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.
The Dutch government has announced a plan to phase out animal use for safety testing on chemical substances, food ingredients, pesticides, and medicines by the year 2025. On December 15, the Netherlands National Committee for the Protection of Animals Used for Scientific Purposes (NCad) presented a roadmap for reducing animal use to the Dutch Agriculture Ministry. The roadmap document, “Transition to Non-animal Research,” is available on the NCad website, as is a press release about the document.
NICEATM Deputy Director Nicole Kleinstreuer is senior author on one article and co-author on a second article to be included in a special issue of Reproductive Toxicology focused on developmental angiogenesis. The articles describe collaborations among NICEATM, the U.S. Environmental Protection Agency, and other investigators to use transgenic zebrafish to test predictions made using adverse outcome pathways on how chemicals can disrupt blood vessel formation during development. Links to the articles by McCollum et al. and Tal et al. are available on the NICEATM publications page.
On November 30, the U.S. Environmental Protection Agency (EPA) published "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations and Supporting Retrospective Analysis." The new guidance expands the potential for data waivers for acute dermal studies and includes a policy statement to waive all acute lethality dermal studies for formulated pesticide products. EPA expects this waiver guidance to reduce the use of laboratory animals, potentially up to 2,500 or more each year. The guidance document is available on the EPA website.
David Allen has been named recipient of the Society of Toxicology (SOT) 2017 Enhancement of Animal Welfare Award. Allen, of Integrated Laboratory Systems, Inc., is principal investigator on the NICEATM support contract. He is also past president of SOT’s In Vitro and Alternative Methods specialty section and current president of the American Society for Cellular and Computational Toxicology.
The Enhancement of Animal Welfare Award is presented annually to an SOT member to recognize contributions made towards the development and application of methods that replace, refine, or reduce the need for experimental animals. Allen will receive the award at the annual SOT meeting in March 2017 in Baltimore, MD.
Several new non-animal methods are now available on the Tracking System for Alternative Methods Towards Regulatory Acceptance (TSAR) website.
TSAR was developed by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) to track the progress of alternative non-animal methods for testing chemicals or biological agents. TSAR provides a summary description of each method as well as information on the method’s validation status. Where available, TSAR includes records and documents associated with each step in a method’s validation.
The TSAR website includes information on methods being considered by member and observer organizations of the International Cooperation on Alternative Testing Methods (ICATM). The ICATM collaboration addresses three critical areas of cooperation: test method validation studies, independent peer review of the validation studies, and the development of formal recommendations on alternative testing methods. ICATM member organizations include EURL ECVAM, Health Canada, ICCVAM, the Korean Center for the Validation of Alternative Methods, the Japanese Center for the Validation of Alternative methods, and observers representing Brazil and China. Additional information about ICATM is available on the NICEATM website.
In a November 8 Request for Information, the National Library of Medicine announced that it is soliciting stakeholder input as part of its ongoing strategic planning process. The RFI and NLM’s planning process are organized around the role of NLM in these four areas:
The November 8 RFI is intended to obtain public input on goals and priorities for NLM’s next strategic plan. Many NLM stakeholders replied to a similar RFI in 2015 in the context of NLM’s leadership transition and emerging NIH data science priorities. Input provided in 2015 is already under consideration and does not need to be re-submitted.
The deadline for responses to the November 8 RFI is January 9, 2017. More information about the RFI, including how to submit input, is available on the NIH Grants website.
In a November 2 ceremony, NICEATM Deputy Director Nicole Kleinstreuer received the Lush Cosmetics’ Young Researcher Prize recognizing efforts to eliminate animal use for chemical safety testing. Five researchers in the Americas received the honors presented at Lush Cosmetics headquarters in Vancouver.
Kleinstreuer is the first U.S. federal government employee to receive a Lush Prize. She is also part of a group of U.S. federal employees named as finalists for the Science prize for advancing non-animal approaches to identify endocrine-active substances. Lush Prize winners in this and other categories will be announced later in November.
A list of the 2016 Young Researcher Prize winners from the Americas and more information about the Lush Prize are available on the Lush Prize website. Video summaries of the prize winners’ work are available on the Lush Cosmetics website.
