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December 2009

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B I an d
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NA NO M A T E R IA L S
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N A Parliamentary Secretary for Health, the Honorable Mark Butler MP has announced
the release of Proposal for Regulatory Reform of Industrial Nanomaterials – a public
A
N S discussion paper which is part of a consultation package on a proposal to strengthen
the regulation of industrial nanomaterials in use in Australia.
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. Theand
purpose of the consultation is to
gather views on the impact and
feasibility of the proposed changes to DISINFECTANTS
industrial nanomaterial regulation on
business, the community, researchers
NICNAS Annual and
Report 2008-09
government. NICNAS and the Therapeutic Goods Administration
NICNAS developed the proposal (TGA) are undertaking stakeholder consultations on the
now
in conjunction with its Nanotech- impact of proposed changes to the regulation of
available household and commercial grade hard surface
nology Advisory Group, which
comprises representatives from disinfectants on business, the community and
industry, the community and researchgovernment. The consultations, running for four weeks
sectors. (finishing on 12 February 2010) will inform a final
………………… continued on page 3 Government decision on any reforms.
……………………………………… continued on page 10

ISSN 1444 -120 9


also in this issue:
2 A word from our Director
3 NICNAS and nanomaterials, Compliance framework
4 NICNAS assessment reports, New publications
5 PEC process; Cosmetics advisory group PRIOR
ITISAT
6,7 International chemical safety update ION
feature
7 Staff news
8 US – Australia cooperative arrangements pp 11-1
3
9 LRCC evaluation; Industry Engagement Group
10 Disinfectant consultation; Upcoming events
11-13 SPECIAL FEATURE: NICNAS’s Prioritisation project
a word from
A 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
the Director 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
Dr Marion 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
Healy 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.

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

Contacting NICNAS
Do 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
2
NICNAS and Nanomaterials
continued from page 1 … particle size and surface characteristics. This information
The discussion paper addresses the six trigger areas for will be used in assessing health and environmental risks
regulatory reform identified by the independent Monash from the use of these substances.
Report: Review of the Possible Impacts of Following the release of the paper, NICNAS held public
Nanotechnology on Australia’s Regulatory Frameworks.1 consultation meetings on the proposal in Sydney (on 16
The discussion paper proposes specific regulatory November) and Melbourne (18 November). Depending on
measures for the emerging field of nanotechnology in demand from other centres, NICNAS may also organise
industrial chemicals. These address three elements: sessions elsewhere – or group consultations by
teleconference may be arranged for individuals or
• regulation of nanoforms of new chemicals
organisations who could not make it to meetings.
• regulation of nanoforms of existing chemicals,
and The consultation package also contains a questionnaire to
encourage written submissions and a business impact
• the principle of an integrated approach for survey that seeks more detailed information on possible
industrial nanomaterials within the NICNAS business impacts of the proposal. The period for comment
framework as a longer term strategy. on the proposal, including the return of the completed
The options in the proposal aim to maintain or enhance questionnaire and business impact survey, closes at 5pm
existing levels of public health, worker safety and on Friday 12 February 2010.
environmental protection in light of the uncertain risks To obtain a copy of the Public Discussion Paper,
posed by industrial nanomaterials, while facilitating the associated information and documents for written
ability of the community to gain from the potentially submissions, visit:
beneficial aspects of this technology, and the ability of www.nicnas.gov.au/Current_Issues/Nanotechnology/Stake
industry to innovate. holder_Consultation.asp, phone: 02 8577 8800 / 1800 638
Under the proposal, the health and environmental 528, or email: info@nicnas.gov.au.
impacts of nanomaterials will be assessed by NICNAS If you would like to register your interest for any further
pre-market on a case-by-case basis. This will ensure that public meetings (subject to demand) or a discussion by
appropriate risk assessments are conducted and controls teleconference, please contact NICNAS on the above
recommended when required. numbers or email.
Introducers will be required to provide scientific data
relevant to the assessment of nanomaterials such as 1. A Summary of the findings from the Monash Report (review) is
available on the NICNAS webpage.

