Biosafety Protocol agrees important work on risk assessment of GMOs

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

11 December 2018
Published by Third World Network
www.twn.my 

Biosafety Protocol agrees important work on risk assessment of GMOs 

Sharm el-Sheikh, 10 Dec (Lim Li Ching and Lim Li Lin) — Parties to the Cartagena Protocol on Biosafety have adopted a decision that puts its important risk assessment work firmly back on track, after previous setbacks. 

The Cartagena Protocol, which is a Protocol to the Convention on Biological Diversity (CBD), is the only international treaty that specifically regulates genetic engineering and genetically modified organisms (GMOs) or living modified organisms (LMOs), as they are known in the Protocol. 

The Ninth meeting of the Conference of the Parties serving as the Meeting of the Parties (COP-MOP 9) to the Cartagena Protocol on Biosafety was held in Sharm el-Sheikh, Egypt from 17th to 29th November 2018. 

Risk assessment is the central pillar of the Cartagena Protocol, necessary to assess the effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health. 

At COP-MOP 8 in 2016, risk assessment proved to be the most divisive issue, pitting developing countries requesting for further risk assessment guidance against many developed countries and some developing countries with biotechnology and trade interests. 

Due to opposition by some Parties, COP-MOP 8 did not endorse the Guidance on Risk Assessment on Living Modified Organisms and Monitoring in the Context of Risk Assessment, that had been developed, revised and improved by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management since it was first set up in 2008. 

It also did not extend the mandate of the AHTEG, and the proposed work on specific risk assessment guidance on living modified fish and LMOs produced through synthetic biology was not taken further, as was initially anticipated. 

This was a setback as the AHTEG had already developed outlines on those topics, which Parties had previously identified as priorities. Genetically modified salmon has already been bred in Panama and sold for human consumption in Canada. 

Some LMOs produced through synthetic biology have been approved for commercial production, such as living modified yeast whose metabolic pathway has been genetically engineered to produce compounds for the manufacture of biodiesel. 

However, at the meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) that took place in July 2018, Parties began to breathe some life back into the process. 

The SBSTTA had considered the results of an extended multi-stage process involving submissions by Parties, discussions in the Online Forum on Risk Assessment and Risk Management and subsequent peer review of the report of the online discussions. 

It had been tasked to "recommend a way forward to address the needs, priorities and gaps identified by Parties" for consideration of COP-MOP 9, "including the possible establishment of a new AHTEG, with the understanding that new guidance proposals should only be presented upon approval by the COP-MOP". 

At COP-MOP 9, Parties focused on the areas of disagreement that could not be resolved at SBSTTA – whether or not LMOs produced through genome editing should be subject to further work in the following areas: 

(i) In international cooperation, knowledge sharing and capacity-building to support Parties and others in assessing the potential adverse effects on the conservation and sustainable use of biodiversity, taking into account risks to human health, the value of biodiversity to indigenous peoples and local communities, and relevant experiences of individual countries in performing risk assessment of such organisms; 

(ii) For inclusion in a study to inform the application of criteria to facilitate the process of identifying and prioritizing specific topics that may warrant consideration for developing risk assessment guidance; and 

(iii) As a topic for the development of risk assessment guidance for consideration by COP-MOP 10 in 2020.

During the discussions in the Working Group, some Parties including Brazil, New Zealand, Paraguay, Switzerland, as well as Malawi speaking for the Africa Group, requested the deletion of all the references to LMOs produced through genome editing. Some of these Parties held the view that some organisms produced through genome editing were not LMOs. 

While the European Union (EU) felt that "LMOs produced through genome editing" was too broad a category and that the work set out in the decision should focus on specific topics and well-defined examples of LMOs, such as LMOs containing engineered gene drives and LM fish, it was open to working on a compromise on this issue. This view was supported by Norway. 

