Progress 09/01/15 to 03/31/18
Outputs
Target Audience:The target audience reached by our efforts during this project include the participants in the workshop who came mainly from government or related agencies with responsibilities for risk assessment of GMOs in 11 different countries (Argentina, Australia, Brazil, Canada, Colombia, European Union, India, Japan, Mexico, South Africa, and the United States). This audience was targeted because these are individuals who have direct experience conducting risk assessments and who could assess the guidance on risk assessment being developed under the Cartagena Protocol based on their own experiences in risk assessment, and who are in a position to contribute to the debate concerning this guidance. A number of observers were also present at the workshop, mainly from US agencies involved with the regulation of biotechnology. In addition, a handout based on the outcome and consensus points from the workshop was distributed at the 8th Meeting of the Parties (MOP8) of the Cartagena Protocol in Cancun, Mexico in December 2016, targeting all interested parrticipants attending the MOP from across the globe. A presentation was delivered by PI K. Hokanson in a plenary sessions at the 14th International Symposium on Biosafety of Genetically Modified Organisms (ISBGMO14) in Guadalajara, Mexico in June 2017, describing the workshop and the consensus points from it, targeting a global and diverse audience from academia, industry, and governments. A publication is still planned for submission to the journal Frontiers in Plant Science, to target the broader scientific community and other interested parties. Changes/Problems:The timing for publication has been delayedfrom the original proposal, because it was determined by the PI and the steering committee for the workshop, that there will be more impact if a publication were to comeout after the revised version of the guidance has been discussed at MOP8, rather than before MOP8 as originally proposed. Currently, publication is pending further discussions of the need for guidance on risk assessment that will take place at the SBSTTA22 meeting in July. The original budget request was solely travel funds for the participants at the workshop in Feb 2016, but travel costs came in below budget and additional support for travel was provided by the US State Department. Therefore, funds in this project were redirected to cover the costs of a writing workshop and publication costsin a NCE. Because publication has been further delayed, it became necessary to complete the project before remaining funds could be used for publciation costs. A small amount of remaining funds were rebudgeted to cover sunstantial administrative support from the Stakman Borlaug Center for the organization of the workshop. What opportunities for training and professional development has the project provided?The project provided an opportunity for professional development of the PI (K. Hokanson) through an invitation to deliver a plenary address at ISBGMO14. Co-authors (A. Roberts, M. Garcia Alonso) on the manuscript being developed were also able to attend the ISBGMO14 through partial support for their travel to attend a manuscript writing meeting for the workshop publication at the same time as ISBGMO14. How have the results been disseminated to communities of interest?To date, the results have been circulated informally to communities of interest in the form of the consensus points that came out of the workshop discussion. The consensus points from the workshop were formally shared in a handout at COPMOP8, and a presentation on the workshop was delivered at the ISBGMO14. A publication to be submitted to Frontiers in Plant Science is still planned for July 2018. What do you plan to do during the next reporting period to accomplish the goals?Final Report - Overall Impact A. Scientific Problem/Issue:The Cartagena Protocol has implications for trade and global food security, and it is critical that the Protocol be implemented in a practical manner without creating unnecessarily strict regulatory barriers. Therefore, it is critical that the 'Guidance on Risk Assessment' under the Cartagena Protocol reflects what countries actually do in practice. B. How did this funding address theproblem:The workshop supported by this conference grant addressed the need to review the guidance for risk assessment that was being developed under the Cartagena Protocol for Biosafety. It provided a unique opportunity