Evaluations Roadmap

Strengthened national capacity for industrial chemical risk reduction.

Actions

• Undertake evaluations that are proportionate to the risk from the introduction of an industrial chemical 
• Protect human health and the environment by providing information and risk management recommendations for uptake by:
  • Commonwealth, state and territory regulators
  • industry
  • community.

Evaluations

Ongoing post-market evaluation of industrial chemicals helps to reduce the risk posed by the introduction and use of industrial chemicals. It ensures industry, risk managers and the community have access to up-to-date information on the hazards and risks of industrial chemicals as well as our risk management recommendations. We will:

• evaluate prioritised industrial chemicals using a range of information about hazard characteristics and potential exposure to humans and the environment
• make risk management recommendations for uptake by: 
  • Commonwealth, state and territory regulators
  • industry 
  • community
• be transparent about our progress 
• continue to build our scientific capability so we produce high-quality risk assessments. We’ll achieve this through staff training and engaging with stakeholders. 

We will provide transparent and scientific evidence-based information to help the public and industry make informed choices around chemical safety. We will share information with risk managers in a timely way to support regulatory decision making, such as setting risk management standards. This will increase confidence and trust in Australia’s industrial chemicals regulatory system. 

Next: Targeting evaluations

Risk-proportionate, transparent and targeted evaluations.         

Actions

• Target chemicals for evaluation using the Evaluation Selection Analysis (ESA) criteria and process.
• Maintain and update prioritisation tools and adopt innovative methods to allow efficient and consistent screening. 
• Create a validated a list of chemicals that are not commercially active for industrial use in Australia (inactive chemicals).

What can trigger an evaluation?

• New information from the public, national and international regulators and industry, including information provided under the IC Act.  
• Information identified through compliance monitoring and audit activities. 
• Presence of emerging concerns. 
• International or national regulatory activity.
• Findings from our assessment of chemicals eg arising from information requirements.
• Request from risk managers.
• Prioritisation of the chemicals listed on the Inventory. 

The scope of our evaluations can vary and cover a class of chemicals or a single chemical.

How we prioritise chemical evaluations

Our priority is to evaluate industrial chemicals with higher potential for adverse impacts on human health or the environment.

We will only evaluate a chemical if we are satisfied that there is a need to evaluate it. This approach will ensure that we do a risk-proportionate and efficient evaluations.

We use the ESA method to identify chemicals for evaluation based on set criteria. We have different criteria for human health and the environment. 

To select a chemical for evaluation, we will consider the need for:

• risk management recommendations (eg, scheduling the chemical in the Poisons Standard)
• regulatory changes under the IC Act (eg, a variation to the terms and conditions that apply to the introduction of a chemical under certificate), or 
• a change to the Inventory listing (for example, the listing of a misidentified chemical).

In addition, we may select a chemical for an evaluation if there is a need to publish information about it. For example, to provide information on the risk of an adverse event (for example, skin reaction to chemicals). 

We apply extra criteria and approaches for prioritising chemicals that meet the circumstances listed above. 

The ESA method we use comprises these 3 steps:

• high throughput selection of candidates
• application of weighting modifiers
• determining the priority for evaluations.

This 3-step process will allow the publication of a rolling action plan for evaluations.

Identifying industrial chemicals not for commercial use

As part of prioritising Inventory-listed chemicals, we will also create a list of ‘inactive’ chemicals. We will work to validate this list so we can confirm they are not commercially active in Australia. As we identify ‘inactive’ chemicals, we’ll be able to direct more of our resources to meet our objectives to evaluate higher concern chemicals.

Next: Knowledge and evidence

Produce evaluations that are targeted and evidence-based through effective use of data

Actions

• 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.

Obtaining information

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.

Read more in 'What happens during an evaluation'

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.

Learn about circumstances when AICIS can call for information

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).

See a list of prescribed bodies that we can consult

Next: Capacity building

Supporting best practice through education and training

Actions

• Promote stakeholder understanding of the purpose and components of evaluations through education.  
• Use novel validated risk evaluation methods and processes adopted by other regulators.
• Conduct systematic peer reviews of evaluations and peer review exchange for more complex evaluations with international regulators.

Scientific capability

We will build on our strengths and capacity through:

• implementing our science strategy 
• adopting peer review processes that ensure scientific integrity
• developing assessment tools and guidance 
• engaging in national and international initiatives such as new assessment methodologies (NAMS)
• exchanging information to align with international harmonisation efforts.

New assessment methodologies 

Consistent with international practice, we use a combination of methods and data sources to inform our chemical evaluations, and monitor developments in these areas, including:

• quantitative structure activity/use relationships (QSAR/QSUR)
• read-across
• in chemico
• in vitro
• in vivo
• adverse outcome pathways (AOPs)
• -omic technologies.

Learn about the ban on the use of animal data

International and academic engagement

To maintain best practice, we will actively engage with our international counterparts:

• ensuring that our skills and knowledge base keep pace with international developments
• enhancing evaluation findings through data exchange, sharing of training materials and peer review 
• using the International Uniform Chemical Information Database (IUCLID) and the Organisation for Economic Cooperation and Development (OECD) QSAR Toolbox).    

