Biosecurity (Listed Human Diseases) Determination 2016

The instrument advances a small set of core legal concepts: (1) the concept of a statutory “listed human disease”; (2) the use of a legislative instrument to enumerate diseases; and (3) the deployment of categorical and descriptive labels, some of them broad, as the operative content of the list.

1. Listed human disease as a legal category. Section 4 states that “each of the following human diseases is a listed human disease” and then lists eight items (s 4). The Determination does not define what legal consequences flow from a disease being listed; rather it supplies the label that will be referenced by the Biosecurity Act 2015. The authority for the instrument is explicitly stated in s 3 as subsection 42(1) of the Biosecurity Act 2015.

2. Enumeration by name and category. The instrument uses a mixture of specific disease names and broader disease categories. The specific names include Middle East respiratory syndrome, plague, severe acute respiratory syndrome (SARS), smallpox and yellow fever (s 4(a)-(g)). Broader categories include “human influenza with pandemic potential”, “viral haemorrhagic fevers”, and “human coronavirus with pandemic potential” (s 4(a), (f), (h)). That mix matters because specific names pick out discrete, historically recognised conditions, while categorical items require some assessment of whether a particular pathogen or outbreak falls within the category.

3. Functional qualifiers. Two items include the qualifier “with pandemic potential” (human influenza; human coronavirus). The Determination itself does not provide criteria for assessing “pandemic potential” or identify the decisionmaker who makes that assessment; the instrument therefore creates a list entry that is contingent on a further factual and legal determination outside the text of the Determination (s 4(a), (h)).

4. Compilation and amendment features. The compiled instrument includes endnotes that record registration, commencement and amendment history (endnotes 1-4). Those endnotes also show that s 4 was amended by the 2020 determination (endnote 4). The Legislation Act 2003 is mentioned in the endnotes as empowering editorial changes in compiled laws; the Determination itself is silent on editorial practice.

In short, the main concept is a statutory delegation of disease labelling to a legislative instrument, where the label will be relied upon by the Biosecurity Act 2015 to trigger powers and duties located in that Act rather than inside this Determination.

The Determination as a standalone instrument directly affects the legal characterisation of the diseases listed in s 4 by declaring them to be “listed human diseases” within the meaning used by the Biosecurity Act 2015 (s 4; s 3). Because the Determination does not itself set out enforcement mechanisms, obligations, or rights, its immediate effect is classificatory rather than prescriptive. The practical consequences therefore arise through the interaction between this classification and the provisions of the Biosecurity Act that reference listed human diseases.

Who will therefore be affected in practice depends on who is subject to measures under the Biosecurity Act when the Act is applied to a listed human disease. The Determination itself does not name persons, agencies, industries or classes of travellers or businesses that will be regulated. However, the following points about affected parties flow directly from the instrument’s form and from its relationship to the Biosecurity Act as stated in s 3:

• Regulated persons under the Act. Any person, importer, carrier, healthcare provider, employer, or state or territory authority that is subject to a power, duty or regulatory requirement in the Biosecurity Act that is triggered by a “listed human disease” will be affected when one of the diseases named in s 4 is the subject of an application of the Act. The Determination supplies the list that causes the Act’s disease‑specific powers to become relevant.

• Public health and clinical services. Public health agencies and clinical services will be implicated to the extent the Act authorises or requires disease control measures for listed human diseases. The Determination designates diseases that those agencies may be required to respond to under the Act.

• International travellers and carriers. Naming diseases such as yellow fever or smallpox as listed diseases signals that border measures, if and when imposed under the Biosecurity Act, could be applied to persons arriving from or transiting through areas where those diseases are present. The Determination itself does not impose quarantine or movement restrictions, but it identifies diseases that could be subject to such measures under the Act.

• Institutions and employers. Entities with obligations under the Biosecurity Act when listed diseases are present will have to adapt if the Act’s powers are used. The Determination’s naming of broad categories such as “viral haemorrhagic fevers” or coronaviruses with pandemic potential means those institutional responsibilities could arise for a range of pathogens that fall within those categories.

