EPA announced the Chemical Right-to-Know Initiative on Earth Day 1998. One of its goals was to ensure that adequate data be made publicly available to assess the special impact that industrial chemicals may have on children. Toward meeting this goal, EPA identified industrial/commercial chemicals to which children have a high likelihood of exposure and the information needed to assess the risks to children from these chemicals. EPA is currently pursuing the collection, development, and public dissemination of this information through the Voluntary Children's Chemical Evaluation Program (VCCEP).
In August 1999, EPA announced the initiation of a stakeholder involvement process to get input on all aspects of VCCEP. EPA held three public stakeholder meetings and took comments on possible designs for a voluntary program. EPA also took steps to consider animal welfare and to reduce, or in some cases eliminate, animal testing, while at the same time ensuring that public health is protected. After considering all the comments of interested stakeholders, the Agency developed the VCCEP Pilot.
On December 26, 2000, EPA launched the VCCEP Pilot by asking companies that manufactured or imported one or more of the 23 chemicals selected for the program to volunteer to sponsor their chemicals and provide information on health effects, exposure, risk, and data needs. Thirty-five companies and 10 consortia responded, volunteering to sponsor 20 chemicals.
Under the VCCEP Pilot, EPA collects three tiers of increasingly detailed information on a chemical from its sponsor. So far EPA has asked companies to volunteer to sponsor their chemical(s) for Tier 1. After completing the evaluation of some Tier 1 chemical assessments, EPA asked companies to volunteer to sponsor Tier 2 testing for some of those chemicals. EPA gives sponsors the opportunity to commit to one tier at a time. Companies are only asked to sponsor a particular tier when EPA believes the data to be provided are necessary to understand the chemical’s potential impact on children. During their sponsorship, companies collect and/or develop health effects and exposure information on their chemical(s) and integrate that information in a risk assessment. A "data needs assessment," also developed by the sponsor, discusses the need for additional data, which can be provided as part of the next tier of information to fully characterize the risks the chemical may pose to children.
In VCCEP, a sponsor is a company or group of companies that volunteer to collect and/or develop information on health effects, exposure, risk and additional data needed to fully characterize a chemical's risk to children.
Information submitted by sponsors is evaluated in a peer consultation by a group of scientific experts with extensive and broad experience in toxicity testing and exposure evaluations. Toxicology Excellence for Risk Assessment (TERA) organizes and facilitates the peer consultations and forwards results to EPA and the sponsor(s) concerning the adequacy of the assessments and the need to develop additional information to fully assess risks to children. EPA considers the results of the peer consultation and announces whether additional higher tier information is needed. If additional information is needed, sponsors are asked to volunteer to provide the next tier of information. If additional information is not needed, EPA and the sponsors cooperate in appropriate risk communication and, if necessary, risk management. The status of the VCCEP review of the 20 sponsored chemicals is available.
CHEMICALS IN THE VCCEP PILOT:
Acetone (CAS No. 67-64-1)
Benzene (CAS No. 71-43-2)
*Chlorobenzene (CAS No. 108-90-7)
Decabromodiphenylether (CAS No. 1163-19-5)
Decane (CAS No. 124-18-5)
*m-Dichlorobenzene (CAS No. 541-73-1)
p-Dichlorobenzene (CAS No. 106-46-7)
p-Dioxane (CAS No. 123-91-1)
*Ethylene dibromide (CAS No. 106-93-4)
n-Dodecane (CAS No. 112-40-3)
Ethylbenzene (CAS No. 100-41-4)
Ethylene dichloride (CAS No. 107-06-2)
Methyl ethyl ketone (CAS No. 78-93-3)
Octabromodiphenylether (CAS No. 32536-52-0)
Pentabromodiphenylether (CAS No. 32534-81-9)
a-Pinene (CAS No. 80-56-8)
Tetrachloroethylene (CAS No. 127-18-4)
Toluene (CAS No. 108-88-3)
Trichloroethylene (CAS No. 79-01-6)
Undecane (CAS No. 1120-21-4)
Vinylidenechloride (CAS No. 75-35-4)
m-Xylene (CAS No. 108-38-3)
o-Xylene (CAS No. 95-47-6)
* Unsponsored Chemicals
For the most part, 23 chemicals were selected for the VCCEP pilot if monitoring data indicated that:
- exposure to humans had occurred; and
- the chemicals are present in the environment
The monitoring data used to identify chemicals with evidence of human exposure included samples from human blood, breast milk, and exhaled breath. Presence in the environment was established by monitoring data indicating presence in indoor air or presence in drinking water as an unregulated contaminant.
Chemicals not selected were screened from the VCCEP pilot if they were being adequately addressed by another risk management program, were being phased out, or were not manufactured or imported in the United States. Other chemicals were deferred because of ongoing assessments which were similar in scope to VCCEP. Additional details on how chemicals were selected for the VCCEP pilot are provided in the document "Chemical Selection Methodology."
Because the ultimate objective of the VCCEP is to evaluate the potential risks to children from exposure to certain chemicals, EPA has been requesting information on both hazard (health effects) and exposure. The health effects information being requested is a subset of the test battery developed by EPA to assess the effects of pesticides on children's health. EPA's Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Science Advisory Panel advised that this test battery would also be appropriate in VCCEP to assess the health effects of industrial chemicals to which children might be exposed. The health effects information is being submitted in three "tiers" with the "Tier 1" tests being the same as those requested in the HPV Challenge Program. If there is existing data for a Tier 2 or 3 test, those data are being submitted with the Tier 1 information. Following are the health effects tests in the VCCEP listed by tier:
|Tier 1||Tier 2||Tier 3|
|Acute toxicity||Subchronic toxicity||Neurotoxicity screening battery|
|Repeated dose toxicity with reproductive and developmental toxicity screens||Prenatal
Reproductive and fertility effects
|Bacterial reverse mutation assay||Immunotoxicity|
vitro or in vivo
chromosomal aberrations or
in vivo micronucleus test
vivo chromosomal aberrations or
in vivo micronucleus test
|Metabolism and pharmacokinetics|
EPA also requested that exposure information be submitted so it could determine the likely extent of children's exposure to the VCCEP chemicals. Exposure information needed for this evaluation program includes population groups exposed, sources of exposure, as well as frequencies, levels, and routes of exposure. Exposure information submitted for Tier 1 may be readily available screening level information with more detailed analyses submitted for upper tiers.
Additional information on VCCEP, including the stakeholder involvement process and other historical documents, is available in Docket Number OPPTS-00274. The public docket is located in EPA West at 1301 Constitution Avenue, NW, Washington, DC and is open to the public from 8am to 4pm, excluding public holidays. Because of flood damage to the public docket in June 2006, you should call the Docket at (202) 566-1744 to make an appointment and get directions to the temporary location.