The regulatory framework for industrial chemicals

A1. A detailed industrial chemicals risk assessment and management manual be developed. The manual would:
  • describe the roles and responsibilities of each of the agencies involved in risk assessment and management of industrial chemicals
  • describe NICNAS’ processes and approach to risk assessment and management
  • explain how NICNAS’ processes and approach interact with other risk assessors and managers of industrial chemicals.
A2.Following the cessation of the Standing Committee on Chemicals16, an ongoing Australian Government cross-portfolio group be established to consider chemical policy issues for the Australian Government. The group could for example: work to minimise duplication between Australian Government agencies; identify and develop options to address ‘gaps’ in regulatory coverage; and facilitate a co-ordinated approach to risk.

A3. Memorandum of Understanding (MOU) between NICNAS and other agencies (both Commonwealth and State and Territory) be reviewed and re-negotiated (or new ones developed) to ensure clarity regarding relative roles and responsibilities.

New industrial chemicals

Please note that each of the options detailed below would be likely to result in changes to the ICNA legislation (either the Act or the Regulations) as well as changes to administrative documents.

B1. In relation to all notification and assessment categories (for exemptions, permits and certificates):
  • reduce the number of categories
  • review current volume thresholds, data requirements and applicability criteria with a view to harmonising these with overseas arrangements where possible17. The objective of this would be to better clarify and harmonise data requirements and reduce complexity for industry.
B2. In relation specifically to exemptions:
  • consider new or expanded exemptions (e.g. options described in the LRCC evaluation report on increasing the volume limits and extending the 1% concentration exemption for non-hazardous chemicals in products)18.
B3. In relation to permits and assessment certificates:
  • introduce a pre-assessment statutory screening process, with timeframes, to enable NICNAS to refuse an application if it does not include all the necessary information. Additional information would only be able to be provided following a request from NICNAS or under the legislative obligations to provide new relevant information (note the PC Report – recommendation 4.5).
B4. In addition, in relation specifically to assessment certificates:
  • streamline the assessment process (note the PC Report – recommendation 4.1). For example, a model operating in the US EPA involves four distinct successive technical phases: chemistry review, hazard evaluation, exposure evaluation and the risk assessment/risk management phase. These phases are structured to ‘drop’ (from further assessment) chemicals of low risk early in the review enabling resources to focus on higher risk chemicals. As an example, polymers which meet select criteria are commonly dropped during the chemistry review. Such an approach could be considered for the assessment of new chemicals
  • enable NICNAS to refuse an assessment certificate if NICNAS considers that there is unacceptable public health, worker safety or environmental risk and risk management strategies cannot manage the risk to an acceptable level. 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
  • enable NICNAS to impose conditions of use on an assessment certificate where such conditions would automatically be removed/lifted once NICNAS receives notification from the relevant risk manager that they have implemented measures in order to manage the risk19. Any conditions of use imposed by NICNAS would only extend to the introducer (importer or manufacturer) as is the case with permits. Further, NICNAS would not impose conditions which are general obligations under, for example, work health and safety law. Conditions would only be imposed where a control is necessary beyond a generic obligation20. For example, where a concentration limit is necessary.
B5. In relation to AICS:
  • provide that after five years, or if the holder of an assessment certificate applies to NICNAS to have the chemical entered on AICS (to enable its introduction by anyone), require that if the chemical is subject to conditions of use (because risk management measures have not yet been imposed by the relevant risk manager) that either: the chemical not be entered on AICS until these measures are in place; or these conditions also carry over to AICS. As for assessment certificates, the conditions on AICS would be removed once other risk managers have ‘filled the gap’ (note the PC Report – recommendation 4.4)
  • enable NICNAS to refuse to enter a chemical on AICS if NICNAS considers that there is unacceptable public health, worker safety or environmental risk and risk management strategies cannot 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
  • provide that if, during the 5 years following assessment of a new chemical, the introducer decides (for commercial reasons) to stop introducing the chemical, NICNAS may choose not to enter the chemical on AICS provided this occurs with the agreement of the company.
B6. 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 applicant’s 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.Top of Page

Existing industrial chemicals

Amend the ICNA Act to:

C1. 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. 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 AICS. 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 mechanisms21.
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.Top of Page

Post market monitoring and enforcement

D1. Streamline the secondary notification process for existing chemicals. Consistent with the possible changes described at C2, the ICNA Act could be amended such that:
  • NICNAS re-assessment following secondary notification could either occur using a streamlined approach or through the more comprehensive PEC-style approach, depending on the nature of the hazards and risks
  • AICS could list the function or use of the chemical related to the original assessment. This gives clarity to the existing secondary notification obligations for significant variations to use.
D2. Supplement existing secondary notification requirements with a more comprehensive system of adverse effects reporting for new and existing industrial chemicals. Such a system would require introducers to mandatorily report adverse effects but would also enable anyone else, including users and risk managers, to report adverse effects to NICNAS. This could be similar to the APVMA system for adverse experience reporting.

