Information session on proposed amendments to the Gene Technology Act

Rachel Schulz

My name is Rachel from the TGA Learn within the Regulatory Engagement branch, and I would like to start today's webinar off with an acknowledgement of country. In the spirit of reconciliation, the Department of Health and Aged Care acknowledges the traditional custodians of the country throughout Australia and their connections to land, sea and community. We pay our respects to the elders past and present, and extend that respect to all Aboriginal and Torres Strait Islander people here with us online today. 

Now, let's get started on today's presentation with our first speaker, Sarah Syme, the Assistant Secretary of the Regulatory Engagement branch at the Department of Health and Aged Care. Her responsibilities include gene technology policy and governance. As a member of the gene technology policy and governance team, we also have Kirstine who’s working on the outcomes of the Third Review of the scheme for almost three years. And I'll now hand over to Sarah to start today's webinar. Thank you. 

Sarah Syme

Good afternoon, everyone. I'm extremely pleased to be presenting to you today on the draft Gene Technology Amendment Bill. The public consultation on proposed amendments to the Gene Technology Act marks an important milestone in implementing a number of recommendations of the Third Review of the National Gene Technology Scheme, as well as the risk tiering framework and other measures requiring legislative amendment outlined in the Decision Regulation Impact Statement. 

Today, we'll provide you with an overview of the scheme, the consultation process, and the package, and of the proposed amendments contained in the draft bill. We have published a consultation paper, the exposure draft, and a future law compilation, along with several information sheets on the Department of Health and Aged Care Consultation Hub. 

Any questions will be addressed at the end of the presentation, so please continue to use the Slido link shared with you. As many of you would be aware, the scheme was established in the year 2000. It's a collaboration between all Australian governments supporting a nationally consistent regulatory scheme for gene technology in Australia. The purpose of this scheme is to protect the health and safety of people and to protect the environment. 

The regulatory system achieves this through identifying risks relating to gene technology and managing those risks by regulating dealings with genetically modified organisms. 

The scheme was first created to address a regulatory gap. Periodic reviews of the scheme are undertaken, with the Third Review taking place between 2017 and 2018. The Third Review found that, overall, the scheme is working well and has operated successfully in assessing and managing the risks posed by GMOs, but that there are opportunities to update and modernise the scheme that would strengthen it and make sure it remains fit for purpose. 

The scheme should ideally be flexible enough to deal with future developments and challenges in areas such as health, medicine, agriculture, plants, and animals. The Third Review made 27 recommendations, all of which gene technology ministers have agreed to implement. The amendments to the gene technology legislation will largely complete implementation of the Third Review.

This consultation is open until the 8th of November 2024. The public consultation will inform any changes that need to be made before the draft bill is introduced into Federal Parliament, and we encourage all stakeholders to contribute. While the draft bill provided for consultation is substantially complete, there are areas which are subject to further development. These have been outlined in the consultation paper and will be included in the final proposed draft that will be submitted for consideration by parliament. 

A body of work is also being progressed on changes to the gene technology regulations, which will carry a lot more detail of how specific provisions will work. This will be subject to a separate consultation period in the future. At the conclusion of this consultation period, the department will consider the feedback received and prepare supplementary drafting instructions to action any further amendments that may be required. 

Finally, all gene technology ministers will be asked to consider and endorse the revised exposure draft prior to introduction to parliament. A suite of documents is now available on the consultation hub. The exposure draft is a version of the draft bill released for the purpose of this consultation. The exposure draft is structured in the same way as the current Gene Technology Act, with some parts of the Act being amended or repealed and new parts being introduced. 

The future law compilation of the GT Act mirrors the amendments in the draft bill, but provides a view of the GT Act as proposed to be amended. It's a useful tool for locating the proposed amendments in the context of the current act, and visualising how the proposed amendments will appear following passage of the draft bill. 

The consultation paper accompanies the draft bill and is aimed to assist in providing context and understanding for the need for the proposed amendments. It documents the proposed amendments by reference to eight key themes, each discussed in a different chapter of the consultation paper. It also provides background information on the scheme, the Third Review, and the Decision RIS. 

Attachment A to the consult paper chronologically identifies key amendments in the draft bill, and essentially serves as an index to assist individuals reading the draft bill to quickly locate discussion of a certain amendment in the consultation paper.

