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QUESTION ON NOTICE

Question:

21 November 2022

140. On page 47 of the TGA non-clinical report it states no unique in-vivo metabolites of ALC- 0159 were observed in the rat pharmacokinetic study, but N,N-ditetradecylamine formed by slow amide hydrolysis was identified in hepatocytes and liver S9 fractions from mouse, rat, monkey and human – Substances predicted as likely to meet criteria for category 1A or 1B carcinogenicity, mutagenicity, or reproductive toxicity, or with dispersive or diffuse use(s) where predicted likely to meet any classification criterion for health or environmental hazards, or where there is a nanoform soluble in biological and environmental media. https://echa.europa.eu/substance-information/- /substanceinfo/100.037.611 141. Why didn’t the TGA identify the accumulation of N,N-ditetradecylamine a risk from the vaccine?

Answer:

Question Number: 265
PDR Number: SQ22-000636
Date Submitted: 21/11/2022
Department or Body: Department of Health

140 The primary route of metabolism identified for ALC-0159 involves amide bond hydrolysis yielding N,N-ditetradecylamine. This metabolite was only identified in vitro in isolated mouse, rat, monkey and human preparations. The metabolite was not detected in vivo in rats after an IV dose of ALC-0159. The human exposure to ALC-0159 as part of the Pfizer vaccine is 50 ?g, which is below the threshold of toxicological concern (TTC) of 120 ?g/day for substances with a dosing period of less than one month over a lifetime (ICH guideline M7: www.ema.europa.eu/en/documents/scientific-guideline/ich-guidelinem7r1-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit_en.pdf). Even if N,N-ditetradecylamine is formed from ALC-0159 in vivo, the amount of the metabolite would be much lower than the amount of ALC-0159 in the vaccine dose. Therefore, neither ALC-0159 nor N,N-ditetradecylamine from COVID-19 vaccination is considered to pose a carcinogenic risk. As per the ICH guidelines, which are used by regulators in all major developed countries, guidelines no further risk assessment was required. 141 N,N-ditetradecylamine was not detected in rats in vivo after an IV dose of ALC-0159. This means there is no accumulation of N,N-ditetradecylamine. See also the response to Question 140.

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28/11/2022

Senator RENNICK: Do we have any costings for storage? How much will it cost, in terms of storage, to get to our 2030 target? Mr Duggan: A lot of this is, of course, private provisions. In fact, you’d hope that the vast majority of it was. Government has policies that would assist thatSenator RENNICK: That is fine, but we’re told every day that renewables are cheaper. I want that quote substantiated by proper costings, whether it’s funded publicly or privately, because it’s going to end up either out of the taxpayer’s pocket or on their energy bill. So I’m looking for costings just on storage. I want it on other issues as well, such as transmission, but I’m asking: do you have costings on that storage? Ms Brunoro: We’ll take that on notice. The difficulty with answering that question with any kind of precision is that, in terms of deep storage, it will relate to a number of technologies-it’s the same for deep and shallow. It will ultimately depend on the precise mix of those, but we can do things at a high level with respect to the nature of the type of storage that fits within that and provide some estimates to you. Senator RENNICK: So you don’t have definite figures at the moment? Mr Duggan: What we can do for you-and we’ll have to take this on notice-is look at the existing pipeline of projects that are underway and what the private proponents have told us about the cost of those things. We can add to that: through Rewiring the Nation or other policies that are helping to assist that, we can break down the government contribution to that. But we just don’t have all that detail in front of us. Senator RENNICK: I want government and private, because, ultimately, it going to cost the consumer through taxes or energy bills. But is that fair to say that that’s not completed yet? Mr Duggan: We will take that on notice and we’ll endeavour to do our best to come back to you.

