Witness Brief - George Petersen

Position Emeritus Professor, President of the Academy Council, Royal Society of New Zealand

Executive Summary

1. I am President of the Academy Council and a member of the Council of the Royal Society of New Zealand. I am an Emeritus Professor of the University of Otago, where I held the Chair of Biochemistry for 31 years (1968—99). I hold the degrees of MSc in chemistry (University of New Zealand), and MA, DPhil and DSc in biochemistry (University of Oxford). I was elected a Fellow of the Royal Society of New Zealand in 1985.
2. I have had over 40 years research experience in the general field of nucleic acid structure and function and have made extensive use of in vitro recombinant DNA technology. I was involved in drawing up the first New Zealand guidelines for laboratory experiments in this field and was appointed foundation Chair of the Advisory Committee on Novel Genetic Techniques (ACNGT) in 1978, and a member of the Interim Advisory Group (IAG), set up in 1989 to oversee national guidelines for field testing and release of GMOs. I served on both of these committees until they were superseded by ERMA in 1998.
3. In preparing this submission, the Royal Society canvassed the opinion and comments of the appropriate member societies and of the Academy. The submission therefore represents a consensus view of many practising scientists and members of the community with an interest in science. Understandably there was some disparity, both of perception and opinion, between the views expressed by the experimental biological scientists and the social scientists. For this reason, the submission is presented in two parts. It is intended that I should act as presenting witness for Part A (experimental biological sciences). Dr Hugh Campbell will present Part B (social sciences).
4. There was considerable unanimity among the experimental biological scientists that GM technology has a significant potential for good in New Zealand, and that a blanket ban on the use of the technology for commercial or environmental purposes would be to the detriment of New Zealand as a competitor for international markets. Applications that are perceived to have an environmental risk should continue to be evaluated on a risk/benefit basis by a statutory body such as ERMA.
5. The Society supports retaining statutory regulation of GM as an essential part of maintaining public confidence in the use of this technology. However, there is strong dissatisfaction among experimental biological scientists with the wording of the HSNO legislation, and the consequent constraints it imposes on laboratory-based research in New Zealand. The regulations devised to try to get around the deficiencies of the Act are not in accord with international practice and have placed New Zealand scientists at a disadvantage relative to their overseas counterparts, while other deficiencies of the legislation which cannot be remedied by regulation (e.g. the rules governing the importation of low-risk GMOs into containment) threaten to undermine international research collaborations.
6. We are critical of the design of the Act, which aims at gathering all legislation relating to scientific 'hazards' under one regulatory umbrella. While some relief might be found in the short term by amendments to the existing Act, we submit that the only workable solution is to revise the legislation completely. Such a revision should involve the separation of the Act into at least two, or more, parts of which one would deal solely with GMOs.
7. We submit that any revision of that part of the Act that deals with GMOs must recognise that the 'risks' associated with the use of GMOs differ according to whether the GMO is being considered with respect to:
• contained laboratory experiments
• contained field testing
• partially contained field testing
• full-scale environmental release

and that the assessment of risk of each of these applications of GE requires a different approach in each case.

8. Particularly important is the recognition that internationally accepted containment guidelines have been developed for experimental work in category (a) and that, under appropriate containment, work in this category poses no environmental risk. The present practice of requiring all work in this category to be described on the basis of the biology of the modified organism rather than of the unmodified organism and the experimental procedures involved is contrary to accepted international practice and should, we submit, be abandoned. We propose an alternative mechanism for the assessment and approval of such experiments.
9. We propose that the adjudication of containment for all 'low risk' laboratory experiments, and for the importation of 'low risk' GMOs into containment be delegated to institutions undertaking genetic manipulation and follow accepted international practice of classification on the basis of the organism and experimental procedures involved. IBSCs should still be required to report their determinations to ERMA.
10. We propose that ERMA appoint an advisory committee of scientists experienced in the field of GMO development to advise IBSCs in cases where the experimental risk cannot automatically bedesignated as "low risk" or where it cannot be accurately assessed.
11. We submit that field testing and environmental release should remain under the control of ERMA, and that each application should be considered on a case-by-case basis.
12. We submit that field testing be considered as part of the research process, and that the assessment procedures be streamlined to allow fully contained field trials to proceed without unnecessary delays.
13. We submit that the legislation should be amended to provide ERMA with greater flexibility in placing controls both on partially contained field testing and release.

