CEF meets in Canberra

The CEF met in Canberra on 19 August 2011 and was briefed on current government thinking on regulatory reform by the Hon. Catherine King MP, Parliamentary Secretary for Health and Ageing.

In particular, Ms King announced the Government's commitment to accelerating the process for assessing existing chemicals that are in use, and on the Australian Inventory of Chemical Substances (AICS) but which have not been assessed. NICNAS will assess 3,000 of these chemicals that are known to be used in high volume, subject to regulatory restriction overseas, or have been detected in human blood. Funding will be addressed through the draft Cost Recovery Impact Statement.

Pictured above right, at Parliament House: Dr Andreas Lopata, Dr Marion Healy, Ms Renata Musolino, Mr Nick Miller,
Mr James Courtney, Dr David Oakenfull, Ms Jane Bremmer,
Mr Justin Roberts. Absent: Ms Pamela Grassick

COAG Standing Committee on Chemicals

The Council of Australian Governments (COAG) Standing Committee on Chemicals (SCOC) was set up in 2009 with the objective of streamlining Australia’s complex regulatory system.

Chemicals and plastics are regulated to maintain public and occupational health and safety; protect the environment; and maintain national security. At the national level responsibility is currently divided between several government agencies that include:
• National Industrial Chemicals Notification and Assessment Scheme
• Australian Pesticides and Veterinary Medicines Authority
• Safe Work Australia
• Food Standards Australia New Zealand
• Therapeutic Goods Administration
• Australian Competition and Consumer Commission.

The SCOC is charged with achieving an effective and efficient national system of chemicals and plastics regulation. It held stakeholder forums in October 2010 and August 2011 to seek the views of industry and community representatives.

The SCOC's third progress report has been published and is available on the SCOC's website (please click SCOC or follow the links to the Chemicals and Plastics - SCOC pages at: www.innovation.gov.au/Industry).

Lead in Children's Playgrounds

At the 25th CEF meeting (held on 6 May 2011) members raised concern with NICNAS over residues of lead chromate found in children’s playground equipment in Esperance, Western Australia. The discovery was made by the Western Australian Department of Health, which found that ten playgrounds were affected, some with readings 250 times the safe standard.

The WA Department of Health has posted a notice on their website advising local governments and the public that if equipment is found to have lead residues then it should be removed and not repainted. It also advises parents to wash their children’s hands after playing on public playground equipment.

CEF member Ms Jane Bremmer has written formally to the Australian Competition and Consumer Commission (ACCC) and NICNAS requesting details of the actions that these regulatory agencies will take to ensure the protection of children’s health - not only in WA but throughout Australia.

The ACCC has advised that the issue is beyond their regulatory responsibility. NICNAS indicated that the state health department was the appropriate authority to deal with government-owned playgrounds. NICNAS will raise the matter with the federal Environmental Health Committee (enHealth).

Ethylene Propylene Diene Monomer (M-class) rubber

Also at the 25th CEF meeting, members raised concerns about the use of Ethylene Propylene Diene Monomer (M-class) rubber (EPDM) which is used extensively in synthetic turf and soft fall materials in children’s playgrounds, schools and sports fields.

NICNAS advised that this chemical was grandfathered on to the AICS and has not been subject to any human health or environmental toxicological assessments by NICNAS or the Australian Government. Research by NICNAS had indicated that the chemical is of low toxicity. Any adverse effects are due to the impurities or additives in products containing EPDM.

CEF members are concerned about the increasing and widespread use of this chemical in rubber products in the public domain and particularly in children’s playgrounds.

At the 26th CEF meeting, NICNAS reported back with available hazard information for EPDM, noting that potential toxic effects from products containing EPDM may be attributed to the residual monomers and other constituents contained within the product.

Coal Seam Gas chemicals

At the last CEF meeting (CEF 26) in August 2011, NICNAS indicated that a preliminary analysis of chemicals currently known to be used in coal seam gas (CSG) production is being undertaken with a view to identifying which chemicals will require a priority assessment of their human health and environmental impacts.

NICNAS will also produce chemical safety information sheets on CSG chemicals for the community, industry and the government.

The CEF members advised NICNAS that they would like to be closely engaged with the production of public information sheets relating to this issue.

NICNAS's 2010 Stakeholder Survey

At CEF 25, members received a detailed report on the findings of NICNAS’s 2010 stakeholder survey which sought stakeholder feedback on AICS; Communications; Training and workshops; Cosmetics; the Cost Recovery Impact Statement (CRIS); New chemical notifications; and Overall NICNAS service.

Invitations to participate in the NICNAS survey were sent to 6,105 NICNAS contacts (including all Registrants, a variety of individuals representing community groups and academics) and an additional 246 contacts from within Government (individuals from departments which work with NICNAS).

From these, 1,069 responses were received – with 50% from the industry sector. While 29% of respondents did not indicate their sector, the remaining 21% comprised the education/research/scientific sector (3%), government (3%) NGOs (3%) and industry associations/peak bodies (1%). Eleven percent indicated they belonged to ‘other’ sectors.

