Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting, 67700-67702 [05-22229]

Download as PDF 67700 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. Abstract: Section 12(b)(2) of TSCA requires that any person who exports or intends to export to a foreign country a chemical substance or mixture that is regulated under TSCA sections 4, 5, 6, and/or 7 submit to EPA notification of such export or intent to export. Upon receipt of notification, EPA will advise the government of the importing country of the U.S. regulatory action with respect to that substance. EPA uses the information obtained from the submitter via this collection to advise the government of the importing country. Responses to the collection of information are mandatory (see 40 CFR part 707). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. III. What are EPA’s Burden and Cost Estimates for this ICR? Under PRA, ‘‘burden’’ means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this collection of information is estimated to be about 0.878 hours per response. The following is a summary of the estimates taken from the ICR: Respondents/affected entities: Companies that export from the United States to foreign countries or that engage VerDate Aug<31>2005 16:11 Nov 07, 2005 Jkt 208001 in wholesale sales of chemical substances or mixtures. Estimated total number of potential respondents: 350. Frequency of response: Annually. Estimated total/average number of responses for each respondent: 25. Estimated total annual burden hours: 7,550 hours. Estimated total annual burden costs: $382,130. IV. Are There Changes in the Estimates from the Last Approval? There is an increase of 100 hours (from 7,450 hours to 7,550 hours) in the total estimated respondent burden compared with that identified in the information collection request most recently approved by OMB. This increase represents the net effect of an increase in the estimated number of notices sent to EPA and a decrease in the number of firms sending notices, based on EPA’s recent experiences with TSCA section 12(b) notices. This increase is an adjustment. V. What is the Next Step in the Process for this ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT. List of Subjects Environmental protection, Reporting and recordkeeping requirements. Dated: October 18, 2005. Susan B. Hazen, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. 05–22253 Filed 11–7–05; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [OPPT–2005–0054; FRL–7744–2] Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 SUMMARY: There will be a meeting of the Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) on November 30 through December 2, 2005, in Raleigh, NC. This meeting, as with all EDMVAC meetings, is open to the public. Seating is on a first-come basis. The purpose of the meeting is to receive advice and input from the EDMVAC on: EPA’s Applied Approach to Validation, OECD Uterotrophic Peer Review Report, Steroidogenesis Using the H295R Cell Line, Avian Studies, and an update on the Pubertal Assays. DATES: The meeting will be held on Wednesday, November 30, 2005, from 8 a.m. to 5 p.m.; Thursday, December 1, 2005, from 8:30 a.m. to 5 p.m.; and Friday, December 2, 2005, from 8:30 a.m. to noon, eastern standard time. Request to attend and/or make public comments in the meeting must be received by EPA on or before November 28, 2005. Individuals requiring special accommodations at the meeting, including wheelchair access, should contact the person listed under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to the meeting. ADDRESSES: The meeting will be held at the Holiday Inn Brownstone Hotel and Conference Center, 1707 Hillsborough St., Raleigh, NC 27605; telephone number: (919) 828–0811; e-mail:https:// www.brownstonehotel.com Requests to attend and/or make public comments in the meeting may be submitted by e-mail, telephone, fax, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. Comments may be submitted electronically, by fax, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Jane Smith, Designated Federal Official (DFO), Office of Science Coordination and Policy (7203M), Office of Prevention, Pesticides and Toxic Substances (OPPTS), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (202) 564– 8476; fax number: (202) 564–8482; email address: smith.jane-scott@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 interest if you produce, manufacture, E:\FR\FM\08NON1.SGM 08NON1 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices use, consume, work with, or import pesticide chemicals and other substances. To determine whether you or your business may have an interest in this notice you should carefully examine section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996 (Public Law 104–170), 21 U.S.C. 346a(p), and amendments to the Safe Drinking Water Act (SDWA) (Public Law 104–182), 42 U.S.C. 300j–17. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPPT–2005–0054. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other related information. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that are available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566–1744, and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is (202) 566–0282. