Modification of the Voluntary Children's Chemical Evaluation Program; Notice of Public Meeting
[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Notices]
[Page 36512-36514]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn08-48]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2006-0341; FRL-8370-4]
Modification of the Voluntary Children's Chemical Evaluation
Program; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA will hold a public meeting to give the stakeholders in the
Voluntary Childrens Chemical Evaluation Program (VCCEP) and interested
members of the public an opportunity to comment on the modifications
the Agency intends to make to VCCEP. The modifications are based on the
responses the Agency received to its request for comment on the
implementation of the VCCEP pilot. The modifications will primarily
address the timeliness and efficiency issues of the program in order to
increase its productivity and ability to provide information to the
public on the potential risks to children of exposure to certain
chemicals. The meeting will also provide the public with an opportunity
to comment on the use of the modified VCCEP approach to address certain
data and assessment needs identified in EPA's review of high production
volume (HPV) and mid production volume (MPV) chemicals under its
Chemical Assessment and Management Program (ChAMP).
DATES: The meeting will be held on Tuesday, July 22, 2008, from 9 a.m.
to 11 a.m.
Requests to participate in the meeting must be received on or
before July 17, 2008.
To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.
ADDRESSES: The meeting will be held at the Environmental Protection
Agency, 1201 Constitution Ave., NW., Rm. 1153, Washington, DC 20460.
Requests to participate in the meeting, identified by docket
identification (ID) number EPA-HQ-OPPT-2006-0341, may be submitted to
the technical person listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact: Catherine Roman, Chemical
Control Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8157; e-mail
address: roman.catherine@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of particular interest to those chemical manufacturers
(including importers) who produce or import chemical substances that
are subject to the Toxic Substances Control Act (TSCA), in particular
those chemical manufacturers (including importers) that are sponsoring
chemicals in VCCEP, individuals or groups concerned with chemical
testing and childrens health, and animal welfare groups. Because other
entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket ID number EPA-HQ-OPPT-2006-0341. All documents in the docket are
listed in the docket's index available at http://www.regulations.gov.
Although listed in the index, some information is not publicly
available, e.g., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
[[Page 36513]]
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
II. Background
VCCEP was designed to collect health effects, exposure, and risk
information on chemicals to which children are likely to be exposed,
and to make that information available to the public so the public may
better understand the potential health risks to children associated
with certain chemical exposures, and to allow EPA and others to
evaluate the risks of these chemicals so that mitigation measures may
be taken as appropriate. EPA announced VCCEP in December 2000 (Ref. 1)
and requested chemical manufacturers and importers to participate in a
pilot of the program by voluntarily sponsoring their chemical if it
were among those selected by EPA. The pilot began in 2001 when companies
volunteered to sponsor their chemicals in response to EPAs request.
In 2006, at what was approximately the midpoint in the
implementation of the pilot phase of VCCEP, EPA sought to evaluate how
well the pilot was meeting the objectives of VCCEP. To that end, EPA
requested that the public submit comments on their experience with the
pilot phase of VCCEP and its opinions on the progress of the pilot
phase to date (Ref. 2). Additionally, EPA developed a list of questions
in order to focus comments on certain features of the VCCEP pilot on
which the Agency particularly wanted input. The comments EPA received
were summarized and made available to the public on the VCCEP website
(http://www.epa.gov/oppt/vccep). Some of the main comments concerned
the timeliness and efficiency of the program, the chemicals selected
for the pilot program, the use of a tiered approach to testing, and the
use of a Peer Consultation process to review chemical assessments.
Based on those comments and also internal Agency discussions, EPA has
developed a list of modifications that it believes will improve the
future performance of VCCEP. Although the VCCEP program will continue
to operate primarily as described in the Federal Register notice
launching the program (Ref. 1), certain modifications to address the
main concerns of the Agency, stakeholders and the public are being
contemplated by EPA. EPA wants to share and discuss the contemplated
modifications with the VCCEP stakeholders and the public and listen to
any additional comments. Therefore, EPA will hold a public meeting on
July 22, 2008, at EPA headquarters in Washington, DC. The modifications
which will be the basis for the discussions at the public meeting are
as follows:
1. Chemical selection. To address the concern that the chemicals
covered in the VCCEP Pilot were a set of particularly well-studied
chemicals for which, in most cases, little additional assessment was
needed, future VCCEP chemicals will primarily be selected from
chemicals that, when assessed as part of ChAMP, are identified as being
of special concern and as presenting hazard/exposure data needs that
are relevant to characterizing risks to children. (A more detailed
description of ChAMP is provided in this unit as well as at (
http://www.epa.gov/ChAMP). Chemicals that also meet the original VCCEP
chemical selection criteria which were evidence of presence in human
tissues and in relevant environmental media (e.g., indoor air, drinking
water, and food) will be a particular focus of future VCCEP activity.
