. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/AUS/306 
8 October 2012  
 (12-5436) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  AUSTRALIA 
If applicable, name of local government involved:    
2. Agency responsible:  Australian Government Department  of Agriculture, Fisheries and 
Forestry 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Veterinary vaccines, other veterinary therapeutics and in vivo  veterinary 
products 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Guidelines for managing the risk of transmitting 
transmissible spongiform encephalopathies (TSEs) via veterinary vaccines and other  in vivo  
veterinary products  Language(s):  English  Number of pages:  46 
http://www.daff.gov.au/ba  
6. Description of content:  The Australian Government Department of Agriculture, Fisheries 
and Forestry (DAFF) has updated its 2005 revi ew of Australia's biosecurity requirements 
for veterinary vaccines, other veterinary ther apeutics and in vivo veterinary products in 
relation to transmissible spongiform encephalopathies (TSEs).  
The Guidelines detail the management of TSE ri sks associated with various raw materials 
used in veterinary therapeutic and vaccin e production.  These guidelines are based on a 
matrix of factors such as tissue or country TSE risk categories, susceptibility of the species 
of origin and of the target species, manufacturing method and degree of processing, and method of administration of the veterinary v accine/therapeutic.  Other factors such as age 
of the source animal, slaughter method, testing, TSE agent dilution and history of safe use 
may also be considered where appropriate. 
A draft policy review was issued on 10 November 2011 for a 60-day consultation period, 
which closed on 9 January 2012 (Biosecurity Australia Advice 2011/21).  DAFF considered the stakeholder comments re ceived in finalising the Guidelines. 
Adjustments to the guidelines may be necessary from time to time as scientific knowledge 
continues to grow, international standards e volve and the number of countries reporting 
changes to their TSE status. G/SPS/N/AUS/306 
Page 2  
 
  7. Objective and rationale:  [ ] food safety, [X] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from other 
damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[X] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)  OIE Terrestrial Animal Health Code 2011 
Chapter 11.5 Bovine spongiform encephalopathy and Chapter 14.9 Scrapie;  and 
the Manual of Diagnostic Tests and Va ccines for Terrestrial Animals 2011: 
Chapter 1.1.8 Principles of veterinary vaccine production.  
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [X] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:  The requirements for the use of bone derived gelatine and 
collagen are better aligned with the OIE Terrest rial Animal Health Code and the European 
Medicines Agency, which require specified  treatments for bone derived gelatin from 
controlled BSE risk countries, in addition to the removal of specified risk materials. 
9. Other relevant documents and language (s) in which these are available:  Nil   
10. Proposed date of adoption (dd/mm/yy) :  3 October 2012 
Proposed date of publication (dd/mm/yy) :  3 October 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  3 October 2012 
[X] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Not applicable 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:    
13. Texts available from:  [X] National Notification Authority, [X] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body:   Texts are 
available at the following web address, or  alternatively, from the Australian SPS 
Notification Point:  http://www.daff.gov.au/ba  
The Australian SPS Notification Point 
GPO Box 858 Canberra  ACT  2601 Australia 
Fax:  +(61 2) 6272 3678 
E-mail:  sps.contact@daff.gov.au