The Continuum of Health Risk Assessments Edited by Michael G. Tyshenko pdf

THE CONTINUUM OF
HEALTH RISK
ASSESSMENTS

Edited by Michael G. Tyshenko
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The Continuum of Health Risk Assessments
Edited by Michael G. Tyshenko


Published by InTech
Janeza Trdine 9, 51000 Rijeka, Croatia

Copyright © 2012 InTech
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First published April, 2012
Printed in Croatia

A free online edition of this book is available at www.intechopen.com
Additional hard copies can be obtained from


The Continuum of Health Risk Assessments, Edited by Michael G. Tyshenko
p. cm.
ISBN 978-953-51-0212-0

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Contents
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Preface IX
Part 1 Typical Health Risk Assessment
Case Studies for Novel Risks 1
Chapter 1 The Risk of Blood-Borne
Viral Infection due to Syringe Re-Use 3
Tamer Oraby, Susie Elsaadany, Robert Gervais,
Mustafa Al-Zoughool, Michael G. Tyshenko, Lynn Johnston,
Mel Krajden, Dick Zoutman, Jun Wu and Daniel Krewski
Chapter 2 Professional Drivers and Psychoactive
Substances Consumption: First Results from
Medical Surveillance at the Workplace in Italy 21
Gian Luca Rosso, Mauro Feola, Maria Paola Rubinetto,
Nicola Petti and Lorenzo Rubinetto
Part 2 Health Risk Assessment Case
Studies for Emerging Risks 29
Chapter 3 Xenotropic Murine Leukemia
Virus-Related Virus as a Case Study:
Using a Precautionary Risk Management Approach
for Emerging Blood-Borne Pathogens in Canada 31
Michael G. Tyshenko, Susie ElSaadany, Tamer Oraby,
Marian Laderoute, Jun Wu, Willy Aspinall,
Daniel Krewski and Peter R. Ganz
Chapter 4 Ultrafine and Fine Aerosol Deposition in the Nasal

Airways of a 9-Month-Old Girl, a 5-Year-Old Boy
and a 53-Year-Old Male 47
Jinxiang Xi, JongWon Kim and Xiuhua A. Si
Chapter 5 Safety, Security and Quality:
Lessons from GMO Risk Assessments 73
Alice Benessia and Giuseppe Barbiero
VI Contents

Part 3 Improving Future Risk Assessment Analyses 109
Chapter 6 Breast Cancer Prognostication
and Risk Prediction in the Post-Genomic Era 111
Xi Zhao, Ole Christian Lingjærde and Anne-Lise Børresen-Dale
Chapter 7 Physics of Open Systems: A New Approach
to Use Genomics Data in Risk Assessment 135
Viacheslav Ageev, Boric Fomin, Oleg Fomin, Tamara Kachanova,
Chao Chen, Maria Spassova and Leonid Kopylev
Chapter 8 New Models for the In Vitro Study of Liver Toxicity:
3D Culture Systems and the Role of Bioreactors 161
Giovanna Mazzoleni and Nathalie Steimberg

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Preface
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There are a myriad number of different types of risks that, as individuals, we face
every day that impact human health. Exposure to hazards can result from the natural
and build environments with modulation of this exposure due to other factors such as
our biology (eg. genetics, age, gender and comorbid conditions) and social interactions
(eg. lifestyle choices and our level of risk acceptance). A broad population health
approach includes determinants of health, this is the collective label given to factors
and conditions that are thought to have an influence on health. Using such an
extended understanding of the risk issue and its determinants of health context are
very important to the scope of risk assessment efforts.
Many risks that we face on a daily basis may be unavoidable, so there is an expectation
by individuals that the level of risk is being managed and reduced to safe levels
through evidence-based risk assessments and public health interventions. There has
been a growing recognition that risks need to be viewed in their public health context
to ensure that the most important risks are prioritized and addressed. Under a
broader public health imperative, risk assessments are used as an important process to
quantify the probability of harmful effects to individuals, sub-populations (eg.
vulnerable patient groups) or entire populations. Thus, both quantitative and
qualitative risk assessments help to evaluate the risks associated with hazards, help to
prioritize the risks, and allow for cost-effective option generation to eliminate or
control the hazards.
The completion of risk assessments, appropriate in scope, can help decision-makers to
select the most efficient and effective evidence based strategies. With limited
government health budgets challenged by an aging population demographic such an
understanding can improve resource allocation. Risk assessment must be sufficiently
broad to ensure adequate understanding of the risk and to identify effective risk
management options.
This book presents an interesting and diverse collection of health risk assessments and
health risk management research for known, and emerging risks that span a
continuum towards future developments that aim to improve risk assessment
analyses. Two case studies for existing health risks are presented in the first section

and utilize surveys and look-back modeling methods. The second section deals with
X Preface

