Senate Rural and Regional Affairs and Transport Legislation Committee [Part 2], , 3:26:01 to 3:49:08
The committee questions the APVMA on its inconsistent use of PFAS definitions and the assessment of pesticide residues in food. Concerns are raised about cumulative exposure and the potential for industry capture within the regulatory agency.
Topics: Health, EPBC Act, Food security
Speakers: Scott Hansen, Senator Lidia Thorpe, Speaker 22, Speaker 5, James Deller
>> Thank you, chair. Um, thank you for appearing so late, being patient. Um, I'm just going to follow on from some of the things that, um, Senator PCO has talked about. Particularly one that concerns me is ATPMA is the only majority industry funded chemical regulation body in the OECD. You receive your income from fees, charges, and levies from the industries. How do you ensure you make decisions independent of chemical company influence? And how often does ATPMA require independent toxicological assessment of a proposed chemical in addition to or instead of industry provided toxicological data?
>> APVMA
>> APA. Are you not? >> Yeah. Thank you.
>> Um and thanks for that question. So we are cost recovered that's the government policy arrangement for funding of us and we're funded by the fees that the the applicants pay upfront and then on a levy collection of sale. We do receive government appropriations to assist us with the funding of our um activities around emergency use permits, minus permits, or that that's what's being proposed. And but the legislation makes it really clear as to what we can consider and can't consider. It it also puts the emphasis on the applicant to actually provide the information to satisfy us to make sure that we are satisfied to the legislative requirements that we need to follow to be able to approve a chemical. So it needs to demonstrate that it's safe. It needs to demonstrate it's safe to people, to the environment, to the target animal or crop that's being applied to. It needs to demonstrate it's efficacious. It needs to demonstrate the fact that it's not going to unduly influence trade. And if it does those things, our legislation means that we have to approve it. And if it doesn't do those things, then it means we have to refuse it. Um, it's that legislative underpinning that sort of gives us that independence. It it's also bits have been added along the way, such as the fact that companies can't just keep adding drip feeding information to us to try to get us over the line. the submission and the package that they give us up the front. The only way they can add additional information to that is if we deliberately ask for it. Anything else they give us, we don't take into account um and we arrive at our conclusion based on that package of information that they provide.
>> Thank you. Australia's PAS National Environmental Management Plan, the NEMP 3.1, adopts the OECD definition of PAS. Substances containing at least one fully furinated carbon atom, the same definition used by the Department of Climate Change, Energy and the Environment, and Water. And given many of the newer pesticides are meeting this definition such as isocycloerum, does the APVMA accept and apply that same OECD NEP definition of PAS?
>> Yeah. So we actually don't get to consider the classes of chemicals as such. We look at each application, each product that gets brought to us. So say serum um when it gets brought to us, we look at it as it in its own right as its own chemical structure regardless of how many carbon and fluoride atoms it has joined up together. We then look at what else gets mixed in with it in that formulation that it's going to be used in. And we run our environmental and our health assessments on the individual chemicals and that combination of chemicals that are together. And I say that because for a number of government agencies, classifications such as what falls into the definition of PAS is important for their standards and their guidelines. For us, we look at each and every single one of them because they all break down differently. Isocyclo serum is a good example. like the Americans don't count it because it doesn't it doesn't look like a PAS to start with but it actually breaks down and one of its one of its um oh help me metabolites one of its metabolites is actually a PAS and so the European Union calls it a um and OECD calls it a um a PAS we look at it as a chemical structure in its own right I I know it's different to how some of our partners in the um in the environment department and partners across and Department of Health with regards to um Akus and so forth at the industrial chemical regulator look but we look at the individual chemicals one by one and look at their some of them break down quickly and have a relatively short halflife some of them hang around forever >> and we run different tests for each and every one of those individual chemicals
>> or pest hangs around forever. So to be clear, you do or don't accept the OECD NEP definition.
>> Uh both definitions have total relevance in terms of what they're trying to look for and what they're trying to do. We don't need to apply it in our sense because we look at each and every individual chemical um itself regardless of whether it's going to meet the OECD or whether it's going to meet the US definitions. We largely rely on OECD guidelines for all of our assessment pieces. So for example, all of our environmental assessment of chemicals that are classified as PAS. We run a European calculator to sort of calculate um the risks associated with them. We use a US calculator to help us calculate worker exposure and what the risks are associated with that. So we we draw from both but we look at the individual chemical on its own rather than giving it a a label as to whether it's a US or EU PAS.
Uh so so you don't use a single definition of PAS.
>> No because it doesn't really come into our assessments.