The results indicate that NICNAS stakeholders generally view NICNAS positively. However they believe there are opportunities for NICNAS to improve outcomes across a range of areas including our support services, training and workshops and our publications.

Satisfied NICNAS stakeholders outnumber dissatisfied stake-holders by at least 3:1 across all measures (up to 16:1). Particularly strong satisfaction was observed in relation to ratings for NICNAS staff (including their courtesy, helpfulness and knowledge), their scientific approach to assessments, and the ease of contacting NICNAS. Low levels of dissatisfaction (9% or under) were observed across all service areas tested in the survey. Satisfied stakeholders outnumbered dissatisfied stakeholders 7:1 on an overall service rating (with only 7% dissatisfied in this area).

Chemical Safety Updates

DEHP, Triclosan and Chrysotile Asbestos

Diethylhexyl phthalate
Diethylhexyl phthalate, known as DEHP, was identified as a chemical requiring public health risk assessment in March 2006 by NICNAS. DEHP is used as a plastic softener in the manufacture of a range of polyvinyl chloride (PVC) industrial and consumer products. The assessment aimed to determine the effects on children and adults from repeated or prolonged exposure to DEHP in some cosmetics and toys that contain the chemical. 

DEHP is almost completely absorbed by the body if swallowed or inhaled. It is not easily absorbed by the skin. The potential for immediate toxic impacts is low as is the risk of DEHP causing eye and skin irritation or increased sensitivity. Repeatedly exposing rodents to DEHP did result in adverse effects on the liver, kidneys and reproductive system (mainly males). Studies with rats showed that DEHP in some instances caused certain types of leukaemia and cell tumours. The toxic impacts on the liver and kidneys of rodents were considered to be species specific and do not prove that the same impacts will occur in humans.

The limited number of studies conducted so far does not provide consistent evidence of DEHP impacting on the reproductive systems of humans, though consistent results in rodent studies are considered relevant enough to provide information to consumers to limit exposure.

The main route of exposure to children of DEHP is through the mouthing, chewing and sucking of toys and childcare articles containing DEHP. Risk of absorbing DEHP through normal handling is considered minimal. The second exposure pathway is through the skin via cosmetics containing DEHP or in some cases inhalation. Given the low acute toxicity of DEHP this risk is considered low, however there is a slightly higher risk to pregnant and breastfeeding women using multiple products containing DEHP.

NICNAS has recommended that the Australian Competition and Consumer Commission consider appropriate regulatory measures to limit exposure to DEHP in toys and childcare equipment and that the use of DEHP in cosmetics is considered for scheduling.

The ACCC has introduced a permanent ban from January 2011 on the use of DEHP in certain plastic products. This follows an interim ban that was effective from March 2010.
The delegate for scheduling has determined that DEHP will be listed in Appendix C of the SUSMP (see: www.tga.gov.au/industry/scheduling-poisons-standard.htm).

Triclosan
The chemical triclosan is an antimicrobial agent that is contained in many consumer products at very low concentrations. It is imported into Australia as a raw chemical (and also as an ingredient in cosmetics and personal care products) and is used as an ingredient in many personal care products, therapeutic products and cleaners. Concerns about the impact of triclosan on the environment caused NICNAS to conduct the world’s first full risk assessment of the chemical to determine its potential impacts on human health and the environment.

The assessment found that the chemical posed no risk to the general public, though the use of several products containing triclosan simultaneously raised some concerns. Triclosan was detected in breast milk samples at extremely low levels, though there is no evidence of harm to babies from this exposure. The assessment did not find convincing evidence that humans exposed to triclosan are at risk of building antibacterial resistance. Workers exposed to large amounts of triclosan dust can experience inhalation toxicity, respiratory, skin and eye irritation, therefore workplace practices such as engineering controls and the use of personal protective equipment to reduce exposure are recommended. In regards to the environment, measured levels of triclosan in Australia are low compared to international studies and the risk does not warrant regulatory action at this time. NICNAS does however recommend wider sampling studies be conducted to monitor the issue.

The NICNAS study recommended: OHS and transport regulations be amended and that suppliers and employers of workers at risk of exposure be advised of changes to Material Safety Data Sheets and product labels; and that allowable limits for triclosan in cosmetics and personal care products are set through the scheduling process. Since the release of the report, the delegate for deciding amendments to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) has announced a schedule 6 entry for triclosan in cosmetic preparations for human use containing more than 0.3% triclosan. This scheduling decision comes into effect on 1 May 2012. Further information is available at: www.tga.gov.au/pdf/scheduling/scheduling-decisions-1103-final.pdf

Chrysotile Asbestos
Chrysotile is a type of asbestos that is used in the manufacture of vehicle brake pads, linings, clutch plates and gaskets.  In the past it was also used in the manufacture of some insulation, cement materials, vinyl floor tiles, piping and sealants. The material was assessed by NICNAS in 1999 and a phase out of the product was recommended. Any product containing more than 0.1% chrysotile is classed as a Hazardous Substance and the product is categorised under class 9 of the Australian Dangerous Goods Code which sets restrictions over its storage and transport.