• Regulators and decisionmakers. Administrative decisionmakers applying the Biosecurity Act will use this Determination as the statutory list. The Determination therefore constrains and structures the scope of regulatory action by identifying which diseases are in the category that attracts the Act’s disease‑specific regime.

In short, the Determination affects parties only insofar as the Biosecurity Act applies to “listed human diseases”, and this instrument provides the content of that phrase by listing the eight disease items in s 4. The Determination does not itself impose fees, penalties or duties on any named person or class.

The Determination contains no explicit duties, rights, powers or procedural rules. Section 4 performs a labelling function: it declares that each disease named is a listed human disease (s 4). Section 3 states the instrument’s legal authority as subsection 42(1) of the Biosecurity Act 2015. Because the Determination does not itself set out regulatory obligations, the immediate legal effect is to render the named diseases subject to whatever duties, powers and rights the Biosecurity Act attaches to the category “listed human disease”.

That means the following descriptive points about duties and rights can be stated from the Determination itself:

• No duties or rights in the Determination. The text does not create, modify or repeal any person’s duties or rights. It is a declaring instrument. Any duties and rights that operate in relation to the diseases listed in s 4 derive from the Biosecurity Act or from other subordinate instruments that implement the Act’s powers.

• Conditional legal effect. For an individual or organisation to have a duty or right related to a disease in s 4, an enabling provision in the Biosecurity Act must be engaged. The Determination’s legal work is to make the disease category available to the Act. The Determination is therefore a necessary but not sufficient legal step to trigger Act‑based obligations.

• Administrative discretion located outside the Determination. The instrument does not include criteria, thresholds, timelines or processes for decisionmaking. Any discretion to add, remove, or otherwise act on a listed disease is exercised under the Biosecurity Act’s processes and not within this Determination. The Determination therefore does not constrain how duties are exercised; it only specifies which diseases can be the subject of those duties under the Act.

• Scope of disease categories. Some entries in s 4 are broad categories or include functional qualifiers (for example “with pandemic potential”), which implies that the scope of duties and rights contingent on the list depends on further factual assessment by the authority using the Act. The Determination does not set out who makes that assessment nor the evidentiary standards to be applied.

• Procedural silence. The instrument does not set out appeal rights, notice obligations, consultation requirements or other procedural protections. Those will be determined by the Biosecurity Act and any subordinate instruments made under it.

Readers should therefore treat this Determination as part of a two‑step legal mechanism: it identifies named diseases; the Biosecurity Act supplies the duties and rights that may attach. To know the precise duties and rights that arise when a disease is listed requires consulting the Biosecurity Act itself and any accompanying regulations or determinations that exercise the Act’s powers.

The Determination contains no penalty provisions, enforcement mechanisms, compliance processes, infringement notices, civil sanctions, or criminal offences within its text. Section 4 lists diseases, and s 3 records the legislative authority; there is no section in this instrument that prescribes penalties or enforcement processes.

Consequently, any penalties or enforcement action in relation to these diseases would arise under the Biosecurity Act 2015 or subordinate instruments made under it, not from this Determination directly (s 3). The Determination’s role is to determine which diseases fall within the Act’s disease category; it does not itself define what constitutes an offence, how breaches are to be prosecuted or administratively sanctioned, or the remedies available to affected persons.

The compilation endnotes reiterate that the document is a compiled instrument; they make explicit that the Legislation Act 2003 authorises editorial and presentational changes and that modifications by other laws can affect the compiled text (endnotes 1 and 3). Those notes do not introduce enforcement material. Similarly, the amendment history and registration details set out times when the list changed, but do not identify enforcement responses or sanctions associated with those changes (endnote 3 and endnote 4).

Practically, a lawyer, compliance officer or risk manager must therefore consult the Biosecurity Act 2015 and any regulations, determinations or directions issued under that Act to determine:

• which enforcement powers are available when a particular disease on the list is the subject of an outbreak; and

• what penalties or sanctions could be applied to persons who fail to comply with measures invoked because a listed human disease is present.

This Determination should be read as the definitional instrument that allows the Act’s enforcement provisions to be invoked; it does not itself contain enforcement clauses.

