PREM in Europe: What is Driving the Build up of Requirements?

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1 PREM in Europe: What is Driving the Build up of Requirements? Dr. Patrick Rüdelsheim General Partner biosafety and biotechnology regulatory services

2 Perseus bvba - Founded in Service provider for biosafety and biotechnology regulation - Combining technical background with an in depth knowledge of the European & International regulatory requirements for biological material - First hand experience dealing with regulatory issues for over 20 years, including commercial release of GM crops

3 PREM in Europe: What is Driving the Build up of Requirements? Are requirements increasing? What are the drivers? What can be learned from this? A very personal view.

4 PREM in EU GMO Regulatory framework Directive 90/220 Directive 2001/18/EC Council Decision 2002/18/EC

5 PREM in EU A moving target Directive 90/220 Directive 2001/18/EC Council Decision 2002/18/EC EFSA RA Guidance EFSA GS Chapter EFSA PREM Opinion EFSA RA Guidance EFSA PREM Opinion

6 PREM in EU Directive 2001/18/EC on the deliberate release into the environment of GMOs an obligation for notifiers to implement monitoring plans in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after they have been placed on the market. General surveillance always required, case specific monitoring based on the environmental risk assessment. Differentiation between cultivation and importation.

7 Case-specific monitoring Is a direct outcome of the pre-release risk assessment conclusion where the scientific information leads to a testable hypothesis Relies upon the individual characteristics of each GM crop, its specific modification and its environmental risk assessment. Should not be mandatory for all case but may be required to verify specific elements of the pre-release environmental risk assessment.

8 Case-specific monitoring Effects focused where there is a reason to believe that, based on scientific data, hazard is likely/possible and further information is needed to better understand its consequences under conditions of commercial use. or Exposure driven when a hazard is likely and proposed conditions of containment under commercial use are imposed to ensure environmental protection. In this situation, case-specific monitoring is designed to show that risk mitigation is effective.

9 Example Case-specific monitoring

10 Case-specific monitoring Challenges Pre-market risk assessment should not be confirmed by CSM as a matter of principle, but only if there remains substantial uncertainties that can only be addressed by PREM. CSM should not aim to simply confirm the absence of effects on a larger scale/longer timeframe CSM is not evidenced if there is no logical hypothesis

11 General surveillance Broad requirement designed to address adverse effects unanticipated in the prerelease risk assessment. No testing for specific assumptions, mechanistic causes or specific risks develop testable hypothesis later! Not (necessarily) crop or trait related, implying a generic approach to determining any unanticipated effects of a biotechnology derived plant and its use.

12 General surveillance Tools Joint applicant s effort Farmers questionnaires: experienced to work with and observe their crop. General monitoring networks: experienced to observe valued components. Ongoing research & scientific literature Stewardship elements Issue alerts

13 General surveillance Substantial challenges How to conduct general monitoring in highly disturbed and dynamic agricultural systems? What do we look for? How do we look for it? How do we analyze the collected information? What is an unusual effect? When is an effect adverse? Is the adverse effect associated with the biotechnology derived crop or its cultivation?

14 Substantial challenges General surveillance

15 General surveillance Overlap with Adverse Effect Reporting After regulatory review is completed and a biotechnology derived crop has been commercialized, mot authorities have requirements to report any information relevant to an adverse effect associated with the product. Technology dvelopers are required to report meaningful information relevant to the risk assessment thougout the life of a product. No agreement on added-value of general surveillance.

16 PREM in Europe: What is Driving the Build up of Requirements? Requirements are increasing What are the drivers? What can be learned from this?

17 Drivers for changes Experience with PREM NO Only limited experience with cultivation of Bt corn and modified starch potatoes

18 Drivers for changes Avoiding responsibility for decision 1995 We have no more reasonable question to ask at field trial scale level, but does that give us sufficient confidence to give up all control? 2010 We understand that PREM may not add much information, but the public would not understand that we don t do anything. Call for better decisions; continued control

19 Drivers for changes An impossible balance between stakeholders Let me make clear at this point that the strict EUwide authorisation system, which is based on science, safety and consumer choice, remains fully in place. This means that a very thorough safety assessment and a reinforced monitoring system are priorities in GMO cultivation and are therefore being pursued vigorously. John DALLI Member of the European Commission, responsible for Health and Consumer Policy at the 6th European Conference of GMO-free regions Brussels, 16th September 2010

20 Drivers for changes Power struggle Who decides on risk assessment, risk management, product approvals? European Parliament Council 27 MS Governments European Commission 27+ MS Authorities EFSA GMO Panel MS Advisory bodies

21 Drivers for changes Broadened discussion, independency What should be protected? What causes the effect? Why are involved parties not acceptable? Who is an acceptable party? Who will pay for monitoring?

22 PREM in Europe: What is Driving the Build up of Requirements? Requirements are increasing Drivers Experience Not ready to take up responsibility Balancing stakeholder s interest Power struggle Scope of issues, independency What can be learned from this?

23 Lessons There seems to be an increasing demand for information to make better decisions for biotechnology crops. While PREM and especially general surveillance appear to meet this need, there are many important challenges to address. The value and relevance of the information to achieving environmental policy and risk management goals must be weighed against the cost in money, resources, time and negative perception created.

24 Lessons PREM should focus on effects of concern to stakeholders. Is the plan appropriate and does it address the concern? What scientific rigor and scientific power is needed? How will regulators use the information obtained? Who will do the monitoring and for how long? Who will pay for monitoring? Reference: Recommendation on Post Market Environmental Monitoring to Policy and Decision Makers at the Regional and National level FAO Expert Consultation (2005)

25 Thank you for Technologiepark 3 B-9830 Zwijnaarde Belgium your attention M F patrick.rudelsheim@perseus.eu biosafety and biotechnology regulatory services