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Australasian College of Toxicology & Risk Assessment10th Annual Scientific Meeting & Continuing Education Day

Rydges Capital Hill, Canberra 27– 29 September 2017

Wednesday 27 September 2017

Continuing Education Day New Approaches / Methodologies in Risk Assessment

Thursday 28 September 2017 – Friday 29 September 2017

10th Annual Scientific Meeting Risk Assessment of Novel Technologies

ACTRA GRATEFULLY ACKNOWLEDGES THE 2017 ASM SPONSORS

Silver Sponsor

Bronze Sponsors

Student Prize Sponsor

Australasian College of Toxicology & Risk Assessment 10th Annual Scientific Meeting & Continuing Education Day2

WELCOMEI would like to welcome you to the 10th Annual Scientific Meeting (ASM) of the Australasian College of Toxicology and Risk Assessment (ACTRA). The ASM will provide an important opportunity for ACTRA members and delegates to network; present their work; gain insight into new research developments and innovative finds; discover the latest industry trends and hear presentations on current science from distinguished keynote speakers both nationally and internationally.

The ASM will be held over two days at the Rydges Capital Hill in Canberra, from Thursday 28 September to Friday 29 September 2017. The theme for the 2017 ASM is “Risk Assessment of Novel Technologies”. This topic has generated considerable interest, particularly from regulatory agencies, with a total 101 delegates registered for the ASM up to Friday 15 September 2017. This is a great outcome and the record for an ASM. I thank Les Davies, Chair of the Local Organising Committee (COC), and members of the LOC for their contribution and achieving this record number of delegates.

On behalf of our members, I would also like to acknowledge the generosity of sponsors for the 2017 ASM: Sumitomo Chemical Australia Pty Ltd; ToxConsult Pty Ltd; Australian Government Department of Health, Office of the Gene Technology Regulator and Benchmark Toxicology Services Pty Ltd.

The ASM keynote address will be delivered by Dr Harvey Glick (Monsanto). There are seven other invited speakers (Owain Edwards, CSIRO; Irene Horne, Therapeutic Goods Administration; Janet Gorst, FSANZ; Mélanie Kah, University of Vienna; David Saltmiras, Monsanto; Peter Thygesen, Office of the Gene Technology Regulator; and Mark Tizard, CSIRO). They will be covering a range of topics relating to toxicology and health risk assessment. Professor Mike Roberts, USA/UQ; Nick Fletcher, FSANZ and Chris Lee-Steere, Australian Environmental Agency will present the Continuing Education Course “New Approaches/Methodologies in Risk Assessment,” preceding the ASM on Wednesday, 27 September 2017.

The ASM also provides a forum for ACTRA members and non-members to submit papers on various research topics and other commentaries. This year there are some thirteen submitted papers covering aspects of risk assessment, toxicology, regulatory activities, and ecotoxicology, as well as the winner of the student prize.

The ACTRA Student Prize was put forward by ACTRA in 2015. Its aim is to encourage postgraduate students in toxicology and/ or risk assessment to participate more fully in ACTRA activities. ACTRA acknowledges the generous support of Benchmark Toxicology Services for the award of the 2017 prize. This year, the prize is awarded to Slavica Kandic, from RMIT University in Melbourne on the topic “Heavy metals in vegetable garden soils: Impact of house age, house material, road distance and soil characteristics”.

Finally, the ACTRA Annual General Meeting (AGM) will be held during the lunch break on Thursday 28 September. All ACTRA members are encouraged to attend to hear what the Board has been doing to progress the activities of ACTRA and to contribute forward thinking and planning. We also need 10% of the membership to reach a quorum at the meeting.

I am looking forward to seeing you all in Canberra, and I hope you will take this opportunity to catch up with your friends and colleagues, and enjoy some stimulating science to boot!

Peter Di MarcoPresident 2015 – 2017, ACTRA

Rydges Capital Hill, Canberra | 27 – 29 September 2017 3

CONTINUING EDUCATION DAYNew Approaches / Methodologies in Risk Assessment

Wednesday 27 September 2017

Time Speakers Topic / Title

08:30 – 09:10 Registration: Tea/Coffee

09:10 – 09:30 Peter Di MarcoACTRA President

Welcome and Introduction

09:30 – 10:10 Nick FletcherFSANZ

Benchmark Dose (BMD) methodology for setting human health regulatory endpoints

10:10 – 10:50 Chris Lee-SteereAustralian Environmental Agency

Taming the complexity – use of computer software to efficiently perform high tier environmental risk assessments

10:50 – 11:20 Morning Tea

11:20 – 12:00 Michael RobertsUniversity of South Australia & University of Queensland

The strengths and weaknesses of physiologically-based pharmacokinetic modelling in a regulatory context

12:00 – 13:00 Lunch

13:00 – 14:20 Nick FletcherFSANZ

Breakout Exercise 1: Benchmark Dose (BMD) methodology for setting human health regulatory endpoints

14:20 – 15:40 Chris Lee-SteereAustralian Environmental Agency

Breakout Exercise 2: Taming the complexity – use of computer software to efficiently perform high tier environmental risk assessments

15:40 – 16:10 Afternoon Tea

16:10 – 17:30 Michael RobertsUniversity of South Australia & University of Queensland

Breakout Exercise 3: The strengths and weaknesses of physiologically-based pharmacokinetic modelling in a regulatory context

17:30 – 17:40 Close of Continuing Education Day

4 Australasian College of Toxicology & Risk Assessment 10th Annual Scientific Meeting & Continuing Education Day4


CONTINUING EDUCATION DAY GUEST SPEAKERSDr Nick Fletcher Principal Toxicologist & Manager of Risk Assessment, Chemical Safety and Nutrition, Food Standards Australia New Zealand (FSANZ), Canberra, ACT

Dr Nick Fletcher has worked in a number of Australian Government regulatory agencies, gaining extensive experience and knowledge in the evaluation of the safety of therapeutic goods, agricultural and veterinary chemicals, food chemicals and contaminants. Nick has a PhD in toxicology from Karolinska Institute in Stockholm, Sweden, and a research background on the effects of persistent organic pollutants on nuclear-receptor signalling pathways.

Chris Lee-Steere Director, Australian Environmental Agency P/L, Canberra, ACT

Chris is the Director of Australian Environment Agency Pty Ltd. For over twenty years he has been involved in the regulation of agricultural, veterinary and industrial chemicals in Australia, primarily in the field of environmental risk assessment. Chris worked for eight years with the Department of the Environment, undertaking environmental risk assessments of agricultural and veterinary chemicals for the Australian Pesticides & Veterinary Medicines Authority (APVMA) and of industrial chemicals for the National Industrial Chemicals Notification & Assessment Scheme (NICNAS).

Since leaving the Department, Chris has been working as a consultant in this field, primarily undertaking environmental assessments for the APVMA, but also assisting industry with their regulatory submissions for active constituent approvals and product registrations. He is particularly interested in the development of computer-based methods to improve the efficiency, consistency and accuracy of environmental risk assessments.

