SSBA Newsletter Issue 29 - October 2019

Security Sensitive Biological Agents Regulatory Scheme Newsletter.

Page last updated: 11 November 2019

PDF printable version of SSBA Newslette Issue 29- October 2019 (PDF 981 KB)



Non-registered Entities Handling African Swine Fever Virus - a Tier 2 SSBA

In light of the changing distribution of African swine fever virus (ASFV) in the region, laboratories that would not usually screen for or handle ASFV may be required to test specimen samples that could contain the disease.

ASFV is a Tier 2 security sensitive biological agent (SSBA). Entities not registered to handle ASFV under the SSBA Regulatory Scheme must report the receipt, handling and destruction of any suspected or confirmed ASFV samples to the Department of Health (Health) under the National Health Security Act 2007 (the Act), the National Health Security Regulations 2018 (NHS Regulations) and the SSBA Standards. In particular, the Act establishes the Scheme and outlines the requirements for handling SSBAs. It also provides for inspectors to be appointed by Health to exercise monitoring powers on premises handling suspected or confirmed SSBAs.

If, on the basis of your facility’s usual testing procedures, you form a reasonable suspicion that you are handling ASFV, you must arrange for confirmatory testing or destroy the suspected ASFV specimen as soon as possible and within two business days after forming your suspicion. Reasonable suspicion does not apply just because an SSBA is not yet ruled out but rather that, on the balance of probabilities assessed by your laboratory, the agent is likely to be an SSBA.

If you are unable to perform confirmatory testing in-house, you must also report any transfer of the suspected SSBA to another facility for confirmatory testing. Once the results of confirmatory testing are received, you must also report the outcome. The appropriate reporting form is available online. Reports must be submitted to Health as soon as possible and within two business days after you form the suspicion, on the basis of your usual laboratory testing, that you are handling a suspected SSBA.

The first time your facility submits a report, it must be sent to the department via registered post. Subsequent reports may be sent electronically following establishment of an online account for reporting. Non-registered entities that are handling suspected or confirmed ASFV must also comply with Parts 9, 9A and/or 10 of the SSBA Standards, as applicable.

A guideline that further describes the requirements for handling a person or animal, or samples from a person or animal, affected by an SSBA can be found here.

AusCheck System Update

The AusCheck System is used by SSBA registered entities to conduct National Health Security (NHS) checks for the purposes of the SSBA Regulatory Scheme. The latest AusCheck system release was successfully deployed on 5 September 2019. This introduced minor backend improvements to the AusCheck system and remediated some minor bugs affecting the system. Further system upgrades are confirmed for late October and late November/early December. Ongoing support is available via email and through the AusCheck enquiries line at 1300 097 974, fax 02 6275 6999 or email AusCheck@homeaffairs.gov.au.

SSBA Scheme Awareness

Stakeholders are encouraged to circulate this newsletter to other interested groups or parties where appropriate. Stakeholders are also encouraged to regularly access the SSBA Regulatory Scheme website, which is routinely updated with new information.

SSBA Data Collection System (DCS)

The SSBA DCS enables registered and non-registered facilities to submit information about their SSBA holdings to the Department of Health, which is then recorded on the National Register of SSBAs (NRSSBA).

Health assesses the information submitted, and if correct, approves it for inclusion on the NRSSBA. Facilities are notified in writing when reports are accepted.

The first time an entity is required to report to Health must be done via registered post. The SSBA Regulatory Scheme team will then establish an online account through which subsequent reports can be submitted.

Please contact the SSBA Regulatory Scheme if you require assistance with access.

The DCS can be accessed here.

Spot Checks

All facilities handling SSBAs or biological agents suspected of being SSBAs are subject to inspections under the SSBA Regulatory Scheme. The main aim of inspections is to monitor an entity’s compliance with the NHS Act, NHS Regulations and the SSBA Standards. Inspections also provide opportunities to increase compliance through communication, education, and the provision of advice.

Spot checks are a subset of routine monitoring and can be conducted at any time on registered and non-registered facilities. A spot check may be conducted as part of a follow-up review or it may be conducted in response to information received by the SSBA Regulatory Scheme about potential SSBA handlings.

Spot checks commence with liaison with the Responsible Officer, Deputy Responsible Officer or Contact Officer. At least 24 hours notice will be provided to assist with provision of any arrangements associated with inspectors being on site.

Spot checks usually involve the following activities:

A physical inspection of the facility, a review of relevant records and discussions with relevant staff;

A follow-up letter is provided to the facility outlining the outcome of the inspection including any Corrective Action Requests;

Occasionally a follow up inspection may be required.

More information about spot checks can be found in Guideline 10—’SSBA Monitoring Inspections’.

SSBA Mailing List

Please remember to notify the SSBA Regulatory Scheme if your contact details change.

The SSBA Regulatory Scheme uses a mailing list to send out the SSBA newsletter and other information about the scheme.

If you need to update your contact details, or know of others that would like to be added to the SSBA mailing list, please email the details to ssba@health.gov.au

Feedback

If you would like to provide feedback or discuss any aspect of the SSBA Regulatory Scheme, please contact us at ssba@health.gov.au

Check out our website at: www.health.gov.au/SSBA