On the other hand, some Parties including Belarus, Bolivia, Uruguay and Venezuela wanted to keep the specific references to LMOs produced through genome editing, given that genome editing techniques are new techniques of modern biotechnology that are more powerful and flexible than those of classical genetic engineering, allowing for deeper interventions, but with potential off-target effects. They felt that all Parties, especially those from developing countries and economies in transition, could benefit from further guidance on risk assessment of these LMOs. 

Even as delegates in Sharm el-Sheikh deliberated on genome editing at COP-MOP 9, news headlines from a conference in Hong Kong on the birth of alleged gene-edited babies alarmed scientists and the public alike. 

The scientist claiming responsibility for this was widely condemned for conducting the experiment without due regard for ethical or safety considerations, bringing attention to the fact that there are no international rules or guidance specific to this new field of genetic engineering technologies, and that international cooperation, knowledge sharing and capacity-building to help Parties in assessing its potential adverse effects are needed. 

Although Parties were urged to focus on bracketed text, there were some, such as Brazil, Costa Rica, Honduras, Paraguay and the Philippines, who insisted on questioning already agreed text, such as on the establishment of the AHTEG and the consideration of development of new risk assessment guidance at COP-MOP 10. 

Due to the divergences in opinion, a Contact Group chaired by Horst Korn (Germany) was set up to negotiate on these issues. 

At the Contact Group, the discussion on LMOs produced through genome editing was eventually separated into two parts. First, whether LMOs produced through genome editing should be included in the paragraph calling for broad international cooperation, knowledge sharing and capacity-building to support Parties and others in assessing its potential adverse effects. 

Secondly, whether LMOs produced through genome editing should be one of the subjects of the study commissioned by the CBD Executive Secretary which would be subsequently reviewed and analysed by the AHTEG, for informing the application of criteria to facilitate the process of identifying and prioritizing specific topics that may warrant consideration for developing risk assessment guidance. In addition, the issue of whether risk assessment guidance should be developed for LMOs produced through genome editing was also being considered here. 

These were considered to be separate classes of issues as the first is more general in nature and based on needs and priorities already identified previously by Parties which included LMOs containing engineered gene drives, LM fish and LMOs produced through genome editing. 

Compromise text, which included LMOs developed through genome editing, was eventually agreed and adopted: 

"Calls for broad international cooperation, knowledge sharing and capacity-building to support, inter alia, Parties in assessing the potential adverse effects on the conservation and sustainable use of biodiversity from living modified fish and other living modified organisms produced through new developments of modern biotechnology, including LMOs developed through genome editing and LMOs containing engineered gene drives, taking into account risks to human health, the value of biodiversity to indigenous peoples and local communities, and relevant experiences of individual countries in performing risk assessment of such organisms in accordance with annex III of the Cartagena Protocol; …" 

However, the second issue of potentially developing risk assessment guidance for LMOs produced through genome editing as well as including it in the study was not accepted. As a result, all references to LMOs produced through genome editing in this respect were deleted from the decision. 

Therefore, the abovementioned study commissioned by the Executive Secretary, which will be reviewed and analysed by the AHTEG, will only focus on LMOs containing engineered gene drives and LM fish. In addition, COP-MOP 10 will only consider whether additional guidance on risk assessment is required for LMOs containing engineered gene drives and LM fish. 

Nonetheless, Parties were relieved that an AHTEG has now been established, as opposition to this since the last COP-MOP has continued. There will now be further work on risk assessment, including a decision on new guidance at COP-MOP 10 in 2020, which had been opposed at the last COP-MOP in 2016. 

There is furthermore, no barrier to further consideration of LMOs produced through genome editing in future risk assessment work, including by the AHTEG. This is because the AHTEG is tasked to, inter alia, "consider the needs and priorities for further guidance and gaps in existing guidance identified by Parties" in response to a previous decision, for which some Parties’ submissions had already identified LMOs produced through genome editing. 

SOCIO-ECONOMIC CONSIDERATIONS 

The Parties to the Cartagena Protocol also adopted several other important decisions at the Sharm el-Sheikh meeting. 

