Security Sensitive Biological Agents (SSBA) Regulatory Scheme

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 background of the scheme.

List of SSBAs

We regulate the handling of agents on the list of SSBAs. The Minister for Health and Ageing determines which biological agents are of security concern to Australia and on this list.

The list is divided into 2 tiers:

• Tier 1 biological agents (those of the highest security concern)
• Tier 2 biological agents (those of a high security concern).

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.

For more information, see

• the latest version of the standards
• the legislative framework
• other Australian laws that relate to biological agents
• international conventions and agreements.

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
• 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 Ageing can suspend some, or all, of the regulations for handling SSBAs. 

The minister does this to protect the Australian community, economy or environment.

Read more 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 Regulatory Scheme.

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

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

Our online training facility helps stakeholders understand the requirements of the scheme and meet training obligations. It:  

• 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

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.

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:

• National Health Security Act 2007
• National Health Security Regulations 2018
• 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.

For help complying with the SSBA Standards, you can use the:

• Internal review tool
• Security Risk Assessment and Risk Management Plan.

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:

• information security
• National Health Security checks
• providing access to other regulatory schemes.

Resources

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