Professor Michael Roberts NHMRC Senior Principal Research Fellow, Professor of Therapeutics and Pharmaceutical Science, School of Pharmacy and Medical Sciences, University of South Australia, SA & Professor Clinical Pharmacology and Therapeutics and Director of Therapeutics Research Centre, The University of Queensland, QLD

Michael’s body of work includes 8 books, 483 peer reviewed research publications and 61 book chapters. He holds current NHMRC, ARC and US FDA grants. He has been awarded the Australasian Pharmaceutical Science Association Medal “for outstanding achievements in pharmaceutical science” and the Michael Rand Medal for “outstanding contribution to the disciplines of clinical and experimental pharmacology or toxicology nationally and internationally” by the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists. He is a Director of and Chair of the Education Board for the Australian College of Pharmacy, of which he is also a Fellow, an APVMA Fellow in Nanoscience and a Fellow of the Australian Academy of Health and Medical Science.


ANNUAL SCIENTIFIC MEETINGNovel Technologies in Risk Assessment

Thursday 28 September 2017

Time Speaker Topic


09:00 – 09:20 Peter DiMarcoACTRA President

Welcome and Introduction

09:20 – 10:10 Mark TizardCSIRO

Using RNA for gene silencing in plants and insects: challenges, benefits, and risks

10:10 – 10:30 Peter ThygesenOffice of the Gene Technology Regulator

New biotechnology techniques: Challenges for regulation and risk analysis


11:00 – 11:50 Harvey GlickMonsanto Company

Regulation of precision breeding technologies: Challenges and opportunities

11:50 – 12:10 Brian PriestlyACHHRA & Monash University

Fit-for-purpose TDIs: Matching short-term exposures to TDIs based on lifetime exposure

12:10 – 12:20 Discussion and Questions

12:20 – 14:00 Lunch ACTRA AGM

14:00 – 14:15 Shahnaz BakandUniversity of Wollongong

Nanotoxicology and safety evaluation of nanoparticles in sunscreen products in vitro

14:15 – 14:30 Shahnaz BakandUniversity of Wollongong

Nanotechnology and nanosafety: Risk management of manufactured nanomaterials

14:30 – 15:20 Mélanie KahUniversity of Vienna

Ecological risk assessment of nanotechnology products: the case of nano-enabled pesticides


15:50 – 16:30 Janet GorstFSANZ

Food derived using new technologies: lessons learned from GM food safety assessment

16:30 – 16:45 Roger DrewToxConsult

PFAS half-life in sheep of different ages and gender


PFAS tissue distribution in sheep

17:00 – 17:15 Tarah HagenToxConsult

Assessment of PFOS effects on stock welfare and productivity


17:30 – 17:40 Close of Day 1 of ASM

18:30 – 22:00 Conference Dinner


ANNUAL SCIENTIFIC MEETINGNovel Technologies in Risk Assessment

Friday 29 September 2017

Time Speaker Topic


09:00 – 09:50 Owain EdwardsCSIRO

Modifying Mendel: Assessing the risks and benefits of using gene drives

09:50 – 10:30 Irene HorneTherapeutic Goods Administration

Toxicity assessment of anti-sense oligo-nucleotide therapeutics


11:00 – 11:10 Award of Student Prize

11:10 – 11:35 Slavica KandicStudent Prize Winner

Heavy metals in vegetable garden soils; Impact of house age, house material, road distance and soil characteristics

11:35 – 12:15 David SaltmirasMonsanto Company

Sustainable food production systems


12:30 – 13:45 Lunch

13:13 – 14:25 David SaltmirasMonsanto Company

Update on the global regulatory status and safety profile of glyphosate

14:25 – 14:45 Tarah HagenToxConsult

Toxicity Equivalency Factor for health risk assessment of PFNA


PFOS hard surface screening criteria for risk assessment

15:00 – 15:20 Katie RichardsonSenversa

Assessing vapour risk from shallow coal tar and degraded hydrocarbon sources


15:50 – 16:10 Rhian CopeTherapeutic Goods Administration

Ketamine-positive hair samples in a medical practitioner – Is it addiction or occupational exposure?

16:10 – 16:30 Katie RichardsonSenversa

Recreational soil exposure: How deep and how often?

16:30 – 17:00 General Discussion, Summing-up, and Close of Meeting


ASM GUEST SPEAKERSOwain Edwards Group Leader, Environmental and Synthetic Genomics, Domain Leader, Environment and Biocontrol, Synthetic Biology Future Science Platform, Centre for Environment and Life Sciences, CSIRO, Perth, WA

Owain Edwards obtained a BSc in Zoology from the University of Guelph in 1986. He was awarded his MSc in Entomology from the University of Missouri-Columbia, USA, in 1989 and his PhD in Entomology from the University of California, Berkeley, USA, in 1994. Prior to joining CSIRO in 1998, Dr Edwards undertook postdoctoral studies at the University of Florida and the US Department of Agriculture to study ecological and genetic factors controlling the establishment of natural enemies in classical biological control programs. Dr Edwards’ research at CSIRO has focused on the molecular basis of aphid-host plant interactions, leading to board membership in the International Aphid Genomics Consortium (IAGC) and strong collaborations with the Institute of Zoology (CAS Beijing), Kansas State University (USA), INRA Rennes (France) and BGI Shenzhen (China). His work on aphids has broadened to examine the molecular basis of all aphid interactions with their environment, including the genetic and epigenetic factors controlling aphid polyphenism and the molecular basis of insecticide resistance.

Harvey Glick Senior Director, Asia, Regulatory Policy & Scientific Affairs Monsanto Company, Singapore

Harvey Glick has been actively involved in agricultural research and development for over 35 years. He studied agronomy at McGill University in Montreal where he received a Bachelor of Science in Agriculture. He obtained his Master’s degree in plant physiology at the University of Manitoba and received his PhD at the University of Manitoba on full scholarship in plant physiology and biology. He has also completed an executive business management program at the University of Western Ontario. Over the past 30 years at Monsanto, Harvey has lived and worked in Canada, Belgium and the US and currently is based in Singapore. He has held a variety of positions in the technology, commercial development and marketing organizations. He helped introduce the first biotech crop to Canadian farmers in 1995 and has been involved in the development of biotech crops for Europe, Asia and the Americas. Currently he leads Regulatory Policy and Scientific Affairs for Asia and is directly involved in bringing the next generation of innovative new products to farmers in Asia. He is a frequent speaker at conferences focused on agricultural biotechnology, food security and sustainable food production systems. He serves on the Board of Directors for the International Life Sciences Institute (ILSI) in Asia and the Asia Food Information Council (AFIC).

Janet Gorst Senior Scientist, Biological Sciences, Food Standards Australia New Zealand (FSANZ), Canberra, ACT

Janet Gorst has a background in plant tissue culture and a PhD, from the Australian National University, in plant cell biology. She joined the Australian Public Service in 2005 as a Policy Officer in International Food Standards within the Department of Agriculture, Fisheries and Forestry. In late 2006, she joined the Office of the Gene Technology Regulator as an Evaluator in the Plant Evaluation section. She moved to her current position as a Senior Scientist in the Risk Assessment – Biological Sciences Section at Food Standards Australia New Zealand (FSANZ) in 2009, where she is primarily involved with assessing applications received for GM foods.

