Presentation 2 - Review of the Gene Technology Regulations

Presentation 2 - Review of the Gene Technology Regulations

Slide 1

Review of the Gene Technology Regulations 2001

Slide 2

Why is a review needed?

•Technology has changed since the definitions of ‘GMO’ and ‘gene technology’ were last amended

•It’s unclear to stakeholders whether organisms modified by some new technologies are GMOs

Slide 3

What is a GMO?

Section 10 of the Gene Technology Act 2000:

A GMO is

(a)an organism that has been modified by gene technology or

(b)inherited traits that occurred because of gene technology

the Regulations can also declare things to be GMOs or not GMOs

Gene technology is any technique for the modification of genes or genetic material

the Regulations can declare techniques not to be gene tech.

Slide 4

What is a GMO?

To determine whether an organism is a GMO under the definition in the Gene Technology Act 2000 the organism must first meet the definition of GMO in section 10 and then also be found not to match any exclusions to that definition listed in Schedule 1 of the Gene Technology Regulations 2001

Slide 5

Technical Review of the Regulations

Primary aim:

Bringing the lists of exclusions in the Regulations up to date with current science to provide clarity

An important constraint: can’t alter the policy settings

Slide 6

Scope of the technical review

•organisms and techniques whose regulatory status is currently unclear

eg some site-directed nuclease techniques

•Classification level of specific GMO dealings where scientific understanding of risk has changed

eg whether current classification levels are appropriate

Slide 7

What is out of scope

•Policy settings of the regulatory scheme

eg definitions in GT Act, including process trigger

•The regulatory status of techniques and organisms where this is currently well-established

•Matters in the remit of other regulators

eg food regulation, including labelling, by Food Standards Australia New Zealand

Regulation of research involving human embryos by the National Health and Medical Research Council

Slide 8

Site-directed nucleases

Slide 9

Oligo-directed mutagenesis

Cibus' Rapid Trait Development System:

Slide 10

Features of new technologies

Natural mutations and mutagenesis are outside the scope of the gene technology regulatory scheme ie dealings with organisms developed with these methods are not regulated Dealings with organisms developed by inserting transgenes are subject to regulation There is a large difference in the extent of sequence changes and the features of the processes used between these two groups of techniques

Slide 11

Features of new technologies

SDN 1 involves a random repair process and produces sequence changes similar to natural mutations and mutagenesis SDN 2 and oligo directed mutagenesis involve a guided repair process using an oligonucleotide to guide small sequence changes that may be identical to the outcomes of SDN 1 SDN 3 also involves guided repair using a long template to insert new sequences with similar outcomes to inserting transgenes by other gene technology techniques There are distinct process features for SDN 1 random repair and SDN 2 oligo directed mutagenesis and SDN 3 guided repair There are no clear separations in the extent of sequence changes that can be produced using these techniques with the techniques making a continuum between mutagenesis and inserting transgenes in terms of sequence changes produced SDN 1 SDN 2 and oligo directed mutagenesis are sometimes collectively referred to as genome editing

Slide 12

Current public consultation

OGTR is seeking submissions on four options for how new technologies could be regulated

After the consultation closes the Regulator will decide which option to pursue

Submissions close on 2 December

Slide 13

Options for regulating new technologies

option 1:no change

Option 1 would not clarify the regulatory status of dealings with organisms developed using SDN 1 SDN 2 or ODM Dealings with organisms developed using SDN 3 are currently regulated

Slide 14

Options for regulating new technologies

option 2: regulate all SDN techniques and ODM

Slide 15

Options for regulating new technologies

option 3: regulate SDN techniques and ODM if repair template is used

Option 3 is to exclude dealings with organisms developed using SDN 1 from regulation and regulate dealings with organisms developed using SDN 2 and ODM

Slide 16

Options for regulating new technologies

option 4: regulate techniques with outcomes different to conventional breeding

Option 4 is to exclude dealings with organisms developed using SDN 1 ODM and SDN 2 from regulation

Slide 17

Other topics for the review

•Regulatory burden implications of proposed options

•Contained laboratory research on gene drives

•RNA interference techniques

•Any other proposals for amendments to technical or scientific aspects of the Regulations

Slide 18

How to make a submission

•Clearly identify your preferred option

•Provide science-based arguments or refer to published research to support your position

•Answer any consultation questions relevant to you

•Focus on issues within the scope of the review

•Submit by 2 December

Slide 19

Review process – short term

  1. public consultation on options until 2 Dec
  2. OGTR to consider issues raised
  3. Regulator to choose an option to pursue after considering:

•Scientific understanding

•Potential risks

•Policy settings of the scheme

•Office of Best Practice Regulation requirements

Slide 20

Review process – if amendments recommended

  1. Prepare draft amendments
  2. Public consultation on draft amendments
  3. Finalise drafting taking submissions into account
  4. Formal State and Territory consultation
  5. Regulation-making process

Slide 21

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