Federal Register: October 22, 2002 (Volume 67, Number 204)
DOCID: FR Doc 02-26733
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Reports and guidance documents; availability, etc.:
SUBJECT CATEGORY:
National Toxicology Program (NTP)
DOCUMENT 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 2122, 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 EC17, Research Triangle Park, NC, 27709, (phone) (919) 5413398, (fax) (919) 5410947, (email) niceatm@niehs.nih.gov. 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. 1627816279, 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
2122, 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. 106545, 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. 106545 directs the ICCVAM to coordinate the technical review of new, revised, and alternative test methods of interagency interest. The committee also coordinates crossagency 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. 0226733 Filed 102102; 8:45 am]
BILLING CODE 414001P
SUMMARY:
National Toxicology Program—; Validation of Alternative Methods (ICCVAM) Expert Panel Report on the Current Status of In Vitro Test Methods for Detecting Endocrine Disruptors,
DOCUMENT BODY 2:
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.