The National Library of Medicine has updated its online ToxTutor course. ToxTutor is a self-paced tutorial for users of NLM chemical and toxicology databases that covers the key principles of toxicology. The ToxTutor update incorporates recent advances in the science of toxicology, provides more information on alternatives to animal testing, and features responsive design to support use on mobile devices. ToxTutor is available on the NLM website.
A December 8 NLM webinar will introduce new users to the NLM database ALTBIB: Resources for Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing. The webinar will describe the history, purpose, and scope of ALTBIB, identify key people who work on ALTBIB, and demonstrate the features of the resource. Participants will gain hands-on experience with practice exercises and leave the webinar with a sense of what ALTBIB can and cannot do for animal alternative searches. The webinar is free and open to residents of the United States.
The National Toxicology Program at the National Institute of Environmental Health Sciences requests available data and information on approaches and/or technologies currently used to identify substances with the potential to cause excessive inflammation or exaggerated immune responses leading to tissue injury when swallowed, inhaled, or absorbed through the skin. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that could be used to evaluate the potential of chemicals to induce inflammation and immune-related conditions.
Submit data and information: please submit data and information by December 12.
The Institute for In Vitro Sciences has released a technical training video that describes a cell-based in vitro method for assessing phototoxicity, the potential for chemicals to cause damage upon exposure to light. The video is available in English, with subtitled versions available in Chinese and Portuguese. It is designed to help scientists from industry and regulatory agencies perform these animal-saving methods in their own laboratories. A previous video describing methods for eye irritation testing is also available in all three languages.
IIVS is a non-profit organization dedicated to the promotion of non-animal test methods. Production of both the phototoxicity and eye irritation videos was supported by the European Partnership for Alternative Approaches to Animal Testing, a partnership between industry and the European Commission that supports replacement, reduction and refinement of animal use for meeting regulatory requirements.
The Scientific Advisory Committee for Alternative Toxicological Methods met at the National Institute of Environmental Health Sciences on September 27, 2016. SACATM advises NICEATM and the Interagency Coordinating Committee on the Validation of Alternative Methods on NICEATM and ICCVAM activities. ICCVAM agencies outlined a roadmap for the replacement of animals for the six most commonly used acute toxicity tests. SACATM input was requested on the proposed effort to develop a strategy for the implementation of human-based predictive approaches for complex toxicological endpoints resulting from repeat dose studies, such as developmental toxicity and carcinogenicity. Materials from the meeting are available on the SACATM past meetings webpage.
Raymond Tice, former NICEATM Deputy Director and NTP Biomolecular Screening Branch chief, received the William and Eleanor Cave Award from the Alternatives Research and Development Foundation. The William and Eleanor Cave Award is given to recognize contributions to advancing alternatives to the use of animals in testing, research, or education. The award was presented September 29 in a ceremony at the annual meeting of the American Society for Cellular and Computational Toxicology.
Tice, who retired from NTP in 2014, served as NICEATM Deputy Director from 2005 until assuming leadership of the Biomolecular Screening Branch in 2008. The ARDF award recognized him for his efforts in those roles to lead the interagency Tox21 high-throughput testing program. In her remarks at the award ceremony, ARDF President Sue Leary recognized this work as “a key factor in implementing a plan and moving forward a vision that will benefit human health and spare animals.” As part of the award, Tice received a $10,000 honorarium, half of which he donated to establish a student award program for the ASCCT. Read press release with more details about Tice’s career and the William and Eleanor Cave Award
NICEATM Director Warren Casey was a panelist for a September 13 Congressional briefing on “Alternatives to Animal Testing: Emerging Uses and Policy Implications.” Casey and other panelists discussed how to use non-animal and alternative toxicology and safety testing methods to better protect consumers and public health while using fewer animals. Topics considered included how to spark research that advances the development and application of alternatives, as well as what policy discussions are required to ensure regulatory frameworks can adapt while realizing the fastest possible innovation. The briefing was organized by the American Chemical Society and the Johns Hopkins Bloomberg School for Public Health, and sponsored by the offices of Representatives Earl Blumenauer (D-OR) and Ken Calvert (R-CA).
