IMAP Framework

National Industrial Chemicals
Notification and Assessment Scheme
Inventory Multi-tiered Assessment and

Prioritisation (IMAP) Framework
NICNAS:IMAP Framework
Glossary
TERM Explanation
2D two dimensional
ACCORD Australian Consumer and Specialty Products Association (was ACPSA)
ACGIH American Conference of Industrial Hygienists
ACHHRA Australian Centre for Human Health Risk Assessment
AICS Australian Inventory of Chemical Substances
AIOH Australian Institute of Occupational Hygienists
ALCAS Australian Life Cycle Assessment Society
APVMA Australian Pesticides and Veterinary Medicines Authority
ATSDR [US] Agency for Toxic Substances and Disease Registry
BAF bioaccumulation factor
BCF bioconcentration factor
BMF biomagnification factor
C&L classification and labelling
CCRIS Chemical Carcinogenesis Research Information System
CLP [regulation] on Classification, Labelling and Packaging
CMR Carcinogenic, mutagenic and reproductive
CosIng [EU] Cosmetics Ingredients List
DoE Department of the Environment
(formerly
DSEWPaC and
DEWHA)
DSL [Canadian] Domestic Substances List
EC European Commission
EC Existing Chemicals
EC50 Median effective concentration
EEWG Environmental Expert Working Group
EIMS Electronic information management system
EPA Environmental Protection Authority
EPI [US EPA] Estimation Programs Interface
EU European Union
EWG expert working group
FSANZ Food Standards Australia and New Zealand
GHS Globally Harmonised System of Classification and Labelling of Chemicals
HazFIT Hazard Flag Identification Toolkit
HHEWG Human Health Expert Working Group
HPV High Production Volume [Program]
HSDB Hazardous Substances Data Bank
HSIS Hazardous Substances Information System
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TERM Explanation
HVICL High Volume Industrial Chemicals List
IARC International Agency for Research on Cancer
IMAP Inventory Multi-tiered Assessment and Prioritisation
IPCS International Program on Chemical Safety
ISG Implementation Steering Group
Koa octanol/air partition coefficient
Kow octanol/water partition coefficient
IUR/CDR Inventory update reporting/Chemical data reporting
LC50 Median lethal concentration
LD50 Median lethal dose
LOAEC lowest observable adverse effect concentration
LOAEL Lowest observed adverse effect level
NICNAS National Industrial Chemical Notification and Assessment Scheme
NIHHP National Institute of Health Household Product Database
NOEC No observed effect concentration
NPI National Pollutant Inventory
NTP RoC National Toxicology Program—Report on Carcinogens
OECD Organisation for Economic Co-operation
PBT Persistent, bioaccumulative and toxic
PC Productivity Commission
PEC Predicted environmental concentration
PNEC Predicted no-effect concentration
PRTR Pollutant Release and Transfer Register
QSAR Quantitative Structure Activity Relationship
REACH [EU] Registration, Evaluation, Authorisation and Restriction of Chemicals
RQ Risk quotient
RSC Review Steering Committee
SIDS Screening Information Data Sets
SMILES Simplified molecular input line entry system
SPIN Substance in Preparations in the Nordic Countries
STP [model] Sewage Treatment Plant
SVHC Substances of very high concern
TGA Therapeutic Goods Administration
TWP Technical Working Party
US United States
Unknown or variable composition, complex reaction products,
UVCB
biological material
WHO World Health Organisation
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TERM Explanation
WHS Worker health and safety (was OHS)
Table of contents
Glossary.......................................................................................................................................1
Table of contents.......................................................................................................................iii
Introduction................................................................................................................................1
Background.................................................................................................................................1
Existing Chemicals (EC) Program...........................................................................................2
Review of the Existing Chemicals Program.......................................................................2
Framework development—consultation...................................................................................3
Framework development—approach.......................................................................................4
Exposure approach development.............................................................................................6
Hazard approach development................................................................................................6
Pilot evaluation........................................................................................................................7
Staged implementation of the IMAP Framework....................................................................8
Overview of IMAP Framework.................................................................................................9
Scientifically robust risk-based approach..............................................................................10
Achieving assessment outcomes early in the framework.......................................................10
Using overseas data...............................................................................................................11
Advancements in assessment methodologies........................................................................11
A flexible approach to exposure information (actual, surrogate or default)...........................11
Multi-tiered assessment............................................................................................................11
Tier I assessment...................................................................................................................11
Tier II assessment..................................................................................................................13
Tier III assessment.................................................................................................................13
Risk characterisation................................................................................................................13
Human health risk characterisation........................................................................................14
Tier I human health assessment and prioritisation matrix.................................................14
Environmental risk characterisation......................................................................................19
Information considered in the IMAP Framework.................................................................23
Hazard Information...............................................................................................................23
Classification information/international lists of chemicals...............................................23
International assessments.................................................................................................24
Predictive models.............................................................................................................24
Tabulated empirical data..................................................................................................25
Other data sources............................................................................................................25
Exposure information............................................................................................................26
Actual exposure data held by NICNAS............................................................................26
Surrogate information sources..........................................................................................26
Publication of assessment information....................................................................................28
Tier I assessment...................................................................................................................28
Tier II assessment..................................................................................................................28
Tier III assessment.................................................................................................................28
Publication of assessment outcomes......................................................................................29
References.................................................................................................................................29
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This document outlines the development, key features and staged implementation of the
Inventory Multi-tiered Assessment and Prioritisation (IMAP) Framework.
Introduction
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is
assessing the human health and environmental impacts of previously unassessed industrial
chemicals listed on the Australian Inventory of Chemical Substances (AICS). The
implementation of a new framework for the accelerated assessment and prioritisation of
chemicals on AICS arose from recommendations from an independent review of the
NICNAS Existing Chemicals Program (see Footnote 1) and subsequent review conducted by
the Productivity Commission (Productivity Commission 2008). 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.
Background
The National Industrial Chemical Notification and Assessment Scheme (NICNAS) was
established in 1990 under the Industrial Chemicals (Notification and Assessment) Act 1989
(Cwlth) to complement existing regulatory assessment mechanisms for agricultural and
veterinary chemicals, pharmaceuticals and food additives.
NICNAS‘s assessment process for chemicals in the Existing Chemicals Program has recently
been independently reviewed, along with a review by the Productivity Commission. The
recommendations from these reviews resulted in a new assessment process—the Inventory
Multi-tiered Assessment and Prioritisation (IMAP) Framework. The staged implementation of
the IMAP Framework (the framework) commenced in July 2012.
The framework will assess industrial chemicals registered on the national inventory, the
Australian Inventory of Chemical Substances (AICS). The AICS contains a listing of all
industrial chemicals used in Australia from 1 January 1977. The chemicals in the Existing
Chemicals Program (which form the majority of AICS) were listed without assessment of
their effects on human health and the environment. The AICS also includes chemicals
assessed through its New Chemicals Program after February 1990 when NICNAS was
established.
The framework objectives are to:
 identify and rapidly assess existing chemicals of concern;
 improve chemical safety information flow and chemicals management; and
 deliver a flexible and transparent approach that is more responsive to the needs of
industry, community and government stakeholders for the large number of chemicals on
AICS still requiring assessment.
1
Copies of Promoting Safer Chemical Use: Towards better regulation of chemicals in Australia (Final
report and recommendations), December 2006, are available from NICNAS on request.
Published: Tuesday, 27 August 2013 P a g e | 1 of 29

