[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