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Involvement of expert peers in the development and
review of risk assessment documents and methodologies has expanded in
recent years with government agencies and others seeking the benefits of
having experts review work products before finalization. TERA
has spent the last 10 years developing and refining procedures for
involving experts in the development and review of risk
assessment documents and methods. Through a variety of peer involvement
tools, including peer input, peer consultation and peer review, TERA
assists sponsors and authors in developing high quality results that are
based on the best science. By engaging a broad range of experts from
various backgrounds and perspectives, the assessment, method, protocol
or document is strengthened through the identification of additional
data and approaches, testing of assumptions, discussion of
uncertainties, and shortcomings in logic or scientific rationales. Risk
assessment is a multi-disciplined and complex process; no single person
or organization has all the definitive answers for every situation. In
many cases, involving others can strengthen the end result.
As a non-profit organization,
Toxicology Excellence for Risk Assessment (TERA)
provides a variety of opportunities and services to engage expert
peers in the development and improvement of risk assessment methods and
documents. TERA’s work organizing peer input, peer consultation,
and peer review is intended to meet the needs of public and private
sponsors who have developed risk assessment documentation. Work
products have included chemical assessments, hazard evaluations, site
assessments, risk methodologies and guidance documents, protocols for
studies, and research plans.
TERA works with each sponsor to design a
peer involvement strategy that is most effective for the type of work
product and stage of development. Options include peer input, peer
consultation and peer review. We can plan open public meetings, letter
reviews by mail, workshops, or other means of involving experts. We can
engage external experts or utilize TERA scientists’ extensive
experience in risk assessment, to provide the sponsor with the type of
input that would be most helpful. Because the ultimate purpose of peer
involvement is to help the authors and sponsors make sure their
documents reflect the best science and analysis, we do not conduct the
reviews in a vacuum. For most panel meetings, authors present their
work and answer panel experts’ questions so that the experts may
understand what the authors did and the authors may understand the
experts comments and recommendations.
Our peer involvement efforts follow the principles
that are the cornerstone of our program – scientific robustness,
selection of appropriate expertise, and transparency. A fourth
principle, independence, is key for all peer reviews and important for
many peer input and consultation efforts. TERA conducts its
scientific peer reviews in accordance with U.S. EPA peer review
procedures (as described in
EPA 2006). In addition, TERA has developed its peer review
and consultation program following principles highlighted by the
American Industrial Health Council’s 1995 report Fundamental
Scientific Peer Review Principals
and utilizing approaches used by the National Academy of Sciences
and EPA’s Science Advisory Board. Peer input and peer consultations
utilize the peer review guidance as appropriate.
For more information on
the Independent Peer Review and Consultation Program, click on the links
below or contact
Ms. Jacqueline Patterson.
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