Irene HorneSenior Toxicologist, Therapeutic Goods Administration, Canberra, ACT

Irene Horne has a PhD in Microbiology and Molecular Biology from the University of Queensland, with several years research experience with the CSIRO. Dr Horne has worked for approximately 10 years as a Toxicologist for the Therapeutic Goods Administration, the Office of Chemical Safety in the Federal Department of Health, and Safe Work Australia. She has gained wide experience in the assessment of non-clinical pharmacology and toxicology studies of new therapeutic agents, in the conduct of human health risk assessments, and in the examination of occupational exposure standards for chemicals.

Mélanie Kah Research Fellow, Department of Environmental Geosciences, University of Vienna, Austria

Mélanie Kah graduated with a MSc in Agronomy and Soil Sciences (University of Nancy, France), before completing her PhD on the fate of ionisable pesticides in soils (University of York, UK). She was then recruited by the UK Food and Environmental Research Agency (FERA), where she assessed the exposure and hazard of a wide range of contaminants, within projects commissioned by government and industry. In 2009, Mélanie moved to the University of Vienna (Austria), where she develops projects looking at the interactions between organic contaminants and natural/ engineered nanoparticles. Mélanie is currently a Distinguished Visitor at CSIRO Land and Water in Adelaide (August 2017 - July 2018).

Mark Tizard Project Leader & Senior Research Scientist, Genome Engineering, Health & Biosecurity, Australian Animal Health Laboratory, CSIRO, VIC

Benchmark Dose (BMD) methodology for setting human health regulatory endpointsNick Fletcher Chemical Safety and Nutrition, Food Standards Australia New Zealand, Canberra, ACT

Traditionally, the No-Observed-Adverse-Effect-Level (NOAEL) approach has been used to determine the point of departure (PoD) on dose-response curves from animal toxicology studies. However, this approach to determining a NOAEL or LOAEL is subject to significant limitations, such as dependence on the dose selection in the study, dose spacing, and sample size of the study. The NOAEL/LOAEL approach also fails to take into consideration the shape of the dose–response curve and other related information. The benchmark dose (BMD) method, originally proposed as an alternative to the NOAEL methodology in the 1980s, addresses many of the limitations of the NOAEL method in estimating the PoD. The presentation will consider the advantages and drawbacks of benchmark dose methodology, review recent methodological developments and statistical software, and contrast international approaches used by the European Food Safety Authority (EFSA), the United States Environment Protection Agency (US EPA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Consideration will also be given to potential novel applications of benchmark dose methodology.


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ABSTRACTSContinuing Education Day27 September 2017

Taming the complexity – use of computer software to efficiently perform tiered environmental risk assessmentsChris Lee-SteereAustralian Environment Agency Proprietary Limited, Canberra, ACT

There is constant pressure on regulators to do more with less. At the same time, data requirements to adequately consider the risks of substances to the environment are increasing, along with the number and complexity of assessment methods to properly determine robust ecotoxicity end-points and environmental fate. The increasing complexity in tiers of risk assessment results in significant increases in time and cost burdens. It is possible to address complexity in risk characterisation, which is largely a formulaic process, through the development of appropriate software. In addition to saving time, the application of such software results in much greater consistency of approach, reproducibility of assessments, and certainty of assessment outcomes (whether favourable or not). This presentation reviews the development of such software for environmental risk assessments of plant protection products. It includes high tier, probabilistic exposure modelling unique to the Australian environment (where required) and performs the full range of environmental risk characterisation calculations to aquatic and terrestrial environments. Applying this approach has demonstrated time savings in risk assessment of greater than 90%, freeing up time for assessors to focus on data assessment and establishment of appropriate end-points. In this software, runoff methodology is completely Australian-specific and, at the highest tier, incorporates real world data for slopes, soil types, stream flow and rainfall. This allows both temporal and spatial assessments, which can result in targeted risk-management decisions. The terrestrial methodology characterises risk for uniquely Australian species, but risk equations and processes follow international best-practice such as use of dose-based risk quotients for birds and mammals. Changes in best practice methodology such as evolving methods for characterising risk to pollinators can readily be incorporated into the software. Possible future requirements (e.g. risk assessment for reptiles) can be readily included.

The focus of the group exercise will be on the exposure component of environmental risk assessments, calculating food intake rates based on allometric equations, diet types, energy levels (including metabolisable energy) and water fractions in dietary items etc. Following a limited consideration of end-point setting, workshop participants will perform several risk assessments based on the information from examples provided.

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The strengths and weaknesses of physiologically-based pharmacokinetic modelling in a regulatory contextMichael Roberts1, Jeffrey E Grice2, Xiaowen Liang2 and Xin Liu2

1 School of Pharmacy and Medical Sciences, University of South Australia & Therapeutics Research Centre, Diamantina Institute, The University of Queensland, Translational Research Institute, QLD

2 Therapeutics Research Centre, Diamantina Institute, The University of Queensland, Translational Research Institute, QLD.

Physiologically-based pharmacokinetic modelling (PBPK) is commonly used to predict exposures to drugs and environmental toxins when there is limited human data to define the internal dose in a target organ. This paper introduces the concepts of pharmacokinetics, pharmacokinetic modelling and PBPK modelling, PBPK model development and validation criteria. The application of PBPK and its advantages and weaknesses in a regulatory context are then discussed. We conclude by considering a number of examples where PBPK has been used in risk assessment e.g. perfluorooctane sulfonate (PFOS), volatile compounds and pesticides and how PBPK models are applied in predicting human equivalent dose values from animal NOAEL and LOAEL levels using interspecies, route to route and high dose to low dose extrapolation. Finally, we consider the interrelationship between dose metric choice and PBPK in risk assessment.


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Using RNA for gene silencing in plants and insects: Challenges, benefits and risksMark Tizard Australian Animal Health Laboratory, CSIRO

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ABSTRACTSDAY 1 – Annual Scientific Meeting28 September 2017

New biotechnology techniques – Challenges for regulation and risk AnalysisPeter ThygesenOffice of the Gene Technology Regulator, Canberra, ACT

Keywords: Biotechnology regulation risk

Advances in genetic technologies pose challenges for regulation and risk analysis in terms of things to be regulated and assessed, and new tools for regulatory evaluation. These new techniques, such as ‘gene editing’ and ‘gene drives’, are the subject of significant scientific and public debate, domestically and internationally.

In Australia, genetically modified organisms (GMOs) are regulated under the Gene Technology Act 2000. Regulatory decision making is underpinned by science-based risk analysis which comprises risk assessment, management and communication (Risk Analysis Framework 2013). Various new technologies may pose challenges in one or all of these three areas. For example, debate on new techniques includes societal concerns, expectations and engagement, and thus is clearly related to risk communication.

Questions of how to conduct environmental risk assessment (ERA) of GMOs have been vigorously debated for two decades, including over qualitative vs quantitative approaches and laboratory vs field studies. This debate has intensified with the advent of new technologies. For example, engineered gene drives that confer super-Mendelian inheritance and ‘drive’ a trait into a whole population have raised concerns about current containment and ERA approaches (US National Academies, 2016). However, it may be argued that specific issues raised in connection with new technologies are different in degree rather than type with other GMOs and organisms.

