and

DISINFECTANTS

December 2009

ISSN 1444-1209

also in this issue:

2 A word from our Director3 NICNAS and nanomaterials, Compliance framework4 NICNAS assessment reports, New publications5 PEC process; Cosmetics advisory group6,7 International chemical safety update7 Staff news8 US – Australia cooperative arrangements9 LRCC evaluation; Industry Engagement Group 10 Disinfectant consultation; Upcoming events11-13 SPECIAL FEATURE: NICNAS’s Prioritisation project

A NAB I and

ABC NANOMATERIALSANAANS

The release of this package kicked off a period of public consultations – closing on 12 February 2010 – on a NICNAS proposal for regulatory reform of industrial nanomaterials. The purpose of the consultation is to gather views on the impact and feasibility of the proposed changes to industrial nanomaterial regulation on business, the community, researchers and government.

NICNAS developed the proposal in conjunction with its Nanotech-nology Advisory Group, which comprises representatives from industry, the community and research sectors. ………………… continued on page 3

Parliamentary Secretary for Health, the Honorable Mark Butler MP has announced the release of Proposal for Regulatory Reform of Industrial Nanomaterials – a public discussion paper which is part of a consultation package on a proposal to strengthen the regulation of industrial nanomaterials in use in Australia.

NICNAS Annual Report 2008-09 now available

PRIORITISATION feature

pp 11-13

NICNAS and the Therapeutic Goods Administration (TGA) are undertaking stakeholder consultations on the impact of proposed changes to the regulation of household and commercial grade hard surface disinfectants on business, the community and government. The consultations, running for four weeks (finishing on 12 February 2010) will inform a final Government decision on any reforms. ……………………………………… continued on page 10

a word froma word from the Directorthe Director

……

Dr Marion HealyDr Marion Healy

Contacting NICNASDo you have an industrial chemicals issue or matter you would like to raise with us? Please feel free to call or write to us. Our contact points are: Freecall: 1800 638 528 Email: info@nicnas.gov.au Post: GPO Box 58, SYDNEY, NSW 2001 AUSTRALIA

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Please note: NICNAS will close on Thursday 24 December 2009 and re-open in the New Year on Monday 4 January 2010.

s 2009 draws to a close it is timely to reflect on NICNAS’s recent achievements and challenges and consider the key activities before us in 2010. A major focus has been finalising the assessments of several priority existing chemicals. The assessment process for sodium cyanide – which considered the environmental impacts – has now reached the final stages and the final report will be published in early 2010. The first of a series of nine assessments of phthalates – that for diethylhexyl phthalate – will be released for public consultation in late January 2010.

As highlighted in this edition of NICNAS Matters, there has been significant progress in developing an alternative approach to identifying chemicals on the national inventory that warrant further investigation. This approach moves away from examining individual or even groups of related chemicals in detail. Instead it aims to examine the chemicals on the inventory in total using a series of filters to ultimately identify those chemicals of highest priority for further attention. NICNAS is currently developing the tools and approaches required for this process and has made good progress in developing the necessary ‘filters’ as well as acquiring essential expertise in new modeling tools. I anticipate that these tools and approaches will be finalised by June 2010 and we will then move into the next phase of the project.

With the application of nanotechnology to industrial chemicals, we reviewed our current regulatory framework to determine if amendments are needed. Public consultation docu-ments are now available and propose some amendments to the notification requirements across the spectrum of nanomaterials not currently on the national inventory as well as the nanoform of chemicals that are already on the inventory. NICNAS is seeking submissions and comments from you until 12 February 2010, and we will use the information and views provided to chart a way forward in 2010.

There has been significant progress on several projects to improve the efficiency of the notification and assessment process for new chemicals. Earlier this year, NICNAS implemented new notification categories that were developed under the Low Regulatory Concern Chemicals (LRCC) initiative and these new categories have been adopted enthusiastically by some industry sectors. Some feedback indicates that further guidance material and training would be helpful and we will be responding to this feedback in the coming months. The evaluation of the industry impact of those LRCC reforms introduced in 2004-05 has now been completed and we are now moving onto the impact of those reforms on the community and government sectors - this will be a major undertaking in the first half of 2010.

Another project for which we will be seeking input from you in 2010 is the development of a cost recovery impact statement. As a cost recovered agency, NICNAS needs to review its cost recovery arrangements periodically and NICNAS is now commencing this review. We expect to be undertaking stakeholder consultations in the first half of 2010 as part of this review.