PLoS Computational Biology is presenting a Computational Biology Symposium on the National Institutes of Health campus on Friday, September 16, from 9:30 a.m.-4:00 p.m. Keynote speakers will include Dr. David J. Lipman of the National Center for Biotechnology Information, Dr. Jennifer Lippincott-Schwartz of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Dr. Bert Vogelstein of Johns Hopkins Medical Institutes. The agenda also includes two discussion panels comprised of PLoS Computational Biology editors from a range of fields. The morning panel will consider the “Biggest Challenges and Greatest Opportunities in Computational Biology over the Next 10 Years,” while the topic of the afternoon panel is “How Computational Biology Will Affect Human Health.”
The symposium is open to all National Institutes of Health staff and the wider community. Attendance is free and no preregistration is required. More information is available on the PLoS website. The symposium will also be webcast; more information about the webcast is available on the NIH Videocast website.
A U.S. Food and Drug Administration (FDA) notice in the September 8 Federal Register requested comments on draft guidance titled “ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies—Questions and Answers.” The draft guidance facilitates interpretation of the ‘‘S3A Guidance: The Assessment of Systemic Exposure in Toxicity Studies,’’ especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies, and acknowledges the benefits (and some limitations) of the use of microsampling. Comments on the draft guidance are requested by December 7.
The Organisation for Economic Co-operation and Development (OECD) has issued a new series of documents relevant to development of adverse outcome pathways (AOPs). An AOP organizes existing information about biological interactions and toxicity mechanisms into a model that describes how a chemical exposure might cause a toxic effect or disease. In recognition of the key role that AOPs will play in development of predictive approaches to toxicity testing, OECD established its AOP Development Programme in 2012.
The newly issued documents, including a User’s Handbook that provides practical instructions for AOP developers and reviewers, are available on the OECD iLibrary website. More information on the AOP Development Programme is on the OECD website.
The National Center for Advancing Translational Sciences (NCATS) and the Center for the Advancement of Science in Space are promoting a new program for research on the International Space Station United States National Laboratory (ISS-NL): we’re sending tissue chips to space! This program will leverage recent advances in tissue engineering and microfabrication to create microphysiological systems and organ-on-chip technology platforms to better understand the molecular and cellular basis of human disease in microgravity. Translation of this research to the ISS-NL promises to accelerate the discovery of molecular mechanisms that underlie a range of common human disorders and advance understanding of therapeutic targets and treatments in a reduced fluid shear, microgravity environment that recapitulates cellular and tissue matrices of Earth.
An informational webinar will be held September 6 to provide interested investigators an opportunity to learn more about the Chips in Space initiative. Presenters will include investigators experienced in developing spaceflight experiments for the ISS-NL.
Register for the webinar
Read more information about the Chips in Space initiative
NCATS has published a notice of intent to publish a funding opportunity for this initiative. Grant applications are not currently being solicited, but interested investigators are encouraged to begin developing meaningful collaborations and responsive projects.
Current regulatory guidelines in many countries require safety and tolerability data from two animal species, a rodent and a non-rodent, before first administration of potential new medicines to humans. The United Kingdom National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs) is collaborating with the Association of the British Pharmaceutical Industry to review data with the goal of determining whether data from one species could be sufficient for the progression of a potential new drug into human clinical trials.
While a number of companies have already committed to this effort, NC3Rs is still seeking biopharmaceutical companies and contract research organizations to participate and contribute data to this project. Those interested should contact Helen Prior at NC3Rs. More information about the project is on the NC3Rs website.
A Proposed Rule published by the U.S. Food and Drug Administration (FDA) in the August 24 Federal Register describes amendments to the regulations for good laboratory practice (GLP) for nonclinical laboratory studies. The new amendments will require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. FDA is proposing additional management responsibilities and standard operating procedures consistent with the proposed requirement for a GLP Quality System. In addition, the testing facility definition will be revised to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity. Comments on the Proposed Rule are due by November 22.
On August 2, OECD published “Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests.” This document, designated number 237 in OECD’s Series on Testing and Assessment, provides guidance on approaches to minimize the use of animals for acute toxicity testing.
Clarification of these approaches is important to ensure that regulatory authorities are provided with the appropriate data required for decision-making and that reduction of animal use for testing can be undertaken without compromising the integrity of the hazard information.
