BARDEN, Mr Graeme, Executive Director, Australian Industrial Chemicals Introduction Scheme, Department of Health, Disability and Ageing CRAM, Dr Ed, Executive Director, Agricultural Chemicals, Australian Pesticides and Veterinary Medicines Authority CUTHBERT, Dr Sandra, Chief Executive Officer, Food Standards Australia New Zealand LARTER, Dr Claire, Assistant Secretary, Regulatory Science Branch, Department of Health, Disability and Ageing O'MULLANE, Dr Matt, General Manager, Food Safety Branch, Food Standards Australia New Zealand RUMBLE, Dr Sarah, Assistant Secretary, Regulatory Integrity and Governance Branch, Department of Health, Disability and Ageing [via video] [14:21] CHAIR: Welcome. Thank you very much for appearing before the committee today. The Senate has resolved that an officer of a department of the Commonwealth or of a state shall not be asked to give opinions on matters of policy and shall be given reasonable opportunity to refer questions asked of the officer to superior officers or to a minister. This resolution does not preclude questions asking for explanations of policies, or factual questions about when and how policies were adopted. Commonwealth officers appearing today are also reminded of the Senate order specifying the process by which a claim of public interest immunity should be raised, and a copy of the order is available from the secretariat. The extract read as follows— Public interest immunity claims That the Senate— (a) notes that ministers and officers have continued to refuse to provide information to Senate committees without properly raising claims of public interest immunity as required by past resolutions of the Senate; (b) reaffirms the principles of past resolutions of the Senate by this order, to provide ministers and officers with guidance as to the proper process for raising public interest immunity claims and to consolidate those past resolutions of the Senate; (c) orders that the following operate as an order of continuing effect: (1) If: (a) a Senate committee, or a senator in the course of proceedings of a committee, requests information or a document from a Commonwealth department or agency; and (b) an officer of the department or agency to whom the request is directed believes that it may not be in the public interest to disclose the information or document to the committee, the officer shall state to the committee the ground on which the officer believes that it may not be in the public interest to disclose the information or document to the committee, and specify the harm to the public interest that could result from the disclosure of the information or document. (2) If, after receiving the officer's statement under paragraph (1), the committee or the senator requests the officer to refer the question of the disclosure of the information or document to a responsible minister, the officer shall refer that question to the minister. (3) If a minister, on a reference by an officer under paragraph (2), concludes that it would not be in the public interest to disclose the information or document to the committee, the minister shall provide to the committee a statement of the ground for that conclusion, specifying the harm to the public interest that could result from the disclosure of the information or document. (4) A minister, in a statement under paragraph (3), shall indicate whether the harm to the public interest that could result from the disclosure of the information or document to the committee could result only from the publication of the information or document by the committee, or could result, equally or in part, from the disclosure of the information or document to the committee as in camera evidence. (5) If, after considering a statement by a minister provided under paragraph (3), the committee concludes that the statement does not sufficiently justify the withholding of the information or document from the committee, the committee shall report the matter to the Senate. (6) A decision by a committee not to report a matter to the Senate under paragraph (5) does not prevent a senator from raising the matter in the Senate in accordance with other procedures of the Senate. (7) A statement that information or a document is not published, or is confidential, or consists of advice to, or internal deliberations of, government, in the absence of specification of the harm to the public interest that could result from the disclosure of the information or document, is not a statement that meets the requirements of paragraph (1) or (4). (8) If a minister concludes that a statement under paragraph (3) should more appropriately be made by the head of an agency, by reason of the independence of that agency from ministerial direction or control, the minister shall inform the committee of that conclusion and the reason for that conclusion, and shall refer the matter to the head of the agency, who shall then be required to provide a statement in accordance with paragraph (3). (d) requires the Procedure Committee to review the operation of this order and report to the Senate by 20 August 2009. (13 May 2009 J.1941) (Extract, Senate Standing Orders) CHAIR: I invite each organisation to make some short opening remarks, and then we'll go to questions. I might start with the Australian Industrial Chemicals Introduction Scheme. Mr Barden : Thank you very much, Chair, and thank you for inviting the Australian Industrial Chemicals Introduction Scheme—which I'll refer to as AICIS from here on—to appear before you today. AICIS is the national regulator responsible for assessing human health and environmental risks of industrial chemicals, authorising their manufacture and import—which