HSNO Discussion Document Released

Improving the operation of the Hazardous Substances and New Organisms (HSNO) Act is the focus of a public discussion paper released by Environment Minister, Marian Hobbs.

The discussion paper seeks the public’s views on changes that might be made to the main legislation controlling new organisms, including genetically modified organisms – the Hazardous Substances and New Organisms Act 1996.

"The discussion document covers a wide range of the issues around the operation of the Act," Marian Hobbs said. "It is a significant step towards ensuring that all necessary policy is in place before the restricted period on the release of genetically modified organisms is lifted in October 2003. Feedback from this discussion paper will help advance our policy development."

The Royal Commission on Genetic Modification reported in July 2001 that the basic regulatory framework for genetic modification in New Zealand is appropriate. This discussion document seeks feedback on ways to further enhance the regulations and the operation of the Act.

"I have asked officials to report back with policy proposals early next year, so a Bill can be introduced to Parliament during 2003," Marian Hobbs said.

The discussion paper Improving the Operation of the HSNO Act for New Organisms; Including Proposals in Response to Recommendations of the Royal Commission on Genetic Modification covers areas including:

· Changes to the grounds for the Minister for the Environment to 'call in' applications for HSNO approval to include ethical and spiritual matters
· Creating a category of conditional release, as an interim stage of release between field trials and full release.
· Issues around liability for possible adverse effects from genetically modified organisms. The government has not formed a view about liability issues and is not proposing any changes but the document does set out the issues and options to be considered.
· Comment on several proposals arising from operational experience of the Act since it commenced in July 1998. Some of these proposals affect the hazardous substances part of the Act.

"Genetically modified organisms are only one type of new organism under the Act. The paper also discusses changes that do not relate to the recommendations of the Royal Commission on Genetic Modification, as it is opportune to raise them now," Marian Hobbs said.

Under the Act ‘new organisms’ also includes exotic species kept in zoos or used for biological control. The Act has transitional arrangements for dealing with zoo and circus animals that need to be updated.

"The Government has also agreed to undertake separately a review of certain aspects of the Environmental Risk Management Authority’s operations," Marian Hobbs said. "This review will assess whether the Authority has the capacity to meet the demands placed on it by the HSNO Act. Some of the discussion in Part B of this document will be informative for this review."

Submissions on the discussion document will close on Friday 15 November 2002. The Ministry for the Environment is offering to provide speakers to talk to groups who want assistance in making submissions.

The paper will be available on the Ministry for the Environment website:
http:// http://www.mfe.govt.nz

Questions and Answers

What areas are being covered by the discussion document? Topics discussed in the paper include: • approval processes for low-risk genetic modification research • human cell lines and new organisms regenerated from human tissues • streamlining approval processes for the assessment of GMO medicines • options for possible implementation of a new approval category called ‘conditional release’ • protection of confidential supporting information • extension of the grounds for ministerial call-in to include significant cultural effects • liability issues in relation to genetically modified organisms • updating the regulation of zoos and circus animals.

How do I contribute? The Ministry for the Environment is asking for written submissions on the proposals in the document. As the document covers a range of topics, we ask that the submissions focus on those specific areas on which people want to express views. Specific questions have been asked throughout the document to help you focus your submission.

Copies of the public discussion paper can be obtained from the Ministry for the Environment by visiting the Ministry’s website http:// http://www.mfe.govt.nz, emailing mailto: mailto:HSNOamend@mfe.govt.nz, phoning (04) 917 7493, or by writing to PO Box 10-362, Wellington.

What is the process from here? The closing date for written submissions is the 15th November, during this period officials led by the Ministry for the Environment will be available to speak to groups to help with the drafting of submissions. Officials will then report to Cabinet early in the New Year with potential policy proposals. It is expected this will lead to the drafting of an amendment Bill to the HSNO Act.

What does the HSNO Act do? The Hazardous Substances and New Organisms (HSNO) Act 1996 is environmental and health and safety legislation designed to manage the risks of using hazardous substances in business and at home, and the risks of introducing new organisms into this country. This includes the importation and creation of genetically modified organisms. Further information about the Act can be obtained from http:// http://www.hsno.govt.nz

How do I find out about the Royal Commission on Genetic Modification? Information about the Royal Commission on Genetic Modification including the final report and submissions to the commission can be found at http:// http://www.gmcommission.govt.nz.

How do I find out more information about genetic modification? Basic information about genetic modification can be found at the website http:// http://www.gm.govt.nz. Topics that can be found there include ‘How genetic modification is regulated in New Zealand’, ‘How is the safety of genetically modified food assessed?’ and ‘How is GM being used in New Zealand research?’.

What other work is happening during the restricted period? Attached to this document is separate timetable of the work being undertaken during the restricted period.

What’s the aim of the discussion paper? The discussion paper is focussed on two areas: those parts of the government’s response to the Royal Commission where legislative change may be required improvements to the operation of the HSNO Act based on experience for new organisms with the Act since 1998

A lot of the issues that are being raised in the public discussion paper are very technical. Officials need to hear the views of experts and people with an interest in these areas so quality policy options can be put forward.

Why should we simplify the approval process for laboratory research of genetically modified organisms? The proposals in the discussion paper aim to better align the procedures with the way scientific research actually takes place and reduce unnecessary compliance costs without changing the scope of what would be permitted as low-risk work, or altering the level of security for this work.

