These announcements were originally distributed via the NICEATM News email list. Subscribing to the NICEATM News email list will notify you directly of publication of NICEATM Federal Register notices, availability of ICCVAM reports, notices of upcoming meetings, requests for public comments or data, and other events of interest to our stakeholders.
In an effort to make information on NICEATM and ICCVAM activities more easily available to stakeholders, NICEATM has launched a new website. The new NICEATM website resides within the existing National Toxicology Program (NTP) website, reflecting NICEATM's increased involvement in NTP high-throughput screening and other activities. The site condenses summaries of past and current NICEATM and ICCVAM activities into a reduced number of webpages for easier navigation. The site also includes a section dedicated to ICCVAM processes and activities.
NICEATM Federal and contract support staff will continue to be actively involved in developing and maintaining content for the new NICEATM website. Please contact NICEATM webmaster Cathy Sprankle with questions or comments about the new site.
The U.S. Environmental Protection Agency (EPA) today announced the release of chemical screening data accessible through the new interactive Chemical Safety for Sustainability or iCSS Dashboard. The iCSS Dashboard provides access to data from innovative screening technologies for chemicals that are found in industrial and consumer products, food additives and drugs.
As part of this data release, EPA is announcing the ToxCast Data Challenges, a series of challenges inviting the science and technology community to work with the data and provide solutions for how the new chemical screening data can be used to predict potential health effects. Challenge winners will receive awards for their innovative research ideas.
For more information, visit these EPA websites:
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has published its recommendations on the use of the direct peptide reactivity assay (DPRA) for identification of potential skin sensitizers. The EURL ECVAM recommendation and other information about the DPRA can be found on the European Union's Institute for Health and Consumer Protection website.
The FDA Center for Devices and Radiological Health is organizing a workshop on methods used for thrombogenicity testing of blood-contacting medical devices. The workshop will be held on April 14, 2014, at the FDA White Oak campus in Silver Spring, MD, and there is no registration fee to attend. Please contact Dr. James Kleinedler at FDA for information.
Overview: The current thrombogenicity test paradigm relies heavily on animal studies. FDA has traditionally recommended a 4-hour in vivo canine thrombogenicity test model, but this paradigm has been called into question by subject experts due to inconsistent and unreliable results, as well as the expense to conduct this testing and animal welfare concerns. This workshop will bring together academia, industry professionals, and FDA regulators to discuss the advantages and limitations of both in vivo and in vitro thrombogenicity test methods. Workshop participants will discuss methods related to the testing of blood-contacting devices for a broad range of cardiovascular applications. Ideas generated during this workshop will facilitate development of new guidance and standards for thrombogenicity testing.
Agenda: A preliminary agenda includes the following topics: 1) Strengths and weaknesses of in vivo thrombogenicity test methods; 2) Current methodologies for conducting in vitro thrombogenicity testing (e.g. effective test endpoints, blood conditions, static vs. dynamic methods); 3) Correlation between in vitro/ in vivo thrombogenicity test results and clinical outcomes; and 4) Special testing considerations for catheters, stents, grafts, ventricular assist devices and bypass circuit components. The over-arching objective of the workshop is to review test methods that are likely to predict clinical thrombogenic potential of blood-contacting medical devices.
The UK’s National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) leads the discovery and application of new technologies and approaches to minimise the use of animals in research and improve animal welfare. The Centre funds research, supports training and development, and stimulates changes in regulation and practice.
The NC3Rs is currently accepting applications for its international 3Rs Prize 2013. The prize is awarded to recognize an outstanding primary research paper reporting an original scientific or technological advance with the potential for significant impact on one or more of the 3Rs (replacement, reduction and refinement of the use of animals in research). Sponsored by GlaxoSmithKline, the 3Rs Prize consists of a £18k grant, and a £2k personal award. Papers published in a peer-reviewed journal in any discipline between September 2010 and September 2013 are eligible. The main focus of the research paper does not have to be the 3Rs. Nominations are accepted from authors, colleagues and journal editors and will be considered by a prestigious judging panel. The prize is awarded to the principal investigator, research team leader, or other nominated author, and investigators outside of the UK are eligible to apply. Awards will be announced in February 2014.
For more information, visit the NC3Rs website. Deadline for nominations is December 11, 2013.
The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) is accepting public comments on draft recommendations for two non-animal test methods. The direct peptide reactivity assay is recommended as a screening test to identify substances with the potential to cause allergic contact dermatitis. The Bhas 42 cell transformation assay is recommended as a screening test to identify potential carcinogens.
