Announcements Sent to the NICEATM News List in 2017
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.
July 31: USDA Exemptions Help Reduce Live Animal Use in Leptospira Vaccine Potency Testing
Leptospirosis is a transmissible bacterial disease of animals and humans caused by infection with any of the pathogenic members of the genus Leptospira. The organism is shed in the urine and milk of infected animals and may cause symptoms of renal and hepatic disease, which could be fatal. Disease transmission to man and animals is reduced by the vaccination of cattle, swine, and dogs. In light of this, the potency of these vaccines must be tested by law.
In April 2017, the U.S. Department of Agriculture–Animal and Plant Health Inspection Service–Center for Veterinary Biologics (USDA-APHIS-CVB) issued CVB Notice 17-06, “Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa.” This notice permits the removal of back-titration hamsters when potency testing vaccines containing L. pomona and L. grippotyphosa in accordance with 9 CFR 113 §101-104. This exemption to the codified test can reduce animal use up to 50% for these serogroups. CVB Notice 17-06 along with the 2015 CVB Notice 15-13, “Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae” are available on the USDA-APHIS website.
CVB Notice 17-06 is the latest action in a continuing effort by USDA, an ICCVAM member, to reduce the number of hamsters required for potency testing of leptospirosis vaccines. In 2013, APHIS issued Veterinary Services Memorandum No. 800.102, which permitted the use of the in vitro ELISA test developed by CVB as a complete alternative to live animal usage required under 9 CFR 113 §101-104. CVB provides supplemental assay methods for in vitro testing using the ELISA test. All of these documents are available on the NICEATM website.
July 31: NICEATM and ICCVAM Activities at World Congress
NICEATM and ICCVAM scientists will be active participants at the Tenth World Congress on Alternatives and Animal Use in the Life Sciences, which runs August 20-24 in Seattle, Washington. ICCVAM members will co-chair four presentation sessions and participate on roundtable panels on regulatory issues and big data. NICEATM and ICCVAM scientists will also share their latest work in 16 oral and poster presentations. A full list of NICEATM and ICCVAM activities at World Congress is on the NICEATM website.
July 18: Toxics Accepting Applications for Postdoc Travel Award
The journal Toxics is accepting applications for a travel award from postdoctoral fellows or trainees involved in toxicology research. The award of 800 Swiss francs (approximately $800 U.S.) will support travel to an international conference in 2018 at which the awardee will give an oral or poster presentation.
Applicants should submit the following to firstname.lastname@example.org by November 30:
- A 500-word description of current and future work
- CV including complete publication list
- A description of the conference to be attended and the work to be presented
- A letter of recommendation from the applicant’s supervisor or PI
Applications will be assessed by an evaluation committee chaired by Toxics Editor-in-chief Prof. Dr. David Bellinger. The winner will be announced in January 2018.
July 18: World Congress Late-breaking Abstracts Due July 31
Late-breaking abstracts will be accepted through July 31 for the Tenth World Congress on Alternatives and Animal Use in the Life Sciences, which runs August 20-24 in Seattle, Washington. Full instructions for submitting late-breaking abstracts are available on the World Congress website, as are the complete scientific program, registration and housing information, and other conference information.
July 18: Slides Available from BioMed21 Workshop
Presenters’ slides from the June 26-27 workshop “BioMed21 – A Human Pathway-based Approach to Disease and Medicine” are now available. The presentations from government, academic, and industry scientists addressed how to implement a human systems-biology platform for understanding disease and improving interventions.
The workshop was co-organized by NICEATM and the Human Toxicology Project Consortium. In addition to the presentations, an overview of the workshop and background materials are available on the NICEATM website.
July 5: ASCCT Abstract Submssion Deadline Extended
The deadline for abstract submissions for the annual meeting of the American Society for Cellular and Computational Toxicology has been extended to July 10. ASCCT will consider abstracts relevant to replacement of animal use for acute systemic toxicity testing or implementation of the Lautenberg Chemical Safety Act for oral presentations during the plenary sessions focused on these topics. ASCCT also welcomes submission of abstracts on other topics relevant to in vitro and computational toxicology and will consider these for oral or poster presentations. Authors will be notified of abstract acceptance by August 1.
