Review of National Gene Technology Scheme - Phase 3 Consultation - Online Submissions

General comments:
As in most analyses, the exposition of new technical developments has been biased towards developments that have captured most attention, especially the newest gene-editing methods such as CRISPR-Cas9, as well as those that trigger both scientific and ethical unease, especially gene drives. It should be noted that these methods in current form all involve changes to the NUCLEAR genome.

This is unfortunate as there has been little or no consideration of methods that target changes in the PLASTID genome of plants or involve ORGANELLE TRANSFER in plants. Neither of these methods is new – in principle or practice – but implementations reaching the contemporary regulatory stage have so far been absent. This position can be expected to change rapidly as they offer major new opportunities and advantages, including speed, accuracy and inherent low risk compared with nuclear-genome modifications.

Together with other upcoming approaches not targeted to making changes in the nuclear genome, the paucity of expertise available in Australia and, thus readily to the OGTR, is of concern. These applications also raise commercial-in-confidence implications not foreseen in late regulatory (Theme 2) Findings.

Finding 3: Agree

Finding 4, Synthetic biology: Agree with approach.

Finding 5, Human Germline Therapy: Agree

Finding 6, Intentional environmental release – biological control
I agree

However, for the GM-crop field it would be helpful if the “gain-of-function” discussion for control of pests attacking a crop plant drew a distinction between GM-modified (or with modified DNA under any definition) crops and plants to be grown and managed by humans in a human-controlled environment and GM-modified plants for general release into the environment (see Finding 7 below). Modern crop plants – GM or otherwise – are very low risk as invaders of native (wild) landscapes (undisturbed by human activity or natural catastrophes); they don’t survive so represent a low general environmental risk.

Finding 7, Gene Drive:
I agree.

Current gene drive proposals involve “animals” (insects, mammals, no-plant pests) which inherently inhabit and survive in non-human controlled environments (see comments for Finding 6 above).

But on the other hand, ethical and other concerns also arise from proposals for “gene drives” to address the catastrophic effects of introduced diseases of trees in native forests even though the desired outcomes appear beneficial. Again, see comments for Finding 6 regarding crop plants.

Finding 8 - regulatory trigger:
On balance, I support the finding that retention of a general process trigger rather than move to a product trigger is more appropriate at this time. The main factors influencing my support are non-scientific, namely the need to assuage community concerns which would be heightened by a change and could lead to a negative reception at the next stage of political and governmental consideration, and to minimize complexity and delays in effecting legislative changes and putting other proposed “instruments” in Themes 2 and 3 into practice.

My support, however, is conditional on a sensible, early, risk-based exit strategy for decision of “no need to be regulated” for crop field trials and general release, such as has now been adopted by the USDA.

But finally, as a scientist I would still argue (as in my submission to Phase 1) that a product trigger would better capture risks, especially given technological advances that greatly increase the power for rapid, cheap and thorough characterization of the product and represent a superior evidence-based approach to risk management.

Finding 9 – risk tiering:
I support. Based on arguments presented in the Report, this would seem also to include an early exit strategy, as discussed for Finding 8 (see response above).

Finding 10 – streamlining regulation
I generally support the suggestion to streamline paperwork through introduction of IT. However, as with all form-based applications I am concerned about the “quality” and workability of the user interface and whether it would be “fit-for-purpose”.

It is not clear whether an electronic document or online form is proposed. Such applications’ software developed by IT experts are often too complex, inflexible, dependent on computer architecture and O/S level or browser (type and version, and require mindless repetition of data. If adapted from generic software they are usually full of bugs and not fit-for-purpose. The cost of “IT support” for users’ enquiries could be a major cost if not done right.

The suggestion for streamlining by moving handling of some DNIR and DIR applications to IBCs appears sensible and could have time and convenience advantages for academic applicants, in particular. However, a valid concern is made in the Report about the capacity of IBCs to handle the additional work of such load shifting.

