Kingdom;

Tel: +44 1784 438214; Mobile: +44 7808 766080

Email: [email protected]

Mr. Thomas Kuhn Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES), Austria

AGES - Austrian Agency for Health and Food Safety

Division for Food Safety, Institute for Food Safety Vienna

Spargelfeldstrasse 191, A-1220 Wien

Tel:. + 43 (0) 50555-32600, Fax: + 43 (0) 50555-32630

Cell: + 43 (0) 664-8398085

Email: [email protected]

Mr. Wim Reybroeck Institute for Agricultural and Fisheries Research

Technology and Food Science Unit - Food safety

Brusselsesteenweg 370, 9090 Melle

Tel +32 9 272 30 11; Fax +32 9 272 30 01

Email: [email protected]

Mr. James Sasanya

(Scientific Secretary)

IAEA

Mr. Daniel Wunderlin Instituto de Ciencia y Tecnología de Alimentos Córdoba – ICYTAC, CONICET-Univ. Nac. Córdoba, Bv. Dr. Juan Filloy s/n, Ciudad Universitaria, 5000- Córdoba, Argentina

TE: +54 351 4333193/94 Ext 125

Email: [email protected]

Mr. Johannes Corley IAEA

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9.Annex 1. AGENDA

Provisional Program for a Consultants’ Meeting for the IAEA Coordinated Research Project:

“Development and Strengthening of Radio-Analytical and Complementary Techniques to Control Residues of Veterinary Drugs and Related Chemicals in Aquaculture Products”,

2015-2019” Joint FAO/IAEA Division, Vienna, Austria, 23 – 27 June 2014

Vienna International Centre, Room MOE19 (Building M, Room 19)

Monday 23 June 08:20 09:10 All Registration at UN Pass Office, Gate 1 (with proper

identification)

09:10 09:25 All Introductions

09:25 09:40 Mr. Carl Blackburn Opening remarks/Welcome

09:40 09:45 All Selection of Chair/rapporteur

09:45 09:50 All Agenda consideration

09:50 10:05 Mr. James Sasanya Background and terms of reference

10:05 10:20 Ms Viitaniemi Kyoko/Ms Ana Maria V. Ojeda

House keeping

10:20 10:50 All Break

Additional Presentations

10:50 11:20 Mr. Bashur Bashur The IAEA Programme of Coordinated Research Activities

11:20 11:35 Mr. James Sasanya The role of MS laboratories in CRPs and linkages with Agency laboratory in Seibersdorf

11:35 11:55 Mr. Philip Kijak Aquaculture products and Food Safety in the USA.

11:55 12:15 Mr. Wim Reybroeck Use nuclear/isotopic nuclear techniques e.g. radio receptor assays to control of chemical contaminants in foods; solutions to laboratory challenges

12:15 13:45 All Lunch Additional presentations

13:45 14:05 Ms. Uzma Maqbool Transfer of CRP knowledge to end users e.g. through Technical Cooperation Projects and any other mechanism

14:05 14:25 Mr. Mathew Nindi Analytical sample preparation: Innovations, challenges/solutions

14:25 14:45 Mr. Rajendra Patel Emerging food safety issues in food safety.

14:45 15:05 All Break

15:05 15:25 Mr. Daniel Wunderlin Contaminants in aquatic environments: distribution patterns

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15:25 17:00 All Discussion of presentations

18:00 All Hospitality Event (Cocktail) at MOE19 next to MOE Coffee corner, VIC

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Tuesday 24 June 08:00 10:30 Group discussions.

•Feasibility of preparing analytical kits for the project (Wim)

•Feasibility of preparing isotope labelled compounds and reference standards for the project (Philip)

•Analytical method development/validation and application for Veterinary Drug residues (Philip; All)

•Analytical method development/validation and application for other contaminants (David, Mathew, Uzma, Thomas)

•Optimum project implementation (James/Andrew; All)

•Potential challenges/bottlenecks and ways forward (All)

•Any other technical application (All)

10:30 11:00 Break 11:00 12:30 Group discussions continued 12:30 13:45 Lunch 13:45 15:15 Group discussions continued 15:15 15:45 Coffee break 15:45 17:00 Draft CRP proposal design Wednesday 25 June 08:00 10:30 Identify areas of research 10:30 11:00 Break 11:00 12:30 Identify areas of research 12:30 13:45 Lunch 13:45 15:15 Group discussions 15:15 15:45 Break 13:45 17:15 Recommendations (requirements, scope and objectives and strategies). 18:30 - Joint dinner Thursday 26 June 08:30 10:30 Presentation/discussion: How developed Member State laboratories can support

networking among food safety institutions/laboratories (Raj, Philip, Ms. Britt Maestroni/James, Wim)