Finally, anyone interested in providing a submission will be able to review the draft provisions and submit their feedback by answering the related questions on the consultation hub. The questions follow the order of the provisions as listed in the consultation paper, and are also located in the paper itself. Where possible, reasoning and supporting information would be very useful. 

If you intend to provide a submission, you are welcome to provide as much or as little information in each section as required. It is also not essential to provide feedback on all provisions. It's possible to provide feedback on only the areas that you are most interested in.

The proposed amendments will incorporate the first major changes to the regulatory scheme in more than 20 years of operation. In line with the focus of the Third Review and the Decision RIS, the proposed amendments will modernise and futureproof the scheme to ensure that it is consistent with best regulatory practice and appropriately flexible to respond to technological changes and scientific developments. The anticipated benefits of the reform are discussed in detail in the consultation package. 

At a high level, the proposed amendments will continue to protect the Australian public and the environment from risks posed by dealings with genetically modified organisms, by identifying and managing such risks. It will introduce the risk tiering framework endorsed by all governments in July 2021, and will ensure commensurate and responsive risk-based regulation. Well-defined risk tiered categories will enable different risks to be managed proportionately. 

The revised structure of the scheme will ensure there is sufficient flexibility to move dealings with GMOs between authorisation categories based on identification of new risks, a history of safe use, and other additional factors. Amendments to key definitions that influence the scope of the scheme will be updated to improve regulatory coverage, clarify the scope of regulation and capture changing uses of gene technology. 

Finally, stakeholders will benefit significantly from changes to reduce regulatory burden through streamlining application processes and regulatory requirements. Research in Australia involving genetically modified organisms and gene technology is increasing, with applications across agriculture, health, industry and environment. 

The scheme has its origin in genetically modified cotton and canola and, as identified by the Third Review, the GT Act is drafted within the context of agricultural applications of gene technology. Research and developments in gene technology are expanding, with applications in agriculture, including pest control, medical research, and commercial therapies, biomanufacturing and species conservation. 

The use of gene technology in the medical sector is also on the rise. More proportionate regulation of clinical trials will encourage industry to undertake trials in Australia, leading to the development of novel treatments and improved access for Australian patients. Biotechnologies, including synthetic biology, have been listed as critical technology in the national interest. 

Both the Commonwealth and state governments have identified biotechnology as a crucial area of investment. The proposed amendments will diminish the complexity of the current regulatory system and perceived lack of flexibility for new or emerging product, reducing barriers to innovation previously identified by stakeholders. 

Protection of threatened species, management of feral animals and weeds and sustainable agriculture are key areas where gene technology can make substantial contributions to the environment. Vaccines that protect Australian fauna from disease are being developed with gene technology and the development of genetically modified crops that have increased yields with less energy input will help make agriculture more sustainable by reducing carbon emissions. 

I'll now hand over to Kirstine McGee, to take you through the material in the consultation paper in more detail. 

Kirstine McGee

Thank you so much, Sarah. I'll take you through each of the eight themes for the eight chapters of the consultation package. We’re starting with chapter one. As identified by the Third Review, the pace of scientific discovery in the field of gene technology is accelerating. Key definitions in the Gene Technology Act that establish which GMO activities are within the scheme have become outdated. This can lead to uncertainty surrounding the regulation of new technology, which can both stifle innovation and diminish the scheme's ability to manage emerging risks. 

The review also recommended clarifying that human beings are not considered to be GMOs for the purposes of the scheme. To respond to both of those review recommendations four and six, amendments are proposed to key definitions underpinning the scheme. As mentioned, the draft bill includes new definitions for deal with, which currently comprises a list of activities with GMOs that are captured under regulation. 

The possession, use, and supply of GMOs are currently regulated only insofar as they're related to another dealing. The draft bill, however, is proposing to elevate those activities to primary dealings, such that they fall within the remit of the scheme in their own right. These amendments will provide broad regulatory coverage of gene technology and ensures all potential activities with GMOs are regulated under the scheme. 

This proposed amendment is not anticipated to increase the number of people that would require a new authorisation under the scheme, as current research and commercialisation activities generally already involve one or more of the primary dealings in the current act. 

To further futureproof the scheme, the bill also empowers additional dealings to be prescribed within the regulations. Consistent with the approach set out in the consultation and decision regulatory impact statements, the draft bill also proposes to amend the definition of gene technology to also capture the creation of genes or genetic material within its scope. 