Existing Chemicals (EC) Program

This key program assesses chemicals listed on AICS as a priority in response to concerns
raised about their human health or environmental effects—or both. Recommendations on
the safe use of existing chemicals made in EC assessment reports describe measures to
mitigate identified risks to human health and the environment.
Review of the Existing Chemicals Program

The NICNAS EC Program was independently reviewed between May 2003 and
December 2006 (see Footnote 1). The review examined the program against emerging
national and international trends to determine if it was sufficiently responsive and
flexible to meet the national needs and priorities of NICNAS‘s stakeholders, while
ensuring continued efficient and effective use of resources.
The review‘s major concerns were that:
 most chemicals on AICS were initially listed without assessment when AICS was
established, based on their history of use, and most have not since been assessed for their
effects on human health and the environment; and
 the current Priority Existing Chemical assessment process is not flexible enough to respond
adequately, or in a resource-efficient manner, to stakeholder concerns.
The review confirmed that the assessment process is neither flexible nor resource-efficient
and recommended mechanisms to:
 better determine national priorities for assessing existing industrial chemicals;
 efficiently use relevant overseas testing and assessment reports; and
 improve response to the needs of the community, government and industry
regarding access to scientifically sound information on industrial chemical hazards
and risks.
An external Review Steering Committee (RSC) comprising three representatives each from
the community, industry and government, and with an independent chair, managed the
review. It was supported by a number of technical working groups, each composed of two
community, industry and government representatives.
The review consulted extensively with business, the community and governments to achieve
its stated aims, culminating in the final report and recommendations (see Footnote 1), which
has 23 recommendations for improving flexibility and increasing responsiveness to
stakeholder needs. The report and its recommendations were endorsed by the Director of
NICNAS and have been supported by successive governments since early 2007.
The final report included several recommendations for change that affect which chemicals are
to be assessed, including:
 Recommendation 4.1: That NICNAS develop an overall framework for the screening
of chemicals of concern, including the weighting of data elements (hazard, risk
indicators, adverse incidents), public nomination processes and other scientific-based
criteria in consultation with stakeholders and using the principles and protocol of the
NICNAS Community Engagement Charter; and
 Recommendation 4.2: That NICNAS undertakes screening of AICS-listed chemicals for
hazard and/or risk indicator elements with a focus on:
o chemicals that are on the High Volume Industrial Chemicals List (HVICL)
(risk indicator element);

o unassessed chemicals on the Hazardous Substances Information System (HSIS)—

hazard element;
o chemicals classified as hazardous to the environment for example under Globally
Harmonised System of Classification and Labelling of Chemicals (GHS) when
introduced, (hazard element);
o chemicals that are carcinogens, mutagens, and/or reproductive toxicants (CMR)
(hazard element);
o chemicals that are persistent, bioaccumulative and toxic (PBT) (risk indicator); and
o chemicals in use with other agreed health and/or environmental effects, for example
sensitisation and neurotoxicity (hazard element) (NICNAS 2006).
The recommendations in the review were supported by the Productivity Commission (PC) in
its Research Report on Chemicals and Plastics Regulation (see Footnote 2). The PC
considered the NICNAS EC Program and recommended (Recommendation 4.6) that:
NICNAS should implement a program to greatly accelerate the assessment of existing
chemicals that:
 screens all existing chemicals to develop a list of high-priority chemicals for assessment;
 makes greater use of simulation techniques based on the hazards of chemical
analogues [chemicals with similar characteristics]; and
 reviews the scope for recognising the existing chemical assessment schemes of a range of
other countries as ―approved foreign schemes. Priorities should be the schemes operated
by Canada, the European Union [EU] and the United States (Productivity Commission
2008).
Framework development—consultation
NICNAS has worked extensively with stakeholders and technical experts since 2008 to
develop a framework for the assessment and prioritisation of chemicals on AICS. The
consultation process is illustrated in Figure 1.
2
The Australian Government Productivity Commission‘s Research Report, Chemicals and Plastics
Regulation can be accessed at: <http://www.pc.gov.au/__data/assets/pdf_file/0017/82331/chemicals-plastics-
regulation.pdf>

Figure 1: Framework development—consultation
Implementation Steering Group

Industry, Community, Australian and State/Territory
Governments Representatives
Exposure information
Industry Workshop—Dec ‘09
Technical Working Party • Inventory management systems
Industry, Community & Availability of exposure info
•
Government nominees
Stakeholder Workshop—Dec ‘10
• Examine 3 options for provision
of exposure indicator
information
Expert Workshop—Mar ‘12

• Information to allow refinement
of surrogate and default
exposure
approaches
Human Health Environmental

Hazard Hazard Criteria
Criteria Expert Group
Expert Group
The primary stakeholder consultative group, the Implementation Steering Group (ISG)
consisted of members from the community, industry and government (Commonwealth, state
and territories). This group was supported by a Technical Working Party (TWP) and two
expert groups: one concentrating on environmental matters (Environmental Expert Working
Group—EEWG), the other on human health (Human Health Expert Working Group—
HHEWG).
Additional consultation processes were employed to explore mechanisms to obtain and use
information to help determine the potential for exposure of the public, workers and the
environment to chemicals on AICS. These included:
 an industry consultation workshop to explore the availability of data from inventory
management systems;
 a subsequent multi-stakeholder workshop to gain views on three options for industry to
provide exposure indicator information; and
 an expert workshop on IMAP exposure estimation.
Framework development—approach
To develop the framework NICNAS explored international approaches, focusing on Canada,
the USA, Europe and international agencies such as the Organisation for Economic Co-
operation and Development (OECD) and the World Health Organisation (WHO). The
Canadian scheme was selected as the best approach on which to base the framework due to
the similarity between the two countries’ regulatory arrangements, the resources needed for
the program, the impact on industry and program objective.
Consequently, NICNAS worked very closely with Canada, reducing duplication of effort

and resources in the developmental work.

Key features adapted from the Canadian scheme include screening chemicals against risk-
based criteria, using a tiered risk-based model to align the assessment effort against human
health and environmental chemical impacts, and using separate approaches for human health
and environmental assessments. Lessons learned from Canada, such as integrating assessment
outcomes into the screening process, have also been incorporated to optimise the framework.
Over 10 options for the framework were explored, including:
 three hazard-driven options to deprioritise chemicals solely on the basis of hazard
before seeking volume and use information from industry;
 two risk-based options that required a variety of exposure information from industry at an
early stage;
 one option that adopted the Canadian priorities/deprioritised chemicals;
 one option that looked at ways to reduce the number of chemicals for consideration; and
 three modified risk-based options developed in conjunction with stakeholders
and technical experts.
The options took into consideration information from consultations with stakeholders
and pilot/preliminary studies carried out by NICNAS as listed below:
 initial prioritisation of a subset of 1000 chemicals randomly selected from AICS based on
national/international classifications focusing on human health;
 analysis of Quantitative Structure Activity Relationship (QSAR) model results for
the organic chemicals in the 1,000 subset focusing on human health;
 applying environmental criteria agreed by the EEWG to Canadian empirical/QSAR data
collected on organic chemicals on the Canadian inventory;
 applicability of Canadian use/volume data to Australian prioritisation; and
 analysis of the 5,000 AICS chemicals not on other inventories.
The options were evaluated against objectives and general principles for assessment and
prioritisation of AICS. Other factors considered included:
 the practicality of the information types sought from industry (for example identity of
chemicals, volume and use data) taking into account feedback from the December 2009
industry workshop (the Workshop Report—NICNAS Exposure Data Workshop
Tuesday 27 October 2009 is available on request to imap@nicnas.gov.au);
 how information could be sought from industry (for example publication of hazard-
based lists, targeted requests for information and collecting exposure information on
introduced chemicals);
 the extent to which information from the Canadian categorisation of the Canadian
Domestic Substances List (DSL) could be used;
 the extent to which overseas information could be used to reduce duplication of effort;
 the potential for early outcomes;
 the extent to which low-concern chemicals and classes of chemicals can be removed
from further consideration in the assessment process to ensure that resources are not
unnecessarily spent on these chemicals; and
 the resource implications for both NICNAS and industry.
Many Canadian approaches and tools could be built on, although adopting the outcomes
from the Canadian categorisation of the DSL was considered not appropriate as the
relevance of the Canadian exposure information to Australia is uncertain, that is: chemicals
that were not categorised for further assessment in Canada due to low potential for exposure
could have high potential for exposure in Australia. In addition, certain worker health and

