Chemicals in the News: Carbendazim
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Last updated 10 May 2011
Carbendazim is a fungicide registered in Australia for the control of a wide range of fungal diseases such as mould, black spot, mildew, scorch, rot and blight in a variety of crops.
As of 5 May 2011 there were 15 carbendazim products registered in Australia. In 2008-09 carbendazim product sales accounted for slightly over one percent of fungicide sales in Australia in that year.
Carbendazim is currently being reviewed because of occupational health and safety, residue and public health concerns. Regulatory decisions taken to date have restricted its uses and raised awareness of the risks it may present.
The APVMA commenced its review in 2007 following advice from the Office of Chemical Safety and Environmental Health (OCSEH) that exposure to carbendazim and its parent compounds could cause developmental abnormalities in experimental animals, and hence might pose a potential public and occupational health and safety risk to people. In initiating the review the APVMA addressed potential human health concerns by suspending the label approvals of carbendazim products and issuing new instructions for use. These new instructions provided revised safety directions for use of the product and a birth defects warning statement, to be attached to the container.
New restrictions currently in place
In January 2010, following consideration of advice in relation to both the human health and residues components of the review, the APVMA revoked the previous suspension and applied a new suspension that extended the warnings and amended the instructions of use.
These new instructions effectively discontinued pre and post-harvest use of carbendazim on grapes, cucurbits and melons, citrus fruit, custard apple, mango, pome fruit, stone fruit and the use of carbendazim on turf.
The new suspension instructions also had the effect of restricting access to carbendazim products to suitably trained and competent people authorised to purchase and use Schedule 7 products.
Permitted uses of carbendazim
Carbendazim is currently permitted for use on roses, bananas, strawberries, ginger seed pieces (pre-planting), sugar cane setts (pre-planting), pasture, red clover and subterranean clover, chickpeas, faba beans, lentils, vetch, macadamias and in timber preservation. Under individual permit, carbendazim may also be used on onion bulbs post harvest for seed production only, and on pyrethrum (non-food crop), mungbeans and mushrooms (once only per crop when preparing casing material from peat). Although carbendazim is permitted for these purposes, its actual use is believed to be limited.
Preliminary review findings for carbendazim
The APVMA has published the preliminary review findings (PRF) report for carbendazim. The PRF outlines the proposed regulatory outcomes for the future use of carbendazim. This report affirms the previous interim suspension actions and proposes also that uses on roses and certain other crop groups (without sufficient residues data) should also be removed at the end of the review. The period for period of public comment ended on 5 August 2011.
The APVMA will issue a final report once it has considered the submissions to the PRF and any other new information.For more detail see Carbendazim Review page.
Carbendazim is currently registered in the European Union following a re-registration review (external site) in 2007 that found that carbendazim fulfilled safety requirements, and that there were no unacceptable effects on the environment when used according to directions.
The current EU re-registration review of carbendazim is expected to be finalised in June 2011. The APVMA will consider whether the findings of the EU review have any new information that should be considered in the APVMA review of carbendazim.
United States of America
Carbendazim is registered in the United States for ornamental plants.
Carbendazim is currently registered in Canada following a re-evaluation in 2006 (external site). The risk assessment found that the use of carbendazim as a fungicide to control Dutch elm disease in elm species presented minimal risk to workers and the environment.
WHO/FAO Joint Meeting on Pesticide Residues (JMPR)
The JMPR evaluated the toxicology of carbendazim in 1973, 1976, 1977, 1978, 1983, 1985, 1995 and 2005. In its 2005 consideration of carbendazim, the JMPR noted that carbendazim is a developmental toxicant and teratogen (can cause malformations of an embryo or a foetus) in rats. JMPR set a lower health standard for women of childbearing age than for the general population (including children). It noted that an additional safety factor for the severity of effects was unnecessary since the underlying mechanism is clearly understood and there is a clear threshold for these effects. It further noted that there was no evidence for developmental toxicity or teratogenicity after administration of carbendazim in the diet - the effects only occurred after administration of large doses given directly into the stomach.
International Programme on Chemical Safety (IPCS) of the WHO
In 1995, the International Programme on Chemical Safety (IPCS) of the WHO evaluated the toxicology of carbendazim. It concluded that carbendazim represented a very low risk for acute poisoning in humans. Given likely exposures and the low rate of dermal absorption of carbendazim, it was considered unlikely that it would cause systemic toxicity effects either in the general population or in occupationally-exposed subjects. These conclusions were drawn from animal data and limited human data, but were supported by the understanding of the mode of action of carbendazim.