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Notice

National Toxicology Program; National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Data on Non-Animal Methods and Approaches for Determining Skin and Eye Irritation Potential of Antimicrobial Cleaning Product Formulations; Request for Nominations for an Independent Expert Panel

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Information about this document as published in the Federal Register.

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AGENCY:

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

ACTION:

Request for data and nomination of panelists.

SUMMARY:

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM are requesting the submission of data that would assist in evaluating the validation status of non-animal methods and approaches used for determining the skin and eye irritation potential of antimicrobial cleaning product formulations to meet regulatory hazard classification and labeling purposes. Additionally, NICEATM is also requesting the nomination of scientists for consideration as potential members of an independent scientific expert panel (“Panel”) to evaluate the proposed methods and approaches. The ICCVAM will consider the conclusions and recommendations from the Panel in developing its recommendations on the validation status of these methods.

DATES:

Nominations and data should be received by noon on May 5, 2005.

ADDRESSES:

Nominations and data should be sent by mail, fax, or email to Dr. William S. Stokes, Director of NICEATM at NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) 919-541-2384, (fax) 919-541-0947, (e-mail) niceatm@niehs.nih.gov. Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709.

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FOR FURTHER INFORMATION CONTACT:

Dr. William S. Stokes, Director of NICEATM, (phone) 919-541-2384, (fax) 919-541-0947, (email) niceatm@niehs.nih.gov.

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SUPPLEMENTARY INFORMATION:

Background

In June 2004, the Environmental Protection Agency (EPA) asked ICCVAM to evaluate the validation status of proposed non-animal approaches for determining the skin and eye irritation potential of antimicrobial cleaning product formulations for meeting regulatory hazard classification and labeling requirements. ICCVAM considered the EPA's request and recommended that the evaluation of these non-animal approaches proceed as a high priority. ICCVAM agreed to work with the EPA and representatives of its Pesticide Program Dialogue Committee (PPDC) to help assure that the submission provided to ICCVAM contains all relevant information, data, and appropriate analyses as described in the “ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods” (NIH publication 03-4508). The NICEATM on behalf of ICCVAM plans to convene an independent scientific expert panel to review the submission, develop conclusions on the validation status of these methods, and make recommendations about the usefulness and limitations of these methods for their intended purpose. The date for the expert panel meeting has not been determined but will be announced in a future Federal Register notice.

Request for Data

Data, the nomination of experts, and other information submitted in response to this notice should be sent to NICEATM at the address given above. Data received by the deadline will be made available on the ICCVAM/NICEATM Web site at http://iccvam.niehs.nih.gov and considered by the Panel and ICCVAM.

When submitting data or information on protocols, please reference this Federal Register notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable). NICEATM prefers the submission of raw untransformed data in addition to any summary data including the submission of copies of pages from applicable study notebooks and/or study reports, if available. In vivo and in vitro data for each substance are preferred. Post-marketing surveillance data, ethical human studies, and accidental exposure reports also are sought when available and applicable. Each submission for a chemical or product should preferably include the following information when available:

  • Common and trade name.
  • Chemical Abstracts Service Registry Number (CASRN) for each ingredient of a formulation, and the percent composition of each ingredient.
  • Chemical structure.
  • Chemical class.
  • Product class.
  • Commercial source.
  • Test protocol used for either in vivo or in vitro testing.
  • The extent to which the study complies with national/international Good Laboratory Practice (GLP) guidelines.
  • Date and testing organization.

Request for the Nomination of Scientists for the Expert Panel

NICEATM invites the nomination of scientists with relevant knowledge and experience that can serve on the Panel to evaluate in vitro dermal and ocular toxicity test methods. Areas of relevant expertise include, but are not limited to: human and animal dermatotoxicology/ophthalmology with an emphasis on evaluation and treatment of chemical injuries, in vivo dermal/ocular toxicity testing, in vitro dermal/ocular toxicology, test method validation, and biostatistics. Each nomination should include the person's name, affiliation, contact information (i.e., mailing address, e-mail address, telephone and fax numbers), a brief summary of relevant experience and qualifications, and curriculum vitae, if possible. NICEATM and ICCVAM will also consider nominations previously submitted in response to a request for scientific experts for the evaluation of in vitro ocular test methods (Federal Register, Vol. 69, No. 57, pp. 13859-13861, March 24, 2004, available at http://iccvam.niehs.nih.gov/​) and do not need to be resubmitted.

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 (Pub. L. 106-545, available at http://iccvam.niehs.nih.gov/​about/​Start Printed Page 13513PL106545.htm) establishes ICCVAM as a permanent interagency committee of the NIEHS under the NICEATM. NICEATM administers the 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 can be found at the following Web site: http://iccvam.niehs.nih.gov.

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Dated: March 9, 2005.

Samuel Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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[FR Doc. 05-5471 Filed 3-18-05; 8:45 am]

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