25 May 2015

Extending the Legal Deposit Regime to Digital Material – Regulation Impact Statement – The Attorney General’s Department

On 29 October 2014 the Government introduced the Civil Law and Justice Legislation Amendment Bill 2014. A part of this Bill changes the legal deposit requirements. Legal deposit is a requirement under section 201 of the Copyright Act 1968 that publishers deposit a copy of library material to the National Library of Australia (NLA).  This requirement currently applies to material that is in print form, published in Australia, and in which copyright subsists.

The proposal will enable the NLA to meet its statutory function of providing a comprehensive collection of publications relating to Australia and the Australian people. Currently if a publisher publishes relevant documents in digital-only form they do not need to deposit that material with the NLA. Given the increase in digital-only publications over recent years there is concern that the record of Australia’s cultural heritage held by the NLA is being eroded.

There are two main parts to the changes. Digital-only material needs to be provided to the NLA subject to other carve-outs and hard-copy material can be provided in soft-copy format.

The need to provide digital only material will increase costs to industry, while the ability to substitute soft-copy for hard-copy material will reduce costs to industry. It is estimated that regulatory costs will be reduced by $125,000 per annum.

A Regulation Impact Statement (RIS) was prepared by the Attorney General’s Department and assessed as compliant and consistent with best practice by the Office of Best Practice Regulation (OBPR).


13 May 2015

National Disability Insurance Scheme Quality and Safeguarding Framework

COAG Consultation Regulation Impact Statement – COAG Disability Reform Council

On 16 February 2015, the Council of Australian Governments (COAG) Disability Reform Council released a Consultation Paper canvassing proposals for a quality and safeguarding framework for the National Disability Insurance Scheme (NDIS).

The national framework seeks to maximise the opportunities for people with disability to make decisions about their supports while also enabling them to live free from abuse, neglect and exploitation. The framework also seeks to promote innovation, continuous improvement and best practice in the provision of supports.

The Consultation Paper considers options for five specific elements of the framework that potentially have significant regulatory impacts on participants in the NDIS, their families, and community organisations and businesses providing supports under the NDIS. These elements include:

  • Registration of providers by the National Disability Insurance Agency;
  • Systems for handling complaints;
  • Ensuring staff are safe to work with participants;
  • Safeguards for participants who manage their own plans; and
  • Reducing and eliminating restrictive practices in NDIS funded supports.

The Consultation Paper was prepared by the NDIS Senior Officials Working Group for the Disability Reform Council and assessed as adequate by the Office of Best Practice Regulation in accordance with the COAG Best Practice Regulation Guide.


16 April 2015

Reducing the Regulation of Stock Food and Pet Food – Regulation Impact Statement – Department of Agriculture

On 5 March 2015, the Australian Government amended the Agricultural and Veterinary Chemicals Code Regulations 1995 in relation to stock food and pet food.

The reforms will see lower risk stock foods and pet foods excluded from pre-market assessment and registration by the Australian Pesticides and Veterinary Medicines Authority (APVMA) providing they meet certain requirements relating to claims, labels, manufacture and ingredients.

A Regulation Impact Statement (RIS) analysed options for reform of the regulations and recommended self-determination by industry to better align regulatory effort with risks. The Office of Best Practice Regulation (OBPR) has agreed to regulatory cost savings of $7.8 million per annum.

The RIS was prepared by the Department of Agriculture and assessed as compliant and consistent with best practice by the OBPR.


16 April 2015

Interconnection of Smoke Alarms – COAG Decision Regulation Impact Statement – Australian Building Codes Board

On 28 November 2013 the Australian Building Codes Board (ABCB) agreed to introduce a requirement in the Building Code of Australia to require interconnection of smoke alarms in dwellings and sole-occupancy units.  This change took effect from 1 May 2014.

The Building Code of Australia (BCA), which is part of the National Construction Code (NCC) series, requires smoke alarms, a smoke alarm system or a smoke detection system to be installed throughout new Class 1 dwellings, within sole-occupancy units of Class 2 or 3 buildings and in a Class 4 part of a building (buildings in which occupants sleep).