The Determination is expressly made under subsection 42(1) of the Biosecurity Act 2015 (s 3). That is the only direct cross‑reference in the instrument’s operative text. The endnotes and compilation header add further statutory context by referencing the Legislation Act 2003 as the authority for editorial changes to compilations and noting that this document is a compiled form that reflects amendments up to a given date (compilation header; endnotes 1 and 3).

From the instrument’s language the following interactions with other laws and instruments can be stated:

• Primary interaction with the Biosecurity Act 2015. The Determination supplies the content of the statutory phrase “listed human disease” as used in the Biosecurity Act. Therefore, any other provision of Commonwealth law that in turn references the Biosecurity Act or that uses the phrase “listed human disease” will indirectly be affected by changes to this Determination. The Determination itself does not change other statutes; it changes the content of a definition that other instruments and decisions under the Biosecurity Act will rely on.

• Subsidiary instruments and directions. Because this Determination is a legislative instrument created under the Biosecurity Act, subordinate instruments, directions or notices made under the Act will operate with the diseases named here in mind. The Determination therefore functions as a foundational item in the chain of instruments that implement biosecurity responses under Commonwealth law.

• Compilation and amendment metadata. The endnotes state that the Determination has been amended and compiled, and that editorial changes authorised by the Legislation Act 2003 may appear in the compiled text (endnotes 1 and 3). Those endnotes reflect the legislative process for managing subordinate instruments once they are made, but do not create substantive interaction effects with other distinct Acts except insofar as those other Acts refer to the Biosecurity Act or to the category the Determination names.

• Consistency with international law. The Determination does not mention international health regulations, treaties, or foreign law. Any interaction with international obligations would therefore be indirect and would depend on how the Biosecurity Act and executive practice take account of international instruments when applying measures to listed human diseases.

• Modification by other laws. The compilation notes include a general statement that if the compiled law is modified by another law, the compilation will not necessarily show that modification in its text but that the compiled law operates as modified (endnote 1). That indicates that this Determination can be modified by subsequent legislative action and that users should check the current status on the Legislation Register.

In sum, the Determination interacts principally and directly with the Biosecurity Act 2015, and its broader legal impact on other laws is mediated through the Act and any subordinate instruments made under the Act. The Determination itself is silent on interaction with particular statutes, agencies or international instruments.

The compiled document and its endnotes provide a concise record of the instrument’s registration, commencement and amendment events up to the compilation date. The following facts are recorded in the compilation and endnotes and are the only amendment history shown in this material.

• Original instrument: The Biosecurity (Listed Human Diseases) Determination 2016 was registered on 14 June 2016 (F2016L01027) and commenced on 16 June 2016, pursuant to s 2(1) item 1 of that instrument (endnote 3). That registration and commencement established the initial list as at 2016.

• Amendment instrument: The instrument was amended by the Biosecurity (Listed Human Diseases) Amendment Determination 2020, which appears in the endnotes as being registered on 21 January 2020 (F2020L00037) and commenced on 21 January 2020 (endnote 3). The compilation header also records that the compilation date is 21 January 2020 and that the compilation includes amendments up to F2020L00037.

• Specific provision changes: Endnote 4 records amendment detail at the provision level. It states that section 4 was amended by F2020L00037 (endnote 4). It also records that section 2 was repealed by Law referred to as “LA s 48D” (endnote 4). The table in endnote 4 shows how provisions were affected, but the compiled text reproduced in this document contains only sections 1, 3 and 4. The endnotes therefore identify the specific loci of amendment.

• Compilation registration: The compilation header shows the compiled instrument’s registration date as 3 February 2020, and the compilation date as 21 January 2020. The compilation claims to include amendments up to F2020L00037 (compilation header).

• Editorial and uncommenced amendments: The endnotes state that uncommenced amendments are not shown in the compiled text and that editorial changes authorised by the Legislation Act 2003 may be applied in preparing the compilation (endnote 1). The compilation therefore signals that a user should check the Legislation Register for any amendments made but not yet commenced at the compilation date, or for subsequent modifications.

Operationally, the amendment recorded in 2020 altered section 4 in some respect, although the compiled instrument presents the consolidated text rather than showing the pre‑amendment text. Practitioners should therefore note that while the compiled text is current to the stated compilation date, the instrument has an amendment history and may be open to further amendment by instruments made under the Biosecurity Act or by other legislative changes.