10:30 11:00 Break 11:00 12:30 Develop CRP proposal including logical framework matrix (LFM) and tentative

workplan 12:30 13:45 Lunch 13:45 15:15 Develop CRP proposal including LFM and tentative workplan 15:15 15:45 Break 15:45 17:00 How developed Member State laboratories can support networking among food

safety institutions/laboratories (Linda Stolker’s presentation); Develop CRP proposal including LFM and tentative workplan

Friday 27 June 08:30 10:30 Discuss potential project contract/technical/ agreement holders 10:30 11:00 Break 11:00 12:30 Prepare meeting report 12:30 13:45 Lunch 13:45 15:15 Prepare meeting report 15:15 15:45 Break

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15:45 17:00 Finalize meeting report 17:00 End of meeting

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10.ANNEX 2. CRP PRPOSAL

Proposal for a Coordinated Research Project (CRP)

Title: Development and Strengthening of Radio-Analytical and Complementary Techniques to Control Residues of Veterinary Drugs and Related Chemicals in Aquaculture Products

CRP Code: 2084 CRP ID: …………

Budget Cycle: 2015-19

Project: 2.1.3.2 (2000017): Traceability as an approach to control food contaminants and improve food safety PB Activity: ……………

Division: NAFA

Responsible officer: SASANYA James Jacob

Alternate Project Officer: BLACKBURN Carl Michael /CANNAVAN Andrew

Funding Choice: ……………………….

Summary: Aquaculture practices (fish and seafood farming) is becoming more widespread for the inexpensive and intensive production of protein rich foods. Innevitably, agrochemical inputs such as veterinary pharmaceuticals and related substances are required to control aquaculre related diseases and improve yields. Residues of such inputs, plus unintended natural toxins in aquaculture products and feeds, pose public health risks. This requires robust national regulatory frameworks underpinned by sound laboratories, to safeguard consumers and enhance international trade in aquaculture products. Research is needed now on analytical methods that will strengthen laboratory performance and nuclear and isotopic techniques can play an important role. In the period 2000–2012 intensive aquaculture production increased at an average annual rate of 6.2% from 32.4 million to 66.6 million tons. In the same period, growth was relatively

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faster in Africa (11.7 %) and Latin America and the Caribbean (10%). Global aquaculture production in 2012 was at an all-time high of 90.4 million tons (live weight equivalent) worth US$144.4 billion, comprising of 66.6 million tons of food fish and 23.8 million tons of aquatic algae. China alone produced 43.5 million tons of food fish and 13.5 million tons of aquatic algae. Global production of food fish and aquatic algae for 2013 was estimated at 70.5 million and 26.1 million tonnes, respectively1,2. Intensive production practices and exacerbating factors such as polluted water supplies and climate change have resulted in a rise in disease outbreaks and increased use of pharmacologically active substances in aquaculture including licensed and prohibited veterinary medicines and compounds such as malachite green. This has significant public health implications as a result of development of microbial and parasitic resistance to these compounds and the presence of toxic residues in food. Consequently, many countries, including developing ones, have implemented food control regulations and good aquaculture practices to guarantee the quality and safety of foods, safeguard public health and improve market access for aquaculture products in both national and international markets. Laboratories that meet international standards are critical stakeholders in such regulatory mechanisms. However, to meet the standards and conduct risk assessments there is a need for research to strengthen relevant technology and expertise. While nuclear-based analytical techniques present numerous advantages, the technology is still lacking in many Member States and should be researched, developed and transferred. This CRP aims to fill this gap and will strengthen Member State analytical laboratories and national residue monitoring programs thus contributing to the improvement of food safety, better aquaculture production practices and enhancement of national and international trade in aquaculture products through reduction of export rejections and detentions.

Background Situation Analysis: The global drive for food security underlines the importance of food safety and the need to protect the consumer. The increased demand for aquaculture products as a protein source, public awareness about safe food, requirements of international markets, and the importance that agricultural/aquaculture product exports play in the economies of many Members States, all combine to create a need for national food safety systems to control various microbiological and chemical hazards. Residues and/or contaminants in aquaculture products as well as in the environment could pose a risk3,4. Thus, major issues currently confronting the aquaculture industry in terms of ensuring public health and meeting international trade requirements are food safety, quality and traceability. Food safety laboratories must therefore have technical capabilities (including development and validation of analytical methods) to demonstrate that they can confidently detect these contaminants and support risk management, communication, good agricultural practices and trade concerns.

Robust regulatory frameworks to minimize contaminants and control the use of veterinary medicines, and encourage the use of good aquaculture practices, underpinned by a strong laboratory network are vital for assuring the quality and safety of aquaculture products.

Veterinary pharmaceuticals and related substances7,8,9 are widely used in aquaculture and their misuse could result in unsafe residues in fish or shrimp. In addition aquaculture could also be affected by environmental contaminants. Aquaculture practices and regulatory mechanisms are at different levels of development in different countries that produce and export aquaculture products. These countries could benefit from IAEA support to reduce the rejection or detention of non-compliant products and the consequent severe economic losses.

