Announcements Sent to the NICEATM News List in 2015
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.
December 15: NICEATM and ICCVAM to Hold Forum at SOT
NICEATM Director Dr. Warren Casey and ICCVAM Co-chair Dr. Anna Lowit (U.S. Environmental Protection Agency) will lead a discussion forum on NICEATM and ICCVAM activities during next March’s Annual Meeting of the Society of Toxicology. The meeting is intended to be an open discussion of the challenges and opportunities to replace current regulatory requirements using animals. Participants are encouraged to bring forward for discussion specific examples of challenges to the implementation of alternatives within their organizations. The forum will be held Monday, March 14, 2016, from 5:00-6:00 p.m. in the Belle Chasse room of the Hilton New Orleans Riverside in New Orleans.
December 15: IIVS Workshop on In Vitro Exposure Assessment Tools for Inhaled Tobacco Products
The Institute for In Vitro Sciences is holding a workshop on In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products on April 4-6, 2016, in Bethesda, Maryland. Speakers from industry, government, academia, and nonprofits will discuss the current status of in vitro to in vivo correlations, whole tobacco smoke and e-cigarette aerosol/vapor constituents, in vitro exposure systems, dosimetry approaches, and the exposure microenvironment, as well as promising technologies that may advance science in these areas. Moderated breakout sessions and a poster session will provide opportunities to explore topics in greater detail; deadline for poster abstract submission is January 31. Early bird registration deadline is February 15; for more information and to register, visit the workshop website.
December 15: Registration Open for Pan-American Conference on Alternative Methods
The Center for Alternatives to Animal Testing at Johns Hopkins University School of Public Health will host the Pan-American Conference for Alternative Methods in Baltimore on April 12-14, 2016. This conference will bring together experts and stakeholders from across the Americas, with a focus on the Six Rs: Replacement, Reduction, Refinement, Read-across, Relevance, and Roadmaps. Although the agenda is still under development, those interested in attending are encouraged to register early, as attendance will be limited to 300 participants on a first-come, first-served basis. There will be no registration fee charged for attendance.
Abstracts are being accepted for oral and poster presentations; deadline is January 15, 2016. Your abstract should be emailed to email@example.com as a Microsoft Word document. Abstracts must include abstract title, complete author list indicating presenter and including contact information, and authors’ affiliations. Abstracts may include figures and references. Submitter should indicate whether the abstract is to be considered for an oral presentation.
For more information and to register, email Jamie DeRita at firstname.lastname@example.org.
December 15: Lush Prize Winners Announced
The Lush cosmetics company awards cash prizes every year to recognize key contributors towards replacing animal use for testing. This year’s awards, announced last month, included £250,000 to be shared among the Adverse Outcome Pathway (AOP) Programme of the Organisation for Economic Co operation and Development and four individual researchers for their contributions to advancing AOPs. A number of other prizes were awarded to researchers in recognition of their work to better understand toxicity mechanisms or develop novel testing systems. The complete list of prize winners is available on the Lush Prize website.
December 1: UK Roadmap for Advancing Non-animal Technologies Published
The National Centre for the 3Rs (NC3Rs) along with five partner organizations have developed “A Non-animal Technologies Roadmap for the U.K.” The document was developed to guide the efforts of those working to advance development of non-animal technologies in drug discovery, safety, and toxicology in the U.K. Recommendations in the document include fostering cross-sector collaborations, widening engagement to include those in a broader range of disciplines, engaging regulators in development and use of non-animal technologies, and establishing a strategic advisory board for these efforts. A link to the document is available on the NC3Rs website.
November 12: ECHA Requests Alternatives Information in Testing Proposals
In a November 2 press release, the European Chemicals Agency (ECHA) announced that it has started requesting alternatives information from registrants who submit new testing proposals for vertebrate animal tests. This action responds to a proposal from the European Ombudsman addressing complaints that ECHA was not fulfilling its obligations to ensure the avoidance of unnecessary animal testing. In addition to requesting information about consideration of alternatives, ECHA will provide registrants with all the information at its disposal which could allow them to avoid animal testing.
ECHA is the European agency charged with administering the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, which requires chemical manufacturers to assess and manage the risks posed by chemicals and provide appropriate safety information for their users. Information received from registrants on consideration of alternative tests will be published together with the testing proposals on ECHA's testing proposals consultation web page. ECHA will report in March 2016 on additional steps taken in response to the Ombudsman’s proposal.
