Index
What are 'new organisms'?
What is a genetically modified organism (GMO)?
How do I know if I need approval from ERMA New Zealand for a 'new
organism'?
How do I know if the plant or animal I want to bring in is a 'new
organism'.
What is a conditional release?
How does a conditional release differ from a field test or
full (unconditional) release?
What will the duration be of conditional release approvals?
Who is going to check what happens after a new organism is approved?
How do I determine an organism is NOT new?
Are there any new organisms that the HSNO Act prohibits altogether?
Who might be introducing new organisms to New Zealand and be affected
by HSNO?
Why is the HSNO Act needed to control new organisms?
How will the Authority make its decisions on new organisms?
What about genetically modified food?
If my organisation is involved in GMO development how do we go about
setting up and getting approval for our own biological safety committee?
Who will carry out enforcement for new organisms?
What do enforcement officers do?
What are the penalties for serious offences (non-compliance) under
the HSNO Act?
What about emergencies?
Is it really possible to keep GM crops separate from non-GM crops?
Will GM genes spread through the soil/air?
If something goes wrong who is liable?
Will it be possible to maintain the choice for GM free food?
How will ERMA New Zealand verify the information provided with applications?
How will ERMA New Zealand consider effects on Māori cultural and
spiritual values?
Are any risk levels acceptable?
How will risk be assessed?
How cautious is the Authority in the light of imperfect information?
How transparent will ERMA New Zealand be in its processes?
How will the monitoring take place following a GMO release?
A new organism is a new species coming into New Zealand for the first
time, for example, a fish for marine farming, an exotic new zoo animal,
or a new tree species such as pine trees genetically modified to improve
wood strength and growth rate. A new organism could also be a plant or
animal developed in New Zealand through genetic modification. It doesn't
include human beings but does include an organism that is in New Zealand
solely in a registered containment facility. For more information on the
definition of 'new organism' see Interpretations & Explanations of
Key Concepts (protocol) [pdf
- 170 kb]. A genetically modified organism (GMO) is any organism in which the genes
or other genetic material have been modified by using in vitro (recombinant
DNA) techniques. New organisms are defined in the HSNO Act. Also, our Protocol document,
Explanation and Interpretation of Key Concepts, (protocol) [pdf
- 170 kb] has more information. If you are still uncertain the best
thing to do is phone us and have a talk about your proposal. It is up to the importer to work out if they have a 'new organism', as
defined by the HSNO Act. For plants, there is a list of species permitted
to be in New Zealand on the Plant
Biosecurity Index which is kept by the Ministry of Agriculture and
Forestry (MAF). There is no fully comphrehensive list of the species that
are lawfully present in New Zealand, importers would need to consult with
relevant organisations that hold this type of information (eg Crown Research
Institutes). ERMA New Zealand is happy to advise regarding relevant information
sources to determine what plants, animals and microorganisms are present
in New Zealand. For more information see How
to establish if an organism is "new". Conditional releases can apply to conventional new organisms (plants,
animals and micro-organisms) as well as to GMOs. Conditional release can
also cover a wide range of circumstances including a scientific trial
(which is much like a field test) at one end of the range, through to
a full commercial release at the other. An example of a conditional release would be the importation of camels
for trekking on the condition that only castrated males are imported and
released so that a self-sustaining population does not establish. Another
example would be the conditional release of a GM crop (for example resistant
to certain pests) in a particular location for the purpose of gathering
information rather than producing material for commercial sale. And of
course a conditional release might apply to the same GM crop being grown
for commercial purposes. Prior to the HSNO Act being amended (2003) it was not possible to obtain
a release approval that was able to set controls to manage risks. Instead
applicants could only choose between either fully contained approvals
(including field trials) or full (unconditional) releases with no controls.
