Draft National Standard for environmental risk management ...€¦ · Web viewNational Standard for Environmental Risk Management of Industrial Chemicals Explanatory Document is

DRAFT FOR CONSULTATION

National Standard for Environmental Risk Management of Industrial ChemicalsExplanatory Document

November 2016

DRAFT FOR CONSULTATION© Copyright Commonwealth of Australia, 2016.

National Standard for Environmental Risk Management of Industrial Chemicals Explanatory Document is licensed by the Commonwealth of Australia for use under a Creative Commons Attribution 4.0 International licence with the exception of the Coat of Arms of the Commonwealth of Australia, the logo of the agency responsible for publishing the report, content supplied by third parties, and any images depicting people. For licence conditions see: https://creativecommons.org/licenses/by/4.0/

This report should be attributed as ‘National Standard for Environmental Risk Management of Industrial Chemicals Explanatory Document, Commonwealth of Australia 2016’.The Commonwealth of Australia has made all reasonable efforts to identify content supplied by third parties using the following format ‘© Copyright, [name of third party] ’.

Disclaimer

The views and opinions expressed in this publication are those of the authors and do not necessarily reflect those of the Australian Government or the Minister for the Environment and Energy.

While reasonable efforts have been made to ensure that the contents of this publication are factually correct, the Commonwealth does not accept responsibility for the accuracy or completeness of the contents, and shall not be liable for any loss or damage that may be occasioned directly or indirectly through the use of, or reliance on, the contents of this publication.

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

of Industrial Chemicals, 31/33665 | i

https://urldefense.proofpoint.com/v2/url?u=https-3A__creativecommons.org_licenses_by_4.0_&d=CwMFAg&c=H7f3rkJOSswqgMCk7xB61Q&r=WyVzGOfCvc7oioMXsha5cHTNaOQknAVpaaazPXpSWz0&m=gWxsZevh-JEd9ap7gR1WVd1TyEH9P1Z5yGoIqki8-p0&s=o1028eqhAQ80XA_OF7wvUiitkSkq49XmRfSlT7OKTrA&e=


Purpose of this Explanatory ReportThe 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.




Table of contentsPurpose of this Explanatory Report...................................................................................................................

1. Glossary...................................................................................................................................................

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

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

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

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

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

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

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

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

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

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

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

7.1 Introduction.......................................................................................................................

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

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

7.4 Articles..............................................................................................................................

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

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

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

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

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

8.1 Introduction.......................................................................................................................

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

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

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

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

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

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

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

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




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

Industrial Chemicals, 31/33665




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

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

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

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

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

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

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

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

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

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

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

12.7 Administration...................................................................................................................

13. References...........................................................................................................................................

Table indexTable 1: Environment Schedules..........................................................................................................

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


of Industrial Chemicals, 31/33665 | iii


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

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

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

Figure 4: Australian criteria for persistence (P) categorisation based on the half-life of a chemical in different media...............................................................................................

Figure 5: Uptake and elimination of substances during bioconcentration and bioaccumulation processes (adapted from (ECETOC 2003).......................................................................

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

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

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



1. GlossaryAcronyms 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 The most effective and advanced stage in the development of




technology 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.

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.

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



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 (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:


of Industrial Chemicals, 31/33665 | iii


— 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.

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

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

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


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


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.

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


of Industrial Chemicals, 31/33665 | v


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.

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

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



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.


of Industrial Chemicals, 31/33665 | vii


2. Introduction to the National StandardThe 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 human health. However, prevention of chemicals being released to the environment will reduce human exposure to chemicals through the environment.

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

Management of Industrial Chemicals, 31/33665


— 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

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

Management of Industrial Chemicals, 31/33665 | 9


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 StandardThe 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 StandardThe 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 StandardThe 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 StandardThe 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 StandardAll 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 ChemicalsAs 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 (Figure1) 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 Standard6.1 A Brief History of the ReformsIn 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 StatementA 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. 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.

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


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 PaperThe 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 PaperIn 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.




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)

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

Industrial Chemicals, 31/33665 | 19


— 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)

— 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 ChemicalsAll 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

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



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 chemicalIf 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 ArticlesGenerally, 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 considerationsEnvironmental 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.




7.7 Explanation of Scheduling CriteriaScheduling 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 criteriaThe 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




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


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.pdf9 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.

10 Global Assessment of the State-of-the-Science of Endocrine Disruptors, World Health Organisation, International Programme on Chemical Safety (2012)




This category currently includes:

— 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?

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

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 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.

If the answer to this question is ‘yes’, then the substance is recommended for 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 substancesThe 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 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 productsSome 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 substancesBioaccumulation 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.

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∨BAF=CtCwL/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 SubstancesToxic 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:

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.

11 The Environmental Risk Assessment Guidance Manual for Industrial Chemicals can be found at http://www.scew.gov.au/resource/chemical-risk-assessment-guidance-manuals





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 CategorisationAs 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 ClassificationThe 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

H420Harms 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 IntroductionEach 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 MeasuresThe 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 measuresThe 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 requiring that hazardous by-products or residues are not discharged to the environment, using measures that are practicably achievable.

12 EPA Victoria (2013) Demonstrating Best Practice, Publication No. 1517




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 MeasuresThe 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 measuresGeneral 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.




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





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.

GU_2.6 This is a general requirement applicable to manufacturers and industry that store, handle and 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.

GU_2.7 This is a general requirement applicable to manufacturers and industry that store, handle and 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 containmentRisk 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


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.





Identifier Comment

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.

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 disposalIn 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

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,





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 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 watersThe 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


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.

Do not release the chemical 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.

Do not release the chemical substance to freshwater at a concentration greater than [x concentration].

W_1.3 This measure is applicable where the discharge relates to a particular surface water body, or it is necessary to specify different discharge criteria freshwaters.

