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.