Assessing the Default Assumption That Children Are Always at Risk

Calabrese, Edward J.

doi:10.1080/20018091094204

Cited by 15 publications

(3 citation statements)

References 72 publications

(58 reference statements)

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“…On that basis, infants and children on average are less sensitive than adults to chemical toxicity (i.e., the average ratio is greater than 1.0), but when they are not, the 3.16 kinetic component ofUFH adjusts the adult human kinetic parameter to that of the infant or child for 91% of the chemicals tested (i.e., adjust the adult animal LD50 to that of the younger animals for 86% of the chemicals tested. Calabrese (2001) showed a similar analysis of age comparisons for LD50 determinations in laboratory animals for 313 chemicals. Ninety-seven adult to young LD5o ratios (31%) were between 0.5 and less than 2.0, indicating that adults and young animals were equally sensitive.…”

Section: Adequacy Of Ufh For Childrenmentioning

confidence: 74%

Differential Sensitivity of Children and Adults to Chemical Toxicity

Scheuplein

Charnley²,

Dourson³

2002

Regulatory Toxicology and Pharmacology

185

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Animals can be useful predictors of chemical hazards to humans. Growth and development are compressed into a shorter period in animals, which makes interpretation of animal testing inherently more difficult. However, similar events occur in both humans and laboratory animals and testing that covers the full period of animal development can reasonably be considered an appropriate surrogate for human development. Some have proposed an additional 10-fold factor for the extra protection of children when estimating safe exposures. Use of such an additional factor, as required by the Food Quality Protection Act (FQPA), is meant to address the same issues covered by the EPA's database uncertainty factor, UFD, and ad-448~I

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Section: Adequacy Of Ufh For Childrenmentioning

confidence: 74%

Differential Sensitivity of Children and Adults to Chemical Toxicity

Scheuplein

Charnley²,

Dourson³

2002

Regulatory Toxicology and Pharmacology

185

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“…Although many toxicologists believe that classic tests used over the years have done a good job at identifying those chemicals that are likely to adversely affect young animals, it is clear that not all of the commonly used chemicals have undergone the complete battery of testing and that relatively few studies have attempted to characterize subtle effects due to dosing in utero or shortly after birth. Whether only a few or hundreds of new studies need to be conducted to assure ourselves that we understand the risks to the fetus or the young child is a topic that will undoubtedly be debated for many years (Calabrese 2001). However, if many new studies are to be conducted, they could well require that new and innovative toxicity test methods be developed and that different approaches for analyzing the dose-response curve, and for extrapolating the results to lower doses, may be needed.…”

Section: Discussionmentioning

confidence: 99%

Current Methods for Evaluating Children's Exposures for Use in Health Risk Assessment

Williams

Holicky

Paustenbach

2003

Journal of Children's Health

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Despite the relatively long history of incorporating child-specific safety or exposure factors into U.S. health risk assessments, there has been a growing perception that past scientific and regulatory approaches were not sufficiently protective of infants and children. To address these concerns, a wide range of activities have occurred over the last few years that will likely generate new information on childspecific issues and identify data gaps in current knowledge about children's exposures and health risks. For example, the new publication by the Centers for Disease Control and Prevention, National Report on Human Exposure to Environmental Chemicals, will provide unique information on environmental chemical exposures in the U.S. population using biomonitoring (i.e., blood and urine) analyses. Although preliminary reviews have attempted to summarize what is known about the factors that influence children's exposure and sensitivity to environmental contaminants, there does not appear to be a comprehensive published summary of children's exposure assessment methodologies, or clear guidance on how to prioritize future research needs or deal with data uncertainties. In this paper, we provide an overview of the traditional human health risk assessment paradigm, as well as a reasonably complete discussion of how to assess children's exposures for human health risk assessments via inhalation, dermal, and ingestion routes. Several additional approaches are also discussed that might be worthwhile components of future children's exposure assessments, including: (1) probabilistic (Monte Carlo) techniques, (2) formal expert judgment studies, and (3) value-of-information (VOI) analyses. The information presented here should be useful for persons involved in child-specific

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“…Children's health issues have become an increasingly important topic of scientific research over the last decade. In particular, greater attention has focused on the potential for children's increased (or reduced) susceptibility to chemicals and on children's unique behavior and exposure patterns (ATSDR, 1997; Armstrong et al , 2000; Bruckner, 2000; Calabrese, 2001; Charnley, 2001; Charnley & Putzrah, 2001; Cohen‐Hubal et al , 2000; Dourson et al , 2002; Etzel et al , 1999; Juberg, 2002; Scheuplein et al , 2000; Schneider & Freeman, 2000; U.S. EPA, 2003; Weaver et al , 1998).…”

Section: Introductionmentioning

confidence: 99%

VCCEP Pilot: Progress on Evaluating Children's Risks and Data Needs

Williams¹,

Patterson²,

Briggs³

2006

Risk Analysis

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The Voluntary Children's Chemical Evaluation Program (VCCEP) is designed to provide information to the public on children's potential health risks associated with chemical exposures. The key question of the VCCEP is whether the potential hazards, exposures, and risks to children have been adequately characterized, and, if not, what additional data are necessary. To answer this question, manufacturers or importers of 23 chemicals were asked by the U. S. Environmental Protection Agency (U.S. EPA) to sponsor their chemicals in the first tier of a pilot program. These chemicals were selected for evaluation because they have been found as contaminants in human tissue or fluids (adipose tissue, blood, breath, breast milk, or urine); food and water children may eat and drink; or air children may breathe (including residential or school air). Under the VCCEP framework, sponsoring companies agree to prepare Tier 1 hazard, exposure, and risk assessments on the individual chemicals, and identify the need for additional data. These assessment documents are submitted to the U.S. EPA and subsequently undergo review by experts in an independent peer consultation meeting that is open to the public. Following this peer consultation process, the U.S. EPA reviews each submission and makes a data-needs determination, which may include requesting further data collection or generation by the sponsor. Sponsoring companies then decide whether to volunteer for the next tier and collect or generate the requested data. The purpose of this article is to describe the VCCEP process and to review and present the key findings from the first set of chemicals that have been fully or partially evaluated under the pilot program (vinylidene chloride, decabromodiphenyl ether, pentabromodiphenyl ether, octabromodiphenyl ether, acetone, methyl ethyl ketone, decane, undecane, and dodecane). Specifically, we provide a brief summary of the sponsors' submissions, the peer consultation panels' discussions, and the U.S. EPA's data-needs decisions. Although we do not attempt to conduct independent analyses of the underlying data, we do identify a number of common themes that have emerged during implementation of the pilot program and discuss several key issues that could become important in the future. The information presented here should be useful for various parties interested in the progress of the VCCEP and the results of the initial (Tier 1) children's assessments.

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Assessing the Default Assumption That Children Are Always at Risk

Cited by 15 publications

References 72 publications

Differential Sensitivity of Children and Adults to Chemical Toxicity

Differential Sensitivity of Children and Adults to Chemical Toxicity

Current Methods for Evaluating Children's Exposures for Use in Health Risk Assessment

VCCEP Pilot: Progress on Evaluating Children's Risks and Data Needs

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