IVLs arbete som tredjepartsgranskare av miljöinformationen på ww.fass.se. av Jörgen Magnér (PhD in Applied Environmental Science)

Transkript

1 IVLs arbete som tredjepartsgranskare av miljöinformationen på ww.fass.se av Jörgen Magnér (PhD in Applied Environmental Science)

2 Granskningsarbetet på IVL Granskningsteamet: Eva Brorström-Lundén (Tidigare projektledare) Linda Örtlund (Projektledare) Lisette Graae (Granskare) Emelie Westberg (Granskare) Jörgen Magnér (Granskare)

3 Granskningsarbetet på IVL Erfarenhetsåterkoppling från granskningsarbetet: Self-declarations of environmental classification in - experiences from the reviewing process (IVL Report B2087, Lilja et al. 2013). Self-declarations of environmental classification in - experiences from the reviewing process during 2012 (IVL Report B2124, Andersson et al. 2013). Self-declarations of environmental classification in Experiences from the reviewing process during 2013 (IVL Report B2213, Örtlund et al. 2014). Self-declarations of environmental classification in - experiences from the reviewing process during 2014 (IVL Report B2250, Graae et al. 2015). Self-declarations of environmental classification in - experiences from the reviewing process during 2015 (IVL Report B2267, Graae et al. 2016). Forskningsprojekt del i förbättringsarbetet The design and development of a database and assessment tool (2013). Multivariata analys på nedbrytbarhet i miljön för läkemedel (Rahmberg and Björk 2012, internal report U4186). Evaluation of measured levels of pharmaceuticals in WWTPs and reduction rates data from the national and regional screening in Sweden (Rahmberg et al. 2014, B 2161). Fate of pharmaceutical residues - in sewage treatment and on farmland fertilized with sludge. (Magnér et al. 2016, IVL report B2284).

4 Fate of pharmaceutical residues - in sewage treatment and on farmland fertilized with sludge Prover togs från Petersborgs gård, Skåne Slam Jord Markvatten (Lysimeter) Syfte: Om spridning av slam på åkermark bidrar väsentligt till spridning av läkemedelsrester till vatten och grundvatten Reference: Magnér J, Rosenqvist L, Rahmberg M, Graae L, Eliaeson K, Örtlund L, Fång J, Brorström-Lundén E. (2016) Fate of pharmaceutical residues - in sewage treatment and on farmland fertilized with sludge. IVL report B2284.

5 Läkemedel som ingick i studien 24

6 Resultat från studien Uppmätta halter av läkemedel i prover: Slam 15 av 24 läkemedel ( ng/g dw) Jord 4 of 24 läkemedel ( ng/g dw) Markvatten (Lysimeter) endast Caffeine återfanns i ett av proverna (69 ng/l) 110 Acidic pharmaceuticals 110 Basic & neutral pharmaceuticals Concentration remaning in soil (ng/g) Diclofenac Furosemide Hydrochlorothiazide Ibuprofen Naproxen Ramipril Warfarin Ketoprofen Paracetamol Number of column-volumes of water Concentration remaning in soil (ng/g) Atenolol Amlodipine Bisoprolol Caffeine Carbamazepine Citalopram Fluoxetine Metoprolol Oxazepam Propranolol Ranitidine Risperidone Sertralin Simvastatin Terbutaline Number of column-volumes of water

7 Slutsatser Slamspridning på åkermark utgör en försumbar del av de läkemedelsrester som återfinns i naturliga vatten. Resultatet från studien tyder på att de studerade läkemedlen fastläggs i jord för att med tiden brytas ned på plats.

8 Pågående forskningsprojekt 2016 Öka transparansen Kommunicera erfarenheter från granskningsarbetet Visa på fördelar och begränsningar med systemet Ge förslag på framtida förbättringar

9 Evaluation and future perspectives experiences from the reviewing process of the self-declaration system for environmental classification of pharmaceuticals Introduction and background I. Background and motives for the environmental legislation of APIs I I. European Commission (EC) technical guidance document I IV. European Environment Agency (EEA)strategies European Medicines Agency (EMA) guidelines Medical Products Agency (MPA) and Swedish medicinal legislation Historical perspective of the initiatives behind environmental classification of APIs I. The Swedish Association of Local Authorities and Regions (SALAR) and the National Corporation of Swedish Pharmacies I IV. LIF and the Swedish Environmental Classification and Information System (SECIS) EFPIA, EU and IMI The National Agency for Public Procurement Current status of SECIS I. The reviewing process Continuous improvements in guidelines for pharmaceutical companies

10 Evaluation and future perspectives experiences from the reviewing process of the self-declaration system for environmental classification of pharmaceuticals Method I. Evaluating the statistics of the reviewing process from 2005 to now Results I. Statistics of the reviewing process from 2005 to now I. Annual statistics of published documents Annual statistics of remarks given by the reviewer I Statistics of published document with significant environmental risk IV. etc...

11 Evaluation and future perspectives experiences from the reviewing process of the self-declaration system for environmental classification of pharmaceuticals Discussion I. Pros and cons with SECIS I. Dependent vs. independent host? I IV. Transparency (company owned data/intellectual properties) Different risk assessment for the same API Missing data/ No data no market? V. Predicted no effect concentration (PNEC) vs. fish plasma model (FPM) VI. V Possibilities to compare different API with the same mode of action? Handling mixtoxicity and additive effects Future improvements I. Pharmaceuticals released before 2006 I IV. Medicines sold Over-the Counter (OTC) Generic substitution system API vs. product brand V. Environmental declared pharmaceuticals

12 Några nya idéer för 2017 års projekt