For example, some Member States with very meager economies can lose about USD$ 50 million in fish products alone due to bans by major trading blocks such as the European

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Union10. Also, the chemicals could persist in aquaculture habitats and may end up in sediments thus prolonging exposure. Extensive and frequent use of antimicrobials in aquaculture is also associated with the development and spread of antimicrobial resistance11,12, which is also a cause for public health concern, further underlining the need to monitor the use of these drugs.

Some agrochemicals and natural toxins (mycotoxins), posing health risks, could unintentionally end up in aquaculture products13. Mycotoxins not only have negative health effects of fish and shrimps, causing economic losses, but could also occur at levels in aquaculture that cause a potential risk to consumers.

At the heart of every national control program is a functional laboratory with relevant analytical tools and personnel meeting national or internationally set quality control/assurance standards and coping with the large sample size required for a reliable monitoring program. Sensitive, precise, robust and cost effective analytical methods are required to sustain such laboratories. Among the available technology, nuclear techniques can provide significant advantages and this CRP seeks to use these technologies to strengthen the detection capabilities in Member States. New analytical methods will be developed, including improved environmentally friendly techniques, validated and transferred amongst laboratories (especially to developing Member States) published in peer reviewed journals and made available via the Food Contaminant and Residue Information System (FCRIS) database14.

The CRP will directly benefit all Member State laboratories involved in chemical residue programs, policy makers, research and regulatory agencies and aquaculture farmers among other stake holders. Overall, the project is expected to improve food safety and to enhance international trade in aquaculture products, by reducing the number of rejections and detentions and increasing consumer confidence in aquaculture products.

Selected References: 1.FAO: The State of World Fisheries and Aquaculture: opportunities and challenges.

2014. http://www.fao.org/3/a-i3720e.pdf. Accessed 23 June 2014. 2.FAO Coordinating Working Party on Fishery Statistics (CWP),

http://www.fao.org/fishery/cwp/handbook/j/en. Accessed 23 June 2014. 3.Better Management Practices for Omani Aquaculture:

http://www.raisaquaculture.net/uploads/media/better%20management%20practices.pdf. Accessed 23 June 2014.

4.New York Times, http://tinyurl.com/kpv8fuh. Accessed 24 June 2014. 5.Red Analitica de Latino America y el Caribe, http://red-ralaca.net. Accessed 24 June

2014. 6. Amaro, HM, et al. 2011. Antimicrobial activities of microalgae: an invited review. In:

A Méndez-Vilas (Ed.). Science against Microbial Pathogens: Communicating Current Research and Technological Advances. Formatex Microbiology Book Series, Nova Science Publisher, Volume 3, pp. 1272-1284.

7.Nácher-Mestre, J., Serrano, R., Portolés, T., Berntssen, M.H.G., Pérez-Sánchez, J, and Hernández, F. (2014). Screening of Pesticides and Polycyclic Aromatic Hydrocarbons in Feeds and Fish Tissues by Gas Chromatography Coupled to High-Resolution Mass Spectrometry Using Atmospheric Pressure Chemical Ionization: J. Agric. Food Chem., 62 (10), pp 2165–2174.

8.Kan, C. A., and G. A. L. Meijer. (2007). The risk of contamination of food with toxic substances present in animal feed. Anim. Feed Sci. Technol. 133:84-108.

9.Stolker, A.A.M., Zuidema, T. and Nielen, M.W.F. (2007). Residue analysis of veterinary drugs and growth promoting agents. TRAC Trends Anal. Chem. 26: 967–

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979.Tacon, A.G., and Metian, M. (2008) Aquaculture feed and food safety. Ann N Y Acad Sci 1140: 50–59.

10.The Fish Site. (2013). Pakistan's Seafood Allowed to Enter EU After Ban Lifted, 29 July;http://www.thefishsite.com/fishnews/20865/pakistans-seafood-allowed-to-enter-eu-after-ban-lifted.

11.Cabello, FC., Godefrey, H. P., Ivanova, L., Dolz, H., Millanao, A., and Buschmann, A. H. (2013) Antimicrobial use in aquaculture re-examined: its relevance to antimicrobial resistance and to animal and human health. Environmental Microbiology. Volume 15, Issue 7, pages 1917–1942, July 2013.

12.Hoa, P. T. P., Managaki. S., Nakada. N., Takada, H., Shimizu, A., Anh, D.H., Viet, P. H., and Suzuki. S. (2011). Antibiotic contamination and occurrence of antibiotic-resistant bacteria in aquatic environments of northern Vietnam; Science of the Total Environment, 409; 2894–2901.

13. Woźny,M., Obremski, K., Jakimiuk, E., Gusiatin,, and M., Brzuzan, P. (2013). Zearalenone contamination in rainbow trout farms in north-eastern Poland; Aquaculture 416–417: 209–211.

