Executive summary

The options and proposals are being presented here for discussion. We would like your input on options and proposals in regard to:

• Approval processes for laboratory research – to simplify the approval processes for both the development of low-risk genetically modified organisms (GMOs) in the laboratory in New Zealand and their importation from overseas laboratories, thereby reducing unnecessary compliance costs without changing the scope of what is considered low-risk
• Human cell lines and tissue regeneration – to address gaps in HSNO Act coverage options are proposed for ensuring appropriate regulatory oversight for research involving genetic modification of human cell lines, and for amending the HSNO Act to cover the regeneration from tissues, using cloning and related techniques, of organisms that are not currently in New Zealand. The proposed amendments would not extend to human cloning as the term organism in the HSNO Act specifically excludes human beings
• Conditional release of GMOs – to introduce another category of approval that would enable ERMA to approve organisms for release with certain controls attached to them
• Assessment of GMO medicines – to reduce duplication and streamline the assessment and approval of medicines that are or contain GMOs, four general options are presented for changes to the agencies responsible for the approval of GMO medicines and how the health and environmental risk assessments might be incorporated
• Confidential information – to revise the protection given to confidential information provided with applications for approvals: comment is sought on what level of protection is appropriate
• Ministerial call-in – to revise the grounds for ministerial call-in: the Minister is able to ‘call-in’ and decide on applications where she considers there may be significant effects; it is proposed that the grounds be extended to include ‘significant cultural effects’
• Zoo and circus animals – to complete the transition to the HSNO regime for animals in existing registered zoos and circuses that are new organisms
• Enforcement agency for new organisms – to specify an enforcement agency for new organisms: it is proposed that the Ministry for Agriculture and Forestry’s enforcement role for new organisms in containment be formalised
• Miscellaneous operational issues – to address a variety of issues arising from experience in the operation of the HSNO Act for new organisms, including:
  • a longer time for the Environmental Risk Management Authority (ERMA) to make and release its decision on applications
  • how to deal with the establishment of new organisms in New Zealand that arrive through natural means or as accidental ‘hitchhikers’
  • problems with the classification of new organisms at the species level
  • shortening the time within which a compliance order must be complied with
  • allowing a greater time to mount a prosecution
  • review of the list of prohibited new organisms
  • what constitutes a large-scale fermentation
  • clarification of the decision making criteria for new organisms in containment.

In addition, the issues around liability for the possible impacts of GMOs are discussed. Submissions are sought on whether there are liability issues which are unique to GMOs, the adequacy of existing liability rules, and, if they are not adequate, the range of options for reform. This section does not presuppose legislative change in this area.

To help you make your submission we have included questions for discussion (in shaded boxes) throughout the document. If you are responding to a question, please refer to the question number. If you wish to comment on other issues, please refer to the relevant paragraph or section of the document.