Voluntary Children's Health Chemical Testing Program, Stakeholder Involvement Process; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA will hold a third public meeting to involve stakeholders in the design and development of a voluntary program to ensure that test data are publicly available for industrial chemicals to which children and prospective parents may have a high likelihood of exposure. The purpose of the voluntary testing program is to obtain data needed to assess the potential health risk of chemical exposure to children and prospective parents. At this meeting, stakeholders will have an opportunity to give their reactions to EPA's revised Framework Document for a testing program either as individuals or as representatives of organizations.

DATES:

The meeting will be held on April 26 and 27, 2000, from 9 a.m. to 5 p.m. Requests to pre-register for the meeting must be received on or before April 21, 2000. Written comments on the Framework Document, identified by docket control number OPPTS-00274B, must be received on or before May 12, 2000.

ADDRESSES:

The meeting will be held at the National Rural Electric Cooperative Association (NRECA) Conference Center at 4301 Wilson Boulevard, Arlington, VA.; telephone number: (703) 907-5500. Requests to pre-register for the meeting should be directed to the technical person listed under FOR FURTHER INFORMATION CONTACT. Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.D. To ensure proper receipt by EPA, your comments must identify docket control number OPPTS-00274B in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Barbara Cunningham, Director, Office Program Management and Evaluation (7401), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

For technical information contact: Ward Penberthy, Chemical Control Division (7405), OPPT, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 260-0508; e-mail address: chem.rtk@epamail.epa.gov. Electronic messages must identify docket control number OPPTS-00274B and the heading, “Voluntary Children's Health Chemical Testing Program, Stakeholder Involvement Process,” in the subject line on the first page of your message.

SUPPLEMENTARY INFORMATION:

I. General Information:

A. Does this Notice Apply To Me?

This action is directed to the public in general. This action may, however, be of interest to those chemical manufacturers and processors who are or may be required to conduct testing of chemical substances under section 4 of the Toxic Substances Control Act (TSCA), individuals or groups concerned with chemical testing and children's health, animal welfare groups, or other members of the general public. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document or 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 revised Framework Document, additional information about the third stakeholder meeting, an electronic copy of this document, or information on the first and second stakeholder meetings, you may go directly to the website at http://www.epa.gov/chemrtk/childhlt.htm. The Framework Document and the meeting agenda should be on this website by April 12, 2000.

2. In person. The Agency has established an official record for this meeting under docket control number OPPTS-00274B. The official record consists of the documents specifically referenced in this notice, any public comments received during an applicable comment period, and other information related to the Voluntary Children's Health Chemical Testing Program, 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, which includes printed, paper versions of any electronic comments that may be submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, 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 of the Center is (202) 260-7099.

3. By telephone. If you need additional information about this action, you may also contact the persons identified under FOR FURTHER INFORMATION CONTACT.

A copy of the Framework Document may be obtained by calling the TSCA Hotline at (202) 554-1404. A request to the TSCA Hotline can be made before April 12, 2000, but cannot be filled until April 12, 2000.

C. How Can I Pre-register for this Meeting?

You may request to pre-register for this meeting through the mail, by phone, or electronically. Direct your request to the technical person listed under FOR FURTHER INFORMATION CONTACT. Your request must be received by EPA on or before April 20, 2000, and must identify yourself, your organization, and a telephone number or e-mail address where you may be reached. To ensure proper receipt by EPA, you must identify docket control number OPPTS-00274B and the heading, “Voluntary Children's Health Chemical Testing Program, Stakeholder Involvement Process,” in the subject line of the first page of your request.

D. How and to Whom Do I Submit Comments?

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-00274B in the subject line on the first page of your response.

1. By mail. Submit your comments to: Document Control Office (7407), OPPT, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 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 above. 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 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-00274B. Electronic comments may also be filed online at many Federal Depository Libraries.

E. How Should I Handle CBI Information 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 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 under FOR FURTHER INFORMATION CONTACT.

F. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the general approach presented in the “Framework Document” cited in Unit I.B. and discussed in Units II. and III. EPA also invites your views on new approaches we have not considered, the potential benefits or impacts of these various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during 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 copies of any 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 that you provide.

5. Provide specific examples to illustrate your concerns 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. To ensure proper receipt by EPA, be sure to identify the docket control number OPPTS-00274B in the subject line on the first page of your response. You may also provide 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 toxicity testing and exposure information 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 industrial chemicals and additional relevant data sources. Comments on the test battery previously submitted to EPA's Scientific Advisory Panel (SAP) need not be resubmitted.

