Note: As of 2022, the former Animal Alternatives in ERA and Bioaccumulation Committees have merged to form the Next Generation ERA Committee
To ensure the development of a sound technical basis for alternative test methods as a means to reduce, refine, or replace standard ecotoxicity test procedures around the globe.
The committee aims to provide a forum to coordinate the debates and best emerging practices of the alternatives and animal model development sciences to meet existing hazard assessment, effluent assessment, risk assessment, classification and labeling, and other regulatory needs.
This group is tasked with developing a strategy to update and augment the EnviroTox database (https://envirotoxdatabase.org) and refine and further develop applicable tools. Ongoing work is focused on development of case studies and updating/augmenting the database. Recent efforts have focused on developing manuscripts to describe and document the approaches and tools within EnviroTox, including a focus on algal acute to chronic ratios as well as PNECs.
Plans for a 2020 meeting with key stakeholders to help develop a comprehensive testing and evaluation plan for effluent NAMs were put on hold due to COVID-19. However, work will progress in 2021 related to sharing of information and development of a template to collect existing effluent information, with plans for an in-person meeting when travel allows. An overview of the research proposal that was developed in 2019 was presented at the 2020 SETAC Europe Virtual Annual Meeting and discussions are ongoing to identify additional funding to support (and potentially expand) the research project.
This team, a collaboration between HESI and NC3Rs, is assessing available in vitro/in silico methods (new approach methodologies [NAMs]) to evaluate chemicals that may act via an endocrine pathway in fish and amphibians.
This team, a collaboration between HESI and NC3Rs, is evaluating current in vivo EDC tests in fish and amphibians, focusing on analysis of historical control data. This will involve several efforts related to analysis and communication of available in vivo information. The overall purpose is to provide a foundation upon which new alternative methods will be evaluated and to critically assess existing in vivo test methods.
This group is developing a manuscript based on the output and critical discussions from the February 2020 workshop.
The initial work of this committee focused on the development and scientific issues surrounding the fish embryo test (FET) as an animal alternative. While accepted as an Organization for Economic Cooperation and Development (OECD) guideline, uptake and use in regulatory assessments has been hampered due to a lack of interpretational guidance. A new initiative to develop qualitative and quantitative weight-of-evidence frameworks for assessment of acute fish toxicity using a wide range of lines of evidence is proposed. A working group, led by Dr. Adam Lillicrap (NIVA), successfully received European Chemical Industry Council Long-Range Initiative (CEFIC-LRI) funding (€250,000 for 2 years) to develop a Bayesian network model with collaboration from HESI and committee members. The kick-off meeting for the project was held in Spring 2020, and work is underway. HESI will receive a total of $20,000 to support staff time on this project over the next 2 years.
Deputy Director
Director, Center for Environmental and Ecological Health (CEEH)
membry@hesiglobal.orgMichelle Embry received her PhD in Toxicology in 2004 and her BS in Biology and Environmental Science and Policy in 1998 from Duke University. She is currently the Deputy Director of Environmental Science at HESI, where she provides leadership, technical direction, and guidance to varied, multi-stakeholder, collaborative committees on topics related to risk assessment and environmental protection worldwide.
Prior to joining HESI in 2006, Dr. Embry worked as an Ecological Risk Assessor at the US EPA’s Office of Pesticide Programs. She has expertise in both human health and ecotoxicology, with an emphasis on integrated approaches and alternative methods. Her current project portfolio includes the Animal Alternatives in Environmental Risk Assessment Committee and the Development of Methods for a Tiered Approach to Assess Bioaccumulation of Chemicals Committee, two of HESI’s projects aimed at improving ecological risk assessment. Dr. Embry’s work also includes the Risk Assessment in the 21st Century (RISK21) Committee, which developed a scientific, transparent, and efficient approach for human health risk assessment, including a web-based tool that has led to outreach and training activities on risk assessment approaches worldwide. In addition, she works with HESI staff and partners on project development related to chemical risk assessment issues.
Dr. Embry is an elected member of the SETAC North America Board of Directors (2014 to present), chair of the SETAC Global Partners Advisory Committee, and a member of the SETAC Bioaccumulation and Animal Alternatives Advisory Group Steering Teams. She is a full member of the Society of Toxicology (SOT) and a member of the SOT Risk Assessment and Mixtures Specialty Sections. She was a member of the ECETOC Task Force on Information to be Considered in a Weight-of-Evidence-Based PBT/vPvB Assessment of Chemicals (Annex XIII of REACH) in 2013 to 2014 and was a steering team member of the SETAC Adverse Outcome Pathway (AOP) Pellston Workshop (Spring 2017). Dr. Embry is also one of the founding partners on the “eco data hub” initiative, started in Fall 2016.
