Hana HamdanHana Hamdan

National Industrial Chemicals National Industrial Chemicals Notification and Assessment Scheme Notification and Assessment Scheme

(NICNAS) (NICNAS) November 2008 .

Overview of Regulation Overview of Regulation of Industrial Chemicals in of Industrial Chemicals in

AustraliaAustralia

Regulation of Chemicals

Industrial Chemicals

NICNASMedicines Medical Devices

TGAFood

Additives and Residues

FSANZPesticides

Veterinary Medicines

APVMA

Regulation of Industrial ChemicalsRisk Assessment -

NICNAS

OHS, public health, environmental

OHS Controls

ASCC

S &T legislation

Public Health Controls

NDPSC

S & T legislation

Environmental Controls

S & T legislation

Risk Management Controls – NICNASAnnotation of national inventoryPermits – condition of useNational standardsListed on International treaties

Product Safety

ACCC

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 structureThe structure of NICNAS reflects its key

activities

Committees Industry Government Consultative Committee Community Engagement Forum States and Territories MOU* Group

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

Parliamentary Secretary to the Minister of Health and Ageing

Australian Government Department of Health and Ageing

Director, NICNAS

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

• Exemption categories

• Advice to Director – some categories

• Record keeping – some categories

• Annual Reporting (Major Obligation #4) – most categories

Major Obligation #3: New ChemicalExemptions

Quantity Restriction

Other Criteria Advice Required?

Annual Reporting?

Record Keeping?

Cosmetic-low volume

<10 kg/yr No unreasonable risk*

No Yes Yes

Cosmetic-low volume

10-100 kg/yr No unreasonable risk*

Yes –

(advice required)

Yes Yes

Cosmetic 1% of any product

Non hazardous*

No Yes Yes

Non-Cosmetic

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 volume

100 kg/yr None No Yes No

R&D – site limited

No Constrained by apparatus

Yes –

Form 6

No No

Tran-shipment

No Stays in Customs

<30 days

No Yes No

Exemption Categories

• 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)

Major Obligation #4: Annual Reporting

New Chemicals TeamReforms 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 – nowReview of impact of already implemented changes

Country Comparison

New Chemicals Schedule Data Requirements

Information / Test Data US Standard

Australia (polymer low

concern)

Australia (Mn < 1000)

Australia (Mn > 1000)

CHEMICAL IDENTITY & COMPOSITION

Chemical Name, Marketing Name, CAS No.

Methods of Determination (GPC, IR, UV-Vis, etc.)

Molecular Weight Distribution

Composition (hazardous / nonhazardous components)

Residual Monomers, Reactants, Impurities

PHYSICO-CHEMICAL PROPERTIES

Data in

BP/MP, Density/Specific Gravity, Solubility

possession

Octanol/Water Partition Coefficient has to be

Vapour Pressure submitted

Flash Point, Flammability, Auto-Ignition and EPA

Other Properties (Explosive, Oxidising, etc.)

may require

TOXICOLOGICAL PROPERTIES test data and

Acute Oral/Dermal Toxicity, Skin/Eye Irritation

further tests

Skin Sensitisation after the

Ames, Chromosome Aberration review

Others (Repeat Dose, Chronic, Carcinogenicity)

period.

Notifying a New Chemical

AICSNotification & Assessment Team

Existing Chemicals

+5 years

Permits

Certificates

NICNAS

Import or Manufacture a

New Chemical?

How to Notify

Notification Category

• 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

Certificates

• Conditions are imposed

specifying volume and

duration

• Assessment time frames:

14 - 28 days

• No reports published

• Chemical not added to AICS

Permits

Permits vs. Certificates

Permit Categories

• Commercial Evaluation Chemicals

• Commercial Evaluation Chemical Renewal*

• Low Volume Chemicals

• Low Volume Chemical Renewal*

• Early Introduction Permits

• Controlled Use Permits (Export Only)*

Data Requirements for Permits

Commercial Evaluation

Low Volume Chemical

Early Introduction

Exposure data (occupational and public) Environmental impact Label and MSDS

Chemical identity Use pattern Volume Duration of introduction

Classification Summary of health and environmental effects

Use and distribution arrangements with customer agreement

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

Permits

Certificate Categories

Standard (STD)

Limited (LTD)

Polymer of Low Concern (PLC)

Non Self Assessed

Polymer of Low Concern

Non Hazardous Polymer

Non Hazardous Chemical

Self Assessed

Data requirements for Certificates

SCHEDULE B Chemical identity Physiochemical properties Use pattern Import volume Exposure data (occupational, public, environmental) MSDS Label

SCHEDULE C Toxicological data Ecotoxicological data

SCHEDULE A Classification Summary of health and environmental effects

SCHEDULE D Polymer data

Standard Requires A,B, & C

(where applicable D)

LimitedRequires A,B

(where applicable D,where available C)

Polymer of Low ConcernApproved Form (mainly A, B & D,

where available C)

Certificates

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

Certificates

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? 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) 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

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;

Processes

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