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Voluntary Children's Chemical Evaluation Program (VCCEP)
In the December 26, 2000 Federal Register,
EPA announced the Voluntary Children's Chemical Evaluation Program (VCCEP)
which is intended to provide data to enable the public to understand the
potential health risks to children associated with certain chemical exposures.
EPA asked companies which manufacture and/or import 23 chemicals which
have been found in human tissues and the environment in various monitoring
programs to volunteer to sponsor their evaluation in Tier 1 of a pilot
of the VCCEP. Thirty-five companies and ten consortia responded and volunteered
to sponsor 20 chemicals.
BACKGROUND:
One part of the Chemical Right-to-Know Initiative, announced on Earth
Day 1998, was the goal of ensuring that there are adequate publicly available
data to assess the special impact that industrial chemicals may have on
children. EPA responded by identifying industrial/commercial chemicals
to which children have a high likelihood of exposure, determining what
information is needed to assess the impact on children as a result of
exposure to those chemicals, and pursuing the collection, development,
and public dissemination of that information in a voluntary program. In
August 1999, EPA announced the initiation of a stakeholder involvement
process in which it sought stakeholder input on all aspects of the 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 VCCEP was developed and
its implementation as a "VCCEP Pilot" is described below.
VCCEP PILOT:
The VCCEP consists of three tiers which a sponsor could commit to separately.
EPA asked companies to volunteer to sponsor chemical(s) they manufacture
or import in Tier 1 of the VCCEP pilot. As part of their sponsorship,
companies would 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" would also be developed by the sponsor. The
Data Needs Assessment would discuss the need for additional data, which
could be provided by the next tier, to fully characterize the risks the
chemical may pose to children.
The information submitted by the sponsor would be 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) will organize and facilitate the Peer Consultations
and forward the results to EPA and the sponsor(s) concerning the adequacy
of the assessments and the need for development of any additional information
to fully assess risks to children. EPA will consider the results of the
Peer Consultation and announce whether additional higher tier information
is needed. If additional information is needed, sponsors will be asked
to volunteer to provide the next tier of information. If additional information
is not needed, EPA and the sponsors will cooperate to conduct appropriate
risk communication and, if necessary, risk management.
The VCCEP pilot will be evaluated to identify efficiencies which can be
applied to the subsequent implementation of the VCCEP.
23
CHEMICALS IN THE VCCEP PILOT:
| CAS
No. |
Chemical
Name |
|
CAS
No. |
Chemical
Name |
| 67-64-1 |
Acetone |
|
108-88-3 |
Toluene |
| 71-43-2 |
Benzene |
|
108-90-7 |
Chlorobenzene |
| 75-35-4 |
Vinylidenechloride |
|
112-40-3 |
n-Dodecane |
| 78-93-3 |
Methyl
ethyl ketone |
|
123-91-1 |
p-Dioxane |
| 79-01-6 |
Trichloroethylene |
|
124-18-5 |
Decane |
| 80-56-8 |
a-Pinene |
|
127-18-4 |
Tetrachloroethylene |
| 95-47-6 |
o-Xylene |
|
541-73-1 |
m-Dichlorobenzene |
| 100-41-4 |
Ethylbenzene |
|
1120-21-4 |
Undecane |
| 106-46-7 |
p-Dichlorobenzene |
|
1163-19-5 |
Decabromodiphenylether |
| 106-93-4 |
Ethylene
dibromide |
|
32534-81-9 |
Pentabromodiphenyl
ether |
| 107-06-2 |
Ethylene
dichloride |
|
32536-52-0 |
Octabromodiphenyl
ether |
| 108-38-3 |
m-Xylene |
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For the most part, chemicals were selected for the VCCEP pilot if there
were monitoring data indicating that exposure to humans had occurred and
if the chemicals are present in the environment. The biomonitoring data
sets used for VCCEP pilot chemical selection 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 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 are similar in scope
to VCCEP. Additional details on how chemicals were selected for the VCCEP
pilot are provided in the document "Chemical Selection
Methodology," which is available on this website under "Information
on VCCEP Chemicals".
HAZARD AND EXPOSURE INFORMATION REQUESTED:
Because the ultimate objective of the VCCEP is to evaluate the potential
risks posed to children by exposure to certain chemicals, EPA is requesting
information on both hazard (health effects) and exposure. The health effects
information being requested is a subset of the test battery developed by
the EPA to assess the effects of pesticides on children's health. EPA's
Science Advisory Panel advised that the test battery would also be appropriate
in the VCCEP to assess the health effects of industrial chemicals to which
children might be exposed. The health effects information will be submitted
in three tiers with the Tier 1 tests being the same as those requested in
the HPV Challenge Program. 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
developmental toxicity
Reproductive and fertility effects |
Carcinogenicity
Developmental neurotoxicity |
| Bacterial
reverse mutation assay |
Immunotoxicity |
|
In
vitro or in vivo
chromosomal aberrations or
in vivo micronucleus test |
In
vivo chromosomal aberrations or
in vivo micronucleus test |
|
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Metabolism
and pharmacokinetics |
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EPA also requested exposure information to be submitted so that the likely
extent of children's exposure to the VCCEP chemicals can be determined.
The exposure information needed for this evaluation program includes population
groups exposed, sources of the exposure, as well as frequencies, levels,
and routes of exposure. The exposure information submitted at Tier 1 may
be readily available screening level information with more detailed analyses
submitted at upper tiers.
ADDITIONAL INFORMATION:
Additional information on the VCCEP, including the December
26, 2000 Federal Register notice, frequently
asked questions, and the stakeholder involvement
process, is available on this web site under "About VCCEP". The current
status of the VCCEP pilot chemicals can be found on this web site under
"Information on VCCEP Chemicals". This web site will also be used for future
announcements concerning the VCCEP.
![[PDF]](https://webharvest.gov/peth04/20041111194409im_/http://www.epa.gov/oppt/images/pdficon.gif)
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