is referred to in legislation as introduction—publishing risk information and making risk management recommendations to risk management authorities. The overall regulatory framework for industrial chemicals comprises AICIS and Commonwealth, state and territory authorities that set and implement standards to protect the public, workers and the environment. Within that framework, AICIS regulates individual industrial chemicals, including chemicals used to manufacture plastics, such as polymers and plastic additives. AICIS does not regulate finished or formulated products. Instead, we regulate the introduction of individual chemicals used as ingredients in the manufacture of products like paints, adhesives, solvents, cosmetics and cleaning products. We provide risk management recommendations to downstream regulators who can set standards and manage risks using the chemical risk information that AICIS provides. This includes chemicals used to manufacture products like plastic bags, packaging, toys and the plastic components of consumer products from which chemicals may be unintentionally released. New industrial chemicals that are likely to present higher risk and which have not previously been manufactured in or imported into Australia, must undergo an AICIS pre-market risk assessment and authorisation. This includes chemicals with effects of higher concern, such as effects on reproduction and development, and chemicals that persist and accumulate in the environment. Industry is required to provide information to support all applications for assessment. We can and do require further information when we have concerns arising from that information, other information that we hold or overseas hazard assessments. We place a greater weight on data generated using internationally recognised and validated approaches, particularly OECD test guidelines, so that our assessments and recommendations are science based, robust and transparent. These approaches include a developing suite of tools that were not available to earlier regulators, such as computational and other methods that can model the chemical effects on humans and the environment, supplementing empirical evidence from studies. AICIS also assesses and reassesses chemicals that are already listed on the Australian Inventory of Industrial Chemicals, and we're actively working on risk-proportionate assessment of the remaining unassessed chemicals, prioritising those of highest concern. Our current evaluation of 522 PFAS is an example of this work, demonstrating that, while AICIS's final regulatory decisions must be made chemical by chemical under legislation, we do assess groups of chemicals and make recommendations to risk managers about those chemical groups. I look forward to AICIS assisting the committee today. Thank you. CHAIR: I'll now go to the Australian Pesticides and Veterinary Medicines Authority. Dr Cram. Dr Cram : Thanks for inviting APVMA to appear today. APVMA is Australia's independent regulator of agricultural and veterinary, or agvet, products, and this includes products that are used to control pests and diseases and products used to treat animal diseases. In line with the risk based approach to chemical regulation, a separate regulator was established to manage these agvet products up to the point of sale, because they do carry inherently high risks. We're a product based regulator. Before an agvet product can be registered or approved under a permit, the APVMA must be satisfied that the product doesn't pose a risk to the health and safety of people or the environment and also that the product is effective and won't impact trade. APVMA receives comprehensive information for every product and assesses it in accordance with international best practice. When risks are identified, APVMA has a broad range of regulatory options available to manage the risks of these products. APVMA also has powers to review any active constituents or registered products when new information emerges, and these powers include varying the conditions of use, suspending or cancelling approvals and registrations, and undertaking compliance and enforcement actions including recalls. Ultimately, the APVMA's role is to regulate agvet chemicals to protect the health and safety of people, animals and the environment, and to support primary industries, biosecurity and international trade for all Australians. I look forward to supporting the committee today. CHAIR: Thanks very much. We'll now go to Food Standards Australia New Zealand. Dr Cuthbert: Thank you, Chair, and thank you to the committee for the opportunity to appear today. Food Standards Australia New Zealand, FSANZ, is the independent statutory authority within the joint Australia-New Zealand food regulatory system, responsible for developing food standards. These standards set the legal requirements for food produced or imported for sale in Australia and New Zealand, supporting a safe food supply for consumers. Enforcement of food standards is undertaken by Australian states and territories—the Department of Agriculture, Fisheries and Forestry for imported foods at the border and New Zealand's Ministry for Primary Industries in New Zealand. FSANZ operates as part of a broader regulatory framework for chemicals. Agencies such as AICIS assess the risks of industrial chemicals and provide risk management recommendations, and FSANZ draws on that work, alongside international evidence and our own assessments, to set standards that address chemicals as they appear in food. These include chemicals that may migrate into food from packaging or contact material. In establishing or reviewing food standards, FSANZ undertakes risk analysis