Smoke alarms installed to comply with the BCA provisions are required to be located in strategic positions such as hallways serving bedrooms, in order to facilitate an early response by occupants to a fire within a dwelling. In some circumstances, the size or layout of the dwelling or sole-occupancy unit necessitates the installation of more than one smoke alarm within that dwelling or sole-occupancy unit. For example, a two-storey dwelling or sole-occupancy unit requires at least one smoke alarm to be installed on each storey (even if there are no bedrooms located on one of those storeys).

Under the change to the Code, multiple smoke alarms must be interconnected within all new Class 1 dwellings, within sole-occupancy units of Class 2 or 3 buildings and in a Class 4 part of a building. This means that when one alarm is activated, it will activate all other alarms in the occupancy. Additions/extensions that require more than one smoke alarm will also have to interconnect those smoke alarms in order to comply with the BCA. However, they are not required to be interconnected with any other smoke alarms in the existing dwelling.

The ABCB was compliant with the COAG RIS requirements, preparing adequate Regulation Impact Statements at the consultation and decision-making stages. The RIS was published on the ABCB website on 25 March 2014.


16 April 2015

Amendments to the new regulatory framework for in-vitro diagnostic medical devices – Regulation Impact Statement – Department of Health

On 17 October 2014, the Australian Government announced amendments to the regulatory framework for in-vitro diagnostic medical devices (IVDs) to overcome previously unanticipated problems when previous regulatory changes were introduced in 2010.

IVDs are pathology tests and related instrumentation used to carry out testing on human samples. They are typically used in diagnostic pathology laboratories, other laboratories (blood and tissue screening laboratories), at point of care, and in some cases, in the home. The safety and quality of IVDs are regulated by the Therapeutic Goods Administration (TGA). Prior to 2010, the level of IVD regulation in Australia was very limited. Changes to the regulatory framework were introduced in 2010 that require all IVDs to undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use.

Prior to its full implementation, however, a number of previously unanticipated issues with the new framework were identified. These included:

  • difficulties some members of the sector were experiencing in meeting the timeframe for existing IVDs to be registered on the Australian Register of Therapeutic Goods (ARTG);
  • difficulties Australian laboratories were experiencing in meeting the regulatory requirements for higher-risk (Class 4) IVDs; and
  • the unintended omission of susceptibility and predisposition tests from the regulatory framework.

The proposed changes address these problems. In particular, the proposed changes to the regulation of Class 4 in-house IVDs are expected to allow for the continued supply of these IVDs, which was not assured under the July 2010 changes.

The proposed rule changes have been assessed as likely to have a measurable but contained impact on the economy with minor impacts on competition. A Regulation Impact Statement (RIS) canvassing the proposed changes was prepared and certified by the Department of Health consistent with Australian Government best practice regulation requirements, and the OBPR notes that the process followed by the department and the level of analysis contained in the RIS was consistent with best practice.

The RIS estimates a small (approximately $100,000 per annum) average annual regulatory cost saving. The OBPR has agreed to the regulatory cost saving.

The RIS can be downloaded from the TGA website.

IVD regulation National Manager Certification Letter – [DOC 155KB] RTF Icon

IVD regulation National Manager Certification Letter – [PDF 403 KB]  PDF document

IVD regulation OBPR Assessment Advice – [DOC 227 KB]  RTF Icon

IVD regulation OBPR Assessment Advice – [PDF 131 KB] PDF Icon


9 April 2015

Radiocommunications Licence Conditions (Apparatus Licence) Determination 2015 – Remaking of sunsetting instrument without amendments – Australian Communications and Media Authority

The Australian Communications and Media Authority (ACMA) remade one sunsetting legislative instrument without significant amendments on 20 February 2015: the Radiocommunications Licence Conditions (Apparatus Licence) Determination 2015.

The instrument seeks to address public health concerns with exposure to electromagnetic radiation from telecommunications transmitters. Exposure limits are drawn from the Radiation Protection Standard for Maximum Exposure Levels to Radiofrequency Fields—3 kHz to 300 GHz published by the Australian Radiation Protection and Nuclear Safety Agency (the ARPANSA Standard).

In line with the Australian Government best practice regulation requirements for sunsetting legislative instruments, the ACMA has assessed the operation of this instrument in consultation with affected stakeholders and has certified that the instrument is operating efficiently and effectively.

Therefore the Office of Best Practice Regulation notes that a Regulation Impact Statement is not required for this regulation to be remade.

