Public Research & Regulation Initiative

1. Public Research & Regulation Initiative Piet van der Meer, Kim Meulenbroeks Klaus Ammann PRRI session in EBC, Symbiosis, European Biotechnology Congress In Barcelona, 17. September 2007 European Federation of Biotechnology

2. PRRI - Background Fact: Tens of thousands public sector scientists in developing and developed countries are involved in biotechnological research for agricultural production, health care and environmental protection. Fact: International agreements can have a strong impact on public research in modern biotechnology. Fact: Up to 2004, the public research sector has not been represented in an organised way in international agreements.

3. PRRI – Background (continued) • Consequently: • The public research sector has not been able to provide scientific input in the negotiations. • The absence of the public research sector has contributed to the misperception that modern biotechnology is the domain of a handful of big multinationals.

4. The Public Research & Regulation Initiative PRRI was established in 2004 with the objective to: Offer a forum for the public research sector to be informed about and involved in international negotiations relevant to modern biotechnology, such as the Cartagena Protocol on Biosafety.

5. Public Research & Regulation Initiative Phase 1: 2004-2005: ‘Raising awareness’: Phase 2: 2005 – 2006: ‘Try out’ Involvement of public research sector scientists in MOP2 and MOP3 of the Biosafety Protocol Phase 3: 2006 - onwards: Organised involvement of the public research sector in all international negotiations relevant for modern biotechnology.

6. Phase 2: Try out participation in MOP2 and MOP3 MOP2: June 2005, Montreal • Preparatory meeting, weekend before MOP2 • Participation in MOP2, 30 May – 3 June 2005 30 PRRI participants MOP3: March 2006, Brazil • Preparatory meeting, weekend before MOP3 • Participation in MOP3, 13 – 17 March 2006 40 PRRI participants from 25 countries in Africa, Asia, Eastern Europe, Latin and North America, Western Europe and several international organisations

7. Objectives for PRRI participation in negotiations • Making negotiators aware that a substantial part of research on modern biotechnology is conducted for the public good in public research institutes worldwide. • Bringing more science to international negotiations. • Expressing views of the public research sector about regulations, where necessary offering proposals for fine-tuning or amendments.

8. PRRI participation in MOPs • Make interventions • Meetings with other delegations • Organise PRRI side-events • Attend side-events organised others • Informal discussions with delegates

9. Conclusions from the ‘try out’ phase • Public researchers have become aware of the need to participate in international negotiations and are prepared to invest time and resources. • PRRIparticipation in negotiations is effective and appreciated. PRRI has become a well recognized entity. • PRRI will participate in MOP4 (2008, Germany). • PRRI will participate in other international fora, such as the Convention on Biological Diversity, the Aarhus Convention, Codex Alimentarius, and regional regulations such as EU regulations.

10. Phase 3: 2006 onwards • Structured organisation: • Forum of PRRI members (almost 200 scientists), • PRRI Steering Committee, • PRRI Working groups (13) • PRRI Secretariat. • Publications: newsletters, website, briefing papers, position papers, Q&A, ‘Myth buster’ page, etc. • IFPRI-PRRI database on public research

11. Steering Committee Chairman: Em. Prof. Marc van Montagu, Institute for Plant Biotechnology for Developing Countries (IPBO), Belgium Members: • Dr. Nevena Alexandrova, AgroBioInstitute (ABI), Bulgaria • Em. Prof Klaus Ammann, Delft University of Technology, the Netherlands • Dr. Roger N. Beachy, Donald Danforth Plant Sience Center, United States • Prof. Yaroslav Blume, Institute of Cell Biology and Genetic Engineering, Ukraine • Dr. Premendra D. Dwivedi, Industrial Toxocology Research Centre, India • Dr. Ismail El Hadrami, Laboratoire de Physiologie Végétale, Marocco • Dr. Christian Fatokun, International Institute of Tropical Agriculture (IITA), Nigeria • Prof. Behzad Ghareyazie, Strategic Research Center of Iran, Iran • Willy de Greef, Institute for Plant Biotechnology for Developing Countries (IPBO), Belgium