Conditional release approvals are intended to fill the gap between containment
and full (unconditional) release approvals by allowing controls to be
imposed on releases. The key differences between the different application
types are set out in the table below: Applicants for a conditional release approval are expected to provide
comprehensive, high quality information on the environmental, cultural,
economic, social and other effects of the organism(s) involved. For example,
in cases where co-existence issues are important, the applicant will be
required to submit detailed information on the range of possible environmental
and economic effects, and the likely effectiveness of possible controls
in mitigating any potential adverse effects. The HSNO Act sets out provisions that could restrict the duration of
a conditional release approval. The Authority has adopted the following
approach to deciding on the duration for conditional release approvals: This policy is consistent with the concept that if controls are no longer
required then there is no reason for maintaining a conditional release
approval. In the case of a conditional release, the organism remains a
"new organism" when all controls have expired, and a new HSNO
approval would be needed for its continued use. All approvals to use new organisms within containment, or under conditional
release, are subject to "controls" (ie requirements covering
all aspects of the allowable use of the new organism). HSNO Act controls
on new organisms will be put into effect by Ministry of Agriculture and
Forestry (MAF) as the enforcement agency. As the Authority makes decisions on new organisms, these are listed on
the HSNO Organism Register . If people are not sure what species are approved
to be imported, they should contact MAF or ERMA New Zealand for advice.
There will be species which do not appear in any of the above lists, which
may not be a 'new organism'. To clarify the status of such organisms,
the Authority may formally declare whether or not a species is a 'new
organism'. The Authority will decide the status of the organism once you
have completed and send us in the Section
26 Determination Form. The Act has a full schedule of animals
and plants which are banned. These include: " Any snake of any species
" Any venomous reptile " Beavers, gerbils, prairie dogs, moles and cane
toads. It also prohibits a number of plants. The legislation affects a number of different sectors: importers of plants,
including nurserymen, commercial growers, researchers and gardeners; importers
of animals, including agricultural research groups, zoos, wildlife parks;
and scientists involved in genetic modification e.g. people working on
new and improved food crops, pine trees or sheep. In the past we have brought many new species into our environment without
realising the consequences e.g. possums which have become pests, or plants
which have become weeds. As well as damaging the ecosystem, we have had
to spend millions of dollars on pest and weed control. With HSNO, now
there is a process for evaluating new species before they come in. In
recent times, there have been rapid developments in genetic engineering
and we need a way of managing this too. The HSNO Act provides a public
process, to weigh up the positive and negative effects. It puts the emphasis
on assessing risks, to help decide if it is safe to bring something new
into New Zealand and if so, under what conditions. If there is scientific
uncertainty about the effects, the Authority has to consider the need
for caution. The Authority makes its decisions under the HSNO Act. It must also follow
detailed criteria set down in a formal Methodology developed in accordance
with the HSNO Act. It has to weigh up the risks, costs and benefits in
each case. Some decisions for low risk GMOs are delegated to Institutional
Biological Safety Committees (IBSC), in scientific institutions. The IBSCs
must also follow the Act and the Methodology. Applications to field test
or release a new organism are publicly notified, allowing for submissions.
The Authority may also notify some development applications. The Authority does not make decisions on GM Food as such. The import
or labelling of genetically modified food is covered by the Food Act and
Food Standards Australia New
Zealand (FSANZ, formely known as Australia New Zealand Food Authority,
ANZFA). However, the HSNO Act does cover the genetic modification of living
organisms that may later be consumed as food e.g. vegetables or dairy
cattle. For example, the Authority would cover the development or import
of a genetically modified tomato plant, but does not control the import
of cans of soup made from a GM tomato crop. Please contact ERMA New Zealand. We are able
to delegate authority to institutional biological safety committees that
meet the criteria to approve low risk genetic developments. These committees
will report to ERMA New Zealand on their decisions, progress and results
of approved experiments. The Ministry of Agriculture and Forestry
(MAF) is the primary agency undertaking new organism enforcement activities. Enforcement officers will visit premises from time to time to check that
controls on new organisms are being complied with. The frequency of inspections
should reflect the risks involved. Highrisk situations should be checked
often, while low risk situations may be visited on a less frequent basis.
