National Standard for Environmental Risk Management of Industrial Chemicals

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

December 2015

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CONTENTS Purpose ....................................................................................................................................... 3

Overview of Timeline for Implementation ................................................................................. 4

1 Context ................................................................................................................................. 5

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

1.2 Current arrangements for managing industrial chemicals ............................................... 6

1.3 Problems with the current arrangements ........................................................................ 7

1.4 Previous Consultation .................................................................................................... 7

2 The National Standard ........................................................................................................ 8

2.1 Schedules under the Standard ....................................................................................... 8

2.2 Outcomes-based risk management conditions ............................................................. 10

2.3 Scheduling and Decision Making Process .................................................................... 11

2.4 Benefits of the National Standard ................................................................................. 13

3 Next Steps.......................................................................................................................... 15

Appendix A - Glossary of Terms ............................................................................................. 16

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PURPOSE

The Commonwealth and state and territory environment ministers have agreed to implement a National Standard to enable a nationally consistent approach to environmental risk management of industrial chemicals across Australia.

The primary purpose of this paper is 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.

This document recaps the context of the reforms to environmental risk management of industrial chemicals, including the reform parameters agreed to by Australia’s environment ministers. The paper also provides 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 Regulation Impact Statement, which has been considered by Ministers. As part of this, the paper invites preliminary feedback from industry and community representatives in response to a small number of questions posed which will help inform subsequent stages of the detailed design of the Standard and noting that further and more substantive consultation will be undertaken during 2016.

A Brief History of the reforms to establish a National Standard

In August 2008 the Australian Government’s independent research and advisory body, the Productivity Commission, released a Research Report on Chemicals and Plastics Regulation. The report highlighted a number of issues with the current Australian framework for managing risks to the environment posed by industrial chemicals. In November 2008, the Council of Australian Governments 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. The Decision RIS also detailed the impact each option would have on the community, industry and governments.

Environment Ministers from the Commonwealth and all states and territories met in July 2015 and have 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 Standard will be established by the Commonwealth and 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 enables the Commonwealth and state and territory environment agencies to commence work on the detailed design and implementation of the reforms, allowing for consultation and engagement with industry and community representatives as part of this phase. For more detailed information on the context and parameters of the reforms agreed to by Ministers, please refer to the Decision RIS1.

1 The Decision RIS is available on the Office of Best Practice Regulation website

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OVERVIEW OF TIMELINE FOR IMPLEMENTATION

The National Standard, its Schedules, criteria for chemical scheduling, decision-making and scheduling processes, and management conditions are expected to be developed in detail during 2016. The final Standard will then be considered by Australia’s environment ministers, which is anticipated to occur in late 2016.

The Commonwealth and states and territories will be actively seeking feedback and input on the design and proposed functioning of the Standard to ensure it is fit-for-purpose and to ensure the objectives of the reforms are met.

The diagram below overviews the key steps involved in the implementation of the National Standard. The shaded box in the diagram highlights where we are in the process currently, and summarises the key opportunities to have your say on the detailed design of the Standard over the coming period.

Figure 1: Timeline for the Reforms

Page 15 of this paper contains further information on how you can provide input at this stage of the process and/or if you would like to register your interest to be kept informed about subsequent consultation processes on the implementation of the Standard.

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1 CONTEXT

The sections below provide the context for reforming Australia’s approach to the management of risks to the environment posed by industrial chemicals. The context together with the case for reform, options considered and impact analysis are canvassed in the Decision RIS which can be accessed on the Office of Best Practice Regulation website for more information. Definitions for many of the terms used in this paper are included in Appendix A - Glossary of Terms on page 16 of this document.

1.1 Industrial Chemicals

Industrial chemicals have a range of uses. They are used in every workplace and household in the country. Industrial chemicals are any chemical that is not used in medicines (human and animal), pesticides, foods and food additives, or chemicals used for therapeutic reasons. Therefore, industrial chemicals are used in everything from mining and manufacturing processes, to domestic and cosmetic products. The diagram below outlines industrial chemical uses in Australia.

Figure 2: Examples of industrial chemical uses in Australia

Most industrial chemicals are not harmful to the environment or human health. However, there are some chemicals that can result in significant harm if not managed appropriately. In Australia there are examples where industrial chemicals have contaminated the environment. One historic example of this is the release of waste containing toxic chemicals, known as dioxins, into Sydney Harbour many years ago. Because of this contamination, the New South Wales government recommends that people do not eat any fish caught in waterways to the west of the Sydney Harbour Bridge.

