draft national standard for environmental risk management ......standard and explanatory report...

DRAFT FOR CONSULTATION

National Standard for Environmental Risk

Management of Industrial Chemicals

Explanatory Document

November 2016


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© Copyright Commonwealth of Australia, 2016.

National Standard for Environmental Risk Management of Industrial Chemicals Explanatory

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Purpose of this Explanatory Report

The primary purpose of this Explanatory Report is to outline the design and operation of the

National Standard for environmental risk management of industrial chemicals (herein referred to

as the ‘National Standard’) including scheduling and decision-making under the National

Standard. The approach to the National Standard aligns with the policy intent set out in the

Decision Regulation Impact Statement considered and agreed by Environment ministers from

the Australian Government and all states and territories.

This Explanatory Report provides supporting information for the scheduling criteria, risk

management measures and outlines the processes that will support decision-making under the

National Standard. The Report serves to support the National Standard, and provide further

information for stakeholders to better understand the intent and requirements of the National

Standard.

This Report includes the following information:

Detail related to the National Standard including explanation of the Environment

Schedules and criteria for categorisation into Environment Schedules

Principles underpinning the risk management measures

A discussion on other Regulations, Codes and Standards that have assisted with

developing the framework and risk management measures

An outline of the process for the decision-making, adoption and application of the

National Standard and its risk management measures.

This Report should be read in conjunction with the National Standard. [Following agreement by

Government and implementation of the legislation to enact the National Standard, the National

Standard and Explanatory Report should be read in conjunction with the Commonwealth

legislation and specific legislation that has been enacted in each state or territory.]

Stakeholders should note that the contents of this document should be considered with the

understanding that any aspect presented in this document may change based on feedback from

consultation and issues identified during legislative drafting. While the policy intent and details

informed by consultation will be presented before Parliament for consideration, the Australian

Government and state and territory governments will make the final decision on the National

Standard. The Australian Government and state and territory governments will also make the

final decision in relation to legislation in the respective jurisdictions.


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Table of contents

Purpose of this Explanatory Report........................................................................................................... i

1. Glossary .......................................................................................................................................... i

2. Introduction to the National Standard ............................................................................................ 7

2.1 Summary of key features of the National Standard ............................................................. 7

2.2 Scope of the National Standard ........................................................................................... 9

2.3 How to use the National Standard ..................................................................................... 10

2.4 Contributors to the National Standard ............................................................................... 10

3. Exclusions from the National Standard ........................................................................................ 12

4. Exemptions from the National Standard ...................................................................................... 12

5. Industrial Chemicals ..................................................................................................................... 13

6. Background to the National Standard .......................................................................................... 15

6.1 A Brief History of the Reforms ........................................................................................... 15

7. National Standard Schedules and Criteria ................................................................................... 18

7.1 Introduction ........................................................................................................................ 18

7.2 Prohibited or Restricted Chemicals ................................................................................... 19

7.3 Products and mixtures containing one or more industrial chemical .................................. 20

7.4 Articles ............................................................................................................................... 20

7.5 Degradation products......................................................................................................... 20

7.6 Location specific considerations ........................................................................................ 20

7.7 Explanation of Scheduling Criteria ..................................................................................... 21

7.8 Hazard characteristics of substances ................................................................................ 34

8. Risk Management Measures for Industrial Chemicals ................................................................ 46

8.1 Introduction ........................................................................................................................ 46

8.2 Applying Risk Management Measures .............................................................................. 46

8.3 Outcomes-based risk management measures .................................................................. 47

8.4 Types of Risk Management Measures .............................................................................. 48

9. Assignment of Risk Management Measures to Environment Schedules .................................... 66

9.1 Enforcing Risk Management Measures ............................................................................. 67

9.2 Targeted stages of a chemical lifecycle ............................................................................. 67

10. Examples of chemical scheduling ................................................................................................ 69

10.1 Environment Schedule 1 Chemical Substance ................................................................. 69






10.7 Environment Schedule 6 or 7 Chemical Substance .......................................................... 75



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11. Existing Management Approaches that Align with the National Standard ................................... 76

11.1 Supporting Documents ...................................................................................................... 76

11.2 International Principles....................................................................................................... 79

12. Scheduling and Decision Making Processes ............................................................................... 83

12.1 Convention Chemicals ....................................................................................................... 85

12.2 Information to be made available under the National Standard ........................................ 90

12.3 Risk Assessment ............................................................................................................... 90

12.4 Risk Management Recommendations ............................................................................... 91

12.5 Advisory Committee ........................................................................................................... 92

12.6 Decision Maker .................................................................................................................. 95

12.7 Administration .................................................................................................................... 96

13. References ................................................................................................................................... 97

Table index

Table 1: Environment Schedules ........................................................................................................... 18

Table 2: National PBT criteria ................................................................................................................ 25

Table 3: GHS Hazard Statements for classification of long term environmental hazards ..................... 27

Table 4: GHS Hazard Statements for classification of short term environmental hazards .................... 28

Table 5: Criteria for Bioaccumulation (B) Categorisation ....................................................................... 28

Table 6: Characteristics of persistent substances .................................................................................. 36

Table 7: Criteria for Bioaccumulation (B) Categorisation ....................................................................... 40

Table 8: Characteristics of bioaccumulative substances ....................................................................... 41

Table 9: Criteria for Toxicity (T) Categorisation ..................................................................................... 43

Table 10: Characteristics of toxic substances ........................................................................................ 44

Table 11: GHS Hazard Statements for classification of environmental hazards ................................... 45

Table 12: General use risk management measures .............................................................................. 49

Table 13: Risk management measures relating to storage, handling and containment ........................ 51

Table 14: Risk management measures relating to treatment and disposal ........................................... 53

Table 15: Risk management measures to protect waters ...................................................................... 58

Table 16: Risk management measures to protect land ......................................................................... 63

Table 17: Risk management measures to protect air ............................................................................ 64

Table 18: Basis for Risk Management Measures .................................................................................. 67

Table 19: Key persons, documentation and processes under the National Standard ........................... 85


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Figure index

Figure 1: Examples of industrial chemical uses ..................................................................................... 13

Figure 2: Chemical lifecycle and exposure ............................................................................................ 14

Figure 3: Disappearance of a chemical according to first-order kinetics ............................................... 34

Figure 4: Australian criteria for persistence (P) categorisation based on the half-life of a

chemical in different media ................................................................................................ 35

Figure 5: Uptake and elimination of substances during bioconcentration and bioaccumulation

processes (adapted from (ECETOC 2003) ....................................................................... 39

Figure 6: Risk assessment and risk management ................................................................................. 81

Figure 7: Roles, processes and decision making under the National Standard .................................... 84




1. Glossary

Acronyms and Abbreviations

AICS Australian Inventory of Chemical Substances

BAF Bioaccumulation factor

BCF Bioconcentration factor

BMF Biomagnification factor

COAG Council of Australian Governments

ICNA Act Commonwealth Industrial Chemicals (Notification and Assessment) Act 1989

NICNAS National Industrial Chemicals Notification and Assessment Scheme

OBPR Office of Best Practice Regulation

OECD Organisation for Economic Cooperation and Development

PEC Predicted Environmental Concentration

PNEC Predicted No-Effect Concentration

RIS Regulation Impact Statement

SAICM Strategic Approach to International Chemicals Management

US EPA United States Environment Protection Agency

Glossary of terms

Note: Definitions below align with the current Industrial Chemicals (Notification and

Assessment) Act 1989 (ICNA Act). Reforms to the ICNA Act mean that some definitions related

to industrial chemicals may be updated and refined. Where appropriate, these new definitions

will be reflected in the legislation for the National Standard.

Accidental Release Release of a chemical substance that is uncontrolled and unintended despite management approaches being in place to prevent the release.

Advisory Committee The expert body established to provide risk management advice to the Decision Maker under the National Standard.

Article An object that:

is manufactured for use for a particular purpose, being a purpose that requires that the object have a particular shape, surface or design, and

is formed to that shape, surface or design during manufacture, and

undergoes no change of chemical composition when used for that purpose except as an intrinsic aspect of that use

but does not include a particle or a fluid.

Best available technology

The most effective and advanced stage in the development of activities and their methods of operation which indicates the practical suitability of particular techniques for providing the basis for emission


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limit values and other permit conditions designed to prevent and, where that is not practicable, to reduce emissions and the impact on the environment as a whole.

Bioaccumulation Bioaccumulation is the increase in concentration of a chemical substance in or on an organism relative to the concentration of the chemical substance in the surrounding medium. Bioaccumulation results from both bioconcentration and biomagnification processes further defined in Section 7.8.2.

Chemical substance For the purposes of this paper, a chemical substance describes a:

chemical element, including a chemical element

contained in a mixture, or

compound, polymer or complex of a chemical element,

including such a compound, polymer or complex

contained in a mixture, or

substance of unknown or variable composition, complex

reaction products or biological materials (UVCB), or

naturally-occurring chemical

but does not include:

an article, or

a radioactive chemical, or

a mixture.

The use of ‘Chemical’, ‘Chemical Substance’ or ‘Substance’ in the context of the paper refers to those with industrial uses (see Industrial chemical).

Concern Concern is a measure of the potential consequences of a chemical substance being introduced and used in Australia.

Potential consequences of a chemical substance’s use could be positive or negative. They include considerations of the risk defined by the risk assessment, the inherent hazard characteristics of a chemical substance or its degradation products, and any relevant social and economic impacts related to a chemical’s use.

Chemicals are proposed to be categorised in High (Environment Schedules 7 and 8), Intermediate (Environment Schedules 3 to 6) and Low (Environment Schedules 1 and 2) Concern Environment Schedules.

Consumer A person in the general public who purchases chemicals or their products for personal and domestic use.

Controlled release Release to the environment that is intended and managed to prevent excessive release.

Decision Maker The Decision Maker is the person with responsibility to make decisions under the National Standard. The Decision Maker is the Minister responsible for the federal Environment portfolio or their delegate.

The Department Australian Government Department of the Environment and Energy.

Adverse effect A change in the morphology, physiology, growth, development, reproduction, or life span of an organism, system, or (sub)population that results in:

(i) an impairment of functional capacity, (ii) an impairment of the capacity to compensate

for additional stress, or



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(iii) an increase in susceptibility to other influences (WHO/UNEP/OECD/ILO, 2004).

Endocrine active An endocrine active substance has the potential to be endocrine active in aquatic or terrestrial organisms but is not demonstrated to be endocrine disrupting.

Endocrine disruptor An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or populations.

Environment The natural world including the surroundings which life inhabits. For the purposes of the National Standard, environment does not include people’s indoor dwellings or places of business.

Environment agency A statutory authority that has responsibility for the management and protection of the environment.

Environment ministers Ministers responsible for the environment portfolios in their respective jurisdictions.

Environmental harm Environmental harm for the purposes of the National Standard is the consequence of a chemical having an adverse effect on organisms or other aspects of the environment, such as waterways or the ozone layer.

Environment Schedule For the purpose of the National Standard, there are seven (7) groups, referred to as Environment Schedules, into which chemicals can be categorised. Each Environment Schedule, with its own criteria, outlines a set of conditions that describes how industrial chemicals in that Environment Schedule are to be managed. Chemicals are assigned to a particular Environment Schedule based on their concern to the environment. Substances of lowest concern to the environment are categorised in Environment Schedule 1 and substances of highest concern to the environment are categorised in Environment Schedule 7.

Estuarine water Confined coastal waters where fresh and salt waters meet, either seasonally or for longer periods, and tides are experienced. Estuaries may also be closed to the ocean through formation of adaptable barriers such as sand bars for a period of time and may become hypersaline.

Exposure (environmental)

Exposure is the amount of chemical released to the environment and the route by which it is released. Environmental exposure assessments in risk assessments characterise either the extent to which organisms may be exposed to a chemical stressor, or the concentration of a chemical in various environmental compartments (e.g. water, soil, air), which may then have the potential to affect organisms. The three main steps to an exposure assessment are:

Release estimation

Consideration of the environmental fate and partitioning

behaviour

Derivation of a predicted environmental concentration.

Additional information on environmental exposure assessment is presented in the Environmental Risk Assessment Guidance Manual for Industrial Chemicals1.

1 The Environmental Risk Assessment Guidance Manual for Industrial Chemicals can be found at

http://www.scew.gov.au/resource/chemical-risk-assessment-guidance-manuals



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Freshwater For the purpose of the National Standard, freshwater is inland surface waters that are not salty. This includes water bodies such as rivers, lakes and inland wetlands.

Groundwater Naturally occurring water that is held underground in spaces, cracks or crevices in soil, sand and rock.

Hazard (environment) The environmental hazards of a chemical are those characteristics of a substance, whether they be measured, observed or calculated, that have the potential to cause harm to an organism, or any other aspect of the environment, for example, the ozone layer. A chemical’s properties, and therefore hazards, are characteristics that generally do not change, although new information on them may become available.

High ecological value aquatic system

A high ecological value aquatic system is a waterway that is relatively undisturbed areas, protected due to their ecological significance are designated as being of 'high conservation value'. This would include pristine waters in National Parks or other defined areas, marine reserves or wetlands of significance such as those detailed in the Ramsar Convention. These areas will be specifically defined for the purposes of the National Standard.

Industrial chemical Under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth), an industrial chemical is any chemical that has an industrial use (s 7(1)). The term 'industrial use' is defined to mean a use other than an excluded use (s 7(2)). The term 'excluded use' is defined in s 7(2). Therefore, an industrial chemical is any chemical that is not:

An agricultural chemical or a constituent of an agricultural

chemical; or

A veterinary chemical or a constituent of a veterinary

chemical; or

A therapeutic chemical or an ingredient or component in

the preparation or manufacture of goods for therapeutic

use; or

A food intended for consumption by humans or animals

or a constituent in such food; or

A food additive in food referred to above.

Jurisdictions The Australian Government and state and territory governments.

Land Land refers to soil and sediment, and includes moisture and air within the soil.

Marine water For the purposes of the National Standard, marine waters mean surface waters that are in the open-ocean or unprotected coastal habitats. Marine waters are at or near the full salinity of seawater.

Nanomaterial A nanomaterial is a material intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).

National Standard The National Standard is the term used to describe the Environment Schedules with standard set of risk management measures for industrial chemicals according to a chemical’s level of concern to the environment. The National Standard will outline the standard risk management measures, scheduling criteria, scheduling processes and scheduling decisions.



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Perfluorinated functionality

Substances that contain perfluorinated functionality are substances

containing perfluorinated bonds in a carbon chain length of three or

more. Carbons in a substance that are fully fluorinated, that is, all

bonds that are not C-H or C-C bonds are C-F bonds, are

perfluorinated. Both polymers and chemicals may contain

perfluorinated functionality.

Persistent A chemical substance that has a:

half-life in water greater than two months, or

half-life in soil greater than six months, or

half-life in sediment greater than six months, or

half-life in air greater than two days

Radioactive substance A chemical substance having a specific activity >35 becquerels/g.

Risk (environmental) Risk is the probability of adverse effects caused under specified circumstances by an agent in an organism, a population, or an ecological system. It is based on the hazard of a chemical and its level of exposure for a specific use and location. Risk is analysed during the risk assessment process and can be represented simplistically as:

Risk = function (Hazard × Exposure).

Risk assessment Risk assessment is the systematic scientific evaluation of potential adverse effects resulting from exposure to a hazardous agent or situation. Risk assessment requires the integration of both quantitative as well as qualitative scientific information. Risk assessments that inform scheduling decisions under the National Standard will be undertaken by the Risk Assessor.

Risk assessor The risk assessor for the purposes of the National Standard is the Australian Government. Risk assessments are currently undertaken through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The risk assessor will complete risk assessments and make risk management recommendations to the National Standard.

Risk management Risk management is the process by which policy actions are chosen and implemented to control risks identified in the risk assessment. Risk management involves consideration of the scientific evidence and risk assessment and, if needed, any social or economic factors. For the purposes of the National Standard, risk management involves the scheduling decisions (including decisions on risk management measures), implementation of decisions by jurisdictions, and relevant compliance and enforcement activities.

Risk management advice

Risk management advice is prepared by the Advisory Committee for consideration by the Decision Maker. Risk management advice outlines the considered risk management recommendation and any socio-economic implications for a scheduling decision.

Risk management measure

Risk management measures are outcomes-based requirements that apply to chemicals scheduled under the National Standard. They will outline the outcome that must be achieved for chemicals in order to prevent harm to the environment.

Risk management recommendation

Risk management recommendations are prepared by the risk assessor following scientific evaluations of the risks posed to the environment. Risk management recommendations are included in the risk assessment and take into consideration the scheduling criteria under the National Standard.

Scheduling criteria Scheduling criteria are developed upfront and outline the hazards and risks taken into consideration by the risk assessor when developing a risk management recommendation.


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Scheduling decision Scheduling decisions are made by the Decision Maker. They will outline the Environment Schedule to which a chemical is assigned based on its scope of assessment and the risk management measures that are appropriate for the chemical. Scheduling decisions will be enforceable and be publicly available.

Scope of assessment A defined scope of assessment is a description of the parameters within which the risk assessment was undertaken. This may include volume and use information and any other relevant information regarding the particulars of the chemical that lead to the risk characterisation. The scope may be describe broadly or narrowly.

Surface water Naturally occurring water bodies and waterways that occur on the surface of the planet without deep penetration, for example, oceans, seas, lakes, and rivers.

Terrestrial Area of Ecological Significance

An area of land that is relatively undisturbed areas, protected due to their ecological significance are designated as being of 'high conservation value'. This would include National Parks or other defined areas of significance. These areas will be specifically defined for the purposes of the National Standard.

Toxicity Toxicity is the ability of a substance to cause poisonous effects resulting in severe biological harm or death after exposure to, or contamination with, that substance.

Uncontrolled Release Intentional release of the chemical substance to the environment or through waste streams that is not or cannot be managed. For example, a number of consumer products are intentionally released to the environment following use or during use. This would be considered uncontrolled release.

User A chemical user is anyone who uses a chemical for its intended purpose, or undertakes an action in relation to the use of the chemical such as storage, disposal or handling.

Waterways A passageway for water to travel, for example, rivers and canals. Waterways may be naturally occurring or man-made.


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2. Introduction to the National

Standard

The National Standard for environmental risk management of industrial chemicals

provides a framework for managing the risks that industrial chemicals may pose to the

environment. The Australian Government, and state and territory environment agencies

are committed to working together to achieve a nationally consistent regulatory regime for

managing the environmental risks associated with industrial chemicals. The overarching

objectives of the National Standard are:

To achieve better protection of the environment through improved management of

the environmental risks posed by industrial chemicals.

To provide a nationally consistent, transparent, predictable and streamlined

approach to environmental risk management of industrial chemicals for

governments, industry and the community.

The benefits of a nationally consistent approach to the management of risks industrial

chemicals may pose to the environment include:

Providing Australians greater confidence that potentially harmful, high risk

chemicals are subject to appropriate and consistent environmental measures

across the nation

Reducing regulatory burden by making it simpler and more cost-effective for

industry to fulfil its obligations for managing the environmental implications of

chemicals by streamlining current systems, reducing fragmentation, and improving

transparency, simplicity and consistency

Increasing information about, and understanding of, chemicals and the

environment so that governments, industry and the community can make informed

choices about chemicals and help identify areas needing greater attention so that

resources can be allocated strategically to deliver improved outcomes

Implementing an outcomes-based risk management approach to encourage

continued innovation in environmental protection and also enable industry to keep

costs related to risk management as low as possible

Assisting Australia in meeting its international obligations for sound management of

chemicals.

2.1 Summary of key features of the National Standard

The National Standard aims to provide a nationally consistent, transparent

approach to environmental risk management of industrial chemicals.

The National Standard will apply to all industrial chemicals. Industrial chemicals are

those regulated under the Industrial Chemicals (Notification and Assessment) Act

1989 (ICNA Act), or any amended legislation resulting from the reforms to the

ICNA Act.

The National Standard aims to fill a gap in the Australian chemicals management

framework that was identified for environmental management of industrial

chemicals. Therefore, the National Standard does not explicitly manage risks to


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human health. However, prevention of chemicals being released to the

environment will reduce human exposure to chemicals through the environment.

The National Standard includes the process for scheduling chemicals following

completion of an environmental risk assessment by an Australian Government.

Industrial chemicals will be categorised into one of seven Environment Schedules

depending on their level of concern to the environment, that is, their inherent

hazard characteristics and the risk they pose to the environment. Chemicals will be

considered to be Low, Intermediate or High concern to the environment and

management responses will be proportionate to this level of concern.

Each Low and Intermediate concern Environment Schedule will have a set of

predefined risk management measures. Specific risk management measures for

the chemical in the Environment Schedule will form part of the scheduling decision.

The Decision Maker (the Federal Minister for the Environment portfolio or their

delegate) will make the final scheduling decision for industrial chemicals under the

National Standard

High concern chemicals may have their use severely restricted or be prohibited

from import, manufacture and use in Australia. Measures to manage the risk of

restricted chemicals will be detailed on a case-by-case basis.

Risk management measures will be directive outcomes targeted at the regulated

community. That is, the risk management measures will outline what the regulated

community needs to achieve. This is in contrast to some other environmental

regulations that may set environmental outcomes, such as pollution limits in

waterways. However, risk management measures under the National Standard

should result in meeting the outcome of environmental protection by minimising

release of chemicals into the environment.

The regulated community will be responsible for determining the best approach for

meeting risk management measures and demonstrating compliance with the

measure.

Once a chemical is scheduled under the National Standard, the risk management

measures will be enforceable and penalties may apply for non-compliance.

If the scheduling decision was made based on inaccurate or out of date

information, or new information is available that may change the risk to the

environment and subsequent risk management measures, a request for variation

of the scheduling decision may be made.

The National Standard will not apply to accidental release of chemicals, only

chemicals released during the normal, intended use of the chemical, and activities

related to the use of the chemical (such as storage, disposal or handling). Other

regulations and codes need to be considered in these circumstances.

In the first instance, attempts should be made by all Australians to prevent release

of chemicals into the environment, or substitute chemicals of concern for safer,

greener alternatives.

Anyone using industrial chemicals, or undertaking activities related to the use of

the chemicals (such as storage, disposal or handling), is responsible for

management of the chemical and preventing its release into the environment to the

extent possible.




Where a chemical is used more broadly by consumers, risk management will need

to be undertaken at the point in the supply chain where the risk management

measures are most capable of being met. That is, the general public is not

expected to need to comply with the National Standard. Manufacturers, importers

or suppliers should ensure the risk management measures will be met during

normal, intended use, and activities related to the use, of the chemical.

In meeting the risk management measures, the regulated community needs to take

into consideration the potential broader impact of their actions on the environment.