November 2: Report on 2014 UK Animal Use Available
The 2014 edition of the “Annual Statistics of Scientific Procedures on Living Animals” was released October 22 by the UK Home Office. This report satisfies a requirement in the U.K. Animals (Scientific Procedures) Act 1986 “to collect and publish statistical information on the use of protected animals in regulated procedures during the previous calendar year and to lay that information before Parliament.” “Protected animals” are defined as any living vertebrate other than man and cephalopod species. Therefore, this report represents a comprehensive snapshot of animal use for experimental, educational, or other scientific purposes.
November 2: Summit on Animals, Public Health, and Ethics December 9-10
The Johns Hopkins University (JHU) Bloomberg School of Public Health’s Group on the Integration of the Relationship between Animals, Public Health and Ethics is holding a Summit on Animals, Public Health and Ethics on Dec. 9-10 to kick off a collaboration to explore the intersection of animal, human, and environmental health. Topics to be discussed include animal models of human disease, food animals and public health, zoonotic diseases and public health, and ethics of the human use of animals. The Summit will be held in Feinstone Hall at JHU in Baltimore, and there is no charge to attend.
October 19: USDA Issues Guidance for Reducing Animal Use for Vaccine Testing
The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) recently issued CVB Notice 15-13, Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae. The notice describes an exemption from the titration requirement in vaccination-challenge potency assays for Leptospira Serogroups Canicola and Icterohaemorrhagiae. Removal of the back-titration hamsters could reduce animal use by 50% for potency testing on these two fractions. The policy is effective Oct. 8. CVB Notice 15-13 is available on the USDA website.
October 19: EURL ECVAM Issues Status Report on Alternative Methods Activities
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has published a comprehensive report on recent activities related to human and ecological health, the development and validation of alternative methods, information dissemination, and regulatory implementation. The report includes summaries of EURL ECVAM's activities in the Adverse Outcome Pathway Programme of the Organisation for Economic Co-operation and Development, status updates on all of the methods recently submitted for review, databases of test methods and validation reference chemicals, and collaborations with other organizations. The report is available on EURL ECVAM’s website.
October 19: National Academy of Sciences to Examine Low-dose Toxicity
A new committee of the National Academy of Sciences will examine whether the current toxicity testing practices of the U.S. Environmental Protection Agency (EPA) adequately consider adverse human health effects of low doses of endocrine-active chemicals. Committee activities will include convening a scientific workshop to support systematic reviews of human and animal toxicology data for chemicals that affect the estrogen or androgen system. The committee will also consider how to use adverse outcome pathway (AOP) or other mechanistic data, including high-throughput data and pharmacokinetic information, to elucidate under what circumstances human and animal data may be concordant or discordant.
The committee held its first meeting Oct. 13; the next meeting will be on Nov. 17–18 in Washington, D.C. Information on the committee, including links to information about upcoming meetings and a list of committee members, is available on the National Academies website.
October 2: Workshop on In Vitro Tools for Assessment of Tobacco Products
The Institute for In Vitro Sciences (IIVS) will present a workshop on In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products on April 4-6, 2016, in Bethesda, Maryland. Speakers from industry, government, and academia will present on topics including tobacco smoke and e-cigarette aerosols, in vitro exposure systems that incorporate an air–liquid interface, and dosimetry approaches for particles and vapors. Registration and poster abstract submission will open December 1; refer to the IIVS website for updates.
September 16: Winners of In Vitro Inhalation Test Award Announced
The PETA International Science Consortium Ltd. (PISC) recently announced the winners of a $200,000 award for the design of an in vitro test to predict the development of lung fibrosis in humans following exposure to nanomaterials, such as multi-walled carbon nanotubes. Investigators at the University of Fribourg (Switzerland) and Heriot-Watt University (United Kingdom) will jointly develop the test method. PISC will also support MatTek Corporation’s development of a 3-D reconstructed primary human lung tissue model to be used in the method.
The three laboratories were chosen based on their qualifications to meet the study design recommendations, which were developed at an expert working group meeting co-organized by PISC and NICEATM. The February 2015 meeting was attended by international experts from government, industry, academia, and nonprofit organizations and was held at EPA headquarters in Washington, D.C. The long-term goal is to develop additional in vitro assays and computer models that can be used in combination to predict the inhalation toxicity of nanomaterials. Visit the PISC website for more information about the February 2015 expert working group meeting.
