AHTEG GUIDANCE ON RISK ASSEEEMENT AND RISK MANAGEMENT,

1. AHTEG GUIDANCE ON RISK ASSEEEMENT AND RISK MANAGEMENT, BY RUFUS EBEGBA Federal Ministry of Environment, Abuja- Nigeria rebegba@hotmail.com

2. Content: • Over view • AHTEG Report • AHTEG Recommendations • Roadmap for Risk Assessment of Living Modified Organisms(LMOs), • Specific Types of LMOs and Traits • Nigeria and the Testing of the Road Map, • Conclusion

3. 1.0 Over View

4. 1.0 Over View • In 2000 Parties signed the Cartagena Protocol on Biosafety and it came into force on the 11th of September 2003, • The objective of the Protocol is : “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, specifically focusing on transboundarymovements”. • The protocol calls on Parties to ensure that risk assessment is carried out to assist in the process of making informed decisions regarding living modified organisms (LMOs).

5. 1.0 Over View . COP-MOP4 established: an open-ended online forum on specific aspects of risk assessment through the Biosafety Clearing-House; and (ii) an Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management with the objective to develop further guidance on specific aspects of risk assessment and risk management, The AHTEG is made of 18 Party members, 3 Non Part members, 6 Organizations • The guidance document was presented to COP-MOP5 and Parties welcomed the document “Guidance on Risk Assessment of Living Modified Organisms’’ produced through the joint efforts of the two groups.

6. 1.0 Over View • COP-MOP5 mandated both the AHTEG and the Open-ended Online Forum to further work, primarily online, with the view to achieving the following expected outcomes: (a) A revised version of the “Guidance”; (b) A mechanism, including criteria, for future updates of the lists of background materials; and (c) Further guidance on new specific topics of risk assessment selected on the basis of the priorities and needs of the Parties and taking into account the topics identified in the previous intersessional period.

7. 2.0 AHTEG Report .A number of activities were carried out by the AHTEG including face to face meetings of AHTEG, several rounds of ad hoc discussion groups and real-time online conferences under the Open-ended Online Forum • Other activities include, online discussions of the AHTEG, a face-to-face meeting of the sub-working groups and teleconferences of the AHTEG Bureau. • Future activities related to the “Guidance on Risk Assessment of Living Modified Organisms” such as activities to further develop the capacity of Parties to conduct and review risk assessments, additional specific LMos guidance, updating of reference materials, discussions in view of new knowledge.

8. .2.0 AHTEG Report • After its last meeting in Montreal in June 2012, the Group agreed that the “Guidance on Risk Assessment of Living Modified Organisms” which consists of the following sections would be submitted to the Parties at their sixth meeting : a. Roadmap for Risk Assessment of Living Modified Organisms b. Risk Assessment of Living Modified Plants with Stacked Genes or Traits C.Risk Assessment of Living Modified Crops with Tolerance to Abiotic Stress d. Risk Assessment of Living Modified Trees e. Risk Assessment of Living Modified Mosquitoes f: Monitoring of Living Modified Organisms Released into the Environment,

9. 2.1 AHTEG Recommendations AHTEG has proposed the following recommendations to COP-MOP6: a. Regarding the “Guidance on Risk Assessment of Living Modified Organisms” • To endorse the “Guidance on Risk Assessment of Living Modified Organisms”. • Request Executive Secretary of CBD to make the Guidance available to Parties in all six United Nations languages through the Biosafety Clearing-House (BCH).

10. 2.1 AHTEG Recommendations • Parties, as appropriate, to translate the Guidance into national languages, and make them available in the BCH for wider dissemination. • Encourage Parties, other Governments and relevant organisations involved in risk assessment, to use and test the Guidance in actual cases of risk assessment and share their experiences on its practicality, usefulness and utility through the BCH, their third national reports and any other surveys, interviews and/or questionnaires as may be organized by the Secretariat.

11. 2.1 AHTEG Recommendations • Request the Executive Secretary, subject to the availability of funds, to gather and analyse feedback provided by Parties on the practicality, usefulness and utility of the Guidance and make recommendations to the next COP-MOP on possible points for improvement. • Establish a mechanism to ensure the regular update of the background documents to the Guidance, as follows: • The Secretariat should invite Parties, non-Parties, relevant organizations and all BCH users, on an annual basis, to submit suggestions for updating the list of proposed background materials linked to the Guidance, ensuring that the documents are relevant and linked to specific sections of the Guidance;

12. 2.1 AHTEG Recommendations • Once the mandate of the AHTEG is completed, a regionally balanced online group of ten experts in risk assessment (two experts per region), is nominated by the Parties and selected by the COP-MOP Bureau to serve for a period of four years, to discuss and provide feedback on the proposed background documents; • One person selected from among the group of experts will have the responsibility of the final approval, update, rearrangement or rejection of the proposed background materials; • All documents added to the list of background materials by the group of experts should be relevant and linked to specific sections of the Guidance

13. 2.1 AHTEG Recommendations • Documents will be re-validated by the group of experts every 5 years after their inclusion on the list. Documents not revalidated after five years will initially be labelled for one year as “possibly outdated” and later deleted from the list of background materials after an additional year. • A brief report on the work of the group of experts and its experience with the mechanism should be sent to the COP-MOP.