Many of you have contributed to NICNAS‘s projects and/or worked with NICNAS on business activities through the year. We have greatly appreciated your input and the working relationship that we have with you. The NICNAS staff and I wish you a safe and happy Christmas and holiday season and looking forward to working with you again in 2010.

A

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NICNAS Compliance & Enforcement FrameworkNICNAS Compliance & Enforcement Framework

continued from page 1 …

The discussion paper addresses the six trigger areas for regulatory reform identified by the independent Monash Report: Review of the Possible Impacts of Nanotechnology on Australia’s Regulatory Frameworks.1

The discussion paper proposes specific regulatory measures for the emerging field of nanotechnology in industrial chemicals. These address three elements:

regulation of nanoforms of new chemicals

regulation of nanoforms of existing chemicals, and

the principle of an integrated approach for industrial nanomaterials within the NICNAS framework as a longer term strategy.

The options in the proposal aim to maintain or enhance existing levels of public health, worker safety and environmental protection in light of the uncertain risks posed by industrial nanomaterials, while facilitating the ability of the community to gain from the potentially beneficial aspects of this technology, and the ability of industry to innovate.

Under the proposal, the health and environmental impacts of nanomaterials will be assessed by NICNAS pre-market on a case-by-case basis. This will ensure that appropriate risk assessments are conducted and controls recommended when required.

Introducers will be required to provide scientific data relevant to the assessment of nanomaterials such as

NICNAS and Nanomaterials

The role of NICNAS is to ensure compliance with the Industrial Chemical (Notification & Assessment) Act 1989, the Regulations 1990 and Cosmetics Standard 2007.

Guidance on NICNAS requirements is published through our website, in the monthly Chemical Gazette and in regular newsletters. Registrants are invited to attend training and information sessions held annually in Australian capital cities to increase awareness of the NICNAS role and obligations of the introducer of relevant industrial chemicals.

NICNAS undertakes compliance activities in a cooperative approach to encourage voluntary compliance and streamline regulatory impact. NICNAS utilises information provided to other government agencies to help monitor compliance and reduce the burden on business. Registrants may be selected for audit at random or in response to particular concerns for that business or a particular industry.

particle size and surface characteristics. This information will be used in assessing health and environmental risks from the use of these substances.

Following the release of the paper, NICNAS held public consultation meetings on the proposal in Sydney (on 16 November) and Melbourne (18 November). Depending on demand from other centres, NICNAS may also organise sessions elsewhere – or group consultations by teleconference may be arranged for individuals or organisations who could not make it to meetings.

The consultation package also contains a questionnaire to encourage written submissions and a business impact survey that seeks more detailed information on possible business impacts of the proposal. The period for comment on the proposal, including the return of the completed questionnaire and business impact survey, closes at 5pm on Friday 12 February 2010.

To obtain a copy of the Public Discussion Paper, associated information and documents for written submissions, visit: www.nicnas.gov.au/Current_Issues/Nanotechnology/Stakeholder_Consultation.asp, phone: 02 8577 8800 / 1800 638 528, or email: info@nicnas.gov.au.

If you would like to register your interest for any further public meetings (subject to demand) or a discussion by teleconference, please contact NICNAS on the above numbers or email.

1. A Summary of the findings from the Monash Report (review) is available on the NICNAS webpage.

Compliance and enforcement action is undertaken when non-compliance is identified from various sources of information. NICNAS responds and takes appropriate action when persons self report possible breaches, when persons provide information of possible third party allegations and NICNAS audit processes detect instances of non-compliance.

Investigations of a serious nature may require NICNAS officers to exercise their legislated powers to gather information with consent, obtain a search warrant to enter and search premises or obtain an injunction to seize items introduced in breach of the legislation. Any matter investigated and found to be a significant contravention of our legislation will be referred to the Director of Public Prosecutions for consideration of prosecution action.

The NICNAS Service Charter outlines the standards of service that the users of the Scheme and the public can expect. … to page 7

Recent NICNASpublications

CONSULTATION / DISCUSSION PAPERS

Regulation Impact Statement on TGA and NICNAS proposed regulation of disinfectants

Proposal for regulatory reform of industrial nanomaterials

Papers used for Industrial Nanomaterials consultations with stakeholders

Papers used at Hard Surface Disinfectants consultations with stakeholders

Exposure Workshop discussion paper: technical issues relating to provision of data to NICNAS by industry within the AICS prioritisation project

REPORTS

NICNAS Annual Report 2008-09

Complex Soap TH17 Secondary Notification Report

LRCC Reforms: an evaluation of the impact on industry (final)

INFORMATION SHEETS AND ALERTS

Complex Soap TH17 Secondary Notification Report (overview and recommendations)

CHEMICAL GAZETTES October 2009 November 2009 December 2009

Sodium cyanide (NaCN)

Why declared a PEC

Environmental concerns: mass bird poisonings resulting from consumption of cyanide-contaminated water at tailings dams; potential release of toxic and flammable hydrogen cyanide gas when NaCN comes in contact with water; high acute toxicity to aquatic life, birds and animals; high chronic toxicity to aquatic life

Aim of assessment

To test validity and impact of issues raised during declaration of NaCN

Key outcomes

Please see Recommendations in Sodium Cyanide Information Sheet (Sept ’09).

