4 December 2014

Revised regulation of ‘scope of registration’ applications in VET sector – Regulation Impact Statement – Department of Industry

On 11 September 2014, the Minister for Industry announced that the Australian Skills Quality Authority (ASQA) will expand the delegation for registered training providers (RTOs) to make decisions about changing the scope of their registration.

The new approach will reduce red tape for highly compliant RTOs, by addressing the need for training providers to seek approval from ASQA before they offer new courses or make changes to the courses they are already delivering.

This will be achieved through ASQA inviting the most highly compliant RTOs to receive a delegation, under section 226 of the National Vocational Education and Training Regulator Act 2011, which will enable them to manage their own scope without the need to apply to ASQA for changes. There will be no legislative changes to the NVETR Act or associated standards.

The change is expected to reduce the compliance costs for those RTOs who no longer need to prepare change of scope applications, reduces their delay costs from waiting for approvals, and avoids the need for them to pay application fees. However, higher risk providers, including new market entrants, will continue to face these costs. There is also likely to be a saving to the ASQA through no longer processing applications from low risk providers.

The revised regulation has been assessed as likely to have a measurable but contained impact on a sector of the economy with minor impacts on competition.

The RIS prepared and certified by the Department of Industry, wasassessed as compliant by the Office of Best Practice Regulation, with the RIS also being consistent with best practice.

The RIS estimated the average annual regulatory cost saving at $3.32 million per annum. The OBPR has agreed to the regulatory cost saving.


4 December 2014

Maximum level for tutin in honey – COAG Decision Regulation Impact Statement – Food Standards Australia New Zealand

On 29 October 2014, Food Standards Australia New Zealand (FSANZ) approved a variation to the Australia New Zealand Food Standards Code (the Code) to provide for maximum levels (ML) for tutin in honey and comb honey.

Tutin is a plant-derived neurotoxin, which can sometimes be present in honey produced in parts of New Zealand. Following a severe poisoning incident in New Zealand in 2008 temporary MLs for tutin in honey and comb honey (of 2 mg/kg and 0.1 mg/kg, respectively) were adopted into the Code while further research and evaluation was conducted. The temporary MLs were due to expire on 31 March 2015.

The variation to the Code reduces to 0.7 mg/kg and makes permanent the ML of tutin in honey. This ML is based on scientific research that indicates that some people may have adverse reactions to tutin even at levels below the current temporary MLs. The new MLs may result in higher testing and blending costs for some New Zealand honey producers, but will reduce the risk to public health from tutin poisoning.

For comb honey, the new ML has also been set at 0.7 mg/kg. For comb honey producers, the new ML does not impose any change on current industry practices since compliance with the existing New Zealand Tutin Standard for comb honey will ensure compliance with the standards in the Code.

A Council of Australian Governments Decision RIS has been prepared by FSANZ, and assessed as adequate by the Office of Best Practice Regulation.


28 November 2014

Managing interactions with Australian Sea Lions in the Gillnet Hook and Trap Sector of the Southern and Eastern Scalefish and Shark Fishery – Post-Implementation Review – Australian Fisheries Management Authority

On 27 April 2011, the Australian Fisheries Management Authority (AFMA) announced changes to existing management arrangements in the Southern and Eastern Scalefish and Shark Fishery, aimed at providing stronger protection for Australian Sea Lions. These changes included additional closures of fishing areas and new monitoring arrangements.

A regulation impact statement (RIS) – assessed as adequate by the Office of Best Practice Regulation (OBPR) – was required to inform the decision to change the management arrangements. A draft RIS was submitted prior to the implementation of the regulation, however due to the urgent requirement of the regulation, adequate consultation was unable to be completed before the action was taken.  The RIS was deemed to be inadequate by the Office of Best Practice Regulation  and AFMA was assessed as non-compliant under the then Government’s RIS requirements. As a result, a Post implementation Review (PIR) has been undertaken by AFMA in line with the Government’s best practice regulation requirements.

The PIR found that the measures taken in 2011 were appropriate and continue to be necessary in order for AFMA to pursue its legislative objectives under the Fisheries Management Act 1991.

The PIR has been assessed as compliant by the OBPR.


28 November 2014

Optimal Period of Registration for the Do Not Call Register – Regulation Impact Statement – Department of Communications

On 22 October 2014, the Minister for Communications introduced legislation to make the registration period for numbers on the Do Not Call Register indefinite. The proposal was strongly supported by consumers and will enable them to avoid having to periodically re-register their telephone and fax numbers.