The compiled Determination and its endnotes provide no record of judicial decisions, administrative appeals, or litigation referring to or interpreting this Determination. There are no cases named or cited anywhere in the instrument or in the endnotes. The only procedural history recorded is the registration and amendment dates recorded in the compilation notes (endnotes 1-4).

Because the Determination is a subordinate legislative instrument that performs a classificatory role, disputes about its legal effect would typically arise in litigation about the Biosecurity Act itself or about decisions made under that Act which turn on whether a particular disease is a “listed human disease”. The Determination does not itself include a statement of procedure for judicial review or appeal; any challenge to the listing or to actions taken by administrators in reliance on the Determination would proceed under the general administrative law and judicial review principles applicable to decisions under the Biosecurity Act and other relevant statutes. The compiled text does not record any such proceedings.

Practitioners seeking litigation history relevant to the Determination should therefore:

• search case law and tribunal databases for proceedings that involve the Biosecurity Act and that refer to the Determination’s list as an issue in dispute;

• examine administrative decisions under the Biosecurity Act in which the classification of a disease as a listed human disease is material; and

• consult legislative and parliamentary materials, including amendment instruments and explanatory materials, to establish the administrative context in which the Determination operates.

None of those items appear in this compilation. The only judicial or tribunal materials present in the compilation are the standard endnote descriptions of compilation, amendment and editorial change; they do not record litigation.

The Determination is short, but several practical legal and compliance issues arise from its form and wording. Each of these “gotchas” follows directly from the text and from the instrument’s relationship to the Biosecurity Act as recorded in s 3.

1. Classification versus consequence. The Determination only lists diseases; it does not state what measures will be applied when a disease is listed. Readers can err by assuming that listing itself imposes immediate operational requirements. The legal consequences of listing are borne out in the Biosecurity Act, not in this Determination (s 4; s 3). Misreading the Determination as setting out duties or penalties is a common pitfall.

2. Broad categories have interpretive work. Items such as “viral haemorrhagic fevers” and “human coronavirus with pandemic potential” are categories rather than individual pathogen names (s 4(f), (h)). That leaves substantial interpretive work to the authority that applies the Biosecurity Act. The Determination does not provide criteria for deciding whether a particular virus or outbreak falls within those categories, meaning that a practitioner must identify which decisionmaker, and what processes, will determine category inclusion in practice.

3. Functional qualifiers: “with pandemic potential”. Two entries use the phrase “with pandemic potential” (s 4(a) and s 4(h)). The Determination does not define “pandemic potential”, does not set an evidentiary standard, and does not identify the actor who will assess that potential. This introduces uncertainty about when those entries will be operationally engaged. Users must therefore look beyond the Determination to the Biosecurity Act and administrative practice to understand how “pandemic potential” is assessed.

4. Potential overlap between entries. The list includes both “severe acute respiratory syndrome (SARS)” and “human coronavirus with pandemic potential” (s 4(d), (h)). SARS is known historically as a coronavirus‑related syndrome. The Determination does not say how overlaps are to be handled, whether both entries can apply simultaneously, or whether one entry takes precedence for particular regulatory responses. That ambiguity can matter in operational planning and in legal challenges.

5. No procedural safeguards or timelines. The Determination is silent about consultation, notice, review or time limits for listing or delisting. Any procedural protections must be sought in the Biosecurity Act or in secondary instruments. Practitioners should not assume that such protections are embedded in the Determination.

6. Changes over time and compilation issues. The compilation endnotes show the Determination has been amended (endnote 3 and 4). The compiled text is current to the compilation date and includes amendments up to the instrument cited. However, uncommenced amendments, editorial changes and later modifications may not be visible in the compilation. Parties relying on the list must check the Legislation Register to confirm the current operative instrument and its commencement state (endnotes 1 and 3).

7. Names versus scientific classification. The Determination uses common disease names rather than specifying pathogens at the level of species or strain. For example, “plague” and “smallpox” refer to historically recognised diseases, but the instrument does not identify the causative organisms by taxonomic name. That can create difficulties when new strains or related organisms emerge and there is a question whether they fall within the listed name.

