03-13432. Endocrine Disruptor Screening Program; Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Request for Nominations for Membership

AGENCY:

Environmental Protection Agency (EPA).

ACTIONS:

Notice.

SUMMARY:

As mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA), amended by the Food Quality Protection Act (FQPA) of 1996, EPA implemented an Endocrine Disruptor Screening Program (EDSP). As part of the EDSP, the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) was established in 2001, is a Subcommittee under the National Advisory Council for Environmental Policy and Technology (NACEPT). The members of the EDMVS may serve up to three 2-year terms. This notice is a request for nominations for new members of the EDMVS from interested organizations. NACEPT is a chartered federal advisory committee subject to the provisions of the Federal Advisory Committee Act (FACA). Through NACEPT, the EDMVS provides technical advice and recommendations to EPA regarding validation of the Tier I screening and Tier II testing methods for the EDSP. Background information regarding the Agency's EDSP and the EDMVS are discussed in Unit III. of the SUPPLEMENTARY INFORMATION. This information is being provided to allow interested persons and organizations to review the scope of activities when nominating qualified individuals for membership on the EDMVS.

DATES:

Nominations, identified by docket ID Number OPPT-2003-0011 must be received on or before June 30, 2003.

ADDRESSES:

Nominations for membership may be submitted electronically, by fax, or through hand delivery/courier. Follow the detailed instructions as provided in Unit II. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Barbara Cunningham, Director, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20406-0001; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Jane Smith, Designated Federal Official (DFO) for the EDMVS, Exposure Assessment Coordination and Policy Division (7203M), Office of Science Coordination and Policy, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

This action is directed to the public in general. You may be interested in nominating members to the subcommittee set forth in this notice if you are a member of an environmental/public interest organization, a public health organization, an animal welfare organization, academia, or Federal agencies, state, local, or tribal governments. You also may be interested in activities of EPA's EDSP if you produce, manufacture, use, consume, work with, or import pesticides or other chemicals. To determine whether you or your business may have an interest in this notice you should carefully examine section 408(p) of the FFDCA, as amended by the 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 affected by this action. If you have any questions regarding the applicability of this action, consult the technical persons 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-2003-0011. This official public docket consists of this Notice, public comments regarding this Notice, 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 is available for public viewing at EPA's Docket Center, Rm. B102 - Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. EPA's Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. EPA's Docket Center Reading Room telephone number is [phone] and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is [phone].

2. Electronic access. An electronic version of the public docket is available through EPA's electronic docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket to submit nominations and comments 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 edocket system, select “search,” then key in the appropriate docket ID number (OPPT-2003-0011). Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1.

You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​, or you may obtain electronic copies of this document, and certain other related documents through the EDSP Web site for the EDMVS at http://www.epa.gov/​scipoly/​oscpendo/​edmvs.htm.

3. In person. The Agency has established an administrative record for the EDMVS under docket ID number OPPT-2003-0011. The public version of the administrative 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 EPA Docket Center. See I.B.1. for docket center information.

II. How Can I Nominate Potential Members to the Endocrine Disruptor Methods Validation Subcommittee?

You may nominate technically qualified persons for membership to the EDMVS electronically, by fax or in person/courier service. A technically qualified nominee could come from industry, an environmental/public interest organization, a public health organization, an animal welfare organization, academia or Federal agencies, State, local or tribal governments or any other group knowledgeable in endocrine disruption, method validation or related topics. Nominations for membership may be submitted by individuals or on behalf of organizations, and must include a curriculum vitae of the nominee detailing his or her specific area of relevant scientific expertise. (Please exclude the following information from the curriculum vitae: The nominee's social security number, birth date and place, home address, and telephone number.) Technically qualified persons may also nominate themselves. Current members whose terms are about to expire may be renominated or self-nominate as their time and interests allow. Current members being renominated will be evaluated in the same manner as newly nominated candidates. Members of the EDMVS are selected by EPA taking into consideration their relevant scientific expertise and diversity of perspectives on mammalian, ecological, and in vitro endocrine disruptor screening and testing methods and procedures, toxicity test methods standardization and validation, and chemical and pesticide regulatory processes. Members will be appointed for 2 years. In appointing members, EPA will seek to achieve balanced representation from among the following sectors: the agrichemical and commodity chemical industries; environmental/public interest organizations; public health organizations; animal welfare organizations; Federal agencies; State, local and tribal governments; academia; consumers, and the public.

Nominations must be received by EPA on or before June 30, 2003. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT-2003-0011 in the subject line on the first page of your submission. Do not include the nominee's private information, such as, social security number, birth date and place, home address, and telephone number. You may submit your nomination electronically, by fax, in person, or by courier. We normally would accept requests by mail, but in this time of delays in delivery of Federal government mail due to health and security concerns, we cannot assure your request would arrive in a timely manner.

