A new quality assurance system for the evaluation of ecotoxicity studies submitted under the new substances notification regulations in Canada

Abstract

New substances destined for import into, or manufacture in, Canada must be reported to Environment Canada and Health Canada under the New Substances Notification Regulations (Chemicals and Polymers) (NSNR). With the use of information provided by the notifier, and other complementary information available to the 2 departments, the New Substances Program conducts ecological and human health risk assessments. Over the past 10 y, more than 750 ecotoxicity studies have been submitted to the New Substances Program of Environment Canada under the NSNR. Most of these experimental studies are not publicly available but are useful in the ecological risk assessment of new substances and for the development of Quantitative Structure-Activity Relationships (QSARs). In this paper, we describe the development and validation of a computer-based scoring system and our approach in the development of scoring methods used to assess the quality and usability of ecotoxicity studies with fish, Daphnia spp., and green algae. Results of ranking exercises conducted with these methods are described and discussed, together with the potential use of these results in a regulatory context. In addition, the methods are discussed in comparison with other similar evaluation schemes described in the literature.

Integrated Testing Strategy (ITS) – Opportunities to better use existing data and guide future testing in toxicology

“…this has recently been recognized, and first attempts toward an objective assessment have been put forward (Schneider et al, 2009;Hulzebos and Gerner, 2010;Jaworska et al, 2010a). Interestingly, similar developments are taking place in ecotoxicity (Hobbs et al, 2005;Breton et al, 2009). …”

Assessing the reliability of ecotoxicological studies: An overview of current needs and approaches

“…Where applicable, special attention was directed to the applicability of these attributes to WoE. Some of these methods include a tiered approach that consists of first identifying publications or studies for review to be put into a data set (USEPA ; Beasley et al ) and then performing relevance and reliability assessments (Klimisch et al ; USEPA ; Van Der Kraak et al ; Beasley et al ; Moermond et al ), whereas other methods focus only on reliability assessment (e.g., Durda and Preziosi ; Hobbs et al ; Breton et al ; Schneider et al ). For the purpose of this comparison, we focused only on the differences regarding assessment of reliability.…”

“…Several methods have been tested on case studies, either internally (Durda and Preziosi ; Breton et al ; Van Der Kraak et al ; Beasley et al ) or using an external “round‐robin” or ring test assessment. For example, the method presented by Hobbs et al () was tested using 2 studies and 23 participants, whereas a round‐robin test of the CRED method by Moermond et al () used 8 studies and 75 participants (Kase et al, ).…”

Assessment of PBTs in the European Union: a critical assessment of the proposed evaluation scheme with reference to plant protection products

“…An internationally accepted procedure was proposed by Klimisch et al [30], and similar guidelines are used in other jurisdictions [31]. The procedure classifies data from the literature in four categories: reliable without restrictions, reliable with restriction, not reliable, and not assignable.…”