Environmental Footprint: Update of Life Cycle Impact Assessment methods – Ecotoxicity freshwater, human toxicity cancer, and non-cancer

In 2011 the EC-JRC published the International Reference Life Cycle Data System (ILCD) Handbook recommendations on the use of Impact Assessment models for use in LCA (EC-JRC 2011a). This created the basis for the Product and Organisation Environmental Footprint (PEF/OEF) recommendations for impact categories and models as per Recommendation 2013/179/EU on the use of common methods to measure and communicate the life cycle environmental performance of products and organisations (EC 2013a). This Commission Recommendation is expected to contribute to the Building the Single Market for Green Products (EC 2013b) by supporting a level playing field regarding the measurement of environmental performance of products and organisations. In the context of the PEF, the model retained and recommended for assessing the impact of elementary flows on freshwater aquatic ecosystems and human cancer and non-cancer toxicity was the model USEtox 1.01. However, due to the difficulties encountered in using the model and in interpretation the results, the PEF Technical Advisory Board (TAB) has decided not to include the freshwater aquatic toxicity, human cancer and human non-cancer toxicity impact categories in the list of mandatory impact categories to be used for hotspot analysis and for communication to consumer of to business. The Joint Research Centre (JRC-Ispra) was then mandated by DG environment to conduct an in-depth evaluation of the model and data used to calculate CFs and to come with a proposal to 1) address the issue reported by the Pilots and 2) increase the number of available CFs. Using the physicochemical and toxicity data available in the REACH, EFSA and PPDB database, and building on the feedback collected during a PEF stakeholder workshop organised in February 2018 and on the preliminary outcomes of the UNEP-SETAC Pellston workshop organised in June 2018, JRC has new aquatic toxicity characterisation factors for about 6000 substances and about 3500 for human toxicity non-cancer. The report describes the methodology followed to generate those new characterisation factors. Furthermore, a contribution analysis has been performed comparing the contribution to this new CFs versus old ones used in the PEF pilots.JRC.D.1 - Bio-econom

Development and Validation of a Risk Score for Chronic Kidney Disease in HIV Infection Using Prospective Cohort Data from the D:A:D Study

Ristola M. on työryhmien DAD Study Grp ; Royal Free Hosp Clin Cohort ; INSIGHT Study Grp ; SMART Study Grp ; ESPRIT Study Grp jäsen.Background Chronic kidney disease (CKD) is a major health issue for HIV-positive individuals, associated with increased morbidity and mortality. Development and implementation of a risk score model for CKD would allow comparison of the risks and benefits of adding potentially nephrotoxic antiretrovirals to a treatment regimen and would identify those at greatest risk of CKD. The aims of this study were to develop a simple, externally validated, and widely applicable long-term risk score model for CKD in HIV-positive individuals that can guide decision making in clinical practice. Methods and Findings A total of 17,954 HIV-positive individuals from the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study with >= 3 estimated glomerular filtration rate (eGFR) values after 1 January 2004 were included. Baseline was defined as the first eGFR > 60 ml/min/1.73 m2 after 1 January 2004; individuals with exposure to tenofovir, atazanavir, atazanavir/ritonavir, lopinavir/ritonavir, other boosted protease inhibitors before baseline were excluded. CKD was defined as confirmed (>3 mo apart) eGFR In the D:A:D study, 641 individuals developed CKD during 103,185 person-years of follow-up (PYFU; incidence 6.2/1,000 PYFU, 95% CI 5.7-6.7; median follow-up 6.1 y, range 0.3-9.1 y). Older age, intravenous drug use, hepatitis C coinfection, lower baseline eGFR, female gender, lower CD4 count nadir, hypertension, diabetes, and cardiovascular disease (CVD) predicted CKD. The adjusted incidence rate ratios of these nine categorical variables were scaled and summed to create the risk score. The median risk score at baseline was -2 (interquartile range -4 to 2). There was a 1: 393 chance of developing CKD in the next 5 y in the low risk group (risk score = 5, 505 events), respectively. Number needed to harm (NNTH) at 5 y when starting unboosted atazanavir or lopinavir/ritonavir among those with a low risk score was 1,702 (95% CI 1,166-3,367); NNTH was 202 (95% CI 159-278) and 21 (95% CI 19-23), respectively, for those with a medium and high risk score. NNTH was 739 (95% CI 506-1462), 88 (95% CI 69-121), and 9 (95% CI 8-10) for those with a low, medium, and high risk score, respectively, starting tenofovir, atazanavir/ritonavir, or another boosted protease inhibitor. The Royal Free Hospital Clinic Cohort included 2,548 individuals, of whom 94 individuals developed CKD (3.7%) during 18,376 PYFU (median follow-up 7.4 y, range 0.3-12.7 y). Of 2,013 individuals included from the SMART/ESPRIT control arms, 32 individuals developed CKD (1.6%) during 8,452 PYFU (median follow-up 4.1 y, range 0.6-8.1 y). External validation showed that the risk score predicted well in these cohorts. Limitations of this study included limited data on race and no information on proteinuria. Conclusions Both traditional and HIV-related risk factors were predictive of CKD. These factors were used to develop a risk score for CKD in HIV infection, externally validated, that has direct clinical relevance for patients and clinicians to weigh the benefits of certain antiretrovirals against the risk of CKD and to identify those at greatest risk of CKD.Peer reviewe