The meeting is September 21-22 at the Institute for In Vitro Sciences in Gaithersburg, MD. More information about the meeting, a preliminary program, and a link to register are available on the ASCCT website.
June 28: Small Business Phase II Grants for Alternative Methods Development
The National Institute of Environmental Health Sciences is funding grants to U.S. small businesses for development of medium- to high-throughput assays. Assays developed under these grants should evaluate the effects of toxicants on pluripotent or induced pluripotent cells with respect to cell differentiation and the resulting differentiated cell populations. The ability to incorporate genetic diversity in these assays would be useful. Results from these assays should help identify mechanisms of chemically induced biological activity, prioritize chemicals for more extensive toxicological evaluation, and support more predictive models of in vivo biological response.
Letters of intent for this funding opportunity are due September 4, with applications due October 4.
Full funding announcement on NIH website (posted June 23)
June 28: World Congress Early Bird Registration Deadline Extended
Register by July 10 to get early discounted registration for the Tenth World Congress on Alternatives and Animal Use in the Life Sciences. Full registration includes admission to all scientific events and exhibitions for the duration of the meeting, August 20-24. One-day and accompanying person registration options are also available. Registration information and other meeting details, including a list of plenary speakers, are available on the meeting website.
June 28: Computational Biologist Position Available
UES, Inc., is seeking a computational toxicologist for a position at the U.S. Air Force School of Aerospace Medicine. The position will focus on the development and application of kinetic and statistical models that use data from physiology, biology, pharmacokinetics, toxicology, and exposure characterization. The successful candidate will have a Ph.D. in biology, environmental toxicology, pharmacokinetics, toxicology, pharmacology, biomedical engineering, chemical engineering, or other related discipline, with a rigorous foundation in applied and quantitative science. Experience with at least one programming or scripting language is required. Experience with computational modeling is preferred, as is experience working with biological data from toxicity, metabolism, and pharmacokinetic studies. The successful candidate should also have experience in risk and exposure assessments. Strong communication skills and a willingness to collaborate are essential. Candidates must be U.S. citizens. A complete job description and a link to apply are available on the UES website.
June 23: Canadian Centre for Alternative to Animal Methods Established
A June 15 news article announced the establishment of the Canadian Centre for Alternatives to Animal Methods (CCAAM). CCAAM and its subsidiary, the Canadian Centre for the Validation of Alternative Methods, aim to promote the use of non-animal methodologies in biomedical research, education, and chemical toxicity testing. CCAAM will conduct multidisciplinary biomedical research to understand human health and disease using only human-based biomaterials and methods. In partnership with Health Canada and other Canadian regulators, CCAAM will expedite the development, validation, and acceptance of alternative chemical testing methods. CCAAM will also train the next generation of scientists, ethicists, and policy makers through its academic degree program in Animal Replacement Science at the University of Windsor.
June 23: European Committee Issues Opinion on Non-human Primate Use
Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued an updated opinion on the need for non-human primates in biomedical research, production, and testing of medical products and devices. The SCHEER opinion, adopted by the committee at its May 18 meeting, notes that the current state of knowledge precludes proposal of a timetable for phasing out non-human primate use in Europe at this time. However, the opinion provides recommendations of how to replace, reduce, and refine use of non-human primates for these purposes, and identifies research that should be done to advance the replacement of non-human primates with non-animal methods.
June 23: Postdoctoral Fellow Opportunity in Computational Toxicology at NIEHS
A computational toxicology postdoctoral fellowship is available at the National Institute of Environmental Health Sciences (NIEHS). The successful candidate will develop and apply computational methods, tools, and applications across projects in the areas of computational toxicology, bioinformatics, and computational biology. Candidates should have a Ph.D. in computational biology, computer science, biomedical engineering, bioinformatics, or a related discipline. Programming skills are required, ideally in R and/or Python. Experience in Bayesian modeling, deep belief networks, and the application of computational methods to high throughput screening data are highly desirable. Excellent verbal and written communication skills and the ability to simultaneously work on a variety of diverse projects are essential.