Advances in genetic technologies have also provided new tools for scientific discovery and analysis such as ‘omics’ (e.g. transcriptomics, metabolomics, proteomics) and bioinformatics, and there are calls for these to be used in the evaluation of GMOs.

This presentation will explore lessons for the ERA of new technologies from experience of risk analyses of ‘traditional’ GMOs and non-GM organisms, and the utility of new techniques for the prediction of adverse effects in regulatory risk assessments.


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Regulation of precision breeding technologies: Challenges and OpportunitiesHarvey Glick Monsanto Company, Singapore

In this presentation Dr Glick will present an industry perspective on the challenges facing regulators around the world as they develop guidelines and legislation on how to regulate new genetic technologies, including the latest gene-editing technologies.

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Fit-for-purpose TDIs: matching short-term exposures to TDIs based on lifetime exposureBrian G PriestlyAustralian Centre for Human Health Risk Assessment, Monash University School of Public Health & Preventive Medicine, Melbourne, VIC

The most common practice in human health risk assessment (HHRA) is to compare estimated exposures to a health-based toxicological reference value (TRV) such as the Acceptable/Tolerable Daily Intake (A/TDI). TDIs are conventionally based on long-term rodent toxicity studies (e.g. 2-yr rat) and assume equivalence to lifetime exposure in humans, although TRVs for some endpoints (e.g. Acute Reference Doses (ARfD) for pesticides, developmental toxicity, acute respiratory irritancy) may be based on shorter term exposures more relevant to these endpoints. The problem is how to adapt TRVs based on lifetime exposures to the intermittent, variable and/or short-term exposures, however averaged or combined, more commonly encountered in HHRA based on environmental exposures. These issues were raised at the 2016 ACTRA ASM (Fred Leusch) and have been canvassed in some key papers [e.g. Geraets et al (2016) and Felter et al (2011)] that provide a basis for approaches to exposure time adjustment of TRVs. Haber’s Rule is one commonly applied method. Essentially, it assumes that the product of (dose/exposure concentration) x (exposure time) is a constant (CxT=k, or CnxT=k). Haber’s Rule adjusts (Increases) the TDI by a factor based on the ratio of the scenario exposure time to the exposure time used to derive the TRV (usually lifetime). While Haber’s Rule may be suitable for the short-term inhalation exposures for which it was developed, it may be less suitable for the exposures commonly encountered in environmental HHRA. This paper describes some of the factors that need to be taken into consideration in adjusting a TRV (e.g. ADME differences, endpoint-specific adjustments, mode-of-action). Given that a TDI based on chronic (lifetime?) exposure is likely to be most conservative, and will remain as the method of choice for Tier 1 HHRA, what evidence will be needed to justify an adjustment to the TDI for shorter-term exposures?

References:

Geraets L, Nijkamp M.M. & ter Burg W. (2016). Critical elements for human health risk assessment of less than lifetime exposures. Reg.Toxicol. Pharmacol. 81: 362-371.

Felter S.P. et al (2011). A proposed framework for assessing risk from less-than-lifetime exposures to carcinogens. Crit Rev Toxicol. 41: 507-544.


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Nanotoxicology and safety evaluation of nanoparticles in sunscreen products in vitroShahnaz Bakand1, 2, Amanda Hayes2 and Finance Dechsakulthorn2 1 School of Health & Society, University of Wollongong, NSW2 School of Chemistry, The University of New South Wales, Sydney, NSW

Keywords: In vitro toxicity, Nanoparticles, Risk assessment

Nanotechnology has led to the development and commercialisation of a diverse range of nanoparticles (NPs) and nanomaterial (NM) products with novel physicochemical characteristics. Sunscreen applications benefit largely from nanoscales of zinc oxide (ZnO) and titanium dioxide (TiO2) but toxicological profiles of these products are still poorly characterised. The objective of this research was to explore the potential of in vitro methods in the toxicological and safety evaluation of NPs in sunscreens. A tiered approach was developed using in vitro assays and skin-penetration models. Cytotoxicity was assessed using human skin fibroblasts and a range of bioassays (MTS, NRU, ATP) and physicochemical characteristics of test particles were investigated using analytical techniques (SEM/TEM). The skin penetration of sunscreens was investigated on freshly excised human abdominal skin using a Franz cell diffusion apparatus followed by three staining techniques (Hematoxylin and Eosin, Gomori trichrome and van Gieson). The results demonstrated that ZnO particles were more potent than TiO2 particles in terms of altering mitochondrial activities, damaging cell membranes and causing cell death. ZnO nanoparticles (IC50 = 6.64 ± 0.37 ppm) were found to be more potent than ZnO microparticles (IC50 = 24.66 ± 2.56 ppm) and the ATP assay was the most sensitive bioassay selected. Our findings revealed that the smaller particle size of ZnO NPs could potentially relate to the higher toxicity when compared to microscale particles. Photomicrographs of human skin suggested that both ZnO and TiO2 NPs penetrated through the epidermis following topical application. The significant keratinocyte solubilisation observed was also an indication of adverse effects. Therefore, the toxicity and safety evaluations should be considered in the early stage of any sunscreen product development. In vitro methods developed in this research could potentially be implemented as advanced tools for the toxicity and safety assessment of NPs in sunscreen products and other consumer applications.

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Nanotechnology and nanosafety: Risk management of manufactured nanomaterials Shahnaz Bakand and Leanne Treadwell

School of Health & Society, University of Wollongong, NSW

Keywords: Nanoparticles, Nanosafety, Nanotechnology

Novel engineered nanoparticles (NPs) and nanomaterials (NMs) are emerging worldwide, introducing many potential benefits in diverse fields of science, medicine and consumer products. However, benefits should always be balanced against risks as NMs may also affect human health and the environment. Risk assessments in relation to products and processes involving NMs are very important to the manufacturer and users of these products but, available information in relation to risk assessment of NMs is still limited. The objective of this research is to introduce a systematic and scientific approach for risk management of NMs. The interaction of NMs with biological systems is significantly associated with their unique physicochemical characteristics such as small size distribution, large surface area to mass ratio and surface characteristics but, currently many uncertainties exist in relation to NMs and identification and characterization of their potential effects. It is likely that workers in research laboratories and manufacturing industries are the main groups currently exposed to NPs, but details about exposed populations and exposure scenarios are yet to be characterised. In this research, a risk management approach will be discussed, in order to address challenges that exist in relation to engineered NMs. A systematic and scientific approach for hazard identification, risk assessment, and risk control will be adapted to NPs and NMs to protect the health and safety of exposed populations particularly workers involved in NM manufacturing and production. Different profiles of NMs required for the comprehensive risk management will be discussed, including physicochemical, hazard and exposure profiles. Further, the risk assessment of NMs will be described in more detail, utilising a Control Banding technique tailored for NMs. This technique offers a simplified process for controlling exposures to NMs, based on the risk level determined for a particular operation in the absence of firm toxicological and exposure data.


