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Office of Chemical Safety

The Office of Chemical Safety (OCS) is responsible for human health risk assessment policy and practice for veterinary medicines and pesticides. OCS is responsible for ensuring that Australia fulfils its obligations under international agreements relating to the regulation of chemicals and for collecting statistics about chemicals.

Assistant Secretary - Graeme Barden

The Office of Chemical Safety (OCS) is responsible for human health risk assessment policy and practice for veterinary medicines and pesticides. OCS is responsible for ensuring that Australia fulfils its obligations under international agreements relating to the regulation of chemicals and for collecting statistics about chemicals.

The OCS is responsible for:

• using robust science to monitor developments, provide policy advice and regulate to address threats to human health posed by chemical and biological health risks;
• providing human health risk assessment advice to Australian regulators regarding pesticides and veterinary chemical products in order to protect the health of people using or otherwise exposed to these chemicals;
• supporting the regime of scheduling medicines and poisons, which ensures a uniform system for the classification of medicines, agricultural and veterinary and other chemicals, in the interests of public health and safety;
• regulating the import, export, and manufacture of controlled drugs and chemicals to fulfil Australia’s obligations under international treaties and national legislation;
• implementing relevant COAG reforms related to the Productivity Commission’s Research Report on Chemicals and Plastics Regulation and managing a Better Regulation Ministerial Partnership to review the National Industrial Chemicals Notification and Assessment Scheme; and
• liaising with the Standing Committee on Chemicals on chemical regulation.

Agricultural and Veterinary Chemicals Assessment Team

• providing scientific assessment services for new and existing pesticides and veterinary medicines to the Australian Pesticides and Veterinary Medicines Authority (APVMA), the scheduling delegates, the Advisory Committee for Chemicals Scheduling (ACCS) and the Advisory Committee for Medicines Scheduling (ACMS);
• establishing and updating appropriate public health standards for pesticides and veterinary medicines, including Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) limits;
• establishing and updating first aid instructions, warning statements and safety directions, which communicate the hazards, precautions and protective equipment that are appropriate for pesticides and veterinary medicines and which are printed on product labels;
• providing advice to the APVMA on adverse experience reporting schemes for pesticides and veterinary medicines;
• providing advice to international agencies on best-practice toxicological and occupational health and safety assessment guidelines; and
• providing human health and safety advice and assessment services to other areas of the Department and other portfolios in the Australian Government, such as the National Health and Medical Research Council (NHMRC).

Scheduling Secretariat and Chemical Policy Section

Chemical Policy

The Chemical Policy sub-section

• provides chemical policy advice to the Department and government stakeholders;
• provides policy advice to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS);
• provides policy advice on the new national arrangement for medicines and poisons scheduling;
• contributes to national public policy on such matters as the implementation of the Globally Harmonised System of Chemicals Classification and Labelling (GHS) and review of the National Registration Scheme; and
• supports portfolio representation on the Standing Committee on Chemicals.

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Scheduling Secretariat

Scheduling is designed to prevent or minimise the potential for harm to the community from exposure to chemicals and medicines by regulating the supply of and access to these substances. Until 30 June 2010 scheduling decisions were made by the National Drugs and Poisons Schedule Committee (NDPSC), an independent expert committee. With the implementation of revised scheduling arrangements commencing 1 July 2010, the power to make scheduling decisions has been conferred on the Secretary of the Department of Health and Ageing, or delegate(s).

The revised arrangements also established two expert advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), to provide recommendations to the delegate, in relation to the scheduling of medicines and chemicals, respectively. The ACMS and ACCS also provide advice to the Delegate in relation to restrictions to be imposed in respect of particular substances and to any other matter referred to it by the Delegate.

The OCS provides the Secretariat for the scheduling function. The Secretariat provides technical and administrative support to the scheduling delegates, the ACCS and the ACMS, and maintains the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Although each Australian state and territory has its own legislation governing certain matters relating to medicines and chemicals (such as where consumers may purchase a particular medicine or chemical, or how a particular medicine or chemical product is to be packaged and labelled), the vast majority of medicines and chemicals are classified by state and territory governments in accordance with the SUSMP. This means that a uniform national approach to the scheduling of substances and to labelling and packaging requirements can be achieved.

Medicines and chemicals are classified according to the Schedules in which they are included. A number of factors are considered in the scheduling of substances, including:

• potential for abuse;
• safety in use;
• legitimate need for the substance; and
• the extent and pattern of use of the substance.

The ACCS and the ACMS operate under the Therapeutic Goods Act 1989 (as amended) and the Therapeutic Goods Regulations 1990 (as amended). Further information regarding the scheduling of medicines and chemicals is available from the TGA website.

Standard for the Uniform Scheduling of Medicines and Poisons

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) contains the decisions of the Delegate regarding the classification of chemicals and medicines for inclusion in relevant state and territory legislation. It also includes model provisions about containers and labels, a list of products for which exemptions from those provisions is recommended, and recommendations about other controls on medicines and chemicals.

The SUSMP is presented with the aim of promoting uniformity in the scheduling of substances and in labelling and packaging requirements throughout Australia.

Further information regarding the SUSMP is available from the TGA website.

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Drug Import/Export Licensing and Compliance Section

The Treaties and Compliance Section administers a legislatively-based control regime for licit drugs covering border controls, manufacture and domestic transactions. The section is responsible for granting permits and licenses that authorise the import and export of certain narcotic drugs, psychotropic substances, precursor chemicals, antibiotics and androgenic/anabolic substances controlled under the Customs (Prohibited Imports) Regulations and Customs (Prohibited Exports) Regulations.

The section also collects data relating to domestic drug movements, manufacture and consumption from which it produces reports for state/territory governments and to meet Australia's obligations to the United Nations International Narcotics Control Board.

Chemical and Plastics Regulatory Reforms Taskforce

The time-limited Chemicals and Plastics Regulatory Reforms Taskforce has been established to support a review that will investigate how regulatory settings may be improved to enhance both the competitiveness of the Australian chemical industry and public health and environmental outcomes.

The review will include, but is not limited to, assessing and making recommendations in relation to:

• the role and functions of the National Industrial Chemicals and Assessment Scheme (NICNAS) as set out in the Industrial Chemicals (Notification and Assessment) Act 1989 and the extent to which they adequately reflect stakeholder expectations and international best practice, having regard to the broader context of chemicals regulation in Australia;
• the governance and consultation arrangements of NICNAS and the extent to which they support the effective delivery of NICNAS’ functions;
• the efficiency and effectiveness of NICNAS’ operating arrangements and business processes, with particular regard to the protection of human and environmental health, the management of risk, and compliance costs for business; and
• any implications for the resourcing of functions currently cost recovered, should the review recommend changed responsibilities.

The review will have particular regard to the recommendations of the Productivity Commission Research Report: Chemicals and Plastics Regulation, July 2008 and relevant commitments made under the Council of Australian Governments’ Seamless National Economy National Partnership Agreement, 2009.

Following the review, the Chemicals and Plastics Regulatory Reforms Taskforce will provide advice to the Australian Government on proposed reforms and any recommended legislative changes necessary to implement those reforms.