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr/. A meeting agenda, a list of EDMVAC members and information from previous EDMVS meetings are available electronically, from the EPA Internet Home Page at https://www.epa.gov/scipoly/oscpendo/. An electronic version of the public docket is available through EPA’s electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at https://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public VerDate Aug<31>2005 16:11 Nov 07, 2005 Jkt 208001 docket that are available electronically. Once in the system, select ‘‘search,’’ then key in the appropriate docket ID number. C. How Can I Request to Attend the Meeting or Submit Comments? You may submit a request to attend and/or make public comments in the meeting through e-mail, telephone, fax, or hand delivery/courier. We would normally accept requests by mail, but in this time of delays in delivery of government mail due to health and security concerns, we cannot assure your request would arrive in a timely manner. Do not submit any information in your request that is considered CBI. Your request must be received by EPA on or before Novemer 28, 2005. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT–2005–0054 in the subject line on the first page of your request. In accordance with the Federal Advisory Committee Act (FACA), the public is encouraged to submit written comments on the topic of this meeting. The EDMVAC will have a period available during the meeting for public comment. It is the policy of the EDMVAC to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EDMVAC expects that public statements presented at its meeting will be on the meeting topic and not be repetitive of previously submitted oral or written statements. 1. Electronically. If you submit an electronic request to attend and/or make public comments in the meeting or comments as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your request or comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the request or comment and allows EPA to contact you in case EPA cannot read your request or comment due to technical difficulties or needs further information on the substance of your request or comment. EPA’s policy is that EPA will not edit your request or comment, and any identifying or contact information provided in the body of a request or comment will be included as part of the request or comment that is placed in the official public docket, and made available in EPA’s electronic public docket. If EPA cannot read your request or comment due to technical difficulties and cannot contact you for clarification, PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 67701 EPA may not be able to consider your request or comment. i. EPA Docket. You may use EPA’s electronic public dockethttps:// www.epa.gov/edocket/, and follow the online instructions for submitting materials. Once in the system, select ‘‘search,’’ and then key in docket ID number OPPT–2005–0054. The system is an ‘‘anonymous access’’ system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your request. ii. E-mail. Requests to attend and/or make public comments in the meeting or comments may be sent by e-mail to oppt.ncic@epa.gov, Attention: Docket ID Number OPPT–2005–0054. In contrast to EPA’s electronic public docket, EPA’s e-mail system is not an ‘‘anonymous access’’ system. If you send an e-mail request directly to the docket without going through EPA’s electronic public docket, EPA’s e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA’s e-mail system are included as part of the request that is placed in the official public docket, and made available in EPA’s electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM by hand delivery, courier, or package service, such as Federal Express, to the person listed under FOR FURTHER INFORMATION CONTACT. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. Do not submit any disk or CD ROM through the mail. Disks and CD ROMs risk being destroyed when handled as Federal Government mail. 2. Telephone or fax. Telephone or fax your request to participate in the meeting to the person listed under FOR FURTHER INFORMATION CONTACT. 3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201 Constitution Ave., Washington, DC. Attention: Docket ID Number OPPT–2005–0054. 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. II. Background In 1996, through enactment of FQPA, which amended the FFDCA, Congress directed EPA to develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an E:\FR\FM\08NON1.SGM 08NON1 67702 Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate. In 1996, EPA chartered a scientific advisory committee, the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), under the authority of FACA, to advise it on establishing a program to carry out Congress’ directive. EDSTAC recommended a multi-step approach including a series of screens (Tier I screens) and tests (Tier II tests) for determining whether a chemical substance may have an effect similar to that produced by naturally occurring hormones. EPA adopted almost all of EDSTAC’s recommendations in the program that it developed, the Endocrine Disruptor Screening Program (EDSP), to carry out