The proposal has been assessed as likely to have a measurable but contained impact on the economy with minor impacts on competition.

A Regulation Impact Statement (RIS) was prepared and certified by the Department of Communications under the March 2014 Australian Government Guide to Regulation and has beenassessed as compliant by the Office of Best Practice Regulation.

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

The RIS estimates the average annual regulatory cost saving at $3.48 million per annum. The OBPR has agreed to the regulatory cost saving.


25 November 2014

Pharmacy location rules – Post–implementation Review – Department of Health

The Department of Health has completed a Post-implementation Review (PIR) on the 2010 decision to renew the pharmacy location rules. These rules prescribe location-based criteria that must be satisfied in order to establish a new pharmacy or relocate an existing pharmacy.

A RIS was required to be prepared for the renewal or retention of pharmacy location rules as these could entail a restriction on competition, and were assessed by the Office of Best Practice Regulation (OBPR) as likely to have a measurable impact on the economy. Because an adequate RIS was not prepared at the decision-making stage, a PIR was required to be prepared within 1-2 years of the implementation of the decision to renew the rules.

The review noted that the costs of extending the location rules include the potential for higher cost of non-subsidised medicines; possibly reduced geographical access to pharmacies in urban areas; and an administrative impost for pharmacists who want to relocate or expand (estimated at $1 million per year). However it found that these costs were outweighed by the benefits of the rules, which maintain a reasonably well-distributed geographical spread of pharmacies in Australia, including (and especially) in rural and remote areas. The review also noted that targeted easing of the rules could provide for greater benefits to the community.

The PIR was completed by the Department of Health in October 2014 and was assessed as adequate by the OBPR.


24 November 2014

Proposed changes to the National Quality Framework for Education and Care Services – COAG Consultation Regulation Impact Statement – Education Council

On 7 November 2014, the Education Council released a Council of Australian Governments (COAG) Consultation Regulation Impact Statement (RIS) containing a number of proposed changes to the Education and Care Services National Law Act 2010, the Education and Care Services National Regulations 2011, and to associated guidance material, all of which are part of the National Quality Framework (NQF).

The Education Council has highlighted potential changes in a number of areas. These include changes to the regulation of Family Day Care services and Outside School Hours Care, as well as the possibility of expanding the scope of services regulated under the NQF.

The COAG RIS for consultation was prepared for the Education Council and has been approved by the Office of Best Practice Regulation. It can be downloaded from the NQF consultation website.

The consultation period closes on 16 January 2015.

 


13 November 2014

New Standards for Vocational Education and Training (VET) Sector – COAG Decision Regulation Impact Statement – COAG Industry and Skills Council

On 26 September 2014, the COAG Industry and Skills Council endorsed new standards for Registered Training Organisations (RTOs) and VET regulators, and noted that there was a requirement for further development of qualification requirements for teachers delivering the Certificate IV in Training and Assessment. The draft standards were subsequently amended to strengthen requirements for the delivery of this qualification, and the Commonwealth Minister for Industry made the new standards on 20 October 2014 (Standards for Registered Training Organisations 2015 and Standards for VET Regulators 2015). The new standards strengthen requirements for aspects of the delivery of training and assessment, including responsibility for training delivered by a third party, and governance requirements for RTOs; clarify continuing requirements, including requirements for engagement with industry and validation of assessment; and change the Regulator Standards to facilitate a more risk-based approach to regulating RTOs.

In the context of broader national VET reforms, the new standards contribute to addressing employer and other concerns with inconsistency in the relevance and quality of vocational education and training. Specific areas being targeted are the industry-relevance of the development and delivery of training, inadequate skills and knowledge of some VET trainers and assessors, insufficient information for consumers, the complexity of the standards and inadequate enforcement arrangements for poor quality providers. The Regulation Impact Statement (RIS) identified likely transition costs for the sector of $32.6 million, but ongoing savings of around $5 million a year. Benefits for trainees and employers are also anticipated.

The Australian Government Department of Industry’s VET Reform Taskforce prepared a decision‑making RIS that was provided to the COAG Industry and Skills Council to inform the decision. The RIS was assessed as compliant by the Office of Best Practice Regulation.

A consultation RIS was previously prepared by the former Office of the National Skills Standards Council and released for public consultation on 12 March 2013.


