70 FR 67 pgs. 17995-17997 - Endocrine Disruptor Methods Validation Advisory Committee(EDMVAC); Notice of Public Meeting
Type: NOTICEVolume: 70Number: 67Pages: 17995 - 17997
Docket number: [OPPT-2005-0012; FRL-7708-9]
FR document: [FR Doc. 05-7043 Filed 4-7-05; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2005-0012; FRL-7708-9]
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 DisruptorMethods Validation Advisory Committe (EDMVAC) on April 26-28, 2005,in Washington, DC. This meeting, as with all EDMVAC meetings, is open tothe public. Seating is on a first-come basis. The purpose of the meetingis to receive advice and input from the EDMVAC on: Steroidogenesis,Uterotrophic, Fish Screen Studies, and Amphibian Metamorphosis Assays.
DATES:
The meeting will be held on Wednesday, April 26,2005, from 12:30 p.m. to 5:30 p.m.; Thursday, April 27, 2005, from 8:30a.m. to 5:30 p.m.; and Friday, April 28, 2005, from 8 a.m. to 12:15 p.m.,eastern standard time.
Request to participate in the meeting must be received by EPA on orbefore April 21, 2005. To ensure proper receipt by EPA, it is imperativethat you identify docket identification (ID) numberOPPT-2005-0012 in the subject line on the first page of yourrequest.
Individuals requiring special accommodations at the meeting, includingwheelchair access, should contact the person listed under FOR FURTHER INFORMATION CONTACT at least 5 business daysprior to the meeting.
ADDRESSES:
The meeting will be held at RESOLVE, 1255 23rd St.,NW., Suite 275, Washington, DC 20037.
Requests to participate in the meeting may be submitted by e-mail,telephone, fax, or through hand delivery/courier. Follow the detailedinstructions as provided in Unit I. of the SUPPLEMENTARYINFORMATION .
Comments may be submitted electronically, by fax, or through handdelivery/courier. Follow the detailed instructions as provided in Unit I.of the SUPPLEMENTARY INFORMATION .
FOR FURTHER INFORMATION CONTACT:
Jane Smith, DesignatedFederal 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, use, consume, workwith, or import pesticide chemicals and other substances. To determinewhether you or your business may have an interest in this notice you shouldcarefully examine section 408(p) of the Federal Food, Drug, and CosmeticAct (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 SafeDrinking Water Act (SDWA) (Public Law 104-182), 42 U.S.C.300j-17. Since other entities may also be interested, the Agency hasnot attempted to describe all the specific entities that may be interestedin this action. If you have any questions regarding this action, consultthe person listed under FOR FURTHER INFORMATION CONTACT .
B. How Can I Get Additional Information, Including Copies of thisDocument or Other Related Documents?
1. Docket . EPA has established an official public docketfor this action under docket identification (ID) numberOPPT-2005-0012. The official public docket consists of thedocuments specifically referenced in this action, any public commentsreceived, and other related information. Although a part of the officialdocket, the public docket does not include Confidential BusinessInformation (CBI) or other information whose disclosure is restricted bystatute. The official public docket is the collection of materials thatare available for public viewing at the EPA Docket Center, Rm. B102-ReadingRoom, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPADocket 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 telephonenumber is (202) 566-1744 and the telephone number for the OPPTDocket, 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 EPAInternet under the " Federal Register " listings at http://www.epa.gov/fedrgstr/ . A meeting agenda, a list ofEDMVAC members and information from previous EDMVS meetings are availableelectronically, from the EPA Internet Home Page at http://www.epa.gov/scipoly/oscpendo/ .
An electronic version of the public docket is available through EPA'selectronic public docket and comment system, EPA Dockets. You may use EPADockets at http://www.epa.gov/edocket/ to submit or viewpublic comments, access the index listing of the contents of the officialpublic docket, and to access those documents in the public docket that areavailable electronically. Once in the system, select "search,"then key in the appropriate docket ID number.
C. How Can I Request to Participate in the Meeting or SubmitComments?
You may submit a request to participate in the meetingthrough e-mail, telephone, fax, or hand delivery/courier. We wouldnormally accept requests by mail, but in this time of delays in delivery ofgovernment mail due to health and security concerns, we cannot assure yourrequest would arrive in a timely manner. Do not submit any information inyour request that is considered CBI. Your request must be received by EPAon or before April 21, 2005. To ensure proper receipt by EPA, it isimperative that you identify docket ID number OPPT-2005-0012in the subject line on the first page of your request.
In accordance with the Federal Advisory Committee Act (FACA), the publicis encouraged to submit written comments on the topic of this meeting. TheEDMVAC will have a period available during the meeting for public comment.It is the policy of the EDMVAC to accept written public comments of anylength, and to accommodate oral public comments whenever possible. TheEDMVAC expects that public statements presented at its meeting will be onthe meeting topic and not be repetitive of previously submitted oral orwritten statements.
