TABLE 2-1 Three Tiers of Voluntary Children’s Chemical Evaluation Program

Tier 1

Tier 2

Tier 3

Acute toxicity

Subchronic toxicity

Neurotoxicity screening battery

Repeated dose toxicity with reproductive and developmental toxicity screens

Prenatal developmental toxicity


Reproductive and fertility effects

Developmental neurotoxicity

Bacterial reverse mutation assay



In vitro or in vivo chromosomal aberrations or in vivo micronucleus test

In vivo chromosomal aberrations or in vivo micronucleus test


Metabolism and pharmacokinetics


SOURCE: EPA, 2004c.

to children, said Balbus. He noted that this is a situation that creates a potential conflict of interest, since the sponsoring company would have strong disincentives to write in a public document that their product was posing risks to children. Some of the expert peer consultation panelists reviewing the VCCEP studies have questioned several of the assumptions within the risk assessment documents, as well as some of the interpretations of the toxicity studies, observed Balbus. Furthermore, the pace of the VCCEP pilot has been very slow. Of 23 chemicals identified for this pilot back in 1999, the first chemical was evaluated in January of 2003, and the EPA did not finalize their review of that first chemical until late in 2005.

In conclusion, Balbus said that Environmental Defense feels strongly that well-designed voluntary programs can have an important role in speeding the pace of data generation, but they are not able to completely replace regulatory frameworks, and they demand dedication of government resources to ensure proper oversight and quality of the output.

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