Carbendazim chemical review

In February 2006, the APVMA began considering carbendazim for review because of occupational health and safety, residue and public health concerns. This action was based on advice from the Office of Chemical Safety, within the Department of Health, that exposure to carbendazim and compounds that can form it (such as thiophanate-methyl) could cause developmental abnormalities in experimental animals and hence might pose a potential public and occupational health and safety risk.

The APVMA Chemical Review team sought advice from the Office of Chemical Safety (OCS) and APVMA’s Residues Section regarding the priority for a review of carbendazim and its scope.

The scope of this review included toxicology, occupational health and safety and residues in food (dietary exposure risks).

In March 2007 Notices were sent to holders and the commencement of the review was announced in the APVMA Gazette in April 2007.

The review commenced 30 June 2007, being the deadline for submissions to the review.

The APVMA also suspended the labels of all carbendazim products in June 2007, to revise the safety directions for users of carbendazim and add a birth defects warning statement to all labels.

The Human Health Risk Assessment report and the Residues evaluation report (including dietary exposure assessment) for the review of carbendazim were published as Volumes 2 and 3 of the Preliminary Review Findings for the review of carbendazim (May 2011).

The APVMA completed assessments of the data provided for this review and released the Preliminary review findings for public comment in the period from May to August 2011.

The preliminary review findings supported the previous APVMA actions and proposed:

• the removal of uses of carbendazim products on roses because of occupational health and safety concerns
• the removal of uses of carbendazim on bananas, strawberries, pastures (including clovers), ginger and sugarcane, unless suitable residues data are made available
• minor revisions of the safety directions established in the May 2007 suspension
• the addition of re-entry intervals to the labels for agricultural uses.

The APVMA has now considered public comments received following the publication of the Preliminary review findings report and is satisfied that the use of carbendazim products according to the proposed variations to labels does not pose an unacceptable hazard to human health.

In June 2007, the APVMA suspended carbendazim labels to revise the safety directions for carbendazim and added a birth defects warning statement to all labels.

In January 2010, the APVMA again suspended labels to add instructions for use that amended the signal heading from Schedule 6 to Schedule 7, extended the warning statement to include male infertility in laboratory animals, and discontinued pre-harvest and post-harvest uses of carbendazim on grapes, cucurbits, melons, citrus fruit, custard apple, mango, pome fruit, stone fruit, as well as all instructions for use on turf.

The review of carbendazim was completed and the final Review findings report was published on 15 August 2012.  At this time, in addition to the previous action to amend labels and remove uses on grapes, cucurbits, melons, citrus fruit, custard apple, mango, pome fruit, stone fruit and turf:

• the use of carbendazim products on roses was removed from labels because of occupational health and safety concerns
• the use of carbendazim on bananas, strawberries, pastures (including clovers), ginger and sugarcane, was removed from labels as suitable residues data was not made available
• The safety directions on labels were revised and re-entry intervals added to label instructions

Six products were cancelled by the APVMA because their approved labels did not include any of the remaining approved use patterns for carbendazim, and 12 products were affirmed following variation of their labels as described above.

Eight active constituent approvals for carbendazim were affirmed following the finalisation of the review.

Affected actives, products and labels are listed in the APVMA Gazette Notice of 14 August 2012.