consistent with the Codex Alimentarius Commission's risk analysis framework and the World Health Organization's principles for the risk assessment of chemicals in food. Underpinning these approaches is the principle that risk is a function of both hazard, which is the potential of a substance to cause harm, and exposure—how much of that substance a person actually consumes through their diet. The committee has rightly drawn attention to vulnerable populations, including infants, children and pregnant women. FSANZ absolutely shares that focus. FSANZ applies a cautious, evidence based approach to emerging contaminants that may affect sensitive life stages, recognising both the importance of protecting vulnerable populations and the need for regulatory decisions to be grounded in robust, reproducible evidence. There remain significant scientific and methodological limitations in this area, most notably the absence of harmonised analytical methods, insufficient exposure data and limited toxicological evidence of adverse health effects at levels relevant to human dietary exposure. Without those foundational elements, enforceable food standards would not be scientifically robust nor practically effective. However, FSANZ is not passively waiting for the science to mature; we are actively monitoring the work of international bodies, including reviews completed by the WHO and FAO, and engaging with counterpart agencies to track emerging approaches to risk assessment and risk management for microplastics in food. Domestically, the Australian Total Diet Study, our primary tool for understanding what Australians are actually exposed to through their diet, is able to assess specific chemicals of concern, providing the kind of nationally relevant exposure data that can inform regulatory responses. FSANZ welcomes the committee's focus on this issue and is pleased to assist with the inquiry. Thank you. CHAIR: Thank you. I'm going to go to Senator Askew to kick us off. Senator ASKEW: Thank you for your time this afternoon and for those introductory comments. They were very helpful. As you can imagine, we've had quite a lot of interesting evidence provided. I'm not sure if you've been following along, but it's been quite an eye-opener to hear some of the evidence that's out there. I'll start from the chemical side of things in regard to the regulatory framework. Are there current chemical regulatory frameworks fit for emerging contaminants, and how do you monitor and become aware of those as they come through? Mr Barden : We have a system that we use that is continuously looking for new information from around the world. Regulators may make new decisions in other parts of the world. I think the system has got over 93—possibly more now—different sources. We drag that information into our system. We use it to rank different chemicals according to hazard and exposure information that's available, and then we use that to make choices about which chemicals or chemical groups we would put under what, in the legislation, is called evaluation. That's an opportunity to reassess or even assess for the first time the chemicals which are authorised in Australia. Senator ASKEW: Some of the evidence that we've received along the way is that there are more. Microplastics have a lot of chemicals, there are a lot of things that are put into them, they're not all the same and it's not uniform across it. In the case of something like that, would you treat them as classes of chemicals, or would it be something you'd have to do individually? Mr Barden : As we've done with PFAS—we're doing a single evaluation of 522 PFAS. We're treating the class at once at this phase of our work. Then, if it occurred to us that our work demonstrated that there were PFAS used at larger volumes than others, then we would design a risk assessment approach that was commensurate with that relative introduction volume in the country. Senator ASKEW: In your opening statement, you mentioned the ingredients, I suppose, of products and so on. You then provide advice downstream—is that to the producers who manufacture products? Is that how it works? Mr Barden : Our advices go to anyone who'll be engaging with the chemicals. We publish evaluation statements and assessment statements under the law, and that will provide information to persons conducting a business to the kind of controls that will assist in management of risk. We also provide information and recommendations to the risk managers. That's typically the hazard classification process of Safe Work Australia, poisons scheduling by the department of health and the IChEMS arrangements that are administered by the environment department. Senator ASKEW: In relation to the microplastics and nanoplastics that we're looking at, the evidence that we've heard, especially with the work that's been done in the EU and the US, is that there's quite a bit of research that's already been done into this space, and there are actually some legislative guidelines in place. Are you aware of those, and is it something that you've been looking at for consideration in Australia? Mr Barden : If you're talking about controls governing the fate of microplastics in environments in other parts of the world, the answer is no, because that's not the extent of our regulatory authority. Senator ASKEW: I might open that up to the other witnesses—whether you've been aware of what's been going on in other jurisdictions and also whether that's something that you've been considering in relation to the work you're doing here in Australia. Dr O'Mullane : Thanks for that question. Yes, absolutely. Just to go back to your previous line of questioning, the Australian