safety (WHS) hazards were not included in the Canadian criteria used to identify chemicals
of concern, as WHS matters are not considered in the Health Canada assessments.
The ISG and TWP supported a risk-based approach, which considered both hazards and
potential for exposure. Stakeholders indicated the difficulty for industry to provide exposure
information, the desirability of using overseas-generated information to reduce duplicated
effort, and the need to achieve assessment outcomes early in the program.
Exposure approach development

Input from the ISG and TWP produced three modified risk-based options. These options,
which differed in the approach to provision of exposure information by industry, were
presented to a broad stakeholder workshop in December 2010 (the Workshop Report—
NICNAS workshop on options for the framework for the assessment against risk-
based criteria and prioritisation of chemicals on the Australian Inventory of Chemical
Substances (AICS) is available on request). Participants included individual companies,
industry associations, state and territory governments, Australian government
departments, and community representatives.
In the workshop, concerns were raised about the cost for industry to voluntarily provide
data. Consequently, NICNAS developed a flexible risk-based framework, which does not
require up front industry participation. This approach uses surrogate information, for
example from overseas sources, or conservative default values, where actual or surrogate
information is not available. This approach, and further refinement of surrogate and default
exposure methods, were discussed at an expert workshop on exposure estimation in March
2012 (the Workshop report—NICNAS workshop on exposure estimation in the inventory
multi-tiered assessment and prioritisation (IMAP) framework is available on request).
Hazard approach development

Two expert working groups (EWGs) were established to develop scientific criteria for
environmental and health hazard indicators respectively.
The Environmental EWG (EEWG):
 defined the environmental hazard indicators;
 developed scientific criteria for the hazard indicators including a framework to determine
persistence, bioaccumulation and toxicity (PBT);
 identified predictive models appropriate for the program; and
 developed approaches for the different classes of chemicals on AICS and managing the
different data sources.
The criteria developed for PBT are based on the National PBT criteria, which have been
adopted from international criteria. The guidance material for approaches for handling
various classes of chemicals on AICS was available from Canada, which the EWG members
supported. A strategy for the use of predictive models was also agreed.
The Human Health EWG (HHEWG):
 identified the human health hazard indicators;

 reviewed scientific criteria developed by NICNAS for the indicators; and

 advised on the practicality of using the criteria.
The HHEWG agreed on the following hazard indicators as being relevant: acute toxicity,
corrosivity/irritation, sensitisation, repeated dose toxicity, genotoxicity, carcinogenicity,
reproductive/developmental toxicity, neurotoxicity and endocrine disruption. The group also
agreed on the criteria for the indicators, based on comparison of the various
national/international classification and labelling schemes, in order to maintain alignment
with overseas countries and ensure that the work undertaken by them could be efficiently
used in the framework.
A hierarchy for these indicators based on their relative severity of effect was agreed.
Carcinogenicity, genotoxicity and reproductive/developmental toxicity (including
neurotoxicity and endocrine disruption), were given higher weighting because they
are considered more important.
The hierarchy is: carcinogenicity = genotoxicity = reproductive/developmental toxicity =
neurotoxicity = endocrine disruption > acute toxicity > repeat-dose toxicity > sensitisation >
irritation.
Following a pilot evaluation of the framework (see below), independent expert advice was
sought to confirm the grouping of the agreed hazard indicators and also on mechanisms to
identify chemicals and polymers of low concern (see Risk characterisation for more
information).
Pilot evaluation
The ISG and TWP agreed that a pilot should be run to evaluate the framework—including
the criteria and approaches developed by the EWGs—before implementation.
Consequently, NICNAS undertook a pilot evaluation on the 1,000 randomly selected
chemicals from AICS. Although random, the 1,000 chemicals were considered to represent
the overall distribution of chemical classes on AICS.
The pilot‘s purpose was to test the practicality of the hazard criteria developed by the EWGs
and optimise technical aspects of the framework.
Based on the outcomes, the pilot was deemed a success, confirming the appropriateness of
the approaches and methodologies to be used for the framework. It also enabled additional
strategies and procedures to be developed, before implementing the framework, to enhance
the efficiency, quality and consistency of the assessments.
The pilot:
 confirmed the applicability of the hazard criteria and approaches developed by the EWGs;
 demonstrated the efficiency that can be gained by applying the multi-tiered framework;
 demonstrated that the framework will deliver chemical safety information and
recommendations for regulatory outcomes at an early stage;
 confirmed that international information can be extensively integrated into the framework
and respective assessments;
 enabled a strategy to be developed to leverage international information appropriately
to ensure efficiency and reduce duplication of effort;

 validated the use of surrogate exposure information from overseas sources and
conservative default exposure values where Australian data were not
available;
 strengthened NICNAS‘s QSAR modelling capabilities and helped to develop a strategy to
use this advancement in assessment methodologies;
 led to refinements in assessment tools and approaches;
 increased the framework’s scientific robustness by developing internal guidance and
quality assurance strategies, including a Tier I validation step and peer review
strategy;
 provided information for the key elements and format required for the assessment
report templates; and
 supplied the necessary features of an EIMS to ensure efficient management, organization
and tracking of the large amounts of input and output data generated through IMAP.
The enhancements to the framework identified during the pilot have been adopted for
chemical assessment in Stage One of the framework‘s implementation.
Staged implementation of the IMAP Framework

The framework is being implemented in stages. From July 2012, NICNAS began assessing
around 3,000 existing chemicals on AICS using the framework (up to at least Tier II). The
chemicals in the first group to be assessed are identified as Stage One chemicals.
The Stage One chemicals were identified based on characteristics agreed by stakeholders as
priorities for early consideration, and from sources subsequently identified by NICNAS
and stakeholders (see Table 1 below).

