SSBA Newsletter Issue 20 - October 2012

Security Sensitive Biological Agents Regulatory Scheme Newsletter

Page last updated: 23 November 2012

PDF printable version of SSBA Newsletter Issue 20 - October 2012 (PDF 149 KB)

Handling and Reporting Suspected SSBAs
Regular Report
Identity Checks
Non-registered Facility Requirements
Did You Know

Handling and Reporting Suspected SSBAs

The requirements for handling biological agents suspected of being SSBAs are set out in Parts 9 and 9A of the SSBA Standards. Reporting requirements for suspected SSBAs are set out below.
  • If you destroyed the SSBA before in-house or external confirmatory testing you must report this to DoHA within two business days.
  • If you undertook in-house confirmatory testing of the suspected SSBA, you must report the results of the confirmatory testing to DoHA within two business days after receiving the result.
  • If you arranged for another facility to undertake confirmatory testing of the suspected SSBA, you must report the transfer of the suspected SSBA to DoHA within two business days and then report the confirmatory test result within two business days of receiving the result. If the transfer and the results of confirmatory testing both occur within two business days, you can submit one report.

If you are reporting the results of confirmatory testing of a suspected SSBA that was undertaken by another facility you should use the Non-Registered Facility Report and select Results of Confirmatory Testing (from an external laboratory only). The Confirmed SSBA option should only be selected if it arrived in your facility as a known SSBA (already confirmed by laboratory testing).

Regular Report Reminder

Facilities registered to handle Tier 1 SSBAs must submit their bi-annual report for the1 April 2012 to 30 September 2012 period to the Department of Health and Ageing (DoHA) by 31 October 2012.
Bi-annual reports are mandatory for these facilities. If the entity or facility details have not changed during the reporting period, please submit a ‘nil’ report.
You may submit your report by using the web-based Data Collection System or the paper-based form available on the SSBA web site.

Identity Checks

Under clause 3.5 of the SSBA Standards an identity check must be conducted by a registered entity before authorising persons under clause 3.3 of the SSBA Standards. If a person is required to undergo an NHS check, this must be completed before submitting the NHS check to AusCheck. It should be noted that identity checks must be undertaken even if a person holds a National Security Clearance or has been a long-term employee of the entity.Top of Page
The identity check must include:
  • evidence of commencement of identity in Australia
  • linkage between identity and the person
  • evidence of operation in the community
  • evidence of residential address.

The entity must keep a record of what documents were provided to satisfy the criteria above, but it is not required to keep copies of the actual documents.
Further details about the requirements for identity checks can be found under Clause 3.5 of the SSBA Standards.

Non-Registered Facility Requirements

Non-registered facilities are only required to comply with Parts 9 and 9A of the SSBA Standards. Part 9 outlines the requirements for handling biological agents suspected of being an SSBA, while Part 9A deals with the requirements for handling an SSBA following a positive confirmatory testing result. The objective is to ensure that SSBAs (suspected or confirmed) are handled securely while at a non-registered facility. Parts 9 and 9A cover:
  • restricting access to SSBAs (suspected or confirmed) to persons who have a need to handle the agent
  • maintaining a record of who has accessed
  • SSBAs (suspected or confirmed) including their identity and the date and time of access
  • storing SSBAs (suspected or confirmed) securely e.g. in a locked freezer, cupboard or non-transportable container
  • destroying SSBAs (suspected or confirmed) so that no SSBA leaves the entity without being destroyed or inactivated (unless being transferred for disposal or confirmatory testing)
  • validating waste disposal procedures
  • maintaining records (12 months for Tier 1 SSBAs and 6 months for Tier 2 SSBAs).

Did you know…

If a facility is registered to handle an SSBA for research purposes, and the research details change, you must report this to DoHA. Changes could include the principal researchers, collaborators, funding sources, research objectives or goals, or committee oversight.
To submit changes to research details using the web-based Data Collection System select the Administrative Changes Tab, then select the Change of Purpose web form. Once in web form select the button for Would you Like to Add a New Purpose then in the text box below under the heading New Purpose for Handling enter update to research purpose. Enter the specific changes to the research using the section Handling an SSBA for Research Purposes.
Paper-based forms are also available on the SSBA website. All paper-based reports must be sent to DoHA by registered post or courier.
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