In general, contamination occurs when chemicals are not properly managed. It may also be the case that people using the chemicals do not know the possible adverse effects they can have on the environment. The latter is the case for the contamination of Sydney Harbour.

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Removing chemicals from the environment and cleaning contaminated sites can cost hundreds of millions of dollars. Industry and governments have spent almost $200 million trying to remediate Sydney Harbour.

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 lifecycle is outlined in the diagram below.

Figure 3: Chemical lifecycle and exposure

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.

1.2 Current arrangements for managing industrial chemicals

All levels of government share responsibility for managing industrial chemical safety in Australia. The Commonwealth is responsible for undertaking national risk assessments of chemicals and setting management standards. States, territories and local governments are responsible for on the ground management of chemicals at locations such as industrial sites, sewage treatment plants and landfills.

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) aids in the protection of the Australian people and the environment by assessing industrial chemicals to identify any risks they may pose to the environment and human health. The NICNAS is a statutory scheme administered by the Australian Government Department of Health.

Following risk assessment, recommendations may be made as to the most appropriate way to manage chemicals. These recommendations are made to government agencies responsible for managing the risks. Risk management agencies (the risk managers) are responsible for reviewing and implementing management recommendations. In reviewing recommendations, risk

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managers consider the scientific evidence, as well as engineering, economic, social and political factors, when choosing options for risk management. Risk managers are also responsible for compliance and enforcement activities.

1.3 Problems with the current arrangements

The current Australian framework for managing risks to the environment from industrial chemicals is fragmented and inconsistent. The framework is generally ineffective for consistently managing hazardous chemicals. It is inefficient for businesses, difficult for the community to engage with and duplicative.

Under the current arrangements, each jurisdiction implements risk management recommendations for the environment in different ways. Some jurisdictions, for different reasons, may also choose not to manage certain chemicals. In other jurisdictions, risk management recommendations are only partially addressed. When jurisdictions decide to manage a chemical, there are often differences in their approaches. This inconsistency can be confusing and costly for businesses that operate across borders. These businesses have to abide by different rules and regulations in each jurisdiction.

The current system may also not be able to effectively protect the environment into the future. Between 25 and 45 chemicals that are newly introduced into Australia each year may have the potential to harm the environment if they are not properly managed. There are also approximately 38,000 industrial chemicals on the Australian Inventory of Chemical Substances (AICS) that are allowed to be used in Australia and have not been assessed for their risks to the environment or human health. NICNAS is leading work to review chemicals that are on the AICS. It is expected that a portion of these chemicals may require some level of management to protect the environment.

For more information on these issues, please refer to the Decision RIS.

1.4 Previous Consultation

The reform of Australia’s approach to environmental risk management of industrial chemicals has been developed in consultation with a wide range of stakeholders including governments, industry and the community, over a number of years.

A Consultation RIS was released in April 2013. PricewaterhouseCoopers facilitated public consultation. This consultation included public forums, focus groups, one-on-one meetings and written submissions. Feedback from the Consultation RIS informed development of the Decision RIS. The feedback received on the Consultation RIS resulted in the proposal to develop a National Standard, canvassed in detail in the Decision RIS. The Decision RIS was developed in cooperation with states and territories and with ongoing engagement with industry.

The process for assessing the risks of chemicals at the Commonwealth level is also currently under review. The risk assessment reforms are being led by NICNAS. The Department of the Environment is working closely with NICNAS to ensure the objectives of both reforms are met and to ensure they are implemented in an integrated manner. For more information on these reforms, please see the NICNAS website.

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2 THE NATIONAL STANDARD

This section outlines, at an overarching level, the proposed design of the National Standard and associated processes, consistent with the information and policy intent set out in the Decision RIS agreed to by Environment Ministers. Initial feedback is invited in relation to aspects of the Standard that will assist with more detailed design and inform subsequent consultation opportunities.

The National Standard, or Australian Chemicals Environment Standard (ACE Standard), as it is currently proposed to be known, will enable a nationally consistent approach to managing the risks that industrial chemicals may pose to the environment. The ACE Standard will address the problems with the current framework to manage chemical risks. The ACE Standard will outline a single, national decision on the management of risks that a chemical poses to the environment. The objectives of implementing the ACE 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 ACE Standard will consist of a number of groups (Schedules) into which chemicals can be categorised. This concept is similar to other chemical management regimes such as the Standard for Uniform Scheduling of Medicines and Poisons that is in place to protect public health. Industrial chemicals will be assigned to a particular Schedule under the ACE Standard based on their level of concern to the environment. Determining the level of concern that a chemical poses to the environment involves consideration of the harm that the chemical could cause to the environment (hazards), the likelihood the chemical will cause harm from its use (risk), and any other relevant impacts the chemical’s use may have on society (socio-economic considerations). To prevent significant harm to the environment, management responses for chemicals of concern will be proportionate and appropriate.

