CHANGES TO CHANGES TO THE GENE TECHNOLOGY ACT, THE GENE TECHNOLOGY ACT, REGULATIONS & GUIDELINESREGULATIONS & GUIDELINES

Information forInformation forAccredited Organisations, Accredited Organisations,

IBCs & ResearchersIBCs & Researchers

June 2007June 2007

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Purpose of this sessionPurpose of this session

To inform organisations, IBCs & To inform organisations, IBCs &

researchers using gene technology researchers using gene technology

of recent and imminent changes to of recent and imminent changes to

Gene Technology regulation, Gene Technology regulation,

and their implicationsand their implications

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Background to changes:Background to changes: - Why ? How ? What ? When ?Why ? How ? What ? When ?

Changes to: Changes to: - Gene Technology ActGene Technology Act- Gene Technology RegulationsGene Technology Regulations- GuidelinesGuidelines

Implementation & Implementation & implicationsimplications

OverviewOverview

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BACKGROUND TO CHANGES BACKGROUND TO CHANGES

……

Why, How, What & WhenWhy, How, What & When

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(i) REGULATOR’s(i) REGULATOR’s REVIEWREVIEW of the Gene of the Gene Technology Regulations in response to Technology Regulations in response to stakeholders & operational experience stakeholders & operational experience – – amendments commencedamendments commenced 31 March 2007 31 March 2007

WHY have changes been made WHY have changes been made ??

(ii) INDEPENDENT REVIEW(ii) INDEPENDENT REVIEW of the of the operation of the Gene Technology Act operation of the Gene Technology Act – – amendments to commenceamendments to commence 1 July 2007 1 July 2007

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i. Regulator’s Review - i. Regulator’s Review - OverviewOverview

Initiated in response to stakeholder Initiated in response to stakeholder & OGTR experience& OGTR experience

Within existing policy setting Within existing policy setting - Technical changes onlyTechnical changes only

Extensive consultation & draftingExtensive consultation & drafting- Included GTTAC, risk assessmentsIncluded GTTAC, risk assessments

Approved by States/TerritoriesApproved by States/Territories

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Expanded list of host-vector systemsExpanded list of host-vector systems

Regulations clarified (Regulations clarified (e.g.e.g. complementation, viral vectors, oncogenes, complementation, viral vectors, oncogenes, pathogenic) pathogenic)

More flexible information requirementsMore flexible information requirements

Appropriate regulation of organisms with Appropriate regulation of organisms with history of safe usagehistory of safe usage

Commenced Commenced 31 March 200731 March 2007

ii. Regulator’s Review – . Regulator’s Review – 2006 2006 RegulationsRegulations

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iiii. Independent Review - . Independent Review - PurposePurpose

Scope, object & operation of ActScope, object & operation of Act Regulatory burdenRegulatory burden Interface with other systemsInterface with other systems Review inter-governmental Review inter-governmental

agreementagreement State/Territory/Commonwealth State/Territory/Commonwealth

response October 2006response October 2006

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Variation application Variation application – – 90 day decision90 day decision

Emergency provision Emergency provision – – rapid approval to address rapid approval to address threat,threat,

issued by Minister, limited issued by Minister, limited periodperiod

Inadvertent dealings Inadvertent dealings – – ‘unintended possession’ ‘unintended possession’ temporary licence for temporary licence for

disposaldisposal Advisory committees Advisory committees – – combine GTEC with GTCCCcombine GTEC with GTCCC

(December 2007) (December 2007) Direction Powers Direction Powers – – clarify Regulator’s ability to clarify Regulator’s ability to

directdirect

iiii. Independent Review – . Independent Review – Act Act changeschanges

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Dealings Involving Intentional Release Dealings Involving Intentional Release (DIRs)(DIRs)

New ‘limited & controlled’ category New ‘limited & controlled’ category ((e.ge.g. field . field trial)trial)­ for ‘experimental’ purposefor ‘experimental’ purpose­ containment proposed by applicantcontainment proposed by applicant­ 1 round of consultation1 round of consultation­ 150 days (or 170 days if ‘significant risk’)150 days (or 170 days if ‘significant risk’)

