Submitter details
1. Submitter name
Individual or organisation name
(Required)
Bat Janssen
Part 1: Introduction
1. In your view, are these objectives the most effective for developing policy changes to improve the regulatory settings for genetically modified organisms?
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Yes
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No
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Unsure
If not, what should the objectives be, and why? Please explain your answer here.
Both the first and third bullet points are OK. But the second bullet point is too specific. By specifically mentioning only health, biomedical research, therapies and medicines it suggests that other GMO research is not part of the objectives. My worry is that a lawyer could argue that these changes should not apply to non-medical research.
This leaves two options, first try and list all the possible valuable research outcomes that are intended to be benefited by these changes, or second, list no specific type of research at all.
I would strongly favour the second since it is far more flexible and proof against future research goals.
I would suggest replacing bullet point 2 with something like
“contributes to better outcomes for New Zealanders through better research outcomes and innovation”
This leaves two options, first try and list all the possible valuable research outcomes that are intended to be benefited by these changes, or second, list no specific type of research at all.
I would strongly favour the second since it is far more flexible and proof against future research goals.
I would suggest replacing bullet point 2 with something like
“contributes to better outcomes for New Zealanders through better research outcomes and innovation”
2. What features and overall approach would you like to see in a New Zealand regulatory framework for genetically modified organisms?
Please explain your answer here.
I believe it is important to have a system which focuses on the risks associated with the outcome of the modification and not on source material or method of modification or place where the modification occurred. Because the regulation will be subject to scrutiny and challenge it needs to be consistent throughout all the changes so that the intent of the regulations is absolutely clear and obvious to courts and authorities that might be tasked with ruling on specific issues.
Given our experience with a legislation that was focused on technology I would favour an approach that was agnostic with respect to technology and instead focused on the outcome rather than the method used to achieve that outcome. Thus it should be the resulting organism that should be assessed for risk to safety, environment or culture and not the method or technology used to develop that organism.
That does not mean methods should not be considered for safety (physical, cultural and environmental) but rather that the safety questions around methods used should be part of normal lab operations and independent of GMO regulations.
While I am not sure how to achieve it, I believe the regulation needs to avoid regulatory creep where what was initially intended to make work with GMOs easier becomes progressively more restrictive over time as people change interpretation of the regulations. This is particularly vulnerable to the organisations and individuals charged with auditing acting to increase the importance of their job by making the regulations more restrictive.
I think these regulations need to consider the overall goal of GMO field trials and eventual commercial release of GMOs in order to allow the research to have beneficial impact on society. In particular these regulations must maintain a rigorous focus on the risk of the resulting organism and not the methods used to develop the organism nor the containment conditions in which the organism was developed. While the changes outlined here cannot alter the HSNO act itself they should consider that fundamental principles established in these regulations should provide a template and guide for subsequent replacement of the HSNO act.
Given our experience with a legislation that was focused on technology I would favour an approach that was agnostic with respect to technology and instead focused on the outcome rather than the method used to achieve that outcome. Thus it should be the resulting organism that should be assessed for risk to safety, environment or culture and not the method or technology used to develop that organism.
That does not mean methods should not be considered for safety (physical, cultural and environmental) but rather that the safety questions around methods used should be part of normal lab operations and independent of GMO regulations.
While I am not sure how to achieve it, I believe the regulation needs to avoid regulatory creep where what was initially intended to make work with GMOs easier becomes progressively more restrictive over time as people change interpretation of the regulations. This is particularly vulnerable to the organisations and individuals charged with auditing acting to increase the importance of their job by making the regulations more restrictive.
I think these regulations need to consider the overall goal of GMO field trials and eventual commercial release of GMOs in order to allow the research to have beneficial impact on society. In particular these regulations must maintain a rigorous focus on the risk of the resulting organism and not the methods used to develop the organism nor the containment conditions in which the organism was developed. While the changes outlined here cannot alter the HSNO act itself they should consider that fundamental principles established in these regulations should provide a template and guide for subsequent replacement of the HSNO act.
Proposal 1: Introduce a risk-tiering framework for laboratory research
3. Do you agree with the proposed change: to establish a risk-tiering framework modelled on the risk tiering framework under Australian regulations?
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Yes
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No
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Please explain your answer here.
Yes
But
The details are important see Q42
Given the tier structure in Appendix 3 this change would greatly simplify lab operation and record keeping without increasing risks to safety, culture and environment.
It is worth noting that such a structure is largely how most labs in the world operate without any evidence of harm or any evidence of “escape” from the lab and as such it would be expected that changing to such a system would not result in harm in New Zealand.
Assuming a tier structure roughly in line with the Australian tiers this change would dramatically reduce the time taken to track and record low risk GMOs. An additional benefit is the cost to import low risk GMOs for use in research (eg competent cells) would be greatly reduced and the importation process much simplified.
Another big advantage of this system is it reduces the number of minor non-compliance breaches associated with the complicated record keeping required for low-risk GMOs. This would allow effort to be focused on areas of genuine risk.
But
The details are important see Q42
Given the tier structure in Appendix 3 this change would greatly simplify lab operation and record keeping without increasing risks to safety, culture and environment.