for indiviudals involved in risk assessments of GMOs from a number of countries where risk assessments are actually being conducted, to compare their experience with risk assessment to what is found in the Protocol and in the Guidance.Individuals who participated in the meeting came from Australia, Argentina, Brazil, Canada, Colombia, European Union, India, Japan, Mexico, The Netherlands, South Africa, and United States (APHIS and EPA). (These individuals participated as experts with experience in risk assessment, not as representatives of their agencies or governments.) C. What was learned: The participants in this workshop arrived at nine main consensus points regarding the Guidance on Risk Assessment. These consenus points are as follows: The Roadmap does not capture the experience that has been gained in the last 25 years of LMO risk assessment. Many basic concepts presented in the Roadmap are relevant for ERA, but the Roadmap is organized in a way that confounds the risk assessment process. There is a lack of clarity on the objectives and the target audience for the Roadmap. The Roadmap is not always consistent with and goes beyond the scope of Annex III. The level of detail and attention given to certain subjects in the Roadmap is disproportionate in terms of relevance to ERA. The treatments of uncertainty and monitoring in the Roadmap, in particular, are not consistent with Annex III, nor based on experience with risk assessment. The Roadmap is not currently appropriate for field trials. Key terms and concepts should be more clearly identified, defined, and linked to existing terminology in general use for ERA, and put into the appropriate context. These concerns with the Roadmap need to be adequately addressed and agreed upon before any additional guidance (including boxes) is considered. A one-page hand-out briefly describing the workshop and sharing the consensus points was shared at the 8th Conference of the Parties serving as the Meeting of the Parties (COPMOP8) where the Guidance on Risk Assessment was presented to the Parties for a decision. D. Impacts: At COPMOP8, the Parties decided not to endorse the Guidance on Risk Assessment. It is available for Parties to use, but it is in no way required or recommended. It is difficult to know whether the workshop and the consensus points that were shared from it directly impacted this decision, but the decision not to endorse the Guidance does align with the concerns identified during our workshop, and represents a favorable outcome forregulatory agencies and product developers (public and private) and ultimately growers and consumers, internationally. Discussions on other guidance for risk assessment are ongoing under the Protocol;therefore, a publication describing the workshop, planned for submission before COPMOP9 in November, will have additional impact. Indirectly, theglobal experts who were participants in the workshop were appreciative of the unique opportunity to sit together and discuss their experiences with risk assessment of GMOs in the workshop compared to the guidance, and the value and potential impact of this networking opportunity should not be underestimated. E. US Federal regulatory agencies:Although the US is not a Party to the Cartagena Protocol, the US has participated as an active 'observer' at the MOPs, and in the online forum and as members (with observer status) of the Ad Hoc Technical Expert Group (AHTEG) for Risk Assessment and Risk Management. It is in the interest of the US to stay abreast of the discussions that take place under the Protocol, and to be consistent (or aware of inconsistencies) with the decisions that come out of the negotiations. The US participation in the workshop discussion also contributed to potential harmonization of US and other country regulatory processes. F. Impact number counts: Total number of peer-reviewed publications:1 Assessing the Guidance for Risk Assessment under the Cartagena Protocol for Biosafety.Manuscript in preparation. Frontiers in Plant Science. (Planned for submission in July 2018) Total number of students trained: 0 Total number of presentations: 1 Karen Hokanson, plenary speaker.When Science meets Policy: the Undoing of the Guidance on Risk Assesment under the Cartagena Protocol on Biosafety. The 14th International Symposium on Biosafety of Genetically Modified Organisms (ISBGMO), Guadalajara, Mexico. June 5-8, 2017. Total number of patents filed or awarded: 0
Impacts
What was accomplished under these goals?