13 November 2014

National Livestock Identification System – COAG Decision Regulation Impact Statement – Agriculture Ministers' Forum

On 22 October 2014, the Minister for Agriculture announced that Agriculture Ministers from each State and Territory jurisdiction had agreed to make necessary improvements to the National Livestock Identification Scheme (NLIS) for sheep and goats by building on the systems already in place. The scheme is important for managing biosecurity, food safety, and animal welfare risks. The COAG Decision Regulation Impact Statement (RIS) for improving the NLIS assesses the costs and benefits of three options for improving traceability:

  • Option 1: Enhanced mob-based system— improvements in the verification and enforcement of business rules throughout the supply chain.
  • Option 2: Electronic identification system—the electronic tagging of animals with exemptions for sheep and goats sold directly from their property of birth to abattoirs or export depots.
  • Option 3: Electronic identification system without exemptions.

The RIS identifies Option 1 as the preferred option for implementation and recommends that further work be undertaken at the state level to clarify the appropriate values for initial traceability and implementation costs for all options. The RIS also recommends that the costs and benefits of transitioning from a mob-based system to an electronic identification system be reviewed within five years since the costs of implementing alternative options may change over time with changes in labour and capital costs. The COAG decision RIS was prepared by Australian Bureau of Agricultural and Resource Economics and Sciences for the Agricultural Minister’s Forum, and assessed as adequate by the Office of Best Practice Regulation.


12 November 2014

Australian Transaction Reports and Analysis Centre – Proposed Changes to the Annual Compliance Report – Regulation Impact Statement

On 2 October 2014, the Australian Transaction Reports and Analysis Centre (AUSTRAC) commenced consultation on proposed changes to its annual compliance report.

Certain entities have an obligation to prepare an annual report (the ‘annual compliance report’) relating to their compliance with anti-money laundering and counter terrorism financing rules.

The annual compliance report comprises an online questionnaire with fixed choice responses across 22 key question areas. The report is a component of AUSTRAC’s risk-based approach to supervision of compliance with relevant rules.

The Regulation Impact Statement (RIS) prepared by AUSTRAC for the proposed changes identified three problems with the current arrangements:

  • The current compliance questions are not as relevant as when first developed.
  • The regulatory burden of the current arrangements on certain entities may not be proportionate to their risk of non-compliance.
  • Some stakeholders have indicated that they consider the report to have little or no value to them.

It is proposed to replace the current annual compliance report with an enhanced compliance report and an annual return. The enhanced compliance report is essentially an updated version of the current compliance report while the annual report would require a reporting entity to provide a comprehensive report on its business environment, money laundering and terrorism financing risk and the effectiveness of its anti-money laundering and counter terrorism financing program.

Certain larger business will be required to prepare both reports, while certain smaller and lower risk businesses will only need to prepare the enhanced compliance report.

Overall it is estimated that the proposal will result in a net reduction in the regulatory burden on businesses by $85,200 per year.

The RIS was prepared by AUSTRAC andassessed as consistent with best practice at the early assessment stage by the Office of Best Practice Regulation.

 

 


12 November 2014

Pre-market assessment of Australian-manufactured medical devices – Regulation Impact Statement – Department of Health

On 15 October 2014, the Australian Government announced changes to the regulation of therapeutic goods that will allow Australian manufacturers of medical devices to obtain market approval for most of their products using conformity assessment certification from European notified bodies.

Conformity assessment is the examination of evidence and procedures to ensure that both the medical device and the process used to make the device comply with the requirements of the therapeutic goods legislation. Under current arrangements, Australian manufacturers are required to have their products undergo conformity assessment by the Therapeutic Goods Administration (TGA) before their products can be marketed in Australia. If they wish to export their products, Australian manufacturers require an additional assessment by organisations certified by overseas regulators (‘notified bodies’). This is in contrast to overseas manufacturers, who only need to have their products assessed by the overseas notified bodies.

The proposed changes will allow Australian manufacturers to choose to either have conformity assessment conducted by the TGA or an alternative conformity assessment body, such as a European notified body. This will put Australian manufacturers of all but the highest-risk products on an equal footing with those from overseas, avoiding the need for duplicate conformity assessments for those manufacturers wishing to export their products to Europe. In many cases this could allow locally-made medical devices to get to market more quickly. The new rules will not apply to the very highest risk devices, including devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 in vitro diagnostic devices: these devices will still need TGA conformity assessment.

The proposed rule changes have been assessed as likely to have a measurable but contained impact on the economy with minor impacts on competition. On 8 August 2013 a Regulation Impact Statement (RIS) canvassing the proposed changes was prepared by the Department of Health and was published. The RIS was subsequently finalised and certified by the Department 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 the average annual regulatory cost saving at $6.12 million per annum. The OBPR has agreed to the regulatory cost saving.

The RIS can be downloaded from the TGA website.