[Federal Register Volume 64, Number 165 (Thursday, August 26, 1999)]
[Notices]
[Pages 46673-46677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22203]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-00274; FRL-6089-1]
Voluntary Children's Health Chemical Testing Program, Initiation
of a Stakeholder Involvement Process; Notice of Public Meetings
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA will hold three public meetings to involve stakeholders in
the design and development of a voluntary program to test commercial
chemicals to which children may have a high likelihood of exposure. The
purpose of the voluntary testing program is to obtain toxicity data
needed to assess the risk of childhood exposure to commercial
chemicals. At the kickoff meeting, stakeholders will have an
opportunity to give their reactions, either as individuals or as
representatives of organizations, to EPA's preliminary thoughts on
criteria and considerations that could be used to select chemicals for
testing and the test battery. Stakeholders will also have an
opportunity to provide their views on new or alternative approaches
that might be used in this program. EPA is also interested in obtaining
stakeholder input on the key design features of a voluntary testing
program that could be used to gather the needed test data. Two
subsequent meetings of the Stakeholder Involvement Process will be
organized around sets of invited participants which will separately
discuss with EPA the different issues related to the voluntary testing
program. The two subsequent meetings will also be public meetings and
there will be an opportunity for public comment at the conclusion of
each discussion between the invited participants and EPA. The
information which is developed in the course of this process in the
interest of developing a voluntary testing program may also be
considered in the development of a possible test rule under section 4
of the Toxic Substances Control Act (TSCA).
DATES: The kickoff meeting of the Stakeholder Involvement Process will
be held from 9 a.m. to 5 p.m. on September 22, 1999, and from 9 a.m. to
12 noon on September 23, 1999. This public meeting will be followed by
two subsequent meetings currently scheduled for November 30-December 1,
1999, and January 19-20, 2000. These will be the dates unless a Federal
Register document is published changing the dates or canceling the
[[Page 46674]]
meetings. The dates will also be confirmed on the website at http://
www.epa.gov/chemrtk/childhlt.htm.
Those who have pre-registered to attend the kickoff meeting, may
also pre-register to present oral comments at the meeting by September
10, 1999.
Comments, identified by docket control number OPPTS-00274, must be
received on or before September 21, 1999.
ADDRESSES: The kickoff meeting will be held at the Swissotel
Washington, The Watergate, 2650 Virginia Ave., NW., Washington, DC.
To pre-register to attend the kickoff meeting or to present oral
comments at the meeting, contact the technical person listed in the
``FOR FURTHER INFORMATION CONTACT'' section.
Comments may be submitted by mail, electronically, or in person.
Please follow the detailed instructions for each method as provided in
Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPPTS-00274 in the subject line on the first page of
your response.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Christine Augustyniak, Environmental Assistance Division (7408), Office
of Pollution Prevention and Toxics, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460; telephone number: (202) 260-3949;
e-mail address: augustyniak.christine@epa.gov.
For technical information or to pre-register to attend or to
present oral comments at the kickoff meeting contact: Ward Penberthy,
Chemical Control Division (7405), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC
20460; telephone number: (202) 260-0508; e-mail address:
chemrtk@epamail.epa.gov. Electronic messages should reference the
Voluntary Children's Health Chemical Testing Program, Stakeholder
Involvement Process as their subject. When pre-registering to present
oral comments, please indicate the public comment session to which your
comments are most relevant (see tentative agenda for the kickoff
meeting provided on the website at http://www.epa.gov/chemrtk/
childhlt.htm under ``Meeting Information'').
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 interest to those persons who are or may be required to
conduct testing of chemical substances under TSCA section 4,
individuals or groups concerned with chemical testing and children's
health, animal welfare groups, or other members of the general public .
Since various individuals or groups may 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 this
action, please consult the person listed in the ``FOR FURTHER
INFORMATION CONTACT'' section.
B. How Can I Get Additional Information, Including Copies and Other
Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
To access the ``Background Information Document'' (Ref. A),
additional information about the stakeholder meetings, as well as
obtain an electronic copy of this document, you may go directly to the
website at http://www.epa.gov/chemrtk/childhlt.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPPTS-00274. The official
record consists of the documents specifically referenced in this
action, as well as the documents listed as references in the
``Background Information Document'' (Ref. A). The official record also
consists of any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as confidential business information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available
for inspection in the TSCA Nonconfidential Information Center, North
East Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The
Center is open from noon to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Center is (202) 260-7099.
C. How and to Whom do I Submit Written Comments on this Notice?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPPTS-00274 in the subject line on
the first page of your response.
