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Status report on pharmaceuticals in the Baltic Sea Dmitry Frank-Kamenetsky HELCOM Pharmaceuticals in the environment the global perspective Occurrence, effects, and potential cooperative action under SAICM


  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

  3. www.pharmaceuticals-in-the-environment.org 3

  4. Number of countries worldwide in which pharmaceuticals have been found in the aquatic environment Number of countries Pharmaceutical Therapy Group Diclofenac Analgesics 50 Carbamazepine Antiepileptic drugs 48 Ibuprofen Analgesics 47 Sulfamethoxazole Antibiotics 47 Naproxen Analgesics 45 Estrone Estrogens 35 17- β -Estradiol Estrogens 34 17- 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 Analgesics Synthetic estrogen Veterinary Antibiotic group parasiticide Non-target Vulture Fathead minnow Dung fly and beetle Maize (Zea mays) organism (Pimephales promelas) (Gyps Willow (Salix fragilis) bengalensis) Effects Population collapse Population collapse due to Mortality of eggs Adverse effects on root due to renal failure and larvae growth. Death of maize at feminization of male fish high conc. Study type Wildlife Whole-lake experiment Laboratory and field Greenhouse Reference Oakes et al. 2004 Kidd et al. 2007 Liebig et al. 2010 Michelini et al. 2012

  6. What is the source of the pharmaceuticals Data analysis found in the environment?  Urban areas are a major contributor.  Discharge from manufacturing, animal husbandry, and aquaculture are important regionally. 100 % 90 % unknown % of MEC database entries 80 % Pharma Production 70 % Urban 60 % Manure/Sludge 50 % Application - Irrigation 40 % Application - Industry 30 % Hospital Wastewater 20 % Aquaculture 10 % Animal Farm 0 % 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. Central WWTPof St. Petersburg Diclofenac 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, Kokemä- enjoki, 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 15307-79-6), 17-beta-estradiol (E2) (CAS 50-28-2) and 17-alpha- ethinylestradiol (EE2) (CAS 57-63-6) shall be included in the first watch list

  12. Policy Area Hazards of the EU Strategy for the Baltic Sea Region (EUSBSR) decided to give the topic of pharmaceuticals in the Baltic environment increased attention in the years 2015-2017. The decision was based on: • the generally growing concern over potential environmental impacts of pharmaceutical substances, • the current policy movements within HELCOM, the EU and internationally, • the interest in more knowledge and coordinated action by several Baltic Sea countries. Two concrete activities are planned for 2015-2016: 1. Produce a status report on concentrations of pharmaceuticals in the Baltic Sea environment, based on available data, 2. Organize a stakeholder conference to stimulate network building in the Baltic region and the development of good quality project applications to the Interreg programme.

  13. The scope of the assessment: Assessment of the state of contamination of the Baltic Sea environment by pharmaceutical substances including: • Measured concentrations of pharmaceuticals in Baltic coastal and offshore areas, primarily in biota, water and sediment. The concentrations should be compared to effect limits when available. • Environmental effects of pharmaceuticals in the Baltic Sea conditions (or measured/observed effects of pharmaceuticals on Baltic biota)

  14. The scope of the assessment: Assessment of the pressure on the Baltic Sea environment including: • Consumption/use of pharmaceuticals in the countries: human, agriculture, aquaculture, veterinary. • Information on production of pharmaceuticals in the HELCOM area – to map potential hot spots for releases of pharmaceuticals. • Pathways - point source of input of pharmaceuticals e.g. sewage treatment plant outlets, riverine loads [likely only available through screening studies]; concentration of pharmaceuticals in sewage sludge; concentration of pharmaceuticals in manure/sludge and sewage water from animal farming

  15. 1 st step - scope availability and source of data (no data collection) . - National sources of data on consumption/use of pharmaceuticals e.g. (specify per different of activity; e.g. human use, agriculture, veterinary) o authorities (environmental, health care s, veterinary, agricultural etc.) o professional associations o projects/studies - National sources of data on pathways of pharmaceuticals into the environment such as concentration of the compounds in waste water, sludge, manure etc. o authorities o professional associations o projects/studies - What is the accessibility to existing data e.g.: o open access - data base o reports o restricted - Contact persons [likely a number of contact person in different authorities/institutions] Sources of relevant data with restricted access (e.g. commercial data, data which require anonymising etc.) should be identified.

  16. 2 nd step – a template for data collection will be prepared based on the results from the 1 st step. The data will be collected in several categories: a. available data on pharmaceutical concentrations in the Baltic environment, coastal and open water (water, biota, sediment) b. available data on effects on Baltic biota c. available data on sources including information on production and consumption of pharmaceuticals and pathways – concentration of these substances in waste water, sludge, manure etc. The metadata, such as coordinates for concentration data, analytical methods, detection limits, data quality, etc., appropriate for the different categories will be collected.

  17. 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 – Compilation of Final report Fabruary 2016

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