M13 - The Voluntary Children's Chemical Evaluation Program: Progress in Meeting the ChallengesAndreas 1:30 - 3:00 pm
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| Chair(s): Lee Salamone
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M13.1 The VCCEP Challenge: the Utility of the Exercise So Far. L. Salamone; American Chemistry Council Lee_Salamone@americanchemistry.com
Abstract: The Voluntary Children’s Chemical Evaluation Program (VCCEP) pilot was developed by EPA after lengthy discussions with several interested groups. Its goals are multiple: pilot a tiered and integrated chemical evaluation strategy for assessing potential risk to children in a cost- and resource-effective way; pilot a method for choosing chemicals that is based on criteria that indicate some potential for children (or potential parents) to be exposed; examine whether Peer Consultation is a useful way to seek advice and review from experts; push the development of child-specific exposure assessment to the next level. Industry sponsors of VCCEP chemicals will have written and submitted eleven chemicals for Peer Consultation by the end of 2004. The pilot program is halfway to completion: are the goals being met? What challenges remain?
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M13.2 The Tiered Risk-Based Approach to Evaluating Children’s Health. R. Becker; American Chemistry Council Rick_Becker@americanchemistry.com
Abstract: Under the VCCEP framework, initial risk characterizations are based on available toxicity and exposure information. Hazard assessment requires, at minimum, the internationally harmonized core set of toxicity tests (OECD-SIDS/HPV Challenge) to identify effect and no effect levels for all major organs from acute & repeat dosing, in utero exposures, reproductive studies & the potential to damage DNA. Exposure evaluation provides, at minimum, child-focused screening level information on intakes/doses for defined age periods. Margins of exposure are then calculated and used as the basis for evaluating potential actions. Biologically based toxicity criteria can also be used as part of the decision matrix to indicate which specific type of study is important to gain greater certainty concerning a substance’s potential hazard to children. Options for actions include: low priority for further studies, refining the exposure assessment and/or conducting additional toxicity tests. Recognizing that for certain substances, specific types/quality of toxicity testing information would be lacking, one challenge the VCCEP pilot was designed to address was - based on available toxicity information coupled with a child-focused exposure assessment - could the risk characterization be judged sufficient? Could such a risk characterization be used to determine whether children are protected from potential risks with acceptable degree of scientific confidence? Specific VCCEP risk characterizations will be presented to illustrate how the VCCEP framework has 1) fostered assessments of the adequacy of risk characterizations, in the absence of information on every possible toxicity test, and 2) has provided a scientific rationale for those cases in which specific additional tests or exposure assessment work would be beneficial to providing greater certainty to the risk characterization.
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M13.3 Peer Consultation in Risk Assessment. J. Patterson, D. Briggs; Toxicology Excellence for Risk Assessment patterson@tera.org
Abstract: Peer consultation is a process that is used in the field of risk assessment to solicit input and advice from technical experts and sometimes from stakeholders. The output of a peer consultation is generally opinions of individual panel members, not necessarily consensus, or agreement, from the panel as a whole. Toxicology Excellence for Risk Assessment (TERA) is conducting a variety of peer consultations to explore additional ways to gain expert review for risk assessment documents. TERA has organized peer consultations to solicit expert opinion from panels on topics such as physiologically based pharmacokinetic modeling of trichloroethylene, dermal exposure guidance, and to facilitate data gathering and initial analysis of data in an interactive process for evaluators to seek, gather, and clarify data from subject matter experts. TERA has also been organizing and conducting peer consultations for Voluntary Children's Chemical Evaluation Program (VCCEP) chemical assessments which is a pilot program to evaluate risks to children and identify data needs. The VCCEP pilot peer consultations have offered an opportunity to develop procedures and practices in a number of areas, including conflict of interest and bias determinations, selection of balanced panels and how to involve stakeholders, preparation of meeting reports, and how to present discussion results.
This work has been funded in part by the U.S. EPA (cooperative agreement X-82916801); however, the views expressed in this poster are those of the authors and do not represent the views of the funding agency.
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M13.4 Future Challenges Facing the VCCEP. W. Penberthy, O. Hernandez; U.S. Environmental Protection Agency penberthy.ward@epa.gov
Abstract: The VCCEP pilot program is underway. Some challenges have been met, but still others remain. The remaining challenges include utilization of peer consultation report by EPA and others; communication about the findings under the pilot and the value of the pilot; application of VCCEP
model for decision making beyond the pilot program.
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