To develop 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 assessment.
The 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.
To 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. Office 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.
Members 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.
TERA 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.