So does APVMA uh sorry. So what why should different arms of the government apply different definitions of PAS to the same chemicals with the result that a substance may be regulated as a forever chemical by the environment department but not by the pesticides regulator. And so again, it
comes down to the fact that we will look at that individual structure of that chemical and we'll say we model what it's accumulation in a soil might be for 50 years and we'll model that and we'll say is it safe to environment or not regardless of which definition it meets in terms of whether it's classified by the Europeans or the Americans as as a a PAS. And so for us, which one of those two is not really a consideration that we take into account in our assessment and modeling? We look at the actual chemical structure of each and every one of these chemicals that gets classified, >> which means that those government agencies that do need to use a definition of PAS to work out policies and guidelines. You're right, they should all have a singular um definition that's used by Australia. I'm just not sure which one it is cuz we don't look at it as a PAS. We look at it as a chemical structure in its own right.
>> Okay. So, isocycloerum is a recently registered and now widely sprayed insecticide that meets the OECD NEP definition of PAS. This year, APVMA proposed increasing the permitted residues of isoccyloerum on berries, a food eaten raw, unpeeled, and in quantity by young children by between roughly 70 and 500 times. What consideration did the APVMA give to the persistence and PAS status of isocycloerum and to cumulative dietary exposure in children in reaching that proposal?
>> Good question. I'll see if Mr. D wants
>> Thank you, Senator. So for is cycle serum the APVMA considered a complete high-quality data package that met the international standards for pesticide residues both for the registered uses and the use approved under permit um which includes the berry use. So expected residues in food were assessed using Australian consumption data and internationally recognized methods for assessing dietary exposure both So, Food Centers Australia New Zealander who is our sort of partner um in assessing uh food um exposure risks. They independently reviewed the dietary exposure assessment and they agreed that consumer so exposure to IClo is cycllo
>> So, can can I just add a couple of Maximum residue limits are probably one of the worst named things in terms of trying to explain to anyone. The maximum residue limit is the amount of residue that the maximum amount of residue that is expected to be found in a product if it is being used legally It is magnitudes away from what a safe level is because the safe level we build in in this case we build in a 100 times safety factor to reduce down what the both the ADI so the the acute level exposure. So how much if you ate quickly in one day it might lead to an acute toxicity versus or the acute reference dose which gives you that longer term that that accumulation point that you were just raising. So we build in a safety margin of over a 100 from those numbers and then make sure that the use pattern is going to end up with residues that are nowhere near that safety limit. If it starts to get near that safety limit, we changed the rules on the labels. We did that recently, for example, with dimeth and berries where we had the same challenge of blueberry consumption increasing significantly, meaning that the numbers that were being eaten increase, which started to get close or started to approach our safety margin, that 100 times safety margin increase [clears throat] the withholding period between spraying and when berries could be picked. to further allow time for it to degrade in the berry and be present at a lower level. The the presence of a chemical in foods, and I know everyone will have their own view, but the presence of a chemical in foods doesn't necessarily inherently mean it's What we do is we consider how much of a product should still be found if because it's only able to be used if it's going to meet the safety requirements. If it's being used according to the label, how much should it be found so that we can use that as a compliance tool to actually find where people are using it incorrectly or illegally and to be able to use that as a compliance tool to understand and carry out investigations or to help the state to carry out those investigations. That 500fold increase for example was actually moving the treatment time to closer towards the harvest point which meant that there was a higher amount of the residue in the berry but that was still I think it was and you might have to remind me I think it was 10% of that 100 times safety margin that ended up being as a result of what was in those berries. So still incredibly even when modeled over the long-term exposure that we do in terms of modeling that. It's a difficult thing when you start talking about increasing residues by 500% though to sort of get that
>> It's turning me off berries that's for sure. Um so APVMA sets maximum residue limits or MRLs for pesticides on food items. Before any MRL can be proposed or established, the APMA must assess whether expected residues associated with the proposed use pattern are safe for consumers. Am I correct that you assess this and set the MRL in isolation for each pesticide? Meaning you do not look at a cumulative effect if a food crop has been sprayed with several pesticides.
>> Uh we do look at a cumulation effect and we do look at total exposure within a diet as well. So both for one product that might be used across 20 different crops, we our calculators assess the potential exposure across that whole diet um and builds that into the models that we do as well as looking at the accumulation across a likely diet of chemicals that act and behave in the same way because those mode of operation might work together to create a risk. So we do um we do look at that. What we also do though cuz we we set the MRL for that use pattern. We then present or give all that information across to food standards Australia and New Zealand who have shared responsibilities for um residues in food. They maintain the food standards code and that food standards code establishes the legal requirements for any food sold in Australia and New that that code actually has a schedule attached to it that specifies the maximum residue limits which are legally permitted in or on any food sold in Australia before an MRL is included in that. So we'll do our calculations, we'll provide that to fizz and then they do their calculations and assess whether the resulting dietary exposure fits within um relevant healthbased guidance values. Um and if it does then they include that in that schedule 20 in their act. If not then they don't and it it is not legally able to be sold in
so when I wrote a letter to APVMA in July this year um about my concerns with the use of PAS pesticides and whether APVMA assesses for safer alternatives when allowing chemicals onto the market. The response stated that the legislation does not allow the APVMA to undertake comparative assessments between registered products or determine whether alternative technologies may be preferable. Whose role is it then?