Amendments to the act are also proposed to clarify the interaction between the Gene Technology Act and the Research Involving Human Embryos Act, which was recently amended by Maeve's Law. Maeve's Law ensures a single regulator for the use of mitochondrial donation techniques in humans and for associated research. The proposed amendments retain the status quo, noting that mitochondrial donation techniques are already excluded from the remit of the scheme under Maeve's Law.

Finally, amendments to the definition of genetically modified organism are proposed to capture organisms that have been created by gene technology, and to clarify that human beings are not considered to be GMOs for the purposes of the scheme. Human beings were never intended to be regulated by the scheme. If human beings were to be regulated by the scheme, this could result in undesirable consequences. It's also not appropriate to regulate human beings in the same way as plants and animals are regulated under the scheme. 

In addition, there are also multiple other pieces of legislation regulating genetic modification in relation to human beings. Through the consultation, the stakeholders are asked to consider whether, in their view, these proposed amendments to the key definitions provide a greater clarity as to the scheme’s scope and assist to future proof the scheme. 

The draft bill also inserts a new section 15A to the Gene Technology Act, which governs the operation of the scheme. These amendments are proposed to clarify the intersection between the gene technology regulator and other Commonwealth regulators and their legislation. This is intended to reduce duplication in the assessment of risk posed by GMO dealings under different regulatory schemes, as well as ensuring that the proposed amendments to the deal with definition don't contribute to an unnecessarily regulatory overlap and duplication. 

Stakeholders are asked to consider whether this mechanism is suitable to manage circumstances where dealings with GMOs may also be regulated under other schemes. Amendments to section 15A are also proposed to clarify that the minister or regulator are not required to consider intended adverse impacts on weeds, pests, or pathogen when the intended purpose of the dealing with the GMO is to suppress or eradicate that specific weed, pest, or pathogen. This is not a policy shift, but merely included to clarify the existing revisions. 

Chapter three of the consultation paper describes the authorisation pathways that are proposed to be introduced into the scheme and proposed amendments to the current authorisation pathways. These proposed authorisation pathways are consistent with those underpinning the preferred regulatory option identified in the Decision Regulatory Impact Statement. Detail on each pathway and relevant provisions is provided within the consultation paper. 

The proposed authorisation pathway is included in the draft bill, classifies dealings with GMOs according to indicative risk. This slide is a diagrammatic representation comparing the existing and proposed authorisation pathways. The revised structure aims to ensure responsiveness to rapidly changing technologies, while maintaining existing governance and regulatory oversight through the Gene Technology Ministers’ Meeting, states and territories, and the regulator. 

Some of the proposed changes relate to terminology and change of language to reinforce that dealings are within the scope of the scheme, but do not necessarily require notification to the regulator. One of the key changes is the introduction of the new authorisation pathway for GMO permits, which may result in reduced evaluation timeframes for proponents undertaking those specified types of GMO dealings. 

Most of the details surrounding risk tiering framework will be contained in the amendment regulations and proposed rules to be made by the regulator, which will be subject to a separate consultation process, as mentioned by Sarah. 

To support the proposed reduction of upfront regulatory assessments, the draft bill in chapter four of the consultation paper, the draft bill proposes to adopt standard monitoring, investigation, and enforcement powers of the Regulatory Powers Standard Provisions Act. This aims to provide the Office of the Gene Technology Regulator with tools to help ensure compliance and a suite of enforcement measures that are found in other modern regulatory schemes. 

In some cases, penalties in the revised bill are significantly higher than the existing GT Act. Penalties have been formulated consistent with the Commonwealth Guide to Framing Offences issued by the Australian Government Attorney-General. The proposed maximum penalties are reflective of potential risk to human health and the environment posed by non-compliance. We are asking you to review these new monitoring, investigation and enforcement powers contained in the draft bill and advise whether they support the scope. 

Chapter five of the consultation paper describes proposed amendments relating to certification of facilities and accreditation of organisation. The draft bill proposes to introduce new offence provisions for breaches of conditions by accredited parties and holders of certification. Provided requirements and conditions for accreditation and certification can be specified in the rules to be made by the regulator. Include decision criteria regarding suitability of an organisation to be accredited. Amend conditions of suspending and cancelling accreditation, so that accreditation will not be suspended on the request of the holder, but accreditation may be suspended or cancelled if requirements are no longer met. 

