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

SRA 2013 Annual Meeting Abstracts
M4-C.2 Pate-Cornell, ME; Stanford University;
mep@stanford.edu
On black swans and perfect storms
I will discuss the origins of the terms "black swans" and
"perfect storms", their relations to different types of
uncertainties, and the way they have sometimes been used as
excuses for bad decisions. I will then address some risk
management strategies to deal with different classes of
situations. These include monitoring (e.g. of signals of
epidemics for the CDC) and gathering of information about
marginal and conditional probabilities (e.g. weather data) of
events that in rare combinations, can have disastrous effects. In
all cases, the use of systems analysis and probabilities (mostly
Bayesian) is key to decision support.
W4-A.4 Patel, M*; Owens, EO; Kirrane, E; Ross, M; National
Center for Environmental Assessment, U.S. Environmental
Protection Agency; patel.molini@epa.gov
Transparently Implementing the Causal Framework in
the EPA NAAQS Review
For Integrated Science Assessments (ISAs), EPA assesses the
body of relevant literature to draw conclusions on the causal
relationships between relevant air pollutant exposures and
health or environmental effects related to the review of the
National Ambient Air Quality Standards (NAAQS). Causal
determinations are made by applying EPA’s causal framework
that describes consideration of the consistency of evidence
from various scientific disciplines (e.g., epidemiologic,
controlled human exposure, animal toxicological studies), as
well as evidence for plausible modes of action for each of five
causal determinations. A challenge in the ISAs is
communicating the consistent application of the framework
across the various evaluated outcomes for which the evidence
may vary in quantity, consistency, and the relative
contributions from the various scientific disciplines. In order to
better communicate how EPA considers the supporting
evidence, uncertainties, and coherence across disciplines in
drawing causal determinations, EPA developed summary of
evidence tables for use in the ISAs. With these tables, EPA
concisely summarizes the available evidence across scientific
disciplines and demonstrates how this evidence relates to the
attributes described in the causal framework. To describe the
nature of the available evidence, these tables summarize the
types of study designs available, potential biases, the control
for potential confounding factors, consistency of evidence, the
relative contributions from various scientific disciplines, and
the exposure or biomarker levels associated with outcomes.
This session will describe how the causal framework used in the
NAAQS review is implemented and transparently applied using
the ISA for lead as an example. Disclaimer: The views
expressed are those of the authors and do not necessarily
reflect the views or policies of the US EPA.
W2-F.4 Patterson, J*; Nance, P; Dourson, M; Toxicology
Excellence for Risk Assessment; patterson@tera.org
Best Practices for Independent Peer Reviews
High quality peer review is very valuable to ensure that the
science used to support regulatory and public health decisions
is sound. Peer reviewers evaluate the adequacy of the scientific
data to support the conclusions. They consider whether key
data were identified and interpreted correctly, appropriate
methodologies were used, analyses of data are appropriate,
uncertainties have been clearly identified along with the
attending implications of those uncertainties; and information
and conclusions are clearly communicated. Increasing attention
has been given to selection of peer reviewers and determining
whether particular individuals may have conflicts of interest.
Ensuring the independence of the experts is an essential
principle for high quality peer review. Other key principles and
practices are also important: using a robust scientific approach
to focus the experts on the key scientific issues and questions;
selection of experts with appropriate discipline knowledge and
contextual experience; and transparency in the process and
communication of results to be most beneficial to informing
public health decisions. Additional practices and activities have
been suggested, such as instituting an independent evaluation
of whether document authors addressed the recommendations
of the peer reviewers in finalizing their documents. As peer
review becomes more widely used by government agencies and
others, the perspectives and thoughts of the experts themselves
must also be considered.
P.33 Patterson, J*; Becker, R; Borghoff, S; Casey, W; Dourson,
M; Fowle, J; Hartung, T; Holsapple, M; Jones, B; Juberg, D,
Kroner O, Lamb J, Marty S, Mihaich E, Rinckel L, Van Der
Kraak G, Wade M, Willett C; 1,5,11 Toxicology Excellence for
Risk Assessment (TERA); 2 American Chemistry Council; 3, 9,
15 Integrated Laboratory Systems (ILS); 4 National Institute of
Environmental Health Sciences; 6 independent consultant; 7
Center for Alternatives to Animal Testing, Johns Hopkins
University; 8 Battelle;10 Dow AgroSciences; 12 Exponent, Inc.;
13 The Dow Chemical Company; 14 ER2;16 University of
Guelph; 17 Health Canada; 18 Humane Society of the United
States; patterson@tera.org
Workshop on lessons learned, challenges, and
opportunities: The U.S. Endocrine Disruptor Screening
Program
Fifty-two chemicals were recently screened using 11 Endocrine Disruptor
Screening Program (EDSP) Tier 1 assays and the data submitted to the EPA
for review. Over 240 scientists participated in a workshop on the EDSP in
April 2013 to share scientific learnings and experiences with the EDSP and
identify opportunities to inform ongoing and future efforts to evaluate the
endocrine disruption potential of chemicals. The first session focused on the
conduct and performance of the 11 Tier 1 assays. Speakers and workshop
participants highlighted challenges in conducting the assays and solutions
developed by the laboratories, as well as issues relevant to data
interpretation. The second session focused on how to apply relevant
information from the current Tier 1 battery to identify potential modes of
action and the value of a weight of evidence (WoE) assessment for
evaluating potential interactions with endocrine pathways. Presentations
and discussions explored the development of critical systematic evaluation
of existing data prior to implementation of Tier 2 testing, and application of
alternative data to replace Tier 1 assays. The third session provided
perspectives on the future of endocrine screening and the promise of in vitro
high-throughput analyses, toxicity pathways, and prediction models. A
number of common themes and suggestions emerged from the extensive
discussions, including that a critical review and update of current Tier 1
testing guidelines is needed, the use of biomonitoring data for
exposure-based prioritization, reducing the number of animals used in
testing, and use of a robust WoE approach to align available Tier 1 data with
potency and exposure information to better inform decisions on Tier 2
testing.
December 8-11, 2013 - Baltimore, MD