|
|
|
Roadmaps, Strategic plans |
| In vitro, in silico, in chemico |
Industrial chemical, Household products
Pesticides |
US / EPA OPPT; EPA OPP |
Interim science policy: use of alternative approaches for skin sensitization as a replacement for laboratory animal testing ([b@349582]a) |
| IVIVE, AOP, IATA, DA, In vitro, In Chemico, In silico, RA |
Industrial chemical, Household products |
US / EPA OPPT |
Strategic plan to promote the development and implementation of alternative test methods within the TSCA program EPA ([b@349582]b) |
| In vitro, RA, |
Industrial chemical, Household products |
US / EPA |
New approach methods work plan, reducing use of animals in chemical testing EPA (US EPA, 2021b) |
|
Industrial chemical, Household products |
Canada / HC HECSB |
Fact sheet series: Topics in risk assessment of substances under CEPA (Health Canada, 2023) |
| In silico, In vitro, In chemico, RA, omics |
Industrial chemical, Household products |
Canada / HC HECSB; HC PMRA |
Canadian regulatory perspective on next generation risk assessments for pest control products and industrial chemicals [@354300] |
| RA, WoE, In silico, In vitro |
Industrial chemicals |
ECHA |
4th report on the use of alternatives to testing on animals for REACH [@349449] |
| In vitro, In chemico, DA |
Pesticides |
US/EPA OPP |
Process for evaluating & implementing alternative approaches to traditional in vivo acute toxicity studies for FIFRA regulatory use (US EPA, 2016b) |
| In vitro, in chemico |
All |
US / ICCVAM |
Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies - A Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Validation Workgroup (VWG) March 2024 [@349486] |
| OoC |
All |
Europe |
ORCHID project (Organ-on-Chip development) - a roadmap for organ-on-chip technology [@349513; @349512] |
| General |
Pesticides |
Europe / EFSA |
Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment [@349456] |
| Organ - on - a chip |
All |
Europe / JRC |
Organ on-chip roadmap towards standardisation [@349495] |
| Machine learning |
All |
Europe / EFSA |
Machine Learning Techniques applied in risk assessment related to food safety [@349455] |
| General |
All |
US/ ICCVAM |
A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States |
| Exposure |
|
Europe |
The European exposure science strategy 2020–2030 |
| General |
All |
Europe / EFSA |
Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment [@349463] |
|
|
|
Frameworks / Guidance documents accepted by regulatory bodies |
| Read - Across |
Industrial chemicals |
ECHA |
Read-Across Assessment Framework (RAAF) [@349448] |
| In vitro |
Pesticides |
US /EPA OPP |
Use of an alternate testing framework for classification of eye irritation potential of EPA pesticide products (US EPA, 2015) |
|
Pesticides |
US / EPA OPP; Canada / HC PMRA |
ReCAAP: A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays (Hilton et al., 2022) |
| QSAR models |
All |
International/ OECD |
(Q)SAR Assessment Framework: Guidance No. 386 for the regulatory assessment of (Quantitative) Structure - Activity Relationship models, predictions, and results based on multiple predictions [@349544] |
| Omics |
All |
International / OECD |
Omics Reporting Framework (OORF): Guidance No. 390 on reporting elements for the regulatory use of omics data from laboratory-based toxicology studies |
| PBK |
All |
International / US EPA; FDA and JRC |
Reporting template from drugs expanded to environmental chemicals- PBPK model reporting template for chemical risk assessment applications [@349578] |
| In vitro, in silico, in chemico |
Industrial chemical, Household products |
US / CPSC |
Guidance on Alternative Test Methods and Integrated Testing Approaches (CPSC, 2022) |
| QSAR models |
All |
International/ OECD |
Guidance document No 69 on the validation of (Quantitative) Structure-Activity relationships [(Q)SAR] models [@349528] |
| PBK models |
All |
International/ OECD |
Guidance document No. 331 on the characterisation, validation and reporting of Physiologically Based Kinetic (PBK) models for regulatory purposes [@349541] |
| In vitro, in chemico |
All |
International / OECD |
Guidance Document No. 286 on Good In Vitro Method Practices (GIVIMP), OECD Series on Testing and Assessment [@349535] |
| In vitro, in chemico |
All |
International / OECD |
Guidance Document No. 211 for Describing Non-Guideline In Vitro Test Methods, OECD Series on Testing and Assessment [@349531] |
| DA |
All |
International / OECD |
Guidance Document No. 255 on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment [@349534] |
| IATA, AOP |
All |
International / OECD |
Guidance Document No. 260 for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) [@349532] |
|
Pesticides |
US / EPA OPP |
Guidance for waiving or bridging of acute (US EPA, 2012, 2016a, 2020) and repeat dose (US EPA, 2012) toxicity tests
for pesticides (for formulations and single-active ingredients) |
|
Pesticides |
Canada / HC PMRA |
Guidance for waiving or bridging of mammalian acute toxicity tests for pesticides (Health Canada, 2013); Acute Dermal Toxicity Study Waiver (Health Canada, 2017) |
| In silico, In vitro, RA |
Pesticides |
Europe / EFSA |
Guidance on dermal absorption [@349455] |
| PBK models |
All |
International / OECD |
Characterisation and application of physiologically based pharmacokinetic models in risk assessment [@349593] |
| Read - Across |
All |
International / OECD |
Guidance Document No. 194 on Grouping of Chemicals, Second Edition [@349534] |
| IATA |
all |
International/OECD |