12. Steering Committee Members: • Prof. Jonathan Gressel, Plant Sciences Weizmann Institute of Science, Israel • Dr. Desiree Hautea, University of the Philippines, The Philippines • Prof. Calestous Juma, Kennedy School of Government, Harvard University, USA • Prof. Julian Kinderlerer, University of Cape Town, South Africa, and Delft University of Technology, the Netherlands • Dr. Charles Mugoya, The Association for Strengthening Agricultural Research in Eastern and Central Africa (ASARECA), Uganda • Prof. Magdy Madkour, Arid Land Agricultural Research Institute (ALARI), Ain Shams University, Egypt • Dr. Zaida Lentini, International Center for Tropical Agriculture (CIAT), Colombia • Dr. Susana Sirvas-Cornejo, Universidad Nacional Federico Villarreal, Peru • Dr. Natalia Stepanova, Centre Bioengineering of the Russian Academy of Sciences (RAS), Russia • Prof. Paul S. Teng, Nanyang Technological University, National Institute of Education, Singapore • Dr. Arnoldo Khaleel Ventura, Office of the Prime Minister, Jamaica

13. Working Groups • Public Sector Research in Modern Biotechnology • Biosafety Protocol & Biodiversity Convention • Aarhus Convention • EU Directives and Regulations • Risk Assessment and Risk Management • Liability and Redress • GURTS • GM Trees • Intellectual Property Rights (IPR) • Field Trials • Technology Transfer • Communication and Public Perception • Outreach to non-English speaking public researchers

14. Funding • Governments • European Commission (2006-2009) • International organisations and institutions • Private sector PRRI’s budget and its donors are published on the PRRI web site

15. Collaboration with other organisations • Memoranda of Understanding: • FARA (Forum for Agricultural Research in Africa) • BSBA (Black Sea Biotechnology Association ) • IFPRI (The International Food Policy Research Institute) • EFB (European Federation on Biotechnology) • Under discussion: • ISBR (International Society for Biosafety Research) • ABSF (African Biotechnology Stakeholders Forum) • ANBio (Associaçao Nacional de Biossegurança)

16. WWW.PUBRESREG.ORG

17. PRRI - IFPRI Activities: The ABC - Database The Public Research and Regulation initiative (PRRI) and the International Food Policy Research Institute (IFPRI) have started a web-based database of agricultural biotechnology R&D activities performed by public research institutions in developed and developing countries. Agricultural Biotechnology Capacity Database

18. The ABC - Database The ABC – Database is a collaborative effort between TheInternational Food Policy Research Institute (IFPRI) and the Public Research and Regulation Initiative (PRRI) The IFPRI - PRRI ABC-Team: Dr. José Falck-Zepeda, Patricia Zambrano, Mulugeta Bayeh Prof. Klaus Ammann, Kim Meulenbroeks, Dr. Mike May

19. The ABC - Database The Agricultural Biotechnology Capability Database aims to serve as: A) an independent, transparent primary knowledge resource B) a forum for informed debate on the role of GM crops in agricultural programs C) a tool to identify bottlenecks in product development D) a resource for future partnering and technology transfer

21. The ABC - Database We need your input! • To test the entry fields and the viability of the design. • To add information and research projects and give suggestions for collecting and disseminating the data. • The database is accessible through our websites http://ifpri.catalog.cgiar.org/abc/index.htm andwww.pubresreg.org

22. ‘Mythbuster’ page • PRRI aims to inform policymakers, regulators and the general public about science and of misperceptions and misrepresentations about science. • Some of those misperceptions and misrepresentations are addressed on the 'Mythbuster‘ page of the PRRI web site • The Mythbuster page contains brief summaries of the myths and offers the opportunity to give comments and to provide links to relevant peer reviewed articles. • Suggestions for 'myths to be included' can be sent to Prof. Klaus Ammann

27. Marshall, A. (2007) • Gm Soybeans and Health Safety—a Controversy Reexamined. Nature Biotechnology, 25, 9, pp 981-987 • http://www.botanischergarten.ch/Ermakova/Marshall-Ermakova-Reexamined-2007.pdf

28. Bruce M. Chassy, L. Val Giddings, Alan McHughen and Vivian Moses. Ermakova states that RR soybeans and protein isolate were purchased from ADM in the Netherlands. ADM does not sell (and has never sold) pure 100% RR soybean preparations. It is accordingly not possible for Ermakova to have obtained RR soybeans from this source as stated. The best that can be said is that commercial products sold by ADM would have been an indeterminate and variable mixture of conventional and non-GM soybeans.