Connie Mitchell is a Senior Scientific Program Manager at HESI. Prior to joining HESI in early 2020, she was an ORISE Fellow at the US Environmental Protection Agency working on chemical prioritization under the Toxic Substances Control Act. She completed her graduate studies in Environmental Toxicology at the University of California Riverside. There she investigated flame retardant-induced developmental toxicity. As a Senior Scientific Program Manager, she provides scientific, strategic, and management support to collaborative scientific committees involving academic, government, nonprofit, and private sector scientists. She manages the Emerging Systems Toxicology for Assessment of Risk (eSTAR) Committee, Next Generation Ecological Risk Assessment Committee (Eco-Risk), and the Botanical Safety Consortium (BSC).
Environment and Climate Change Canada
Procter & Gamble Company
Shell Global Solutions
Texas Christian University
L'Oreal Corporation
Norwegian Institute for Water Research (NIVA)
Dr. Adam Lillicrap is the Research Manager for the section of Ecotoxicology and Risk Assessment which employs 24 dedicated research scientists and several PhD students and post-Doctoral scientists. He is also NIVA’s GLP Manager and has been project managing and study directing regulatory ecotoxicity tests according to Good Laboratory Practice (GLP) for over 20 years. Adam is a EUROTOX Registered Toxicologist (ERT) and is involved in numerous international committees and expert working groups. Adam is the Norwegian representative at the OECD validation management group for ecotoxicity test methods (VMGEco). Adam is also the Norwegian expert for fish within the OECD and the Norwegian representative for ISO Water Quality test standards. Adam has been working with zebrafish embryos for ecotoxicity assessments for over 20 years and was an industry nominated expert to the OECD regarding the implementation of the Fish Embryo Toxicity (FET) test guideline. Subsequently, Adam was elected as an independent advisor for the validation management group of the ring trial of the FET test. Over the years, Adam has been very active in the field of animal alternatives for ecotoxicity testing, chairing many sessions at SETAC and currently chairs the SETAC global animal alternatives interest group. He has been actively promoting the use of alternative methods for hazard assessments of chemicals at a regulatory level and was the project lead for the newly adopted ISO standard and OECD test guideline for a cytotoxicity assay (RT-gill W1 cell line). Adam was also the chairperson for the Cefic LRi Research Liaison Team for the project CELLSens and is currently leading the Cefic LRi project (ECO 51) entitled Strengthening Weight of evidence for FET data to replace acute Fish Toxicity (SWiFT). Adam was also the coordinator for a JPI Oceans Knowledge Hub for contaminants of emerging concern in the marine environment. Adam has a thorough understanding of the regulatory complexities regarding the adoption of alternative test methods and the need for a weight of evidence approach to gain regulatory acceptance. Adams main interests involve understanding how chemicals are regulated within an environmental context, and how to influence policy making decisions for regulatory frameworks.
US Environmental Protection Agency
Middle Tennessee State University
Swiss Federal Institute of Aquatic Science and Technology (Eawag)
Sanofi
Integrated Environmental Assessment and Management, 2021
Many regulations are beginning to explicitly require investigation of a chemical's endocrine disrupting properties as a part of the safety assessment process, for substances already on or about to be placed on the market. Different jurisdictions are applying distinct approaches. However, all share a common theme requiring ...
Regulatory Toxicology and Pharmacology, 2021
Derivation of Predicted No Effect Concentrations (PNECs) for aquatic systems is the primary deterministic form of hazard extrapolation used in environmental risk assessment. Depending on the data availability, different regulatory jurisdictions apply application factors (AFs) to the most sensitive measured endpoint to ...
Frontiers in Toxicology, 2021
The ecological threshold of toxicological concern (ecoTTC) is analogous to traditional human health-based TTCs but with derivation and application to ecological species. An ecoTTC is computed from the probability distribution of predicted no effect concentrations (PNECs) derived from either chronic or extrapolated acute ...
Chemosphere, 2021
Algal toxicity studies are required by regulatory agencies for a variety of purposes including classification and labeling and environmental risk assessment of chemicals. Algae are also frequently the most sensitive taxonomic group tested. Acute to chronic ratios (ACRs) have been challenging to derive for algal species ...
Science of the Total Environment, 2019
There is growing evidence that single substances present below their individual thresholds of effect may still contribute to combined effects. Here, the possible use of ecotoxicological threshold concentrations of no concern (i.e. 5th percentile of statistical distribution of ecotoxicological values) is investigated to ...
Environmental Toxicology and Chemistry, 2019
Multiple modes of action (MOA) frameworks have been developed in aquatic ecotoxicology, mainly based on fish toxicity. These frameworks provide information on a key determinant of chemical toxicity, but the MOA categories and level of specificity remain unique to each of the classification schemes. This study aimed to develop a ...
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