Congress’ directive. EPA is in the process of developing and validating the screens and tests that EDSTAC recommended for inclusion in the EDSP. In carrying out this validation exercise, EPA is working closely with the Interagency Coordinating Committee for the Validation of Alternate Methods (ICCVAM) and other validation groups, as appropriate. EPA also is working closely with the Organization for Economic Cooperation and Development’s (OECD) Endocrine Testing and Assessment Task Force to validate and harmonize endocrine screening tests of international interest. Finally, to ensure that EPA has the best and most up-to-date advice available regarding the validation of the screens and tests in the EDSP, EPA chartered the Endocrine Disruptor Methods Validation Subcommmittee (EDMVS) of the National Advisory Council for Environmental Policy and Technology (NACEPT). The EDMVS convened nine meetings between October 2001 and December 2003. In 2003, NACEPT recommended EDMVS become an Agency level 1 FACA Committee due to the complexity of the recommendations. The EDMVAC was chartered in 2004. The EDMVAC provides independent advice and counsel to the Agency on scientific and technical issues related to validation of the EDSP Tier I screens and Tier II tests, including advice on methods for reducing animal use, refining procedures involving animals to make them less stressful, and replacing animals where scientifically appropriate. EDMVAC and previous EDMVS meeting information and corresponding docket numbers are available electronically, from the EPA Internet Home Page at https:// www.epa.gov/scipoly/oscpendo/. You may also go to the EPA Docket at https:// VerDate Aug<31>2005 16:11 Nov 07, 2005 Jkt 208001 www.epa.gov/edocket/, and follow the online instructions for submitting materials. III. Meeting Objectives for the November 30–December 2, 2005 Meeting The objectives for the November 30 through December 2, 2005 meeting (docket ID number OPPT–2005–0054) are to review and discuss: EPA’s Applied Approach to Validation, Uterotrophic (Tier I Assay, OECD) Peer Review Report, Steriodgenesis (Tier I Assay) Using the H295R Cell Line, Avian 2–Generation (Tier II Assay, OECD) and receive an update on the Pubertal (Tier I) Assays. A list of the EDMVAC members and meeting materials are available at https:// www.epa.gov/scipoly/oscpendo/ and in the public docket. List of Subjects Environmental protection, Endocrine disruptors, Hazardous substances, Health, Safety. Dated: October 27, 2005. Clifford Gabriel, Director, Office of Science Coordination and Policy. [FR Doc. 05–22229 Filed 11–7–05; 8:45 am] BILLING CODE 6560–50–S I. General Information ENVIRONMENTAL PROTECTION AGENCY [OPPT–2005–0008; FRL–7741–5] Workshops on How to Report for the 2006 Inventory Update Rule (IUR) Information Collection - Fall 2005; Notice of Public Meeting Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: The EPA is convening two public workshops to provide training for affected parties responsible for reporting during the 2006 Inventory Update Rule information collection. The workshops will focus on the Instructions for Reporting, industry case studies, and submission of IUR data over the internet. The Instructions for Reporting were revised in response to amendments to 40 CFR Part 710 promulgated on January 7, 2003. These workshops are open to the public. DATES: Each workshop will take place over 1 day. These workshops will begin at approximately 8:30 a.m. and end at 4:30 p.m. The workshops will be held in Fall 2005: Washington, DC (December 5); Los Angeles, CA (December 12). PO 00000 Frm 00045 Fmt 4703 Persons planning to attend the workshops are directed to the IUR website @ www.epa.gov/oppt/iur/. This website contains workshop information, as well as IUR background information, draft documents, and a link to the workshop registration site. All workshop materials can be downloaded from the IUR website or the EPA electronic docket www.epa.gov/edocket (Docket Identification Number: OPPT– 2005–0008) in portable document format (PDF). 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 number: (202) 554–1404; e-mail address: TSCA-Hotline@epa.gov. For technical information contact: Franklyn Hall, Economics, Exposure and Technology Division (7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 20460–0001; telephone number: (202) 564–8522; email address: hall.franklyn@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: Sfmt 4703 A. Does this Action Apply to Me? You may be potentially affected by this action if you manufacture chemical substances currently subject to reporting under the Inventory Update Rule (IUR) as amended on January 7, 2003 and codified as 40 CFR part 710. Persons who process chemical substances but who do not manufacture or import chemical substances are not required to comply with the requirements of 40 CFR part 710. Potentially affected entities may include, but are not limited to: • Chemical manufacturers and importers currently subject to IUR reporting, including manufacturers and importers of inorganic chemical substances (NAICS codes 325, 32411). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions at 40 CFR 710.48. If you have any E:\FR\FM\08NON1.SGM 08NON1

