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June 2007

CHANGES TO THE GENE TECHNOLOGY ACT, REGULATIONS & GUIDELINES Information for Accredited Organisations, IBCs & Researchers. June 2007. Purpose of this session.

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June 2007

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  1. CHANGES TO THE GENE TECHNOLOGY ACT, REGULATIONS & GUIDELINESInformation forAccredited Organisations, IBCs & Researchers June 2007

  2. Purpose of this session To inform organisations, IBCs & researchers using gene technology of recent and imminent changes to Gene Technology regulation, and their implications

  3. Overview • Background to changes: • Why ? How ? What ? When ? • Changes to: • Gene Technology Act • Gene Technology Regulations • Guidelines • Implementation & implications

  4. BACKGROUND TO CHANGES …Why, How, What & When

  5. WHY have changes been made ? (i) REGULATOR’sREVIEW of the Gene Technology Regulations in response to stakeholders & operational experience – amendments commenced 31 March 2007 (ii) INDEPENDENT REVIEWof the operation of the Gene Technology Act – amendments to commence 1 July 2007

  6. i. Regulator’s Review - Overview • Initiated in response to stakeholder & OGTR experience • Within existing policy setting • Technical changes only • Extensive consultation & drafting • Included GTTAC, risk assessments • Approved by States/Territories

  7. i. Regulator’s Review – 2006 Regulations • Expanded list of host-vector systems • Regulations clarified (e.g. complementation, viral vectors, oncogenes, pathogenic) • More flexible information requirements • Appropriate regulation of organisms with history of safe usage • Commenced 31 March 2007

  8. ii. Independent Review - Purpose • Scope, object & operation of Act • Regulatory burden • Interface with other systems • Review inter-governmental agreement • State/Territory/Commonwealth response October 2006

  9. ii. Independent Review – Act changes • Variation application – 90 day decision • Emergency provision – rapid approval to address threat, issued by Minister, limited period • Inadvertent dealings – ‘unintended possession’ temporary licence for disposal • Advisory committees – combine GTEC with GTCCC (December 2007) • Direction Powers – clarify Regulator’s ability to direct

  10. ii. Independent Review – Act changes Dealings Involving Intentional Release (DIRs) • New ‘limited & controlled’ category (e.g. field trial) • for ‘experimental’ purpose • containment proposed by applicant • 1 round of consultation • 150 days (or 170 days if ‘significant risk’) • Intentional release (e.g. commercial) - 255 days • 1 July 2007 commencement

  11. ii. Independent Review - 2007 Regulations • No mandated containment of exempt dealings • New class of (PC1) NLRDs • Annual NLRD reporting only • Subject to passage of legislation • 1 July 2007 commencement

  12. ii. Independent Review – Other • No reporting of exempt dealings • Harmonisation of guidelines • PC2, PC4 Certification Guidelines • Transport Guidelines • Accreditation Guidelines • Co-operation with other regulators • 1 July 2007 commencement

  13. CHANGESINDETAIL …

  14. Non - GMOs i. Regulator’s Review- from 31 March 2007 • Schedule 1 (non-GMOs) now includes: • Naked plasmid DNA (clarification) • Introduction of naked recombinant nucleic acid into somatic cells (previously Exempt) • New Schedule 1Alists techniques that are not gene technology

  15. Shifting Regulatory Oversight Other GM animals & plants In vitro human VV + oncogene Tg mice & rats Non-exempt H/V + oncogene etc Non-exempt H/V + e.g. GFP Large scale + exempt H/V GM viruses, toxins etc Exempt H/V + e.g. GFP Knockout mice 21 June 2001 EXEMPT NLRD DNIR 31 March 2007 EXEMPT NLRD DNIR 1 July 2007 EXEMPT PC2 NLRD DNIR PC1 NLRD

  16. 31 March 2007 1 July 2007 Containment • Conducted according to Regulators guidelines • No intentional release • No specified containment • (still) No intentional release Dealings • Increased exempt host/vector list • More dealings exempt eg GM mice/rats, C. elegans Removal of some viral vectors & GM mice/rats from exempt Forms No Change (no forms) No Change (no forms) Oversight No Change (annual Reporting) Remove all reporting requirements Exempt Dealings