NICNAS Compliance & Enforcement Framework


The. role of NICNAS is to ensure compliance with the Compliance and enforcement action is undertaken when
Industrial Chemical (Notification & Assessment) Act 1989,non-compliance is identified from various sources of
the Regulations 1990 and Cosmetics Standard 2007. information. NICNAS responds and takes appropriate action
when persons self report possible breaches, when persons
Guidance on NICNAS requirements is published through provide information of possible third party allegations and
our website, in the monthly Chemical Gazette and in NICNAS audit processes detect instances of non-
regular newsletters. Registrants are invited to attend compliance.
training and information sessions held annually in
Australian capital cities to increase awareness of the Investigations of a serious nature may require NICNAS
NICNAS role and obligations of the introducer of relevant officers to exercise their legislated powers to gather
industrial chemicals. information with consent, obtain a search warrant to enter
and search premises or obtain an injunction to seize items
NICNAS undertakes compliance activities in a introduced in breach of the legislation. Any matter
cooperative approach to encourage voluntary compliance investigated and found to be a significant contravention of
and streamline regulatory impact. NICNAS utilises our legislation will be referred to the Director of Public
information provided to other government agencies to Prosecutions for consideration of prosecution action.
help monitor compliance and reduce the burden on
business. Registrants may be selected for audit at The NICNAS Service Charter outlines
random or in response to particular concerns the standards of service that the
for that business or a particular industry. users of the Scheme and
3 the public can expect. … to page 7
Recent assessment reports:
PEC [Priority Existing Chemical] and Secondary Notification
*
Sodium cyanide (NaCN)
Why Environmental concerns: mass bird poisonings resulting from
declared a consumption of cyanide-contaminated water at tailings dams; Recent NICNAS
PEC potential release of toxic and flammable hydrogen cyanide gas publications
when NaCN comes in contact with water; high acute toxicity to
aquatic life, birds and animals; high chronic toxicity to aquatic CONSULTATION / DISCUSSION
life PAPERS
Aim of To test validity and impact of issues raised during declaration Regulation Impact Statement on
assessmen of NaCN TGA and NICNAS proposed
t regulation of disinfectants
Key Please see Recommendations in Sodium Cyanide Information Proposal for regulatory reform of
outcomes Sheet (Sept ’09). industrial nanomaterials
Current Draft PEC report released for public comment on 11 Sept 09. Papers used for Industrial
status of Decisions on requests to vary draft report (concerning NaCN Nanomaterials consultations with
report toxicity to wildlife and circumstances other than hypersalinity stakeholders
that are protective to wildlife and other matters) are available
on the NICNAS website. Papers used at Hard Surface
Disinfectants consultations with
stakeholders
Complex Soap TH17 (a barium salt)
Exposure Workshop discussion
Details of Component (less than 35%) to a variety of ready-to-use paper: technical issues relating to
uses etc grease products; more than half is used in new automotive, provision of data to NICNAS by
machinery & equipment manufacturing sites with the rest used industry within the AICS
in repairs & maintenance; not manufactured in Australia – prioritisation project
importation volume has not exceeded 5 tonnes per year in the
past 4 year REPORTS
Why re- New data provided (was classified as hazardous substance in NICNAS Annual Report 2008-09
assessed its assessment as a new chemical in 2002)
(as 2ndary Complex Soap TH17 Secondary
Notification) Notification Report
Outcome Based on new data provided, chemical is not classified as LRCC Reforms: an evaluation of the
hazardous under the NOHSC Approved Criteria for Classifying impact on industry (final)
Hazardous Substances (2004)
INFORMATION SHEETS AND
Current Final Complex Soap TH17 Secondary Notification report was
ALERTS
status of published on NICNAS website on 6 Oct 2009 after mandatory
report public comment period, during which no comments were Complex Soap TH17 Secondary
received Notification Report (overview and
recommendations)
Diethylhexyl phthalate (DEHP) CHEMICAL GAZETTES
Why Concerns regarding potential adverse health effects – October 2009
declared a particularly reproductive and developmental health effects – November 2009
PEC due to exposure to phthalates & their widespread use in December 2009
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
Please see page 5 for a diagram
Aim of To examine public health risk explaining procedures
assessmen following declaration of
t a chemical
as a PEC.
Current DEHP draft report will be released for public comment on 25
status of Jan 2010.
4 report
Procedures following a Priority Existing Chemical (PEC) declaration

1. Declaration 2. Information gathering


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

4. Checking draft for errors 3. Assessment


On completion of the draft assessment report a copy is When all information for the assessment is
sent to each applicant with a letter asking them to collected, the assessment begins. This
correct any errors in the report. NICNAS is notified stage may take 6 months or more. If no
about such errors by the applicant(s) within 28 days of applications are lodged during the
notice being sent. The notified errors are verified by information-gathering stage, the director
NICNAS and the draft report is amended accordingly. may cause an assessment report to be
prepared.

