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The U.S. Environmental Protection Agency (EPA) has collaborated with the Alternative Testing Working Group (ATWG) to develop a non-animal approach for
evaluating the eye irritation potential of antimicrobial cleaning products (AMCPs). 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) 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.
IIVS submitted this BRD, 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 reviewed the BRD and requested additional data and information prior to compiling an
ICCVAM Summary Review Document and ICCVAM recommendations. These documents were evaluated in May 2009
by an independent scientific peer review panel. The Panel also reviewed the validation status of the
in vivo low volume eye test, which is proposed as reference data to partially substantiate
the validity of the in vitro test methods used in the test strategy. ICCVAM will consider the peer
review panel's comments, as well as comments from the public and from the Scientific Advisory Committee on
Alternative Toxicological Methods, as it develops its final recommendations for U.S. Federal agencies.
Read the Peer Review Panel Report
[PDF]
Federal Register Notice:
Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing
Methods and Approaches: Notice of Availability and Request for Public Comments (74 FR 33444, July 13, 2009)
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
Federal Register Notice:
Announcement of an Independent Scientific Peer Review Panel on Alternative Ocular Safety
Testing Methods; Availability of Draft Background Review Documents (BRD); Request for Comments (74 FR 14566, March 31, 2009)
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
View Submission Letter from Dr. Rodger Curren, Institute for In Vitro Sciences, Inc. (IIVS)
to Dr. William Stokes, NICEATM [PDF]
Federal Register Notice:
Non-Animal Methods and Approach for Evaluating Eye Irritation Potential and Labeling Requirements for Antimicrobial
Cleaning Products (AMCPs): Request for Nominations for an Independent Expert Panel and Submission of Relevant Data (73 FR 18535, April 4, 2008)
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
Related Federal Register notice previously published
Federal Register Notice:
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 (70 FR 13512, March 21, 2005)
View Federal Register notice [PDF]
View comments submitted on Federal Register notice
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