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Ecological risk assessment of nanotechnology products: The case of nano-enabled pesticidesMélanie KahUniversity of Vienna, Department of Environmental Geosciences and Environmental Science Research Network, and currently Distinguished Visitor, CSIRO Land and Water, Glen Osmond, SA

Keywords: Nanopesticide, Nanofertiliser, Fate, Exposure assessment

Research into nanotechnology applications for use in agriculture has received a lot of attention recently. There has been a particular interest in developing novel agrochemicals in the form of so-called ‘nanopesticides’ and ‘nanofertilizers’. The adequate assessment of nano-enabled agrochemicals is essential to identify the potential new risks and benefits that the novel products represent relative to currently-used agrochemicals. However, available data on the fate and effects of nano-enabled agrochemicals are limited, and it is not known whether the nano-enabled products can be adequately evaluated within current regulatory framework. The use of nano-enabled agrochemicals represents one of the few intentional diffuse inputs of engineered particles in the environment, and several products are ready for market applications. Establishing an adequate framework for their evaluation is thus particularly urgent. Outcomes from the last decade of intensive research on the fate and effects of engineered nanoparticles are very useful to build on, but adaptations are needed to suit some characteristics that are inherent to agrochemicals. The aim of the presentation will be to (i) review the current state of knowledge and the latest trends in R&D in the field of nano-enabled pesticides; (iii) analyse the suitability of current exposure assessment procedures to account for the new risks and benefits; and (ii) discuss options for refinements.

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Food derived using new technologies: lessons learned from GM food safety assessmentJanet Gorst, Lisa KellyFood Standards Australia New Zealand, Canberra, ACT

A number of new breeding techniques (NBTs) have emerged over the last decade which are increasingly being applied to plants and animals, and hence the production of food. Many of these techniques were not in existence at the time the safety assessment approach for genetically modified (GM) foods was elaborated at an international level, or when gene technology regulations were adopted by governments around the world.

Since 1999, Food Standards Australia New Zealand (FSANZ) has completed the pre-market safety assessment of more than 70 GM foods. The safety assessment approach is based on a scientific comparison of the GM food with a non-GM (conventional) counterpart with a history of safe use and generally does not rely on whole food animal feeding or toxicity studies. Despite often intense criticism and scrutiny, this approach has been universally adopted and continues to be regarded as the most appropriate approach to assessing the safety of GM foods.

The emergence of NBTs for modifying genomes, and the similarity of derived foods to the products of conventional breeding, has generated debate about whether pre-market assessment and approval should be required, as is currently the case for GM foods. FSANZ has recently commenced a review of foods derived using NBTs to consider this.

The presentation will discuss some of the questions raised by the emergence of NBTs, such as: Is pre-market assessment of derived food products warranted? Can the presumption of safety applied to conventional food be applied to foods derived from NBTs? What would be the approach to assessing these new types of foods and could some of the new analytical tools, such as “omics” be used to simplify this approach? In considering these questions, the discussion will draw on some the lessons learned from nearly 20 years of GM food safety assessment.


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PFAS half-life in sheep of different ages and genderRoger Drew1, Tarah Hagen1, David Champness2 and John Ryan3

1 ToxConsult Pty Ltd, Melbourne, VIC2 Principal Veterinary Officer, Agriculture Victoria, Department of Economic Development, Jobs, Transport and Resource,

Hamilton, VIC3 District Veterinary Officer, Agriculture Victoria, Department of Economic Development, Jobs, Transport and Resource,

Wangaratta, VIC

Keywords: PFAS, half-life, sheep.

Currently there is only one publication available on PFAS accumulation in sheep (Kowalczyk et al. 2012). This is a pilot study with PFOS in just two lactating dairy sheep, and elimination kinetics were not determined. The study reported herein took advantage of the availability of a flock of sheep of different breeds, raised for meat production, which had accumulated PFAS from impacted farm dam water. The objective was to determine PFAS depuration kinetics in sheep kept under Australian farm conditions that would assist with appropriate management of their welfare and/or disposal. The flock had been on a research farm with no PFAS exposure for approximately 3 months before the study began.

Blood from 10 – 15 animals from the following groups was obtained on day 0. Ewes (EL, 4-7 yrs. old) that had twin lambed (sampled within 24 hours of parturition), non-pregnant ewes (ENP, 4-6 yrs old), hoggets (H, 1.5 yrs. old), and rams (R, 4-6 yrs. old). From each group, individuals (n=5) with the highest serum PFOS concentration were selected for determination of PFAS serum half-life (t½). During the study some of the selected animals were lost for reasons unrelated to PFAS exposure.

Analysis for 23 different PFASs in serum was undertaken by AsureQuality Laboratories, NZ. PFOS and PFHxS were the only PFASs measurable in serum. There were no significant differences in PFOS (means 20 – 35 ng/mL) or PFHxS (means 2.2 – 12.3 ng/mL) concentrations between the groups at day 0. For PFOS t1/2 there was no difference between linear and branched isomers. PFOS t1/2 in rams was significantly longer (p<0.05) than H and EL groups. It is apparent female hoggets lose PFOS more quickly than other groups. Overall the data indicate age and lactation, but not gender, influence PFOS clearance in sheep. Where quantitated PFHxS t1/2 was less than PFOS.

Reference:

Kowalczyk, J., Ehlers, S., Fürst, P., Schafft, H. and Lahrssen-Wiederholt, M. (2012). Transfer of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) from contaminated feed into milk and meat of sheep: pilot study. Archives of Environmental Contamination and Toxicology. 63: 288-298

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PFAS tissue distribution in sheepRoger Drew1, Tarah Hagen1 and John Ryan2

1 ToxConsult Pty Ltd, Melbourne, VIC2 District Veterinary Officer, Agriculture Victoria, Department of Economic Development, Jobs, Transport and Resource,

Wangaratta, VIC

Keywords: PFAS, distribution, sheep.

Two different flocks of sheep that had accumulated PFAS from farm dam water were assessed for PFAS tissue distribution (serum, muscle, liver and kidney). Flock 1 was assessed 3.5 years earlier than Flock 2. For Flock 1 PFAS was measured by NMI using contemporary techniques available at the time. Flock 2 PFAS was measured by AsureQuality using newly available PFAS standards and enhanced chromatography.

Despite many PFAS measured in water only a few were measurable in sheep tissues (LoR 1 ng/g). Although of different age and PFAS steady state status, for total PFOS (t-PFOS) there was no difference in tissue:serum ratios between Flock 1 and Flock 2 (n = 10 animals each) when equivalent quantitation methods were used, or with serum concentration.

From Flock 2 it was found:

• Application of instrument response to linear standard PFOS (L-PFOS) markedly affects quantitation of branched-PFOS (b-PFOS) compared with use of b-PFOS; 30 - 45% less depending on tissue.

• In each tissue relative PFAS concentration is PFOS > PFHxS > PFHpS.

• There is very little diMe-branched PFOS in tissues.

• In different tissues monoMe-b- PFOS is 33 – 52% of the total PFOS concentration.

• There is different distribution of b-PFOS compared with L-PFOS.

• Application of L-PFOS tissue:serum ratios to branched-PFOS serum data overestimates t-PFOS concentration in tissues.