5. Variation of draft report 6. Publication of final report


Draft report is made available to the public by notice in If there are no applications lodged with the
the Chemical Gazette. Persons and organisations have AAT, a summary report of the PEC
the opportunity to request changes to the draft assessment is published. The final
assessment report within 28 days of its availability to the assessment report is issued to all
public. Submitted requests are either accepted or applicants and respondents (contacted
refused based on sound scientific judgment or advice persons such as past introducers), to
and a copy of the decisions is sent to the applicant and Federal departments responsible for human
made available to the public. An appeal to the and environmental health, and relevant
Administrative Appeals Tribunal (AAT) may be lodged authorities in each State and Territory. It is
by the variation applicant to contest NICNAS’s decision also publicly available upon request and via
to refuse the variation request. the NICNAS website.

NICNAS’s Cosmetic Advisory Group


The Cosmetic Advisory Group (CAG) has members identity of new chemicals in products previously
from industry, community and government, as well as regulated as therapeutics but now regulated as
two members with specific expertise – one in health, cosmetics, that were in commerce under TGA before the
one in formulation. At present, work is focussing on legislative changes were introduced.
implementation of the remaining elements of the Work is under way in NICNAS to prepare a list of
reforms to the therapeutic/cosmetic interface, which chemicals which may meet these criteria and which
came into force in 2007. industry can use in making their nominations of eligible
The two major current areas of work are: chemicals. In the next step, we will seek industry input to
the list of potential chemicals through the Chemical
1. The addition to the industrial chemicals regulatory Gazette. Other consultation mechanisms will also be
framework of chemicals not currently on AICS but used to ensure that the relevant information reaches all
already assessed and used as ingredients of interested companies.
therapeutic (TGA) products, where these products are
now regulated as cosmetics. 2. Data requirements for UV filters: the data
requirements will match the requirements of the TGA for
At its meeting in April, the CAG agreed to NICNAS’s these chemicals. This is required because some
staged approach to identifying and validating chemicals products containing UV filters are now
eligible for incorporation into the industrial chemicals regulated by NICNAS. For further
regulatory regime. As a first stage information will be information please see the
requested from industry about the notice in the October 2008
5
Chemical Gazette.
International chemical safety
update
Clearing House on New Chemicals OECD Perfluourinated Chemicals Activity
NICNAS, as Chair of the Clearing House, announcesThe OECD survey format on PFOS, PFAS, PFOA,
that the next meeting to be hosted by Japan will be perfluorocarboxylic acid (PFCA) and their related
held in Tokyo 24-26 February 2010. In the lead-up tocompounds and mixtures containing these substances has
the meeting the working groups under the Clearing been finalised, along with a global list of manufacturers of
House (A: parallel process, B: exemptions and these compounds identified by BIAC.
exclusions, C: electronic notification software, and D:
NICNAS assisted in developing the survey itself as well as
outreach and communication) are preparing topics
procedural matters (including the confidentiality of material
for discussion and further progressing actions agreed
submitted) and is conducting it on the OECD’s behalf.
at the first meeting held in Sydney last April.
Questionnaires were sent to companies and responses were
The Tokyo meeting will be held in the week before due by end September.
the APEC Chemical Dialogue events (planned for 1-4
NICNAS is currently preparing a report of the survey responses
March, in Hiroshima, Japan with the Good
for the OECD, for discussion at the OECD Joint Meeting of the
Regulatory Practice: Case Study Workshop on the
Chemicals Working Party on Chemical Pesticides and
Chemicals Sector - From Principles to Practice
Biotechnology in February 2010.
workshop on 1-2 March. The LRCC reform initiative
and ‘Parallel Process’ work-sharing activity under theGlobal legally binding instrument on mercury
Clearing House will be presented as case studies at
Negotiations for a global legally binding instrument (LBI) on
the APEC workshop.
mercury were initiated this year by the Governing Council for
SIAM 29 the United Nations Environment Programme (UNEP). The LBI
is likely to take the form of a multilateral environmental
Twenty-eight chemicals were scheduled for
1 agreement similar to the Stockholm and Basel Conventions.
discussion at OECD SIAM 29 (The Hague, late
The Department of the Environment, Water, Heritage and the
October). NICNAS reviewed a chemical category
Arts (DEWHA) is coordinating Australia’s participation in
called long chain chlorinated paraffins (LCCP) that
negotiations and NICNAS provided technical advice on
consists of three chemicals. These break down in the
industrial uses.
environment to short chain chlorinated paraffins
2
(SCCPs) which NICNAS assessed as a preliminaryThe Stockholm Convention’s Persistent Organic Pollutants
assessment in 2001. Review Committee’s (POPRC) 5th meeting was held in Geneva
Assessments for 20 chemicals were agreed at SIAMin mid October. A subsidiary body to the Stockholm
29. Agreed conclusions for chemicals discussed willConvention, POPRC reviews proposals submitted by Parties to
soon be submitted for the Task Force on Hazard the Convention for listing new chemicals in Annex A, B and/or
Assessment and then to the Joint Meeting of the C.
Chemicals Committee and the Working Party on The Committee reviewed information provided (including by
Chemicals, Pesticides and Biotechnology for NICNAS) and concluded that hexabromocyclododecane
endorsement through written procedure. Interim (HBCD) met criteria for adverse effects, persistence,
implementation of the new HPV Chemicals programbioaccumulation and long-range transport in Annex D of the
started at SIAM 29 with the official submission of Convention. It invited the submission of Annex E information
targeted assessments and with draft assessments on HBCD, based on which it will develop a risk profile for
proposed for agreement through written procedure. consideration at its next meeting.
Three additional phthalate chemicals (sponsored by The POPRC reviewed the revised risk profile of short-chained
Canada) were peer reviewed by NICNAS for Canadachlorinated paraffins (SCCPs) and decided to postpone a
during the preparation of the screening assessment decision to its next meeting. In the meantime additional
reports. information on environmental and health effects of SCCPs, as
well as trends in the levels in the environment will be gathered2.
…. to page 7