September 16: Updated 3Rs Websites Available
The 3Rs-Centre Utrecht Life Sciences has updated two websites that support reduction of laboratory animal use and refining animal experiments. Both websites can help researchers with the alternatives literature searches required when planning experiments.
- The Interspecies Database enables comparisons of physiological, anatomical and biochemical parameters of different animal species and humans. By using the database, researchers can choose the animal model for their experiments that best approximates the human situation. This saves time, money, and laboratory animals, and improves scientific research quality. Users of the database have reported an average annual 20% reduction in animal use, with some users reporting a 40% reduction in animal use.
- The Humane Endpoints website provides insights into the recognition and application of humane endpoints in rodents and supports efforts to prevent unnecessary suffering in laboratory animals. The website offers information, videos, and photographs of rodent species; users who complete free registration can also access training modules. These resources have been used in laboratory animal sciences courses worldwide.
Both website updates are projects of the newly established 3Rs-Database program of the 3Rs-Centre Utrecht Life Sciences (ULS). The 3Rs-Centre ULS is part of the department of Animals in Science and Society, faculty of Veterinary Medicine, Utrecht University. Its mission is to stimulate the development, acceptance, and implementation of 3Rs methods within academia, government, and industry in The Netherlands. Read the press release announcing the launch of the updated databases
August 25: NIH Presents Conference for Small Business Grant Applicants
The National Institutes of Health (NIH) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Conference will be held in Seattle, Washington, on October 27–29. This event is the largest annual conference for SBIR/STTR applicants. Presentations will provide overviews of Department of Health and Human Services (HHS) SBIR/STTR programs, funding opportunities, and the application review process. The agenda is organized into tracks so that attendees with a range of experience levels and business objectives can all benefit from attending the conference. Attendees will also have an opportunity to network with and get advice from SBIR/STTR staff of several HHS agencies.
View information about the conference
NIH is also presenting a Regional Seminar on Program Funding and Grants Administration on October 14–16 in San Diego, California.
August 25: New OECD Test Guidelines Available
In July, the Organisation for Economic Co-operation and Development (OECD) adopted four new test guidelines:
- Test No. 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene
- Test No. 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
- Test No. 492: Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
- Test No. 493: Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity
OECD also published updates of 11 previously adopted test guidelines for assessing a wide range of chemical hazards. Most of the new or updated test guidelines describe methods with the potential to reduce or replace animal use for chemical testing.
OECD test guidelines represent internationally agreed-upon testing methods used by government, industry, and independent laboratories to characterize potential chemical hazards.The new and updated test guidelines are available on the OECD iLibrary website.
August 19: Nature Biotechnology Paper Reports Results of Crowdsourcing Challenge
An international study published in Nature Biotechnology presents the combined results of a crowdsourcing initiative to test how well the effects of a toxic compound can be predicted in different people. The study shows that computational methods can be used to predict some toxic effects on populations, although they are not yet sensitive enough to predict such effects in individuals. It also presents algorithms useful for environmental risk assessment.
The community-based challenge, known as the DREAM Toxicogenetics Collaboration, was led and organized by scientists from NIEHS, EMBL-EBI, Sage Bionetworks, IBM, the University of North Carolina, and the NIH’s National Center for Advancing Translational Sciences. Hundreds of computational biologists from all over the world tried their hand at predicting the toxicities of environmental compounds that had potential adverse health effects. One key benefit of the study is that it offers new methodologies for improvements in some areas of hazard evaluation and assessment.
August 7: Report Outlines Predictive Toxicology Approach for Defense Applications
The National Academies Press has issued a report on “Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense.” Prepared in response to a request by the U.S. Department of Defense, the report provides a conceptual approach that could be used to evaluate chemicals that could pose threats to deployed personnel. In addition to providing an overview of current computational and high-throughput testing approaches and methods for integrating data and predictions, the report summarizes lessons learned from current high-throughput screening programs and suggests initial steps for investment. The report can be read online or downloaded as a PDF for free.
