NICNAS Reforms Treatment of Confidential Commercial Information Workshop

To provide an overview of: current protection of CCI objectives of proposed changes to CCI options under consideration Purpose of the workshop

The most appropriate way to protect CCI while ensuring transparency and availability of assessment information to the public and workers We seek your advice

Improve: - transparency -usefulness of assessment information Maintain protections for information that is genuinely CCI Align internationally where possible Enable information (including CCI) to be provided to risk managers Objectives of reforms

Application - to have information treated as exempt (from publication) Test – publishing information could reasonably be expected to prejudice substantially the commercial interests of the applicant, and that this prejudice outweighs the public interest with respect to publishing that information Basic information - cannot be exempt information (e.g. known name, general use, precautions and restrictions, recommendations, emergency procedures, certain physical and chemical data, certain data re health and environmental effects) Current approach – Exempt information

Chemical identity Market information – exact introduction volumes Specifics of use – including function of the chemical in a product, exact concentrations, detailed operation descriptions Polymer details – molecular weight, monomer ratios and polydispersity Commonly requested exempt information

Application - to have the chemical added to confidential AICS Test – As for exempt information Disclosure - Presence on AICS disclosed only to those with bona fide intent to introduce Review - Inclusion on confidential AICS reviewed every 5 years Current approach – Confidential AICS

Current treatment of CCI Notifier can apply for certain information to be exempt from publication Statutory test Publish assessment with/without exempt information Notifier can apply for listing on Confidential AICS Statutory test Publish chemical on the public or confidential AICS Reviewed: 5 yearly using same test Disclosure: bona fide introduction Commercial interest VS public interest Confidential indefinitely

Publishing information options Current publication requirementsProposed publication requirements Exempt Chemicals - Summary published annually Exempted -No requirements Permits - List of permits published annually Reported -No requirements Assessment certificates - Assessment report published Assessed - Assessment Statement published (including Exempted/Reported chemicals assessed by NICNAS) NICNAS assessment (PEC, IMAP, secondary notification) - Assessment report published NICNAS initiated assessment - Assessment Statement published AICS - CAS number, chemical name, molecular formula, associated name, conditions of use (if any), statement if secondary notification applies AICS - CAS number, chemical name, molecular formula, associated name, defined assessment scope, conditions of use (if any), link to Assessment Statement

Limitations of existing approach Does not address Government objectives: No public information available for chemicals on the Confidential AICS Undermines public confidence Unusual situation – introducers advised of confidential listing but unable to access risk assessment information No linking of assessment report to chemical on public AICS Limits transparency and reduces meaningfulness for consumers, workers and others

Only circumstances NICNAS will publicly release information about a chemical - publication of an Assessment Statement - entries on AICS - to a bona fide enquirer Less information published Will link assessed AICS chemical to Assessment Statement Proposed approach

Four proposals under consideration 1. Masking chemical names 3. CCI protections for other information ? 4. Full disclosure to Government risk managers Any other options that meet objectives? 2. Generalising use/scope description

Feedback from CP1: Mixed support Application – To remove/make generic one or more components of chemicals name Test – Commercial and public interest Outcome – Agreed masked name for all publication purposes (Assessment Statement and for AICS) Advantages and disadvantages of this approach? Implementation issues? Period of masking? Impact of disclosure of name in other countries? Is confidential AICS still needed? Proposal 1 - Masked names

Fully defined name (no masking) Reaction product of 3,5-di-tert-butyl-2-hydroxybenzoic acid and aluminium sulfate Single masking Reaction product of 3,5-di-tert-butyl-2-substituted-benzoic acid and aluminium sulfate (masking the hydroxy group) Reaction product of di-tert-butyl-2-hydroxybenzoic acid and aluminium sulfate (deleting a set of position numbers) Double masking Reaction product of di-tert-butyl-carboxyl-hydroxy-arene and aluminium sulfate (deleting all position numbers and masking parent structure) Masking Names (Example 1)

Fully defined name (no masking) 6,9-bis(hexadecyloxymethyl)-4,7-dioxanonane-1,2,9-triol Single masking 6,9-bis(hexadecyloxymethyl)-4,7-dioxanonanetriol (deleting the “1,2,9-”) 6,9-bis(hexadecyloxymethyl)-4,7-dioxanonane-1,2,9-trisubstituted (masking the triol group) 6,9-bis(hexadecyloxymethyl)-4,7-dioxaalkane-1,2,9-triol (masking the parent structure) Double masking bis(hexadecyloxymethyl)dioxaalkanetriol (deleting all position numbers, and masking parent structure) Masking Names (Example 2)

Common features of international masked name regimes: minimum level of masking used to protect CCI all chemicals are on the public inventory some chemical identity information available despite masking enables identification of published assessment information Additional justification required for double or greater masking International use of masked names

Application - For generalised scope/use description Test – Commercial and public interest Outcome – A generalised scope/use description for all publication purposes (Assessment Statement and for AICS) Advantages and disadvantages of this approach? Implementation issues? Proposal 2 – Application to generalise scope/use

Specific useGeneralised use Dispersant ingredient in a paint at 6% to be applied to structures such as bridges Industrial surface coatings up to 10% concentration Viscosifier in drilling fluids at a concentration of 4.5 kg per cubic metre of drilling fluid, introduced at 33 tonnes per annum Additive in drilling fluid at a concentration of < 5 kg per cubic metre of drilling fluid, introduced at up to 50 tonnes per annum Generalised use examples

Is there other information that: is not basic information is not the chemical name or use would otherwise be published by NICNAS but could require protection? Proposal 3 – Any other information that may require protection

New legislative provision authorising NICNAS to release information to government risk management agencies Will include provisions to ensure confidentiality is maintained by the receiving agencies Proposal 4 – Disclosure to risk managers

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