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Call for abstracts for European retreat on Animal Research Ethics


Animal Research Ethics as Interaction of Research Ethics, Animal Ethics and (Animal Protection) Law. International Perspectives on Theoretical and Cultural Differences

An interdisciplinary European retreat for young scholars

Sept 5-9, 2022 at Hannover Medical School, Germany

Deadline for abstracts: Jan 31, 2022

Animal experiments are controversially discussed in society and science, but distortions are also apparent between animal ethics and biomedical research ethics. For some years now, efforts have been made to reconnect animal ethics and research ethics in particular. This one-week, international retreat organized by the Institute for Ethics, History and Philosophy of Medicine at the Hannover Medical School (MHH) is intended to address questions of the conception and implementation of a (more) international animal research ethics in the context of basic and translational biomedical research.


In detail, the retreat will examine the interplay between research ethics, animal ethics and (animal welfare) laws. In doing so, cultural differences will also be considered, which influence the manifestations of the concepts up to the actual regulations (with a focus on Europe). This examination is necessary to enable a plausible conception of a common animal research ethics as well as to better understand the current implementation of such an ethics: How and to what extent could national and cultural differences be reduced? How could related problematic practices be addressed (e.g., "ethics dumping", the outsourcing of research to countries with less stringent legal requirements)? Furthermore, the retreat will address how realistic international efforts actually are, and what influence cultural, religious, and political interests might have.


Conference theses

Eight predefined theses guide the discussions that will be stimulated by the participating young scholars as well as the invited presentations by experts (see below):

  • The task of a (more) international animal research ethics is to take a mediating position between animal ethics and research ethics. (T1)
  • Animal ethics tends to absolute positions, research ethics to weighing processes in animal experimentation ethics. (T2)
  • Operationalizing benefits and harms in trade-offs is challenging, as both are poorly quantifiable and the concrete benefit of an experiment is somewhat uncertain, while the harm to the research animals is manifest. (T3)
  • (Animal) ethics can justify universal demands, but law can only justify particular national and international demands. (T4)
  • The national differences in law, but also in theory, can be traced back to different cultural and/or religious imprints and make it difficult to develop common (best practice) standards. (T5)
  • For the harmonization/internationalization of animal research ethics, scientific standards and positioning (guidelines, recommendations, position papers, etc.) are more decisive than legal requirements. (T6)
  • Approving authorities for animal experiments must work according to internationally uniform criteria so that problems such as “ethics dumping” can be prevented. (T7)
  • The overarching goal of a (more) international animal research ethics is to reduce animal experimentation or to improve the quality of research. (T8)


The following experts have confirmed their participation so far:

  • Prof. André Bleich (Hannover Medical School)
  • Alice DiConcetto, LLM (Animal Law Europe)
  • Prof. Herwig Grimm (University of Veterinary Medicine Vienna)
  • Dr. Kathrin Herrmann (Animal Protection Commissioner of Berlin)
  • Prof. Peter Kunzmann (University of Veterinary Medicine Hannover)
  • Prof. Helena Röcklinsberg (Swedish University of Agricultural Sciences)
  • Prof. Peter Sandøe (University of Copenhagen)


    The number of participants is limited to 15 young scholars (i.e., doctoral candidates and postdocs up to five years after thesis defense) from Germany and other European countries. Scholars from non-European countries are welcome to apply as well but preference will be given to European candidates. The conference language will be English, with the exception of a public evening lecture. Participants receive a financial compensation for travel up to 300 € (Germany) and 600 € (other countries), respectively. Accommodation (incl. dinner each day) will be provided

    If you are interested to participate in the interdisciplinary retreat, we expect an oral presentation (about 20 min) that addresses one of the conference theses. Further, all participants are given the possibility to contribute to a shared publication on animal research ethics.


    Your application should include:
  • an anonymized abstract (max. 1000 words) including
  • a clearly indicated thematic allocation to one of the eight conference theses (T1-T8)
  • a short curriculum vitae (max. 2 pages) and
  • a publication list (max. 1 page).

    Please send your application to until January 31, 2022 and clearly indicate in the subject line of your e-mail the conference thesis your abstract deals with. The selection of candidates will be based on thematic relevance and quality of the abstract as well as on previous scientific qualifications. All applicants will be informed about the acceptance of their proposed talk by April 2022 at the latest.


    Dr. phil. Marcel Mertz (Project lead)
    Dr. PH Hannes Kahrass (Project lead)
    Felicitas Selter, PhD (Coordinator)


    Felicitas Selter, PhD
    Institute for Ethics, History and Philosophy of Medicine
    Hannover Medical School, Carl-Neuberg-Straße 1
    30625 Hanover, Germany
    phone: 0049-511 532-5810 (F. Selter) or - 4278 (Secretary's office)

     The conference is funded by the German Federal Ministry of Education and Research (BMBF); pending final approval.

NC3Rs project grant scheme open for applications


The 2022 NC3Rs Project grant call has opened and the outline application form is now available on Je-S. This scheme supports the development of new approaches that will make a 3Rs impact in any area of medical, biological or veterinary research. Awards are for up to 36 months and funded at 80% FEC, with the amount requested dependent upon the science.

Outlines should be submitted by 4pm on Tuesday 11 January.

German BMBF calls for applications for projects on alternatives to animal experiments


The German Ministry for Education and Research (BMBF) aims to consolidate and strengthen Germany's leading international position in the field of alternative methods. Funding applications for excellent projects aiming to develop new methods to replace or reduce animal experiments (module I) and concepts that support the widespread use of alternative methods (e.g. education and training courses) and strategies to implement alternative methods (module II) will be considered.

Universities, research institutions and companies may apply. The project duration is three years. Projects may be submitted by March 15 every year beginning with 2022. Project applications received after the deadline will be considered for the following funding period.

More information [in German]

ECEAE prize for animal-free antibodies


The European Coalition to End Animal Experiments is calling for applications for a prize for animal-free antibodies.

Deadline: January 15, 2022

Application criteria

The applicants must fulfill the following criteria:

  • The application should focus on the innovative development and / or application of animal-free antibodies for research or medical purposes
  • The application can be for ongoing or completed projects
  • The project must not contain any animal experiments or animal-derived products such as fetal calf serum (FCS), bovine serum albumin (BSA), milk powder, etc.
  • The applicants must be based on the continent of Europe. Applicants from EU and non-EU member states in Europe are welcome to apply
  • The applicants must be prepared to accept the prize at an event in Brussels in spring of 2022, and give a short presentation. Travel expenses will be covered
Prize amount and award ceremony

The prize amounts to €10.000 and can be awarded to an individual researcher or a researcher consortium, a university department, an industrial company or other type of research facility. The prize will be awarded at an event in Brussels in March/April 2022.

Application documents

Please submit the following application documents in English:

  1. A project description containing title, abstract, short background, research aims, methodological procedures, time plan and project milestones (for ongoing projects) or outcomes of the project (for completed projects). The project description should be focused on the development or application of animal-free antibodies and it should include a declaration that no animal experiments were performed and no animal-derived materials were used, including in buffers, cell media, blotting reagents, etc. (up to 6 pages).
  2. A description of the applicant’s motivation to develop and / or use animal-free antibodies (1 page).
  3. A tabular curriculum vitae of the applicant with a publication list.

Call for tender as PDF 

Contact person: Dr. Dilyana Filipova E-mail: References:

1. EU Science Hub - European Commission: Better antibodies without using animals. 11.5.2020

2. Viegas Barroso JF et al. EURL ECVAM recommendation on non-animal-derived antibodies, Publications Office of the European Union, 2020

NICEATM releases ICE 3.5


On October 11, NICEATM released version 3.5 of the Integrated Chemical Environment (ICE; ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds expanded capabilities and new data to the existing ICE resources.

ICE version 3.5 includes the following expanded capabilities:

  • New result selection options in the Chemical Quest and Curve Surfer tools.
  • Application of Saagar fingerprints (described in Sedykh et al. 2021: to Chemical Quest searches.
  • Ability to display AC50 plots in Search results.

In addition, updated data have been added for acute oral toxicity, cancer, and skin sensitization, and modeling tools are using updated absorption, distribution, metabolism, and excretion data.

NC3Rs launches organ-on-a-chip online resource


Organ-on-a-chip (OoC) technologies are promising tools to reduce the reliance on animal models in basic and applied research. The NC3Rs has created a new resource bringing together their OoC activities as well as other global programmes and initiatives. As well as showcasing the NC3Rs' portfolio of reports and projects in this area, the resource provides information and support for the OoC community, including technology developers, end-users, regulators and in vivo researchers who are looking to adopt alternative approaches.

FDA draft guidance on carcinogenicity testing; Comment by December 6


In an October 5 Federal Register notice (86 FR 54982;, the U.S. Food and Drug Administration (FDA) announced draft guidance for industry, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.” The draft guidance expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals. It introduces an integrative approach that provides specific weight-of-evidence criteria that inform whether a 2-year rat study adds value in completing a human carcinogenicity risk assessment. The draft guidance also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model.

FDA is accepting comments on the draft guidance through December 6. The draft guidance and a link to submit comments are available at

Swiss 3RCC calls for nominations for 3Rs Awards


The Swiss 3RCC gives out two annual awards: the Swiss 3RCC's 3Rs Award and a Young 3Rs Investigator Award to individuals for work conducted in Switzerland.

The main 3Rs Award of CHF 4'000.- is given for exceptional work has made a significant contribution to the Replacement, Reduction, Refinement of animal experimentation (the 3Rs Principle).

A further CHF 1000.- prize, the Young 3Rs Investigator Award, is given to to researchers in the early stages of their career for their individual achievements advancing the 3Rs principle.

Applications will be evaluated based on the quality of the contributions and on their impact on the 3Rs in either a scientific, regulatory, industrial or educational context. In addition to the financial award, the awardee will be given the possibility to have a short video made about his/her activities contributing to the implementation of the 3Rs and/or to present his/her work in a 3R-dedicated event organized by the 3RCC.

Nominees are initially internally reviewed and short-listed, followed by an external endorsement by at least 3 international experts in the field. 

Thomas Hartung wins EUROTOX Merit Award


Prof. Heather Wallace, President of EUROTOX, presented the EUROTOX Merit Award to Thomas Hartung at the opening ceremony of the Virtual 2021 EUROTOX Congress on September 27, 2021.

Thomas Hartung, MD, PhD, is the Doerenkamp-Zbinden-Chair for Evidence-based Toxicology at Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA with joint appointments at The Whiting School of Engineering Molecular Microbiology and Immunology Georgetown University, Washington, DC and the University of Konstanz, Germany. He also is Director of the Centers for Alternatives to Animal Testing (CAAT) in the US and Europe. He is the former Head of the European Commission’s Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy. He is Chief Editor of Frontiers in Artificial Intelligence and has authored more than 580 scientific publications.

The EUROTOX Merit Award is presented annually at the EUROTOX Congress to a European toxicologist with a long and outstanding career in the discipline. Achievements in academia, public service or industry may be recognized. Emphasis should be put on individual contributions strengthening the science of toxicology.

EMA implements new measures to minimise animal testing during medicines development



EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles — replace, reduce and refine; commonly referred to as 3Rs — through EMA’s Innovation Task Force (ITF). This action will facilitate the development and implementation of New Approach Methodologies (NAMs) that are in line with the European Union legislation on the protection of animals used for scientific purposes.

ITF is a dedicated forum for early dialogue between regulators and developers of medicines to discuss innovative aspects such as emerging therapies, methods and technologies. Set up to ensure coordination across the Agency, the ITF is a multidisciplinary group that includes scientific, regulatory and legal competences. It will provide an opportunity to discuss 3R-compliant methods and facilitate their integration into the development and evaluation of medicinal products.

The ITF’s service is free of charge and any NAMs adhering to the 3Rs principles that can be used to fulfil testing requirements are eligible for consideration.

Alternative approaches to animal models, such as improved tests based on human and animal cells, organoids, organ-on-chips and in silico modelling, provide opportunities to develop better and more predictive scientific tools to protect human and animal health as well as the environment.

Opening the ITF platform to discussions of 3Rs-compliant methodologies is expected to encourage prioritising and speeding up the integration of alternative methods into the regulatory framework. This action supports the reduction of animal use and is in line with EMA's Regulatory Science Strategy to 2025 aiming to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine.

EMA press release, 29/09/2021

QSAR Toolbox 4.5 for animal-free assessment of skin sensitisation released


The updated QSAR Toolbox (version 4.5) includes an automated workflow for defined approaches for skin sensitisation. The recently published OECD guideline includes computational methods for assessing skin sensitisation without testing on animals. The Toolbox is the only freely available tool that can be used to do that. The new version also has a simplified web interface and enables structural searches in IUCLID databases.

The QSAR Toolbox is a free software supporting chemical hazard assessment, co-developed by ECHA and OECD. It helps to minimise testing on animals. Its results are based on existing experimental data and knowledge on the mechanisms of toxicity.

NIH NCATS supports the first three Microphysiological Systems World Summits with grant


The initiative to create a series of MPS World Summits has been awarded a grant by the National Center for Advancing Translational Sciences (NCATS), one of 27 Institutes and Centers at the National Institutes of Health (NIH) in support of the organization of the first three Microphysiological Systems World Summits.

About 40 organizations (and counting) as well as a continuously expanding Scientific Advisory Committee of experts in the field have teamed up to organize the May 30-June 3, 2022 inaugural World Summit in New Orleans and similar events in Europe 2023 and the US West Coast in 2024. The series was kicked-off with a virtual conference on June 24, 2021 with the theme "Towards regulatory acceptance", which will be followed by a second virtual event on December 9, 2021 on "Systems engineering of microphysiological systems".

The MPS (Microphysiological Systems) World Summit will bring together a global audience, including institutions (government, health foundations, charities), the academic research community (universities, research institutes), environmental and human toxicity researchers, the pharmaceutical and other industries (cosmetics, chemical, and food industries), medical centers and practitioners, patient associations, and policy makers and testing centers—in a series of global conferences to create a roadmap for MPS technologies. This will be a first step in establishing an international MPS society. 

The MPS World Summit offers multiple sponsoring opportunities as detailed on the website to which the companies listed below have already committed:

  • Gold sponsor: Emulate
  • Silver sponsors: AxoSim, Hesperos, InSphero, Obatala
  • Bronze sponsor: Nortis
  • Exhibitors: Aracari, Mimetas, Vitrocel Systems GmbH, TissUse

In related good news, the latest issue of Science features the article:

Roth, A. and MPS-WS Berlin 2019 [Marx, U., Vilén, L., Ewart, L., Griffith, L. G., Hartung, T., Ingber, D. E., Mendrick, D. L., Steger-Hartmann, T. and Tagle, D. A.]. Human microphysiological systems for drug development. Science 2021, 373:1304-1306. doi: 10.1126/science.abc3734

which was a direct result of the hightly cited t4 workshop report published in ALTEX:

Marx, U., Akabane, T., Andersson, T. B. et al. (2020). Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development. ALTEX 37, 365-394. doi:10.14573/altex.2001241

Joint motion for a resolution to accelerate the transition to innovation without the use of animals adopted by European Parliament


A joint motion for a resolution entitled “European Parliament resolution on plans and actions to accelerate the transition to innovation without the use of animals in research, regulatory testing and education (2021/2784(RSP))” was submitted to European Parliament on September 13 by representatives of the PPE, S&D, Renew, Verts/ALE, ECR and The Left Groups and adopted on September 15. The motion calls on the Commission to establish a high-level inter-service taskforce to design an EU-wide action plan with a clear and ambitious timeline and a list of milestones to phase-out live animal use for scientific purposes as soon as this is scientifically possible and without lowering the level of protection for human health and the environment. The motion acknowledges the important contributions of animal-based research to date and states that alternative methods are not available to replace all animal testing yet, however experiments that are carried out on animals should take place in optimal conditions that minimize pain, distress, and suffering. To achieve the transformation, the motion highlights that the development of alternative animal-free methods, technologies, and instruments necessary for change must be accelerated by preferential funding of non-animal methods across all EU research and innovation initiatives. It further calls on the Commission to set reduction goals in consultation with ECHA, EFSA and other relevant agencies, and to support education and training in advanced non-animal models.

Recordings of WC11 keynote lectures, talk shows, awards & closing ceremony available online


The keynote lectures given during the 11th World Congress on Alternatives and Animal Use in the Life Sciences held virtually on August 23 to September 2, 2021 are available on-demand at the following links:

André Kuipers:

Russel Thomas:

Donald Ingber:

Jason Ekert:

Malcolm McLeod:

Anna Deplazes:

Tharanga Thoradeniya:

Ger Janssen:

Joseph Wu:


Recordings of the talk shows can be viewed here:




The WC11 Award Ceremony can be rewatched here:

Rewatch the WC11 Closing Ceremony here:

2021 ALTEX Prize awarded to Taylor Rycroft


We are pleased to announce that Dr Taylor Rycroft of the Environmental Laboratory, U.S. Army Engineer Research and Development Center, Vicksburg, MS, USA has won the ALTEX Prize 2021 as first author of the article "AOPERA: A proposed methodology and inventory of effective tools to link chemicals to adverse outcome pathways". The article was selected by the ALTEX Editorial Board, the Board of ALTEX Edition and the ALTEX editorial office as the best article published in ALTEX during 2020. The award was presented on September 2 at the 11th World Congress on Alternatives and Animal Use in the Life Sciences in Maastricht in 2021.

The ALTEX Prize is awarded annually and is kindly sponsored by the Doerenkamp-Zbinden Foundation.