The main risk to humans from chrysotile is from inhaling it, which can result in lung cancer, mesothelioma and asbestosis. Smoking combined with chrysotile exposure increases the risk of lung cancer. NICNAS advises that there may be no safe exposure level for chrysotile, so all exposure should be avoided and that the use and importation of the product be phased out. Where it is used exhaust ventilation should always be employed to avoid exposure, specific existing procedures for handling spills and disposal of the product must be followed and workers using chrysotile should be trained on its safe use and undergo regular health checks. Home mechanics should also be aware that replacing brake parts can cause exposure to chrysotile. The national exposure standard for chrysotile is 0.1 fibre/ml of air.

National Asbestos Management Review

Asbestos is a toxic substance which can lead to mesothelioma and lung disease. It is endemic in the Australian built environment, in buildings built prior to the mid- to late-1980s. It was finally banned from import and use in December 2003. The problem we face now is what to do with it, and how to manage it.

Australia has one of the highest incidences of mesothelioma in the world. The Australian Government last year commissioned Mr Geoff Fary, previously an ACTU Assistant Secretary, to make recommendations for the development of a national strategic plan to improve asbestos awareness and management. Mr Fary has been asked to report on:
• the enhancement of education and public awareness
• the efficacy of asbestos import and export controls
• asbestos removal, handling, storage and disposal
• mandatory reporting and disclosure where asbestos is detected, and
• mandatory collection of data and reporting on associated health issues.

The Asbestos Management Review Issues paper was released for public comment (please see: http://www.deewr.gov.au/WorkplaceRelations/Policies/AMR/
Pages/default.aspx). While the CEF did not make a submission to this review, the ACTU (and other peak union councils, including the VTHC), unions and Asbestos Diseases support groups did. The report must be provided to government by 30 June 2012.

Please also see Chemical Safety Updates: Chrysotile Asbestos (previous item).

NICNAS Cost Recovery Impact Statement – CRIS

The Australian Government requires its cost recovered entities to undertake a CRIS every five years. NICNAS is currently finalising the draft CRIS, in consultation with the Department of Health and Ageing (DoHA) and other government stakeholders to ensure the CRIS meets the government’s cost recovery policy and guidelines. Supporting documentation is also being drafted, including a broad overview of NICNAS costs relative to comparable national and international regulators, a summary of issues raised by stakeholders through written submissions and the online survey and a trend analysis of major NICNAS activities since the 2005 CRIS.

The CEF provided input in response to the initial discussion paper, both through attendance at briefings and through a written submission. We intend to make a submission to the draft CRIS once it is released for public comment (currently planned for October/November). During the six-week public comment phase, NICNAS will be running public meetings in a number of cities (advice will be provided on the NICNAS website www.nicnas.gov.au).

Changes to the NICNAS Act

The Parliamentary Secretary for Health and Ageing, the Hon. Catherine King, MP, introduced the Industrial Chemicals (Notification and Assessment) Amendment (Inventory) Bill 2011 into Parliament on 6 July 2011.  It was passed without amendment by the House of Representatives on 18 August 2011 and by the Senate on 15 September 2011. The Bill received Royal Assent on 26 September and became law on 27 September 2011.

The Bill completes reforms to the cosmetic/therapeutic chemicals interface and makes technical changes that will enhance the administrative efficiency of NICNAS's assessment processes.

The changes will enable the Director of NICNAS to add to the public section of the Australian Inventory of Chemical Substances (AICS) chemicals that are transferred to the industrial chemicals framework, under certain circumstances. The measure includes a public and appealable process to maintain transparency and accountability.

NICNAS will apply this new mechanism as soon as possible to cosmetic chemicals in certain products previously regulated by the Therapeutic Goods Administration that were transferred to NICNAS in 2007 - a change that will address a regulatory gap in the protection of public health by maintaining the legislated basis for the controls on these cosmetic ingredients. 

The Bill is also designed to enhance the administrative efficiency of the assessment processes, including:
• removal of the need to prepare and publish summary assessment reports, while maintaining easy public access to key information on these assessments, and 
• provision of greater certainty to industry as to what data NICNAS requires to undertake a new chemicals assessment.

The passage of the Bill through Parliament follows consultations with key stakeholders during 2010 and 2011 and is supported by industry, community and government stakeholders alike. NICNAS will inform stakeholders of when and how it will implement the measures in the Bill.

NICNAS and the ECHA

NICNAS is to be congratulated on successfully negotiating a Memorandum of Understanding with the European Chemicals Agency (ECHA).
The Memorandum will facilitate technical cooperation, encourage harmonisation to reduce duplication, and support the sharing of experience about operations, regulatory capacities and the dissemination of information.

The full text of the Memorandum, signed in May this year, can be found at: http://echa.europa.eu/doc/ECHADocuments/echa_australia_
mou_20052011.pdf