[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: [email protected].
    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: 
[email protected]. 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: ``[email protected],'' 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

[[Page 46676]]

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