WRITTEN QUESTION E-3411/00 by Erik Meijer (GUE/NGL) to the Commission. Tenfold increase in VICH standards relating to toxic impact of veterinary medicine residues in soil and water.
Date: 2000-11-07
Institutions: European Parliament, Provisional data
Subjects: antibiotic, environmental impact, health risk, pollution, public health, toxic substance, transparency in decision-making, veterinary drug, veterinary legislation, waste

6.6.2001

EN

Official Journal of the European Communities

C 163 E/111

(2001/C 163 E/119)

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 Interna-
tional 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.

C 163 E/112

Official Journal of the European Communities

EN

6.6.2001

(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.

(2001/C 163 E/120)

WRITTEN QUESTION E-3416/00

by Jonas Sj(cid:246)stedt (GUE/NGL) to the Commission

(7 November 2000)

Subject: Repayment of fees in the Cresson case

Ex-Commissioner Cresson(cid:146)s personal friend Mr R. Berthelot was called upon to repay some of the fees of
SEK 1,2 million he received in relation to his appointment as an AIDS expert.

Have any repayments yet been made?

Answer given by Mr Kinnock on behalf of the Commission

(8 January 2001)

The Commission is pursuing its claim for the reimbursement of sums due to it because of the fact that
M. Berthelot did not satisfactorily fulfil his visiting scientist contract.

The Commission(cid:146)s claim has been contested and the matter will consequently be pursued before the
relevant jurisdiction. Following the launch of recovery proceedings there was no reaction to the initial
summons to pay the sums due. A formal decision requesting payment is therefore about to be adopted.

No sums have been recovered to date.