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Scientific advice - technical focus group - Gene Technology regulations and powers of regulator

J Bruning made this Official Information request to Ministry of Business, Innovation & Employment

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From: J Bruning

Dear Ministry of Business, Innovation & Employment,

Sir Peter Gluckman (2011) has noted that ‘steps need to be taken early on to ensure that the scientific advice is:
• focused on the data and its appropriate interpretation;
• unbiased with respect to its use of data;
• open about what is known and not known;
• able to communicate in terms of probabilities and magnitude of effect;
• free from conflicts of interest, provided apolitically and independent of any particular end-user perspective.'
(OPMCSA, 2011, Towards better use of evidence in policy formation: a discussion paper).

The public have been told:
'A technical advisory group of 12 scientists and researchers will also support the Ministry of Business, Innovation and Employment on gene technology regulation procedures and technical matters, aiming to ensure officials' interpretation of the relevant science is accurate and risks and opportunities clearly understood.'
https://www.rnz.co.nz/news/political/524...

'The Technical Advisory Group provides technical advice to MBIE on up-to-date gene technology regulation, including regulatory procedures and science and technical matters related to biotechnology, genetic techniques and gene therapies.

The Technical Advisory Group ensures that officials’ 'interpretation of relevant science is accurate, that opportunities and risks are clearly understood and that technical considerations are effectively incorporated into policy development.'
https://www.mbie.govt.nz/science-and-tec...

OIA REQUEST

[1] Please supply the terms of reference sent to the technical focus group. This is to confirm that there are systems in place to ensure that the information is free of bias and that there are protocols to ensure that the technical focus group have powers and resources to review and consider probabilities, risks, uncertainties and magnitude of likely impact outside the information sent to them by them, so that science advice is independently provided.

[2] Please supply all scientific information, including that which is listed in policy papers, including references and appendices, sent to the technical focus group.

This necessarily includes advice regarding the FSANZ proposals to change the definition of a GMO and remove process-based risk assessment. Obviously, the FSANZ outcome will impact the risk environment i.e. scientific and technical considerations of risk in relation to New Zealand’s native species and agricultural production and export. (Officials are aware the FSANZ work is in parallel with, and relevant to, MBIE's current consultation.)

[3] This question concerns the extent to which the technical focus group can consider uncertainty and future risks, and the extent to which MBIE have provided them with existing policy documents.

As science advisors, the technical advisory group will be considering future biosecurity risk, including genetic pollution. MBIE plans to create legislation which permits genetically edited organisms to be released into ecosystems (from a microbiomes, toto pasture, water-courses, and native forests) that with no boundaries, that are complex, linear and dynamic.

To quote Peter Gluckman ‘Precision is not the outcome, rather an assessment of probabilities’… There can be a danger of scientists claiming greater certainty than can be justified. Scientific advice must proceed through processes that are cognisant of, and act to limit, such potential distortions.’

New gene editing techniques such as CRISPR-Cas have accelerated development speed and shortened the bench-to-market timeline. Scientists are increasingly using artificial intelligence (AI) to identify development opportunities in whatever genome scientists want to work with – from mammals, to fish to insects and microbes. Gene editing can also be conducted in the outdoors, and removal of process-based risk assessment and potential exclusion of up to 94% of GMO foods as not GMO for the purposes of risk assessment (Bohle, Schneider, Mundorf et al 2024), not only will result in more development in New Zealand (including from offshore developers seeking permissive regulatory jurisdictions) but more releases in New Zealand.

(For references please see this document: https://psgr.org.nz/stewarding-biotechno...)

As the Royal Commission in 2001 advised, navigation over the longer term involves establishing principles and institutions to support the changing risk environment.
https://environment.govt.nz/assets/Publi...

Attorney General Judith Collins and MBIE allegedly desire to remove the precaution from the legislation and have not appeared to have taken the findings of the Royal Commission into account. There has been no policy paper reasoning considering the risks/benefits of insertion of precaution and/or precautionary principle in legislation text (or removal) would better serve New Zealand culturally, economically and environmentally. New Zealand is a signatory to the many treaties which also require consideration of the precautionary principle.

