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The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is the Australian government’s regulatory body for industrial chemicals. NICNAS is designed to help protect workers, the public and the environment from the harmful effects of industrial chemicals. It does so by making risk assessment and safety information on chemicals widely available and providing recommendations for safe use.

History

Despite an extensive history of chemical manufacture, use, import and export, it was not until the advancement in manufacturing technologies and processes in the mid 20th century, that the value of chemical assessment and regulation was fully realised. Industrial chemical assessment and regulation is still a relatively new phenomenon for many governments including Australia since they were not subject to governmental review that other types of chemicals (e.g. pesticides and pharmaceuticals) were prior to the establishment of the Acts listed in the below.

In 1989, the Australian federal government enacted the Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act), which led to the establishment NICNAS in 1990. Since then, the Australian government has continued to improve the assessment, regulation and management of industrial chemicals for the protection of human health and safety.

The Rio Earth Summit in 1992 marked Australia’s commitment to the development of Chemwatch1992, marked by the Rio Earth Summit, in 1998 saw Australia's commitment to the development of Chemwatch, the Federal Government has adopted significant changes in chemical assessment regimes and management. They incorporate; the development of a National Profile of Chemical Management Infrastructure and remodelling of chemical assessment regimes under cooperative agreements with New Zealand, Canada and the United States.

Organisation

Structure of organisation

The structure of NICNAS is a direct reflection of its function. The Director of NICNAS is also the Parliamentary Secretary to the Minister of Health and Ageing. The Director is also a member of numerous committees in order to consult and discuss with relevant industries, key groups and the community to ensure that all are informed and practices comply with standards and regulations set out by NICNAS.

The organisations’ activities flow into three key areas including: business and communication strategy; regulatory strategy; and scientific strategy. Each branch has specific responsibilities that focus on its own area, but retain a certain level of transparency to ensure that all groups work cohesively. Business and communication focuses on office management, finance, corporate governance and media. The regulatory arm concentrates on compliance reporting and reforms. The scientific branch is responsible for notification and assessment, review and treaties, as well as rapid risk assessment.

Another pivotal responsibility of NICNAS is cohesion of Australian legislative measures with international regulations

Scope and funding

All NICNAS activities are funded by the fees charged for the registration of new and existing industrial chemicals as well as the fees and administration charges for the assessment of chemicals. The administration fees and charges are outlined in the cost recovery policy as set out by the Department of Finance and Deregulation.

The recovery cost policy is based on three tier system where the administration charge is fixed for all chemicals being assessed, however, the charge for assessment of a new chemical is based on a formula: 75% Wage Price Index/ 25% Consumer Price Index6.

Legal authority

NICNAS administers the ICNA Act, as well as the Industrial Chemicals (Notification and Assessment) Regulations 1990 and the Cosmetics Standard 2007. The ICNA Act provides a number of enforcement powers to NICNAS (see “Enforcement Powers”).

Objectives

The objectives of the NICNAS are to provide a national assessment and notification scheme for the following purposes:

• Assisting in the protection of the Australian people and the environment from the harmful effect of industrial chemicals,

• Offering information and making recommendations about chemicals to workers, industry, the community and other regulatory agencies,

• Providing effect to Australia’s obligations under international agreements relating to the regulation of chemicals

• Assembling statistics in relation to chemicals.

Functions and powers

NICNAS’ purpose is to help protect workers, the public and the environment from the harmful effects of industrial chemicals. It does so by providing a national system of notification and assessment of industrial chemicals, as well as publicising risk assessment, safety information and recommendations for safe use of industrial chemicals. NICNAS also informs importers and manufacturers of their responsibilities under the Industrial Chemicals (Notification and Assessment) Act 1989 ("the ICNA Act").

Chemical Regulation

The chemical properties and potential health and environmental effects of any new chemical must be notified to and assessed by NICNAS before it is introduced to Australia. Chemicals currently used in Australia are also reviewed (priority industrial chemicals) and any person may nominate an industrial chemical for assessment. NICNAS then makes this information widely available to the public and industry through its website and publications.

The Australian Inventory of Chemical Substances

The current Australian Inventory of Chemical Substances (AICS) was formed under the Industrial Chemicals Act 1989. Its first manifestation was as the Australian Core Inventory of Chemical Substances in 1984. The AICS is a list of all industrial chemicals used in Australia between 1 January 1977 and 28 February 1990, as well as any additions or corrections to the list since. The AICS is maintained by NICNAS and contains over 38,000 chemicals. Any industrial chemical listed on the AICS is regarded as an ‘existing’ industrial chemical. Any industrial chemical not listed on the AICS is regarded as a ‘new’ industrial chemical.