We will link with academic institutions to: 

• strengthen our engagement with research and develop knowledge about chemicals 
• develop new assessment tools and methodologies 
• consolidate data  
• improve our regulatory capability 
• improve opportunities for knowledge transfer  
• increase university students’ awareness of regulatory science as a career option.

Maximising use of information by applying chemical informatics! 

Chemical informatics is key to supporting the high-throughput and accelerated evaluation of large numbers of chemicals.

What is chemical informatics?

The regulatory application of chemical informatics involves:

• organising
• quality-assuring
• visualising and 
• applying large amounts of electronic information to support prioritisation, risk assessment, and recommendations for risk management of chemicals. 

Chemical informatics means we can maximise the use and re-use of large amounts of quality assured chemical information to optimise the resources we need to evaluate chemicals. It also helps us complete and publish high-quality chemical evaluations in a timely way. Work to further develop our existing capabilities in chemical informatics will be an essential part of delivering our evaluations.

Next: Leadership and engagement

Utilising global chemical intelligence for innovation

Actions

• Maintain strategic relationships with national and international regulatory authorities.
• Engagement with a range of stakeholders to gain an understanding of each of the sector's needs.
• Work with stakeholders to support the uptake of recommendations.
• Expand relationships with stakeholders to maximise use and exchange of available information.
• Regularly review stakeholder relationships to maintain currency and effectiveness.

Engagement

Engagement with stakeholders will be an important part the Evaluation work undertaken under AICIS. We will be able to extend the Scheme’s reach and access to chemical intelligence to innovate and better inform evaluation outcomes. It should also fill chemical data gaps, put more certainty into our risk assessments and increase stakeholder confidence in the evaluations.

Continued engagement with Australian risk management agencies should promote effective risk management, enabling evaluation recommendations to be addressed by these agencies. Providing supporting information for risk management and identifying chemicals that are unlikely to require further regulation to manage risks should inform their decision making.

The Scheme’s key stakeholders include public, industry, workers, community groups, local and international regulatory bodies, academia, national networks and risk managers. These stakeholders play a pivotal role in the planning and implementation of AICIS evaluations. We will engage with stakeholders in a variety of ways to efficiently maximise their input and to promote the safe use of chemicals.

Accessing global intelligence

We will ensure our approach to evaluations continues to align with international best practice. Using global chemical intelligence will help us to innovate to improve our capability, develop new methodologies/approaches and produce high-quality evaluation outcomes. 

Enabling global partnerships should also help build on resources, including the use of international data, innovative risk evaluation methods and processes. Taking part in global forums such as WHO, APEC and OECD will give us the opportunity for improved harmonisation of evaluation results.

Next: Informing choice

Enabling choices about the use of chemicals through provision of risk information.

Actions

• Continue to publish chemical safety information through evaluation statements on our website. 
• Conduct evaluations for chemicals that include:  
  • chemicals that are unlikely to require further regulation to manage risks to human health and/or environment
  • identified substitutes for high concern chemicals
  • chemicals introduced to Australia in articles.
• Put in place strategies to ensure chemical safety information is suitable to allow stakeholders to make informed decisions.

Strategies to enable informed choice

We will evaluate chemicals and publish information to support industry, workers, regulators and the general public to make informed choices about chemical use and risk mitigation measures. This includes publishing on our website a list of our current evaluations, as well as chemicals that are candidates for future evaluations. See our rolling action plan for details.

Communicating evaluation findings

The evaluation statements we publish on our website will provide a range of interested parties with concise information about identified risks and recommended risk management measures. This information can be used to inform decisions about effective ongoing management of potential risks associated with the use of chemicals.

Internationally, there is a push to publish more information on chemicals identified as potential substitutes to allow informed decision-making. The availability of this information has beneficial effects for worker safety, consumer and environmental protection. During the ESA process, we will identify chemicals with enough information to determine that they are unlikely to require further regulation to manage risks to health or the environment.

The Rolling Action Plan, which lists our chemicals prioritised for evaluation will also include:

• chemicals unlikely to require further regulation to manage risks to health 
• chemicals unlikely to require further regulation to manage risks to the environment.

Publishing the analysed risk information at the ESA stage will improve the flow of chemical safety information.

See more information about Evaluation Statements

Supporting evidence-based chemical substitution

Chemical groupings

Chemicals selected by industry to substitute those being phased out are frequently based on functional or structural similarity. We will continue to group chemicals for evaluation. We may base groupings on:

• chemical structures
• functional uses
• common metabolites
• degradation products

The grouping approach may include any potential substitutes that also meet the grouping rationale. Grouping allows us to make consistent decisions for similar chemicals or identify trends where more targeted recommendations apply to a subset of a chemical group. It will also increase the efficiency of our evaluation methods and maximise the use of available data.

The publication of this type of information will allow direct comparison of the hazards associated with the chemicals and identify any information gaps.

Chemicals in articles

Global reporting of the presence or absence of hazardous substances in articles is limited. The lack of information can:

• prevent people from making informed choices
• create a potential mismatch between the regulatory burden on manufacturers and importers of articles in Australia  
• reduce the global pressure to find safer substitutes.

Under our laws, we can evaluate any industrial chemical or matters relating to an industrial chemical. This means we can evaluate chemicals introduced into Australia in articles. We can do this even if the chemical introduction is not subject to listing or categorisation requirements.