PDF printable version of COAG Standing Council on Environment and Water submission (PDF 289 KB)
Submission in response to the Review of the National Industrial Chemicals Notification and Assessment Scheme Discussion Paper
A submission from the National Chemicals Environmental Management Working Group on behalf of the Senior Officials Committee to the COAG Standing Council on Environment and Water1
The Standing Council on Environment and Water (SCEW) is implementing three reforms arising out of the Council of Australian Governments’ (COAG) responses to Recommendations 9.1, 9.2 and 9.3 of the Productivity Commission’s 2008 Research Report on Chemicals and Plastics Regulation
. The SCEW reforms are part of a tranche of national reforms under Outcome 16 (Chemicals and Plastics Regulation) of the National Partnership Agreement to Deliver a Seamless National Economy
. The Outcome 16 reforms were developed to facilitate ‘improved national coordination and oversight to achieve an effective and efficient national system of chemicals and plastics regulation, while maintaining appropriate OH&S, public health and environmental protections.’
The Review of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has significant implications for the SCEW reforms.
In this context, the NChEM Working Group supports options to increase engagement between chemical regulators, such as revisiting or negotiating new memoranda of understanding between downstream regulators and NICNAS, and creating an ongoing forum to consider chemical policy issues. As the national risk management regulators for industrial chemicals are established by inter-jurisdictional cooperative arrangements, it is important to consider how these options can increase involvement of state and territory regulatory agencies, as well as providing better coordination between Commonwealth agencies.
The NChEM Working Group considers that:
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- the resources available for NICNAS should not be diverted to other functions at the expense of its hazard and risk assessment function, particularly for those regulatory functions more appropriately performed by other bodies;
- any changes to NICNAS should be coordinated with reforms underway arising from COAG’s decisions on the Chemicals and Plastics Regulatory Reform Agenda, which is now very advanced in the implementation process;
- engagement with jurisdictions is essential if the proposed options to the notification and assessment categories for exemptions, permits and certificates and related matters are pursued;
- expansion of NICNAS responsibilities into chemicals in articles would not be appropriate as this is already addressed under Commonwealth legislation;
- legislative responsibility for administering the import and export of Stockholm and Rotterdam Convention chemicals should be transferred to the Australian Government Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC) as already agreed by the Commonwealth and advised to COAG in relation to the Rotterdam Convention; and
- NICNAS should have appropriate data collection, compliance and enforcement powers to better perform its core role in hazard and risk assessment.
As the options raised in the NICNAS Review discussion paper are necessarily high level, the NChEM Working Group would like to emphasise the need for ongoing consultations with the Commonwealth, state and territory agencies responsible for implementing chemical risk management regulation to ensure the outcomes are effective, efficient and complementary.
In 2006, COAG identified chemicals and plastics as a priority area for review. A ministerial taskforce was created to develop ‘a streamlined and harmonised national system of chemicals and plastics regulation.’ As part of this work, the Productivity Commission was asked to undertake a review of chemicals and plastics regulation across all sectors in Australia and internationally.
The scope of the Productivity Commission review of chemical regulation was broad, encompassing primary and subordinate legislation, co-regulation, quasi-regulation and self regulation in each jurisdiction. The Commission was asked to:
- examine the interrelationships between the different tiers of government in Australia—Australian, state and territory and local—and identify any inconsistencies and duplication
- make recommendations for reforms to regulations and regulatory arrangements to enhance national uniformity and consistency, streamline data requirements and assessment processes.