New Zealand Food Standards Code does regulate contaminants. As emerging or new contaminants come up, and there's enough information there to indicate scientifically that there are some risks that need to be managed, then we can certainly step in and set food standards. We have a lot of engagement internationally, as Dr Cuthbert already mentioned, with the Codex Alimentarius, which is an international food standard setting body, important for protecting public health and safety but also for trade as well. So we have those sort of connections, and also with our counterparts in many countries of the world. I think it's fair to say, in relation to microplastics specifically, it certainly is an emerging area of focus for food regulators and food standards setting bodies. Notwithstanding that comment, there's certainly still lots of research and information to gather to actually support a potential standard setting process. Senator ASKEW: It's certainly evidence we've received that there's definitely a need to put some further research behind it but also that we need to be taking precautionary steps as well. Is it at a point, do you think, where microplastics should be regulated as a category Are we getting to that point where we need to be doing something about that, do you think? Dr O'Mullane : In the food space, I think the evidence is still emerging. This is one of the great challenges. In our submission that we've provided to the committee, one of the research focuses is in that area of analytical method development. While there are lots of published studies which are looking at levels of microplastics in things like bottled water and the environment, we really do need to see some robust, reliable analytical methods specifically to quantify levels in food. What that's going to do is give us a really good indication or measure of dietary intake or dietary exposure. That's one of the key factors that we need in addition to some more information around the toxicology so we're able to set those safe levels of upper dietary intake that will then drive the standard-setting process. Globally, there's certainly a focus in the food space, but there's a recognition almost universally that there are some research needs in that space. Senator ASKEW: In the food space, do you actually have regulation over the packaging and so on that the food is presented in? Dr O'Mullane : The Food Standards Code does regulate food contact material so that would include packaging. There is a general requirement in there that any food contact material must not contaminate food. That's the extent of the regulation. I will add that in that contaminate standard that I have already mentioned, we do have the ability to set regulatory limits for individual packaging chemicals or plastic chemicals if there is a scientific need to do that. As Dr Cuthbert said, in our work that we've done through the Australian Total Diet Study we've actually looked historically at levels of packaging chemicals in the Australian food supply, so that's food for retail sale, which is the remit of FSANZ. Those studies have shown consistently that levels are actually very low, so we haven't needed at that point to step in and set regulatory limits, but there is always a potential for us to retest and to look more deeply at this, particularly— Senator ASKEW: I'm sorry to interrupt you. When you are testing, what were you actually testing? Dr O'Mullane : We've tested for things like phthalates, bisphenol A, PFAS, other packaging chemicals. We did quite a broad screen of a whole range of packaging chemicals in the food supply, and most weren't detectable. Where we did find some low levels, when we put it through a risk assessment process, it didn't actually exceed those safe limits, those so-called health based guidance values. That work was undertaken a few years ago, and so there could be cause, going forward, to look at retesting, potentially picking up some of the newer chemicals as well. We're probably a few months away from starting to plan our 29th Australian Total Diet Study and we're already having conversations around what are some of the chemicals we could potentially look at there as part of that work. Senator ANANDA-RAJAH: Senator Askew, would you mind if I— Senator ASKEW: Jump in! Senator ANANDA-RAJAH: On that point, even though you're detecting very low levels, or perhaps negligible levels, the issue we're hearing is that these are chemicals that are accumulative, right? They are accumulating in us over a long period of time. Does your hazard analysis take that into account? Dr O'Mullane : Certainly the behaviour of it and chemicals. So we'll go not to the plastic particles per se, but the chemicals that potentially make them up. As part of our standard processes, we're able to look at the potential of those chemicals to accumulate. Coming back to something Dr Cuthbert said, routinely we are looking at sensitive subpopulations, such as children. We're able to look at the data across different life stages. When we do our dietary exposure assessments, we actually look at the dietary intake of specific age groups across the population as well. We've got a pretty well-established mechanism for looking at these types of things. But obviously maintaining the connection internationally is critical because this is an emerging area and, as you know, there is a lot of research work going on. We need to make sure that we are plugged into that. CHAIR: Can I also ask a supplementary? Senator ASKEW: Yes; go for it. CHAIR: We heard from Dr Muncke, from Switzerland, this morning. She is part of the Food Packaging Forum Foundation. In her evidence, she talked about the fact that