29 July 2014 AICS Consultation Corporate and Regulatory Strategy Programme NICNAS GPO Box 58, Sydney, NSW 2001 Email: NICNAS.consultations@nicnas.gov.au Dear Sir/Madam, The Plastics and Chemicals Industries Association (PACIA) is the peak national body representing the chemistry sector in Australia. PACIA members include chemical manufacturers, importers and distributors, logistics and supply chain partners, raw material suppliers, plastic fabricators and compounders, plastics and chemical recyclers and service providers to the sector. PACIA welcomes the opportunity to provide further comment on the draft guidelines relating to listing chemicals on the confidential section of the Australian Inventory of Chemical Substances (AICS) and exempt information. PACIA would like to take this opportunity to recommend some revisions to the redrafted guideline to ensure that NICNAS’ approach encourages innovation and investment in the Australian chemicals industry. Businesses invest significant capital when developing new technologies and derive a commercial advantage from maintaining confidentiality with respect to the identity of a new chemical. Failure to maintain confidentiality with respect to sensitive commercial information in Australia may have significant impacts globally. The decision process for confidential listing on AICS and exempt information must provide notifiers with confidence that decisions to protect sensitive commercial information will be conducted fairly, efficiently, transparently and accountably. This submission makes specific recommendations that will, if accepted and accommodated, facilitate an innovative and sustainable chemical industry in Australia. Our submission also highlights some NICNAS procedures for implementing these guidelines that NICNAS should consider to ensure a fair, efficient, transparent and accountable process. Should you have any questions regarding the content of this submission or require any additional information from PACIA or clarification, please do not hesitate to contact Mr Nick Zovko on (03) 9611 5417. Yours Sincerely, Regulatory Policy Manager PLASTICS AND CHEMICALS INDUSTRIES ASSOCIATION ABN: 77 063 335 615 Level 10, 10 Queen Street, Melbourne, Victoria, 3000 Phone: 03 9611 5400 Fax: 03 9611 5499 PO Box 422 Flinders Lane, VIC 8009 Email: info@pacia.org.au W eb: www.pacia.org.au Canberra Office: 02 6230 6985 Introduction PACIA welcomes the opportunity to provide comments on the NICNAS draft guidelines for confidential listing and exempt information. These comments and suggestions are offered to ensure that NICNAS provides the best guidance to notifiers that allow them to understand how to successfully make an application for AICS confidential listing or for exempt information. Clear guidance in these areas will ensure that notifiers can make the best decision about whether to pursue confidential listing. Confidential listing and exempt information are important components of the regulatory system for industrial chemicals. It allows businesses to protect sensitive commercial information in relation to current and future operations from industry competitors so that they may: Recoup product research and development costs; Maximise returns on investments made in introducing new chemicals and technologies into the Australian market; and Facilitate and encourage continuing research and investment. Many PACIA members operate in a global marketplace and must make decisions about where investments in new chemicals, products and technologies should be made. The disclosure of commercial sensitive information does not just impact Australia, but can have global market repercussions. Businesses will not risk their global competiveness where there is uncertainty in protecting confidential business information. Without appropriately balanced measures to allow manufacturers and introducers to recoup the benefits of their investments, Australia risks losing newer, safer and more sustainable technologies as companies decide not to introduce new products into Australia. Clear, consistent guidelines must aid notifiers to make successful applications for confidential listing and to confirm exempt information. However, the guidelines should not be applied restrictively. Notifiers must remain free to provide additional, relevant information and argument that is not specified in the guidelines in support of their application. While introduction of these guidelines does not require legislative change, PACIA remains concerned that increasingly restrictive and conservative interpretations of existing rules may result in increased regulatory burdens and minimise flexibility in administration of the Industrial Chemicals (Notification and Assessment) Act 1989. PACIA recommends revisions to the guidelines in the following areas: Exempt information and confidential requirements requires further distinction The proposed guidelines may benefit from a more comprehensive discussion of the scope of exempt information. NICNAS has advised that it’s not changing the regulatory bar, just improving the guidance. The drafted guideline is implying the same level of persecution on both categories (confidential AICS listing and exempt information) in regards to justification requirements and is implying further burden from current practice. Under current practice, NICNAS staff accepts certain information as exempt from public disclosure with limited justification and the justification is not as comprehensive as the confidential AICS listing applications. PACIA does recognise that under the Act, the statutory test for both categories is the same, but PACIA argues that the two categories (confidential listing and exempt) are fundamentally different and consequently, the sorts of information and argument that could be used to satisfy the test would therefore also be different. The confidential AICS listing is a post market analysis (determination if chemical identity still needs to be considered confidential after 5 years), while exempt information applies to publication of a chemical which in most circumstances has more sensitivity in relation to disclosure, which could prejudice commercial interests to a greater degree if disclosed, such as in new chemical notifications (pre-market). PACIA recommends that NICNAS should consider including within the guidelines, that applications of exempt information can be positively decided by the Director (or delegate) with limited justification where a clear detriment to the notifier is apparent. The Director or its delegate should have the knowledge to accept that an applicant’s commercial interests would be prejudiced (with limited justification) by the 2 publication of certain exempt information where requested by the applicant, such as disclosure of a chemical identity in a new chemical notification, as under current practice. There is significant information supplied to NICNAS with a new chemical assessment that if the chemical identity is disclosed it would undermine competitive advantage, i.e. give competitors knowledge of chemical linkages to new technology in products and use, percentage of new chemical in new marketed products, volume or market share projections, etc. Therefore an applicant requesting exempt information from publication should be accepted with limited justification, as the risk of undermining competitors advantage should be understood by the level of disclosure. The draft guideline fails to distinguish between the two different elements on exempt and confidential information requirements. The requirements to support an exempt application are much less onerous. Therefore, NICNAS should consider including within the guidelines a discussion on the different nature