14.Food Contaminant and Residue Information System, http://nucleus.iaea.org/fcris/.

Overall objective:

To enhance national control programs for residues of veterinary pharmaceuticals and related chemicals in aquaculture products and feeds (including water) by helping food safety laboratories develop and/or strengthen radio-analytical and complementary techniques.

Specific Objectives: 1) To develop a reliable, tailored monitoring strategy based on the use of validated tests

including radio-receptor or radio immunoassays for screening, group-specification and confirmation of residues and contaminants in aquaculture products and in water and feed used in aquaculture, to ensure consumer safety and strengthen Member State competitiveness in international food markets;

2)To research and develop or optimize protocols (incorporating innovative sample preparation techniques) and instrumentation for radio-receptor or radio-immunoassays to limit costs, to prevent false positive test results and to improve the detection capability;

3) To develop SOPs supported by validation dossiers; 4) To develop procedures for producing test materials (e.g. blank and incurred test

material) vital for method validation and daily laboratory use; 5)To perform research on, and identify markers as indicators of aquaculture production conditions. 6) To generate data on consumer risk exposure to contaminants in aquaculture products, and on indicators of aquaculture production conditions.

Nuclear Component: This CRP will use peaceful nuclear and isotopic techniques including (but not limited) to the following:

- Radio-receptor techniques: use of H-3 and C-14 labelled radio-tracer compounds along with liquid scintillation counters;

- Radio-immunoassays (RIA); - Isotope labelled (Deuterated and C-13) compounds along with complementary

chromatographic techniques in sample preparation to improve precision; - Electron capture detectors with Ni-63; - Isotope Ratio Mass Spectrometry (IRMS).

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Financial Resources Inputs: Quantity/N

umber 2015 2016 2017 2018 2019 Total

Research Contracts

11 88,000€ 88,000€ 88,000€ 88,000€ 88,000€ 440,000 €

Research Agreements

4

Bulk purchases (e.g. PT Materials; RRA, RIA reagents)

11 RCs x 2 (at 2000 €)

22,000€ 22,000€

44,000€

RCMs 4 (2500 € x 15 participants)

37,500€ 37,500€ 37,500€ 37,500€ 150,000 €

Publication of manuals/protocols

11 x 2000€ 22,000€ 22,000€

Scientific & technical exchanges

4 (2500€) 10,000€ 10,000€

20,000€

Total 125,500 € 120,000 € 125,500 € 157,500 € 147,500 € 676,000 €

Explanation/Justification: • Four Research Coordination Meetings (RCMs) are necessary to keep the research

programme coordinated, and on track and ensure that the network functions effectively;

• A minimum of 11 research contracts considering geographical representation will ensure the CRP’s goals are realized;

• If funds permitted, two technical contracts would support the production of necessary consumables. The methods proposed in the detection strategy should be fully validated for the following parameters: detection capability, selectivity, specificity and test robustness, applicability and stability. Research will be performed to modify or optimize radio-receptor protocols and the way instrumentation is used in order to limit costs, prevent false positive test results and improve the detection capability.

• The CRP requires 4 Scientific and technical exchanges between agreement holder institutions and research contractors or between contract holders in support of inter-laboratory work to ensure that analytical methods researched are internationally transferrable. Additional skills will be acquired on production of incurred materials. This will be achieved through short visits to laboratories such as the Center for Veterinary Medicine of the US Food and Drug Administration. Knowledge acquired will be used to train others in the various regions on sustainable production of such

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materials. Specialized training will also be sought on the optimum use of liquid scintillation counters in chemical contaminant residue monitoring, including strategies to reduce false positive rates, auto-sampling and preparation of a master validation protocol.

•Publication of manuals/protocols or a special issue will enable take-up of the methodology produced by the project in a wide range of Member States, in the CRP and others that are not directly involved, including through the TC programme;

•At least 4 research agreements are required to provide overarching expertise and guide the technical development within the CRP.

Other resources required: Two selected institutions that produce or provide reference materials, radioactive and stable isotope labelled reagents as well as internal standards, will be considered for technical contracts. This would help maximize the use of liquid scintillation counters already existing in many Member State laboratories for radio-receptor assays of chemical food contaminants. Researchers from CSI will be required to participate in the production of some of the above materials at an appropriate expert laboratory. The researchers will also participate in the generation of a primary validation study to characterize the performance criteria of radio receptor assays. All these would require additional funds since technical contract funds are limited (if available) and doctoral fellowships have not been considered.

Participation of Agency’s laboratories: The Food and Environmental Protection Laboratory in Seibersdorf will contribute scientific and technical support including in the harmonization and transfer of analytical techniques (e.g. in relation to Technical Cooperation projects; interregional workshops etc); where possible the laboratories will participate in inter-laboratory tests.