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.

6
NICNAS staff news
Recent 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.

International chemical safety update … continued from page


6
Memorandum of Cooperative arrangements with US and Canada
Understanding
with ERMA New US EPA|
Zealand 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
In September, Inventory of Chemical Substances (AICS)
NICNAS met with
ERMA and Health Canada & Environment Canada
industry Recognising Canada’s major achievement of categorising the Designated Substances List
representatives (DSL) NICNAS has focused efforts on activities that would contribute to the efficient and
and progressed effective prioritisation of chemicals on AICS. A staff member visited Health Canada and
the revitalised Environment Canada to learn from the Canadian experience in categorising the chemicals on
MoU, moving it their inventory. Utilising the Canadian experience, tools and approaches will reduce the
close to duplication of efforts in prioritising the chemicals on AICS and save resources. Discussion with
finalisation. The Canada also included the comprehensive cooperative arrangement incorporating both new
revised MoU will and existing chemicals and the development of separate work plans for new and existing
reinvigorate and chemicals. Through this visit and other ongoing NICNAS initiatives, links between Canada and
strengthen liaison Australia are being progressively strengthened.
between the Other recent achievements in cooperative activities include:
agencies.
A draft 12-month
• the inclusion of Canadian expertise on the Environmental Expert Working Group
(EEWG – see Prioritisation feature on page 12)
workplan was
developed with • NICNAS peer reviewing major assessments conducted by Canada, and
ERMA staff. • 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 Compliance & Enforcement Framework … continued from page 3


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
7 of non-compliance, and the options available to resolve non-compliance.
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).