The draft recommendations are available on the European Union Institute for Health and Consumer Protection website . EURL ECVAM is accepting comments on both draft recommendations through September 13. Comments may be submitted by email to JRC-ECVAM-CONTACT@ec.europa.eu.
In a Federal Register notice published July 29, NTP announced that it is accepting nominations of environmentally responsive genes and suggestions of criteria that could be used to prioritize these genes.
View complete notice — View text version of notice
NTP is planning to compile a comprehensive and prioritized list of environmentally responsive genes that might be targets for screening cell or tissues obtained from humans, rats, mice, zebrafish, and Caenorhabditis elegans against large numbers of substances. The goal is to generate a minimum list of 1000 genes for each species that would provide the maximal toxicogenomic information on (1) effects that reflect general cellular responses, independent of cell type or species, and (2) gene expression changes that are specific by organ and/or cell type.
Nominated genes and/or recommendations on prioritization criteria should be submitted electronically in Microsoft Excel or Word formats to Genelist@niehs.nih.gov. The submission deadline is August 23, 2013. For more information, please contact Dr. Elizabeth Maull.
The objective of this three-month Challenge is to build predictive models of cytotoxicity based on data obtained from in vitro studies in which lymphoblastoid cell lines derived from 884 individuals were exposed to 156 environmental toxicants and drugs. This computational Challenge aims to engage diverse communities of scientists in competitively solving one or both of two related subchallenges. In subchallenge 1, participants are asked to model interindividual variability in cytotoxicity based on genomic profiles in order to predict cytotoxicity in unknown individuals. In subchallenge 2, participants are asked to predict population-level parameters of cytotoxicity across chemicals based on structural attributes of compounds in order to predict median cytotoxicity and mean variance in toxicity for unknown compounds. Interested individuals can sign up to participate.
The Challenge closes on September 15, 2013. The top-scoring team(s) will be announced in November 2013. The winner of each subchallenge will be invited to speak at the 2013 DREAM conference to be held on November 8-12 in Toronto, Canada in conjunction with the Sixth Annual RECOMB/ISCB Conference on Regulatory and Systems Genomics.
In a Federal Register notice published March 12, the U.S. Consumer Product Safety Commission (CPSC) announced new guidance to clarify the definition of “strong sensitizer” as the term applies to substances and products regulated by the CPSC. The CPSC also issued a proposal to update the supplemental definition of “strong sensitizer” under the Federal Hazardous Substances Act (FHSA).
New Guidance on Strong Sensitizers
The CPSC guidance document is titled “Strong Sensitizer Guidance.” The CPSC issued the document to assist manufacturers of chemical products in understanding how the CPSC assesses whether such products might be strong sensitizers and thus require cautionary labeling under the FHSA. The document describes the types of data that the CPSC considers in making such a determination and available methods for generating such data. It notes that a determination that a particular product is a strong sensitizer must occur on a case-by-case basis and does not solely depend upon the presence of a strong sensitizer in the product.
Proposal to Update the FHSA
The CPSC proposal to update the definition of “strong sensitizer” under the FHSA would update the definitions for “sensitizer,” “significant potential for causing hypersensitivity,” “normal living tissue,” and “severity of reaction.” The goals of the updated definitions are to “eliminate redundancy, remove certain subjective factors, incorporate new and anticipated technology, rank the criteria for classification of strong sensitizers in order of importance, define criteria for ‘severity of reaction,’ and indicate that a weight-of-evidence approach will be used to determine the strength of the sensitizer.”
CPSC is accepting comments on the proposal through May 28, 2013. Instructions for submitting comments are included in the Federal Register notice announcing the proposal.
An editorial entitled "15 Years Out: Reinventing ICCVAM" by NIEHS and NTP Director Linda Birnbaum appeared in the Feb. 1 issue of Environmental Health Perspectives. In the editorial, Dr. Birnbaum summarizes the history and purpose of ICCVAM and notes that concerns have been raised about the lack of implementation of ICCVAM-recommended methods. She goes on to state that NIEHS is beginning to move forward with an approach that will allow ICCVAM's activities to be driven by the partner regulatory agencies. At the same time, NICEATM will expand its scope and begin to provide bioinformatic and computational toxicology support to NIEHS Tox21 projects, with the goal of better positioning ICCVAM to address how data from high-throughput assays can be integrated into the regulatory framework.
Dr. Birnbaum concludes the editorial by noting recent leadership changes at NICEATM. Dr. William Stokes, who has served as the director of NICEATM since its inception, retired from the Public Health Service in December 2012. Dr. Warren Casey, who has served as Deputy Director of NICEATM, is now acting director of NICEATM.
ICCVAM Committee response to the editorial (April 2013)