Video — Evaluations

AICIS Evaluations

This video is a general overview on AICIS Evaluations
You’ll learn what an AICIS Evaluation is and how the evaluations process will work. We’ve also put together some examples to give you a clearer picture of evaluations under AICIS together with information about our planned roadmap for them. 

Evaluation overview

Evaluations help us to achieve our main goal of helping to protect human health and the environment by providing information and recommendations about managing the risks of industrial chemicals.

Evaluations are analogous to NICNAS assessments under the IMAP framework, Priority Existing Chemicals and Secondary notification assessments, but with the advantage of greater flexibility to vary the scope, target and timeframe. 

Evaluations allow us to:

• continue assessing chemicals listed on the Inventory
• identify and quickly assess chemicals of concern
• respond to emerging concerns and new information, including information provided by chemical introducers
• publish up-to-date information on chemicals and their risks
• maintain the Inventory's accuracy

Evaluations can be for a single chemical or a group of chemicals introduced under any introduction category. 

An evaluation can cover a class of chemicals introduced across multiple introduction categories. 

An evaluation can also cover introduction of chemicals that are not subject to categorisation or registration obligations, for example, we can evaluate a chemical released from an article. 

Evaluations can focus on any matters relating to a chemical such as identity, exposure, hazard or risk to human health, or environment, or both. An evaluation can also relate to circumstances of a chemical introduction. For example, an evaluation can focus on the nanoform of an industrial chemical.

So what prompts us to do an evaluation? There are several triggers that may lead to an evaluation. 

We’re continuing the work started under the NICNAS IMAP framework to prioritise and assess previously unassessed chemicals listed on the Inventory. 

Our post-introduction monitoring activities will help us identify whether we need to evaluate a potential risk relating to a chemical introduction. 

Information obligations on introducers mean we may receive new hazard information that lead to an evaluation. 

We need to do an evaluation before we can add a chemical previously regulated under another Commonwealth law to the Inventory or to replace a misidentified chemical on the Inventory.

We may also receive nominations for evaluations. We will need to prioritise any nominations together with other potential candidates for evaluation using our prioritisation approaches. 

Evaluation process

Given the breadth of chemicals that can be selected for evaluation, a strategic approach to identifying and selecting chemicals is required. Before commencing an evaluation, we undertake a screening process, called evaluation selection analysis (ESA).

We initiate an evaluation by informing stakeholders through either a notice or publication on our website.

During the evaluation, we consult at several stages to provide opportunities for input. 

We complete the evaluation process by the publication of a statement and subsequent referral of any recommendations. We will now go through the steps of the process in more detail.

To ensure a risk-proportionate and efficient approach to evaluations, we only initiate an evaluation following an evaluation selection analysis (ESA). During the ESA, we screen the available data and determine the: 

• need for an evaluation 
• scope of the evaluation and the 
• adequacy of the available data for conducting the evaluation.

For listed chemicals, we also apply weighting criteria and approaches for prioritising and selecting chemicals for evaluation. 

So what happens when we commence an evaluation? 

For chemicals under a certificate, we send a notice to each certificate holder that states the reason for the evaluation and time period for completion. For all other chemicals, we publish on our website the subject of the evaluation (such as the chemical name or class of chemicals being evaluated), the reason for the evaluation and the time period for the evaluation. This information is communicated through our rolling action plan.

The rolling action plan is our work plan for chemicals prioritised for evaluation. It is a way to transparently communicate what evaluations are being planned and will include the subject, reason and timeframe for each evaluation.

The publication of our work plan will enable interested parties to voluntarily give us information and assist with stakeholder awareness. 

The content of the rolling action plan is agile to ensure that we are responsive to new information and changing circumstances. For example, the timeframe of an evaluation may change if we become aware of new information that may impact the outcome of the evaluation or we may add a chemical to the rolling action plan if we need to respond to an adverse event. We will communicate changes to the rolling action plan through our website. 

Introducers and other interested parties will have several opportunities to provide input to the evaluation process including by providing information and commenting on evaluation outcomes. 

For chemicals being introduced under a certificate, we send the draft evaluation statement and any request for information to the certificate holder. For other evaluations, calls for information may be targeted or general, voluntary or mandatory. In most cases, we will consult publicly on the preliminary evaluation statement though our website.

During an evaluation, we may consult with Australian standard-setting bodies and/or state and territory risk-management agencies. We must consult if we are considering a change to a certificate. 

Calls for information assist us where there is limited information. They help us make more risk-proportionate decisions through the provision of evidence that will remove the need to make precautionary assumptions and conservative estimates of risk. For an evaluation of a chemical under a current certificate, we can make a call for information by written notice to any holder of, or person covered by, the certificate.