August 7: Call for Proposals for New Users or New Applications of In Vitro Tissue Models
The PETA International Science Consortium Ltd. (PISC) and MatTek Corporation are offering 3-D reconstructed human tissue models – for free! PISC is offering three awards of $5000 each to proposals of sound scientific merit that show potential to reduce or replace animal testing. Awards will be redeemable for human cell-based tissue models from MatTek Corporation. Proposals can address one of two options:
- Option 1: New experimental applications: Open to any researcher or company in North America and Europe, these proposals will describe applications for MatTek’s dermal, ocular, respiratory, intestinal, oral, or vaginal tissue models in new in vitro regulatory test methods or research areas that have historically used animals.
- Option 2: New users: Open only to researchers and companies in North America and Europe that have not previously used MatTek tissues, these proposals will allow grantees to become proficient in the use of the EpiDerm and EpiOcular models for regulatory testing.
More information on the awards is available on the PISC website. Proposals are due by October 5; winners will be announced by November 2.
July 28: NIH Invites Comments and Suggestions on a Framework for the NIH-wide Strategic Plan
In order to advance its mission, NIH is developing an NIH-wide Strategic Plan. The goal of this 5-year plan is to outline a vision for biomedical research that ultimately extends healthy life and reduces illness and disability. NIH senior leadership and staff have developed a proposed framework for the Strategic Plan that identifies areas of opportunity across all biomedicine and unifying principles to guide NIH’s support of the biomedical research enterprise. The aim is to pursue crosscutting areas of research that span NIH’s 27 Institutes, Centers, and Offices. The Strategic Plan is due to the Congress in late December 2015.
NIH published a Request for Information (RFI) seeking input from stakeholders throughout the extramural community and the general public regarding the Framework for the 5-year NIHS-wide Strategic Plan on July 22, 2015. Feedback to the RFI may be submitted through the NIH Grants website. Comments are due by August 16.
June 29: EPA Requests Comments on Use of High-Throughput Assays for EDSP
The Environmental Protection Agency (EPA) requests comments on a plan to incorporate validated ToxCast/Tox21 high-throughput assays and an associated computational model as an alternative to three Tier 1 tests used in its Endocrine Disruptor Screening Program (EDSP) to assess estrogenic activity. Described as “groundbreaking” in an EPA press release (available at http://go.usa.gov/3vPsz), the use of high-throughput assays and computational methods will accelerate the pace of screening, decrease costs, and reduce animal testing. The EPA plan was developed and validated by EPA and NICEATM scientists and is described in detail in a paper by Browne et al. in the journal Environmental Science and Technology. Comments on the plan are requested by August 18.
June 29: USDA Requests Comments on Petition to Revise Animal Use Reporting Requirements
The Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) has received a petition from the National Anti-Vivisection Society (NAVS) to increase the level of detail in information collected from research facilities in their reports on animal use. NAVS is asking that the annual report required under the Animal Welfare Act include more information on how animals are being used for research and experimentation.
APHIS is soliciting comments to help determine what action, if any, to take in response to this request. In particular, APHIS invites responses to the following questions. Comments are requested by August 24.
- Should APHIS amend the regulations to require research facilities that use animals for teaching, testing, and experimentation to provide specific information about how regulated animals are used (for example, for safety testing, teaching purposes, or disease research)? Would reporting this information improve animal welfare? If so, how?
- If research facilities were required to report the purposes of their animal research activities, what types of information should be provided, and why?
- What might be the effects, if any, on research facilities if they are required to collect and report this additional information?
- Does the annual reporting form currently required to be used by research facilities capture sufficient information? If not, what information is missing?
June 11: EPA Updates Guidance on Non-Animal Eye Irritation Tests
The U.S. Environmental Protection Agency (EPA) has updated its guidance document describing a non-animal testing scheme for assessing eye irritation potential of EPA-registered antimicrobial cleaning products. The testing scheme uses the bovine corneal opacity and permeability, EpiOcular, and cytosensor microphysiometer assays to identify antimicrobial cleaning product Toxicity Category I, II, and III eye irritants.
June 11: Partners Sought for Development of Botulinum Neurotoxin Test
Researchers from the University of Freiburg, Germany, have developed a novel automated bioluminescence assay (BLB-Test) for detecting botulinum neurotoxin. The BLB-Test has the potential to replace the standard mouse lethality bioassay currently used for detection of botulinum neurotoxin in animal, food, and environmental samples. The developers are seeking partners to validate and commercialize the assay, and the National Centre for the Replacement Refinement and Reduction of Animals in Research (NC3Rs) has issued a “CRACK IT” challenge to identify potential partners. Funding is available until October 27.