Current status of report

Draft PEC report released for public comment on 11 Sept 09. Decisions on requests to vary draft report (concerning NaCN toxicity to wildlife and circumstances other than hypersalinity that are protective to wildlife and other matters) are available on the NICNAS website.

Complex Soap TH17 (a barium salt)

Details of uses etc

Component (less than 35%) to a variety of ready-to-use grease products; more than half is used in new automotive, machinery & equipment manufacturing sites with the rest used in repairs & maintenance; not manufactured in Australia – importation volume has not exceeded 5 tonnes per year in the past 4 year

Why re-assessed (as 2ndary Notification)

New data provided (was classified as hazardous substance in its assessment as a new chemical in 2002)

Outcome Based on new data provided, chemical is not classified as hazardous under the NOHSC Approved Criteria for Classifying Hazardous Substances (2004)

Current status of report

Final Complex Soap TH17 Secondary Notification report was published on NICNAS website on 6 Oct 2009 after mandatory public comment period, during which no comments were received

Diethylhexyl phthalate (DEHP)

Why declared a PEC

Concerns regarding potential adverse health effects – particularly reproductive and developmental health effects – due to exposure to phthalates & their widespread use in consumer products. One of the nine phthalates undergoing assessment for public health risk in applications such as children’s toys, childcare articles and in cosmetics

Aim of assessment

To examine public health risk

Current status of report

DEHP draft report will be released for public comment on 25 Jan 2010.

Recent assessment reports:PEC [Priority Existing Chemical] and Secondary Notification *

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Please see page 5 for a diagram explaining procedures following declaration of a chemical as a PEC.

The Cosmetic Advisory Group (CAG) has members from industry, community and government, as well as two members with specific expertise – one in health, one in formulation. At present, work is focussing on implementation of the remaining elements of the reforms to the therapeutic/cosmetic interface, which came into force in 2007.

The two major current areas of work are:

1. The addition to the industrial chemicals regulatory framework of chemicals not currently on AICS but already assessed and used as ingredients of therapeutic (TGA) products, where these products are now regulated as cosmetics.

At its meeting in April, the CAG agreed to NICNAS’s staged approach to identifying and validating chemicals eligible for incorporation into the industrial chemicals regulatory regime. As a first stage information will be requested from industry about the

NICNAS’s Cosmetic Advisory Group

identity of new chemicals in products previously regulated as therapeutics but now regulated as cosmetics, that were in commerce under TGA before the legislative changes were introduced.

Work is under way in NICNAS to prepare a list of chemicals which may meet these criteria and which industry can use in making their nominations of eligible chemicals. In the next step, we will seek industry input to the list of potential chemicals through the Chemical Gazette. Other consultation mechanisms will also be used to ensure that the relevant information reaches all interested companies.

2. Data requirements for UV filters: the data requirements will match the requirements of the TGA for these chemicals. This is required because some products containing UV filters are now regulated by NICNAS. For further information please see the notice in the October 2008 Chemical Gazette.

Procedures following a Priority Existing Chemical (PEC) declaration

1. Declaration

A chemical is declared a PEC by notice in the Chemical Gazette.

2. Information gathering

Introducers (manufacturers/importers) of the chemical lodge applications for assessment. Application must include information specified in the declaration notice that would assist in the assessment. Additionally, specific persons (eg. past importers/manufacturers) may be contacted by NICNAS to provide information for the purposes of the assessment.

4. Checking draft for errors

On completion of the draft assessment report a copy is sent to each applicant with a letter asking them to correct any errors in the report. NICNAS is notified about such errors by the applicant(s) within 28 days of notice being sent. The notified errors are verified by NICNAS and the draft report is amended accordingly.

3. Assessment

When all information for the assessment is collected, the assessment begins. This stage may take 6 months or more. If no applications are lodged during the information-gathering stage, the director may cause an assessment report to be prepared.

