In February 2012, ICCVAM forwarded final test method recommendations on the BG1Luc ER TA test method to U.S. Federal agencies for consideration (77 FR 8258), in accordance with the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3). The ICCVAM Authorization Act requires member agencies to review ICCVAM test method recommendations and notify ICCVAM in writing of their findings no later than 180 days after receipt of recommendations. The Act also requires ICCVAM to make ICCVAM recommendations and agency responses available to the public. Agency responses are to include identification of relevant test methods for which the ICCVAM test method recommendations may be added or substituted and indicate any revisions or planned revisions to existing guidelines, guidances, or regulations to be made in response to these recommendations.
ICCVAM agencies responded with their concurrence on the technical aspects of the BG1Luc ER TA test method recommendation and their agreement that the ICCVAM BG1Luc ER TA test method is a validated screening test to identify substances within vitroER agonist activity or ER antagonist activity. The EPA responded that they regard the BG1Luc ER TA test method as an alternative to the OCSPP 890.1300 test guideline for transcriptional activation currently used in their EDSP. Several agencies also indicated that they would communicate the ICCVAM recommendations to stakeholders and encourage their appropriate use. Complete agency responses are available athttp://iccvam.niehs.nih.gov/methods/endocrine/end_eval.htm.
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safetytesting information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological and safety-testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (enhance animal welfare and lessen or avoid unrelieved pain and distress), or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods and strategies applicable to the needs of U.S. Federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies applicable to the needs of Federal agencies. Additional information about NICEATM and ICCVAM can be found on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).
SACATM was established in response to the ICCVAM Authorization Act (42 U.S.C. 285l-3) and is composed of scientists from the public and private sectors. SACATM advises ICCVAM, NICEATM, and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods. Additional information about SACATM, including the charter, roster, and records of past meetings, can be found athttp://ntp.niehs.nih.gov/go/167.
ICCVAM. 2011. ICCVAM Test Method Evaluation Report: The LUMI-CELL® ER (BG1Luc ER TA) Test Method: AnIn VitroAssay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals. NIH Publication No. 11-7850. Research Triangle Park, NC: NIEHS. Available:http://iccvam.niehs.nih.gov/methods/endocrine/ERTA-TMER.htm.
Dated: August 13, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.