June 11: June 17 Webinar Provides Introduction to QSAR Toolbox
QSAR Toolbox is a software application developed by the Organisation for Economic Co‑operation and Development to make quantitative structure–activity relationship (QSAR) tools more readily available, usable, and transparent. The European Chemicals Agency (ECHA) will present an “Introduction to OECD QSAR Toolbox Webinar” on June 17. The webinar will review the QSAR Toolbox workflow and present examples that use the QSAR Toolbox to assess skin sensitization and short-term fish toxicity hazards. The webinar will take place from 11 a.m. to 2 p.m. Helsinki time (please note that this is 4:00 to 7:00 a.m. EDT). Information and a link to registration are available on the ECHA website; webinar presentations will also be posted on this page after the webinar.
June 11: NASA Requests Information for Tissue Engineering Challenge
The U.S. National Aeronautics and Space Administration (NASA) is seeking input on a Tissue Engineering Challenge being considered for 2015. Competitors in the challenge would create thick tissue constructs with cells performing functions of one of the four major solid organs (heart, lung, liver, kidney) and remaining alive long enough to advance scientific research capabilities. The purposes of the current Request for Information are (1) to gather feedback on the challenge being considered, (2) to determine the potential level of interest in this challenge, and (3) to understand how technology emerging from the challenge could be used in non-government applications. NASA welcomes responses to this request from all segments of industry, academia, and government. Responses to this request are due July 11.
May 29: ASCCT Annual Meeting to be Held October 1-2 in RTP
The 4th Annual Meeting of the American Society for Cellular and Computational Toxicology will be held October 1–2 at the Environmental Protection Agency in Research Triangle Park, North Carolina. The theme of the meeting is “Integrated Approaches to Testing and Assessment: Promises and Challenges of a More Flexible Approach to Toxicity Testing,” and the program will include presentations of case studies that apply integrated approaches to testing and assessment. Plenary speakers will include NICEATM Director Warren Casey speaking on “Moving Beyond One Test: Leveraging the Whole Toolbox for Integrated Decision Strategies,” and Craig Rowlands of The Dow Chemical Company speaking on “Chemicals and Risk: New Approaches to Current Practices.” There will also be a poster session and oral presentations selected from submitted abstracts; abstract submission deadline is July 15. More information will be available soon on the ASCCT website.
May 29: Training Materials Available for QSAR Toolbox
QSAR Toolbox is a software application developed by the Organisation for Economic Co operation and Development to make quantitative structure–activity relationship (QSAR) tools more readily available, usable, and transparent. Training materials for QSAR Toolbox are now available. These include tutorial slide sets with step-by-step instructions describing how to use QSAR toolbox for a number of applications, including predicting skin sensitization potential, aquatic toxicity, and Ames mutagenicity. There are also video tutorials available for some applications.
May 29: Webinar to Address Regulatory Acceptance of Non-Animal Tests
The PETA International Science Consortium (PISC) and Chemical Watch newsletter have teamed up to present a series of webinars on modern testing strategies for REACH. The last of these webinars, “Regulatory Processes Involved in Acceptance of Non-Animal Tests” will be presented on June 10 at 10 a.m. U.S. Eastern Time. Speakers will include Derek Knight, senior scientific advisor to the European Chemicals Agency, and Karin Kilian, policy officer for the environment directorate of the European Commission. A link to register for the upcoming webinar and links to recordings and slides of past webinars in the series are available on the PISC website.
May 21: USDA Updates Guidelines for Validation of In Vitro Potency Assays
The U.S. Department of Agriculture Center for Veterinary Biologics (USDA CVB) recently updated Veterinary Services Memorandum No. 800.112, “Guidelines for Validation of In Vitro Potency Assays.” This memorandum provides guidance concerning the information a manufacturer of veterinary vaccines and other biological products should provide when submitting a new potency assay for consideration by the CVB. These guidelines apply to in vitro assays used to determine the potency of such products, and provide a framework for designing in vitro potency assays and the studies needed to validate those assays. Use of in vitro assays may replace, reduce, or refine animal use for this purpose.
Veterinary Services Memorandum No. 800.112 and other recently published CVB documents are available on the USDA website.