Table 1: Sources used to identify the Stage One chemicals

Category
Chemicals reported in the NICNAS 2006 High Volume
Chemical Survey
Chemicals for which NICNAS
Chemicals on the NICNAS candidate list
holds exposure data
Chemicals for which NICNAS holds data as a result of various
other information gathering activities or technical projects
Chemicals assessed as part of the Canadian Challenge
i
program
Chemicals assessed as part of the Canadian
Petroleum Sector Stream Approach
Chemicals classified as carcinogenic, mutagenic or reprotoxic
(CMR) chemicals
International Nomenclature of Cosmetic Ingredients (INCI)
listed chemicals listed on Annex II of the Cosmetic
Chemicals identified as Regulation EC No 1223/2009 (banned)
a concern or for which
INCI listed chemicals listed on Annex III and V of the Cosmetic
action has been taken
overseas Regulation EC No 1223/2009 (restricted)
Chemicals with United States (US) Environmental Protection
Agency (EPA) action plans
ii
Chemicals included in the EU REACH Substances of Very
High Concern Candidate List
Chemicals listed in Annex VXII of EU REACH Regulation
2006
OECD Perfluorinated chemicals
Chemicals detected in umbilical cord blood in a study

Chemicals detected in conducted by the Environmental Working Group
international studies analysing
chemicals present in the Chemicals detected in umbilical cord blood in a study
blood of babies’ umbilical conducted for Greenpeace and the World Wildlife Fund UK
iii
cords. by TNO .
i Additionally NICNAS is liaising with Canada to identify some of the chemicals categorised as medium
priority chemicals for cooperative work.
ii Registration, Evaluation, Authorisation ad Restriction of
Chemicals
iii iii Netherlands Organisation for Applied Scientific Research
Stage One of this program will conclude with a 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 assessment and prioritisation of the remainder of the chemicals on
the AICS.
Overview of IMAP Framework

The framework is a science- and risk-based model designed to match the assessment effort
with the effects of chemicals on human health and the environment. It consists of three tiers
of assessment, with the assessment effort increasing with each tier, as illustrated in Figure 2.

Figure 2: IMAP Framework
The framework aims to resolve the main issues raised by stakeholders, including the
difficulties indicated by industry to provide exposure information, the desirability of reducing
duplication of efforts through using information generated overseas and achieving assessment
outcomes early in the program.
Key features of the framework are:
 scientifically robust risk-based approach;
 achieving assessment outcomes early in the framework;
 using overseas data;
 advancements in assessment methodologies; and
 a flexible approach to exposure information (actual, surrogate or default).
Scientifically robust risk-based approach

The framework uses simple and transparent criteria to determine the potential exposure and
risks from chemicals to human health and the environment. The framework also allows for
expert judgment (for example peer review) to be applied where appropriate.
Achieving assessment outcomes early in the framework

This approach takes into account advice and requests from stakeholders, including industry
and the community, to produce assessment outcomes early in the program and for each tier
(see Figure 2). The effort and resources that will be used should match the potential risk of
the chemical. At each successive tier, the comprehensiveness (and hence resource
intensiveness) of the assessments increases, while the number of chemicals requiring
assessment decreases.
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Using overseas data

A number of other countries and international agencies are generating or gathering
information about the human health and environmental effects of a broad range of chemicals.
To ensure efficiency and reduce duplication of effort, NICNAS will use this information,
where appropriate, for the Australian context. To maximise this information, the
framework‘s human health and environmental scientific criteria are aligned with existing
hazard classification frameworks already in use across industry and internationally.
Advancements in assessment methodologies

To ensure best practice in assessing chemicals in Australia, NICNAS will use internationally
recognised assessment tools to fill gaps in available data on a number of human health and
environmental hazard indicators. Foremost among the tools and approaches to be used will be
Quantitative Structure Activity Relationship (QSAR) models or computational models for
predicting toxicity and data from suitable analogue (similar) chemicals.
A flexible approach to exposure information (actual, surrogate

or default)
The greatest challenge when assessing the risks from existing chemicals on AICS is
NICNAS‘s limited information on identity, volume and usage information on the chemicals
currently being imported and/or manufactured in Australia. The framework uses surrogate
information to estimate exposure, such as from overseas sources, or conservative default
values, where actual or surrogate information is not available, in the early stages (Tier I and
Tier II assessments).
Multi-tiered assessment
The framework is a three-tiered assessment process where information about a chemical‘s
hazardous properties, as well as the nature and extent of its usage, is employed to characterise
risk. Tier I and Tier II assessments are illustrated in Figure 3. The data that will be used and
the assessment approach and output in each of the tiers reflect the increasing resources
needed for assessment at a higher level.
Tier I assessment
The Tier I assessment has both an assessment and prioritisation role.
The primary aim is to identify chemicals that are not expected to pose a concern to workers,
public health or the environment to minimise resources used in the assessment. These
chemicals are considered fully assessed at the end of Tier I. The balance of chemicals is then
prioritised for further assessment at Tier II.
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Figure 3: Tier I and Tier II assessment
The Tier I assessment is a high throughput approach using tabulated electronic data that
are:
 publicly available;
 held by NICNAS; or
 readily generated using QSAR modelling.
These data can be efficiently applied to all chemicals on AICS to assess:
 health effects;
 environmental effects; and
 exposure indicator criteria.
The assessment consists of three parts:
1. applying exclusion filters;
2. applying risk characterisation tools (see Risk characterisation); and
3. validating Tier I assessment outcomes.
Applying exclusion filters
As advised by the ISG and TWP, certain low-risk chemicals are identified as a first
step before applying the risk characterisation tools in Tier I.
Tier I exclusion criteria have been developed to identify:
 polymers with reactive functional groups consistent with polymers of low concern
(PLCs) (see Identification of polymers of low concern to human health on the
NICNAS website: www.nicnas.gov.au for more information); and
 chemicals of low concern (see Identification of chemicals of low concern to human
health on the NICNAS website: www.nicnas.gov.au for more information).
In addition, chemicals on AICS with a high probability of not having an industrial or
cosmetic use (that is, excluded use chemicals having a solely therapeutic or pesticide use,
which are assessed by the Therapeutic Goods Administration—TGA, and the Australian
Pesticides and Veterinary Medicines Authority—APVMA, respectively) are being

identified at an early stage.
Validating Tier I assessment outcomes
After applying the risk characterisation tools and approaches, the Tier I assessment outcomes
will undergo an appropriate level of validation that will include:
 cross checking chemicals not expected to pose a concern against national/international
lists of concern chemicals;
 peer reviewing chemicals not expected to pose a concern by an acknowledged expert; and
 undertaking a preliminary chemical-by-chemical evaluation on a particular aspect of the
assessment for example exposure, where this has a potential to change the outcome of the
Tier I assessment.
Tier II assessment
The aim of the Tier II assessment is to:
 refine assumptions from the Tier I assessment to identify further chemicals that pose no
unreasonable risk to human health or the environment;
 provide high level hazard and/or risk information about chemicals;
 make recommendations on regulatory controls to safely use chemicals; and
 identify those chemicals that require further assessment to determine their risk
and recommend regulatory controls for safe use.
The Tier II assessment is an evaluation of risk information on a substance-by-substance or
chemical category-by-category. A chemical category is a group of chemicals whose
physiochemical and human health and/or ecotoxicological properties and/or environmental
fate properties are likely to be similar or follow a regular pattern, usually as a result of
structural similarity‘ (OECD 2009).
The Tier II hazard and risk information (combined with any information from Tier I) will be
summarised in a Tier II assessment template. Where appropriate, recommendations on
regulatory controls for safe use and/or further assessment at Tier III will be made.
Tier III assessment

Tier III assesses those chemicals that have been identified during a Tier II assessment as
requiring further assessment. Tier III assessments are conducted to consider specific concerns
that could not be resolved during the Tier II assessment.
Two main types of Tier III assessments are anticipated, those for which:
1. more complex consideration of the data collated during the Tier II assessment is required;
and
2. additional information needs to be obtained to better refine the risk characterisation.
Risk characterisation
Human health and environmental assessments use different tools and approaches. Assessing
risks to humans, including workers and the general public, uses a single set of tools and
approaches.