• MonoMe-b- PFOS is taken up less by tissues than is L-PFOS.

• Each PFAS is accumulated to different extents by different tissues; – Liver > kidney > muscle. – PFOS > PFHpS > PFHxS (i.e. tissue to serum ratios are according to PFAS carbon length).

• Applying the tissue:serum ratios for PFOS to PFHxS or PFHpS concentrations in serum overestimates the concentrations in edible tissues.

The PFAS tissue:serum relationships reported herein will improve dietary PFAS risk assessments when sheep suspected of having assimilated PFAS are biomonitored with serum PFAS measurements.


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Assessment of PFOS effects on stock welfare and productivityTarah G. Hagen and Roger Drew

ToxConsult Pty Ltd, Melbourne, VIC

Keywords: PFOS, stock welfare, productivity

Perfluorooctane sulphonate (PFOS) is a globally important environmental pollutant due to its very long persistence, mobility and bioaccumulation. It is highly likely that if stock animals are located in the vicinity of historical point source PFOS releases which have impacted water, soil or fodder that the animals have assimilated this chemical. While much attention has been paid to understanding the potential effect of PFOS on human and environmental health, little has been done regarding assessment of the welfare and productivity of stock animals. Patently this has important economic implications.

Studies with experimental animals (monkeys and rodents) clearly show observed effects are proportional to serum concentration. Thus for PFOS, it is well recognised serum concentration is a better dose metric for assessing risk of harm than is the external exposure (dose). Species dose-effect differences are driven by marked species differences in toxicokinetics of PFOS rather than in tissue responsiveness to a given serum concentration (toxicodynamic differences). However for some endpoints rodents appear to be very sensitive due to their responsiveness to PPARα stimulation.

Here we present a margin of exposure approach for assessing the welfare and productivity of stock that have been exposed to PFOS and have been biomonitored with serum PFAS measurements. The approach assumes stock animals will be at least as sensitive as experimental animals. It involves comparison of stock serum PFOS concentrations with no observed effect, or low observed effect serum concentrations derived from experimental animals. Relevant sensitive endpoints for stock assessment are changes in body weight and body weight gain, fecundity, offspring performance, and liver effects. Critical serum values in experimental animals are supported by a limited number of field and experimental stock studies that have measured serum concentrations.

The approach is illustrated with Australian examples where sheep and cattle have assimilated PFOS from their environment.

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Modifying Mendel: Assessing the risks and benefits of using gene drivesOwain Edwards Centre for Environment and Life Sciences, Perth, WA

Keywords: Gene drives; Genome editing

Gene drives are genetic mechanisms that promote the inheritance of particular genes and thus increase their prevalence in populations. For many years the use of such technology has been proposed as a potential solution to address certain environmental and public health issues. Genome editing tools, such as CRISPR/Cas9, are now providing researchers with unprecedented power to engineer precise and effective synthetic gene-drive technologies. Before considering the release of gene drives, it is imperative that we have a clearer understanding of how they will behave in natural systems. A growing research effort worldwide is focused on safeguard mechanisms that can be included in gene drives to minimise the risk of unintended consequences. At the same time, researchers are recognising that innovative design principles are needed if gene drives are to remain effective in an environment where all evolutionary forces are acting against them. Appropriate deployment of gene drives will require a fundamental knowledge of the target organism and its ecosystem in order to adequately assess the risks and benefits. It will be essential to find the appropriate balance of design principles that improve efficacy with those that suppress unwanted spread, so that the desired beneficial outcome is achieved without any unintended consequences.


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Toxicity assessment of anti-sense oligonucleotide therapeuticsIrene HorneTherapeutic Goods Administration, Canberra, ACT

The first anti-sense oligonucleotide (ASO) therapeutic agent was approved in Australia in 2000. Despite some early effort to develop ASOs, very few have been granted marketing approval worldwide, due to adverse reactions or a lack of efficacy in clinical trials. A significant number of ASOs are in ongoing or recently completed clinical trials as a result of advances in the chemical modification of ASOs, leading to the use of lower doses and less frequent dosing intervals, and a greater understanding of nucleotide sequences that lead to some of the adverse reactions. Since 2013, a small number of ASOs have achieved marketing approval in the US. This number is expected to grow significantly in the coming years. Based on extensive research, it is clear that the potential toxicities of ASOs may consist of exaggerated pharmacological effects (at least in animal species), off-target hybridisation effects, sequence-related non-hybridisation effects and sequence-independent chemical class effects, associated with the backbone chemistry of the ASO. These toxicities, the adequacy of animal models in toxicity studies and the adequacy of the standard set of genotoxicity tests for ASO products will be discussed during the presentation.

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STUDENT PRIZE WINNERMetals in vegetable garden soils: Impact of house age, house material, road distance and soil characteristics Slavica Kandic, Dr Suzie Reichman, Dr Susanne Tepe and Dr Ewan BlanchRMIT University, Melbourne Campus, VIC

Heavy metal concentrations emitted from non-point sources in urban areas may pose a risk to human health. Many of the north-west suburbs of Melbourne have been contaminated by heavy metals due to their industrial heritage. Industrial premises are being acquired by investors in the anticipation of residential rezoning. This research paper explores the relationships between contaminant metals in vegetable garden soil and house age, house construction material, and the distance from non-arterial and arterial roads. Previous research mostly suggests that elevated metals in suburban soils are a matter of concern, usually comparing soil metal concentrations to the exposure guidelines, but very little is known about the sources and extent of public exposure to heavy metals from vegetable garden soils. This study highlights that the traffic conditions (distance from arterial and non-arterial roads, slow/high speed roads) the house age, and the use of lead based paints explains approximately 75% of soil metal variability. This study assessed the relationships between soil characteristics, house material, house age and road distance and heavy metals (Cd, Cr, Ni and Pb) in garden soils. Significant enrichment was found for Cd (0.12-1.04 mg/kg), Cr (11.55-49.41 mg/kg), Ni (7.57-40.46 mg/kg), and Pb (12.92-772.92 mg/kg), with Pb exceeding the Ecological Investigation Level (300 mg/kg) for residential use. One-way Anova was used to assess differences in heavy metal concentrations in garden soils based on house material. Wooden houses were found to be significantly different to brick and concrete houses for Pb (p<0.0001) and Cd (p<0.001). Significant correlations were found between backyard garden soil metal concentration and the house age for Pb (R=0.83, p<0.001) and Cd (R=0.42, p<0.0002) and the distance from arterial roads for Pb (R=0.38, p=0.002). Stepwise multiple regression analysis was used to develop a model for predicting heavy metal concentrations in backyard garden soils using multiple predictors: Cd, Cr, Ni and Pb concentrations in soil, house age, the distance from non-arterial and arterial roads, speed limit, soil characteristics (EC, pH, SOM and CEC). The most significant predictors were total metals in soil and home age, identifying the risk of metal deposition from multiple sources in vegetable gardens of north-west of Melbourne. Further research will be undertaken to develop predictive models for uptake of heavy metals by a range of vegetables and bioaccessibility of accidentally-ingested soil and vegetables.

y =33.07+1.76e0.05X

r2=0.83, P<0.0001

Home age (years)

0 20 40 60 80 100 120 140

Pb in

soi

l (m

g/kg

)

0

200

400

600

800

Fig 1 Representative map of sampling area, North West of Melbourne Victoria. The map represents a range of soil Pb concentrations across 30 sites.

