E7-24799. National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): Ten-Year Anniversary ...

AGENCY:

National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS.

ACTION:

Announcement of public symposium and availability of document.

SUMMARY:

NICEATM invites attendance at a public symposium to mark the tenth anniversary of ICCVAM. The symposium, entitled “Celebrating Ten Years of Advancing Public Health and Animal Welfare With Sound Science: Envisioning New Directions in Toxicology” will be held February 5, 2008, at the U.S. Consumer Product Safety Commission (CPSC) Headquarters in Bethesda, MD. The NICEATM-ICCVAM Five-Year Plan (2008-2012) will also be discussed and made available on February 5.

DATES:

The symposium will be held on February 5, 2008. Those interested in attending the symposium are encouraged to register with NICEATM by February 1, 2008, although registration will also be available on-site.

ADDRESSES:

The symposium will be held in the CPSC Hearing Room, located at CPSC Headquarters, Bethesda Towers Bldg., 4330 East West Highway, Bethesda, MD. Registration information and other details about the symposium can be found on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/​meetings/​10thAnnivSymp/​10thAnnivSymp.htm or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below). The NICEATM-ICCVAM Five-Year Plan will be available at the symposium and electronically on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm after February 5. Print copies may be obtained by contacting NICEATM.

FOR FURTHER INFORMATION CONTACT:

Ms. Debbie McCarley, NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail) [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The Director of the NIEHS established an ad hoc ICCVAM in September 1994 to respond to requirements in the NIH Revitalization Act of 1993 (42 U.S.C. 285 l-1, Public Law 103-43). This Act required NIEHS to establish criteria for the validation and regulatory acceptance of alternative toxicological testing methods. NIEHS was also required to recommend a process to achieve the regulatory acceptance of scientifically valid alternative test methods. The ad hoc ICCVAM was comprised of representatives from 15 Federal agencies, which are now represented on ICCVAM.

In 1997, the ad hoc ICCVAM published its final report, Validation and Regulatory Acceptance of Toxicological Test Methods. In the same year, NIEHS established a standing ICCVAM committee to implement a process by which new test methods of interagency interest could be evaluated and to coordinate cross-agency issues on development, validation, acceptance, and national and international harmonization of toxicological test methods. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l-3, Public Law 106-545) established ICCVAM as a permanent interagency committee of NIEHS under NICEATM. The law was enacted “To establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness.”

Over the last 10 years, ICCVAM, with scientific support from NICEATM, has evaluated over 185 test methods with the potential to reduce, refine or replace the use of animals in regulatory safety testing. ICCVAM has developed and transmitted recommendations to Federal agencies for alternative methods for the four most commonly used toxicity tests. These science-based technical evaluations have been used to support adoption of test methods as guidelines by the Organisation for Economic Co-operation and Development and other international organizations. NICEATM and ICCVAM have also worked with Federal agencies and other stakeholders to link research and development activities to the standardization and validation of alternative test methods that may be used in regulatory testing. The symposium on February 5, 2008, will recognize the 10-year anniversary of ICCVAM and discuss future directions in toxicology testing and the NICEATM-ICCVAM Five-Year Plan.

Preliminary Agenda

• Welcome
• ICCVAM and NICEATM: The First Ten Years
• A Vision Towards the Future: The NICEATM-ICCVAM Five-Year Plan
• The Evolution and Future of Toxicology: Where We've Come From and Future Prospects
• Toxicology Testing in the 21st Century: A Vision and a Strategy—A Report of the National Research Council of the National Academies
• Future Directions in Test Method Development—Toxicology Research, Development, Translation, and Validation: Insights and Activities from selected ICCVAM Agencies: NIEHS/NTP, EPA, FDA
• Panel Discussion—Toxicology Research, Development, Translation, and Validation: The Way Forward for ICCVAM and Its Stakeholders
• Closing Remarks

Symposium Attendance and Registration

The symposium will be held on Tuesday, February 5, 2008, from 1-5 p.m., in the CPSC Hearing Room, located at CPSC Headquarters, Bethesda Towers Bldg., 4330 East West Highway, Bethesda, MD. The symposium is open to the public and there is no charge to attend; attendance is limited only by the available space. Individuals who plan to attend are encouraged to register in advance with NICEATM. Registration information is available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/​meetings/​10thAnnivSymp/​10thAnnivSymp.htm or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT above). Persons needing special assistance in order to attend, such as sign language interpretation or other reasonable accommodation, should contact 919-541-2475 voice, 919-541-4644 TTY (text telephone, through the Federal TTY Relay System at 800-877-8339), or e-mail to [e-mail]. Requests should be made at least seven days in advance of the event.

NICEATM-ICCVAM Five-Year Plan

NICEATM and ICCVAM, working in conjunction with Federal agency program offices, have prepared the NICEATM-ICCVAM Five-Year Plan. The plan describes how NICEATM and ICCVAM will facilitate the research, development, translation (activities carried out to characterize if there is evidence of relevance and applicability of a test method for a specific testing purpose), validation, and regulatory acceptance of alternative test methods. Acceptance of such methods will reduce, refine, and replace the use of animals in testing, while maintaining scientific quality and the protection of human health, animal health, and the environment. Development of the plan took place over a 14-month period during which there were multiple opportunities for comment on the plan by ICCVAM stakeholders, the public, and the Scientific Advisory Committee on Alternative Toxicological Methods (see Federal Register notices: Vol. 71, No. 218, pp. 66172-73, November 13, 2006; Vol. 72, No. 83, pp. 23831-32, May 1, 2007; and Vol. 72, No. 83, pp. 23832-33, May 1, 2007).

The plan addresses ICCVAM's vision to play a leading role in fostering and promoting the development, validation, and regulatory acceptance of scientifically sound alternative test methods both within the Federal government and internationally. Implementing this plan involves four key challenges. The first challenge is to identify priority areas for the next five years and to conduct and facilitate activities in those areas. The second challenge involves identifying and promoting research initiatives that are expected to support the future development of innovative alternative test methods. The third challenge is to foster the acceptance and appropriate use of alternative test methods through outreach and communication. The last challenge is to develop partnerships and strengthen interactions with ICCVAM stakeholders in order to facilitate meaningful progress.

The NICEATM-ICCVAM Five-Year Plan will be presented at the February symposium and copies will be available. The NICEATM-ICCVAM Five-Year Plan will also be available electronically after February 5 on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm. Print copies may be obtained by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT above).

Background Information on ICCVAM and NICEATM

ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (available at http://iccvam.niehs.nih.gov/​docs/​about_​docs/​PL106545.pdf) establishes ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operational support for 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 is available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov.

Dated: December 12, 2007.

Samuel H. Wilson,

Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program.