  17. NLRDs i. Regulators Review- from 31 March 2007 • Reclassification of dealings • Increase from 5 to 12 types of NLRD • Changes to dealings that involve: • Viral vectors able to transduce human cells (clarified as NLRD) • Complementation of knockouts (now NLRD) • Large-scale low risk (now NLRD)

  18. NLRDs ii. Independent Review –from 1 July 2007 • New PC1 NLRD category: • GM mice & rats • Oncogenic modification in exempt host/vector • Viral vectors able to transduce human cells • PC2 NLRD: • Same as current dealings & requirements

  19. Forms • Removal of Information requirements from Regs • New short forms New internal IBC form Oversight Can start after IBC notifies OGTR Can start after IBC assessment (only annual reporting to OGTR) NLRDs

  20. Forms Oversight • New surrender forms • Info requirements removed from Regs No change (DNIR application vetted by IBC then sent to OGTR for evaluation) No change No change Dealings • Downgrading of licences to NLRDs e.g.V V’s in tissue culture, large scale low risk • Older lentiviral vectors, impairment of disease treatment now DNIR No change DNIRs

  21. Viral Vectors • Recognition of : • In vitrovs In vivo • Ability to enter human cells • Context of inserted gene • Replication defective vs replication competent • Table of dealings on OGTR IBC web page

  22. Viral Vectors VECTOR HOST GENE CLASSIFICATION 2001 31 MARCH 1 JULY Non-retroviral vector which cannot transduce human cells eg. FAV In vitro Marker Exempt Exempt Exempt Higher risk gene e.g. oncogene NLRD (e) Exempt PC1 NLRD (b) In vivo Marker NLRD (c) NLRD (c/d) PC2 NLRD (c/d) Higher risk gene DNIR DNIR DNIR Non-retroviral vector which can transduce human cells eg. Ad5 In vitro Marker Exempt Exempt PC1 NLRD (c) Higher risk gene e.g. oncogene NLRD (e) NLRD (e) PC2 NLRD (i) In vivo Marker NLRD (c) NLRD (c/d) PC2 NLRD (c/d) Higher risk gene DNIR DNIR DNIR

  23. GUIDELINES

  24. Exempt and PC1 Guidelines • Exempt dealings guidelines • Required minimum for exempt dealings until 1 July • ‘guidance’ only after 1 July • Certified PC1 guidelines • Required for PC1 NLRD after 1 July

  25. PC2 & PC4 Guidelines • PC2 lab/animal/plant Certification guidelines: • Requirements before Certification • Conditions of certification ongoing • Behavioural requirements (for GMO work only) • Outcome-focus & Regulator’s power to exclude persons • PC4 Certification Guidelines - more detailed • One application form for all facility types • Commence 1 July 2007

  26. Other Guidelines • Transport Guidelines • Conditions linked to containment level • Outcome focus e.g. decontaminate outside of container • Explanatory notes • Accreditation Guidelines • No ‘exempt’ dealing reporting requirement • Must have IBC (own/other) in place • New instruments to be issued • Commence1 July 2007

  27. IMPLEMENTATION

  28. Transitional Arrangements • IBCs apply to OGTR for DNIR  NLRD • IBCs & project supervisors notified • NLRD  DNIR • if already started must have new licence by 31 March 2008 • if new need licence before starting

  29. Transitional Arrangements cont… • NLRD  Exempt • IBCs & researchers determine category • Exempt  PC1 NLRD • No new NLRD required if approved before 31 March • If started between 31 March – 30 June must have IBC approval • PC1 certification required by 1 July 2007

  30. Impact on IBCs • More NLRDs & Exempt (rather than DNIRs) • IBC oversight of Exempt & NLRD dealings (exempt dealings not reported, annual reporting only for NLRDs) (from 1 July 2007) • No specified containment for Exempt dealings (from 1 July 2007) • Fewer PC2 animal facilities required (PC1 for GM rats & mice from 1 July 2007)

  31. FUTURE CHANGES • Targeted amendments to Regulations • Submit a case (with scientific evidence) through IBC to Gene Technology Regulator

  32. Summary • Exempt truly exempt - from1 July • New PC1 NLRD - from1 July • Overall less administration for IBCs • Transitional arrangements • Guidance on OGTR website - IBC page www.ogtr.gov.au/ibc/index.htm

  33. Mailing AddressMDP 54, PO Box 100Woden ACT 2606Web Sitewww.ogtr.gov.au Emailogtr@health.gov.auTelephone1800 181 030

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