Fig 2 The relationship between the total Pb in garden soil (n=30) and house age, exponential growth graph curve.

Fig 3 The relationship between the total Cd in garden soil (n=30) and house age, linear regression.

Fig 4 The relationship between the total Pb in soil and the garden distance from the arterial roads (m); speed limit range was 70-100 km/h.


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Fig 5 The relationship between the total Pb in garden soil and house material. Houses from each site were divided by building material. Columns with different letters above them are statistically different.

Fig 6 The relationship between the total Cd in garden soil and house material. Houses from each site were divided by building material.

STUDENT PRIZE WINNER continued

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Sustainable food production systemsDavid SaltmirasSmall Molecule Toxicology, Monsanto Company, Saint Louis, USA

In this presentation David will discuss the challenge of sustainable food production systems and the range of technologies to help farmers increase productivity; these include new plant breeding technologies as well as microbials, bioinformatics and precision agricultural systems.


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Update on the global regulatory status and safety profile of glyphosateDavid SaltmirasSmall Molecule Toxicology, Monsanto Company, Saint Louis, USA

Glyphosate and glyphosate-based herbicides have a history of safe use spanning over 40 years. With the adoption of glyphosate-based herbicides in more than 160 countries, expert evaluations of relevant toxicology data have been undertaken repeatedly over the decades. At least seven separate regulatory toxicology data packages have been generated by different registrant companies in different laboratories across the globe, and results of these data packages have been remarkably consistent. Expert regulatory reviews to date have concluded that glyphosate is not acutely toxic via oral dermal and inhalation routes, not carcinogenic, not genotoxic, not neurotoxic, not immunotoxic, not a reproductive toxicant, and not an endocrine disruptor. Despite the favourable toxicology profile, low human exposure and extensive regulatory reviews which have consistently aligned regarding glyphosate’s lack of carcinogenic potential in humans, the International Agency for Research on Cancer (IARC) classified glyphosate as Category 2A “probably carcinogenic to humans” in IARC meeting 112. IARC’s classification is inconsistent with the conclusions of regulatory authorities around the world and the opinions of recognized scientific authoritative bodies, including science driven expert groups operating under the World Health Organization; the International Program on Chemical Safety (IPCS), Joint Meeting on Pesticide Residues (JMPR) and Water Sanitation Hygiene (WASH). Post-IARC monograph 112 regulator reviews/opinions in the European Union, Canada, Australia, Korea, New Zealand, and Japan have all concluded that based on the scientific weight of evidence, glyphosate is not genotoxic and unlikely to pose a cancer hazard to humans. Rationale for the stark contrast between the global scientific/regulatory communities and IARC will be discussed.

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Toxicity equivalency factor for health risk assessment of PFNATarah G. Hagen and Roger Drew

ToxConsult Pty Ltd, Melbourne, VIC

Keywords: PFNA, toxic equivalency, PFOA

PFNA, along with other PFAS, is often found in environmental media and in the human food chain. However there is currently no reputable Australian or international toxicity reference value (TRV) to facilitate a human health risk assessment from PFNA exposure. PFNA is structurally similar to PFOA (8-carbon chain) but has a 9-carbon backbone. Since PFOA has a comprehensive toxicological database and an established Australian TRV there is an opportunity to derive a provisional TRV for PFNA using ‘read across’ methods applied to equivalent toxicological studies for PFNA and PFOA.

A comprehensive literature search identified a PFNA developmental toxicity study in mice that showed the same critical endpoints (increased maternal liver weight, decreased pup body weight gain and survival) as with PFOA (Das et al. 2015). However, PFNA appears to have higher potency for these effects (i.e. the same magnitude of effect occurs at lower serum concentrations). PFNA also exhibits a longer half-life (26d) in female mice than PFOA (16d) at a 1 mg/kg single gavage dose. As with PFOA, the developmental toxicity of PFNA appears to be mediated by PPARα.

The PFOA TDI is based on decreased pup weight gain in a murine developmental study (Lau et al. 2006) with the same design as employed for PFNA; the serum PFOA:PFNA ratio at which a 10% reduction occurs is 3. The most sensitive endpoint for PFNA was increased maternal liver weight; the ratio of the PFOA to PFNA serum concentrations resulting in a 10% increase in maternal liver weight is 2.3.

We suggest a PFOA toxicity equivalency factor of 3 for PFNA is appropriate when assessing the effects of PFNA. Thus for risk assessment, the TRV for PFOA could be divided by 3 to cater for potential increased potency of PFNA. The provisional TRV suggested for PFNA is 0.053 µg/kg/d.

References:

Das, K. P., Grey, B. E., Rosen, M. B., Wood, C. R., Tatum-Gibbs, K. R., Zehr, R. D., Strynar, M. J., Lindstrom, A. B. and Lau, C. (2015). Developmental toxicity of perfluorononanoic acid in mice. Reproductive Toxicology. 51: 133-144.

Lau, C., Thibodeaux, J. R., Hanson, R. G., Narotsky, M. G., Rogers, J. M., Lindstrom, A. B. and Strynar, M. J. (2006). Effects of perfluorooctanoic acid exposure during pregnancy in the mouse. Toxicological Sciences. 90: 510-518.


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PFOS hard surface screening criteria for risk assessmentRoger Drew and Tarah G. HagenToxConsult Pty Ltd, Melbourne, VIC

Keywords: PFOS, hard surface

PFOS is frequently found in soil at Australian sites with history of past use of PFOS-containing firefighting foams. It is possible fine dust containing PFOS may infiltrate and/or be tracked into buildings onsite and/or be present on outdoor equipment. Inadequate occupational hygiene practices may also result in transfer of PFOS from worker clothing to hard surfaces which in turn may be transferred to other persons or back to the same individual at a different time. This potential occupational exposure pathway is not routinely evaluated in most PFOS risk assessments.

To address this, we have derived a health-based surface screening criterion for PFOS which can be used in conjunction with surface wipe data to judge the likelihood of exceeding the Australian tolerable daily intake (TDI) by persons who may have bare hand contact to PFOS contaminated surfaces.

The criterion is derived using default conservative assumptions for hand-to-mouth transfer as nominated by US EPA (2003). The derivation accounts for background exposures and allocates 50% of the TDI to other potential exposure pathways. Embedded in the criterion is an assumption that adults (male or female) may be exposed to the hard surfaces (bare hands) 4 hours each and every day. Consistent with US EPA (2003), dermal and inhalation exposure of dust from hard surfaces was not quantitatively included as these pathways are unlikely to be operable.

The calculated target criterion is 1.6 µg PFOS/100 cm2 surface. Exceedance of the criterion does not necessarily indicate an unacceptable human health risk or that surfaces need to be discarded or cleaned. The decision should be based on the extent that the conservatism in the criterion is eroded and the type of surface affected.

