Seeds Stewardship Programs and Relevance to Gene Editing

Transcription

1 Seeds Stewardship Programs and Relevance to Gene Editing Santosh Kumar, M.S., Global Stewardship Manager 24 October 2017

2 Agenda Stewardship, the typical questions, what, why, how... Quality Management and Stewardship How to confirm what you are working with? Expectations for Commercialization, Discontinuation and Incident Management Concluding Thoughts

3 Stewardship: A Critical Seed Company Practice Responsible use throughout the product life-cycle R&D Product Development Seed or Plant Production Marketing & Distribution Crop Production Crop Utilization Product Discontinuation

4 Stewardship: A Critical Seed Company Practice Responsible use throughout the product life-cycle Why?

5 Stewardship: A Critical Seed Company Practice Responsible use throughout the product life-cycle Why? Customer and Public Expectation Value-chain stakeholder expectation R&D Risk reduction License to Operate

6 Stewardship includes the need to determine safety and performance

7 Stewardship includes the need to determine safety and performance Establish Safety Food Feed Environment Establish Performance Agronomic characteristics Reproducibility Stability

8 Stewardship includes the need to determine safety and performance Establish Safety Food Feed Environment Regulated Not Regulated Establish Performance Agronomic characteristics Reproducibility Stability

9 Stewardship includes the need to determine safety and performance Establish Safety Food Feed Environment Regulated Not Regulated Establish Performance Agronomic characteristics Reproducibility Stability

10 Stewardship includes the need to determine safety and performance Establish Safety Food Feed Environment Regulated Not Regulated Establish Performance Agronomic characteristics Reproducibility Stability Regulated Not Regulated

11 How to Implement Stewardship Practices? Available Guidance

12 How to Implement Stewardship Practices? For each stage of the life cycle there is a standard set of information presented that serves as step-wise guidance for developing the quality management practices. This standard set of information follows Hazard Analysis and Critical Control Points (HACCP) principles. Guide to Seed Quality Management Practices, July The ETS program is designed to appropriately promote stewardship and quality management regardless of the geographic location of an operation or activity and the regulatory authority under which you may be operating. ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and.. Available Guidance

13 How to Implement Stewardship Practices? For each stage of the life cycle there is a standard set of information presented that serves as step-wise guidance for developing the quality management practices. This standard set of information follows Hazard Analysis and Critical Control Points (HACCP) principles. Guide to Seed Quality Management Practices, July The ETS program is designed to appropriately promote stewardship and quality management regardless of the geographic location of an operation or activity and the regulatory authority under which you may be operating. ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and.. Available Guidance

14 How to Implement Stewardship Practices? For each stage of the life cycle there is a standard set of information presented that serves as step-wise guidance for developing the quality management practices. This standard set of information follows Hazard Analysis and Critical Control Points (HACCP) principles. Guide to Seed Quality Management Practices, July The ETS program is designed to appropriately promote stewardship and quality management regardless of the geographic location of an operation or activity and the regulatory authority under which you may be operating. ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and.. Available Guidance

15 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Movement Phytosanitary Seed laws Export-import Biotech Nagoya Protocol

16 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Identification (labelling / unique identifier) Movement Phytosanitary Seed laws Identify Export-import Biotech Nagoya Protocol

17 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Identification (labelling / unique identifier) Traceability Security (access control) Inventory Management Movement Phytosanitary Seed laws Export-import Identify Tracking Biotech Nagoya Protocol

18 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Identification (labelling / unique identifier) Traceability Security (access control) Inventory Management Cross-pollination and Commingling prevention Movement Phytosanitary Seed laws Identify Tracking Separation Export-import Biotech Nagoya Protocol

19 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Identification (labelling / unique identifier) Traceability Security (access control) Inventory Management Cross-pollination and Commingling prevention Product Quality Movement Phytosanitary Seed laws Identify Tracking Separation Confirmation Export-import Biotech Nagoya Protocol

20 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Identification (labelling / unique identifier) Traceability Security (access control) Inventory Management Cross-pollination and Commingling prevention Product Quality Continuous Improvement Movement Phytosanitary Seed laws Identify Tracking Separation Confirmation Check Compliance Export-import Biotech Nagoya Protocol