Each Schedule under the ACE Standard will outline a set of conditions that describe how chemicals in that Schedule should be managed. Not all conditions will be appropriate for every chemical in the Schedule. Therefore, along with a Schedule recommendation, a risk assessment report will also recommend the most appropriate management conditions for the chemical. The aim of having management conditions is to prevent chemicals being released to the environment at levels that could cause harm to the environment. Conditions for the management of chemicals in each Schedule will be publicly available.

Chemicals that are of high concern to the environment will have more stringent requirements for management compared to chemicals of lower concern to the environment, which may not need any management. This is because release of higher concern chemicals could cause significant and long-lasting harm if released to the environment.

Further details of the ACE Standard and preliminary proposals for the Schedules and categorisation processes are outlined below.

2.1 Schedules under the Standard

The ACE Standard includes three general categories– High, Intermediate and Low Concern. These categories are proposed to be broken down into a number of discrete Schedules.

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The level of concern a chemical poses to the environment, and therefore the likely level of risk management required, increases proportionately from Schedule 1 to 8. Schedules 1 and 2 are proposed to be for Low Concern chemicals. Schedule 3, 4, 5 and 6 are proposed to be for Intermediate Concern chemicals. Schedule 7 and 8 are for High Concern chemicals.

Based on a review of the chemicals that have previously been introduced into Australia and the chemicals on the Australian Inventory of Chemical Substances, the majority of chemicals introduced into and used in Australia each year are expected to be Low Concern chemicals. Very few chemicals are High Concern chemicals.

Although Low Concern chemicals will require minimal (or no) risk management, it is intended that they will still be Scheduled under the ACE Standard. This will improve transparency and allow businesses and the community to identify chemicals that have been determined to be Low Concern to the environment. This information is intended to support businesses and the community to make informed decisions about the chemicals and products they use and buy.

The diagram below provides an indicative overview of the ACE Standard and Schedules. A Discussion Paper for more detailed consultation and feedback is due for release in March 2016. The Discussion Paper will outline the ACE Standard in more detail and seek input on the development of risk management conditions for each of the Schedules.

Figure 4: Indicative presentation of the Schedules under the ACE Standard

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Chemicals will be scheduled under the ACE Standard based on their concern to the environment for a particular use and volume. Therefore, a chemical with several different uses and different assessed risks may be assigned to different Schedules. To help businesses and the general public engage with the Standard, the following information will be published in a database online:

• The chemical name/identifier

• The Schedule the chemical is assigned to

• The risk management conditions applicable for the chemical’s use

• The use of the chemical as published in the NICNAS risk assessment

• The volume of the chemical as published in the NICNAS risk assessment

• The chemical hazards, if any, as published in the NICNAS risk assessment

• The date of the decision

• Any other key information that led to the decision.

Businesses and the public will be able to use this information to better understand risks chemicals may pose to the environment from their use and the management of chemicals in Australia. Businesses will also be able to use the information to make informed judgements about chemicals they use and possible scheduling outcomes based on the scheduling of similar chemicals.

Section 2.1 - We welcome your initial feedback

Q 2.1 – 1. A list has been provided above that outlines the information that will be publicly available along with a scheduling decision. Is there any other relevant information that should be made publicly available regarding a decision under the ACE Standard?

Q 2.1 – 2. More detail will be provided regarding criteria for scheduling in a Discussion Paper that will be released in March 2016. Are there any initial comments you would like to make on the proposed Schedules outlined under the Standard, noting these may change during the development of appropriate management conditions?

Q 2.1 – 3. Are there any comments you would like to provide on the proposed name of the National Standard, that is, the Australian Chemicals Environment Standard?

2.2 Outcomes-based risk management conditions

The ACE Standard will specify risk management conditions that are outcomes-based but remain specific enough to be achievable and measurable. Outcomes-based conditions outline the end result that a person or business must achieve. Examples of possible outcomes-based conditions are:

• Do not dispose of the chemical to sewer in concentrations greater than [x units]

• Do not allow wildlife to access the chemical in concentrations greater than [x units]

• Do not release the chemical directly to surface waters

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Outcomes-based conditions under the ACE Standard, whilst outlining the end result that a person or business must achieve, are intended to be measurable, achievable and relevant. Outcomes-based conditions will allow businesses to determine how best to meet the required environmental outcome for a particular chemical. This approach encourages innovation and allows businesses to identify the most cost-effective solution for their situation.