Objective 1. Bring together a group of individuals from the regulatory authorities in those countries that have experience with 'actual cases' of risk assessment for general release into the environment, to examine and compare how the information in these risk assessments fit into the steps outlined in Annex III of the Protocol (2016-100% Complete) A workshop took place on Feb. 1-3, 2016 in Washington DC, which brought together a group of individuals working with the regulatory authorities in those countries that have experience with 'actual cases' of risk assessment for general release into the environment, to review the guidance on risk assessment and compare this information to actual cases of risk assessments in their country, noting how these fit into the steps outlined in Annex III. The workshop was organized by the University of Minnesota Stakman-Borlaug Center for Sustainable Plant Health and was hosted in Washington DC in the facilities of the International Life Science Institute (ILSI). Financial support for the workshop was primarily through this conference grant from the USDA NIFA Biotechnology Risk Assessment Grant Program, with additional support from the USDA Foreign Agricultural Service. Individuals who participated in the workshop were from: Argentina, Australia, Brazil, Canada, Colombia, European Union, India, Japan, Mexico, South Africa, and the United States. Participants presented summaries of risk assessments in their countries compared to the guidance document for risk assessment being developed under the Cartagena Protocol. At the end of the meeting, the participants agreed on nine 'consensus points' that capture the departure of the guidance from their experiences with actual cases of risk assessment of GM plants. Objective 2. Share the outcome of this discussion in a report before the 8th Meeting of the Parties (MOP8) (2016-100% Complete) The consensus points were shared informally before MOP8 and a1-page handout describing the workshop and the consensus points was shared at MOP8.Although the meeting took place in Feb. 2016, the group of individuals who attended the meeting were able to reconnect with each other during the negotiations of the Cartagena Protocol in Dec. 2016. There the Meeting of the Parties (MOP) took a decision to 'take note of' the Risk Assessment Guidance, but not to 'endorse' or even 'acknowledge' the guidance document. This represents progress on the major goals of the project. A presentation titled "When Science Meets Policy: The Undoing of the Risk Assessment Guidance under the Cartagena Protocol on Biosafety' was delivered by PI K. Hokanson in a plenary session at the 14th International Symposium on Biosafety of Genetically Modified Organisms (ISBGMO14) in Guadalajara, Mexico in June 2017, which included a description ofthe workshop and the consensus points from it. A publication on the outcome of this workshop will be submitted to the Research Topic on Biosafety of GMOs in Frontiers in Plant Science, but submission is still pendingand will depend on the discussions of the need for additional guidance on risk assessment that will take place at the SBSTTA22 meeting in July 2018. The outcome of those discussions will shape the tone of the publication to have the most impact. A journal submission is targeted for July 2018.
Publications
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Progress 09/01/16 to 08/31/17
Outputs
Target Audience:During this reporting period, a handout based on the outcome and consensus points from the workshop was distributed at the 8th Meeting of the Parties (MOP8) of the Cartagena Protocol in Cancun, Mexico in December 2016, targeting all interested parrticipants attending the MOP from across the globe. In addition, a presentation was delivered by PI K. Hokanson in a plenary sessions at the 14th International Symposium on Biosafety of Genetically Modified Organisms(ISBGMO14) in Guadalajara, Mexico in June 2017, describing the workshop and the consensus points from it, targeting a global and diverse audience from academia, industry, and governments. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?The project provided an opportunity for professional development of the PI(K. Hokanson)through aninvitation to deliver a plenary address at ISBGMO14. Co-authors (A. Roberts, M. Garcia Alonso) on the manuscript being developed were also able to attend the ISBGMO14 through partial support for their travel to attend a manuscript writing meeting for the workshop publicationat the same time as ISBGMO14. How have the results been disseminated to communities of interest?The consensus points from the workshop were shared in a handout at COPMOP8, and a presnetation on the workshop was delivered at the ISBGMO14. What do you plan to do during the next reporting period to accomplish the goals?The project has requested a no cost extension (NCE) through March 2018 with the intention to complete a publication. The remaining funds have been used to help support the attendance of several co-authors at a meeting to prepare this manuscript, in the margins of the ISBGMO14 in Guadalajara in June 2017. The manuscript is still under development and will be submitted for publication before the end of the current NCE. It will reflect the outcome of the workshop in relation to the final decision atMOP8 regarding the risk assessement guidance.
Impacts
What was accomplished under these goals?
Although the meeting took place in Feb. 2016, the group of individuals who attended the meeting were ableto reconnect with each other during the negotiations of the Cartagena Protocol in Dec. 2016. There theMeeting of the Parties (MOP) took a decision to 'take note of' the Risk Assessment Guidance, but not to 'endorse' or even 'acknowledge', andtheconsensus points reachedduring the workshop in Feb 2016 and shared with participants at the MOP in the form of a handout supported this decision by the MOP. This represents progress on the major goals of the project.
