APVMA review of maldison—suspension of product and associated labels

The Australian Pesticide and Veterinary Medicine Authority (APVMA) has published a notice in the 22 March 2016 Gazette providing notice that the agency has suspended the registration of product 33018 Nufarm Maldison 500 Insecticide (product 33018) and all associated labels as specified in Table 1 below. The suspension will be in effect from 15 March 2016 until 1 March 2017. The suspension will include a phase-out period from 15 March 2016 until 1 March 2017 under the conditions of a deemed permit under s.45B of the Agvet Code, allowing possession, custody, supply and use of the product according to label directions. The deemed permit does not allow manufacture or import of the product. The APVMA declares that after 1 March 2017, s.45B (1) of the Agvet Code ceases to apply in respect of product 33018 and the permit will not be in force.

 

Product number Product name Holder Label approval(s)
33018 Nufarm Maldison 500 Insecticide Nufarm Australia Limited 0100, 0103, 0207, 0402, 0901

 

 

The APVMA review of maldison commenced in 2003 due to human health concerns including the potential formation of toxic impurities during storage. As part of the review, the APVMA conducted a chemical stability assessment of product 33018 and determined that the concentration of the toxic impurity, isomalathion, exceeded the safe limit after extended storage, based on Food and Agricultural Organisation of the United Nations (FAO) specifications for maldison (2013). Consequently, it appears to the APVMA that the product does not meet the safety criteria as defined under s5A of the Agvet Code (the safety criteria) as it may:

  • be an undue hazard to the safety of people exposed to it during its handling;
  • have an effect that is harmful to human beings.

Under s.41(1)(b) of the Agvet Code, the APVMA may suspend the registration of a chemical product if it appears the product may not meet the safety criteria. In addition, the APVMA may also suspend the approval of a label under s.44(2) of the Agvet Code if the APVMA suspends the registration of the inter-related chemical product. The following instructions apply to people dealing with product 33018 during the period of suspension from 15 March 2016 until 1 March 2017:

  • possession, custody, supply and use of product 33018 in accordance with label directions is permitted;
  • manufacture or import of product 33018 is not permitted.

Failure to comply with the instructions regarding this product is an offence which attracts a fine of 300 penalty units. The APVMA may undertake further regulatory actions for product 33018 during the suspension period which may impact the suspension conditions.

APVMA Gazette, 22 March 2016 ;http://www.apvma.gov.au ;