5. Variation of draft report

Draft report is made available to the public by notice in the Chemical Gazette. Persons and organisations have the opportunity to request changes to the draft assessment report within 28 days of its availability to the public. Submitted requests are either accepted or refused based on sound scientific judgment or advice and a copy of the decisions is sent to the applicant and made available to the public. An appeal to the Administrative Appeals Tribunal (AAT) may be lodged by the variation applicant to contest NICNAS’s decision to refuse the variation request.

6. Publication of final report

If there are no applications lodged with the AAT, a summary report of the PEC assessment is published. The final assessment report is issued to all applicants and respondents (contacted persons such as past introducers), to Federal departments responsible for human and environmental health, and relevant authorities in each State and Territory. It is also publicly available upon request and via the NICNAS website.

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Clearing House on New Chemicals

NICNAS, as Chair of the Clearing House, announces that the next meeting to be hosted by Japan will be held in Tokyo 24-26 February 2010. In the lead-up to the meeting the working groups under the Clearing House (A: parallel process, B: exemptions and exclusions, C: electronic notification software, and D: outreach and communication) are preparing topics for discussion and further progressing actions agreed at the first meeting held in Sydney last April.

The Tokyo meeting will be held in the week before the APEC Chemical Dialogue events (planned for 1-4 March, in Hiroshima, Japan with the Good Regulatory Practice: Case Study Workshop on the Chemicals Sector - From Principles to Practice workshop on 1-2 March. The LRCC reform initiative and ‘Parallel Process’ work-sharing activity under the Clearing House will be presented as case studies at the APEC workshop.

SIAM 29

Twenty-eight chemicals were scheduled for discussion at OECD SIAM1 29 (The Hague, late October). NICNAS reviewed a chemical category called long chain chlorinated paraffins (LCCP) that consists of three chemicals. These break down in the environment to short chain chlorinated paraffins (SCCPs)2 which NICNAS assessed as a preliminary assessment in 2001.

Assessments for 20 chemicals were agreed at SIAM 29. Agreed conclusions for chemicals discussed will soon be submitted for the Task Force on Hazard Assessment and then to the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology for endorsement through written procedure. Interim implementation of the new HPV Chemicals program started at SIAM 29 with the official submission of targeted assessments and with draft assessments proposed for agreement through written procedure.

Three additional phthalate chemicals (sponsored by Canada) were peer reviewed by NICNAS for Canada during the preparation of the screening assessment reports.

OECD Perfluourinated Chemicals Activity

The OECD survey format on PFOS, PFAS, PFOA, perfluorocarboxylic acid (PFCA) and their related compounds and mixtures containing these substances has been finalised, along with a global list of manufacturers of these compounds identified by BIAC.

NICNAS assisted in developing the survey itself as well as procedural matters (including the confidentiality of material submitted) and is conducting it on the OECD’s behalf. Questionnaires were sent to companies and responses were due by end September.

NICNAS is currently preparing a report of the survey responses for the OECD, for discussion at the OECD Joint Meeting of the Chemicals Working Party on Chemical Pesticides and Biotechnology in February 2010.

Global legally binding instrument on mercury

Negotiations for a global legally binding instrument (LBI) on mercury were initiated this year by the Governing Council for the United Nations Environment Programme (UNEP). The LBI is likely to take the form of a multilateral environmental agreement similar to the Stockholm and Basel Conventions. The Department of the Environment, Water, Heritage and the Arts (DEWHA) is coordinating Australia’s participation in negotiations and NICNAS provided technical advice on industrial uses.

The Stockholm Convention’s Persistent Organic Pollutants Review Committee’s (POPRC) 5th meeting was held in Geneva in mid October. A subsidiary body to the Stockholm Convention, POPRC reviews proposals submitted by Parties to the Convention for listing new chemicals in Annex A, B and/or C.

The Committee reviewed information provided (including by NICNAS) and concluded that hexabromocyclododecane (HBCD) met criteria for adverse effects, persistence, bioaccumulation and long-range transport in Annex D of the Convention. It invited the submission of Annex E information on HBCD, based on which it will develop a risk profile for consideration at its next meeting.

The POPRC reviewed the revised risk profile of short-chained chlorinated paraffins (SCCPs) and decided to postpone a decision to its next meeting. In the meantime additional information on environmental and health effects of SCCPs, as well as trends in the levels in the environment will be gathered2. …. to page 7

International chemical safety update

1. Screening (Information Data Set) Initial Assessment Meeting

2. Short chain chlorinated paraffins (SCCPs) were also considered for inclusion in the annexes of the Stockholm Convention in 2006. They are a group of synthetic compounds mainly used in metal working fluids, sealants, as flame retardants in rubbers and textiles, in leather processing and in paints and coatings. The risk profile has been developed and will be coordinated by the POPRC. NICNAS provided comments on the draft risk profile.