1. By mail. Submit your comments to: Document Control Officer
(7407), Office of Pollution Prevention and Toxics (OPPTS),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: OPPT Document
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M
St., SW., Washington, DC. 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) 260-7093.
3. Electronically. You may submit your comments electronically by
e-mail to: oppt.ncic@epa.gov,'' or mail your computer disk to the
address identified in Unit I.C.1. of this document. Do not submit any
information electronically that you consider to be CBI. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on standard disks in WordPerfect 5.1/6.1 or ASCII file format.
All comments in electronic form must be identified by docket control
number OPPTS-00274. Electronic comments may also be filed online at
many Federal Depository Libraries.
D. How Should I Handle CBI that I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. Please note that, in the
absence of steps by EPA leading to disclosure, none of the information
marked ``CBI'' will be available for consideration in the Stakeholder
Involvement Process; commenters may want to consider this point in
developing their submissions. In addition to one complete version of
the comment that includes any information claimed as CBI, a copy of the
comment that does not contain the
[[Page 46675]]
information claimed as CBI must be submitted for inclusion in the
public version of the official record. Information not marked
confidential will be included in the public version of the official
record without prior notice. If you have any questions about CBI or the
procedures for claiming CBI, please consult the technical person listed
in the ``FOR FURTHER INFORMATION CONTACT'' section.
E. How Can I Request an Opportunity to Present Oral Comments to the
Agency at the Kickoff Meeting of the Stakeholder Involvement Process?
Those who have pre-registered to attend the kickoff meeting, may
also pre-register to present oral comments at the meeting by contacting
the technical person listed in the ``FOR FURTHER INFORMATION CONTACT''
section by September 10, 1999. Although this meeting is open to the
public, there may be time limitations which will restrict the number of
oral presentations which can be accommodated. Therefore, EPA strongly
encourages those who wish to present oral comments to contact EPA and
register in advance. Other presentations of oral comments will be
accommodated as time allows. When you pre-register to present oral
comments, you must identify the name of the individual who will make
the presentation, the organization (if any) the individual represents,
any requirements for audio visual equipment (e.g., overhead projector,
35mm projector, chalkboard, etc), and the public comment session to
which the comments are most relevant. The topics to be covered in the
four public comment sessions to be held during the kickoff meeting are
listed in the tentative agenda provided on the website at http://
www.epa.gov/chemrtk/childhlt.htm under ``Meeting Information.'' There
is no limit on the length of written comments, but oral comments will
be limited to 5 minutes. We encourage presenters to coordinate their
oral comments with others as appropriate. When pre-registering, please
inform the technical person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section of your plans to coordinate presentations. You are
requested to provide at least 35 written copies of your oral statement
by the date of the meeting. It is encouraged that you bring copies
sufficient for the number of people who plan to attend the kickoff
meeting; this number will be available on the website at http://
www.epa.gov/chemrtk/childhlt.htm under ``Meeting Information'' several
days before the meeting date. These written statements will become a
part of the public version of the official record.
F. What Should I Consider as I Prepare My Comments for EPA?
EPA invites you to provide your views on the general approach
presented in the ``Background Information Document'' cited in Unit I.B.
and discussed in Unit II. of this notice. EPA also invites your views
new approaches that have not been considered, the potential benefits or
impacts of these various approaches (including possible unintended or
unidentified benefits or impacts), and any other data or information
that you would like the Agency to consider in the development of a
voluntary testing program via the stakeholder process. You may find the
following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide specific technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate. If you estimate potential benefits or burden
reductions (e.g., attributable to a voluntary program), explain how you
arrived at the estimate.
5. Provide specific examples to illustrate the key points which
underlie your views regarding benefits and impacts.
6. Offer alternative ways to improve the voluntary testing program.
7. Make sure to submit your comments by the deadline in this
notice.
8. At the beginning of your comments (e.g., as part of the
``Subject'' heading), be sure to properly identify the document you are
commenting on. You can do this by providing the docket control number
assigned to the notice (OPPTS-00274), along with the name, date, and
Federal Register citation.
G. Are There Issues on Which EPA is Particularly Interested in
Receiving Comment?
EPA encourages interested parties to submit comments on chemical
testing which are relevant to children's health and any aspect of this
notice. Commenters are encouraged to identify other criteria for
identifying children's exposure to commercial chemicals, such as
bioavailability, and additional relevant data sources, especially as
they relate to use in consumer products. Comments on the test battery
previously submitted to EPA's Scientific Advisory Panel (SAP) need not
be resubmitted.
II. Background Information Document
EPA has prepared a document entitled ``Background Information on
the Children's Health Chemical Testing Program'' (Ref. A), which is
referred to in this notice as the ``Background Information Document.''
