E6-19094. National Institute of Environmental Health Sciences; National Toxicology Program; NTP Interagency Center for the Evaluation of Alternative Toxicological Methods; Development of a NICEATM/ICCVAM 5-Year Plan To Research, Develop, Translate, ...

AGENCY:

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

ACTION:

Request for comments.

SUMMARY:

The NIEHS and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) request public comments that can be considered by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and agency program offices in development of a NICEATM/ICCVAM 5-year plan that addresses: (1) Research, development, translation, and validation of new and revised non-animal and other alternatives assays for integration of relevant and reliable methods into federal agency testing programs and (2) identification of areas of high priority for new and revised non-animal and alternative assays for the replacement, reduction, and refinement (less pain and distress) of animal tests.

DATES:

Submit comments on or before December 31, 2006.

ADDRESSES:

Comments should preferably be submitted electronically at the NICEATM/ICCVAM 5-Year Plan Web site: http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm. Comments can also be submitted by e-mail to [e-mail]. Written comments may also be sent by mail or fax to Dr. William S. Stokes, NICEATM Director, NIH/NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) 919-541-2384, (fax) 919-541-0947. Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION:

Background

Congress established ICCVAM to promote development, validation, and regulatory acceptance of new or revised alternative toxicological test methods that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness (42 U.S.C. 285l-3). Congress requests of NIEHS that NICEATM and ICCVAM in partnership with relevant federal agencies develop a 5-year plan that addresses (1) research, development, translation, and validation of new and revised non-animal and other alternative assays for integration into federal agency testing programs and (2) identification of areas of high priority for new and revised non-animal and alternative assays for replacement, reduction, and refinement (less pain and distress) of animal tests. At this time, the NIEHS and NICEATM seek public comments that can be considered by the ICCVAM and agency program offices in development of the plan. The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting at the NIEHS on November 30 will also provide an additional opportunity for public input (http://ntp.niehs.nih.gov/​go/​7441).

Request for Comments

The NIEHS and NICEATM invite public comments for consideration by ICCVAM and agency program offices in development of the NICEATM/ICCVAM 5-year plan. With regard to refining, reducing, and replacing animal use, ICCVAM has previously identified and ranked the types of regulatory safety tests that it considers should have the highest priority for the development and validation of alternative test methods.

1. Acute eye irritation and corrosion

2. Biologics/vaccines

3. Acute skin toxicity (including irritation/corrosion, sensitization, absorption)

4. Acute systemic toxicity (oral/dermal/inhalation)

5. Chronic toxicity/carcinogenicity

6. Reproductive/developmental toxicity

7. Endocrine disruptors

8. Neurotoxicity

9. Immunotoxicity

The NIEHS and NICEATM seek public input on the following questions. One of the elements that might be considered in answering questions 2-4 is the priority areas listed above.

1. Do you have comments on the priority areas for the development and validation of alternative test methods listed above?

2. Considering available science and technology, what development, translation, and validation activities are most likely to have the greatest impacts within the next five years on refining, reducing, or replacing animal use?

3. What research and development activities hold the greatest promise in the long-term for refining, reducing, or replacing animal use?

4. What are appropriate measures for evaluating progress in enhancing the development and use of alternative test methods?

Individuals submitting comments are asked to include appropriate contact information (name, affiliation, mailing address, phone, fax, email and sponsoring organization, if applicable). All comments received by December 31, 2006, will be posted on the ICCVAM-NICEATM Web site (http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm) and identified by the individual's name and affiliation and/or sponsoring organization, if applicable.

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 conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes scientific validation and regulatory acceptance of toxicological test methods that more accurately assess safety and hazards of chemicals and products and that refine, reduce, and replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, available at http://iccvam.niehs.nih.gov/​about/​PL106545.htm) 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. SACATM is a federally chartered advisory committee that provides advice to NICEATM, ICCVAM, and NIEHS on ICCVAM and NICEATM activities. Additional information about ICCVAM and NICEATM can be found at the following Website: http://iccvam.niehs.nih.gov. Information about SACATM is available at http://ntp.niehs.nih.gov/​go/​167.

Dated: November 2, 2006.

Samuel H. Wilson,

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