When is the genetic modification of an organism considered low-risk? The circumstances in which the genetic modification of an organism is considered a low-risk genetic modification are specified in the HSNO (Low-Risk Genetic Modification) Regulations 1998. Such genetic modification developments pose low-risk to public health and the environment, and include most of the routine laboratory genetic research and teaching work carried out by universities and research institutes.

What gaps are there in the coverage of the HSNO Act? The discussion paper covers two areas that have been identified as gaps in the coverage of the HSNO Act: The genetic modification of human cell lines. Although the genetic modification of animal cell lines currently requires approval under the HSNO Act, the same modification of human cell lines does not. This is because humans, their tissues and their cells are specifically exempt from coverage under the HSNO Act through being excluded from the definition of an organism. New organisms regenerated from tissues. Neither the importation of tissue samples nor any development activity (other than genetic modification) requires a HSNO approval. Improvements in cloning and related technologies since the commencement of the HSNO Act mean that it is now possible to produce an animal not currently in New Zealand (a new organism) from imported tissue using a surrogate mother, without a HSNO approval, thereby bypassing the usual requirements to fully evaluate the effects of introducing that new species of organism into New Zealand.

The proposed amendments would not extend to human cloning as the term organism in the HSNO Act specifically excludes human beings.

What is the conditional release of genetically modified organisms? Currently there is no intermediate stage between release and field-test, where new organisms must be held in containment. Some problems have been raised with this approach, such as the inability to carry out research on the environmental effects of a new organism in less contained conditions, or to monitor the impacts of organisms after they are released, or to limit their location (for example, to facilitate the possible co-existence of GM and conventional or organic agriculture). Once released to the environment, new organisms (including both GMOs and imported species) are no longer considered ‘new’. Currently, they are not subject to the HSNO Act and can be used freely by anyone, anywhere in the country.

Conditional release was recommended by the Royal Commission as part of the strategy of proceeding with caution while preserving opportunities. It provides an intermediate stage where, for example, wider testing on genetically modified organisms can take place but with controls placed on it.

Why are we looking at the assessment procedures for medicines containing genetically modified organisms? At present, medicines that are or contain a GMO require assessment and approval under both the Medicines and HSNO Acts. The Royal Commission on Genetic Modification recommended that imported medicines and pharmaco foods that include live GMOs be approved for use by Medsafe without additional approval from ERMA. In response, the Government directed officials to report on options to reduce duplication and streamline the approval processes under the Medicines Act and the HSNO Act for medicines.

Why do we need to look at issues surrounding confidential information? Several industry groups have expressed concern with the confidentiality of information (including confidential supporting information) provided to ERMA and the NZ Food Safety Authority with applications under the HSNO and ACVM (Agricultural Compounds and Veterinary Medicines) Acts, respectively. In general, such information is subject to both the New Zealand Bill of Rights Act and the Official Information Act (OIA). Rights under the Bill of Rights Act include the right to seek, receive and impart information of any kind and in any form. The OIA presumes that information will be disclosed unless there are grounds for withholding the information.

New Zealand has certain obligations under the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement. This agreement provides for the protection of data from unfair commercial use. The purpose of this provision is to provide certainty that the information applicants provide is properly protected to ensure full and frank disclosure when obtaining regulatory approval.

In accordance with the TRIPs agreement, the HSNO Act provides protection for confidential supporting information (section 55). Under the HSNO Act, such protection is provided for hazardous substances that are also the subject of innovative agricultural compound or innovative medicine applications under the ACVM and Medicines Acts respectively. In submissions to the Royal Commission on Genetic Modification, there were concerns as to the limitations of the special protection. The Royal Commission identified that there is no protection for confidential supporting information provided to ERMA for any new organisms (whether genetically modified or not). Such protection is not required under the TRIPS agreement unless the organism can be considered part of a pharmaceutical or agricultural chemical product that utilises new chemical entities.

What does ‘Ministerial Call-In’ mean? The Minister for the Environment is able to ‘call-in’ and decide on applications on the grounds that the Minister considers they will have significant effects. The provision is similar to call in under the Resource Management Act. The Royal Commission recommended that the HSNO Act be extended to include significant cultural, ethical and spiritual issues as grounds for the Minister’s call-in powers.

What does the liability issues section cover? This section addresses the issue of liability for harm that might be caused by genetically modified organisms. It asks whether the existing liability regime is sufficient to deal with harm that might be caused by genetically modified organisms.

Liability issues were considered by the Royal Commission, which took the view that the current liability regime is adequate and recommended that, for the time being, there was no need to change existing liability rules. It was not persuaded that from a legal liability perspective there is anything so radically different in GM as to require new or special remedies. The Commission recognised, however, that liability issues raise difficult questions and suggested that the Government might wish to refer them to the Law Commission for more intensive study.

The Law Commission identified a number of reasons why existing liability rules may not always operate effectively in the context of harm that might be caused by GMOs. It also noted that existing liability rules will not ensure that all harm that could potentially be caused by GMOs will be compensated, and that it is unlikely that any liability regime could guarantee this.

This section briefly discusses: • whether there are liability issues unique to GMOs • the functions of civil liability rules • the existing liability rules that might apply where harm is caused by GMOs • the difficulties that have been identified in applying these rules • the broad range of options for responding to the liability issues raised by GMOs spanning no change to the status quo, modifications to the existing liability regime and a generic liability regime.

It must be clearly emphasised that, unlike other sections of this document, the Government is not at this point proposing any changes in relation to liability in respect of GMOs. This section simply sets out the issues and options to be considered and invites comments on these.

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