Helena Kandárová announced as winner of the 2021 Doerenkamp-Zbinden Prize


The Board of Trustees of the Doerenkamp-Zbinden Foundation for Animalfree Research has chosen the Slovak scientist Dr. Helena Kandárová, ERT from the Centre of Experimental Medicine at Slovak Academy of Sciences, in Bratislava, Slovakia, as the Doerenkamp-Zbinden Prize winner in the year 2021. The 10 000 CHF Prize was presented to her on September 2 at an online ceremony during the 11th World Congress on Alternatives and Animal Use in the Life Sciences in Maastricht. Helena Kandarova receives the prize for her outstanding achievements in the field of alternatives to animal testing.

NICEATM releases ICE 3.4


On June 7, NICEATM released version 3.4 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds new tools and expanded capabilities to the existing ICE resources.

ICE version 3.4 includes the following new tools and expanded capabilities:

  • Chemical Quest (Beta): uses fingerprints to predict structure similarity.
  • Drawing of 2D structures (part of the Chemical Quest tool): users can draw their own structures and query ICE for all chemicals that are similar to the drawn structure.
  • Query by multiple chemical identifiers: CASRNs, DTXSIDs, SMILES or InChiKeys are now accepted as inputs into all ICE tools.
  • Send assays to other ICE tools: users can switch between ICE tools and keep the same assays selected.

New data and data updates include:

  • Developmental/reproductive in vivo assays from NTP and the European Chemicals Agency.
  • Dermal irritation in vivo assays (rat Draize skin irritation/corrosion test).
  • Updates to ICE curated high-throughput screening data and data from the Open Structure-activity/property Relationship App (OPERA).

ICE is available at

NC3Rs launches interactive 3Rs self-assessment tools


The NC3Rs has launched two online 3Rs self-assessment tools that research groups and institutions can use to collate, track and benchmark their 3Rs activities. These interactive tools, which are secure and free-to-use internationally, help researchers, ethics committee members and others to identify and implement 3Rs opportunities.

Leaders of research groups and institutions who want to ensure an optimal 3Rs culture need to be able to evaluate their current activities, understand their strengths and establish what should be improved and how. Through consultation with the scientific community, NC3Rs has developed two 3Rs self-assessment tools: one for individual research groups and one for research institutions (i.e. universities and other academic, research-intensive organisations). Each tool consists of a series of questions on the 3Rs, divided into categories that reflect the breadth of potential 3Rs activities across different levels. Once each question set is completed, the system automatically scores the responses and provides bespoke feedback on what is being done well and what improvements the research group or institution could make.

ECHA reports critical issues with EOGRT studies, review ongoing


Experts from ECHA and Member States have found critical issues in the design and conduct of extended one-generation reproductive toxicity (EOGRT) studies. The issues can compromise data analysis and may raise questions over compliance or requests for further studies if there is a concern. ECHA encourages registrants and test laboratories to consider the issues and improve ongoing and future EOGRT studies accordingly.

The EOGRT study (EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity in REACH since March 2015. 

ECHA’s advice on improving EOGRT studies

European Pharmacopoeia to put an end to the rabbit pyrogen test


At its 170th session in June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years.

The Ph. Eur. test for pyrogens (general chapter 2.6.8) consists of measuring the rise in body temperature evoked in rabbits by the intravenous injection of a sterile solution of the substance to be examined. It was first published in the Ph. Eur. in 1986.

The majority of pyrogens are bacterial endotoxins and these can be detected using the bacterial endotoxins test (BET) described in Ph. Eur. general chapters 2.6.14. Bacterial endotoxins and 2.6.32. Test for bacterial endotoxins using recombinant factor C. However, in some cases, non-endotoxin pyrogens may also be present and these are not detected by the BET. A test covering all types of pyrogens is therefore required to confirm the absence of non-endotoxin pyrogens.

General chapter 2.6.30. Monocyte-activation test (MAT) was added to the Ph. Eur. in 2009, providing an in-vitro alternative to the RPT that is capable of detecting both endotoxin and non-endotoxin pyrogens. The publication of this chapter was a significant step forward in terms of animal welfare, in accordance with the Council of Europe’s European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes.

However, despite multiple efforts since then to encourage developers to apply the MAT instead of the RPT, rabbits continue to be used extensively to detect pyrogenic substances.

There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected. The Ph. Eur. is committed, for all these texts, to replacing the test for pyrogens with a suitable in-vitro alternative, ultimately leading to the complete elimination of the RPT. In the meantime, users are actively encouraged to seek alternatives to chapter 2.6.8, the best option being the MAT.

Throughout the process, users will have the opportunity to comment on a case-by-case basis, since each of the texts concerned will go through the standard public enquiry in Pharmeuropa.

OECD adopts new Guideline on Defined Approaches on Skin Sensitisation


The OECD has published a new Guideline on Defined Approaches for Skin Sensitisation (OECD GL No. 497). This is a new type of OECD Guideline that uses several types of combined information to provide chemical safety information and can replace the need for animal test data. The project to develop this new Guideline started in 2017 and was led by the United States, the European Commission Joint Research Centre and Health Canada, supported by a group of nominated experts. The Defined Approaches (DAs) were validated using an extensively curated large set of human and mouse reference data on skin sensitisation. A supporting document providing details on the data curation and performance characteristics of the DAs on skin sensitisation will be published soon in the OECD Series on Testing and Assessment

A Defined Approach (DA) consists of selected information sources (e.g. in silico predictions, in chemicoin vitro data) used in a specific combination, and resulting data are interpreted using a fixed data interpretation procedure (DIP) (e.g. a mathematical, rule-based model). DAs are intended to overcome some limitations of the individual methods. 

The first three DAs included in this Guideline use combinations of OECD validated in chemico and in vitro test data, in some cases along with in silico information.  The DAs included in this Guideline have shown to either provide the same level of information or be more informative than the LLNA (OECD TG 429) for hazard identification (i.e. sensitiser versus non-sensitiser).  In addition, two of the DAs provide information for sensitisation potency categorisation that is equivalent to the potency categorisation information provided by the LLNA.

 This new Guideline is intended to be the first of more harmonised defined approaches adopted across OECD member countries and countries adhering to the Mutual Acceptance of Data system to 1) address regulatory needs, 2) enhance the utility of individual methods when used in testing strategies, and 3) reduce use of animal testing.


Further new test guidelines and updates include:

Section 4

Test No. 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method

Test No. 250: EASZY assay - Detection of Endocrine Active Substances, acting through estrogen receptors, using transgenic tg(cyp19a1b:GFP) Zebrafish embrYos

Test No. 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists
Test No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

Test No. 442C: In Chemico Skin Sensitisation

Test No. 405: Acute Eye Irritation/Corrosion

Test No. 406: Skin Sensitisation


Section 2

Test No. 249: Fish Cell Line Acute Toxicity - The RTgill-W1 cell line assay

Test No. 211: Daphnia magna Reproduction Test

Einstein Center for Alternative Methods in Biomedical Research in Berlin established


The Einstein Center for Alternative Methods in Biomedical Research will officially commence work on July 1, 2021. The Einstein Foundation will provide financial support amounting to €5.3 million until the end of 2026, but will make part of its funding subject to the Center's positive interim assessment by the Foundation’s independent research board in 2024. Additional funding will be made available by the State of Berlin.

The Einstein Center 3R (Replace, Reduce, Refine) aims to develop new therapies for human diseases by improving the transferability of research while also taking into view animal welfare. Research will focus on 3D human organoids designed to replace animal testing. These organoids shall resemble human organs as closely as possible in terms of maturity and complexity, i.e., “micro-organs” with vascular or immune systems.

The Einstein Center will accommodate six research projects focusing on the intestines, lung, heart, brain, liver, and neuromuscular junctions, respectively. These will be complemented by two cross-sectional quality assurance projects designed to improve the models and define measures and principles to guide the projects’ research. In addition, the Center will set up an imaging and analysis platform in order to improve the comparability of human and animal-based models regarding the specific characteristics of diseases such as COVID-19.

The Center’s long-term aim is to build a Berlin-wide research network that explores tissue models and develops cutting-edge projects. It will also be involved in education and training as well as communication and outreach programs.

Three new Horizon 2020 research projects kick off


The EU is funding the three multi-partner research projects PrecisionTox, ONTOX and RISK-HUNT3R under the call „Advancing safety assessment of chemicals without use of animal testing” with a total funding volume of € 60 million over five years.

PrecisionTox, with 15 partners led by the University of Birmingham, started on February 1. The goal of the project is to identify molecular key event (KE) biomarkers that predict chemically induced adverse health effects in humans and to facilitate their uptake into regulatory and industry practice. This goal is supported by three core concepts: PhyloToxicology, which replaces mammalian models with an evolutionarily diverse suite of non-sentient animal species from across the tree of life; Quantitative Susceptibility, which determines safety factors based on genetic variability; and Embedded Translation, which engages key stakeholders in project planning, selection of chemicals for investigation, and case studies for regulatory application.

ONTOX, with 18 partners led by the Vrije Universiteit Brussels, will kick off on May 1. The consortium aims to deliver a generic strategy to predict systemic repeated dose toxicity effects. This will be combined with tailored exposure assessment to enable human risk assessment. The focus will be on 6 new approach methodologies (NAMs) addressing adverse outcomes in the liver (steatosis and cholestasis), kidneys (tubular necrosis and crystallopathy) and developing brain (neural tube closure and cognitive function defects). The NAMs will integrate available data into physiological maps, quantitative adverse outcome pathway networks and ontology frameworks and use artificial intelligence technology to identify data gaps to be filled by targeted in vitro and in silico testing. The NAMs will be evaluated and applied in collaboration with industrial and regulatory stakeholders to maximize end-user acceptance and regulatory confidence.

RISK-HUNT3R, with 37 partners led by the Universiteit Leiden, will start on June 1. The vision of the RISK-HUNT3R consortium is to provide a fully human-centric risk assessment strategy encompassing exposure assessment, information on chemical distribution in the body, hazard characterization, adverse outcome prediction, and determination of actual risk in defined scenarios, also factoring in human (disease) genetics and exposome data. The applicability of all critical test systems integrated into the next generation risk assessment strategy will be assessed. Engagement with all key stakeholders from different industry sectors and international regulatory agencies based on real-world case studies will allow critical evaluation and warrant genuine acceptance of the novel safety testing framework that will be in concordance with the European Commission’s “Green Deal”. The project will seek commercial exploitation of the validated safety assessment approaches to ensure sustainability of the project outcomes and fortify the innovation capacity of the industry sectors involved.

Interactive map of global 3R resources online


Norecopa has published an interactive world map to highlight a range of resources relevant to laboratory animal science and welfare. These are divided into two groups called Centres (which highlight organisations at specific locations) and Associations (networks between countries). Filters in the right margin can be used to turn these on and off. Suggestions for additions are welcome, and may be sent to Adrian Smith.

NICEATM releases ICE 3.3


On March 12, NICEATM released the version 3.3 update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds two new tools, new features including expanded activity visualization, and new datasets to existing ICE resources.

New tools:

  • Curve Surfer: allows users to view and interact with concentration-response curves from curated high-throughput screening data.
  • Physiologically Based Pharmacokinetics (PBPK) tool: this tool, based on the the U.S. Environmental Protection Agency (EPA) httk package (, allows users to generate predictions of tissue-specific chemical concentration profiles following a dosing event.

Updates to existing tools:

  • Search tool: users can get detailed visualization of query results.
  • In Vitro to In Vivo Extrapolation (IVIVE) tool: users can now upload their own in vivo data to overlay on the results.
  • Chemical Characterization: new visualizations include bioactivity PCA plots and Consumer Use Explorer, which allows users to view chemical use categories from the EPA Consumer Products Database (CPDat).

New data:

  • Cancer data from multiple sources, including detailed data from NTP two-year cancer bioassays and in vivo and in vitro genotoxicity studies.
  • Developmental and reproductive toxicity (DART) in vivo bioassays from the EPA’s Toxicity Reference Database (ToxRefDB).
  • Updated in vivo human predictive patch test data set for skin sensitization characterization compiled by NICEATM and the German Federal Institute for Risk Assessment (BfR).

ICE is available at

NC3Rs releases new research culture hub


The NC3Rs is committed to facilitating a good research culture, supporting reproducible and ethical research through effective application of the 3Rs. They have produced a new hub that features a range of resources to help you strengthen the research culture of your group, department or institution. These focus on experimental design and reporting, open research and communication, and promoting a culture of care. As a funder the NC3Rs also has a responsibility to help foster a fair and inclusive research culture.

The term research culture encompasses the actions and behaviours of individuals and the values and ethos of institutions, both of which can have a significant impact on the effective application of the 3Rs and the humane use of animals.

The research culture hub one element of the NC3Rs Resource hubs.

Recordings of online symposium on animal euthanasia available


The Swiss Federal Food Safety and Veterinary Office (FSVO), UFAW (the Universities Federation for Animal Welfare) and HSA (the Humane Slaughter Association) together organised the 3rd symposium on Humanely Ending the Life of Animals as a virtual meeting on November 3rd and 4th. Recordings of the sessions are available. This symposium continues a growing initiative to identify, refine and implement alternative methods to CO2 for humanely ending the life of mice, rats, poultry and pigs to improve animal welfare in the laboratory, the slaughterhouse and during emergency depopulation. Carbon dioxide is commonly used for stunning animals prior to killing. It allows several animals to be killed at once, reduces the need for handling, and is a reliable method. However, research in laboratory rodents, poultry, and pigs has indicated that it causes considerable aversion at concentrations above ambient conditions. Currently, there are no available alternatives with desirable characteristics.

More information:

Switzerland initiates national research programme to advance the 3Rs 


On 3 February 2021, the Swiss Federal Council initiated a new national research programme "Advancing 3Rs - Animals, Research and Society". The main objectives of NRP 79 are to reduce the number of animal experiments in scientific research, to improve animal experimentation, and to develop basic principles on ethical and societal aspects in this field. The programme, which is endowed with 20 million Swiss francs, will run over five years. The Swiss National Science Foundation is responsible for the implementation of the NRP 79. The Swiss 3RCC is coordinating its activities with those of the new NRP.
More information: 

EPA list of alternative test methods to animal testing updated


EPA has updated its list of alternative test methods or strategies (New Approach Methodologies or NAMs) that do not require new vertebrate animal testing. This action helps meet the requirements of the Toxic Substances Control Act to reduce and replace, to the extent practicable and scientifically justified, the use of vertebrate animals in the testing of chemical substances or mixtures.

The updated list incorporates the following changes from the 2019 List:

  • Added one new test guideline that relates to human health effects.
  • Incorporated two additional EPA guidance documents that reduce the use of animal testing.
  • Added version 9.0 of the organic chemicals’ module of OncoLogicTM, a more user-friendly version of the most widely used piece of this system that evaluates a chemical’s potential to cause cancer.

For more information on alternative test methods and strategies to reduce vertebrate animal testing, please visit:

EPA finalizes guidance to waive dermal toxicity tests for pesticides


Today, the U.S. Environmental Protection Agency (EPA) delivered on EPA Administrator's directive to reduce animal testing by finalizing guidance that will allow researchers to forego testing chemicals on animal skin in certain circumstances to determine whether pesticides lead to adverse effects. 

“Today’s action is another example of how EPA is moving closer to achieve our goal  of eliminating  the use of mammals in chemical testing by 2035,” saidEPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn. “Our guidance expands the ability for waivers for dermal toxicity studies while allowing the agency to continue to make  science-based decisions about pesticide registrations without the need to conduct unnecessary additional animal tests.”  

In October 2020, EPA released the proposed guidance for a 30-day comment period which received stakeholder input. In developing the guidance, EPA conducted a retrospective analysis with the U.S. Department of Health and Human Service. The joint analysis found that requirements for such studies provides little to no added value in the regulatory decision making process.   

The final dermal toxicity guidance will allow registrants to apply for waivers for studies on single-active ingredients used to develop end use products. This guidance is expected to save up to 750 test animals annually from unnecessary testing as well as EPA, industry and laboratory resources. 


In September 2019, Administrator Wheeler issued a directive  calling for the Agency to reduce animal testing and funding 30 percent by 2025 and eliminate it by 2035. In support of this directive, EPA has taken many steps since then to reduce, replace, and refine animal testing requirements: 

  • In September 2019, EPA announced $4.25 million in funding for five universities to research and develop alternative test methods for evaluating chemical safety. 
  • In December 2019, EPA convened a conference for achieving reduced animal testing in chemical safety research 

and updated its list of NAMs that could be used in the agency's work under the amended TSCA. The updated list includes 21 new test guidelines related to health and ecological effects and six additional EPA policies that reduce the use of animal testing. 

FDA publishes report on advancing alternative methods


The U.S. Food and Drug Administration has published the report, “Advancing New Alternative Methodologies at FDA,” which demonstrates the significant progress that the FDA has made in laying the groundwork for integrating alternative approaches into regulatory programs.

Developed by the FDA’s Alternative Methods Working Group, the report and its outlined activities build upon the Predictive Toxicology Roadmap, a framework to spur the development and evaluation of emerging technologies that can help potentially replace, reduce, and/or refine animal testing and to incorporate them into the agency’s regulatory review. The roadmap ensures that the end users of this new technology—FDA regulators—are involved up front as these technologies evolve from design to testing to qualified context of use.

As noted in the report, the FDA has developed the Advancing Alternative Methods webpage, which hosts related publications, presentations, and a webinar series that enables developers to showcase their pioneering technologies to FDA scientists. The FDA will continue to update its progress on alternatives in real time for stakeholders on its website.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of the U.S. food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Baden Württemberg limits use of animals for higher education


On December 16, the parliament of the State of Baden Württemberg voted for a change in the Higher Education Act, which will allow students to complete their studies without using animals. The amendment states that animals shall not be killed for teaching purposes if scientifically equivalent alternatives are available. Universities and colleges are to develop such alternative methods to avoid and reduce animal use, and study courses are to be designed in such a way that animals are not used to illustrate biological, chemical or physical processes if scientifically equivalent alternatives are available. In case alternatives are not available, students must be given the option to fulfill the course requirements without the use of animals.

