1. WP4 - Analysis of legislation, ethical issues, regulations and intellectual property ResistVir Meeting 6 th July 2006, Helsinki, Finland Dr Mike Adcock SIBLE, University of Sheffield, UK

2. Part One – WP4

3. Partners WP4 University of Sheffield, UK (USFD) Central Science Laboratory, UK (CSL) Technology Codes Ltd, Ireland (Codes) University of Azores, Portugal (CBA-UA) Consejo Superior de Investigaciones Científicas, Spain (CSIC) Universidad Politécnica de Madrid, Spain (UPM) Wageningen University and Research Centre, Netherlands (WU)

4. Objectives To collate and analyse of existing standards, legislation, codes of practice, regulations, and intellectual property (IP) issues at European and national level regarding virus/vector resistant GM and traditionally-bred crops To produce recommendations and guidelines for future standards, legislation, codes of practice, regulations, and intellectual property issues, so as to promote the safe use of GM and traditionally-bred crops To be informed of relevant issues by the project partners and disseminate information on legislation, regulations and IP To address ethical issues, if and when they arise

5. Task 4.1: Review of standards, legislation, ethical issues, codes of practice, regulations, and intellectual property issues at national and European level. Collate and analyse legislation, codes of practice, regulations, and intellectual property issues controlling the testing and use of virus/vector resistant GM and traditionally-bred crops. Encouraging the involvement of external organisations in this task when appropriate. New developments will be added to the initial report at Months 19, 24 and 35.

6. Task 4.2: Produce a report on current legislation, regulations and intellectual property issues with recommendations Co-ordinate the legislation, technology practices, regulations and intellectual property issues workshop Produce a report with recommendations for future standards, legislation, codes of practice, regulations, and intellectual property issues for the production and use of virus/vector resistant GM and traditionally-bred crops Disseminate the report at the final seminar

7. Deliverables (months 1-18) Legislation, technology practices, regulations and intellectual property issues report completed Month 10, Responsible partner: Codes Legislation, technology practices, regulations and intellectual property issues workshop Month 18, Responsible partner: CLS/USFD Report on recent developments Legislation, technology practices, regulations and intellectual property Month 19, Responsible partner: CSL

8. Milestones Completion of legislation, technology practices, regulations and intellectual property issues report Task 4.1, Month 10, Responsible partner: Codes Feedback from legislation, technology practices, regulations and intellectual property issues Workshop analysis and report Task 4.2, Month 19, Responsible partner: CSL

9. Part Two – Progress

10. Activities Identify relevant legislation at the EU level Collect all Relevant EU legislation Identify this legislation at Member State level Gather this legislation from all member states

11. Main Legislation Directive 2001/18 the deliberate release into the environment of GMOs Directive 98/81 contained use of genetically modified micro-organisms Regulation 1829/2003 genetically modified food and feed Regulation 1830/2003 concerning the traceability and labelling Regulation 1946/2003 transboundary movements of GMOs Regulation 258/97 Novel food and feed Recommendation 2003/556 Co-existence Directive 98/44 Biotech patenting

12. Key Legislation KeywordsEUUK Plant health2000/29 and 95/44Plant Health order 2005 Deliberate release2001/18GMO regulations (DR) 2002 GMO Contained use98/81Regulations (CU) 2000 Traceability and labelling 1830/2003 1829/2003 GMO regulations (T&L) 2004 Food and feed258/97GM Food regulations 2004 Cartagena1946/2003GMO (TM) 2004 Biotech inventions98/44Patent Regulations 2000

13. Legislation Obtained KeywordsEUCollected Deliberate release2001/18Austria, Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (16) Contained use98/81Austria, Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (16)

14. Legislation Obtained KeywordsEUCollected Traceability and labelling 1830/2003 1829/2003 Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Portugal, Spain, Sweden, UK (14) Biotech inventions98/44Austria, Belgium, Czech republic, Denmark, Estonia, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (18)

15. Other Member states Some legislation Latvia, Slovenia, Slovakia No legislation Cyprus, Greece, Luxembourg, Malta,

16. Activities Analyse whether legislation appropriate and effective with respect to the use of virus/vector resistant GM and traditionally-bred crops Started this analysis with EU and UK legislation Identify Intellectual Property issues Workshop on legislation, regulations and intellectual property issues Workshop report

17. Part Three - Future

18. Deliverables (months 18-24) Legislation, technology practices, regulations and intellectual property issues seminar Month 18 (?), Responsible partner: WU Recent developments in legislation, technology practices, regulations and intellectual property issues added to the web site Month 24, Responsible partner: UPM

