Status report on pharmaceuticals in the Baltic Sea. Dmitry Frank-Kamenetsky HELCOM

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1 Status report on pharmaceuticals in the Baltic Sea Dmitry Frank-Kamenetsky HELCOM

2 Pharmaceuticals in the environment the global perspective Occurrence, effects, and potential cooperative action under SAICM

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4 Number of countries worldwide in which pharmaceuticals have been found in the aquatic environment Pharmaceutical Therapy Group Number of countries Diclofenac Analgesics 50 Carbamazepine Antiepileptic drugs 48 Ibuprofen Analgesics 47 Sulfamethoxazole Antibiotics 47 Naproxen Analgesics 45 Estrone Estrogens β-Estradiol Estrogens α-Ethinylestradiol Estrogens 31 Trimethoprim Antibiotics 29 Paracetamol Analgesics 29 Clofibric acid Lipid-lowering drugs 23 Ciprofloxacin Antibiotics 20 Ofloxacin Antibiotics 16 Estriol Estrogens 15 Norfloxacin Antibiotics 15 Acetylsalicylic acid Analgesics 15 Pharmaceuticals in the environment the global perspective Occurrence, effects, and potential cooperative action under SAICM

5 Some selected examples of adverse effects of pharmaceuticals on non-target organisms in field and environmental observations Pharmaceutical Diclofenac 17α-Ethinylestradiol Ivermectin Sulfonamide Therapeutic group Non-target organism Analgesics Synthetic estrogen Veterinary parasiticide Vulture Fathead minnow Dung fly and beetle (Gyps (Pimephales promelas) bengalensis) Population collapse Population collapse due to Mortality of eggs due to renal failure feminization of male fish and larvae Antibiotic Maize (Zea mays) Willow (Salix fragilis) Effects Adverse effects on root growth. Death of maize at high conc. Study type Wildlife Whole-lake experiment Laboratory and field Greenhouse Reference Oakes et al Kidd et al Liebig et al Michelini et al. 2012

6 % of MEC database entries Data analysis What is the source of the pharmaceuticals found in the environment? Urban areas are a major contributor. Discharge from manufacturing, animal husbandry, and aquaculture are important regionally. 100 % 90 % 80 % 70 % 60 % 50 % 40 % 30 % 20 % 10 % 0 % unknown Pharma Production Urban Manure/Sludge Application - Irrigation Application - Industry Hospital Wastewater Aquaculture Animal Farm 6

7 Research Project on Global relevance of pharmaceuticals in the environment (UBA) First Screening of Baltic Sea Data shows: 300 Data entries (published until 2013) Measured environmental concentrations (MEC) from different countries (Sweden, Norway, Germany) Veterinary and human pharmaceuticals detected Different compartments (surface water, sediment, ) 38 pharmaceutical substances + metabolites listed Variety of therapeutic indications covered (antidepressants, antibiotics, hormones, analgesics, ß- blockers, lipid lowering agents, ) 7

8 Diclofenac Central WWTPof St. Petersburg Concentration of Diclofenac in the effluent varied from 355 ng/l to 550 ng/l. Taking into account daily sewage water release in St.Petersburg total input of pain killer from the city can be estimated as about 400 kg per year. The studies screening diclophenac concentration in influent and effluent water of the WWTP were carried out in Finland, Sweden and Germany. The highest published concentration in influent water is 7000 ng/l and in effluent 3900 ng/l.

9 HELCOM core indicator A second holistic assessment of the Ecosystem Health of the Baltic Sea (HOLLAS II) is based on the set pf core indicators Diclofenac concentration HELCOM pre core indicator. The proposed GES-boundary for surface water is 10 ng L -1 Screening studies of diclofenac concentrations in the rivers Vantaa, Aura, Kokemäenjoki, Kuro shown triple exceedance of the GES-boundary even at distance about 2 kilometres from WWTP s discharges.

10 HELCOM Ministerial Declaration 20 May 2010, Moscow further assess the environmentally negative impacts of pharmaceuticals and other substances that are not monitored regularly; HELCOM Copenhagen Ministerial Declaration 3 October 2013, Copenhagen, Denmark to collect information on pharmaceuticals and assess the status of contamination of pharmaceuticals and their degradation products in the marine environment;

11 EU directive 2013/39/EU amending Water Framework Directive The contamination of water and soil with pharmaceutical residues is an emerging environmental concern. Article 8c Specific provisions for pharmaceutical substances to reducing discharges, emissions and losses of such substances into the aquatic environment, taking into account public health needs and the cost-effectiveness of the measures proposed. Article 8b Watch list Diclofenac (CAS ), 17-beta-estradiol (E2) (CAS ) and 17-alphaethinylestradiol (EE2) (CAS ) shall be included in the first watch list

12 Status report on pharmaceuticals in the Baltic Sea The state of contamination Environmental effects of pharmaceuticals in the Baltic Sea conditions. The pressure on the Baltic Sea environment including: Information on production of pharmaceuticals in the HELCOM area to map potential hot spots for releases of pharmaceuticals. Consumption/use of pharmaceuticals in the countries: human, agriculture, aquaculture, veterinary. Pathways - concentration of pharmaceuticals in municipal sewage water, sewage sludge, manure, sewage water from animal farming, possible input from medical waste.

13 Availability and source of data - National sources of data on consumption/use of pharmaceuticals e.g. (specify per different of activity; e.g. human use, agriculture, veterinary) - National sources of data on pathways of pharmaceuticals into the environment such as concentration of the compounds in waste water, sludge, manure etc. - What is the accessibility to existing data e.g.: - Contact persons [likely a number of contact person in different authorities/institutions]

14 Provisional timetable Date Activity May 2015 Information about process at Pressure and State&Conservation meetings; ask for information about data availability and data sources from CPs Information about process to PA Hazards steering group June 2015 Collect information about data availability and data sources from CPs Develop and send out template for collecting data on concentrations and effects July 2015 Assess availability of data for sources, consumption, use and production Develop and send out template for collecting data on Pressures - sources and pathways August 2015 Collect data on concentrations and effects Start compilation of data on concentrations and effects September 2015 Collect data on Pressures - sources and pathways October 2015 Report on concentrations and effects ready Discussion on progress in data compilation at Pressure Group meeting November 2015 Presentation of the report on concentrations and effects at State&Conservation meeting Workshop/Stakeholder conference (PA Hazard - HELCOM) back-to-back with State&Conservation meeting December 2015 Fabruary 2016 Compilation of Final report