For example, excessive water use should be avoided and dilution of chemicals

should not be substituted for limiting use and release of chemicals.

Guidance will be developed to support compliance with the new requirements.

2.2 Scope of the National Standard

The National Standard outlines risk management approaches for industrial chemicals.

Industrial chemicals are defined under the Industrial Chemicals (Notification and

Assessment) Act 1989 and will be consistent with any changes made to this Act.

Industrial chemicals can enter the environment at any stage during their lifecycle. The

lifecycle of a chemical includes all stages of a chemical’s useful life, from manufacture to

disposal. The National Standard is applicable to users of chemicals during all stages of a

chemical’s lifecycle in Australia, from introduction to end of life.

The National Standard includes three general categories for industrial chemicals – High,

Intermediate and Low Concern. These general categories are broken into a total of seven

specified categories known as Environment Schedules. Substances of lowest concern to

the environment are categorised in Environment Schedule 1 and substances of highest

concern to the environment are categorised in Environment Schedules 6 and 7. Section 7

outlines further information on the Environment Schedules and the scheduling criteria.

Each of the seven Environment Schedules has a set of clear, outcomes-based risk

management measures. The risk management measures under the National Standard

target risks to the environment from the intended use of industrial chemicals and may

cover the entire lifecycle of the chemical. The risk management measures focus on

protecting the environment from the releases of industrial chemicals that may occur

during the intended use of the chemical. Responsibility for managing environmental risks

of chemicals throughout their lifecycle will be targeted at those who have the capability of

understanding and preventing release of chemicals to the environment. For example,

where a chemical is used in consumer products, the product manufacturer or importer will

be responsible for ensuring the use of that chemical of product does not breach the risk

management measures during the intended, normal use of the chemical or product by

consumers.

The outcomes-based risk management measures under the National Standard will

encourage continued innovation in environmental protection and allow industry to keep

costs related to risk management as low as possible. To avoid duplication and ensure an

appropriate separation of regulatory responsibilities, the National Standard has been

developed to integrate with existing regulatory regimes in the Australian chemicals

framework. The risk management measures are further explained in Section 8 of this

document.




2.3 How to use the National Standard

The National Standard sets out measures related to processes associated with use of

industrial chemicals that have an environmental risk assessment completed by an

Australian government.

The National Standard will be used by:

Australian governments, and the Risk Assessor through the National Industrial

Chemicals Notification and Assessment Scheme (NICNAS), as a tool for

recommending appropriate scheduling and risk management measures

the Decision Maker in reviewing scheduling recommendations, requesting advice

and making scheduling decisions

jurisdictions to undertake compliance and enforcement activities pertaining to

their responsibilities

the chemical industry and users to understand decisions on the risk management

requirements for protecting the environment.

The National Standard may also be used by the chemical industry as a guide to possible

scheduling and risk management decisions for the chemicals in use and proposed to be

used, and the community to increase the general awareness of requirements of industrial

chemical use and disposal in Australia.

2.4 Contributors to the National Standard

The National Standard has been developed with valuable contributions of the Chemicals

Management and Standards Group (CMSG), comprised of representatives from

Australian environment agencies working in partnership. The agencies are:

Australian Government Department of the Environment and Energy

Environment and Planning Directorate, Australian Capital Territory

Environment Protection Authority, New South Wales

Environment Protection Authority, Northern Territory

Department of Environment and Heritage Protection, Queensland

Environment Protection Authority, South Australia

Department of Primary Industries, Parks, Water and Environment, Tasmania

Department of Environment, Land, Water and Planning, Victoria

Environment Protection Authority, Victoria

Department of Environment Regulation, Western Australia

GHD Pty Ltd has provided valuable technical assistance in developing the National

Standard and the supporting documents.

Many organisations and individuals who attended the public information workshops in

2016 and who provided submissions following the public comment periods for the

Discussion Paper and draft National Standard also contributed to the content.

Staff from Australian Government agencies that contributed to the development of the

National Standard include:

Australian Government Department of Health, including staff working for the

National Industrial Chemicals Notification and Assessment Scheme




Australian Government Department of Defence

Australian Government Department of Industry, Innovation and Science

Australian Government Department of Prime Minister and Cabinet

Australian Government Attorney General’s Department

Australian Government Department of Infrastructure and Regional Development

Australian Government Department of Agriculture and Water Resources




3. Exclusions from the National

Standard

The National Standard does not apply to chemicals that are solely:

agricultural chemicals or constituents of an agricultural chemical

veterinary chemicals or constituents of veterinary chemicals

therapeutic chemicals or ingredients or components in the preparation or

manufacture of goods for therapeutic use

foods intended for consumption by humans or animals or constituents in such food

food additives in foods intended for consumption by humans or animals

articles2

radioactive chemicals

trace contaminants that occur naturally in the environment.

The National Standard also does not specifically consider:

requirements for protection of human health, although many of the requirements

for protecting the environment may also indirectly protect human health through

reduced exposure to chemical in the environment.

measures that should be adopted in the event of accidental release of industrial

chemicals outside their intended use.

specific requirements for packaging and labelling industrial chemicals, however

labelling may be the most efficient and cost-effective method for introducers and

manufacturers to meet the outcomes of the risk management measures and

communicate requirements through the supply chain.

measures which the broader community of consumers will need to comply with.

4. Exemptions from the National

Standard

All chemical substances that are not excluded from the National Standard as described in

Section 3 are covered by the requirements under the National Standard. Chemicals used

solely for the purposes of research will be exempt from potential import restrictions,

subject to approval by the Decision Maker under the National Standard. However, all

other relevant risk management requirements must be adhered to ensure safe use of the

chemical substance and limit its exposure to the environment.

2 Articles containing chemicals of High Concern to the environment can be covered to ensure

international obligations relating to Convention on industrial chemicals are met. Other chemicals that

leach from articles may also be included under the Standard.




5. Industrial Chemicals

As outlined in Section 7 of the Industrial Chemicals (Notification and Assessment) Act

1989 (the ICNA Act) and for the specific purpose of the National Standard, industrial

chemicals are defined as “any chemical that has an industrial use.” An industrial use is

defined to mean anything other than an excluded use.

Excluded use, in relation to a chemical, means:

a. use as an agricultural chemical or a constituent of an agricultural chemical; or

b. use as a veterinary chemical or a constituent of a veterinary chemical; or

c. therapeutic use or use as an ingredient or component in the preparation or

manufacture of goods for therapeutic use; or

d. use as food intended for consumption by humans or animals or a constituent of

such food; or

e. use as a food additive which is further defined as a chemical whose inclusion in

food as a food additive is permitted under the Australia New Zealand Food

Standards Code (as defined for the purposes of the Food Standards Australia New

Zealand Act 1991).

However, a chemical may have both an industrial and excluded use and will be assessed

under the ICNA Act according to its industrial use.

An industrial chemical can be an element, compound or ingredient in a mixture or

product. Chemicals are used in every workplace and household in Australia and they

have a range of uses. Industrial chemicals are used in everything from mining and

manufacturing processes, to domestic and cosmetic products. The diagram below (Figure

1) outlines industrial chemical uses in Australia.

Figure 1: Examples of industrial chemical uses




A large portion of industrial chemicals are of low risk to the environment. However, some

chemicals can result in significant harm if not managed appropriately. In Australia, there

are examples where industrial chemicals have contaminated the environment. For

example, trichloroethylene contamination concerns in the air, soil and groundwater

recently resulted in the need to evacuate homes in Adelaide’s suburbs.

In general, contamination occurs when chemicals are not properly managed. It may also

be the case that people using the chemicals are unaware of their possible adverse effects

on the environment.

Removing chemicals from the environment and cleaning contaminated sites can cost

hundreds of millions of dollars. For example, in the Botany Bay area, pumping up and

remediating groundwater contaminated with chlorinated hydrocarbons has involved

building a treatment plant at a cost of $167 million.3

Chemicals can enter the environment at any stage during their lifecycle. The lifecycle of a

chemical includes all stages of a chemical’s useful life, from manufacture to end of life

processes. The lifecycle is outlined in Figure 2. The extensive use and distribution of

industrial chemicals in Australia means that chemicals are being released to the

environment from many locations across the nation every day. Chemicals are released

from industrial, commercial and domestic sources. Without appropriate management,

industrial chemicals could end up in our waterways, the air we breathe or our drinking

water and food we eat. This can be harmful to the environment and everything living in it,

including people.

Figure 2: Chemical lifecycle and exposure

3 National Water Commission (2012), Groundwater Essentials

http://www.nwc.gov.au/__data/assets/pdf_file/0020/21827/Groundwater_essentials.pdf

http://www.nwc.gov.au/__data/assets/pdf_file/0020/21827/Groundwater_essentials.pdf




6. Background to the National

Standard

6.1 A Brief History of the Reforms

In 2006, the Council of Australian Governments (COAG) identified chemicals and plastics

as a ‘regulatory hotspot’ and requested that the Productivity Commission review

Australia’s system of regulating chemicals and plastics across all sectors. The

Productivity Commission’s 2008 Research Report on Chemicals and Plastics Regulation4

highlighted that management of environmental risks from industrial chemicals across

jurisdictions was fragmented and inefficient, and less effective than other chemical risk

management regimes. Other chemical risk management regimes include health,

transport and occupational health and safety that have established frameworks for

managing the risks associated with industrial chemicals.

The Productivity Commission also recognised that existing national regulatory

arrangements for industrial chemicals were not sufficient to provide adequate

environmental protection.

In November 2008, COAG agreed to the recommendations made and tasked

Environment ministers with implementing the reforms relating to environmental risk

management. Two Regulation Impact Statements (RIS) - a Consultation RIS, and later, a

Decision RIS - were prepared to support the policy. The RISs considered approaches to

manage the risks posed to the environment from industrial chemical use. The

Consultation RIS was publicly released in 2013. Feedback on the Consultation RIS

informed the development of the Decision RIS. The Decision RIS presented options for

consideration by Environment ministers.

Environment ministers from the Australian Government and all states and territories met

in July 2015 and agreed to establish a National Standard for environmental risk

management of industrial chemicals.

In accordance with the preferred option outlined in the Decision RIS (Option 2), the

National Standard has been established under Commonwealth legislation and will be

implemented by each state and territory.

The preferred option in the Decision RIS sets out the parameters for the reforms agreed

to by ministers and enabled the Australian Government and state and territory

environment agencies to work on the detailed design and implementation of the reforms.

The development of the National Standard involved consultation and engagement with

industry and community representatives to formulate the nationally consistent,

transparent, predictable and streamlined approach.

The reform of Australia’s approach to environmental risk management of industrial

chemicals was developed in consultation with a wide range of stakeholders including

governments, industry and the community, over several years.

6.1.1 Consultation Regulation Impact Statement

A Consultation RIS was released in April 2013. PricewaterhouseCoopers facilitated public

consultation. This consultation included public forums, focus groups, one-on-one

meetings and written submissions. Feedback from the Consultation RIS resulted in the

proposal to develop a National Standard, canvassed in detail in the Decision RIS.

4 Available at http://www.pc.gov.au/projects/study/chemicals-plastics/docs/report

http://www.pc.gov.au/projects/study/chemicals-plastics/docs/report




Stakeholders agreed that there is benefit in government reform to protect the

environment and improve the effectiveness and efficiency of risk management actions for

industrial chemicals that have the potential to cause environmental harm.

Feedback received favoured an approach that harmonises implementation of national

decisions, is economical and integrated with the proposed changes arising from the

review of NICNAS and existing risk management frameworks implemented by states and

territories.

6.1.2 Decision Regulation Impact Statement

The Decision RIS was developed in cooperation with states and territories and with

ongoing engagement with industry. There is no requirement for formal public consultation

for finalisation of a Decision RIS supported by a Consultation RIS. However, one-on-one

meetings were held with selected stakeholders to ensure the proposal supported

feedback received on the Consultation RIS.

The Decision RIS outlined the concept of a National Standard for the environmental risk

management of industrial chemicals and three options for its implementation. Option 2

was deemed as being the preferred option for implementation and agreed by

Environment ministers. Option 2 is a cooperative approach where the National Standard

and decision-making powers would be established under Commonwealth legislation, with

automatic adoption under jurisdictional legislation for implementation and compliance.

6.1.3 The National Standard Information Paper

The Information Paper on the pathway for design and implementation of the National

Standard was released in December 2015. The primary purpose of the information paper

was to outline the key steps involved in the implementation of the National Standard,

including opportunities for consultation and input into the detailed design and intended

operation of the National Standard.

The paper recapped the context of the reforms, including the reform parameters agreed

to by Australia’s Environment ministers. The paper also provided an overview of the

proposed design and scheduling and decision-making processes under the National

Standard, in accordance with the policy intent set out in the Decision RIS.

As part of this, the paper invited preliminary feedback from industry and community

representatives in response to a small number of questions posed which informed

subsequent stages of the detailed design of the National Standard, noting that further and

more substantive consultation was to be undertaken during 2016.

Five responses were received on the information paper. Responses were generally

supportive of the establishment of the National Standard and noted that more details

would be useful to understand the design and processes of the National Standard and

the risk management measures.

6.1.4 The National Standard Discussion Paper

In March 2016, a Discussion Paper on the Environmental Risk Management of Industrial

Chemicals was released in collaboration with consultancy firm GHD Pty Ltd (GHD). The

primary purpose of the paper was to outline the proposed design and operation of the

National Standard, including scheduling and decision-making under the National

Standard. The paper provided an overview of intended Environment Schedules for

industrial chemicals and how risk management measures may be applied for the

Environment Schedules under the National Standard. The proposals aligned with the

policy intent set out in the Decision RIS. Questions throughout this paper addressed

some specific concerns or questions that were raised in submissions on the Information

Paper.




Stakeholders were invited to attend a series of public forums to discuss the Discussion

Paper. Stakeholders also had the opportunity to lodge written submissions in response to

it. In April 2016 representatives from GHD, supported by Australian Government

Department of the Environment and state and territory representatives, facilitated a series

of stakeholder workshops on the Discussion Paper and the intended approach to the

National Standard.

Stakeholders from governments, industry and the community participated in the

workshops that were held in Adelaide, Perth, Sydney, Melbourne and Brisbane.

Feedback received during these workshops was documented and has assisted in the

development of the National Standard and this Explanatory Document.


18 | GHD | Report for Department of the Environment and Energy - National Standard for Environmental Risk Management of


7. National Standard Schedules and

Criteria

Scheduling Criteria are outlined in Section 2 of the National Standard and are further explained in

Section 7.7

7.1 Introduction

The National Standard will be enacted in Commonwealth legislation. Along with other legislative

requirements and processes, the legislation will specify the scheduling criteria, risk management

measures and scheduling decisions made under the National Standard.

The National Standard contains three general categories in which industrial chemicals will be

categorised – High, Intermediate and Low Concern. These general categories span seven

Environment Schedules as outlined in Table 1.

Table 1: Environment Schedules

Concern Category

Environment Schedule

High Concern

Environment Schedule 7

Prohibited Substances

High Concern


Restricted Substances

Intermediate Concern


Substances with a potentially significant and long lasting impact on the environment



Hazardous, higher risk substances



Hazardous, moderate risk substances

Low Concern


Hazardous, low risk substances

Low Concern


Not hazardous and low hazard substances

Industrial chemicals are assessed for their risk to the environment and subsequently assigned into a

particular Environment Schedule based on their level of concern to the environment. This is

consistent with a risk-based, proportionate approach. Determining the level of concern that a

chemical poses to the environment involves consideration of:

the harm that the industrial chemical that could cause to the environment (hazard)

the likelihood that the chemical may cause harm to the environment based on the intended

use and volume of use of the industrial chemical (risk)


GHD | Report for Department of the Environment and Energy - National Standard for Environmental Risk Management of

Industrial Chemicals, 31/33665 | 19

certain socio-economic impacts of the chemical’s use in Australia, further detailed in Section

12.5.9.

The scheduling criteria are based on internationally accepted information requirements for assessing

and managing the risks chemicals pose to the environment. The criteria were developed based on

information considered by and available to environmental risk assessors under the ICNA Act. In

general, the criteria are based on a determination of the persistence, bioaccumulation and

toxicity of chemicals, where appropriate, and also incorporate other characteristics for chemicals

that are known to cause harm to the environment.

A single industrial chemical with several different uses and different assessed risks may be

categorised into different Environment Schedules depending on the concern the chemical poses to

the environment. Each scheduling decision outlines the scope of the risk assessment that was

undertaken including the use and volume of use of the chemical substance. Further information on

the risk assessment process is outlined in the Environmental Risk Assessment Guidance Manual for

industrial chemicals5 and on the NICNAS website.

The approach will ensure risk management requirements are risk based and proportionate and that

chemicals will be scheduled alongside other chemicals that require similar regulatory controls.

Inclusion of an industrial chemical in an Environment Schedule does not indicate:

that the industrial chemical is available for general use

that it has been approved and/or is available for any use

that its risk to the environment will be the same if used for a purpose other than the stated use

that it negates any obligation for assessment of the industrial chemical for any other use.

Chemical users and introducers must continue to meet their obligations under the ICNA Act and all

relevant state and territory regulations.

7.2 Prohibited or Restricted Chemicals

All chemicals that are persistent, bioaccumulative and toxic according to the National PBT Criteria or

are otherwise high concern to the environment (see Section 7.7.3) will have restricted use or be

prohibited under the National Standard.

If a chemical is a Prohibited substance, it is not to be imported, manufactured or used in Australia.

However, the National Standard may specify specific exemptions for a chemical as outlined in

Section 4. Alternatively, if a party seeks to undertake an activity that is otherwise inconsistent with a

management measure, that party may request a specific exemption from the Decision Maker.

Risk management measures for high concern chemicals in Environment Schedule 6 will be

recommended to the Decision Maker by the Advisory Committee or through a risk analysis for

Convention chemicals undertaken by the Australian Government. Risk management measures may

be chosen from all available standardised risk management measures that apply to any of the

Environment Schedules, or tailored risk management measures may be developed to ensure

appropriate management of the chemical.

Where Australia is a party to an international convention, risk management measures will be

consistent with the relevant international convention. Risk management measures that are set out in

international conventions include obligations relating to the import, manufacture, use, emissions,

storage and end of life processes (e.g. disposal, destruction, recovery, recycling, reuse, reclamation,

5 http://www.scew.gov.au/system/files/resources/bffdc9e9-7004-4de9-b94f-b758140dbc8c/files/cmgt-nchem-eragm-

industrial-chemicals-200902.pdf




etc) of a chemical. The Decision Maker must consult with states and territories on the risk

management measures to meet international obligations.

Following review of available information, the Advisory Committee may also determine that the

chemical recommended for Environment Schedules 6 or 7 does not meet the criteria to be

categorised as a High Concern chemical and may advise the Decision Maker that the chemical be

scheduled in Environment Schedule 5 or below. The Decision Maker may take into consideration the

available information in making their decision, including the recommendation from the Risk Assessor,

advice from the Advisory Committee and any other relevant information that supports the decision to

be made.

7.3 Products and mixtures containing one or more industrial

chemical

If a preparation contains two or more industrial chemicals scheduled under the National Standard,

the importer, manufacturer or user should consider the risk management measures and whether

they will be achieved for the scheduled chemicals in the product or mixture. Where a user will not be

capable of making such decisions, the importer or manufacturer will be responsible for ensuring use

and disposal of the product will not be in contradiction to the risk management measures under the

National Standard. This will be the case for products and mixtures sold to the public or intended to

be used in any other uncontrolled environment.

7.4 Articles

Generally, the National Standard will not cover chemicals imported into Australia in ready to use

articles. However, chemicals known to leach from articles may be assessed for their risk to the

environment and included under the National Standard. Risk management of chemicals in articles

may also extend to High Concern chemicals where it will support management of these chemicals

for the purpose of meeting Australia’s obligations under international conventions.

7.5 Degradation products

The potential for a degradation product to persist in the environment is a particularly important

consideration when the degradation product persists in the environment and is of greater concern to

the environment than the parent chemical.

The potential for a chemical to degrade in the environment over time and the likelihood that the

degradation product will persist and will be of greater concern than the parent chemical will be

considered in the risk assessment. If the chemical is likely to persist and form a degradation product

of greater concern, the scheduling recommendation will be made based on the degradation product.

7.6 Location specific considerations

Environmental risk assessments are generally undertaken at a national level. However, the first

stage of all risk assessments is a problem formulation stage that identifies the key risks that should

be the focus of the risk assessment. During problem formulation, it may be determined that location

specific considerations need to be taken into account, especially where particularly sensitive

environments are involved. The location may be consideration of a region such as a city or marine

reserve, down to the site and environment in which the chemical is used. The specificity of the risk

assessment is determined on a case-by-case basis and is often proportionate to the potential risk of

the chemical. Therefore, chemicals in higher schedules may have a greater consideration of their

location specific risks.


GHD | Report for Department of the Environment and Energy - National Standard for Environmental Risk Management of

Industrial Chemicals, 31/33665 | 21

7.7 Explanation of Scheduling Criteria

Scheduling Criteria are outlined in Section 2 of the National Standard

The scheduling criteria are based on the information considered during an environmental risk

assessment in Australia. The environmental risk assessment process and policy is outside the scope

of the National Standard. Guidance on the assessment of risks to the environment from industrial

chemicals is outlined in the Environmental Risk Assessment Guidance Manual for Industrial

Chemicals6.

7.7.1 Scheduling criteria

The criteria for scheduling will be legislated criteria used in the formulation of scheduling and risk

management recommendations. The scheduling criteria apply to chemical substances, or relevant

degradation products or by-products formed during use or following end of life processes. A chemical

substance will be scheduled based on the characteristics of that which is of most concern to the

environment, whether it be the chemical itself, or its degradation product or by-product.

The following information is provided to support understanding of the scheduling criteria and justify

why chemical substances are categorised into particular schedules. The questions Sections 7.7.2

and 7.7.3 are all considered as part of the risk assessment process and will be answered by the Risk

Assessor. Risk assessment policy and methods are based on international best practice for

environmental risk assessment of chemicals.

Questions are intended to flow from one to the next. Answering ‘yes’ to a higher numbered question

may result in the end of a process, meaning that answering ‘no’ to any of the subsequent questions

does not mean the scheduling will change. The answer to all questions must be ‘no’ for chemicals to

be in Environment Schedule 1.

The following information should be seen as guidance to support stakeholders’ understanding of the

categorisation process.

6 http://www.scew.gov.au/system/files/resources/bffdc9e9-7004-4de9-b94f-b758140dbc8c/files/cmgt-nchem-eragm-

industrial-chemicals-200902.pdf




7.7.2 Scheduling decision trees


GHD | Report for Department of the Environment and Energy - National Standard for Environmental Risk Management of Industrial Chemicals, 31/33665 | 23




7.7.3 Explanation of questions in categorisation decision trees

Question 1 – Is the substance Persistent, Bioaccumulative and Toxic (PBT) or otherwise

of significant environmental concern?