It is worth noting that such a structure is largely how most labs in the world operate without any evidence of harm or any evidence of “escape” from the lab and as such it would be expected that changing to such a system would not result in harm in New Zealand.
Assuming a tier structure roughly in line with the Australian tiers this change would dramatically reduce the time taken to track and record low risk GMOs. An additional benefit is the cost to import low risk GMOs for use in research (eg competent cells) would be greatly reduced and the importation process much simplified.
Another big advantage of this system is it reduces the number of minor non-compliance breaches associated with the complicated record keeping required for low-risk GMOs. This would allow effort to be focused on areas of genuine risk.
4. Do you agree with the issues outlined?
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Yes
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No
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Would you add any issues to the list? Why? Please explain your answer here.
While the Australian regulations appear to be largely clear and well considered there is (understandably) no consideration of the special nature of Taonga species. While the safety and environmental risks may be the same as in Australia the cultural risks are significantly different.
5. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
No
6. Do you agree with the proposed establishment of accredited biosafety committees and an Environmental Protection Authority biosafety committee?
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Yes
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No
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Unsure
Please explain your answer here.
However I would note that different ABSCs will have different expertise according to the organisation with which they are associated and some ABSCs may have limited expertise. While some ABSCs may simply apply the risk tier structure I believe that some ABSCs should be able to assess organisms not already within the risk tier structure and provide expert assessment of the appropriate risk tier that would then be applied universally (with appropriate oversight).
Additionally, some, but probably not all, ABSCs will require representation from relevant iwi where taonga species are being considered or may be affected. I am not certain (and definitely not qualified to judge) how broadly or narrowly consideration of taonga species needs to be assessed. In some cases a nationwide decision of cultural risk will be necessary but there may be cases where local considerations are more relevant.
Additionally, some, but probably not all, ABSCs will require representation from relevant iwi where taonga species are being considered or may be affected. I am not certain (and definitely not qualified to judge) how broadly or narrowly consideration of taonga species needs to be assessed. In some cases a nationwide decision of cultural risk will be necessary but there may be cases where local considerations are more relevant.
7. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
It is stated that ABSCs are intended to be different and simpler to operate.
“This is because the criteria under the risk tiers will be more explicit than interpretive. For instance, organisms included under that risk tier will be explicitly listed, rather than using interpretive criteria…”
However, a danger of defining explicit organisms in risk tiers is that as technology changes new organisms may become more useful and unless the risk tiers are regularly updated then ABSCs may be unable to approve newer technologies.
This feature undermines the desire to make the regulations future proof.
One possible solution is that if an ABSC is asked to assess a new organism not explicitly included in the risk tiers that some ABSCs be given the power to recommend assignment of new organisms into the risk tiers allowing other ABSCs to approve them. The advantage is that the ABSC approached with a new organism is likely to be associated with an institute where expertise on that organism is most likely to already exist making an informed judgement easier.
Obviously such a system would need to be subject to oversight.
A danger of ABSCs is that they have a tendency to become more restrictive in their assessments over time. This tendency would act over time to undermine the objective of proportionately managing risk.
“This is because the criteria under the risk tiers will be more explicit than interpretive. For instance, organisms included under that risk tier will be explicitly listed, rather than using interpretive criteria…”
However, a danger of defining explicit organisms in risk tiers is that as technology changes new organisms may become more useful and unless the risk tiers are regularly updated then ABSCs may be unable to approve newer technologies.
This feature undermines the desire to make the regulations future proof.
One possible solution is that if an ABSC is asked to assess a new organism not explicitly included in the risk tiers that some ABSCs be given the power to recommend assignment of new organisms into the risk tiers allowing other ABSCs to approve them. The advantage is that the ABSC approached with a new organism is likely to be associated with an institute where expertise on that organism is most likely to already exist making an informed judgement easier.
Obviously such a system would need to be subject to oversight.
A danger of ABSCs is that they have a tendency to become more restrictive in their assessments over time. This tendency would act over time to undermine the objective of proportionately managing risk.
Proposal 2: Reduce the assessment and approval requirements for medicines that are, or contain, new organisms
8. Do you agree with the proposed changes: to streamline assessments under section 38I of the Hazardous Substances and New Organisms Act 1996, to introduce an alternative assessment pathway for medicines unlikely to result in viable new organisms from being released into the environment, and to enable rapid assessment of medical devices?
Please select one item
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Yes
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No
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Unsure
9. Do you agree with the issues outlined?
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Yes
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No
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Unsure
Would you add any issues to the list? Why? Please explain your answer here.
The statement
”the EPA would still retain the right to decline an application under section 38I, should it determine that a rapid assessment would be insufficient for a particular application.”
lacks any definition of what might constitute “insufficient”. It would be helpful is examples of insufficient were given.
”the EPA would still retain the right to decline an application under section 38I, should it determine that a rapid assessment would be insufficient for a particular application.”
lacks any definition of what might constitute “insufficient”. It would be helpful is examples of insufficient were given.
10. Are there other policy changes that, in your view, would provide more benefits or better meet the objectives than the proposed changes above?
Please explain your answer here.
No
Proposal 3: Replace current record-keeping requirements
11. Do you agree with the proposal to replace the current record-keeping requirements with a new labelling and accounting requirement?
