Office of Chemical Safety
Friends of the Earth
Public submissions to the review of the National Industrial Chemicals Notification and Assessment Scheme.
Friends of the Earth submission to the Better Regulation Ministerial Partnership review of NICNASFriends of the Earth Australia Nanotechnology Project Ph: 03 9419 8700 Extension 03 PO Box 222 Fitzroy VIC 3065 ABN: 18 110 769 501
Friends of the Earth welcomes the opportunity to submit comments to the Better Regulation Ministerial Partnership, ahead of the development of a formal discussion paper. We apologise for the late submission of these comments and ask that they be considered as part of the BRMP review.
Please note that these comments are not comprehensive. We submit these short comments to highlight some particular concerns we have in relation to chemicals regulation and the parameters of this inquiry.
We would like to state our concern that by limiting this inquiry to NICNAS and ‘industrial chemicals’, the inquiry will inevitably overlook key chemicals regulatory challenges, for example in relation to agricultural and environmental applications regulated by the APVMA, or for occupational settings in which regulation and activities undertaken by Safe Work Australia are clearly relevant to the safe handling of industrial chemicals. We note that nanotechnology poses a serious and growing challenge for chemicals regulation, but that regulatory responsibility for it is spread across at least seven federal regulators. We are concerned that by limiting this inquiry to NICNAS that it will thereby exclude from consideration the critical question of whether Australian regulation as a whole is capable of effectively managing public, occupational and environmental risks associated with chemical exposure, including those associated with nano-forms of both ‘new’ and ‘existing’ chemicals.
We would furthermore like to state our concern that the inquiry is taking place with a key goal of "reduction of regulatory burden" or "deregulation". We suggest that the primary goal of regulation of industrial chemicals must be to safeguard human health and that of the environment. Promoting industry development and/ or reducing compliance costs must be subsidiary goals.
It has been our experience that the staff of NICNAS currently struggle with the significant job of enforcement, compliance, chemicals assessment and the tracking of commercial use of nanomaterials. We would be extremely concerned to see any reduction in regulatory power or resourcing for NICNAS activities. Especially in the area of nanotechnology, there is an urgent need for new and nano-specific regulation, in order to redress the substantive gaps that leave nano-forms of existing chemicals effectively unregulated.
Friends of the Earth notes that NICNAS has already undertaken extensive work to ensure that as much as possible, data from overseas assessments of chemicals under comparable schemes are used for Australian assessments, which already minimises costs to industry here.
Finally, we are concerned at the implied assumption that existing regulation is sufficient to manage risks to health and safety. We note that this is patently not the case in three key areas in which Friends of the Earth works: nanotechnology, coal seam gas extraction, and endocrine disrupting chemicals (see detailed comments in point 3 below).
Objectives of the BRMP
- Role and functions of NICNAS to extent that reflect international best practice
- Governance and consultation arrangements
- Efficiency and effectiveness of NICNAS operating arrangements having regard to protection of human and environmental health, management of risk and compliance costs for business
- Implications for resourcing functions currently cost recovered.
Objective 1: Role and functions of NICNAS to the extent that they reflect international best practiceDespite the strong technical work that is undertaken by NICNAS staff, it is not possible for its activities to ‘reflect international best practice’. This is due to:
- Complexity of the regulatory framework. According to the Government’s Standing Committee on Chemicals, there are nine Federal Ministries involved in the regulation of chemicals and plastics. The efficacy of this arrangement should certainly be assessed in the BRMP review
- The enormous ‘backlog’ of chemicals which have not yet been assessed. There are almost 40,000 industrial chemicals listed on AICS which have been ‘accepted’ for use, having been listed at the time the AICS was established, although for the majority no assessment has even been conducted by NICNAS. This is a major barrier to NICNAS carrying out effective chemicals governance. It is effectively disaster-driven regulation, where chemicals are assumed to be safe until proven (by the community or by accident) to be so harmful that an assessment is conducted. We note that internationally, other jurisdictions have taken proactive measures to close similar gaps, for example the Toxic Use Reduction program in the United States, or REACH in Europe.
- A lack of Australian data on both exposures and uses of chemicals. This is a major barrier to improving our understanding of disease etiology and to removing or reducing threats to occupational, public and environmental health.
- The enormous technical challenges associated with effective risk assessment of both new and existing chemicals (eg see comments below about nanomaterials and endocrine disruptors). It is our concern that validated, nano-specific safety assessment methodologies and standardised characterisation protocols remain years away. In the mean time, people and the environment remain at risk of unassessed nanomaterials, which the early scientific evidence suggests may pose serious new risks. It is our strong view that until validated, nano-specific regulations are developed and implemented, and NICNAS and other regulators have sufficient power to deliver effective assessment, and enforcement and compliance, that this new generation of chemicals should not be permitted in commercial use.
Objective 2: Governance and consultation arrangementsGovernance: Friends of the Earth recognises that NICNAS requires additional powers and greater resourcing in order to fulfil its core responsibilities, especially in relation to nanomaterials, but more broadly in relation to endocrine disruptors and other chemicals for which emerging toxicological research suggests that existing risk assessment measures are inappropriate.
Consultation: We recognise the strong commitment that NICNAS has made to public consultation, including through ongoing consultation with stakeholders through the formalisation of the IGCC and the CEF, and ensuring community and industry representation on the various technical working groups, additional to technical experts. We recognise the value that this engagement has delivered, with more comprehensive and robust input into new regulatory and administrative arrangements.
