Transcript Document

Overview of Regulation of
Industrial Chemicals in
Australia
Hana Hamdan
National Industrial Chemicals
Notification and Assessment Scheme
(NICNAS)
November 2008
.
Regulation of Chemicals
Industrial
Chemicals
Medicines
Medical Devices
NICNAS
Food Additives
and Residues
TGA
Pesticides
Veterinary Medicines
APVMA
FSANZ
Risk Assessment NICNAS
OHS, public health,
environmental
OHS Controls
Regulation of Industrial
Chemicals
Risk Management Controls – NICNAS
Annotation of national inventory
Permits – condition of use
National standards
Listed on International treaties
ASCC
S &T legislation
Environmental
Controls
S & T legislation
Public Health Controls
Product Safety
NDPSC
ACCC
S & T legislation
Trades Practice ACT
About
NICNAS
• NICNAS – National Industrial Chemicals
Notification and Assessment Scheme
• Operates under Commonwealth Legislation:
Industrial Chemicals (Notification and
Assessment) Act 1989
• Reports to the Minister for Health and Ageing, via
the Parliamentary Secretary
NICNAS’s
structure
The structure of NICNAS
reflects its key
activities
Committees
 Industry Government
Consultative Committee
 Community Engagement Forum
 States and Territories MOU*
Group
Parliamentary Secretary
to the Minister of Health
and Ageing
Australian Government
Department of Health
and Ageing
Director, NICNAS
Science Strategy
 Notification and Assessment
 Review and Treaties
 Rapid Risk Assessment
Regulatory Strategy
 Compliance and Reporting
 Reform
Business Management
and Communication
 Media and Communication
 Corporate Governance
 Finance and Office Management
NICNAS’s activities include:
• assessing industrial chemicals that are new to Australia for their health
and environmental effects, before use or release into the environment;
• assessing industrial chemicals that are already in use in Australia
(known as existing chemicals) in response to concerns about their safety
on health and environmental grounds;
• making risk assessment and safety information on chemicals and their
potential OHS, public health and environmental risks widely available to
workers, the public, industry and government agencies; and
• enabling the public, organisations and key stakeholders to have effective
input into decision-making processes regarding the safe use of
chemicals.
Governance
• 100 % cost recovered from NICNAS
assessment fees and registration charges of
chemical introducers
• Industry Government Consultative
Committee
• Community Engagement Forum
• MOUs with the States and Territories
Engagement with Stakeholders strong client service focus
• Industry Engagement Group: Technical matters
focussing on new chemicals and reforms
• Cosmetic Advisory Group: Cosmetic reforms and
amendments to the cosmetic standard
• Nanotechnology Advisory Group: focuses on
emerging issues and impact on the regulatory
framework
• Outreach activities: educational training and
updates on new reforms
Engagement with Stakeholders strong client service focus
• Implementation Steering Group:
Implementation of the existing chemical review
recommendations
• Technical Advisory Group: Advises the Director
on considerations of applications for listing on the
confidential inventory
• Free consultancy service for pre-notification of
new chemicals
Major Obligation #1: Registration
• Mandatory for all importers and
manufacturers of “relevant industrial
chemicals”
• Lower threshold now $1
• Tiered structure /Annually
• Registration year: 1 September to 31
August
Major Obligation #2: New Chemicals
• Australian Inventory of Chemical
Substances
• Lists all chemicals known to be available
for use in Australia ~38,000 chemicals
listed
• Chemical identity only (no tox or safety)
• Can be annotated: information or use
restriction
Major Obligation #3: New Chemical
Exemptions
• Exemption categories
• Advice to Director – some categories
• Record keeping – some categories
• Annual Reporting (Major Obligation #4) –
most categories
Exemption Categories
Quantity
Restriction
Other Criteria
Advice
Required?
Annual
Reporting?
Record
Keeping?
Cosmeticlow volume
<10 kg/yr
No
unreasonable
risk*
No
Yes
Yes
Cosmeticlow volume
10-100 kg/yr
No
unreasonable
risk*
Yes –
(advice
required)
Yes
Yes
Cosmetic
1% of any
product
Non
hazardous*
No
Yes
Yes
NonCosmetic
100 kg/yr
No
unreasonable
risk
No
(optional
advice)
Yes
Yes
Exemption Categories
Quantity
Restriction
Other
Criteria
Advice
Required?
Annual
Reporting?
Record
Keeping?