The draft bill also proposes to introduce some new additional requirements for holders of certification. More detail on the criteria for certification and accreditation will be specified in the rules, and again, will be part of that separate consultation process. We would like stakeholders to consider the policy intent described in chapter five of the consultation paper and indicate whether they support this underlying policy intent. 

The draft bill also proposes to revise the current commercially confidential information framework. Current processes for CCI are resource intensive, and because CCI declarations are not time limited, information retains CCI status indefinitely. The major shift in the proposed approach to CCI is to only require the regulator to consider claims that information is commercially confidential. 

If the regulator proposes to disclose that information, for example as part of a public consultation on a regulatory assessment and risk management plan, or as part of an extract of information from the GMO record. Otherwise, information claimed to be CCI will be treated as claimed CCI under the draft bill. Other amendments are proposed to the use and disclosure of information generally. 

The draft bill includes provisions which expressly establish permitted uses and disclosures of regulator information, and this is also in line with a recent review of secrecy provisions of all Commonwealth legislation undertaken by the Attorney-General's Department. Again, the use and disclosure provisions are subject to further development, but we would like you to consider the proposed measures, noting that slight changes may be required following the receipt of input. And I'd now like to hand back to Sarah. 

Oh, sorry. Chapter seven of the consultation paper we'll move to now, summarises minor technical and consequential amendments to both the GT Act and other Commonwealth legislation, including certain powers and functions of the regulator that can't be delegated, such as internal review of decisions or making of the rules that relate to risk tiering. 

Also, changes to streamlining committee appointments, removing references to codes of practice, streamlining application processes, specifying consideration periods for different types of application, enabling rules to be issued by the regulator, and specifying those consultation requirements before those rules are made. Clarifying disallowance exemptions. Providing for corresponding state and territory legislation to adopt the rules, and some additional functions for the regulator. 

It's important to note that the draft bill enables fees for applications in response to recommendation 22 of the Third Review, which recommended that further consideration be given to the most appropriate funding mechanisms to support the ongoing operation of this scheme. It's important to note that any proposal to introduce fees in the future will be subject to a separate consultation phase. 

The review also recommended reducing regulatory burden through streamlining processes and regulatory requirements. As such, the draft bill inserts a new division in part 12 of the act, to bring together all matters relating to applications and to create common requirements for all applications. 

The new division includes common approaches to how an application must be made, circumstances in which an application may be withdrawn, circumstances in which the regulator may require an applicant to give further information, and timeframes for making reviewable decisions. The draft bill also sets out relevant consideration periods for those different types of applications, and does enable the regulations to prescribe alternate consideration periods for specific types of applications. 

And then finally, chapter eight of the consultation paper describes how the legislative reforms proposed in the draft bill will come into effect. The reforms proposed in the draft bill make significant changes to the existing regulatory framework. As such, it's essential to allow for a smooth transition to the new regulatory framework. The draft bill proposes that the new regulatory framework will commence 12 months after royal assent. This will allow for development of the amendment regulations and rules to be made by the regulator and other administrative activities, including publication of application forms. 

This final chapter outlines a proposal for how existing approvals for dealings with GMOs, commercial confidential information, certification and accreditation are to be managed during the transition period and once the bill comes into effect, and how applications under consideration for GMO dealings, accreditation and certification will be traded within the transition period. And now I'd like to hand back to Sarah. 

Sarah Syme

Just a flag that all submissions must be provided by 8th November 2024. And we ask that everyone provides their submissions through the consultation hub. If you have any issues, please get in touch with us. The Gene Tech implementation address is on the screen now, or there's a telephone number that you can call. 

We will soon move into the questions. We'll be covering all questions relevant to the material covered here today, and this includes those submitted on registration. Questions that aren't able to be covered in the time today will be recorded, and we will compile those with a frequently asked questions document that will be published with the slides on the Gene Tech Scheme website. It will take us a couple of days, probably, to compile those, so we'll make sure they're available. But you can always email us for assistance. 

I will now hand back to the webinar team. Thanks, everyone. 

Rachel Schulz

Here are just some information resources. 

Sarah Syme

We just wanted to introduce the Q&A panel that we have today. We have the gene tech regulator, Dr Raj Bhula, from the Office of the Gene Technology Regulator. We have the AS of the Regulatory Practice and Compliance Branch, Neil Ellis. And Louisa Matthew, Director of the Regulatory Practice section. And Kirstine and I will also be fielding questions today. 

Rachel Schulz

Our first question again, how will you ensure a future-proof GT Act? 