The technical advisory group must be interested in stewardship/kaitiakitanga over the longer term (see Boston, Bagnall and Barry, 2019, Joseph, 2021, Principles of the Treaty of Waitangi). For the regulator to have foresight and understand risk into the future - not just present risk, the technical advisory group may be considering former Parliamentary Commissioner for the Environment Jan Wrights' criteria:
- irreversible
- cumulative – building up over time
- large in scale or pervasive
- increasing or even accelerating in scale and/or distribution
- likely to tip a natural system over a threshold into another state

a. Please supply all meetings/memos/email discussions with the technical focus group with regards to how scientific uncertainty will be managed and how future risk from the scaling up of releases into the is scientifically, culturally and politically justifiable.

Please include all meetings/memos/email discussions with the technical focus group referencing precaution and/or the precautionary principle; and the findings of the Royal Commission and work by the Parliamentary Commissioner for the Environment.

Discussions around uncertainty and precaution may include the potential for gene edited organisms to have changes to the genome but not be classed as not-GMO as regulators class them as comparable to conventional bred organisms, and how uncertainties relating to risk and contamination in future has been scientifically assessed and communicated by the technical focus group.

b. The technical focus group will presumably be interested in there being sufficient regulatory powers to surveil and assess the changing risk environment, so as to protect health, the economy and the environment. Please supply all discussions with the technical focus group concerning proposed powers for the regulator.

This may include the potential powers to monitor the published scientific literature and surveil the global environment (for newly identified risks from off-target and unanticipated impacts from GMO development and release, regulatory changes, court decisions), and monitor and assess releases into the environment for the long term.

[4] Please supply 'up to date gene regulation' information on how regulations in the top performing OECD nations and the latest decisions by the European Parliament compare against Australia and the proposed hybrid regulations, that have been sent to the technical expert group for assessment.
For example: https://www.europarl.europa.eu/doceo/doc...

Thank you,

Sincerely,

Jodie Bruning.

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J Bruning left an annotation ()

Please note - all places where I state - focus group - should be interpreted to mean 'technical advisory group'.

I apologise for any confusion.

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From: NoReplyMinisterialServices
Ministry of Business, Innovation & Employment


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Kia ora Jodie Bruning,
 
On behalf of the Ministry of Business, Innovation and Employment I
acknowledge your email of 19/11/2024 requesting, under the Official
Information Act 1982, the following:
OIA REQUEST

[1] Please supply the terms of reference sent to the technical focus
group. This is to confirm that there are systems in place to ensure that
the information is free of bias and that there are protocols to ensure
that the technical focus group have powers and resources to review and
consider probabilities, risks, uncertainties and magnitude of likely
impact outside the information sent to them by them, so that science
advice is independently provided.

[2] Please supply all scientific information, including that which is
listed in policy papers, including references and appendices, sent to the
technical focus group.

This necessarily includes advice regarding the FSANZ proposals to change
the definition of a GMO and remove process-based risk assessment.
Obviously, the FSANZ outcome will impact the risk environment i.e.
scientific and technical considerations of risk in relation to New
Zealand’s native species and agricultural production and export.
(Officials are aware the FSANZ work is in parallel with, and relevant to,
MBIE's current consultation.)

[3] This question concerns the extent to which the technical focus group
can consider uncertainty and future risks, and the extent to which MBIE
have provided them with existing policy documents.

As science advisors, the technical advisory group will be considering
future biosecurity risk, including genetic pollution. MBIE plans to create
legislation which permits genetically edited organisms to be released into
ecosystems (from a microbiomes, toto pasture, water-courses, and native
forests) that with no boundaries, that are complex, linear and dynamic.