May 5: May 14 Webinar on Regulatory Acceptance of Alternative Methods
The Mid-Atlantic Society of Toxicology will present a webinar on “Regulatory Acceptance of Alternative Methods: Current Status and Future Directions.” NICEATM Director Warren Casey will speak on “Predicting in vivo effects using in vitro data: the future of alternatives.” Other speakers include George DeGeorge of MB Research Labs, Rodger Curren of the Institute for In Vitro Sciences, and Thomas Hartung of the Johns Hopkins Center for Alternatives to Animal Testing. The webinar will be presented on May 14 from 10:00 a.m. to 12:00 p.m.
May 5: FDA to Discuss Topics in Advance of International Meeting
The Food and Drug Administration (FDA) is holding a regional public meeting on May 15, 2015, to provide information and receive comments in advance of the steering committee and working group meetings of the International Conference on Harmonization (ICH) to be held in June in Fukuoka, Japan.
May 5: ECHA Issues Advice on Skin Sensitization Tests
The European Chemicals Agency (ECHA) has published advice on the use of non-animal skin sensitization tests to fulfill European testing requirements including Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Two non-animal tests covered by the ECHA advice were adopted as test guidelines in February by the Organisation for Economic Co-operation and Development (OECD). The two methods are the direct peptide reactivity assay and the Keratinosens ARE-Nrf2 luciferase test method. The human cell line activation test, which is also discussed in the ECHA advice, is still being considered by OECD and is available in draft form.
April 30: Welcome to NICEATM News!
Welcome to the new “NICEATM News” listserv. We have switched to this new listserv to enhance our communications with you. The new listserv will provide us with more capability, such as the ability to attach files to notices. As a subscriber to the “ICCVAM-all” listserv you have been automatically subscribed to the new listserv. If you have any questions, let us know at NICEATMNews@mail.nih.gov.
April 23: NTP Requests Comments on Human "S1500" Gene Set
NTP requests comments on a set of human genes that have been identified and prioritized as environmentally responsive genes. This set of approximately 1500 "sentinel" genes was developed with input from the scientific community, to be used in toxicogenomics studies to screen human cells or tissues against large numbers of chemicals and evaluate transcriptional changes in response to chemical exposures. The goal is to develop a gene set that (1) is representative of highly diverse gene expression changes reported to date, (2) is capable of predicting the gene expression changes observed across the transcriptome, and (3) covers all major biological pathways.
The current version of the human S1500 gene set can be found on the NTP website. This site will be updated as changes to the list are made. The consensus strategy for selection of an appropriate sentinel gene set can be accessed at the same site. Comments on the gene set should be submitted as Microsoft Word or Excel files to Genelist@niehs.nih.gov by May 15.
April 14: FDA Science Forum
The FDA will hold a Science Forum on May 27-28 at their White Oak Campus in Silver Spring, Maryland. The Forum will highlight the FDA’s cutting-edge research, demonstrate how this research informs FDA’s regulatory decision-making, and provide an opportunity for internal and external participants to develop collaborations. The focus of this year’s Forum will be FDA’s eight Regulatory Science priority areas, one of which is “Modernize Toxicology to Enhance Product Safety.”
The Forum is open to FDA staff, FDA collaborators, and the public; you may attend in person or view presentations remotely. There is no registration fee, but in-person and remote attendees must register by May 15, and early registration is recommended for in-person attendees as seating is limited. More information and links to registration forms are available on the FDA website.
April 14: UK Issues Update on Animal Reduction in Scientific Research
The United Kingdom Home Office and partner agencies have published a report, "Working to Reduce the Use of Animals in Scientific Research: Delivery Report." This document describes progress on actions set out in the similarly titled "Delivery Plan" published in February of 2014. The document is available on the Gov.UK website.
March 18: Request for Proposals for In Vitro Method Development
The PETA International Science Consortium Ltd. (PISC) is accepting proposals for funding of the development and preliminary validation of in vitro methods for hazard assessment of inhaled aerosolized multiwalled carbon nanotubes. This request builds on recommendations from a February workshop at which experts from various sectors and disciplines considered requirements for in vitro models for this purpose and made recommendations on cell types, exposure systems, endpoints, and dosimetry considerations for such systems. For more information and an application form, please visit the PISC website. The deadline for proposals is May 29.