1. Electronically. You may submit your nomination electronically. Do not submit any information electronically that you consider to be CBI or information protected under the Privacy Act. Use WordPerfect 6.1/8.0 or ASCII file format and avoid the use of special characters and any form of encryption.

i. EPA docket. You may use EPA's electronic public docket to submit a nomination. Go to EPA Dockets at, http://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-2003-0011. Please see Unit I.B.1.

ii. E-mail. Nominations may be sent by e-mail to the technical contact listed under FOR FURTHER INFORMATION CONTACT, or directly to the docket at [e-mail], Attention: Docket ID number OPPT-2003-0011.

iii. Disk or CD ROM. You may submit nominations on a disk or CD ROM by courier or package service, such as Federal Express, to: the OPPT Document Control Office (DCO) in EPA East Building Room 6428, 1201 Constitution Ave., NW., Washington, DC, Attention: Docket ID number OPPT-2003-0011. 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 [phone]. 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. Due to security measures, disks and CD ROMs risk being destroyed when handled as Federal government mail.

2. By fax. Send your nomination(s) to the technical contact identified under FOR FURTHER INFORMATION CONTACT.

3. In person or by courier. Deliver your nomination to: OPPT Document Control Office (DCO). See Unit II.1.iii. for Document Control Office information.

III. Background

A. Action

EPA's ongoing implementation of EDSP is science-driven, and supported by the recommendations and comments of knowledgeable scientists and stakeholders. Information on the EDMVS meetings to date, a list of the current members of the EDMVS, and other EPA EDSP-related information are available at http://www.epa.gov/​scipoly/​oscpendo/​edmvs.htm.

The EDMVS held it's initial meeting in October 2001. All 26 members started their membership with that meeting and 25 of the original members remain with the subcommittee. In October 2003, 25 of the current members will have served their initial 2-year term and may reapply to the subcommittee or not, as time and responsibilities may dictate.

The purpose of this Federal Register notice is to solicit nominations for scientists who would be interested in serving on this cutting edge subcommittee. You may nominate others and you may self-nominate. Qualifications for subcommittee membership are discussed in Unit II. of the SUPPLEMENTARY INFORMATION.

EPA hopes to announce its selection of members for the subcommittee's third and fourth years by September 2003.

B. The Purpose of the Endocrine Disruptor Methods Validation Subcommittee

1. Purpose and authority. The EDMVS was established in accordance with the FACA (5 U.S.C. app. 2 section 9(c)). The EDMVS is a subcommittee of EPA's NACEPT. The purpose of the EDMVS is to assist NACEPT in providing advice and counsel to EPA on scientific issues associated with the conduct of studies necessary for validation of Tier I and Tier II assays for EPA's EDSP. The EDMVS explores issues regarding: The development and choice of initial protocols; prevalidation study designs; validation study designs; the integration of prevalidation, and validation study results into EDSP Tier I and Tier II methods documents suitable for external peer review. All EDMVS recommendations are forwarded to the Agency through NACEPT. Taking into consideration this advice and recommendations, EPA will manage and conduct prevalidation and validation laboratory studies.

2. Objective and scope of the activity. The EDMVS and NACEPT provide a forum for diverse groups of individuals representing a broad range of interests to consult with and make recommendations to the Agency on matters relating to the development, optimization, and validation of endocrine disruptor screening and testing methods. The subcommittee will analyze issues, review data and protocols, compile information, make recommendations to the Agency through NACEPT, and undertake other activities necessary to meet its responsibilities. The complete Mission Statement is available at: http://www.epa.gov/​scipoly/​oscpendo/​edmvs.htm, press enter and page down to “EDMVS Subcommittee Mission Statement.”

3. Meetings. The EDMVS may hold up to six meetings a year. These meetings generally are held in Washington, DC and usually last for 2-3 days. Meeting materials to be discussed are distributed to members prior to the meetings. A regular employee of EPA acts as the DFO and will be present or represented at all meetings. All EDMVS meetings are called, announced, and held in accordance with FACA and NACEPT rules, which require open meetings and an opportunity for interested persons to file comments before or after meetings, or to make statements during the public meetings to the extent time permits. The date, time, location, and any public participation instructions for each meeting are announced in the Federal Register at least 15 days before the meeting date. Each meeting is conducted in accordance with an agenda. Meeting information and the agenda are posted on the Agency's web site as soon as available.

To date, the EDMVS has held six, meetings starting with a 2-day meeting October 30-31, 2001. Other face-to-face meetings were held; December 10-12, 2001; March 25-27, 2002; and July 23-24, 2002. There have been two 2-hour teleconferences, each on a single topic. There are face-to-face meetings planned for June 5-6, 2003 and August 19-21, 2003.

C. Establishment of the Endocrine Disruptor Screening Program

The complexity of the scientific and regulatory issues surrounding the endocrine disruptor issue led EPA to seek broad expert advice and counsel beyond the Agency. EPA held a public meeting in May of 1996 requesting advice on how to develop a scientifically defensible, pragmatic approach to endocrine disruptor screening and testing. The stakeholder feedback indicated that a broad based multi-sector stakeholder committee should be established under the FACA. Following a second public meeting and analysis of stakeholder interests (Keystone Center Convening Report), the Agency chartered the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC).