If the answer to this question is yes, the chemical is High Concern to the environment and

prioritised for management under the National Standard. The import, manufacture or use of

these substances in Australia is not recommended. However, there are circumstances where

their use has a net benefit to the community, usually in terms of protecting public and worker

health and safety. All substances identified to be PBT in the risk assessment will be in

Environment Schedule 6 (Restricted Substances) or Environment Schedule 7 (Prohibited

Substances). An expert Advisory Committee will review all PBT substances and develop

appropriate management controls.

Persistent, bioaccumulative and toxic substances

For the substance to be considered persistent, bioaccumulative and toxic (PBT), it must meet all

three hazard characteristics (P and B and T) of the National PBT Criteria. Table 2 outlines the

criteria with further explanation in Section 7.8. The PBT Criteria mainly apply to organic

chemicals although modified tests can be undertaken on inorganic chemicals to determine their

toxicity and bioaccumulation potential. Inorganic chemicals of concern are considered to be

substances otherwise of significant environmental concern.

Persistent, bioaccumulative and toxic (PBT) chemicals are of particular concern to the

environment. PBT chemicals persist for long periods, accumulate in biota and can give rise to

toxic effects after a greater time and at a greater distance from the source than chemicals

without PBT properties. Also concerning is that a cessation of emissions of these chemicals will

not necessarily result in a reduction in concentration in the environment, that is, their effects

following release may be irreversible.

It is difficult to quantitatively or even qualitatively assess the risk of such chemicals. The

additional concerns that may not be adequately addressed by traditional risk assessment

methodologies include:

concern that such substances may accumulate in parts of the environment and that:

– the effects of such accumulation are unpredictable in the long-term

– such accumulation would be practically difficult to reverse

– determining where a PBT chemical is likely to accumulate is difficult to estimate as

they can travel long distances from the source.

concern that remote areas of the oceans should remain untouched by hazardous

substances resulting from human activity, and that the intrinsic value of pristine

environments should be protected.

Because exposure to PBT chemicals is long-term, effects may not be identified in the short-

term, or even over a generation. Therefore, a ‘safe’ concentration may be impossible to

determine.



of Industrial Chemicals, 31/33665 | 25

Table 2: National PBT criteria7

Hazard characteristic

Environmental medium (or compartment or trophic level)

Indicators and numerical thresholds for positive hazard categorisation

Persistence Air Half-life in air (T½) ≥ 2 days

Water Half-life in water (T½) ≥ 60 days

Soil Half-life in soil (T½) ≥ 6 months

Sediment Half-life in sediment (T½) ≥ 6 months

Bioaccumulation Aquatic BAF ≥ 2000 or BCF ≥ 2000 or

log Kow ≥ 4.2 (if BAF and BCF are not

available)

Terrestrial log Koa > 6 and log Kow ≥ 2

Food-chain bioaccumulation potential BMF > 1

Toxicity Aquatic - Acute

Fish

Invertebrates

Algae or other aquatic plants

96 h LC50 ≤ 1 mg/L and/or

48 h EC50 ≤ 1 mg/L and/or

72 or 96 h ErC50 ≤ 1 mg/L

Aquatic - Chronic

Fish

Invertebrates

Algae or other aquatic plants

Chronic NOEC or ECx ≤ 0.1 mg/L and/or

Chronic NOEC or ECx ≤ 0.1 mg/L and/or

Chronic NOEC or ECx ≤ 0.1 mg/L

BCF = bioconcentration factor; BAF = bioaccumulation factor; Kow = n-octanol/water partition

coefficient; Koa = octanol/air partition coefficient; BMF = biomagnification factor; LC50 =

concentration lethal to 50% of the population; E(r)C50(x) = concentration that has adverse

effects to 50% of the population (or growth rate for algae); NOEC = No Observable Effect

Concentration.

Note: These are the general criteria and may not be directly applicable to difficult to test

substances such as some surfactants. The risk assessment will identify and justify the PBT

characteristics of the chemical.

Substances otherwise of significant environmental concern

Substances that are otherwise of significant environmental concern are those that are highly

hazardous to the environment and are often subject to restrictions or bans internationally. These

include substances that deplete the ozone layer and inorganic compounds such as toxic metals

that are known to be extremely hazardous to the environment (e.g. mercury and lead). Of

course, where legislation already exists for the national management of these chemicals in

Australia, the Advisory Committee will take this into consideration when developing risk

management advice. Chemical substances or groups of chemicals that meet these

characteristics will be listed and guidance documents will be provided.

7 The National PBT Criteria are also outlined on the NICNAS website under the Inventory Multi-tiered

Assessment and Prioritisation (IMAP) Framework documentation and in the Environment Risk Assessment

Guidance Manual for Industrial Chemicals available online.




Question 2 – Are any PBT substances reasonably expected to form as degradation or by-

products during use or after disposal?

While a substance itself may not be persistent, bioaccumulative or toxic, it may degrade to form

a PBT substance during use or upon release to the environment.

Some degradable substances may not degrade completely in the environment and may only

undergo primary degradation (the substance loses its original structure and properties). These

substances have the potential to form persistent degradation products that may need

consideration for categorisation of the parent substance. As degradation products may have

different physico-chemical properties to their parent, they should also be considered separately.

The potential for a degradation product to persist in the environment is a particularly important

consideration when the degradation product fulfils the criteria for categorisation as a PBT

substance.

If the answer to this question is yes, the substance is High Concern to the environment and

prioritised for management under the National Standard. The import, manufacture or use of PBT

substances in Australia is not recommended. All PBT substances will be in Environment

Schedule 6 (Restricted Substances) or Environment Schedule 7 (Prohibited Substances). An

expert Advisory Committee will review all PBT substances and develop appropriate

management approaches for consideration by the Decision Maker.

Question 3 – Is the substance an inorganic species containing a metal of concern to the

environment?

Most environmental risk assessment methods have been developed for organic chemicals and

as such do not adequately consider the unique characteristics of metals. Therefore, to carry out

an accurate risk assessment, metals must be assessed separately to organic substances or the

organic component of a substance.

Metals occur naturally in the earth’s crust and can exist in the environment in many different

forms. Although standard PBT criteria cannot be applied to inorganic substances, metals can be

considered to persist in the environment as they do not break down to simpler compounds (e.g.

carbon dioxide and water). Some metals are essential to the functioning of organisms. However,

there are a number of metals that are of concern to the environment.

Metals of significant environmental concern such as mercury and lead are considered High

Concern to the environment and meet the criteria under Question 1 above. There are other

metals that are not of the same level of concern, but still may require management to prevent

harm to the environment. These metals include those which display toxicity to organisms above

certain concentrations and can exist in the environment in a bioavailable form that means they

are available for consumption or absorption by organisms.

Metals that meet the criteria for answering yes to this question include:

Copper

Nickel

Cadmium

Zinc

Silver

Chromium

Aluminium




Question 4 – Is the substance or could the substance harm the environment with long

lasting effects in line with the GHS criteria?

The GHS classification for long lasting environmental hazard consists of four toxicity

classification categories and one category for the potential for depletion of the ozone layer. The

criteria for classification of a substance into the chronic categories follow a tiered approach

where the first step is to identify if available information merits a long-term hazard classification.

Classification can be done using available toxicity data. If chronic toxicity data is not available,

acute toxicity data and environmental fate data are used for classification.

The GHS hazard statements for effects on the environment are outlined in Table 3. More

information on classification of substances under the GHS and guidance for classification of

substances can be found in Part 4: Environmental Hazards of the Globally Harmonised System

of Classification and Labelling of Chemicals (GHS), 3rd Revised Edition8.

Table 3: GHS Hazard Statements for classification of long term

environmental hazards

Hazard Number Hazard Statement

H410 Very toxic to aquatic life with long lasting effects

H411 Toxic to aquatic life with long lasting effects

H412 Harmful to aquatic life with long lasting effects

H413 May cause long lasting harmful effects to aquatic life

H420 Harms public health and the environment by destroying the ozone in the upper atmosphere

Question 5 – Is the substance acutely harmful, toxic or very toxic to aquatic organisms in

line with the GHS criteria?

The GHS classification for acute environmental hazard consists of three classification

categories. The criteria for classification of a substance in the acute categories are defined on

the basis of acute toxicity data only.

The GHS hazard statements for effects on the environment are outlined in Table 4. More

information on classification of substances under the GHS and guidance for classification of

substances can be found in Part 4: Environmental Hazards of the Globally Harmonised System

of Classification and Labelling of Chemicals (GHS), 3rd Revised Edition9.

8 Available at: https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev04/English/ST-SG-AC10-

30-Rev4e.pdf 9 Available at: https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev04/English/ST-SG-AC10-

30-Rev4e.pdf




Table 4: GHS Hazard Statements for classification of short term

environmental hazards


H400 Very toxic to aquatic life

H401 Toxic to aquatic life

H402 Harmful to aquatic life

Question 6 – Is there evidence to suggest the substance is hazardous to organisms other

than aquatic organisms?

The effects to aquatic organisms are considered to best represent the toxicity of an industrial

chemical in the environment. This is because the primary exposure pathway for most industrial

chemicals is generally the sewer. Surface waters are also thought to be the most likely sink for

chemicals released into other compartments in the environment, whether it be through leaching

from soils or becoming associated with water or particles in the atmosphere and returning to

earth in rain.

Aquatic organisms are also generally considered to receive a higher relative dose of a chemical

than terrestrial organisms. They live in the contaminated medium and can be quite sensitive to

changes, including changes in water temperature, pH, dissolved oxygen, turbidity and dissolved

organic carbon, to name a few.

However, in some cases, substances can be harmful to other organisms if those organisms are

exposed to them. The answer to this question is yes if there is sound evidence (studies, test

data, observations) that a substance may harm any organism in the environment other than

aquatic organisms.

Question 7 – Is the substance bioaccumulative?

Bioaccumulation is the general term that is used to describe substances that are accumulated

by organisms either directly from the surrounding media, respiration or through the consumption

of food containing the substance. Bioaccumulation of a substance in an organism is not a

hazard, but may result in a body burden which can lead to toxic effects.

A substance is bioaccumulative if it meets the following criteria for bioaccumulation (consistent

with the PBT criteria outlined above).

Table 5: Criteria for Bioaccumulation (B) Categorisation

Bioaccumulation (B)

Aquatic

BCF or BAF ≥ 2000

or

log Kow ≥ 4.2

Terrestrial Log Koa > 6 and log Kow ≥ 2


Where BCF = bioconcentration factor; BAF = bioaccumulation factor; Kow = n-octanol/water

partition coefficient; Koa = octanol/air partition coefficient; BMF = biomagnification factor




Question 8 – Does the substance contain any perfluorinated functionality?

Perfluorinated functionality in a substance can be identified structurally. Carbons that are fully

fluorinated, that is, all bonds that are not C-H or C-C bonds are C-F bonds, are perfluorinated

and substances containing these bonds in a carbon chain length of three or more are

substances that contain perfluorinated functionality.

Substances with perfluorinated functionality are a diverse group of compounds resistant to heat,

water, and oil. These substances are very persistent and resist degradation in the environment.

The carbon-fluorine bond is one of the strongest and most difficult bonds to break, generally

requiring very high temperatures to break the molecule apart. These substances can also

bioaccumulate which means their concentration increases over time, particularly in blood and

organs of organisms. Because of their unique characteristics and historic release to the

environment, surface waters are regularly found to be contaminated with these substances,

even significant distances from their sources.

Polymers containing perfluorinated functional groups may also be of concern. Even for polymers

that are considered to be persistent, it is likely that the last remaining part of a polymer after

years of breaking down will be the perfluorinated functional group. Therefore, polymers that

contain perfluorinated functional groups but otherwise appear to be not hazardous, may

contribute to the total environmental load of perfluorinated substances in the environment over

time.

Because of their properties, it is difficult to quantitatively or qualitatively assess the risk of

substances containing perfluorinated functionality. Therefore, these substances are targeted for

management to prevent excessive release to the environment.

Question 9 – Is there any evidence to suggest the substance is an endocrine disruptor?

An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the

endocrine system and consequently causes adverse health effects in an intact organism, or its

progeny, or populations10.

Endocrine disruptors interfere in some way with hormone action and in so doing can alter

endocrine function such that it leads to adverse effects on the health of organisms in the

environment. Of particular concern is the potential for these substances to be active at very low

concentrations and cause infertility or reduced fertility in organisms, or irreversible

developmental abnormalities. These changes can have serious impacts on ecosystems and

cause serious damage to populations in the environment.

Evidence to suggest that a substance is an endocrine disruptor includes relevant studies, test

data or observations that a substance is an endocrine disruptor. Guidance will be provided on

how endocrine disruptors are characterised.

Question 10 – Is there evidence to suggest that the substance has other characteristics

that may result in adverse short or long term effects on the environment?

In some circumstances, substances may not be hazardous through toxicity or bioaccumulation,

but may have other characteristics that may result in short or long term effects on the

environment. These substances currently have unquantifiable risks, but there is evidence to

suggest their presence in the environment may have possible adverse effects.

This category currently includes:

10 Global Assessment of the State-of-the-Science of Endocrine Disruptors, World Health Organisation,

International Programme on Chemical Safety (2012)




nanomaterials

substances that are persistent with the potential to have adverse effects on the

environment as they accumulate

substances that have the potential to be endocrine active in aquatic or terrestrial

organisms but are not demonstrated to be endocrine disrupting.

These characteristics will be identified in the risk assessment.

Substances in this category that are otherwise not identified as hazardous (at least harmful,

bioaccumulative, perfluorinated or endocrine-disrupting) will be recommended for inclusion in

Environment Schedule 3. This will enable release to the environment to be managed

appropriately and include the potential for a watching brief to ensure a change in circumstances

is reported. This category will also have the potential to be reviewed to include substances with

emerging but yet unquantifiable risks to the environment.

Question 11 – Is the substance reasonably expected to form degradation or by-products

during use or after disposal that are hazardous to the environment?

For the purpose of categorisation under the National Standard, substances are considered

hazardous (but not High Concern) to the environment if the answer to any of questions 3 to 10

is yes. That is, the substance:

could harm the environment with long lasting effects

is acutely harmful, toxic or very toxic to aquatic organisms

is at least harmful to organisms other than aquatic organisms

is bioaccumulative

contains perfluorinated functionality

is an endocrine disruptor or potential endocrine disruptor

has other characteristics that may result in adverse short or long term effects on the

environment

While a substance itself may not be hazardous to the environment, it may degrade to form a

substance that is hazardous during use or upon release to the environment.

Some degradable substances may not degrade completely in the environment and may only

undergo primary degradation. These substances have the potential to form persistent

degradation products that may need consideration for categorisation of the parent substance.

As degradation products may have different physico-chemical properties to their parent, they

may be considered separately in the risk assessment. The potential for a degradation product to

persist in the environment is a particularly important consideration when the degradation

product fulfils the criteria for categorisation as a moderately hazardous substance.

If the answer to this question is yes, the substance should be categorised under the National

Standard according to the hazard of the degradation product. For example, if the degradation

product contains perfluorinated functionality and is toxic to aquatic organisms, the parent

substance should be categorised into the appropriate Environment Schedule for the

degradation product.

Inorganic substances containing metals of concern to the environment

Chemical substances that contain both a metal and non-metal component will be considered for

both components against the scheduling criteria. Chemicals will be recommended for

scheduling based on the component that represents the highest concern to the environment.




For example, if one component is in Environment Schedule 3 and the other is in Environment

Schedule 4, the chemical will be assigned to Environment Schedule 4 and appropriate risk

management measures applied.

Question 12 – Is the metal in a form that it is or could become bioavailable following

release from the assessed use?

Not all metals will be bioavailable once in the environment. For example, if a metal is not mobile

or is not able to readily cross the membranes of organisms, then it is not likely to be a significant

risk to the environment. However, substances that are water soluble or water dispersive may

have a higher likelihood of being or becoming bioavailable. The risk assessment will identify the

likelihood that a substance is bioavailable once in the environment and the extent to which it is

released to the environment.

If the chemical substance contains a metal of concern to the environment, but is not

bioavailable, it will be categorised into Environment Schedule 3 (unless the non-metal

component has a higher scheduling recommendation). If it is determined that the metal

component is bioavailable, the chemical will be categorised into Environment Schedule 4 or

Environment Schedule 5 depending on the effects the metal may have on the environment

(Question 13).

Question 13 – What are the effects of the metal under the environmental conditions for

assessed use and release?

As with other chemicals, metals may be harmful, toxic or very toxic to the environment with

acute or long lasting effects. As metals are persistent in the environment, their effects, both

acute and long lasting, can have long term implications if not managed appropriately. Therefore,

they will be categorised into Environment Schedules 4 and 5.

Metals that are toxic or very toxic with acute or long lasting effects according to the GHS, or

metals likely to accumulate in organisms causing adverse effects, will be in Environment

Schedule 5.

Metals that are Harmful to the environment according to the GHS will be in Environment

Schedule 4.

Question 14 – Is the PEC ≥ PNEC OR, where the PEC cannot be calculated, is the

substance released to the environment AND very toxic with long lasting effects?

This question is asking for consideration of the risks that harmful, toxic or very toxic substances

may pose to the environment. The predicted environmental concentration (PEC) and the

predicted no-effect concentration (PNEC) are calculated in the risk assessment (refer to the

Risk Assessment Guidance Manual for environmental risk assessment of industrial chemicals).

If the assessed concentration of the substance in the environment without additional controls

(PEC) is greater than or equal to the concentration predicted to cause harm to the environment

(PNEC), then the chemical is more than likely to have an adverse impact on the environment for

the assessed use. Therefore, stricter management of the risks the chemical substance poses to

the environment is required to ensure emissions to the environment are limited.

If the answer to this question is ‘yes’, the chemical substance will be categorised into

Environment Schedule 5.




Question 15 – Is the substance very toxic with acute or long lasting effects AND

persistent or bioaccumulative?

Chemical substances for which the answer to this question is ‘yes’, meet the criteria for being

categorised as toxic and bioaccumulative (BT), or toxic and persistent (PT) according to the

National PBT Criteria. Chemical substances with these characteristics will be in Environment

Schedule 5 to ensure their release to the environment is prevented through appropriate

management. BT and PT chemical substances are particularly hazardous to the environment

and have increased effects burden on organisms compared to chemical substances that are just

considered toxic.

Question 16 – Is the substance bioaccumulative AND persistent or an endocrine

disruptor?

Similarly to Question 15, these substances meet the criteria to be categorised as persistent and

bioaccumulative (PB) according to the National PBT Criteria or are bioaccumulative and

endocrine disruptors. These chemical substances are particularly hazardous to the environment

and have increased effects burden on organisms compared to chemical substances with one

particular hazard characteristic. Chemical substances with these characteristics will be in

Environment Schedule 5 to ensure their release to the environment is prevented through

appropriate management.

Question 17 – Is the PEC/PNEC ≥ 0.1 OR, where the PEC cannot be calculated, is the

substance released to the environment AND toxic with long lasting effects?

If the answer to Question 17 is ‘yes’, then the substance is released to the environment and

classified as toxic with long lasting effects, or the assessed concentration of the substance in

the environment without additional controls (PEC) is greater than or equal to 10% of the

concentration predicted to cause harm to the environment (PNEC).

1 > PEC/PNEC ≥ 0.1

This means that the substance is not likely to harm the environment at the current level of

exposure to the environment, but if the circumstances were to change slightly, release of the

substance may cause harm to the environment. This may occur in the following circumstances,

for example:

the release volume increases 10 fold, either due to an increase in introduction volume (or

introducers) or changes in business practices.

the daily effluent volume in a sewage treatment plant is lower than assessed. This may

occur because the substance is now used in the same way but in a location with a

smaller population or there is a seasonal variation in the effluent volume.

the volume of water in the receiving environment decreases, such as in times of drought.

These are just a few examples of where small changes may result in increased risk to the

environment.

If the answer to this question is ‘yes’, then the substance is recommended for Environment

Schedule 4. Substances with these characteristics should be managed to prevent excessive

releases to the environment and ensure the PEC doesn’t change if the circumstances change.

Question 18 – Is the substance bioaccumulative OR an endocrine disruptor?


Schedule 4.




Endocrine-disrupting substances should be managed to prevent excessive releases to the

environment. These substances can be active at very low concentrations. They can have

serious impacts on ecosystems and cause serious damage to populations in the environment.




hazard, but may result in a body burden which can lead to toxic effects. A substance is

bioaccumulative if it meets the criteria for bioaccumulation outlined in the National PBT criteria.

Question 19 – Is the PEC/PNEC ≥ 0.01 OR the chemical at least harmful with long lasting

effects?

If the answer to Question 19 is ‘yes’, then the substance is released to the environment and

classified as harmful with long lasting effects, or the assessed concentration of the substance in

the environment without additional controls (PEC) is greater than or equal to 1% of the

concentration predicted to cause harm to the environment (PNEC). Considering the answer to

Question 17 would need to be ‘no’ for this question to be considered, the assessed

concentration of the substance in the environment without additional controls (PEC) is also less

than or equal to 1% of the concentration predicted to cause harm to the environment (PNEC).

0.1 > PEC/PNEC ≥ 0.01

This means that the substance is not likely to harm the environment at the current level of

exposure to the environment. However, as with Question 14, if the circumstances were to

change moderately, release of the substance may cause harm to the environment.


Schedule 3. Substances with these characteristics should have some mitigating measures to

prevent excessive exposure, but not as stringent as those to mitigate the potential risks of

Environment Schedule 4 substances.

If the answer is ‘no’, the substance will be recommended for Environment Schedule 2.

Question 20 – Is the substance also persistent OR is it an endocrine disruptor [as well as

being bioaccumulative]?

This question is the same as Question 16, but in a different path of the decision tree.

Similarly to Question 15, these substances meet the criteria to be categorised as persistent and

bioaccumulative (PB) according to the National PBT Criteria or are bioaccumulative and

endocrine disruptors. These chemical substances are particularly hazardous to the environment

and have increased effects burden on organisms compared to chemical substances with one

particular hazard characteristic. Chemical substances with these characteristics will be in

Environment Schedule 5 to ensure their release to the environment is prevented through

appropriate management.

If the answer to this question is ‘no’, the chemical substance will be categorised in Environment

Schedule 4.

Question 21 – Is the substance also an endocrine disruptor [as well as having

perfluorinated functionality]?