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Memorandum of Understanding with ERMA New Zealand

In September, NICNAS met with ERMA and industry representatives and progressed the revitalised MoU, moving it close to finalisation. The revised MoU will reinvigorate and strengthen liaison between the agencies. A draft 12-month workplan was developed with ERMA staff.

International chemical safety update … continued from page 6

Cooperative arrangements with US and Canada

US EPA|A staff member from NICNAS visited the US EPA with a major focus on identifying techniques, modelling tools and approaches that can be used for prioritising chemicals on Australian Inventory of Chemical Substances (AICS)

Health Canada & Environment CanadaRecognising Canada’s major achievement of categorising the Designated Substances List (DSL) NICNAS has focused efforts on activities that would contribute to the efficient and effective prioritisation of chemicals on AICS. A staff member visited Health Canada and Environment Canada to learn from the Canadian experience in categorising the chemicals on their inventory. Utilising the Canadian experience, tools and approaches will reduce the duplication of efforts in prioritising the chemicals on AICS and save resources. Discussion with Canada also included the comprehensive cooperative arrangement incorporating both new and existing chemicals and the development of separate work plans for new and existing chemicals. Through this visit and other ongoing NICNAS initiatives, links between Canada and Australia are being progressively strengthened.

Other recent achievements in cooperative activities include:

the inclusion of Canadian expertise on the Environmental Expert Working Group (EEWG – see Prioritisation feature on page 12)

NICNAS peer reviewing major assessments conducted by Canada, and

the further development of a new cooperative bilateral arrangement that encompasses both new and existing chemicals with a bilateral workplan for NICNAS and Environment Canada/Health Canada for the two categories as well.

NICNAS staff newsRecent starters at NICNAS (pictured below, left to right): Mr John Attard (Compliance and Reporting), Dr Jason Cherry (New Chemicals), Dr Mark Kinnear, Ms Malsha Kitulagodage and Dr Farah Reza (Existing Chemicals).

Mr Graeme Rayner has commenced as acting Team Leader, Compliance and Reporting.

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The Charter also outlines the avenues available for review if these standards are not met.

Comments relating to compliance and enforcement issues may be directed to the Team Leader of Compliance & Reporting, on 02 8577 8800 or via email at registration@nicnas.gov.au

The purpose of the Compliance and Enforcement Framework document (posted on the NICNAS website) is to increase the transparency of NICNAS’s approach by outlining the methods used to maximise voluntary compliance, our approach to identified instances of non-compliance, and the options available to resolve non-compliance.

NICNAS Compliance & Enforcement Framework NICNAS Compliance & Enforcement Framework … continued from page 3

Less than a year ago, the Office of Pollution Prevention and Toxics (OPPT) of the Environmental Protection Agency of the United States (US EPA) and NICNAS formalised an arrangement to provide for the sharing of information and expertise in chemical risk identification and management. It was intended that the two governmental organisations would develop mechanisms to achieve efficiencies of resources in the review and management of new and existing chemicals and enhance the respective abilities of the two governmental organisations to protect human health and the environment.

The Arrangement has borne its first fruit. Scott Sherlock, an attorney advisor with OPPT, has spent six weeks with NICNAS. During his time here Scott received detailed information on NICNAS’s approaches to chemical risk management. Equally important though was that Scott and NICNAS staff worked out the protocols and procedures for the exchange of information and expertise. Central to these exchanges are the protocols and processes for the secure transmission and storage of the information, some of which might be business sensitive data. EPA meanwhile has advised of its willingness to make available both data and US EPA assessments on chemicals the companies want to introduce into Australian commerce.

During this year it is expected that a variety of data exchanges on assessed new chemicals under the cooperative arrangements. The arrangements will enable Australian companies / industry to use notifications previously assessed in the US and vice versa.

During his six weeks at NICNAS, Scott was a valuable resource to NICNAS. With his experience serving as counsel for the Toxic Substances Control Act (TSCA) Inventory and the Inventory Update Rule (IUR) he

provided useful input on topics including EPA policy on inventory listings, new chemicals operations at the US EPA and the evolution of EPA’s approach to collecting exposure type data.