In the framework, chemicals are compared against human health hazard, environmental
hazard and exposure indicator (volume and use) criteria to determine:
 those chemicals that are not expected to pose an unreasonable risk to workers, public
health and the environment;
 those that are considered to require regulatory controls for safe use; and
 those that require further assessment to determine their risk.
Where appropriate, the framework also allows expert judgements to be applied.
Human health risk characterisation

One of the key tools developed to characterise the human health risk at Tier I of the
framework is a matrix. This is used to group chemicals with similar level of concern, based
on their potential human health hazard and the potential for exposure, for further
assessment. The matrix is used to characterise risks for both workers and the public.
At Tier II the risks to workers and the public are identified based on information about the
chemical‘s use; hazard and current regulatory controls and the relevance of regulatory
controls applied overseas. Additional regulatory controls to mitigate risks to workers and the
public are identified where necessary.
Tier I human health assessment and prioritisation matrix

The matrix has five hazard bands representing different severities of hazard indicators, and
five exposure bands, which represent a different relative potential for exposure
(see Figure 4). There is an increase in the hazard indicator severity from hazard band zero
(no indication of hazard) to hazard band four. Similarly, the highest and lowest potential for
exposure are bands four and zero respectively. Zero equals a chemical that does not meet the
definition of an industrial chemical as defined in the Industrial Chemicals (Notification and
Assessment) Act 1989, or is known not be introduced into Australia.
Matrix: Allocating an exposure band
Exposure bands give an indication of the potential relative exposure to a chemical. An
exposure band is assigned using information on the amount of an individual chemical being
introduced into Australia and its uses. There are three main steps:
1. deriving a use multiplier for a chemical;
2. calculating an exposure score; and
3. assigning the exposure band.
Although exposure to the public and workers are considered separately, the highest
exposure band from each of these considerations is used for risk characterisation for any
given chemical.
The exposure bands were finalised following a multi-stakeholder workshop held in
March 2012 (the Workshop report—NICNAS workshop on exposure estimation in the
inventory multi-tiered assessment and prioritisation (IMAP) framework is available on
request).

Figure 4: Tier I human health assessment and prioritisation matrix

Increasing exposure

Exposure band
0 (no
1 2 3 4
exposure)
0 (no Not
Not expected Not expected Not expected Not
indication expected to
to pose a to pose a to pose a expected to
of hazard) pose a i i i
i concern concern concern pose a
concern i
concern
Not
Not expected Not expected Not expected Requiring
expected to
1 to pose a to pose a to pose a further
pose a i i i ii
i concern concern concern assessment
concern
Increasing hazard
Hazard band
Not
Not expected Not expected Requiring Requiring
expected to
2 to pose a to pose a further further
pose a i i ii ii
i concern concern assessment assessment
concern
Not
Not expected Requiring Requiring Requiring
expected to
3 to pose a further further further
pose a i ii ii ii
i concern assessment assessment assessment
concern
Not
Requiring Requiring Requiring Requiring
expected to
4 further further further further
pose a ii ii ii ii
i assessment assessment assessment assessment
concern
i Tier I assessment complete

ii Tier II assessment required
Derivation of use multiplier

All known uses for a chemical are sorted into five broad categories: cosmetic, domestic,
commercial, site-limited and non-industrial, and allocated a use multiplier.
The use multiplier is a weighting system that reflects the estimated fraction of the total
introduced chemical that is available for exposure.
Table 2 provides an overview of the categories with examples to demonstrate how the
use multiplier is allocated.

Table 2: Categories, use multipliers and exposure potential

Category Example Use Potential for exposure
multiplier
Site limited Plastic 0.001 Negligible exposure: this would be uses within a
manufacture limited number of highly controlled workplaces with
many engineered safety protocols and workers
wearing protective clothing, or uses where the
chemical would be consumed or incorporated into an
article where it is fully contained during normal use
and disposal.
There is no exposure to the general public.
Commercial Commercial 0.01 Incidental exposure: chemicals used in mixtures or

printing products predominantly in the workplace, which would
have safety controls in place, but not to the extent of
site limited. It could also include chemicals used by
hobbyists or by people who undertake jobs that would
predominantly be done in a commercial environment
such as car maintenance.
Domestic Cleanin 0.1 General exposure: chemicals used in household

g domestic mixtures or products, or in articles where
product a significant proportion of the chemical is released
during normal use.
Cosmetic Personal 1 Intentional exposure: the mixture or product is

care product intended solely for direct personal application onto the
human body including the skin, hair, nails, lips, teeth
and mouth—generally for cleaning, perfuming or
protection.
Non industrial for example 0 Not regulated by NICNAS

TGA, APVMA
The categories‘ breadth and logarithmic scale for the use multipliers reflects the nature of the
data that will be considered in Tier I, for example it is acknowledged that the estimated
fraction available for exposure for wash-off cosmetics is lower than for leave-on cosmetics,
but Tier I data does not differentiate between the two. These considerations will be made at
Tier II, providing sufficient information is available.
The use categories and use multiplier allocation for the internationally derived use codes
being used in Tier I were refined following an expert workshop on exposure held in
March 2012 (the Workshop report—NICNAS workshop on exposure estimation in the
inventory multi-tiered assessment and prioritisation (IMAP) framework is available on
request).
Calculating the exposure score
An exposure score, which is an estimate of the total volume available for exposure, is derived
by applying the use multiplier to the total introduced volume (in tonnes) of the chemical:
VOLUME × USE MULTIPLIER = EXPOSURE SCORE
If a chemical fits into more than one use category, the usage with the highest potential
for exposure (highest use multiplier) is used to calculate the exposure score.

If no use and/or volume information is available at Tier 1, use multiplier and/or

volume defaults of 0.1 and/or 100 t respectively will be assigned (see Exposure
information in Information considered in the IMAP Framework below).
Exposure band
Chemicals are assigned into an exposure band based on the calculated exposure score
as shown in Table 3.
Table 3: Exposure bands

Exposure score Exposure band
< (less than) 1 = band 1
≥ (more than or equal to) 1 and < 10 = band 2
≥ 10 and < 100 = band 3
≥ 100 = band 4
In cases where Australian volume information is not available, a default volume of 100 t is
assumed, exposure bands will essentially be determined based on the identified use as shown
in Table 4.
Table 4: Exposure bands (use category)

Use category Exposure band
cosmetic = band 4
domestic = band 3
commercial = band 2
site-limited = band 1
non-industrial. = band 0
If NICNAS has information about the volume of a chemical used, its default exposure band
could change.
Matrix: Allocating a hazard band
Hazard bands represent a number of the hazard indicators agreed by the HHEWG as
shown in Table 5.