The ``Background Information Document'' describes the history of this
program, EPA's preliminary thoughts on criteria and considerations that
could be used to select chemicals for testing and the test battery, and
how the test data would be used. The ``Background Informaton Document''
and a list of its references are provided on the website at http://
www.epa.gov/chemrtk/childhlt.htm. A paper copy of the ``Background
Information Document'' and each of its references are available in the
public version of the official record, OPPTS-00274, which is located at
the address provided in Unit I.B.2. of this notice.
III. Voluntary Testing Program
Although EPA has the authority to require manufacturers and
processors to conduct toxicity testing of chemicals for which certain
findings have been made under section 4 of TSCA, before proposing such
a section 4 test rule, EPA wants to first provide the opportunity for
stakeholders including manufacturers, processors, and a wide variety of
interested parties to participate in the development of a testing
program which involves conducting such testing voluntarily. EPA
believes that the involvement of industry and other stakeholders in the
early stages of the development of this testing program can promote
cooperation, expedite the testing process, and benefit everyone
concerned. On May 24, 1999, EPA took an initial step toward developing
a voluntary testing program by meeting with representatives from a
range of organizations with an interest in children's health issues and
toxicity testing. This group discussed the use and possible operating
features of a stakeholder involvement process to develop a voluntary
chemical testing program and the issues that might be appropriate for
consideration. In light of these discussions, EPA has determined that
stakeholder meetings might be helpful on such topics as the criteria
and data sources for chemical selection, the test battery, and the
design of the voluntary testing program. The meeting also produced a
list of organizations which may have an interest in a stakeholder
involvement process.
Since the May 1999 meeting, EPA has secured a professional
facilitator to help convene and manage a stakeholder
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involvement process. The facilitator has prepared a document entitled
``Preliminary Findings and Recommendations: Voluntary Children's Health
Testing Program Stakeholder Involvement Process'' (Ref. B) to better
define the approach that will be taken to initiate discussion. The
document is available on the website at http://www.epa.gov/chemrtk/
childhlt.htm.
IV. Stakeholder Involvement Process
EPA has considered a number of sources of chemicals to which
children may be exposed, but realizes that the wide range of parties
interested in children's health is a resource which should be fully
utilized to identify candidate chemicals for this testing program.
Using a stakeholder involvement process, EPA intends to bring together
and obtain input from knowledgeable individuals who represent parties
that would be affected by any forthcoming testing program, i.e.
stakeholders. These stakeholders would include child health advocates,
pediatricians, chemical manufacturers and processors, trade
associations, Federal agencies, State health departments, and animal
welfare advocates. The stakeholders will have an equal opportunity to
present their viewpoints at the kickoff meeting of the Stakeholder
Involvement Process.
Due to possible time limitations, those wishing to present oral
comments at the kickoff meeting are advised to pre-register with the
technical person listed in the ``FOR FURTHER INFORMATION CONTACT''
section and follow the instructions in Unit I.E. of this document. Oral
comments will be limited to 5 minutes and copies of your statement must
be provided as explained in Unit I.E. of this document. We encourage
presenters to coordinate their oral comments with others as
appropriate. When pre-registering, please inform the technical person
listed in the ``FOR FURTHER INFORMATION CONTACT'' section of your plans
to coordinate presentations. To enable as many interested parties as
possible to contribute their ideas and provide opinions, EPA plans to
have the professional facilitator lead the meeting.
Persons wishing to file written comments should follow the
instructions in Unit I.C., D., and F. of this document. There is no
limit on the length of written comments and all interested parties are
permitted to file written comments before the kickoff meeting. These
written comments, along with copies of oral statements and a summary of
the oral discussion at the meeting, will become a part of the public
version of the official record and will be considered by EPA during the
development of the voluntary testing program.
If you wish to observe the meeting but not present oral comments,
you are advised to pre-register for the meeting due to possible space
limitations. To pre-register you must identify yourself and your
organization as described in the ``FOR FURTHER INFORMATION CONTACT''
section. Seating of others at the kickoff meeting will be on a first-
come basis after those who have registered in advance of the meeting
have been accommodated.
In the two subsequent meetings, EPA believes it will be necessary
to limit the number of active participants to some extent in order to
achieve a meaningful dialogue with stakeholders. Therefore, EPA
proposes to structure each of the two subsequent meetings as three
roundtable discussions with roughly two dozen invited participants at
each discussion. EPA will identify and invite a balanced group of
individuals and organizations who are believed to represent the
interests of the various groups of stakeholders and whom it believes
will have information useful to each discussion. Each of the roundtable
discussions will address one of the three issue areas listed in Unit
V.A. of this document. Depending on the issues to be discussed, the
invited participants at each roundtable discussion may not be the same
individuals. At the conclusion of each discussion between the invited
participants and EPA, there will be an opportunity for public comment.