19. Activities Analysis of member states legislation and regulations Analysis of Intellectual Property Issues Organisation of workshop Addition of information on legislation to website

20. Deliverable (months 24-36) Recent developments in legislation, technology practices, regulations and intellectual property issues added to the web site Month 35, Responsible partner: USFD Suggested guidelines and recommendations report Month 35, Responsible partner: USFD Milestones Report circulated to interested stakeholders (Tasks 4.1/4.2, Month 36, Responsible partner: USFD)

22. Part Two - Regulation

23. Regulation Why Scientific uncertainty Public concern Economic factors Purpose The purpose of regulations should be to insure safety and efficacy, to limit potential product risks while encouraging innovation and economic development.

24. Trigger for Regulatory Mechanism Europe Using modern biotechnology as defined in the Directives that triggers the regulatory process US The use of organisms, i.e. the product not the process Canada The concept of novelty is used to trigger the regulatory process

25. Background Series of Directives, Regulations and Guidelines From the laboratory to field trials to placing on the market to labelling and traceability Case by case basis Risk assessments of its impact on human health and the environment, food safety assessments

26. Directive 2001/18 Principles for the environmental risk assessment Mandatory post-market monitoring Mandatory information to the public First approvals to be limited to a maximum of ten years The consultation of the Scientific Committee(s)

27. Environmental Risk Assessment Identification of any characteristics of the GMO(s) which may cause adverse effects Evaluation of the potential consequences of each adverse effect Evaluation of the likelihood of the occurrence of each identified potential adverse effect Estimation of the risk posed by each identified characteristic of the GMO(s) Application of management strategies for risks from the deliberate release or placing on the market of GMO(s)

28. Deliberate Release (Part B) Submit dossier to MS Regulatory Authority Consent permits GMO to be grown on specified sites under certain conditions Releases are small scale / strict risk management conditions Monitored for several years Subsequent releases larger All applications placed on public register

29. Placing on the Market (Part C) Decision at EU level Dossier submitted by one MS to European Commission Other MS evaluate and comment No objections then Commission instructs MS to issue marketing consent GMO can be marketed in all MS

30. Placing on the Market (Part C) If MS objections raised and maintained decision taken at Community level Scientific Committee and European Food Safety Authority If favourable, then goes to Regulatory Committee If favourable, Committee adopts decision If not favourable a draft decision submitted to Council of Ministers Must adopt or reject within 3 months No decision, then Commission can adopt decision

31. Directive 98/81 Regulates the contained use of genetically modified micro-organisms for research and industrial purposes Requires MS to take measures to avoid adverse effects of human health and the environment Requires risk assessment, premises to meet certain standards and management and emergency plans

32. Regulation 1829/2003 To protect human life and health, animal health and welfare, the environment and consumers' interests in relation to GM food and feed, whilst maintaining the effective functioning of the internal market; To lay down Community procedures for the authorisation and supervision of GM food and feed To lay down provisions for the labelling of GM food and feed. Food containing or consisting of GMOs Food produced from or containing ingredients produced from GMOs.

33. Labelling Traces of GMOs in products, whose presence is adventitious or technically unavoidable, will continue to be exempt from the labelling requirement unless they exceed the 0.9% threshold. The threshold fro the adventitious presence of GMOs is set at 0.5% for this type of "contamination" for GMOs which have been given scientific approval.

34. Regulation 1830/2003 Framework for the traceability of products of or containing GMOs, and food and feed produced from GMOs Facilitate accurate labelling, monitoring the effects on the environment and health Facilitate appropriate risk management and withdrawal of products

35. Traceability Producer of product consisting of or containing GMOs must inform receiver of product that that it contains or consists of GMOs; the unique identifier(s) assigned to those GMOs Information passed on but can be if form of unique identifier(s) Systems and standardised procedures in place to allow the holding of information for a period of five years from each transaction,

36. Other legislation Regulation 258/97 Rules for authorisation and labelling of novel foods and food ingredients Regulation 1946/2003 Sets out procedures that must be followed for the export of GMOs to third countries Implements obligations under the Cartagena Protocol Recommendation 2003/556 Co-existence of GM and non-GM agriculture Liability and redress systems

37. Initial Questions Highly regulated The purpose of regulations should be to insure safety and efficacy, to limit potential product risks while encouraging innovation and economic development. Are the regulations effective, appropriate and proportional with respect to virus/vector resistant GM and traditionally-bred crops ? Do we have to many Regulations in EU? If so why?