28/11/2022

Senator RENNICK: Thanks very much. Yet again, in terms of the overall modelling, have you got a breakout of how many turbines you need, how many solar panels you need to get to 82 per cent renewables? Ms Brunoro: Again, the Integrated System Plan does provide an indication of the type of the level of renewable energy, so just bear with us a second. Mr Peisley: Sorry, I don’t think we do have that figure in front of us. We’re happy to take it on notice and get it to you. Ms Brunoro: But if it gives you a sense of it, it’s nine times the amount of the existing variable renewable energy that currently is-well, as of when the last Integrated System Plan came out, it was operating in the NEM at that point. So that gives you the quantum ofSenator RENNICK: So nine times what? Ms Brunoro: Nine times. Senator RENNICK: Yes, but what? Ms Brunoro: The variable renewable energy that is currently in the National Electricity Market. Senator RENNICK: So what’s the cost of that? Ms Brunoro: Again, Senator, it depends on the mix of technologies that you’re going to deploy. There are some figures that we can pull out for you around what they roughly think around different-solar versus wind for instance. We can actually seek to provideSenator RENNICK: So can you give me some definite costings on that? Not now, but on notice?

28/11/2022

1. According to the December 2020 update, Australia emitted 499 million tonnes of carbon dioxide equivalent to a 5 per cent decrease on 2019. Australia’s grasslands are estimated to be 440 million hectares and native forest 147 million hectares, a total of approximately 587 hectares. It is estimated forest and grasslands absorb between 0.5 and 2 tonnes of carbon per hectare. Assuming an average of 1 tonne of CO2 absorbed by these landscapes then isn’t Australia already at net zero? 2. Can the CSIRO provide a comprehensive roadmap of the work required for Australia to meet a 43% reduction in CO2 by 2030? This roadmap should set out the length of transmission lines, the number of transmission towers, the number of solar panels (for a given wattage), the number of wind turbines (for a given wattage), the number of batteries (for a given storage), the amount of lithium, copper, cobalt, nickel, concrete, and steel etc. needed to build the aforesaid generators and storage. It will need to include the amount of land needed for solar, wind, transmission, and storage products and the biodiversity offsets. Could the amount of CO2 required to build, recycle, or dispose of the aforementioned items also be included. Likewise, could the cost of building, recycling, and disposing of the aforementioned items also be clearly outlined. Biodiversity impacts such as increased tyre wear due to heavier batteries in cars, increased breaking distance on roadkill, impact on bats and birds from transmission lines and wind turbines, and removal of native flora and fauna due to land use should also be clearly outlined. 3. If the CSIRO cannot provide, can it state which department is responsible for maintaining and tracking the roadmap and refer the question onto them? 4. Could the change in Earth’s temperature as a result of Australia undertaking the 43% reduction in CO2 measures please be stated in order to ensure appropriate benchmarking and accountability if targets are not met? 5. Could the CSIRO confirm if every country uses the same methods to calculate CO2 emission and reductions? If not, why not? What guarantees are there under the Net Zero that Australia won’t be disadvantaged as a result of signing up to the Net Zero pledge?

23/11/2022

1. Can the Department of Climate Change, Energy, the Environment and Water provide a comprehensive roadmap of the work required for Australia to meet a 43% reduction in CO2 by 2030. This roadmap should set out the length of transmission lines, the number of transmission towers, the number of solar panels (for a give wattage), the number of wind turbines (for a given wattage), the number of batteries (for a given storage), the amount of lithium, copper, cobalt, nickel, concrete, and steel etc. needed to build the aforesaid generators and storage. It will need to include the amount of land needed for solar, wind, transmission and storage products, and the biodiversity offsets. Could the amount of CO2 required to build, recycle, or dispose of the aforementioned items also be included? Likewise, could the cost of building, recycling, and disposing of the aforementioned items also be clearly outlined? Biodiversity impacts such as increased tyre wear due to heavier batteries in cars, increased breaking distance on roadkill, impact on bats and birds from transmission lines and wind turbines, and removal of native flora and fauna due to land use should also be clearly outlined. 2. If the Department cannot provide, can it state which department is responsible for maintaining and tracking the roadmap and refer the question onto them?

21/11/2022

1. Regarding wind turbines, are there standards to ensure that the epoxy used will have a UV filter to stop the epoxy breaking down and allowing bisphenol A to run off into the environment?

21/11/2022

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