References:

US EPA (2003). World Trade Center indoor environment assessment: selecting contaminants of potential concern and setting health-based benchmarks. Prepared by the Contaminants of Potential Concern (COPC) Committee of the World Trade Center Indoor Air Task Force Working Group.

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Assessing vapour risk from shallow coal tar and degraded hydrocarbon sourcesKatie RichardsonSenversa, Melbourne, VIC

Keywords: vapour risk; coal tar; shallow soil.

Vapour risks are best assessed utilising soil vapour concentrations, as this approach removes the uncertainty associated with estimating partitioning between soil and soil vapour. However, on redevelopment sites with shallow impacts (e.g. <1.5 m below ground level), it may not be possible to collect soil vapour samples which are considered robustly representative of soil vapour concentrations that may underlie a future building (given the absence of the building and the potential for atmospheric effects). The aim of this presentation is to outline possible approaches for assessing potential vapour risks from shallow impacts, with particular emphasis on coal tar sources and heavily degraded hydrocarbon fuels. The presentation provides general results regarding the likely levels of vapour risk associated with these sources, and suggested approaches for undertaking site-specific assessments.

Appropriate assessment of potential vapour risks from shallow coal tar and heavily degraded fuel sources is critical for reducing unnecessary remediation and facilitating site closures, but available screening assessment options for these sources are limited. Understanding source composition is key to undertaking such assessments. Case studies are presented, providing potential screening approaches, and indicating that (based on example literature data), potential vapour risks from coal tars may be significantly higher than indicated by the HSLs, and potential vapour risks from degraded fuel sources may be significantly lower


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Ketamine positive hair samples in a medical practitioner: Is it addiction or occupational exposure? Rhian Cope Commonwealth Department of Health, Canberra, ACT

Keywords: Ketamine, occupational exposure, hair testing

Background: Dr X, an anaesthesiologist, was found collapsed in the St. Somewhere Hospital Day Surgery Unit. He was found with syringes of propofol and fentanyl. Dr X was subsequently the subject of a regulatory agency notification and required to undergo treatment for drug addiction. This included repeated urine and hair screening for drugs of abuse. After several months of treatment Dr X returned to work as an anaesthesiologist at St. Somewhere Hospital. Approximately 1.5 months after returning to work Dr X was again subjected to routine urine and hair testing. His urine sample was clean, but his head hair sample contained 79 pg/mg of ketamine and detectable levels of norketamine. Dr X had administered ketamine to patients since his return to work.

Case study: This case study will explore the issue of whether or not Dr X had relapsed and abused ketamine. Could Dr X’s positive hair ketamine be explained on occupational exposure? What are the implications of the positive norketamine finding? Is this a false positive test? Should Dr X be allowed to continue to practice as an anaesthesiologist? What value should be the hair ketamine cut off level be? What are the implications of this for legal thresholds for driving?

Note: The information and opinions expressed in this abstract are those of the author only and do not represent official policies or decisions of the Australian Commonwealth Department of Health.

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Recreational soil exposure: How deep, and how often?Katie RichardsonSenversa, Melbourne, VIC

Keywords: Recreational soil contact

For the purpose of developing health investigation levels, the NEPM provides recreational soil exposure parameters which may be overly conservative for many recreational sites, depending on their layout, vegetation coverage, and general use. Developing reasonable estimates for how recreational users might come into contact with non-volatile shallow soil impacts can be critical in the assessment of potential risks on recreational sites, to avoid over-estimating potential risks, which could potentially result in unnecessary remediation. Selected Australian and international guidance documents and previously completed assessments (including audits) have been reviewed to help determine a reasonable and defensible exposure depth range and exposure frequency for recreational users coming into contact with

shallow soils. It is noted that separate consideration would be required for other receptors on recreational sites (e.g. intrusive workers) who may have a greater potential for direct soil exposure.

Overall, previously completed assessments are considered to provide a strong precedent for the adoption of an exposure depth range of 0 – 0.3 mBGL. This depth range is considered to be supported by the reviewed guidance, which generally recommends similar or shallower exposure depth ranges for recreational users (where these receptors are discussed), or comparable depth ranges for residential receptors (for whom exposure to deeper soils is considered to be more likely). It is noted in particular that there are many examples from international guidance (particularly from the USA) where the adopted exposure depth range for recreational users is substantially shallower than 0 – 0.3 mBGL. In addition, the review indicates that, for recreational users, it may be appropriate to adopt lower exposure frequencies than NEPM defaults for all except the shallowest soils (e.g. 0 – 0.1 mBGL

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A WORD FROM OUR SPONSORS


HOW we regulate: • risk analysis of GMOs – assessment, management and communication • sound regulatory science – to inform and support decision making • best practice regulation – requirements commensurate with risk • engagement with regulated stakeholders – cooperative compliance • engagement with other Australian regulators – reciprocal advice, avoid duplication • engagement with the public – open & transparent, consult on all environmental releases • engagement internationally – contribute to, be informed by, international guidance – work towards harmonised requirements & approaches

WHAT we regulate: – work with GMOs, including: • environmental releases – field trials and commercial scale releases • laboratory research and physical containment facilities

WHO we are: – the Office of the Gene Technology Regulator • protecting the Australian community and environment through regulation of genetically modified organisms (GMOs).

more information or subscribe to OGTR news www.ogtr.gov.au or call 1800 181 030 or email [email protected]

Ensuring genetically modified organisms are safely managed

ToxConsultTOXICOLOGY CONSULTING AUSTRALASIA

Expert judgement based on sound science

ToxConsult Pty Ltd is proudly committed to the development and progression of toxicology in risk assessment by sponsorship of ACTRA.

By providing expert opinion based on sound science our mission is to assist a variety of industries and government to defensibly manage the risk posed by chemicals in the environment.

Our work primarily involves evaluating the potential for chemical exposures to affect human and environmental health and welfare.

We use contemporary toxicological knowledge to develop scholarly HHRAs, guidelines and standards, compile toxicological profiles, interpret data, and provide assistance on any matters relating to chemical exposure and human or environmental health.

Contact us or visit our website for our range of expertise and projects we’ve been involved in:

[email protected]

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www.toxconsult.com.au

NOTES


HOW we regulate: • risk analysis of GMOs – assessment, management and communication • sound regulatory science – to inform and support decision making • best practice regulation – requirements commensurate with risk • engagement with regulated stakeholders – cooperative compliance • engagement with other Australian regulators – reciprocal advice, avoid duplication • engagement with the public – open & transparent, consult on all environmental releases • engagement internationally – contribute to, be informed by, international guidance – work towards harmonised requirements & approaches

WHAT we regulate: – work with GMOs, including: • environmental releases – field trials and commercial scale releases • laboratory research and physical containment facilities

WHO we are: – the Office of the Gene Technology Regulator • protecting the Australian community and environment through regulation of genetically modified organisms (GMOs).

more information or subscribe to OGTR news www.ogtr.gov.au or call 1800 181 030 or email [email protected]

Ensuring genetically modified organisms are safely managed

www.actra.org.au

Australasian College of Toxicology & Risk AssessmentNational SecretariatSuite 5, 250 Gore Street, Fitzroy VIC, 3065P: 0423 082 521E: [email protected]

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