and demonstrate the TERA
peer consultation process, TERA is conducting Peer
Consultation meetings for the pilot Voluntary Children's
Chemical Evaluation Program (VCCEP).
The VCCEP program is a voluntary pilot program and part of the U.S.
Environmental Protection Agency's (EPA) Chemical Right-to-Know
Initiative. The goal of the VCCEP pilot is to enable the
public to better understand the potential health risk to children
associated with certain chemical exposures. The key question of
the program is whether the potential hazards, exposures, and risks to
children have been adequately characterized, and , if not, what
additional data are necessary. The EPA has asked companies that
manufacture and /or import 23 chemicals (that have been found in human
tissues and the environment in various monitoring programs) to
volunteer to sponsor chemical evaluations in a pilot program.
Sponsorship requires the companies to collect or develop health
effects and exposure information on their chemicals and then to
integrate that information in a risk assessment and a data needs
VCCEP pilot program uses a tiered testing approach. For
toxicity data, specific types of studies have been assigned to one of
three tiers. For exposure data, the depth of exposure
information increases with each tier. If data needs are
identified through this process, the sponsor will choose whether or
not to volunteer for any additional data generation or testing and
whether to provide additional assessments.
provide wide-ranging scientific review of the sponsor's assessment,
each submission undergoes review and discussion by a peer consultation
panel. The purpose of the panel meeting is to provide a
science-based peer consultation on the data needs for the chemical,
utilizing the assessment submitted by the sponsor, as well as the
expertise and knowledge of the panel. Members of the peer
consultation panels are selected by TERA based on their
expertise in scientific disciplines relevant to the chemicals, test
methodologies, and risk assessment issues that will be
discussed. Nominations for panel members are welcome from all
interested parties. TERA selects the panel members from
among those nominated and qualified, supplemented when needed by other
experts TERA may independently identify.
Each panel member discloses information regarding
potential conflicts of interest and biases. TERA
evaluates these disclosures in selecting the panel members following procedures
in accordance with the U.S.
of Management and Budget,
the National Academy of Sciences, and the U.S. EPA. These
procedures are described in more detail at http://www.tera.org/Peer/COI.html.
Panel members bring a wide range of views and perspectives to the peer
consultations, reflecting the interest in VCCEP by a wide range of
stakeholders. The panel does not attempt to reach consensus,
rather the individual opinions of the members are noted.
of the public are invited to attend the peer consultation meetings and
may provide brief oral and written technical comments on the
assessment document for the panel's consideration.
prepares meeting reports summarizing the sponsor's presentations, the
panel discussions, and any comments from the public. Panel
members review and comment on the draft report. The sponsor also
is given the opportunity to review the draft report to confirm the
accuracy of the sponsor presentations and comments. Reports are
made available to the public on TERA's
Peer review and Consultation website.