there are 15,000 food contact chemicals. She said there is more than a couple of decades worth of evidence to say that we should be regulating food packaging. We also heard from the Australian Food and Grocery Council this morning, who I think made it fairly clear that, unless regulations change, they are not actually going to change anything in their packaging. And while I take your point that some of these chemicals are low, we also heard from scientific experts this morning who talked about the fact that, as consumers, we don't know what those chemicals are and therefore we don't have a choice as to whether we're consuming them. We heard in previous evidence—I can't remember if it was in Adelaide or Melbourne—the example of BPA and how people are buying plastic water bottles and containers that say 'BPA free', but people aren't being informed that it now has BPF and BPS and the like, and so consumers are in the dark. My question to you is: should consumers at least be made aware that some of these food contact chemicals are in there? Are you aware of the work that Food Packaging Forum and others are doing and incorporating that into your work going forward? Dr O'Mullane : Wherever there is new information, including from that forum, we're more than happy to look at it. I think it's our duty to have a look at that. In terms of the work we've done, we're really transparent. We're publishing all of these studies and having the communication around them. The risk communication element of this is critical, as you've identified. Certainly, it's important that we also keep bringing it back to—and this has already been raised so far in the conversation—the scientific evidence and the basis for potentially stepping in and setting regulations. We can do that where there's an acceptable minimum level of scientific information to do that. That's both in terms of the exposure side, which we need to be able to quantify pretty accurately across the Australian diet, as well as good dose response information for the potential adverse effects. CHAIR: From my perspective, as a consumer, I'm not going to go and read all the studies that you're doing and the communication that you're putting out, but, when I walk into the supermarket and I've got a choice to buy product A or product B, and product A has food contact chemicals in it and product B doesn't, at the moment, there's no way I can make an informed choice as a consumer. Dr Cuthbert: You definitely shouldn't need to be trying to choose between product A and product B. It's definitely our remit and job to make sure that any chemicals within any of those products are safe, which is why we maintain monitoring the scientific valuation. For example, if there were 15,000 chemicals, we would then be working globally to figure out which ones we should be prioritising, assessing and looking for; how much is being transferred into food products; and monitoring to ensure that anything that you can buy on the shelf continues to be safe. If it's not safe, we definitely have a role to step in and rectify that. CHAIR: The evidence that we seemed to be getting from Dr Muncke this morning was that there are actually lots of chemicals that aren't being kept out of food packaging that should be, and so maybe there's more work to be done in that space. Senator ANANDA-RAJAH: I think, to follow on from the chair and Senator Askew, our exposure to these chemicals in plastics is not just confined to health. It's coming at us from every direction. It's almost like you need a multimodal model, right, to factor your work into other types of exposures. That's the piece that's missing here. From your perspective, you're saying: 'Well, it's very low. Australians don't need to be alarmed.' I don't want to alarm people, but, in the context of our lives, we are getting hit with this everywhere. What kind of research or approach should we be taking to better understand Australians' exposure to and risk from these chemicals, holistically? Dr O'Mullane : I think you raise a good point, and that's that we focus on the food supply, but there are other potential sources. How do we integrate the exposures? It's all data driven as well, so we need to have the reliable information to be able to do that, and we would do that if it were possible to do that with the information that's there. CHAIR: Does biomonitoring play a role in that? We've had a lot of evidence from other experts who said that Australia doesn't have a national biomonitoring program and that the value of those sorts of programs is that you can start to pick up those more cumulative impacts and start to target where information needs to come from. Would something like that add to the work that all of your organisations do? Dr Cuthbert: We love evidence that comes from any source, so I'm not going to say that any evidence that's available wouldn't be useful. The more evidence, the better. Dr O'Mullane : It's a great question, but, if with that biomonitoring data, which is really useful, there's always that question around the sources or roots of exposure. So if we're trying to quantify how much is coming from food, how much is coming from water and how much is coming from air and then making some decisions about how to manage exposure it's difficult to do with those biomonitoring studies, and even those studies themselves don't necessarily provide the kind of quantitative information that we need to actually set those safe levels of exposure. CHAIR: I'm going to go back to Senator Askew, because we jumped in. Senator ASKEW: I was going to go further down that path. Should there be some sort of labelling in regard to packaging? When we look at food