The current situation

There are currently approximately 39,000 existing chemicals listed on AICS. Many of these were ‘grandfathered’ onto AICS and have not yet been assessed by NICNAS.

Until recently NICNAS predominantly used the process described in the ICNA Act (described below) to assess existing industrial chemicals. This Priority Existing Chemicals (PECS) process is limited and rigid.

In response to concerns regarding the need to accelerate and prioritise the assessment process for existing chemicals, NICNAS developed a science and risk based framework for the assessment and prioritisation of chemicals on the AICS (in consultation with stakeholders and technical experts). This is known as the Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework.

From July 2012 existing chemicals assessments will predominantly be undertaken using IMAP.

The IMAP approach better enables appropriate assessment and prioritisation of existing chemicals.

The problem

Problems with the assessment process for existing chemicals include the following:
  • the ICNA Act describes a detailed legislative assessment process for the assessment of Priority Existing Chemicals (PECs). While such a process may be appropriate for chemicals of national significance, the full PEC process is not appropriate for all assessments of existing chemicals. As noted by a number of stakeholders, the existing chemicals assessment processes is unnecessarily detailed and cumbersome for many chemicals. Although NICNAS can adopt non-legislative assessment processes to increase flexibility, this lacks regulatory certainty for NICNAS and stakeholders
  • the information-gathering and sharing powers in the Act are very limited and do not adequately enable NICNAS to request and obtain information in relation to existing chemicals. For example, the circumstances under which NICNAS can mandatorily call for information on uses, volumes and effects of existing chemicals are highly prescriptive. This limits NICNAS’ ability to undertake risk assessments and often results in the use of conservative default assumptions in the absence of accurate use and volume information
  • if NICNAS identifies serious concerns as part of the assessment of an existing chemical, the capacity of NICNAS to impose conditions on the use of the chemical (to manage any significant risks) is unclear. NICNAS does not have the power to remove the chemical from AICS. In such circumstances, the regulatory safeguards for the introducer are also uncertain
  • underutilisation of international assessments. Some stakeholders suggested that NICNAS should adopt assessments and/or assessment outcomes from the EU, USA, Japan, New Zealand and Canada rather than duplicating assessments. Other stakeholders strongly disagreed with this suggestion and supported independent assessment by NICNAS taking into account unique Australian conditions
  • no capacity to identify those chemicals that are no longer being introduced but are still on AICS. Regulatory effort is therefore potentially wasted in considering these chemicals as part of the existing chemical review. This has potential to impose unnecessary costs on industry.

The objectives of reform

In addition to the objectives identified in relation to new industrial chemicals, the objectives of any reform of the regulation of existing chemicals are to:
  • streamline the assessment process, where possible, to ensure that the assessment approach is commensurate with the risk and is directed towards the most efficient management of the aggregate risk of all industrial chemicals (note the PC Report – recommendation 4.1)
  • ensure transparency in any decision-making processes in relation to existing chemicals
  • enable stakeholders to participate in the assessment process through, for example, opportunity to comment on the assessment report and its conclusions and recommendations
  • ensure that NICNAS has access to adequate information to enable it to properly conduct risk assessments in relation to existing chemicals.

Possible options for reform

The options below could be implemented as a package, individually or as a combination of options (note that C3 and C5 are complementary). Some possible options are to amend the ICNA Act to:Top of PageC1. Maintain the existing assessment process for PECs but remove unnecessary prescriptive detail (including, for example, the requirement for both a preliminary assessment and a full assessment).

C2. Introduce a new legislative assessment process for non-PECs. Assessment outcomes would be published to ensure transparency but the assessment process would be simplified, could be carried out in relation to more than one chemical at the same time (e.g. assessment of a group or class of similar chemicals) and assessments could be more focused. For example, assessments could focus on a particular health effect or use pattern.

C3. Broaden the mandatory information-gathering powers to enable NICNAS to better undertake risk assessment activities and to adequately manage AICS (for example, to enable NICNAS to seek information from industry in support of option C5). The circumstances under which NICNAS may request such information would need to be tightly defined and be proportional to the risk. Care would also need to be taken to ensure that introducers are not required to submit the same information to multiple regulatory bodies.

C4. Remove the general power for NICNAS to impose conditions of use on chemicals after a chemical has been entered on AICS12. This would be replaced with a much more limited power which would enable NICNAS to:
  • impose a condition of use on a chemical listed on AICS only if an assessment of an existing chemical has been undertaken and the assessment has demonstrated that a condition of use is necessary, in order to protect public heath, worker safety and the environment, and that there is no other means by which the risk can be addressed
  • remove a chemical from AICS if NICNAS considers that there is unacceptable public health, worker safety or environmental risks, and risk management strategies are inadequate to manage the risk to an acceptable limit. The legislation would clearly define the very limited circumstances in which this power would be used and would also ensure there are in-built procedural fairness and consultation mechanisms.
C5. Establish a new Part on AICS for chemicals that are no longer being introduced into Australia. It is proposed that NICNAS would seek information from industry regarding those chemicals that have been introduced into Australia over the previous 5 years. Those chemicals that are on AICS but have not been introduced by any manufacturer or importer over the last 5 years would be placed on a separate list within AICS. If, after a further 5 years, no-one introduces the chemical the chemical would be removed from AICS following public notification and opportunity to comment.

C6. Ensure that, if the legislative changes detailed above are progressed, that all necessary consequential changes are made to the legislation. For example, to ensure the protection of applicants’ appeal rights, align confidentiality provisions and provide for adequate transparency and input into regulatory decisions. Statutory timeframes for regulatory decisions would also need to be reviewed and adjusted in line with the new processes.

Input sought from stakeholders

Do these options address the problems identified in relation to existing chemicals? If not, why not?

What are the implementation implications?

If these options were (or were not) to be adopted, how would this impact on your organisation?

12 Currently NICNAS has the power to add a chemical to AICS and impose conditions if responsibility for the regulation of the chemical has been transferred from another Commonwealth regulator such as the TGA or APVMA (refer section 15AA and 15AB of the ICNA Act). If Option C4 were adopted, it is proposed that the power to add such chemicals to AICS (and impose necessary conditions) would be retained.

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