For other evaluations if we think a stakeholder has the information we need for an evaluation, we can issue a mandatory call for information. Our legislation only permits us to make a mandatory call for information if:

• we haven’t been able to get the information by any other means or
• the information is necessary to confirm whether a chemical or class of chemicals is being introduced, or is in use, in Australia or
• the information is necessary to establish if there are risks to human health or the environment associated with the chemical or
• the information is necessary for Australia to meet its obligations under international agreements or arrangements

We can make a mandatory call for information to:

• introducers of a chemical during the previous 12 months or in the next 12 months
• other people we believe have information relevant to the evaluation

Calls for information will not mean anyone has to conduct more tests or otherwise generate additional data. 

At the end of an evaluation, we publish an evaluation statement on our website. For chemicals under a certificate, we also send the statement to the certificate holder. The evaluation statement contains the subject of the evaluation, the parameters or scope of evaluation and a summary of the evaluation. The statement also includes the conclusion of the evaluation regarding any risks to human health or the environment and the recommendations for managing identified risks. 

The next slide will go into more detail the potential recommendations from an evaluation. 

The most frequent recommendation from an evaluation will be recommendations for risk management, for example for worker health and safety a recommendation to amend the Hazardous Chemicals Information System or for public health a recommendation to list a chemical in the Poison Standard.

An infrequent outcome, where this is necessary to manage risks, will be a recommendation to vary the terms of a certificate or listing. If the variation relates to conditions of use, we must have consulted with the relevant national standard setting body. 

A rare outcome will be a recommendation to cancel a certificate or remove a chemical from the inventory. This is only where the risks cannot be managed by other mechanisms and follows consultation with the relevant national standard setting body. 

The first example is for a chemical under a certificate. Two years after being issued a certificate, a certificate holder becomes aware of new hazard information that was not considered in the original assessment. In line with the Act, the certificate holder provides this information to AICIS. Our Evaluation Selection Analysis indicates a potential need for risk management and we decide to initiate an evaluation. To do this we send a notice to the certificate holder. We may also request further information if we need this to complete our evaluation. Following completion of a draft evaluation statement, we send this to the certificate holder. The certificate holder then has at least 20 working days to make a submission about the statement. Following the end of the comment period, we publish the final statement on our website and send a copy to the certificate holder. We will then refer any recommendations to the relevant risk management body. 

The second example is for a chemical listed on the inventory. Our prioritisation work identifies that international restrictions are in place for a chemical. Our Evaluation Selection Analysis indicates a potential need for risk management and we decide to initiate an evaluation. To do this we include the chemical on our rolling action plan that is published on our website. Any interested parties can then voluntarily provide information on the chemical. We may also further call for information if we need this to complete our evaluation. Following completion of a preliminary evaluation statement, we publish this on our website for public consultation. Following the end of the comment period, we publish the final statement on our website. We will then refer any recommendations to the relevant risk management body.

Evaluation Roadmap

The Roadmap describes a strategic approach to identifying priorities for evaluating industrial chemicals as part of the new scheme and achieving outcomes from those evaluations. The Roadmap has been developed based on lessons learned from implementing the IMAP framework, an analysis of international chemical prioritisation approaches and feedback from our stakeholders.

The Roadmap will be in effect for 4 years from 1 July 2020 and we will regularly review it to maintain its relevance. We have designed the Roadmap to support the legislated framework for conducting evaluations and align with international best practice. It provides transparency for our decision-making and supports the strategic identification of chemicals that require evaluation regardless of the introduction pathway. It will build on the work started through the IMAP framework to deliver evidence-based outcomes that are agile enough to respond to new information and emerging concerns.

The Roadmap also outlines an action plan. There are 6 action areas. 

1. Proportionate risk-based approach to evaluations 
2. Evaluation prioritisation 
3. Knowledge and evidence based decision-making
4. Capacity building
5. Leadership and engagement
6. Informing choice about the use of chemicals

The Roadmap aims to strengthen our national capacity for risk reduction. We will deliver targeted and evidence based evaluations through applying prioritisation approaches and implementing data strategies. We will continue to build capacity of our staff and stakeholders in a number of areas, including the use of new assessment methodologies. We will continue to develop and maintain strategic relationships with stakeholders to support capacity building and maximise the use and exchange of information. We will continue to publish chemical safety information including on chemicals that are of low risk to allow people to make informed choices about the use of chemicals.

Thank you for your attention! We hope this has helped you understand the new scheme, and how you can help make it work effectively. For further information, including guidance material and links to our legislation, please visit our website.