PDF printable version of Organic Arsenical Products Task Force submission (PDF 59 KB)
July 26, 2012
Department of Health and Ageing (MDP 71)
GPO Box 9848
CANBERRA ACT 2601
Re: Comments of the Organic Arsenical Products Task Force on the Discussion Paper: Review of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)—June 2012
Dear Sir or Madam:
These comments are submitted on behalf of the Organic Arsenical Products Task Force (Task Force)1
. The Task Force appreciates this opportunity to comment, and applauds the Australia Department of Health and Ageing’s interest in improving both the competitiveness and public health and environmental outcomes of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).
As more fully discussed below, the Task Force encourages enhanced communication among Australian and other global regulatory and scientific bodies to achieve greater international harmonization to avoid duplication of assessment efforts where chemicals have been subject to contemporary evaluations in other jurisdictions. Specifically, the Task Force urges NICNAS to acknowledge the scientific review of arsenic scheduled to be undertaken shortly in the United States by the National Academy of Sciences (NAS) and to consider the results of this arsenic assessment as Australia embarks upon its review of chemicals pursuant to its Inventory Multi-tiered Assessment and Prioritization (IMAP) framework.
In September 2011, the Australian government initiated a review of NICNAS, its industrial chemicals regulatory program. This review focused on “how the regulatory settings may be improved to enhance both the competitiveness of the Australian chemical industry and public health and environmental outcomes.”2
Several stakeholder submissions expressed support for greater international harmonization among regulatory bodies to leverage the utility of contemporary chemical assessments generated in other jurisdictions. These stakeholder submissions “expressed concern about the duplication of assessment effort where chemicals have been subject to contemporary evaluations in jurisdictions such as Europe and North America.”3
Stakeholders suggested that, for new chemicals, NICNAS “should better align its regulatory processes with those of other countries” and “should use information generated overseas, including regulatory assessments, to ensure more timely assessments.”4
The same sentiment was expressed for existing chemicals, where it was explained that “this would reduce the cost to industry and would enable NICNAS to focus its attention on those chemicals that have not already been assessed by other countries.”5
This is also timely as NICNAS is about to embark on an accelerated review schedule for existing chemicals, as required under its Inventory Multi-tiered Assessment and Prioritization (IMAP) framework, which is expected to lead to “enhancements in chemical safety information flow and chemicals management.”6
Use of existing “overseas” information is a natural fit to the intent and objectives of the IMAP effort, which is the “identification and rapid assessment
of existing chemicals” (emphasis added).7
Given that there are approximately 3,000 “Stage One” chemicals to be screened and possibly assessed over the next four years, this requires NICNAS staff to complete three screenings/ assessments a day—clearly an unsustainable pace even for the most efficient government employee. By necessity, NICNAS would appear to need to rely on overseas existing chemical assessments to complete its ambitious task. The assessment of 3,000 existing chemicals in the next four years does not seem possible without reliance on previously prepared assessments in some manner.
The Task Force notes also that inclusion in IMAP as a “Stage One Chemical” is predicated upon the existence of overseas information. Two of the three inclusion criteria are “chemicals identified as a concern or for which regulatory action has been taken overseas” and “chemicals detected in international studies analysing chemicals present in the blood in babies’ umbilical cords.”8
Australia’s approach is explicitly reliant upon other countries’ identification of hazards of concern and collection of umbilical cord blood. NICNAS’ regulatory approach would appear to be partially reliant upon the regulatory and scientific judgment of other international bodies. A logical extension of this approach would include deference to other international chemical assessments. Accordingly, the Task Force urges that high-quality contemporary chemical assessments prepared by credible regulatory and scientific bodies in North America, Europe, and other jurisdictions be considered by NICNAS to a much greater degree to achieve international harmonization, and avoid “reinventing the wheel.”
NAS Review of Arsenic
In this regard and of specific relevance to Task Force members, arsenic compounds have been included as a Stage One chemical, almost entirely based on the fact that there is “concern or action overseas.” In the United States, NAS has been directed by Congress and commissioned by the U.S. Environmental Protection Agency to perform an exhaustive assessment of both cancer and non-cancer endpoints, to be complete in approximately three years. NICNAS is urged to leverage the findings of this assessment. The NAS is a distinguished, globally recognized scientific body and its findings are entitled to significant deference. The result of the arsenic assessment will be available well within the IMAP four-year timeframe.
The Task Force appreciates this opportunity to comment.
ORGANIC ARSENIC PRODUCTS TASK FORCE
Michal Eldan, Ph.D.
A full list of all 2012 submissions can be viewed at June 2012 submissions to the review of NICNAS