Risk assessment׳s insensitive toxicity testing may cause it to fail

Buonsante, Vito; Muilerman, Hans; Santos, Tiago P.; Robinson, Claire; Tweedale, Anthony C.

doi:10.1016/j.envres.2014.07.016

Cited by 20 publications

(12 citation statements)

References 83 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Meanwhile, the EU and ECCC draft databases of chronic toxicity data show neither the same preference for sensitive organisms, nor the distortion in the shape of the SSD over time. These results do not support the notion that industry support of toxicity studies leads to a bias toward publishing insensitive data as was suggested in a recent review (Buonsante et al ). Nevertheless, these results do suggest that legitimate concerns about bias in published toxicity data are warranted.…”

Section: Discussioncontrasting

confidence: 87%

An analysis of potential bias in the sensitivity of toxicity data used to construct sensitivity distributions for copper

Croteau¹,

Santore²,

DeForest

et al. 2019

Integr Envir Assess & Manag

View full text Add to dashboard Cite

Since the mid‐1970s, thousands of studies have evaluated the toxicity of various chemicals to aquatic organisms. Results from many of these studies have been used to develop species sensitivity distributions (SSDs) or genus sensitivity distributions (GSDs) for deriving water quality guidelines. Recently, there has been more emphasis on evaluating the toxicity of chemicals to sensitive organisms rather than the entire range of sensitivities. The SSD approach is intended to inform the derivation of guidelines for the protection of all species, not just those that were included in the SSD. The overemphasis of the more sensitive end of the SSD can contribute to a skew in the observed distribution such that the shape of the distribution is distorted from what it would be if all species could be tested, which ultimately affects the derived guideline value. The freshwater acute Cu GSD derived by the US Environmental Protection Agency (USEPA) is one that exemplifies this trend, with one‐third of the genera in the GSD belonging to only 3 taxonomic families, all of which are nearer to the sensitive end of the distribution. The stronger representation of the more sensitive families does not seem to mirror the overall abundance of species within those families in nature. This tendency toward testing sensitive organisms is not seen in the chronic Cu SSD. In the present study, Cu toxicity literature is reviewed and long‐term trends in the availability of toxicity information for species of varying sensitivity are examined. As part of the present review, the apparent bias that favors the publication of toxicity data for sensitive taxa is demonstrated, and implications for the representativeness of SSDs and their use in developing water quality guidelines are discussed. Integr Environ Assess Manag 2019;00:000–000. © 2019 SETAC

show abstract

Section: Discussioncontrasting

confidence: 87%

An analysis of potential bias in the sensitivity of toxicity data used to construct sensitivity distributions for copper

Croteau¹,

Santore²,

DeForest

et al. 2019

Integr Envir Assess & Manag

View full text Add to dashboard Cite

show abstract

“…Compliance with guidelines and Good Laboratory Practice does not guarantee validity and relevance of the study design, statistical rigour and attention to sources of bias. 25 26 The majority of research after the initial marketing approval, including epidemiology studies, will be conducted in research laboratories using various models to address specific issues related to toxicity, often with no testing guidelines available. Peer-reviewed and published findings have great value in understanding mechanisms of carcinogenicity and should be given appropriate weight in an evaluation based on study quality, not just on compliance with guideline rules.…”

Section: Mechanistic Informationmentioning

confidence: 99%

Differences in the carcinogenic evaluation of glyphosate between the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA)

Portier¹,

Armstrong

Baguley

et al. 2016

J Epidemiol Community Health

151

View full text Add to dashboard Cite

“…The preference for GLP studies has led to marketing authorization dossiers which rely almost exclusively on contract laboratory data provided by the registrants, while excluding peer-reviewed studies from the scientific literature. This has been openly criticized [ 18 ], and several regulatory frameworks [ 1 , 5 , 6 , 8 ] have recently recommended to take all available information into account. This is important since hazard and risk assessments and the derivation of environmental quality criteria (EQC) or standards (EQS) for individual chemicals often suffer from limited data availability.…”

Section: Introductionmentioning

confidence: 99%

Criteria for Reporting and Evaluating ecotoxicity Data (CRED): comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies

et al. 2016

View full text Add to dashboard Cite

BackgroundThe regulatory evaluation of ecotoxicity studies for environmental risk and/or hazard assessment of chemicals is often performed using the method established by Klimisch and colleagues in 1997. The method was, at that time, an important step toward improved evaluation of study reliability, but lately it has been criticized for lack of detail and guidance, and for not ensuring sufficient consistency among risk assessors.Results A new evaluation method was thus developed: Criteria for Reporting and Evaluating ecotoxicity Data (CRED). The CRED evaluation method aims at strengthening consistency and transparency of hazard and risk assessment of chemicals by providing criteria and guidance for reliability and relevance evaluation of aquatic ecotoxicity studies. A two-phased ring test was conducted to compare and characterize the differences between the CRED and Klimisch evaluation methods. A total of 75 risk assessors from 12 countries participated. Results show that the CRED evaluation method provides a more detailed and transparent evaluation of reliability and relevance than the Klimisch method. Ring test participants perceived it to be less dependent on expert judgement, more accurate and consistent, and practical regarding the use of criteria and time needed for performing an evaluation.ConclusionsWe conclude that the CRED evaluation method is a suitable replacement for the Klimisch method, and that its use may contribute to an improved harmonization of hazard and risk assessments of chemicals across different regulatory frameworks.Electronic supplementary materialThe online version of this article (doi:10.1186/s12302-016-0073-x) contains supplementary material, which is available to authorized users.

show abstract

Risk assessment׳s insensitive toxicity testing may cause it to fail

Abstract: There are abundant modern experimental methods (and rigorous epidemiology), and an existing systematic review system, to at long last allow academia's toxicity studies to be used in most risk assessments.

Cited by 20 publications

References 83 publications

An analysis of potential bias in the sensitivity of toxicity data used to construct sensitivity distributions for copper

An analysis of potential bias in the sensitivity of toxicity data used to construct sensitivity distributions for copper

Differences in the carcinogenic evaluation of glyphosate between the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA)

Criteria for Reporting and Evaluating ecotoxicity Data (CRED): comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies

Contact Info

Product

Resources

About