Estimates: Community Affairs Legislation Committee (Department of Health)
Senator RHIANNON: Dr Richards, I also had some questions on NICNAS and animal testing. I came in when you were in the middle of some of your questions; I apologise if I am repeating any. I want to start off with some process questions, so that I can understand the situation. What information does NICNAS require companies to provide about animal tested substances in order to fulfil data requirements set out in the industrial chemicals act?
Dr Richards : I have already answered this question for Senator Ruston today, but I am happy to repeat my answer.
Senator RHIANNON: I will look at it. I did come in while Senator Ruston-
Dr Richards : It is quite simple. The Industrial Chemicals (Notification and Assessment) Act has schedules in the act which set out the data requirements for the different types of chemical assessment. As I pointed out in my answer to Senator Ruston's question, the act also allows the director of NICNAS, or a delegate, to vary those data requirements on application from the company. A company might have an obligation to submit data which might involve an animal test. It is within their right under the act to apply to have a variation so as not to provide those data and to provide other data. Provided that we are satisfied that we can complete an assessment without those data, we usually agree to those variations.
Senator RHIANNON: Following on from some of the discussions about the budget paper and the $4.2 million, I thought it was over four years. I thought at one point in the discussion you said that it was over two years. Could you clarify that? Is that my misunderstanding from the budget papers?
Dr Richards : The primary implementation of the reforms is over two years. The bulk of the funds are in the first two years. There is a small amount of funding in the fourth year. So technically it is over four years. The fourth year figure is $400,000.
Senator RHIANNON: Thanks for clarifying that. In relation to this announcement, what measures will be taken under this framework to ensure a commitment to consumer safety and modern scientific developments through the increased acceptance of non-animal alternative test methods?
Dr Richards : As I answered in my earlier question, the fundamental reform that is being introduced is the establishment of three classes of chemicals with varying requirements for assessment and notification. Class 1 does not require notification or assessment; class 2 requires notification but not assessment; and class 3 requires both notification and assessment by NICNAS. The criteria by which a chemical is allocated to a class, or the criteria that determine the class to allow someone to decide what class their chemical fits into, will be subject to wide consultation with all relevant stakeholders, including representatives of civil society-NGOs, public health and environmental interest groups.
Senator RHIANNON: On the data sharing, will compulsory data sharing be introduced to help prevent the duplication? As you know, one of the concerns is that often there is duplication in animal testing.
Dr Richards : Under our act, there is absolutely no requirement for an animal test to be repeated if it has already been done for the purposes of another regulatory scheme. Under the OECD, Australia is a signatory to what is called the MAD scheme, the mutual acceptance of data, which obviously is anything but mad. For tests, whether they are animal tests or any other tests, that have been conducted in accordance with OECD test guidelines and with good laboratory practice, all signatories, which is all OECD members plus a lot of other countries that are not OECD members, accept those data without requiring those tests to be repeated.
I think it is also fair to say that NICNAS is an unashamed plagiarist. The first place we go looking is every other regulator and every other scientific source of data that we can find and, if we can find the data that satisfy us anywhere we can, we use those data in our assessments. I do not believe that there is any statutory obligation on us to share data, but it is our standard practice.
Senator RHIANNON: Thank you, Chair.