An August 2015 workshop sponsored by the National Institute of Environmental Health Sciences evaluated the scientific support for the Low-Dose Mixture Hypothesis of Carcinogenesis and developed a research agenda. A report from this workshop is now available on the Environmental Health Perspectives website. NICEATM Deputy Director Nicole Kleinstreuer, Ph.D., was a breakout group moderator and co-authored the report.
The Low-Dose Mixture Hypothesis of Carcinogenesis suggests that ongoing low-dose exposures to mixtures of commonly encountered environmental chemicals can produce effects in concert that promote carcinogenesis. The workshop report describes the science that supports this novel theory, identifies knowledge gaps, recommends future methodologies, and explores preventative risk assessment and policy decision making that incorporates cancer biology, environmental health science, translational toxicology, and clinical epidemiology. The workshop participants concluded that the theoretical merits of the Low-Dose Carcinogenesis Hypothesis are well founded with clear biological relevance and the premise warrants further investigation.
In its Sunday, August 7, edition, The Raleigh News and Observer named NICEATM Director Warren Casey, Ph.D., as its “Tar Heel of the Week.” The newspaper’s weekly feature recognizes North Carolinians who have made important contributions to their areas of interest or expertise.
The article noted that Casey, recipient of this year’s Society of Toxicology Enhancement of Animal Welfare Award, was among those leading the effort towards a coordinated U.S. strategy to replace animal use for regulatory testing, an effort that will require changing policy and practice across multiple agencies in the Federal government. “As much as agencies have tried to do things on their own, to really have an impact, we’re going to have to have a national conversation on how to get away from animal testing,” the article quoted Casey as saying.
The effort to develop a new national strategy for reducing our reliance on animal testing will be the subject of the upcoming meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) on September 27 at the National Institute of Environmental Health Sciences in Research Triangle Park, NC. Materials for the SACATM meeting will be posted on the NTP website when they are available.
The Society of Toxicology (SOT) Food Safety Specialty Section is presenting two webinars on in vitro testing applications to food safety. Both webinars are free and open to the public.
The Organisation for Economic Co-operation and Development (OECD) has just released Version 3.4 of the QSAR Toolbox. The new version contains many new features and functionality improvements, including:
QSAR Toolbox 3.4 also contains updates of ten databases, fourteen profilers, and five metabolic simulators, as well as bug fixes and many other usability improvements.
The fifth annual meeting of the American Society of Cellular and Computational Toxicology (ASCCT) will be September 29-30 at EPA in Research Triangle Park. Featured speakers and topics include Thomas Hartung on read-across and Mahendra Rao on pluripotent stem cells.
The meeting is open to ASCCT members and non-members; registration is required. A student mentoring session will be held during lunch on September 29. If you are interested in participating in this session as a mentor or mentee, please indicate your interest when you register.
A draft program for the meeting is available. Abstracts are being accepted for the poster session; a small number of submitted abstracts will be selected for oral presentations. The deadline for abstract submission is July 22.
A bill signed into law June 22 by President Obama updates the Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) provides the EPA with the authority and a consistent source of funding to evaluate chemicals on the basis of health risks. The new law also includes language that requires EPA to develop a plan to promote the use of alternative methods that reduce, refine, or replace vertebrate animal testing and include in that plan a list of acceptable alternative methods.
The highlights of the Lautenberg Chemical Safety Act were outlined in a blog post by EPA Administrator Gina McCarthy. A news release from the Physicians Committee for Responsible Medicine summarizes aspects of the bill relevant to alternative methods development.
The Food and Drug Administration (FDA) has issued a final guidance document on the use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process.” FDA developed the guidance document to assist industry in preparing applications and notifications on medical devices so that the devices are appropriately evaluated for the potential for adverse reactions.
FDA will present a webinar on the new guidance on July 21 at 1:00 p.m. Eastern Daylight Time. The webinar is open to the public and there is no charge to view.
EPA is releasing five training videos providing guidance on EPA’s 40 CFR Part 158W data requirements for antimicrobial pesticides. These training videos will help the public and the pesticide industry better understand the pesticide registration process and make the process more efficient and transparent. The videos include the 2013 amendments to the data requirements that were made to ensure pesticide risk management decisions are founded on the best available sound science.
