Conditional release – how it would work
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