The point above is also related to the issue of funding IBCs, which is already a concern (I and others have noted in Phase 1 submissions); the cost is currently borne by institutions with few dedicated paid staff and assessment done (voluntarily) by academics/scientists. Thus, this suggestion is not merely one of resourcing OGTR.

Commercial-in-Confidence applications need to continue to be dealt with at OGTR level.

The matters covered under the discussion for Finding 10 are too broad and I believe should have been split into 3 separate areas: IT, load-shifting to IBCs and commercial-in-confidence.

Finding 11 – operation of GM Register: I support

Finding 12 – potential new harms; DIY biology
I support but note that in US and Canada oversight is usually undertaken by the equivalent of IBCs with both monitoring and encouragement by working scientists in the field and usually/often with experiments conducted in institutional facilities. Perhaps an extension to existing programs would be appropriate in some cases, e.g. the CSIRO-Plant Industry (Canberra) Discovery Centre.

It is clear that the GTR needs to be involved/take responsibility but it is not at all clear how DIY Biology oversight of compliance with Codes of Practice should be resourced. Perhaps the Regulator needs to be resourced but not for the funds to be spent within the OGTR. As I noted in my Phase 1 submission (p. 9), in the US the FBI has a unit with a named (and known to the public) Special Agent, who circulates widely within the US DIYbio community attending meetings etc.; this seems to represent a “friendly policing and intelligence-gathering” approach by staff with the training to undertake such a role and act appropriately with the public.

Findings 13 and 14 – future-proofing regulation and principles based regulation

General comments: As noted in my submission to Phase 1, the schematic for the connections of the GTR/OGTR to other “bodies”, now shown in amended form as Figures 1 and 3 on p. 46 and p.73 of the Draft Report, does not show arrows indicating who (or how! – mechanism?) CAN (or in past practice, has done), initiate communications with the GTR/OGTR on general or specific issues (not specific applications) covered by the discussion in the Draft Report. That is, the extent and direction of interactions with the connected bodies shown in Figure 3 are opaque.

I note that the OGTR web site is “uninviting” and provides no invitation or mechanism for the “Regulated Community” (stakeholders?) or “Public” to initiate such communications. The “Have your say” pull-down menu is only for comments on submitted applications. Under Contact Us it notes only:
You can contact us to:
• obtain further information on the work of the OGTR;
• Subscribe to OGTR News to receive regular updates on the work of the OGTR; and
• provide feedback on our website or other information and publications.

Finding 13: I generally support, but there is still no mechanism for stakeholders or the public to draw matters of new developments to the attention of the GTR AND request consideration, which might include referring on to relevant committee, e.g. GTTAC.

It is likely that stakeholders, including scientists, and the public will in many cases be best placed to provide relevant technical or other information to the GTR in a timely fashion (i.e. early warning before it appears in secondary literature as appears to be the only sources accessed by OGTR) or to seek advice for novel uses of GMOs or use of novel GMO methods, including those they themselves are developing (yes! not all Australian researchers simply “import” new methods being developed internationally).

In my Phase 1 submission (p.11), I noted the following recommendation by the US White House Review of GMOs:
“Product developers who are uncertain regarding the relevant regulatory requirements, particularly small businesses, are encouraged to contact the agencies early in the product development process to obtain information from the agencies on potential safety and regulatory requirements that may be associated with their intended products.”

This option does not appear anywhere in the Theme 2 Findings.

Finding 14: I generally support.

Finding 15 – Market access and international trade: I support.

Finding 17 – National consistency:
It is not clear why no comment is made on the possible disadvantages of the mirror approach.

Findings 18 and 19 – Moratoria: I agree

Finding 20 – Benefit consideration:
I agree that consideration of benefits by OGTR is a tricky issue as it goes beyond risk. However, in the longer term, and with increasing evidence for some traits, I hope it may become a criterion, for example for environmental benefits of GM pest-resistant traits in crops that greatly reduce the use of pesticide chemicals and human benefits of nutritional-enhancement traits in crops.