between a confidential and exempt application to improve transparency and expectation. Hypothetical example of a successful & unsuccessful exempt application The Productivity Commission recommended1 inclusion of hypothetical examples of confidential applications. The draft guideline has included two hypothetical examples of a successful and unsuccessful confidential application, but it would be beneficial to also include examples of exempt applications in regards to a successful and unsuccessful application. PACIA does understand that there is difficulty on covering all exempt situations as the application is diverse in circumstances. However, we do recommend that examples in a new chemical application would be the predominant area in which NICNAS interacts commonly in regards to exempt information and would be considered as a suitable candidate for the hypothetical. Furthermore, the inclusion would also help to distinguish and compare the data requirements for confidential AICS listing versus an exempt application. Clarification on timed decisions of exempt information The current draft guideline is silent in relation to timing on decisions of exempt information. Businesses invest significant capital when developing new technologies and derive a commercial advantage from maintaining exempt information. This is a critical parameter in determining whether to pursue new chemical introductions. Early decisions by NICNAS on exempt information would allow industry to better manage its chemical introduction decisions and ensure effective management of staff time for both industry and NICNAS. Early communication on the decisions of exempt information (during screening for new chemical application) by NICNAS would enable the notifier to decide whether to pursue the chemical introduction early within its application. Early decision by NICNAS would minimise the unnecessary resourcing spent by the notifier and NICNAS in pursuing a likely withdrawn notification. It may also stop the notifier in progressing any deficiencies in the notification based from the initial screening from NICNAS. PACIA recommends that the guide should include an estimated time on communicating exempt decisions, to ensure best practice is adopted within the stewardship of the exempt decision process. Communication of exempt decisions by NICNAS The guideline states, that confidential decision are notified by the Directors in writing. However, the guide is not clear on how decisions on exempt information will be communicated to applicants. Under the Industrial Chemicals (Notification and Assessment) Act 19892 (ICNA Act), it notes that “The Director must give the applicant written notice of the decision about the application”. PACIA recommends that the guide should reflect the legislative requirements in regards to communicating decisions and include the type of information it may provide to an applicant to improve the transparency of the guide. 1 2 Productivity Commission (PC) in its Research Report on Chemicals and Plastics Regulation, 2008 (page 75) Exempt information, section 75. 3 Refund applicability of a withdrawn assessment The guideline notes, that the assessment application may be withdrawn in an event of a rejected exempt application3. PACIA considers that this could be further expanded and include a statement that an applicant may be entitled to a refund for a withdrawn chemical assessment and link a reference to the NICNAS handbook under - Screening applications to notify a new chemical, which provides guidance on an estimated refund entitlement to improve the transparency. The fees for some assessment applications or permits are high in cost in regards to fees, therefore the entitlement to refund should be highlighted to allow stakeholders to make informative decisions on any rejected exempt applications. Inclusion of data security within the guideline The securing of confidential information is becoming a very large concern for industry to ensure its trade secrets are protected, especially as data security threats continue to develop in complexity and sophistication. PACIA members invest significant capital when developing new technologies and derive a commercial advantage from maintaining information from public disclosure. The guideline lacks information on how commercial information will be kept secure from cybersecurity threats, data theft, misappropriation and inadvertent disclosure/transmission of confidential corporate information. The draft guide has only a brief comment in the FAQ’s, which we believe needs to be expanded and have its own subsection within the guideline. To encourage business to bring new chemistries in Australia, there needs to be recognition within the guideline on how commercial confidential information will be kept secure from security threats. If a company believes its intellectual property is susceptible to disclosure via inadequate security controls, it simply will not invest in Australia. Therefore PACIA strongly recommends that the guideline should include provisions on how NICNAS will ensure protection of confidential business information from security threats and prevent inadvertent disclosures to ensure safe data handling control to attract innovation and investment in Australia. Inclusion of the “SDS statement with limited distribution” on public interest impact In regards to the public interest test, the previous guideline had a statement which noted the following: “there are cases where a chemical’s SDS is not available to the public, but only available to commercial clients who may, for example, be using small quantities of the chemical in a reformulation. In such cases, access to the SDS is restricted and the chemical’s identity is thus not public” The draft guideline does not have this statement present. PACIA recommends that this statement should be re-instated as it provides further insight and logic on the public interest test. Conclusion The Australian chemicals and plastics industry plays a critical enabling role, supplying inputs to 109 of Australia’s 111 industries. This means that innovation and growth within the Australian chemistry industry has a multiplier effect in creating jobs and investment in supply chains across Australia. The ability to protect commercial confidential information from disclosure is key element in fostering innovation within Australia. Australia contributes 0.8%4 of global chemical sales and our low market share makes us susceptible for bypass in regards to new chemistries, especially where rules are ambiguous and not balanced by appropriate commercial protection and public interests. The decision process for commercial sensitive information must instill confidence to applicants that decisions to protect sensitive commercial information will be conducted fairly, transparently and accountably. Notifiers will not risk their global competiveness, especially in countries which have low 3 4 options available to an applicant if the decision is to reject an application (pg. 16) PACIA extraction from the latest available statistics released from the International Council of Chemical Associations. 4 market share where there is uncertainty that chemical identity could be publicly disclosed under unfair decisions. NICNAS is the first interface of chemical legislation within Australia and the guideline will share direct interface with notifiers in regards to judgment consideration on introducing new chemicals into Australia. Therefore, to maintain a sustainable chemical future in Australia and encourage innovation, it is imperative that NICNAS improve the guideline in relation to; administration of exempt information; handling of confidential information; and general transparency 5