additives, we've got numbers on the side of different things. Is that where we need to be going to alert people to the fact that there are microplastics in either the containers that they're in or what's contained in the food? Is that something that we should be looking at or heading towards? Dr Cuthbert: I think our role, as I said before, is really to ensure that anything that is available for sale is safe. So, if we started to create a limit, for example, then our evaluation would be assessing all of the potential exposure points that people could be building up those amounts from and making sure that over the course of their life they won't be being exposed to more than what's acceptable. So I still think our role is to ensure that there aren't things available on the market shelves that are going to be unsafe for consumption. Senator ASKEW: One of the things that we've been looking towards is what recommendations we will be putting into our report, which is obviously the outcome at the end of this inquiry. There's a lot of evidence internationally that we think we should be looking at. There are a lot of suggestions that we will be putting forward from us. Is there anything in each of your specific areas that you would like us to be looking towards or to be asking other departments about to give some guidance so that we can have some sort of way forward at the end of this in regard to dealing with it? Your requirement for evidence is great, but, as we've heard, it's not that easy to do some sort of trial where you haven't got exposure to any microplastics or plastics, because everybody, every day, is going to be exposed to them, so you're never going to have a control. So there has to be some way that we can go forward to be able to provide you with the relevant evidence that you need but also, in the meantime, deal with the emerging contaminants that are out there rather than just ignore it until we get to crisis point. So all three organisations can give us any feedback you like on that. Where do we need to go? Mr Barden : One of the things that I've observed with the European system is the publication of a regulatory needs document, which helps provide the research community with areas that the chemical regulator over there considers will be helpful to their remit and the work that they're seeking to do. Reflecting on evidence that was given this morning, as well as the NHMRC before us, for whatever decisions that might be made around biomonitoring and the like, having an opportunity to turn that, then, into information that informs the research community of the type of information that would help each of us do our jobs, I personally think, in my role, would be a useful thing. Senator ASKEW: Did you want to add anything, Dr Larter? Dr Larter : No. Senator ASKEW: Dr Cram? Dr Cram : We're evidence based regulators, and the more evidence we have the better we can regulate. Senator ASKEW: Fair enough. Dr O'Mullane : To reiterate my earlier comments about the analytical methods, that will really support that quantitation of what's actually in food and support that risk characterisation more effectively. I know there is a lot of work going on in Australia at the moment in the analytical method development space. A lot of that is not necessarily—it has an environmental focus. There are lots of different compartments that it's potentially looking at, so, for us, some good, robust, reliable analytical methods that would enable us to quantify microplastics would be helpful. CHAIR: I have one question before I go to Senator Ananda-Rajah. If I heard things correctly in the opening remarks, AICIS looks at chemical by chemical? Mr Barden : We regulate chemical by chemical. CHAIR: Sorry, you regulate chemical by chemical. Is it a similar approach for Food Standards Australia New Zealand? Dr O'Mullane : Generally, but if there is evidence that we have available to be able to combine chemicals together, we will do that. CHAIR: Whereas APVMA do product regulation. I guess this is one of my questions as a nonscientist. We're hearing that we've got plastic products, be they containers, food containers or things we put on our skin—you name it—that contain multiple chemicals. Why is it that, when it comes to pesticides, we want to know how they all interact together before we allow them to come to market, but, with the other two, we're just doing it chemical by chemical and not really considering what that means when they're all put together? Dr Cram : I mentioned in my opening statement that the kinds of products that APVMA regulates are inherently of higher risk. They are designed to have impacts on biological systems. I think that's probably part of the reason why there is a separate product regulator for agvet chemicals. CHAIR: Some of the evidence we're hearing is that we know they're high risk now, but we didn't know DDT was high risk in the beginning. That's why I'm interested in the answer to this question. Mr Barden : In terms of industrial chemicals, the Australian framework is a risk based framework as well, and it's designed consistent with the principles of the OECD, of which Australia is a member. We, as a country, signed up to an approach which is to create a regulatory framework in which, when there is the highest likelihood of harms, the greater the data requirement for assessment would be. I don't know if Dr Cram knows how many agvet chemicals there are, but the number of consumer products, let alone all the other products used, from the industrial chemicals that we regulate, is absolutely massive. I can't conceive of a single regulator being able to properly assess and regulate all of those products for the specific