Outcome 3 - Knowledge and evidence
Produce evaluations that are targeted and evidence-based through effective use of data.
- Apply a weight of evidence approach to deliver high quality evaluations.
- Maximise the use of international assessment materials and facilitate the acceptance of information from stakeholders.
- Actively group chemicals to enhance efficiency and promote consistent decision-making.
- Provide transparency for stakeholders on upcoming evaluations by giving notices and publishing a rolling action plan for evaluations.
Use of available information
We need a range of information to produce robust evaluations including data on hazard characteristics and potential exposure to humans and the environment.
We draw on a range of publicly available sources, including:
- international and national assessments and databases
- our assessments or those done by the previous scheme, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
- literature reviews
- advice from other regulators, both national and international
- external peer reviews
- analogue, in vitro, in chemico and in silico data
- biological and environmental monitoring data
- other computational data.
International and national assessment data
We confirm the scientific integrity of information before using it to:
- inform an ESA
- determine an initial risk profile
- decide the priority for evaluation
- identify and validate chemicals unlikely to need further regulation to manage risks.
Where possible, we will ‘group’ chemicals using scientific and technical guidance. This will promote efficiency and consistent decision making on similar chemicals based on:
- chemical structure
- common toxic species (for example, esters, salts)
- mode of action
- functional use
- physico-chemical properties.
When information is not available
We use conservative assumptions based on a technical rationale and scientific principles so that we do not underestimate the risks to human health or the environment. We inform ‘data poor’ evaluations through inferring properties and use patterns of chemicals using data for similar substances or international practices.
Data assumptions and increasing certainty in evaluation findings
With the lack of specific Australian exposure data and the global move away from the use of traditional animal toxicity data, we use relevant information to inform the following assumptions will help us do an evaluation:
- inferring use patterns from international data
- making assumptions on volume
- using results from QSAR modelling
- applying read-across and use of analogues.
If available international or national data are not enough to estimate volumes, we assume an annual introduction volume of 100 tonnes. Doing this assists us to estimate the magnitude of human and/or environmental exposure. We established this assumption after consultation with stakeholders. It is typically greater than actual introduction volumes and results in a conservative estimation of the risk posed by the chemical.
Where we need to rely on results from QSAR modelling and read-across methods for an evaluation, we scale them to account for the degree of uncertainty. This also provides a conservative estimate of actual hazard and risk to ensure risk management recommendations that protect human health and the environment.
We make every effort to obtain use and volume estimates. Australian use and exposure information will not be readily available for most chemicals listed on the Inventory. International data are a vital source of surrogate exposure information for these industrial chemicals. Where data are not readily available and is required to complete an evaluation we may seek information from stakeholders. Provision by regulated entities (or other sources) of more accurate data on uses and volumes will allow refinement of risk estimates.
Opportunities to participate
Introducers and other interested parties have several opportunities to provide input to the evaluation process, including by:
- nominating chemicals for evaluation
- providing information for evaluations
- commenting on evaluation outcomes.
We prioritise any nominations with other potential candidates for evaluation. Nominations would need to include key information on the hazards and potential for human health or environmental exposure to the industrial chemical so we can decide on the appropriate priority.
We will keep stakeholders informed about the chemicals we will evaluate through:
- our rolling action plan
- notices on our website, or
- direct communication with certificate holders.
This early communication will allow interested parties to voluntarily give us information and help with stakeholder preparedness.
As well as publishing lists of chemicals for evaluation, we may also do targeted voluntary calls for information.
Consultations and calls for information
Often we can evaluate a chemical with information we have on hand or that we have received through consultation. When we publish or update our Rolling Action Plan, there will be opportunity for stakeholders to give information voluntarily. Sometimes, we may need to make it a requirement that they provide information.
We can issue a call for information during an evaluation, for example to a specific introducer or industry sector. However, anyone can provide us with information at any time about a chemical. Anyone giving information to us may flag information as confidential.
We can consult with risk management bodies at any time during an evaluation. In particular circumstances, we must consult with specific standard-setting bodies and/or state and territory risk-management agencies (prescribed bodies).