Friday, 24 February 2012

EU Science for Environment Policy by AstraZeneca

Just a quick reminder to beware of so-called scientific studies being bandied about everywhere you look.  The one below had the logo of the European Commission on it which at first glance gives it credence despite the clarification that “contents and views included in Science for Environment Policy are based on independent, peer-reviewed research and do not necessarily reflect the position of the European Commission.”  Whether AstraZeneca is capable of producing independent, peer-reviewed research is in my mind very questionable.  After reading the rubbish report I wasn’t surprised to note the contact at the end though.

If this is the sort of information that politicians in Europe are basing decisions upon, no wonder biodiversity is still on the landslide.
23 February 2012

To cite this article/service:
"Science for Environment Policy": European Commission DG Environment News Alert Service, edited by SCU, The University of the West of England, Bristol. European Commission DG ENV News Alert Issue 274 23 February 2012

 A recent study has considered the levels at which active pharmaceutical ingredient (API) residues are safe when released into water bodies from drug manufacturing plants. It proposes that environmental reference concentrations and maximum tolerable concentrations are adopted for each API.

New approach to risk assessing pharmaceutical emissions

Pharmaceuticals and compounds

derived from medicines have been found in the environment over recent decades using better detection techniques. The most widespread route by which they enter the environment is from sewage containing residues excreted by people who have taken medicines. In addition, unused medicines are frequently thrown away down toilets or sinks.

A further source of pharmaceutical contamination are the effluents from drug manufacturing plants, The authors identify these as having the potential, if not controlled, to cause localised ‘hotspots’ of pharmaceuticals which could adversely affect the local receiving environment.

The environmental risk assessment of a substance is typically based on the concentration of the substance in the environment that is predicted to have no harmful effects over time, i.e. the PNEC (predicted no-effect concentration). This is compared with the predicted environmental concentration (PEC). The environmental reference concentration (ERC) approach proposed by the authors for APIs is based on established environmental quality standard concepts currently used in much national and international legislation. The ERC concept is similar to that of a PNEC. The ERC is defined as ‘the average concentration of an API in the receiving surface water environment that, based on current scientific knowledge, would be unlikely to result in any adverse long-term effects’. For each API, the study calculated four ERCs: ERC
aquatic, intended to protect freshwater organisms, such as algae, invertebrates and fish; ERCmarine to protect marine organisms; ERCpredator to protect predators that eat fish, such as otters; and ERChuman to protect people. Typically, the lowest ERC for each API is used to set discharge standards at individual manufacturing sites.

Four MTC values, MTCaquatic, MTCmarine, MTCpredator and MTChuman were also calculated. The MTC is defined as ‘the maximum concentration of an API in surface waters which can be tolerated for short-term exposures’ (typically less than 24 hours). Whereas ERCs are designed to protect the environment and human health from long-term effects of APIs, MTCs are intended to protect against short-term higher emissions of APIs into the environment which often occur during the manufacture of drugs in batches or when machinery is cleaned between batches.

A comparison of the ERC and MTC values for 30 APIs revealed wide ranges, e.g. for ERCs from less than 0.1 ng/l to more than 10 μg/l. Significantly, different values were found for drugs that act in a similar manner, e.g. the ERCs for three beta-blockers ranged across two orders of magnitude. A wide range of ERCs was also found for four APIs that act differently on hormonal systems. This suggests that toxicity and ecotoxicity values should be determined for each API and not assumed to be similar to those for other drugs with the same mode of action or in the same class.

In some cases, ERC
aquatic was not necessarily the lowest value, implying that people or fish-eating predators could be more sensitive to specific APIs than aquatic species. At some sites, where there are particular environmental concerns, such as the presence of wading birds, it might be necessary to look particularly closely at avian toxicology and exposure before deciding on the most relevant ERC.

The authors stress that emission control measures, such as cleaning techniques and waste disposal, should be tailored to the individual sites and the different APIs. Expert judgement will often be needed to decide the most appropriate risk management strategies for the different sites.

Murray-Smith, R.J., Coombe, V.T., Grönlund, M.H. et al. (2011) Managing Emissions of Active Pharmaceutical Ingredients from Manufacturing Facilities: An Environmental Quality Standard Approach. Integrated Environmental Assessment and Management. DOI: 10.1002/ieam.1268.


Chemicals, Risk assessment, Water