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Yes
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No
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Please explain your answer here.
I would note that research requires record keeping anyway. Knowing the history and characteristics of samples is a normal part of research.
As such the existing record keeping requirements both duplicate scientific record and require largely irrelevant information to be recorded.
Our experience with the systems is they are error prone and time consuming without any additional benefit. They also consume a huge amount of auditing time that could and should be better spent.
As such the existing record keeping requirements both duplicate scientific record and require largely irrelevant information to be recorded.
Our experience with the systems is they are error prone and time consuming without any additional benefit. They also consume a huge amount of auditing time that could and should be better spent.
12. Do you think labelling requirements should also include that new organisms should be able to be linked to the relevant HSNO Act approval?
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Yes
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No
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Unsure
If not, why? Please explain your answer here.
From our experience including the HSNO approval numbers on labels only serves to create the possibility of errors with no improvement in risk management. It is of far greater value to have the researchers read and understand the relevant controls for management of risks than to have them mechanically apply a number to a label.
13. Do you agree with the issues outlined?
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Yes
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No
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Unsure
14. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
No
I’d comment though that under the current regime most (all) of the training is focused on ensuring the records have all the numbers and boxes correct and very little training on the actual handling of GMOs in a manner appropriate to their risk. In my opinion this emphasis on spreadsheets and numbers increases the risk of harm and exists for the ease of auditing and not for the reduction of risk.
I’d comment though that under the current regime most (all) of the training is focused on ensuring the records have all the numbers and boxes correct and very little training on the actual handling of GMOs in a manner appropriate to their risk. In my opinion this emphasis on spreadsheets and numbers increases the risk of harm and exists for the ease of auditing and not for the reduction of risk.
Proposal 4: Adjust internal audit frequency to be proportionate to risk
15. Do you agree with the proposed change: to reduce the internal audit frequency requirement for containment facilities operating at Physical Containment level 1?
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Yes
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No
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Unsure
16. Do you agree with the issues outlined?
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Yes
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No
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Unsure
Would you add any issues to the list? Why? Please explain your answer here.
At present most of the time spent on internal audits and MPI inspections is focused on checking spreadsheets and registers. With the changes to risk tiers most of those registers will be gone. This means much more time is available to actually inspect the physical labs. As a result audits and inspections should both be quicker and more likely to address genuine hazards. I would argue that, as a consequence, audits and inspections could be reduced in frequency.
I particular I see no benefit from 6 monthly internal audits for PC2 and I believe a 24 month inspection cycle would also achieve the same results as a 12 monthly cycle for both PC1 and PC2 facilities.
I particular I see no benefit from 6 monthly internal audits for PC2 and I believe a 24 month inspection cycle would also achieve the same results as a 12 monthly cycle for both PC1 and PC2 facilities.
17. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
Yes. Reduce audit and inspection frequencies further and keep them focused on physical containment.
Proposal 5: Adjust the requirements for the movement of new organisms to be proportionate to risk
18. Do you agree with the proposed change: to remove movement authorisation requirements for laboratories, and containment facilities operating at PC1, provided specific conditions are met?
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Yes
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No
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Please explain your answer here.
Yes and No
Yes the change is good
No you cannot specify “unbreakable”. That word can never be achieved and is far too easily challenged by lawyers. Simply delete the word unbreakable.
There are several definitions of suitable containers for transport of GMOs developed by other countries.
Yes the change is good
No you cannot specify “unbreakable”. That word can never be achieved and is far too easily challenged by lawyers. Simply delete the word unbreakable.
There are several definitions of suitable containers for transport of GMOs developed by other countries.
19. Do you agree with the issues outlined?
Please select one item
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Yes
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No
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Unsure
Would you add any issues to the list? Why? Please explain your answer here.
The conditions for transfer are inconsistent with the new model of risk tiers.
The conditions for transfer should refer only to the risk associated with the organism and not refer to where the organism was developed or how the organism was developed.
In particular, the requirements for PC level, confirmation by facility managers and recording of the movement are all inconsistent with the rest of these new regulations and merely replicated existing paperwork that has been all but eliminated in the rest of the regulations. The maintenance of a transfer register does not reduce the risk but merely maintains an existing bureaucracy.
These three bullet points should be deleted
• The containment facility the organisms are being sent to is operated at a PC level equal to or greater than PC1.
• The facility operator of the sending facility confirms the movement meets these requirements.
• Both the sending and receiving facilities record the movement in a register.
The third bullet point should be replaced by something like
• The facility the organisms are being sent to is operated at a PC level appropriate to the risk tier of the transferred organisms.
The conditions for transfer should refer only to the risk associated with the organism and not refer to where the organism was developed or how the organism was developed.
In particular, the requirements for PC level, confirmation by facility managers and recording of the movement are all inconsistent with the rest of these new regulations and merely replicated existing paperwork that has been all but eliminated in the rest of the regulations. The maintenance of a transfer register does not reduce the risk but merely maintains an existing bureaucracy.
These three bullet points should be deleted
• The containment facility the organisms are being sent to is operated at a PC level equal to or greater than PC1.
• The facility operator of the sending facility confirms the movement meets these requirements.