14. 2.1 AHTEG Recommendations b) Regarding the development of additional guidance on specific topics • Extend the mandate of the Open-ended Forum and AHTEG beyond the sixth meeting of the Parties to the Protocol, with revised terms of reference, to develop guidance on new topics, taking into account any results of use and testing of the revised Guidance, as well as the needs of Parties and the list of topics in Annex IV; • Ensure that online discussions are chaired and/or moderated to enhance their usefulness; • Encourage Parties to nominate additional experts with relevant and practical experience in risk assessment to participate in the online forum on risk assessment, and highlight the importance of the participation of their experts;

15. 2.1 AHTEG Recommendations c. Regarding capacity-building in risk assessment and risk management • Requests the Secretariat, subject to the availability of funds, to: • Ensure coherence between the Training Manual on Risk Assessment and Part I of the Guidance (i.e., Roadmap); • Develop an advance educational package that integrates the Guidance into the Training Manual (e.g., e-learning material); • Conduct training using the advance educational package for risk assessors, taking into consideration actual cases of risk assessment

16. 2.1 AHTEG Recommendations • Follow up on the training exercise by gathering additional feedback from Parties on the practicality, usefulness and utility of the Guidance through online discussions or other means, as appropriate; • Conduct international and/or (sub-) regional workshops on Risk Assessment and Risk Management with special emphasis on applying the Guidance in the process of actual decision making under the procedures of the Protocol. • Request the Global Environmental Facility and invite Parties, other Governments and international organisations to provide funds and in-kind assistance to implement the capacity-building activities that are included in these recommendations, as appropriate.

17. 2.1 AHTEG Recommendations d. Regarding risk assessment in general • Urge Parties to provide the BCH with prompt and detailed information on their risk assessments of LMOs for introduction into the environment, including field trials, as well as LMOs for direct use as food, feed, or for processing (LMO-FFPs) with the view to sharing their experiences.

18. 2.1 AHTEG Recommendations Topics for future development by AHTEG • Risk assessment of living modified microorganisms and viruses; • Risk assessment of living modified animals, including fish; • Risk assessment of living modified organisms produced through synthetic biology; • Risk assessment of living modified algae; • Risk assessment of living modified pharmaplants; • Risk assessment of living modified plants for biofuels;

19. 2.1 AHTEG Recommendations • Risk assessment living modified organisms for production of pharmaceutical and industrial products; • Risk assessment and management of LMOs intended for introduction into unmanaged ecosystems; • Interface between risk assessment and risk management; • “Co-existence” between LMOs and non-LMOs in the context of small scale farming, • Socio-economic considerations in the context of environmental risk assessment

20. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) • The Roadmap is to complement Annex III of the Cartagena Protocol(CPB) and, • guide national biosafety policies and legislations, facilitate and enhance the effective use of Annex III by elaborating on the steps and points to consider in environmental risk assessment. • The Roadmap describes integrated risk assessment process in three sub-sections: Overarching Issues in the Risk Assessment Process”, “Planning Phase of the Risk Assessment”, and “Conducting the Risk Assessment..

21. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) i) Overarching Issues: This section gives guidance on issues that are relevant to all the steps of the risk assessment which include, quality of Information, relevance of information, Identification of uncertainty. ii) Planning Stage of Risk Assessment: Risk assessments are carried out on a case-by-case basis, in relation to the likely potential receiving environment, which starts by establishing its context and scope in a way that is consistent with the country’s protection goals, assessment endpoints, risk thresholds, management strategies and policies.

22. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) • The following points may be taken into consideration, as appropriate, that are specific to the Party involvedand to the particular risk assessment, • existing environmental and health policies and strategies , • Intended handling and use of the LMO, including practices related tothe use of the LMO, taking into account user practices and habits.

23. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) The nature and level of detail of the information that is needed which may, • among other things depend on the biology/ecology of the recipient organism, • the intended use of the LMO and its likely potential receiving environment and the scale and duration of the environmental exposure (e.g., whether it is for import only, • field testing or for commercial use, • Identification of methodological and analytical requirements,

24. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) • including requirements for review mechanisms, • experience and history of use of the non-modified recipient organism, taking into account its ecological function, • approaches for describing the potential adverse effects of the LMO and its transfer, handling and use, • use of terms for describing the likelihood and risks and the acceptability or manageability of risks .

25. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) • Risk assessments can be conducted in a comparative manner where risks associated with an LMO are considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment, aimed at identifying changes between an LMO and • its comparator(s) that may lead to adverse effects.

26. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) iii) Conducting the Risk Assessment • Risk assessment under the Protocol is defined as a science-based process that includes at least the following common components of “hazard identification”, “exposure assessment”, “hazard characterization”, and “risk characterization” in the following steps .. • Step 1: “An identification of any novel genotypic and phenotypic characteristics associated with the LMO that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health,

27. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) • Step 2: “An evaluation of the likelihood of adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism.” • Step 3: “An evaluation of the consequences should these adverse effects be realized.”

28. 3.0 Roadmap for Risk Assessment of Living Modified Organisms(LMOs) • Step 4: “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.” • Step 5: “A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks”Specific Types of LMOs and Traits.

29. Figure 1. The Roadmap for Risk Assessment.

30. 4.0 Specific Types of LMOs and Traits • i)Risk Assessment of Living Modified Plants with stacked Genes or Traits: • A number of stacked genes in a single LM plant and the number of LM plants with two or more transgenic traits is growing which calls for specific guidance, • multiple traits can be achieved by transformation with a multi-gene transformation cassette,

31. 4.0 Specific Types of LMOs and Traits • retransformation of an LMO or simultaneous transformation with different transformation cassettes or vectors, • Risk assessments of LM plant follow the general principles outlined in the Roadmap, • also take into account the specific issues outlined in this section of the present document.

32. 4.0 Specific Types of LMOs and Traits • For the purpose of this document, a stacked event is an LMO generated through conventional cross-breeding involving two or more LMOs that are either single transformation events or already stacked events. • This guidance also includes considerations for unintentional stacked events as the result of natural crossings between stacked events and other LMOs or compatible relatives in the receiving environment.

33. 4.0 Specific Types of LMOs and Traits • The Planning phase of the Risk Assessment follows the same general phase as the general risk assessment phase. • Issues to consider in conducting the Risk Assessment include: • a)Sequence characteristics at the insertion sites, genotypic stability and genomic organization,

34. 4.0 Specific Types of LMOs and Traits • b)Potential interactions between combined genes and their resulting phenotypic changes and effects on the environment, • c) Combinatorial and cumulative effects, • d) Crossing and segregation of transgenes, • e) Methods for distinguishing the combined transgenes in a stacked event from the parental LMOs

35. 4.0 Specific Types of LMOs and Traits • ii) Risk Assessment of Living modified plants with tolerance to abiotic stress: • For the purpose of this guidance, “abiotic stresses” are non-living environmental factors which are detrimental to or inhibit the growth, development and/or reproduction of a living organism. • Types of abiotic stresses include, for example, drought, salinity, cold, heat, acidic or basic soils, soil pollution and air pollution (e.g., nitrous oxides, ozone, high CO2 concentration).

36. 4.0 Specific Types of LMOs and Traits • Increased tolerance to abiotic stress has long been a target of plant breeders working towards improved crops that would be able to cope with the stress. • An important consideration in performing a risk assessment of an LM plant with tolerance to abiotic stress is the multiple interactions between the new trait and the receiving environment and the associated need to design properly controlled field experiment

37. 4.0 Specific Types of LMOs and Traits Questions that may be relevant to the risk assessment of LM plants with tolerance to abiotic stress in connection with the intended use and the receiving environment include: • Does the tolerance trait have the potential to affect other tolerance and/or resistance mechanisms of the LM plant, • Does the tolerance trait have the potential to provoke an increase of the invasiveness, persistence or weediness of the LM plant that could cause adverse effects to other organisms, food webs or habitats? • Does an LM plant arising from outcrossing with the abiotic stress tolerant LM plant have the potential to change or colonize a habitat or ecosystem beyond the targeted receiving environment?