The Act gives enforcement officers the power to enter premises to collect
information and evidence. An enforcement officer can also issue a compliance
order requiring a person: The penalties for breaching the HSNO Act are fines of up to $500,000
in the case of an individual; and, in the case of a body corporate, the
greater of $10 million, or three times the value of any commercial gain
from the contravention, or 10 per cent of the turnover of the body corporate
and all its interconnected bodies corporate, if the commercial gain canniot
be ascertained. In addition, a person could be found to have civil liability
for acts or omissions in breach of the Act. An enforcement officer can declare an emergency under the HSNO Act in
specified circumstances of actual or imminent danger. If such an emergency
is declared, the enforcement officer has wide powers to deal with it.
MAF has contingency plans in place to respond to new organism emergencies. Absolute separation of GM and non-GM crops is difficult to achieve, especially
for pollen producing plants. The key issue is generally the separation
required between crops in order to reduce risks to an acceptable level
e.g. the risk of cross pollination. The degree of separation required
depends on the type of crop and genetic modifications introduced, the
nature of surrounding horticultural and agricultural activities, and the
level of cross mixing that is acceptable. Cross mixing may also be an
issue in the processing of harvested crops. A gene is made up of DNA (Deoxyribose Nucleic Acid) that by itself or
in concert with others, determines the characteristics of living organisms.
Genes are found in all plant, animal or micro organism cells. For this
reason the soil is already filled with DNA. It is very unlikely GM genes or any other genes from transgenic or nontransgenic
plants or animals will transfer their special characteristics to other
organisms in the soil or air. Most stray DNA i.e. other than in a living
organism is degraded in soil during the natural processes of decay. An issue often raised is the possibility that genes in plant DNA could
be acquired and expressed by environmental microbes. This acquisition
of genes occurs through a process called Horizontal Gene Transfer (HGT). From the published bacterial genome sequences currently available there
is no evidence to suggest that genes from plants have been successfully
acquired and expressed by environmental microbes during bacterial evolution.
This suggests that the chance of horizontal gene transfer occurring and
resulting in the permanent acquisition of material is extremely low. However,
most transgenes (foreign genes inserted into a host organism) currently
used in crop modification are of bacterial origin. These transgenes may
thus have a higher probability of transfer to soil bacteria than regular
plant DNA. Currently, no such transfer has been observed under field conditions.
Transfer has been demonstrated though, under laboratory conditions. Even if transfer does occur the key issue is whether this could lead
to harmful effects. This question is always considered when ERMA New Zealand
considers GMO field trial or release applications. There are strict new provisions in the law that impose strict civil liability
rules for harm caused by non-complying activities and also a civil penalty
regime for breaches. The combined effect of these changes is to create
greater incentives for those who are approved users of GM organisms to
fully comply with all required controls and regulations and to provide
better remedies if harm occurs. The Government has taken the view that there are no unique liability
issues raised by GM organisms (as compared to any other regulated activities).
The current law already provides that persons suffering any harm caused
by a GM activity or technology may be able to bring a claim to recover
their loss under grounds including negligence, nuisance and breach of
statutory duty. ERMA New Zealand is not responsible for the regulation of GM food. Labelling requirements and other information for genetically modified
food in New Zealand can be obtained from: New
Zealand Food Safety Authority or Food
Standards Australia New Zealand In order to be considered by the Authority, each individual application
to ERMA New Zealand needs to be supported by adequate and sound information.
There needs to be a good description of the organism and its possible
risks, costs and benefits. That means its effects on the physical environment
and on public health and safety, social and cultural impacts and economic
issues. The information needs to reflect the significance of the issues.
The more significant the possible effects, the more detailed the information
that will need to be supplied. Once an application is lodged, the staff at ERMA New Zealand then look
at whether the information supplied meets the statutory requirements and
is correct and sufficient to enable a good quality decision to be made.
There are a number of highly skilled scientists and staff from differing
fields of expertise who are employed by ERMA New Zealand to carry out
this process. Once all the information is collated and validated, an evaluation
and review (E & R) report is then produced by ERMA New Zealand staff
which is provided to the Authority to assist the decision making process.