Assumptions: • Availability of adequate funds for research and related support activities (e.g.

provision of reference, incurred and materials as well as exchange of personnel);

• The rapidly growing aquaculture industry and trade will be hampered if food hazards are not controlled as demanded by authorities and consumers (local and international);

• The control of such hazards (especially the chemical) is underpinned by sound food safety analytical laboratories that are well equipped, with trained staff and adhering to international standards;

• Adoption and application of nuclear and/or isotopic techniques will improve the detection capability and the efficiency of such laboratories and facilitate study of the linkage between environmental issues and aquaculture;

• Quality proposals (on a diverse range of chemical hazards relevant to the aquaculture industry) will be received from competent, committed and properly equipped institutions to realize the objectives of the project and meet Member State needs;

- Mechanism to promote practical networking and collaboration will be in place;

• Outputs of the project will be continually disseminated e.g. through TC programs well before the CRP concludes;

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• Laboratory institutional capabilities in residue analysis will be greatly enhanced through this CRP.

Related TC Projects: Several projects across regions (to be selected from a drop down list)

Expected Research Outputs: •Screening, quantitative and confirmatory techniques for monitoring and control of for

pharmacologically active compounds, mycotoxins and other relevant chemicals in aquaculture, feeds and water are developed, validated and applied;

• Standard Operating Procedures/protocols and laboratory manuals of analytical methods for pharmacologically active compounds, mycotoxins and other relevant chemicals are developed and disseminated;

• Enhanced laboratory competences according to international standards e.g. through inter-laboratory studies, implementation of fellowships/scientific visits or fielding expert missions;

•Dissemination of information on the use of liquid scintillation counters for radio-receptor assays in residue analysis;

•Reports on markers/indicators along with optimized analytical methods;

•Protocols and data produced to support implementation of Codex guidelines and contribute to setting guidelines on respective contaminants;

•Comprehensive CRP report including TECDOC or a special issue publication produced.

Potential collateral output

•Masters, PhD, postdoctoral related research benefiting from the CRP research; •Automated reading of radio-receptor assay tool explored; •Development of radio- receptor and radio-immunoassay kits explored; •Interregional laboratory networking promoted; •Complementary non-nuclear analytical techniques improved and knowledge about

testing at production sites enhanced; •Stakeholder workshops conducted and the awareness of safety of aquaculture products

enhanced.

Expected Research Outcomes: The CRP will help strengthen capabilities of food safety laboratories and national programs for the monitoring and control of veterinary pharmaceuticals and relevant contaminants in aquaculture products and feeds (including water). Consequently, consumer confidence will grow in the safety of aquaculture products resulting in improved access to the local and international market.

Additional benefits A better understanding of aquaculture control programs among stakeholders (policy makers, research and regulatory agencies, aquaculture farmers and consumers).

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Relationship to Sub-programme objective and other Agency Programmes and Sub-programmes: This CRP is under the subprogramme 200015 “Improving Food Safety and Consumer Protection”, and specifically project 2000017 “Traceability to improve food safety and quality and enhance international trade” in line with Joint FAO/IAEA Division’s effort to ensure food security guided by the promotion of Atoms for Peace and or Development. The expected outputs and outcome of the CRP will contribute to improving food safety and quality as well as international trade and protect consumers. By contributing to availability/accessibility of safe and quality food, the CRP will also contribute to the Joint Division’s mission to fight food insecurity.

Project action plan including required inputs are shown in the Logical Matrix Framework

Logical Framework: Project Design Elements Verifiable Indicators Means of Verification Important Assumptions

Overall Objective:

To enhance national control programs for residues of veterinary pharmaceuticals and related chemicals in aquaculture products and feeds (including water) by helping food safety laboratories develop and or strengthen radio-analytical and complementary techniques.

Number of functional laboratories and residue monitoring programs

Reports by national or importing country food safety authorities; IAEA reports;

CRP conducted; suitable committed participants identified; findings transferred and applied; transparent reporting ; system in place

Specific Objectives:

1.To develop a reliable, tailored monitoring strategy based on the use of validated tests including radio-receptor or radio immunoassays for screening, group-specification and confirmation of residues and contaminants in aquaculture products and in water and feed used in aquaculture, to ensure consumer safety and strengthen Member State competitiveness in international food markets;

- Number of active laboratories testing contaminants in aquaculture and feed samples in support of national programs

1.National, laboratory, project reports; transferable methods available to share

Suitable participants with realistic work plans identified; funds available and remitted in time; prompt procurements where applicable; ideas are feasible and where a technical contract is in place, immediate support.

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2.To research and develop protocols (incorporating innovative sample preparation techniques) and instrumentation for radio-receptor or radio-immunoassays to limit costs, to prevent false positive test results and to improve the detection capability;

2. Protocols/kits developed or optimized

2. Project and/or laboratory reports

Suitable participants with realistic work plans identified; funds available and remitted in time; prompt procurements where applicable; ideas are feasible and where a technical contract is in place, immediate support.