The position is in the Computational Toxicology group in the Biostatistics and Computational Biology Branch of the NIEHS Division of Intramural Research. The Computational Toxicology group is led by NICEATM Deputy Director Nicole Kleinstreuer. To apply, send curriculum vitae including publication list, brief summary of past/current research, and the names of three references to email@example.com.
June 23: NICEATM Research Featured in Special Issue of Reproductive Toxicology
NICEATM Deputy Director Nicole Kleinstreuer is a coauthor of three articles in a special issue of Reproductive Toxicology that focuses on developmental angiogenesis. The three articles coauthored by Kleinstreuer describe projects conducted with the U.S. Environmental Protection Agency and other collaborators that use high throughput screening assays to identify and characterize potential vascular disrupting chemicals. Other articles in the issue describe basic research into the mechanism of angiogenesis and new alternative models for identifying potential vascular disrupting chemicals.
June 23: Save the Date: Regulatory Summit USA in October
The fifth annual Chemical Watch Regulatory Summit USA will be held October 18-19 in the Washington, DC, area. One half-day session of the program will focus on the impact of recent updates to the Toxic Substances Control Act. Other sessions will review current regulatory initiatives in U.S. states, Canada, Europe, and other regions. Speakers will represent regulatory agencies, academia, industry, and NGOs. Registration for the meeting is open and a preliminary program available on the Chemical Watch website.
June 16: Registration Extended for BioMed21 Workshop on Human Disease Pathways
Registration has been extended for the June 26-27 workshop “BioMed21: A Human Pathways Approach to Disease Research.” The workshop will explore existing systems biology projects and approaches, and consider how these projects might be better coordinated to optimally improve disease understanding and interventions. Speakers include scientists from the U.S. Food and Drug Administration, National Institutes of Health, and pharmaceutical industry collaborators.
The workshop, organized by NICEATM and the Human Toxicology Project Consortium, will be held at the National Institutes of Health in Bethesda, Maryland. An updated agenda is available on the NICEATM website. If you would like to attend the workshop in person, please register by Thursday, June 22. Participants who are not able to attend in person can register to view a webcast of plenary sessions.
June 16: Small Business Grants Available for Alternative Methods Development
The Department of Health and Human Services has released a new solicitation of Small Business Innovation Research and Small Business Technology Transfer applications for grants funded by the National Institutes of Health and other agencies. Included in this solicitation are funding opportunities for technologies to improve predictivity in toxicology testing offered by the National Institute of Environmental Health Sciences. More information about the grant solicitation and other funding opportunities is available on the NICEATM website.
June 16: EPA Announces Meetings, Requests Nominations of Panel Members
The Environmental Protection Agency will hold two meetings of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) in the coming months. Both meetings will be held at EPA in Arlington, Virginia. The FIFRA SAP provides scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues impacting health and environmental regulatory actions. EPA is requesting nominations for experts to serve as ad hoc members of the FIFRA SAP for each of these meetings. Nominations for either panel should be submitted by July 21.
The Oct. 24-27 FIFRA SAP meeting will consider and review physiologically based pharmacokinetic modeling to address pharmacokinetic differences between and within species. Nominees to serve on the expert panel for the meeting should have expertise in areas including physiologically based pharmacokinetic modeling, pharmacokinetics, pharmacodynamic modeling, in vitro to in vivo extrapolation, human health risk assessment, neurotoxicity, and exposure assessment.
Read the Federal Register notice containing the meeting announcement and request for nominees
The Nov. 28-30 FIFRA SAP meeting will consider and review the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” Nominees to serve on the expert panel for the meeting should have training and experience in computational model development, high-throughput assay development, biostatistics and performance-based validation, as well as general expertise in toxicology, physiology, biochemistry, endocrinology, and epidemiology.