Among these, COP-MOP 9 took note of the "Guidance on the Assessment of Socio-Economic Considerations in the Context of Article 26 of the Cartagena Protocol on Biosafety". It also extended the mandate of the AHTEG on Socio-Economic Considerations to supplement the Guidance, which it will do following a process of collection of information and case studies via submissions from Parties and discussion in an online forum. 

This was significant progress, as there was stiff opposition to the extension of the AHTEG, so much so that a Contact Group was established to deal with this issue. The Contact Group was chaired by Natalhie Beatriz Campos Reales Pineda of Mexico. 

The vehement opposition to the extension of the AHTEG, led by Brazil and supported by a handful of Latin American Parties, as well as some Parties from the Africa Group, took many by surprise. 

This is particularly because the Africa Group had, in the past, very strongly fought for the inclusion of socio- economic considerations in the Cartagena Protocol, as it had recognised that farmers and populations in the African continent were particularly vulnerable to any adverse socio-economic impacts of LMOs. 

CONTAINED USE 

The surprising stance of the Africa Group, which had historically been in support of precautionary approaches to biosafety, was also reflected in the discussions on contained use. 

The Compliance Committee of the Cartagena Protocol had recommended an important reminder to Parties that a field trial, confined field trial or experimental introduction is to be regarded as intentional introduction into the environment and not contained use. 

Contained use is defined in paragraph (b) of Article 3 of the Cartagena Protocol as "any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment". 

Contained use is usually regarded as being within a physical structure such as a laboratory and this is reflected in guidance such as that set out in the WHO Laboratory Biosafety Manual. 

Some African Parties, however, insisted that confined field trials (in an open environment) were to be regarded as contained use and objected to the clarification proposed by the Compliance Committee. The issue was eventually resolved by specifying that a field trial, confined field trial or experimental introduction is to be regarded as intentional introduction into the environment when the conditions specified in paragraph (b) of Article 3 of the Protocol are not met. 

LIABILITY AND REDRESS 

Another significant biosafety development was the entry into force in March 2018 of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. 

At Sharm el-Sheikh, Parties to the Supplementary Protocol took a decision that it was obliged to under Article 10 of the Supplementary Protocol, to request a comprehensive study, which addresses, inter alia, (a) the modalities of financial security mechanisms; (b) an assessment of the environmental, economic and social impacts of such mechanisms, in particular on developing countries; and (c) an identification of the appropriate entities to provide financial security. 

Financial security was one of the most contentious issues that dogged the negotiations of the Supplementary Protocol. It is critical because, if for any reason the responsible party cannot pay for the damage caused by an LMO, financial security provides some means to do so.

The compromise in the Supplementary Protocol recognizes the right of Parties to provide for financial security under their national laws, and requires that the first meeting of the COP-MOP after entry into force of the Supplementary Protocol requests the Secretariat to undertake the comprehensive study. 

However, ironically, the study is subject to the availability of funds from the Voluntary Trust Fund, despite being an obligation in the Supplementary Protocol. This is because the Supplementary Protocol does no have core funding from the budget of the Secretariat. Thus, any funds needed to support the activities of the Secretariat for the Supplementary Protocol, for the biennium 2019-2020, will be funded by its Parties. 

OTHER DECISIONS 

COP-MOP 9 also adopted decisions on unintentional transboundary movements and emergency measures; matters related to the financial mechanism and resources; monitoring and reporting; assessment and review of the effectiveness of the Cartagena Protocol; operation and activities of the Biosafety Clearing-House; review of experience in holding concurrent meetings of the CBD, Cartagena Protocol and Nagoya Protocol; capacity- building; compliance; enhancing integration under the convention and its Protocols with respect to biosafety- related provisions; procedure for avoiding or managing conflicts of interest in expert groups; preparation for the follow-up to the Strategic Plan for Biodiversity 2011-2020 and the Strategic Plan for the Cartagena Protocol on Biosafety 2011-2020; and budget for the integrated programme of work of the Secretariat. +

Biosafety Protocol agrees important work on risk assessment of GMOs

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

11 December 2018
Published by Third World Network
www.twn.my 

Biosafety Protocol agrees important work on risk assessment of GMOs 

Sharm el-Sheikh, 10 Dec (Lim Li Ching and Lim Li Lin) — Parties to the Cartagena Protocol on Biosafety have adopted a decision that puts its important risk assessment work firmly back on track, after previous setbacks. 