• Both the sending and receiving facilities record the movement in a register.
The third bullet point should be replaced by something like
• The facility the organisms are being sent to is operated at a PC level appropriate to the risk tier of the transferred organisms.
20. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed option above?
Please explain your answer here.
This section should be rewritten from the perspective of managing movement of organisms in a manner consistent with the risk tier of those organisms. Where organisms are of a risk tier that requires management in labs of PC1 or below transfers should merely require sealed containment and labelling. Organisms with a higher risk tier may require more substantial containment.
Record keeping should be consistent with the record keeping required for the risk tier of the organism.
I would note that the complexity of the existing system for transfers results in regular failures by suppliers of routine laboratory organisms. The exercise of opening inspecting and recording packages of low risk organisms is very time consuming and it is common for distributors and overseas suppliers to fail to include necessary documentation resulting in wasted time and effort for everyone involved without any change in the risk of harm to environment, staff or culture.
Record keeping should be consistent with the record keeping required for the risk tier of the organism.
I would note that the complexity of the existing system for transfers results in regular failures by suppliers of routine laboratory organisms. The exercise of opening inspecting and recording packages of low risk organisms is very time consuming and it is common for distributors and overseas suppliers to fail to include necessary documentation resulting in wasted time and effort for everyone involved without any change in the risk of harm to environment, staff or culture.
Proposal 6: Reduce regulatory requirements for the use of eukaryotic somatic cells
21. Do you agree with the proposed change – to include certain eukaryotic somatic cells under risk tier 1 of the risk-tiering framework outlined in Proposal 1?
Please select one item
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Yes
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No
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Please explain your answer here.
There are two bullet points which I believe are far too restrictive
First
“The donor nucleic acid must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy human beings, animals, plants or fungi.”
This bullet point restricts any work on gene function and discovery where the source is a pathogen of any kind – regardless of the risk tier of the resulting organism. Thus, you could transfer a gene for a well-understood completely safe protein but because it came from a pathogen the new cell line would have to be managed as if it was a higher risk tier.
This largely restricts work on understanding pathogenicity which is a very important area of research. It also restricts work where the genes under question have no role in pathogenicity, simply based on the source organism. Finally, it is inconsistent with the other changes in the document where it is the risk of the change that should be assessed not simply its source or method.
In short, where the modification could be expected to result in pathogenicity then those cell lines should be included in a different risk tier but not simply that the donor DNA came from a pathogenic organism.
Second
“The plant cells or tissues cannot spontaneously generate a whole plant and cannot be regenerated into a whole plant.”
It is a feature of plants that all cells can be regenerated into a whole plant – albeit usually with significant effort. This bullet effectively excludes all plant cell cultures from tier 1 regardless of the actual risk from those cells or the plants into which they might potentially (unlikely) regenerate.
Again, this bullet focuses on the method and source rather than the outcome. A culture of GM tomato cells may regenerate into a GM tomato but if that tomato poses no risk to safety, environment or culture the cell line should be regulated according to the actual risk of escape and potential harm – in most cases negligible.
First
“The donor nucleic acid must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy human beings, animals, plants or fungi.”
This bullet point restricts any work on gene function and discovery where the source is a pathogen of any kind – regardless of the risk tier of the resulting organism. Thus, you could transfer a gene for a well-understood completely safe protein but because it came from a pathogen the new cell line would have to be managed as if it was a higher risk tier.
This largely restricts work on understanding pathogenicity which is a very important area of research. It also restricts work where the genes under question have no role in pathogenicity, simply based on the source organism. Finally, it is inconsistent with the other changes in the document where it is the risk of the change that should be assessed not simply its source or method.
In short, where the modification could be expected to result in pathogenicity then those cell lines should be included in a different risk tier but not simply that the donor DNA came from a pathogenic organism.
Second
“The plant cells or tissues cannot spontaneously generate a whole plant and cannot be regenerated into a whole plant.”
It is a feature of plants that all cells can be regenerated into a whole plant – albeit usually with significant effort. This bullet effectively excludes all plant cell cultures from tier 1 regardless of the actual risk from those cells or the plants into which they might potentially (unlikely) regenerate.
Again, this bullet focuses on the method and source rather than the outcome. A culture of GM tomato cells may regenerate into a GM tomato but if that tomato poses no risk to safety, environment or culture the cell line should be regulated according to the actual risk of escape and potential harm – in most cases negligible.
22. Do you agree with the issues outlined?
Please select one item
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Yes
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No
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Unsure
Would you add any issues to the list? Why? Please explain your answer here.
The issues raised overstate the risk of actual harm and the potential for escape from the lab. The issues raised focus on methods and source material and not on outcome of the modification – this is inconsistent with the fundamental changes proposed.
As noted previously if the changes are internally inconsistent they will be vulnerable to challenge.
As noted previously if the changes are internally inconsistent they will be vulnerable to challenge.
23. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
No
Proposal 7: Clarify the regulatory status of certain biotechnologies
24. Do you agree with the proposed change: to clarify the regulatory status of the introduction of ribonucleic acid (RNA) into an organism, the introduction of deoxyribonucleic acid (DNA), and epigenetic modifications under the HSNO Act?