II. Background

EPA is holding a series of public meetings to involve stakeholders in the design and development of a voluntary program to ensure that toxicity test data and exposure information on industrial chemicals to which children and prospective parents may have a high likelihood of exposure are made publicly available. The toxicity and exposure data developed by the voluntary program will be used to assess the potential health risk to children and prospective parents associated with that chemical exposure. EPA is using a stakeholder involvement process to bring together and obtain the individual opinions of knowledgeable persons who represent parties that could be affected by any forthcoming program. The stakeholders that have provided their opinions so far include child health advocates, pediatricians, chemical manufacturers and processors, trade associations, Federal agencies, and animal welfare advocates. In the Federal Register notice announcing the stakeholder involvement process published in the Federal Register of August 26, 1999 (64 FR 46673) (FRL-6089-1), EPA identified three issues on which the Agency would like to receive stakeholder input. These included:

1. Which chemicals should be tested?

2. Which tests should be used?

3. How should the program be implemented?

At the kickoff meeting held September 22, 1999, EPA oriented the stakeholders to the background and future plans and goals for this project. EPA informed 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. EPA then took comment on its initial efforts and on other issues which were of special interest to stakeholders. Also at the kickoff meeting, the Chemical Manufacturers Association (CMA) announced that its members had developed a voluntary testing program which would conduct the same testing contemplated by EPA but in three tiers and with hazard and exposure triggers. A summary of this meeting and the text of most of the presentations are available to the public; to access this information, see instructions provided in Units I.B.1. and I.B.2.

Following the first meeting, EPA initially developed a Framework Document which described how a voluntary program could be structured. The Framework Document addressed how chemicals could be selected for the program and how tests could be tiered and triggered. In mid November 1999, EPA released the Framework Document as a “strawman” proposal and announced it would be a major point of discussion at the second public stakeholder meeting on November 30-December 1, 1999. For the second stakeholder meeting, EPA invited participants from diverse stakeholder interests to participate in roundtable discussions with EPA. EPA had asked stakeholders to participate in the selection of the invited participants via a Nomination Process which had been announced at the first meeting and on the website: http://www.epa.gov/chemrtk/nominate.htm. EPA did not ask the invited participants to reach agreement or provide any collective recommendations. EPA's intent was to obtain information about their individual perspectives based on their unique experiences and background. Accordingly, EPA did not organize the stakeholder involvement process as an advisory committee as defined in the Federal Advisory Committee Act, 5 U.S.C. App. Although the meeting was centered around the discussions between EPA and the invited participants, this was a public meeting that other stakeholders and members of the public could attend and, at the conclusion of each discussion, present their opinions to the group. The primary focus of the second meeting was the Framework Document and how tiered testing and triggers could best be used to obtain needed toxicity data. A summary of this meeting is available to the public; to access this information, see instructions provided in Units I.B.1. and I.B.2.

III. Public Stakeholder Meeting

The third public meeting of the Stakeholder Involvement Process will be held April 26-27, 2000. This meeting will follow the format of the second meeting in which invited participants and EPA representatives discuss the issues of concern to stakeholders. EPA is preparing a revised Framework Document to reflect EPA's current thinking on how the voluntary program could be structured to meet EPA's objective of obtaining needed data to ensure that toxicity test data and exposure information are made publicly available. This Document will be the major focus of discussion at the third meeting, as it will serve as a second “strawman” proposal. The revised Framework Document and the meeting agenda will be made available by April 12, 2000. Instructions for obtaining a copy of the Framework Document are provided in Unit I.B. Instructions for obtaining the meeting agenda are provided in Units I.B.1. and I.B.2.

The meeting will be an open public meeting. As such, there will be opportunities for public comment from anyone who wishes to provide oral comments at the conclusion of each roundtable discussion between the invited participants and EPA. Oral comments from the public may be limited to 5 minutes to allow all those who wish to comment a chance to speak. Commenters with prepared statements are requested to provide at least 35 written copies of their statements. It is encouraged that commenters bring copies sufficient for the number of people who plan to attend the meeting; this number will be under “Meeting Information” on website www.epa.gov/chemrtk/childhlt.htm several days before the meeting. The written statements will become a part of the public version of the official record. To enable as many interested parties as possible to contribute their ideas and provide opinions, EPA plans to have a professional facilitator lead the meeting.

Although this is a public meeting, there may be space limitations. Therefore, EPA encourages those who wish to attend to register in advance by following the instructions in Unit I.C. Seating of others at the meeting will be on a first-come basis after those who have registered in advance of the meeting have been accommodated.

In addition to the opportunity to present oral comments at the meeting, the public may also submit written comments on the Framework Document. In order to provide sufficient time for persons interested in responding in writing, including those persons unable to attend the public meeting, the Agency will accept such comments until May 12, 2000. Instructions for submitting written comments are provided in Unit I.D.

The purpose of the meeting is for EPA to obtain information and the individual perspectives of the invited participants and the public. EPA is not asking the roundtable participants to reach agreement or provide any collective recommendations. Accordingly, EPA does not intend to organize the stakeholder involvement process as an advisory committee as defined in the Federal Advisory Committee Act, 5 U.S.C. App. The information which is obtained in the course of this process may also be considered in the development of a possible test rule under TSCA section 4.

List of Subjects

• Environmental protection
• Chemicals
• Children
• Hazardous substances
• Health and safety