The Cartagena Protocol, which is a Protocol to the Convention on Biological Diversity (CBD), is the only international treaty that specifically regulates genetic engineering and genetically modified organisms (GMOs) or living modified organisms (LMOs), as they are known in the Protocol. 

The Ninth meeting of the Conference of the Parties serving as the Meeting of the Parties (COP-MOP 9) to the Cartagena Protocol on Biosafety was held in Sharm el-Sheikh, Egypt from 17th to 29th November 2018. 

Risk assessment is the central pillar of the Cartagena Protocol, necessary to assess the effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health. 

At COP-MOP 8 in 2016, risk assessment proved to be the most divisive issue, pitting developing countries requesting for further risk assessment guidance against many developed countries and some developing countries with biotechnology and trade interests. 

Due to opposition by some Parties, COP-MOP 8 did not endorse the Guidance on Risk Assessment on Living Modified Organisms and Monitoring in the Context of Risk Assessment, that had been developed, revised and improved by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management since it was first set up in 2008. 

It also did not extend the mandate of the AHTEG, and the proposed work on specific risk assessment guidance on living modified fish and LMOs produced through synthetic biology was not taken further, as was initially anticipated. 

This was a setback as the AHTEG had already developed outlines on those topics, which Parties had previously identified as priorities. Genetically modified salmon has already been bred in Panama and sold for human consumption in Canada. 

Some LMOs produced through synthetic biology have been approved for commercial production, such as living modified yeast whose metabolic pathway has been genetically engineered to produce compounds for the manufacture of biodiesel. 

However, at the meeting of the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) that took place in July 2018, Parties began to breathe some life back into the process. 

The SBSTTA had considered the results of an extended multi-stage process involving submissions by Parties, discussions in the Online Forum on Risk Assessment and Risk Management and subsequent peer review of the report of the online discussions. 

It had been tasked to "recommend a way forward to address the needs, priorities and gaps identified by Parties" for consideration of COP-MOP 9, "including the possible establishment of a new AHTEG, with the understanding that new guidance proposals should only be presented upon approval by the COP-MOP". 

At COP-MOP 9, Parties focused on the areas of disagreement that could not be resolved at SBSTTA – whether or not LMOs produced through genome editing should be subject to further work in the following areas: 

(i) In international cooperation, knowledge sharing and capacity-building to support Parties and others in assessing the potential adverse effects on the conservation and sustainable use of biodiversity, taking into account risks to human health, the value of biodiversity to indigenous peoples and local communities, and relevant experiences of individual countries in performing risk assessment of such organisms; 

(ii) For inclusion in a study to inform the application of criteria to facilitate the process of identifying and prioritizing specific topics that may warrant consideration for developing risk assessment guidance; and 

(iii) As a topic for the development of risk assessment guidance for consideration by COP-MOP 10 in 2020.

During the discussions in the Working Group, some Parties including Brazil, New Zealand, Paraguay, Switzerland, as well as Malawi speaking for the Africa Group, requested the deletion of all the references to LMOs produced through genome editing. Some of these Parties held the view that some organisms produced through genome editing were not LMOs. 

While the European Union (EU) felt that "LMOs produced through genome editing" was too broad a category and that the work set out in the decision should focus on specific topics and well-defined examples of LMOs, such as LMOs containing engineered gene drives and LM fish, it was open to working on a compromise on this issue. This view was supported by Norway. 