Read the Federal Register notice containing the meeting announcement and request for nominees
June 6: ECHA Report Shows Wide Use of Alternatives
The European Chemicals Agency (ECHA) has issued its third report on the use of alternative methods under REACH. The report shows that most registrants consider and use alternatives to animal testing. The most common alternative method, read-across, uses information on similar substances to predict toxicity. Read-across has been particularly useful for human health endpoints such as developmental and reproductive toxicology. Other frequently used approaches include weight-of-evidence analysis and QSAR prediction. A press release and the full report are available on the ECHA website.
June 6: Nominations Open for the 2017 Lush Prizes
Nominations are open through July 24 for the 2017 Lush Prizes. To promote alternatives to animal testing for consumer products, Lush Cosmetics will award up to £350,000 in prizes to recipients in the areas of science, training, public awareness, and lobbying, and to promising young researchers in the field. Researchers working anywhere in the world may nominate themselves or others for the prizes; however, individuals or organizations awarded prizes in 2016 are not eligible for the 2017 prizes. Detailed information about the prizes is available on the Lush Prize website.
June 6: Symposium on Friday, June 9: Toxics in Everyday Life
The UCLA Center for Occupational and Environmental Health is presenting the free, one-day symposium “Toxics in Everyday Life.” The symposium will describe what “toxics” are, where they can be found, and how they can affect consumers and workers. Speakers will also describe how people can protect themselves and what business and advocacy groups are doing to protect people from toxic exposures. The symposium will be held this Friday at the UCLA School of Law in Los Angeles, and plenary sessions will be webcast.
June 6: NTP Update Newsletter
Articles in the June issue of the NTP Update newsletter summarize the ICCVAM Public Forum and preview the upcoming “International Symposium on Systematic Review and Meta-analysis of Laboratory Animal Studies” to be held at the National Institute of Environmental Health Sciences in August.
June 5: Slides and Video Available from ICCVAM Public Forum
Presenters’ slides and the webcast recording of the May 23 ICCVAM public forum are now available. Presentations at this year’s public forum included updates from eight ICCVAM member agencies, as well as summaries of ICCVAM’s interactions with several international organizations.
NICEATM Director Warren Casey presented a plan for the development of a U.S. strategic roadmap to establish new approaches for evaluating chemical safety. The roadmap was the focus of most of the public comments presented at the meeting. Upcoming opportunities to comment on the roadmap include the June 29 meeting of the NTP Board of Scientific Counselors and the September 18-19 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods.
June 5: Agenda Available for BioMed21 Workshop on Human Disease Pathways
An agenda is available for the June 26-27 workshop “BioMed21: A Human Pathways Approach to Disease Research.” The workshop will explore existing systems biology projects and approaches, and consider how these projects might be better coordinated to optimally improve disease understanding and interventions. Speakers include scientists from the U.S. Food and Drug Administration, National Institutes of Health, and pharmaceutical industry collaborators.
The workshop, organized by NICEATM and the Human Toxicology Project Consortium, will be held at the National Institutes of Health in Bethesda, Maryland. Registration is open now; participants may attend in person or view a webcast of plenary sessions.
June 5: ASCCT to Present June 8 Webinar on Neurotoxicity Screening
The American Society for Cellular and Computational Toxicology (ASCCT) will present a webinar on “Combination of Multiple Neural Crest Migration Assays to Identify Environmental Toxicants from a Proof-of-concept Chemical Library.” Johanna Nyffeler of the University of Konstanz, Germany, will describe a study that evaluated the ability of in vitro cell migration assays to identify developmental neurotoxicants.
The webinar is scheduled for Thursday, June 8, at 11:00 a.m. Eastern Daylight Time. The webinar is free and open to both ASCCT members and non-members. Register for the webinar
June 5: Conference on Inflammation, Aging, and Chronic Disease
Registration is open for the “Inflammation, Aging and Chronic Disease Conference” at Stanford University on November 27-28. NICEATM Deputy Director Nicole Kleinstreuer will speak at the conference in a session titled “Environment and Immune Modulation.”