formulations, if I'm understanding your question correctly. CHAIR: It seems a bit back-to-front. Someone gave some evidence this morning, and they said, 'If we knew what we knew about plastics when we first designed them and they were introduced, they wouldn't have got past the approval stage.' It's interesting to me that it's almost like the problem is so big now we'll just deal with the bits we can and we'll just have to live with the consequences of the rest. I'm interested in the answer to that question around food and, particularly, packaging and contact chemicals. Dr O'Mullane : This is in relation to the combined effects and mixtures, and I was going to comment that quite a bit of work has been done internationally around cumulative exposures and cumulative risks and mixtures as well. Generally, those studies have indicated that, unless a chemical has the same mechanism of toxic action in the body, it's not necessary to add them together, if that makes sense. In terms of packaging, I'll go back to my earlier comments around the way the Food Standards Code regulates packaging chemicals, which really is putting the onus on the manufacturer to ensure the safety and the suitability of that packaging material. That's an important co-regulatory comment to make. As I've said, we have the potential to establish regulatory limits for packaging chemicals where the data supports that. Equally, the packaging manufacturers, I understand, are importing a lot of material from Europe and North America, where they have quite stringent standards around the use of packaging chemicals. Then there's also the role for groups like the ACCC and local authorities in terms of potentially enforcing the quality of packaging material. That's an important point to make. CHAIR: Thank you. Senator Ananda-Rajah. Senator ANANDA-RAJAH: Are our food standards for packaging similar to the EU? Dr O'Mullane : We don't have a specific packaging standard in the Food Standards Code. If you go into the Food Standards Code, there is not a list of packaging chemicals that have been assessed or are listed. We have, as I said earlier, a general requirement that any food contact packaging material has to be safe and suitable, and must not contaminate, and it would then be up to jurisdictional food regulators to enforce that, potentially. Senator ANANDA-RAJAH: Does any jurisdiction have a food standard packaging code? Does the EU have one? I thought it did. Dr O'Mullane : That's a good question. I'll have to take that on notice. I don't know. Senator ANANDA-RAJAH: I don't know if any of you have read the Lancet Countdown. Have you read this paper that was published in the Lancet on microplastics? I'm going to suggest you read it. It's quite sobering reading. This is a top medical journal. On food contact chemicals, it says that a systematic review of nearly 950 studies on plastic food contact materials reported that 40 per cent of nearly 4,000 chemicals 'are released into food or food stimulants under specific conditions', and that more than roughly 1,400 plastic food contact chemicals 'have been detected in humans of all ages': Migration of plastic chemicals into foodstuffs increases at higher temperatures and with longer periods of contact time. Fat content and acidity of foodstuffs also influence the extent of release, as does serving size— Then, paradoxically, it states that, in fact, children and infant food could have higher exposure to these chemicals than adult food, just because of the surface area issue. I feel like there's a disconnect between this and what you've told us—but I don't dispute your analysis. Is there a problem? What am I missing here? Dr O'Mullane : Yes, where there's a suitable analytical method, we can measure and look and do a risk assessment on that chemical. Dr Cuthbert: On what you've said, I don't think that's a disconnect from how we operate in Australia. We are very connected to all these international regulators who do the same thing. I'll again mention the Australian Total Diet Study, where we're regularly assessing how many of these chemicals are being exposed to the food supply and then being consumed. There is a monitoring activity that we undertake to test how that is then playing out across Australia, to understand and to then decide whether we need to create limits and put any standards within the code to respond to that. Senator ANANDA-RAJAH: I think we're coming at this all the wrong way. Can I be completely frank: I think trying to prove causality or harm is just too hard with something like this. We have heard that there's a dearth of data in Australia, on longitudinal human data; we just don't have those studies. If we were to wait 25 years, or one generation, we know that plastics will have gone from around 400 megatons now to nearly a billion megatons; that's what this Lancet paper tells us is the trajectory. It's an exponential increase. If we were to take a more precautionary approach to food packaging, what would those principles look like in terms of the harms we're trying to prevent? The onus would then fall onto the producers to stick to those principles. Have you, or has anyone, thought about that paradigm? Dr O'Mullane : It's a good question. As I've said, the onus is always on the packaging manufacturers to make sure their product is safe and suitable. I'm sorry, could you repeat the question? Senator ANANDA-RAJAH: You said the onus was on the packagers to prove it's safe, but safety is very difficult to prove with the current tools we have. In Australia the data is scant. Dr O'Mullane : Coming back to what Dr Cuthbert said in her opening address, the system for setting food standards and for our analysis is risk based; it's not present based. 