The amendment, which will come into effect early 2021, follows similar provisions in seven other German states (Bremen, Hessen, Nordrhein-Westfalen, Rheinland-Pfalz, Saarland, Sachsen-Anhalt and Thüringen).

Virtual Human Platform based exclusively on human biology gains funding


How great would it be if we could assess the safety of chemicals and pharmaceuticals without the use of laboratory animals? To be able to test the safety of chemicals solely based on human physiology and biology, including such vulnerable groups as infants, the elderly or the sick? Researchers from, among others, Utrecht University, University of Applied Sciences Utrecht and the National Institute for Public Health and the Environment (RIVM) are developing a Virtual Human Platform to assess the safety of chemicals and medicines without the use of laboratory animals. The consortium will receive 9.9 million Euros from the Dutch Research Agenda: Research on Routes by Consortia (NWA-ORC) for this purpose. Thanks to the contribution of foundations, government and private sector organisations, the total funding comes to 11.2 million Euros. The project is led by Juliette Legler (Utrecht University), Cyrille Krul (University of Applied Sciences Utrecht) and Anne Kienhuis (RIVM). 

More information

USP includes in vitro batch release test for insulins


The United States Pharmacopeia has added an in vitro cell-based assay for the batch release of two insulins (glargine and lispro) as an alternative to the rabbit blood sugar bioidentity assay to Chapter <121> Insulin Assays. The rabbit assay, which requires 8-24 animals per batch, is not required in the European Union. Sanofi, which exports insulin to the US, began to validate an experimental in vitro test as an alternative to the rabbit assay in 2012, which was accepted in 2016 (see Hack et al., 2017, doi:10.14573/altex.1708091) and included in the guideline in December 2020.

Joint statement on implications of recent ECHA Board of Appeal decisions


Cruely Free Europe, The European Coalition to End Animal Experiments (ECEAE), Eurogroup for Animals, Humane Society International (Europe) and PETA UK have issued a joint statement regarding the use of animals to test cosmetics ingredients under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Even though the testing of cosmetics ingredients on animals is banned under the EU Cosmetics Regulation, the European Chemicals Agency and the European Commission have argued that even ingredients used exclusively in cosmetics may still be tested on animals under REACH if there is a possibility of workforce exposure during the manufacturing process. For cosmetics ingredients also used in other types of products, tests on animals may, they say, be required regardless of any potential for workforce exposure.

The statement reads as follows:

When the European Union banned the testing of cosmetics products on animals in 2004 and prohibited the sale of cosmetics ingredients that relied on newly generated animal test data in 2013, consumers, companies and animal protection organisations rightly claimed a ground-breaking victory after decades of campaigning. These bans have since been a beacon of change for animals around the world, and in 2018, their significance was reinforced when the European Parliament overwhelmingly supported a call for a global end to animal testing for cosmetics. Now, this progress is substantially weakened by the current stance of the European Chemicals Agency (ECHA) and the European Commission.
A series of testing decisions by ECHA made with the backing of the European Commission, along with recent decisions by the ECHA Board of Appeal, have challenged a basic principle of interpreting EU legislation by disregarding the clear intention of legislators and thereby seriously undermining the cosmetics testing ban. In addition, the European Commission's Chemicals Strategy for Sustainability is set to re-open the Cosmetics Regulation, with the potential to introduce new testing requirements at the expense of many more animals' lives.
Already, thousands of animals are being condemned to suffer in additional testing of cosmetics ingredients that have been manufactured and marketed safely under the EU's Cosmetics Regulation for decades – and the bans that animal advocates fought so hard to achieve, and that the public and many scientists support, are effectively being rendered meaningless.
It is imperative that the purpose of the Cosmetics Regulation – that cosmetics products are safely brought to market using only non-animal data – be met without compromising the bans. For ingredients marketed under the Cosmetics Regulation that have a history of safe use by consumers and of controlled handling on the factory floor, robust protection of both workers and consumers is already enabled through a variety of non-animal assessment methods and the careful application of exposure assessments. When regulators decide that a new ingredient cannot be brought safely to market without animal testing, its introduction should be delayed until additional non-animal test methods are available.
Continued requests for renewed testing of existing cosmetics ingredients are set to severely limit the availability of products and ingredients marketed within the cruelty-free sector. The European Commission must come clean to consumers and parliamentarians, who still believe that cosmetics in the EU must be free from animal testing, over measures taken to weaken the bans. European consumers expect to be able to buy cosmetics that have not been tested on animals, and the European Commission and ECHA have a duty to ensure that this is the case by applying the law properly.
The recent administrative decisions are not the end of the road for the cosmetics testing and marketing bans. We maintain that new safety assessment data for cosmetics substances imported into, manufactured or sold within the EU may only rely on non-animal assessment methods. The wishes of citizens and legislators are clear: ECHA and the European Commission must be held accountable and compelled to uphold the terms of the EU cosmetics animal test and marketing bans as originally intended.
As animal protection organisations, we call for the European Parliament and the European Commission to ensure that the following mandates are urgently carried out:
- The EU bans on animal testing for cosmetics and the marketing of ingredients tested on animals must be fully upheld and implemented as intended by the legislators.
- EU test requirements – including requirements set out in REACH – must not undermine the bans but instead must apply a substance-tailored approach to ensure consumers, workers, and the environment are protected without further tests on animals.
- The European Commission must devise a robust testing strategy for cosmetics ingredients using only available non-animal assessment strategies so that the implementation of the Chemicals Strategy for Sustainability reflects the overwhelming support for strengthening – rather than weakening – the protection of animals in Europe.

Doerenkamp-Zbinden Prize 2020 awarded


Marcel Leist, Thomas Hartung, Bas Blaauboer, Pierre Cosson, and Mohammad Abdulkader Akbarsha, the five endowed chairs of the Doerenkamp-Zbinden Foundation, have jointly received the Doerenkamp-Zbinden Prize 2020 in acknowledgement of their outstanding work in the promotion of alternatives to animal testing. The prize was presented on November 5, 2020. 

More information about the prize can be found here

FDA partnership to apply lung chips to safety evaluation of COVID-19 vaccines and therapies


The U.S. Food and Drug Administration (FDA) has entered into a Cooperative Research and Development Agreement (CRADA) with Emulate, Inc. to enable multiple studies using Emulate’s Organ-Chips across FDA offices in priority research areas. Organ-Chips are in vitro systems that recreate the natural physiology of specific human tissues and organs. Some projects will evaluate COVID-19 vaccines or investigate human immune response against SARS-CoV-2, the virus that causes COVID-19. Under the CRADA, FDA will use a range of Organ-Chips to study the safety, efficacy, and mechanisms of action of drugs regulated by the FDA. This new CRADA agreement follows the successful completion of the first Emulate CRADA with the FDA initiated in 2017 that focused on toxicity studies using Emulate’s Liver-Chip. Details on the CRADA are provided in Emulate’s October 29 press release, available at

Presentations and video available from EPA NAMs Conference


The U.S. Environmental Protection Agency (EPA) hosted the Second Annual “Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing” virtually on October 19-20. The virtual conference was presented in response to the September 2019 directive by EPA Administrator Andrew Wheeler to reduce the EPA’s use of mammalian studies.

Conference topics included:

• Implementation of animal testing reduction at EPA.
• State of the science in development of NAMs.
• Current limitations of NAMs.
• Developing scientific confidence in NAMs.

To view the conference presentations and recordings, visit the conference website at If you attended the conference and would like to submit feedback on the EPA New Approach Methods Work Plan, email

Lush Prize 2020 winners announced


The nine winning projects, organisations and scientists from seven countries, plus two commendations, as well as a winner of the Andrew Tyler Award were announced at a virtual prizegiving on November 11, 2020. The winners share a total prize fund of £250,000. The 2020 LUSH Prize saw the highest number of submissions to date, with 137 entries from 34 countries. No awards were given this year in the categories Political Achievement Award or Public Awareness (Future).


Environment and Animal Society of Taiwan (EAST)
Project: Erasing mandatory animal testing requirements and prioritising non-animal testing methods in the chemical registration process.

Also commended:
Medical Device In Vitro Irritation Team (MD-IV-IT)
Project: In Vitro Irritation Testing of Medical Devices.


SOKO Tierschutz
Project: Undercover investigation at the Laboratory of Pharmacology and Toxicology.


Dr Tim Allen, The MIE Atlas Team, Cambridge University
Project: In Silico Models to Predict Human Molecular Initiating Events.

Also commended:
Dr Azra Raza, MDS Centre, Columbia University
Project: Tissue Repository.


Helpathon Team
The Netherlands
Project: TPI Helpathon.


All Young Researcher winners receive £10,000 each.

Edoardo Carnesecchi
Institute for Risk Assessment Sciences, Utrecht University, The Netherlands
Project: Early neurodevelopmental disturbances during sensitive periods of stem cell differentiation.

Nadine Dreser
University of Konstanz, Germany
Project: An innovative software platform to assess chemical mixtures toxicity and exposure.

Dr Domenico Gadaleta
Computational Toxicology Unit, Laboratory of Environmental Chemistry and Toxicology, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, Italy
Project: Development of an Integrated Screening Method Based on Quantitative Structure-Activity Relationships Predicting Molecular Initiating Events of Neurotoxicity.

Dr Johanna Nyffeler
US Environmental Protection Agency, USA
Project: High-throughput phenotypic profiling of human neural progenitor cells to identify putative modes-of-action of developmental neurotoxicants.

Dr Yuan Pang
Tsinghua University, China
Project: Construction of advanced in vitro tissue models based on 3D bioprinting and their application in drug discovery and toxicity test.


The Andrew Tyler Award for outstanding contribution to ending animal testing (a non-financial prize)

Andrew Rowan PhD
Andrew is President of Wellbeing International, and former CEO of Humane Society International. He has also served on the committees of several animal protection groups, including the World Society for the Protection of Animals.

Sandra Coecke announced as winner of 2020 Björn Ekwall Memorial Award


Dr Sandra Coecke, senior scientist at European Commission Joint Research Centre, Ispra, Italy, is the recipient of the Björn Ekwall Memorial Award for the year 2020 in recognition of her work on the development and validation of new in vitro cell- and tissue-based methods for in vitro toxicity testing for the replacement of animal experiments. Sandra Coecke is also highly recognized for her leading role in the development of the European Commission Joint Research Centre’s guidance document on Good Cell Culture Practice (GCCP) and the OECD’s guidance document on Good In Vitro Method Practices (GIVIMP). The Scandinavian Society for Cell Toxicology (SSCT) established the Björn Ekwall Memorial Foundation in 2001. The main goal of the BEMF is to honour the memory of Dr. Björn Ekwall by giving a reward to the scientists who have substanctially contributed to the field of cell toxicology, e.g. by developing new in vitro tests or via mechanistic or validation studies.

NICEATM releases ICE 3.2


On October 20, NICEATM released an update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This update adds the following features to these ICE tools.

  • In Vitro to In Vivo Extrapolation (IVIVE): a new inhalation model from the U.S. Environmental Protection Agency (EPA) httk package ( is available that allows estimation of an equivalent administered dose based on a gas exposure. The IVIVE tool also now allows the user to specify whether experimental or predicted data are used for absorption, distribution, metabolism, and excretion (ADME) parameters.
  • Chemical Characterization: query results are now displayed using two principal component analysis plots: a static plot that compares query chemicals to a background of a larger chemical set and a dynamic plot that compares query chemicals to one another based on physicochemical properties or molecular descriptors.

Other new resources in ICE 3.2 include:

ICE is available at

Recordings of "The 3Rs across Europe" webinar series available


Europe is home to a vibrant 3Rs community with a range of organisations who fund or promote science and technology developments that lead to opportunities to replace, reduce and refine the use of animals in research. To celebrate the 3Rs in Europe, six organisations came together in September 2020 to organise a virtual event highlighting the latest 3Rs advances over three days of talks. Recordings of each talk are now available to watch online.

OECD releases eight IATA case studies


The Organisation for Economic Co-operation and Development (OECD) supports the development of integrated approaches to testing and assessment (IATA). IATA provide a means by which all relevant and reliable information about a chemical is used to answer a defined hazard characterization question. Information considered can include toxicity data, exposure routes, use cases, and production volumes.

The OECD IATA Case Studies Project allows countries to share and explore the use of novel methodologies in IATA for chemical hazard characterization within a regulatory context. Eight new case studies illustrate the use of NAMs for predicting systemic toxicity, developmental and reproductive toxicity, and neurotoxicity from chemicals such as caffeine, p-alkylphenols, and carboxylic acids. Information about the Case Studies Project and links to the new case studies are available at

EPA announces guidance to waive toxicity tests on animal skin


The U.S. Environmental Protection Agency (EPA) is continuing to follow through on EPA Administrator Andrew Wheeler’s commitment to reduce animal testing by seeking public comment on draft guidance that would allow researchers to forego testing chemicals on animal skin in certain circumstances to determine whether pesticides lead to adverse effects.

“This proposed guidance is a great example of how we can continue to protect human health and the environment and make science-based decisions about pesticide registrations without needing to conduct unnecessary tests on the skin of animals,” said EPA Administrator Andrew Wheeler. “Today’s action puts EPA on a path of eliminating the need for all mammal testing by 2035.”

“With this draft policy the Agency continues to make real progress in reducing animal testing requirements, saving animals and resources while maintaining environmental and human health protections,” said Physicians Committee for Responsible Medicine Vice President for Research Policy Kristie Sullivan. “The Physicians Committee encourages companies to consider this draft guidance to avoid dermal toxicity tests and thanks those involved in this analysis and resulting policy.”

The proposed dermal toxicity guidance would allow waivers for studies on single-active ingredients used to develop end use products to apply for waivers. In developing the guidance, EPA conducted a retrospective analysis and concluded that its requirement for such studies provides little to no added value in regulatory decision making. This guidance, when finalized, is expected to save up to 750 test animals annually from unnecessary testing as well as EPA, industry and laboratory resources.

EPA will take comments on the proposed guidance for 30 days after publication in the Federal Register. Comments can be submitted online at (Docket ID No. EPA-HQ-OPP-2016-0093). After carefully considering public input, EPA will finalize the Guidance.

In addition, EPA has launched a new webpage  that provides metrics and strategies for reducing and replacing animal testing, including links and resources to all pertinent guidance and workplans tied to the larger Toxicology in the 21st Century Initiative across the federal government.


In September 2019, Administrator Wheeler issued a directive calling for the Agency to reduce animal testing and funding 30 percent by 2025 and eliminate it by 2035. To support these efforts:

EPA will host its Second Annual Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing  virtually on October 19 and 20, 2020.

To learn more about EPA efforts to reduce animal testing, visit:

Center for Contemporary Sciences launches to advance human-specific research models that will end animal testing


A new organization in the biomedical field has launched with a mission to improve lives through education, funding and championing scientific innovation based on human biology.

Center for Contemporary Sciences (CCS) is an independent 501(c)3 organization that is advancing human-specific research methods and testing to improve lives. The organization will serve as a hub of the latest information, resources and innovation in the biomedical field. 

The team at CCS includes researchers, doctors and experts with diverse backgrounds in biomedical sciences. “Our end goal is to help create a biomedical research paradigm that delivers safe and effective therapies faster and more efficiently. By doing so, we can deliver true hope to patients suffering from currently untreatable diseases, and to their families. We can heal ourselves without harming animals and do so more quickly,” shared Dr. Aysha Akhtar, President and CEO of CCS. 

One of the ways they hope to enrich the scientific field is through collaboration. CCS partners with scientists, corporations, government agencies and academia to further scientific discovery. The organization is pioneering the transition to innovative human-specific medical research and testing methods including  3D human-tissue culture, human stem-cells, organ-and body-on-a-chip methods, human spheroids and organoids, bioprinting, and more.

They are committed to creating funding opportunities by connecting investors and biotech companies as well as increasing the pipeline of biomedical students to new testing technologies.

As one of their first initiatives, the Center for Contemporary Sciences is building several databases to become the “go-to” resource for the latest innovations within the biomedical field.

“Greater than 90% of drugs and vaccines fail in human clinical trials, despite showing signs of safety and efficacy in animal and traditional laboratory tests. Human-specific research approaches are, by their nature, more predictive of human biology and disease than nonhuman methods,” added Dr. Jarrod Bailey, Director of Science and Technology at CCS. 

“We therefore need, urgently, to shift the focus of biomedical research and testing away from animals and towards hi-tech, cutting-edge human-based methods.”

Compassion fatigue in laboratory animal research: Recording available


Many laboratory animal technicians enter this profession because they love animals, but this caring role may come at a cost to their own wellbeing. The NC3Rs recently held a joint webinar with the North American 3Rs Collaborative (NA3RsC), presented by NA3RsC Fellow Dr Megan LaFollette, focusing on compassion fatigue and the effect it can have on animal care staff.

Virtual SACATM meeting considers ICCVAM’s future directions


The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) met virtually in a public webcast on September 2-3. Over 200 people viewed or participated in the webcast, making it one of the most broadly viewed SACATM meetings ever. SACATM meets annually to advise NICEATM, ICCVAM, and the director of the National Institute of Environmental Health Sciences regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

Recognizing the occasion of ICCVAM’s 20th anniversary, SACATM members and commenters praised ICCVAM’s work to advance alternatives to animal testing and identified opportunities for further progress. Specific areas mentioned included genotoxicity and carcinogenicity and replacement of animal use for antibody production.