Chronic inflammation is now widely accepted as a common mechanism of many diseases associated with aging, including cancer, neurodegenerative disorders, and cardiovascular disease. In this conference organized by the Institute for Immunity, Transplantation and Infection, Stanford School of Medicine, participants will discuss critical aspects of the “exposome” and its relation to inflammation, possible mechanisms that trigger both the onset and resolution of inflammation, and the links between maladaptive immune responses and tissue damage in aging.
Abstracts are being accepted through July 15; early discounted registration dates are available through August 15. More information is available on the Stanford University website.
May 24: OpenTox USA Abstract Deadline Extended to May 31
OpenTox USA 2017, focused on “Application of In Vitro-In Silico Approaches in Toxicology, Safety Assessment, and Regulation,” will be held July 12-13 at the Searle Conference Center, Duke University, Durham, North Carolina. The meeting’s five sessions will cover: application of omics data in safety assessment; data management and knowledge sharing infrastructures; adverse outcome pathway development; integrated approaches to testing and assessment; and exposure assessment.
Registration is open for the meeting, and the deadline for submitting poster abstracts has been extended to May 31. A full program for the meeting and links to register and submit abstracts are available on the OpenTox website.
May 24: June Workshop to Focus on Human Disease Pathways
A June 26-27 workshop at the National Institutes of Health in Bethesda, Maryland, will focus on human pathway-based approaches to disease and medicine. The “BioMed21” workshop will explore existing systems biology projects and approaches, and consider how these projects might be better coordinated to optimally improve disease understanding and interventions.
The workshop is being organized by NICEATM and the Human Toxicology Project Consortium. Registration is open now on the NICEATM website; participants may attend in person or view a webcast of plenary sessions.
May 24: Grants Offered to Support Review Articles
Humane Society International and The Humane Society of the United States are offering grants of up to $10,000 to support the development and open-access publication of in-depth, independent review articles. Each review will focus on a specific area of human disease, evaluate the human relevance and limitations of conventional research models, and offer recommendations for optimizing the funding and use of advanced, human-specific tools and approaches.
Applicants should be health researchers with Ph.D. or equivalent degrees employed in the academic, private, or public sectors of the United States, Canada, European Union, or South Korea. Retirees from such positions are also eligible to apply. Applications will be accepted from single authors or groups. Grantees’ publications must be submitted to and accepted for publication by a high-visibility, peer-reviewed journal. Lead authors of grantees’ publications will also be expected to attend a workshop in early 2019 to explore the findings and recommendations of funded review articles and to contribute to a subsequent workshop report.
The application deadline is June 30; successful grantees will be notified by July 17. More information is available on the Human Toxicology Project website.
May 24: OECD and ECHA to Present June 1 Webinar on QSAR Toolbox
The Organisation for Economic Co-operation and Development (OECD) and the European Chemicals Agency (ECHA) will present a webinar to demonstrate the new features of the OECD’s QSAR Toolbox Version 4.0 resource. The QSAR Toolbox is a software application that governments, chemical industry, and other stakeholders can use to fill gaps in toxicity data needed for assessing the hazards of chemicals.
In the webinar, OECD will present a brief overview of the purpose and history of the QSAR Toolbox, review basic concepts and organization of the Toolbox, and explain where to get support for Version 4.0. ECHA will present practical examples for the use of the QSAR Toolbox v4.0, with focus on the new functionalities.
The webinar is scheduled for June 1 at 6:45 a.m. Eastern Daylight Time (12:45 p.m. Europe Summer Time). Register for the webinar on the OECD WebEx site. A previous presentation by ECHA of the basic functionalities of Version 4.0 of QSAR Toolbox is available on YouTube; those planning to attend the June 1 webinar are encouraged to watch the YouTube video before the webinar.