2. Changes to the assessment approach.
• To ensure timely completion of chemical assessments,
specific due dates for sponsor assessment submissions and peer
consultations will be established in sponsor commitments, including
timelines for responding to follow-up actions/requests.
• To bring concerns for potential chemical risks to prompt
resolution, EPA will indicate in its Tier 1 Data Needs Decision when it
believes it is reasonable to combine Tiers 2 and 3 as used in the VCCEP
Pilot into a single tier. EPA recognizes that a three tier approach may
be acceptable when the sponsor can demonstrate that it is sound
scientifically and that a delay in the public availability of Tier 3
data would not have potential public health impacts.
3.Peer consultation modifications. Under the modified approach
envisioned by EPA, the following points would be agreed to in advance
by EPA and the sponsoring company or the VCCEP approach will not be
used for purposes of obtaining needed information.
• The peer consultation process will remain the mechanism to
review sponsor-generated assessments and the sponsor will be
responsible for contracting with an independent third party to manage
the peer consultation and will bear the associated financial burdens.
• Distinguishing between ``data needs'' and ``data gaps,''
which was a useful outcome of the VCCEP Pilot, will be used in VCCEP
peer consultations.
• So that sponsors can better address concerns identified in
the peer consultation before EPA develops a Data Needs Decision, the
sponsor will promptly develop revised assessments that respond to
issues identified in the Peer Consultation Meeting Report and make them
publicly available. The sponsor will amend its assessments within 90
days after the Peer Consultation Meeting Report is made available to
them. EPA will use the amended assessments and the Peer Consultation
Meeting Report to make its Data Needs Decision within 90 days of
receipt of the revised assessments. The sponsor will then have 4 months
after the receipt of the Data Needs Decision, as is current practice in
the VCCEP Pilot, to decide whether to commit to the next tier of
assessment, if necessary.
The meeting on July 22, 2008, will also provide the public with an
opportunity to comment on the use of the modified VCCEP approach to
address certain data and assessment needs identified in EPA's review of
HPV and MPV chemicals under ChAMP, including environmental toxicity,
environmental fate, and aspects that may go beyond mammalian toxicity.
ChAMP was established by EPA as a mechanism to partially address the
Security and Prosperity Partnership (SPP) commitments announced by the
United States, Canada, and Mexico in Montebello, Canada in August 2007.
These commitments included a number of national and regional
commitments to trilateral cooperation in the assessment and management
of chemicals in North America. The United States has committed, by
2012, to assess and initiate needed actions on chemicals produced above
25,000 pounds per year (lb./yr.) in the country. High production volume
(HPV) chemicals are manufactured and imported in quantities greater
than 1,000,000 lb./yr. and moderate production volume (MPV) chemicals
are manufactured and imported in quantities greater than
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25,000 lb./yr. but less than 1,000,000 lb./yr. EPA's ongoing efforts
under ChAMP to screen and prioritize the risks of chemicals will be a
major component of EPA's efforts to meet its SPP commitments.
EPA believes that an adaptation of the modified VCCEP approach
could provide a flexible framework to further evaluate certain
chemicals identified by EPA in its ChAMP screening-level assessments as
presenting special concerns and associated follow-up action involving
hazard/exposure data development or assessment.
EPA believes that in most instances, the detailed evaluation of SPP
follow-up cases under the modified VCCEP approach should generally
begin at Tier 1. Sponsor-developed assessments should build on EPA's
SPP screening-level assessments, consider EPA recommended follow-up
actions (including conducting higher tier tests specifically identified
as priorities by EPA on the basis of its initial assessment), and
include a more highly developed quantification of exposures.
III. How Can I Request to Participate in this Meeting?
You may submit a request to participate in this meeting to the
technical person listed under FOR FURTHER INFORMATION CONTACT. Do not
submit any information in your request that is considered CBI. Requests
to participate in the meeting, identified by docket ID number EPA-HQ-
OPPT-2006-0341, must be received on or before July 17, 2008.
IV. References
1. EPA. Voluntary Children's Chemical Evaluation Program; Notice.
Federal Register (65 FR 81699, December 26, 2000) (FRL-6758-5).
Available on-line at: http://www.epa.gov/fedrgstr.
2. EPA. Implementation of the Pilot Voluntary Children's
ChemicalEvaluation Program; Request for Comment; Notice. Federal
Register (71 FR 67121, November 20, 2006) (FRL-8057-1). Available on-
line at: http://www.epa.gov/fedrgstr.
List of Subjects
Environmental protection, Chemicals, Child Health.
Dated: June 20, 2008.
James B. Gulliford
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances
[FR Doc. E8-14528 Filed 6-26-08; 8:45 am]
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