Scott also met and addressed staff of the Plastics and Chemicals Industries Association and ACCORD and was a presenter at the Asia Oceania Soap & Detergents Association Conference (AOSDAC09) in Melbourne. Additionally he was a presenter at a New Chemicals Training workshop and was a resource at the Industry Engagement Group (IEG) meeting of October at NICNAS. Towards the end of his assignment at NICNAS, Scott had the opportunity to meet our Parliamentary Secretary, the Hon Mark Butler, further strengthening relationships with the US EPA.

Over the last several years there has been a broad recognition that national governmental chemical management entities benefit through collaboration with their foreign governmental peers. The sharing of data and expertise, can lead to better risk management approaches for the benefit of all. This approach has been successful with Canada. Now NICNAS is in the process of moving beyond the ‘confidence building’ stage with US EPA and expects Australian stake-holders, to benefit from this initiative in the coming years.

It complements the long existing relationship that NICNAS has with Canada and NICNAS's leadership role in the OECD sponsored ‘parallel process’ initiative under the OECD Clearing House on New Chemicals whereby a lead country develops a hazard assessment to be considered by other countries in their hazard and risk assessment.

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Developments and progress in the US and Australian Cooperative Arrangement Framework

Parliamentary Secretary Hon Mark Butler (second

from right) visited NICNAS to meet with US EPA staff-

member Mr Scott Sherlock (centre), and (L to R)

Dr Sneha Satya (Team Leader Existing Chemicals),

Dr Marion Healy (Director) and Ms Hana Hamdan

(Team Leader Notification and Assessment).

The NICNAS Industry Engagement Group (IEG – pictured at right) was established in March 2009 to provide a forum through which NICNAS can liaise with industry representatives on technical issues relating to the regulation of industrial chemicals. Members of the IEG represent a broad range of industry sectors including those for plantation and paper products, consumer cosmetics and household products, paint, plastics and chemicals, food and grocery and the mining and petroleum sectors.

The second IEG meeting was held on 15 October 2009, with agenda items – for either information or discussion purposes – ranging from strategies for progressing the review of the NICNAS Handbook for Notifiers to input into upcoming NICNAS training activities, the collection of data for the AICS prioritisation project, and the provision of updates on current reform activities.

A particular highlight was the presentation and discussion coordinated by Mr Scott Sherlock (NICNAS’s visitor from the United States Environmental Protection Agency – USEPA)

LRCC evaluation … release of final report on the evaluation of the impact to industry

Second NICNAS Industry Engagement Group meeting

regarding work-sharing arrangements between Australia and the US.

A key outcome of the meeting was agreement that a small group of members assist in reviewing drafts of the revised version of the NICNAS Handbook for Notifiers.

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The first phase of the LRCC evaluation project is now complete. In this first phase the impacts on industry have been evaluated by Campbell Research - an independent consultant commissioned by NICNAS.

This involved 23 in-depth, one-on-one stakeholder consultations with peak bodies, industry leaders and a broad range of companies who interact with NICNAS about LRCCs. The findings of these consultations were explored through a series of case studies and were tested across industry using an online survey. Additionally, some limited consultation took place with community, OHS and environmental representatives

A draft report detailing the findings from this first phase was released for public comment in July 2009. The public comment period ran for 5 weeks, with six submissions being received.

The final report for the first phase, incorporating the feedback received, is now available

online at: www.nicnas.gov.au/About_NICNAS/Reforms/LRCC_Evaluation.asp}.

NICNAS thanks all those who provided input during this first phase. The level of participation was very good, with more than 800 industry stakeholders participating in the online survey, ensuring that the evaluation findings will be useful in considering future improvements to these LRCC initiatives.

The second phase of the evaluation is planned during 2009-10. This is intended to concentrate on the impact of the reforms on the community and other stakeholders, such as other government agencies. It will expand on preliminary comments from community representatives included in the first phase and provide a more comprehensive overall evaluation of the LRCC reforms.

Please call 02 8577 8800.

Upcoming eventsAT HOME

November 29 - 2 Dec Australasian Society of Clinical & Experimental Pharmacologists & Toxicologists (ASCEPT) Annual Scientific Meeting, Sydney

December4 Australian College of Toxicology and Risk Assessment (ACTRA) Annual Scientific Meeting, Canberra

5-9 Australian Institute of Occupational Hygienists (AIOH) Conference on New and Emerging Issues, Canberra

6-10 Pacific Polymer Conference, Cairns

February 201018 Cosmetic Advisory Group 2, NICNAS

22-26 International Conference on Nanoscience and Nanotechnology (ICONN) Sydney

March

16 NICNAS Industry Government Consultative Committee (IGCC) 36, at NICNAS

July

8-10 IUPAC & RACI National Convention: Chemistry for a sustainable world, Melbourne