May 11: OECD Group Approves Proposal for Test Guideline Development
An OECD committee has approved a proposal to develop a performance-based test guideline for defined approaches for skin sensitization. If ultimately adopted by the OECD, this test guideline will make it easier to validate and implement non-animal testing methods for skin sensitization.
Skin sensitization testing, currently primarily performed using mice and guinea pigs, is required by regulatory agencies worldwide for a variety of chemical products. Skin sensitization is a complex process, and replacing animal testing with non-animal methods requires data from several methods to be considered in combination to adequately predict toxic effects. Defined approaches are a means by which data from several non-animal test methods can be considered in combination. They combine input data from several specific sources, such as non-animal test methods or computational models, using an objective data interpretation procedure such as a machine-learning model, flowchart, or decision tree.
The test guideline proposal was developed by NICEATM and ICCVAM scientists working with Canadian and European collaborators in the International Cooperation on Alternative Test Methods. The proposal was approved by the Working Group of National Coordinators of the OECD Test Guidelines Programme at its meeting in April.
Approval of the proposal allows for the establishment of expert groups and conduct of meetings to develop a performance-based test guideline for defined approaches for skin sensitization. Performance-based test guidelines describe characteristics that constitute acceptable performance for a general class of test methods that, while differing in protocol details, are all intended to measure the same biological effect. Approval of a performance-based test guideline for defined approaches for skin sensitization is expected to allow regulatory authorities to more readily accept defined approaches for skin sensitization testing, which will advance the goal of elimination of animal use for skin sensitization testing worldwide.
May 11: Free Webinar: OECD QSAR Toolbox for Beginners
A free ChemicalWatch webinar on Tuesday, May 16, will provide a comprehensive overview of the recently released Version 4.0 of QSAR Toolbox. The QSAR Toolbox, developed by the Organisation for Economic Co-operation and Development, is a software application that governments, chemical industry, and other stakeholders can use to fill gaps in toxicity data needed for assessing the hazards of chemicals. The webinar will include an interactive question-and-answer session with the audience and speakers.
The webinar is at 9:00-10:30 a.m. EDT (2:00-3:30 p.m. British Summer Time). Register for the webinar on the ChemicalWatch website. Registrants who are unable to view the live webinar will have access to a recording and slides from the webinar. More information about QSAR Toolbox is available on the OECD website.
May 3: ASCCT Meeting September 21-22; Abstract Submission Open
The 6th Annual Meeting of the American Society for Cellular and Computational Toxicology is scheduled for September 21-22, 2017, at the U.S. Food and Drug Administration (FDA) office in College Park, MD. The September 21 plenary session will focus on the advancement of alternatives for acute toxicity testing, and the September 22 plenary session will focus on the alternative methods requirements of the Lautenberg Chemical Safety Act and the use of in vitro and computational methods to address those requirements. The meeting will also include a poster session, mentoring and networking opportunities, and a reception and awards ceremony.
Abstracts for presentations at the meeting are due July 1. Abstracts relevant to the plenary session themes will be considered for oral presentations during these sessions. Submission of abstracts on all topics related to cellular and computational toxicology are also welcomed for oral and poster presentations. Authors will be notified of abstract acceptance August 1.
Details on the meeting and abstract submission are available on the ASCCT website; registration and a draft agenda will be available soon.
May 3: Registration Open for ICCVAM Public Forum
Registration is open to attend the ICCVAM public forum on May 23 at the National Institutes of Health in Bethesda, Maryland. ICCVAM holds annual public forums to share information and facilitate direct communication of ideas and suggestions from stakeholders. ICCVAM agencies will give presentation on their activities relevant to the ICCVAM mission. This year’s forum will also provide an opportunity for stakeholder input on an effort to establish a U.S. national strategy to explore new approaches for evaluating the safety of chemicals and medical products in the United States.
More information about the public forum and links to register to attend in person or view the webcast are available on the NICEATM website. Those planning to attend in person are encouraged to preregister by May 12.
