[Federal Register Volume 73, Number 66 (Friday, April 4, 2008)]
[Notices]
[Pages 18535-18536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Non-Animal 
Methods and Approach for Evaluating Eye Irritation Potential for 
Antimicrobial Cleaning Products (AMCPs): Request for Nominations for an 
Independent Expert Panel and Submission of Relevant Data

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

ACTION: Request nominations for an independent expert panel and 
submission of relevant data.

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SUMMARY: At the request of the U.S. Environmental Protection Agency 
(EPA), the Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) is planning to assess the validation 
status of a proposed non-animal approach for evaluating the eye 
irritation potential of AMCPs that meets hazard classification and 
labeling requirements. On behalf of ICCVAM, NICEATM requests:
    1. Nominations of expert scientists to serve as members of an 
independent peer review panel.
    2. Submission of relevant data and information on AMCPs or related 
substances obtained from (1) human testing or experience including 
reports from accidental exposures, (2) rabbits using the standard eye 
test or the low volume eye test (LVET), and (3) in vitro test methods 
for assessing ocular irritation, such as the Bovine Corneal Opacity and 
Permeability (BCOP) test, the Cytosensor Microphysiometer (CM) test, 
and the EpiOcular test, and data supporting the accuracy and 
reproducibility of these methods.

DATES: Submit nominations and data by May 19, 2008. Data submitted 
after this date will be considered in the evaluation, if feasible.

ADDRESSES: Submit nominations and data to Dr. William S. Stokes, 
NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle 
Park, NC, 27709, (fax) 919-541-0947 (e-mail) [email protected]. 
Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 
3128, Research Triangle Park, NC, 27709. Responses can also be 
submitted electronically via the ICCVAM-NICEATM Web site (http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm).

FOR FURTHER INFORMATION CONTACT: Other correspondence should be 
directed to Dr. William S. Stokes (919-541-2384 or 
[email protected]).

SUPPLEMENTARY INFORMATION:

Background

    In June 2004, the EPA Office of Pesticide Programs informed NICEATM 
that they were developing, via a subgroup of the Pesticide Program 
Dialogue Committee, a non-animal assessment approach for evaluating eye 
irritation potential and labeling requirements for AMCPs. Subsequently, 
the EPA in collaboration with the Alternative Testing Working Group 
(ATWG) developed a non-animal approach for this limited group of 
products. The ATWG is comprised of seven consumer product companies 
(Clorox, Colgate Palmolive, Dial, EcoLabs, Johnson Diversey, Procter & 
Gamble, and SC Johnson). The Institute for In Vitro Sciences, Inc. 
(IIVS), which coordinated the EPA-ATWG collaboration, performed 
additional testing to complete parallel sets of in vivo and in vitro 
data, and prepared a background review document (BRD) describing the 
final approach. More information concerning this submission is 
available at: http://iccvam.niehs.nih.gov/methods/ocutox/AMCP.htm.
    In January 2008, IIVS submitted the BRD, An In Vitro Approach for 
EPA Toxicity Labeling of Anti-Microbial Cleaning Products, to NICEATM. 
The EPA and the ATWG requested that NICEATM and ICCVAM use information 
within the BRD to conduct a technical review of the proposed approach 
to determine whether ICCVAM could assure the EPA, with a reasonable 
degree of certainty, that the approach would be useful for making 
labeling decisions for AMCPs that appropriately inform the user.
    NICEATM and ICCVAM are now conducting a preliminary evaluation of 
the submission to determine its completeness and adherence to ICCVAM 
guidelines, which are available at http://iccvam.niehs.nih.gov/SuppDocs/SubGuidelines/SD_subg034508.pdf. If they decide to move 
forward with an evaluation, NICEATM and ICCVAM will convene an 
independent peer review panel to review the validation status of the 
proposed approach.

Request for Nominations of Scientific Experts

    NICEATM requests nominations of scientists with relevant knowledge 
and experience to serve on the peer review panel should it be convened. 
Areas of relevant expertise include, but are not limited to:
     Biostatistics
     Human and veterinary ophthalmology, with an emphasis on 
evaluation and treatment of chemical injuries
     In vivo ocular toxicity testing
     In vitro ocular toxicology
     Test method validation
    Each nomination should include the nominee's name, affiliation, 
contact information (i.e., mailing address, e-mail address, telephone 
and fax numbers), curriculum vitae, and a brief summary of relevant 
experience and qualifications. Nominations previously submitted to 
NICEATM in response to an earlier request for scientific experts for a 
possible peer panel review of in vitro ocular test methods used to 
evaluate AMCPs (Federal Register Vol. 70, No. 53, pp. 13512-13513, 
available at http://iccvam.niehs.nih.gov) do not need to be 
resubmitted.

Request for Data

    NICEATM invites the submission of relevant data and information on 
AMCPs or related substances obtained from (1) human testing or 
experience including reports from accidental exposures, (2) rabbits 
using the standard eye test or the low volume eye test (LVET), and (3) 
in vitro test methods for assessing ocular irritation, such as the 
Bovine Corneal Opacity and Permeability (BCOP) test, the Cytosensor 
Microphysiometer (CM) test, and the EpiOcular test, including data 
supporting the accuracy and reproducibility of these methods.
    Although data can be accepted at any time, data received by May 19, 
2008 will be considered during the ICCVAM

[[Page 18536]]

evaluation process. Relevant data received after this date will be 
considered during the ICCVAM evaluation process, if feasible. All 
information submitted in response to this notice will be made publicly 
available and may be incorporated into future NICEATM and ICCVAM 
reports and publications as appropriate.
    When submitting data, 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 that data be submitted as copies of pages from 
study notebooks and/or study reports, if available. Raw data and 
analyses available in electronic format may also be submitted. Each 
submission for a substance should preferably include the following 
information, as appropriate:
     Common and trade name
     Chemical Abstracts Service Registry Number (CASRN)
     Chemical and/or product class
     Commercial source
     In vivo or in vitro test protocol used
     Individual animal or in vitro responses at each 
observation time (i.e., raw data)
     The extent to which the study complied with national/
international Good Laboratory Practice (GLP) guidelines
     Date and testing organization
     Physical and chemical properties (e.g. molecular weight, 
pH, water solubility, etc.)

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, and replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 2851-3, 
available at (http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) established 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 following Web 
site: http://iccvam.niehs.nih.gov.

    Dated: March 24, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
[FR Doc. E8-6969 Filed 4-3-08; 8:45 am]
BILLING CODE 4140-01-P