Less than a year ago, the Office of Pollution Prevention provided useful input on topics including EPA policy on
and Toxics (OPPT) of the Environmental Protection inventory listings, new chemicals operations at the US
Agency of the United States (US EPA) and NICNAS EPA and the evolution of EPA’s approach to collecting
formalised an arrangement to provide for the sharing of exposure type data.
information and expertise in chemical risk identification Scott also met and addressed staff of the Plastics and
and management. It was intended that the two Chemicals Industries Association and ACCORD and was
governmental organisations would develop mechanisms a presenter at the Asia Oceania Soap & Detergents
to achieve efficiencies of resources in Association Conference (AOSDAC09) in Melbourne.
the review and management of new and existing Additionally he was a presenter at a New Chemicals
chemicals and enhance the respective abilities of Training workshop and was a resource at the Industry
the two governmental organisations to protect human Engagement Group (IEG) meeting of October at NICNAS.
health and the environment. Towards the end of his assignment at NICNAS, Scott had
The Arrangement has borne its first fruit. Scott Sherlock,the opportunity to meet our Parliamentary Secretary, the
an attorney advisor with OPPT, has spent six weeks withHon Mark Butler, further strengthening relationships with
NICNAS. During his time here Scott received detailed the
information on NICNAS’s approaches to chemical risk US EPA.
management. Equally important though was that Scott Over the last several years there has been a broad
and NICNAS staff worked out the protocols and recognition that national governmental chemical
procedures for the exchange of information and expertise. management entities benefit through collaboration with
Central to these exchanges are the protocols and their foreign governmental peers. The sharing of data and
processes for expertise, can lead to better risk management approaches
the secure transmission and storage of the information, for the benefit of all. This approach has been successful
some of which might be business sensitive data. EPA with Canada. Now NICNAS is in the process of moving
meanwhile has advised of its willingness to make beyond the ‘confidence building’ stage with US EPA and
available both data and US EPA assessments on expects Australian stake-holders, to benefit from this
chemicals the companies want to introduce into initiative in the coming years.
Australian commerce.
It complements the long existing relationship that NICNAS
During this year it is expected that a variety of data has with Canada and NICNAS's leadership role in the
exchanges on assessed new chemicals under the OECD sponsored ‘parallel process’ initiative under the
cooperative arrangements. The arrangements will enableOECD Clearing House
Australian companies / industry to use notifications on New Chemicals whereby a lead country
previously assessed in the US and vice versa. develops a hazard assessment to
During his six weeks at NICNAS, Scott was a valuable be considered by other countries
resource to NICNAS. With his experience serving as in their hazard and risk
counsel for the Toxic Substances Control Act (TSCA) assessment.
Inventory and the Inventory Update Rule (IUR) he
8
LRCC evaluation
… release of final report on the evaluation of the impact to
industry
The first phase of the LRCC evaluation project is now online at: www.nicnas.gov.au/About_NICNAS/Reforms
complete. In this first phase the impacts on industry/LRCC_Evaluation.asp}.
have been evaluated by Campbell Research - an
NICNAS thanks all those who provided input during this
independent consultant commissioned by NICNAS.
first phase. The level of participation was very good,
This involved 23 in-depth, one-on-one stakeholder with more than 800 industry stakeholders participating in
consultations with peak bodies, industry leaders andthe online survey, ensuring that the evaluation findings
a broad range of companies who interact with will be useful in considering future improvements to
NICNAS about LRCCs. The findings of these these LRCC initiatives.
consultations were explored through a series of case
The second phase of the evaluation is planned during
studies and were tested across industry using an
2009-10. This is intended to concentrate on the impact
online survey. Additionally, some limited consultation
of the reforms on the community and other
took place with community, OHS and environmental
stakeholders, such as other government agencies. It
representatives
will expand on preliminary comments from community
A draft report detailing the findings from this first representatives included in the first phase and provide a
phase was released for public comment in July 2009. more comprehensive overall evaluation of the LRCC
The public comment period ran for 5 weeks, with sixreforms.
submissions being received.
Please call 02 8577 8800.
The final report for the first phase, incorporating the
feedback received, is now available

Second NICNAS Industry Engagement Group meeting


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 regarding work-sharing arrangements between
current reform activities. Australia and the US.
A particular highlight was the presentation and A key outcome of the meeting was agreement that a
discussion coordinated by Mr Scott Sherlock small group of members assist in
(NICNAS’s visitor from the United States reviewing drafts of the revised
Environmental Protection Agency – USEPA) version of the NICNAS Handbook
for Notifiers.
9
Consultations on options for reforming the
regulation of hard surface disinfectants
Public consultation on regulatory impact: submissions close Friday 12 February (from page 1)