Do not release the chemical substance to estuarine waters at a concentration greater than [x concentration].

W_1.4 This measure is applicable where the discharge relates to a particular surface water body, or it is necessary to specify different discharge criteria for estuarine waters.

Do not release the chemical 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.

Do not release the chemical substance to marine water [above its limit of quantification].

W_1.6 This measure is applicable where the discharge relates to a particular 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.

Do not release the chemical substance to freshwater [above its limit of quantification].

W_1.7 This measure is applicable where the discharge relates to a particular 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.

Do not release the chemical substance to estuarine water [above its limit of quantification].

W_1.8 This measure is applicable where the discharge relates to a particular estuarine surface water body, or it is necessary to specify different discharge criteria for different types of estuarine 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.

Do not release the chemical substance into marine water which has a pH value [greater than/less than/equal to pH value].

W_1.9 This measure is applicable where the hazardous characteristics of the chemical are dependent on the properties of the receiving marine water that can affect speciation and toxicity (generally pH).

Do not release the chemical substance into freshwater which has a pH value [greater than/less than/equal to pH value].

W_1.10 This measure is applicable where the hazardous characteristics of the chemical are dependent on the properties of the receiving freshwater body that can affect speciation and






toxicity (generally pH).

Do not release the chemical substance into estuarine water which has a pH value [greater than/less than/equal to pH value].

W_1.11 This measure is applicable where the hazardous characteristics of the chemical are dependent on the 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 %].

W_1.12 This measure is applicable where the chemical may degrade and cause oxygen depletion

Do not release the chemical into freshwater where it will result in a reduction of Dissolved Oxygen of greater than [x %].

W_1.13 As W_1.12

Do not release the chemical into esturine water where it will result in a reduction of Dissolved Oxygen of greater than [x %].

W_1.14 As W_1.12

Do not release the chemical substance to waterways that discharge into a high ecological value aquatic system.

W_1.15 This measure is applicable where the 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.

Do not release the chemical 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

W_1.17 This measure is applicable where the release of a chemical to a particular aquatic high ecological value system






system [above x concentration]. may occur, such as through drilling operations or sewerage operations, and where the acceptable 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

Do not release the chemical substance to groundwater with a concentration greater than [x 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.

Do not permit the chemical 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.

Do not permit the chemical substance to spread beyond [x distance] from the source of injection in groundwater.

W_2.4

This measure can be achieved by limiting the injection of the chemical 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.

Do not release the chemical substance to groundwater which has a pH value [greater than/less than/equal to pH value].

W_2.6 This measure is applicable where the hazardous characteristics of the chemical are dependent on the properties of the receiving groundwater that can affect speciation and toxicity (generally pH).

Do not release the chemical 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 landThe 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

Do not apply the chemical substance to 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

L_1.3 This measure is applicable where the release of a chemical to a particular terrestrial area of ecological significance




Risk Management Measures Identifier Explanatory comment

concentration]. may occur, such as through distribution of biosolids, and where the acceptable 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 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.

Do not apply the chemical substance to 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 airThe 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

Do not release the chemical 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.

Do not release the chemical 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.

Do not release the chemical substance to air during periods of

A_1.4 This is to protect sensitive receptors that are located in a particular direction




[high/low] winds and where winds are [above x speed/below x speed].

from the source of chemical use

Do not release the chemical to air when the direction of the wind is toward a sensitive aquatic or terrestrial ecosystem within [x distance] of the release zone [and the wind is greater than x speed]

A_1.5 As A_1.4

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 SchedulesAs 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 MeasuresThe 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 scheduling10.1 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.




10.2 Environment Schedule 1 Chemical SubstanceChemical 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.




10.3 Environment Schedule 2 Chemical SubstanceChemical 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]




10.4 Environment Schedule 2 Chemical SubstanceChemical 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]




10.5 Environment Schedule 3 Chemical SubstanceChemical 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].




10.6 Environment Schedule 4 Chemical SubstanceChemical 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 SubstanceChemical 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 DocumentsSome 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 ANZECCThe 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.




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 MeasuresThe 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 PrinciplesRisk 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 SAICMThe 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 OECDAustralia 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 CanadaThe 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 advising the Canadian

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


federal government on activities under the Act and on cooperative, coordinated approaches to the management of toxic substances.

11.2.4 European UnionIn 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 AmericaThe 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



DRAFT

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



DRAFT

— 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 StandardNote: Areas outside the yellow background are outside scope of this paper.

DRAFT

12.1 Convention ChemicalsChemicals 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.



DRAFT

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 DecisionThe 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.



DRAFT

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 AssessmentRisk 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



DRAFT

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 RecommendationsRisk 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 CommitteeThe 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 CommitteeThe 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.



DRAFT

— 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 MeetingsThe 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 MembershipThe 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 InterestAll 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 ChairThe 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 ResignationAppointed 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 RemunerationThe 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 OutcomesAll 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,



DRAFT

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 impactsThe 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 MakerThe 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 AdministrationThe 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.



DRAFT

13. References

Arnot JA and Gobas FAPC (2006). A review of bioconcentration factor (BAF) assessments for organic chemicals in aquatic organisms. Environment Reviews, 14, pp 457-297.

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.



http://www.epa.gov/oppt/exposure/pubs/episuite.htm

http://www.epa.gov/scipoly/sap/meetings/2008/october/methodology.pdf

http://www.unece.org/?id=3623

http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html

http://www.oecd-ilibrary.org/environment/oecd-series-on-testing-and-assessment_20777876

http://www.oecd-ilibrary.org/environment/oecd-series-on-testing-and-assessment_20777876

http://oasis-lmc.org/



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.



http://www.epa.gov/oppt/newchems/tools/21ecosar.htm

DRAFT

