[Federal Register Volume 69, Number 77 (Wednesday, April 21, 2004)]
[Notices]
[Page 21564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program (NTP), National Institute of 
Environmental Health Sciences (NIEHS), National Institutes of Health 
(NIH), NTP Interagency Center for the Evaluation of Alternative Test 
Methods (NICEATM); In Vitro Endocrine Disruptor Test Methods: Request 
for Comments and Nominations

SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and the Scientific Advisory Committee on 
Alternative Toxicological Methods (SACATM) have identified in vitro 
endocrine disruptor screening methods as a priority for validation. 
ICCVAM has published guidelines for development of in vitro endocrine-
disruptor estrogen and androgen receptor binding and transcriptional 
activation assays. In these guidelines, ICCVAM recommends that priority 
be given to assays that (1) do not require the use of animal tissue as 
the receptor source, but rather use recombinant-derived proteins and 
(2) do not use radioactive materials. On behalf of the ICCVAM, NICEATM 
invites the nomination for validation studies of in vitro test methods 
that meet these recommendations and for which there are standardized 
test method protocols, pre-validation data, and proposed validation 
study designs. At this time, ICCVAM has received nominations for two in 
vitro endocrine-disruptor screening methods purported to meet these 
recommendations. Information on the nominated methods is posted on the 
ICCVAM/NICEATM Web site (http://iccvam.niehs.nih.gov) or available from 
NICEATM (contact information provided below). ICCVAM will consider 
nominations and comments received in response to this notice and 
develop recommended priorities for proposed evaluation and validation 
studies of endocrine disruptor screening methods.

Request for Comments and Nomination of In Vitro Endocrine Disruptor 
Test Methods

    Comments and nominations submitted in response to this notice 
should be sent by mail, fax, or e-mail to NICEATM (Dr. William S. 
Stokes, Director, NICEATM, NIEHS, 79 T. W. Alexander Drive, P.O. Box 
12233, MD EC-17, Research Triangle Park, NC 27709, (phone) 919-541-
2384, (fax) 919-541-0947, (e-mail) [email protected]) by June 7, 
2004, in order to ensure their consideration by the ICCVAM.

SUPPLEMENTARY INFORMATION: In May 2003, ICCVAM published a report 
entitled, ``ICCVAM Evaluation of In Vitro Test Methods for Detecting 
Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor 
Binding and Transcriptional Activation Assays' (NIH Publication No. 03-
4503; available: http://iccvam.niehs.nih.gov/methods/endocrine.htm). 
During its evaluation of in vitro endocrine disruptor screening assays, 
ICCVAM recommended that preference be given to development of assays 
that (1) do not require the use of animal tissue as the receptor 
source, but rather use recombinant-derived proteins and (2) do not use 
radioactive materials. ICCVAM also recommended minimum procedural 
standards that should be incorporated in standardized test method 
protocols and minimum lists of chemicals that should be used for 
validation studies. ICCVAM subsequently received nominations of two 
methods for validation studies. The first nomination is for a biosensor 
system that can assess estrogen receptor binding and transcriptional 
activation. The second nomination is for a stably transfected 
recombinant cell-based transcriptional method. The methods meet the 
ICCVAM's recommendations for studies that do not require the use of 
animals as a receptor source or use radioactive materials. Both methods 
detect receptor agonist and antagonist activity.
    ICCVAM reviewed the two nominations described above and unanimously 
approved the following draft recommendation: ``Evaluation studies for 
in vitro receptor binding and transcriptional activation test methods 
that do not require the use of animals should receive a high priority 
for support. Prior to the initiation of such studies, the proposed 
validation studies should be evaluated for adherence to relevant 
recommendations in the report: ``ICCVAM Evaluation of In Vitro Test 
Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor 
and Androgen Receptor Binding and Transcriptional Activation Assays'' 
(NIH Publication No. 03-4503) by the ICCVAM Endocrine Disruptor Working 
Group (EDWG) and NICEATM.''
    ICCVAM subsequently presented these nominations and its 
recommendation to the SACATM at its March 10-11, 2004 meeting. SACATM 
concurred with ICCVAM that endocrine disrupting screening assays should 
be a priority.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use, generate, or 
disseminate toxicological information. ICCVAM promotes the development, 
validation, regulatory acceptance, and national and international 
harmonization of toxicological test methods that more accurately assess 
the safety or hazards of chemicals and products and test methods that 
refine, reduce and replace animal use. The ICCVAM Authorization Act of 
2000 (Pub. L. 106-545, available at http://iccvam.niehs.nih.gov/about/PL106545.htm) established ICCVAM as a permanent interagency committee 
of the NIEHS under the NICEATM. NICEATM administers the ICCVAM and 
provides scientific support for ICCVAM and ICCVAM-related activities. 
NICEATM and ICCVAM work collaboratively to evaluate new and improved 
test methods applicable to the needs of Federal agencies. Additional 
information about ICCVAM and NICEATM can be found at the following Web 
site: http://iccvam.niehs.nih.gov.

    Dated: April 9, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-8980 Filed 4-20-04; 8:45 am]
BILLING CODE 4140-01-P