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Improving the Environmental Risk Assessment of Substances of Unknown or Variable Composition, Complex Reaction Products, or Biological Materials
Author(s) -
Salvito Daniel,
Fernandez Marc,
Jenner Karen,
Lyon Delina Y.,
Knecht Joop,
Mayer Philipp,
MacLeod Matthew,
Eisenreich Karen,
Leonards Pim,
Cesnaitis Romanas,
LeónPaumen Miriam,
Embry Michelle,
Déglin Sandrine E.
Publication year - 2020
Publication title -
environmental toxicology and chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.1
H-Index - 171
eISSN - 1552-8618
pISSN - 0730-7268
DOI - 10.1002/etc.4846
Subject(s) - environmental risk assessment , risk assessment , government (linguistics) , risk analysis (engineering) , environmental toxicology , computer science , hazard , process (computing) , biochemical engineering , variable (mathematics) , industrial ecology , hazard analysis , management science , business , engineering , chemistry , ecology , biology , toxicity , mathematics , mathematical analysis , philosophy , linguistics , computer security , organic chemistry , sustainability , aerospace engineering , operating system
Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs) pose unique risk assessment challenges to regulators and to product registrants. These substances can contain many constituents, sometimes partially unknown and/or variable, depending on fluctuations in their source material and/or manufacturing process. International regulatory agencies have highlighted the difficulties in characterizing UVCBs and assessing their toxicity and environmental fate. Several industrial sectors have attempted to address these issues by developing frameworks and characterization methods. Based on the output of a 2016 workshop, this critical review examines current practices for UVCB risk assessment and reveals a need for a multipronged and transparent approach integrating whole‐substance and constituent‐based information. In silico tools or empirical measurements can provide information on discrete and/or blocks of UVCB constituents with similar hazard properties. Read‐across and/or whole‐substance toxicity and fate testing using adapted emerging methods can provide whole‐substance information. Continued collaboration of stakeholders representing government, industry, and academia will facilitate the development of practical testing strategies and guidelines for addressing regulatory requirements for UVCBs. Environ Toxicol Chem 2020;39:2097–2108. © 2020 Health and Environmental Sciences Institute. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.