Risk Assessment and Management

NICNAS conducts two types of risk assessment: quantitative (to measure the risk posed by an existing chemical) and qualitative (to describe the risk posed by a new chemical). NICNAS assessment reports include toxicity, environment, OHS and public health assessments. NICNAS undertakes a four-step risk assessment procedure:

• Hazard identification: determination and description of any adverse effects a substance may cause at any dose
• Hazard characterisation: evaluation of dose-response relationship for each of the adverse effects
• Exposure assessment: evaluation of exposure routes to a chemical in the environment
• Risk characterisation: interpretation and combination of the previous steps to provide a practical estimate of the risk and any limitations and uncertainties.

NICNAS then produces risk management guidelines, which are regularly reviewed. These aim to balance:

• the risk posed by a substance;
• the economic, political and social costs of implementing strategies to minimise or eliminate the identified risk;
• and the social and economic benefits of risk minimisation.

Registration

Any individual or business who wishes to import or manufacture industrial chemicals for commercial purposes must register with NICNAS, regardless of the amount or toxicity of the industrial chemical. Registration lasts for the maximum of one year from 1 September to 31 August in the following year and must be renewed each year. The registration is for the individual or business so that they may lawfully import or manufacture the relevant industrial chemical, not registration of the chemical itself. The Register of Industrial Chemical Introducers lists all of the organisations registered with NICNAS. Registration allows NICNAS to keep people and business fully informed of their legal obligations and safety information. An annual registration fee is charged, which is based on the value of chemicals imported and/or manufactured:

NICNAS Fees and Charges Registration Tier	Value of Industrial Chemicals Introduced	2010-11 Registration Cost
1	≤$499,999	$395
2	$500,000 - $4,999,999	$1,577
3	≥$5,000,000	$9,201

Industrial Chemicals

The definition of an industrial chemical is a ‘catch-all’ phrase designed to cover all chemicals other than identified exceptions. Industrial chemicals include paints, dyes, pigments, solvents, adhesives, plastics, inks and laboratory chemicals. It also includes chemicals used in mineral and petroleum processing, refrigeration, printing, photocopying, household cleaning products, cosmetics and toiletries. Products designed to dispense industrial chemicals (e.g. ballpoint pens dispense ink), articles (e.g. plastic chairs, glow sticks and photographic film) and radioactive chemicals are not included. Other chemicals outside the scope of NICNAS which are regulated by other organisations include:

• Medicines and medicinal products (Therapeutic Goods Administration)
• Pesticides and veterinary chemicals (Australian Pesticides and Veterinary Medicines Authority)
• Food or food additives. (Food Standards Australia New Zealand)

A chemical may have multiple uses. So long as one of those uses is industrial, the person or organisation importing or manufacturing the chemical must be registered with NICNAS. For example, ethylene oxide is used industrially to produce other chemicals and as a fumigant in agricultural products.

Commercial purpose

NICNAS registration is required only when the industrial chemical(s) is to be used for commercial purposes. A commercial purpose includes any use or sale by a business. Non-commercial purposes include personal use, non-profit research, charity, and teaching.

Compliance

NICNAS ensures that importers, manufacturers and exporters of industrial chemicals are aware of and exercise their obligations under the ICNA Act. These include: the registration of industrial chemical importers and manufacturers; chemical-specific obligations associated with new and existing chemicals; and obligations on exporters under international treaties. NICNAS encourages voluntary compliance by industry but also has extensive enforcement powers to ensure compliance.

Enforcement Powers

Informal enforcement powers

NICNAS’ focus on cooperating with industry allows for informal enforcement actions. NICNAS’s enforcement policy states that such actions may be taken where:

• non-compliance was inadvertent and not deliberate;
• it was the first instance of non-compliance;
• the person or business cooperates with NICNAS to with the Act; and/or
• informal action provides adequate deterrence.

Formal enforcement powers

The ICNA Act provides a number of formal enforcement powers to NICNAS:

• the Director may request and gather information as well as revoke permits and certificates;
• Inspectors may search premises to monitor compliance or in relation to a suspected breach of the ICNA Act either by consent or with a warrant;
• Inspectors may seize samples of substances, photograph the premises and inspect and copy records;
• Inspectors may require persons to answer questions and produce any documents or records; and
• NICNAS may apply for an injunction to stop an unregistered importer or manufacturer from introducing any industrial chemicals.

