Laural Consulting

Public submissions to the review of the National Industrial Chemicals Notification and Assessment Scheme.

Page last updated: 20 March 2012

PDF printable version of Laural Consulting submission (PDF 217 KB)

SUBMISSION TO the Better Regulation Ministerial Partnership

Sam A. Bruschi, Ph.D, MBA
Laural Consulting (Adelaide, South Australia)

I welcome the opportunity to present a very brief submission as a private and unaffiliated and toxicologist with over 25 years experience (nationally and internationally). This submission only broadly addresses the specific Objectives as stated in the "CALL FOR PUBLIC SUBMISSIONS ON BETTER REGULATION OF INDUSTRIAL CHEMICALS" of November 1st, 2011.

In the future, NICNAS will face ever increasing challenges in the regulation of chemicals. These challenges - if not adequately addressed have the potential to impact severely on the health of the Australian public. Ultimately, any such impacts (if realised) will be borne by the taxpayer and remedial measures will be magnified post hoc. Suffice it to say that it is common knowledge that per capita asbestos-related diseases in Australia are amongst the highest in the world and contribute an enormous cost burden1. This can even be expected to increase in the future.

Admittedly, in many ways, the above is an "unfair" example. The field, of toxicology has progressed substantially in the 40 or so years since the realisation of the inherent hazards of asbestos use. As it stands today toxicology has the technology, expertise and collective wisdom to act proactively. As a discipline it is a necessary component in the regulation of potentially dangerous chemicals in the workplace, therapeutics and the environment. Toxicology is at the core of reasoned and judicious regulation.

Nonetheless, in one way at least the example of asbestos is pertinent and pressing. Current evidence points to complex and long-term health ramifications for the use of some new technologies (specifically nanotechnology and so-called "carbon nanotubes" which will have numerous commercial applications very soon).

1 Park E-K, Takahashi K, Hoshuyama T, Cheng T-J, Delgermaa V, et al. 2011 Global Magnitude of Reported and Unreported Mesothelioma. Environ Health Perspect 119(4): doi: 10.1289/ ehp.1002845

The NICNAS model of full cost recovery.

At this time the current NICNAS model of cost-recovery fails on several fronts. It is my opinion that: it can only be expected to worsen in the future as new and formidable challenges present themselves to NICNAS.

These include, but are not limited to, the following
  • An inability to provide adequate internal resources to the continuous and obligatory reappraisals of PEC’s on the AICS. This is driven by the constant availability of new information across many fronts reflecting the dynamic nature of research.
    • My personal but limited observations are that this is not reflected at the level of the high technical capacity of NICNAS but rather in the prioritisation of assessments to those more directly linked to cost recovery. The flow-on effects would seem to be on International Best Practise obligations and sub-optimal cross government activities.
  • NICNAS does not currently have any instruments to expand AICS to include indispensable information on:
    • the carcinogenic potential and/or status of a chemical (including the approx. 40,000 chemicals listed on AICS which have been "accepted" for use but which have not been assessed by NICNAS)
    • the frequency of adverse health effects (including cancer formation) from a chemical's use
    • the quantity of potentially highly hazardous chemicals current held in Australia (via importation or manufacture)
    • the location(s) of highly hazardous chemicals within Australia
    • the use of chemicals of concern which are likely directly regulated by other government authorities (e.g. TGA, FSANZ, Safe Work Australia, the National Pollution Inventory, etc.)

Rationale for an expanded NICNAS regulatory capacity,

It is becoming increasingly evident in toxicology that many "new" chemicals slated for industrial (and even therapeutic) use may not have the pronounced detrimental effects of those of the past. As recently stated by L.S. Birnbaum (Director, NIEHS-USA) "We are past the point of looking for missing arms and legs.2. Nonetheless, she observes that “.. incremental differences ... (in hazard; MY INSERTION) ... - are significant" .

The lack of a capacity to independently verify information provided to NICNAS by 3rd parties with potential "vested interests" limits the capacity of NICNAS to act as the final arbiter of public safety with regard to chemicals.

My experience as an academic of over 12 years in the USA has led me to embrace the model adopted by the regulatory agencies in that country (such as the US EPA and FDA). In these circumstances, an agency has the capacity to confirm or negate data provided to them. Such capacities would seem to be inconsistent with a user-based cost recovery model. A centralised governmental capacity to assess and regulated will undoubtedly result in an end gain to the Australian public and would ultimately decrease the financial burden on the user.

For example, as a recent case in point, many new "nanotechnology “start-up" companies are small and do not have the financial resources to support user based cost-recovery. In these "start-ups" government imposed compliance costs can mean the difference between success or failure prior to going to market.

2 Cited by J Groopman (The New Yorker, May 31, 2010)

Recommendations for NICNAS efficiency; effectiveness and risk management functions.

Recommendation # 1

NICNAS should possess an independent verification capacity with research expertise in the determination of the hazard potential and toxicological profile of critical (priority) chemicals.

This capacity would ideally be "in-house" to maintain complete independence. Alternatively, formalised linkages to CSIRO may suffice.

An independent verification capacity would also negate public concerns, as has already been evident on the perceived impartiality of other government agencies.3

Recommendation #2

NICNAS to be provided with resources to shift from its current model of,an ad hoc and post hoc approach to regulation.

A proactive approach to chemicals regulation such as observed in the EU REACH framework - will provide NICNAS with the organisational resilience to face the complex challenges of the future and will also reduce unnecessary compliance costs to industry.

An obligation for state and federal governments and agencies to comply with NICNAS chemical assessments (as restrictions on use or bans).

3 For example, TGA and FSANZ (refer SBS “Insight”, 2008, J. Brockie on GM Food Safety & ABC 4 Corners, 2010, Joint replacement failures with “fast-tracked” approval based on supplier-generated safety data).

Recommendation #3

NICNAS in concert with other relevant and appropriate government agencies to be provided with the capacity to review chemical safety in the context of end-consumer products.

The current legal framework does not provide for precautionary assessment(s) of final end-consumer products with possible human or environmental safety concerns. The relevant legislation becomes operative only after damage is seen to be done or witnessed wherein fit for purpose" provisions and other like clauses can be invoked.

Likewise, similar considerations for potential environmental damage under the current legislation appear to me to be even more insubstantial.

Recommendation #4

NICNAS to be provided with the capacity to expand the AlCS to update critical information and to also include mandatory disclosures on:
  1. the carcinogenic potential and/or status of a chemicals
  2. the frequency of adverse health effects (including cancer formation)
  3. the quantity of potentially hazardous chemicals current held
  4. the location(s)of highly hazardous chemicals within Australia

Recommendation #5

NICNAS operations to be reviewed with reference "silo-ed" expertise vis--vis other elevant government departments.

NICNAS, APVMA, TGA and FSANZ (etc.) operations to be reviewed in conjunction - and with reference to - any redundancies of information held and with a view to the consolidation of such information and without loss of NICNAS integrity.

Dr. Sam A. Bruschi
Laural Consulting, Adelaide South Australia