Teeth and The Biosecurity Framework
4th Apr 16
The dental industry is currently reviewing the draft of the 2016 Biosecurity (Prohibited and Conditionally Non-prohibited Goods) Determination that prohibits the import of some goods and / or places restrictions on their importation. The list of goods affected includes human teeth and bones thus the reform is of some interest to the dental industry.
Key Issues For The Dental Industry —
The purpose of the draft Biosecurity (Prohibited and Conditionally Non-prohibited Goods) Determination 2016 is to provide a list of the goods or class of goods that are prohibited goods or conditionally non-prohibited goods for the purpose of the Biosecurity Act (Cth) 2015.
A preliminary review has identified two areas where the draft Determination may impact the businesses that manufacture and supply dental products.
Human blood, human tissue and similar goods —
Specific provisions apply to the following classes of goods: Human blood or blood components; Human enzymes; Human secretions, excretions or exudates; Human semen, embryos or ova; Human tissue extracts; and Human tissue.
The exposure draft states that these goods must not be brought or imported into Australian territory unless the goods are: Covered by an import permit; or the goods are are for human therapeutic use and are not antibodies or cell lines.
Teeth and bones from a human body —
Specific provisions apply to the following classes of goods: Teeth from a human’s body (other than as part of human remains); and Bones from a human’s body (other than as part of human remains).
The exposure draft states that these goods must not be brought or imported into Australian territory unless the goods are: Covered by an import permit; or The goods are clean and have no adhering tissue, blood or faeces.
The draft determination is currently being reviewed by the ADIA-DRC Dental Regulation Committee and to ensure that the views of the dental industry are reflected in ADIA's advice to the Australian Government member businesses have been invited to tender their advice concerning the draft. Further information is availabe via the link below:
As the draft Biosecurity (Prohibited and Conditionally Non-prohibited Goods) Determination 2016 replaces the Quarantine Proclamation 1998 there has been little changes as the same import conditions as currently provided in the Quarantine Proclamation have been transposed into the Goods Determination for most goods.
A major change is in the administrative processes behind issuing a Goods Determination. Unlike for the Quarantine Proclamation, which was made by the Governor‑General, the Goods Determination will be made jointly by the Director of Biosecurity and the Director of Human Biosecurity, both officers of the Department of Agriculture and Water. As a result, future amendments to this instrument will follow a far more streamlined process than under the Quarantine Act (Cth) 1908.
ADIA member businesses with an interest in this matter are encouraged to review the consultation page referenced above.
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. On matters associated with tax policy, ADIA staff that negotiate with the Australian Government at a parliamentary and departmental level receive advice and guidance from members that who serve on the ADIA-DRC Dental Regulation Committee.
Currency of Information —
This update was issued on 5 April and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations.
The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
29th Jan 18
A new edition of the Australian Dental Industry Intelligence Report has been commissioned by ADIA, research that will provide the industry with the most authoritative assessment of the Australian dental products market.
3rd May 18
Proposals from the Australian Government to impose new cost imposts on suppliers of low-risk medical devices will eliminate the entire benefit of its tax cuts for many small businesses in Australia’s dental industry.