Hana Hamdan National Industrial Chemicals Notification and Assessment Scheme (NICNAS) November Overview of Regulation of Industrial Chemicals in Australia Overview of Regulation of Industrial Chemicals in Australia

Regulation of Chemicals Industrial Chemicals NICNAS Medicines Medical Devices TGA Food Additives and Residues FSANZ Pesticides Veterinary Medicines APVMA

Regulation of Industrial Chemicals Risk 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 – NICNAS Annotation of national inventory Permits – condition of use National standards Listed 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 structure The 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 Chemical Exemptions

Quantity Restriction Other CriteriaAdvice Required? Annual Reporting? Record Keeping? Cosmetic- low volume <10 kg/yrNo unreasonable risk* NoYes Cosmetic- low volume kg/yrNo unreasonable risk* Yes – (advice required) Yes Cosmetic  1% of any product Non hazardous* NoYes Non- Cosmetic  100 kg/yr No unreasonable risk No (optional advice) Yes Exemption Categories

Quantity Restriction Other Criteria Advice Required? Annual Reporting? Record Keeping? R&D – low volume  100 kg/yr NoneNoYesNo R&D – site limited NoConstrained by apparatus Yes – Form 6 No Tran- shipment NoStays in Customs <30 days NoYesNo 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 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

Country Comparison New Chemicals Schedule Data Requirements Information / Test DataUS 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 Coefficienthas to be Vapour Pressuresubmitted Flash Point, Flammability, Auto-Ignitionand EPA Other Properties (Explosive, Oxidising, etc.) may require TOXICOLOGICAL PROPERTIES test data and Acute Oral/Dermal Toxicity, Skin/Eye Irritation further tests Skin Sensitisationafter the Ames, Chromosome Aberrationreview Others (Repeat Dose, Chronic, Carcinogenicity) period.

Notifying a New Chemical AICS Notification & 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: 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: 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) Limited Requires A,B (where applicable D, where available C) Polymer of Low Concern Approved Form (mainly A, B & D, where available C) 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 Certificat es

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 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 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