Intentional release (Intentional release (e.g.e.g. commercial) - 255 days commercial) - 255 days 1 July 2007 1 July 2007 commencementcommencement

iiii. Independent Review – . Independent Review – ActAct changeschanges

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ii. Independent Review - ii. Independent Review - 2007 2007 RegulationsRegulations

No mandated containment No mandated containment of exempt dealingsof exempt dealings

New class of (PC1) NLRDsNew class of (PC1) NLRDs Annual NLRD reporting onlyAnnual NLRD reporting only Subject to passage of Subject to passage of

legislationlegislation 1 July 20071 July 2007 commencement commencement

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ii. ii. Independent Review – Independent Review – OtherOther No reporting of exempt dealingsNo reporting of exempt dealings Harmonisation of guidelinesHarmonisation of guidelines

PC2, PC4 Certification GuidelinesPC2, PC4 Certification Guidelines Transport GuidelinesTransport Guidelines Accreditation GuidelinesAccreditation Guidelines

Co-operation with other regulatorsCo-operation with other regulators 1 July 20071 July 2007 commencement commencement

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CHANGESCHANGESININ

DETAIL …DETAIL …

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i. Regulator’s Reviewi. Regulator’s Review - from 31 March - from 31 March 20072007

Schedule 1 (non-GMOs) now includes: Schedule 1 (non-GMOs) now includes: - Naked plasmid DNA (clarification)Naked plasmid DNA (clarification)- Introduction of naked recombinant nucleic Introduction of naked recombinant nucleic

acid into somatic cells (previously Exempt)acid into somatic cells (previously Exempt)

New Schedule 1ANew Schedule 1A lists lists techniquestechniques that that are are notnot gene technology gene technology

Non - GMOsNon - GMOs

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Other GM animals & plants

In vitro human V V + oncogene

21 June 2001

EXEMPT NLRD DNIR

Knoc

kout

mice

Tg mice & rats

Non-exempt H/V + oncogene etc

Large scale + exempt H/V

Non-exempt H/V + e.g. GFP

GM viruses, toxins etc

Exempt H/V + e.g. GFP

EXEMPT NLRD DNIR

Shifting Regulatory OversightShifting Regulatory Oversight

PC1 NLRD PC2 NLRDEXEMPT DNIR

31 March 2007

1 July 2007

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• No specified containmentNo specified containment

• (still) No intentional release(still) No intentional release

• Conducted according to Conducted according to Regulators guidelinesRegulators guidelines

• No intentional releaseNo intentional releaseContainmentContainment

1 July 20071 July 200731 March 200731 March 2007

Exempt DealingsExempt Dealings

Removal of some Removal of some viral vectors & GM viral vectors & GM mice/rats from exemptmice/rats from exempt

• Increased exempt Increased exempt host/vector list host/vector list

• More dealings exempt More dealings exempt egeg GM mice/rats, GM mice/rats, C. elegansC. elegans

DealingsDealings

No Change (no forms)No Change (no forms)No Change (no forms)No Change (no forms)FormsForms

Remove all reporting Remove all reporting requirementsrequirements

No Change (annual No Change (annual Reporting)Reporting)OversightOversight

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i. Regulators Reviewi. Regulators Review - from 31 March 2007- from 31 March 2007

Reclassification of dealings Reclassification of dealings - Increase from 5 to 12 types of NLRDIncrease from 5 to 12 types of NLRD

Changes to dealings that involve:Changes to dealings that involve:- Viral vectors able to transduce human cells Viral vectors able to transduce human cells

(clarified as NLRD)(clarified as NLRD)- Complementation of knockouts Complementation of knockouts (now NLRD)(now NLRD)- Large-scale low risk Large-scale low risk (now NLRD)(now NLRD)

NLRDsNLRDs

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ii. Independent Review –ii. Independent Review – from 1 July 2007from 1 July 2007