emerging health risk and provides three case studies and demonstrates the difficulties
of assessing new risks when the scientific evidence base is limited. The third section
provides case studies that challenge traditional assessments to improve future risk
assessment methods.
Case studies for existing risks in the first section include drug use in Italian
professional delivery truck drivers and using look-back risk assessment for syringe re-
use in Canada. The first chapter by Oraby et al. describes the occurrence of syringe re-
use reported in a Canadian health care setting on approximately 1,400 patients in the
province of Alberta. Multiple syringe re-use events may act as a vector to transmit
both RNA and DNA viruses. This look-back study analyzed the risks for Hepatitis B
(HBV), Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) using a
probabilistic model with sensitivity analyses.
The second chapter case study by Rosso et al. presents a medical survey that tests
professional drivers for the presence of various psychoactive substances. Positives
were identified by using a commercially available immunoassay rapid kit test which
indicates consumption of psychoactive drugs. This is of interest and important since
the dependence on drugs may pose a risk to drivers in their profession affecting their
reaction time and driving judgment. This is one of the first and important
contributions to the literature in this area. The study is of high importance as drivers
under the influence of psychoactive drugs may endanger themselves or others if
impaired at the jobsite.
Case studies for emerging risks in the second section include evidence-based
precautionary interventions to safeguard blood supplies, the evaluation of
nanoparticle deposition in the lung and nasal airways and the discourse surrounding
emerging potential health risks of genetically modified animals consumed as food.
The third chapter by Tyshenko et al. reviews a case study concerning xenotropic
murine leukemia virus-related virus (XMRV) and its emergence as a potential new

blood pathogen that occurred in 2009; a lack of information for decision-making
confounded risk assessment and early management decision-making. The chapter
provides insight into the early assessment process and the application of precaution,
an often poorly described management action rarely captured in peer review
literature. The situation surrounding this potential new threat to blood safety was
largely resolved in mid-2011 when it was determined that the virus was an artifact
from contaminated patient samples and from contamination stemming from a
diagnostic test kit widely used by researchers. The case study provides good
assessment and management insight into the application of early precautionary action
and the use of expert opinion for proactive risk management of emerging blood-borne
pathogens.
The fourth chapter by Jinxiang et al. assesses the airflow and aerosol dynamic
characteristics within the nasal cavity for three different individuals. The study
assesses and models the physical dimensions of the nasal airway and lungs for an
Preface XI

infant, child, and an adult to characterize breathing resistance, airflow dynamics, and
particle transport/deposition during inhalation. Such a comprehensive model allows
for the modeled deposition of submicrometer aerosols (nanosized particles and
particulate matter sizes larger that nano to determine the total deposition as well as
localized deposition of particles). The results are important, prospectively, since they
may lead to a better understanding of the developmental respiratory physiology and
the associated effects on children’s health response to environmental pollutants, or the
medical outcome from inhalation therapy for infants and children from nanoparticle-
containing medicines. The model also has applications for adults who may experience
high nanoparticle exposure through the workplace as an occupational hazard and may
be exposed to synthetic nanoparticles of this concentration.
The fifth chapter by Benessia and Barbiero discusses the epistemic and normative
issues surrounding the uncertainty, risks and knowledge gaps of genetically modified
organisms (GMOs). Genetically modified salmon is the first animal seeking regulatory

approval but it is still unapproved after more than a decade of risk assessments. The
authors use this as a case study to explore the context and "ways of knowing"
surrounding risk assessments to show how regulatory oversight and policy that are
framed for GMOs may be inadequate for providing assurances of long term
environmental and health safety. The interplay between science, society and
governance is important in the area of GMOs, which once approved and released into
the environment, may have unexpected and uncontrollable impacts. The salmon
contains genetic modifications for fast growth which could have unknown effects on
wild populations should they be released into the wild. The issue focuses the concerns
over global environmental safety and security stemming from the risk assessments of
not only GM salmon but all follow-on genetic modifications to animals. The authors
conclude that the way in which risk assessments are completed for GMOs presents a
paradox to environmental and public safety. The solution to this problem suggested
by the authors is to invoke a more transparent, wider public democratization of the
issues surrounding GMOs to incorporate local, social, cultural and ecological public
values. The chapter reinforces the theme of incorporating broader determinants of
health similar to the other case studies dealing with emerging health risks.
Looking towards the future of risk assessments, the final section deals with improving
health risk assessments through the use of personalized genomics, new approaches
using genomics data in risk assessments, and new in silico modeling for
toxicogenomics analyses. The sixth chapter by Zhao et al. presents microarray
expression profiling in breast cancer risk assessment. The chapter reviews and
describes breast cancer microarrays, the algorithms used, the established gene
signature, and the limitations with combining gene signatures for improved prediction
of cancer therapy. The authors provide a potential improvement for breast cancer
gene-expression signature analyses that will be of great interest to those involved in
breast cancer therapy and gene expression profiling.
XII Preface

The seventh chapter by Ageev et al. uses formaldehyde exposure as a case study. The

formaldehyde exposure data is re-analyzed to reveal exposure effects on gene
expression levels not previously observed with the datasets. This type of analysis can
provide better estimates of gene expression activity at low doses for well characterized
chemical hazards.
The final chapter by Mazzoleni and Steimberg provides an excellent overview of
current and new models for the study of liver toxicity with a focus on cultured cells
and culture methods. The use of new 3D culture and emerging bioreactor models for
toxicity testing fits well with the future paradigm of toxicity risk assessments that seek
to move towards in vitro and in silico methods.
Overall, the book is a collection of interesting case studies that provides a continuum
of risk assessment methods and epistemology for known, emerging and future risks.
The book will be of interest to risk assessors, epidemiologists, toxicologists, and
anyone involved in health policy or health studies.

Michael G. Tyshenko PhD, MPA
McLaughlin Chair in Biological Risk Assessment
Institute of Population Health, University of Ottawa,
Ottawa, Ontario
Canada




Part 1
Typical Health Risk Assessment
Case Studies for Novel Risks