The purpose of the Productivity Commission review was to consider the chemical regulation framework and make recommendations to improve this framework as a whole. The recommendations and analysis in the Productivity Commission report released in 2008 ultimately came to underpin the reforms being progressed under Outcome 16 of the National Partnership Agreement to Deliver a Seamless National Economy
When considering the framework for regulating industrial chemicals, the Productivity Commission concluded that:
‘ … industrial chemical hazard and risk assessments should ideally be performed by a dedicated technical expert agency separately from the subsequent standard setting needed to manage the risks of those chemicals. The case for separation of assessment from standard setting is particularly strong for industrial chemicals because they are used in a variety of ways, and the standard setting would more appropriately be handled by experts in the field.’ 2
This is broadly consistent with the current regulatory framework, in which NICNAS has responsibility for national hazard and risk assessment of industrial chemicals but has restricted risk management responsibilities except for chemicals introduced under permits which are defined by limited circumstances, and for monitoring chemicals which are exempt from assessment. Risk management bodies that comprise jurisdictional representation such as the poisons scheduling framework, Safe Work Australia and the National Transport Commission are responsible for setting risk management requirements for industrial chemicals in their sectors, where necessary.
The expanded risk management powers for NICNAS listed as options in the NICNAS Review Discussion Paper differ from that envisaged in the Productivity Commission report. If these options were to be pursued, it raises significant questions for the relationship with existing regulatory arrangements and other regulatory reforms requested by COAG in response to the Productivity Commission’s recommendations. It is important that the NICNAS options take note of this broader context and reform agenda.
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The options outlined in the NICNAS discussion paper are listed in Attachment A
. More detailed comments on the options proposed in the NICNAS paper are described below.
Options relating to the Regulatory Framework for Industrial Chemicals
The first three options aim to clarify the roles and functions of chemical regulators and increase policy interaction between NICNAS and other chemical regulators. In principle, the NChEM Working Group supports the proposals; however, it will be important to ensure that all jurisdictions are involved in the further development and implementation of these options. As noted by the Productivity Commission, national policy for chemical regulation is generally set by the ministerial councils in each sector, and control of use of chemicals is regulated either separately by the Commonwealth, states and territories, or cooperatively as part of a national scheme.
In relation to Option A1, the NChEM Working Group can support in principle the development of a risk assessment and risk management manual, however, it would require cross-portfolio and inter-jurisdictional collaboration to ensure that the end product is an agreed and accurate description of the role of each agency in the chemical regulation framework. We further note that this has already been done in some sectors. For example, the Office of the Gene Technology Regulator has published a Risk Analysis Framework covering both the risk analysis process and the approach for developing risk management decisions and licence conditions.
Similarly, in February 2009, the Environment Protection and Heritage Council (the predecessor to SCEW) finalised and published an Environment Risk Assessment Manual for Industrial Chemicals, and a similar manual for pesticides and veterinary medicines. The Guidance Manuals describe the process undertaken by the Department of Sustainability, Environment, Water, Population and Communities for environmental risk assessments, and provide an overview of:
- the steps taken to carry out an environmental risk assessment on industrial and pesticides and veterinary medicines, including lifecycle considerations;
- what data are needed and how they are used;
- nationally adopted criteria, such as Persistence/Bioaccumulation/Toxicity (PBT);
- how international considerations are taken into account; and,
- how risk assessors come to their recommendations about environmental risk management actions.
The Guidance Manuals outline the current practice for conducting environmental risk assessment of industrial chemicals, pesticides and veterinary medicines in Australia.
Industry was supportive of the development and publication of these documents. Similar risk assessment manuals for industrial chemical assessments for other sectors may assist in providing increased transparency to the risk assessment process.
Option A2 proposes to establish an ongoing cross-portfolio chemical policy group amongst Commonwealth chemical agencies. An ongoing cross portfolio group (similar to the Standing Committee on Chemicals) may improve the interface between NICNAS and other chemical policy and regulation agencies. As mentioned above, the majority of chemical risk management regulation is implemented either by, or in cooperation with, the states and territories through ministerial councils or national cooperative agreements. For this reason, it is important to maintain representation from state and territory jurisdictions when developing national policy frameworks. The SCOC currently has state and territory representatives for each of the ministerial councils (where possible) to ensure that all jurisdictions are adequately represented in the policy discussions.