Comparing options for deriving chemical ecotoxicity hazard values for the European Union Environmental Footprint, Part II

The EU Commission published in 2013 a recommendation on the use of a common method to measure and communicate the life cycle environmental performance of products and organizations. In November 2013, started a four years pilot exercise with industries, NGOs, and academia to assess the effectiveness of the method on 25 product categories. One of the impact categories in the environmental footprint pilot program, freshwater ecotoxicity, was identified for improvement by, among other points, increasing the number of chemicals for which an aquatic toxicity indicator is available. For this work, we used ecotoxicity data (54,353 test data points) extracted from the REACH ecotoxicity database and compared multiple approaches to calculate final substance toxicity indicator (e.g. hazard values): the USEtox® approach, using only acute EC50 equivalent data, and using only chronic NOEC equivalent data. The species sensitivity distribution at 10, 20 and 50% potential affected fraction (PAF) of species were evaluated. Using REACH ecotoxicity database, 3845, 4853 and 5560 hazard values could be calculated for the USEtox® model, following an acute only and chronic only approaches, respectively. The USEtox® approach provides hazard values similar to the ones based on acute EC50 data only. While there is a large amount of variability in the ratios, the data support acuteEC50eq to Chronic NOECeq ratios (calculated as geometric mean) of 10.64, 10.90 and 4.21 for fish, crustacean and algae respectively. Comparison of the calculated hazard values with the criteria used by the EU chemical classification, labelling and packaging regulation (CLP) shows the USEtox® method underestimates the number of compounds categorized as very toxic to aquatic life and/or having long lasting effects. In contrast, use of the chronic NOEC data shows a good agreement with CLP. The selection procedure applied on the original REACH database led to the exclusion of 83% of the available ecotoxicity data (not meeting minimum quality requirements) and to a final database where > 98% of the chemicals have only three of less ecotoxicity valuesJRC.D.1-Bio-econom

Using REACH for the EU Environmental Footprint: building a usable ecotoxicity database, Part I

The European Union Environmental Footprint (EU‐EF) is a harmonized method to measure and communicate the life cycle environmental performance of products and organizations. Among 16 different impact categories included in the EU‐EF, 1 focuses on the impact of substances on freshwater ecosystems and requires the use of toxicity data. This paper evaluates the use of the aquatic toxicity data submitted to the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.It presents an automated computerized approachfor selecting substance ecotoxicity values, building on a set of quality and reliability criteria to extract the most relevant data points for calculating the substance specific hazard values. A selected set of criteria led to the exclusion of approximately 82% of the original REACH ecotoxicological data available as of May 2015 due to incomplete initial encoding of the data by the REACH registrant, missing information such as duration of exposure, endpoint measured, species tested, and imprecise toxicity values (i.e., reported with greater than or less than signs). From an initial set of 305068 ecotoxicity data records available in the REACH database, the final usable database contains 54 353 toxicityrecords (29421 characterized asacute and 24941 aschronic)covering 9 taxonomic groups,withalgae, crustaceans, and fish representing 93% of the data. This data set is valuable for assessing the environmental toxicity of the substance contained whether through traditional substance risk assessment, product toxicity labeling, life cycle assessment (LCA) or environmental impact assessment approaches. However, the resulting loss of approximately 82% of the data suggests that changes in procedures used to generate, report, and document the data within REACH are needed to improve data utility for the various assessment approaches. The rules used to select the data to be used are the primary focus of this article. Integr Environ Assess Manag 2019;15:783–795. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC)JRC.D.1-Bio-econom