ABROAD

November 30 - 1 Dec OECD Exposure Task Force, Paris, France

December

9 – 11 UN 18 th Subcommittee of Experts on the GHS of Classification and Labelling of Chemicals Geneva, Switzerland

February

9-11 OECD Joint meeting of the Chemicals Committee & Working Party on Chemicals, Pesticides & Biotechnology, Paris, France24-26 OECD Clearing House on New Chemicals, Tokyo, Japan

March

1-4 APEC Chemicals Dialogue (including Regulator’s Forum and Workshop on Good Regulatory Practices for Chemical Regulation) Hiroshima, JapanApril

20-23 SIDS Initial Meeting Paris, France

© Commonwealth of Australia 2009. This work is copyright. Apart from educational or training purposes and any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Canberra ACT 2600 or posted at: http://www.ag.gov.au/cca

A NICNAS/TGA Consultation Regulatory Impact Statement, released on 11 November 2009 and which forms the basis of the consultations, is currently available to download from the NICNAS Homepage.

The consultation document focuses on the regulatory arrangements for household and commercial grade disinfectants (without specific claims), sanitisers, sanitary fluids and antibacterial surface wipes. These products are currently regulated under the therapeutic goods regime and are exempt from pre-market assessment scrutiny by the TGA.

The public consultations continue a review of the current regulatory framework for household and commercial grade hard surface disinfectant products, which for the purposes of the review are defined as substances that

Consultations on options for reforming the regulation of hard surface disinfectantsPublic consultation on regulatory impact: submissions close Friday 12 February (from page 1)

are applied to an inanimate object or surface to kill a range of micro-organisms. The review does not include products to sterilise surgical instruments.

NICNAS is encouraging written submissions as part of the public consultation, and comments received will be used to inform a regulatory impact analysis, and in developing a final Government position. NICNAS also held public meetings in Sydney on 16 November, Brisbane on 17 November and Melbourne on 18 November.

If you would like to register your interest for any further public meetings (subject to demand) or a discussion by teleconference, please contact NICNAS on the above numbers or email.

To obtain a copy of the consultation regulatory impact\ statement and other associated information visit: www.nicnas.gov.au, phone: 02 8577 8800 / 1800 638 528, or email: info@nicnas.gov.au .

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Please note: The NICNAS office will close on Thursday 24 December 2009 and re-open on Monday 4 January 2010.

SPECIAL FEATURE: NICNAS’s Prioritisation Project

The prioritisation of chemicals on the AICS

PLEASE NOTE: Full details and a history of the Existing Chemicals Program Review may be found on the NICNAS website (at www.nicnas.gov.au/About_NICNAS/Reforms/Review_Of_The_Existing_Chemicals_Program.asp)

Overview of the project:

Aim Prioritise chemicals for assessment in a more targeted manner so that unassessed chemicals of greatest hazard and exposure can be screened by applying a risk based approach with the use of a set of rigorous and transparent screening criteria

Objective Identify chemicals on AICS for further consideration by using indicators or elements of risk (ie. hazard and exposure). This will allow a large number of chemicals to be assessed in an efficient and effective manner

Method Base priority for each chemical on risk to humans and the environment, rather than hazard alone (meaning that information on the use of each chemical and the amount in use in Australia (“Exposure Data”) will be important for determining priority)

Results / outputs

Prioritised list of substances (eg. high hazard and/or exposure) for further consideration

What is the Australian Inventory of Chemical Substances (aka AICS or the Inventory)?

A list of … all (38 000) industrial chemicals that were nominated by industry as available for use in Australia between 1 January 1977 and 28 February 1990A … also contains new chemicals subsequently assessed (and corrections, as required)

Contains … chemical identity data for over 38 000 chemicals.

Doesn’t contain …

information on toxicity, use, manufacturers or importers (as this information was not collected at the time it was compiled) except for assessed chemicals

A legal device …

that distinguishes new from existing chemicals:

existing chemicals: industrial chemicals listed on AICS – can be imported or manufactured in Australia without first being notified to NICNAS

new chemicals: industrial chemicals not included on AICS, unless outside the scope of the Industrial Chemicals (Notification and Assessment) Act 1989 or otherwise exempt from notification – must be notified and assessed before being manufactured or imported into Australia

Maintained by NICNAS

Features … A non-confidential (public) section and a confidential section.

A. Most of the 38 000 (approximately) AICS-listed chemicals were “grandfathered” onto the list in 1990 and have not been formally assessed for their effects on human health and the environment, either by NICNAS or internationally.