Evidence by Section (as specified in the matters set out in the Warrant)

Evidence by Section

Witness briefs are to be structured in line with the matters specified in the Warrant and the sections numbered accordingly
Each section should stand alone, and include a section summary, identifying the issues addressed in the section
Witness briefs may address all or only some of the sections (as specified in the Warrant). However section numbers should be retained, for example, if a brief addresses matters (a), (c) and (e), the sections shall be numbered (a), (c), and (e), rather than a, b, and c
Witness briefs may, within each section, adopt a sub-section approach using different headings; however, each paragraph should be consecutively numbered

Section A Recommendations

The Warrant has set the Commission the task of receiving representations upon, inquiring into, investigating, and reporting on the items set out in Section A (1) and (2) below

Section A (1)

Section A (1) Summary

15. When considering New Zealand's strategic options for GM, it is crucial that the Royal Commission distinguish two basic different levels of use:
• as 'tools' used in low-risk work in approved containment facilities
• used outside of containment in the wider community.
16. Worldwide, GM technologies have become an integral part of the 'tool box' for biological research in containment, and have proven completely safe in this context. We recommend that New Zealand maintain and develop its capability in GM research.

A (1)

17. There is an overwhelming strategic justification for New Zealand to continuing using GM technologies in research and development. New Zealand has developed a strong capability in GM technology, and such techniques are critical to our understanding of the functioning of living organisms. Without research using GM technologies, many opportunities for new discoveries and new industries will be lost. Key staff will be lost, and attracting talented foreign scientists to our institutes will be impossible. Nevertheless, long-term monitoring of GM developments and field trials is imperative for public confidence in science and regulatory authorities.
18. Taking into account the safety and monitoring of the research, the need to retain a competitive research capacity and the current and predicted global market, we believe that New Zealand's best strategic option is to encourage and support a culture that fosters high-quality science and rigorously evaluates and researches safety issues.
19. For these reasons we urge the Commission to acknowledge the ongoing strategic requirement:

Recommendation: New Zealand should maintain and develop a capability in basic research in biological science involving the use of GM technologies, coupled with a rigorous assessment and monitoring system.

Section A (2)

A (2) any changes considered desirable to the current legislative, regulatory, policy, or institutional arrangements for addressing, in New Zealand, genetic modification, genetically modified organisms, and products

Section A (2) Summary

20. The development and importation of GMOs for research and GM applications is covered by the HSNO Act 1996. However, the overly prescriptive nature of the Act, as it pertains to low-risk GM-based research, is unwarranted and is distracting both ERMA and research institutions from their primary functions.
21. The Royal Society's submission summarises the problems with the HSNO Act and looks at solutions to each of these. It then examines whether such changes would be better handled by amendments to the HSNO Act, or by producing a separate Act specifically to cover the construction and use of GMOs in New Zealand.

A (2)

22. The HSNO Act is overly prescriptive as it pertains to low-risk GM-based research. This is unwarranted, and is distracting both ERMA and research institutions from their primary functions. The Act needs be reviewed and modified to eliminate unnecessary detailed reporting of routine safe practices, delays in the application process and the compliance costs for both the research institutions and ERMA.
23. In the short term, the HSNO Act could be revised in the following ways:
• Recommendation: Allow ERMA to delegate to institutions undertaking GM research the authority to import low-risk GMOs into containment
• Recommendation: Allow certain categories of low-risk laboratory-based experiments to be exempt from detailed application requirements.
• Recommendation: Allow ERMA to delegate to institution power to adjudicate on GMOs currently classified as A, B and C.
• Recommendation: ERMA should appoint a committee of experienced scientists to advise institutions and IBSCs on questions of containment for GMOs in Category C.