Agencies

[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67700-67702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22229]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2005-0054; FRL-7744-2]


Endocrine Disruptor Methods Validation Advisory Committee 
(EDMVAC); Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: There will be a meeting of the Endocrine Disruptor Methods 
Validation Advisory Committee (EDMVAC) on November 30 through December 
2, 2005, in Raleigh, NC. This meeting, as with all EDMVAC meetings, is 
open to the public. Seating is on a first-come basis. The purpose of 
the meeting is to receive advice and input from the EDMVAC on: EPA's 
Applied Approach to Validation, OECD Uterotrophic Peer Review Report, 
Steroidogenesis Using the H295R Cell Line, Avian Studies, and an update 
on the Pubertal Assays.

DATES: The meeting will be held on Wednesday, November 30, 2005, from 8 
a.m. to 5 p.m.; Thursday, December 1, 2005, from 8:30 a.m. to 5 p.m.; 
and Friday, December 2, 2005, from 8:30 a.m. to noon, eastern standard 
time. Request to attend and/or make public comments in the meeting must 
be received by EPA on or before November 28, 2005.
    Individuals requiring special accommodations at the meeting, 
including wheelchair access, should contact the person listed under FOR 
FURTHER INFORMATION CONTACT at least 5 business days prior to the 
meeting.

ADDRESSES: The meeting will be held at the Holiday Inn Brownstone Hotel 
and Conference Center, 1707 Hillsborough St., Raleigh, NC 27605; 
telephone number: (919) 828-0811; e-mail:https://www.brownstonehotel.com
    Requests to attend and/or make public comments in the meeting may 
be submitted by e-mail, telephone, fax, or through hand delivery/
courier. Follow the detailed instructions as provided in Unit I. of the 
SUPPLEMENTARY INFORMATION.
    Comments may be submitted electronically, by fax, or through hand 
delivery/courier. Follow the detailed instructions as provided in Unit 
I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Designated Federal 
Official (DFO), Office of Science Coordination and Policy (7203M), 
Office of Prevention, Pesticides and Toxic Substances (OPPTS), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8476; fax 
number: (202) 564-8482; e-mail address: smith.jane-scott@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 interest if you produce, manufacture,

[[Page 67701]]

use, consume, work with, or import pesticide chemicals and other 
substances. To determine whether you or your business may have an 
interest in this notice you should carefully examine section 408(p) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act (FQPA) of 1996 (Public Law 104-170), 21 
U.S.C. 346a(p), and amendments to the Safe Drinking Water Act (SDWA) 
(Public Law 104-182), 42 U.S.C. 300j-17. Since other entities may also 
be interested, the Agency has not attempted to describe all the 
specific entities that may be interested in this action. If you have 
any questions regarding this action, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPPT-2005-0054. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
related information. Although a part of the official docket, the public 
docket does not include Confidential Business Information (CBI) or 
other information whose disclosure is restricted by statute. The 
official public docket is the collection of materials that are 
available for public viewing at the EPA Docket Center, Rm. B102-Reading 
Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA 
Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The EPA Docket Center Reading Room 
telephone number is (202) 566-1744, and the telephone number for the 
OPPT Docket, which is located in the EPA Docket Center, is (202) 566-
0282.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr/. A meeting agenda, a list of 
EDMVAC members and information from previous EDMVS meetings are 
available electronically, from the EPA Internet Home Page at https://
www.epa.gov/scipoly/oscpendo/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at https://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.

C. How Can I Request to Attend the Meeting or Submit Comments?

    You may submit a request to attend and/or make public comments in 
the meeting through e-mail, telephone, fax, or hand delivery/courier. 
We would normally accept requests by mail, but in this time of delays 
in delivery of government mail due to health and security concerns, we 
cannot assure your request would arrive in a timely manner. Do not 
submit any information in your request that is considered CBI. Your 
request must be received by EPA on or before Novemer 28, 2005. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
ID number OPPT-2005-0054 in the subject line on the first page of your 
request.
    In accordance with the Federal Advisory Committee Act (FACA), the 
public is encouraged to submit written comments on the topic of this 
meeting. The EDMVAC will have a period available during the meeting for 
public comment. It is the policy of the EDMVAC to accept written public 
comments of any length, and to accommodate oral public comments 
whenever possible. The EDMVAC expects that public statements presented 
at its meeting will be on the meeting topic and not be repetitive of 
previously submitted oral or written statements.
    1. Electronically. If you submit an electronic request to attend 
and/or make public comments in the meeting or comments as prescribed in 
this unit, EPA recommends that you include your name, mailing address, 
and an e-mail address or other contact information in the body of your 
request or comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the request or comment and allows EPA to 
contact you in case EPA cannot read your request or comment due to 
technical difficulties or needs further information on the substance of 
your request or comment. EPA's policy is that EPA will not edit your 
request or comment, and any identifying or contact information provided 
in the body of a request or comment will be included as part of the 
request or comment that is placed in the official public docket, and 
made available in EPA's electronic public docket. If EPA cannot read 
your request or comment due to technical difficulties and cannot 
contact you for clarification, EPA may not be able to consider your 
request or comment.
    i. EPA Docket. You may use EPA's electronic public dockethttps://
www.epa.gov/edocket/, and follow the online instructions for submitting 
materials. Once in the system, select ``search,'' and then key in 
docket ID number OPPT-2005-0054. The system is an ``anonymous access'' 
system, which means EPA will not know your identity, e-mail address, or 
other contact information unless you provide it in the body of your 
request.
    ii. E-mail. Requests to attend and/or make public comments in the 
meeting or comments may be sent by e-mail to oppt.ncic@epa.gov, 
Attention: Docket ID Number OPPT-2005-0054. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail request directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the request that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM by 
hand delivery, courier, or package service, such as Federal Express, to 
the person listed under FOR FURTHER INFORMATION CONTACT. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption. 
Do not submit any disk or CD ROM through the mail. Disks and CD ROMs 
risk being destroyed when handled as Federal Government mail.
    2. Telephone or fax. Telephone or fax your request to participate 
in the meeting to the person listed under FOR FURTHER INFORMATION 
CONTACT.
    3. By hand delivery or courier. Deliver your comments to: OPPT 
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201 
Constitution Ave., Washington, DC. Attention: Docket ID Number OPPT-
2005-0054. 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.