A person found in breach of the Act will be liable for fines of up to $33,000 for an individual and $165,000 for a company. Italic text

Reforms and Consultations

NICNAS has conducted a number of reforms and consultations across a wide range of industrial chemicals. NICNAS aims to maintain an open and transparent system to uphold existing health and safety and environmental standards.

Existing chemicals program

NICNAS has implemented reforms to its Existing Chemical Program (ECP). NICNAS works with similar regulatory agencies in other countries by exchanging information, in an effort to speed up processes, cut duplication and to reduce the costs of assessing chemicals. A review of the ECP was undertaken from 2003-06, following concerns the program was not assessing chemicals in the most efficient manner. Implementations of recommendations from the review commenced in 2007 and are ongoing.

Publications

NICNAS supplies chemical safety information free of charge to a variety of stakeholders, through a variety of mechanisms. The three major publications are the NICNAS Handbook, the Chemical Gazette, and the NICNAS Annual Report. Other publications include chemical assessment reports, information sheets, safety sheets, chemical alerts, guidance notes, newsletters, surveys and brochures. NICNAS maintains a website which makes all of these publications readily available.

NICNAS Handbook

The NICNAS Handbook for Notifiers(1) is compiled to assist all Australian manufacturers and importers to comply obligations under the ICNA Act.

The Chemical Gazette

Companies, organisations, government departments and individuals may subscribe to the Chemical Gazette(12), a monthly publication to update all readers about the latest changes made to the NICNAS legislation, highlight newly assessed chemicals and updates in Register of Industrial Chemical Introducers.

Annual Report

Every year an annual report is generated in accordance with Section 108 of the ICNA Act(13). The annual report is a constructed overview of the achievements and performance of NICNAS composed by the Director and the corporation. A collection of every published report can be viewed on the NICNAS website

NICNAS Matters e-newsletter

NICNAS Matters e-letters(14) are a means of communication to all members of the public. It is published electronically for easy access to address:

• All recent amendments related to industrial chemicals
• National and International events NICNAS is or have been involved in
• Upcoming events and seminars
• A community section for staff news and
• Summaries and links to any recent publication.

International

International forums

It soon became evident among nation states that transparency of chemical regulation was necessary. In order to conform to the established national chemical assessment and labelling regimes and ensure the protection of human health and safety, as not all nations had the infrastructure to assess, regulate and monitor the use of certain industrial chemicals. Hence, at the United Nations Conference on Environment of 1992, Agenda 21 was born. Agenda 21 contained two major directives (of both which NICNAS participated) that would lead to future programs for cooperation and transparency 3. They were the establishment if the Intergovernmental Forum for Chemical Safety (IFCS) and the outline of programs in Chapter 19. The former promoted access and availability of industrial chemical information and risk assessment regimes, allowing for the establishment of channels of communication between participating nations. NICNAS had also participated in and contributed to many initiatives outline within Chapter 19. They incorporated the OECD High Production Volume Program; prepared assessments for the Concise International Chemical Assessment Documents; committed to negotiations for an agreement for Global Harmonisation Strategies and where possible utilised OECD SIDS Initial Assessment Reports when conducting a Priority Existing Chemical Assessment3. An important forum for Australia is the APEC Chemical Dialogue (CD) and Regulatory Forum, as it focuses on industry chemical trade challenges and the adoption of workable chemical regulation practices in the Asia-Pacific region.

Bilateral works

There are numerous bilateral cooperative arrangements between NICNAS and similar organisations of other nations that were ratified for the ultimate purpose of cooperative and global harmonization of chemical assessment and regulation. They include:

• Memorandum of Understanding with Environmental Risk Management Authority (ERMA), New Zealand; ratified 7 November, 20027.
• Department of Health of Canada and Department of Environment of Canada; ratified in 2002 and renewed in 20079.
• Cooperative Arrangement with the Office of Pollution Prevention and Toxics of the Environmental Protection Agency of the U.S.; ratified in 31 December, 2008

The predominant objectives of these arrangements collectively are:

• exchange of information on chemical management regimes
• access to reviews, assessments and data regarding relevant industrial chemicals
• implementation of consistent regulatory practices where feasible
• maintaining contact between organisations