'Presence' doesn't necessarily mean 'problem'. That analysis of what's present is critical, but we need to then look at how much people are eating. That's looking at what foods things may be present in and at what the dietary consumption patterns are across Australia, and then being able to compare that intake, that dose, with some kind of safety limit. There needs to be some type of comparator there. This is where this dose-response relationship information is important for the critical adverse effects. Those so-called health based guidance values are set on the most sensitive adverse effect relevant to be protective of humans. So the idea of a precautionary approach is difficult to practically implement because of the lack of information. As I said, it's risk based; it's not hazard based. What you're maybe talking about is a hazard based approach, if I'm not mistaken. What I'm talking to is the fundamental risk analysis paradigm that is used globally in this space. A precautionary approach doesn't fit neatly into that paradigm. Hopefully, that makes sense. Senator ANANDA-RAJAH: Yes, I think it does. I think that's the nub of it, isn't it, that all these papers from expert after expert are calling for precautionary approach, but our regulatory paradigm is not a match for that. Do you have any thoughts on how it could become a match for that? Dr O'Mullane : That's a huge policy question. I'm not sure that we can offer much there. I mean, there's a lot at stake here. We're hearing about in-utero transmission, blood-brain barriers being breached, microplastics in every organ in the body, early onset cancer, dementia, insulin resistance. I mean, it's a list as long as my arm—low birth weight, very low birth weight, which has been persistent in First Nations communities, who are also exposed to high levels of plastics. I mean, the list just goes on—IVF success rates not moving in 30 years, fertility falling throughout the world—and we are getting pummelled with more and more plastic. I really would love you to think of how we should better regulate and what you need for us to put the onus on the producers to keep our people safe. CHAIR: I might take that as a comment. Senator ANANDA-RAJAH: My one last question: on the topic of fertiliser, can you just comment, Dr Cram, on whether microplastics are an issue in fertilisers used in Australia, because there's been a lot of commentary overseas around this issue. Dr Cram : The APVMA regulates fertilisers that make a claim around enhancing growth promotion. Most of them don't actually fall within our regulatory remit. If it's a plant hormone that's added to the fertiliser, then we do a risk assessment but it's focused around that plant hormone and the action of that plant hormone, so our risk is more focused around the chemical there that has the agricultural or veterinary impact. Mr Barden : In other circumstances, the ingredients of other fertilisers would be treated as industrial chemicals and come through AICIS. As I've stated before, though, our ability to consider microplastics in a finished product doesn't exist. Senator ANANDA-RAJAH: So how would we compel you to consider it? Would that have to come from the government or from someone else? Mr Barden : The law would have to change, but I think there's quite a policy consideration required. I wouldn't see it as simply giving up. There's the relationship between our legislation and other parts of the regulatory framework. Senator ANANDA-RAJAH: You have to forgive me. Which act would we have to look at to amend? Mr Barden : AICIS operates under the Industrial Chemicals Act. But if we were being asked to consider a microplastic in a product that we may know very little about, that would principally be the challenge. If the fertiliser was being produced with nine out of 10 components already authorised and we were being asked to assess a new 10th, that would be our assessment; it wouldn't be of the fully formulated product. So that's fundamentally perhaps where your question is going—whether industrial chemicals should be ingredient or product based. Senator ANANDA-RAJAH: Is that your job, Dr Cram? If the final product was used in agriculture and it was potentially contaminating the soil and food chain with microplastics, would that be in your purview? Dr Cram : Only to the extent that the fertiliser makes a claim about being an agricultural veterinary chemical; otherwise, it doesn't fit into our regulatory remit. The states and territories set limits around things like heavy metals in fertilisers at the moment. Senator ANANDA-RAJAH: So there's a regulatory gap here, by the looks of it, a blind spot around microplastics in fertiliser? Dr Cram : We look at the whole product when it falls within our remit. If plastics in that product were something that we considered to be a risk then we could ask for information around those sorts of things. But as I said, it's only those that fall within our regulatory remit that we look at. Senator ANANDA-RAJAH: And your regulatory remit does not have microplastics in it. Is that right? Dr Cram : It's product based. It depends on the claims that are made in the product, so most fertilisers don't fall into the category of being an ag/vet chemical. Senator ANANDA-RAJAH: I'm going to take that as being a blind spot. CHAIR: Thank you very much to all of you for coming along and for giving us your evidence this afternoon. The committee will be reporting to the Senate on Wednesday 26 May 2026 and has agreed that responses to questions on notice should be provided by close of business on Wednesday 15 April 2026. Proceedings suspended from 15:11 to 15:20 .