As the instrument was remade without amendments there are no compliance cost changes.

Remaking of Instruments Certification letter – [Word Doc Icon 450KB]

Remaking of Instruments Certification letter – [PDF document 375 KB]


10 March 2015

Export regulation enabled by the Horticulture Marketing and Research and Development Services Act 2000

Regulation Impact Statement – Department of Agriculture

On 14 January 2015, the Minister for Agriculture wrote to Citrus Australia Limited (CAL), the Australian Horticultural Exporters Association and the export control body, Horticulture Innovation Australia Limited, advising of his decision to extend the horticulture export efficiency powers (EEPs) for a further two years, to 31 January 2017. EEPs had been due to terminate on 31 January 2015.

The EEPs allow horticultural industries to apply to the government for conditions to be placed on horticultural produce exported from Australia such as:

  • requiring the use of specific importing or exporting agents;
  • establishing quality, colour, shape or size standards for produce; and
  • requiring exporting businesses to participate in an approved export program.

A regulation impact statement (RIS) was completed in December 2014, which presented 3 options:

  • maintain the current EEP arrangements)
  • cease the current EEP arrangements by revoking the orders and the regulations
  • cease the current EEP arrangements by revoking the orders and the regulations and removing the head of powers.

The Minister decided to extend the EEP arrangements for two years to enable the citrus industry to work with Horticulture Innovation Australia Limited to improve the operational effectiveness (including compliance), transparency and communication activity associated with the powers. The decision by the Minister to extend the EEP arrangements by 2 years will not result in any changes to compliance costs to businesses.

The RIS prepared and certified by the Department of Agriculture was assessed as compliant and consistent with best practice by the Office of Best Practice Regulation.


26 February 2015

Enhancing Online Safety for Children – Regulation Impact Statement – Department of Communications

On 3 December 2014, the Parliamentary Secretary to the Minister for Communications introduced legislation containing a range of proposals to combat cyber-bullying and provide a safer online environment for children. The proposals included the establishment of the Children’s e‑Safety Commissioner and setting out the Commissioner’s functions and powers, and are supported by a range of non regulatory actions including an education and awareness raising campaign.

The proposals were informed by public and industry consultation conducted throughout 2014.

The proposals have been assessed as likely to have a measurable but contained impact on the economy.  A Regulation Impact Statement (RIS) was prepared and certified by the Department of Communications and has been assessed as compliant by the Office of Best Practice Regulation (OBPR).

The OBPR notes that the process followed by the Department of Communications and the level of analysis contained in the RIS were consistent with best practice.

The RIS estimates the average annual regulatory cost at $0.43 million per annum, and identifies offsets. The OBPR has agreed to the regulatory cost and offset estimates.


19 February 2015

Telecommunications (Interception and Access) Amendment (Data Retention) Bill 2014 – Stakeholder request – Attorney-General’s Department

On 30 October 2014 the Attorney-General and the Minister for Communications announced the introduction of the Telecommunications (Interception and Access) Amendment (Data Retention) Bill 2014.

The Australian Government’s Guide to Regulation (Guide) states that the choice of Regulation Impact Statement (RIS) appropriate to the task is up to the agency in conjunction with the OBPR. The Attorney-General’s Department chose to complete a short-form RIS for the proposal to implement a mandatory data retention regime. The Department is compliant with the RIS requirements.

This web post responds to a request from a stakeholder consistent with the Government’s User Guide to the Australian Government Guide to Regulation (page 8)


19 February 2015

Changes to foreign investment screening arrangements – Stakeholder request – Department of the Treasury

On 11 February 2015 the Prime Minister, Treasurer and the Minister for Agriculture announced changes to the screening arrangements for foreign investment in Australia’s agricultural sector.

The Australian Government’s Guide to Regulation (Guide) states that the choice of Regulation Impact Statement (RIS) appropriate to the task is up to the agency in conjunction with the Office of Best Practice Regulation (OBPR). The Department of the Treasury chose to complete a short-form RIS for the proposed changes to the foreign investment screening arrangements. It was the OBPR’s view that for this proposal a standard-form RIS would have been consistent with best practice. The Department is compliant with the RIS requirements.

This web post responds to a request from a stakeholder consistent with the Government’s User Guide to the Australian Government Guide to Regulation (page 8).