21 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Identification (labelling / unique identifier) Traceability Security (access control) Inventory Management Cross-pollination and Commingling prevention Product Quality Continuous Improvement Records / Documents Movement Phytosanitary Seed laws Identify Tracking Separation Confirmation Check Compliance Create Evidence Export-import Biotech Nagoya Protocol

22 Essential Elements of Stewardship Practices for Seed Products Compliance with applicable regulations Identification (labelling / unique identifier) Traceability Security (access control) Inventory Management Cross-pollination and Commingling prevention Product Quality Continuous Improvement Records / Documents Movement Phytosanitary Seed laws Identify Tracking Separation Confirmation Check Compliance Create Evidence Export-import Biotech Nagoya Protocol Whether the process/product falls under biotech regulations or not

23 Stewarding Seed Products Quality Management Practices Basics of a Quality Management System: Pose relevant questions, assess answers, develop procedures to address identified risks, train, ensure management support/guidance, monitor, document, review and modify again as needed Plan Act Do Check

24 Stewarding Seed Products Quality Management Practices Basics of a Quality Management System: Pose relevant questions, assess answers, develop procedures to address identified risks, train, ensure management support/guidance, monitor, document, review and modify again as needed Plan Act Do Check Verification - internal and/or independent external audit?

25 Stewarding Seed Products through the product life-cycle Early Research Stewardship Considerations Are there purity standards, other standards? Confirm whether starting materials conform to standards (Critical Control Point, CCP) Compliance Checks Assess and mitigate potential for misidentification, track and trace, inventory management For gene editing technology, during the editing process are there any foreign genome elements potentially incorporated? Early Research Technical proof of concept Confirm Control Identify Track If so would the product at this stage be a regulated product.. process? Assess and mitigate potential for loss of containment CCP Check Compliance Record Assess and mitigate entry into other product lines via cross-pollination (Separation) Hand-off to the next phase Assess and mitigate entry into other product lines via commingling? (Clean equipment, clean facilities, separation strategies

26 Stewarding Seed Products through the product life-cycle - Development Stewardship Considerations Confirm whether starting materials conform to standards (Critical Control Point, CCP) Is the field site optimal (historical records, volunteers) Compliance Checks Assess and mitigate potential for misidentification, track and trace, inventory management Assess and mitigate for loss of confinement Development Commercial proof of concept Confirm Control Identify Track Assess and mitigate entry into other product lines or species via cross-pollination (Separation) CCP Check Compliance Record Assess and mitigate entry into other product lines via commingling? (Clean equipment, clean facilities, separation strategies) Hand-off to the next phase Assess how to verify working with the intended product (Product integrity)

27 Stewarding Seed Products through the product life-cycle - Seed Production Stewardship Considerations Confirm whether starting materials conform to standards (Critical Control Point, CCP) Is the field site optimal (historical records, volunteers) Compliance Checks Assess and mitigate potential for misidentification, track and trace, inventory management Assess and mitigate for loss of confinement Seed production and commercialization Confirm Control Identify Track Assess and mitigate entry into other product lines or species via cross-pollination (Separation) CCP Check Compliance Record Assess and mitigate entry into other product lines via commingling? (Clean equipment, clean facilities, separation strategies) Assess how to verify working with the intended product (Product integrity) Sales of the intended fit for purpose product into the market place

28 Are there Detection Methods to Identify Gene Edited Products?

29 Are there Detection Methods to Identify Gene Edited Products? Confirm identity/ intended product PCR methods Sequencing Biochemical Enzymatic Bio-assay

30 Are there Detection Methods to Identify Gene Edited Products? Confirm identity/ intended product PCR methods Sequencing Biochemical Enzymatic Bio-assay Challenging to establish at low levels whether a gene edited product or a natural mutation

31 Role of Stewardship at Commercialization Engagement with value-chain stakeholders Timely communications of plans to launch Timely communications on seed product regulatory status prior to launch Assessment on need for mitigation strategy and readiness to implement

32 Role of Stewardship at Commercialization Engagement with value-chain stakeholders Timely communications of plans to launch Timely communications on seed product regulatory status prior to launch Assessment on need for mitigation strategy and readiness to implement

33 Role of Stewardship at Commercialization Responsible launch of a new gene edited product Engagement with value-chain stakeholders Timely communications of plans to launch Timely communications on seed product regulatory status prior to launch Assessment on need for mitigation strategy and readiness to implement