Information gathered during the application analysis and decision making
stages comes from a wide range of sources, covering a wide range of issues;
scientific, technical, social, and cultural. ERMA New Zealand may also
seek additional or more specialised information from advisory committees
or expert reviewers, from within New Zealand or internationally. HSNO is effects based legislation. Any effects on Māori cultural and
spiritual values will be assessed and considered alongside all other effects,
e.g. environmental, human health, social and economic effects. The HSNO Act requires that decision makers take into account 'the relationship
of Māori and their culture and traditions with their ancestral lands,
water, sites, valued flora and fauna and other taonga' and the principles
of the Treaty of Waitangi. Therefore applications which involve issues
of significance to Māori must incorporate the results of consultation
with Māori either locally or nationally. However, the purpose of consultation
is to provide information, not give "approval". Decision making
is very firmly vested in the Authority or persons/bodies to whom decision
making power has been delegated. Ngā Kaihautū Tikanga Taiao is the Māori advisory committee to the Authority,
consisting of up to eight members who are appointed by the Authority to
provide advice on matters relating to policy, process and applications
from a Māori perspective. Kaupapa Kura Taiao is the Māori Unit within
the Agency charged with providing the Authority with Māori advice on specific
applications and is also responsible for implementing the Māori participation
programmes. The Māori National Network is a network of key contacts within
the Māori community who are involved in environmental issues and who potentially
have an interest in HSNO. They also provide a valuable source of information
sharing and consultation on a wide range of broad issues relating to HSNO.
There is no such thing as zero risk - everything we do involves a certain
amount of risk. The purpose of risk based decision making is to identify
and assess those risks so that they can be either managed or prevented.
The Authority makes decisions based on weighing up the beneficial effects
(benefits) and adverse effects (risks and costs) that would result if
the substance or organisms were approved. In making this decision the
Authority takes into account any controls that may be placed on the organism/
substance and the likely effects of the subject of the application being
unavailable. If the Authority decides that the beneficial effects outweigh
the adverse effects it may approve the application (subject to controls
where relevant). Alternatively, if the Authority decides that the adverse
effects outweigh the beneficial effects, it will decline the application.
However there are limits to how far benefits can be used to balance up
risks. There are some levels of risk which are unacceptable no matter
what the level of benefit. For new organisms, the Act itself deals with
the issue of maximum acceptable biophysical risk through the "minimum"
standards in section 36 of the Act. These are very strong criteria. There
is no equivalent to s36 for hazardous substances, but the Authority is
always careful to look at the risks, as well as the benefit/risk balance. There is a whole area of practice and study called 'risk assessment'.
While different types of risk are assessed in different ways, the common
thread is that risks have characteristics which include the source of
risk, the risk, method or means of exposure, nature of the impact, the
magnitude of occurrence (how big is it) and a likelihood of occurrence
(how likely is it to happen). Under HSNO, applicants are asked to identify and assess the risks and
costs (adverse effects) as well as the benefits (beneficial effects) of
their new organism/ hazardous substance. Both adverse and beneficial effects
are assessed either using numbers (quantitative assessment) or descriptions
(qualitative assessment). Qualitative assessments are often necessary
because of the lack of numerical data. The Authority reviews the information available to them from the applicant,
submitters, and external experts (where relevant) and makes its own assessment
based on all this information. For further information see the Technical Guides series. The principal
technical guide is: Other guides available are: The Authority is very aware of the importance of the quality of the information
available to decision making. All information provided by applicants,
submitters and any external experts is reviewed to make sure that it is
correct and that it meets the purpose for which it is required. Information
may be imperfect because it can't be verified, because it is limited in
scope, or because it isn't the type of information that is relevant to
making the decision. Some information will be imperfect because it is
incomplete or uncertain. Where information is considered to be imperfect
and where it is considered that more or better quality information is
needed for the Authority to make a sound decision, the applicant, a submitter,
or an external expert may be asked to provide additional information.
The amount and type of information required will depend how important
it is to making a sound decision, and on how available the information.
