International Conference on Environmental Risk Assessment (ERA) of Genetically Engineered (GE) Plants April 15-17, 2012

Transcription

1 International Conference on Environmental Risk Assessment (ERA) of Genetically Engineered (GE) Plants April 15-17, 2012 Risk Assessment under the Cartagena Protocol Dr. Sol Ortiz Secretaría Ejecutiva CIBIOGEM, México

2 Outlook Background The Advanced Informed Agreement The risk assessment under the Protocol The need for further guidance The AHTEG and the Roadmap A caution message

3 Background The origins The trigger for the development of the Protocol has been the observation, in the 1990s, that LMOs were developed mainly in industrialized countries, but would be exported to developing countries, for all kinds of purposes: environmental testing, use as seed, and use for food, feed and processing. These LMO would be assessed for environmental safety in the country of provenance, but the performance of an independent risk assessment for the situation in the receiving country was not mandatory under any international agreement. TheCPBhasbeendevelopedtomakesurethatareceivingcountry can not be in a situation that it receives LMOs, by transboundary movement,andisnotawareofthis,ordoesnothaveareasonable time to perform its own environmental risk assessment.

4 Background Article 19. Handling of Biotechnology and Distribution of its Benefits 3. The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. COP 2 Decision II/5 (November 1995) CONSIDERATION OF THE NEED FOR AND MODALITIES OF A PROTOCOL FOR THE SAFE TRANSFER, HANDLING AND USE OF LIVING MODIFIED ORGANISMS. Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health,

5 Background Its negotiation started in The text was adopted 5 years later in Text includes: introduction, preamble, 40 articles and 3 annexes. The CPB entered into force September 11th Today 162 countries are Parties to the Protocol.

6 Article 7. Application of the Advance Informed Agreement Procedure 1. the advance informed agreement procedure in Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of an LMO for intentional introduction into the environment of the Party of import. 1. Notification (art. 8) 2. Acknowledgement of Receipt of Notification (art. 9) 3. Decision procedure (art. 10) Review of Decisions (art. 12) Risk assessment (art 15 and annex III) & Risk Management (art. 16)

7 Risk Assessment Under the Cartagena Protocol Article 15. Risk Assessment 1. Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health. 2. The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10. It may require the exporter to carry out the risk assessment.

8 Annex III. Risk Assessment Objective 1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health. Use of risk assessment 2. Risk assessment is, inter alia, used by competent authorities to make informed decisions regarding living modified organisms. Risk assessment Risks management Informed decision making

9 Annex III. Risk Assessment General principles 3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by relevant international organizations. 4. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk. 5. Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment. Risk assessment is a comparative process, with the appropriate comparator, not an academic exercise or data collection.

10 Annex III. Risk Assessment General principles 6. Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment. Receiving environment Genetic modification Intended use Recipient organism Case by case approach

11 Annex III. Risk Assessment Methodology 7. The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances. NEED to KNOW vs NICE to KNOW Clearly identify the information that will inform the risk hypotheses

12 Annex III. Paragraph 8 8. To fulfill its objective, risk assessment entails, as appropriate, the following steps: 1 (a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health; 2 (b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism; 3 (c) An evaluation of the consequences should these adverse effects be realized; 4 (d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;

13 Annex III. Paragraph 8 8. To fulfill its objective, risk assessment entails, as appropriate, the following steps: 5 (e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks; and Recommendation Risk management Decision making

14 Annex III. Paragraph 8 8. To fulfill its objective, risk assessment entails, as appropriate, the following steps: Uncertainty? (f) Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.

15 Annex III. Paragraph 8 8. To fulfill its objective, risk assessment entails, as appropriate, the following steps: Uncertainty? Request further information on the specific issues Implement appropriate risk management and/or Monitor the living modified organism Do not get paralyzed, keep moving, keep looking, keep learning

16 Annex III. Paragraph 9 Points to consider 9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects: (a) Recipient organism or parental organisms. The biological characteristics of the recipient organism or parental organisms, including information on taxonomic status, common name, origin, centres of origin and centres of genetic diversity, if known, and a description of the habitat where the organisms may persist or proliferate; (b) Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological characteristics of the donor organisms; (c) Vector. Characteristics of the vector, including its identity, if any, and its source ororigin,anditshostrange;

17 Points to consider Annex III. Paragraph 9 (d) Insert or inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced; (e) Living modified organism. Identity of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism or parental organisms; (f) Detection and identification of the living modified organism. Suggested detection and identification methods and their specificity, sensitivity and reliability; (g) Information relating to the intended use. Information relating to the intended use of the living modified organism, including new or changed use compared to the recipient organism or parental organisms; and (h) Receiving environment. Information on the location, geographical, climatic and ecological characteristics, including relevant information on biological diversity and centres of origin of the likely potential receiving environment.