Table 5: Hazard bands

Hazard Band Carcinogeni
4 Mutagenic
Reproductive/developmental toxicity
i
Endocrine disruption
ii
Neurotoxicity
Hazard Band Acute toxicity—Very Toxic/Toxic (oral LD50 ≤300 mg/kg bw; dermal
iii
3 LD50 ≤1000 mg/kg bw; inhalation LC50 ≤10 mg/L vapour)
High chronic/repeat dose toxicity (oral LOAEL ≤10 mg/kg bw/d; dermal
LOAEL ≤20 mg/kg bw/d; inhalation LOAEC ≤50 ppm/6-h/d gas, ≤0.2
iii
mg/L/6-hr/d vapour or ≤0.02 mg/L/6-hr/d dust/mist/fume)
Corrosive (irreversible
damage) Respiratory sensitiser
Hazard Band Harmful chronic/repeat dose toxicity (oral LOAEL >10 mg/kg bw and
2 ≤100 mg/kg bw/d; dermal LOAEL >20 mg/kg bw/d and ≤200 mg/kg
bw/d; inhalation LOAEC >50 and ≤250 mg/L/6-hr/d gas, >0.2 and
≤1.0 mg/L/6-hr/d vapour or >0.02 and ≤0.2 mg/L/6-hr/d
iii
dust/mist/fume)
Skin sensitiser
Hazard Band Acute Toxicity—Harmful (oral LD50 >300 and ≤2000 mg/kg bw; dermal
1 LD50 >1000 and ≤2000 mg/kg bw; inhalation LC50 >10 and ≤20 mg/L
iii
vapour )
Irritant (reversible damage)
Hazard Band All indicators fall outside the criteria listed in Hazard bands 1–4
0
i Based on list of endocrine disrupting chemicals from the European Commission’s Endocrine
Disrupters website.
ii Based on list of neurotoxic chemicals from US Agency for Toxic Substances and Disease Registry (ATSDR).
iii Based on GHS cut-offs for hazard classification. For chronic/repeat dose toxicity, GHS cut-offs are provided
as guidance values (that is: the dose/concentration at or below which significant health effects are observed).
The preferred species for oral and inhalation toxicity: rat; for dermal toxicity: rat or rabbit.
The chosen combination of hazard indicators in each band reflects the hierarchy of
indicators agreed by the HHEWG (carcinogenicity = genotoxicity =
reproductive/developmental toxicity > acute toxicity > repeat dose toxicity > sensitisation >
irritation) and judgement on the level of risk of particular endpoints for the use categories
(cosmetic, domestic, commercial and site-limited). Hazard bands were finalised following
the pilot evaluation of 1,000 random AICS chemicals and subsequent independent expert
peer review. More information on hazard band development is provided in Human health
hazard indicators and hazard banding which is available on request.
To allocate a hazard band for a chemical, hazard information is compared against the
criteria agreed by the HHEWG for each indicator (the Human Health Hazard Indicators
and Hazard Criteria provided in 2010 to the ISG/TWP out of session is available on
request). Where a chemical meets the criteria for any hazard indicator, the chemical is then
placed in the highest relevant hazard band, that is: if the chemical meets the criteria for
hazard band two and three, the chemical will be placed in hazard band three.

Matrix: Outcome
Exposure and hazard bands will be assigned, based on the available information, to
determine if a chemical is either not expected to pose a concern or requires further
assessment. The greater the potential for exposure the lower the hazard band needed to
prioritise a chemical for further assessment.
In addition, for chemicals that have an indication of chronic/repeat dose toxicity but
which have not been identified as requiring Tier II assessment (on the basis of the matrix),
an additional step will be undertaken. This step will check each chemical individually for
biopersistence or bioaccumulation data for consideration when deciding if a Tier II
assessment is needed.
Environmental risk characterisation

Risk assessments are conducted according to the guidelines and principles of the
Environmental risk assessment guidance manual for industrial chemicals (EPHC, 2009),
which is currently used by Department of the Environment (DoE) to conduct environmental
risk assessments for new and existing industrial chemicals. The Risk assessment manual is,
in turn, based on international best practice for environmental risk assessments.
The framework builds on the standard risk-assessment paradigm by including additional
measures designed to identify substances of inherently high concern, based on specific
combinations of environmental hazard characteristics endorsed by the EEWG. The key
hazard characteristics are the environmental persistence (P), bioaccumulation potential in
organisms (B), and (eco)toxicity (T) of a chemical. Chemicals which exceed the nationally
adopted thresholds for all three of these environmental hazard characteristics (Table 6) are
categorised as PBT chemicals. These are considered to be of inherently high concern for the
environment and are prioritised for environmental assessment at Tier II in the framework.
Chemicals identified as having a concern for the environment for other reasons, such as the
identified use-pattern is of high concern, for example localised release into surface waters,
will also be prioritised for environmental assessment at Tier II.

Table 6: Indicator parameters and respective numerical thresholds to be used to

categorise the environmental persistence, bioaccumulation potential, and toxicity
(PBT) of IMAP chemicals
Hazard Environmental medium Indicators and numerical
characteristic (or compartment or thresholds for positive hazard
trophic level) categorisation
Persistence Air t1/2 = 2 days
Water t1/2 = 2 months (that is: 60 days)
Soil t1/2 = 6 months
Sediment t1/2 = 6 months
Bioaccumulation Aquatic BAF ≥2000 or
BCF ≥2000
or
Terrestrial log Koa >6 and log Kow ≥2
Food-chain BMF >1

bioaccumulation potential
Toxicity Aquatic-Acute
Fish 96 h LC50 ≤1 mg/L and/or
Crustacea 48 h EC50 ≤1 mg/L and/or
Algae or other aquatic plants 72 or 96 h ErC50 ≤1 mg/L

Aquatic-Chronic
Fish Chronic NOEC or ECx ≤0.1 mg/L and/or
Crustacea Chronic NOEC or ECx ≤0.1 mg/L and/or
Algae or other aquatic plants Chronic NOEC or ECx ≤0.1 mg/L
In addition, the risks to the environment from an imported or locally manufactured

industrial chemical will be quantitatively characterised in terms of its risk quotient (RQ)—
the ratio of the predicted environmental concentration (PEC) of the chemical substance in an
environmental compartment (for example water, air, soil and sediment) and its predicted no-
effect concentration (PNEC) in that compartment (RQ = PEC ÷ PNEC).
The predicted no-effect concentration (PNEC) will be calculated for each chemical from
the lowest LC50/EC50 for affected organisms in the environment (for example, fish, aquatic
invertebrates and algae in an aquatic ecosystems), using a conservative assessment factor.

The predicted environmental

concentration (PEC) is calculated using Model used to calculate PEC at Tier I
standard exposure scenarios based on a In consultation with states and territories, a model
chemical‘s use. RQ is calculated for the was developed in 2003 to predict the concentration
environmental compartments likely to of chemicals in surface waters when they are
be exposed to the chemical based released through STPs (EPHC 2009). According to
the model, chemicals are assumed to be diluted by
on information about its use.
the total volume of water used daily by the
In the framework, an RQ <1 (that is: Australian population, assuming 200 L per person
PEC < PNEC) is considered to show and a total population of 22.6 million. It is
that the intended use of the chemical at conservatively assumed that the entire annual use
the proposed annual volume of use volume of the chemical is released evenly over
260 days/year corresponding to release on
will not pose an unreasonable risk to
working days only (5 days/week).
the environment, meaning that no risk
reduction measures are required, unless the substance is also of concern to the environment
for other reasons (see above). An RQ >1 indicates that there is a potentially unreasonable
risk to the environment because the predicted environmental concentration exceeds the
PNEC for that environmental compartment.
Chemicals for which the RQ ≥1, or identified as having high concern to the environment for
other reasons (such as PBT characteristics) during the Tier I assessment process are
submitted for Tier II risk assessment (see Figure 5). In subsequent tiers, an evaluation of data
on a chemical-by-chemical or chemical category-by-category basis will be undertaken to
refine inputs for the environmental risk characterisations. This includes refining predicted
hazards based on more complex models, refining the PEC (regarding environmental
mitigation measures using persistence data and physicochemical parameters) and considering
chemical risk management nationally and internationally.

