This content is current only at the time of printing. This document was printed on 14 September 2020. A current copy is located at http://www.xlg888.com/node/899
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Special data (Part 10) - Products of gene technology
Some active constituents and agvet chemical products that the APVMA regulates are produced using gene technology. These constituents and products are derived or produced from a genetically modified organism (GMO). Such products are referred to as GM products.
The Gene Technology Act 2000 applies to GMOs and GM products and operates in conjunction with other Commonwealth and state regulatory schemes relevant to these materials. If a GM product is used for a purpose that fits the definition of an agricultural chemical product or a veterinary chemical product, it is within our jurisdiction, in addition to being under the Gene Technology Act.
The Agricultural and Veterinary Chemicals (Administration) Act 1992 requires us to consult with the Gene Technology Regulator when we decide whether to approve an active constituent, register an agvet chemical product, approve a label, vary or reconsider any approvals or registrations, or issue a permit for a GM product. We must ensure that any advice given by the Gene Technology Regulator is taken into account when we make a decision on the approval, registration or reconsideration of such products.
Therefore, if your application contains any active constituent or product derived from or produced by a GMO, you must inform the APVMA. This includes any organism that has been modified by gene technology and any organism that has inherited particular traits from an organism in which the traits in the parent organism were the result of genetic modification.
In lodging an application involving a GM product, you should include:
- information addressing the statutory criteria
- information clearly identifying any constituent that is a GMO or that has been produced by or from a GMO
- data detailing any hazards that are additional to the primary hazard or that alter that hazard
- any proposed risk-management strategies for these hazards, to allow us to apply risk-management strategies on a case-by-case basis.
If you are planning to seek approval for an active constituent for a GM product, register a GM product or seek a permit for a GM product, you should contact us for guidance on specific data for that application.