NICNAS Reforms Community Stakeholder Workshop

Input from non-industry stakeholders on NICNAS Reforms Working within parameters of Government decision to adopt a risk- based and proportionate framework to assess industrial chemicals Workshop focus

Address community stakeholder concerns i.e. public health, worker safety and the environment Clear up some misconceptions Seek further advice on issues of concern Workshop purpose

Broad support for: Reducing complexity and confusion Focusing on higher risk chemicals Categorising chemicals based on hazard and exposure Publishing assessment statements for all NICNAS assessments NICNAS ability to: - refuse a certificate -initiate an assessment -issue voluntary and mandatory calls for information -only add chemicals to AICS after an assessment Responses to Consultation Paper 1 - Community

Access to easy-to-understand information for non-experts Any reduction in health and environmental protections Assessment of existing chemicals i.e. why is IMAP changing? Adequacy of public information – o why not publish information on Reported chemicals? Treatment of nanomaterials Animal testing Whether sufficient monitoring and enforcement powers o concerns that audit target for Class 2 seems too low Areas of concern - Community

Health and environmental protections NICNAS initiated assessments (NIA) Information to be made publicly available Nanomaterials Animal testing Future consultation Focus workshop discussion on:

Are there any other issues that you would like to cover? Have your say

Assessment effort more proportionate to risk Maintain health, safety and environmental protections Greater use of international assessment materials Reduction in regulatory burden ̴ $23 million annually Objectives of NICNAS Reform

Protections

Focus on higher risk chemicals Greater capacity to review chemicals already in use Capacity to prevent/stop introduction if risks cannot be managed Increased transparency for workers and others by linking NICNAS assessment statements to AICS Greater acceptance of non-animal test methods Encourages introduction of newer, safer chemicals Pre-market assessment for medium to high risk chemicals Strengthened audit, monitoring and enforcement powers (CP3) No pathway to AICS without NICNAS assessment How will protections be maintained?

NICNAS initiated assessments (NIA)

Current: NICNAS may initiate an assessment of any chemical on AICS Administrative = IMAP Legislative = PEC, secondary notification Future: Any chemical can be subject to NIA Replace PECs, IMAP and secondary notifications Concern: Key lessons learnt from IMAP review will be incorporated Tailored size and extent of the assessment Assessment Statements published for all NIA Risk managers’ and public consultation if any change proposed Proposed changes to NIA

NICNAS Initiated Assessments (NIA)

How should NICNAS prioritise chemicals for NIA? Have your say

Information to be made public

Criteria for all categorisations Notification of proposed NIA (not under certificate) Details of any proposed changes to AICS Assessment statement for all assessments Assessment statements linked to AICS entry Audit and compliance –CP3 What will be made public?

What information is most useful to the public? What changes could make the NICNAS website easier to use? How is chemical information best presented? How should NICNAS balance the need to protect legitimately confidential commercial information with the need for transparency? Have your say

Nanomaterials

CP2 includes more detail about nanomaterials: highest hazard band (E) for environment highest hazard band (D) for health This means: all nanomaterials will be assessed by NICNAS unless use is - transshipment, or -R&D < 100 kg per annum o with no direct release to the environment o treated prior to release to landfill/sewer if hazardous Assessment of nanomaterials

Animal testing

More flexibility applied to information considered sufficient (including waiver capacity) Greater acceptance of data from analogues and non-animal test methods Aligned with requirements for EU REACH and Canada: information on repeated dose toxicity -only required for chemicals introduced at >10T for non- cosmetic use -no current validated in vitro or in silico alternatives Reduced use of animal testing

Chemicals with low exposure will not require NICNAS pre-market assessment and will have less information requirements Means less animal testing because: o fewer chemicals will require information to be available on all hazard endpoints o more flexibility in information used to determine any risks of introducing the chemical Reduced use of animal testing

Future consultation

Is CP2 an improvement on CP1? Are community workshops useful? How can we involve community members better in addition to existing mechanisms? We’re using the NICNAS website, direct s and the SCC to reach the community – how can we use these mechanisms more effectively? Future consultation