New PC1 NLRD category:New PC1 NLRD category: - GM mice & ratsGM mice & rats- Oncogenic modification in exempt host/vector Oncogenic modification in exempt host/vector - Viral vectors able to transduce human cellsViral vectors able to transduce human cells

PC2 NLRD:PC2 NLRD:- Same as current dealings & requirementsSame as current dealings & requirements

NLRDsNLRDs

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31 March31 March 1 July1 July

ContainmentContainmentNo Change - still PC2 No Change - still PC2 unless given exemption unless given exemption e.g. e.g. large animals in PC1large animals in PC1

Two classes – PC1 & PC2Two classes – PC1 & PC2

NLRDsNLRDs

DealingsDealings

• More types of NLRDsMore types of NLRDs• Some existing licences Some existing licences

being downgradedbeing downgraded• Many NLRDs now exemptMany NLRDs now exempt

GM rats, mice & V Vs which GM rats, mice & V Vs which transduce human cells in transduce human cells in certified PC1 facilitiescertified PC1 facilities

New internal IBC formNew internal IBC form• Removal of Information Removal of Information

requirements from Regsrequirements from Regs• New short formsNew short forms

FormsForms

Can start after IBC Can start after IBC assessment (only annual assessment (only annual reporting to OGTR)reporting to OGTR)

Can start after IBC notifies Can start after IBC notifies OGTROGTROversightOversight

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31 March31 March 1 July1 July

ContainmentContainment No Change - still PC2-PC4No Change - still PC2-PC4 No changeNo change

DNIRsDNIRs

No changeNo change

• Downgrading of licences to NLRDs Downgrading of licences to NLRDs e.g.e.g. V V’s in tissue culture, large scale low riskV V’s in tissue culture, large scale low risk

• Older lentiviral vectors, impairment of Older lentiviral vectors, impairment of disease treatment now DNIRdisease treatment now DNIR

DealingsDealings

No changeNo change• New surrender forms New surrender forms • Info requirements removed from RegsInfo requirements removed from RegsFormsForms

No changeNo changeNo change (DNIR application vetted by No change (DNIR application vetted by IBC then sent to OGTR for evaluationIBC then sent to OGTR for evaluation))

OversightOversight

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Recognition of :Recognition of :- In In vitrovitro vs vs In In vivovivo- Ability to enter human cellsAbility to enter human cells- Context of inserted geneContext of inserted gene- Replication Replication defectivedefective vs replication vs replication

competentcompetent

Table of dealings on OGTR IBC web Table of dealings on OGTR IBC web pagepage

Viral VectorsViral Vectors

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Viral VectorsViral Vectors

DNIR DNIR DNIRHigher risk gene

PC2 NLRD (c/d)NLRD (c/d)NLRD (c)Marker

In vivo

PC2 NLRD (i)NLRD (e)NLRD (e)Higher risk gene e.g. oncogene

PC1 NLRD (c)ExemptExemptMarker

In vitroNon-retroviral vector which

can transduce

human cellseg. Ad5

DNIR DNIR DNIR Higher risk gene

PC2 NLRD (c/d)NLRD (c/d)NLRD (c)Marker

In vivo

PC1 NLRD (b)ExemptNLRD (e)Higher risk gene e.g. oncogene

ExemptExemptExemptMarker

In vitroNon-retroviral vector which

cannot transduce

human cells eg. FAV

1 JULY31 MARCH2001

CLASSIFICATIONGENEHOSTVECTOR

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GUIDELINEGUIDELINE

SS

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Exempt dealings guidelinesExempt dealings guidelines- RequiredRequired minimum for minimum for

exempt dealings exempt dealings untiluntil 1 July 1 July- ‘‘guidance’ only guidance’ only afterafter 1 July 1 July

Certified PC1 guidelinesCertified PC1 guidelines- RequiredRequired for PC1 NLRD for PC1 NLRD afterafter

