PSGRNZ's submission on the Gene Technology Bill 2024 to the Health Select Committee.

Introduction below. PDF link to the 50-page document which is in 2-parts. Part I: Deficient policy formulation and Part II: Recommendations including text analysis.

PSGR thanks the Health Committee for this opportunity to contribute to scrutiny and examination of this Gene Technology Bill. The Gene Technology Bill cannot result in legislation that will achieve the purposes [see clause 3] drafted into the Bill by the Ministry of Business Innovation and Employment (MBIE), the Honourable Judith Collins and Crown Law. The legislation is marked by what has been excluded.

PSGR’s submission is in two parts (PDF):

• Part I: Deficient Policy formulation. The Bill’s drafters have drafted text to narrowly restrict Regulatory powers and prevent wider regulatory scrutiny. This not only leaves New Zealand vulnerable to slow moving problems, it would result in the Regulator having insufficient scope and inadequate information in emergency situations that would enable the Regulator to assure the health and safety of people.

• Part II: Recommendations including critical analysis of Bill text. Makes in-depth recommendations and outlines problems and gaps in the Bill text.

  

In order to claim that the Hazardous Substances and New Organisms Act 1996 (HSNO Act) is out-of-date, MBIE resort to inappropriate citations where those citations fail to lay out an argument that demonstrates any extent of scientific reasoning and impartiality. The ‘out-of-date’ claim has resulted in the jettisoning of key principles and overriding obligations necessary to guide the production of secondary (delegated) legislation. Such legislation would assist officials to monitor, review and analyse risks from novel, patentable gene editing technologies within highly politicised environments.

The manifold deficiencies reveal an unfortunate knowledge gap, an absence of expertise across MBIE, Minister Judith Collins and Crown Law in drafting this proposed regulatory legislation that is demonstrably unfit for purpose, and unable to achieve the purpose of protecting human and environmental health.

MBIE have failed to justify their scientific claims relating to what organism might be classed as is distinguishable and notifiable, or indistinguishable and exempt. MBIE’s unscientific presumption is that these organisms present the same risks as do conventionally bred organisms. There is a large body of scientific literature contradicting this belief, that MBIE has failed to disclose. There is no awareness that highly complex methods used by developers and industry, such as multiplexing, can equally lead to complex and unpredictable outcomes.

MBIE’s and Minister Collins’ actions fails an impartiality test. Policy and Bill text demonstrates a prevailing pre-determination and bias concerning the imagined safety of novel gene edited (GE) organisms.

MBIE fail to communicate that the Productivity Commissioner recommended a public review that would include Māori and the general public. MBIE have short-circuited this recommendation by heading to directly conduct a tightly controlled policy consultation process and then immediately release a Bill.

The analysis by PSGR (see below) suggests that poor policy processes have resulted in deficient and biased policy unfit for purpose. This has resulted in hastily drafted legislation carrying none of the hallmarks of robust, anticipatory legislation that can guide the conduct of regulatory officials when information is uncertain and complex.

PSGR’s response highlights two false assumptions. Firstly, that the risks of current gene technologies can be managed by regulatory organisation and regulatory controls. However, the present state of knowledge about the risks of this technology and its still-emergent science are simply not known with any due rigour; and may not be known for several generations to come because life-forms are so complex in their dynamic organisation and symbioses.

Secondly, proponents of the Bill have been evidently persuaded that current gene technologies that altered life-forms present proportionately greater benefits from their associated patents on new food types rather than presenting massive risks of harm to our nation’s people; our nation’s established GE-free food exports; and our nation’s unique GE-free environment. In eliminating risk-benefit and economic assessment, they have resorted to rhetoric rather than fact, rendering their claims unfit for policy and law-making.

This Bill or any other similar Bill cannot propose effective controls on risks of from genetic modification (including processes of gene editing) because governments around the world have virtually eliminated funding of basic science research in the life-sciences for decades – New Zealand included.

Therefore, there is no adequate pool of relevant science know-how about complex risks arising from applied science genetic manipulation that might credibly be able to administer, effectively, legislation that purports to control risks arising to the public and the environment from that genetic manipulation.

The Regulator and all scientists operating under this legislation would be effectively straight-jacketed into only considering risks of notifiable GMOs, but would have no authority to evaluate risks arising from MBIE’s ‘exempted and very low-risk’ organisms.

Regulators constantly juggle uncertainty, and primary legislation should be designed to empower regulatory officials to proactively identify and review scientific information for public benefit.

MBIE, Minister Collins and Crown Law have drafted a Bill for a watered down, inflexible, arbitrary, and pro-industry regime that is unfit for purpose. The Bill unduly limits regulatory powers in unconstitutional and unethical ways. This Bill cannot and will not protect the safety of human, animal and environmental health.

In addition to our recommendations in Part II, PSGR recommend that your Select Committee should report back to the House that this Bill presents such great risks to our nation’s GE-free international trade in food products, and our indigenous flora and fauna, such that the merely assumed benefits claimed by proponents of this Bill could never match or exceed those risks in any reasoned argument.

PSGR recommends that the HSNO Act remain the foundation legislation for gene technology using process-based risk assessment to determine regulatory scope, i.e., ‘any organism that has been altered using processes of genetic modification, including all gene editing tools and techniques’.

PSGR recommendations describe information gathering and analysis that must be undertaken before the HSNO Act is altered. These actions are required, so that the public and law makers can determine whether or not modifying the HSNO Act 1996, is necessary to do at all. This is PSGRs’ preferred approach.

In addition to PSGR’s recommendations, PSGR recommend that there is a public enquiry into the conduct of both the Attorney-General and Ministry of Business, Innovation and Employments’ conduct concerning the oversight and management of the underpinning policy of the Gene Technology Bill, and the Gene Technology Bill. PSGR consider that there is evidence, that good process may have been by-passed and dismissed in many ways, and that the Attorney General’s role in this may have been questionable and inappropriate.

To read more please click to our 50-page submission (PDF).

PSGR thanks the wide group of multidisciplinary experts who acted as peer reviewers for this document. Disciplinary backgrounds include: biotechnology, medicine, molecular biology, engineering, and the social sciences (research).