A NICNAS/TGA Consultation Regulatory Impact Statement, Upcoming events


released on 11 November 2009 and which forms the basis
the public meetings is free.
of the consultations, is currently available to download from AT HOME
the NICNAS Homepage.
November 29 - 2 Dec Australasian Society of
The consultation document focuses on the regulatory Clinical & Experimental Pharmacologists &
arrangements for household and commercial grade Toxicologists (ASCEPT) Annual Scientific Meeting,
disinfectants (without specific claims), sanitisers, sanitary Sydney
fluids and antibacterial surface wipes. These products are December
currently regulated under the therapeutic goods regime and 4 Australian College of Toxicology and Risk
are exempt from pre-market assessment scrutiny by the Assessment (ACTRA) Annual Scientific Meeting,
TGA. Canberra
The public consultations continue a review of the current 5-9 Australian Institute of Occupational Hygienists
regulatory framework for household and commercial grade (AIOH) Conference on New and Emerging Issues,
hard surface disinfectant products, which for the purposes Canberra
of the review are defined as substances that 6-10 Pacific Polymer Conference, Cairns
are applied to an inanimate object or surface to kill a range ofFebruary 2010
micro-organisms. The review does not include products to 18 Cosmetic Advisory Group 2, NICNAS
sterilise surgical instruments. 22-26 International Conference on Nanoscience and
NICNAS is encouraging written submissions as part of the Nanotechnology (ICONN) Sydney
public consultation, and comments received will be used to March
inform a regulatory impact analysis, and in developing a final 16 NICNAS Industry Government Consultative
Government position. NICNAS also held public meetings in Committee (IGCC) 36, at NICNAS
Sydney on 16 November, Brisbane on 17 November and July
Melbourne on 18 November.
8-10 IUPAC & RACI National Convention: Chemistry
If you would like to register your interest for any further public for a sustainable world, Melbourne
meetings (subject to demand) or a discussion by
teleconference, please contact NICNAS on the above ABROAD
numbers or email. November 30 - 1 Dec OECD Exposure Task Force,
Paris, France
December
To obtain a copy of the consultation regulatory impact\
9 – 11 UN 18th Subcommittee of Experts on the GHS
statement and other associated information visit: of Classification and Labelling of Chemicals Geneva,
www.nicnas.gov.au, phone: 02 8577 8800 / Switzerland
1800 638 528, or email: info@nicnas.gov.au .
February
9-11 OECD Joint meeting of the Chemicals
Committee & Working Party on Chemicals,
Please note: The NICNAS office will close on Pesticides & Biotechnology, Paris, France
Thursday 24 December 2009 and re-open on 24-26 OECD Clearing House on New Chemicals,
Monday 4 January 2010. Tokyo, Japan
March
© Commonwealth of Australia 2009. This work is copyright. Apart from
educational or training purposes and any use as permitted under the
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10
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 / Prioritised list of substances (eg. high hazard and/or exposure) for further consideration
outputs

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

A legal that distinguishes new from existing chemicals:


device … 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.

11
SPECIAL FEATURE:
NICNAS’s Prioritisation Project
Advisory bodies set up for implementation of EC Review recommendations

Group Role

Implementation Steering Guides NICNAS in implementing EC Review recommendations


Group (ISG)

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 Provides expert advice on environmental hazard indicators or elements of risk
Working Group (EEWG) 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 Provides expert advice on human health hazard indicators and criteria
Working Group
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.

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)

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.

12
SPECIAL FEATURE:
NICNAS’s Prioritisation Project
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 What type of inventory Are you able to supply What issues make it
inventory management management system do some or all of the difficult to supply some
system to track your you use? Electronic or information items a, b or all of this
import and/or some other system? and c with your existing information?
manufacture of inventory management
individual chemicals? system?

Options for data collection

Options Publishing lists of chemicals and asking industry to Asking each company to provide the requested
given: provide the requested information on the chemicals information on all industrial chemicals that they
on the list that they introduce C introduce

Questions: Are either of the options above Do either of these options raise Are there other specific options
more compatible with your specific difficulties for your for collecting the information that
inventory management systems? company? If yes, what are could be considered?
these?

Threshold quantity

Questions: Would the creation of a quantity threshold, Would it be more consistent with your inventory
below which reporting is not required, assist management system if the threshold was optional, ie you
you in limiting the work involved in supplying could report chemicals at lower quantities if it was more
information? efficient to do so?

Reporting period

Questions: What time period would best Are you able to provide If not, are you able to commence
represent your turnaround time appropriate retrospective data collecting data once a NICNAS
for stock of all individual for all chemicals over this time request is foreshadowed or
chemicals or chemical products period? published?
that you introduce?

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.

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