Louisa Matthew

I think the future proofing of The GTA is around those changes to definitions and to the addition of the risk tiering. As new technologies emerge, as this increasing knowledge of how things work, things can move between those risk tiers and have risk proportionate regulation. 

Rachel Schulz

Next question. Will any fees be imposed on applications to OGTR? 

Neil Ellis

I'm happy to take that one. The current Gene Technology Act has the capability to charge fees for services, and that is maintained in this new exposure draft bill, but of course broadened with the new range of activities that are now available. In terms of where to next with that, there's been no decisions and there are no time frames to introduce fees and charges at this point. If we're heading down that way, at some stage in the future, there'll be further consultations. 

Rachel Schulz

Thank you, Neil. Next question. Do the amendments intend to address the discrepancy with WA’s GT legislation not being a corresponding law? 

Dr Raj Bhula

I can jump in on that one. The Commonwealth legislation can't address those matters, that's something entirely for the WA government.

Rachel Schulz

Thank you, Dr Bhula. What types of dealings will fall into lower authorisation pathways, or have less regulation under the changes? 

Louisa Matthew

I can get started. Kirstine, please add if you would like to. The consultation paper includes examples of the types of GMO dealings that can be included in the lower risk tiers. By that, I would take it the questioner is referring to permits, non-notifiable dealings, and notifiable dealings. But as Kirstine’s mentioned in her presentation, all of those details are going to be set out and subject to future consultation on the gene technology regulations amendments that are under development at the moment. 

Kirstine McGee

Thanks, Louisa. 

Rachel Schulz

Will the proposed changes clarify that animals vaccinated with mRNA vaccines are not GMOs or is that a regulatory question? 

Dr Raj Bhula

That is really a regulation change that would be involved in clarifying whether animals vaccinated with an mRNA vaccine are not GMOs, and that doesn't rely on the amendments to the bill getting through. We could do that as a rate change. 

Rachel Schulz

Thank you. The time given to participate at the webinar was short. What other ways can people ask questions who were not able to attend today? 

Sarah Syme

Thank you. Absolutely. The email address, which has just been put back up on the screen now, feel free to send an email through with any questions you have about the documentation or how to navigate the process. There's also a telephone number there that you can call that is staffed during business hours for you to get answers in a shorter time frame, if they're quick and easy questions. Absolutely, send through an email or give us a call. 

Rachel Schulz

Thank you, Sarah. Is a high-level summary of the changes available? 

Sarah Syme

There are a number of documents available through the consultation hub. The three documents there should give you a very good summary of the changes as we're proposing to make them. I would encourage you to read those in full and if you have specific questions after that, to use the email address to get in touch.

Rachel Schulz

Next question. Considering smaller organisations with a limited number of OGTR certified spaces and tightly resourced teams, what, if any, impacts do you foresee on the operations of these types of organisations through the proposed changes to the act? 

Louisa Matthew

To answer the question takes a few assumptions. I'm going to assume that this is an organisation currently undertaking mostly notifiable low-risk dealings and exempt dealings. The GMO dealings that are currently notifiable low-risk dealings will predominantly be moved over to notifiable dealings. The dealings that are currently exempt dealings will predominantly become non-notifiable dealings. And in both of those changes there won't be substantial differences in how somebody needs to go about undertaking these dealings, or even where those dealings need to be done. 

If that's the case for this small organisation, there'd be minimal impact. You would, of course, need to check that that does actually hold up for your specific circumstances. I suggest you have a look at the consultation paper, particularly the sections that talk about the transition to the amended scheme. 

Rachel Schulz

Thank you, Dr Matthew. What do you think the time frame is for these changes to go through parliament? When will the consultation period for the new regulations/rules start, etc.? I assume there will be a lot of detail in these documents.

Sarah Syme

Absolutely. I think that is the $64 million question. We are working as quickly as we can to, once the public consultation closes, to analyse the feedback that we get to make any necessary changes. That involves us working with the Office of Parliamentary Counsel at the federal level. They do all of the drafting of legislation before it gets submitted to parliament for approval. We need to work with them to go through that process and then, as most of you would likely be aware, there's a pending federal election that needs to occur sometime before, towards the end of May next year. 

We will, at some point between now and then, have a caretaker period and the dissolution of parliament for an election. We are working around some of those things. We don't know when those will occur yet. We are working as quickly as we can to get through that. 