1 July1 July

Exempt and PC1 GuidelinesExempt and PC1 Guidelines

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PC2 lab/animal/plant Certification guidelines:PC2 lab/animal/plant Certification guidelines:- Requirements Requirements before before CertificationCertification- Conditions of certification Conditions of certification ongoingongoing- BehaviouralBehavioural requirements (for GMO work only) requirements (for GMO work only)- Outcome-focus & Regulator’s power to exclude personsOutcome-focus & Regulator’s power to exclude persons

PC4 Certification Guidelines - more detailed PC4 Certification Guidelines - more detailed One application form for all facility typesOne application form for all facility types Commence Commence 1 July 20071 July 2007

PC2 & PC4 GuidelinesPC2 & PC4 Guidelines

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Transport GuidelinesTransport Guidelines- Conditions linked to containment levelConditions linked to containment level- Outcome focus Outcome focus e.g. e.g. decontaminate decontaminate outsideoutside of of

containercontainer- Explanatory notesExplanatory notes

Accreditation GuidelinesAccreditation Guidelines- No ‘exempt’ dealing reporting requirementNo ‘exempt’ dealing reporting requirement- Must have IBC (own/other) in placeMust have IBC (own/other) in place- New instruments to be issuedNew instruments to be issued

CommenceCommence 1 July 20071 July 2007

Other GuidelinesOther Guidelines

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IMPLEMENTATIONIMPLEMENTATION

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IBCs apply to OGTR for IBCs apply to OGTR for DNIR DNIR NLRD NLRD- IBCs & project supervisors notifiedIBCs & project supervisors notified

NLRD NLRD DNIR DNIR- if already started must have new licence if already started must have new licence

by by 31 March 200831 March 2008- if new need licence before startingif new need licence before starting

Transitional ArrangementsTransitional Arrangements

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NLRD NLRD Exempt Exempt- IBCs & researchers determine categoryIBCs & researchers determine category

Exempt Exempt PC1 NLRD PC1 NLRD- No new NLRD required if approved before 31 No new NLRD required if approved before 31

MarchMarch

- If started between 31 March – 30 June must If started between 31 March – 30 June must have IBC approvalhave IBC approval

- PC1 certification required by 1 July 2007PC1 certification required by 1 July 2007

Transitional Arrangements Transitional Arrangements cont…cont…

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More NLRDs & Exempt More NLRDs & Exempt (rather than DNIRs)(rather than DNIRs)

IBC oversight of Exempt & NLRD IBC oversight of Exempt & NLRD dealings dealings (exempt dealings not reported, (exempt dealings not reported, annual reporting only for NLRDs) (from annual reporting only for NLRDs) (from 1 July 1 July 20072007))

No specified containment for Exempt No specified containment for Exempt dealings dealings (from (from 1 July 20071 July 2007))

Fewer PC2 animal facilities required Fewer PC2 animal facilities required (PC1 for GM rats & mice from (PC1 for GM rats & mice from 1 July 20071 July 2007))

Impact on IBCsImpact on IBCs

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FUTURE FUTURE CHANGECHANGE

SS Targeted amendments to Regulations

Submit a case (with scientific evidence) through IBC to Gene Technology Regulator

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Exempt Exempt truly truly exempt - exempt - fromfrom 1 July1 July

NewNew PC1 NLRD - PC1 NLRD - fromfrom 1 July1 July

Overall less administration for IBCsOverall less administration for IBCs

Transitional arrangements Transitional arrangements

Guidance on OGTR website - IBC pageGuidance on OGTR website - IBC page

www.ogtr.gov.au/ibc/index.htmwww.ogtr.gov.au/ibc/index.htm

SummarySummary

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Mailing AddressMailing AddressMDP 54, PO Box 100MDP 54, PO Box 100

Woden ACT 2606Woden ACT 2606

Web SiteWeb Sitewww.ogtr.gov.au www.ogtr.gov.au

EmailEmailogtr@health.gov.auogtr@health.gov.au

TelephoneTelephone1800 181 0301800 181 030