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Collection of data on the impact on business of proposed changes to regulation of hard surface disinfectants

Consultation

19 December 2008

This consultation closed on 19 December 2008.

In February 2008, the Therapeutic Goods Administration (TGA) and the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) released for public comment a consultant's report on proposed changes to the current regulatory regime for hard surface disinfectants. The next stage in the process is the preparation of a response to the consultant's report and as a part of that, NICNAS and the TGA are required to consider the impact on business of any proposed changes and to develop a regulatory impact statement (RIS). We are now seeking responses to the RIS survey.

The following letter was sent to stakeholders on 10 November 2008.

Dear Stakeholder

Collection of data on the impact on business of proposed changes to regulation of hard surface disinfectants

In February 2008 the TGA and NICNAS released for public comment a consultant's report on proposed changes to the current regulatory regime for hard surface disinfectants. The report can be found on the NICNAS website and the TGA website.

Public meetings were subsequently held and submissions sought. A summary of the options put forward by the consultant is attached.

The next stage in the process is the preparation of a response to the consultant's report and as a part of that, NICNAS and the TGA are required to consider the impact on business of any proposed changes and to develop a regulatory impact statement. Consideration of the impact on business will better inform the decision making process.

Attached to this letter is a survey, which we ask that you complete. If you are not familiar with NICNAS, you should be aware that, like the TGA, operating costs of the NICNAS scheme are fully recovered from industry and your business may become liable for fees and charges if regulation of certain hard surface disinfectants is moved to the regulatory regime for industrial chemicals administered by NICNAS. In particular, all introducers of industrial chemicals must be registered with NICNAS and pay an annual fee. There could also be assessment fees for any new disinfectant chemical you may introduce in the future.

We suggest you visit the NICNAS website at www.nicnas.gov.au for information on NICNAS registration, new chemical notification and associated fees.

Your advice on the issues raised in the survey will be extremely valuable.

In order to allow us to progress this matter, we would appreciate your comments by 19 December 2008.

Yours sincerely

Dr Larry Kelly
Head
Office of Devices Blood and Tissues

Dr Marion Healy
Director
NICNAS

5 November 2008

Enclosures

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