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The NChEM Working Group supports Option A3 to update and create new memoranda of understanding (MOUs) between NICNAS and other chemical regulators that will increase clarity of the roles and responsibilities of each agency involved in chemical regulation. We see that an MOU would be crucial for underpinning NICNAS’ interaction with the new decision–making framework for the environment and the Commonwealth, state and territory environmental risk managers. This would assist agencies becoming aware of the potential risk management issues raised by a chemical before the assessment certificate is finalised, facilitating more timely risk management decisions by chemical risk management regulators.
Options relating to new industrial chemicals
These options are currently still very high level. While there is in-principle support for the objectives, it will be important to receive further information and have jurisdictional involvement about any proposed changes to the notification and assessment categories for exemptions, permits and certificates, or changes to the assessment process outlined in options B1, B2, and the first bullet point of B4. This information and involvement should demonstrate how the options would improve the efficiency of the assessment process without undermining the effectiveness of the risk assessment and subsequent risk management process.
It is important to ensure that the risk assessment process provides sufficient information to enable risk managers to develop scientifically sound risk management measures. For this reason, consultation with regulatory agencies in all jurisdictions on these proposed options, if they were to be pursued, will be needed to ensure that amendments to the assessment process can have regard to the other half of the system—the risk managers.
The NChEM Working Group supports in principle Option B3 to allow NICNAS to refuse an application that is incomplete.
Parts of Option B4 and Option B5 propose to expand the role of NICNAS to:
- refuse an assessment certificate for a substance it considers cannot be adequately risk managed; and
- impose interim conditions of use until regulators are able to introduce permanent risk management decisions.
While the reason and intent for these options is understood, in practice they raise some concerns, particularly whether there would be sufficient engagement with other chemical regulators and affected jurisdictions in the making of these decisions to ensure appropriateness and compatibility of decision making.
In our experience, a number of factors need to be taken into account to assess whether a chemical could be risk managed, including the practicality of risk management for the jurisdiction into which the chemical may be introduced. As concluded by the Productivity Commission, risk management decisions are best made by the agencies with expertise and understanding of the issues involved. Of concern is that NICNAS acting alone would not be the body best placed to assess whether a chemical presents an unmanageable environmental risk as it does not have the understanding of the capabilities, applicability or costs for each jurisdiction of such matters as disposal and treatment facilities, the relevant environmental regulatory frameworks and policy settings operating in each state and territory, or the regional environmental circumstances. Expecting it to acquire this understanding would be unrealistic. Efforts to do so would require a large increase in resources for NICNAS and potentially replicate the role of state and territory environmental agencies and existing Commonwealth environmental policies and legislation.
The environmental risk management reforms that the SCEW is progressing at the direction of COAG already aim to fill the gap in risk management for the environment in a more comprehensive manner, involving the jurisdictions, than would be possible for NICNAS to undertake alone. The reforms aim to provide a national framework to bring together Commonwealth, state and territory environmental expertise in making and implementing national risk management decisions to protect the environment from the impacts of industrial chemicals and to give greater national consistency in decision making for industry.
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In relation to interim risk management measures described in the third bullet point of Option B4, similar issues of risk management expertise and understanding arise. In addition, interim risk management measures could create a more complex, unpredictable and burdensome regulatory framework for industry, which could be subject to changing risk management controls on the same chemical, but from different regulators. This could also result in a complex appeal process for both interim and final risk management decisions, particularly in cases where the final risk management decision by the risk management regulator differed from the NICNAS interim controls.
