Program - Society of Toxicology

Society of Toxicology 2011
Program Description (Continued)
Abstract #
#2503 3:55 BENEFICIAL ROLE OF NRF2 IN
REGULATING NADPH GENERATION
AND CONSUMPTION. ​K. C. Wu, J. Y. Cui and
C. D. Klaassen. Pharmacology, Toxicology, and
Therapeutics, University of Kansas Medical Center,
Kansas City, KS.
Wednesday Afternoon, March 9
2:30 PM to 3:30 PM
Room 201
Meet the Director: U.S. FDA Director
Chairperson(s): Michael P. Holsapple, International Life Sciences
Institute, Washington, D.C.
Lecturer: Jesse Goodman, U.S. FDA, Silver Spring, MD.
U.S. FDA has defined regulatory science as the science of developing
new tools, standards and approaches to assess the safety, efficacy, quality
and performance of U.S. FDA-regulated products (see Advancing Regulatory
Science for Public Health, 2010, accessible at: www.fda.gov/
scienceresearch/specialtopics/regulatoryscience/ucm228202.htm).
No area of science is more important to our ability to predict a product’s
safety, or assess the potential significance of chemical substances
in products, than toxicology. Well performed toxicology studies have
undoubtedly protected consumers from many unsafe products and from
contaminants that pose true threats to health. Yet most of the toxicology
tools in use for regulatory assessment have as of yet been essentially
unchanged by the molecular and cellular revolutions of the last 40 years.
A wealth of innovation based on application of genomic, proteomic,
metabolic, cell based and modeling tools is being applied, largely in
the research community, to assessing the effects of novel and existing
compounds. These tools, if and as they are validated for their predictive
capabilities, offer the potential to revolutionize toxicology and its
use in safety assessments, dramatically improving our ability to detect,
understand and manage potential risks. Improvements should occur both
in sensitivity and in specificity—the goal should be to detect true risks,
but to not reject products that are safe due to false positive signals that
may not be predictive of target effects in humans (or, for that matter,
in other parts of the ecosystem). In addition, there are compelling
reasons to limit animal testing where other methods may either replace
or improve prediction. In recognition of this potential, U.S. FDA has
made “Transforming Toxicology” one of its broad strategic priorities
in its Advancing Regulatory Science Initiative. U.S. FDA is including
support for new approaches to toxicology in its joint NIH/FDA regulatory
science grants, as well as in efforts in both its product centers and
at the National Center for Toxicological Research. Enhancing toxicology
studies for nanoparticles would receive enhanced support at U.S. FDA,
and through collaborative studies, under the President’s 2011 budget
proposal currently before Congress, which includes the first dedicated
budget support line for regulatory science at U.S. FDA. The Office of
the Chief Scientist recently formed a new U.S. FDA-wide Chemical
and Environmental Science Council (CESC) to serve as a focus for
more proactively managing the growing U.S. FDA portfolio of crosscutting
chemical and toxicology issues, and to enhance scientific and
policy communication, collaboration and training across U.S. FDA and
with external partners. U.S. FDA has been increasingly engaged with
colleagues in diverse agencies such as NIEHS (including through the
NTP), U.S. EPA (including through the Tox-21 initiative and multiple
specific issues), CDC and CPSC, among others. Such collaboration has,
for example, been critical in the scientific response to potential health
threats from the Gulf Oil Spill. Through these and other efforts, U.S.
FDA has raised the profile of toxicology within the Agency and signaled
its support for collaboration to advance the science needed to inform the
best possible decisions.
Abstract #
Wednesday Afternoon, March 9
3:45 PM to 4:45 PM
Room 201
Meet the Director: U.S. EPA Director
Chairperson(s): Michael P. Holsapple, International Life Sciences
Institute, Washington, D.C.
Lecturer: Paul Anastas, U.S. EPA, Washington, D.C. (invited).
Paul Anastas, Ph.D. is the Assistant Administrator for EPA’s Office
of Research and Development (ORD) and the Science Advisor to
the Agency. Known widely as the “Father of Green Chemistry” for
his groundbreaking research on the design, manufacture, and use of
minimally-toxic, environmentally-friendly chemicals, Dr. Anastas has an
extensive record of leadership in government, academia, and the private
sector.
Dr. Anastas will participate in the Annual Meeting as guest lecturer in
the Meeting the Director series of lectures, as well as serve as a panelist
in a Workshop session entitled “Safer Products for a Sustainable World:
Linking Chemical Design and Toxicology”, which will take place on
Tuesday, March 8 from 9:00 AM to 11:45 AM.
Wednesday Afternoon, March 9
4:30 PM to 5:50 PM
Room 144
Roundtable Session: Assessment of Nanoparticle Exposure in
Occupational Settings and in Inhalation Toxicology Studies:
Is There a Best Dosemetric to Use?
Chairperson(s): Günter Oberdörster, University of Rochester, Rochester,
NY, and David Warheit, DuPont Haskell Global Centers, Newark, DE.
Sponsor:
Nanotoxicology Specialty Section
Endorsed by:
Inhalation and Respiratory Specialty Section
Occupational and Public Health Specialty Section
Regulatory and Safety Evaluation Specialty Section
Nanotechnology involves the design and manipulation of materials at the
nanoscale size range. The capacity for assessing hazards or quantifying
exposures to engineered nanomaterials for workers or consumers is limited,
and may require new or different methodologies to provide information
for effective risk assessment and risk management. Exposure assessments
are important components for determining health risks. However, currently
used methodologies are inadequate for quantifying nanoparticulate exposures,
because most of the occupational exposure data is represented in the
gravimetric form of mass/volume of sampled air. Our goal is to address this
controversial issue with a focus on practicability of measurements under
workplace conditions. Therefore it is important to discuss the proposed
change in dose metrics for inhalation toxicity studies with engineered aerosolized
amorphous silica nanoparticles. Accordingly, rats were exposed to
freshly generated nanoparticles at two different particle size ranges. The
particle aerosols were characterized by particle numbers using SMPS technology.
Our panel of experts will address the merits of using surface area
metrics based on measurements of particle numbers and material-specific
density for quantifying particle exposures and their use for risk assessment.
Our panel will present real-time instrumentation for measuring airborne
particle surface area and morphology of nanoparticle agglomerates—two of
the important metrics for toxicity evaluation. In addition, recent exposure
assessments in manufacturing facilities involving silicon nanoparticles and
carbon nanotubes will be presented. It is also important to note the effect of
agglomerate structure size on the bioactivity of nanoparticles and present
current methods used to disperse nanoparticles for in vitro and in vivo
testing which we will address. Finally, we will discuss methods to convert in
vivo lung burdens to appropriate in vitro test concentrations of nanoparticles
for hazard screening.
Wednesday
Poster Sessions
Regional Interest Session
Roundtable Sessions
Symposium Sessions
Thematic Sessions
Workshop Sessions
337