Chemicals with perfluorinated functionality are very persistent in the environment. Because of

their properties, it is difficult to quantitatively or qualitatively assess the risk of substances

containing perfluorinated functionality. Answering ‘yes’ to this question will result in the chemical

substance being categorised in Environment Schedule 5. This is due to the potential for




significant burden on organisms from the perfluorinated functionality in combination with

endocrine disruption.

If the answer to the question is ‘no’, the chemical substance only contains perfluorinated

functionality and is therefore categorised in Environment Schedule 4.

7.8 Hazard characteristics of substances

7.8.1 Persistent substances

The persistence of a chemical is the measure of its potential to resist degradation upon entering

the environment. Degradation in the environment can be either an abiotic process such as

hydrolysis, or a biotic process such as biodegradation. If a chemical is resistant to degradation

processes in the media in which it is present, it is classified as persistent.

While persistence is considered in conjunction with bioaccumulation and toxicity, it is not always

a negative attribute. For example, if a chemical is expected to release much more harmful

products upon degradation, the fact that the chemical is persistent may reduce its level of

concern.

The persistence of a chemical is a difficult property to measure. Persistence cannot be

measured directly but can only be inferred from measurements of degradation. Environmental

measurements are considered the most representative measurement of potential degradation

and rates. However, in vivo measurements are site specific and likely to be influenced by

environmental factors that make interpretation of data difficult. Therefore, the degradation rate

measured in vitro is used to interpret the potential for a substance to degrade and,

consequently, the potential for the chemical to be categorised as Persistent (P).

The half-life of a substance indicates the potential for that substance to be persistent in the

environment. As outlined in Figure 3, according to first-order kinetics, after five half-lives the

amount of a chemical remaining in the environment is expected to be minimal, equating to

approximately 3% of the initial concentration [100% ÷ (½)5]. For example, a chemical with a half-

life of 6 days is expected to be reduced to 3% of its initial concentration after 30 days, whereas

a chemical with a half-life of 70 days will take 350 days to get to the same concentration

(ECETOC 2003).

Figure 3: Disappearance of a chemical according to first-order kinetics

The extrapolation of degradation data to the environment is further described in detail in

Persistence of Chemicals in the Environment - Technical Report No. 90 (ECETOC 2003).




Criteria for Persistence categorisation

The Australian criteria for categorisation of persistence are detailed in Figure 4. These criteria

are based on degradation half-lives of chemicals in the environment.

Figure 4: Australian criteria for persistence (P) categorisation based on the

half-life of a chemical in different media

For the purposes of assessment, a P categorisation for a chemical is considered for all media

where the chemical is expected to be realistically present. A realistic presence for a chemical is

considered to be when a chemical is present in any medium at levels greater than 5% (OECD

2000). That is, if a chemical is volatile and expected to partition to air at levels above 5%, the

potential for the chemical to persist in air will be considered.

It is also important to note that degradation in marine water is expected to be slower than

freshwater. If interpreting persistence of a chemical in marine water using freshwater data, a

lower half-life threshold for categorisation of persistence may be considered. For example, in

cases where only freshwater data is available, the European Centre for Ecotoxicology and

Toxicology of Chemicals (ECETOC) recommends the threshold is lowered to ≥ 40 days for

categorisation of the chemical as persistent.

Substances persistent in air

Substances that are persistent in air have the potential to travel long distances and be

distributed in areas some distances from the source of emission. The chemical that is

distributed over long distances has the potential to cause adverse environmental effects in

otherwise pristine environments.

Reliable measured or calculated data that indicates partitioning to air is reasonably significant,

that is greater than 5%, initiates an examination of the half-life of the chemical in air. If the

chemical is determined to have a half-life in air greater than two days, and the chemical is not

persistent in water, the chemical is categorised as P* (Persistent (in air)).

General characteristics of persistent chemicals

There are several ways that a substance may degrade in the environment. These processes

can be broken down into biotic and abiotic processes. The characteristics of potentially

persistent substances are outlined in the table below. The degradation processes include

biodegradation potential, as well as potential for a substance to hydrolyse, photolyse and

oxidise in the environment.




Table 6: Characteristics of persistent substances

Property Degradation potential

Water solubility Compounds that are sparingly soluble in water tend to be more resistant to biodegradation possibly due to an inability of microorganisms to reach microbial enzyme sites, a reduced rate of availability due to solubilisation, or absorption or trapping in inert materials (Boethling and Mackay 2000). Equally, hydrolysis will be limited for poorly soluble substances.

Molecular composition Simple, carbon-based substances are likely to easily degrade under environmental conditions. Functional groups that are commonly encountered by microorganisms in natural products are usually degraded easily, most likely due to the organisms evolving to develop the required enzyme systems to obtain carbon and energy from the metabolism (Boethling and Mackay 2000).

Primary amines are more susceptible to biodegradation then secondary amines, with tertiary and cyclic amines being the most persistent of the amine compounds (Boethling and Mackay 2000).

Polycyclic aromatics are more susceptible to biodegradation if their structure contains less than three aromatic rings.

Electron withdrawing substituents, such as nitro groups and halogens, increase the persistence of a chemical as aerobic microbial degradation favours electron rich structures. Electron-donating functionalities, such as phenols and amines, generally increase biodegradation rates (Boethling and Mackay 2000, Mayo-Bean, Moran et al. 2012).

The presence of polyethylene glycol (PEG) and polypropylene glycol (PPG) groups indicate that a compound has the potential to degrade under environmental conditions.

Linearity Highly branched compounds are frequently resistant to biodegradation because increased substitution hinders β-oxidation, the process by which alkyl carbon chains and fatty acids are usually biodegraded (Boethling and Mackay 2000).

Hydrolysable functionality

Hydrolysis is a bond-making, bond-breaking process in which a molecule reacts with water to form a new bond with the oxygen atom from water and breaking the bond in the original molecule. That is;

RX + H2O → ROH + HX

Compounds susceptible to hydrolysis include carboxylic acid esters, amides, halocarbons, epoxides, nitriles, carbamates, sulfonylureas and organophosphate esters.

Amides are less hydrolytically reactive than esters. Amides generally require an acid or base for measurable reaction rates. Hydrolysis of compounds via a base-mediated reaction are less likely to occur as the acid and neutral processes generally dominate the environmental pH range (Boethling and Mackay 2000).

Atmospheric oxidation potential

The presence of reactive species in the atmosphere can initiate a number of chemical transformations in the atmosphere. Hydroxyl (OH) radicals, NO3 radicals and ozone react with organic compounds to form transformation products.

All organic compounds except chlorofluorocarbons and certain Halons (saturated carbon compounds containing only carbon, fluorine, chlorine




Property Degradation potential

and/or bromine) react with OH radicals. This is the dominant loss process for 90% of the organic compounds in the atmosphere (Boethling and Mackay 2000).

NO3 radicals also react with a large number of organic compounds. These reactions are potentially important tropospheric loss processes for unsaturated compounds, organosulphur compounds and certain nitrogen containing compounds (Boethling and Mackay 2000).

Reactions with ozone are only significant for compounds containing unsaturated carbon-carbon bonds and certain nitrogen containing compounds (Boethling and Mackay 2000).

Photolysis potential in surface waters

Direct photolysis occurs in compounds that absorb ultraviolet (UV) light from in the sunlight region of the electromagnetic spectrum (wavelengths > 295 nm). Only a small proportion of synthetic organic compounds absorb UV and visible light in the sunlight region. Compounds that absorb sunlight between 300 and 450 nm include nitro- or polyhalogenated benzenes, naphthalene derivatives, polycyclic aromatics and aromatic amines, nitroalkanes, azoalkanes, ketones and aldehydes. Polycyclics, azoaromatics, and quinones absorb visible light (Boethling and Mackay 2000).

Indirect photolysis occurs due to light reacting with compounds other than the compound of interest to form intermediate oxidants or excited states that cause chemical changes on the compounds of interest. These intermediate compounds are formed from dissolved organic matter and nitrate ions in water, and ozone and NO2 in the air. Singlet oxygen (the electronically excited state of molecular oxygen) and peroxy radicals that are formed are selective and electrophilic. Therefore, only electron-rich compounds undergo relatively rapid indirect photolysis. These include phenols, furans, aromatic amines, polycyclic aromatic hydrocarbons and alkyl sulphides (Boethling and Mackay 2000).

Persistence of degradation products

Some degradable chemicals may not completely mineralise in the environment, that is, they

may only undergo primary degradation. These chemicals have the potential to form persistent

degradation products that may need consideration for categorisation of the parent chemical. As

degradation products may have different physico-chemical properties to their parent, they

should also be considered separately. The potential for a degradation product to persist in the

environment is a particularly important consideration when the degradation product fulfils the

criteria for categorisation as PBT.

Biological degradation of organic compounds is the most desirable degradation process

because it generally results in end-products that have been completely mineralised into

inorganic compounds. Photoreactions are often complex reactions that can produce products

with chemical, physical and biological properties quite different from their parent compounds:

more water soluble, less volatile and less likely to be taken up by biota. Photooxidation removes

many potentially harmful chemical from the environment, although occasionally more toxic

products are formed (Boethling and Mackay 2000).

7.8.2 Bioaccumulative substances




hazard, but may result in a body burden which can lead to toxic effects.




There are three processes that may lead to a chemical being categorised as Bioaccumulative

(B). These are bioconcentration, bioaccumulation and biomagnification. Definitions for these

terms in this context are as follows:

Bioconcentration The process by which a chemical substance is absorbed by an organism from the ambient environment only through its respiratory and dermal surfaces.

Bioaccumulation The process in which a chemical substance is absorbed in an organism by

all routes of exposure as occurs in the natural environment

Biomagnification The increase in concentration of the test substance in or on an organism (or specified tissues thereof) relative to the concentration of test substance in the food. This is often also described as accumulation of substances via the food chain




Bioconcentration and bioaccumulation are the net result of competing processes of the uptake,

metabolism and elimination of a substance. Uptake can be through the respiratory surface (and

from the diet for bioaccumulation), and elimination through respiratory exchange, faecal

egestion, metabolic biotransformation of the parent compound, and growth dilution (Figure 5)

(ECETOC 2003). Growth dilution, however, is not an elimination process, but rather a reduction

in the concentration of a chemical purely due to an increase in the tissue mass. The degree of

bioaccumulation also depends on a number of factors such as the degree of bioavailability, the

physiology of the test organism, maintenance of a constant exposure concentration and

exposure duration (EPHC 2009).

Figure 5: Uptake and elimination of substances during bioconcentration and

bioaccumulation processes (adapted from (ECETOC 2003)

Determination of bioaccumulation potential

The potential for a substance to bioaccumulate can be determined through consideration of the

n-octanol/water partition coefficient (Kow), the bioconcentration factor (BCF), bioaccumulation

factor (BAF) and biomagnification factor (BMF). The octanol/air partition coefficient (Koa) can be

used in conjunction with the Kow to determine the bioaccumulation potential of a substance in

terrestrial organisms.

The BCF is the ratio of the concentration of a chemical in the tissue of an aquatic organism to its

concentration in water, in situations where the organism is exposed through the water only and

the ratio does not change substantially over time. Like BCF, the BAF is the ratio of the

concentration of a substance in the tissue of an aquatic organism to its concentration in water,

however it includes situations where both the organism and its food are exposed and the ratio

does not change substantially over time. Units for BCF and BAF are in litres per kilogram of

tissue (L/kg) (US EPA 2003). When a steady-state between uptake and elimination processes is

reached, BCF and BAF are calculated as follows, where Ct is the concentration of the

substance in tissue and Cw is the concentration of the substance in water:

𝐵𝐶𝐹 𝑜𝑟 𝐵𝐴𝐹 =𝐶𝑡

𝐶𝑤

L/kg

If a steady-state is not reached, or it is not feasible under experimental conditions, the BAF and

BCF can be estimated from the ratio of the uptake and elimination rate constants (Arnot and

Gobas 2006).

The BMF is the unitless ratio of the concentration of a chemical in a predator organism at a

particular trophic level to the concentration of the chemical in the tissue of its prey organism at

the next lowest trophic level for a given water body and substance exposure (US EPA 2003).

For inorganic, organometallic, and ionic chemicals for which lipid and organic carbon partitioning




does not apply, a BMF can be calculated using concentrations of the substance in the tissue of

organisms at two successive trophic levels. The calculation is as follows where BMF(TL,n) is the

biomagnification factor for trophic level “n”, C(TL,n) is the concentration of a substance in tissue of

predator organism at trophic level “n” and C(TL,n-1) is the concentration of substance in tissue of

prey organism at the trophic level “n-1”:

𝐵𝑀𝐹(𝑇𝐿,𝑛) =𝐶(𝑇𝐿,𝑛)

𝐶(𝑇𝐿,𝑛−1)

The BMF for non-ionic organic chemicals (and certain ionic organic chemicals to which similar

lipid and organic carbon partitioning behaviour applies) is calculated in a similar manner,

however the lipid-normalised concentration of the substance in tissue is used (Arnot and Gobas

2006).

For further information about calculation of BCF and BAF in different biological or chemical

phases, and details of lipid-normalisation, please refer to Development of National

Bioaccumulation Factors (US EPA 2003) and A review of bioconcentration factor (BAF)

assessments for organic chemicals in aquatic organisms (Arnot and Gobas 2006).

Criteria for Bioaccumulation categorisation

The Australian criteria for categorisation of bioaccumulation are detailed in Table 7.

Table 7: Criteria for Bioaccumulation (B) Categorisation

Bioaccumulation (B)

Aquatic

BCF or BAF ≥ 2000

or

log Kow ≥ 4.2

Terrestrial Log Koa > 6 and log Kow ≥ 2


Where BCF = bioconcentration factor; BAF = bioaccumulation factor; Kow = n-octanol/water

partition coefficient; Koa = octanol/air partition coefficient; BMF = biomagnification factor

General characteristics of bioaccumulative chemicals

Structural and physico-chemical properties of substances can be used to estimate the potential

for bioaccumulation of the substance. Substances that have limited bioavailability for any reason

are likely to have a reduced potential for bioaccumulation. General points of the structural and

physico-chemical properties of bioaccumulative chemicals are listed in Table 8 below.




Table 8: Characteristics of bioaccumulative substances

Property Bioaccumulation potential

Molecular size Above certain molecular dimensions, it is less likely that substance will be able to cross biological membranes and it will not be available for bioaccumulation. This is possibly due to the stearic hindrance of the passage of substance through gill membranes. A bioavailability cut-off for chemicals of ≥ 0.95 nm minimal internal cross section has been proposed (ECETOC 2003)

Molecular weight For similar reasons to molecular size, a cut-off limit of 1000 g/mol has been proposed (UNECE 2009). This is also the generally accepted cut-off for assessment of bioaccumulation potential in Australia11.

Water solubility Highly water soluble chemicals are less likely to bioaccumulate because they are expected to readily partition to the aqueous phase. Similarly, chemicals that are only sparingly soluble have less potential to bioaccumulate based on limited bioavailability.

Partitioning behaviour Substances with a high n-octanol/water partition coefficient (Kow) are generally more lipid soluble and more likely to bioaccumulate. In Australia, substances with a log Kow ≥ 4.2 are considered to have an equivalent bioaccumulation potential to substances with a BAF or BCF ≥ 2000. However, if the log Kow is high (> 8), the substance is expected to have reduced bioavailability based on low water solubility and, therefore, a reduced potential to bioaccumulate (EPHC 2009, UNECE 2009).

Degradability If a substance is readily mineralised under environmental conditions, or rapidly metabolised in organisms, it has a low potential for bioaccumulation. A persistent substance or a substance with persistent degradants has an increased chance of bioaccumulation.

7.8.3 Toxic Substances

Toxic substances are those substances that have an adverse effect on an organism at a given

concentration. All substances have the potential to cause toxic effects. However, it is the dose

that determines whether a substance is harmful to an organism.

Ecotoxicity may cover effects to organisms at a number of different biological levels. Effects

may be considered at the subcellular, cellular, organism, population, community and ecosystem

levels of organisation (Klaassen 2008). The routine approach for assessment of ecotoxicity is to

look at effects to populations (groups of the same species) at a number of different levels within

the food chain (trophic levels). For example, an initial effects assessment is conducted on, at

least, a producer, primary consumer and secondary consumer. The effects to aquatic organisms

are considered to best represent the toxicity of an industrial substance in the environment

because:

11 The Environmental Risk Assessment Guidance Manual for Industrial Chemicals can be found at






The primary exposure pathway for most industrial substances is generally the sewer. This is

also the assumption for release of cosmetics and substances used domestically. Surface waters

are also thought to be the most likely sink for chemicals released into other compartments in the

environment, whether it be through leaching from soils or becoming associated with water or

particles in the atmosphere and returning to earth in rain (EPHC 2009).

Aquatic organisms are generally considered to receive a higher relative dose of a chemical than

terrestrial organisms. They live in the contaminated medium and can be quite sensitive to

changes, including changes in water temperature, pH, dissolved oxygen, turbidity and dissolved

organic carbon, to name a few. Aquatic organisms can also absorb the chemical directly from

the water as well as consuming it through food, drinking water and air (EPHC 2009).

Therefore, categorisation of toxicity generally focuses on aquatic organisms. The routine trophic

levels used for analysis of toxicity to aquatic organisms are algae, aquatic invertebrates

(crustaceans) and fish.

An initial effects assessment also needs to consider the partitioning, persistence and

bioaccumulation potential of a substance as these parameters can help determine the amount

of chemical that is present in the compartment and the period over which it is likely to be

present.

Of course, some chemicals may not fall within the constraints of the routine risk assessment

and the approach to analysis should be considerate of the potential hazards and exposure of a

chemical. When unsure, available information on the toxicity of a chemical to organisms other

than aquatic organisms may help determine an appropriate approach to for the risk assessment.

For further information on the approaches to effects assessment, refer to the Environmental

Risk Assessment Guidance Manual for Industrial Chemicals (EPHC 2009).

Criteria for Toxicity categorisation

For the purposes of categorising a substance as Toxic, a toxic substance is one that is

considered more than likely to cause adverse effects at relatively low concentrations. The

Australian criteria for Toxicity categorisation are outlined in Table 9.

Acutely toxic effects are those that cause adverse effects to an organism after a single dose or

a short period of exposure. Acute aquatic toxicity tests, for example, are generally conducted

between 48 and 96 hours and focus on sub-lethal effects (such as lethargy, flotation or

suppression in algal growth rate) and mortality.

Chronic toxicity tests are generally conducted over several weeks to several months and aim to

take into consideration the effect that a substance has on reproduction, inter-generational

effects, and growth and development. Chronic toxicity tests are particularly informative for

hazard assessment of persistent and bioaccumulative substances.




Table 9: Criteria for Toxicity (T) Categorisation

Toxicity (T)

Acute Aquatic Toxicity

Fish 96 h LC50 ≤ 1 mg/L

and/or

Crustacea 48 h EC50 ≤ 1 mg/L

and/or

Algae or other aquatic plants 72 h EC50 ≤ 1 mg/L

Chronic Aquatic Toxicity

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

It is not always possible to quantitatively determine the potential for a substance to be toxic to

organisms in the environment. For example, for very persistent substances, or where the hazard

to organisms is extrapolated beyond the constraints of the available data, the long-term toxicity

hazard is not quantifiable. In these cases, the analysis may conclude that the long-term risk to

the environment is unknown based on the available information.

The Mode of Action (MOA) and Adverse Outcomes Pathway (AOP) can be used to inform a

qualitative risk assessment. MOA and AOP information describes key events and processes

leading to molecular and functional effects that generally explain the overall processes of effects

on organisms from a qualitative perspective. Known toxicity resulting from a particular MOA may

be used to determine the potential for a chemical with the same MOA to cause toxic effects.

Therefore, a qualitative assessment of the potential for a chemical to cause harm can be made.

General characteristics of toxic chemicals

Structural and physico-chemical properties of substances can be used to estimate the potential

for a chemical to be toxic to organisms at low concentrations.

The US EPA’s ECOlogical Structure-Activity Relationship (ECOSAR) program uses the

structural characteristics and physico-chemical properties of a chemical to perform an

estimation of the potential toxicity of a chemical. These properties in particular are outlined in

Table 10.




Table 10: Characteristics of toxic substances

Property Toxicity potential

Molecular weight At high molecular weights (> 600 g/mol), the passive absorption of a substance through respiratory membranes of aquatic organisms decreases significantly. For chemicals with a molecular weight above 1000, absorption is expected to be negligible. However, judgement should be used when determining if this is an appropriate assumption to apply. For some chemicals, the molecular weight is not limiting because the effects are not due to absorption. For example, some polycationic polymers with molecular weights in excess of 1 000 000 are highly toxic as they act directly on the respiratory membranes of aquatic organisms (Mayo-Bean, Moran et al. 2012).

Water solubility For a substance to cause toxic effects to organisms, it needs to be bioavailable. Therefore, chemicals with limited water solubility are not expected to be readily bioavailable are expected to have a reduced potential to cause toxic effects. Some chemicals that have predicted limited water solubility may still have toxic effects. For example, chemicals that have low water solubility but have surface active properties may still be bioavailable if they are water dispersible.

Partition coefficient As the n-octanol/water partition coefficient (log Kow) increases, the solubility of a substance decreases in water. The US EPA ECOSAR program uses a log Kow cut-off of 5.0 for acute effects (6.4 for acute effects to algae) and 8.0 for chronic effects. At values greater than these cut-offs, a chemical is considered to cause “no effects at saturation”. The difference in log Kow cut-offs between acute and chronic tests is expected. The hydrophobic nature of a test substance might not allow equilibrium to be achieved within the standard exposure durations for acute tests, but the equilibrium may ultimately be achieved during chronic studies (Mayo-Bean, Moran et al. 2012).

7.8.4 Interpreting Data for Categorisation

As categorisation of a chemical may not always be clear cut, a degree of expert judgement is

required in the risk assessment to examine the information available and come to a conclusion

based on the weight of evidence. In cases where reliable measured data is not available, all

available information, including computer modelled structure-activity relationships, should be

used, interpreted and discussed to reach a transparent conclusion. The reliability of the

categorisation will be made explicit.

7.8.5 GHS Classification

The Globally Harmonised System of Classification and Labelling (GHS) addresses the

classification of chemicals by types of hazard and proposes harmonised communication

elements, such as labels and safety data sheets. It aims to ensure that information the hazard

and toxicity of chemicals is available in order to enhance the protection of human health and the

environment during the handling, transport and use of these chemicals (UNECE 2013).

