On behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests public comment on nominations received for validation studies on four in vitro test methods. Following validation studies, these test methods may have the potential to reduce or replace animal use for regulatory testing. ICCVAM requests public comments on the appropriateness and relative priority of these activities. NICEATM also seeks data generated using in vitro
test methods relevant to the nominations, as well as relevant in vivo
Requests for comments and data were announced in a Federal Register
notice published May 23, 2011. The complete Federal Register
notice is available on the NICEATM-ICCVAM website at:http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/FR/FR-2011-12627.pdfNomination for the Detection and Quantification of Botulinum Neurotoxins
NICEATM seeks data generated using alternative test methods for detecting and quantifying botulinum neurotoxins (BoNT), including but not limited to three test methods nominated by BioSentinel Pharmaceuticals, Inc. (BioSentinel). Data from the standardized mouse LD50 assay currently used for these endpoints are requested for comparison.
Participants in a 2006 ICCVAM-sponsored workshop on alternative methods for botulinum toxin testing noted that some available methods might be useful as replacements for the standard mouse LD50 assay in the future given additional development and validation efforts. Following appropriate validation and demonstration of adequate performance, the three test methods nominated to ICCVAM by BioSentinel methods may have the potential to meet regulatory requirements for detection and quantification of BoNTs in a range of applications, thus reducing or replacing animal use in the standard assay.Nomination for the Detection of Non-Endotoxin Pyrogens
In addition, NICEATM seeks data generated using alternative test methods for identifying non-endotoxin pyrogens, including but not limited to the monocyte activation test, which was nominated to ICCVAM by Biotest AG. Data on non-endotoxin pyrogens tested in the rabbit pyrogen test are requested for comparison.
In a 2008 report on their evaluation of in vitro
methods proposed for assessing the potential pyrogenicity of pharmaceuticals and other products, ICCVAM noted that the evaluated test methods could be applicable for detection of a wider range of pyrogens than was included in their recommendations. ICCVAM thus recommended future studies that could expand the applicability of the test methods. In response to these recommendations, Biotest AG has nominated a commercialized version of one of these tests for additional validation studies to evaluate its usefulness for identifying non-endotoxin pyrogens.Public Comment Invited
Based on the information provided by the test method sponsors, ICCVAM proposes that the recently nominated activities are of sufficient interest and applicability to warrant further evaluation. ICCVAM's preliminary recommendation is that both nominations should have a high priority for further discussion to assess what information is needed to adequately characterize the usefulness and limitations of the proposed test methods, and any other similar in vitro
test methods, for these endpoints.
As part of the nomination review process, NICEATM invites public comments on these nominations and on the appropriateness and draft relative priority assigned by ICCVAM to the nominated activities. ICCVAM will finalize its recommendations on the priority of these nominations after considering comments received from the public and from the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), which will comment on the ICCVAM draft recommendations at its meeting in June 2011.
Comments on the nominations may be submitted via the NICEATM-ICCVAM website athttp://iccvam.niehs.nih.gov/contact/FR_pubcomment-Nom.htm
Comments may also be submitted via email to NICEATM at firstname.lastname@example.org
. Individuals or institutions interested in submitting data in response to this request are also encouraged to contact NICEATM via email for more information. Data submissions and comments are requested by July 7, 2011.
More information about the June meeting of SACATM is available on the National Toxicology Program website athttp://ntp.niehs.nih.gov/go/32822About NICEATM and ICCVAM
ICCVAM is an interagency committee composed of representatives from 15 U.S. Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of safety testing methods that more accurately assess the safety and health hazards of chemicals and products and that reduce, refine (decrease or eliminate pain and distress), or replace animal use. NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies.
ICCVAM has contributed to the approval or endorsement of over 40 alternative safety-testing methods by Federal regulatory agencies and international organizations since its establishment in 1997. Appropriate use of these test methods can significantly reduce animal use and improve animal welfare. ICCVAM has also identified critical research, development, and validation efforts needed to further advance numerous other alternative methods.
NICEATM and ICCVAM welcome nominations and submissions of alternative safety testing methods for validation studies and/or technical evaluations. Nominations and submissions are welcome from any individual or organization. Please contact NICEATM at email@example.com
for more information or to discuss a possible nomination or submission.
Additional information about other NICEATM and ICCVAM activities can be found on the NICEATM-ICCVAM website at http://iccvam.niehs.nih.gov/