The NChEM Working Group, however, does share the concern behind the options about the existing gap in time between the issuing of an assessment certificate by NICNAS, which allows a chemical to be introduced and used, and the subsequent making of risk management decisions for that chemical by the regulatory agency for that sector. We suggest that a better solution in Option B4 than NICNAS imposing interim risk management conditions would be the proposal that NICNAS withhold its assessment certificate where there is significant concern about the chemical. This could be for a set timeframe which would allow the relevant downstream regulatory body to consider the case as a matter of priority so that the final decision for the industry notifier which had submitted the chemical for assessment would be provided as quickly as possible. This approach would have dual advantages in that it is more consistent with the nature of NICNAS’s current assessment functions and would avoid the possibility of different interim and long term risk management decisions by NICNAS and the downstream regulatory body.
Greater consultation with risk management agencies by NICNAS before finalisation of the chemical hazard and risk assessment, combined with implementation of options A2 and A3 to increase interaction with risk management regulators, particularly with states and territories, could facilitate more timely risk management decisions. The environmental risk management framework currently being progressed by the SCEW would be aiming to minimise time to decision and would provide a single national point for all jurisdictions rather than NICNAS having to interact with multiple agencies within each sector, as well as between sectors. For environmental matters, this would be a simpler solution, as it would provide a purpose-designed, established mechanism for achieving inter-jurisdictional agreement amongst the agencies responsible for environmental management, noting that most industrial facilities relevant to chemicals, as well as recycling and disposal facilities, are administered by states and territories.
Options relating to existing industrial chemicals
It is important that any changes to the role and functions of NICNAS do not duplicate the roles of current risk management regulators or undermine confidence in the hazard and risk assessment process undertaken by NICNAS. As with the proposed options to change the assessment process for new chemicals, any changes to the assessment of existing chemicals would need to be subject to extensive consultation with existing chemical risk management regulators in all jurisdictions.
The NChEM Working Group supports options C1, C2, C3 and C5 in principle; however the discussion paper lacks sufficient detail to make an informed submission on potential outcomes and impacts of the proposed changes. If pursued, these options would require detailed consultations with existing chemical risk management regulators to ensure that the process for assessing existing chemicals meets the needs of the chemical risk management regulators in each jurisdiction. This will help ensure that chemical risk management regulators have continued confidence in the assessment process, and would reduce the likelihood of regulators in one or more jurisdictions developing regulations without the assistance of the hazard and risk assessment.
It is not clear whether Option C4 is intended to expand the role of NICNAS to allow NICNAS to generate chemical controls for any chemical to be included on AICS, or whether the proposal is to clarify the current wording of certain subsections to reinforce that the provisions only apply to adopting the risk management conditions of other regulators if the chemical is transferred to NICNAS from that regulator.
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Option C4 suggests that the power to impose conditions of use on chemicals after entry into AICS, set out in s15AA and s15AB of the Industrial Chemicals (Notification and Assessment) Act 1989
, be removed and replaced with powers to:
- impose a condition of use if an assessment has been undertaken and has demonstrated the condition is necessary; and
- remove a chemical from AICS if NICNAS considers that there are unacceptable public health, worker safety or environmental risks that cannot be risk managed.
We understand that subsections 15AA and 15AB were introduced in December 2011 to allow the Director of NICNAS to add chemicals which have been transferred from other Commonwealth regulatory schemes onto AICS without further assessment from NICNAS, and to maintain the chemical controls of the previous regulator over that chemical.
If the intention is to allow NICNAS to generate chemical controls for any chemical to be included on AICS, similar concerns arise as discussed for options B4 and B5 about the expansion of a direct risk management role for NICNAS, independent of the role of other risk management bodies. These concerns about lack of appropriate knowledge and expertise, duplication and impact on other regulators and jurisdictions might be alleviated by NICNAS being obliged to consult and obtain the support of other relevant regulators before taking regulatory action.
Options relating to Post market monitoring and enforcement
The NChEM Working Group supports in-principle Options D1, D2 and D3 which we see as efforts to ensure that chemicals are used in a manner that is consistent with the use and exposure patterns assessed by NICNAS, and that significant changes to chemical use should be subject to a further hazard and risk assessment.