Guidance Document No. 255 onon the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment [@349533] |
| All |
Cosmetics |
EU / SCCS |
The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 12th revision |
| Omics |
All |
Europe |
GLP for omics - Framework for the quality assurance of omics technologies considering GLP requirements [@349496] |
| WoE |
All |
International / OECD |
Guidance document No. 311 on the Guiding Principles and Key Elements for Establishing a Weight of Evidence for Chemical Assessment [@349537] |
|
|
|
List of Alternative Test Methods |
| In vitro |
Industrial chemical, Household products |
US / EPA O
PPT |
List of alternative test methods and strategies (or new approach methodologies [NAMs]), Second update: 4 February 2021 (US EPA, 2021a) |
| In vitro, In chemico |
All |
Europe / EURL ECVAM |
TSAR - Tracking System for Alternative methods towards Regulatory acceptance Overview of non-animal methods that have been proposed for regulatory safety or efficacy testing of chemicals or biological
Agents (EURL ECVAM, n.d.) |
| In vitro, In chemico, In silico, Waiving |
All |
US / NTP, NICEATM |
List of alternative methods accepted by US Agencies [@349524] |
| In vitro, In chemico, In silico |
All |
Japan / JaCVAM |
List of alternative test methods endorsed by JaCVAM for regulatory uses [@349488; @349489] |
| In vitro, In chemico |
All |
Korea / KoCVAM |
List of test guidelines for alternative test methods in Korea [@349501] |
|
|
|
Project/Initiative, Other documents |
| General |
drugs, chemicals |
Europe |
EU-ToxRisk – An Integrated European ‘Flagship’ Programme Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st century - https://eu-toxrisk.eu |
| General |
All |
Europe |
Next-generation risk assessment of chemicals – Rolling out a human-centric testing strategy to drive 3R implementation: The RISK-HUNT3R project perspective - https://www.risk-hunt3r.eu/ |
| General |
contaminants, chemicals, drugs |
Europe |
Euromix - A tiered strategy for risk assessment of mixtures of multiples chemicals - https://www.euromixproject.eu/index.html |
| TK, IVIVE PBPK |
food/feed improvement compounds, drugs |
Europe / EFSA |
EFSA - TK plate [@349594] |
| TK, IVIVE PBPK |
chemicals, food/feed improvement compounds, |
Europe |
Neurosome and HBM4EU [@349432] |
| General |
All |
Europe |
ONTOX - https://ontox-project.eu/project |
| General |
All |
Europe |
EHEN cluster -The European Human Exposome Network is the world’s largest network of projects studying the impact of environmental exposure on human health - https://www.humanexposome.eu/ |
| General |
All |
International |
PARC - Partnership for the Assessment of Risks from Chemicals aims to support risk assessors and risk managers to respond to current and future challenges, the PARC aims to stimulate research and innovation in chemicals risk assessment by developing a collaborative network with public research entities - https://www.eu-parc.eu/ |
| General |
All |
US / EPA |
APCRA - Accelerating the Pace of Chemical Risk Assessment is an international government-to-government initiative whose aim to promote collaboration and dialogue on the scientific and regulatory needs for the application and acceptance of NAMs in regulatory decision making - https://www.epa.gov/chemical-research/accelerating-pace-chemical-risk-assessment-apcra |
| General |
All |
Europe |
ASPIS Cluster - joint collaboration of the H2020 funded projects ONTOX, PrecisionTOX, RISK-HUNT3R and JRC and represents Europe’s effort towards the sustainable, animal-free and reliable chemical risk assessment of tomorrow - https://aspis-cluster.eu/ |
| General |
Cosmetics |
International |
ICCR - International Cooperation on Cosmetics Regulation voluntary international group of cosmetics regulatory authorities from Brazil, Canada, Chinese Taipei, the European Union, Israel, Japan, Republic of Korea, and the United States who meet on an annual basis to discuss cosmetics safety and regulation, as well as enter into a constructive dialogue with relevant cosmetics industry trade associations - https://www.iccr-cosmetics.org/ |
| General |
All |
US / NICETAM |
ICE - Integrated Chemical Environment addresses the data needs frequently expressed by NICEATM stakeholders and provides high-quality curated data and appropriate tools to support development and evaluation of new, revised, and alternative methods - https://ice.ntp.niehs.nih.gov/ |
| In vitro bioactivity |
Industrial chemicals Household products |
Canada / HC HECSB |
Science approach document - Bioactivity exposure ratio: Application in priority setting and risk assessment (Health Canada, 2021) |
|
Industrial chemicals |
ECHA |
How to use alternatives to animal testing to fulfil the information requirements for REACH registration ECHA (ECHA, 2016) |
|
|
Europe / EFSA |
Advancing human health risk assessment (Lanzoni et al., 2019) |
| In vitro, In chemico |
Pesticides |
Europe / EFSA |
Development of IATA case studies on DNT risk assessment (EFSA Panel on Plant Protection Products and their Residues (EFSA PPR Panel et al., 2021) |
| IATA |
All |
International/OECD |
Develop IATAs for complex endpoints together with reporting and assessment strategies. Several relevant endpoints e.g. DNT, systemic toxicity, read-across (https://www.oecd.org/chemicalsafety/risk-assessment/iata/) |
| RAx |
All |
International |
EU-ToxRisk advisory document describing the different assessment steps of a read-across approach enriched with NAM data. NAMs to support RAx with regard to toxikodynamic and kinetic properties [@349562] |