[Federal Register Volume 71, Number 223 (Monday, November 20, 2006)]
[Notices]
[Pages 67121-67124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19574]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2006-0341; FRL-8057-1]
Implementation of the Pilot Voluntary Children's Chemical
Evaluation Program; Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is requesting comment on the implementation of the pilot
phase of the Voluntary Children's Chemical Evaluation Program (VCCEP).
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. EPA announced the program in December
2000 and the pilot began in 2001 when companies volunteered to sponsor
their chemicals under VCCEP. At what is approximately the midpoint in
the implementation of the pilot phase of VCCEP, EPA is preparing to
evaluate how well it is meeting its objectives for VCCEP. To this end,
EPA is seeking comments from participants and observers about the
operations and experience under the VCCEP pilot to this point. If
requested, EPA will hold a public meeting to take comment on the
implementation of the pilot phase of VCCEP.
DATES: Comments must be received on or before January 19, 2007.
Requests for a public meeting must be received on or before
December 11, 2006.
ADDRESSES: To submit comments: Submit your comments, identified by
docket identification (ID) number EPA-HQ-OPPT-2006-0341, by one of the
following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2006-0341. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0341. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., 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, EPA Docket Center (EPA/DC). The EPA/DC suffered structural
damage due to flooding in June 2006. Although the EPA/DC is continuing
operations, there will be temporary changes to the EPA/DC during the
clean-up. The EPA/DC Public Reading Room, which was temporarily closed
due to flooding, has been relocated in the EPA Headquarters Library,
Infoterra Room (Room Number 3334) in EPA West, located at 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal 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. EPA visitors are required to show photographic
identification and sign the EPA visitor log. Visitors to the EPA/DC
Public Reading Room will be provided with an EPA/DC badge that must be
visible at all times while in the EPA Building and returned to the
guard upon departure. In addition, security personnel will escort
visitors to and from the new EPA/DC Public Reading Room location. Up-
to-date information about the EPA/DC is on the EPA website at http://www.epa.gov/epahome/dockets.htm.
To request a public meeting: Submit your request, identified by
docket ID number EPA-HQ-OPPT-2006-0341, to Catherine Roman by one of
the following methods:
E-mail address: [email protected].
Mail: Chemical Control Division (7405M), Office Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: Catherine
Roman.
Hand Delivery: 1201 Constitution Ave., NW., Washington,
DC, EPA East, ATTN: Catherine Roman. Ask the reception desk to call
(202) 564-4780. Such deliveries should be made during normal working
hours, 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone
[[Page 67122]]
number: (202) 554-1404; e-mail address: [email protected].
For technical information contact: Catherine Roman, Chemical
Control Division (7405M), Office Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-4780; e-mail
address: [email protected].
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), individuals or
groups concerned with chemical testing and children's 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed CBI. In addition to one complete
version of the comment that includes information claimed as CBI, a copy
of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at the estimate.
vi. Provide specific examples to illustrate your concerns, and
suggested alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is requesting comment from stakeholders, interested parties,
and the general public on the implementation of the VCCEP pilot and is
also evaluating the progress of the VCCEP pilot toward meeting its
objectives. 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 a December 26, 2000 Federal Register notice
(Ref. 1) and requested chemical manufacturers and importers to
participate in a VCCEP pilot by voluntarily committing to sponsor an
information collection on 23 chemicals. The VCCEP pilot is intended to
allow EPA to gain insight as to how best to design and implement VCCEP
in order to effectively provide the Agency and the public with the
means to understand the potential health risks to children associated
with exposure to chemicals to which children may be exposed. EPA
intends the VCCEP pilot to be the means of identifying efficiencies
which can be applied to the subsequent implementation of VCCEP.
Several factors were considered in selecting the 23 chemicals for
the VCCEP pilot; they included substantial production/importation (one
million lbs. or more per year), presence in the environment, and
biomonitoring evidence of presence in humans. A detailed description of
the selection process used by EPA is in the document entitled
Methodology for Selecting Chemicals for the Voluntary Children's
Chemical Evaluation Program (VCCEP) Pilot (Ref. 2).