38. 4.0 Specific Types of LMOs and Traits • Does an LM plant expressing tolerance to a particular abiotic stress have other advantages in the targeted receiving environment that could cause adverse effects? • What are the adverse impacts in regions that have not been exposed to commercial agriculture but may become exposed to stress tolerant LM plants. Issues to consider in conducting the Risk Assessment include: • Unintended characteristics including crosstalk between stress responses, • Testing the LM plant in representative environments, • Persistence in agricultural areas and invasiveness of natural habitats, • Effects on the abiotic environment and ecosystem:

39. 4.0 Specific Types of LMOs and Traits iii)Risk Assessment of LM Mosquitoes: • Living modified (LM) mosquitoes are being developed through modern biotechnology to reduce transmission of vector-borne human pathogens, particularly those that cause malaria, dengue and chikungunya, • specific and comprehensive considerations should be undertaken with regard to the potential benefits and adverse effects of LM mosquitoes,

40. 4.0 Specific Types of LMOs and Traits • The biology and ecology of mosquitoes on the one hand, • their impact on public health as vectors of human and animal diseases, • on the other hand, pose specific considerations and challenges during the risk assessment process. Two strategies of modern biotechnology: • namely self-limiting and self-propagating strategies, are being developed to produce LM mosquitoes to control vector-borne diseases.

41. 4.0 Specific Types of LMOs and Traits • Another strategy is paratransgenesis, which is under development to control, reduce or eliminate the capacity of the mosquitoes to transmit pathogens. • This document focuses on the risk assessment of LM mosquitoes of the family Culicidae, developed through self-limiting and self-propagating strategies to be used in the control of human and zoonotic diseases.

42. 4.0 Specific Types of LMOs and Traits Planning Phase of the Risk Assessment should focus on, for instance: • the kinds of possible adverse effects for which there are scientifically plausible scenarios; (b) the species as well as ecological and epidemiological processes that could be affected by the introduction of the LM mosquitoes; (c) the protection goals of the country where the LM mosquitoes will be introduced; and (d) a conceptual link between the identified protection goals and the introduction of the LM mosquito into the environment. The line/strain used as a recipient organism for transformation may serve as a comparator for the risk assessment of LM mosquitoes. Issues to consider in conducting the Risk Assessment are similar to the general risk assessment but specific to mosquitoes.

43. 4.0 Specific Types of LMOs and Traits v)Monitoring of Living Modified Organisms Released into the Environment: • This is to provide guidance on monitoring of living modified organisms released into the environment and build on and complement the Roadmap for Risk Assessment of Living Modified Organisms (LMOs). • Monitoring may help detect changes related to adverse effects, • in a timely manner, • before the consequences are realized, • and may inform on the need for appropriate response measures (e.g., changes to risk management strategies, emergency response measures, a new risk assessment, or re-evaluation of prior decisions).

44. 4.0 Specific Types of LMOs and Traits • A monitoring plan is developed when the recommendation of a risk assessment and/or the national biosafety policy calls for monitoring activities to be carried out in conjunction with the environmental release. • The following may be considered: • choice of indicators and parameters for monitoring (“what to monitor?”); • Monitoring methods, including the establishment of baselines and the duration of monitoring (“how to monitor?”); • Monitoring sites and regions (“where to monitor?”); Reporting of monitoring results (“how to communicate?”).

45. 4.0 Specific Types of LMOs and Traits • Monitoring typesinclude • i)monitoring during experimental, short-term and/or small-scale environmental releases. • ii) Monitoring during long-term and/or large-scale environmental releases, • iii) Monitoring to evaluate the efficacy of specific risk management strategies, • iv)Protection of human health: to ascertain, changes due to long-term exposure to the LMO or its products, • v)Maintenance of plant health, • vi) Protection of soil quality. vii) Conservation of biological diversity.

46. 4.0 Specific Types of LMOs and Traits • Challenges in the implementation of Monitoring Plan • (i) lack of capacity for the establishment of robust observation, detection or identification methodologies, • (ii) difficulty in establishing cause-effect relationships (causalities) between the LMO(s) and observed changes in the indicator(s) or parameter(s); and • (iii) the interpretation of monitoring results and relating them to further specific actions.

47. 4.0 Specific Types of LMOs and Traits v) Risk Assessment of Living Modified Trees • This guidance focuses on true botanical trees and does not cover any additional species such as palms, bamboos and shrubs. • Although not addressed specifically in this guidance, where some of the characteristics of trees are shared by other plant species, • such as perennial growth or vegetative propagation, this guidance is to also provide some insights useful for the evaluation of LMOs of those species . • Overarching issues in the risk assessment of LM tree are similar to the ones elaborated in the road map. • Some other issues that required consideration include :

49. 4.0 Specific Types of LMOs and Traits • a)Transboundary movements of LM trees and the Cartagena Protocol, • b)Planning Phase of Risk Assessment of LM Trees, • Conducting the Risk Assessment.

50. 5.0 Nigeria and the Testing of the Road Map • Nigeria as a country, currently carries out Confined Field Trials(CFT) as prelude to overt LMOs general/commercial releases. The use of the Road Map has been considered during some of the application review processes as a means of testing the road map. • The document is also being considered in the ongoing development of relevant guidelines and regulation in Nigeria.