March 18: Webinar to Describe Tools for In Vitro to In Vivo Extrapolation
A webinar titled “COSMOS: Automated In Silico Tools for In Vitro to In Vivo Extrapolation,” will be presented on April 13 at 10:00 AM U.S. Eastern Time. EURL ECVAM scientists will provide the latest information on computational tools developed by the COSMOS project (http://www.cosmostox.eu/) within the Seurat 1 cluster (http://www.seurat-1.eu/). These automated tools can be used to extrapolate from in vitro concentration to in vivo human exposure doses or viceversa, in order to perform a better risk assessment. These tools are based solely on in vitro and in silico predictions thus promoting the 3Rs approaches.
Feb. 27: National Library of Medicine Seeks Input on Mission and Vision
The National Library of Medicine (NLM) has issued a Request for Information on the current value and future need for NLM programs, resources, research and training efforts, and services such as databases, software and collections. Input is requested from the general public and specifically from stakeholder groups such as researchers, health professionals, and individuals or institutions that use NLM services. Of particular interest is input on how NLM could better position itself to address challenges associated with biomedical informatics, big data, data science, electronic health records, and digital publications. Responses will be considered by a working group of the Advisory Committee to the NIH Director as part of a process of articulating a new strategic vision for NLM. The complete Request for Information can be found on the NIH website. Responses are requested by March 13.
Feb. 27: New Version of OECD QSAR Toolbox Available
QSAR Toolbox is a software package developed by the Organisation for Economic Co-operation and Development (OECD) to make quantitative structure–activity relationship (QSAR) technology readily accessible, more transparent, and less costly, thereby increasing regulatory acceptance of QSAR analyses. An update of the QSAR Toolbox (version 3.3.2) is now available. The update contains some new scientific features, including improvement and modifications of the general mechanistic Cramer schemes, as well as bug fixes and usability improvements. QSAR Toolbox can be downloaded from the QSAR Toolbox website, where you can also find the release notes with the change log and an upgrade manual for this new version.
Feb. 10: EPA Requests Comment on Three Draft Test Guidelines
The U.S. Environmental Protection Agency requests comment on three draft test guidelines in its 890 Series, “Endocrine Disruptor Screening Program Test Guidelines.” The draft guidelines relate to the following three non-mammalian species tests identified under Tier 2 of the Endocrine Disruptor Screening Program: Japanese quail 2-generation reproduction test; Medaka extended 1-generation reproduction test; and Larval amphibian growth and development assay. The draft test guidelines and supporting documents are available on the Regulations.gov website. Comments are requested by March 31.
Feb. 10: OECD Publishes New Test Guidelines for Skin Sensitization
The Organisation for Economic Cooperation and Development recently published Test Guideline 442C, “In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA),” and Test Guideline 442D, “In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method.” Both test methods are available on the OECD ILibrary website.
Feb. 10: FDA Hosts Workshop on Systematic Review
The U.S. Food and Drug Administration will hold a workshop titled “What is Systematic Review? An Introductory Course” on March 9 at the Center for Food Safety and Applied Nutrition in College Park, Maryland. This workshop will present a framework for systematic review and evidence integration for reaching hazard identification conclusions.
Feb. 10: Upcoming Alternatives Assessment Webinars
Registration is now open for two upcoming Alternatives Assessment webinars. On Tuesday, February 17, a webinar on "The Use of QSARs, Read-Across, and Analogue Approaches to Inform Decision-Making in Alternatives Assessments" will be presented by Dr. Jay Tunkel and Ms. Cathy Rudisill of SRC, Inc. On Thursday, February 26, a webinar on "Alternatives Assessment Under REACH: Lessons Learned" will be presented by Theirry Nicot and Dennis Mottet of the European Chemicals Agency, Julius Waller of the EPPA, and Tatiana Santos of the European Environment Bureau..
Feb. 4: Webinar on Acute Toxicity Testing March 5
The PETA International Science Consortium, Ltd., and Chemical Watch are presenting a webinar series focused on alternative methods and testing strategies that can be used to meet REACH requirements. The fifth of these webinars, which focuses on acute systemic toxicity, will be presented March 5 from 11 a.m. to 12 p.m. U.S. Eastern Time. Dr. Pilar Prieto, European Union Reference Laboratory on Alternatives to Animal Testing (EURL ECVAM), will present on EURL ECVAM’s recently released strategy to replace, reduce and refine the use of animals in the assessment of acute mammalian systemic toxicity. Following Dr. Prieto’s talk, Dr. Lawrence Milchak from 3M will speak to industry experiences on the use of alternative strategies to meet acute toxicity testing requirements.