In relation to the first part of Option D1, further information would need to be provided to explain how the re-assessment process would be streamlined for chemicals that are identified as being lower risk, and what criteria would be used to classify chemicals that would be subject to the streamlined process.
The NChEM Working Group is positive towards the second part of Option D1, to list on AICS the function or use that was assessed for introduction of the listed chemical. Any significant change in the proposed function or use of a hazardous chemical should require a new assessment.
This approach seems to be consistent with the intent of the current section 13 of the Industrial Chemicals (Notification and Assessment) Act 1989
, which was inserted by the Industrial Chemicals (Notification and Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004
. The Explanatory Memorandum described section 13 as giving:
…the Director the ability to annotate the Australian Inventory of Chemical Substances (AICS) to include additional particulars. These include details of the assessment of the industrial chemical, details of use, if applicable, and any other conditions, such as conditions that may give rise to secondary notification requirements.
Top of pageThis will give industry and the community better access to information about industrial chemicals and introducers will no longer have to try to envisage what uses their chemicals might be put to in the future because a particular chemical will only be able to be introduced for the specific use or uses that are specified for that chemical in the AICS. This will also prevent chemicals that have been assessed for a particular use from being imported or manufactured for a different use that has not been assessed, and which could be more harmful to health, safety and the environment.3
The NChEM Working Group also supports, in-principle, the possible introduction of an adverse experience reporting requirement, as suggested under Option D2. Adverse experience reporting provides important feedback on the operation of the risk assessment system. This system should include mechanisms for action on adverse experience reports. Clarification would be needed in relation to who would be expected to use the adverse reporting system (e.g. introducers, government agencies, industrial facilities). The system would probably be most effective if it were restricted to chemical users with a requisite level of technical expertise to make useful reports.
Option D3 suggests that a contemporary compliance and enforcement regime be introduced for NICNAS. The NChEM Working Group supports this concept in-principle; however, compliance and enforcement should focus on NICNAS’ current roles of risk assessment, administration of permits and post market monitoring of chemicals.
Options relating to other reforms affecting both new and existing chemicals
The NChEM Working Group supports options E1 and I1, supports in principle option F2 and does not support option I2. In relation to Options E2 and F1, the discussion paper lacks sufficient detail to make informed comment. Options G1 and G2 do not contain information on what is being proposed for NICNAS. The NChEM Working Group does not support options G1 and G2 regarding regulation of chemicals in articles if they were to involve an expansion of NICNAS’ responsibilities into chemicals in articles.
The NChEM Working Group strongly supports Option E1 to allow NICNAS to release information to other Commonwealth and state and territory regulatory agencies, to allow them to undertake their regulatory functions. This option would improve the interface between NICNAS and the risk management regulators, and address a major impediment to regulators developing risk management measures based on the NICNAS hazard and risk assessment in a timely fashion.
In relation to Option E2, we are unable to comment as we are unsure whether this option applies to the confidential section of AICS, to chemicals on the inventory more generally.
In relation to Option F1, the discussion paper lacks sufficient detail to make informed comment on potential outcomes and impacts of the proposed changes for how international assessments would be further utilised in the assessment for permits.
In relation to Option F2, which proposes increased alignment of the NICNAS assessment process with comparable international processes, the NChEM Working Group supports alignment in principle, including the use of relevant international data, taking cognizance of the decisions of comparable overseas regulators to reduce the regulatory burden on industry, to reduce time to market and to facilitate good regulatory decisions in Australia. However, the discussion paper lacks sufficient detail to make an informed submission on potential outcomes and impacts of the proposed changes. Such measures need to applied with good scientific judgement, recognising that regulators in overseas countries such as the United States of America, Canada and the European Union have taken their decisions with regard to their country’s specific environmental features which may differ from Australia (for example, water flows, soil chemistry, temperature, rainfall and biota). In some cases, the differences may significantly affect the environmental risk posed by the chemical.