1. Electronically . If you submit an electronic requestto participate in the meeting or comments as prescribed in this unit, EPArecommends that you include your name, mailing address, and an e-mailaddress or other contact information in the body of your request orcomment. Also include this contact information on the outside of any diskor CD ROM you submit, and in any cover letter accompanying the disk or CDROM. This ensures that you can be identified as the submitter of therequest or comment and allows EPA to contact you in case EPA cannot readyour request or comment due to technical difficulties or needs furtherinformation on the substance of your request or comment. EPA's policy isthat EPA will not edit your request or comment, and any identifying orcontact information provided in the body of a request or comment will beincluded as part of the request or comment that is placed in the officialpublic docket, and made available in EPA's electronic public docket. IfEPA cannot read your request or comment due to technical difficulties andcannot contact you for clarification, EPA may not be able to consider yourrequest or comment.
i. EPA Docket . You may use EPA's electronic publicdocket http://www.epa.gov/edocket/ , and follow the onlineinstructions for submitting materials. Once in the system, select"search," and then key in docket ID numberOPPT-2005-0012. The system is an "anonymous access"system, which means EPA will not know your identity, e-mail address, orother contact information unless you provide it in the body of yourrequest.
ii. E-mail . Requests to participate in the meeting orcomments may be sent by e-mail to oppt.ncic@epa.gov ,Attention: Docket ID Number OPPT-2005-0012. In contrast toEPA's electronic public docket, EPA's e-mail system is not an"anonymous access" system. If you send an e-mail requestdirectly to the docket without going through EPA's electronic publicdocket, EPA's e-mail system automatically captures your e-mail address.E-mail addresses that are automatically captured by EPA's e-mail system areincluded as part of the request that is placed in the official publicdocket, and made available in EPA's electronic public docket.
iii. Disk or CD ROM . You may submit comments on a diskor CD ROM by hand delivery, courier, or package service, such as FederalExpress, to the person listed under FOR FURTHER INFORMATIONCONTACT . These electronic submissions will be accepted in WordPerfector ASCII file format. Avoid the use of special characters and any form ofencryption. Do not submit any disk or CD ROM through the mail. Disks andCD ROMs risk being destroyed when handled as Federal Government mail.
2. Telephone or fax . Telephone or fax your request toparticipate in the meeting to the person listed under FOR FURTHERINFORMATION CONTACT .
3. By hand delivery or courier . Deliver your commentsto: OPPT Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201Constitution Ave., Washington, DC. Attention: Docket ID NumberOPPT-2005-0012. The DCO is open from 8 a.m. to 4 p.m., Mondaythrough Friday, excluding legal holidays. The telephone number for the DCOis (202) 564-8930.
II. Background
In 1996, through enactment of FQPA, which amended the FFDCA, Congressdirected EPA to develop a screening program, using appropriate validatedtest systems and other scientifically relevant information, to determinewhether certain substances may have hormonal effects in humans. In 1996,EPA chartered a scientific advisory committee, the Endocrine DisruptorScreening and Testing Advisory Committee (EDSTAC), under the authority ofFACA, to advise it on establishing a program to carry out Congress'directive. EDSTAC recommended a multi-step approach including a seriesof screens (Tier 1 screens) and tests (Tier 2 tests) for determiningwhether a chemical substance may have an effect similar to that produced bynaturally occurring hormones. EPA adopted almost all of EDSTAC'srecommendations in the program that it developed, the Endocrine DisruptorScreening Program (EDSP), to carry out Congress' directive.
EPA is in the process of developing and validating the screens and teststhat EDSTAC recommended for inclusion in the EDSP. In carrying out thisvalidation exercise, EPA is working closely with, and adhering to theprinciples of the Interagency Coordinating Committee for the Validation ofAlternate Methods (ICCVAM). EPA also is working closely with theOrganization for Economic Cooperation and Development's (OECD) EndocrineTesting and Assessment Task Force to validate and harmonize endocrinescreening tests of international interest.
Finally, to ensure that EPA has the best and most up-to-date adviceavailable 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 andTechnology (NACEPT). The EDMVS convened nine meetings between October 2001and December 2003. In 2003, NACEPT recommended EDMVS become an Agencylevel 1 FACA Committee due to the complexity of the recommendations. TheEDMVAC was chartered in 2004. The EDMVAC provides independent advice andcounsel to the Agency on scientific and technical issues related tovalidation of the EDSP Tier 1 screens and Tier 2 tests, including advice onmethods for reducing animal use, refining procedures involving animals tomake them less stressful, and replacing animals where scientificallyappropriate. EDMVAC and previous EDMVS meeting information andcorresponding docket numbers are available electronically, from the EPAInternet Home Page at http://www.epa.gov/scipoly/oscpendo/ . You may also go tothe EPA Docket at http://www.epa.gov/edocket/ , and follow the onlineinstructions for submitting materials.
III. Meeting Objectives for the April 26-28, 2005 Meeting
The objectives for the April 26-28, 2005 meeting (docket ID numberOPPT-2005-0012) are to introduce the newly established EDMVACCommittee, review and discuss: Steroidogenesis (Tier 1 Assay),Uterotrophic (Tier 1 Assay, OECD), EPA Fish Screen Multi-Chemical Studies(Tier 1 Assay), OECD Fish Screen Phase 1B (Tier 1 Assay), AmphibianMetamorphosis Phase 1 Report and Phase 2 Draft Plan (Tier 1 Assay, OECD).
A list of the EDMVAC members and meeting materials are available at http://www.epa.gov/scipoly/oscpendo/ and in the publicdocket.
List of Subjects
Environmental protection, Endocrine disruptors, Hazardous substances,Health, Safety.
Dated: April 1, 2005.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. 05-7043 Filed 4-7-05; 8:45 am]
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