>> Uh so um as far as I see no one does that. So what we regulate and we look at each and each individual chemical and we can't take into account or have consideration to is there an alternative that's cheaper or an alternative that's safer. We have to look at the merit of that individual application and and again our legislation ties us that if it meets the statutory criteria of safety efficacy if it meets it we must register it. If it doesn't we must not. We don't get to compare it against other things
are you able to change the this policy or legislation?
>> Um bit above my pay scale, uh senator thought, but I'm happy to take on board um the concerns you've raised in a constructive way and see if we can come back to you on notice with a more wholesome answer.
>> Yeah, thank you. Um, this country records some of the world's highest rates of cancer, motor neurone disease, and Parkinson's disease with highest concentrations in rural and agricultural areas exposed to pesticides. In 2020, France established a pesticide victims compensation fund national scheme that compensates farmers, agricultural workers, and children exposed prenatally for pesticide related illnesses including Parkinson's disease, prostate cancer, and certain blood cancers funded in part by a levy on pesticide sales on a polluter pays basis. Given the evidence linking pesticide exposure to these same conditions in this country, has the APVMA or the government undertaken any assessment of whether a comparable compensation fund should exist in this
>> Oh, sorry. [clears throat] >> I was just going to say, Senator, um that wouldn't ordinarily be a matter for APV made to comment on. uh they're strictly I guess kind of an independent assessor of agriculture and um veterary um chemicals and medicines. Um ultimately any compensation scheme would be a matter for government.
government.
>> Uh I'm unaware of any consideration of
So kids getting poisoned by eating poison berries, getting sick. >> We know PAS is there's cancer clusters in this country. So So the question is would the government maybe consider a [snorts] fund that helps pay, you know, firefighters for example, they're all, you know, got cancers from using the PAS. Like it's about a compensation to help those people recover. from being poisoned by the foods that they're eating.
>> Well, I I don't accept um that you've put that case here tonight. Uh sir, I think it's been a a good set of questions and a thorough set of answers from the APVMA uh in terms of how the process works, which you know, I've I've found really interesting as well. But I don't think the accusations that you make are accurate in terms of what the evidence has been tonight.
>> Sorry, I missed the last bit. I don't
think the accusations that you make match the evidence with what's been
>> Okay. I was talking about PAS. Uh there's certainly a lot of evidence of the damage that does to people's health and we had a whole PAS inquiry that told us that.
>> Yeah. and and uh it's not really a responsibility of of um uh this department in terms of how that's being
>> even though this department is using PAS to spray berries, it's not not related to that.
>> Well, we I think we've talked through um the scientific approach that the APVM VM APVMA have had uh in regards to that
>> Okay. Um to your knowledge, how many other countries have established Oh, don't worry about that one. Um so, previous reviews of AP VMA have found large industry capture. We heard this in evidence just before in relation to paraquat. Um is there anything being done to address that issue?
Um uh Senator so the um I probably don't accept the premise of the question as as characterized. What I would say is that previous reviews have identified a range of opportunities for improvement both to a agriculture and veterary chemical uh veterary medicine's um policy and regulation and the APV APVMA's operations and governance. Um the government's response to um a number of those reviews um is captured in a detailed response. In that detailed response um the government sets out what it will do in response to um a range of those recommendations and we are currently reporting on our implementation in relation to that detailed response um on a periodic basis.
>> Thank you. I just have one more question chair. Thank you. Um, do you agree that it would be an increased chemical burden for an individual consuming a food that has been sprayed with several pesticides?
>> I'm going to be really annoying and saying, well, that depends. The simple answer is yes, but all chemicals break down at different speed and different rate. And so it depends when it's been sprayed on the food or on the source. It depends on how long between being sprayed and when it's being um harvested and then the time between that and when it's been um consumed. But the general premise of of if all thing other things are equal. Yes. Um but as I said each and every chemical and this is part of the challenge for us in our task is we have to look at each and every one of these chemical structures and go how does it behave and what does it do when it's used in accordance or used in a way that's proposed and to work out what that burden looks like by trying to map out what the the rate of [clears throat] um degradation and depletion of those residues are to work out how do we continue to ensure to make sure food is
>> Okay, thank you. No further questions.