May 3: NICEATM Deputy Director, Collaborators Comment on Progress Toward Animal Replacement
NICEATM Deputy Director Nicole Kleinstreuer and a number of NICEATM collaborators in academia, industry, and animal welfare organizations commented on progress toward replacing animals for chemical safety testing in the April 24 issue of Chemical and Engineering News. The article “Big Data, Big Deadlines Spur Change in Toxicity Testing” is available on the C&E News website.
May 3: FDA Reaches Food Safety Agreement with Australia
FDA has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing that their food safety systems are comparable. This recognition means that the FDA and Australian Department of Agriculture and Water Resources are confident that they can leverage each other’s science-based regulatory systems to ensure food safety, and establishes a framework for regulatory cooperation in a variety of areas ranging from scientific collaboration to outbreak response. FDA has similar agreements with New Zealand and Canada.
April 20: FDA Partners with Industry to Develop Organs-on-Chips
On April 11, the U.S. Food and Drug Administration (FDA) announced a multi-year research and development agreement with Emulate, Inc., to evaluate the company’s “Organs-on-Chips” technology in laboratories at the FDA’s Center for Food Safety and Applied Nutrition. The project will focus first on developing a liver chip, but the agreement may expand in the future to kidney, lung, and intestine models. The ultimate goal is to predict how specific organs will respond to potential chemical hazards found in foods, cosmetics, or dietary supplements more precisely than with current methods.
More details about the agreement are available in an FDA blog article by FDA ICCVAM representative Suzanne Fitzpatrick.
April 10: OECD Releases Update of QSAR Toolbox
The Organisation for Economic Co-operation and Development (OECD) has released version 4.0 of QSAR Toolbox. The QSAR Toolbox is a software application that governments, chemical industry, and other stakeholders can use to fill gaps in toxicity data needed for assessing the hazards of chemicals.
Version 4.0 of QSAR Toolbox features:
- Automated and standardized workflows for skin sensitization and short-term toxicity to fish
- Improved customizable reports
- An updated software system
- Expansion of databases with the introduction of reliability scores for alerts and databases
- Enhanced ADME information and improved presentation
The QSAR Toolbox can be downloaded from the OECD website. This page includes detailed information about QSAR Toolbox and the new features in version 4.0.
March 24: OECD Releases Guidance Document on Integrated Approaches to Testing and Assessment
OECD recently released a “Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches for Testing and Assessment (IATA)”. This guidance document is intended to:
- Provide a framework for developing and using IATA
- Describe how IATA can be based on the adverse outcome pathway concept
- Provide examples on how AOPs can be used in the development of IATA
IATA provide a means for combining the data from different testing methods, with the objective of predicting chemical toxicity more accurately than with any single test method.
The OECD Programme on Hazard Assessment addresses chemical hazards. One of the programme’s current efforts is on the development and application of IATA and the collation of comments on new hazard assessment methodologies.
More information on IATA can be found at the OECD website. The new guidance document can also be downloaded from this page.
March 3: New Agency Joins ICCVAM
The National Institute of Standards and Technology has joined ICCVAM. NIST participation will provide ICCVAM with interest and experience in the study of process controls, measurement artifacts, and interlaboratory testing.
ICCVAM was established to facilitate and promote development and regulatory acceptance of new toxicological tests with the potential to replace, reduce, or refine animal use. The expertise within NIST will benefit ICCVAM, especially in the development of validation studies to assess the appropriateness of new test methods for specific purposes. In particular, NIST has experience with cell-based and small model organism assays, which are becoming increasingly important as alternatives for traditional animal tests. NIST also brings to ICCVAM additional expertise in experimental design and statistical analysis.
This event represents the first time ICCVAM has expanded its membership to include a new member agency since its inception in 2000. NIST, which is part of the U.S. Department of Commerce, has been interacting with ICCVAM since 2015. The agency submitted an official request to join ICCVAM in January 2017, which was approved in February by National Institute of Environmental Health Sciences Director Linda Birnbaum.