Please select one item
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Yes
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No
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Unsure
Please explain your answer here.
The change does improve a bad piece of law but does not address the fundamental problem with trying to regulate by method instead of outcome.
Furthermore, the exclusions given require the proof of a negative which is almost impossible in biology.
For example it is impossible to be 100% certain that RNA “cannot result in an alteration of the organism’s genomic sequence”
A better phrasing might be “is not expected to be able to alter the organism’s genomic sequence”
Similarly the next line could be “Is not expected to give rise to an infectious agent”
Similar language would be better for point 2 and 3 in this section.
Furthermore, the exclusions given require the proof of a negative which is almost impossible in biology.
For example it is impossible to be 100% certain that RNA “cannot result in an alteration of the organism’s genomic sequence”
A better phrasing might be “is not expected to be able to alter the organism’s genomic sequence”
Similarly the next line could be “Is not expected to give rise to an infectious agent”
Similar language would be better for point 2 and 3 in this section.
25. Are there any exclusionary criteria that, in your view, should or should not be associated with any of these three biotechnologies?
Please explain your answer here.
No
26. Do you agree with the issues outlined?
Please select one item
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Yes
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Unticked
No
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Unsure
27. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
No. The fundamental problem with defining and adding new technologies is that it legitimizes a flawed and harmful piece of legislation.
Every time a new exception is added it creates more confusion and more opportunity for litigation. We don’t legislate against specific technologies in computing or engineering and we should not for biology.
Furthermore, such an approach is always going to become outdated and irrelevant with new technology.
Essentially, we must remove this bad piece of law and replace it with legislation that regulates risk from outcomes and not from methodology. Changing the regulations around lab use of GMOs is a small step in the right direction and the more consistent this set of changes is the more likely it is that this approach will be applied to release of GMOs from the lab for field trial and eventually for release to benefit society.
Every time a new exception is added it creates more confusion and more opportunity for litigation. We don’t legislate against specific technologies in computing or engineering and we should not for biology.
Furthermore, such an approach is always going to become outdated and irrelevant with new technology.
Essentially, we must remove this bad piece of law and replace it with legislation that regulates risk from outcomes and not from methodology. Changing the regulations around lab use of GMOs is a small step in the right direction and the more consistent this set of changes is the more likely it is that this approach will be applied to release of GMOs from the lab for field trial and eventually for release to benefit society.
In your view, should the status of any other biotechnologies be clarified under regulations? Please explain your answer here.
see above
Proposal 8: Reduce assessment requirements for low-risk fermentation
28. Do you agree with the proposed change: to remove EPA assessment and approval requirements for fermentation of GMOs meeting the criteria of risk tiers 1 to 3?
Please select one item
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Yes
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No
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Unsure
29. In your view, do you think that the current maximum vessel size not requiring EPA assessment and approval (10 litres) should be increased?
Please select one item
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Yes
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No
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Unsure
Please explain your answer here
There is no reason for a volume limit at all. If the GMO is low risk, then it is low risk at any volume.
30. Do you agree with the issues outlined?
Please select one item
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Yes
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Unticked
No
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Unsure
31. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
No
Proposal 9: Maintain or adjust the approach to standards for containment facilities
32. Of the three options presented below, which is your preferred option?
Please select one item
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Keeping the status quo approach
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Shifting to outcome-based standards
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Shifting to a hybrid approach
Why? Please explain your answer here.
Of the three options I prefer a hybrid approach
For many operators the existing prescriptive approach will be simpler to institute and require simpler assessment.
However, particularly for larger organisations with in-house expertise it may be feasible to adopt an outcome-based standard that reduces cost and maintenance without compromising risk to safety, environment or culture.
BUT it requires both internal and external assessors to allow for flexibility. Unfortunately, because of the nature of their job it is all too common for assessors to get blamed for breaches and as such they become highly conservative. I suspect that this is likely to make any shift to outcome-based standards difficult to maintain.
For many operators the existing prescriptive approach will be simpler to institute and require simpler assessment.
However, particularly for larger organisations with in-house expertise it may be feasible to adopt an outcome-based standard that reduces cost and maintenance without compromising risk to safety, environment or culture.
BUT it requires both internal and external assessors to allow for flexibility. Unfortunately, because of the nature of their job it is all too common for assessors to get blamed for breaches and as such they become highly conservative. I suspect that this is likely to make any shift to outcome-based standards difficult to maintain.
33. Do you agree with the issues outlined?
Please select one item
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Yes
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Unticked
No
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Unsure
34. Do you run a facility that is approved as both a containment facility and a transitional facility?
Please select one item
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Unticked
Yes
Radio button:
Ticked
No
Would the costs of a shift to outcome-based or hybrid standards for new organisms outweigh any benefits to you or those who use your facilities? Please explain your answer here.
I don't run a facility. I am merely a user.
That said I can see that for most facilities having a simple prescriptive set of rules is easier to enact.
However, I can also see that for some facilities with either a narrow focus or significant scale then adopting a bespoke set of standard could well reduce costs without increasing risks.
I would note though that BOTH containment and transitional regulations need to be kept in step with each other. there is no point in modifying one without also modifying the other.