In terms of the regulations and the rules, absolutely, there'll be another consultation process, and there will be a significant amount of detail in those. We don't have a specific time frame. Again, that requires us to work closely with our colleagues at the Office of Parliamentary Counsel, and access to those drafting resources is determined by the Government, so we're really at the mercy of the availability of those resources in order to be able to get those documents out. 

Rachel Schulz

Thanks, Sarah. At the IBC forum last week, there were a number of pertinent questions and clarifications that were discussed. Will those discussions be published, as they may help increase understanding of what is being asked and might reduce the probability of the same questions being asked over and over? 

Neil Ellis

I will take this question. The OGTR hosted the IBC forum last week, and for one of those days, we had sessions about the exposure draft bill and generated discussion about the different topics. We did not collect the information from those discussions, and that was really because the primary purpose of hosting that day was to raise awareness about what was in the bill and provide some guidance to IBCs around what they might like to put into their submission, into the public consultation on the bill.

To answer the question, we won't be able to publish what was raised, and that would come through in the submissions themselves. 

Rachel Schulz

Thank you, Neil. Next question. Is there any intention to run another webinar or to in future?

Sarah Syme

Not during this public consultation phase, we're not intending to have another session like this. We are very happy to answer any questions, as I've highlighted a couple of times, so please do get in touch, but not another webinar. 

Rachel Schulz

What is the timeframe for the subsequent reg changes, rather than the bill amendment to be released or for that consultation period? 

Sarah Syme

This is a bit of a duplicate one, but essentially, we don't have a specified time frame yet. As I highlighted, we're working as quickly as we can with our colleagues at OPC to get access to drafting resources, to get those documents ready for public consultation. But we'll be providing more notice once we have a better sense of it. 

Rachel Schulz

Can the definition of organism be clarified? For example, are immortalised cell lines considered organisms for the purpose of the regulation? 

Dr Raj Bhula

I can jump in there with an idea on that one. The proposed bill doesn't include any amendments to the definition of the word organism, as defined in Section 10 ten the Gene Technology Act. If this questioner thinks that there is a need to clarify, then that would be something suitable to put in a submission, along with supporting information. 

But when it comes to things like immortalised cell lines, not knowing the specifics of what you're talking about, if it's a cell line that's been modified using gene technology, I would assume it clearly is an organism that's a GMO. Please start with that assumption. 

Rachel Schulz

Subsection 15A is proposed to reduce regulatory overlap with other regulators. Will guidance be given about what data assessment performed by the TGA or APVMA, etc., will be acceptable by the OGTR? 

Louisa Matthew

That amendment is really about identifying the risks that are assessed by different regulators, and some of that will appear in regulations later on down the track. 

Dr Raj Bhula

But perhaps an additional thing to note is it wouldn't be a matter for applicants to worry about what information are OGTR is exchanging and what advice OGTR is exchanging with other regulators. That would be a discussion between OGTR and the other regulators, rather than directly with applicants. 

Rachel Schulz

Next question. Is a revised document with tracked changes available? 

Sarah Syme

Yes. We've also loaded the compilation draft with track changes onto the consultation hub. That document followed a day or two after the first publication of the document. If you downloaded them in the first day or two, please go back. We have now uploaded the tracked change version of the compilation draft.

Rachel Schulz

If personalised therapies are developed that involve genetic modification, will the technology be approved or will it require approval of each implementation of the tech, since they will be different? 

Dr Raj Bhula

That question's a little bit hard to answer without context around what type of technology is being talked about here. When it comes to therapeutics applied to people, there are a few different permutations and combinations. If it involves genetic modification of some sort, then it falls in under the remit of the scheme. Which means that some kind of approval would be needed, whether you're doing a clinical trial or you're generating that therapy. But without the context and detail, it's hard to say. 

Louisa Matthew

Perhaps a couple of overarching ideas to keep in mind. It's proposed that the definition of GMO will be amended to clarify that human beings are never GMOs. if you're talking about applying techniques that modify the cells of a human, those humans would not be GMOs, and provided that the therapeutic is not itself a GMO, then regulatory authorisation wouldn't be needed from OGTR. Things are different if the therapeutic is a GMO by itself, though. 

Rachel Schulz

Thank you. What risks have you identified as possibly emerging from these amendments? 