Figure 5: Tier I environmental risk assessment algorithm

Information considered in the IMAP Framework

To ensure efficiency and reduce duplication of effort, NICNAS will use information available
from 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 integrated international information extensively into the framework. This
information contributes to both the Tier I assessment outcome (matrix position for human
health, the no-effect concentration and PBT categorisation for environment) and for the
risk characterisation at Tier II and Tier III.
Hazard Information
Hazard information for human health and environment considered in the framework is
derived from a number of sources including:
 classification information/international lists of chemicals;
 international assessments;
 predictive models;
 tabulated empirical data; and
 other data sources.
Classification information/international lists of chemicals

Available hazard information from national/international classifications will be
automatically matched against chemicals on AICS using the Hazard Flag Identification Tool
(HazFIT). This tool accesses electronic, tabulated information from reputable sources for
easy comparison. HazFIT sources include:
 Hazardous Substances Information System (HSIS);
 European Union (EU) Regulation on Classification, Labelling and Packaging (EU
CLP; conversion of old EU classifications to adopted GHS);
 International Agency for Research on Cancer (IARC);
 National Toxicology Program—Report on Carcinogens (NTP ROC);
 US EPA Cancer Guidelines;
 American Conference of Industrial Hygienists (ACGIH) categories;
 EU list of endocrine disrupters; and
 List of neurotoxic chemicals from ATSDR.
The HHEWG agreed to use the above sources after reviewing a large range of potential
resources.
In addition to the above sources, the framework will use other GHS classification sources,
including those from New Zealand and Japan, and classification and labelling notifications
(C&L) submitted by industry under the new EU CLP.
There were often multiple and varying C&L notifications from industry for an individual
chemical. A strategy was developed to synthesise the multiplicity of information down to a
single classification recommendation so that the information could be consistently applied
at Tier I and Tier II. This involves initially using a worst-case classification at Tier I. If the
C&L data is the sole determinant of a chemical requiring Tier II assessment, a Tier I

validation evaluation is conducted to check if a Tier II assessment is required. At Tier II, a

weight-of-evidence approach is taken to determine the appropriate classification.
International assessments
NICNAS has extensively incorporated international assessment information into the
framework including from:
 The Canadian Categorization of the DSL;
 EU REACH and EU C&L Program;
 European Commission Cosmetic Ingredient Database;
 Scientific Opinions on Cosmetic Substances by European Commission committees;
 Several Programs in the United States such as US EPA‘s High Production Volumes
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;
 OECD eChemPortal; and
 International Program on Chemical Safety (IPCS) Publications.
NICNAS has developed an efficient search strategy using international information about
the human health and environmental impacts of chemicals. This includes accessing the
commercial database Galleria Chemica and several other publically available databases
including eChemPortal.
Predictive models
Based on NICNAS‘s preliminary work it is anticipated that a large proportion of chemicals
on AICS have limited information about the hazardous properties. This makes hazard data
generated from predictive models critical to the framework process.
A comprehensive strategy for using QSAR models has been developed and tested for both
human health and environmental hazards. NICNAS and DoE liaised closely with the
developer of the OECD QSAR Toolbox and OASIS–TIMES models to optimise the strategy,
ensuring that it is robust, practical and resource-efficient.
To identify human health hazards, three conceptually different tools (supported by the
HHEWG) will be used:
 OASIS‘s TIMES models (see Footnote 3)—a mechanistic based QSAR;
 TOPKAT (see Footnote 4)—a statistical based QSAR; and
 OECD QSAR Toolbox (see Footnote 5)—for data and profiling.
The HHEWG supported using all available QSAR tools simultaneously because predictions
from a combination of models that use different training sets and modelling methodologies
3
OASIS‘s TIMES MIX Laboratory of Mathematical Chemistry. Bourgas, Bulgaria can be accessed at:
<http://oasis-lmc.org>
4
DS TOPKAT Accelrys can be accessed at:
<http://accelrys.com/solutions/scientific-need/predictive-toxicology.html>
5
OECD QSAR Toolbox can be accessed at:
<http://www.oecd.org/chemicalsafety/assessmentofchemicals/theoecdqsartoolbox.htm>

(statistical, rule-based and combination) will help to cross-validate the results and
increase the confidence in the final decision on hazard indicators for chemicals with
limited hazard information.
The OECD QSAR Toolbox is used as a pre-filtering step in Tier I before analysing chemicals
with OASIS–TIMES models for human health hazards. The toolbox profiles chemicals based
on mechanistic properties and rules (for example DNA binding). Chemicals can then be
identified as potential irritants, genotoxic chemicals and/or skin sensitisers. The need to
apply the relevant OASIS–TIMES models can be determined based on the outcome of the
profile. For example, a chemical which is predicted to be a potential protein binder (an
indication of the potential for skin sensitisation) in the OECD QSAR Toolbox would be
analysed using the OASIS–TIMES model for skin sensitisation.
The characteristic values for the persistence, bioaccumulation potential in organisms, and
(eco)toxicity properties of a chemical will be calculated using a variety of advanced
computational hazard evaluation tools (OASIS‘s POPs—see Footnote 6 and CATALOGIC
—see Footnote 7, the OECD QSAR Toolbox and the United States Environment Protection
Agency Estimation Programs Interface (EPI) Suite—see Footnote 8—including the
BIOWIN and ECOSAR modules), as agreed by the EEWG.
For both human health and the environment, the OECD QSAR Toolbox will also be used to
fill data gaps based on data from suitable analogues identified using chemical profiling and
grouping techniques.
Tabulated empirical data

Tabulated empirical data for a number of human health and environmental hazard indicator
will be extracted from a number of sources including the OECD Toolbox, eChemPortal and
environmental data from the Canadian experience of categorising their chemical inventory
(the Canadian DSL).
Other data sources

Certain classes of chemicals such as inorganics, polymers and unknown or variable
compositions, complex reaction products and biological materials (UVCBs) are difficult to
model using QSARs. For these chemicals, in order to assign a hazard band or determine key
environmental hazard characteristics, a number of rule-based approaches have been
developed based on the Canadian experience in categorising the DSL (see Table 6).
6
OASIS‘s POPs Laboratory of Mathematical Chemistry. Bourgas, Bulgaria can be accessed at:
<http://oasis-lmc.org/?section=software&swid=2>
7
OASIS CATALOGIC Laboratory of Mathematical Chemistry. Bourgas, Bulgaria can be accessed at:
<http://oasis-lmc.org/?section=software&swid=1>
8
US EPA (2011) Estimation Programs Interface (EPI) Suite™ for Microsoft® Windows, v 4.10. United
States Environmental Protection Agency. Washington DC, USA can be accessed at:
<http://www.epa.gov/oppt/exposure/pubs/episuite.htm>

Table 6: Assessment approaches for different chemical classes
Chemical class Approach

Polymers Hazard characteristics of the reactive functional group
considered
Inorganics Hazard characteristics of the anion and cation are

considered respectively
UVCBs Hazard characteristics of the individual

components considered.
The rule-based approaches are currently being enhanced. Further information will be
published on the NICNAS website to support assessment outcomes as related assessments
are published.
Exposure information
One of the greatest challenges for IMAP is the lack of exposure information held by
NICNAS for the majority of chemicals on AICS. This includes information on chemical
uses and the quantities currently imported and/or manufactured in Australia.
Where possible, the framework uses actual exposure information held by NICNAS. If
actual information is not held by NICNAS, surrogate information from overseas sources, or
conservative default values are used, where actual or surrogate information is not available.
Actual exposure data held by NICNAS

Australian use and volume information will be used where possible. NICNAS currently
holds some exposure data (collated over the years) on around 1300 chemicals including:
 chemicals reported in the NICNAS 2006 High Volume Chemical Survey;
 chemicals on the NICNAS candidate list; and
 chemicals for which NICNAS holds data as a result of various other information
gathering activities or technical projects.
Surrogate information sources

In combination and/or in the absence of Australian information for a chemical, available
international information such as how the chemical is used overseas will be used to
determine the potential for exposure. How the data are formatted will dictate at which tier in
the framework it will be employed. For example:
 International lists reporting chemical use, such as the EU Cosmetics Ingredients List
(CosIng), can identify chemical usage at Tier I because these data sources are
suitably formatted for high throughput assessment in this tier.
 Information from international assessment reports, literature searches, and dossiers
(REACH) will be used to validate default values assigned for chemicals at Tier I and
at Tier II, employing a more resource-intensive chemical-by-chemical approach.
NICNAS has identified and assessed domestic and international exposure data sources for
use in the framework. Comprehensive information has been collected about the effectiveness
and usability for each identified data source. Currently, NICNAS has reviewed over 20
potential data sources that can be used to determine surrogate use.

