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TERA
Builds Partnerships
In fulfilling its mission to protect public
health, TERA builds partnerships between industry and
government to incorporate the best science in the development of
risk assessment values and methods. Such partnerships provide the
opportunity to leverage the scarce government funds that are
available to keep up with the growing number of studies and
improvements in risk methods. For example, it would take over 20
years in order to provide only one update to the over 500
chemicals on IRIS, given the current rate of reevaluations by the
IRIS program. Involving scientists who are not government
employees or government contractors in assessments can take
advantage of expert knowledge on the individual chemical; outside
scientists may also be given more time to fully explore all
technical issues.
TERA fosters partnerships in a number of
ways:
We can bring together two or more groups
interested in a specific chemical, and provide informed
and neutral guidance and advice.
To an existing process we can provide
ongoing neutral technical facilitation and oversight as
needed.
We can work with EPA to facilitate its
review of an assessment prepared by us for an industry
organization. This may result in EPA putting the chemical
on its IRIS list, or even in EPA jointly sponsoring a
portion of the assessment.
TERA's ITER
Peer Review Program provides an avenue for
independent assessments to undergo rigorous review by a
panel experts in risk assessment and other relevant
fields from government, industry, and academia. After
approval by the panel, these values are made widely
available to the public at http://www.tera.org/iter/.
Examples of projects where TERA
has created and worked in partnerships
Alliance for
Risk Assessment. The Alliance for Risk Assessment (ARA)
is a collaborative effort of organizations dedicated to supporting public health
protection by improving the process and efficiency of risk assessment, and
increasing the capacity for developing risk information to meet growing demand.
The ARA provides a unique venue for governmental, industrial,
environmental, and non-profit organizations to collaborate to produce high
quality risk assessment science.
Soluble
Nickel Salts. In an
excellent example of the sorts of partnerships that TERA
likes to build, TERA developed an IRIS Toxicological
Review of soluble nickel salts in a project jointly funded by the
Metal Finishing Association of Southern California (MFASC), U.S.
EPA, and Health Canada
Perchlorate. In association with the
U.S. Air Force, U.S. EPA, the Perchlorate Study Group, and
others, TERA has helped develop protocols for several
studies on perchlorate that will fill in data gaps that currently
exist in the database. TERA has also acted as an
independent study monitor for a number of these studies.
Comparative
Dietary Risk. This project was a cooperative
agreement sponsored by EPA's Office of Water. TERA put
together an multi-disciplinary team and developed a framework for
comparing the possible health risks of consuming contaminated
fish and the potential health benefits lost by not eating fish.
Outside collaborators from a variety of subject areas contributed
to the report, including nutritional science, risk communication,
statistical modelers, environmental anthropology, epidemiology
and medicine. An advisory panel to the project included state
health officials, state and tribal fish consumption advisory
staff, EPA and FDA risk assessors and managers, public interest
groups, and industry.
Copper.
TERA is helping the International Copper Association in the
coordination and oversight of two human studies to identify an
acute nausea threshold for copper in drinking water. TERA
has identified four research institutions of excellence in the
U.S., Ireland, Argentina, and China, and has written two research
protocols to attempt to provide a dose response in humans that
shows a threshold for bolus ingestion of copper in drinking
water.
Formaldehyde. This
project was a collaborative effort with CIIT (Chemical Industry
Institute of Technology), a non-profit research organization. The
first draft of the cancer assessment was completed in 1997. CIIT
and TERA made several presentations on this research,
including talks at the American College of Toxicology meeting
(November 1997) and the annual meeting of the Society for Risk
Analysis (December 1997) and the Society of Toxicology on
numerous occasions. A revised draft of the cancer risk
assessment, prepared primarily by CIIT, was peer reviewed by
Health Canada and the U.S. EPA in March of 1998. This text was
revised and finalized by CIIT during the fall of 1999. U.S. EPA
is in the process of integrating the noncancer toxicity of
formaldehyde into the cancer findings. This integration is
expected to be completed sometime in 2000. TERA's effort
was sponsored by the Formaldehyde Epidemiology, Toxicology and
Exposure Group, an industry trade group. For more information,
call Dr. Michael Dourson at 513-542-7475, extension 14 or Dourson@tera.org.
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