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Objective 3: Efficiency and effectiveness of NICNAS operating arrangements having regard to protection of human and environmental health, management of risk and compliance costs for businessWe recognise that the work of NICNAS staff is of a high technical standard, and is carried out efficiently, as concluded by last year’s Activity Based Costing study. We also recognise the efforts that NICNAS staff have put into active response to the findings of the 2007 Review of Nanotechnology Regulation in Australia (‘the Monash report’). We commend NICNAS for being the most proactive of the federal regulators in this regard. However, we note that the full cost recovery framework and the limits on resources and powers constrain and undermine the work NICNAS can complete. We are particularly concerned about the lack of capacity of NICNAS to pursue necessary market monitoring, enforcement and compliance activities. We note that this is a long-standing challenge in relation to industrial chemicals. We would also like to make some more detailed comments in relation to three areas in which Friends of the Earth works actively: nanotechnology, endocrine disrupting chemicals, and coal seam gas extraction.
It has been our experience that NICNAS staff struggle to obtain accurate data about the commercial use of manufactured nanomaterials. We note that subsequent to NICNAS voluntary industry surveys, voluntary disclosure of commercial use of nanomaterials has been extremely low. It is also our understanding that industry compliance with new regulations introduced this year for notification of nano-forms of new chemicals has been low. We are greatly concerned that further to the anticipated introduction next year of regulation of nano-forms of existing chemicals, NICNAS will not have the necessary resources to pursue education, outreach, detection, enforcement and compliance activities. There is a very real risk that without additional resources to conduct these activities, NICNAS will be effectively unable to regulate the nanotechnology sector. This will leave workers, the public and the environment at risk of exposure to effectively unregulated nanomaterials, and greatly compromise public confidence in the governance of this sector.
We are also particularly concerned about endocrine disrupting chemicals, for example bisphenol A (BPA). In recent years, new toxicological research has thrown into question the paradigms in which risk assessment currently takes place. For example scientists have found that some chemicals react differently at low doses than they do to high doses. Data now exists that shows that chemicals such as BPA, phthalates, polychlorinated biphenyls (PCBs), dioxins, heavy metals such as lead and mercury, perchlorate, and some diverse pesticides such as hexachlorobenzene and atrazine can cause harm at low doses. This is of particular concern in regards to chemicals such as endocrine disruptors that mimic hormones. Endocrine disruptors can disrupt crucial life functions particular in young children and foetuses. Hormones regulate body functions such as digestion, growth and sexual function, so any disruption of proper hormonal function can create health problems. It has been argued in terms of endocrine disruption that "no dose is low enough".
Myers et al (2009) argued that: "We recommend that procedures to establish acceptable exposure levels for endocrine-disrupting compounds incorporate the inability for high-dose tests to predict low-dose results. Setting acceptable levels of exposure must include testing for health consequences at prevalent levels of human exposure, not extrapolations from the effects observed in highdose experiments. Scientists trained in endocrinology must be engaged systematically in standard setting for endocrine-disrupting compounds
We are also concerned that NICNAS lacks the capacity – due to limitations in power and resourcing -to conduct appropriate risk assessment exist in relation to Coal Seam Gas Extraction (‘fraccing’). We note that there are twenty three chemicals involved in fraccing, none of which has had adequate assessment and that NICNAS has no power to gather the necessary information to undertake these assessments. Given the strength of Recommendation 10 of the recent Senate Interim Report1 on fraccing, it is clear that NICNAS requires additional powers:
The committee recommends that the Commonwealth provide funds to NICNAS to enable that organisation to undertake a comprehensive review of the chemicals used in fraccing, having particular regard to the quantities, combinations of chemicals and the way in which these chemicals are used and to confirm safe levels for their use. This study should be completed within the next two years. The Commonwealth and state governments should act promptly to ensure all fraccing activities comply with any NICNAS recommendations.
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Objective 4: Implications for resourcing functions currently cost recoveredNICNAS clearly requires additional funding to ensure core functions are carried out and that the standard of protection of public, worker and environmental health meets community expectations. We recognise the need for greater resourcing to close the gap on the enormous number of unassessed chemicals in commercial use, which are currently putting occupational and public health, and the health of ecological systems, at risk. We also recognise the need for far greater resourcing to ensure that the assessment of the new generation of nano-chemicals can be undertaken effectively. If sufficient resourcing cannot be provided, then the power to support a moratorium on the further commercial use of nanomaterials should be given to NICNAS as a matter of urgency.
We emphasise that NICNAS requires additional powers to ensure that assessments on limiting or banning certain chemicals can be meaningfully implemented. This includes the power to require information on the quantity and use of chemicals and downstream users, to ban or restrict chemicals based on NICNAS assessments and to further increase the use of assessments from comparable overseas schemes. However improvements to NICNAS taken in isolation of a broader approach to chemicals management will inevitably prove inadequate.
We recognise that for certain areas, or categories of chemicals, it makes sense to have an overarching body charged with ensuring that regulation across the various agencies is consistent and sufficient to protect the health of people and environment. This is the case in relation to occupational safety and exposure to toxic chemicals, and also in relation to nanotechnology. This body should be situated outside NICNAS and be empowered to ensure that approaches taken by NICNAS, APVMA, Safe Work Australia, FSANZ, the TGA and other regulators are consistent, complementary, avoid duplication, and ensure that difficult aspects of chemicals assessment or management do not simply fall through the cracks.
1Interim report: the impact of mining coal seam gas on the management of the Murray Darling Basin on the Senate committee website. http://www.aph.gov.au/Parliamentary_Business/Committees/Senate_Committees?url=rrat_ctte/mdb/interim_report/report.pdf
Finally, we support a wide ranging review into Toxics Use and Chemical Regulation as to underpin development of a regulatory regime that reduces the use of toxic chemicals. We suggest that models that should be investigated for improving Australia’s regulation of toxic chemicals include the Toxics Use Reduction program in the United States and that of REACH in the European Union, based on the principles of ‘no data, no market’ and of the ‘right to know’ of workers and the public.
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