Dáil Éireann debate -
Thursday, 24 May 2001

Vol. 537 No. 1

Written Answers. - Carbendazim Usage.

John Bruton

Question:

103 Mr. J. Bruton asked the Minister for Agriculture, Food and Rural Development if Carbendazim is in use as a fungicide here; if traces of it have been found in food on sale here; and if research on animals has shown that it has adverse effects on the reproductive capacity of animals and humans. [15474/01]

Minister for Agriculture, Food and Rural Development (Mr. Walsh)

At present Carbendazim is used as a fungicide in Ireland. Traces of Carbendazim are found in food on sale in Ireland. The results of the annual monitoring programme have been published since 1990.

Carbendazim has been reviewed by the EC under Council Directive 91/414/EEC international review programme for plant protection products. The final decision with respect to inclusion into Annex 1 of this directive and with respect to toxicological classification has not yet been finalised.

Carbendazim has been tested for reproductive and developmental toxicity in rats and rabbits. There are two sets of data available, one carried out using the dietary route of exposure and one set using the gavage or intubation route of exposure. When Carbendazim is administeredvia diet to rats and rabbits, there are no relevant effects on reproduction or development of the foetus. When the gavage dose is used there are severe adverse effects on the testes resulting in infertility and teratogenic effects in the foetuses. The difference in results between the two routes of administration is due to the gradual ingestion and continuous metabolism that occurs via the dietary route so that sufficiently high levels of the chemical cannot occur in the blood.

The scientific committee on plants was asked the following question. Can the SCP comment on the advisability of establishing an acceptable daily intake and an acceptable operator exposure level having regard particularly to the results of reproductive data for the active substance, reference No. SCP/Carben/002-Final, 23 March 2001? In essence this question is asking whether a safe, for the occupationally exposed and the consumer, use of this substance can be recommended. The response referred to the extensive scientific literature which demonstrates that Carbendazim and related substances interfere with cellular division and that this interference is at the root of all of the adverse effects of this substance, including reproductive and developmental effects. They concluded that as a dose related mechanism was firmly established it was therefore possible to identify a dose level that will have no toxicological effect. In other words, a safe use should be achievable.

The current proposal for an ADI is 0.02 mg/kg/day based on the developmental studies in rats and rabbits and includes a 500 fold margin of safety above the lowest no adverse effect level of 10 mg/kg/day. The proposed acceptable operator exposure level is 0.04 mg/kg/day using a 250 fold safety margin.