An entire day of the meeting was devoted to considering the data that are needed to evaluate new methods and tools that can put data to use. Presentations discussed variability in animal data, applications of machine learning, and in vitro human-based models that incorporate genetic diversity. NICEATM scientists showcased computational tools for exploring toxicity data and making toxicity predictions. Presentations from the meeting will be available soon on the NTP website at, and minutes will be posted following their review by the committee.

Save the date for the next ICCVAM public event: the annual ICCVAM Communities of Practice webinar is planned for Tuesday, January 26, 2021. Information will be posted on the NICEATM events webpage at as it becomes available.

ECHA Board of Appeal decisions concerning vertebrate animal testing on cosmetic ingredients


The Board of Appeal adopted two decisions concerning compliance checks of registration dossiers for homosalate and 2-ethylhexyl salicylate, which are used exclusively as ingredients in cosmetic products (cases A-009-2018 and A-010-2018).

In the contested decisions, ECHA had required a registrant to carry out several studies on vertebrate animals on the substances to fulfil registration requirements for human health endpoints, namely a 90-day subchronic toxicity study, two PNDT and two EOGRT studies. In one of the two cases, ECHA also required the registrant to carry out a fish sexual development test.

Vertebrate animal testing on cosmetic ingredients (A-009-2018 and A-010-2018)

The registrant argued before the Board of Appeal that ECHA cannot require studies on vertebrate animals for human health endpoints because the substances are used exclusively as ingredients in cosmetic products.

The Board of Appeal found that the REACH Regulation requires registrants to perform studies on vertebrate animals even if the substance is used exclusively as an ingredient in cosmetic products. The REACH Regulation does not contain an automatic exemption from the information requirements for registration if a substance is used as an ingredient in cosmetic products. A registrant can benefit from an exemption only if it shows that the conditions for an adaptation (for example, a waiver for the studies) are fulfilled.

This conclusion is consistent with the Cosmetics Regulation. The Cosmetics Regulation contains restrictions for vertebrate animal testing on the ingredients of cosmetic products. These restrictions, however, do not prevent registrants from carrying out tests in order to comply with the information requirements of REACH.

Information requirements concerning aquatic toxicity (A-010-2018)

The registrant also argued before the Board of Appeal that ECHA cannot require a fish sexual development test because this test is not a standard information requirement for registration purposes.

The Board of Appeal held that a fish sexual development test is not a standard information requirement for registration purposes (Column 1 of Section 9.1. of Annex IX). However, ECHA has the power to require a fish sexual development test from a registrant, if necessary, as an adaptation (Column 2 of Section 9.1. of Annex IX).

In this case, ECHA had found that a fish sexual development test is necessary because existing information shows that 2-ethylhexyl salicylate may be an endocrine disruptor. As a consequence, ECHA was entitled to require the registrant to carry out a fish sexual development test.


The Board of Appeal rejected both appeals.

Andrew Fasey, Technically Qualified Member of the Board of Appeal and rapporteur for the cases, says: “The two decisions published today are among the most important taken by the Board of Appeal to date. The relationship between the information requirements in REACH and the marketing and testing ‘bans’ in the Cosmetics Regulation have been an issue for many years with several different interpretations. The two decisions adopted today are based on a rigorous analysis of the wording and objectives of the two pieces of legislation. I don’t expect that everyone will agree entirely with these decisions. We have however tried to set out as clearly as possible how and why we have arrived at our conclusions.” 

Further information

The full text of the decisions can be found under the following links:

NAT Database on Non-Animal Technologies


The NAT database (Non-Animal Technologies) recently launched by Doctors Against Animal Experiments (DAAE) gives an overview about animal-free research technologies that are developed all over the world. This database currently contains 250 entries on animal-free methods and will continuously be updated. It is freely available at in English or German and all entries are free for download and sharing. 

Entries contain a short abstract of the respective technology as well as information on contact persons including affiliations and references such as peer-reviewed publications or press releases from universities and research institutes. Commercially available technologies and research models such as microphysiological systems or advanced human cell culture models are also included.  

The NAT database is supposed to inform scientists, regulators, and politicians, as well as the general public, about the power and the advantages of non-animal technologies. Users can run a full text search or use different filter options such as research areas (e.g., oncology, toxicology, or drug development) or research models (e.g. organ-on-a-chip, 3D bioprinting, or computer models). The NAT database also enables a specific search for validated methods, which are additionally labelled in case of regulatory acceptance for safety testing by ECVAM or OECD.

FDA accepting proposals for alternative methods webinar series


The Office of the Chief Scientist of the U.S. Food and Drug Administration (FDA) is launching a webinar series on alternative methods. The webinar series supports FDA’s commitment to promote novel technologies and potentially incorporate them into its regulatory review, as applicable.

Test method developers who participate in this webinar series will have the opportunity to introduce their new technology to FDA and give individual FDA programs the option to contact them for further information. Please note, however, that participation in FDA’s webinar series does not constitute FDA’s endorsement of a new method or oblige FDA to assist the developer in qualifying a new method for regulatory use.

To be considered for the webinar series, please submit the following information to

  • A description of your new method, including origin of cells or species of animal if appropriate.
  • A description of the proposed context of use of your new method.
  • A description of the regulatory issue/gap where the new method could have an impact.
  • Data from use of your method, including any publications.

FDA will respond within 60 days to your webinar submission. For more information, visit

ICCVAM 2018-2019 Biennial Report now available


The ICCVAM Biennial Progress Report 2018-2019 is now available at

The ICCVAM Authorization Act of 2000 directed ICCVAM to prepare a progress report on its first anniversary and every other year thereafter. The latest ICCVAM Biennial Progress Report describes ICCVAM and ICCVAM agency activities from January 2018 through December 2019. Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

  • Publication of A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.
  • Development of the Collaborative Acute Toxicity Modeling Suite, in silico models of acute oral systemic toxicity that predict five specific endpoints needed by regulatory agencies.
  • Expansion of the Integrated Chemical Environment (
  • Development of plans to replace, reduce, or refine animal use for testing by the U.S. Department of Defense, the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration.

This edition of the Biennial Report has been reorganized to make it easier for users to find content of interest. Menu items allow users to view articles by agency or find articles relevant to topics such as in vitro to in vivo extrapolation, cardiotoxicity, or mixtures toxicity. Reference pages list publications of interest as well as providing glossary terms and acronyms relevant to ICCVAM agencies and activities.

Small Business Grants available for test method development


The Department of Health and Human Services (HHS) has released the 2020 Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Omnibus Grant Solicitations. These solicitations will be used by the National Institutes of Health and other offices within HHS to fund researcher-initiated projects in health, medicine, and life sciences.

Projects being funded by the National Institute of Environmental Health Sciences (NIEHS) under this solicitation include development of toxicity screening, testing, and modeling approaches that support Tox21 and other NTP goals. Areas of high priority include development of:

  • Metabolically competent in vitro assay systems for various tissue types.
  • Computational approaches for predictive toxicology.

The first deadline for applications under this announcement is September 5. More information is available on the NICEATM website at

NIEHS has also reissued the Funding Opportunity Announcement for its Commercialization Readiness Pilot program. These grants support commercialization of previously funded SBIR and STTR Phase II and Phase IIB projects by funding activities not typically supported through Phase II or Phase IIB grants or contracts. Small businesses that have had an active National Institutes of Health SBIR or STTR Phase II or Phase IIB award within the last 36 months are eligible to apply. Awardees will receive up to $300,000. Standard SBIR/STTR application deadlines apply for these grants; the next deadline is September 5. More information is available at

ICE version 3.1 now available


On July 24, NICEATM released an update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This update adds the following features to these ICE tools:

  • Search: query results can now be sent directly to the EPA CompTox Chemicals Dashboard.
  • In Vitro to In Vivo Extrapolation (IVIVE): assays can be selected based on mode of action; results can be filtered by mode of action or toxicity endpoint annotation.
  • Chemical Characterization: principal component analysis plots provide an additional option for visualization of chemical properties.

Other new resources in ICE 3.1 include:

  • New Chemical Quick Lists: U.S. Environmental Protection Agency (EPA) List of Active Ingredients and EPA List of Inert Ingredients Food and Nonfood Use.
  • Additional metadata provided in results downloads.
  • New tooltips and information buttons to help users set up queries.

ICE is available at

Händel Animal Welfare Prize 2020 goes to Thomas Hartung and Marcel Leist


Thomas Hartung, MD, PhD, Director of the Center for Alternatives to Animal Testing (CAAT) at the Johns Hopkins Bloomberg School of Public Health, and Marcel Leist, PhD, co-director with Hartung of CAAT-Europe and Chair of the department of In Vitro Toxicology and Biomedicine at the University of Konstanz, have been selected to receive the Ursula M. Händel Animal Welfare Prize by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation). The €80,000 prize is awarded to researchers who improve research animal welfare in line with the principles known as the 3Rs of alternatives: Replacement (of animal experiments with non-animal methods), Reduction (of the numbers of animals used for a particular experiment), and Refinement (reducing pain and distress of laboratory animals).

This award honors the life’s work of both scientists in making major contributions to animal welfare. Hartung was recognized for using artificial intelligence (“read-across”) to predict the toxicity of chemicals without using animals. Instead of using animals, data from a particular chemical is compared to similar chemical structures in toxicological databases to determine possible toxicity. 

The awardees were also recognized for their international networking with multiple international stakeholders (researchers, regulatory authorities, non-governmental organizations, and industry) to advance the acceptance of alternative methods.

The two winners were chosen from among nine nominees and will use the prize money of €80,000 to enable early career scientists to perform research in the 3Rs. The award ceremony is scheduled for October 1st, 2020, at the Interdisciplinary Centre for 3Rs in Animal Research (ICAR3R).

Thomas Hartung has been director of CAAT and co-director of CAAT-Europe since 2009. He has received many prizes for his research work, such as the US Society of Toxicology Enhancement of Animal Welfare Award and the Russell and Burch award of the Humane Society of the United States.

Marcel Leist has been co-director of CAAT-Europe since its foundation in 2009. Leist has received several prizes for his work, including the Animal Welfare Research Award from the German Federal Ministry of Food and Agriculture. 

The Johns Hopkins Center for Alternatives to Animal Testing (CAAT), founded in 1981, is part of the Johns Hopkins University Bloomberg School of Public Health, with a European branch (CAAT-Europe) located at the University of Kostanz, Germany. CAAT promotes humane science by supporting the creation, development, validation, and use of alternatives to animals in research, product safety testing, and education. 

The Ursula M. Händel Animal Welfare Prize goes back to the initiative of the founder of that name. A resident of Düsseldorf, Ursula M. Händel (1915–2011) championed animal welfare over several decades. Dedicated to animal welfare in science and research, Händel provided the DFG with the financial backing for the animal welfare prize. The prize is awarded every two years. 

Information about the prize, its founder Ursula M. Händel, and the prizewinners can be found a the official press release from DFG.

Press Release from the Doerenkamp-Zbinden Foundation.

ECHA issues report on animal and alternatives use


The European Chemicals Agency (ECHA) has issued its fourth report on the use of alternatives to animals for testing required under the REACH regulation. Data on more than 12,000 substances show that registrants are sharing data, using adaptations to avoid animal testing, and employing alternatives to animal testing. Examples include:

  • Registrants used at least one adaptation to avoid animal testing for about 70% of substances. Read-across is the most commonly used adaptation.
  • Use of non-animal tests for evaluating potential for skin and eye irritation and skin sensitization has increased greatly since 2016.
  • Companies are reducing the numbers of animals used for repeat dose toxicity tests and reproductive screening by using the combined test described in OECD Test Guideline 422.

The report and a summary of the report can be found at under the subheading “Reports on Alternatives to Animal Testing.”

OECD updates and corrects eight Test Guidelines


On 26 June, OECD adopted a set of updated and corrected Test Guidelines for chemicals safety testing to keep pace with scientific progress for OECD members and Mutual Acceptance of Data (MAD) adhering countries.

Eight Test Guidelines have been updated (TG 437, TG 458, TG 488, TG 491) and corrected (TG 405, TG 439, TG 442C et TG 471):

EPA releases New Approach Methods Work Plan


On June 23, the U.S. Environmental Protection Agency (EPA) released its New Approach Methods Work Plan, which was created in response to the EPA Administrator’s 2019 directive to prioritize activities that will reduce the use of animal testing while continuing to protect human health and the environment. The work plan was developed by experts across the agency to set the objectives and strategies for using new approach methods to meet the ambitious goals set out in the Administrator's directive. It is available at

Charité 3R Toolbox provides 3Rs related information resources for young scientists


The Charité 3R Toolbox is designed to help scientists – in particular young scientists within academia – to find alternatives to animal research, use fewer laboratory animals, improve the welfare of these animals and, in doing so, enhance the quality of the scientific research.

About 60 years ago, W.M.S. Russell and R.L. Burch developed the ‘principles of the 3Rs’which they published in their book "The Principles of Humane Experimental Technique". Since then, many scholars have proposed the inclusion of additional Rs to supplement the existing three. The Charité 3R Toolbox is structured along the lines of the 6R model proposed by the BIH QUEST Center (position paper Strech & Dirnagl, 2019) which adds robustness, registration and reporting to the existing 3Rs of replacement, reduction and refinement.

Pilar Prieto wins the ALTEX Award 2020


We are pleased to announce that Dr Pilar Prieto of the EU Commission Joint Research Centre (JRC) in Ispra, Italy is the winner of the ALTEX Prize 2020 as first author of the article “Investigating cell type specific mechanisms contributing to acute oral toxicity“. The article was selected by the ALTEX Editorial Board, the Board of ALTEX Edition and the ALTEX editorial office as the best article published in ALTEX during 2019. The award will be presented at the 11th World Congress on Alternatives and Animal Use in the Life Sciences in Maastricht in 2021.

The ALTEX Prize is awarded annually and is kindly sponsored by the Doerenkamp-Zbinden Foundation.

Presentations available from webinar on small business funding


Presentations are now available from the April 17 town hall webinar on “Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing.” The webinar was presented by the National Institute of Environmental Health Sciences (NIEHS) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program in coordination with NICEATM. The presentations are available on the NTP website at A video of the webinar is available on the NIEHS website at

A key component of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States is early interaction between developers of new approach methodologies (NAMs) and end-users, to ensure that the proposed NAMs will meet testing requirements for agency and industry stakeholders. The goal of this webinar was to facilitate improved communication between method developers, including SBIR/STTR applicants, and end-users. The webinar provided an opportunity for assay developers to hear from ICCVAM stakeholders on the desired characteristics and requirements for NAMs. Presenters included representatives from NICEATM, the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, the U.S. Department of Defense, 3M Corporation, and Novartis.

EURL ECVAM recommends use of nonanimal-derived antibodies


The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has issued a recommendation urging end-users and other stakeholders to recognize the scientific validity of nonanimal-derived antibodies and to stop using animals for antibody development and production. The recommendation is based on the opinion of EURL ECVAM’s scientific advisory committee. It states that animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic and therapeutic applications. It also challenges misconceptions about nonanimal-derived antibodies and highlights the scientific and economic benefits of their use. The report is available at; a news release summarizing the report’s recommendations is available at

Use of nonanimal-derived antibodies was the topic of the 2020 ICCVAM Communities of Practice webinar, presented in January. One of the webinar presenters, Rebecca Clewell, served on the scientific advisory committee on whose opinion the EURL ECVAM recommendation was based. Presentations from the webinar are available at

New FDA Webpage Highlights Alternative Methods Working Group


FDA has a long-standing commitment to promote the development and use of new technologies to better predict human and animal responses to substances relevant to its regulatory mission. To strengthen that commitment, FDA launched its Alternative Methods Working Group. This group facilitates interactions with global regulatory bodies interested in implementing alternative methods in toxicology. Additionally, the group examines opportunities and viable ways by which emerging methods and new technologies can support regulatory review of risk, safety, and efficacy of FDA-regulated products.

The Alternative Methods Working Group recently launched its webpage at, which will highlight FDA’s work in this area. A link to this page and to other ICCVAM agency webpages focused on alternative methods is available on the NICEATM website at

WC11 postponed to August 22-26, 2021


Due to the global COVID-19 developments, the Dutch authorities have decided to ban all major events taking place until 1 September 2020. After lengthy and thoughtful considerations, the WC11 organization decided to postpone the 11th World Congress on Alternatives and Animal Use in the Life Science, scheduled to take place August 23-27, 2020 in the Netherlands. The new dates for the 11th congress will be August 22-26, 2021. The venue of the congress will remain the MECC Maastricht, the Netherlands.