On the other hand, some Parties including Belarus, Bolivia, Uruguay and Venezuela wanted to keep the specific references to LMOs produced through genome editing, given that genome editing techniques are new techniques of modern biotechnology that are more powerful and flexible than those of classical genetic engineering, allowing for deeper interventions, but with potential off-target effects. They felt that all Parties, especially those from developing countries and economies in transition, could benefit from further guidance on risk assessment of these LMOs. 

Even as delegates in Sharm el-Sheikh deliberated on genome editing at COP-MOP 9, news headlines from a conference in Hong Kong on the birth of alleged gene-edited babies alarmed scientists and the public alike. 

The scientist claiming responsibility for this was widely condemned for conducting the experiment without due regard for ethical or safety considerations, bringing attention to the fact that there are no international rules or guidance specific to this new field of genetic engineering technologies, and that international cooperation, knowledge sharing and capacity-building to help Parties in assessing its potential adverse effects are needed. 

Although Parties were urged to focus on bracketed text, there were some, such as Brazil, Costa Rica, Honduras, Paraguay and the Philippines, who insisted on questioning already agreed text, such as on the establishment of the AHTEG and the consideration of development of new risk assessment guidance at COP-MOP 10. 

Due to the divergences in opinion, a Contact Group chaired by Horst Korn (Germany) was set up to negotiate on these issues. 

At the Contact Group, the discussion on LMOs produced through genome editing was eventually separated into two parts. First, whether LMOs produced through genome editing should be included in the paragraph calling for broad international cooperation, knowledge sharing and capacity-building to support Parties and others in assessing its potential adverse effects. 

Secondly, whether LMOs produced through genome editing should be one of the subjects of the study commissioned by the CBD Executive Secretary which would be subsequently reviewed and analysed by the AHTEG, for informing the application of criteria to facilitate the process of identifying and prioritizing specific topics that may warrant consideration for developing risk assessment guidance. In addition, the issue of whether risk assessment guidance should be developed for LMOs produced through genome editing was also being considered here. 

These were considered to be separate classes of issues as the first is more general in nature and based on needs and priorities already identified previously by Parties which included LMOs containing engineered gene drives, LM fish and LMOs produced through genome editing. 

Compromise text, which included LMOs developed through genome editing, was eventually agreed and adopted: 

"Calls for broad international cooperation, knowledge sharing and capacity-building to support, inter alia, Parties in assessing the potential adverse effects on the conservation and sustainable use of biodiversity from living modified fish and other living modified organisms produced through new developments of modern biotechnology, including LMOs developed through genome editing and LMOs containing engineered gene drives, taking into account risks to human health, the value of biodiversity to indigenous peoples and local communities, and relevant experiences of individual countries in performing risk assessment of such organisms in accordance with annex III of the Cartagena Protocol; …" 

However, the second issue of potentially developing risk assessment guidance for LMOs produced through genome editing as well as including it in the study was not accepted. As a result, all references to LMOs produced through genome editing in this respect were deleted from the decision. 

Therefore, the abovementioned study commissioned by the Executive Secretary, which will be reviewed and analysed by the AHTEG, will only focus on LMOs containing engineered gene drives and LM fish. In addition, COP-MOP 10 will only consider whether additional guidance on risk assessment is required for LMOs containing engineered gene drives and LM fish. 

Nonetheless, Parties were relieved that an AHTEG has now been established, as opposition to this since the last COP-MOP has continued. There will now be further work on risk assessment, including a decision on new guidance at COP-MOP 10 in 2020, which had been opposed at the last COP-MOP in 2016. 

There is furthermore, no barrier to further consideration of LMOs produced through genome editing in future risk assessment work, including by the AHTEG. This is because the AHTEG is tasked to, inter alia, "consider the needs and priorities for further guidance and gaps in existing guidance identified by Parties" in response to a previous decision, for which some Parties’ submissions had already identified LMOs produced through genome editing. 

SOCIO-ECONOMIC CONSIDERATIONS 

The Parties to the Cartagena Protocol also adopted several other important decisions at the Sharm el-Sheikh meeting. 