This would provide short-term solutions that would help compliance with the HSNO Act, but would leave the Act fundamentally flawed.

24. In the long term it would be preferable to produce a separate Act to cover the construction and use of GMOs in New Zealand, which addresses the above-mentioned problems, and in particular recognises that there are four distinct aspects to the regulation of GM research, each with different kinds of risk: contained laboratory experiments, contained field testing, partially contained field testing, and full-scale environmental release. An Act that distinguishes between these in terms of the regulatory processes governing each kind of activity would greatly enhance the ability of New Zealand scientists to carry out GM research productively and safely.

Section B Relevant Matters

The Warrant has set the Commission the task of receiving representations upon, inquiring into, and investigating, the matters set out in Section B (a) — (n) below

Section B (a)

B (a) where, how, and for what purpose genetic modification, genetically modified organisms, and products are being used in New Zealand at present

Section B (a) Summary

25. The Royal Society encompasses members engaged in an enormous variety of research projects, some of which involve GM. Many of the projects are of direct relevance to New Zealand's knowledge base, both internally and to our export industries.

B (a)

26. Much of the current research in biochemistry and molecular biology draws on the tools of recombinant DNA and GM technologies in a variety of organisms. Genes from micro-organisms, insects, plants, animals and humans are used in in vitro and in vivo experimental systems. Transgenic organisms - including fungi, plants, insects and animals - are used within the appropriate containment systems to study a range of fields, including:
• human diseases (including cancer)
• dairy, meat and forestry industry biotechnology
• reproductive biology and animal husbandry
• plant-pathogen interactions
• water quality
• vaccines
• drug design and diagnostics.

Section B (c)

B (c) the risks of, and the benefits to be derived from, the use or avoidance of genetic modification, genetically modified organisms, and products in New Zealand, including:
(i) the groups of persons who are likely to be advantaged by each of those benefits
(ii) the groups of persons who are likely to be disadvantaged by each of those risks

Section B (c) Summary

27. Whole areas of research in New Zealand would be threatened by the loss of the ability to use GM technologies, because of the effect it would have on research into fundamental aspects of the development and functioning of biological organisms, down to the molecular level. Our assessment is that the risks and benefits of GM use compare well to those for other widely used technologies for basic and applied biological research.

B (c)(i) and (ii)

28. The biological sciences in New Zealand would be threatened by a comprehensive moratorium on GM because of the effect it would have on fundamental research. New Zealand universities and research institutions would not be able to recruit top overseas biological scientists, undergraduates may find it difficult to secure the overseas positions they need to gain experience, and those students or graduates who do succeed in gaining positions overseas that involve GM work will be less likely to return to New Zealand.
29. GM research relevant to our key crop species will be essential for the ongoing viability of conventional agricultural breeding programmes, and for any industry that relies on growing plants. Avoiding GM would mean that new plant-based industries will not develop or be attracted to New Zealand.
30. GM use has immediate and important applications in medicine, both in therapy and diagnosis. For example, three groups who are likely to benefit enormously from GM use are those under suspicion of cancer who undergo diagnostic tests, those who have a diagnosis of a malignancy, those with malignant hyperthermia. The use of GM for theproduction of protein pharmaceuticals such as insulin and human growth hormone is already widely accepted.
31. Work in GMO-based technologies within an appropriately contained laboratory environment has been carried out world-wide for the past 25 years without negative outcome. There are recognised risks associated with any research into new areas, and this includes those involving recombinant DNA and GMOs. However, our assessment is that the risks and benefits of GM use compare well to those for other widely used technologies for basic and applied biological research.

