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

SRA 2013 Annual Meeting Abstracts
W3-B.4 Clewell, III, HJ*; Andersen, M; Gentry, PR; The
Hamner Institutes for Health Sciences, ENVIRON International
Corporation; hclewell@thehamner.org
Pharmacokinetics of formaldehyde and the impact of
endogenous levels on uptake
Formaldehyde is present endogenously, with measurable
concentrations in the tissues and exhaled breath of humans.
While formaldehyde is highly water soluble and readily
absorbed in the respiratory tract, there is little evidence of
systemic delivery. The presence of endogenous concentrations
of formaldehyde adds complexity to understanding the
contribution of exogenous exposure to target tissue
concentrations that may result in adverse effects.
Computational Fluid Dynamic (CFD) modeling has been
conducted to investigate the impact of the presence of
endogenous formaldehyde on the absorption of exogenous
formaldehyde from the nasal cavity of rats, monkeys, and
humans. Based on the CFD modeling, exogenous exposure to
concentrations below 0.2 ppm via inhalation are not expected to
cause increases in tissue concentrations above background,
even at the site of contact. At high exposure concentrations,
formaldehyde concentrations are much greater in the air than
in the tissue, which leads to rapid absorption in the anterior
nasal passages due to the high rate of formaldehyde
partitioning into nasal tissues. At low exposure concentrations,
however, the concentration gradient between air and tissue is
greatly reduced due to the presence of endogenous
formaldehyde in nasal tissues, leading to reduced tissue dose.
Biologically-based dose-response models have previously been
developed to characterize both the toxicokinetics and
toxicodynamics of formaldehyde in the rat and human;
however, these models do not consider endogenous production
of formaldehyde and thus the results at low concentrations may
be questionable. Newer PK models can now track cellular
formaldehyde and differential formation of DNA-adducts from
both endogenous and exogenous formaldehyde. These results
suggest that understanding endogenous concentrations of a
compound such as formaldehyde are of critical importance in
characterizing the shape of the dose response curve in the low
dose region for risk assessment.
W4-J.1 Coglianese, C; University of Pennsylvania;
cary_coglianese@law.upenn.edu
Moving Forward in Looking Back: How to Improve
Retrospective Regulatory Review
Since 1982, the U.S. federal government has implemented an
extensive regulatory review process that considers the costs
and benefits of proposed regulations -- before they are adopted.
By contrast, the federal government has little by way of
institutionalized review of regulations' costs and benefits after
they have been adopted. The Obama Administration -- like
several earlier administrations -- has adopted an ad hoc
retrospective review of existing regulations, or what it calls
"regulatory look-back." This paper assesses the Obama
regulatory look-back initiative, e.g., what it has undertaken and
accomplished, but also analyzes additional steps that could be
taken to improve, and even institutionalize, the practice of
retrospectively evaluating existing risk regulations.
T3-J.1 Coglianese, C*; Carrigan, C; University of Pennsylvania;
cary_coglianese@law.upenn.edu
Why Politicians Think Regulation Kills Jobs...When
Economists Don't
This paper juxtaposes the intense political controversy over the
connection between jobs and regulation with the rather benign
findings of the economics literature. For many politicians,
regulations are "job-killers," while most of the economic
research suggests that regulation yields no substantial net
change in employment. This paper analyzes and explains the
disjunction, showing that politicians respond to the distribution
of job impacts while economists consider aggregate effects.
While for many years, the impact analyses that accompanied
new regulatory proposals contained little attention to
employment effects, this has been because the economists' view
prevailed. Since the 2008 recession, however, the political
process has demanded more explicit focus on job impacts. This
paper considers the rationale for job impact analysis of new risk
regulations from the standpoint of democratic theory.
T1-B.2 Cogliano, V; US Government; cogliano.vincent@epa.gov
Enhancing IRIS: Progress to Date and Future Actions
EPA has made numerous enhancements to its Integrated Risk
Information System (IRIS) program, which evaluates scientific
information on health effects that may result from exposure to
environmental contaminants. These enhancements are intended
(1) to improve the fundamental science of IRIS assessments, (2)
to improve the productivity of the program, and (3) to increase
transparency so issues are identified and debated early. The
IRIS program has also enacted measures to ensure that the
assessments it undertakes will be important to public health
and to EPA’s priorities. As part of improving the fundamental
science of IRIS assessments, the IRIS program is adopting
principles of systematic review in all its new assessments. An
expanded section on hazard identification will identify all health
hazards where there is credible evidence of an effect.
Assessments will include toxicity values for multiple health
effects, increasing their utility in subsequent risk analyses and
decisions. Before work on an assessment begins, conversations
with EPA’s program and regional offices will ensure that IRIS
assessments meet their varied needs, and input from external
stakeholders will help in formulating the problems to be
addressed in the assessment. Improved science, improved
productivity, and improved transparency – these will be evident
in the new, enhanced IRIS program. The views expressed in
this abstract do not necessarily represent the views or policies
of the U.S. Environmental Protection Agency.
December 8-11, 2013 - Baltimore, MD