D3. Introduce into the ICNA Act a comprehensive, graduated and contemporary compliance regime to enable NICNAS to better manage compliance by tailoring penalty provisions to the degree and seriousness of the non-compliance. For example, consideration could be given to the introduction of compliance tools such as assisted resolution, infringement notices and civil penalties.

Other reforms affecting both new and existing chemicals

Release of information and confidential commercial information

E1. Amend the ICNA Act to enable release of information (including confidential commercial information) to other Commonwealth and state and territory agencies where it is necessary for them to fulfil their regulatory responsibilities. For example, to undertake an assessment of risk, to consider risk management strategies in relation to industrial chemicals or to monitor compliance with regulatory requirements.

E2. Amend the ICNA Act such that at the time of listing on AICS, the chemical name would be subject to contemporary confidentiality criteria to increase transparency (e.g. align with work health and safety confidentiality arrangements relating to chemical name).

Use of foreign schemes/international assessments

F1. Increase utilisation of international assessments to support assessment for permits (noting that chemicals subject to permits are lower risk because there are ongoing post-market conditions and controls and there is a narrower set of uses)22.

F2. Better align the categories of, and data requirements for, exemptions, permits and certificates with, for example, the US, Canada and the EU23.

Chemicals in articles

G1. Clarify the role of NICNAS in relation to chemicals in articles as part of the development of the industrial chemicals risk assessment and management manual (option A1) and through the re-negotiation of MOUs where necessary (option A3).

G2. Amend the ICNA Act to clarify the role of NICNAS in the assessment of chemicals in articles, particularly imported articles.

Chemicals in cosmetics

H1. Responsibility for administration and enforcement of the Cosmetics Standard 2007 be transferred to the ACCC but the assessment of chemicals in cosmetics would remain with NICNAS.

H2. New provisions could be introduced into the ICNA Act (and on AICS) to specifically deal with chemicals in cosmetics (rather than continuing to treat them like industrial chemicals). This could include a separate inventory of cosmetic ingredients, a list of ‘pre-approved’ cosmetic ingredients, a list of ingredients that are not to be utilised (based on risk), and a separate list of data requirements for the assessment of cosmetics chemicals. Better alignment with international approaches would also be explored.

Import and export of chemicals under the Stockholm and Rotterdam Conventions

I1. Remove regulations relating to the import and export of Stockholm and Rotterdam Convention chemicals from the ICNA legislation, once appropriate alternative legislation has been enacted.

I2. Retain regulations for the import and export of Stockholm and Rotterdam Convention chemicals under the ICNA Act.

Governance - Committees

J1. Once the preferred reform options have been identified, consider the most appropriate role and membership of committees to best support the Director of NICNAS.

Relationship with the Department of Health and Ageing

K1. DoHA work with NICNAS to clarify roles and responsibilities and address any administrative and resource inefficiencies

16The Standing Committee on Chemicals (SCOC) was established by the Council of Australian Governments under a Memorandum of Understanding to achieve an effective and efficient national system of chemicals and plastics regulation. The Memorandum of Understanding establishing SCOC expires on 7 December 2014. Further information is avaliable at SCOC
17 Option F1 also explores the use of foreign schemes and international assessments (Refer Part 8)
18 LRCC Reforms evaluation
19 An alternative to this approach is to delay the issue of an assessment certificate (or delay the date of effect) until such time as the relevant risk managers have notified NICNAS that appropriate risk management strategies/conditions of use are in place. This option was not supported by the PC (refer page 70 of PC Report).
20 On the basis of a preliminary examination of past assessment certificates it is estimated that approximately 10% of assessment certificates would include recommendations that require controls that go beyond general legal obligations.
21 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 ad such chemicals to AICS (and impose necessary conditions) would be retained.
22 This also has linkages with Option B4, streamlining the assessment process for certificates.
23 This is also discussed in relation to Option B1.

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