EDSTAC was charged with providing advice and recommendations to the Agency regarding a strategy for testing chemical substances to determine whether they may have an effect in humans similar to an effect produced by naturally occurring hormones. EDSTAC consisted of 39 representatives from industry, environmental and public health advocacy groups, state government, other Federal agencies, and academic scientists. Over a 2-year period, EDSTAC held eight meetings. In its final report (available at http://www.epa.gov/​scipoly/​oscpendo/​history/​exesum14.pdf), EDSTAC provided 71 consensus recommendations regarding an endocrine disruptor screening program.

EPA's EDSP was set forth in a notice published in the Federal Register of August 11, 1998 (63 FR 42852) (FRL-6021-3), and described in more detail in a proposed statement of policy published in the Federal Register of December 28, 1998 (FR 67 79611) (FRL-7286-6). The EDSP proposed statement of policy, was subsequently reviewed by a joint panel of the FIFRA Scientific Advisory Panel (SAP) and the EPA Science Advisory Board (SAB) in May 1999. The SAP/SAB issued a final report that concluded that a tiered approach relying on a combination of in vivo and in vitro screens for Tier I and a set of in vivo Tier II tests was scientifically reasonable.

D. Implementation of EPA's Endocrine Disruptor Screening Program

EPA's ongoing implementation of EDSP is science-driven, and supported by the recommendations and comments of EDSTAC, the SAP/SAB Joint Panel, and the EDMVS. The Agency's Implementation is currently proceeding on three fronts: Priority setting for chemicals to be screened and tested: Prevalidation and validation studies on Tier I and Tier II assays; and developing policy and procedures to require endocrine disruptor testing.

1. Priority setting. Priority setting is a separate activity from the EDMVS. For the latest information on priority setting of chemicals for testing see Federal Register of December 30, 2002, (67 FR 79611) (FRL-7286-6) and docket ID number OPPT-2002-0066.

2. Validation process. As a charter member of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), EPA is following the interagency validation framework outlined in the ICCVAM report “Validation and Regulatory Acceptance of Toxicological Test Methods” for validating the EDSP screening and testing methods. The National Institute of Environmental Health Sciences (NIEHS) established ICCVAM as a standing committee of Federal agencies to coordinate and facilitate interagency validation, acceptance, and harmonization of toxicological test methods with an emphasis on reducing animal use, refining procedures involving animals to make them less stressful and replacing animals where scientifically appropriate.

The ICCVAM validation process was designed as a flexible, adaptable framework applicable to conventional and alternative methods, and to meet the needs of diverse test sponsors, Federal agencies and regulatory processes. EPA's EDSP is managing the validation process with substantial involvement of ICCVAM personnel.

Although there is widespread interest in EPA's EDSP, the screening and testing methods are being developed and validated with the specific goal of developing test guidelines for EPA regulatory use. The test guidelines will ultimately be used by chemical manufacturers, pesticide registrants, and other entities to develop data for submission to EPA in support of the Agency's statutorily mandated chemical risk management programs.

In addition to EPA's domestic EDSP validation program, certain screening assays and tests for international use are also being developed by the Organization for Economic Cooperation and Development (OECD) Test Guidelines Program. EPA is an active member of the OECD Test Guidelines Program activities, as well as the latter's Endocrine Disruptor Testing and Assessment Workgroup. EPA will rely upon the OECD mechanism for validating those EDSP screens and tests of international interest. The OECD, EPA, and ICCVAM have also mutually agreed to this administrative arrangement to ensure that all appropriate validation and peer review steps are achieved in both domestic and international efforts.

3. Status of validation of the assays. The table below shows the validation process steps that have been initiated on each of the assays.

Screens/Assays	Literature Review	Initial Protocol Demonstration	Prevalidation Studies	Validation Studies
Amphibian metamorphosis	X	X	X
AR binding	X	X	X
Aromatase	X	X	X
ER binding	X	X	X	X
Fish reproductive	X	X	X
Hershberger	X	X	X
Pubertal female	X	X	X
Pubertal male	X	X	X
Steroidogenesis	X	X	X
Uterotrophic (Tier ?)	X	X	X	X
Amphibian 2-generation development and reproduction test	X	X
Avian 2-generation test	X	X	X
Fish life-cycle test	X
Mammalian 2-generation test		X	X
Mysid life-cycle test	X	X	X

4. Policy and procedures workgroup. The Agency has established a workgroup composed of scientists, economists, lawyers, and policy specialists from different EPA offices that is in the process of developing policy and procedures related to requiring endocrine disruptor testing.

List of Subjects

• Environmental protection
• Endocrine disruption
• Endocrine disruptor screening program

Dated: May 21, 2003.

Stephen Johnson,

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.