NICNAS Reforms – Release of Consultation Paper 4

On 4 October 2016, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) released consultation paper 4 on the NICNAS reforms. The Australian Government has decided to reform the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to make regulatory the introduction of lower risk chemicals, and to continue to protect the Australian people (both workers and the general public) and the environment from any harmful effects of industrial chemicals. There has been extensive consultation with key stakeholders over the past twelve months to assist in developing advice to Government on the practical implementation of these reforms. The new consultation paper outlines the overarching framework for the reforms that is proposed to be set out in new legislation. The implementation detail described in this consultation paper will be included in primary legislation, delegated legislation and in guidance material. The details to be described in delegated legislation will be the subject of further consultation once Government has considered the proposal for the primary legislation. In summary, the proposed framework includes the following key features: Any person who introduces an industrial chemical in Australia (either by importing or manufacturing the chemical) would continue to be required to be registered with NICNAS. NICNAS would continue to maintain the Australian Inventory of Chemical Substances (AICS), which will list ‘existing’ industrial chemicals that any registered person may introduce (in accordance with the defined scope of assessment and any conditions of introduction, if specified on AICS). A registered person who wishes to introduce a ‘new’ industrial chemical (a chemical that is not listed on AICS), or to introduce an ‘existing’ industrial chemical outside the scope of assessment on AICS, would determine the indicative risk of their proposed chemical introduction by considering the chemical’s hazard (the intrinsic properties of the chemical that may cause harm to human health or the environment) and the degree to which people or the environment may be exposed to the chemical as a result of its introduction. Registered introducers would be expected to know the way in which a new chemical is proposed to be used in Australia (and hence its likely exposure to humans and the environment), and to hold (or have timely access to) information on its intrinsic hazards. Introducers are most likely to obtain this information from international sources, and must have the legal right to use any intellectual property associated with this information. The legislation would establish three categories of new industrial chemical introductions: Exempted, Reported and Assessed. Chemical introductions will be categorised separately for human health and environmental risks. The regulatory treatment of the chemical introduction would correspond to the highest category (health or environment), and the assessment would focus on the issues of particular concern. Exempted chemical introductions would be very low risk based on the intrinsic lack of hazard and/or their low exposure to humans or the environment. A registered introducer could import or manufacture an industrial chemical under the Exempted chemical introduction category without any other interaction with NICNAS prior to introduction, but must maintain records as to the basis on which the introducer categorised the chemical introduction as Exempted, and must declare to NICNAS as part of annual registration that they are an introducer under this category. Reported chemical introductions would be low risk based on their hazard and/or exposure, or because they have been assessed for the same introduction and use by a trusted international regulator (as determined by Government). A registered introducer would be required to: report this chemical introduction to NICNAS prior to commencing import or manufacture; maintain records as to the basis on which the chemical introduction was categorised as Reported; and (as part of annual registration) submit an annual declaration to confirm that the chemical introduction continues to meet the criteria for a Reported chemical introduction. Assessed chemical introductions would be medium to high risk chemical introductions based on the chemical hazard and/or exposure. A registered introducer must submit information to NICNAS for a risk assessment, and must not introduce the chemical until an assessment certificate has been granted. The assessment will focus on issues of particular concern for human health and/or the environment. To increase transparency, an assessment statement (appropriately protecting confidential business information (CBI) where necessary) will be published at the time the certificate is granted and linked to the AICS listing at the expiry of the certificate period or earlier on request. NICNAS could, on its own motion, initiate an assessment of any new or existing chemical, or group of chemicals, tailored to address issues of concern. NICNAS would maintain the ability to call for information on chemicals subject to assessment, either on a voluntary or mandatory basis. NICNAS would have broader monitoring and compliance powers, comparable to those of other regulators, because the reduction in the pre-market assessment of lower risk chemical introductions would be balanced by increased post-market monitoring, to ensure that human health and environmental protections are maintained. The legislation would continue to allow introducers to apply for protection of CBI that is required to be provided to NICNAS. Such protection would continue to be subject to a public interest test, to be reviewed every five years. Subject to Government agreement and Parliamentary consideration, the reforms would take effect from July 2018. Some changes to the existing scheme could take effect in advance of the wider reforms taking effect from July 2018 (these are detailed in the new paper). It is proposed there be a twelve-month transition period once the main reforms commence. NICNAS is seeking feedback on the proposed legislative framework described in consultation paper 4. The consultation will run until 4 November 2016. Further details are available at:

NICNAS, 4 October 2016 ; ;