3Rs relevant online training material


The Swiss 3RCC has compiled a dedicated webpage of organisations active in the promotion of the 3Rs who have added online training material on their websites:
NC3Rs – National Centre for the Replacement, Refinement and Reduction of Animals in Research offers different e-learning resources, experimental design resources and for example information on housing and husbandry.  
Labroots offers virtual events and webinars on a range of topics related to the 3Rs. You find keynotes on different in vitro disease models, in silico toxicology and animal models, enrichments, ways to improve reproducibility and the ARRIVE guidelines, which help you improve the design and reporting of animal research. 
CAAT (Johns Hopkins Center for Alternatives to Animal Testing) offers podcasts and free webinars on alternative methods. They include events on how to minimise the use of animals in toxicity testing, how to move beyond animals in the neurosciences and infectious disease research. The 7th Annual 3Rs symposium, co-hosted by the USDA Animal Welfare Information Center (AWIC), NIH Office of Laboratory Animal Welfare (OLAW), the Johns Hopkins Department of Molecular and Comparative Pathobiology, and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), will be held online on June 4-5, 2020. One of CAAT's experts has published a video where he explains how his group is using its in vitro minibrain models to study the effects of SARS-CoV-2 on brain cells.  
SYRCLE The SYstematic Review Center for Laboratory animal Experimentation at Radboud University Medical Centre in the Netherlands offers tools and guidelines for the conduct of systematic reviews of animal studies. 
Eindhoven University of Technology offers a free online statistics course. Instructor Daniel Lakens explains how to design experiments and select your sample sizes so that p-values, effect sizes, confidence intervals and likelihood ratios can answer your research questions. Participants also learn how to interpret evidence in scientific literature given the widespread publication bias, how to perform replication studies, why you should pre-register your experiment and publish it open-access.
The 3R Smart is an information and training platform, which addresses interested laymen as well as scientists and technical staff. The project is funded by the German Ministry of Education and Research (BMBF) and coordinated and developed by the University of Veterinary Medicine Hannover Foundation and the Philipps University Marburg. 
NORECOPA: Norway's National Consensus Platform for the advancement of the 3Rs suggests resources, which may be suitable for schoolchildren and undergraduate students undertaking home learning in connection with the Covid-19 pandemic. Emphasis has been placed on products which are available online, thereby avoiding the need for purchase of equipment. You may find alternatives to dissections in the NORINA database with suggestions on how to replace the use of rats or frogs.
RAT – Research Animal Training (formerly Flaire Learning) offer e-learning modules to support researchers applying for licences in the U.K., but that are also of interest to scientists in Switzerland. The articles and eLearning modules on the RAT site align with the learning outcomes specified for EU training modules. Some learning outcomes require practical tuition, and this should be provided in person. Further information for course attendees, a listing of the eLearning modules currently available, a website feature list, FAQ page and some example screens . 
BIH – Berlin Institute of Health has created a list of resources to help you make the best of this strange and challenging time and increase the quality of your research in the future. 
GV-SOLAS – The German Society of Laboratory Animal Science will organise two livestream events at the end of April. The 49th seminar on laboratory animals and animal research will take place on April 28th and 29th, and the 13th training event of GV-SOLAS for animal welfare officers and members of authorities will take place on April 29th and 30th
SIB – Swiss Institute of Bioinformatics experts are taking part in the global effort to develop dedicated data services, analysis tools and improve knowledge sharing to fight the COVID-19 pandemic. Find a list of tools and resources on a dedicated website of the SIB. 
ASCCT – American Society for Cellular and Computational Toxicology holds webinars on new animal-free testing methodologies. The webinars are available for all to attend and watch at no cost. 

Norecopa calls for contributions to Refinement Wiki


Norecopa invites all members of the research animal community, regardless of their position, to add material to the Refinement Wiki which was launched last month. It can be accessed at Please email Norecopa's secretary ( if you would like to contribute.

Norecopa is greatful for the generous sponsorship for development of the wiki from the Research Fund of the Norwegian Animal Protection Alliance.

Norecopa makes dataset of worldwide educational resources available


Norecopa has embedded a dataset of over 560 resources from 6 continents within education and training in their website. The dataset was produced by the EU Commission's Joint Research Centre (JRC). The data, collected between June and September 2018, provide a snapshot overview of education and training courses and resources on the theory and application of the 3Rs principle offered at high school, university and professional levels worldwide.
Norecopa has used the dataset's categories to make over 70 search filters, so that the number of hits can be expanded or narrowed as desired, e.g. by country, language or potential audience. Searches on the Norecopa website will automatically retrieve hits from this dataset, but the filters can be applied to remove all or some of them, depending on the user's wishes.
The work of integrating the dataset was kindly sponsored by Sanofi, to whom Norecopa is most grateful.
Some of the data will need updating, and cross-checking with data already held in the Norecopa database. This work is ongoing. The dataset complements Norecopa's International Webinar and Meetings Calendar, overview of training courses and the NORINA database of educational and training aids, all of which are updated continuously.

The dataset is described in the 2019 EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches. A total of 569 E&T courses and resources with Three Rs relevance were identified in 52 countries worldwide, the majority located in Europe (72%) and North America (14%). In Europe, more than 80 courses were delivered in the United Kingdom, whilst Germany, Switzerland and the Netherlands provided 41, 29 and 26 courses respectively. Several E&T courses and resources combined both classroom and distance learning formats. Distance learning through, for example, webinars or interactive online resources represented 30% of the total courses and resources. The map of Europe is taken from this report.
Norecopa reminds readers that The Education & Training Platform for Laboratory Animal Science (ETPLAS) has been established to enable information sharing and communication between EU Member States, accrediting/approval bodies and training providers. The ETPLAS website contains comprehensive information about the requirements laid down by the EU Directive and associated guidance documents.

REACH Chemical Data Available Through IUCLID Database


The European Union’s REACH (Registration, Evaluation, and Authorisation of Chemicals) regulation requires companies to identify and manage risks of chemicals. Data required under REACH are submitted to the European Chemicals Agency (ECHA).

On April 17, ECHA updated data from REACH studies available through the IUCLID data resource. The data contain results from studies that relate to physical-chemical properties, environmental fate and pathways, and ecotoxicology and toxicological information. These data may be helpful in the development and use of alternatives to animal testing.

More information about the April 17 data release is available at

FDA Guidance on Immunotoxicity Testing Supports Use of Alternatives


In February, the U.S. Food and Drug Administration (FDA) issued draft guidance on “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.” This guidance supplements previously issued recommendations on nonclinical evaluations of immunotoxic potential and is intended to assist sponsors in such evaluations. The guidance includes several specific recommendations on assessing potential for dermal sensitization:

  • FDA no longer recommends that sponsors conduct the murine local lymph node assay to assess the sensitization potential of topical drug products due to the limitations of the assay.
  • As an alternative to accepted guinea pig tests, FDA will consider a battery of in silico, in chemico, and in vitro studies that have been shown to adequately predict human skin sensitization with an accuracy similar to existing in vivo methods.

The draft FDA guidance is available at

NCATS Funding Use of Tissue Chips to Support COVID-19 Research


The National Center for Advancing Translational Sciences (NCATS) has issued two Notices of Special Interest to support research in collecting and examining data on the risks and outcomes for COVID-19 infections using microphysiological systems (MPS) or tissue chips. Such work is expected to advance the translation of research findings into diagnostics, therapeutics, and vaccines. Applications for both opportunities will be accepted on a rolling basis from May 15, 2020, through January 25, 2022.

NOT-TR-20-017 announces the availability of competitive revisions for investigators and institutions funded through existing grants of the NCATS MPS program. Proposals should address development of MPS models for COVID-19, the use of MPS for rapid detection of COVID-19 infection, or the use of MPS to evaluate potential therapeutics for COVID-19. More information is available at

ASCCT webinar library now open at no cost


As the impact of COVID-19 is felt around the globe, the American Society for Cellular and Computational Toxicology (ASCCT) would like to demonstrate its commitment to sharing educational resources for new non-animal approaches. The ASCCT webinar library is now open to the public at no cost. It includes over 40 expert presentations highlighting innovation in science and policy related topics. The library can be accessed at Should you like to share your work in cellular or computational approaches through our webinar platform please email

ICE version 3.0 now available


On March 11, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods released an update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. The update introduces a new user interface to simplify searches and new tools that will let users explore chemical properties and toxicity in more detail.

The ICE 3.0 update features improvements to the in vitro to in vivo extrapolation (IVIVE) tool. In response to customer requests, ICE now allows users to upload their own data for IVIVE analyses. A new physiologically based toxicokinetic model has been added, and the output graphics have been improved.

Other new resources in ICE 3.0 include:

  • User interface improvements
  • Organization of Tox21 assays in query setup menus based on modes of action
  • Availability of data from in vitro dermal irritation assays
  • Updated property predictions for over 800,000 chemicals from OPERA (Open Structure-activity/property Relationship App;
  • Mapping of Tox21 assays to controlled terms from the NCI Metathesaurus

ICE is available at

NIEHS to present webinar on grant opportunities for NAM development


The National Institute of Environmental Health Sciences (NIEHS) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program, in coordination with NICEATM, will host a webinar-based town hall meeting on “Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing.” The webinar will be held on Friday, April 17 from 1:00-3:00 p.m. EDT. Register at

A key component of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States is early interaction between developers of new approach methodologies (NAMs) and end-users, to ensure that the proposed NAMs will meet testing requirements for agency and industry stakeholders. This webinar will facilitate improved communication between method developers, including small business (SBIR/STTR) applicants, and end-users, providing an opportunity for assay developers to hear from ICCVAM stakeholders on the desired characteristics and requirements for NAMs. The agenda will include short presentations from experts from U.S. federal agencies and industries, including pharmaceutical developers, with time allowed for questions from method developers. Presenters include representatives from NICEATM, the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, the U.S. Department of Defense, 3M Corporation, and Novartis.

New FDA guidance available for in vitro drug interaction studies


The U.S. Food and Drug Administration (FDA) published “In Vitro Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter-mediated Drug Interactions Guidance for Industry” in January. The guidance is available at

This guidance is intended to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product. It focuses on in vitro approaches to evaluate the interaction potential between investigational drugs with cytochrome P450 enzymes and transporters, as well as how in vitro results can inform future clinical DDI studies. The appendices of this guidance include factors to consider when choosing in vitro experimental systems, key issues regarding in vitro experimental conditions, and more detailed explanations regarding model-based DDI prediction strategies.

New version of OECD's eChemPortal now available


The Organisation for Economic Co-operation and Development (OECD) has released eChemPortal v3.0, available at The new version includes a modernized user interface architecture, a refreshed design, improved navigation, and the alignment of eChemPortal to OECD Harmonised Template 2018. The user experience is now more fluid, and the user can search for chemical information more efficiently. New features include quick search functionality from the homepage, filtering and sorting on results tables, and a preliminary indication of the number of results expected in a search by chemical properties.

EU statistics on animal use for scientific purposes in 2015-2017 published


The European Commission has published its 2019 report on animal use for scientific purposes in the EU in 2015-2017. This is the first report compiled according to changed reporting requirements and covers areas of animal use that were not included previously, limiting comparison with previous reports. The report identifies issues with severity reporting as well as consistency of reporting animal use for the maintenance of genetically altered animals. The report also voices concern with the use of animals in areas where alternative methods have reached regulatory acceptance (e.g. skin irritation/corrosion, serious eye damage/eye irritation and pyrogenicity testing) and calls for further attention by the authorities authorizing projects for these use purposes.

The numbers of animals used for the first time for research and testing were 9.59 million (2015), 9.82 million (2016) and 9.39 million (2017) in comparison to almost 11.5 million reported in 2011 (see caveats above). The numbers of procedures (including reuse of animals) were higher by 2% than the number of animals used for the first time in each reported year. The numbers of animals used for the first time for the creation and maintenance of genetically altered (GA) animal lines were 1.59 million (2015), 1.19 million (2016) and 1.28 million (2017).

In 2017, of the animals used for research and testing for the first time, mice, fish, rats and birds together represented 92%. Species of particular public concern (dogs, cats and non-human primates) represented less than 0.3%. No Great Apes were used. While between 2015 and 2017 there was a decrease in the number of amphibians, cephalopods and reptiles (-42%), hamsters (-37%), horses, donkeys and cross-breeds (-25%), and birds (-11%), there was an increase in the numbers of sheep and goats (+9%), cattle (+14%) and non-human primates (NHP) (15%).

2% of the animals used were born outside of the EU; 90% were born in the EU at a registered breeder. However, of the NHPs, only 14% were born in the EU at a registered breeder; most were imported from Africa or Asia. 30% of all NHPs came from self-sustained colonies and 53% were second or higher generation purpose-bred. No NHP used for the first time was captured from the wild in 2017.

In 2017, the main purpose of animal use was research (69%). Subcategories are basic research (45%), translational and applied research (23%), regulatory use (23%) and routine production (5%). Other main purposes were protection of the natural environment in the interest of the health or welfare of human beings or animals, preservation of species, higher education or training for the acquisition, maintenance or improvement or vocational skills and forensic enquiries.

In 2017, severity was categorized as mild (51%), moderate (32%), severe (11%) and non-recovery (6%). Severe uses increased from 2015 to 2016 from 8 to 11%. Batch potency testing resulted in the highest number of severe uses (> 264k). Within a sub-category, the proportion of severity was highest (70%) for production of monoclonal antibodies by the ascites method, followed by diagnosis of diseases (54%) and acute toxicity studies in the area of ecotoxicity (37%).

39% of regulatory uses in 2017 were for toxicity and other safety testing: this amounts to 8% of all animal use. 79% of quality control related uses were for batch potency testing purposes in 2017.

Of GA animals, 17% exhibited a harmful phenotypic alternation. Zebra fish (64%) and mice (38%) were the most common GA species. In 2017, 658K animal uses were carried out to create new GA animal lines. The use of GA NHPs was reported for the first time in the EU in 2017. The use of animals for maintaining colonies of established GA animal lines decreased between 2015 and 2017 from 1 million to 0.6 million.

Video available from webinar on acute toxicity modeling tool


A video recording and slides are available from a January 22 webinar titled “CATMoS: Development and Use of the Collaborative Acute Toxicity Modeling Suite,” presented by the PETA International Science Consortium (PETA-ISC). Links to recordings of all webinars in the PETA-ISC series on “Use of New Approach Methodologies in Risk Assessment” are available at

In this webinar, NICEATM Acting Director Nicole Kleinstreuer and Kamel Mansouri, ILS (contractor supporting NICEATM), discussed development of CATMoS, a free resource for screening organic chemicals for acute oral toxicity. Predictions generated by CATMoS compare favorably with performance characteristics of the in vivo acute oral toxicity test. Kleinstreuer and Mansouri also demonstrated how to use the modeling suite to generate acute oral toxicity predictions.

Nicole Kleinstreuer assumes leadership of NICEATM


As of January 1, Nicole Kleinstreuer has assumed the role of Acting NICEATM Director. Kleinstreuer has been NICEATM Deputy Director since 2016. Before that she worked for ILS, the NICEATM support contractor. In both roles, she has contributed significantly to the development of NICEATM’s capabilities in computational toxicology.

Kleinstreuer received her Ph.D. in bioengineering 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 U.S. Environmental Protection Agency’s National Center for Computational Toxicology. In addition to her work with NICEATM, Kleinstreuer holds a secondary appointment in the Biostatistics and Computational Biology Branch at the National Institute of Environmental Health Sciences (NIEHS) and adjunct faculty appointments at Yale University School of Public Health and Eshelman School of Pharmacy at UNC-CH. Her research focuses on mathematical and computational modeling of biological systems and their susceptibility to perturbations that result in adverse health outcomes. Her achievements have been recognized with awards from a number of organizations, including the Society of Toxicology, Society for Birth Defects Research and Prevention, Australian Mathematical Society, and American Society for Cellular and Computational Toxicology.

The NICEATM leadership change occurs as former Director Warren Casey has accepted the position of Acting Chief of the Biomolecular Screening Branch in the National Toxicology Program Division at NIEHS. Casey will continue as ICCVAM Executive Director, where his responsibilities will focus primarily on administrative and strategic duties.

ALTEX Proceedings gets a facelift


The website of the journal ALTEX Proceedings, which publishes Abstract books and Proceedings of scientific conferences in cooperation with the respective organizers has been upgraded to offer a more user-friendly experience well in time for the upcoming publication of the Abstract book for the 11th World Conference on Alternatives and Animal Use in the Life Sciences in August 2020.

Like ALTEX, ALTEX Proceedings is published with open access to allow scientists from anywhere in the world to stay up to date on current topics in the field of alternative methods.

We are grateful to the Doerenkamp Zbinden Foundation for supporting the website upgrade and to Ixodes Webservices for its design and implementation.

Presentations Available from EPA Conference on NAMs


Presentation slides are available from the First Annual Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing, presented by the U.S. Environmental Protection Agency (EPA) on December 17. Presentations and other meeting materials are available at

This conference was one of EPA’s commitments in the "Directive to Prioritize Efforts to Reduce Animal Testing" signed by Administrator Andrew Wheeler on September 10, 2019, calling for EPA to reduce use of mammalian studies. Presentations discuss both animal and non-animal tests used to satisfy testing requirements and establishing baselines for animal use. Presenters included Acting NTP Biomolecular Screening Branch Chief Warren Casey, Acting NICEATM Director Nicole Kleinstreuer, and ICCVAM Co-chair Anna Lowit, EPA.

A breathing lung-on-a-chip and women’s reproductive organs on-a-chip join the 2020 Lush Prize shortlist


Lush Prize announced its 2020 shortlist on January 6th.  Among the projects shortlisted were:

- a team from Brunel University in London working on organ-on-a-chip platforms using human cells to replicate female organs (vagina, ovaries, placenta and breast) to better understand the causes and treatment of women’s diseases.

- a Swiss start-up company called AlveoliX who have created a lung-on-a-chip with a moving ‘microdiaphragm’ connected to a soft porous membrane where human cells are cultured.

Both these projects were thought to offer promising routes to replace the use of animals in chemical safety testing with more human-relevant scientific data.  In total, 58 projects from 21 countries were shortlisted for the £250,000 prize fund. The full shortlist is available on the Lush Prize website at

               For the first time this year, Lush Prize were pleased to announce that the shortlist contained a group from Turkey, where awareness-raising of animal welfare issues is just beginning to take off.  As before, it also contained nominations from as far afield as China, New Zealand, Chile and Slovakia.

We have reproduced the full 2020 shortlist for the Science Prize below.  Computational toxicology projects were most frequently shortlisted in this category, with six of the 14 shortlisted groups working in this area.  This will partly be a consequence of Lush Prize altering its criteria in 2019 to focus on computational solutions, and may be a consequence of an upsurge in interest in this area too. 