The requested commitment for the VCCEP pilot was for Tier 1
information, with the potential for EPA to request participants to make
additional commitments to Tier 2 and Tier 3 information based on an
evaluation of the Tier 1 submission. As part of their Tier 1
commitments, sponsors were asked to include an expected submission date
that, as described in the December 2000 notice, is based on the amount
of time EPA considered necessary to gather the information (or perform
testing, if necessary) and prepare the assessments. Other guidance on
timeliness provided in the December 2000 notice included the following:
Within 6 months from the publication of the December 2000
notice was the recommended deadline to commit to Tier 1.
Within 4 months after announcing EPA's Data Needs Decision
was the recommended deadline to commit to upper tiers.
Within 1 month after receiving a chemical assessment was
EPA's goal to make it publicly available on the VCCEP website.
During 2001, 35 companies and 10 consortia voluntarily committed to
sponsor 20 of the 23 chemicals in the VCCEP pilot. Three of the twenty-
three chemicals were not sponsored and remain unsponsored. Also in
2001, EPA arranged for a third party, Toxicology for Excellence in Risk
Assessment (TERA), to organize and facilitate public Peer Consultation
meetings to evaluate the chemical assessments to be submitted by the
chemical sponsors. At a Peer Consultation meeting, a panel of
scientific experts with extensive and broad experience in toxicity
testing, exposure evaluation, or the specific chemical discuss the
chemical assessment and offer their opinions on its adequacy and
possible additional data needs. This discussion is held at a public
meeting where interested parties may also present comments. TERA
prepares a report summarizing the opinions expressed at the public
meeting and submits this report to EPA. EPA considers this report when
it reviews the chemical assessment prior to forming its decision
regarding additional data needs of the chemical.
In terms of progress, by the end of August 2006, the VCCEP pilot
sponsors had submitted Tier 1 chemical assessments for 12 of the 20
chemicals; all 12 chemical assessments had been evaluated in public
Peer Consultation meetings; summary reports of the Peer Consultation
meetings for the 12
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chemical assessments were made available; and EPA had reviewed the Peer
Consultation reports and issued Data Needs Decisions for 6 of the 12
chemicals. EPA is in the process of developing Data Needs Decisions for
the remaining 6 chemicals.
In its six Data Needs Decisions, EPA decided that additional data
were needed for three chemicals. A consortium of three companies
organized by the American Chemistry Council (ACC) has agreed to proceed
to Tier 2 of the VCCEP pilot and sponsor the additional information
collection for one of the chemicals. The Tier 1 sponsor of the other
two chemicals with additional data needs informed the Agency that it
will not commit to participate in Tier 2 for those chemicals. For the
other three chemicals for which Data Needs Decisions have been issued,
EPA concluded that the Tier 1 assessments provide sufficient
information to adequately characterize the risk to children of exposure
to those chemicals, and EPA considers the evaluation of these three
chemicals to be completed for purposes of the VCCEP pilot. To summarize
the activity and progress of the VCCEP pilot through August 2006, the
table in this unit indicates how many chemicals have completed
successive stages in the VCCEP pilot:
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Number of chemicals which
Stages in the VCCEP Process have completed each stage
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Sponsor commitment to provide Tier 1 20
information
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Tier 1 chemical assessment submitted 12 *
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Tier 1 chemical assessment has gone 12
through Peer Consultation
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Peer Consultation report available 12
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EPA issued a Data Needs Decision 6
(3 chemicals had Tier 2 data needs, 3
chemicals did not have Tier 2 data
needs.).
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Received a sponsor commitment to provide 1
Tier 2 information
OR ............................
Agency informed it will not receive 2
sponsor commitment to provide Tier 2
information
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* As noted on the VCCEP website, the submission of chemical assessments
for four chemicals (ethylbenzene, ethylene dichloride,
perchloroethylene, and trichloroethylene) has been delayed due to
other commitments to develop the data as part of another effort or
program.