Additional videos will be released in the future as they become available. The videos are available on the EPA website.
EPA is hosting a July 8 workshop on the Transform Tox Testing Challenge. The goal of the workshop is to bring together Stage 1 challenge winners and other experts to discuss the Tox21 and ToxCast programs, the Stage 1 proposals, and feasible expectations for the remainder of the challenge.
EPA, the National Center for Advancing Translational Sciences, and the National Toxicology Program launched the Transform Tox Testing Challenge in January 2016 to encourage development of high-throughput screening assays that incorporate metabolic competence in order to more accurately assess chemical effects and better protect human health. Ten winners of Stage 1 of the challenge, announced in May, will each receive a $10,000 cash prize and will be eligible to compete in Stage 2 of the challenge.
The July 8 workshop will be held at EPA in Research Triangle Park, North Carolina, and will also be webcast via Adobe Connect. The public session (8:30 a.m. to 2:30 p.m.) is open to the public free of charge. For more information about the challenge and to register for the workshop, visit the Transform Tox Testing Challenge website.
A recent article in the ASCO (American Society of Clinical Oncology) Post, a newsletter reporting on oncology research, discussed the potentially significant contribution of environmental chemicals to cancer. The article, “Low-Dose Chemical Exposure and Cancer,” summarized the work of the Halifax Project, whose studies of the effects of exposure to mixtures of environmental chemicals were published last year in a special issue of the journal Carcinogenesis. The ASCO Post article includes a summary of a study conducted by NICEATM Deputy Director Nicole Kleinstreuer, Ph.D., which examined the ability of high throughput screening data to identify potential carcinogens.
The National Institutes of Health (NIH) Library Bioinformatics Symposium will be held Monday, June 20, at the NIH Clinical Center in Bethesda, Maryland. Attendees will learn how scientists are using software licensed by the NIH Library Bioinformatics Support Program to analyze, integrate, and annotate data from multiple genomics technologies, including next-generation sequencing. Presenters will also discuss the applications of these data analysis tools to problems in molecular biology, and how state-of-the-art knowledge bases and pathway analysis applications are transforming downstream functional analysis of data from high-throughput experiments.
The symposium is free and open to the public, but seating is limited. An agenda, presentation abstracts, and a link to registration is available on the NIH website.
The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) will meet Sept. 27-28, 2016, at NIEHS in Research Triangle Park, North Carolina. SACATM advises ICCVAM, NICEATM, and the NIEHS director on activities relevant to the ICCVAM mission. The focus of this year’s SACATM meeting will be to discuss and develop recommendations for implementing a national strategy for replacing, reducing, and refining animal use (3Rs) for regulatory testing.
The SACATM meeting is free and open to the public, and can be attended in person or viewed via webcast. An agenda, other materials, and links to registration for the upcoming meeting will be posted on the SACATM Upcoming Meetings page as they are available.
The fifth annual meeting of the American Society of Cellular and Computational Toxicology (ASCCT) will be Sept. 29-30 at the U.S. Environmental Protection Agency in Research Triangle Park. Featured speakers and topics include Thomas Hartung on read-across and Mahendra Rao on pluripotent stem cells.
Abstracts are being accepted for the poster session; a small number of submitted abstracts will be selected for oral presentations. The deadline for abstract submission is July 22.
The meeting is open to ASCCT members and non-members. Links to the registration and abstract submission pages, as well as a draft agenda and other information, are available on the Annual Meeting webpage.
The Society for Environmental Toxicology and Chemistry (SETAC) is initiating a horizon scanning effort to advance the science and application of the adverse outcome pathway (AOP) framework. This effort will allow SETAC to identify and begin to address issues relevant to the application of the AOP framework to chemical risk assessment in the context of both human and ecological health.
SETAC invites members of the scientific community to submit questions that consider key outstanding challenges or limitations that must be addressed in order to realize the full potential of the AOP framework in research and regulatory decision-making. Submitted questions will guide the development of themes to be addresses during an upcoming, expert-led, 2017 Pellston Workshop®.