30. outside London airport mid August 2007: Their slogan: "We are armed ... only with peer reviewed science".

31. PRRI 2007-2008 activities Main focus: Cartagena Protocol on Biosafety: Participation in MOP4, 12 –16 May 2008,Germany Convention on Biological Diversity: Participation in COP9, 19-30 May 2008,Germany

32. Biodiversity Convention and Biosafety Protocol Convention on Biological Diversity (1992): • Aims: 1) Conservation and 2) sustainable use of biological diversity, and 3) fair and equitable sharing of the benefits of using genetic resources, including by access genetic resources and transfer of technologies • Article 8 (“In situ conservation of biodiversity” ): Obligation to develop National Biosafety Systems • Article 19 (“Handling biotechnology and distribution of its benefits”):- promote and advance priority access to biotechnology - Consider a protocol on biosafety – this became the CPB • Governing body: Conference of the Parties (COP)

33. Biodiversity Convention and Biosafety Protocol Cartagena Protocol on Biosafety (2000): • Aim: to contribute to biosafety and specifically focusing on transboundary movement of LMos • Advance Informed Agreement (AIA) procedure for transboundary movement of LMOs for release • Procedure for LMOs intended for food, feed, and processing (FFP) in the receiving country • Biosafety Clearing House Mechanism • Agreed principles and methodology for risk assessment • Governing body: Meeting of the Parties (MOP) –sometimes also called COP/CMOP

34. PRRI 2007-2008 Activities Aim: Facilitate the participation of public researchers in MOP4 and COP9, May 2008, Germany Preparation • PRRI regional preparatory meetings • Inter-sessional CPB and CBD meetings

35. PRRI 2007-2008 Activities PRRI regional preparatory meetings • Africa, in collaboration with FARA and AfricaBio (in conj. with FARA Science Week 11 June 2007, Johannesburg). • Europe: in collaboration with the EFB (at ECB, 17 September 2007, Barcelona, Spain). • North America, at the international seed meeting, 17 September 2007, Davis, California. • Latin America: in collaboration with ANBio, at the V Biosafety Congress, 21 September, Belo Horizonte, Brazil.

36. PRRI 2007-2008 Activities PRRI regional preparatory meetings under discussion: • Eastern Europe: in collaboration with the BSBA (Late 2007/early 2008). • South East Asia: collaboration with IRRI and APEC (Late 2007/Early 2008) • Middle East - Central Asia: in collaboration with ICARDA (Late 2007 / Early 2008).

37. PRRI 2007-2008 Activities PRRI Participation in CPB and CBD inter-sessional meetings • Ad Hoc Open-ended Working Group of Legal and Technical Experts on Liability and Redress in the context of the Protocol, 19-23 February 2007, Montreal, Canada • Fourth meeting of the Liaison Group on Capacity-building for Biosafety, 26 February - 2 March 2007, Lusaka, Zambia. • The Second International Meeting of Academic Institutions and Organizations Involved in Biosafety Education and Training, 16 - 18 April 2007, Kuala Lumpur, Malaysia • Canada Norway Expert Workshop on Risk Assessment for Future Applications of Modern Biotechnology, 4-6 June Montreal, Canada • Twelfth meeting of the Subsidiary Body on Scientific, Technical and Technological Advice, 2- 6 July 2007 - UNESCO, Paris, France.

38. PRRI 2007-2008 Activities PRRI Participation in inter-sessional meetings • CBD - Ad Hoc Technical Expert Group on Technology Transfer and Scientific and Technological Cooperation, 10-12 Sep 2007, Geneva, Switzerland. • Meeting of the Biosafety Clearing-House Informal Advisory Committee (BCH-IAC), 4-5 Oct 2007, Montreal, Canada. • Fourth meeting of the Ad Hoc Open-ended Working Group of Legal and Technical Experts on Liability and Redress in the context of the Protocol, 22 - 26 October 2007, Montreal, Canada.