For example, a chemical condition stating that a chemical is not to be disposed to sewer in concentrations greater than [x units] is the outcome that needs to be achieved. Businesses will need to determine ways to ensure that the maximum concentration that enters the sewer is not greater than the specified value. There may be a number of approaches that businesses could use to achieve this limit. This is in contrast to outlining exactly how a chemical should be treated to achieve this concentration limit.

Each Schedule under the ACE Standard will contain a number of different chemicals. There are likely to be some differences in these chemicals both in terms of their characteristics as well as how they are used. Risk management conditions for each chemical will be chosen from a list of standardised conditions for each Schedule following the risk assessment. While the conditions under the ACE Standard will be standardised, flexibility will be retained to include specific details based on the risk assessment, as is the case with the examples given in the first two dot points above.

Risk management conditions will be developed with the support of an independent expert consultant. The consultant will develop the conditions in cooperation with the Commonwealth, state and territory governments. The consultant will also engage businesses and the community during the development of these conditions.

2.3 Scheduling and Decision Making Process

The intended scheduling and decision-making processes under the Standard are outlined in the diagram below.

Figure 5: Scheduling and Decision Making Processes

NB: Requests for review by the Advisory Committee can be made by industry, the community, governments or the Decision Maker.

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2.3.1 Risk Assessment

NICNAS will continue to be responsible for risk assessment of industrial chemicals. Only chemicals with a completed environmental risk assessment will be scheduled under the Standard. Once an assessment is complete, a recommendation for the most appropriate Schedule and risk management conditions for the chemical will be made. Recommendations will be based on the chemical’s properties, hazard characteristics and release of the chemical to the environment. Recommendations will be made using a set of predefined criteria that will be publicly available and have regard to the legislation under which NICNAS operates.

2.3.2 Consultation

The consultation period for the ACE Standard will integrate with the NICNAS consultation process. The NICNAS processes are currently the subject of public consultation as part of the NICNAS reforms. Recommendations can be considered during the consultation period. If the recommendations are not consistent with the criteria for scheduling, or they are not appropriate for the chemical, a request can be made for the risk management approach to be reviewed by the Advisory Committee.

2.3.3 Advisory Committee

The ACE Standard will have an Advisory Committee made up of independent experts proposed to be in the fields of industrial chemistry, ecotoxicology, ecology, environmental risk management, policy and/or social and economic impacts of chemical use. The Advisory Committee is proposed to be appointed by the Federal Environment Minister or their delegate. The Advisory Committee will review risk management approaches for all chemicals recommended for the High Concern Schedules. High Concern chemicals may need more bespoke risk management approaches taking into account social and economic impacts of their use in Australia. The Advisory Committee will recommend scheduling and management conditions to the Decision Maker for these chemicals. To streamline scheduling of chemicals under the ACE Standard, the Advisory Committee will not review Low and Intermediate Concern chemicals unless a formal request to do so is made by industry, governments or the community. The Advisory Committee will also review any chemical if requested by the Decision Maker.

The Advisory Committee is expected to meet four times per year on specified dates, likely to be in the middle of each financial quarter. Therefore, chemicals reviewed by the Advisory Committee may take up to four months to schedule under the ACE Standard. If there are no chemicals that need to be reviewed by the Advisory Committee, they will not meet.

Section 2.3 – We welcome your initial feedback

Q 2.3 – 1. Are there any other areas of expertise that may be useful to include on the Advisory Committee?

2.3.4 Decision Maker

The Decision Maker for the ACE Standard is intended to be a delegate of the Federal Environment Minister. The Decision Maker makes the final decision on all chemicals scheduled. The Decision Maker will also have the power to request that risk management recommendations are reviewed by the Advisory Committee and the power to amend the management conditions under the ACE Standard.

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For chemicals that have a completed risk assessment, it is proposed that the Decision Maker will consider chemicals for scheduling once per month. Chemicals will likely be sent to the Decision Maker on the first of each month, or following business day. A decision on chemical scheduling will be made within two weeks of receipt by the Decision Maker. Therefore, chemicals not reviewed by the Advisory Committee may be scheduled in less than 45 days following completion of the risk assessment.

Mechanisms will be in put in place to enable scheduling decisions to be reviewed.

2.3.5 Implementation

After a decision has been made, chemicals will be scheduled under the ACE Standard. The ACE Standard will record all scheduling decisions and management conditions.