Among these, COP-MOP 9 took note of the "Guidance on the Assessment of Socio-Economic Considerations in the Context of Article 26 of the Cartagena Protocol on Biosafety". It also extended the mandate of the AHTEG on Socio-Economic Considerations to supplement the Guidance, which it will do following a process of collection of information and case studies via submissions from Parties and discussion in an online forum. 

This was significant progress, as there was stiff opposition to the extension of the AHTEG, so much so that a Contact Group was established to deal with this issue. The Contact Group was chaired by Natalhie Beatriz Campos Reales Pineda of Mexico. 

The vehement opposition to the extension of the AHTEG, led by Brazil and supported by a handful of Latin American Parties, as well as some Parties from the Africa Group, took many by surprise. 

This is particularly because the Africa Group had, in the past, very strongly fought for the inclusion of socio- economic considerations in the Cartagena Protocol, as it had recognised that farmers and populations in the African continent were particularly vulnerable to any adverse socio-economic impacts of LMOs. 

CONTAINED USE 

The surprising stance of the Africa Group, which had historically been in support of precautionary approaches to biosafety, was also reflected in the discussions on contained use. 

The Compliance Committee of the Cartagena Protocol had recommended an important reminder to Parties that a field trial, confined field trial or experimental introduction is to be regarded as intentional introduction into the environment and not contained use. 

Contained use is defined in paragraph (b) of Article 3 of the Cartagena Protocol as "any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment". 

Contained use is usually regarded as being within a physical structure such as a laboratory and this is reflected in guidance such as that set out in the WHO Laboratory Biosafety Manual. 

Some African Parties, however, insisted that confined field trials (in an open environment) were to be regarded as contained use and objected to the clarification proposed by the Compliance Committee. The issue was eventually resolved by specifying that a field trial, confined field trial or experimental introduction is to be regarded as intentional introduction into the environment when the conditions specified in paragraph (b) of Article 3 of the Protocol are not met. 

LIABILITY AND REDRESS 

Another significant biosafety development was the entry into force in March 2018 of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. 

At Sharm el-Sheikh, Parties to the Supplementary Protocol took a decision that it was obliged to under Article 10 of the Supplementary Protocol, to request a comprehensive study, which addresses, inter alia, (a) the modalities of financial security mechanisms; (b) an assessment of the environmental, economic and social impacts of such mechanisms, in particular on developing countries; and (c) an identification of the appropriate entities to provide financial security. 

Financial security was one of the most contentious issues that dogged the negotiations of the Supplementary Protocol. It is critical because, if for any reason the responsible party cannot pay for the damage caused by an LMO, financial security provides some means to do so.

The compromise in the Supplementary Protocol recognizes the right of Parties to provide for financial security under their national laws, and requires that the first meeting of the COP-MOP after entry into force of the Supplementary Protocol requests the Secretariat to undertake the comprehensive study. 

However, ironically, the study is subject to the availability of funds from the Voluntary Trust Fund, despite being an obligation in the Supplementary Protocol. This is because the Supplementary Protocol does no have core funding from the budget of the Secretariat. Thus, any funds needed to support the activities of the Secretariat for the Supplementary Protocol, for the biennium 2019-2020, will be funded by its Parties. 

OTHER DECISIONS 

COP-MOP 9 also adopted decisions on unintentional transboundary movements and emergency measures; matters related to the financial mechanism and resources; monitoring and reporting; assessment and review of the effectiveness of the Cartagena Protocol; operation and activities of the Biosafety Clearing-House; review of experience in holding concurrent meetings of the CBD, Cartagena Protocol and Nagoya Protocol; capacity- building; compliance; enhancing integration under the convention and its Protocols with respect to biosafety- related provisions; procedure for avoiding or managing conflicts of interest in expert groups; preparation for the follow-up to the Strategic Plan for Biodiversity 2011-2020 and the Strategic Plan for the Cartagena Protocol on Biosafety 2011-2020; and budget for the integrated programme of work of the Secretariat. +

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