Dr Raj Bhula

It's a really hard question to answer. I think the main thing is ensuring that there are no unintended consequences for regulated entities. Making sure that if we get clear feedback during this process, then we will be able to make sure that there's no unintended consequences, because that's our biggest risk, is not wanting to add regulatory burdens. 

Ensuring that regulatory burden, that the whole purpose of these is to ensure that the regulations are flexible and also not add to regulatory burden. I think that's one of our key risks, is just ensuring that we're not adding to regulatory burden. 

Sarah Syme

And the other thing I think I would add is that we've published the Decision Regulatory Impact Statement, where we've had to go through and consider what the impact of the proposed changes to the regulations will be, and outline how we anticipate that it will impact on stakeholders and applicants. There's that information available that highlights some of that. 

Neil Ellis

And just to add on the human health and environmental risk side, I think one of the early slides that you presented, Sarah, was saying one of the whole concepts or themes was to make sure we maintain all those protection goals. That's been something that's very conscious as we work through. And with 25 years or 24 years of experience with the current Gene Technology Act, what has been developed is reflective of all that experience with seeing and managing risk to human health and the environment. 

Sarah Syme

Great point. Thanks, Neil. 

Rachel Schulz

Can you please explain how applications under review with the OGTR will be impacted by the amendments? Do we expect an impact on the time frame for approval of the application? 

Louisa Matthew

I can read this question two ways, so I'll see if I can cover both. This is potentially asking about what will happen to applications made before the amendments would commence, but that aren't decided yet at the time of commencement. There's a section of the consultation paper that specifically talks about how those will be handled. But generally, it's worth noting that the intention is through the transition period there wouldn't be any periods where people can't make applications and where the regulator is unable to decide on applications. 

We want there to be a steady flow of applications being made and decisions being made throughout, so applicants are minimally inconvenienced. 

If the question is asking about how decision time frames for licence applications and other things will be impacted, there's a section of the consultation paper that talks about how the proposed amendments will set out application decision time frames. Important to note there is that that includes for licence applications, the ability for the gene technology regulations to specify alternate time frames. Expect more detail about licence decision time frames to come in later consultation on the regulations. 

Sarah Syme

One more thing I would add to that. In terms of timelines, once the legislation is passed through the parliament, there is, at least at this stage, 12 months before it will take effect, and that gives states and territories opportunity to pass mirror legislation or enact the Commonwealth legislation in their jurisdictions, and to prepare for this to take effect. It won't be an overnight as soon as the legislation is passed, there'll be a period where we know what we need to do and will be ensuring that all of that happens in time. 

Rachel Schulz

Any FAQ section on the website for this public consultation would be helpful. Can this be done? 

Sarah Syme

Yes, absolutely. We've got through more questions than I think we anticipated going through, so that's good. But we'll go through and highlight some of the key themes and pull together an FAQ document that we can publish on the website. 

Rachel Schulz

We have time for another question before we’re at time. With the human exception, you just said that although a person cannot be a GMO, but the therapeutic may be a GMO and be under your remit, this depends on what is an organism, which depends on what you define as a biological entity in the act. So used to reading the states and territories that I read that. Is there a plan to define what biological entities? 

Dr Raj Bhula

Short answer to that is no. 

Louisa Matthew

It's a term used in the definition of organism in the Gene Technology Act, and the bill does not include any proposals to amend that definition of organism or any of the terms used within it. 

Rachel Schulz

We have maybe time for one more question, possibly, I think, before we hand over. Can you please put a link to the document with tracked changes? I can't find it online. 

Sarah Syme

If you can send us an email. We won't have time to find the link in the remaining seconds of the webinar, but if you are able to send us an email, we can try and find the exact link to that for you. 

Rachel Schulz

I think we have one more question on the screen that we can deal with. Will food or material fermentation that use GMOs be assessed? Note FSANZ says it will exclude any consideration of such processes. 

Dr Raj Bhula

The food itself that might be the result of a fermentation process, still falls under the Food Standards Australia and New Zealand remit. We don't assess any food safety risks there. And it depends on what the fermentation process is and whether a modified organism’s being used for fermentation. We would only be looking at that part of the process, but not the end product, which would be the food. I hope that's clear. 

Rachel Schulz

I think that's about it. We have closed off the questions. But a reminder, if you do have outstanding questions you would like to send through to the panel, please make sure that you send through the information to the email address displayed there on the screen. Thank you to the Gene Technology Regulators here with Sarah and Kirstine, as well. We appreciate everyone's time. Thank you.