3. To develop SOPs supported by validation dossiers;

3. Analytical methods developed and/or validated and applied

3. Project and/or laboratory reports

Suitable participants with realistic work plans identified; funds available and remitted in time; prompt procurements where applicable; ideas are feasible and where a technical contract is in place, immediate support.

4. To develop procedures for producing test materials (e.g. blank and incurred test material) vital for method validation and daily use;

4. Number of procedures developed and transferred for application;

- Reports of developed and/or validated and applied methods

Suitable participants with realistic work plans identified; funds available and remitted in time; prompt procurements where applicable; ideas are feasible and where a technical contract is in place, immediate support.

5. To research and identify markers as indicators for the production conditions of aquaculture.

5. Methodologies in place and strategies established

5.Reports of developed and/or validated and applied methods

Suitable participants with realistic work plans identified; funds available and remitted in time; prompt procurements where applicable; ideas are feasible and where a technical contract is in place, immediate support.

6. To generate data on consumer risk exposure to contaminants in aquaculture products and indicators for the production conditions of aquaculture

6. Methodologies applied in national residue monitoring programs and quality data produced

Research or laboratory reports

CSI effectively implement workplan

Outputs:

1.

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2.

3. Screening, quantitative and confirmatory techniques for monitoring and control of pharmacologically active compounds, mycotoxins and other relevant chemicals in aquaculture, feeds and water are developed, validated and applied;

Relevant methods (including validation data), produced and in use

Technical, RCM and laboratory reports; publications

Research implemented as planned; suitable CSI identified

4. Standard Operating Procedures, protocols and laboratory manuals of analytical methods for pharmacologically active compounds, mycotoxins and other relevant chemicals in aquaculture, feeds and water are developed and disseminated;

Protocols, standard operating procedures (SOPs), laboratory manuals produced and in use

Technical, RCM and laboratory reports; publications

Technical contract or alternative in place;

5. Enhanced laboratory competences according to international standards;

Ability to meet ISO 17025:2005 requirements

Technical, RCM and laboratory reports; publications;

Interlaboratory collaboration;

6. Information disseminated to Member State laboratories on optimum use of liquid scintillation counters for radio-receptor assays of food residues and contaminants;

Relevant information gathered and in use

Technical, RCM and laboratory reports; publications;

Quality information available

7. Reports on markers/indicators along with optimized analytical methods produced;

Quality data available and protocols, SOPs, laboratory manuals produced

Project reports Research implemented as planned; suitable CSI

8. Protocols and data produced to support implementation of Codex guidelines and contribute to setting guidelines on respective contaminants;

Codex recommended analytical methods in IAEA database; data shared with risk assessors (e.g. JECFA, JMPR)

IAEA/Nucleus reports; Codex meeting reports

Research conducted as planned and credible data collected

9. CRP report including TECDOC or special issue publication produced;

Quality data available and report (s) drafted

CRP review reports Quality data available

10. Data on risk exposure and indicators of aquaculture production systems generated.

Quality research conducted and data documented

Research and/or national reports

Research conducted as planned and credible data collected

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Outcomes:

1. MS food safety laboratory capabilities established and/or strengthened, with analytical methods that meet national and international standards, are developed and operational in the monitoring of veterinary pharmaceuticals and related chemicals in aquaculture products and feeds;

1. Tangible institutional capacity e.g. ability to develop and apply analytical methods; train others;

1. Laboratory, national evaluation reports;

1. Role of laboratory in residue monitoring appreciated and CRP implemented as planned;

2. Networking among food safety laboratories initiated or enhanced across regions;

2. Practical evidence of inter-laboratory work; exchange visits; sustained sharing of methods, resources and knowledge; co-authorships of publications

3.

2. Laboratory, technical and/or scientific reports;

- Competent research group identified and there is willingness to collaborate;

3. Developed techniques disseminated widely e.g. through the IAEA TC program;

Fellowships or Scientific Visits hosted under TC, bilateral or any other program

3. Laboratory and/or training reports

There is keenness to share and disseminate findings; availability of funds

4. Improved understanding of markers/indicators of production systems associated with inputs for aquaculture production and unintended contaminants;

4. Number of methods to verify indicators; list of some markers or indicators identified; reference values established for each indicator or condition

4. Project and/or research reports; publications

4. Aquaculture products from polluted environments can be distinguished using isotopic or complementary methods; suitable CSIs identified

5. Adherence to international standards for trade in aquaculture promoted among states;

5. More Member States applying international trade standards to food safety programs; more laboratories contributing to Codex meeting/session discussions

5. National and CODEX reports

5. CRP findings disseminated

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6. The advantages of applying nuclear/isotopic analytical techniques to ensure safety and quality of aquaculture products promoted

6. Nuclear/isotopic analytical techniques developed/validated and in use

6. CRP and national residue monitoring reports

6. Quality work is done and awareness mechanisms in place

Activities:

(against each output)