The next most frequently shortlisted projects were organs-on-chips, where four projects made it through to the final cut, including the two mentioned above.  The Science Prize winner in 2018 was the blinking eye-on-a-chip from the BIOLines Research Group at the University of Pennsylvania.

The winners of the 2020 Lush Prize will be chosen by an expert panel of judges on January 24th in London but will not be publicly announced until the Lush Prize Awards Ceremony in May.


Free online course on 3Rs and animal use in science


Young scientists are needed to help meet the European Union’s commitment to replace animal use in science. The European Commission's Joint Research Centre is funding a Massive Open Online Course (MOOC) on the 3Rs (replacement, reduction, and refinement of animal use in science) to provide ideas and examples on how to address the 3Rs in the classroom and develop students’ critical thinking and understanding of science.

The course begins on January 13, 2020, and lasts for five weeks with an estimated workload of four hours per week. It is tailored to secondary school teachers but anyone can register. More information is available at

EPA updates List of Alternative Test Methods and Strategies (or New Approach Methodologies [NAMs])


The U.S. has EPA released an updated version of its List of Alternative Test Methods and Strategies (or New Approach Methodologies [NAMs]). The document can be viewed here:

The list contains links to test guidelines, method protocols, computational tools and databases, and guidances and policies from EPA  that "do not use vertebrate animals to develop new data/information," and additional guidance or other documents that are considered "tools and approaches which may enhance the use of NAMs for regulatory use under TSCA."

New additions to the list include:

  • The ToxCast Estrogen Receptor Agonist Pathway Model
  • In vitro BALB/c 3T3 Cell Transformation Assay
  • Determination of in vitro intrinsic clearance using rainbow trout hepatocytes (OECD TG NO. 319A)
  • Determination of in vitro intrinsic clearance using rainbow trout liver S9 sub-cellular fraction (RT-S9) (OECD TG NO. 319B)
  • Several guidance documents related to waiving or bridging or alternative approaches for acute systemic toxicity, eye irritation, skin sensitization, and endocrine disruption
  • FIFRA SAP reports on endocrine disruption, respiratory toxicity, and the EPA CompTox Chemicals Dashboard




Egon Naef Foundation for In Vitro Research awards its 3R Prize to Carole Bourquin of the University of Geneva


Professor Carole Bourquin receives the Egon Naef Foundation 3R Prize 2019 in recognition for the development of a new in vitro technique that reduces by 20% the number of mice needed for nanoparticle research in immunotherapy.

Nanoparticles allow drugs to be transported to selected sites in our bodies. By targeting the lymph nodes, it is possible to specifically stimulate the immune system, a promising approach to fight cancer. To choose appropriate nanoparticles, researchers test their behavior in animals. Carole Bourquin’s team from the University of Geneva (UNIGE) has developed a technique that makes it possible to perform a first in vitro screening of the nanoparticles. Only the best performers are then tested in animals. This method, which has been awarded the 2019 Egon Naef Foundation Prize for In Vitro Research, reduces the number of mice used in nanoparticle research for immunotherapy.

Immunotherapy research aims to stimulate the immune system to recognize and destroy cancer cells. Nanoparticles can improve treatment effectiveness by delivering the drug in the human body to the exact site where it will trigger the immune response, in the lymph nodes. The most efficient nanoparticles for transporting and releasing drugs into the lymph nodes must be captured by immune cells to be transported to the lymph nodes; they must not be toxic to cells; and they must not activate the immune system against themselves. Until now, nanoparticles were systematically tested in mice to ensure that they meet these three criteria.

The team in Geneva incubated the nanoparticles with immune cells grown in the laboratory. Then it was assessed by flow cytometry whether they had captured nanoparticles and whether or not the cells were in a state of activation. To date there is no non-animal method to predict whether the nanoparticles are transported to the lymph nodes, but the screening method can select the most promising particles before animal testing commences and so reduce the number of animals required for testing.

EPA actions to reduce animal testing


In a September 17 news release, the U.S. Environmental Protection Agency (EPA) announced a draft science policy to reduce testing of pesticides on birds when registering conventional outdoor pesticides. The draft science policy is based on a retrospective study by EPA and People for the Ethical Treatment of Animals that explored the quantitative and qualitative contributions of risk assessment methods using single oral dose and subacute dietary toxicity endpoints to the overall conclusions of acute avian risk. The analysis indicated that, in most cases, the subacute dietary results had little impact on risk conclusions arrived upon by use of acute oral data alone. This finding is expected to reduce the number of animals tested by a total of 60 birds per test, for a total projected animal savings of over 700 animals per year. The news release is available at The draft policy can be found at

An article in Regulatory Toxicology and Pharmacology co-authored by ICCVAM co-chair Anna Lowit summarizes the activities of EPA’s Hazard and Science Policy Council (HASPOC). HASPOC was established in 2012 by the EPA Office of Pesticide Programs to consider requests for waiving animal study requirements for human health risk assessments. Since its inception, HASPOC has evaluated over 1,000 requests to waive animal studies and granted waivers in response to nearly 90% of requests. These waivers have saved over 200,000 animals, $300 million in study costs, and $6 million in study review costs. The article is available at

FDA presents update on Predictive Toxicology Roadmap; video available


At a September 18 public meeting, the U.S. Food and Drug Administration (FDA) presented an update on activities to implement its Predictive Toxicology Roadmap. Speakers from seven FDA centers described how predictive toxicology methods are being advanced towards application to safety and risk assessments. Recordings of the meeting webcast are available on the FDA website at

Presentations available from September 19-20 SACATM meeting


Presentations from the September 19-20 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) are available on the NTP website at (click “Presentations” in far right column under “Meetings”).

In presentations at the meeting, scientists from NICEATM, ICCVAM member agencies, and collaborators described advances in alternatives to animal use. SACATM members expressed support for the current activities and direction of ICCVAM and noted the progress that has been made in advancing alternatives to animal testing.

Discussions on the use of computational methods focused on the limitations and applications of machine learning models in predicting toxicology. Considering the potential uses of microphysiological systems (also known as “tissue chips”) in predicting human toxicity, committee members suggested these might be most useful for early-stage toxicity screening, evaluating effects on diverse populations, and providing models for applications lacking established animal models. They cautioned, however, that the context of use for these platforms need to be clearly defined, and expressed support for developing a roadmap to build confidence in specific applications.

SACATM meets annually to advise NICEATM, ICCVAM, and the director of the National Institute of Environmental Health Sciences regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

NTP web update changes location of NICEATM webpages


An October 2 update to the NTP website implemented a new navigation structure that affects the location and addresses of NICEATM webpages.

Please contact the NICEATM webmaster at if you need any help finding specific content within the NICEATM webpages.

ALTEX supports replacement of research materials associated with pain and suffering in animals


Methods developed to replace animal use for scientific purposes often still make use of a variety of animal-derived materials whose production causes the animals pain and suffering. For example, fetal bovine/calf serum (FBS/FCS), which is used as a universal supplement in cell culture media, is derived from blood drawn from bovine fetuses discovered in pregnant cows during the slaughtering process. If this procedure is performed before the death of the fetus, it may cause the fetus pain and distress.

The journal ALTEX wishes to raise awareness of these issues and of the availability of alternative materials or production methods by recommending to authors to use or develop such approaches, which are also considered to offer better-defined and quality-controlled reagents than the animal-derived materials. While papers submitted for review will not be penalized for using such materials, authors will be asked to consider whether alternative materials might be tested for use in their system in future or would need to be developed from scratch. For example, the FCS-free database maintained by Utrecht University informs on alternative medium supplements to FBS/FCS. Reviewers of scientific papers in ALTEX already often suggest the replacement of FBS/FCS where applicable.

A further animal-derived material is Matrigel, commonly used as a cell scaffold for three-dimensional cell culture, which is produced from Engelbreth-Holm-Swarm (EHS) mouse sarcoma, a tumor grown and propagated in mice. Synthetic hydrogels have been developed as alternatives to Matrigel and some are commercially available.

Monoclonal antibodies, used to mark or bind molecules or to influence their activity, may still be purified from ascites fluid in mice in some countries. This involves inducing an inflammatory reaction in the peritoneal cavity of the mouse, injecting hybridoma (cancer) cells that produce the antibody into the peritoneum and later drawing out (tapping) the ascites fluid. Instead, antibodies can now be produced recombinantly and synthetic aptamers are also used as non-animal affinity reagents.

Obtaining primary animal cells from sentient animals will usually involve some level of pain for the donor animals and should be avoided where possible; models designed to reflect human physiological processes should preferably use human cell-based testing systems to avoid species-specific differences. Proteins and enzymes purified from animal tissue obtained by invasive sampling are often available in recombinant form, e.g. bovine serum albumin.


German Animal Welfare Research Prize 2019 goes to IfADo toxicologist


The Federal Ministry of Food and Agriculture, Germany will award the Animal Welfare Research Prize 2019 to Wiebke Albrecht, a PhD student at the Leibniz Research Centre for Working Environment and Human Factors (IfADo), Dortmund in the group of Jan G. Hengstler, on October 23rd. The prize, which is awarded each year, entails €25,000.

The multi-author publication that was recognized introduces novel test performance metrics to systematically assess and optimize in vitro systems to predict drug-induced liver injury (DILI) and to define the acceptable daily intake of drugs. In the development of in vitro tests to replace animal models, one major challenge is the extrapolation of in vitro cytoxicity results to drug doses that can cause liver toxicity in humans upon oral intake. The performance metrics developed in the study quantify how well a test differentiates between hepatotoxic and non-hepatoxic compounds and how well in vivo hepatotoxic blood concentrations can be estimated. These metrics were employed to optimize test performance on a training set of compounds such that the in vitro concentrations could be extrapolated to in vivo blood concentrations in humans that would be associated with a specific probability of hepatotoxicity, and corresponding oral doses were obtained by reverse modeling. The method also allows the estimation of acceptable daily intake for food additives.




Germany to reform Animal Protection Law following complaint by EC


Following a complaint from the European Commission, the Federal Government of Germany has announced to the Commission that it will reform the German Animal Protection Law, according to an article in the newspaper "Neue Osnabrücker Zeitung". This action is necessary to avert referral to the European Court of Justice. The Commission had initiated treaty violation procedures by sending a letter of formal notice in July 2018. It had critisized that more than 20 Articles and also Annexes of Directive 2010/63 on the protection of animals used for scientific purposes had not been fully translated into national law. For example, the Directive requires that only primates born in capitivity can be used for experiments. This was not transposed fully into German law according to Brussels. Although Berlin had initially rejected the criticism, it has now conceded that some of the stipulations had not been transposed in sufficiently clear language. First drafts of a reformed law and by-law were included in the letter to Brussels according to the report.

The Commission has also sent a letter of formal notice to Poland in July 2019 with regard to shortcomings in the enactment of 19 articles and three Annexes to the Directive 2010/63.

EPA releases draft guidance for waiving in vivo avian toxicity studies


In a September 17 news release, the U.S. Environmental Protection Agency (EPA) announced a draft science policy to reduce testing of pesticides on birds when registering conventional outdoor pesticides. The draft policy is open for public comment until November 1. The news release is available at The draft policy can be found at; email comments to

This document describes the results and implications of a retrospective study conducted by EPA and People for the Ethical Treatment of Animals. The study explored the quantitative and qualitative contributions of risk assessment methods using single oral dose and subacute dietary toxicity endpoints to the overall conclusions of acute avian risk. The analysis indicated that, in most cases, the subacute dietary results had little impact on risk conclusions arrived upon by use of acute oral data alone. This finding is expected to reduce the number of animals tested by a total of 60 birds per test, for a total projected animal savings of over 700 animals per year.

Herbert-Stiller-Prize for Animalfree Research awarded by Doctors Against Animal Experimentation


The Herbert-Stiller-Prize 2019 was awarded by the society Doctors Against Animal Experimentation on occasion of the society's 40th anniversary in Frankfurt am Main, Germany on September 14, 2019. The prize aims to support the winners to realize a planned research project in the field of medicine or life science. Prof. Jens Kurreck and Dr Johanna Berg of the TU Berlin won first prize. Their project aims to optimize animal product-free 3D bioprinting. The second prize went to Dr Mario Rothbauer of the TU Vienna, who plans to develop a human-based cell culture model of the synovium as an organ-on-a-chip model for rheumatoid arthritis research. Both projects will be supported with €20.000.

EPA directed to phase out animal testing by 2035


In a memorandum published September 10, 2019, Administrator Andrew R. Wheeler has directed the United States Environmental Protection Agency (US EPA) to "aggressively pursue a reduction in animal testing" by prioritizing ongoing efforts and directing existing resources towards new activities to reduce animal testing while ensuring protection of human health and the environment. He also indicated that additional agency resources may be activated to support new cross-office activities.
The memo states that more than 200,00 laboratory animals and $300 million have been saved in recent years as a result of collective efforts to reduce animal testing and that new approach methods (NAMs) have extensive benefits, which, apart from reducing the use of animals, allow the evaluation of more chemicals across a broader range of potential biological effects in a shorter timeframe and using fewer resources "while often achieving equal or greater biological predictivity than current animal models".
Specific commitments formulated in the memo are that EPA will reduce its requests for and funding of live mammal studies by 30% by 2025 and eliminate all live mammal study requests by 2035. Any mammal studies requested or funded after this date will require Administrator approval on a case-by-case basis. The EPA will further strive to exclude any reliance of mammal studies from third parties in its approval processes after January 1, 2035, subject to legal requirements.
The Administrator further requests a joint annual conference on NAMs to be held from 2019 forward organized by the Office of Chemial Safety and Pollution Prevention (OCSPP) and the Office of Research and Development (ORD) as a resource on NAM developments to scientists and policy makers.

NICEATM and ICCVAM workshop reports available


NICEATM and ICCVAM scientists were coauthors on three recently published workshop reports.

  • NICEATM Deputy Director Nicole Kleinstreuer is a coauthor of the report on the Ninth Berlin Workshop on Developmental Toxicity held in September 2018. Attendees at this workshop considered the future of in vitro methods for developmental and reproductive toxicology, the potential relevance of alternative species in testing of developmental effects, and risk and hazard assessment of developmental and endocrine effects. Recommendations included the need for a harmonized terminology for classification of anomalies in laboratory animals in developmental toxicity studies for human health risk assessment. The report is available at
  • The October 2018 workshop “Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond” explored how to advance alternative methods for human and veterinary rabies virus vaccine potency testing. NICEATM Director Warren Casey and David Allen, ILS (contractor supporting NICEATM), workshop participants, coauthored the report, which is available at The workshop was co-sponsored by NICEATM and the International Alliance for Biological Standardization-North America.
  • A report from the October 2018 “Summit on Artificial Intelligence in Environmental Health Science and Decision Making” is available at The goal of the summit was to identify and prioritize environmental health sciences research questions that might be investigated with artificial intelligence and machine learning techniques. Kleinstreuer and Lyle Burgoon, U.S. Department of Defense, co-chair of the ICCVAM Ecotoxicology Workgroup, were among the presenters at the summit.

European Organ-on-Chip Society open for active membership


The founding phase is complete: the European Organ-on-Chip Society (EUROoCS) is now welcoming members to join. The annual conference, held this year in Graz (Austria), saw the launch of the community website and the start of its availability as an information resource. “We invite scientists, engineers, as well as regulators and patient representatives interested in these new laboratory models to become active members of the society and contribute to efforts of the Organ-on-Chip community in promoting recognition and implementation of  this exciting research field,” says Christine Mummery, chair of EUROoCS and professor of Developmental Biology at Leiden University Medical Center, the Netherlands 

Organ-on-Chip (OoC) systems are among the latest emerging technologies for healthcare research. It is believed they will accelerate drug discovery, advance drug efficacy and toxicology testing and open new opportunities for personalized medicine. “Organ-on-Chip systems can reduce and perhaps eventually replace animal experiments and provide predictive human data before expensive and lengthy clinical trials actually start,” vice-chair Peter Loskill says. The biophysicist heads the Organ-on-Chip research group at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Germany.  

OECD issues new and updated in vitro and in chemico Test Guidelines


The Organisation for Economic Co-operation and Development (OECD) issued three new and six updated Test Guidelines on June 18. Included among the new documents are tests relevant to replacing or reducing animal use for common acute toxicity endpoints. Links to the new Test Guidelines are available at

  • Test Guideline 494 (new) describes the in vitro Vitrigel-Eye Irritancy Test (EIT) to identify chemicals not requiring classification and labelling for eye irritation or serious eye damage.
  • Test Guideline 442C (updated) describes in chemico assays that measure covalent binding of a test chemical to skin proteins, a key event in the adverse outcome pathway for skin sensitization. The previous TG 442C described the direct peptide reactivity assay. The updated Test Guideline also describes a similar method, the amino acid derivative reactivity assay (ADRA), and discusses how in chemico protein binding assays could be used within integrated approaches to testing and assessment for skin sensitization.
  • Test Guideline 492 (updated) describes in vitro reconstructed human corneal epithelium test methods to identify chemicals not requiring classification and labelling for eye irritation or serious eye damage. The Test Guideline is based on four commercial methods of this type. It includes descriptions of essential test method components and a list of chemicals to be used to demonstrate proficiency with the assays.
  • Test Guidelines 431 and 439 (updated) describe in vitro reconstructed human epidermis test methods to identify chemicals that may cause skin corrosion (TG 431) or irritation (TG 439). The test guidelines were revised to include a greater number of commercial methods of this type. Both Test Guidelines include lists of chemicals to be used to demonstrate proficiency with the assays.