The GHS classification for environmental hazard consists of three acute and four chronic toxicity

classification categories. The acute and chronic classification categories are applied

independently. The criteria for classification of a substance in the acute categories are defined

on the basis of acute toxicity data only. The criteria for classification of a substance into the

chronic categories follow a tiered approach where the first step is to identify if available

information merits long-term hazard classification. If chronic toxicity data is not available, acute

toxicity data and environmental fate data are used for classification. Fate data include the




bioconcentration factor (or, lacking such data, the n-octanol/water partition coefficient) and

potential for the chemical to rapidly degrade under environmental conditions. For the purposes

of the GHS classification, rapid degradation is considered the ability for a substance to degrade

by greater than 70% by biotic or abiotic processes in the aquatic environment within 28 days.

This includes, for example, substances that are readily biodegradable or able to rapidly

hydrolyse into innocuous substances under environmental conditions. In this case, the

hydrolysis products themselves must not meet the criteria for classification.

The GHS hazard statements for effects on the environment are outlined in the table below.

More information on classification of substances under the GHS and algorithms for classification

can be found in Part 4: Environmental Hazards of the Globally Harmonised System of

Classification and Labelling of Chemicals (GHS), 3rd Revised Edition (UNECE 2009).

Table 11: GHS Hazard Statements for classification of environmental hazards


H400 Very toxic to aquatic life

H401 Toxic to aquatic life

H402 Harmful to aquatic life

H410 Very toxic to aquatic life with long lasting effects

H411 Toxic to aquatic life with long lasting effects

H412 Harmful to aquatic life with long lasting effects

H413 May cause long lasting harmful effects to aquatic life

H420 Harms public health and the environment by destroying the ozone in the upper atmosphere




8. Risk Management Measures for

Industrial Chemicals

Refer to Section 3 in the National Standard

8.1 Introduction

Each Environment Schedule under the National Standard has a set of defined risk management

measures. Risk management measures have been established to be directive, outcomes-based

controls that are relevant to the scheduled chemical under the National Standard and the

degree of environmental protection that is required based on the scheduled criteria (as detailed

in Section 7 of this Explanatory Report).

Risk management measures associated with each Environment Schedule aim to prevent harm

to the environment for the assessed use and end of life processes of a chemical. They are also

intended to be implementable, achievable, enforceable, appropriate, proportionate, and

complement existing controls. At the same time, measures attempt to prevent harm to the

environment at the point in the supply chain where the measure will be most effective. In most

cases, this is not likely to be during widespread, consumer use, but with facilities that are

capable of implementing the measures and understanding the effects chemicals can have on

the environment. It should be noted that risk management measures apply to chemical

substances including substances in their neat or diluted forms, and substances in products and

mixtures that have not been chemically altered from the assessed chemical.

A positive outcome of implementing the National Standard is that greater awareness of the

potential impacts chemicals can have on the environment may encourage companies to use

safer, greener chemicals in consumer products. These conscious decisions will also help

prevent harm to the environment.

8.2 Applying Risk Management Measures

The risk management measures have been established to protect the environment from impact

associated with the industrial chemical in question. Measures are aimed to reduce the

environmental risk associated with the industrial chemical to acceptable level and prevent harm

to the environment. Recommendations for risk management will be developed during the risk

assessment based on considerations that include the hazard characteristics and potential

exposure of the chemical to the environment.

The risk management measures are directed toward minimising environmental impact during

the intended, normal use of the chemical. Compliance with the requirements may not be

sufficient for avoiding accidental releases of the industrial chemical to the environment and

avoiding impact on human health. Good industrial practice and the requirements of other related

policies, standards and procedures should be referred to and applied.

In evaluating the most appropriate measures, risk managers take into consideration scientific

evidence and estimates of risk, as well as engineering, economic, social and political factors,

where required. The Risk Assessor will recommend risk management measures as part of an

environmental risk assessment. If the Advisory Committee review the chemical, the Committee

may also provide advice to the Decision Maker or their delegate on appropriate risk

management measures.




An environmental risk assessment will include a risk management recommendation identifying

appropriate risk management measures as identified in the risk assessment. Following a

scheduling decision, the published decision will include the scope of assessment and the

appropriate risk management measures.

More information on the scheduling processes is detailed in Section 12 of this Explanatory

Report.

8.3 Outcomes-based risk management measures

The risk management measures in the National Standard are outcomes-based. The outcomes

will be focussed on what businesses need to achieve, rather than, for example, a concentration

that must not be exceeded in the environment. Outcomes-based measures outline the result

that a person or business must achieve to protect the environment during the intended use of

industrial chemicals and activities associated with the chemical’s use. While the outcomes are

not explicitly environmental outcomes (such as not allowing a concentration in a receiving water

body to exceed a set concentration), they will go toward achieving the desired outcomes for the

environment that is, limiting release of chemicals and preventing their presence in the

environment, where appropriate.

Outcomes-based risk management involves applying the controls necessary to prevent adverse

environmental impacts and ensure adequate protection of the environment. Specifying the

necessary outcome, such as the maximum allowable concentration in water or air that must not

be exceeded, and requiring users to apply appropriate risk-based controls (but not mandating a

particular set of controls), allows businesses to determine how best to meet the required

outcome for a particular chemical. The available options may change over time as technology

and business practices improve.

This approach encourages innovation and allows businesses to make the best decisions for

their situation. This is in contrast to prescriptive risk management that details the actions or

specific controls, for example, that a person or business must put in place. Setting prescriptive

measures has the potential to deter innovation and prevent potential changes to performance of

processes. The way in which each measure is achieved will be the decision of each business in

each different operating environment. Therefore, the onus of proof for compliance with the

National Standard will sit with the regulated community, rather than the regulatory authority.

To assist with compliance, the risk management measures, while outcomes-based, are

generally directive to allow the regulated community to easily identify when they are compliant.

Guidance will also be developed following finalisation of the National Standard to support the

regulated community in understanding their requirements and support understanding of options

for achieving outcomes.

8.3.1 Best Available Techniques

The application of best available techniques is a fundamental aspect that can mitigate

environmental risks from industrial chemicals and the application of relevant risk management

measures. The application of best available techniques can include application of best available

treatment technologies, approaches or practices in pollution control based on nationally or

internationally recognised technologies. In this, consideration should be given to economic and

technical factors, and the measures should be practicable.

The concept of applying best practice has been adopted by Australian states and territories,

such as in Victoria12 where guidance has been provided on demonstrating best practice and

12 EPA Victoria (2013) Demonstrating Best Practice, Publication No. 1517




requiring that hazardous by-products or residues are not discharged to the environment, using

measures that are practicably achievable.

Application of best available techniques provide the opportunity for industrial chemicals to be

managed innovatively and effectively. The concept of best available techniques has been

defined and applied in the reference documents published by the European Union under the

Industrial Emissions Directive relating to Best Available Techniques, and in international

conventions such as the Minamata Convention on Mercury and the Stockholm Convention on

Persistent Organic Pollutants, for example:

“Best available techniques” means those techniques that are the most effective to prevent and,

where that is not practicable, to reduce emissions and releases to air, water and land and the

impact of such emissions and releases on the environment as a whole, taking into account

economic and technical considerations (Minamata Convention on Mercury, 2013).

8.4 Types of Risk Management Measures

The risk management measures have been framed in terms of measures that are generally

applicable, and also in terms of various types or categories of risk management measures that

provide more detailed consideration of risks arising from particular aspects of a chemical’s life

cycle.

Each chemical will have a set of defined risk management measures that must be implemented

based on the outcome of the assessment of the industrial chemical. Each risk management

measure has been defined in terms of standard text, and some of the measures include

amendable text [outlined in square brackets]. Only ‘amendable text’ may be changed during

formulation of a risk management recommendation and will become fixed for the chemical when

the scheduling decision is made.

In general, the risk management measures have been formulated in a hierarchy involving a

progressively greater level of control, ranging from limiting the concentration of discharge,

through to prohibiting release of the chemical to the environment.

8.4.1 General use risk management measures

General use risk management measures should be employed as a minimum to protect the

environment from adverse effects associated with use and the discharge or disposal of an

industrial chemical into the environment that occurs with that use. The general use measures

include requirements to avoid unnecessary or excessive use of a chemical, and to substitute the

use by a chemical with lesser effects where this is practicable.

General use measures apply to all industrial chemicals. General use measures reflect good

practice, and can be expected to already be applied in industry and in the use of chemicals. As

an overall framework, it can be expected that manufacturers and industry that store, handle and

process bulk quantities of a chemical will adopt environmental management systems that

identify where risk to the environment can occur and implement management measures to

control these risks.

It is recognised that it may not be possible to apply risk management measures to the use and

disposal of chemicals in some situations, such as chemicals in consumer products, other than

seeking to avoid unnecessary use.

The general use measures outlined in the National Standard and examples, are listed in Table

12.

https://en.wikipedia.org/wiki/Minamata_Convention

https://en.wikipedia.org/wiki/Stockholm_Convention




Table 12: General use risk management measures

Risk Management

Measure

Identifier Comment

1. Risk Management

Take action to rectify any non-

conformance with the risk

management measures assigned

for the industrial chemical.

GU_1.1 This is a good practice requirement.

2. Release to the environment

Do not permit uncontrolled release

of the chemical substance to the

environment at concentrations that

may cause harm.

GU_2.1 This is a general requirement

applicable to manufacturers and

industry that store, handle and

process bulk quantities of chemicals,

and can be achieved by applying the

procedures outlined in ISO 14001

(Environmental Management

Systems) or similar, and applying

guidelines issued by the

environmental regulatory agencies or

applying guidance such as AS1940

2004 (The Storage and Handling of

Flammable and Combustible Liquids).

This requirement is unlikely to be

applicable to chemicals in consumer

products.

Prevent unnecessary use of

excessive quantities of the

chemical substance so as to

minimise the release of the

chemical substance to the

environment.

GU_2.2 This may be achieved by minimising

use and release of the chemical

through alternatives identified and

systematically considered in

consultation with process and design

experts

Do not use the chemical

substance where it is practicable

to use an alternative chemical

substance that is of lower concern

to the environment for the use.

GU_2.3 As for GU_2.2

Do not dispose of the chemical

where it is practicable to reuse

and recycle the chemical.

GU_2.4 As for GU_2.2.

Do not adopt risk management

measures that will have adverse

impacts on the environment.

GU_2.5 This measure aims to prevent

unintended adverse effects on the

environment or infrastructure from

implementing risk management

approaches. An example of this could

be where a chemical is disposed of to




Risk Management

Measure

Identifier Comment

a sewerage system to avoid

discharge to a receiving water. The

chemical disposed to sewer could

accumulate in the biosolids of the

sewage treatment plant and

adversely affects ecological systems

where the biosolids are being reused.

This also aims to prevent dilution of

chemicals to achieve specified

concentrations where that dilution is

excessive and likely to have adverse

impacts on the environment or

sewage treatment facilities.

Report uncontrolled or accidental

release of a chemical to a state,

territory or federal government

environment agency.




process bulk quantities, requiring that

incidents where a chemical is

released to the environment are

reported to the relevant authorities in

the jurisdiction where the incident

occurred.

Report adverse environmental

effects observed following release

of the chemical to a state, territory

or federal government

environment agency.




process bulk quantities, requiring that

incidents where a chemical is

inappropriately released to the

environment, or released in

accordance with the specified

requirements but have observed

adverse environmental effects, are

reported to the relevant authorities in

the jurisdiction where the incident

occurred. Adverse environmental

effects may include fecundity of

exposed biota.

8.4.2 Risk management measures relating to storage, handling and

containment

Risk management measures relating to storage, handling and containment have the objective of

requiring systems, plant and equipment that will avoid or minimise the risk that there may be

unplanned or uncontrolled release of the chemical to the environment. The storage, handling

and containment risk management measures applied in the National Standard are framed in

terms of general requirement to use appropriate packaging and systems, and specific

requirements relating to situations that can apply. The latter situations include risk management

measures to avoid environmental exposure through storing chemicals in such a way that




animals may be exposed, and to avoid limiting use of chemicals in situations where it is not

possible to control disposal.

It is recognised that provision of information to users of chemicals, such as through appropriate

labelling and packaging is important. Labelling and packaging will not be specific requirements

under the National Standard, however if it is determined that labelling and packaging is the most

efficient and cost-effective method of ensuring compliance risk management measure, they may

be used.

Risk management measures relating to containment are listed in Table 13.

Table 13: Risk management measures relating to storage, handling and

containment

Risk Management

Measure

Identifier Comment

Storage, Handling and Containment

Do not use [packaging/

containment systems/plant and

equipment] for the [storage and/or

handling] of the chemical

substance that may allow the

chemical to leak into the

environment.

SHC_1.1 The intent of this requirement is to

minimise the risk that there may be

unplanned or uncontrolled release of the

chemical to the environment.

This may be achieved by complying with

the requirements of standards and codes

that are applicable to industrial chemicals

and have measures relating to storage,

handling and containment, such as

AS1940-2004 (The Storage and Handling

of Flammable and Combustible Liquids),

and/or products containing industrial

chemicals

For some chemicals used in consumer

products such as cosmetics, release during

use and disposal is expected, so measures

should be employed to reduce the risk of

untreated release to the environment.

Do not use the chemical

substance in situations where its

disposal is not able to be

controlled.

SHC_1.2 This measure can apply where a chemical

should not be used in situations where

disposal of the chemical product is not able

to be controlled and might result in adverse

effects on the environment. This may

occur, for example, for chemicals in

consumer products where control of

disposal will generally not be possible.

Do not permit [bird life/ taxonomic

rank descriptor] come into

contact, or otherwise be exposed,

to the chemical substance [above

x concentration]

SHC_1.3 This may be prevented by avoiding direct

release of the chemical to land or water

where exposure might occur, or avoiding

storing chemical substances in open tanks

or ponds that are easily accessible by and

may be attractive to birds or animals.




Risk Management

Measure

Identifier Comment

This measure can be specified as a

generally applicable requirement without

reference to a particular animal or

organism, or can target the protection of

particular sensitive species such as

mammals, insects or birds relevant at the

point of use or disposal, such as are listed

in the following risk management

measures.

Do not permit

[mammal/taxonomic rank

descriptor] to come into contact,

or otherwise be exposed, to the

chemical substance [above x

concentration]

SHC_1.4 As SHC_1.3

Do not permit [insect/taxonomic

rank descriptor] to come into

contact, or otherwise be exposed,

to the chemical substance [above

x concentration]

SHC_1.5 As SHC_1.3

Do not permit

[invertebrates/vertebrates] to

come into contact, or otherwise

be exposed, to the chemical

substance [above x

concentration]

SHC_1.6 As SHC_1.3

Do not permit [plant/taxonomic

rank descriptor] to be exposed to

the chemical substance above [x

concentration]

SHC_1.7 As SHC_1.3

8.4.3 Risk management measures relating to treatment and disposal

In general, disposal of chemicals and products that incorporate the chemical should involve

treatment or, where appropriate, disposal through accepted and controlled means such as to

sewer, or to landfill.

In terms of treatment, risk management measures have been formulated in terms of no

requirement for treatment; or for higher schedule chemicals, the requirement for treatment to

render the chemical inactive or harmless prior to release to the environment, or destruction of

the chemical substance. The risk management measures include requirements that best

available techniques be applied for treatment; this is in accord with international requirements

relating to chemicals in the higher schedules where, because of characteristics such as toxicity,

persistence and the potential for bioaccumulation, it is important to minimise the quantity of

chemical or its treatment by-products that are released to the environment.




In terms of disposal to sewer, risk management measures in the National Standard have been

formulated in terms of allowing disposal to sewer with no specific requirements relating to

discharge (such as would occur with consumer products), through to specifically requiring an

agreement with the sewerage authority, or specifying a maximum concentration for discharge,

or prohibiting discharge to the sewer. The latter situation might occur, for example, where the

chemical is persistent and bioaccumulative, and could accumulate in and remain in biosolids or

pass through in the effluent to the receiving environment.

With respect to disposal to landfill, risk management measures have been formulated in terms

of allowing disposal to landfill with no specific requirements relating to discharge (such as would

occur with consumer products), through to specifically requiring that the disposal be in

accordance with the relevant licence or other requirements, or specifying requirements for the

landfill infrastructure and control systems (such as landfill liner and leachate collection systems),

or specifying a maximum concentration for disposal to landfill, such as applies for certain

halogenated chemicals such as PCBs.

It is recognised that certain chemicals may have characteristics that would prohibit them to be

disposed of to landfill under other guidelines; these include characteristics such as being bulk

liquids, flammable, or highly odorous.

Risk management measures relating to treatment and disposal are listed in Table 14.

Table 14: Risk management measures relating to treatment and disposal

Risk Management Measure Identifier Comment

1. Treatment

Apply best available techniques when

treating a substance containing the

chemical for disposal.

TD_1.1 “Best available techniques" means

the most effective and advanced

stage in the development of activities

and their methods of operation which

indicates the practical suitability of

particular techniques for providing the

basis for emission limit values and

other permit conditions designed to

prevent and, where that is not

practicable, to reduce emissions and

the impact on the environment as a

whole (EU13).

This measure will typically be required

for higher schedule waste where

residual hazardous substances in the

treated material, effluent or air have

the potential to adversely affect the

environment and must be avoided.

Do not adopt measures for treatment

or disposal that will result in adverse

effects on the environment.

TD_1.2 This includes ensuring that the

treatment of chemical substances

does not result in creation of other

13 European Union reference documents under the Industrial Emissions Directive relating to Best Available

Techniques published by the Joint Research Centre, Circular Economy and Industrial Leadership,





hazardous substances (such as

dioxins and furans) and their release

to the environment at concentrations

of concern, or give rise to negative

environmental impacts; and preferring

treatment methods that fully destruct

or minimise the quantity of the

chemical that is released to the

environment as waste. In the case of

organic halogenated chemicals, this

may be achieved by reference to

guidance issued by Australian or

international environmental regulatory

agencies. Examples of this include

the formation of dioxins and furans

from the thermal treatment of

chlorinated chemicals, the formation

of vinyl chloride monomer from the

reductive treatment of chlorinated

chemicals, or methane or reductive

conditions and heavy metal release

from in-situ reductive treatment of

organic chemicals.,

Do not dispose of empty storage

containers and drums containing the

chemical substance other than

through a

[licensed/approved/treatment/

disposal/facility/receiver]

TD_1.3 Advice on disposal of particular

chemical waste material should be

sought from local and state

governments and is not be covered

by the National Standard.

This measure is unlikely to be

required for domestic products that

are present in small quantities and will

generally fall into the lower schedules.

Treat the chemical substance to

[destroy the chemical/or/render it

inactive/harmless] prior to release to

the environment.

TD_1.4 This may be accomplished by

physical, chemical or biological

treatment to destruct or change the

form of the material so that it is no

longer toxic or bioavailable.’

This measure may be used in

conjunction with measures relating to

discharge to land, water or air that

specify the concentrations that should

not be exceeded.

This requirement is particularly

relevant to chemicals where used at

concentrations that would adversely

affect the environment if discharged

without treatment.





2. Disposal to sewer

Do not discharge the chemical to the

sewer unless it is permitted under the

terms of a [trade waste

agreement/approval/agreed

concentration] with the relevant

sewerage authority.

TD_2.1 Where wastes contain potentially

hazardous chemicals, generally

sewerage authorities will require

industries to enter into a trade waste

agreement that allows certain

compounds and groups of

compounds to be discharged safely

to the sewerage system. In approving

a Trade Waste Agreement the

relevant Authority will consider

factors such as adverse effects on

the sewage treatment process and

release of incompletely treated

wastewater to the environment,

accumulation of the chemical in

biosolids affecting reuse, or formation

of hazardous, odorous or corrosive

gases within the sewerage system

and release in gaseous discharges

from the sewerage system.

Do not discharge to sewer at

concentrations greater than [x

concentration]

TD_2.2 Some substances, such as non-

aqueous liquids, flammable

materials, substances that are highly

odorous, substances that may be

highly toxic to bacteria in sewage

treatment plants, substances which

bioaccumulate in biosolids, or

substances which are present in the

effluent after treatment, may not be

acceptable for discharge to the sewer

other than in low concentrations or in

dissolved form.

Do not discharge the chemical to

sewer [above its limit of quantification]

TD_2.3 This measure applies to chemicals

that should not be released via the

sewer system and should be

disposed of in an alternative

environmentally sound manner.

Do not use the chemical substance at

concentrations greater than [x

concentration] in products intended to

be disposed of to sewer.

TD_2.4 As TD-2.2

Do not discharge to sewer if the

discharge will result in concentrations

in re-purposed biosolids greater than

[x concentration]

TD_2.5 Some substances are resistant to

biodgradation and may accumulate in

biosolids, making the biosolids

unsuitable for reuse.





Do not discharge to sewer if the

sludge from the discharge will be

applied to land as re-purposed

biosolids

TD_2.6 As TD_2.4

3. Disposal to landfill

Do not dispose of wastes containing

the chemical substance to landfill if

the waste composition is contrary to

the requirements of the landfill

[licence/agreement/permit/acceptance

criteria/class].

TD_3.1 Landfill licensing takes into account

the liner and leachate collection

systems at the landfill, and the

chemical concentrations in the waste

and potential for the chemical to

leach.

Generally, landfill operators will not

accept industrial wastes other than

under an agreement and when the

waste complies with the licence, or

when wastes and chemicals are

present in minor quantities such as

occurs with consumer products in

municipal waste.

This requirement has the intent of

ensuring that the acceptance

complies with the licence

requirements of the landfill and is

appropriate for the class of landfill.

Note that landfill licences do not allow

bulk free liquid or flammable or highly

odorous material to be landfilled.

Do not dispose the chemical

substance with a concentration

greater than [x concentration] to a

landfill that does not have sufficient

infrastructure and control systems to

prevent its release to the

environment.

TD_3.2 This requirement may apply to higher

schedule chemicals that have the

properties of toxicity, leachability and

persistence and are present at

concentrations that make careful

control of disposal necessary. This

requirement has been framed in

terms of a maximum allowable

concentration rather than total

prohibition, as it is recognised that

trace concentrations of a chemical in

waste may be acceptable for

disposal, and it may not be

practicable to ensure that waste has

no measureable concentration of a

chemical. This approach has been

taken for Scheduled Wastes such as

PCBs.





Do not dispose the chemical

substance to landfill at concentrations

greater than [x concentration/its limit

of quantification]

TD_3.3 As TD_3.2

8.4.4 Risk management measures to protect waters

The risk management measures for protection of waters recognise that the aquatic ecosystems

in receiving waters can be particularly at risk through discharge of chemicals, and that

measures are required to minimise this risk.

The risk management measures to protect surface waters have been formulated in terms of not

requiring controls other than general use controls and the controls that apply through

environmental pollution legislation, to specifically limiting the concentration of discharge for

higher schedule chemicals, to a prohibition of discharge for the highest schedule chemicals.

