The Department of Healths Office of Chemical Safety (OCS) is guided by a science strategy to meet the challenges of the contemporary scientific and regulatory environment in assessing the health and environmental impacts of industrial chemicals. OCS staff administer NICNAS, which is a science-based assessment scheme of the Australian Government. It exists and operates within a specific legislative framework set out in the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act). The objects of the Act are to:
- assess the risks to human health and environment from industrial chemicals;
- provide information and make recommendations regarding these chemicals;
- give effect to Australias international obligations relating to the regulation of chemicals.
Reforms to the scheme are proposed in the Industrial Chemicals Bill 2017. The objects of the Bill remain essentially unchanged but the reforms re-balance assessment efforts away from pre-market assessment of new chemicals, to increased post-market scrutiny of chemicals. The Bill also proposes to ban the use of data derived from animal testing for the assessments of the risks of chemicals used solely as cosmetic ingredients, resulting in an increased use of data generated using alternative, non-animal test methods. Both the existing and reformed legislation contain expected outputs and outcomes to be achieved (objects of the Act). However, the legislation, as is often the case, does not contain performance standards, and does not define best practice in chemicals risk assessment. A key outcome of the science strategy is to continue to improve the scientific capacity and capabilities of OCS staff and implement best practice assessment methods to support transparent regulatory decision making. The science strategy guides the organisation in:
- identifying best practice in regulatory toxicology and risk assessment;
- undertaking risk assessments in accordance with best practice methodology;
- developing scientific staff capabilities in risk assessment including access to information about current scientific methods and emerging scientific challenges;
- maintaining stakeholder confidence in the regulation of industrial chemicals in Australia; and
- providing implementable, evidence-based recommendations to risk managers.
For OCS staff to maintain best practice in regulatory toxicology and chemicals risk assessment, the following objectives need to be met:
- establishing an organisational culture of identifying and adopting best practice;
- building and maintaining staff scientific expertise, including in priority science areas;
- establishing a repository of scientific information and assessment tools, including corporate knowledge, within the organisation;
- promoting consistency of scientific approaches across assessment programs in OCS; and
- encouraging sharing of information between OCS staff and other chemicals regulators
Establishing an organisational culture of identifying and adopting best practice
Identifying and adopting best practice in regulatory toxicology and chemicals risk assessment requires a cycle of organisational practices.
Best practice requires a commitment not only to potential adoption of new methods and approaches in regulatory toxicology and risk assessment, but to being involved in their development. Staff resources are required to maintain awareness of and contribute to discussions on developments in assessment methods and practices. Staff resources are also required to make informed decisions on the relevance and adoption of new methods and practices for the assessment and regulation of industrial chemicals in Australia.
Building and maintaining staff scientific expertise
Staff expertise needs to be attained and maintained. Due to the limited Australian universities training in toxicology and chemicals risk assessment, the science strategy recognises that the organisation has a key role in training staff. Linkages with universities in Sydney and elsewhere play an important role for enhancing staff expertise. Knowledge of the research underway at universities could assist in utilising appropriate new methods in hazard identification such as use of new types of data including high throughput and omics data, information management systems such as cheminformatics to utilise the high throughput data, exposure assessment methods and risk assessment. Also, staff need a working knowledge of industry practices to conduct occupational exposure and risk assessments.
Establishing a repository of scientific information and assessment tools
The science strategy recognises the need to obtain and maintain information on developments in specific scientific areas and be able to efficiently disseminate information to scientific staff. This requires a central repository of information and assessment tools for easy access by staff to build and maintain expertise. By definition, such a repository requires regular checking and updating. The strategy also recognises the utility and capabilities of new multimedia tools to capture and disseminate information for staff and encourages their use.
Ensuring consistency of scientific approaches
The organisation has several assessment programs. It is essential that the scientific assessment approaches of the different assessment programs are aligned. The assessment activities may differ across the OCS programs, relating to different overall aims of the activities, data availability and legislative responsibilities. However, the strategy recognises the need for consistency across the organisation in assessment approaches, that is, the overall methodologies used for risk assessment, the distinction between acceptable and unacceptable risk, the tools used to assess exposure and hazard, default values used as inputs for these tools and how the outputs of these tools are interpreted. This requires ongoing monitoring of issues by staff, coordination of effort and conversation between the assessment teams.
Ensuring sharing of information between NICNAS, other chemicals regulators and relevant academic community
The organisation must maintain links with other chemical regulators and relevant academic/research community. The science strategy encourages seminars from internal and external speakers and participation of staff in the Regulatory Science network. The Strategy also requires science leaders in the organisation to arrange annual targeted discussions between OCS and Department of the Environment and Energy (DoEE) staff with the aim of building and maintaining staff expertise and alignment of risk assessment approaches.
NICNAS, 31 October 2018 ;