That said I can see that for most facilities having a simple prescriptive set of rules is easier to enact.
However, I can also see that for some facilities with either a narrow focus or significant scale then adopting a bespoke set of standard could well reduce costs without increasing risks.
I would note though that BOTH containment and transitional regulations need to be kept in step with each other. there is no point in modifying one without also modifying the other.
35. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the three options above?
Please explain your answer here.
In general, the PC system is widely used and well understood and while it is prescriptive in nature it does provide safe working environments. Combined with a better risk tier system, which more appropriately places organisms in risk categories based on outcomes, I think the benefits of maintaining the current PC prescriptive system outweigh any costs.
However, there are potentially very specific applications where the nature of the work being done, or the scale of the work being done, warrants the effort of adopting an outcome-based standard.
I think I’m saying I prefer a hybrid approach but mostly based around the prescriptive “PC” standards.
However, there are potentially very specific applications where the nature of the work being done, or the scale of the work being done, warrants the effort of adopting an outcome-based standard.
I think I’m saying I prefer a hybrid approach but mostly based around the prescriptive “PC” standards.
Proposal 10: Require regular reviews of regulatory settings
36. Do you agree with the proposed change: to require the Ministry for the Environment to review the regulatory settings for GMOs at least every five years?
Please select one item
Radio button:
Ticked
Yes
Radio button:
Unticked
No
Radio button:
Unticked
Unsure
37. Do you agree with the proposed frequency of reviews (that is, at least every five years)?
Please select one item
Radio button:
Ticked
Yes
Radio button:
Unticked
No
Radio button:
Unticked
Unsure
38. Do you agree with the issues outlined?
Please select one item
Radio button:
Ticked
Yes
Radio button:
Unticked
No
Radio button:
Unticked
Unsure
Would you add any issues to the list? Why? Please explain your answer here.
I think there needs to be a flexibility in the system to respond to really rapid changes in technology.
It should be possible for an ABSC to instigate a review.
The example of the development of gene editing technology is a case where even a five year delay in assessment would have been too long. A flexible system would allow for new technologies to be addressed rapidly especially where they have the potential to dramatically alter either the scale of change and/or the risk from organisms developed with that new technology.
It should be possible for an ABSC to instigate a review.
The example of the development of gene editing technology is a case where even a five year delay in assessment would have been too long. A flexible system would allow for new technologies to be addressed rapidly especially where they have the potential to dramatically alter either the scale of change and/or the risk from organisms developed with that new technology.
39. Are there other policy options that, in your view, would provide more benefits or better meet the objectives than the proposed change above?
Please explain your answer here.
Fundamentally the entire legislation needs to adopt regulation based on outcomes not based on technology as does the current legislation. We legislate other fields based on risks from the outcomes not on the technology used to achieve that outcome and that should be true for biology as well.
If we regulated pornography based on the method of printing then internet pornography would be unregulated or if pornography legislation was modeled on the HSNO act then we would not allow the internet in New Zealand!
Regularly updating a fundamentally flawed piece of legislation is at least better than doing nothing but still does not solve the problem.
If we regulated pornography based on the method of printing then internet pornography would be unregulated or if pornography legislation was modeled on the HSNO act then we would not allow the internet in New Zealand!
Regularly updating a fundamentally flawed piece of legislation is at least better than doing nothing but still does not solve the problem.
Appendices
40. Of the alternative options outlined, are there any that, in your view, would provide greater benefits or better meet the objectives of this policy work than the proposed changes under each proposal?
Please explain your answer here.
Proposal 4 I think the alternative option is better.
For reasons stated previously, with reduced spreadsheets and GMO registers the job of auditing internally and externally is much easier and can focus on physical risks. That should make less frequent audits more efficient and more thorough.
Proposal 5 the alternative is no better because it focuses on existing PC levels and not the actual risk associated with the GMO. It also retains the pointless registers at both ends of any transfer and makes use of the unenforceable word “unbreakable”.
For reasons stated previously, with reduced spreadsheets and GMO registers the job of auditing internally and externally is much easier and can focus on physical risks. That should make less frequent audits more efficient and more thorough.
Proposal 5 the alternative is no better because it focuses on existing PC levels and not the actual risk associated with the GMO. It also retains the pointless registers at both ends of any transfer and makes use of the unenforceable word “unbreakable”.
41. In your view, have we overlooked any costs, benefits or risks for any of the proposals presented in this document?
Please explain your answer here.
No
42. Are there aspects or specific criteria of the Australian risk-tiering framework that, in your view, should or should not be included in any New Zealand risk tiering framework?
Please explain your answer here.
Yes.
There are several odd inclusions/exclusions that should be discussed and probably altered. I also found the use of the word “dealings” confusing, but I’m not a lawyer.
Overall the logic for assigning risk tiers is sensible and understandable (with the exceptions noted below)
If an organism is unlikely to escape and has no selective advantage, then PC1 or PC0 should be sufficient for containment.
If the transferred genes/DNA confer a selective advantage or is expected to produce toxins or harmful compounds, then PC2 applies.
I think for New Zealand a special category for Taonga species is reasonable. It may not require a change in PC level but may require additional consideration by ABSCs.