They have been trialled in the pilot evaluation of the framework and are listed below:
 IUR/CDR (Inventory update reporting/ Chemical data reporting)
 OECD/ SIDS (Screening Information Data Sets)
 NIHHP (National Institute of Health Household Product Database)
 HSDB (Hazardous Substances Data Bank)
 CCRIS (Chemical Carcinogenesis Research Information System)
 Toxnet Multi-Database
 Galleria
 Nordic SPIN database
 Water Utilities Data
 National Pollutant Inventory (NPI)
 State Environment Agencies
 Public Health Association Australia
 State health authorities
 Australian Life Cycle Assessment Society (ALCAS)
 Australian Institute of Occupational Hygienists (AIOH)
 ACCORD Website
 Poison Information Centre
 Product ingredients list- Johnson& Johnson
 Pollutant Release and Transfer Register (PRTR)
 REACH Dossiers
 Canadian Screening Assessments
Exposure defaults
Conservative default values will be applied if no actual or surrogate exposure information is
available. The conservative volume and use multiplier defaults are 100 t and 0.1
respectively.
The default value for volume is based on information collected by NICNAS for the 2002
and 2006 High Volume Industrial Chemicals List (HVICL) and was derived on the basis
that:
 NICNAS has accurate data on all chemicals imported at over 1000 t each year (around
300 chemicals);
 a degree of uncertainty exists for any combined total volume of less than 1000 t each
year reported for the HVICL, but it is considered likely that almost all chemicals
imported at over 100 t each year would have been subject to at least partial reporting
under the 2006 HVICL; and/or
 chemicals at lower total import volume (<100 t) might not have been reported due to no
individual importers bringing in quantities above the mandatory 20 t reporting threshold.
Although there might be significant overestimates of volume for some chemicals, in the
absence of additional information, NICNAS has no basis to further subdivide volume
estimates.
The highest use multiplier that can be applied to any chemical is 1. This relates to chemicals
used in cosmetics where the entire product is designed for personal application (see
Table 2).

The chemicals used in these products can usually be identified using surrogate sources of
information. Therefore, chemicals for which uses cannot be identified are unlikely to have a
cosmetic use and are then assigned the default use multiplier of 0.1 (the next highest
multiplier after 1).
Other information
Additional information could be used in the framework such as a flag for chemicals at Tier I
or as an input to the Tier II assessment. For example, environmental monitoring data can be
used to help flag chemicals at Tier I for further attention and to help validate the outputs of
predictive models used in the framework.
Publication of assessment information

The framework has been developed to deliver assessment outcomes at each assessment tier.
The level of detail in the assessment output at each tier reflects the relative assessment
effort.
Tier I assessment
For chemicals identified based on the Tier I assessment as not requiring further assessment,
a statement that these chemicals have been determined not to pose an unreasonable risk to
workers, public health and/or the environment will be published. The statement will also
contain details of the use category(s) considered in the assessment.
Tier II assessment
The Tier II hazard and risk information (combined with any information from Tier I) will be
summarised in a Tier II assessment. The key elements and format of the Tier II assessment
have been developed in consultation with relevant standard setting bodies and other
stakeholders. The Tier II assessment report will provide information on:
 chemical identity;
 import, manufacture, use and current restrictions/regulatory controls;
 key health or environmental hazard information; and
 human health or environmental risk characterisation.
In addition, where appropriate, recommendations on regulatory controls for safe use, which
will be made to the relevant standard setting body will also be included. Where a more
detailed assessment is required to determine the risk of the chemical, it will be recommended
for a Tier III assessment, with the Tier II assessment report identifying the scope of the Tier
III assessment. The Tier II assessment report will be published, indicating where required,
that the chemical is prioritised for further Tier III assessment.
Tier III assessment

The Tier III assessment will vary in content depending on the scope of the
assessment identified in the Tier II assessment.

Publication of assessment outcomes

During Stage One of implementation, around 3,000 chemicals will be screened and
assessed—up to at least Tier II—and the outcomes (including recommendations for
risk management measures) published in several batches on the NICNAS web site.
Due to the difference in the risk characterisation criteria for human health and environment,
and to ensure maximum efficiency in the assessment process, human health and
environmental assessments will be conducted separately. The progression of chemicals
through the tiered assessment process and assessment output may differ between human
health and environment.
The timing of the publication of assessment outcomes on the NICNAS web site will align
with the publication of the Chemical Gazette. There will be a public comment period, which
will provide an opportunity for consultation on all assessments seeking input on particular
aspects of the assessment output. For further information on public comment, please visit the
NICNAS website at www.nicnas.gov.au.
References
OECD 2009. Series on testing and assessment No. 102. Guidance document for using the
OECD (Q)SAR application toolbox to develop chemical categories according to the OECD
guidance on grouping of chemicals. Environment directorate: Joint meeting of the chemicals
committee and the working party on chemicals, pesticides and biotechnology. Paris, France.
EPHC (2009). Environmental risk assessment guidance manual for industrial chemicals.
Environment Protection and Heritage Council, Australia,
http://www.ephc.gov.au/taxonomy/term/75. Accessed 2012, Dec 21.
DoHA 2006. NICNAS Existing Chemicals Program Review: Final report

and recommendations 2006.
Regulation Productivity Commission (2008) Chemicals and plastics, Research Report.

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National Industrial Chemicals

Notification and Assessment Scheme

Inventory Multi-tiered Assessment and

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Existing Chemicals (EC) Program

Review of the Existing Chemicals Program

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o unassessed chemicals on the Hazardous Substances Information System (HSIS)—

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Figure 1: Framework development—consultation

Implementation Steering Group

Expert Workshop—Mar ‘12

Human Health Environmental

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Exposure approach development

Hazard approach development

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 reviewed scientific criteria developed by NICNAS for the indicators; and

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Staged implementation of the IMAP Framework

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Table 1: Sources used to identify the Stage One chemicals

Chemicals detected in umbilical cord blood in a study

Overview of IMAP Framework

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Figure 2: IMAP Framework

Scientifically robust risk-based approach

Achieving assessment outcomes early in the framework

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Using overseas data

Advancements in assessment methodologies

A flexible approach to exposure information (actual, surrogate

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Tier III assessment

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Human health risk characterisation

Tier I human health assessment and prioritisation matrix

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Figure 4: Tier I human health assessment and prioritisation matrix

i Tier I assessment complete

Derivation of use multiplier

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Table 2: Categories, use multipliers and exposure potential

Commercial Commercial 0.01 Incidental exposure: chemicals used in mixtures or

Domestic Cleanin 0.1 General exposure: chemicals used in household

Cosmetic Personal 1 Intentional exposure: the mixture or product is

Non industrial for example 0 Not regulated by NICNAS

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If no use and/or volume information is available at Tier 1, use multiplier and/or

Table 3: Exposure bands

≥ (more than or equal to) 1 and < 10 = band 2

≥ 10 and < 100 = band 3