Information about the webinar and a link to registration are available on the Chemical Watch website. Information about the webinar series and links to recordings of past webinars are available on the PETA International Science Consortium website.
Feb. 4: FDA Issues Guidance on Photosafety Testing
The U.S. Food and Drug Administration (FDA) has issued guidance document “S10 Photosafety Evaluation of Pharmaceuticals.” This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. An announcement of availability of guidance was published in the January 27 Federal Register.
Feb. 4: Survey Requests Input on Methodologies for Risk Assessment of Mixtures
The European Commission's Joint Research Centre (JRC) is conducting a survey to collect information on expert experiences and opinions on methodologies for the risk assessment of chemical mixtures. The survey is primarily addressed to experts in authorities, academia, NGOs, consultancy and industry who are involved in the risk assessment (human or environmental) of chemical mixtures. However, JRC is making the survey available to, and welcomes responses from, anyone with a general interest in the issue. The survey is available on the JRC website and will take approximately 20 minutes to complete. Responses are requested by February 28.
Jan. 26: Genotoxicity Dataset Now Available from EURL ECVAM
The Carcinogenicity Genotoxicity eXperience (CGX) dataset is now available on the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) website. The CGX dataset is a collection of publicly available data that can be used for a variety of scientific purposes including structural-based evaluation of chemical genotoxicity and the development of alternative approaches to animal testing such as structure-activity relationships.
Jan. 26: Grants Available from the Alternatives Research and Development Foundation
The Alternatives Research and Development Foundation (ARDF) is soliciting proposals for its 2015 Alternatives Research Grant Program. Grants of up to $40,000 are available to support individual projects of scientific merit and feasibility with potential to significantly reduce or replace laboratory animal use. Preference will be given to projects at U.S. universities and research institutions and projects that use pathway-based approaches. Application deadline for the grants is April 30, 2015.
Jan. 26: Opportunity Available for Development of Aptamer Technologies
OPPORTUNITY AVAILABLE FOR DEVELOPMENT OF APTAMER TECHNOLOGIES
The NC3Rs “CRACK IT” project is seeking collaborators to join with the Aptamer Group on projects to develop aptamers to replace antibodies, to develop new applications for aptamers, and to produce relevant proof-of-concept data. Funding is available until June 17, 2015. For more information, visit the CRACK IT website.
Jan. 26: FutureTox III Conference to be Held November 19-20, 2015
The Society of Toxicology (SOT) will hold its third FutureTox conference on November 19-20, 2015, at the Hilton Crystal City in Arlington, Virginia. The conference, titled “Bridges for Translation—Transforming 21st Century Science into Risk Assessment and Regulatory Decision-Making,” will include plenary and poster presentations as well as topical breakout groups. The overarching objectives of the meeting include advancing the cornerstones for high-throughput risk assessment; taking in vitro data and in silico models forward while reducing reliance on animal testing; and exploring progress and identifying challenges in implementing the emerging “big data” toolbox for regulatory decision-making. A link to the conference website will be available soon on the SOT website.
Jan. 16: Workshop on In Vitro Tools and Models for Drug Discovery
A free workshop on “Validation and Qualification of New In Vitro Tools and Models for the Pre-clinical Drug Discovery Process” will be presented at the National Institutes of Health (NIH) on February 12. The workshop is being organized by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) in partnership with the American Institute for Medical and Biological Engineering and the National Center for Advancing Translational Sciences (NCATS). It will be held in the Lister Hill Auditorium on the NIH campus in Bethesda, Maryland. Additional information, agenda, a link to registration, and information on previous workshops in this series can be found on the NIBIB website.
Jan. 12: Draft EPA Process Document Available for Comment
A draft U.S. Environmental Protection Agency (EPA) document describing a “Process for Establishing and Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies” is now available for comment. The document describes a transparent, stepwise process for evaluating and implementing alternative methods of testing for acute oral, dermal, and inhalation toxicity, along with skin and eye irritation and skin sensitization. In addition, there is a discussion of the three major phases of the process and the implications for reporting information under the Federal Insecticide, Fungicide, and Rodenticide Act. Please submit comments on the document by email to Christopher Schlosser. Comments will be accepted until March 10.