1.0 Evaluate proposals and select CRP participants

Evaluated research contracts and agreements forwarded for consideration

Contracts issued Contracts issued in time;

2.0 Hold RCMs (1, 2, 3) Meetings held and work plans prepared; projects begins and is progressing

RCM reports; progress reports

Contracts renewed, programs of work in place and implemented; meetings held as planned; funds available

3.1. Implement the development and validation of analytical methods for veterinary pharmaceuticals, mycotoxins and related chemicals in aquaculture products, feeds and water

Coordinate and review of project activities according to presented program of work; RCM held

Review and meeting reports

Meeting held; projects implemented according to work plan

3.2. Implement the application of analytical methods for veterinary pharmaceuticals, mycotoxins and related chemicals in aquaculture products, feeds and water

Coordinate and review project activities according to presented program of work;

Review reports Projects implemented according to work plan

4.0 Implement the development of SOPs, protocols, manuals;

Implement the dissemination of SOPs, protocols, manuals and transfer of developed techniques

Analytical methods and experiences documented;

Inter-laboratory studies to test transferred methods; hosting of FEs or SVs

Laboratory reports; End of Mission reports; RCM reports

Expertise available and appropriate program of work in place

5.0 Enhance laboratory competences according to international standards e.g. through inter-laboratory studies, hosting of fellowships/scientific visits or fielding expert missions

Participation in inter-laboratory studies; Proficiency Test (PT) schemes; expert missions

Laboratory reports; End of Mission reports; RCM reports

Capabilities build and there is willingness to participate in PTs and share expertise

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6.0 Dissemination of information on the use of liquid scintillation counters for radio-receptor (and related) assays in chemical and natural residue analysis

Number of reported instruments used in residue analysis, participation in inter-laboratory studies; PT schemes; expert missions

Mail communications; progress and lab reports; lab reports; End of Mission reports; RCM reports

CRP members capable of running radio-receptor assays using their own instrumentation

7.0 Conduct research to evaluate the presence of unexpected contaminants (e.g. pesticides, pharmaceuticals and personal care products) and biotoxins (e.g. mycotoxins and cyanotoxins) in aquaculture products, looking to associate contaminants with their source by isotopic ratio mass spectrometry (IRMS) and complementary techniques

Relevant methods developed, validated and applied; reports generated

Laboratory and project reports

Project(s) on selected compounds performed according to work plan

8.0 Review harmonized protocols and upload them on IAEA database; Collate relevant data on contaminants and share findings with Codex Alimentarius risk assessors and managers

Protocols and data on contaminants produced; information papers prepared for Codex meetings/sessions

IAEA/Nucleus reports; Codex meeting reports

Research conducted as planned and credible data collected

9.0 Produce and publish CRP report (TECDOC or special issue)

Reports complied into TECDOC and/or peer reviewed publications

CRP/review reports CRP completed as planned and quality data produced

10 Produce quality data on risk exposure and indicators of aquaculture production systems

Quality research conducted and data documented

Research and/or national reports

Research conducted as planned and credible data collected

Inputs

1.1. IAEA funding of CM; experts

CM conducted CM report Funds available and experts identified

1.2. Agency input: Project officer; NACA, CCRA input

Proposal submitted to CCRA CCRA report Proposal developed

1.3. Agency input: Contracts issued; MS applications

Quality proposals received and contracts issued

NACA records Project applications received, reviewed, funds availed

2.0Agency (RCM and workshop funds)

Coordination meeting and workshop planned

Agency records; Host Government Agreement received (as applicable)

Meeting scheduled

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3.1. CSI resources; Agency funds (for contracts); Agency technical support

Committed CSI with necessary resources, working closely with Agency

NACA records Suitable CSIs

3.2. CSI resources; Contracts; Agency technical support

Committed CSI with necessary resources, working closely with Agency

NACA records; project reports

Suitable CSIs; resources available

4. Agency support (may include TC program); CSI resources;

Transferable technology developed

Project records; TCP reports

Suitable CSIs; resources available

5. CSI and Agency input that may include TC program (support for Scientific visits/exchanges)

CRP participants planning to share experiences

Project records; TCP reports

Suitable CSIs; resources available

6. CSI resources and Agency input (technical contracts)

Functional technical contract and mechanism for transfer of technology/materials in place

Project records; Suitable CSIs; resources available

7. CSI (infrastructural, human and financial) resources); and Agency resources (human and financial) to support development/validation and application of methods for non-targeted analysis

Reliable methods in place and being applied; data collection ongoing

Project and lab reports Projects on selected compounds performed according to workplan; competent people CSI identified and relevant tools in place

8. CSI and Agency technical input to compile and disseminate protocols and exposure data; Agency (staff funding for Codex Meetings)

CRP implementation ongoing or conducted as planned; Relevant Codex meetings planned for

