Conditional release – how it would work
The new category of conditional release being proposed by the government would allow the Environmental Risk Management
Authority (ERMA) to impose conditions on the release of new organisms, including genetically modified organisms.
At the moment the HSNO Act authorises ERMA only to approve the full containment of new organisms, or full release of new
organisms without any conditions. The Royal Commission on Genetic Modification recommended that the HSNO Act be amended
to provide for a new category of approval called "conditional release", acknowledging that there was a gap in the law as
it currently stands.
It likened the new category of conditional release to clinical trials that have been part of medical research for
decades because it provides the opportunity to gather information about a new organism in a controlled way before
approving it for full release.
Creating a new category of conditional release would allow applications to ERMA for either the conditional release of a
new organism, in which the applicant will propose conditions, or for applications for the general release of a new
organism (release without conditions). When assessing an application for conditional release, ERMA will have the ability
to impose stricter conditions than those proposed in the application. Similarly, when an application is made for general
release, ERMA will have the ability to impose conditions and approve the application as a conditional release rather
than a general release.
Some examples of conditions ERMA could impose under the conditional release category include that only one sex of an
organism be released, a limit on the number of organisms released, or the auditing of the environmental or health
impacts of the new organism. However, this is not a complete list. The government is proposing that ERMA's ability to
impose conditions be broad, but that some matters ERMA may consider when imposing conditions will be listed in the HSNO
Act to provide guidance to both ERMA and those submitting applications to ERMA.
Under the government's proposal for conditional release, ERMA will approve an organism for conditional release using
essentially the same procedures for decision-making as are already available in the Act, including the comprehensive
public process. Once an organism is released with conditions, it will remain a “new organism” and continue to be subject
to the HSNO Act. This means that the existing machinery for checking compliance with conditions (currently set for new
organisms in containment) and taking enforcement action can be used when needed, and the ability to reassess the
organism is available.
While the Government is proposing that conditional release be an intermediate category between fully contained
conditions and release without conditions, it will not be a compulsory stage between containment and release without
conditions. In other words, there will be no particular sequence for approvals under the Act. But an organism cannot
“swap” categories of release without first being reassessed by ERMA. If a new organism is released with conditions, for
example, it will have to undergo a full reassessment by ERMA before it can be released without conditions.
Before considering an organism for conditional release, ERMA must consider whether the new organism could be recovered
or eradicated if desired, and must take into account conditions and their likely effectiveness when determining whether
the minimum standards currently set out in the Act are met. These minimum standards include the likelihood of the
organism significantly affecting natural habitats or displacing native species within them, significantly altering New
Zealand’s genetic diversity, or causing disease or becoming a vector for human, animal or plant diseases. If the minimum
standards are not met, ERMA cannot approve the conditional release of the new organism.
Examples of uses and controls Conditional release could be applied in a wide range of circumstances and the associated
conditions could also vary widely.
An applicant might want to grow GM carrots that when processed into possum bait produce infertility in possums. ERMA
could impose controls restricting the location and size of the crop, and order that the carrots must not be allowed to
flower so that there was no chance of the GM carrot pollen being carried to a non-GM carrot crop. This would allow
applicants to grow the GM carrots to help reduce the possum population, while ensuring that they did not enter the human
food supply.
It could also be used to better understand the action of biological control agents. Laboratory research can test many
features of an insect, for example, that could be used to contain a pest plant or animals in New Zealand. However,
conditional release would allow monitoring of the organism for effectiveness.
Conditions that could be applied include: that only one sex of an organism be released (to prevent breeding) a limit on
the number of released organisms a limit on where the organism can be released restricting how the organism is grown,
raised or used (for example, making sure a plant does not flower) granting approval to a single user only, or only to
users with particular knowledge, management systems, etc. limiting the purposes for which the organism might be used
ensuring suitable disposal of a new organism at the end of research.
Enforcement To work, conditional release needs to have a system of enforcement to ensure the controls imposed by ERMA
when it grants approval are being carried out. That role would be undertaken by the Ministry of Agriculture and Forestry
(MAF) under the direction of the Minister of Biosecurity. The Ministry already has an inspection and enforcement role.
MAF Biosecurity is responsible for protecting New Zealand from unwanted pests and harmful organisms under the
Biosecurity Act and for managing risks to plant and animal health and animal welfare. MAF inspectors also at present
inspect laboratories doing GM work to ensure they are secure and have the proper approvals. MAF’s other duties include
guaranteeing the quality and hygiene standards of our exports and ensuring animals are treated humanely. The Ministry
would receive extra funding to cover its new responsibilities under an amended HSNO Act.