Abstracts (PDF file, 1.8MB) - Society for Risk Analysis

SRA 2013 Annual Meeting Abstracts
M2-E.2 Carrington, C; U.S. Food and Drug Administration;
Clark.Carrington@fda.hhs.gov
Lead: Global burden of disease
At higher doses, lead has been known to result in many toxic
effects, including hemolytic anemia, peripheral and central
nervous system toxicity, renal failure from impaired proximal
tubule function, and reproductive toxicity. At lower doses, the
effects of greatest concern are impaired neurobehavioral
development in children and elevated hypertension and
associated cardiovascular diseases in adults. Dose-response
relationships for the effects of lead are typically characterized
using blood lead as a biomarker. While the diet may be an
important source of exposure to lead, sources such soil, dust,
and drinking water are important as well. Dietary surveys
designed to provide statistically representative estimates of
dietary lead exposure in adults and/or children have been
conducted in many countries, outside of the Europe, North
America and the Pacific Rim, information on dietary exposure
to lead is very limited. Based on the data compiled from the
available literature, national mean population average daily
dietary intakes of lead in children in different countries range
from about 5 to 50 µg per person. Adult lead intakes are
approximately 50% higher. Based on dose-response analyses
that integrated results from multiple epidemiological studies,
IQ decrements attributable to lead were estimated for children,
while increments in systolic blood pressure (SBP) attributable
to lead were estimated for adults. Globally, a modest decrement
of about 1.3 IQ points may be attributed to dietary exposure to
lead. However, lower and higher average decrements were
estimated for some countries (range 0.13 to 2.7 IQ points), and
effects in individuals within a region may encompass an even
larger range. Projected impacts on SBP were generally very
small, which maximum estimated increments of less than 0.2
mm Hg. Estimated increments in relative risk attributable to
dietary lead exposure in cardiovascular diseases ranged from
about 0.01 to 0.1%.
M4-B.2 Castoldi, AF*; Husøy, T; Leclercq, C; Theobald, A;
Pratt, I; EFSA, Parma, Italy; Norwegian Scientific Committee
for Food Safety (VKM), Oslo, Norway; Council for Research and
experimentation in Agriculture (C.R.A.), Rome, Italy;
annafederica.castoldi@efsa.europa.eu
Human health risks related to the presence of BPA in
foodstuffs: the assessment of the European Food Safety
Authority (EFSA)
In the European Union (EU) the use of BPA is authorized (with
a migration limit of 0.6 mg/kg food) in all food contact materials
other than polycarbonate plastic baby bottles. For the latter
articles a temporary ban was decided on a precautionary basis,
because of the scientific uncertainties around BPA’s potential
effects on the developing organism, expressed by EFSA in
2010. EFSA has thus undertaken a re-evaluation of the health
risks for the European population related to the presence of
BPA in foodstuffs, encompassing both a new hazard
characterization and an updated exposure assessment in light
of the most recent scientific evidence (December 2012). In the
EFSA evaluation of 2010 the Tolerable Daily Intake (TDI) of
0.05 mg BPA/kg bw/day was based on the NOAEL of 5 mg/kg
bw/day from a multi-generation reproductive toxicity study in
rats, to which an uncertainty factor of 100 (to account for interand
intra-species differences) was applied. For the new risk
assessment of BPA a weight of evidence approach is being
applied to all publicly available toxicological data on humans,
laboratory animals and in vitro according to the endpoint of
toxicity and taking into account the developmental stage of the
subject at the time of exposure. Occurrence data for BPA in the
EU have been collected through literature search and an ad hoc
call for data addressed to Members States, research
institutions, industries, etc. Both average and high chronic total
exposure to BPA are being estimated considering different
sources and routes of exposure (oral, inhalation and dermal) in
the EU population. Specific scenarios are being developed to
cover the exposure patterns in the different age classes and
vulnerable groups (fetuses, infants and young children) and in
specific groups of consumers. The EFSA’s characterization of
BPA-related health risks for the various subgroups of the EU
population is still ongoing and the outcome will be presented at
the SRA meeting.
M4-G.6 Cha, E*; Wang, Y; Georgia Institute of Technology;
eunjeong.cha@gatech.edu
Risk-informed decision framework for built-environment:
the role of ambiguity
Managing a risk to built-environment from natural and
man-made hazards is an important issue for the prosperity of a
nation. Assessing a risk forms the basis for risk management,
which often involves epistemic uncertainty, also known as
ambiguity, that arises from our ignorance about a risk, such as
lack of data, errors in collected data, and assumptions made in
modeling and analysis. In contrast, aleatory uncertainty arises
from variability of possible outcomes. Epistemic uncertainty
exists in the assessment of a hazard occurrence related to its
magnitude, the associated likelihoods, and the response of a
structure. If ambiguity prevails, risk perception of a decision
maker plays a key role in assessing and managing a risk.
Furthermore, the role of risk perception in risk management of
civil infrastructure becomes significant because of the potential
of catastrophic consequences (e.g. casualties, loss of functions
of the built-environment, etc.) to the public. Studies have
suggested that the risk of low-probability, high-consequence
events tends to be overestimated by the public. Consideration
of ambiguity and risk perception in risk assessment of a
built-environment may lead to a risk management solution that
is different from what is obtained when they are not
incorporated. We will present a risk-informed decision-making
framework that will assist decision makers, particularly
governmental agencies, in allocating resources to enhance the
safety and security of civil infrastructure. In this framework,
epistemic uncertainty is incorporated utilizing the concepts of
Choquet capacity and interval probability. The framework will
be illustrated with an example of a regional hurricane risk
management for residential buildings located in Miami-Dade
County, Florida, with the consideration of the climate change
effect
T4-F.1 Chakraborty, S; University of Oxford;
sweta.chakraborty@gmail.com
Regulation, Law, and Pharmaceutical Safety
This presentation will discuss a study examining the influence
and consequences of regulatory and liability mechanisms on
decision-making on product safety in the pharmaceutical sector
in the EU and UK beginning from the 1970s. The thirty case
studies investigated illustrate that the regulatory regime in
Europe, capturing observations from medical practice, has been
the overwhelming means of identifying post-marketing safety
issues with medicinal products. In contrast with widespread in
the United States of America on litigation as a regulatory
mechanism, product liability cases in Europe have not identified
drug safety issues and function merely as compensation
mechanisms. This study has profound implications for the
design of—and restrictions on—regulatory and liability regimes
in Europe. The study found that drug safety decisions have
increasingly been taken by public regulators and companies
within the framework of the comprehensive and robust
regulatory structure that has developed since the 1960s, and
that product liability litigation has had little or no effect on the
substance of such safety outcomes or regulatory actions. In
those few cases where liability litigation has occurred, it has
typically been some time after regulatory and safety decisions
were implemented. Accordingly, ‘private enforcement’ of public
law has been unnecessary, and features associated with it, such
as extended liability law, class actions and contingency fees,
have not been needed. These findings form a major contribution
to the academic debate on the comparative utility of regulatory
and liability systems, on public versus private enforcement, and
on deterrence versus other forms of behaviour control.
December 8-11, 2013 - Baltimore, MD