The document outlines NICNAS reforms focused on enhancing risk assessment strategies for chemicals in Australia, emphasizing a targeted and flexible approach based on risk levels. It promotes using international data, reducing reliance on animal testing, and implementing responsive evaluations to better address safety concerns. The reforms aim to expedite evaluations by grouping chemicals for more effective data usage and high-quality risk assessments.

1. nicnas.gov.au Slide 1
New approaches to accelerate risk
assessment
Dr Brian Richards
Executive Director, Office of Chemical Safety, Australian
Government

2. nicnas.gov.au Slide 2
NICNAS reforms – a new approach to risk
assessment
Targeted approach to risk assessment
■ make regulatory effort proportionate to risk by
explicitly considering hazard and exposure
■ maintain health and environment protections
■ use international hazard data for local risk assessment
13 June 2017
Low risk chemicals
reduce pre-market
regulatory
requirements
increase post-
market monitoring
Higher risk
chemicals
pre-market
assessment

3. nicnas.gov.au Slide 3
Flexible acceptance of testing methods
13 June 2017
Reducing reliance on animal
testing
■ increase acceptance of silico and
in vitro methods to fulfil
regulatory requirements
■ implement ban on animal testing
for cosmetic ingredients
■ apply ‘weight of evidence’: in
silico < in vitro/in chemico < in
vivo

4. nicnas.gov.au Slide 4
Responsive evaluations
■ Evaluation triggers:
 international regulatory action
 adverse event reports
 requests from risk managers or government
agencies
 prioritised by NICNAS (own motion)
■ flexible process – tailored to focus on issue(s) of
concern
■ voluntary or mandatory calls for information
13 June 2017
Reforms allow evaluation of any industrial chemical (or
group of chemicals):

5. nicnas.gov.au Slide 5
Grouping chemicals
■ NICNAS Inventory Multi-Tiered Assessment and
Prioritisation (IMAP) framework groups chemicals to
‘read across’ data for one chemical to similar chemicals
with no (or limited) data
■ faster output of high quality risk assessments
■ increases availability of chemical safety information
■ maximises use of international information
■ key IMAP elements will be applied to post-reform
evaluations
13 June 2017
Accelerate evaluations by grouping similar chemicals:

6. nicnas.gov.au Slide 6
nicnas.gov.au
Thank you!
Dr Brian Richards
brian.richards@nicnas.gov.au