The NChEM Working Group does not support options G1 and G2 regarding regulation of chemicals in articles if they were to involve an expansion of NICNAS’ responsibilities into chemicals in articles. This would not be appropriate as this is already addressed under Commonwealth legislation. As noted in the NChEM Working Group’s previous submission, the Product Stewardship Act 2011
establishes a comprehensive national framework to enable Australia to more effectively manage the environmental, health and safety impacts of products. Key drivers for a national approach to product stewardship include the need to have regulatory tools to respond to the growing, complex and hazardous waste stream, meet international obligations and encourage responsible action. It also aims to increase consistency nationally.
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The Product Stewardship Act 2011
defines a “product” as a thing (including a substance or mixture of substances) that is manufactured, and includes a regulation making power that can require importers, manufacturers, distributors or users of a product to take specified action in relation to a class of products. The objects of the Act include reducing the impact that substances contained in products have on the environment, and on the health and safety of human beings, throughout the lives of those products. As well, it provides for taking action in reducing or eliminating hazardous substances in products and in waste from products.
We consider that it would not be appropriate for the Industrial Chemicals (Notification and Assessment) Act 1989
to duplicate or conflict with the objects of existing legislation.
The NChEM Working Group supports the adoption of Option I1 (and hence does not support Option I2) that legislative responsibility for administering the import and export of Stockholm and Rotterdam Convention chemicals be transferred to the Australian Government Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC) as already agreed by the Commonwealth and advised to COAG (see page 64 of the NICNAS Review Discussion paper). DSEWPaC has lead responsibility for these Conventions and is responsible for the national treaty making processes which lead to Australia deciding whether to ratify the listing of the chemicals on the Conventions, as well as ensuring that Australia’s obligations under the Conventions in managing the chemicals are met.
In particular, the Stockholm Convention has requirements relating to use and disposal of chemicals which are significant and multifaceted and extend well beyond import and export of the raw chemical, including management of contaminated sites and stockpiles, waste disposal, the development of new destruction technologies and facilities, chemicals in articles, alternatives to the chemicals and the economic impacts on industry. Bringing the Stockholm, Rotterdam and Basel Convention (hazardous waste) responsibilities together into purpose-designed legislation would be a significantly more effective means of meeting Australia’s treaty obligations than the current fragmented approach. This is the approach already used in legislation administered by DSEWPaC for managing ozone depleting substances and synthetic greenhouse gases and legislation for managing hazardous wastes.
The NICNAS Review provides an opportunity to consider how the NICNAS assessment process might best coordinate with the risk management regulators for industrial chemicals in each sector. Increased engagement between NICNAS and the risk management regulators, particularly those in the states and territories, could facilitate increased adoption of risk management recommendations for industrial chemicals, provide a seamless process for industry, and improve health and environmental outcomes.
As NICNAS is the sole national hazard and risk assessment body for industrial chemicals, it is important that the risk assessment process remains the primary role of NICNAS. Expanding NICNAS’ role to increase risk management obligations could duplicate the role of current risk management regulators and create a more complex regulatory scheme. As the majority of chemical exposure to the environment occurs when the chemical is released or disposed of, chemical risk management regulations are best made in consultation with the environment regulators responsible for waste disposal and licensing of industrial facilities.
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The NChEM Working Group would welcome meeting with representatives of the Department of Health and Ageing and the Department of Finance and Deregulation to discuss the review of NICNAS and how it can integrate with the COAG chemical reforms for the environment.
Extract from Discussion Paper—Review of the National Industrial Chemicals Notification and Assessment Scheme: June 2012
Attachment A: Summary of Options
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:
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- 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.
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 health, 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.
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:
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- 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.
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I2. Retain regulations for the import and export of Stockholm and Rotterdam Convention chemicals under the ICNA Act.
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.
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A full list of all 2012 submissions can be viewed at June 2012 submissions to the review of NICNAS