ECHA to scrutinise all REACH registrations by 2027


The European Chemicals Agency ECHA has announced that the European Commission will propose an amendment to REACH, requiring that compliance checks of registration dossiers are performed on 20% of dossiers in each tonnage band instead of currently 5%. This means that around 30% of all dossiers of registered substances will be checked. This amendment is a result of a joint action plan of ECHA and the Commission to improve compliance of registration dossiers and thus ensure that safety data on chemicals is complete.

ECHA further states that it aims to screen all registration dossiers that were submitted by the 2018 deadline - for substances in the > 100 tonnage band by 2023; for substances in lower tonnage bands by 2027. Similar substances will be assessed in groups and substances will be categorized by the end of 2020 as a priority for risk management, data generation or of low priority for further action.

ECHA Press release: ECHA/NR/19/09

Use of cell-based assay for botulinum toxin products approved


Ipsen Pharma has received approvals from U.S. and Canadian regulatory authorities for use of their in vitro Cell-Based Assay to establish stability and potency of its botulinum toxin products. This follows prior approval received in the European Union and Switzerland for this application of the Cell-Based Assay.

The basis of the Cell-Based Assay is the BoCell® technology platform, developed by BioSentinel Inc., a Madison, Wisconsin-based company that specializes in developing platforms for the detection and measurement of botulinum toxins. BioSentinel and Ipsen collaborated closely in development of the Cell-Based Assay, which achieves a level of precision comparable to the mouse-based LD50 assay.

The announcement of the approval is available at

ICE version 2.0 now available


On May 20, NICEATM released a major update of the Integrated Chemical Environment (ICE), available at ICE provides data and tools to help develop, assess, and interpret chemical safety tests. The ICE update introduces a new user interface to simplify searches and new tools that will let users explore chemical properties and toxicity in more detail.

The new ICE home page delivers users easy access to all the tools within ICE, as well as user guides and related information. The updated ICE search tool includes a new module that simplifies assay selection. Another new feature allows users to add chemicals with the same core structure, such as different salt forms and stereochemistry, to their search, which expands the relevant toxicity data returned from the search.

In addition to the search tool, ICE includes in vitro to in vivo extrapolation (IVIVE), machine learning, and chemical characterization tools. The updated IVIVE tool provides more complex models, including those from the U.S. Environmental Protection Agency’s httk package, to improve prediction accuracy.

Slides and video available from ICCVAM Public Forum


Slides and a video recording from the May 23 ICCVAM Public Forum are available on the NICEATM website at ICCVAM holds annual public forums to share information and facilitate direct communication of ideas and suggestions from stakeholders. The May 23 meeting was held at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland.

Over 40 attendees and more than 200 webcast viewers heard presentations by ICCVAM members representing eight U.S. agencies on current activities related to the development and validation of alternative test methods and approaches. Presenters described member agency activities to implement the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States. A key focus was progress made towards reduction and replacement of animal use for acute toxicity tests required by regulatory agencies: acute systemic toxicity, skin and eye irritation, and skin sensitization testing. Public comments submitted to the meeting praised specific actions agencies have taken in the past year to advance the strategic roadmap goals, and suggested additional activities that could support further progress.

ICCVAM activities will also be discussed at the September 19-20 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods, to be held at the U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition in College Park, Maryland. Information about that and other upcoming NICEATM events is available on the NICEATM 3Rs Meetings and Workshops page at

Jan van der Valk receives Björn Ekwall Award


Dr. Jan van der Valk, director of the 3Rs-Centre ULS, has been selected as the recipient of the Björn Ekwall Memorial Award for the year 2019. The annual award recognizes scientists who have substantially contributed to the field of cell toxicology, e.g. by developing new in vitro tests, or via mechanistic or validation studies.
Dr van der Valk was recognized for his work to make scientists aware of the issues regarding the use of fetal calf serum (FCS), which is harvested from bovine foetuses taken from pregnant cows during slaughter. In the past 20 years, Dr van der Valk has organized workshops, given lectures and published several papers on this topic, including recently in ALTEX (doi:10.14573/altex.1705101). The 3Rs-Centre Utrecht Life Sciences and Animal Free Research UK launched the FCS-free Database in 2017, where researchers can find FCS-free media for specific cell-types.

China accepts nine non-animal testing methods for the regulation of cosmetics


China’s National Medical Products Administration (NMPA) has accepted certain non-animal test methods for the regulation of cosmetics as reported by the Institute for In Vitro Sciences. In a March 22 notice, NMPA announced acceptance of nine test methods, including the direct peptide reactivity assay for skin sensitization and the short time exposure test assay for eye irritation. These new regulations will go into effect January 1, 2020 and will be the preferred toxicological tests for the registration and pre-market approval of cosmetic ingredients. 

New book available: Animal Experimentation: Working Towards a Paradigm Change


There is growing recognition that a focus on human-relevant data is needed for the understanding and possible treatment of chronic, complex diseases, many of which are not well understood and, thus, cannot be readily modeled in non-human animals. The technology revolution has greatly changed the field of life sciences and now provides us with tools enabling a shift away from animal experimentation. The 51 experts who have contributed to Animal Experimentation: Working Towards a Paradigm Change (Brill open access) review current animal use in science, and they discuss innovative, human-relevant approaches to advance the life sciences and to accelerate the shift towards the replacement of animals in research, testing and education.
Background: The book was initiated by Kathrin Herrmann, Director of CAAT’s Evidence-based Refinement Program. Besides co-editing the book with Kimberley Jayne, Kathrin wrote the introductory chapter.

You can read the open access book online or purchase a physical copy here.

Read CAAT Director Thomas Hartung's article, Research and Testing Without Animals: Where are We Now and Where Are We Heading? and Refinement on the Way Towards Replacement: Are We Doing What We Can? by CAAT's Director of Evidence-based Refinement program, Kathrin Herrmann. 

Felix Wankel Animal-Welfare-Research-Award for Dorothea Döring


On March 14, 2019 the Felix Wankel Animal-Welfare-Research-Award 2019 was bestowed at the Ludwig Maximilians University in Munich on Dr Dorothea Döring for her work on the behaviour of laboratory dogs and aspects of animal protection in dog husbandry. Prof. Dr Christian Klimmt gave a keynote lecture on public acceptance of animal experiments from the perspective of a communications scientist.

Dr Döring has published an article in ALTEX on the behaviour of dogs before and after rehoming to private homes:

The prize of €30.000 is awarded every two years.


NICEATM SOT presentations available


A webpage summarizing NICEATM and ICCVAM activities at the March 10-14 Society of Toxicology (SOT) annual meeting is available at The page includes links to presentations from the ICCVAM exhibitor-hosted session, “ICCVAM Update on Implementing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.” Six NICEATM poster presentations are also available on the webpage.

Australian cosmetic animal test ban bill passes Senate


The Industrial Chemicals Bill passed by the Australian Senate on February 14, 2019 includes measures to prohibit reliance on new animal test data for chemicals introduced into Australia for use as ingredients in cosmetics. The Government reached an agreement with the Humane Society International to commit to reinforcing measures that ensure that all cosmetic ingredients are included in the ban and to fund and support the development and uptake of non-animal test methods.
To date there are nearly 40 national bans and further national bans are under discussion in numerous states. The Humane Society International with its global campaign #BeCrueltyFree and its partners have played a leading role in raising awareness in the countries and negotiating with the governments on the issue of banning animal testing for cosmetics ingredients.

SOT honors scientists working on alternative methods


The recipients of the 2019 SOT Awards have been announced, among them the following scientists working in the field of alternatives to animal experiments:

Nicole Kleinstreuer, NIEHS/NICEATM will receive the SOT Achievement Award to recognize her leadership and distinction in contributing to the field of toxicology, particularly in the areas of alternative toxicological methods and computational toxicology.
Suzie Fitzpatric, US FDA, wins the SOT Enhancement of Animal Welfare Award for her expertise in alternative toxicological methods and work to improve animal welfare within the field of toxicology.
Yvonne Chang, Oregon State University, will receive the Colgate-Palmolive Award for Student Resaerch Training in Alternative Methods.
Helena Hogberg, Johns Hopkins University, and Hao Zhu, Rutgers, both win the Colgate-Palmolive Grant for Alternative Research.

EURL ECVAM issues status report on alternatives


The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has issued its 2018 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.” The status report describes research, development, and validation activities, as well as initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. Key findings include:

  • Significant progress has been made in combining in vitro and computational methods to 'read-across' toxicological properties between similar chemicals to avoid unnecessary animal testing.
  • There is increased use of alternatives to identify endocrine disruptors and assess chemical mixtures.
  • Challenges still prevent the use of alternatives alone to fully characterize complex toxicological properties of chemicals that cause chronic systemic health effects.

EURL ECVAM, which is part of the European Commission's Joint Research Centre, coordinates research and validation studies on alternatives to animal testing within the European Union. EURL ECVAM also shares knowledge about and promotes use of alternative methods.

A link to the report and an interview with two of its authors are available at More information about EURL ECVAM is available at

ICCVAM members recognized by SOT


The Society of Toxicology will present awards to two ICCVAM members at its annual meeting in March.

Suzanne Fitzpatrick of the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) will receive the 2019 SOT Enhancement of Animal Welfare Award. This award recognizes contributions that advance toxicological science through development and application of methods that replace, refine, or reduce the need for experimental animals. This marks the fourth consecutive year that an ICCVAM or NICEATM affiliated scientist has been honored with this award. Fitzpatrick, who is principal FDA representative on ICCVAM, is a Senior Science Advisor for Toxicology at CFSAN. She is the FDA lead for Tox21 and chair of the FDA Predictive Toxicology Roadmap Committee. She also plays a leading role in FDA evaluations of organs-on-chips technology.

NICEATM Deputy Director Nicole Kleinstreuer will receive the 2019 SOT Achievement Award. This award is presented to an SOT member who, within 15 years since obtaining their highest degree, has made significant contributions to toxicology. Kleinstreuer’s research focuses on mathematical and computational modeling of biological systems and perturbations that result in adverse health outcomes. She has made key contributions to strategies that combine in vitro high throughput assay data with computational models to predict the likelihood of toxicity. She also represents the National Institute of Environmental Health Sciences on ICCVAM.

Collaborative Acute Toxicity Modeling Suite (CATMoS) now available


NICEATM has released the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic chemicals for acute oral toxicity. CATMoS is implemented in v2.0 of the Open Structure-Activity/Property Relationship App (OPERA), a free and open-source quantitative structure-activity relationship (QSAR) tool. OPERA v2.0 can be downloaded from the NIEHS Github repository at
CATMoS is the result of a global collaboration to develop in silico models to predict acute oral toxicity. It is a suite of consensus models developed by combining the results of individual models contributed by participants in the April 2018 Workshop on Predictive Models for Acute Oral Systemic Toxicity (see and The individual models were built using information on chemical structures and rat oral acute toxicity data for nearly 9000 chemicals, and tested using approximately 3000 chemicals.
CATMoS includes models for predicting five acute oral toxicity endpoints: very toxic, non-toxic, U.S. Environmental Protection Agency hazard classification, United Nations Globally Harmonized System of Classification and Labelling of Chemical (GHS) hazard classification, and LD50. Predictions generated by CATMoS may be useful to those developing or triaging new chemicals or for prioritizing existing chemicals for more detailed and rigorous toxicity assessments.

NICEATM Integrated Chemical Environment updated


Updates to the NICEATM Integrated Chemical Environment (ICE) resource were launched in September and November. ICE is available at

Successful computational toxicology projects depend on freely available, high-quality data that are formatted for use in computational workflows. ICE provides data from NICEATM and its partners, as well as other resources and tools, in an environment designed to support chemical safety assessment and new method development.

Recent ICE updates have:

  • Expanded physicochemical property predictions to include over 720,000 chemicals using an updated set of predictive models (described in Mansouri et al. 2018,
  • Updated the curated high-throughput screening data from the Tox21 initiative to include increased curation and the most up-to-date data release
  • Added new workflows to enable:
    • In vitro to in vivo extrapolation (method described in Casey et al. 2018,
    • Construction of machine-learning models to predict chemical hazard
    • Characterization of chemical lists using physicochemical properties to relate chemicals

Future updates will allow users to get physicochemical property predictions on their own data sets, add chemical use descriptions to chemical characterizations, and provide a three-compartment generalized physiologically based pharmacokinetic model for in vitro to in vivo extrapolation.

The History of Alternative Test Methods in Toxicology published


The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique.

The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity.

OECD releases revised GD 150 on evaluating chemicals for endocrine disruption


The revised edition of Guidance Document (GD) 150 includes new and updated test guidelines that have been validated, or are currently in the validation process. Updates to the test guidelines concern all levels in the OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupting Chemicals, and the Conceptual Framework itself has been updated. The revised GD includes various cross-cutting issues and a summary of some experiences gained from using the guidance in the first edition.

Of the five levels of the Conceptual Framework, Level 1 considers existing data and existing or new non-test information and Level 2 considers in vitro assays providing data about selected endocrine mechanism(s)/pathway(s). Levels 3-5 consider in vivo assays on endocrine mechanism(s)/pathway(s), on adverse effects on endocrine-relevant endpoints, and more comprehensive data on adverse effects on endocrine-relevant endpoints over move extensive parts of the life cycle or the organism.

The tests included in Level 2 are:
– Estrogen (OECD TG 493) or androgen receptor binding affinity (US EPA TG OPPTS 890.1150)
– Estrogen receptor transactivation (OECD TG 455, ISO 19040-3), yeast estrogen screen (ISO 19040-1 & 2)
– Androgen receptor transactivation (OECD TG 458)
– Steroidogenesis in vitro (OECD TG 456)
– Aromatase assay (US EPA TG OPPTS 890.1200)
– Thyroid disruption assays (e.g. thyroperoxidase inhibition, transthyretin binding)
– Retinoid receptor transactivation assays
– Other hormone receptors assays as appropriate
– High throughput screens

Use of NAMs in risk assessment webinar series started


A new webinar series on the use of new approach methodologies (NAMs) in risk assessment is being organized by the Physicians Committee for Responsible Medicine, the U.S. Environmental Protection Agency (EPA), and the PETA International Science Consortium Ltd. The first webinar in this series was presented on November 7 and can be viewed at The next webinar in the series is planned for January 2019, and details of the webinar will be posted on the PISC webpage.

The November 7 webinar focused on the two testing strategies included in EPA’s “Policy on the Use of Alternative Approaches for Skin Sensitization Testing” (available at Susanne Kolle described BASF’s “2 out of 3 approach” and Taku Nishijou discussed Kao Corporation’s sequential testing strategy for in vitro skin sensitization testing.

LUSH Prize 2018 awarded


The winners of the LUSH Prize in the categories science, public awareness, training, lobbying and young researchers were announced at a gala dinner in Berlin on November 16. The Andrew Tyler Award was presented to Prof. Dr Horst Spielmann for his lifetime achievements. The dinner followed a conference titled: Is there an end in sight for animal testing? Can Organ-on-a-Chip replace animal use in safety testing with advanced human focused approaches?

NC3Rs launches Tech3Rs newsletter


The NC3Rs has launched a new newsletter aimed at animal technicians, focusing on refinements and animal welfare. Tech3Rs will feature updates on the most relevant resources, research and events, supporting technicians to identify opportunities to embed the 3Rs in practice.

Issues will be published quarterly on the NC3Rs website in a downloadable PDF format. Facilities in the UK can also order hard copies for display.

NICEATM, PISC workshop explores alternatives to animal use for pyrogen testing


A workshop on September 18-19 at NIH explored challenges to acceptance of a human cell-based assay for pyrogen testing of medical devices. The workshop was organized by NICEATM and the PETA International Science Consortium.
Pyrogens are substances that can produce fever when present as contaminants in a drug or medical device. Most pyrogens are biological substances derived from bacteria, fungi, and viruses; material-mediated pyrogens (MMPs), while less common, may also be present. Drugs for injection and medical device products for implantation or other systemic exposure should meet pyrogen limit specifications before they are marketed. Animal-based pyrogen tests are often conducted to investigate the presence of pyrogens. Non-animal monocyte activation tests (MAT) are widely available but infrequently used for pyrogen testing.
At the September workshop, regulators, test developers, medical device manufacturers, and other experts explored how the U.S. Food and Drug Administration Medical Device Development Tools Program could be used to qualify the use of MAT as a standalone pyrogen test for specific medical device contexts-of-use. There was general agreement that the MAT could be qualified as acceptable for batch-release testing for microbial-based pyrogens. However, additional studies were recommended to demonstrate its ability to detect known MMPs. This testing would determine whether the assay can be used for both biocompatibility and sterility or if other information on MMPs would be needed to address biocompatibility.
More information about NICEATM and ICCVAM evaluation of pyrogen test methods is available at An agenda, presentations, and other materials from the meeting are available at

NICEATM and IABS hold rabies vaccine workshop


NICEATM and the International Alliance for Biological Standardization co-organized an October 16-17 workshop “Implementing Non-animal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond” at the National Institutes of Health (NIH) in Bethesda, Maryland. Over 60 scientists from government, academia and industry gathered to develop recommendations to advance alternative methods for human and veterinary rabies vaccine testing.
Presentations on the first day of the workshop detailed the current state of the science of non-animal alternatives to traditional rabies vaccine potency and safety tests. On day two, separate breakout group discussions focused on the steps necessary for implementing alternatives for veterinary and human rabies vaccine potency testing. Participants identified actions and data still needed to achieve this, and laid the foundation for a roadmap towards successful implementation. Meeting outcomes and associated recommendations will be summarized in a report in the journal Biologicals.