The U.S. Food and Drug Administration (FDA) will hold a meeting on May 6 to receive public input and gather information in advance of the International Council for Harmonisation’s June meeting. The May 6 meeting will be held at FDA’s White Oak campus and will be webcast. Details are in an April 18 Federal Register notice.
The North Carolina Association for Biomedical Research and the New Jersey Association for Biomedical Research will convene “3Rs Sharing Conference V” on November 18 at Meredith College in Raleigh, NC. This conference will focus on the potential of new technologies and reduction and refinement approaches to improve biomedical research. More information is available on the conference website.
The National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration (FDA) will hold a workshop on April 5-6, 2016, at the Harvey W. Wiley Federal Building in College Park, Maryland, for scientists involved in assay development for high throughput screening and lead optimization. The goal of the workshop is to share best practices and provide advice for robust assay design and development. During the two-day workshop, drug discovery experts will cover a broad range of critical concepts underlying assay development and lead discovery strategies. The workshop is designed to disseminate critical information about the implementation of robust assay methods that can benefit the entire drug discovery community.
Registration for the workshop is now open. More information about the workshop, a link to registration, and an agenda are available on the NCATS website.
The first Pan-American Conference for Alternative Methods will be held in Baltimore on April 12-14. 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. There is no charge to attend the conference, but attendance will be limited to 300 participants on a first-come, first-served basis.
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 at the Bethesda Marriott in Bethesda, Maryland. Speakers from industry, government, academia, and nonprofit organizations 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. For more information and to register, visit the workshop website.
In a March 17 press release, the U.S. Environmental Protection Agency (EPA) announced the publication of two guidance documents and initiation of a pilot program, all of which will support its goal to significantly reduce animal use for acute effects testing.
“Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies for FIFRA Regulatory Use” describes a transparent, stepwise process for evaluating and implementing alternative methods for the “six-pack studies,” which test for acute oral, dermal, and inhalation toxicity; skin and eye irritation; and skin sensitization. The document includes discussion of three major phases of the evaluation and implementation process, as well as the implications for reporting information required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Establishment of this process and the clear articulation of the related reporting requirements address challenges associated with adopting alternative methods.
EPA is also requesting comment on draft guidance titled “Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations.” This guidance document provides a rationale for waiving all acute dermal toxicity studies for pesticide formulations, and includes a data analysis conducted by the EPA Office of Pesticide Products (OPP) and NICEATM in support of this rationale. EPA is accepting comments on the guidance document until May 16.
Availability of the two documents was announced in an open letter to stakeholders from OPP Director Jack Housenger, who also announced a pilot program to evaluate alternative approaches to classify the toxicity of mixtures. Under the GHS Mixtures Equation Pilot, OPP will accept submission of oral and inhalation toxicity data paired with calculations done in accordance with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) to support the evaluation of pesticide product formulations.
NICEATM Deputy Director Nicole Kleinstreuer, Ph.D., has been named to receive the 2016 F. Clarke Fraser New Investigator Award from the Teratology Society. This award recognizes an active Teratology Society member that has, within 10 years of completion of training, established a successful independent research career in a field relevant to developmental biology. Kleinstreuer will be presented with her award during the Society’s Annual Meeting in June, at which she will give a plenary presentation about her research.
NICEATM Director Warren Casey, Ph.D., has been elected Vice President-Elect of the In Vitro and Alternative Methods (IVAM) Specialty Section of the Society of Toxicology (SOT). Casey will serve as Vice President-Elect for 2016-2017 and will then serve subsequent one-year terms as Vice President, President, and Past President of the specialty section.
The SOT IVAM Specialty Section members have expertise or special interest in the application of in vitro techniques to address problems of cellular toxicity, with a special emphasis on product safety evaluation. IVAM interests include the study of cellular processes involved in adverse outcomes of specific organs as well as whole animals, and the development of systems to predict in vivo toxicity for risk assessment purposes. Other topics of interest include in vitro test validation and all aspects of test development and acceptance for individual or regulatory purposes.