February 15: New Release of Effectopedia Site Available
Effectopedia is an open-knowledge and structured platform to display quantitative information on adverse outcome pathways (AOPs). This collaborative tool is designed to facilitate interdisciplinary efforts for delineating AOPs in an encyclopedic manner with greater predictive power.
The new release of Effectopedia features:
- A stable and user-friendly experience, supported by online training material (videos, introduction tutorials)
- Quantitative features that support entry of dose- and time-response data and can be used to derive response-to-response relationships
- New functionalities for model development and interaction
- Workflow support that allows users to create and save their AOPs locally or publicly
January 20: Advisory Committee Applications Due January 31
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) is recruiting new members for its Scientific Advisory Committee. The ESAC acts as a scientific peer-review body that provides EURL ECVAM with opinions on the adequacy and outcome of formal validation studies of alternative methods, typically in the context of regulatory safety assessment.
Eligible applicants must have a postgraduate university degree and at least 10 years of subsequent experience in relevant fields, have sufficient oral and written English fluency, and have not served on the ESAC since 2009. Applicants will be evaluated for their competence in scientific areas relevant to alternative methods development and their experience in regulatory and safety assessment of chemicals, validation practice, analyzing complex information, and providing scientific advice at a national or international level. Applications are due January 31. More information is available on the EURL ECVAM website.
January 20: Risk Assessment Training Opportunity for Young Scientists
The Joint Research Centre of the European Commission will hold a “Summer School on Alternative Approaches for Risk Assessment” on May 16-19. The Summer School will be hosted by the Centre’s Chemical Safety and Alternative Methods Unit in Ispra, Italy. Tailored for postgraduate students and young scientists, the Summer School aims to give insight into principles and methodologies of human health and environmental risk assessment from a scientific, regulatory, and industrial perspective with a focus on alternative (non-animal) methods.
Attendance is limited to students and scientists who have completed their Ph.D. or master’s degree within the last four years. Applicants must provide a letter of motivation, including one professional reference, and a poster abstract. Selection of participants (100 maximum) will be based on the clarity, relevance, and quality of the application and the relevance of the Summer School to current area of study or job. Preregistration for the Summer School is open until February 14. More information is available on the JRC website.
January 6: National Academies Report: Using 21st Century Science to Improve Risk-related Evaluations
A report released January 5 by the National Academies of Sciences, Engineering, and Medicine makes recommendations on the best ways to incorporate emerging science into risk-based evaluations of chemical safety. The report, “Using 21st Century Science to Improve Risk-related Evaluations”, was prepared at the request of the four Tox21 partner organizations: the U.S. Environmental Protection Agency, National Institute of Environmental Health Sciences, National Center for Advancing Translational Sciences, and the U.S. Food and Drug Administration. The new report discusses both the inherent opportunities and the challenges that will need to be met to achieve the vision described in two earlier National Research Council reports, “Toxicity Testing in the 21st Century” and “Exposure Science in the 21st Century.”
The new report can be read online or downloaded as a free PDF from the National Academies Press website. National Academies Press is also accepting pre-orders for purchase of the paperback edition.
January 4: EPA Launches Voluntary Pilot Program to Reduce Animal Testing
On December 20, 2016, the U.S. Environmental Protection Agency launched a voluntary pilot program to evaluate the usefulness and acceptability of a mathematical tool that estimates the toxicological classification of a chemical, and published guidance on how pesticide companies can submit data for the program. This program is another step toward EPA’s goal of reducing animal testing by adopting better testing methods, as described in the March 2016 Letter to Stakeholders issued by Office of Pesticide Programs Director Jack Housenger.
The mathematical tool, known as the GHS Mixtures Equation, is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Use of the GHS Mixtures Equation can reduce animal use for oral and inhalation toxicity studies of pesticide formulations.
To evaluate the GHS Mixtures Equation, EPA requests submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations. EPA expects that the pilot will run for approximately six months but will begin data analysis sooner if enough data is received.