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IMAP FAQs

Questions

Why is NICNAS implementing a new program for the assessment of chemicals on the AICS?

 

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is assessing the human health and environmental impacts of previously unassessed industrial chemicals that are listed on the Australian Inventory of Chemical Substances (AICS). The implementation of a new framework for the accelerated assessment and prioritisation of chemicals on the AICS arose from recommendations from an independent review of the NICNAS Existing Chemicals Program and subsequent review conducted by the Productivity Commission1. This activity is a major part of the reform of the NICNAS Existing Chemicals program and is in line with initiatives being taken to improve the assessment of chemicals used in industrial processes across the world. The program will deliver a more flexible and transparent program that is responsive to the needs of industry, the community and government.

1 http://www.pc.gov.au/__data/assets/pdf_file/0017/82331/
chemicals-plastics-regulation.pdf

 

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What will be the outcomes of Stage One?

 

Assessment outcomes including recommendations for risk management (where appropriate) for all Stage One Chemicals are being published, leading to more accessible chemical safety information flow and more transparent chemicals management.

Assessment outcomes from Stage One determine whether a chemical:

  • Poses no unreasonable risk to human health or the environment; or
  • Requires risk management measures to be instituted for safe use; or
  • Requires more in-depth assessment to fully determine its impact on human health and/or the environment.

Stage One of this program will conclude with an external review of the framework in the fourth year of operation. This review is expected to make recommendations on the most efficient and effective approach for the accelerated assessment of the remainder of the chemicals on the AICS.

 

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How will the assessments be conducted?

 

NICNAS has developed in consultation with stakeholders - the public, industry and governments and technical experts - a science and risk based framework for the accelerated assessment of chemicals on the AICS. This inventory multi-tiered assessment and prioritisation (IMAP) framework IMAP framework is a science and risk based model designed to align the assessment effort with the human health and environmental impacts of chemicals. It consists of three levels (tiers) of assessment, with the assessment effort increasing with each tier. Further details on the framework is provided here.

 

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How many chemicals are to be assessed and is there a timeframe for the assessments?

 

The new framework, IMAP, for accelerated assessing chemicals, will be applied to chemicals on Australia’s national inventory in a staged manner. During the first stage of its implementation, approximately 3,000 chemicals (termed “Stage One Chemicals”) will be screened and assessed.

 

This first stage will comprise at least the first two tiers of the framework, and take four years to complete.

 

Stage One of this program will conclude with an external review of the framework in the fourth year of operation. This review is expected to make recommendations on the most efficient and effective approach to the accelerated assessment of the remainder of chemicals on the inventory.

 

This stage will also include an external review of the new framework by an independent international expert who will make recommendations

 

In the first year, commencing July 2012, NICNAS will commence the assessment of around 800 chemicals identified from the Stage One Chemicals.

 

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How were the chemicals to be assessed in Stage One chemicals selected?

NICNAS consulted extensively with stakeholders – the public, industry and governments – throughout the development of the framework for the accelerated assessment of chemicals on the Australian inventory. A strong message was that certain groups of chemicals such as those chemicals for which information is already held or which have already been identified as chemicals of concern should be considered for assessment ahead of the majority of chemicals on the national inventory. This included chemicals for which NICNAS already holds exposure information, chemicals identified as a concern or for which regulatory action has been taken overseas and chemicals found in international studies analysing the chemicals present in the blood of babies umbilical cords.

 

Based on these broad criteria and sources identified, NICNAS collated a list of chemicals to be assessed in Stage One. Sources of information used to identify those chemicals of concern or regulated overseas include the Canadian Chemical Management Program, European Union (EU) Cosmetic Regulations, EU Registration, Evaulation Authorisation and Restriction of Chemicals (REACH) Regulations, United States Environment Protection Authority (US EPA) Programs and the Organisation for Economic Co-operation and Development (OECD) chemical programs.

 

The full list of Stage One Chemicals can be found here. All chemicals are searchable by chemical name, CAS number, assessment status and rationale for inclusion in the list.

 

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How were the chemicals to be assessed in the first year selected?

The number and selection of chemicals to be assessed in the first year has been based on a number of factors including:

  • Feedback from stakeholders;
  • Assessment resources available;
  • Availability of overseas assessment information;
  • Availability of Australian specific exposure information;
  • Chemical groupings and assessment approaches;
  • Representation of the three broad groups identified by stakeholders for early consideration; and
  • The ability of other agencies to consider NICNAS recommendations on a number of chemicals in parallel.

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Is it planned to assess the remaining chemicals on the AICS?

Stage One of this program will conclude with an external review of the framework in the fourth year of operation. This review is expected to make recommendations on the most efficient and effective approach to the accelerated assessment of the remainder of chemicals on the national inventory.

 

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Will NICNAS have to request additional data and how will this be done?

 

NICNAS has developed an approach whereby industry would not be required to provide any information on the chemicals they are using, in the early prioritisation and assessment stages (tiers I and II).

 

Nevertheless, the provision of information on volume of introduction and usage of the chemical in Australia may assist NICNAS in making more targeted risk determinations in the Australian context.

 

Additionally non-publically available sources of toxicity and eco(toxicity) data may assist in filling gaps in available data.

 

Therefore, NICNAS welcomed the voluntary provision of information by manufacturers, introducers and users of the Stage One Chemicals, particularly those that will be assessed in the first year, within a 90 day period (ending 15th September 2012). A template was available for the provision of any information.

 

NICNAS will publish the list of chemicals for which assessment will commence in the second year, prior to July 2013, to allow for the voluntary provision of information for these chemicals.

 

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What if I don’t know the use of my chemical?

 

NICNAS understands in some cases companies may not know the full extent of how the chemicals they are introducing are used, (E.g. Bulk suppliers/resellers of chemicals to downstream users). However, other information that companies may hold can assist NICNAS, such as:

  • Names and CAS numbers of chemicals being introduced;
  • Volume information from a particular company where accompanied by an insight into the market share of that company;
  • Concentrations of chemicals imported and/or manufactured in mixtures/products.

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Will NICNAS be considering information generated overseas?

Yes. To ensure efficiency and reduce duplication of effort, NICNAS will utilise information available overseas, where appropriate for the Australian context. To facilitate the use of this information, the human health and environmental scientific criteria are aligned with existing hazard classification frameworks already in use across industry and internationally.

 

NICNAS has extensively incorporated international information into the IMAP Framework including from:

  • The Canadian Categorisation of the Domestic Substances List;
  • EU REACH and EU Classification and Labelling Program;
  • European Commission Cosmetic Ingredient Database;
  • Several Programs in the United States such as US EPA’s HPV Program, US EPA Action Plans and Agency for Toxic Substances and Disease Registry Publications.
  • Organisation for Economic Cooperation and Development (OECD) High Production Volume Program;
  • OECD QSAR Application Toolbox; and
  • International Program on Chemical Safety (IPCS) Publications.

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How will stakeholders be involved in the process?

Regular updates on progress of Stage One will be provided on the NICNAS website and publications in NICNAS matters and Chemical Gazette. NICNAS will also continue to work with key stakeholders through its advisory groups.

 

Opportunity for public comment on the assessment outcomes will be available in accordance with the intent of the Industrial Chemicals (Notification and Assessment) Act. The public comment phase will be notified in the Chemical Gazette and on the NICNAS website.

 

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