The most recent information on the progress of specific chemicals
in the VCCEP pilot is presented on the VCCEP website (http://www.epa.gov/chemrtk/vccep). Since the Fall of 2001, EPA has kept the
public informed of activities in the VCCEP pilot through the VCCEP
website. The website describes VCCEP and how it was developed. It also
lists the chemicals and their sponsors, the date of sponsor commitments
to each tier, the submission dates of chemical assessments, the dates
of upcoming public Peer Consultation meetings, and the completion dates
of Peer Consultation reports and EPA's Data Needs Decisions. Most
importantly, the website makes the cited information available to the
public by providing links to the chemical assessments, the Peer
Consultation reports, and EPA's Data Needs Decisions.
In terms of timeliness for EPA, TERA, and the sponsors meeting the
scheduled goals for the VCCEP pilot, the following observations are
made:
All sponsors committed to Tier 1 by the 6-month deadline.
As part of their Tier 1 commitments, the sponsors for 5 of
the 12 chemicals for which EPA has received a chemical assessment as of
August 2006, provided a projected submission date for their Tier 1
chemical assessment. The chemical assessment for only one of the five
chemicals (decabromodiphenyl ether) was received by EPA by the
projected submission date.
Some of the projected submission dates originally provided
by the sponsors were subsequently revised at the request of the
sponsor, or due to TERA scheduling of Peer Consultation meetings.
EPA made all the chemical assessments available on the
VCCEP website within 1 month of receipt.
Although a recommended deadline for scheduling the Peer
Consultation meetings was not specified in the December 2000 notice,
the meetings for the 12 chemicals for which EPA has received a chemical
assessment as of August 2006 were held within an average of 2.4 months
of receiving the chemical assessment.
Although a recommended deadline for TERA to issue its
report summarizing a Peer Consultation meeting was not specified in the
December 2000 notice, TERA issued its reports for the 12 chemicals for
which EPA has received a chemical assessment as of August 2006, within
an average of 4.1 months after each meeting.
The notice announcing VCCEP (Ref. 1, p. 81714) stated that EPA
expected to evaluate the VCCEP pilot at 3 and 6 years after its
initiation. EPA chose not to conduct an evaluation at 3 years because a
sufficient number of chemicals had not gone through the public Peer
Consultation process and, as a consequence of this, there was
insufficient information to prepare a useful evaluation. Consequently,
EPA decided to conduct a single evaluation at a point 5 years,
approximately midway, into the program (i.e., 2006).
B. What is the Agency's Authority for Taking this Action?
Congress gave EPA the authority to implement TSCA for the purpose
of protecting human health and the environment, in part, by requiring
testing and, if necessary, by restricting the manufacture, processing,
distribution in commerce, use, or disposal of certain chemical
substances. VCCEP is a voluntary program which focuses on collecting
information and developing data necessary to protect children from
risks associated with chemical substances to which they are likely to
be exposed. This notice seeks public involvement in a midpoint
evaluation of how the VCCEP pilot is meeting its objectives and the
overall objectives of VCCEP.
III. Request for Comment
EPA is requesting comment from stakeholders, interested parties,
and the general public on the implementation of the VCCEP pilot, what
modifications might be made to make the VCCEP pilot run more
efficiently, and how well the VCCEP pilot is meeting the objectives of
VCCEP. The main objectives of VCCEP are:
To collect exposure, hazard, and risk information on
chemicals to which children are likely to be exposed.
To make the information available to the public so the
public may better understand the potential health risks to children
associated with certain chemical exposures.
The Agency is particularly interested in receiving your feedback
with regard
[[Page 67124]]
to the list of questions in this Unit III. Commenters should not feel
that they must confine their comments to the following specific
questions, nor should they feel they must respond to any or all of the
questions. Commenters, however, should attempt to provide comments on
the aspects of the VCCEP pilot with which they have had experience and/
or have formed a definite opinion. To be most helpful in the Agency's
evaluation, please provide enough detail to explain or illustrate
conclusions that you have reached based on your experiences.
Have the hazard, exposure, and risk assessments submitted
by the sponsors provided sufficient information to enable the Peer
Consultation panel to adequately evaluate these aspects as they relate
to children from the chemicals in question? Have the Data Needs
Assessments prepared by the sponsors been fair and unbiased?
Has the Peer Consultation process been open, transparent,
timely, and useful as a forum for scientists and experts from various
stakeholder groups to exchange views on sponsors' assessments and
recommended data needs? How might it be improved?