34 Role of Stewardship at Commercialization Responsible launch of a new gene edited product Engagement with value-chain stakeholders Timely communications of plans to launch Timely communications on seed product regulatory status prior to launch Assessment on need for mitigation strategy and readiness to implement

35 Role of Stewardship at Commercialization Responsible launch of a new gene edited product Engagement with value-chain stakeholders Timely communications of plans to launch Timely communications on seed product regulatory status prior to launch Assessment on need for mitigation strategy and readiness to implement

36 Role of Stewardship at Commercialization Responsible launch of a new gene edited product Engagement with value-chain stakeholders Timely communications of plans to launch Timely communications on seed product regulatory status prior to launch Assessment on need for mitigation strategy and readiness to implement

37 Role of Stewardship at Commercialization Responsible launch of a new gene edited product Engagement with value-chain stakeholders Timely communications of plans to launch Timely communications on seed product regulatory status prior to launch Assessment on need for mitigation strategy and readiness to implement

38 Role of Stewardship during Discontinuation Responsible Discontinuation

39 Role of Stewardship during Discontinuation Responsible discontinuation of a seed product if it falls under biotech regulations in key import countries Responsible Discontinuation

40 Role of Stewardship during Discontinuation Responsible discontinuation of a seed product if it falls under biotech regulations in key import countries Engagement with value-chain stakeholders Timely communications of plans to discontinue Timely communications on seed product regulatory status prior to discontinuation Ongoing support of regulatory approvals in key import countries if relevant Responsible Discontinuation

41 Stewardship Includes a Robust Incident Management Approach

42 Stewardship Includes a Robust Incident Management Approach In case of unexpected incidents, allegations, vandalism..

43 Stewardship Includes a Robust Incident Management Approach In case of unexpected incidents, allegations, vandalism.. Ensure contact to appropriate staff within company is known

44 Stewardship Includes a Robust Incident Management Approach In case of unexpected incidents, allegations, vandalism.. Ensure contact to appropriate staff within company is known Have a management plan ready

45 Stewardship Includes a Robust Incident Management Approach In case of unexpected incidents, allegations, vandalism.. Ensure contact to appropriate staff within company is known Have a management plan ready Staff should be trained and ready to implement

46 Stewardship Includes a Robust Incident Management Approach In case of unexpected incidents, allegations, vandalism.. Ensure contact to appropriate staff within company is known Have a management plan ready Staff should be trained and ready to implement Ensure transparency in communication internally and externally

47 Stewardship Includes a Robust Incident Management Approach In case of unexpected incidents, allegations, vandalism.. Ensure contact to appropriate staff within company is known Have a management plan ready Staff should be trained and ready to implement Ensure transparency in communication internally and externally After the incident managed - review, record and improve

48 Stewardship Concluding Thoughts

49 Stewardship Concluding Thoughts Stewardship programs make good business sense

50 Stewardship Concluding Thoughts Stewardship programs make good business sense In seeds we have industry guidance available

51 Stewardship Concluding Thoughts Stewardship programs make good business sense In seeds we have industry guidance available Stewardship programs can be tailored to meet specific needs

52 Stewardship Concluding Thoughts Stewardship programs make good business sense In seeds we have industry guidance available Stewardship programs can be tailored to meet specific needs Stewardship programs can be used to optimize efficiencies

53 Stewardship Concluding Thoughts Stewardship programs make good business sense In seeds we have industry guidance available Stewardship programs can be tailored to meet specific needs Stewardship programs can be used to optimize efficiencies Documents and records provide evidence we do what we say we do

54 Stewardship Concluding Thoughts Stewardship programs make good business sense In seeds we have industry guidance available Stewardship programs can be tailored to meet specific needs Stewardship programs can be used to optimize efficiencies Documents and records provide evidence we do what we say we do Independent audits can provide additional verification

55 Stewardship Concluding Thoughts Stewardship programs make good business sense In seeds we have industry guidance available Stewardship programs can be tailored to meet specific needs Stewardship programs can be used to optimize efficiencies Documents and records provide evidence we do what we say we do Independent audits can provide additional verification Responsible stewardship is key to maintaining our License to Operate

56 Stewardship Concluding Thoughts

57 Any Questions?