The Australian Pesticides and Veterinary Medicines Authority (APVMA) has been working with a number of companies to facilitate the voluntary recall of registered agvet chemical products in response to contamination that occurred during the manufacturing process. The APVMA was first made aware of the contaminations in December 2016 when it received verbal and written notification from Nufarm Australia and Syngenta Australia. In those notifications we were advised that several herbicide products had been found to contain additional chemical actives to those listed in the APVMA registered formulation. A number of voluntary recalls were then initiated by the companies involved and the APVMA has worked with each party to facilitate and actively monitor their voluntary recall actions. The APVMA reviewed the plans put forward by the companies to notify relevant affected parties in the supply chain, which included recall of the faulty products from retailers, distributors, wholesalers and in some cases end users. Recent media interest in the recalls has questioned the APVMAs approach to the issue, suggesting that more could have been done to notify end users of the voluntary recall. APVMA Chief Executive Officer, Ms Kareena Arthy, has assured stakeholders that the safety and effectiveness of agricultural pesticides and veterinary medicines is at the heart of every decision made by the national regulator. Any report that we might have a contaminated or faulty agricultural chemical on the market in Australia is a concern, Ms Arthy said. The APVMA is responsible for the regulation of agvet chemicals up to and including the point of retail sale and we take our work in scientific assessment and risk management very seriously. Maintaining confidence in the regulatory system is vital and its one of the reasons we maintain a comprehensive compliance and monitoring program to ensure there are checks and balances at the retail level. When it comes to the recall of a faulty agvet chemical product we work with each party to ensure risks are appropriately managed and that action is taken promptly, but its important to acknowledge that companies and manufacturers are the ones responsible for product stewardship not the APVMA. Companies also have responsibilities more broadly under Australian consumer law, which includes notifying the ACCC about product recalls, which may then be published on the national recalls website at the discretion of the ACCC. While there are clear legislative obligations for the APVMA to publish compulsory recalls in the Gazette, there is no legislative trigger for the APVMA to publish voluntary recalls on the website www.apvma.gov.au. The ongoing investigation The issue of cross contamination in the manufacturing process for APVMA registered products is complex and under current investigation by the APVMA. A number of agricultural companies in addition to those named in recent media coverage are subject to ongoing investigation. The voluntary recalls that have been advised to APVMA on this matter remain active and have not been closed. The role of the APVMA in product recalls The role of the APVMA is to regulate agricultural and veterinary medicines up to and including the point of retail sale. Beyond this point, state and territory governments are responsible, including controlling the use of these chemicals. It is preferable that product recalls be undertaken voluntarily by the responsible party and the APVMA provides guidance where relevant to ensure appropriate action is taken. The APVMA may issue a compulsory recall in certain circumstances, for example where we consider there is a need for our intervention based on the registration status of an agricultural or veterinary chemical product (i.e. not registered) and/or serious product risk. In the case of the current matter, the APVMA considered the voluntary recall actions proposed by the companies and concluded that on balance, compulsory recalls were not required. As a result of the voluntary recalls undertaken by the companies, the APVMA understands that the majority of the chemical products involved have been removed from sale. More information To notify the APVMA about a faulty registered product, registrants should complete the online form, Notification of a potential or actual recall of an agricultural or veterinary chemical product. This form will detail the steps the registrant plans to put in place (or has put in place) to deal with a faulty product, including any recall action. The APVMA will continue to engage with the company through this process. More detail about the process for product recalls is available from http://apvma.gov.au/node/1081.
APVMA, 23 March 2017 ;http://www.apvma.gov.au ;