EPA wants to emphasize that the two subsequent meetings, like the
kickoff meeting, will be public meetings and all interested parties are
encouraged to attend. Those not specifically invited to participate in
the roundtable discussions will be given the opportunity to observe the
proceedings to the extent space allows and to present information and
opinions during solicitations of comments at the end of each
discussion.
EPA is not asking participants in the Stakeholder Involvement
Process to reach agreement or provide any collective recommendations on
the subjects under discussion or on a detailed design of a voluntary
testing program. EPA's intent is to obtain information and the
individual perspective of the participants based on their unique
experiences and background. Accordingly, EPA does not intend at this
time to organize this Stakeholder Involvement Process as an advisory
committee as defined in the Federal Advisory Committee Act, 5 U.S.C
App.
V. Stakeholder Meetings
A. Kickoff Meeting
EPA will convene the kickoff meeting of the Stakeholder Involvement
Process on September 22 and 23, 1999, at the location listed in the
``ADDRESSES'' section. At this meeting, EPA intends to orient the
stakeholders to the background and future plans and goals for this
project. In so doing, EPA will inform the stakeholders of the Agency's
initial efforts to identify the chemicals to which children and
prospective parents may be highly exposed and the testing needed to
assess the risk of that exposure. Much of this information is contained
in the ``Background Information Document'' (Ref. A) discussed in Unit
II. of this notice. EPA will then take comment on EPA's initial efforts
and also on the following main issues which EPA believes are of special
interest to stakeholders:
1. What criteria, considerations, and data sources should be used
to identify chemicals for which there is a concern for high potential
exposure to children or prospective parents? (What additional criteria
and data sources should be considered? What data sources should not be
considered?)
2. Are there any beneficial modifications which could be made to
the test battery (i.e., the battery presented to the FIFRA SAP in May
1999)?
3. What should be the key design features of this voluntary testing
program?
Comments will be presented first by those who have registered in
advance as described in the ``FOR FURTHER INFORMATION CONTACT'' section
and Unit I.E. of this document and then by others as time allows.
The tentative agenda for the kickoff meeting of the Stakeholder
Involvement Process can be found on the website at http://www.epa.gov/
chemrtk/childhlt.htm under ``Meeting Information.''
B. Subsequent Meetings
At this time, EPA intends to hold two subsequent meetings as part
of the Stakeholder Involvement Process. At these meetings, invited
participants will have roundtable discussions with EPA on the main
issues listed in Unit V.A. of this document. At the first of these
meetings, EPA will also propose an outline of a chemical testing
program which EPA will develop based on the comments presented at the
kickoff meeting and written comments submitted according to the
instructions in Unit I.C., D., and F. of this document. This outline of
a chemical testing
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program will serve as a ``strawman'' proposal, which EPA will make
available prior to the second meeting. EPA expects the ``strawman''
proposal and proposals submitted by other groups to be a major subject
of comment at the roundtable discussions at both of the subsequent
meetings. At the end of each roundtable discussion, comments will also
be solicited from other stakeholders attending the meeting as described
in Unit IV. of this document.
The tentative dates for the two subsequent meetings are November
30-December 1, 1999 and January 19-20, 2000. These will be the dates
unless a Federal Register document is published changing the dates or
canceling the meetings. The dates will also be confirmed on the website
at http://www.epa.gov/chemrtk/childhlt.htm. All meetings will be held
in the Washington, DC area and will be open to the public. Summaries of
the meetings will be placed in the public record, OPPTS-00274.
VI. Public Record
At this time, the public record version of the official record
contains the following:
A. United States Environmental Protection Agency (USEPA).
``Background Information on the Children's Health Chemical Testing
Program.'' Prepared by Chemical Information and Testing Branch,
Chemical Control Division, Office of Pollution Prevention and Toxics
(August 19, 1999).
B. Meridian Institute and The Keystone Center. ``Preliminary
Findings and Recommendations: Voluntary Children's Health Testing
Program Stakeholder Involvement Process.'' Prepared by Tim Mealey and
Paul De Morgan for the USEPA and other interested stakeholders (July
30, 1999).
List of Subjects
Environmental protection, Chemicals, Children, Hazardous
substances, Heath and safety.
Dated: August 20, 1999.
Susan H. Wayland,
Deputy Assistant Administrator for Prevention, Pesticides and Toxics.
[FR Doc. 99-22203 Filed 8-23-99; 4:11 pm]
BILLING CODE 6560-50-F
