PDF printable version of Mobil submission (PDF 26 KB)
Mobil Oil Australia Pty Ltd
ABN 88 004 052 984
12 Riverside Quay
Southbank, Victoria 3006
GPO Box 400C
Melbourne, Victoria 3001
61 3 9270 3333 Telephone
27 July, 2012
Department of Health and Ageing
GPO Box 9848
CANBERRA ACT 2601
Dear NICNAS Committee,
Mobil welcomes the opportunity to provide feedback on the NICNAS ‘Discussion Paper: Review of the National industrial Chemicals Notification and Assessment Scheme (NICNAS), June 2012’.
Our objective in providing this feedback is to help improve the efficiency and effectiveness of the existing chemical assessment process.
Part 4—The Regulatory Framework for Industrial ChemicalsA1:
We support your proposal to develop a risk assessment and management manual that would include the roles and responsibilities of each agency from the notifier’s perspective, explain NICNAS processes and approaches and clarification of the interaction with other risk assessors and various personnel.
The manual should be a comprehensive guidance document for notifiers to refer to, so as to minimise the need for outside consultation (e.g. with Agencies) in order to help in the preparation of the dossier in such a way that it will be easy for NICNAS to assess.
Part 5—New Industrial ChemicalsB3:
Pre-assessment statutory (technical) screening process: In the absence of further detail, it is premature to comment on this proposal. We need to better understand how extensive the data requirements will be in this stage. Rejection of an application should not occur in those instances where only limited chemical data is available. Due to the non-hazardous nature of the chemical substance; there should also be provision for NICNAS to seek information from other international assessments to reach its conclusion.
If pre-assessment screening is included as an add-on to the current lengthy assessment process, this could potentially mean an increase in the time to market and hence result in an adverse impact to business.
Some clarification is also required as to whether the ‘Early Introduction Permit (EIP)’ in the current system will continue or be withdrawn.
In reading sections B3 and B4, we foresee some benefits to both NICNAS and industry in terms of the time and resources to be spent on the assessment when phased appropriately, since the data requirements will be proportional to the hazard and risks of the candidate substance. We expect that a low risk chemical would have a shorter assessment cycle with less data requirements.
Although the proposal states that under very limited circumstances the legislation will allow NICNAS to refuse an assessment certificate, we request NICNAS identify or define the unacceptable public health, safety or environment risk that would trigger such a refusal. Furthermore, we believe that the notifier must be consulted throughout the risk assessment process and well before such an action is taken.
While keeping the proposal under item B4, we believe it could be further simplified by NICNAS clearly stipulating the categories of chemicals (e.g. Polymer of Low Concern: PLC) and the conditions under which they might be exempted from notification so that only chemicals not meeting the exemption criteria are subject to this assessment.
Currently NICNAS requires that substances of low concern (e.g. PLC) are assessed before introduction in the market. We suggest that such substances of low concern be exempted from notification and that this process is replaced by a well-documented ‘self-assessment’ by the notifier for possible future review by NICNAS at a later date.
We support the proposal, however if the notifier subsequently decides to introduce the assessed new chemical at a later date, the process for introduction should be simplified and not require that the assessment previously completed by NICNAS is repeated.
Similarly, please refer to our comments under C5 in Part 6 below.
If a concentration limit is necessary, how will this limit compare to the existing exemptions and permits which also have a volume restriction?
Part 6—Existing Industrial ChemicalsC3:
Again, in the absence of further details, it is premature to comment on this proposal. Imposing the provision of mandatory information creates uncertainties that mean we cannot to offer a comprehensive opinion at this time as the additional efforts required by industry are yet to be determined. We believe that any mandatory information should largely utilise existing or similar test data and not require generation of additional test data.
With regards to removing a chemical from AICS, if NICNAS considers that there are unacceptable risks or that existing risk management measures are inadequate, there should be consultation with impacted industry members at the early stage of the review process, in order to allow industry adequate time to present their position on a scientific basis. Please also refer to comments in B4(b) above under Part 5.
Please refer to our comments under B5(a) in Part 4 above.
Part 7—Post-Market Monitoring and EnforcementD1:
A streamlined approached should be adopted for secondary notification since most of the chemical data is already available to NICNAS and the public from its primary assessment. It should be recognised and understood that sometimes it is not possible to acquire or provide the data on the chemical since it does not originate from, nor is available, to the secondary notifier.
A mechanism needs to be put in place to ensure that reports of adverse effects be accompanied by adequate scientific support.
Part 8—Other Reforms Affecting Both New and Existing ChemicalsE1:
Confidential Business Information (CBI) protection is sought for those items which the notifier considers to be business sensitive or which may lead to competitive advantage not only in the local, but also, in the international markets. This proposal may adversely affect the business interests of Industry.
As an alternative, we suggest prior consultation between the notifier which has sought CBI protection and NICNAS before there is any move to release information to other Commonwealth agencies. In such cases, NICNAS must ensure that there is also a robust process for confidentiality protection within those agencies and other regulatory bodies to ensure that CBI is not made publicly available.
Supply Operations Team Lead
Mobil Oil Australia
A full list of all 2012 submissions can be viewed at June 2012 submissions to the review of NICNAS