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EEWG members: Standing (L to R) Prof. Des Connell (independent expert), Dr David Perry (DEWHA), NICNAS staff members Dr Trang Pham and Dr Kerry Nugent (observer); Seated (L to R) Dr Sneha Satya with independent experts Dr Suzanne Reichmann and Ms Therese Manning. Attending by teleconference: Ms Danie Dubé (Environment Canada)

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SPECIAL FEATURE: NICNAS’s Prioritisation Project

Advisory bodies set up for implementation of EC Review recommendations

Group Role

Implementation Steering Group (ISG)

Guides NICNAS in implementing EC Review recommendations

Technical Working Party Addresses the various recommendations that deal with the screening and prioritisation of chemicals of concern and the development of new assessment products (due to their technical nature)

Environmental Expert Working Group (EEWG)

Provides expert advice on environmental hazard indicators or elements of risk

Advises on robustness of scientific criteria that address these (this will then form part of an overall framework for screening chemicals on the Inventory)

Human Health Expert Working Group

Provides expert advice on human health hazard indicators and criteria

Advises on robustness of scientific criteria that address these (this will then form part of an overall framework for screening chemicals on the Inventory)

Current activities

1: Environmental Expert Working Group (EEWG)

The EEWG is developing scientific criteria for environmental end points for use in the Prioritisation project as a whole. At the group’s second meeting (1 December 09) members discussed the use of predictive models in prioritisation and approaches for prioritising chemicals belonging to various classes (eg. organic, inorganic, polymer etc) and gave consideration to combining and weighting hazard indicators so that a manageable set of chemicals that are of high priority can be identified for further consideration.

2. Exposure Data workshop (see page 13)

3. Human Health Expert Working Group (HHEWG)The HHEWG will meet in the first and second quarters of 2010 and will provide expert advice and assist in developing the scientifically-based criteria for human health endpoints for prioritisation of chemicals on the AICS. It will be chaired by NICNAS and comprise of four external members with expertise in the areas of toxicology, risk assessment and predictive modeling. Members are appointed on the basis of their individual skills, knowledge and expertise. The committee will report to the Technical Working Party.

SPECIAL FEATURE: NICNAS’s Prioritisation Project

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Current activity: Exposure Data workshop

A workshop on issues associated with industry provision of data required for the NICNAS Prioritisation Project was held in Sydney, on 27 October 2009. A discussion paper was provided to participants, and NICNAS sought ideas and suggestions from Industry to facilitate developing a framework for collecting data needed for prioritisation.

The Workshop was attended by representatives of around 20 individual small to large companies and two major industry associations (ACCORD and PACIA). Sectors covered ranged from companies which supply formulated products (including consumer products such as cosmetics) to those which use chemicals industrially.

The afternoon sessions addressed specific technical issues about the availability of data from individual chemical companies. The workshop addressed specific questions:

Availability of exposure information

Questions: Is it feasible within your inventory management system to track your import and/or manufacture of individual chemicals?

What type of inventory management system do you use? Electronic or some other system?

Are you able to supply some or all of the information items a, b and c with your existing inventory management system?

What issues make it difficult to supply some or all of this information?

Options for data collection

Options given:

Publishing lists of chemicals and asking industry to provide the requested information on the chemicals on the list that they introduce C

Asking each company to provide the requested information on all industrial chemicals that they introduce

Questions: Are either of the options above more compatible with your inventory management systems?

Do either of these options raise specific difficulties for your company? If yes, what are these?

Are there other specific options for collecting the information that could be considered?

Threshold quantity

Questions: Would the creation of a quantity threshold, below which reporting is not required, assist you in limiting the work involved in supplying information?

Would it be more consistent with your inventory management system if the threshold was optional, ie you could report chemicals at lower quantities if it was more efficient to do so?

Reporting period

Questions: What time period would best represent your turnaround time for stock of all individual chemicals or chemical products that you introduce?

Are you able to provide appropriate retrospective data for all chemicals over this time period?

If not, are you able to commence collecting data once a NICNAS request is foreshadowed or published?

C Technical impediments to the compilation of this information were also addressed. In particular, the key issue discussed was whether there was any advantage to industry in supplying a limited amount of data on all of the chemicals that a company uses, compared with only supplying information on chemicals as they were named as “of interest” by NICNAS.

Information obtained from the Workshop participants will inform the development of a proposal for data collection which addresses the technical impediments faced by industry.

The information will be further discussed by NICNAS’s advisory committees and, at a later stage, industry will be further consulted.