Security Sensitive Biological Agents (SSBA) Regulatory Scheme

The deliberate release of harmful biological agents (viruses, bacteria, fungi and toxins) can cause significant damage to human health, the environment and the Australian economy. This scheme helps us manage the security of SSBAs and aims to limit the occurrence of acts of bioterrorism or biocrime.

About the program

The deliberate release of harmful biological agents can cause significant harm to human health, the environment and our economy.

The Security Sensitive Biological Agents (SSBA) Regulatory Scheme aims to:

  • designate SSBAs that are of security concern to Australia
  • limit opportunities for acts of bioterrorism or biocrime to occur using SSBAs
  • maintain access to SSBAs for those with a legitimate need to handle SSBAs within secure laboratories
  • provide a legislative framework to regulate the handling of SSBAs.

Legitimate biological research involving SSBAs can have a range of therapeutic benefits, but might also have the potential to be misused to threaten public health or national security. The scientific community refers to this as ‘dual-use’ biological research.  

Learn about the:

Latest news

See previous issues of our newsletter on the National Library of Australia's webarchive.

Legal requirements

Part 3 of the National Health Security Act 2007 (NHS Act) establishes the SSBA Regulatory Scheme.

The National Health Security Regulations 2018 (NHS Regulations) give detail about operations and requirements of the scheme.

The SSBA Standards outline how confirmed and suspected SSBAs and sensitive information associated with SSBAs, must be securely:

  • handled
  • stored
  • disposed of
  • transported.

Read the latest version of the standards.

Learn more about:

Who the scheme covers

The scheme applies to entities and facilities that handle suspected or known SSBAs in Australia.

Entities that handle Security Sensitive Biological Agents (SSBAs) include:

  • individuals
  • body corporates
  • government agencies.

Some entities are exempt from the scheme.

Facilities include:

  • buildings, or parts of buildings
  • laboratories, including mobile laboratories.

Learn more about entities and facilities and the measures you may need to put in place to comply with the scheme in our guideline.

In an emergency

In an emergency disease situation, it is critical that we take action without delay. In these rare cases, the Minister for Health and Aged Care can suspend some, or all, of the regulations for handling SSBAs. The minister does this in order to protect the Australian community, economy or environment.

Read our fact sheet for more information about the emergency disease situation provisions.

Reporting and registering

If you plan to handle SSBAs on an ongoing basis you must register as an entity with the SSBA Scheme.

You must submit an initial registration report to us within 2 business days of starting to handle an SSBA. You must submit this as a hard copy, by registered post or courier.

Our forms collection contains paper-based forms that detail all reportable events to do with handling SSBAs. Where possible, we recommend that you submit all reports – except for the initial registration form, through our online Data Collection System.

Read our guideline on reporting requirements.

Roles and responsibilities

Learn about the responsibilities of top management and SSBA management committees.

Online training facility

We have developed an online training facility (OTF) to help stakeholders understand the requirements of the scheme and to meet training obligations. The OTF:  

  • consists of several modules covering the SSBA Standards and relevant legislation
  • does not have to be completed in a single sitting, you can save your progress
  • includes quizzes at the end of most modules to check understanding.

Login to the training facility

Please contact us if you have any difficulties establishing your new user account or logging on to the system.

Training template

To help you meet entity and facility specific staff training requirements under the SSBA Standards, we have developed a PowerPoint training template.

You can adjust it as needed to suit your audience (for example, laboratory staff, IT staff). The use of the template is not mandatory. You may use other training packages if you prefer.

Please contact us to request a copy of the template.

Inspections and compliance

Entities and facilities that handle security sensitive biological agents (SSBAs) must comply with the regulatory scheme. This means meeting the requirements under the:

  • NHS Act

  • NHS Regulations
  • SSBA Standards.

We monitor this compliance through:

  • the registration process
  • regular reporting
  • routine monitoring inspections and if required, audits.

Find out what to expect when scheduled for a monitoring inspection.

Entities may use the following templates to help them comply with the SSBA Standards:

Access to SSBA facilities and information

Entities and facilities must have policies and procedures for authorising or approving people who need to:

  • handle SSBAs
  • access an SSBA facility
  • access sensitive information relating to SSBAs.

Learn more about:

List of SSBAs

The Minister for Health and Aged Care determines which biological agents are of security concern to Australia.

We regularly review the list to make sure it’s up to date.

Resources

SSBA Standards

The Security Sensitive Biological Agent (SSBA) Standards outline the handling, storage, disposal and transport requirements of confirmed and suspected SSBAs under the National Health Security Regulations 2018. Entities that handle suspected or known SSBAs must comply with these standards.

View the standards

SSBA – Reporting forms

Use these forms to report events related to handling security sensitive biological agents (SSBAs).

View the forms collection

SSBA – Fact sheets

This collection includes fact sheets about the Security Sensitive Biological Agents (SSBA) Regulatory Scheme.

View the fact sheets collection

SSBA – Guidelines

These guidelines support the Security Sensitive Biological Agents (SSBA) Regulatory Scheme.

View the guidelines collection

Contact

Contact us for more information about the Security Sensitive Biological Agent (SSBA) Regulatory Scheme.
Street addresses:

Laboratories and Health Security Section, Department of Health and Aged Care
Level 3, Scarborough House, Atlantic Street
Woden ACT 2606
Australie

Postal addresses:

Laboratories and Health Security Section, Department of Health and Aged Care
GPO Box 9848, MDP 140
Canberra ACT 2601
Australie

Date last updated:

Help us improve health.gov.au

If you would like a response please use the enquiries form instead.