> Classes of Dealings
What are Dealings involving an Intentional Release (DIR) of a GMO into the environment?
Dealings involving an Intentional Release (DIR) of GMOs into the Australian environment are dealings with GMOs outside contained facilities.
These can range from small scale field trials (limited and controlled releases) of GMOs to general/commercial release of GMOs.
DIRs are included on the GMO Record
List of applications and licences for Dealings involving Intentional Release (DIR) of GMOs into the environment
List of intentional release licence applications under consideration.
Evaluation process and flow chart for intentional release licence applications
Each DIR licence application is subject to a comprehensive, science-based, case-by-case analysis process. Sections 48 - 67 of the Gene Technology Act 2000
(the Act) set up a clear process that the Gene Technology Regulator (the Regulator) must follow in preparing a risk assessment and risk management plan (RARMP) and in making a decision about whether or not to issue a licence.
The default decision timeframe for the Regulator to decide on a DIR application is 255 working days. However, DIR applications may qualify for a streamlined process if they meet the criteria outlined on Section 50A of the Act for a 'limited and controlled release' application (including that the principle purpose is research). The Regulator will use the information provided in the DIR application (Forms and Guidelines
) to determine whether or not it is a limited and controlled release application on a case-by-case basis.
The Gene Technology Regulations 2001
specify the timeframes within which the Regulator must make a decision to either issue, or refuse to issue, a licence for the dealings proposed in a DIR application. These timeframes are:
- 255 working days for all DIR applications except for limited and controlled release applications
- 150 days for a limited and controlled DIR applications for which the Regulator has not identified a significant risk
- 170 days for a limited and controlled DIR applications for which the Regulator has identified a significant risk.
These periods do not include weekends or public holidays in the Australian Capital Territory. Also, these periods do not include any days in which the Regulator is formally seeking further information from the applicant in relation to the application.
In accordance with the Act, a RARMP prepared for each DIR application focuses on identifying risks to human health and safety and to the environment posed by the dealings with GMOs proposed in the application.
It also addresses risk management measures (to be covered by licence conditions) to manage any identified risks.
As part of the DIR application evaluation process, the Regulator consults with:
- the public;
- all State and Territory Governments;
- relevant local council(s);
- Australian Government Departments and agencies including: the Department of Agriculture, Fisheries and Forestry; (DAFF); DAFF Biosecurity (formerly the Australian Quarantine and Inspection Service); Food Standards Australia New Zealand; the Australian Pesticides and Veterinary Medicines Authority; the Therapeutic Goods Administration; the National Industrial Chemical Notification and Assessment Scheme and the Department of Foreign Affairs and Trade
- the Commonwealth Minister for the Environment; and
- the Gene Technology Technical Advisory Committee.
The process of consultation on the RARMPs for DIR licence applications provides an opportunity for stakeholders, including the public, to have direct input into the decision making process.
Summary of the evaluation process for DIR licence applications flow chart (HTML)
Summary of the evaluation process for DIR licence applications flow chart (PDF 176 KB)
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