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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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June 2007

CHANGES TO THE GENE TECHNOLOGY ACT, REGULATIONS & GUIDELINESInformation forAccredited Organisations, IBCs & Researchers

June 2007


Purpose of this session

Purpose of this session

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


June 2007

Overview

  • Background to changes:

    • Why ? How ? What ? When ?

  • Changes to:

    • Gene Technology Act

    • Gene Technology Regulations

    • Guidelines

  • Implementation & implications


Background to changes why how what when

BACKGROUND TO CHANGES …Why, How, What & When


June 2007

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


June 2007

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


June 2007

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


June 2007

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


June 2007

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


June 2007

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


June 2007

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


June 2007

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


Changes in detail

CHANGESINDETAIL …


June 2007

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


Shifting regulatory oversight

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


June 2007

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


June 2007

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)


June 2007

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


June 2007

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


June 2007

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


June 2007

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


June 2007

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


Guidelines

GUIDELINES


June 2007

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


June 2007

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


June 2007

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


Implementation

IMPLEMENTATION


June 2007

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


June 2007

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


June 2007

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)


Future changes

FUTURE CHANGES

  • Targeted amendments to Regulations

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


June 2007

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


June 2007

Mailing AddressMDP 54, PO Box 100Woden ACT 2606Web Sitewww.ogtr.gov.au [email protected] 181 030


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