In line with the agreement of Ministers on the Decision RIS, jurisdictions will adopt and implement scheduling decisions under the ACE Standard. Jurisdictions will give effect to these decisions by referencing the Standard in their own legislation. They will be responsible for compliance and enforcement of activities conducted in their jurisdictions.

2.3.6 Secretariat

A Secretariat within the Australian Government Department of the Environment will manage the daily operation of the ACE Standard and ensure information is efficiently disseminated to the Advisory Committee and the Decision Maker. The Secretariat will also be the point of contact for industry and the public.

2.4 Benefits of the National Standard

2.4.1 Benefits to the Community

As noted in the Decision RIS, the ACE Standard will benefit the community in the following ways:

• Improved protection of the environment from harmful chemicals

• Improved protection of human health from reduced risk of exposure to chemicals

• Reduced risk of contamination of the environment from harmful chemicals in urban and regional areas

• Improved general awareness of chemical use and impacts on the environment

• Improved access to information allowing the general public to make informed decisions regarding chemical use

2.4.2 Benefits to Industry

As noted in the Decision RIS, the ACE Standard will benefit businesses in the following ways:

• Improved transparency and predictability: Greater access to information will allow businesses to make informed decisions regarding chemical use and management

• Reduced administrative and compliance costs: It is intended that businesses will only need to understand one approach to risk management rather than up to eight different requirements across all jurisdictions

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• Streamlined scheduling and decision-making process that support clarity and prevent significant delays in time to market

For a full summary of all impacts, including expected costs and benefits of the reform for government, industry and the community, please see the Decision RIS.

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3 NEXT STEPS

The Standard and associated processes will be developed in detail during 2016. If you would like to continue to be engaged during the design phase of the process, please note your interest and provide your contact details in the Cover Sheet with your submission (refer to the Department’s website for further details) or email Chemicals.Management@environment.gov.au.

The table below outlines the indicative dates and key milestones for implementation of the ACE Standard.

Table 1: Key dates for implementation of the Standard

Key Dates Milestones

December 2015 Consultant to be engaged to develop the risk management conditions under the Standard.

5 February 2016 Due date for any feedback you wish to provide on this Paper

March 2016

A Discussion Paper will be released for interested stakeholders to comment. The Paper will include a detailed design of the Standard, the Schedules, criteria for scheduling chemicals under the Standard, and the processes for scheduling and decision-making. The paper will also seek input on risk management conditions appropriate for each Schedule.

March to August 2016

Meetings and discussions with key stakeholders will be held regarding the design of the Standard and the risk management conditions that will be associated with each of the Schedules.

April 2016 Workshop(s) on the design, processes and management conditions under the Standard will be held for stakeholders to coincide with the release of the Discussion Paper.

July 2016 Public release of a draft report outlining proposals for the final design of the Standard and associated processes. Feedback will be invited on the report before it is finalised.

August 2016 Due date for submissions on the draft report outlining the design of the Standard

Late 2016 Final Standard considered by Environment Ministers

2017 - 2018 Drafting and enactment of Commonwealth, state and territory legislation for the Standard; Preparations made for the commencement of operations of the Standard

2018 The Standard is expected to be in full operation in all jurisdictions

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APPENDIX A - GLOSSARY OF TERMS

ACE Standard A standard is a set of established requirements in relation to, in this case, environmental risk management of industrial chemicals. The ACE Standard will establish a standard set of risk management conditions for industrial chemicals according to a chemical’s level of concern to the environment.

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 approved for use 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.

Decision Maker The person with responsibility for scheduling or listing decisions made under the ACE Standard and the risk management conditions assigned to an assessed industrial chemical. The Decision Maker is proposed to be the delegate of the Federal Environment Minister.

Exposure (environmental)

Exposure is the amount of chemical released to the environment and the route by which it is released. Environmental exposure assessments in assessments prepared by NICNAS 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

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have the potential to affect organisms. The three main steps to an exposure assessment are;

• Release estimation

• Consideration of the environmental fate and partitioning behaviour

• Derivation of a predicted environmental concentration.

Additional information on environmental exposure assessment is presented in the Environmental Risk Assessment Guidance Manual for Industrial Chemicals2.

Hazard (environmental)

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, unless new data becomes available.

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.

Risk (environmental) Risk is the likelihood that the hazard will be capable of causing harm to the environment. 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 = Hazard × Exposure

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

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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 management Risk management refers to the process by which policy actions are chosen to control hazards identified in the risk assessment stage. Risk managers consider the scientific evidence and risk estimates – as well as economic, social and political factors – in evaluating options for risk management and choosing one of those options.