Because the potential for effect on aquatic ecosystems varies with the nature of the receiving

water, the risk management measures have recognised particular situations that can apply for

particular uses of a chemical. These include measures relating to marine waters, fresh waters,

estuarine waters, waters or wetlands with high conservation value, and other factors such as

dissolved oxygen, or pH (which can be relevant depending on whether speciation of the

chemical is dependent on pH).

The risk management measures to protect groundwaters have been formulated in terms of not

requiring controls other than general use controls and the controls that apply through

environmental pollution legislation, to specifically limiting the concentration of discharge, through

to prohibiting the discharge. In addition to risk management measures relating to discharge,

measures have been included to limit discharge to groundwater where it will result in the

chemical discharging in groundwater to a surface water and causing an adverse effect, or

affecting the use of groundwater such as may occur for irrigation, or giving rise to a significant

area of groundwater pollution.

High Ecological Value Aquatic Systems

The risk management measures specify “high ecological value aquatic systems”. These will be

specified in legislation and include (but not limited to):

The Great Barrier Reef Marine Park

Commonwealth Marine Reserves

Ramsar Wetlands

State and territory wetlands and waterways of significance (to be defined)

Risk management measures to protect surface water and groundwater from release of industrial

chemicals are listed in Table 15.




Table 15: Risk management measures to protect waters

Risk Management

Measure

Identifier Explanatory Comment

1. Discharge to surface water

Do not release the chemical

substance directly to surface

waters at a concentration greater

than [x concentration]

W_1.1 The threshold concentration will be

determined as part of the

environmental risk assessment, and

will take into consideration the

environmental values (beneficial

uses) of the water that are relevant to

the intended use and disposal of the

chemical (such as to freshwater or

marine waters) and the assessed

use of the chemical in terms of

concentration and volume. The risk

assessment will consider existing

values and environmental

concentrations set in other codes,

standards and guidelines. A

numerical value and units will be

scheduled following decision.


substance to marine water at a

concentration greater than [x

concentration].

W_1.2 This measure is applicable where the

discharge relates to a particular

surface water body, or it is necessary

to specify different discharge criteria

for marine waters.


substance to freshwater at a


concentration].





freshwaters.


substance to estuarine waters at

a concentration greater than [x

concentration].





for estuarine waters.


substance to surface water

[above its limit of quantification]

W_1.5 This measure relates to higher

schedule chemicals or chemicals in

non-aqueous form where any

intentional discharge to surface water

should be avoided, and instead other

methods of disposal not involving

discharge to surface water should be

adopted.




Risk Management

Measure



substance to marine water [above

its limit of quantification].



marine surface water body, or it is

necessary to specify different

discharge criteria for different types

of marine surface waters, and the

hazardous characteristics of the

chemical are such that the chemical

should not be used, or if used, it

must be used in such a way that

release will not occur.


substance to freshwater [above its

limit of quantification].



freshwater body, or it is necessary to

specify different discharge criteria for

different types of freshwater bodies,

and the hazardous characteristics of

the chemical are such that the

chemical should not be used, or if

used, it must be used in such a way

that release will not occur.


substance to estuarine water

[above its limit of quantification].



estuarine surface water body, or it is

necessary to specify different

discharge criteria for different types

of estuarine surface waters, and the


chemical are such that the chemical

should not be used, or if used, it

must be used in such a way that

release will not occur.


substance into marine water

which has a pH value [greater

than/less than/equal to pH value].



chemical are dependent on the

properties of the receiving marine

water that can affect speciation and

toxicity (generally pH).


substance into freshwater which

has a pH value [greater than/less

than/equal to pH value].




properties of the receiving freshwater

body that can affect speciation and

toxicity (generally pH).




Risk Management

Measure



substance into estuarine water

which has a pH value [greater

than/less than/equal to pH value].




properties of the receiving estuarine

water body that can affect speciation

and toxicity (generally pH).

Do not release the chemical into

marine water where it will result in

a reduction of Dissolved Oxygen

of greater than [x %].


chemical may degrade and cause

oxygen depletion


freshwater where it will result in a

reduction of Dissolved Oxygen of

greater than [x %].

W_1.13 As W_1.12


esturine water where it will result

in a reduction of Dissolved

Oxygen of greater than [x %].

W_1.14 As W_1.12


substance to waterways that

discharge into a high ecological

value aquatic system.


release of a chemical to a particular

sensitive or protected receiving water

body may occur, such as through

drilling operations or sewerage

operations. An example of a wetland

with high ecological value would be

an area on the List of Wetlands of

International Importance under the

Ramsar Convention or Great Barrier

Reef Marine Park. Application of this

measure may preclude the use of the

chemical in such locations, or use in

a way that will not result in the

chemical being released even in

trace quantities in waste.


substance to waters that

discharge into waters adjacent to

a high ecological value aquatic

system.

W_1.16 As W_1.15.

Do not use the chemical within

the designated boundaries of a

high ecological value aquatic

system [above x concentration].



aquatic high ecological value system

may occur, such as through drilling

operations or sewerage operations,

and where the acceptable




Risk Management

Measure


concentration in the

product/discharge is able to be

specified such that it will protect the

receiving environment.

An example of a high conservation

area would be an area on the List of

Wetlands of International Importance

under the Ramsar convention, a

National Park or Marine Park.

2. Discharge to groundwater


substance to groundwater with a


concentration].

W_2.1 For certain chemicals for which the

intended use will involve direct

release to groundwater (such as in

drilling fluids) this measure can

require that the concentration of the

chemical in the material used should

not exceed a particular concentration

such as that allowed for direct

release to surface water.

Do not permit the chemical

substance in groundwater to

discharge to surface water [at a

concentration greater than x

concentration].

W_2.2 This measure will protect the

environmental values of a surface

receiving water, where it is possible

that groundwater containing the

substance will discharge to the

receiving water.


substance in groundwater

extracted for use to exceed [x

concentration]

W_2.3 This measure relates to the injection

of a chemical to groundwater and

where the groundwater is extracted

for use, such as for potable purposes

or other use such as irrigation.

Treatment of the groundwater will be

required If the concentration of the

chemical in groundwater exceeds the

criterion for use.

Examples of groundwater use

include aquatic ecosystems,

terrestrial ecosystems, stock, human

health, irrigation, buildings and

aquaculture. These uses may

require protection from groundwater

contamination.


substance to spread beyond [x W_2.4 This measure can be achieved by

limiting the injection of the chemical




Risk Management

Measure


distance] from the source of

injection in groundwater.

to groundwater so that the chemical

will not be detectable in the

groundwater at a certain distance

from the point of injection.

Do not release of the chemical

substance to groundwater [above

its limit of quantification].

W_2.5 This measure relates to higher

schedule chemicals where any

intentional discharge to groundwater

should be avoided. This measure

requires all reasonable efforts to be

taken to ensure the chemical does

not leach into groundwater during the

intended use. This may include

ensuring underground pipelines have

leak prevention systems, or

chemicals are not stored in

underground tanks unless the tanks

and systems comply with the

requirements of relevant codes of

practice.


substance to groundwater which

has a pH value [greater than/less

than/equal to pH value].




properties of the receiving

groundwater that can affect

speciation and toxicity (generally

pH).


substance to groundwater that

recharges a high ecological value

system.

W_2.7 As with W_1.15

Do not use the chemical within [x

distance of] the designated

boundaries of a high ecological

value aquatic ecosystem [above x

concentration]

W_2.8 This measure is similar to W_1.17

but specifically related to impacts on

groundwater.

8.4.5 Risk management measures to protect land

The risk management measures for protection of land recognise that the terrestrial ecosystems

of land can be particularly at risk through the use and disposal of chemicals, and that measures

are required to minimise this risk.

The risk management measures to protect land have been formulated in terms of not requiring

controls other than general use controls and the controls that apply through environmental

pollution legislation, to specifically limiting the concentration of use or disposal for higher

schedule chemicals, or prohibition of use or disposal to land. A risk management measure has

also been included to limit use or disposal to land where this could result in adsorption of the




chemical to soil particles and their mobilisation in stormwater runoff with adverse effects on the

receiving water.

The measures are formulated in terms of protecting urban residential land; in addition,

measures have been provided to protect areas of land will high conservation value such as may

occur with national or state parks.

Terrestrial Areas of Ecological Significance

The risk management measures specify “terrestrial areas of ecological significance”. These will

be specified in legislation and include (but not limited to):

National Parks

State Parks and Wilderness Areas

Risk management measures to protect land from controlled release of industrial chemicals are

listed in Table 16.

Table 16: Risk management measures to protect land

Risk Management Measures Identifier Explanatory comment

1. Release to land

Do not apply the chemical substance to

land at a concentration greater than [x

concentration].

L_1.1 It is important to not apply chemicals to

land in quantities that will affect the

environmental values of the land. The

threshold will be determined in the

environmental risk assessment and

recommended by NICNAS, and will

relate to the assessed use of the land in

terms of the concentration and volume

of the discharge and the resulting

concentration in soil. A numerical value

and units will be scheduled following

decision. This is relevant for industrial

chemicals as pure products or in a

mixture


land where it could be mobilised in

stormwater.

L_1.2 This may be achieved by avoiding

application of a chemical substance,

such as agricultural chemicals, in

quantities and in locations where it may

leach to stormwater or be mobilised with

particulate matter and affect the

environmental values of receiving

waters.

Do not use the chemical within the

designated boundaries of a terrestrial

area of ecological significance [above x

concentration].

L_1.3 This measure is applicable where the


terrestrial area of ecological significance

may occur, such as through distribution

of biosolids, and where the acceptable

concentration in the product/discharge is




Risk Management Measures Identifier Explanatory comment

able to be specified such that it will

protect the receiving environment.

An example of a high conservation area

would be a National Park, Nature

Reserve, State Park, Forest or Nature

Reserve.

Do not apply the chemical substance

with a concentration greater than [x

concentration] within [distance] of the

designated boundaries of a terrestrial

area of ecological significance.

L_1.4 This may be achieved by not applying

the chemical in concentrations and in

locations where it may affect sensitive

terrestrial or aquatic ecosystems in an

area with high conservation value such

as a National or State Park.

This may be applicable to about

inclusion of the chemical in a product or

material that will be applied to land, eg.

biosolids

Do not release the chemical substance

[adjacent to/within] the designated

boundaries of a terrestrial area of

ecological significance [above x

concentration].

L_1.5 This measure is applicable where the

release of a chemical adjacent to a

terrestrial area of ecological

significance. An example of a terrestrial

area of ecological significance is a

National Park, Nature Reserve, State

Park, Forest or Nature Reserve.


land [above its limit of quantification].

L_1.6 This may be achieved by applying

procedures and systems that avoid

release to land.

8.4.6 Risk management measures to protect air

The risk management measures for protection of air recognise that emissions and releases to

air can result in adverse effects on terrestrial ecosystems and, in some cases, affect on the

ecosystems of receiving waters. The measures are formulated in terms of not requiring controls

other than general use controls and the controls that apply through environmental pollution

legislation, to specifically limiting the concentration in discharges to air, through to prohibiting

the release to air.

In addition, measures have been formulated to consider the environmental influences that may

give rise to dispersion of the chemical in gaseous, aerosol or particulate form. Wind can result in

spray drift that may affect a sensitive terrestrial or aquatic ecosystem, and risk management

measures have been included to minimise release.

Risk management measures to protect air from release of industrial chemicals are listed in

Table 17.

Table 17: Risk management measures to protect air

Risk Management Measure Identifier Explanatory comment

1. Discharge to air





substance to air with a

concentration greater than

[x concentration].

A_1.1 The threshold will be determined in the

environmental risk assessment and

recommended by the Risk Assessor

and will relate to the assessed use in

terms of the concentration and volume

and discharge and the resulting

concentration in air. A numerical value

and units will be scheduled following

decision.


substance to air [above its limit of

quantification].

A_1.2 Controls may be met by ensuring that

the storage and handling of chemicals

utilises systems and controls that

provide a high degree of security that

uncontrolled releases of the chemical

in gaseous, aerosol or particulate form

will not occur and that uses of the

chemical are avoided which involve

release of the chemical to air. This

measure may be typically applied to

chemicals that are highly odorous or

toxic, and are volatile or in fine

particulate form.

Examples of such controls for gaseous

chemicals include volatile recovery

systems on the storage tank, and gas

collection such as extraction systems

and air pollution control systems to

treat the collected gas, in industrial

premises where the chemical is

handled.

Do not store or handle the chemical

in locations where it may be subject

to windborne transport.

A_1.3 This requirement may be met by

ensuring that handling and storages of

fine particulate material containing the

chemical are located indoors and are

not located where wind may result in

windborne material and deposition and

adverse effects on ecological systems.

These may include, for example

deposition on the leaves of plants and

foliar damage, or deposition on waters

leading to adverse effects on aquatic

ecosystems.


substance to air during periods of

[high/low] winds and where winds

are [above x speed/below x speed].

A_1.4 This is to protect sensitive receptors

that are located in a particular direction

from the source of chemical use

Do not release the chemical to air

when the direction of the wind is

A_1.5 As A_1.4




toward a sensitive aquatic or

terrestrial ecosystem within [x

distance] of the release zone [and

the wind is greater than x speed]

In addition, this can relate to chemicals

that are sprayed and there is the

concern that spray drift may affect a

sensitive terrestrial or aquatic

ecosystem. Sensitive ecosystems may

include for example an aquatic and

wetland area, or crops or gardens or

protected native vegetation or

protected animal habitat, or livestock

or pasture.

Do not release the chemical to air

when ambient air temperature is

expected to be [above/below x ºC]

A_1.6 As A_1.4 and A_1.5

9. Assignment of Risk Management

Measures to Environment Schedules

As a minimum, risk management measures are required to prevent or minimise releases of

industrial chemicals to the environment. Risk management measures have the objective of

ensuring that releases and exposure will not occur at levels of concern. Risk management

measures under the National Standard ensure that chemicals in higher Environment Schedules

have the highest level of protection. As the chemical moves into higher concern Environment

Schedules, additional or more protective controls will be required to reduce the potential for

environmental impact.

The higher Environment Schedules contain industrial chemicals that can have significant,

adverse effects on the environment, such as industrial chemicals that are persistent,

bioaccumulative and/or toxic. More stringent measures for higher concern chemicals are applied

to reduce the potential for release to the environment in quantities that can give rise to

concentrations of the chemical in the environment that are likely to harm the environment.

Anyone who uses chemicals industrially, commercially or domestically should work towards

using chemicals in a way that prevents harm to the environment. The National Standard outlines

the measures that need to be undertaken to prevent harm.

The Environment Schedules outlined in Section 7 of this Explanatory Report encompass a

range of industrial chemicals that impact various environmental compartments, including air,

surface and ground water, sediment and soil, and not all risk management measures defined

under each Environment Schedule will be appropriate for every chemical in the Environment

Schedule. For example, controls relevant for gases (a risk to the air compartment) may not be

directly applicable to industrial chemicals that are in solid or liquid form.

It is recognised that the chemicals in each Environment Schedule may be different in:

nature and characteristic

the use pattern

volumes of usage and release

exposure pathways for environmental impact

impacts to air, water and/or land.




Table 2 presents the general approach for allocating the risk management measures against

the seven Environment Schedules detailed in Section 7.

Table 18: Basis for Risk Management Measures

Classification Basis for formulating and selecting measures

Environment Schedule 1. Low Concern

Not hazardous and low hazard substances

No additional requirements for controls other than those normally applied to avoid pollution

Environment Schedule 2. Low Concern

Hazardous, low risk substances

Requirements for some control to prevent excessive release into the environment

Environment Schedule 3: Intermediate Concern

Hazardous, moderate risk substances

Requirements for control, but can be expected to control the risk to an acceptable level through light controls.


Hazardous, higher risk substances

Requirements for careful control, but can be expected to control the risk to an acceptable level through these controls.

Controls should include measures that limit releases to the environment as far as is practicable.


Substances with a potentially significant and long lasting effect on the environment

Severely restrict release to the environment as far as is practicable. Require very careful and stringent controls which limit release to the environment and which will control the risk to an acceptable level

Environment Schedule 6 and 7: High Concern

Restricted and Prohibited PBT substances and substances of otherwise significant environmental concern

Restricted or Prohibit use.

9.1 Enforcing Risk Management Measures

The risk management measures take into consideration the need for the measures to be

achievable and implementable by users, and to be measurable and enforceable in each

jurisdiction. It is the responsibility of each jurisdiction, whether it is the Australian Government,

or states and territories, to determine the appropriate compliance and enforcement activities that

are best suited to the jurisdiction’s current regulatory frameworks and resources. A person

conducting or undertaking an activity with industrial chemicals should also have the primary duty

to ensure, so far as is reasonably practicable, that the environment is not adversely impacted by

the conduct. It will generally be the responsibility of each chemical user to demonstrate that the

actions taken to meet the outcome are achieving the appropriate level of protection to the

environment outlined in the risk management measure.

As the National Standard is seeking to harmonise management arrangements at a national

level, it is intended that state and territory governments will use the risk management measures

to guide compliance and enforcement requirements. States and territories have assisted in the

preparation of the outcomes based measures for the National Standard. For High Concern

chemicals that require more specific risk management measures, the Advisory Committee will

consult government agencies before providing risk management advice to the Decision Maker.

The Decision Maker must also directly consult with states and territories in matters related to

convention chemicals. More details on the processes are outlined in Section 12.

9.2 Targeted stages of a chemical lifecycle

Risk management measures under the National Standard will be targeted at the stage of the

lifecycle that is likely to prevent harm to the environment in the most efficient and effective way.




Some industrial chemicals are subject to controls through other codes, such as the Dangerous

Goods Code and codes relating to occupational health and safety. These have requirements

particularly relating to protecting users of chemicals, including packaging, labelling, placarding

and warnings, and requirements relating to transport. The National Standard does not intend to

duplicate these requirements and assumes that the requirements of other applicable codes and

standards will apply. Instead, the National Standard will focus on requirements relating to

protection of the environment arising from storage, handling, manufacturing activities, and end

of life processes.

Risk management measures will be targeted at preventing harm to the environment from the

normal, intended use of the chemical. Measures to prevent accidental release of a chemical will

not be specifically covered under the National Standard but may broadly be covered in

measures for limiting or preventing release. In general, reasonable attempts should be made to

prevent unnecessary or accidental release of any chemical substance into the environment in

quantities that may adversely affect the environment.




10. Examples of chemical scheduling

10.1 Environment Schedule 1 Chemical Substance

Chemical Name/ID Polymer used as an additive in fertiliser

Volume High volume (>1000 T/pa)

PBT Not P; Not B; Not T

Solubility Sparingly soluble

High Concern chemical?

No

Ecotoxicity The polymer is not harmful, toxic or very toxic to the environment with acute or long lasting effects.

Notes The main entry into the environment is via run-off into aquatic systems following applications to agricultural land. High volumes are applied directly to the environment.

The polymer is a binding agent that is readily biodegradable to release the active fertiliser into the soil over a number of days.

Scheduling recommendation

The chemical would be recommended for Environment Schedule 1 as it is not hazardous.

Recommended risk management measures

General use measures would apply to prevent unnecessary release of the polymer to the environment.





Chemical Name/ID Industrial feed stock

Volume Moderate volume (>100 T/pa)


Solubility Insoluble in water


No

Ecotoxicity The chemical is not harmful, toxic or very toxic to the environment with acute or long lasting effects

Notes The main disposal route will be landfill as trade waste following use. The chemical is not readily biodegradable but is inherently degradable. The chemical is not expected to be mobile and expected to remain in landfill following disposal.


The chemical would be recommended for Environment Schedule 1 as it is not hazardous


General use measures would apply to prevent unnecessary release of the chemical to the environment.





Chemical Name/ID Organic Acid used domestically, commercially and industrially



Solubility Water soluble


No

Ecotoxicity The chemical is harmful to aquatic life (H402) according to the GHS.

Notes The main disposal route for the chemical is the sewer. It is likely that the majority will be removed during sewage treatment plant processes, mainly through biodegradation. The chemical will ionise upon entering the environment and be highly diluted. If the entire volume of chemical is released to the sewer each year, the concentration in the environment is unlikely to exceed the concentration that may cause harm to the environment. However, it is also unlikely that the entire volume of the chemical will be released to the sewer during use. Therefore, the chemical is low concern to the environment.


The chemical would be recommended for Environment Schedule 2 as it harmful with acute effects according to the GHS but is not otherwise hazardous



W_1.1 Do not release the chemical substance directly to surface waters at a concentration greater than [x concentration]





Chemical Name/ID Chemical used in domestic and commercial cleaning and disinfecting


PBT Not P; Not B; T

Solubility Water soluble


No

Ecotoxicity The chemical is very toxic to aquatic life (H400) according to the GHS

Notes The main disposal route for the chemical is the sewer. It is likely that the majority will be removed during sewage treatment plant processes, mainly through oxidisation. The chemical will be highly diluted when entering the environment via domestic use. Higher disposal concentrations could be seen from industrial use, but the concentration in the environment is unlikely to exceed the concentration that may cause harm to the environment. Therefore, the chemical is low concern to the environment.


The chemical would be recommended for Environment Schedule 2 based on its classification under the GHS as very toxic but without long lasting effects and is not persistent, bio-accumulative or an endocrine disruptor.




L_1.1 Do not apply the chemical substance directly to land at a concentration greater than [x concentration]





Chemical Name/ID Metal containing compound used as an industrial paint additive


PBT Not P; Not B; T (if in dissolved form)



No

Ecotoxicity Variable in dissolved form. The toxicity of the metal will depend on local environmental conditions (e.g. water hardness) and habitat types.

Very toxic to aquatic life with long-lasting effects (H410) according to the

GHS

Notes The chemical contains a metal that may be hazardous to the environment. The metal is also an essential element in the environment. The main disposal route for the chemical will be landfill at the end of its useful life irreversibly bound to the surface onto which it is painted. A small percentage may be released to the sewer as trade waste following cleaning processes but the volume released is not expected to be significant.


The chemical would be recommended for Environment Schedule 3 based on the presence of a metal of concern, but low bioavailability under the environmental conditions for the assessed use and release.




W_1.15 Do not release the chemical substance to waterways that discharge into a high ecological value aquatic system.

W_1.17 Do not use the chemical within the designated boundaries of a high ecological value aquatic system above [x concentration].


L_1.3 Do not use the chemical within the designated boundaries of a terrestrial area of ecological significance [above x concentration].





Chemical Name/ID Chemical used as an industrial feedstock used as an additive in plastics and resins





No

Ecotoxicity There is evidence suggesting the chemical is an endocrine disruptor. The chemical is not otherwise hazardous to the environment.