Postdoctoral opportunities available at NTP


The U.S. Food and Drug Administration is accepting applications for postdoctoral fellows to develop human cell- and protein-based assays for assessing cardiotoxicity of new drugs. These projects are part of an initiative to design, build, and test new non-animal approaches to assess cardiotoxicity hazard. The initiative is supported jointly by the National Toxicology Program (NTP; Biomolecular Screening Branch and NICEATM), the U.S. Food and Drug Administration Center for Drug Evaluation and Research, and the Health and Environment Sciences Institute.
Candidates for these two postdoctoral positions should have received Ph.D. or equivalent degrees in computer sciences or life/health/medical sciences within the last five years. Work will be done at National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, NC. More information about the projects and instructions for applying are available at

SACATM meeting focuses on key issues in replacing animal testing


At its September 5-6 meeting, members of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) and other experts advised U.S. government scientists on issues to be addressed to replace animal use for safety testing. About 60 participants met at NIEHS for the annual advisory committee meeting. Participants discussed actions needed to advance goals outlined in a strategic roadmap for new approaches to evaluating the safety of chemicals and medical products.
At the meeting, industry representatives indicated a need for regulators to clearly communicate both their information requirements and willingness to accept data from new approach methodologies to fulfill those requirements. Participants also discussed the need for high-quality reference data from past animal tests to evaluate the performance of new methods, and considered issues involved in sharing and using those data.
SACATM, the advisory committee for ICCVAM, is a panel of experts drawn from industry, academia, and animal welfare organizations. SACATM meets annually to advise ICCVAM, NICEATM, and the NIEHS director on activities related to ICCVAM’s mission.
Materials from the SACATM meeting are available at, and a longer summary is available in an article in the October issue of the NIEHS Environmental Factor newsletter at

UK Home Office publishes 2017 statistics on animal experiments


The ‘Annual Statistics of Scientific Procedures on Living Animals, Great Britain’ was published by the UK Home Office on the 19th of July 2018.
The figures show that 3.79 million animal experiments took place in Great Britain in 2017, a slight decrease of 4% compared to the previous year. Of these, 1.90 million (50%) related to the creation or breeding of genetically altered animals who were not used in further procedures, while the remaining 1.89 million experiments (50%) were experiments on animals for various purposes. These purposes were basic research (55%); translational/applied research (17%), regulatory tests (27%), and others (1%).
In 2017, there were increases in the number of experiments conducted on horses (up 18% to 10,600) and cats (up 4% to 198 experiments) in Great Britain. However, there were decreases in the use of other species, including mice (down 10% to 1.1 million), rats (down 2% to 234,000), non-human primates (down 17% to 2,960) and dogs (down 22% to 3,847).
Almost 700,000 experiments (32%) carried out in Great Britain in 2017 were deemed to have caused moderate or severe suffering to the animals involved; moderate or severe suffering was alse experienced by 5% of the genetically altered animals not used for further procedures. Moderate suffering is described by Directive 2010/63/EU as causing short term moderate pain or distress or long-lasting mild pain or distress to animals while severe suffering is described as causing severe pain or distress or long-lasting moderate pain or distress to animals.

German Federal Animal Protection Research Prize awarded for secondary nanobodies


Dirk Görlich and Tino Pleiner of the Max-Planck-Institute for Biophysical Chemistry in Göttingen today receive the Animal Protection Research Prize of the German Federal Ministry of Nutrition and Agriculture (Bundesministerium für Ernährung und Landwirtschaft). The scientists have developed secondary nanobodies as a new form of secondary antibody for use in medicine and research. Secondary nanobodies are based on very small antibodies of Alpakas and are multiplied in bacteria. This approach can reduce the number of animals used for secondary antibody production.

Biomed21 launches newsletter


The Biomedical Research for the 21st Century (BioMed21) Collaboration brings together scientists and institutions from across Europe, Asia and the Americas who share a vision of a human-focused paradigm in health research. This unique mix of biomedical stakeholders provides both a broad, global outlook as well as deep ties at regional and national levels. BioMed21 welcomes new collaboration opportunities with like-minded organizations and individuals.
The Biomed21 website is designed to be a hub for information related to innovative, human-specific approaches in health research, including relevant publications, funding opportunities, workshops, training opportunities, and other events.
The newsletter delivers top highlights to your inbox every quarter.

NIH to build cell map of human body


The National Institutes of Health has issued its first set of research funding awards for the Human BioMolecular Atlas Program (HuBMAP). HuBMAP is an open, global framework that will support research community efforts to map the adult human body at the level of individual cells. The project is planning to award $54 million over the next four years to support:

  • Generating, standardizing, and validating data sets on cell organization and variability
  • Development of new tools and techniques to construct high-resolution tissue maps
  • Coordinating program activities, managing HuBMAP data, and building an atlas of tissue maps

An announcement of the grant awards is available at The project website is located at

ALTEX Prize 2018 awarded to Martin Paparella


The ALTEX Prize 2018 for the best paper published in ALTEX in the previous year was awarded to Dr Martin Paparella, Medical University Innsbruck, as first author of "Uncertainties of testing methods: What do we (want to) know about carcinogenicity" at the social evening of the EUSAAT Congress in Linz on September 25 by Dr Sonja von Aulock. Martin Paparella is a regulatory toxicologist; he is coordinator of the Austrian OECD WNT (Working Group of National Coordinators of the Testing Guidelines programme) and of the PARERE (Preliminary Analysis of Regulatory Relevance) network.
The ALTEX Prize is awarded annually and was again kindly sponsored by the Doerenkamp-Zbinden Foundation.

Input Requested on Scientific Program for 11th World Congress


The 11th World Congress on Alternatives and Animal Use in the Life Sciences (WC11) will be held in Maastricht, the Netherlands, on 23-27 August 2020. Visit the congress website for the latest updates.

The general theme of the congress, “3Rs in Transition: From Development to Application”, emphasizes the increasing focus on the use of better, more human-relevant models for personalized and preventive health care, safer products and innovative research. A scientific committee is currently being established and the first meeting will take place before the end of this year. The scientific committee will set up the scientific program of the congress around four main themes: safety, disease, innovative technologies, and ethics and welfare. Input on topics for the scientific program is welcomed; please visit the congress website for details.

Guidance Document on Good In Vitro Method Practices (GIVIMP) now online


The Guidance Document on Good In Vitro Methods Practices (GIVIMP) is a project led by the European Commission’s Joint Research Centre. The aim of this document is to provide guidance in order to reduce the uncertainties in cell and tissue-based in vitro method derived predictions by applying all necessary good scientific, technical and quality practices from method development to implementation for regulatory use. The document is targeted towards test method developers and test guideline users and provides best practices for designing guideline in vitro methods, carrying out safety tests and assuring quality and scientific integrity of the resulting data. The GIVIMP is intended to be an important resource that can help to avoid a scientific reproducibility crisis in in vitro toxicological sciences.

ICCVAM publishes 2016-2017 Biennial Report


The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has published a report summarizing activities of member agencies during 2016 and 2017.
The 2016-2017 ICCVAM Biennial Report is available at

The report highlights member agency activities supporting toxicology innovation, as well as regulatory agency initiatives to promote the 3Rs (replace, reduce, or refine animal use) and to provide information about the use of in vitro methods.
Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

- Publication of A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.

- Guidance documents published by the U.S. Environmental Protection Agency describing approaches to reduce animal use in testing required for pesticide registration.

- Notices published by the U.S. Department of Agriculture describing approaches to reduce animal use for vaccine testing.

- A Predictive Toxicology Roadmap published by the U.S. Food and Drug Administration.

- A non-animal defined approach developed by NICEATM and EPA that identifies substances that may interact with the androgen receptor.

- A non-animal defined approach developed by NICEATM and ICCVAM to predict skin sensitization risk.

- A proposed method developed in collaboration with international partners to evaluate non-animal approaches to identify skin sensitizers.

- Launch of the NICEATM Integrated Chemical Environment (ICE), an online resource that provides high-quality curated data and computational workflows for chemical safety assessment.

Ellen Fritsche and Hamid Reza Noori to receive Ursula M. Händel Animal Protection Prize 2018


The Ursula M. Händel Animal Protection Prize 2018 of the German Research Council (DFG) will be shared between the toxicologist Prof. Dr Ellen Fritsche of the Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University in Düsseldorf and the mathematician, physicist and physician Dr Dr Hamid Reza Noori of the Max-Planck-Institute for Biological Cybernetics in Tübingen. This is the seventh time the prize will be awarded to scientists who improve animal protection in science in accordance with the 3R principle (Reduce, Replace and Refine).

2018 CRACK IT Challenges announced


This year’s CRACK IT Challenges competition consists of three Challenges identified jointly by the NC3Rs and sponsors:
Challenge 29: ImmuLiver – An immunologically-competent liver model to assess attenuation of yellow fever vaccines.
Challenge 30: RaTSRaman Transmission Spectroscopy for objective monitoring of rheumatoid arthritis progression in rodent models.
Challenge 31: MoshersMouse Smart Hoppers.

This year the competition is funded by the NC3Rs, with co‑funding provided by EPSRC (RaTS) and in-kind contributions from the sponsors.

Improving peer review of in vivo research proposals - videos online


The NC3Rs recently hosted a workshop on experimental design for funding panel members of the NC3Rs, BBSRC, CRUK, MRC and Wellcome Trust. Videos of the workshop presentations are now available to watch online. As well as supporting funding panel members to assess in vivo research proposals, the videos can help applicants to ensure their proposals provide quality information on experimental design.

NC3Rs announce 2019 highlight notice


To encourage funding applications relating to areas of strategic importance to the NC3Rs, regular highlight notices are issued that apply across all funding schemes. The 2019 highlight notice will support the development or transfer of innovative applications of non-mammalian organisms by facilitating new partnerships between rodent and non‑mammalian model organism users. A highlight notice launch event will take place on September 4, 2018 in Central London; attendance is free but registration by August 21, 2018 is essential.


3Rs-Centre ULS launches e-learning on humane endpoints in animal research and veterinary practice


The 3Rs-Centre Utrecht Life Sciences has developed an E-learning module on humane endpoints in animal research and veterinary practice. This module is available free of charge, for everyone who works with animals, on It provides both a solid basic training on humane endpoints, and practice opportunities with case studies. This E-learning will contribute to refinement by preparing the users to make well-balanced decisions regarding animal welfare and science.

3Rs-Centre ULS Newsletter July 2018

Experiments on primates to be reduced by 40% in The Netherlands


Ingrid van Engelshoven, Minister for Education, Culture and Science has called on the Second Chamber to phase out experiments on primates in the Netherlands. The first step will be a 40% reduction of experiments on primates in the Biomedical Primate Research Centre (BPRC) in Rijswijk and a reduction of the colony size by introducing birth control. The letter to the Chamber is a response to the commissioned report "Van Aap na Beter" (from ape to better) of the Rathenau Institute.

With around 1500 primates, the BPRC is Europe's largest primate center.

HESI workgroup surveying use of thyroid assays


The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee Thyroid Hormone Workgroup and the European Teratology Society Thyroid Hormone Task Force have initiated a survey to collect historical data for thyroid hormone measurements from nonclinical studies. This effort aims to provide clarification and guidance regarding the collection, assessment, and interpretation of thyroid hormone data for regulatory toxicology and risk assessment. The data collected will be anonymously archived in a database that will ultimately be available for public use and incorporated into a workshop planned for spring 2019. The ultimate goals of this effort are to improve data interpretation, establish biologically relevant ranges for each assessment, and develop recommendations for best practices for thyroid assessment.

If your organization conducts or has conducted these assays and you are interested in participating in the survey and contributing to the data collection effort, please contact Connie Chen at for more information.


3R relevant OECD Test Guidelines and updates released


On June 25, OECD adopted a set of new and updated Test Guidelines for chemicals safety testing.

Those include two new Test Guidelines on in vitro methods for fish hepatic clearance, TG 319A and TG 319B that can be used to improve in silico predictions of the test chemical bioaccumulation in fish.

Important updates to existing Test Guidelines encompass the inclusion of endocrine-related endpoints in TG 408 (90-d repeated dose toxicity study) and TG 414 (Developmental toxicity study); also Test Guidelines in the area of eye irritation and skin sensitisation have been revised to either improve predictivity of the existing method (TG 438, isolated chicken eye method) or include similar methods to those already existing (me-too methods in TG 442B, TG 442D, TG 492) ensuring more readily usable practical matter by members and Mutual Acceptance of Data (MAD) adhering countries.

A few other Test Guidelines have been slightly amended as well and can be accessed from the sections mentioned below:

A set of supporting documents and Guidance Documents associated to these Test Guidelines will soon be published.

US EPA releases strategic plan to reduce animal testing for TSCA


The U.S. Environmental Protection Agency (EPA) has published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. The document describes how EPA will promote development and implementation of methods and strategies that reduce, refine, or replace vertebrate animal testing to provide chemical safety information required under the Toxic Substances Control Act (TSCA).
The core components of the plan are (1) identifying, developing, and integrating new approach methodologies (NAMs) for TSCA decisions; (2) building confidence that the NAMs are scientific reliable and relevant for TSCA decisions; and (3) implementing the reliable and relevant NAMs for TSCA decisions.
The strategic plan and related documents are available at

NICEATM News June 27, 2018

NC3Rs publish strategy to update ARRIVE guidelines


In 2010 the NC3Rs developed the ARRIVE guidelines, a 20-item checklist covering the key information that should be included in scientific publications describing animal studies to ensure transparency and reproducibility. Despite widespread endorsement of the guidelines, there is mixed evidence of their impact on the quality of reporting. The NC3Rs have published a strategy for the revision of the ARRIVE guidelines, developed with an international working group of experts, in BMJ Open Science.

Report Available from BioMed21 Workshop


The June 2017 BioMed21 workshop, co-organized by NICEATM and the Human Toxicology Project Consortium, examined actions needed to implement a human systems-biology approach to understanding disease and improving interventions. The report from the workshop has been published in the journal Drug Discovery Today and is available at

Catherine Sprankle (NIH/NIEHS)

US Government Accountability Office assesses animal use in federal research


The U.S. Government Accountability Office (GAO) has published a report on the submission of data from agencies to the ANimal and Plant Health Inspection Service (APHIS) and the National Institutes of Health. The report finds that agencies publicly report some data on animal use but do not report other data unless asked. Some data may not be reported accurately because of inadequate instructions, i.e. research with birds, activities outside the United States, and field studies outside a typical laboratory. The GAO recommends that APHIS improve its instructions.
USDA stated that APHIS will take steps to implement GAO's recommendations, with the exception of clarifying reporting instructions for activities outside the United States.

HighlightsFull report

India approves non-animal alternatives to the pyrogen and the abnormal toxicity test


The Indian Pharmacopoeia Commission has replaced the rabbit pyrogen test and the guinea pig abnormal toxicity test with non-animal alternative methods for drugs manufactured and marketed in India according to The Hindu. The new guidelines will come into effect on July 1, 2018.
The pyrogen test, which is used to test drug batches for fever-inducing contaminations, will be replaced by the bacterial endotoxin test or a monocyte activation test. The abnormal toxicity test, a batch test done for vaccines, which has already been stricken from the U.S. and European pharmacopoeia, can be waived if a compliance certificate is obtained from the National Control Laboratory.

California to ban cosmetics and cosmetic ingredients tested on animals


Californian senators have voted for a piece of legislation to ban the sale of cosmetic products tested on animals or cosmetic products containing ingredients tested on animals from January 1, 2020. The bill, authored by Senator Cathleen Galgiani, was supported by the Physicians Committee for Responsible Medicine (PCRM) and Social Compassion in Legislation (SCIL). The state's assembly will make a final decision on the bill by the end of September.

Utrecht Advanced In Vitro Models (U-AIM) HUB inaugurated


The Utrecht Advanced In Vitro Models (U-AIM) was officially launched on May 16, 2018. The goal of U-AIM is to become a “one-stop shop” where high potential in vitro models are being developed, validated and transitioned to stakeholders. Through a strong cooperation between scientists, students, regulators and industry, U-AIM aims to strongly reduce animal experimentation and increase market potential of innovative models. The 3Rs-Centre ULS is directly involved in the U-AIM activities.

FDA final guidance on toxicokinetics studies reduces numbers of animals needed


In a May 10 Federal Register notice, the U.S. Food and Drug Administration (FDA) announced availability of final guidance on the benefits and limitations of the use of microsampling techniques in toxicokinetics studies. Benefits of these techniques include reducing the numbers of animals needed for these studies.

The Federal Register notice is available at All FDA guidance documents are available at

BfR awards fellowship to Malcolm Macleod


The German Federal Institute for Risk Assessment (BfR) has awarded the first Maria Sibylla Merian Fellowship to Malcolm Macleod for his contribution to improving animal welfare.

EPA requests comments on draft policy on skin sensitization testing


The U.S. Environmental Protection Agency has released a draft science policy to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation or sensitization of the skin. The draft policy is open for public comment until June 9, 2018.

NC3Rs awards 2017 International 3Rs Prize


The prize was awarded to Dr Elisa Passini and colleagues from the University of Oxford and Janssen Pharmaceutica for developing an in silico model to predict the potential of drugs to cause heart arrhythmia.

OECD launches QSAR Toolbox version 4.2.


The Toolbox is a software application intended to the use of governments, chemical industry and other stakeholders in filling gaps in (eco)toxicity data needed for assessing the hazards of chemicals. 

SOT announces award winners


Among the prizes to be awarded at the SOT this March, numerous prizes will be awarded for 3Rs related activities.

CERST to become state institute


The parliament of North Rhine Westphalia in Germany has increased the budget of the Centrum für Ersatzmethoden zum Tierversuch (CERST) and will make it a state institute.

Norecopa turns 10


Norway's 3R center and National Consensus Platform for the Replacement, Reduction and Refinement of animal experiments celebrates its anniversary.