[Federal Register Volume 67, Number 204 (Tuesday, October 22, 2002)]
[Notices]
[Pages 64902-64903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26733]


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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) Notice of Availability of an Expert 
Panel Report on the Current Validation Status of In Vitro Endocrine 
Disruptor Screening Methods and a Proposed List of Substances for 
Validation of In Vitro Endocrine Disruptor Screening Methods; Request 
for Comments.
SUMMARY: The NTP Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM) announces the availability of a report 
entitled, ``The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) Expert Panel Report on the Current Status 
of In Vitro Test Methods for Detecting Endocrine Disruptors'' and a 
list of substances proposed by the ICCVAM Endocrine Disruptor Working 
Group (EDWG) for the validation of in vitro endocrine disruptor 
screening methods. Final versions of the Background Review Documents 
(BRDs) reviewed at the May 21-22, 2002 expert panel meeting and the 
summary minutes of this meeting are also available. The NICEATM invites 
public comment on the expert panel report and the proposed list of 
substances for validation.

[[Page 64903]]

Availability of Expert Panel Report, Proposed List of Substances for 
Future Validation, and Final Background Review Documents

    Copies of the expert panel report, the EDWG proposed list of 
substances for validation, and each BRD may be obtained on the ICCVAM/
NICEATM Web site at http://iccvam.niehs.nih.gov, or by contacting 
NICEATM, NIEHS, PO Box 12233, MD EC-17, Research Triangle Park, NC, 
27709, (phone) (919) 541-3398, (fax) (919) 541-0947, (email) 
[email protected].

Request for Comments

    NICEATM invites the submission of written comments on the expert 
panel report and the proposed list of substances for validation of in 
vitro endocrine disruptor methods. When submitting written comments 
please include appropriate contact information (name, affiliation, 
mailing address, phone, fax, email and sponsoring organization, if 
applicable). Written comments and additional information should be sent 
by mail, fax, or email to Dr. William S. Stokes, Director of NICEATM, 
at the address listed above by noon, December 6, 2002. All written 
comments received before this deadline will be posted on the ICCVAM/
NICEATM Web site and made available to ICCVAM agency representatives 
for their consideration prior to the development by ICCVAM of final 
recommendations on these test methods and the proposed list of 
substances for validation.
    The expert panel report, the final list of proposed substances for 
validation, and the ICCVAM recommendations will be compiled into a 
report and forwarded to the Director of the NIEHS and the heads of 
appropriate Federal agencies and posted on the ICCVAM/NICEATM Web site. 
The NIEHS and the Federal agencies will consider these recommendations 
and comments to determine if and how (chemicals and laboratories) 
additional validation studies will be conducted. If a decision is made 
to conduct validation studies on in vitro ER and AR assays, an 
independent peer review panel will be convened to review the results of 
these studies and to propose minimum performance criteria.

Background on the Evaluation of In Vitro Endocrine Disruptor Screening 
Methods and Development of the Proposed List of Substances for Future 
Validation

    A request for data supporting the performance and reliability of 
endocrine disruptor screening methods and for the nomination of expert 
scientists for an independent scientific review panel was previously 
published (Federal Register, Vol. 66, No. 57, pp. 16278-16279, March 
23, 2001, available at http://iccvam.niehs.nih.gov/methods/endocrine.htm). This notice also announced that NICEATM in 
collaboration with the ICCVAM would hold an independent peer review 
panel meeting to assess the current validation status of in vitro 
estrogen receptor (ER) and androgen receptor (AR) binding and 
transcriptional activation assays, and to review proposed minimum 
performance criteria for defining an acceptable screening assay. During 
development of Background Review Documents (BRDs) for in vitro ER and 
AR assays, ICCVAM and NICEATM determined that no validation studies 
using standardized protocols had been completed. As a result, NICEATM 
in collaboration with the ICCVAM held an expert panel meeting on May 
21-22, 2002, to evaluate the current status of ER and AR binding and 
transcriptional activation assays and to develop recommendations for 
their future validation (Federal Register, Vol. 67, No. 66, pp. 16415-
16416, April 5, 2002, available at http://iccvam.niehs.nih.gov/methods/endocrine.htm). At this meeting, the panel reviewed each of four BRDs 
(Estrogen and Androgen Receptor Binding and Transcriptional Activation 
Assays) and developed conclusions and recommendations on the following:
    [sbull] The relative priority that should be given to specific 
assays recommended for further evaluation in validation studies.
    [sbull] The adequacy of the specific protocols recommended for 
validation studies.
    [sbull] The adequacy of the minimum procedural standards 
recommended for each type of assay.
    [sbull] The adequacy and appropriateness of substances recommended 
for validation studies.
    The expert panel's conclusions and recommendations are included in 
the report described above.
    Based on the recommendations of the expert panel and in 
consultation with the EDWG, a combined list of proposed substances for 
future validation was developed. This list is proposed by the EDWG to 
facilitate future validation of in vitro endocrine disruptor screening 
methods and is available as described in this notice.

Background Information on ICCVAM and NICEATM

    ICCVAM was authorized as a permanent interagency committee of the 
NIEHS, under the NICEATM, on December 19, 2000, by the ICCVAM 
Authorization Act of 2000 (P.L. 106-545, available at http://iccvam.niehs.nih.gov/about/PL106545.htm). ICCVAM is composed of 
representatives from fifteen Federal regulatory and research agencies 
that use or generate toxicological information. P.L. 106-545 directs 
the ICCVAM to coordinate the technical review of new, revised, and 
alternative test methods of interagency interest. The committee also 
coordinates cross-agency issues relating to the validation, acceptance, 
and national/international harmonization of toxicological testing 
methods. ICCVAM promotes the scientific validation and regulatory 
acceptance of toxicological test methods that enhance agencies' ability 
to make decisions on health risks, while refining, reducing, and 
replacing animal use wherever possible. NICEATM provides operational 
and scientific support for ICCVAM and collaborates with ICCVAM to 
evaluate new and alternative 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: October 9, 2002.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 02-26733 Filed 10-21-02; 8:45 am]
BILLING CODE 4140-01-P