Notes The majority of the chemical will be irreversibly bound within the polymer matrix of the plastic or resin. In this form, it is not likely to have a high concentration in the environment. However, the chemical may remain attached to plastics and resins in its unbound form and this may be released to the environment, mainly through the sewer system.


The chemical would be recommended for Environment Schedule 4 based on evidence that it is an endocrine disruptor.




W_1.15 Do not release the chemical substance to waterways that discharge into a high ecological value aquatic system.

W_1.17 Do not use the chemical within the designated boundaries of a high ecological value aquatic system above [x concentration].


L_1.3 Do not use the chemical within the designated boundaries of a terrestrial area of ecological significance [above x concentration].

SHC_1.3 Do not permit [bird life/ taxonomic rank descriptor] to ingest, or otherwise be exposed, to the chemical substance [above x concentration].

SHC_1.4 Do not permit [mammal/taxonomic rank descriptor] to ingest, or otherwise be exposed, to the chemical substance [above x concentration].

TD_1.3 Do not dispose of empty storage containers and drums containing the chemical substance other than through a [licensed/approved/treatment/ disposal/facility/receiver].

TD_2.2 Do not discharge to sewer at concentrations greater than [x concentration].

TD_3.3 Do not dispose the chemical substance to landfill at concentrations greater than [x concentration/its limit of quantification].




10.7 Environment Schedule 6 or 7 Chemical Substance

Chemical Name/ID Chemical used in electroplating

Volume Volume less than <100 T per annum

PBT P; B; T

Solubility Slightly soluble in water


Yes

Ecotoxicity Toxic to aquatic life with long-lasting effects (H400) according to the GHS

Notes The chemical is persistent and bioaccumulative.


The chemical would be recommended for Environment Schedule 6 or 7 based on it being persistent, bioaccumulative and toxic.


The chemical is not a convention chemical. The Decision Maker may choose to request the Advisory Committee to consider the risk assessment and determine possible risk management response. The Decision Maker must also consult the State and Territory Board on the risk management response. The Advisory Committee and State and Territory Board will provide advice to the Decision Maker on the scheduling and management of the chemical.




11. Existing Management Approaches

that Align with the National Standard

Industrial chemical use is regulated by a number of industry codes and standards that have

largely been implemented to protect human and occupational health. Industry have adopted and

implemented a range of risk management approaches to protect human health, and these can

also be aligned and enhanced to provide environmental protection.

11.1 Supporting Documents

Some industrial chemicals are subject to controls through other codes, such as the Dangerous

Goods Code and codes relating to occupational health and safety. These have requirements

particularly relating to protecting users of chemicals, including packaging, labelling, placarding

and warnings, and requirements relating to transport. The National Standard does not intend to

duplicate these requirements and assumes that the requirements of other applicable codes and

standards will apply. Instead, the National Standard will focus on requirements relating to

protection of the environment arising from storage, handling, manufacturing activities, and

disposal.

The National Standard has been developed to consider the existing codes, standards and

guidelines that have been implemented on both a national and jurisdictional basis. The risk

management approaches specified in the National Standard have been developed to consider

what users and manufacturers of industrial chemicals are already applying. The following

supporting information has been used as a basis for developing the risk management measures

for the National Standard.

11.1.1 Work Health and Safety Regulations (2012)

The model Work Health and Safety (WHS) Regulations require chemicals to be classified in

accordance with the Globally Harmonised System of Classification and Labelling of Chemicals

(GHS). The GHS becomes mandatory on 1 January 2017 under the model work health and

safety laws.

Workplace hazardous chemicals are substances, mixtures and articles used in the workplace

that can be classified according to their health, physical and chemical (physicochemical)

hazards. Health hazards are hazards like skin irritants, carcinogens or respiratory sensitisers

that have an adverse effect on a worker’s health as a result of direct contact with or exposure to

the chemical, usually through inhalation, skin contact or ingestion. Physicochemical hazards

generally result from the physical or chemical properties, like flammable, corrosive, oxidising or

explosive substances.

The model Work Health and Safety (WHS) Regulations are the basis for hazardous chemicals

regulations in Commonwealth and states and territories. Under the model WHS Regulations

manufacturers and importers of substances, mixtures and articles supplied for use in

workplaces are required to determine whether they are hazardous to health and safety before

supply.

Hazardous Substances Information System (HSIS) is an internet advisory service that provides

information on substances that have been classified by an authoritative source (such as the

European Commission or NICNAS) in accordance with the Approved Criteria for Classifying

Hazardous Substances [NOHSC:1008(2004] 3rd Edition. HSIS has been replaced by the

Hazardous Chemical Information System.




The Hazardous Chemical Information System (HCIS) is a new database that allows information

to be sourced on chemicals that have been classified in accordance with the GHS. HCIS

contains GHS classifications for over 4,500 chemicals as well as a comprehensive database of

Australian workplace exposure standards.

The HSIS and the HCIL have been updated to incorporate assessments made by the National

Industrial Chemicals Notification and Assessment Scheme (NICNAS). These changes reflect

the outcomes of human health assessments made as part of tranches one through seven of the

Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework.

The process of determining whether a substance is hazardous is a series of “gate-way”

questions all focusing on the health effects. It does not provide any risk management controls to

be applied to a hazardous substance classification. Risk phases do provide an indication of the

area of impact e.g. R50 – very toxic to aquatic organisms which, by implication provide

guidance on conditions to avoid.

Under the former National Model Regulations for the Control of Workplace Hazardous

Substances [NOHSC:1005(1994)] and the National Standard for the Storage and Handling of

Workplace Dangerous Goods [NOHSC:1015(2001)], hazardous chemicals were required to be

classified by the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)]

3rd Edition (the Approved Criteria) and the Australian Code for the Transport of Dangerous

Goods by Road and Rail (ADG Code). The criteria included in the Approved Criteria are

adopted from European Community (EC) legislation for classifying dangerous substances.

11.1.2 Australian Code for the Transport of Dangerous Goods by Road & Rail

(2016)

The Australian Dangerous Goods Code, edition 7.4, 2016 (ADG) sets out the technical

specifications, requirements and recommendations applicable for transporting dangerous goods

by road and rail within Australia. The National Transport Commission is responsible for

maintaining this document.

The Code outlines environmentally hazardous substances as a subdivision to Class 9

substances, although the focus is on the aquatic environment. The hazard identification number

“90” has the following meaning “environmentally hazardous substances; miscellaneous

dangerous substances”. Cargo transport units containing environmentally hazardous

substances (UN Nos. 3077 and 3082) must be marked with the environmentally hazardous

substance mark. Where the second character of an EAC is W, X, Y or Z spillages and

decontamination run-off should be prevented from entering drains and watercourses.

The requirements (risk management controls) for storage and handling dangerous goods is not

specific to environmentally hazardous substances, but are general across all Classes. They

include design and inspection requirements that must be met and as such are more prescriptive

than those proposed in the National Standard for Environmental Risk Management of Industrial

Chemicals.

11.1.3 ANZECC

The Australian and New Zealand Environment Conservation Council (ANZECC) Australian and

New Zealand Guidelines for Fresh and Marine Water Quality (ANZECC and ARMCANZ, 2000)

(the Guideline) provide a framework for recognising and protecting water quality and their

environmental values and uses. The environmental values outlined in the Guidelines include

protection of aquatic ecosystems, drinking water, primary and secondary recreation, visual

amenity, and agricultural water for irrigation, livestock and aquatic food cultivation.

http://www.hcis.safeworkaustralia.gov.au/




The Guidelines define the water quality criteria for waterways such as natural rivers, creeks,

lagoons, wetlands, lakes, groundwater, and estuarine and marine waters. These criteria are

established to protect the environmental values that exist. For each environmental value, the

guidelines identify particular water quality characteristics or 'indicators' that can be used to

assess whether the condition of the water supports that value.

The Guidelines are intended to provide stakeholders with tools that will enable the assessment

and management of ambient water quality in a wide range of water resource types, and

according to designated environmental values. These are outlined as a set of guideline trigger

values, which if exceeded, may indicate a potential environmental problem, and so ‘trigger’

further investigation. The Guideline presents limits to acceptable change in water quality that will

continue to protect the associated environmental values. The guideline trigger values are not

intended to be used as mandatory standards because there is significant uncertainty associated

with the derivation and application of water quality guidelines (ANZECC and ARMCANZ, 2000).

The Guidelines provide risk based decision frameworks that allow individual values to be

determined for a given chemical, according to local environmental conditions. Three categories

of ecosystem conditions and levels of protection are recognised, and these include:

1. High Conservation/ecological value systems, typically occurring in national parks,

conservation reserves or in remote and/or inaccessible locations

2. Slightly to moderately disturbed systems, where ecosystems in which aquatic biological

diversity may have been adversely affected to a relatively small but measurable degree

by human activity

3. Highly disturbed systems, with degraded ecosystems of lower ecological value.

11.1.4 National Environment Protection Measures

The National Environment Protection Measures (NEPM) are a set of national objectives

designed to assist in protecting or managing particular aspects of the environment, and these

have been adopted by the States and Territories in their legislation. A number of NEPMs exist

for air, soil contamination and waste.

The objectives of the NEPMs are to provide protection of human health and the environment,

particularly in relation to environmental impacts associated with air quality, site contamination (ie

land and groundwater) and hazardous waste.

In the case of the NEPM (Assessment of Site Contamination) (referred to here as the NEPM

ASC, the NEPM ASC provides guidance on determining the human health and ecological risks

associated with the presence of site contamination (soil and groundwater) and to inform any

remediation or management plan to make the site fit for the current or proposed land use.

Similar to ANZECC, the NEPM ASC establishes soil, groundwater and vapour “investigation

levels” for protection of human health and ecosystems, groundwater resources and aesthetics.

The process of deriving the investigation levels is risk-based, and considers a range of

environmental settings and land use scenarios should consider factors including the protection

of human health, ecosystems, groundwater resources and aesthetics. The investigation

thresholds are to be used as generic screening criteria, with the requirement that when the

thresholds are exceeded, a more detailed site-specific assessment should be undertaken to

better understand the risk and the requirements for management.

The NEPM provides investigation thresholds for a large number of chemical compounds, and

also outlines the approach to developing criteria and assessing the risk for other chemicals for

which investigation thresholds have not been published.

The NEPM ASC does not provide guidance on prevention of site contamination, and owners

and occupiers of sites on which potentially contaminating activities are occurring are subject to




the environmental protection legislation applying in each jurisdiction. Legislation provides for

appropriate controls on potentially contaminating sources, including licensing of industrial

activities, to minimise emissions and its application is the principal strategy for prevention of soil

and groundwater contamination.

With respect to air, the NEPM (Air Toxics) and NEPM (Ambient Air Quality) provide guidance on

monitoring particular ambient air quality parameters and constituents that are important in terms

of protecting human health. Similarly to ANZECC and the NEPM ASC, these NEPMs establish

risk-based screening levels that, if exceeded, trigger the requirement for further investigation

and follow up. These NEPMs have focussed on a small number of chemicals that are in

widespread use and are commonly encountered, and do not extend to a wide range of industrial

chemicals.

11.1.5 Environmental Risk Assessment Guidance Manual for Industrial

Chemicals (2009)

The Environmental Risk Assessment Guidance Manual for Industrial Chemicals (2009) (the

manual) outlines the Australian and international methodologies for environmental risk

assessment of industrial chemicals. The purpose of the manual is to provide risk assessors with

guidance on the environmental risk assessment of industrial chemicals. It also provides other

stakeholders with an understanding of the general process and considerations that risk

assessors employ when assessing the potential risks that chemicals may pose to the

environment.

The manual is used by NICNAS to assess new and existing industrial chemicals under the ICNA

Act (1989). The manual outlines the methods a risk assessor can employ to assess a new or

existing industrial chemical according to best practice. The manual also provides direction to the

nature of the information, methods and tools required when assessing chemicals. The manual

is structured to provide the assessor with information to perform the risk assessment including:

general concepts on environmental risk assessment and the steps undertaken

data requirements

data evaluation for adequacy, suitability and reliability

environmental exposure

methods to assess environmental effects

assessment of persistent, bioaccumulative and toxic chemicals

characterisation of risk and risk management options

The manual is relevant in describing the process of risk characterisation of an industrial

chemical and provides guidance rather than prescriptive methodology. Information relating to

the risk management is outside the scope of the Manual.

11.2 International Principles

Risk management of chemicals relies on a risk assessment of a chemical that is relevant to in

the Australian context. The National Standard has been developed considering Australian uses

and exposures of industrial chemicals, and the Australian risk management framework.

International risk management determinations have been considered to formulate Australia’s

Standard. Risk assessment recommendations specific for the Australian context inform the risk

management decisions, which are also tailored to ensure states and territories and businesses

have the capability and infrastructure available for appropriate protection of the environment.




The approach for the National Standard is consistent with the objectives of the Strategic

Approach to International Chemicals Management (SAICM) and similar to approaches to

environmental risk management of industrial chemicals adopted in other advanced economies.

In particular, the National Standard aims to prioritise pollution prevention and minimise chemical

risks to the environment while providing a transparent, efficient and effective approach to

environmental risk management of industrial chemicals.

Many advanced economies have worked towards achieving the objectives of SAICM. Canada,

the European Union, the United States of America and Japan have approaches to

environmental risk management of industrial chemicals that mirror the objectives of SAICM and

some, along with Australia, contribute to the United Nations Environment Programme (UNEP)

and SAICM.

11.2.1 SAICM

The Strategic Approach to International Chemicals Management (SAICM) is a voluntary

initiative to help countries manage chemicals within their borders to reduce the harmful impact

of chemicals on human health and the environment. SAICM builds upon already agreed

approaches to chemicals management and science-based risk assessment, and seeks to build

the capacity of developing countries and economies in transition to safely manage chemicals.

The scope of SAICM covers agricultural and industrial chemicals throughout their life-cycle, but

explicitly excludes products such as food additives and pharmaceuticals.

11.2.2 OECD

Australia contributes to and benefits from collective efforts under the Organisation for Economic

Co-operation and Development (OECD) and other international bodies to develop standards

and guidelines that help avoid unnecessary duplication and accelerate the management of

chemicals globally.

The OECD Risk Management Programme aims to develop methodologies to support

government and industry efforts to manage risks posed by chemicals and, when appropriate, to

harmonise risk management activities on particular chemicals. The programme includes a

variety of themes such as Chemical Product Policy, Using Non-Regulatory Means to Manage

Risks, Risk Communication, Socio-Economic Analysis, Sustainable Chemistry, Tools for

Research and Development Screening as well as reports on risk management approaches for

specific chemicals.

Following an environmental risk assessment, the focus turns to how to control the identified risk.

The principles of, approaches to, and terminology related to risk management vary across

countries and regions, and are in many cases strongly context dependent.14 However, the

OECD outlines the general risk management process which includes four steps: risk evaluation,

emission and exposure control, risk monitoring and risk communication (See Figure 6).

14 The OECD Environmental Risk Assessment Toolkit: Steps in Environmental Risk Management and Available

OECD Products available on the OEDC website.

http://www.oecd.org/chemicalsafety/risk-assessment/theoecdenvironmentalriskassessmenttoolkitstepsinenvironmentalriskmanagementandavailableoecdproducts.htm




Figure 6: Risk assessment and risk management1516

11.2.3 Canada

The Canadian Environmental Protection Act, 1999 (CEPA) is the most important legislation

available to the Canadian federal government for managing toxic substances. CEPA uses a

‘precautionary approach’ and focuses on pollution prevention and the protection of the

environment and human health in order to contribute to sustainable development. CEPA

provides the Canadian federal government with instruments to protect the environment and

human health, establishes strict timelines for managing substances found to be ‘toxic’ under the

Act17, and requires the virtual elimination of releases to the environment of those declared toxic

substances that are bioaccumulative, persistent, and anthropogenic. CEPA aims to focus on a

shift away from managing individual chemicals towards a systematic, outcomes-focused

management approach.

Risk management tools other than those under CEPA are also available to the Canadian

federal government. Further, other governments in Canada have a role to play in the

management of toxic substances. Environment Canada has committed to considering the range

of tools and to recognising jurisdictional roles when it is developing strategies to manage

substances that are toxic under CEPA. The CEPA National Advisory Committee, consisting of

representatives from provincial, territorial, and aboriginal governments, plays a key role in

15 Adapted from OECD (2014). The OECD Environmental Risk Assessment Toolkit: Tools for Environmental

Risk Assessment and Management available on the OECD website. 16 Adapted from OECD (2014). The OECD Environmental Risk Assessment Toolkit: Tools for Environmental

Risk Assessment and Management available on the OECD website. 17 Section 64 of CEPA defines a substance as "toxic" if it is entering or may enter the environment in a quantity

or concentration or under conditions that: a) have or may have an immediate or long-term harmful effect on the

environment or its biological diversity; b) constitute or may constitute a danger to the environment on which life

depends; or c) constitute or may constitute a danger in Canada to human life or health.

http://www.oecd.org/chemicalsafety/risk-assessment/theoecdenvironmentalriskassessmenttoolkittoolsforenvironmentalriskassessmentandmanagement.htm

http://www.oecd.org/chemicalsafety/risk-assessment/theoecdenvironmentalriskassessmenttoolkittoolsforenvironmentalriskassessmentandmanagement.htm




advising the Canadian federal government on activities under the Act and on cooperative,

coordinated approaches to the management of toxic substances.

11.2.4 European Union

In the European Union (EU), chemical substances are managed under REACH, an integrated

system for the Registration, Evaluation, Authorisation and restriction of Chemicals. REACH is

intended to promote the development of less hazardous substances that can replace existing

substances. The EU takes the position that voluntary measures on chemicals management are

insufficient and that clear requirements will foster greater innovation and competitiveness.

Furthermore, the EU has evaluated the costs and benefits of the proposed legislation,

concluding that estimated costs to the economy (and particularly the chemicals industry) are

considered manageable and strike an appropriate balance relative to projected benefits to

human health and the environment.18

11.2.5 United States of America

The Frank R. Lautenberg Chemical Safety for the 21st Century Act (the update to the Toxic

Substances Control Act 1976 (TSCA)) is the main legislation dealing with the manufacture,

import, use and distribution of chemical substances in the United States (US). The US also has

a substantial number of other Acts related to specific areas of chemical risk management such

as the Clean Air Act, the Clean Water Act, and the Federal Food, Drug and Cosmetic Act.

18 Parliament of Canada (2006) International Management of Chemicals.

http://www.parl.gc.ca/Content/LOP/researchpublications/prb0629-e.htm




12. Scheduling and Decision Making

Processes

The figures and table below outline the overarching roles and functions under the National

Standard. The figure and table detail:

the roles and responsibilities of the Risk Assessor, the Advisory Committee and the

Decision Maker

the development of risk management recommendations and risk management advice to

inform decision-making

the processes for consultation and review of risk management recommendation and

published decisions

matters within scope of this paper and supporting matters outside the scope of this paper.



Figure 7: Roles, processes and decision making under the National Standard

Note: Areas outside the yellow background are outside scope of this paper.




12.1 Convention Chemicals

Chemicals listed or proposed for listing on the Stockholm Convention on Persistent Organic

Pollutants (Stockholm), the Minamata Convention on Mercury (Minamata), and Montreal

Protocol on Substances that Deplete the Ozone layer (Montreal), or other relevant international

conventions, will undergo a different process to other new and existing chemicals. Chemicals on

Stockholm, Minamata and Montreal are likely to be existing chemicals. By the time chemicals

are proposed to be listed on these Conventions, there is general international consensus that

they are of high concern to the environment and should be restricted or prohibited from use.

The Australian Government also plays a pivotal role in the nomination and listing of high

concern chemicals on the Conventions and Australia’s representation at international meetings

is supported with expert analysis on the chemical’s effects and risk to the environment, as well

as the socio-economic impact of these chemicals. In many cases, these chemicals will not need

to go to the Advisory Committee as the analysis will be sufficient for the Decision Maker to

schedule the chemicals. In such cases, states and territories will be and the community may be

consulted directly by the Decision Maker.

Table 19: Key persons, documentation and processes under the National

Standard

Bold text in the table indicates definitions are presented elsewhere in the document.

Term Definition

The National Standard The National Standard will outline scheduling

criteria, scheduling processes and scheduling

decisions for industrial chemicals for which a risk

management recommendation has been made by

the Risk Assessor taking into consideration the

Australia context in which the chemical is used. The

National Standard includes a set of schedules that

indicate an industrial chemical’s level of concern

pertaining to the environment and outline



proportionate risk management measures to prevent

harm to the environment.

Designated Persons

The Risk Assessor for the purpose of the National Standard includes those people working for the Australian Government that undertake scientific evaluations of the risk an industrial chemical poses to the environment. These scientific evaluations take into consideration the chemical’s hazards and likelihood of exposure to the environment in accordance with the current Industrial Chemicals (Notification and Assessment) Act 1989 under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). The Risk Assessor prepares risk assessments, and risk management recommendations that will take into consideration of the National Standard scheduling criteria.

The role of the risk assessor and risk assessment

processes and policy is outside the scope of the

National Standard.

The Advisory Committee will be comprised of

independent experts from a range of scientific and

policy fields related to management of industrial

chemicals. The Advisory Committee will review risk

management recommendations for all chemicals

for which advice is sought from the Decision Maker.

This is likely to include chemicals identified by the

Risk Assessor to meet the criteria for High Concern

chemicals, and any other chemicals assessed by the

Risk Assessor for which a valid request for review

is received. The Advisory Committee may choose to

consult with government agencies, industry and the

broader community in order to inform their review of

the recommendation.

A State and Territory Board will also be available for

advice upon the Decision Maker’s request. Advice

from the Advisory Committee and the State and

Territory Board will remain separate for transparency

in decision-making. Criteria for seeking advice from

the State and Territory Board will be developed in

consultation with jurisdictions and relevant

information will be publicly available.

The Advisory Committee and State and Territory

Board may take into consideration the scientific

analysis presented in the risk assessment and

certain socio-economic considerations that may

affect how a chemical is scheduled or managed. The

Advisory Committee and State and Territory Board

will prepare separate risk management advices to

the Decision Maker.




Further information on the Advisory Committee is

presented in Section 12.5. Details on the operation

and administration of the State and Territory Board

will be developed in consultation with jurisdictions.

The Decision Maker will be the Minister responsible

for the federal environment portfolio or their delegate.

They, or their delegate, will make the final

scheduling decision for industrial chemicals under

the National Standard based on their scope of

assessment, and any decisions on processes under

the National Standard. The Decision Maker must

consider the risk management recommendation

made by the Risk Assessor or an Australian

government and, if any, the risk management

advice prepared by the Advisory Committee or

State and Territory Board. The Decision Maker may

ask the Advisory Committee or State and Territory

Board to review any recommendation or advice

received, noting the specifics of their request to the

Advisory Committee or State and Territory Board.