8. No enforcement text. Because the Determination contains no enforcement provisions, parties can mistakenly look to it for sanctioning or compliance detail. That detail is absent and must be located in the Biosecurity Act.

9. Reliance risk for operational decisions. If an agency or an entity acts solely on the Determination without consulting the Biosecurity Act or other guidance, it may misapply powers or fail to meet procedural requirements that are contained in the Act. The Determination should be treated as a definitional input into a broader statutory and administrative framework.

Each of these issues arises from the text of the Determination as compiled. They should be assessed in conjunction with the Biosecurity Act 2015 and any subordinate measures adopted under the Act.

Because the Determination itself does not impose procedural obligations or specify compliance steps, the immediate compliance requirement is to treat the instrument as the authoritative list of diseases that will attract the Biosecurity Act’s disease‑specific powers. The following practical, source‑grounded steps are consistent with the instrument’s function and with the compilation notes.

1. Treat the Determination as a definitional input. Recognise that s 4 declares the named diseases to be “listed human diseases” for the purposes of the Biosecurity Act 2015 (s 4; s 3). Compliance with any disease‑specific requirements therefore requires consulting the Biosecurity Act and applicable subordinate instruments to determine duties, powers, and processes that apply when one of these diseases is implicated.

2. Monitor the list and its amendments. The compilation and endnotes record that the Determination has been amended (endnote 3 and 4) and that the compiled text is current to a stated date. Practitioners should check the Legislation Register for the current version and for any uncommenced amendments, because the compilation notes that uncommenced amendments are not shown (compilation header; endnote 1).

3. Identify which entries could affect you. Review s 4 and assess whether any of the eight items are relevant to your operations, supply chains, client base, or regulatory exposures (s 4). For example, if your organisation deals with international travel or has operations in areas reporting coronaviruses, the entries “human coronavirus with pandemic potential” and “severe acute respiratory syndrome (SARS)” are directly relevant (s 4(d), (h)). Note that categorical entries such as “viral haemorrhagic fevers” may cover a range of pathogens.

4. Establish decision points and contact points. Because the Determination authorises the Biosecurity Act to operate with respect to the listed diseases, establish processes to identify when health authorities or the Commonwealth exercise powers under the Act in relation to a listed disease. That will require consulting the Biosecurity Act and maintaining direct contact with the administering agency responsible for enforcing the Act.

5. Avoid relying on the Determination alone for operational measures. The Determination does not contain enforcement or procedural rules. Organisations should not adopt or implement internal compliance actions solely on the basis of the Determination without checking whether the Biosecurity Act or other subordinate instruments mandate those actions.

6. Prepare for interpretive uncertainty. The list contains broad categories and functional qualifiers, for example “with pandemic potential” (s 4(a), (h)). Develop internal protocols for how to respond to official determinations of “pandemic potential” or to guidance issued under the Biosecurity Act. That may include pre‑agreed escalation pathways, scenario planning, and legal review points.

7. Maintain documentary audit trails. If actions are taken in response to measures under the Biosecurity Act that are invoked because a disease is on this list, keep records that show the linkage between the Determination, the relevant Act provision, and the administrative decision or direction relied upon. The Determination itself provides the link to the Act, but not to specific administrative acts.

8. Seek authoritative legal guidance where necessary. Where there is ambiguity, for example as to whether a new pathogen falls within “viral haemorrhagic fevers” or “human coronavirus with pandemic potential”, obtain legal advice and consider seeking clarification from the administering agency under the Biosecurity Act. The Determination does not supply interpretive criteria.

9. Check commencement and applicability. The compilation shows commencement dates for the original instrument and the 2020 amendment (endnote 3). When relying on the list for compliance planning, verify the applicable commencement date for any amendment so that you know which entries are active at a given time.

10. Incorporate the list into risk registers. Given the Determination’s role as the statutory list, include the diseases named in s 4 in biosecurity and health risk registers, and map possible regulatory actions under the Biosecurity Act to each disease item to the extent practicable.

These compliance steps are constrained by the text of this Determination and the compilation notes. The Determination does not specify operational detail, so effective compliance depends on integrating the Determination with the Biosecurity Act 2015 and any subordinate materials issued under that Act.