R&D – low  100 kg/yr
volume
None
No
Yes
No
R&D – site No
limited
Constrained
by apparatus
Yes –
Form 6
No
No
Transhipment
Stays in
Customs
<30 days
No
Yes
No
No
Major Obligation #4: Annual Reporting
• Exemptions: lower regulatory burden
on industry
• Counter-balance to ensure maintenance
of health, safety & environmental
standards: Record Keeping and Annual
Reporting requirements
• Alternative : notify the chemical to
NICNAS for a full certificate
assessment
Major Obligation #4: Annual Reporting
• Information required to report:
• Exemptions and self assessments:
• Chemical name + CAS number
• Quantity of chemical (range)
• Use (generic use categories)
• Domestic/Industrial/Both (to
indicate potential for public
exposure)
New Chemicals
Team
Reforms of New Chemicals
• Low regulatory concern chemicals
Fast Track new chemicals
Reduce data requirements
Encourage safer chemicals
Reduce duplication of effort
Reduce costs
Last stage of implementation – now
Review of impact of already implemented changes
Information / Test Data
Country
New Chemicals Schedule Data Requirements
Comparison
US
Standard
Australia
Australia (Mn
Australia (Mn
(polymer low
concern)
< 1000)
> 1000)
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CHEMICAL IDENTITY &
COMPOSITION
Chemical Name, Marketing Name,
CAS No.
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Methods of Determination (GPC, IR,
UV-Vis, etc.)
Molecular Weight Distribution
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Composition (hazardous / nonhazardous
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components)
Residual Monomers, Reactants,
Impurities
PHYSICO-CHEMICAL
PROPERTIES
BP/MP, Density/Specific Gravity,
Solubility
Data in
possession
Octanol/Water Partition Coefficient
has to be
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Vapour Pressure
submitted
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Flash Point, Flammability, Auto-Ignition
and EPA
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Other Properties (Explosive, Oxidising,
etc.)
may require
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How to
Notify
Notifying a New Chemical
Import or
Manufacture a
New Chemical?
Notification &
Assessment Team
Certificates
+5 years
NICNAS
Permits
AICS
Existing
Chemicals
Notification
Category
Permits vs. Certificates
Permits
• Conditions are imposed
specifying volume and
duration
• Assessment time frames:
14 - 28 days
• No reports published
• Chemical not added to
AICS
Certificates
• More data requirements
• Assessment time frame:
28 - 90 days
• Full public reports published
• First 5 years only holder(s) of
the certificate can introduce the
chemical
• Chemical added to AICS
Permit Categories
• Commercial Evaluation Chemicals
• Commercial Evaluation Chemical Renewal*
• Low Volume Chemicals
• Low Volume Chemical Renewal*
• Early Introduction Permits
• Controlled Use Permits (Export Only)*
Permits
Data Requirements for
Permits
Commercial Evaluation
Use and distribution
arrangements with
customer agreement
Low Volume Chemical
Early Introduction
 Classification
 Summary of health and
environmental effects
 Chemical identity
 Use pattern
 Volume
 Duration of introduction
 Exposure data
(occupational and public)
 Environmental impact
 Label and MSDS
Permits
Permits – Commercial Evaluation
Chemicals (CEC)
• Can only be used for evaluation purposes (eg.
trial a new chemical as an ink additive for screen printing)
• Duration and Volume Restrictions (Max 4 tonne,
Max 2 yr)
• Specified use
• User Agreements (must be signed by the applicant and
all users conducting the evaluation)
• No statutory time frame usually 14 days
• Can be renewed once only
Permits
Permits – Low Volume Chemicals
(LVC)
• Duration and Volume Restrictions (Max 100 kg /
1 yr for up to 3 years)
• Statutory time frame 20 days
• Can be renewed any number of times
Permits
Obligations After a Permit Has Been
Issued
• Bound by the permit conditions (on reverse
side of permit)
• For a CEC all users (any parties who signed
Form 8) are also bound by the permit
conditions
• Subject to auditing
• Must complete annual reporting (not EIP)
• Must report to the director at the end of the
permit period
Certificate Categories
Non Self Assessed
Self Assessed
Standard (STD)
Polymer of Low Concern
Limited (LTD)
Non Hazardous Polymer
Polymer of Low Concern
(PLC)
Non Hazardous Chemical
Certificat
Data requirements for es
Certificates
Standard
Limited
Polymer of Low Concern
Requires A,B, & C
(where applicable D)
Requires A,B
(where applicable D,
where available C)
Approved Form (mainly A, B & D,
where available C)
SCHEDULE A
 Classification
 Summary of health and
environmental effects
SCHEDULE B
 Chemical identity
 Physiochemical properties
 Use pattern
 Import volume
 Exposure data (occupational,
public, environmental)
 MSDS
 Label
SCHEDULE C
 Toxicological data
 Ecotoxicological data
SCHEDULE D
 Polymer data
Certificat
es
Post Assessment
Obligations
• The use and volume has changed significantly
• The chemical was to be imported but will now
be manufactured
• The method of manufacture changes
• Additional information on adverse effects
becomes available
• A prescribed event has occurred
Existing Chemicals Program
Main Activities
• Assessment
• International role
• Address emerging issues
Other Activities
• Providing advice to other Government Departments
on existing industrial chemical issues
Assessment Activities
Priority Existing Chemical (PEC) Assessment
15 assessments currently underway
- 4 PBFRs
- triclosan
- 9 phthalates
- sodium cyanide
Hazard Assessment
Recently released 25 phthalate hazard assessments
and Phthalate Compendium
Existing Chemicals Program Review
– why?