39. MOP4 Topics relevant for public research • Risk Assessment and Risk Management; • Biosafety Clearing House (BCH); • Roster of experts; • Capacity building; • Handling, Packaging and Use; • Socio-economic considerations in decision making; • Public Participation; • Liability and Redress; • Review of the functioning of the Protocol.

40. MOP4 - Risk Assessment and Risk Management Risk Assessment - PRRI statements: • based on sound science – i.e. based on scientific reasoning, verifiable and replicable; no ‘fear for flying pigs’ • Comparative – i.e. any risks identified in the risk assessment have to be compared with the risks of using the non modified recipient organism; • Additional information should only be requested if it is clear how it will be used in the risk assessment; • Address explicitly uncertainty - The precautionary approach does not mean ‘zero risk’ • Address explicitly the potential benefits.

41. MOP4 - Risk Assessment and Risk Management Risk Assessment – MOP4 • Specific issue: is there a need for new guidance for future applications of modern biotechnology, e.g. GM Fish, GM Trees, Plant Made Pharmaceuticals, GM vaccines ? • PRRI: • The general principles and methodology for risk assessment in Annex III of the CPB are sound and equally applicable to ‘new’ GMOs – ‘case by case’. • Within the framework of Annex III, specific information and specific risk management considerations may apply to these new cases.

42. MOP4 - Biosafety Clearing House (BCH) PRRI statements • The BCH is of crucial importance for public researchers if they need to know which procedures apply in a country for – for example - field trials and whom to approach. • Many Parties have not yet complied with their obligation to place relevant information on the BCH, This is a serious hindrance to public research. • Placing such information on the BCH is not onerous - it rather requires a couple of hours at a computer.

43. MOP4 - Roster of experts PRRI statements: • Roster of Experts is in principle a good idea, but hasn’t worked to date. • PRRI advises: • Guidance on what constitutes an ‘expert’; • Independent peer review mechanism • Identify the area of expertise of the experts, and provide a curriculum vitae on BCH • Place the work of the experts on the BCH.

44. MOP4 - Capacity building PRRI statements • Capacity building key to implementation of regulations • Many projects duplicative and not focused on results • Recommendations: • Expert identification of the needs of countries, translated into clear, feasible implementation targets • No ‘one size fits all’ approach, • Better coordination between donors • Executing agencies with substantial experience • Assessment of the self-sustainability of the projects • Regional collaboration and coordination

45. MOP4 - Socio-economic considerations PRRI statement: • The socio-economic considerations in decision making need to include the socio-economic benefits of modern biotechnology, including alleviation of poverty and hunger.

46. MOP4 - Liability and Redress (L&R) Issue: Elaboration of international rules and procedures for L&R • Options: • legally binding vs. guidelines • National: civil liability vs administrative approach, • Transboundary: a trans-national regime vs a dispute settlement mechanism • PRRI proposal: guidelines for an administrative system on the national level, complemented by a dispute settlement mechanism

47. MOP4 - Liability and Redress Advantages of an administrative system: - The interest of biodiversity: the emphasis of the administrative approach is on remediation • The interest of the Government: An administrative approach will by itself provide basis for the responsible operator to cover the costs, • The interest of the general public: the system contains access to justice - The interest of public sector research the public research sector will not have to reserve a portion of their limited resources to handle lengthy and costly law suits,

48. MOP4 - Review of the functioning of the Protocol. PRRI statements: • Although it is still early, it is important to start shaping the parameters of the assessment process. • It is important that an assessment be made of the impacts of the implementation of the Protocol on public research in developed and developing countries. • Suggestions for consideration in the review: • Special provisions for confined field trials, • Defining categories for exemptions ex article 7.4 • Guidance on how to take into account in the decision making process the benefits of biotechnology

49. CBD-COP9 Topics relevant for public research • GM Trees • GURTS • Technology Transfer • Access and Benefit Sharing (ABS) and Intellectual Property Rights (IPR) • Agricultural Biodiversity Program

50. COP9 - GM Trees PRRI statements • Because of the numerous potential benefits from GM trees, the PRRI believes that it is essential to intensifybiotechnology research in trees. • Trees cannot be readily studied in the laboratory or greenhouse, the ability to conduct field research is essential.