To quote Peter Gluckman ‘Precision is not the outcome, rather an
assessment of probabilities’… There can be a danger of scientists claiming
greater certainty than can be justified. Scientific advice must proceed
through processes that are cognisant of, and act to limit, such potential
distortions.’

New gene editing techniques such as CRISPR-Cas have accelerated
development speed and shortened the bench-to-market timeline. Scientists
are increasingly using artificial intelligence (AI) to identify
development opportunities in whatever genome scientists want to work with
– from mammals, to fish to insects and microbes.  Gene editing can also be
conducted in the outdoors, and removal of process-based risk assessment
and potential exclusion of up to 94% of GMO foods as not GMO for the
purposes of risk assessment (Bohle, Schneider, Mundorf et al 2024), not
only will result in more development in New Zealand (including from
offshore developers seeking permissive regulatory jurisdictions) but more
releases in New Zealand.

(For references please see this document:
https://aus01.safelinks.protection.outlo...)

As the Royal Commission in 2001 advised, navigation over the longer term
involves establishing principles and institutions to support the changing
risk environment.
https://aus01.safelinks.protection.outlo...

Attorney General Judith Collins and MBIE allegedly desire to remove the
precaution from the legislation and have not appeared to have taken the
findings of the Royal Commission into account. There has been no policy
paper reasoning considering the risks/benefits of insertion of precaution
and/or precautionary principle in legislation text (or removal) would
better serve New Zealand culturally, economically and environmentally. New
Zealand is a signatory to the many treaties which also require
consideration of the precautionary principle.

The technical advisory group must be interested in
stewardship/kaitiakitanga over the longer term (see Boston, Bagnall and
Barry, 2019, Joseph, 2021, Principles of the Treaty of Waitangi). For the
regulator to have foresight and understand risk into the future - not just
present risk, the technical advisory group may be considering former
Parliamentary Commissioner for the Environment Jan Wrights' criteria:
- irreversible
- cumulative – building up over time
- large in scale or pervasive
- increasing or even accelerating in scale and/or distribution
-  likely to tip a natural system over a threshold into another state

a.      Please supply all meetings/memos/email discussions with the
technical focus group with regards to how scientific uncertainty will be
managed and how future risk from the scaling up of releases into the is
scientifically, culturally and politically justifiable.

Please include all meetings/memos/email discussions with the technical
focus group referencing precaution and/or the precautionary principle; and
the findings of the Royal Commission and work by the Parliamentary
Commissioner for the Environment.

Discussions around uncertainty and precaution may include the potential
for gene edited organisms to have changes to the genome but not be classed
as not-GMO as regulators class them as comparable to conventional bred
organisms, and how uncertainties relating to risk and contamination in
future has been scientifically assessed and communicated by the technical
focus group.

b.      The technical focus group will presumably be interested in there
being sufficient regulatory powers to surveil and assess the changing risk
environment, so as to protect health, the economy and the environment.
Please supply all discussions with the technical focus group concerning
proposed powers for the regulator.

This may include the potential powers to monitor the published scientific
literature and surveil the global environment (for newly identified risks
from off-target and unanticipated impacts from GMO development and
release, regulatory changes, court decisions), and monitor and assess
releases into the environment for the long term.

[4] Please supply 'up to date gene regulation' information on how
regulations in the top performing OECD nations and the latest decisions by
the European Parliament compare against Australia and the proposed hybrid
regulations, that have been sent to the technical expert group for
assessment.
For example:
https://aus01.safelinks.protection.outlo...
 
We will endeavour to respond to your request as soon as possible, and no
later than 17/12/2024, being 20 working days after the day your request
was received. If we are unable to respond to your request by then, we will
notify you of an extension of that timeframe. If you have any enquiries
regarding your request feel free to contact us via email to
[1][MBIE request email].
 
Nâku noa, nâ
Ministerial Services
Corporate Services, Finance  & Enablement
Ministry of Business, Innovation & Employment
15 Stout Street, Wellington 6011 |  P O Box 1473 Wellington 6140

References

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