The Decision Maker will also be responsible for

ensuring requests for reviews of risk management

recommendations and variations to scheduling

decisions are valid. The Decision Maker may also

consult publicly.

Recommendation, Advice and Decision Documentation

Risk assessments are completed by the Risk

Assessor. A risk assessment is a systematic

scientific evaluation of potential adverse effects

resulting from exposure to a hazardous agent or

situation. It takes into consideration hazard

information on a chemical as well as the routes and

likelihood of exposure of the chemical to the

environment. Risk assessments require the

integration of both quantitative and qualitative

scientific information. The risk assessment does not

take into consideration socio-economic impacts of a

chemical’s use. International data and assessments

are taken into consideration when assessing the risk

to the environment in the Australian context.

The risk assessment includes the formulation of a

risk management recommendation. Following

implementation of the National Standard, the risk

management recommendation will be made with

consideration of the National Standard scheduling

criteria. The risk management recommendation will

include recommendation of an appropriate

Environment Schedule and appropriate risk

management measures. Consultation is undertaken



when finalising risk assessments and risk

management recommendations.

The risk assessment and associated processes and

policy are outside the scope of the National

Standard.

Risk management advice is prepared by the

Advisory Committee or State and Territory Board

to provide the Decision Maker with the information

needed to make a scheduling decision. The Risk

Management Advice includes consideration of the

risk management recommendation that was made

by the Risk Assessor or any other advice sought

from the Decision Maker, as well as certain socio-

economic implication for a chemical’s use. The risk

management advice will include scheduling and risk

management measure recommendations.

Scheduling Decision

The scheduling decision made by the Decision

Maker outlines the Environment Schedule to which

the chemical will be assigned based on its scope of

assessment, and the risk management measures

that will be required. Scheduling decisions will be

reviewable.

After the scheduling decision is made enforceable,

the decision will be made publicly available. This may

take the form of an online database searchable, for

example, by chemical identifier, Environment

Schedule, date of decision, etc. Published decisions

will be disseminated to all jurisdictions for their

information.

The Risk Analysis and Government

Recommendation relate specifically to High Concern

chemicals that are proposed for or listed on the

Stockholm or Minamata Conventions, or Montreal

Protocol, or other relevant international convention.

The Risk Assessor may complete the Risk Analysis.

However, it may also be completed by an Australian

government as part of treaty making processes.

Data

The National Standard scheduling criteria will be

used by the Risk Assessor in the formulation of a

risk management recommendation for inclusion in

the risk assessment. The scheduling criteria outline

the hazard and risk information that will inform the

assignment of a chemical to a Environment

Schedule. The scheduling criteria will be publicly

available.




Processes

Managers of environmental risks within an Australian

government may request the Risk Assessor to

consider a particular chemical for assessment in the

Australian context and subsequently make a risk

management recommendation to the National

Standard.

Risk assessment processes for new and existing

industrial chemicals are undertaken in accordance

with the Industrial Chemicals (Notification and

Assessment) Act 1989. The risk assessment

processes are outside the scope of this paper.

Consultation 1 is undertaken during the finalisation of

the risk assessment and risk management

recommendation. Consultation 1 will be undertaken

in accordance with the processes outlined in the

Industrial Chemicals (Notification and Assessment)

Act 1989. Consultation in relation to the scientific

analysis in the risk assessment should be referred

to the Risk Assessor. Following finalisation of the

science in the risk assessment, a request for review

of the risk management recommendation may be

made to the Decision Maker at this stage in

accordance with criteria for requesting a review.

Requests for review of risk management

recommendations may be made during

Consultation 1. Requests for review may be made

on scientific, societal or economic grounds in

accordance with designated criteria. The Decision

Maker will be responsible for determining if the

request to review the risk management

recommendation is valid and necessary and

subsequently seek the advice of the Advisory

Committee. If valid, the risk management

recommendation can be reviewed by the Advisory

Committee. The Decision Maker may also seek the

Advisory Committee or State and Territory Board

for any reason.

Consultation 2 may be undertaken by the Advisory

Committee at any time during the review of the risk

management recommendation or variation of a

published decision. The Advisory Committee may

choose to consult government agencies, industry or

the broader community in order to inform their

advice.



Following publication of a decision, jurisdictions will

be responsible for implementing the decisions in

accordance with their legislation. Implementation of

scheduling decisions is outside the scope of this

paper.

There are circumstances where it may be appropriate

for decisions on chemicals to be varied or reviewed.

This may include where the Scheduling Decision

was made based on inaccurate or out of date

information, or new information is available that may

change the risk to the environment and subsequent

risk management measures.

Variations will be initiated by the Decision Maker,

most likely in response to being notified of the need

for variation. The same processes will apply to

variations as initial scheduling decisions.

Criteria for requesting variations will be publicly

available and are further detailed below.

Reviews of decisions may also be undertaken in

accordance with Australian Government

requirements.

12.2 Information to be made available under the National

Standard

To accompany the scheduling decision made under the National Standard, the following

information will be publicly available to support the reasons for the decision:

The chemical name/identifier as published in the risk assessment summary

The scope of the assessment according to which the scheduling decision was made, as

published in the risk assessment summary, including, but not limited to:

– The assessed use of the chemical

– The assessed volume of the chemical

– Other relevant information that affected the assessment of the risk to the environment

The assessed chemical hazards, if any, as published in the risk assessment summary

The Environment Schedule into which the chemical according to its scope of assessment

is assigned

The risk management measures applicable for the chemical’s use

The date of the decision

Any other relevant information that led to the decision.

12.3 Risk Assessment

Risk assessments of industrial chemicals will continue to be undertaken by the Australian

Government. Risk assessments are currently undertaken according to the Industrial Chemicals

(Notification and Assessment) Act 1989 under the National Industrial Chemicals Notification and




Assessment Scheme (NICNAS). References to the Risk Assessor in the National Standard

mean those completing risk assessments through NICNAS.

The Risk Assessor will make a risk management recommendation to the Decision Maker for the

National Standard as to the appropriate Environment Schedule for the chemical, taking into

consideration its scope of assessment (assessed use and volume of use in Australia) and the

scheduling criteria. Scheduling criteria will be publicly available.

The risk management recommendation will also outline appropriate risk management measures

selected from a list of standardised, publicly available measures that are detailed for each

Environment Schedule. Recommendations for risk management measures will need to take into

consideration the chemical’s properties and potential route of release to the environment to

ensure the risk management measures are appropriate for the chemical. Guidance to support

the Risk Assessor in determining appropriate risk management measures will be developed and

publicly available.

The risk assessment framework for industrial chemicals is currently undergoing reform. One of

the main objectives of the reform is to prioritise the assessment of chemicals that are of concern

to the environment and allow use of lower concern chemicals without premarket assessment.

For new chemicals, this may mean that very few Low Concern chemicals will be scheduled

under the National Standard as they will not be assessed for their risk. Existing chemicals on

the Australian Inventory of Chemical Substances (AICS) may be scheduled as Low Concern

chemicals. Chemical introducers wishing to have new chemicals that are Low Concern

scheduled under the National Standard will need to request that Risk Assessor (NICNAS)

conduct an environmental risk assessment.

12.4 Risk Management Recommendations

Risk management recommendations will be made in the risk assessment in line with the

scheduling criteria outlined as part of the legislative framework. Where the chemical is assessed

by the Risk Assessor in the Australian Government, the consultation period for risk

management recommendations made in a risk assessment will integrate with consultation

processes undertaken by the Risk Assessor to ensure that chemicals are scheduled under the

National Standard in a timely and efficient manner.

Risk management recommendations may be considered by governments, the introducer and/or

the community during the consultation period associated with completing the risk assessment. If

further consideration of the risk management recommendation is required, a request for the

recommendation to be reviewed by the Advisory Committee can be made during the

consultation period and after the scientific analysis is finalised. Comments on the scientific risk

assessment during the consultation period will be considered by the Risk Assessor. The

Advisory Committee will not review the scientific risk assessment with the intent of changing the

risk assessment or scientific analysis contained therein.

Requests for review of the risk management recommendation by the Advisory Committee may

be made on scientific, or certain societal or economic grounds. Only the Advisory Committee

will review how certain socio-economic considerations may impact scheduling decisions.

Requests may be made by governments, introducers or the community according to certain

criteria. Any of the following criteria must be met in order to qualify for a review by the Advisory

Committee:

The scientific risk assessment is accurate but the scheduling criteria are not appropriate

for the chemical and do not accurately reflect the chemicals characteristics. For example;

– new chemistries may not have been factored in to the scheduling criteria previously

and the criteria may need amending to accommodate advances in the field, including



chemicals with particular characteristics of concern to the environment not previously

considered.

– new experimental test data for chemicals or groups of chemicals may be available to

indicate the legislated scheduling criteria are not appropriate and should be amended.

The risk management measures are not appropriate for the chemical or the way in which

it is used. Inappropriate risk management conditions in this context refer to conditions

where the requestor of the review is able to justify, based on scientific or certain

economic grounds, that the conditions cannot be met. In this case, the Advisory

Committee may also advise that new risk management measures and associated

schedules are included under the National Standard.

The Decision Maker will determine if the request for review of the risk management

recommendation is valid in accordance with the criteria above.

12.5 Advisory Committee

The Advisory Committee will only meet and review chemicals under certain circumstances:

A risk management recommendation is that the chemical is a High Concern chemical. All

High Concern chemicals will be reviewed by the Advisory Committee and appropriate

scheduling and risk management measures recommended by the Advisory Committee to

the Decision Maker as risk management advice.

A risk management recommendation for Intermediate or Low Concern chemicals has

been requested to be reviewed by industry, governments or the community. The Advisory

Committee will only review chemicals if the request for review is deemed valid by the

Decision Maker. If no review is requested for Intermediate and Low Concern chemicals,

their risk management recommendations from the risk assessment will be forwarded

straight to the Decision Maker for a scheduling decision.

The Decision Maker requests that a risk management recommendation be reviewed.

The Decision Maker requests that a scheduling decision be reviewed.

The Decision Maker requests that the scheduling criteria be reviewed.

The Decision Maker otherwise requests advice on chemical scheduling under the

National Standard.

12.5.1 Role of the Advisory Committee

The role of the Advisory Committee is to:

consider the risk assessments completed by the Risk Assessor for all High Concern

chemicals and recommend appropriate scheduling and risk management measures to the

Decision Maker in their risk management advice based on scientific and certain socio-

economic considerations

review all Intermediate or Low Concern chemicals where a valid request for review has

been made and provide risk management advice to the Decision Maker, taking into

consideration the risk management recommendation and any socio-economic factors

review any risk management recommendation where a request for review has been made

by the Decision Maker and provide risk management advice to the Decision Maker, taking

into consideration the risk management recommendation and any socio-economic factors

provide advice that new risk management measures are included under the National

Standard.




review published decisions of chemicals as requested by the Decision Maker.

consult, as required, with government agencies, industry or the broader community to

inform their reviews of risk management recommendations or scheduled decisions.

12.5.2 Meetings

The Advisory Committee will meet four times per year, but may be convened more or less

frequently as required. Meetings may be held face-to-face or via teleconference. Meetings will

generally be scheduled to take place in the middle of each quarter of the year. Meeting dates

will be published online. The Advisory Committee will only meet if a quorum is achieved through

attendance of at least two thirds of the members.

An agenda, chemicals for discussion, decisions for review, and risk assessments and risk

management recommendations will be forwarded to the Advisory Committee two weeks before

the scheduled date for each meeting. Where possible, risk management advice for the Decision

Maker should be finalised at the meeting and forwarded to the Decision Maker with supporting

reasons for the advice.

12.5.3 Membership

The Advisory Committee will include six members drawn from the following areas of expertise:

Industrial chemistry

Ecotoxicology

Environmental risk management

Policy/soci-economic analysis

Ecology

Chemical regulation.

Any Australian person or person working for a company operating in Australia may be members

of the Advisory Committee. Parties may become members of the Advisory Committee by

invitation or nomination. Parties may be selected from government or the broader community as

long as their position is consistent with the expertise outlined. The Minister for the federal

environment portfolio (the Minister) may invite parties to become members of the Advisory

Committee in consultation with all jurisdictions.

The Minister for the federal environment portfolio will appoint members to the Advisory

Committee in writing. Appointed members will be whoever the Minister believes to be

appropriately qualified based on advice from the Department of the Environment and Energy

and in consultation with state and territory governments. Members are appointed on the basis of

expertise rather than to represent a particular jurisdiction or interest group.

A member may be appointed for a term stated in the member’s appointment but must not be

longer than three years. Such members can be appointed for a further term of up to three years

but may not serve more than three consecutive terms (nine years in total).

Other committees or groups may be formed on an ad hoc basis to inform the Advisory

Committee during their consultation.

12.5.4 Confidentiality and Conflict of Interest

All members are required to sign a confidentiality agreement and declare any interests of the

kind that a member may need to disclose.



Members should declare both pecuniary (which may include professional) interests and non-

pecuniary interests. Members should take into account the nature of the Advisory Committee's

role, functions and responsibilities when determining whether to declare a particular interest.

Members will need to make the following declarations:

A declaration of interest to support the application/expression of interest in relation to the

Advisory Committee membership

A declaration at the time of appointment to the Advisory Committee

An annual declaration

A disclosure of interests declaration prior to meetings

Notification of new or additional interests as soon as practicable after they arise or

become apparent.

All relevant conflicts of interest will be disclosed to the public when a member of the Advisory

Committee is appointed. The duration and dates of their membership will be noted against the

disclosure, as well as the period over which the disclosure is representative of the conflict. The

disclosure is to ensure decisions under the National Standard are transparent and defensible.

Disclosure of interests may extend to declaration by a member of holding strong personal,

philosophical or religious beliefs or convictions, or personal circumstances, family or other

relationships.

The disclosure must be recorded in the minutes of the meeting and the member must not,

unless the Committee otherwise determines, either be present during any deliberation of the

Committee about the matter or take part in any decision of the Committee about the matter.

When the Committee is making a determination about a member who has made a disclosure,

the member, and any other member who has a direct or indirect material personal interest

(whether pecuniary or not) in the matter to which the disclosure relates, must not be present

during any deliberation of the Committee and must not take part in making that determination.

12.5.5 Appointment of Chair

The chair of the Advisory Committee is appointed by the Minister for the federal environment

portfolio or delegate from within the existing Advisory Committee membership. The Chair holds

that office for the term stated in the appointment and may be appointed for further terms, but not

for periods longer than the term of their membership. An Acting Chair may also be appointed by

the Minister, to assume the role and responsibilities of the Chair when he or she is unable to

perform his or her duties.

12.5.6 Resignation

Appointed members may resign from the Advisory Committee by signed notice to the Minister

for the federal environment portfolio. The Chair may resign as Chair and/or as an Advisory

Committee member by signed notice to the Minister.

12.5.7 Remuneration

The remuneration of the Advisory Committee would be based on the fees determined by the

Remuneration Tribunal established under the Remuneration Tribunal Act 1973.

12.5.8 Non-unanimous Outcomes

All risk management advice provided by the Advisory Committee should be made by

consensus. In the exceptional circumstance where it is not possible to reach consensus,




members will be able to vote on the final risk management advice for the Decision Maker that

has not achieved consensus.

All members of the Advisory Committee will have equal voting rights. The risk management

advice is agreed at an Advisory Committee meeting by a majority of the votes of the members

present and voting. Committee members will have the opportunity to outline their reasons for

their vote. The Chair at the Advisory Committee meeting will abstain from the voting round. If

the vote is tied, the Chair has the casting vote. The quorum is two thirds of the Advisory

Committee members.

12.5.9 Consideration of socio-economic impacts

The Advisory Committee may consider socio-economic impacts of the risk management

measures and the chemical’s use in Australia. These impacts may also be considered when

determining restrictions on use, periods of potential phase-out of chemicals and prohibitions.

Only certain socio-economic impacts may be considered by the Advisory Committee. These

considerations will be weighted to ensure the risk management approach is first and foremost

appropriate for protecting the environment and preventing organisms being exposed to harmful

chemicals.

The impacts to be considered by the Advisory Committee in order of highest to lowest weighting

are:

1. Impact on the environment and risks to potentially exposed organisms, including the

estimated cost of restoring the environment to its original state following exposure.

2. Impact on the protection of the environment and human health from the use of the

chemical during emergency response or workplace health and safety.

3. Impact on the chemical industry or segment of the chemical industry

4. Impact on an entity’s abilities to operate competitively in Australia and/or internationally.

The aim of this review is to make sure the measure resulting from the scheduling process is

actually fit for purpose, efficient and effective and consistent with existing chemical regulation

approaches. The states and territories may also work with the Advisory Committee on this

advice. Guidance on how the Advisory Committee considers socio-economic impacts in their

analysis will be prepared to support the legislation and administrative processes.

12.6 Decision Maker

The Decision Maker for the National Standard will be the Minister for the federal environment

portfolio. The decision-making responsibility can be delegated to a member of the Department

of the Environment and Energy’s staff.

The Decision Maker makes the final scheduling decision for all chemicals and decisions on

processes undertaken for scheduling. The scheduling decision must consider the risk

management recommendation from the Risk Assessor and/or advice from the Advisory

Committee and State and Territory Board, if any. The Decision Maker will also have the power

to request that risk management recommendations are reviewed by the Advisory Committee or

State and Territory Board prior to making a scheduling decision. The Decision Maker will also

have the power to request that the Advisory Committee review scheduling decisions under the

National Standard and any risk management measures or scheduling criteria. The Decision

Maker may seek the advice of the State and Territory Board before making any decision.

All chemicals with an environmental risk management recommendation for scheduling

accompanied by an environmental risk assessment will be scheduled under the National

Standard. Chemicals will be forwarded to the Decision Maker following:



finalisation of the risk assessment and preparation of a risk management

recommendation by the Risk Assessor

a risk analysis and an Australian government recommendation for scheduling of a High

Concern chemical

consideration by the Advisory Committee and/or State and Territory Board, if required.

In the majority of cases, chemicals will be forwarded straight to the Decision Maker following

completion of a risk assessment by the Risk Assessor. The Decision Maker will also have the

power to consult directly with government and the community in finalisation of a scheduling

decision.

The Decision Maker will consider chemicals for scheduling once per month. All chemicals for

which a risk management recommendation is finalised after the previous scheduling decision

cut-off will be considered for scheduling. In general, it is expected that the total number of days

between the risk management recommendation is made and scheduling decision being made is

between 14 and 45 days, unless the risk management recommendation is requested to be

reviewed by the Advisory Committee.

All risk management recommendations made by the Risk Assessor for High Concern chemicals,

and Intermediate and Low Concern chemicals for which a valid request for review is made, will

be reviewed by the Advisory Committee. The Advisory Committee will meet four times per year.

Therefore, chemicals reviewed by the Advisory Committee may take up to four months to reach

a scheduling decision under the National Standard.

Following a scheduling decision by the Decision Maker, the chemical will be included on the

National Standard and the decision will be enforceable. Scheduling decisions will be reviewable.

12.7 Administration

The National Standard Secretariat will be located within the Australian Government Department

of the Environment and Energy. The Secretariat will be responsible for:

coordinating communication between external parties and the Advisory Committee, State

and Territory Board or Decision Maker

compiling a list of chemicals for scheduling and their recommended risk management

conditions for the Decision Maker

notifying the public of decisions made under the National Standard including updating

website material as required

organising information for dissemination to the Advisory Committee and/or State and

Territory Board

coordinating and facilitating the meetings of the Advisory Committee and/or State and

Territory Board

preparing the Department’s recommendation on appointment to the Advisory Committee

with appropriate consultation.

Details and guidance for administrative processes will be developed following finalisation of the

National Standard.




13. References

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Boethling RS and Mackay D (ed) (2000). Handbook of Property Estimation Methods for Chemicals: Environmental and Health Sciences. Lewis Publishers, Boca Raton, Florida, USA.

ECETOC (2003). Persistence of Chemicals in the Environment - Technical Report No. 90. European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels, Belgium.

EPHC (2009). Environmental Risk Assessment Guidance Manual for Industrial Chemicals. Environment Protection and Heritage Council, Canberra, Australia. Accessed 9 December 2013 at http://www.scew.gov.au/resource/chemical-risk-assessment-guidance-manuals.

European Commission (2003). Technical Guidance Document on Risk Assessment, Commission Directive 93/67/EEC on Risk Assessment for new notified substances; Commission Regulation (EC) No 1488/94 on Risk Assessment of existing substances; Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Part III.

Klaassen CD (ed) (2008). Casarett's and Droull's Toxicology: The Basic Sience of Poisons (7th edition). McGraw-Hill Companies, USA.

LMC (2011). OASIS Catalogic, v 5.10.9. Laboratory of Mathematical Chemistry, University "Prof. Dr. Assen Zlatarov", Burgas, Bulgaria. Available at http://oasis-lmc.org/.

Mayo-Bean K, Moran K, Meylan B and Ranslow P (2012). Esitmating Toxicity of Industrial Chemicals to Aquatic Organisms using the ECOSAR (Ecological Structure Activity Relationship) Class Program, Methodology Document for the ECOlogical Structure-Activity Relationship Model (ECOSAR) Class Program. United States Environmental Protection Agency (US EPA), Washington DC, USA.

OECD (2000). Guidance Document on Aquatic Toxicity Tesing of Difficult Substances and Mixtures, Environmental Health and Safety Publications Series on Testing and Assessment No. 23. Development OfECa, Paris, France. http://www.oecd-ilibrary.org/environment/oecd-series-on-testing-and-assessment_20777876.

UNECE (2009). Globally Harmonised System of Classification and Labelling of Chemicals (GHS), 3rd Revised Edition. United Nations Economic Commission for Europe, Geneva, Switzerland. Accessed 12 November 2013 at http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html

UNECE (2013). About the GHS. United Nations Economic Comission for Europe, Geneva, Switzerland. Accessed 31 October 2013 at http://www.unece.org/?id=3623.

US EPA (2003). Technical Support Document Volume 2: Development of National Bioaccumulation Factors, Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000). United States Environmental Protection Agency, Washington DC, USA. http://www.epa.gov/scipoly/sap/meetings/2008/october/methodology.pdf.

US EPA (2008). Estimations Programs Interface (EPI) SuiteTM for Microsoft Windows®, v 4.10. United States Environmental Protection Agency, Washington DC, USA. Available at http://www.epa.gov/oppt/exposure/pubs/episuite.htm.

US EPA (2012). The ECOSAR (ECOlogical Structure Activity Relationship) Class Program for Microsoft Windows®, v 1.11. United States Environmental Protection Agency, Washington DC, USA. Available at http://www.epa.gov/oppt/newchems/tools/21ecosar.htm.


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