Continued Suspension of Certain Products Containing Dimethoate and their Associated Label Approvals

The Australian Pesticide and Veterinary Medicine Authority (APVMA) have continued the suspension of the registrations and label approvals for eleven agricultural chemical products containing dimethoate. The suspension of product registrations and label approvals are now in effect until 5 October 2016. Active constituent approvals are not affected by the APVMA’s decision to continue this suspension. The APVMA suspended all products containing dimethoate and their associated labels on 6 October 2011. The dietary exposure concerns that formed the basis of this original suspension of label approvals and product registrations have not altered for the products listed in Table 1. Therefore continued suspension is necessary to ensure that the use of products containing dimethoate does not result in any undue hazard to the safety of people or have an effect that is harmful to human beings. In January 2011, the APVMA published the toxicology component of the report prepared by the Office of Chemical Safety (OCS) in connection with the APVMA’s review of dimethoate: Human Health Risk Assessment of Dimethoate (the OCS Report). The OCS Report revised the public health standards for dimethoate. The Acceptable Daily Intake (ADI) for dimethoate was reduced from 0.02 mg/kg bw/day to 0.001 mg/kg bw/day. In addition, an Acute Reference Dose (ARfD) of 0.02 mg/kg bw was established. The APVMA published its Dimethoate Residues and Dietary Risk Assessment Report (the Residues Report) in August 2011. The Residues Report considered all of the available information relevant to its review of dimethoate, including the public health standards (ADI and ARfD) set out in the OCS Report. The report included the advice that there was a significant risk that short-term dietary exposures to dimethoate residues arising from use patterns included in the previously approved label particulars would be above (and in some cases well above) the relevant public health standard for short-term exposure to dimethoate, the Acute Reference Dose (ARfD) as set out in the Human Health Risk Assessment of Dimethoate report. Based on the findings of the OCS report and the residues report, the APVMA has decided to continue the suspension of product registrations because the continued use of, or other dealings with the products containing dimethoate, in accordance with their instructions for use may be an undue hazard to the safety of people using (i.e. consuming) anything containing dimethoate residues. In addition, the APVMA has decided that the instructions on the previously approved labels associated with those products may no longer be adequate as they do not have appropriate instructions for the circumstances under which the product should be used, the frequency of use of the product and the withholding period after the use of the product for specific use patterns and crop types. The APVMA has decided to continue the suspension of these labels under Subsection 41(2) and to issue modified instructions for the use of these products during the suspension period.

Table 1: Suspended and cancelled products and suspended label approvals

All other products containing dimethoate are not suspended because their approved labels contain instructions that are consistent with the instructions for use of suspended products. These products may be used according to the instructions on their approved labels.

Further instructions on the suspension of dimethoate are available at: http://apvma.gov.au/sites/default/files/gazette_06102015.pdf

APVMA Regulatory Update, 6 October 2015 ;http://www.apvma.gov.au ;