 Faster response to problem chemicals
 More use of overseas assessments
 More information publicly available
 Better use of resources
 Greater emphasis on hazard assessments
 More effective ways to obtain information
on use, exposure
Final Report Recommendations
 Final Report contains 23
recommendations
 Recommendations in 5 key areas
better engagement and communication
categorisation and screening of AICS
improving efficiency
more assessment options
enhanced control powers
Emerging Issues
Nanotechnology
NICNAS’s approach: is the current regulatory framework adequate
to address nanomaterials?
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What is a nanomaterial
How does NICNAS assess potential risks
Management of potential risks
Stakeholder engagement – industry and community
 Informed by call for information (due 29 Jan ’09)
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Introduction of nanomaterials in 2008 (above 100gm)
Nanomaterials being introduced
Determine the volumes
Identify available data
Understand use in industry and R & D
Foreign Scheme arrangements
• In place since 2001- Australia accepts foreign
assessment reports (particularly Canada and
EU member States )
• Reform initiatives- reduce regulatory burden
and strengthening international strategic
alliances (US, Canada, Asia Pacific, EU)
• Drivers: Enhance the regulatory efficiency;
and most importantly, improve
health/environment protection; move towards
international harmonisation.
Recognition of Canada’s New Substances
Notification Regulations (Chemicals and
Polymers) means that Canadian assessments can
be taken into account as an Approved Foreign
Scheme when new chemicals are being evaluated
under Australia’s National Industrial Chemicals
Notification and Assessment Scheme (NICNAS).
The benefit of this arrangement is that, for a new
chemical notified to NICNAS under the approved
provisions, the hazard evaluation in the Canadian
assessment report will be used in the NICNAS
assessment report
Processes
Obtaining Assessment Reports from the
Canadian/other Authority
• Applicants obtain a proforma authorising Environment
Canada to transmit the Canadian assessment report to
NICNAS.
The assessment report must:
• date from post-1994. Preferably, the report should be in
English, however, authorised translations are
acceptable. Electronic reports are also acceptable;
• originate from the national authority of an OECD
Member country, preferably Canada or any European
Union Member State;
Applicants are still required to follow the
notification procedures
• Details of the overseas authority, that is, when and
where notified;
• A copy of all the particulars about the chemical
that were given under the foreign scheme and are
available to the applicant; and
• Any other information about the chemical
available to the applicant, that is, assessment
information or information given under another
foreign scheme.
NICNAS statutory timeframes for assessment remain
unchanged.
Criteria for an Acceptable overseas
Assessment Report
• the identity of the notified chemical;
• the methodology used to conduct the risk
assessment and the relevance of these to the
Australian exposure or use scenario (in the case
of local assessment report); and
• recognised status of the authority through access
to the original data submitted for foreign or local
assessment.
• A letter of validation from the respective authority
should accompany the assessment
• report stating that that the report is the full and
final report issued for the chemical.
• The assessment report must be for an equivalent
assessment category.
NICNAS Experience
• During 2006/07- ~20 foreign assessments out of ~300
• Efficiencies gained by building on previous hazard assessment –
such as modelling; confirming approach eg interpretation of
NOEL
• Learn from international experiences – opportunities for
collaborative work eg global issues (POPs; perfluorinated
chemicals)
• Reduced regulatory burden in cases where alternate reliance on
data/models used by the foreign scheme
• Building confidence in other schemes – a step closer towards
Mutual recognition
• Savings passed to industry through reduced fees and time savings
Formal Recognition of Canada- Acceptance of the
hazard assessments
• Recognise there are differences in the schemes such as OHS
and classification
• Recognise that new information may be available
• Recognise that science and assessment approaches are
continually evolving
• Benefits are too great for industry and the government!
• The experience has taught us the similarities and
recognising the differences
• current cooperation on new chemical assessments would
also extend to work on existing chemicals