II. Background

    In 1996, through enactment of FQPA, which amended the FFDCA, 
Congress directed EPA to develop a screening program, using appropriate 
validated test systems and other scientifically relevant information, 
to determine whether certain substances may have an

[[Page 67702]]

effect in humans that is similar to an effect produced by a naturally 
occurring estrogen, or such other endocrine effect as the Administrator 
may designate. In 1996, EPA chartered a scientific advisory committee, 
the Endocrine Disruptor Screening and Testing Advisory Committee 
(EDSTAC), under the authority of FACA, to advise it on establishing a 
program to carry out Congress' directive. EDSTAC recommended a multi-
step approach including a series of screens (Tier I screens) and tests 
(Tier II tests) for determining whether a chemical substance may have 
an effect similar to that produced by naturally occurring hormones. EPA 
adopted almost all of EDSTAC's recommendations in the program that it 
developed, the Endocrine Disruptor Screening Program (EDSP), to carry 
out Congress' directive.
    EPA is in the process of developing and validating the screens and 
tests that EDSTAC recommended for inclusion in the EDSP. In carrying 
out this validation exercise, EPA is working closely with the 
Interagency Coordinating Committee for the Validation of Alternate 
Methods (ICCVAM) and other validation groups, as appropriate. EPA also 
is working closely with the Organization for Economic Cooperation and 
Development's (OECD) Endocrine Testing and Assessment Task Force to 
validate and harmonize endocrine screening tests of international 
interest.
    Finally, to ensure that EPA has the best and most up-to-date advice 
available regarding the validation of the screens and tests in the 
EDSP, EPA chartered the Endocrine Disruptor Methods Validation 
Subcommmittee (EDMVS) of the National Advisory Council for 
Environmental Policy and Technology (NACEPT). The EDMVS convened nine 
meetings between October 2001 and December 2003. In 2003, NACEPT 
recommended EDMVS become an Agency level 1 FACA Committee due to the 
complexity of the recommendations. The EDMVAC was chartered in 2004. 
The EDMVAC provides independent advice and counsel to the Agency on 
scientific and technical issues related to validation of the EDSP Tier 
I screens and Tier II tests, including advice on methods for reducing 
animal use, refining procedures involving animals to make them less 
stressful, and replacing animals where scientifically appropriate. 
EDMVAC and previous EDMVS meeting information and corresponding docket 
numbers are available electronically, from the EPA Internet Home Page 
at https://www.epa.gov/scipoly/oscpendo/. You may also go to the EPA 
Docket at https://www.epa.gov/edocket/, and follow the online 
instructions for submitting materials.

III. Meeting Objectives for the November 30-December 2, 2005 Meeting

    The objectives for the November 30 through December 2, 2005 meeting 
(docket ID number OPPT-2005-0054) are to review and discuss: EPA's 
Applied Approach to Validation, Uterotrophic (Tier I Assay, OECD) Peer 
Review Report, Steriodgenesis (Tier I Assay) Using the H295R Cell Line, 
Avian 2-Generation (Tier II Assay, OECD) and receive an update on the 
Pubertal (Tier I) Assays.
    A list of the EDMVAC members and meeting materials are available at 
https://www.epa.gov/scipoly/oscpendo/ and in the public docket.

List of Subjects

    Environmental protection, Endocrine disruptors, Hazardous 
substances, Health, Safety.


    Dated: October 27, 2005.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.

[FR Doc. 05-22229 Filed 11-7-05; 8:45 am]
BILLING CODE 6560-50-S
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