Refining tools to bridge the gap between academia and chemical regulation: perspectives for WikiREACH

Abstract

Regulatory hazard and risk assessments of chemical substances have to include all reliable and relevant data to be credible and complete. However, screening the literature for appropriate studies and extracting data is burdensome. Therefore, reducing impediments by making data easily and readily accessible to risk assessors could result in more comprehensive hazard and risk assessments. In this paper, we study WikiPharma, a database that aggregates ecotoxicity data for pharmaceuticals, extracted from peerreviewed studies. The use of the WikiPharma database is explored to develop strategies on how similar tools can bridge between science and policy by providing risk assessors with easily accessible summary data. Specifically, adapting the concept of WikiPharma to industrial chemicals regulated under the REACH regulation is discussed. Experiences with WikiPharma show that there is interest in using peerreviewed studies in regulatory decision-making. However, tools like WikiPharma require constant updates. Hence, as for "WikiREACH", effective incentives are needed to motivate researchers to feed in relevant data for regulatory assessments. Besides, support by automated processes can aid in the labourintensive activity of gathering data. To ensure that such a tool is continuously maintained and compatible with the regulatory system, and thereby useful for hazard and risk assessments of chemicals, it would benefit from being developed in collaboration with the major stakeholders in the field, i.e. regulatory agencies, academia, industry, scientific journals, and providers of research network platforms. Environmental signicanceThis paper addresses how scientic research is (not) used in decision-making, focusing on peer-reviewed toxicity and ecotoxicity studies for regulatory assessments of chemicals. One possible reason for the overall low regulatory use of peer-reviewed studies is that the process of searching for studies is resource demanding. As a consequence, regulatory decisions are not based on all available information. This paper suggests the development of a tool that can facilitate the use of peer-reviewed studies in the REACH context ("WikiREACH"), based on experiences from the use and development of the WikiPharma database for ecotoxicity studies for pharmaceuticals. Creating equivalent tools for other groups of chemicals is possible and an important way forward.

Pharmaceuticals and Environment: a web-based decision support for considering environmental aspects of medicines in use

“…In order to be an adequate tool for risk assessors and decision-makers, a database needs to provide accurate, updated, and easily accessible information that is adapted for the intended users [ 15 ]. There are other databases with the purpose of communicating research results and environmental information, thereby facilitating decision-making.…”

“…The European Medicines Agency (EMA) provides environmental risk assessments for medicinal products approved after 2006 in the European Public Assessment Reports (EPARs) at EMA’s website [ 17 ]. The WikiPharma database and the NORMAN Ecotoxicology Database both provide ecotoxicity data [ 15 , 18 ]. The WikiPharma database was one of the outcomes of the Swedish MistraPharma research program during 2008–2015 which generated new data, e.g., identified pharmaceutical substances that pose risks in the aquatic environment, and issued recommendations for improved environmental risk assessments of human pharmaceuticals [ 19 ].…”

Coral Ecotoxicological Data Evaluation for the Environmental Safety Assessment of Ultraviolet Filters

“…The CPCP ERA, in an effort to reduce duplication of environmental data, will consider both peer‐reviewed and standardized data required by regulatory authorities, which is aligned with efforts to include all relevant information within ERA frameworks in the United States (USEPA, 2011 ) and Europe (ECHA, 2008 ). Ecotoxicity data published in the peer‐reviewed literature often capture endpoints, species, or taxa outside standardized testing protocols that can provide useful and ecologically sensitive information that could otherwise be missed (Ågerstrand et al, 2017a ). Including nonstandard data from peer‐reviewed literature also maximizes the utility of often publicly funded research, which is also aligned with industry's ethical commitment to the three “R's” of animal testing (reduction, refinement, and replacement) and potentially enhances the credibility of ERA among the public, retailers, regulators, and policy‐makers (Mebane et al, 2019 ).…”