WRITTEN QUESTION E-3411/00

by Erik Meijer (GUE/NGL) to the Commission

(7 November 2000)

Subject: Tenfold increase in VICH standards relating to toxic impact of veterinary medicine residues in soil and water

1. Is the Commission aware of the growing concern among scientists over the toxic impact of residues of veterinary medicines in soil and water, as well as over the possible role played by drinking water and vegetables contaminated with such residues in the development of resistance to antibiotics administered to humans and animals for medicinal purposes (see, for example, New Scientist, 19 February 2000)?

2. How does the Commission explain, in this connection, the proposal by VICH (Veterinary International Cooperation on Harmonisation), to which the EU is a party, to raise tenfold from 7,5 g per hectare to 75 g per hectare the level of residues triggering an environmental impact study, despite the fact that:

(a) in the view of experts, there is no scientific justification for changing the threshold in this way;

(b) evidence provided by US representatives on the VICH to support their demand for an increase in the said threshold took no account at all of the issue of resistance to antibiotics;

(c) this decision was taken behind closed doors under a procedure that excludes national environment agencies, which should be able to provide information to their governments and parliaments?

3. Does the Commission agree that, when a decision is taken on an issue such as that referred to in question 2, the health of human beings and animals is more important than the interests and profit hopes of businesses in the agricultural and pharmaceutical sectors?

4. Does the Commission agree that decisions such as those referred to in question 2, which may have far-reaching consequences for public health and the environment, should be taken in accordance with a procedure which is open, transparent and democratic, and which does not exclude experts, concerned parties and the public?

5. What action does the Commission intend to take in order that, in terms of its substance as well as the procedure for adopting it, the VICH decision finally gives priority to public health and environmental concerns?

Answer given by Mr Liikanen on behalf of the Commission

(5 January 2001)

1. The Commission is aware of the concerns mentioned by the Honourable Member.

2. The purpose of environmental safety testing of veterinary medicinal products is to assess the potential harmful effects in the environment, which result from the use of such products and their toxicological profile.

(a) The rationale for selecting the trigger value for predicted environmental concentration (PEC) in soil of 100 µg/kg (75 g per hectare) is that this value was below the level shown to have had effects in ecotoxicity studies conducted on earthworms, microbes, plants and certain aquatic species (this is the battery of studies to evaluate potential adverse effects on the natural environment). The 10-fold increase compared to the initial value set in committee for veterinary medicinal products (CVMP) guidelines was accepted on the basis of a rigorous evaluation of over 20 years of data from the United Nations, provided in a retrospective review of ecotoxicity data for veterinary medicinal products submitted in environmental assessments for public display in the United States from 1973-1997.

(b) Environmental risk assessment guidelines are not directed beyond an assessment of the fate and effects of the drug or its major metabolites in the ecosystem of use. The purpose of the assessment is to ensure that the long-term survival of any species will not be endangered. In the case of antibiotics, the guideline considers the risk of resistance development for soil microorganisms but does not consider the likely risk of their use contributing to anti-microbial resistance in man or animals. Predictions of resistance potential are of course necessary, but these issues should be documented and evaluated in other sections of the regulatory dossier as required under European legislation for marketing authorisations and use of veterinary medicinal products.

(c) The veterinary international co-operation on harmonisation (VICH) guidelines are subject to extensive consultation among authorities and experts. In the Community, this guideline was released by the European medicines evaluation agency in December 1998 and sent to all interested parties, including the Commission and Member States. In addition, the Commission hosted in November 1999 the first public conference of VICH with over 400 delegates from all over the world in attendance, when this guideline was reviewed in depth.

3. to 5. As for the implementation and development of legislation concerning veterinary medicinal products, the Commission would reassure the Honourable Member that its primary aim is to ensure a high level of quality, safety and efficacy of medicinal products to safeguard animal health, public health and the environment. In this context, the Commission will continue to ensure that VICH guidelines have a sound basis for risk assessment, and that their preparation will associate all interested parties in a comprehensive and transparent manner.