I think for New Zealand, specific inclusion of species important to our agricultural sector might make enforcement simpler.
Some inclusions are really specific. That makes knowing which GMO fits where easy but it will require regular updating by an expert panel, most likely an ABSC associated with the organisation most likely to have expertise.
Risk tier 1
Part 1
Item2 Why is C. elegans specifically highlighted as exempt when other similar organisms might offer the same low risk? Is the intention to build a New Zealand list?
Item 3A these are really specific, perhaps too specific to be flexible?
Item 4 why 25 L? Why not 50L or 100L? I’m not sure volume makes any difference to risk, if the organism is safe then it should be exempt at any volume.
Item 4 (2) (ii) says the donor DNA must be “characterised” without being specific about what that might entail. Is sequencing sufficient? I would have thought so but if not then a specific aim of the characterization would help
Part 2 item 10
I think this means that while still in tissue culture then Agrobacterium-mediated transformation of plant material is considered risk tier 1 and would not require a PC lab. This is great and entirely appropriate.
Plant material in tissue culture should all fit into this category as without significant intervention survival of material is dependent on supportive media and controlled growth conditions. Scenarios where such material might somehow escape and survive are largely fanciful. Only if the resultant organism is expected to pose additional risk (eg the transfer of pathogen genes) should PC2 containment be required.
Risk tiers 2 and 3
Schedule 3
Part 1 GMOs suitable for PC1
This section lists several organisms as suitable for PC1 unless they have “an advantage”. I presume this means they are not expected to have a selective advantage which would allow them to persist in the environment. This makes good sense since without an advantage it is likely that any modification would disappear from the population should a GM organism escape containment. That fact makes the risk of harm from escape much lower.
However, it is not clear how the list of organisms was developed. Why is a mouse or rat included in PC1 but not a goat or sheep or cow?
Furthermore, why are plants not included since they are significantly less likely to escape containment in the first place and much easier to track.
I believe this section needs to be expanded to include several other lab model organisms eg zebrafish, drosophila etc and include domesticated animals and agriculturally important species.
I also strongly believe that GM plants should fit into this category.
That is, most GMO plant material should by default be considered suitable for PC1. There is a very low risk of plant material “escaping” from PC1. Furthermore most GMO plant material is low risk to the environment and low risk to safety. Except as noted in part 2 where the resultant organism is expected to contain harmful characteristics.
Part 2 defines GMOs that should be in PC2
Again, this section specifically excludes GM C. elegans, mice, rats, rabbits and guinea pigs which can be studied in PC1.
Everything else appears to be limited to PC2 or PC3.
I cannot see any rational for allowing only those five species to be studied in PC1 but not also allow several other model organisms to also be studied in PC1. I also believe the case could easily be made for inclusion of several domestic animals and agriculturally important animals to be studied under PC1.
In particular GM plants are highly unlikely to run, swim or fly away from the lab (lacking as they do, limbs).
Joking aside there are some cases where pollen might be able to travel some distance but, in most cases, PC1 is sufficient to contain GM plants even for species that produce wind-borne pollen. It is worth noting that even for species where wind pollination is the dominant mode pollination in a greenhouse pollination is difficult to achieve without manual intervention, demonstrating that pollen "escape" is unlikely. And again the risks from any such escape are low.
It is worth noting that in most other countries GM plant material is contained in PC1 laboratories and greenhouses without any instances of escape causing harm.
There are several odd inclusions/exclusions that should be discussed and probably altered. I also found the use of the word “dealings” confusing, but I’m not a lawyer.
Overall the logic for assigning risk tiers is sensible and understandable (with the exceptions noted below)
If an organism is unlikely to escape and has no selective advantage, then PC1 or PC0 should be sufficient for containment.
If the transferred genes/DNA confer a selective advantage or is expected to produce toxins or harmful compounds, then PC2 applies.
I think for New Zealand a special category for Taonga species is reasonable. It may not require a change in PC level but may require additional consideration by ABSCs.
I think for New Zealand, specific inclusion of species important to our agricultural sector might make enforcement simpler.
Some inclusions are really specific. That makes knowing which GMO fits where easy but it will require regular updating by an expert panel, most likely an ABSC associated with the organisation most likely to have expertise.
Risk tier 1
Part 1
Item2 Why is C. elegans specifically highlighted as exempt when other similar organisms might offer the same low risk? Is the intention to build a New Zealand list?
Item 3A these are really specific, perhaps too specific to be flexible?
Item 4 why 25 L? Why not 50L or 100L? I’m not sure volume makes any difference to risk, if the organism is safe then it should be exempt at any volume.
Item 4 (2) (ii) says the donor DNA must be “characterised” without being specific about what that might entail. Is sequencing sufficient? I would have thought so but if not then a specific aim of the characterization would help
Part 2 item 10
I think this means that while still in tissue culture then Agrobacterium-mediated transformation of plant material is considered risk tier 1 and would not require a PC lab. This is great and entirely appropriate.
Plant material in tissue culture should all fit into this category as without significant intervention survival of material is dependent on supportive media and controlled growth conditions. Scenarios where such material might somehow escape and survive are largely fanciful. Only if the resultant organism is expected to pose additional risk (eg the transfer of pathogen genes) should PC2 containment be required.