18 Risk Assessment Under the Cartagena Protocol Objective Use of risk assessment General Principles 1 (a) Steps (Paragraph 8) 2(b) 4 (d) 3 (c)? Points to consider: a b c d e f g h (Paragraph 9) 5 (e) (f) Recomendation ( Decision making)

19 Risk Assessment and the need for guidance It is the aim of the Protocol that all Partieswill, intheend,havetheirown biosafety legal framework, and will be able to perform their own environmental risk assessments aimed at their own environmental situation, and will have a full understanding of the scientific background of environmental risk assessment. Many Parties have not gathered experience yet, on actually doing risk assessment. Communicate and consult with stake holders STEP 2. STEP 1. Plausible scenarios, testable hypotheses STEP 4. STEP 5. STEP 3. Decision-making Apply risk management measures Review: is there new information to consider? Many countries, Parties and non Parties have develop considerable experience on RA for GMO. Practice makes the master

20 Risk Assessment and the need for guidance COP-MOP 3. BS-III/11 B. Potential need for additional guidance 8. Notes that there is existing guidance related to risk assessment and risk management for living modified organisms, but that it is possible that additional guidance may be required on specific aspects of risk assessment and risk management COP-MOP 4. BS-IV/11 I. Further guidance on specific aspects of risk assessment and risk management 3. Decides to establish through the Biosafety Clearing-House an open-ended online forum on specific aspects on risk assessment as referenced to in the annex; 4.DecidestoestablishanAdHocTechnicalExpertGrouponRiskAssessmentandRisk Management according to the modality of work and the terms of reference annexed hereto;

21 Roadmap for Risk Assessment and Risk Management COP-MOP 4. BS-IV/11 TERMS OF REFERENCE FOR THE AHTEG (i) Develop a "roadmap", such as a flowchart, on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol and, for each of these steps, provide examples of relevant guidance documents; (ii) Taking into consideration the identified need for further guidance on specific aspects of risk assessment, including particular types of (i) living modified organisms (for example, fish, invertebrates, trees, pharmaplants and algae); (ii) introduced traits; and (iii) receiving environments, as well as monitoring of the long-term effects of living modified organisms released in the environment, prioritize the need for further guidance on specific aspects of risk assessment and define which such aspects should be addressed first, taking also into account the need for and relevance of such guidance, and availability of scientific information;

22 Roadmap for Risk Assessment and Risk Management 19 Selected experts from Parties selected from different regions, 9 observers: 3 experts from non Parties and 6 from industry, academia and NGOs. Various online Fora and Online real time conferences First meeting of the AHTEG held in Montreal in April 2009, decided to focus on: Roadmap for Risk assessment of all LMOs Risk assessment of LM mosquitoes Risk assessment of LM crops tolerant to abiotic stress LMOs with stacked traits Third meeting of the AHTEG held in Mexico in June 2011, decided to include : Risks assessment of LM trees Post release monitoring Next Meeting in Montreal (June) will revised the documents and develop a recommendation for COP-MOP6.

23 Roadmap for Risk Assessment and Risk Management What is working: the Roadmap, in theory, allows less experienced risk assessors to benefit from the discussions of more experienced practitioners it is a multilateral activity it concentrates attention on the environmental risk assessment since Codex has already provided guidance on food it is a forum for experts to exchange views The process What is not working there is a lack of transparency in how the documents are revised, and how countering viewpoints are considered many of the AHTEG representatives have no practical experience in risk assessment in any field the discussions often descended into political negotiations rather than discussions of science The resulting documents still need improvement and to reflect experience Views at on line forum and real time conferences remain available for further consultation The testing process has provided mixed results

24 Roadmap for Risk Assessment and Risk Management TheRoadmapwillonlybekindofasuccess,iftheresultis: A very clear guidance that makes doing a risk assessment an easy to follow process, aimed at providing solutions, not at creating difficulties. A straightforward tool to get access to guidance documents, where people can find the discussions and questions behind the risk assessment process. This was the original idea (Hans Bergmans Chair for the Roadmap) BUT.

25 Roadmap for Risk Assessment and Risk Management Specific concerns Risks are overstated throughout the Roadmap The Roadmap concentrates heavily on uncertainty, implies that there are accepted methods to incorporate uncertainty analysis : Uncertainty is inherent in risk assessment and is an important discussion with a lot of views. The molecular characterization section is prescriptive, and unconnected to hazard identification eg. Copy number There is little acknowledgment of the use of familiarity and substantial equivalence, concepts developed by the OECD Still needs to clearly differentiate between scope and scale and the differences in a risk assessment for a small scale field trial vs. a commercial release There are no options incorporated into the Roadmap other than pursuing the entire course The process described is long and convoluted and fails to clearly acknowledge contemporary approaches such as problem formulation The flow chart is confusing, contains far too much Horizontal gene transfer remains as a consideration (even for plants)

26 Impact of regulation in Mexico A caution message 140 Applications presented by sector Biosafety Law público privado Moratorium for GM maize

27 Article 7. Application of the Advance Informed Agreement Procedure 1. the advance informed agreement procedure in Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of an LMO for intentional introduction into the environment of the Party of import The advance informed agreement procedure shall not apply to the intentional transboundary movement of living modified organisms identified in adecisionoftheconferenceofthepartiesservingasthemeetingoftheparties to this Protocol as being not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. Let us give a real chance for biotechnology to contribute to human well being using the right tools, in the right way.

28 Acknowledgements AHTEG members: Hans Bergmans Phillip Macdonald THANK YOU