Has the Peer Consultation process been efficient? If not,
what improvements could be made?
Has the Peer Consultation panel adequately considered both
toxicology and exposure information in developing its results?
Does the Peer Consultation process provide a
scientifically rigorous and effective means for eliciting comments and
opinions from the assembled experts on the Peer Consultation panel and
those attending the public meeting, and for assisting EPA in developing
decisions?
Have the communications related to the Peer Consultation
process, activities and outcomes been effective and have they
facilitated public understanding and use of the information generated
from this process?
Should the time allowed for sponsor commitment remain the
same, i.e., 6 months to commit to Tier 1, and 4 months to commit to
subsequent Tiers? (The commitment period is the time for the sponsor to
decide whether to participate in VCCEP, form a consortium, and notify
the Agency.)
How can the timeliness of activities under the VCCEP pilot
be improved? Should specific due dates be established for each step in
the process? If so, how should a missed due date be addressed?
Should the sponsor be requested to commit to more than one
tier at a time? Is it better to run the VCCEP pilot with commitments at
each tier, i.e., three commitments, or to run the VCCEP pilot with two
commitments, i.e., to Tier 1 and to Tiers 2/3?
Are there any ways in which EPA's contributions to the
VCCEP pilot's evaluation and data needs decision process could be
improved or made more effective?
Has the VCCEP pilot made significant progress with respect
to its objectives?
The VCCEP pilot was designed to ensure that health
effects, exposure, and risk information are made available to the
public to enable a better understanding of the potential health risks
to children associated with certain chemical exposures. Does the VCCEP
website provide easy access to and adequate explanation of the
information generated by the VCCEP pilot?
Commenters should follow the guidance provided in Unit I.B. and
under ADDRESSES when preparing and submitting their comments.
IV. Comments Document
EPA will prepare a Comments Document summarizing the comments
received in response to this notice and at a public meeting, if held.
The Comments Document will identify any common themes and will assist
EPA in determining what modifications might be made to make the program
run more efficiently and/or better meet the objectives of VCCEP.
Significant program modifications which the Agency is considering as a
result of this evaluation will be discussed with stakeholders before
implementing.
At this time, once the Comments Document is complete, EPA expects
to make the Comments Document available to the public on the VCCEP
website. The Comments Document will not be published in the Federal
Register, nor will a notice of availability be published in the Federal
Register announcing its appearance on the VCCEP website. However, if
you provide your e-mail address, EPA will notify you by e-mail when the
Comments Document is available on the VCCEP website at http://www.epa.gov/chemrtk/vccep.
V. Public Meeting
If there are requests to do so, EPA will hold a public meeting to
discuss and take comment on the implementation of the VCCEP pilot. To
request a public meeting, follow the directions under ADDRESSES.
VI. Materials in the Docket
An official docket was established for this VCCEP pilot evaluation
under docket ID number EPA-HQ-OPPT-2006-0341. The docket includes
information considered by EPA in developing this notice such as the
documents specifically referenced in this action, any public comments
received, and other information related to this action. In addition,
interested parties should consult documents that are referenced in the
documents that EPA has placed in the public docket, regardless of
whether these referenced documents are physically located in the public
docket. For assistance in locating documents that are referenced in
documents that EPA has placed in the public docket, but that are not
physically located in the docket, please consult the technical contact
listed under FOR FURTHER INFORMATION CONTACT. The public docket is
available for review as specified under ADDRESSES.
1. EPA. Voluntary Children's Chemical Evaluation Program. Federal
Register (65 FR 81700, December 26, 2000) (FRL-6758-5). Available on-
line at: http://www.epa.gov/chemrtk/vccep/pubs/ts00274d.pdf.
2. EPA. Methodology for Selecting Chemicals for the Voluntary
Children's Chemical Evaluation Program (VCCEP) Pilot. December 5, 2000.
Available on-line at: http://www.epa.gov/chemrtk/vccep/vccepmth.htm.
List of Subjects
Environmental protection, Chemicals, Child health.
Dated: November 9, 2006.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E6-19574 Filed 11-17-06; 8:45 am]
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