Risk tiers 2 and 3
Schedule 3
Part 1 GMOs suitable for PC1
This section lists several organisms as suitable for PC1 unless they have “an advantage”. I presume this means they are not expected to have a selective advantage which would allow them to persist in the environment. This makes good sense since without an advantage it is likely that any modification would disappear from the population should a GM organism escape containment. That fact makes the risk of harm from escape much lower.
However, it is not clear how the list of organisms was developed. Why is a mouse or rat included in PC1 but not a goat or sheep or cow?
Furthermore, why are plants not included since they are significantly less likely to escape containment in the first place and much easier to track.
I believe this section needs to be expanded to include several other lab model organisms eg zebrafish, drosophila etc and include domesticated animals and agriculturally important species.
I also strongly believe that GM plants should fit into this category.
That is, most GMO plant material should by default be considered suitable for PC1. There is a very low risk of plant material “escaping” from PC1. Furthermore most GMO plant material is low risk to the environment and low risk to safety. Except as noted in part 2 where the resultant organism is expected to contain harmful characteristics.
Part 2 defines GMOs that should be in PC2
Again, this section specifically excludes GM C. elegans, mice, rats, rabbits and guinea pigs which can be studied in PC1.
Everything else appears to be limited to PC2 or PC3.
I cannot see any rational for allowing only those five species to be studied in PC1 but not also allow several other model organisms to also be studied in PC1. I also believe the case could easily be made for inclusion of several domestic animals and agriculturally important animals to be studied under PC1.
In particular GM plants are highly unlikely to run, swim or fly away from the lab (lacking as they do, limbs).
Joking aside there are some cases where pollen might be able to travel some distance but, in most cases, PC1 is sufficient to contain GM plants even for species that produce wind-borne pollen. It is worth noting that even for species where wind pollination is the dominant mode pollination in a greenhouse pollination is difficult to achieve without manual intervention, demonstrating that pollen "escape" is unlikely. And again the risks from any such escape are low.
It is worth noting that in most other countries GM plant material is contained in PC1 laboratories and greenhouses without any instances of escape causing harm.
Suplementary consultation document for hapū, iwi and Māori
1. In your view, would any of the three options presented below appropriately regulate the genetic modification of cells and tissues from taonga species?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Unticked
No
Radio button:
Ticked
Unsure
Would you make changes to any of them? Please explain your answer here.
I am not competent to comment or judge these issues
I just know we do need to consider them
I just know we do need to consider them
2. Are there any other policy options that you think would be more appropriate for regulating the genetic modification of cells and tissues from taonga species?
Please explain your answer here.
Outside my area of knowledge or expertise
3. Do you think similar restrictions under the proposed risk-tiering framework would appropriately regulate the use of genetic material derived from Māori and genetic material derived from native and taonga species?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Unticked
No
Radio button:
Ticked
Unsure
Please explain your answer here.
Again I don't feel competent to comment.
From what I do understand I think there is likely to be a difference in risk tiering
However I would say operating from a risk structure rather than a method or source structure seems likely to be best
From what I do understand I think there is likely to be a difference in risk tiering
However I would say operating from a risk structure rather than a method or source structure seems likely to be best
4. Is there anything you would change, remove or add to the example restrictions above?
Please explain your answer here.
Outside my area of knowledge or expertise
5. Are there any policy options that you think would better regulate the use of this genetic material?
Please explain your answer here.
Outside my area of knowledge or expertise
6. Do you think either of the two options presented below would best ensure that informed consent is obtained from Māori individuals and their whānau, hapū and iwi?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Unticked
No
Radio button:
Ticked
Unsure
Would you make changes to any of them? Please explain your answer here.
Well outside my area of expertise
7. Are there other options that you think would better ensure that informed consent is obtained from Māori individuals and their whānau, hapū and iwi?
Please explain your answer here.
Outside my area of knowledge or expertise
8. In your view, are there other potential implications for hapū, iwi or Māori arising from the 10 policy changes proposed?
Please explain your answer here.
Outside my area of knowledge or expertise
Provide general feedback
Any general feedback on the consultation
Add your comments, ideas, and feedback here
Largely I feel the risk tier approach is a good way of addressing concerns about the technology present and future.
I think the regulations need to be very consistent in their approach to avoid legal challenge and confusion by ABSCs and those enforcing regulations
I think one danger of this approach is the catastrophising of possible escape.
Another problem is people acting to maintain their job rather than to promote research that is of benefit to New Zealand. This leads to regulatory creep that could undermine the aims of this document and the research itself.
One key point is that the HSNO Act itself needs to be rewritten - preferably separating New Organsims from GMOs and leaving health and safety of labs distinct as well.
I think the regulations need to be very consistent in their approach to avoid legal challenge and confusion by ABSCs and those enforcing regulations
I think one danger of this approach is the catastrophising of possible escape.
Another problem is people acting to maintain their job rather than to promote research that is of benefit to New Zealand. This leads to regulatory creep that could undermine the aims of this document and the research itself.
One key point is that the HSNO Act itself needs to be rewritten - preferably separating New Organsims from GMOs and leaving health and safety of labs distinct as well.