CRP and Codex meeting reports

CRP implemented and related outputs disseminated as planned

9. Agency input (including funds for Final RCM; a workshop) and CSI resources

Programs of work being implemented as planned and sound project reports submitted

Project/review reports; NACA records

CRP implemented as planned

Summary of management and coordination activities Activity 2014 2015 2016 2017 2018 2019

CM and CCRA; CRP announcement

June – Oct

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Evaluate applications; award contracts

Oct-Dec

First RCM X (Q1)

Phase 1 program of work

X X

Second RCM X

Phase 2 program of work

X X

Third RCM X

Phase 3 program of work

X X

Fourth RCM X

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11.ANNEX 3: SOME POTENTIAL PARTICIPANTS

•Agricultural Research Council, Onderstepoort Veterinary Institute, The Republic of South Africa.

•Agri-Food & Veterinary Authority, Singapore.

•Animal and Plant Quarantine Agency, Korea Republic.

•Aquaculture Centre of the Ministry of Agriculture and Fisheries Wealth, Sultanate of Oman.

•Bornova Veterinary Control Institute, Turkey.

•Canadian Food Inspection Agency, Canada.

•Catalan Institute for Water Research (ICRA); IDAEA-CSIC, Water and Soil Quality Research Group, Spain.

•Center for Food and Drug Analysis, Ministry of Food and Drug Safety; Korea Republic.

•Center Suisse de Recherches Scientifiques,Cote d’Ivoire.

•Centre for Disease Control and Prevention Shenzhen or Chinese Academy of Fisheries Science, China People’s Republic.

•Centre for Veterinary Medicine, US Food and Drug Administration, USA.

•Centro de Aplicaciones Tecnológicas y Desarrollo Nuclear, Cuba.

•Colombian Aquaculture Research Center or National Institute for Fisheries and Aquaculture, Colombia.

•Department of Environmental Biotechnology, Faculty of Environmental Sciences; Division of Veterinary Prevention and Feed Hygiene, Faculty of Veterinary Medicine, University of Warmia and Mazury in Olsztyn, Poland.

•Department of Health and Animal Welfare or Department of Pharmaco-Biology, University of Bari, Italy.

•Department of Veterinary Services, Ministry of Agriculture, Malaysia.

•Directorate General for Aquaculture, Ministry of Marine Affairs and Fisheries, Indonesia.

•Directorate of Veterinary Inspection, Croatia.

•Encargado Laboratorio Residuos Biológicos, División Laboratorios Veterinarios, Uruguay.

•Faculty of Veterinary Medicine, Macedonia.

•Federal Agency for the Safety of the Food Chain, Belgium.

•Fish Inspection and Quality Control Division, Department of Fisheries, Thailand.

•Fisheries Research Institute or Makerere University or National Bureau of Standards, Uganda.

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•Fisheries Research Institute, Bangladesh.

•Food Safety Authority, Norway.

•Institute for Agricultural and Fisheries Research, Belgium.

•Institute for Global Food Security or Food Standards Agency or Food and Environment Research Agency or Agri-Food and Biosciences Institute,UK.

•Instituto de Ciencia y Tecnología de Alimentos Córdoba (ICYTAC), CONICET-Universidad Nacional de Córdoba, Argentina.

•Laboratorio Instituto Nacional de Pesca, Ecuador.

•Laboratorio Nacional de Servicios Veterinarios, Costa Rica.

•National Agency for Food and Drug Control, Nigeria.

•National Agriculture and Livestock Laboratories (LANAGRO); Universidade Federal de São Carlos, Centro de Ciências Biológicas e da Saúde; Microbioticos Analisis Laboratoriais, Brazil.

•National Animal Husbandry Health Service or Directorate of Fisheries and Aquaculture, Honduras.

•National Aquaculture Directorate or University of Panama, Panama.

•National Center for Nuclear Sciences & Technology, Tunisia.

•National Fisheries Quality Assurance and Veterinary Directorate or Research Center for Environmental Technology and Sustainable Development, Vietnam.

•Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES), Austria.

•Pakistan Atomic Energy Agency – National Institute for Agriculture and Biology, Pakistan.

•Peruvian Marine Institute or Peruvian Technological Fisheries Instituteor Servicio Nacional de Sanidad Agraria, Peru

• RIKILT - Wageningen University & Research Centre, The Netherlands.

•Southeast Asian Fisheries Development Center Aquaculture Department or The Bureau of Fisheries and Aquatic Resources or Marine Science Institute or Department of Agriculture etc, Philippines.

•The Central Laboratory of Residue Analysis of Pesticides and Heavy Metals in Food (QCAP) or Central Public Health Laboratories or General Authority for Fish Resources Development, Egypt.

•The Fisheries Development Institute, Chile.

•The Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food, Mexico.

•University of Otago, Department of Chemistry, Forensic Geochemistry & Archaeology and Food Authentication, New Zealand.

•University of South Africa, Chemistry Department, South Africa.