Section B (j)

B (j) the main areas of public interest in genetic modification, genetically modified organisms, and products, including those related to:
(i) human health (including biomedical, food safety, and consumer choice)
(ii) environmental matters (including biodiversity, biosecurity issues, and the health of ecosystems)
(iii) economic matters (including research and innovation, business development, primary production, and exports)
(iv) cultural and ethical concerns

Section B (j) Summary

32. Currently there is widespread acceptance of the use of GM-derived therapeutic products in human health care. But New Zealand needs a better presentation of informed comment across all sections of the GM arena.
33. The Independent Biotechnology Advisory Committee (IBAC) was established in New Zealand in 2000, in part to meet this need, but the initiative seems to have been side-lined during the current inquiry. In the future New Zealand will need to commit more resources to providing the public with informed comment and information about the variety of GM applications.

B (j)(i)

34. One of the biggest health concerns is cancer, and it is important to have an internationally accepted high standard of cancer diagnosis and treatment. New Zealand undertakes world-class research in this area, and this attracts scientists to stay in New Zealand. Because of the intensive research done on the way cells function, some of the discoveries from cancer research end up being relevant to other areas, including developments in agriculture, primary production, and more general drug development.

Section B (n)

B (n) whether the statutory and regulatory processes controlling genetic modification, genetically modified organisms, and products in New Zealand are adequate to address the strategic outcomes that, in your opinion, are desirable, and whether any legislative, regulatory, policy, or other changes are needed to enable New Zealand to achieve these outcomes

Section B (n) Summary

35. The recognition this year of an apparently widespread lack of compliance with the HSNO Act has highlighted problems inherent in the Act as it is applied to control laboratory-based experiments involving the construction of GMOs. The legislation in its present form makes unreasonable demands on research workers, in terms of both time and cost, and threatens both the international competitiveness of New Zealand science and the ability of New Zealand scientists to undertake international collaborative research.
36. It is essential that we move quickly to a review of the Act. In the medium to longer term we urge that the legislation be split into two (or more) Acts, of which one could be specifically directed towards the problem of the control of various approaches to the genetic modification of living organisms in New Zealand and the use of the products of such modification.

B (n)

37. The HSNO Act permits ERMA to delegate to institutions the power to make rapid assessments of applications for the development — but not the importation — of GMOs that are deemed to be of 'low risk'. In practice this means that New Zealand scientists can obtain permission from their institutions to develop 'low-risk' GMOs in containment, but must pay a fee of several thousand dollars to obtain permission to import and hold under the same containment the same organism from an overseas laboratory.

We submit that there is clearly an urgent need for the legislation to be amended to allow for the efficient importation of GMOs.

38. The HSNO Act includes all GMOs in the same risk category as organisms to be introduced into New Zealand for the first time. In other words, under the Act GMOs modified in containment or imported into appropriate containment for experimental purposes only are treated as posing the same environmental risk as GMOs proposed for field testing or general release. Regulations to address this have been introduced, but have not succeeded in overcoming the problem.

We recommend that the authority to adjudicate on all experiments to be performed in containment be delegated to institutions undertaking GM research. As an additional safeguard, we recommend that ERMA establish an advisory committee of acknowledged experts to which Category C determinations should be referred for comment before being signed off by the IBSC.

39. Some of the problems discussed above can be readily fixed by simple changes in wording to the Act. Of these, the simplest will be to repair the oversight that prevents ERMA from delegating authority for the importation of low-risk GMOs into containment. In the short term other amendments would bring the requirements for the safe conduct of 'low risk' experiments more into line with accepted international practice.
40. However, these are only short-term solutions, and the Royal Society's preference is for a separate Act. We argue that there are at least four distinct aspects of this problem that such an Act must address:
1. contained laboratory experiments
2. contained field testing
3. partially contained field testing
4. full-scale environmental release.
41. Legislators need to recognise the need for a proper understanding of the nature of the 'risk' involved in each category. In particular, recognition by legislation of the distinction between the two types of field testing would greatly facilitate the regulation of this aspect of research.