Finding 21 – Regulatory burden: I agree

Finding 22 – Clarity: I agree

Finding 24 – Co-ordination with other regulators:
I don’t support the suggestion of a web portal (“clearing house”) as it is too complex, and likely to be unworkable in practice and increase delays and confusion for applicants.

Finding 25 – Co-ordination with other regulators:
Comment: the study method used in the US White House Review of GMOs to investigate inter-operability issues (demarcation of areas of responsibility) of the three relevant US bodies – USDA, EPA and FDA – may be useful here.

Finding 27 – Funding model:
The discussion of the full-cost recovery model omits an important point, namely that it is a proposal for payment for a monopoly service that would allow OGTR to set its own prices; these could provide a driver for increasing staff and set up ongoing problems with increased funding demands and costs for applicants. The model provides no safeguards for applicants for OGTR quality or efficiency or quality of service. The option of a cost structure with additional payment for expedited consideration is likewise of concern.

Finding 28 – Funding model:
The discussion neglects the issue of resourcing the IBCs that already, by delegation, do much of OGTR’s work at no cost to OGTR’s budget or directly to government; IBC costs currently have to be absorbed by the institution. Consideration of the funding model should address this deficiency with a mechanism to recompense IBCs. This might comprise either funding for this purpose included directly in OGTR’s budget or by some other mechanism

Findings 29 and 30 – Public understanding and confidence:

General comments: Reference to broad-scale reviews of regulation of GMOs, such as this Review, both recent and historical and Australian (e.g. recent Productivity Commission Report) and international (e.g. 2016 US NAS Report) show that consideration of this topic, although critical, is almost always postponed to the end and then with half-hearted, undefined, perfunctory-only suggestions offered. Although there is a huge literature on the topic (communication) and many attempts have been made – over now decades – success has been limited at best.

Possibly the first substantial insights into the nature of the problems underpinning connecting productively with members of the public opposed to GMOs – for diverse reasons, but mainly concerns over food safety and environmental safety –, and cogent hints, at least, as to how to address them, is now offered by a book by Mark Lynas "Seeds of Science Why We Got It So Wrong On GMOs". This book was published on 5 April 2018 and thus not available during the Review. It’s a “first of its kind” book (review on https://thewire.in/books/review-how-an-environmentalist-changed-his-mind-about-gmos).

As is well known, Mark Lynas was an early (from 1980s) leading activist in the English anti-GM movements who famously “recanted” in 2013 – and is now a pariah of the anti-GM movement. Rarely, if not uniquely, Mark Lynas knows the leading people behind the anti-GM movement(s) and their philosophical views, as well as, more recently, the scientists and others promoting development and use of GMOs, especially in agriculture. The book also provides case studies and other insights into the activities of charitable bodies such as Greenpeace, especially in Africa, which now have vested interests, and well-funded and organized programs, in prolonging anti-GMO views.

Mark Lynas’ book was researched and written under an independent fellowship from the Alliance for Science at Cornell University founded in 2014 and funded primarily by the Bill and Melinda Gates Foundation.

Finding 29 – Public understanding and confidence:
As clearly articulated by Lynas, providing information – however, balanced and professionally communicated – to the target audiences is not the solution. The target audience(s) is unreceptive – they won’t listen but rather seek only reinforcement of their entrenched views from like-minded people. Lynas articulates reasons for this (human behavior; “tribal”). Thus, the suggested action appears doomed to another failure (see above General Comments). It is likely that the insights into Lynas’ book will spur development of alternative approaches at communication with better chances of success. I suggest that the Forum “watches this space”.

Finding 30 – Public understanding and confidence:
In general I agree but note that the OGTR’s communication record even with “clients” (applicants) is not strong and the additional challenges of communicating effectively (see above) with the general public appear beyond their current capabilities.

Finding 31 – Safety concerns and post market review:
In principle I agree but am concerned about the processes that might be involved in such reviews and their scope (all GMOs under general release?), particularly the potential load on companies marketing the products to provide data to such reviews and whether OGTR will become both “judge and jury”.