If the information is crucial but is difficult to obtain, then a "decline"
may be the best response. Section 7 of the Act requires the Authority to take into account he need
for caution or to be cautious where there is scientific and technical
uncertainty. Caution or being cautious implies taking special care. Where
there is a significant amount of uncertainty the Authority will describe
it in terms of what aspects are uncertain, how this arises, the type of
uncertainty and what might be impacted, and whether further information
would help to reduce it. In all cases the Authority will scope the uncertainty
and seek to put bounds on it to see how much the uncertainty will affect
the decision. ERMA New Zealand strives to be transparent as is practicable and appropriate
in its processes. In general, applications for substances or organisms
that can significantly affect the environment must be publicly notified,
and anybody can then make a written submission - within 30 working days
of public notification - and a hearing will be held if any submitter requests
to be heard, or if the Authority thinks it is necessary. Applications are publicly notified by being posted on the ERMA New Zealand
website and advertisements are placed in the four major daily newspapers.
Specific notification is made to people who have indicated an interest
in a particular type of application. The full application may be viewed
at the ERMA New Zealand office in Wellington or on the website, however,
some information supplied with applications may be confidential. Commercially
sensitive information supplied by applicants will not be released to submitters,
but sufficient information will always be available to enable those interested
to understand the nature of the organism/substance and its risks and benefits.
Decisions are recorded in Bulletin and on the website. A cornerstone of the HSNO Act is the public's right to be heard in regard
to notified applications. Hearings allow New Zealanders to have their
say on a particular application and to talk directly to the Authority.
However, information presented by submitters at hearings must be relevant
to the application. It is the content of a submission that is important,
rather than the number of submissions lodged and the Authority is required
to consider submissions when making decisions on notified applications. All applications, E&R reports and decisions are available in full
in our Registers on the website Monitoring of GMOs is not required under the HSNO Act after a FULL release
as the Authority is unable to place controls on a full release. However,
monitoring requirements may be applied to CONDITIONAL release approvals.
Hence, any "user" of an approval may be required to monitor
for evidence of specific events occurring. Such requirements will be considered and set if felt to be appropriate
at the decision-making stage for each conditional release approval. However
no conditional release applications have been received yet. The Ministry
of Agriculture and Forestry (MAF) is the enforcement agency responsible
for ensuring conditions are adhered to by users of approvals. If you have any further questions contact: info@ermanz.govt.nz.
A full listing of how you can contact ERMA New Zealand is in the Contact
us section.What are 'new organisms'?
What is a genetically modified organism (GMO)?
How do I know if I need approval from ERMA New Zealand for a 'new
organism'?
How do I know if the plant or animal I want to bring in is a 'new
organism'.
What is a conditional release?
How does a conditional release differ from a field test or
full (unconditional) release?
Containment (including field tests)
Conditional Release
Full (Unconditional) Release
What will the duration be of conditional release approvals?
Who is going to check what happens after a new organism is approved?
How do I determine an organism is NOT new?
Are there any new organisms that the HSNO Act prohibits altogether?
Who might be introducing new organisms to New Zealand and be affected
by HSNO?
Why is the HSNO Act needed to control new organisms?
How will the Authority make its decisions on new organisms?
What about genetically modified food?
If my organisation is involved in GMO development how do we go about
setting up and getting approval for our own biological safety committee?
Who will carry out enforcement for new organisms?
What do enforcement officers do?
What are the penalties for serious offences (non-compliance) under
the HSNO Act?
What about emergencies?
Is it really possible to keep GM crops separate from non-GM crops?
Will GM genes spread through the soil/air?
If something goes wrong who is liable?
Will it be possible to maintain the choice for GM free food?
How will ERMA New Zealand verify the information provided with applications?
How will ERMA New Zealand consider effects on Māori cultural and
spiritual values?
Are any risk levels acceptable?
How will risk be assessed?
How cautious is the Authority in the light of imperfect information?
How transparent will ERMA New Zealand be in its processes?
How will the monitoring take place following a GMO release?
