

[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]               
[Page 15724-15726]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-73]                         

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2006-0233; FRL-7771-1]

 
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 Committe (EDMVAC) on April 18 through April 20, 
2006, in Washington, DC. 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: Male and 
Female Pubertals Assay Interlaboratory Studies, EDSP's Applied Approach 
to Validation, Tier 1 Fish Screen Assay Validation Status, updates on 
Tier 1 Aromatase Assay, and Tier 1 Steroidogenesis Cell Based H295R 
Assay.

DATES: The meeting will be held on Tuesday, April 18, 2006, from 12:30 
p.m. to 6 p.m.; Wednesday, April 19, 2006, from 8:30 a.m. to 5:30 p.m.; 
and Thursday, April 20, 2006, 8 a.m. to 1:30 p.m., eastern standard 
time. Request to make public comments at the meeting must be received 
by EPA on or before April 14, 2006.
    To request accommodation of a disability, please contact the person 
listed under FOR FURTHER INFORMATION CONTACT, preferably at least 10 
days prior to the meeting, to give EPA as much time as possible to 
process your request.

ADDRESSES: The meeting will be held at the Capital Hilton Hotel and 
Conference Center, 1001 16th St., NW., Washington, DC 20036; telephone 
number: (202) 393-1000; e-mail: http://www.hilton.com.
.

    Requests to make public comments at 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: For general information or for 
information on access or services for individuals with disabilities: 
William Wooge, 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: 
wooge.william@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, 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.

[[Page 15725]]

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 EPA-HQ-OPPT-2006-0233. 
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 http://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 http://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 http://www.regulations.gov/ 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 ``Advance 
search,'' select ``Docket search,'' then key in the appropriate docket 
ID number.

C. How Can I Request to Give Comments in Person at the Meeting?

    You may submit a request to make public comments at 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 April 14, 2006. To ensure 
proper receipt by EPA, it is imperative that you identify docket ID 
number EPA-HQ-OPPT-2006-0233 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 make 
public comments at 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 docket http://www.regulation.gov/
, and follow the online instructions for submitting 

materials. Once in the system, select ``Advance search,'' select 
``Docket search,''and then key in docket ID number EPA-HQ-OPPT-2006-
0233. 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 make public comments at the meeting or 
written comments may be sent by e-mail to oppt.ncic@epa.gov, Attention: 
Docket ID Number EPA-HQ-OPPT-2006-0233. 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 
at 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 EPA-HQ-
OPPT-2006-0233. 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 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 1 screens) and tests (Tier 2 tests) 
for determining whether a chemical substance may have an effect similar 
to that produced by naturally occurring hormones. EPA adopted almost 
all of

[[Page 15726]]

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 Disruptors 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 
1 screens and Tier 2 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 http://www.epa.gov/scipoly/oscpendo/ You may also go to the EPA Docket at http://www.regulations.gov/., and follow the online 

instructions for submitting materials.

III. Meeting Objectives for the April 18-20, 2006 Meeting

    The objectives for the April 18 through April 20, 2006 meeting 
(docket ID number EPA-HQ-OPPT-2006-0233) are to review and discuss: 
Aromatase Assay Update (Tier 1), Steroidogenesis Cell Based H295R Assay 
Update (Tier 1), Male and Female Pubertals Assay Interlaboratory 
Studies, Fish Screen Assay Validation Status (Tier 1), and EPA's 
Applied Approach to Validation.
    A list of the EDMVAC members and meeting materials are available at 
http://www.epa. gov/scipoly/ oscpendo/ and in the public docket.


List of Subjects

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


    Dated: March 21, 2006.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-4570 Filed 3-28-06; 8:45 am]

BILLING CODE 6560-50-S