Publications
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Progress 09/01/15 to 08/31/16
Outputs
Target Audience:The target audience reached by our efforts during this reporting period include the participants in the workshop who came mainly from goovernment or releated agencies with responsibilities for risk assessment of GMOsin 11different countries (Argentina, Australia, Brazil, Canada, Colombia, European Union, India, Japan, Mexico, South Africa, and the United States). This audience was targeted because these are individuals who have direct experience conducting risk assessments and who can assess the guidance onrisk assessment being developed under the cartagena protocol based on their own experiences in risk assessment, and who are in a position to influence the debate concerningthis guidance. A number of obeservers were also present at the workshop, mainly from US agencies involved with the regulation of biotechnology. Other interested parties from Academia,Industry, and NGOs have also been informally targeted through the sharing of the consensus points agreed upon by the meeting participants. Changes/Problems:The timing for publication has been reconsidered from the original proposal, because it was determined by the PI and the steering committee for the workshop, that there will be more impact if a publication comes out after the revised version of the guidance has been discussed at MOP8, rather than before MOP8 as originally proposed. Thus a NCE has been requested so remaining funds can still be used to cover the cost of writing and publishing the results. What opportunities for training and professional development has the project provided?
Nothing Reported
How have the results been disseminated to communities of interest?To date, the results have been circulatedinformally to interested parties in the form of the consensus points that came out ofthe workshop discussion. What do you plan to do during the next reporting period to accomplish the goals?The project has requested a 'no cost extension' through March 2017. The consensus points from the workshop will be shared more broadly in the months leading up to and at the 8th Meeting of the Parties (MOP8)of the Cartagena Protocol, which will be held in December 2016. The Most recent revisions of the guidance will be discussed by the Parties during MOP8. These revisionswill be throughly reviewed in relation to the consensus points from the workshop, and a journal publication on the outcome of the workshop will be prepared, taking into consideration the current revisions to the guidance. This publication is planned for submissionbefore March 2017.
Impacts
What was accomplished under these goals?
Objective 1. Bring together a group of individuals from the regulatory authorities in those countries that have experience with 'actual cases' of risk assessment for general release into the environment, to examine and compare how the information in these risk assessments fit into the steps outlined in Annex III of the Protocol(2016-100% Complete) A workshop took place on Feb. 1-3, 2016 in Washington DC, which brought together a group of individuals working with the regulatory authorities in those countries that have experience with 'actual cases' of risk assessment for general release into the environment, to review the guidance on risk assessment and compare this information to actual cases of risk assessments in their country, noting how these fit into the steps outlined in Annex III. The workshop was organized by the University of Minnesota Stakman-Borlaug Center for Sustainable Plant Health and was hosted in Washington DC in the facilities of the International Life Science Institute (ILSI). Financial support for the workshop was primarily through this conference grant from the USDA NIFA Biotechnology Risk Assessment Grant Program, with additional support from the USDA Foreign Agricultural Service. Individuals who participated in the workshop were from: Argentina, Australia, Brazil, Canada, Colombia, European Union, India, Japan, Mexico, South Africa, and the United States. Participants presented summaries of risk assessments in their countries compared to the guidance document for risk assessment being developed under the Cartagena Protocol. At the end of the meeting, the participants agreed on nine 'consensus points' that capture the departure of the guidance from their experiences with actual cases of risk assessment of GM plants. Objective 2. Share the outcome of this discussion in a report before the 8th Meeting of the Parties (MOP8)(2016-25% Complete) The consensus points from the workshop have already been circulated to interested parties, and are being considered as parties and other organizations prepare their positions for the MOP. A 'brief' describing the consensus points will be shared at MOP8. This is being prepared currently. A publication on the outcome of this workshop is pending, and will depend on the discussions of a revised version of the guidance that will take place at MOP8 in December 2016. The outcome of those discussions will shape the tone of the publication to have the most impact. A journal submission is targeted for first quarter (Jan-Mar) 2017.
Publications
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