Document ID: EPA-HQ-OPPT-2006-0341-0001
Agency: epa
Document Type: Notice
Title: Implementation of the Pilot Voluntary Childrens Chemical Evaluation Program; Request for Comment
Posted Date: 2006-11-20T05:00Z

[Federal Register: November 20, 2006 (Volume 71, Number 223)]
[Notices]               
[Page 67121-67124]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20no06-53]                         

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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: roman.catherine@epa.gov.
     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: TSCA-Hotline@epa.gov.
    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: 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), 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

[[Page 67123]]

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:

------------------------------------------------------------------------
                                              Number of chemicals which
       Stages in the VCCEP  Process           have completed each stage
------------------------------------------------------------------------
Sponsor commitment to provide Tier 1        20
 information
------------------------------------------------------------------------
Tier 1 chemical assessment submitted        12 *
------------------------------------------------------------------------
Tier 1 chemical assessment has gone         12
 through Peer Consultation
------------------------------------------------------------------------
Peer Consultation report available          12
------------------------------------------------------------------------
EPA issued a Data Needs Decision            6
(3 chemicals had Tier 2 data needs, 3
 chemicals did not have Tier 2 data
 needs.).
------------------------------------------------------------------------
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
------------------------------------------------------------------------
* 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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