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) is conducting a survey to (1) identify all types of knowledge sources that might be relevant to Replace, Reduce or Refine (the “3Rs”) the use of animals for scientific purposes, (2) understand how such knowledge is currently disseminated and (3) highlight what could be done to fill knowledge gaps and enhance knowledge sharing. Information collected through the survey will be considered with other relevant information at a conference on advancing towards the goal of phasing out animal testing to be organized in 2016 by the European Commission. More information and a link to the survey are available on the EURL ECVAM website. Please respond to the survey by March 11..
Nicole Kleinstreuer, Ph.D., has been named deputy director of NICEATM. Kleinstreuer most recently worked for ILS, the NICEATM support contractor, where she led the NICEATM computational toxicology group. In her new role as NICEATM deputy director she will continue to lead NICEATM computational toxicology projects, as well as interacting with NICEATM’s U.S. and international partners and stakeholders.
Kleinstreuer’s research focuses on mathematical and computational modeling of biological systems and those systems’ susceptibility to perturbations that result in adverse health outcomes. She was a key contributor to a strategy that combines in vitro high throughput assays and computational models for measuring estrogen receptor bioactivity (described in Browne et al., 2015), which has been accepted by the U.S. Environmental Protection Agency (EPA) as an alternative to three existing Tier 1 tests in the Endocrine Disruptor Screening Program. She was also lead author on the 2014 Nature Biotechnology paper, “Phenotypic screening of the ToxCast chemical library to classify toxic and therapeutic mechanisms,” recognized as the best paper of 2014 by the Society of Toxicology’s Biotechnology Specialty Section.
A native of Raleigh, North Carolina, Kleinstreuer received her Ph.D. in biomedical engineering from the University of Canterbury in Christchurch, New Zealand, and B.S. degrees in mathematics and biomedical engineering from the University of North Carolina at Chapel Hill (UNC-CH). Prior to joining ILS, she completed postdoctoral training at the EPA’s National Center for Computational Toxicology. Kleinstreuer also maintains an adjunct faculty appointment at the Eshelman School of Pharmacy at UNC-CH.
NICEATM Director Warren Casey, Ph.D., and nine current or former members of the ILS NICEATM contract support team have been named to receive an NIEHS Merit Award. The Merit Award is the highest level honor award given by the NIEHS director and recognizes achievements that support and advance the NIEHS mission. The NICEATM awardees are being recognized for validating the use of computational tools to replace a regulatory requirement for animal-based testing, thereby demonstrating the utility of Tox21 efforts.
The Society of Toxicology (SOT) Medical Device and Combination Products Specialty Section has recognized “Evaluation of an in vitro human dermal sensitization test for use with medical device extracts” (Coleman et al., 2015) as Best Published Paper of 2015. The paper describes a proof-of-concept study evaluating use of the SenCeeTox assay to test medical device extracts for skin sensitization potential. A 21-laboratory international validation study of the SenCeeTox assay will be conducted this year, with publication of results envisioned in fall 2016.
NICEATM Director Warren Casey has won the Society of Toxicology (SOT) 2016 Enhancement of Animal Welfare Award. In announcing the award, SOT specifically noted Casey’s efforts to improve the quality of data from traditional animal studies that are used to evaluate new approaches, and his leadership on projects supporting replacement of animal tests with high throughput screening approaches and computational models.
U.S. government agencies are offering awards totaling $1 million to improve the relevance and predictivity of data generated from automated technology used for toxicity testing.
In a Jan. 8 press release, the U.S. Environmental Protection Agency (EPA) announced that it is partnering with the National Center for Advancing Translational Sciences and the National Toxicology Program to sponsor the Transform Tox Testing Challenge: Innovating for Metabolism. The challenge calls on innovative thinkers to find new ways to incorporate physiological levels of chemical metabolism into high throughput screening assays. This will help researchers more accurately assess effects of chemicals and better protect human health.
Participating teams will compete in three stages for a total award of $1 million. The first stage, which closes April 8, seeks practical designs that may be fully implemented. Up to ten entries may receive a prize of $10,000 each and an invitation to continue to the second stage, prototype development. The final stage will involve testing by the sponsoring agencies of commercially viable methods or technologies.
The challenge is closed to federal employees acting within the scope of their employment but is open to all other segments of government, industry, academia, or non-governmental organizations.