Changes to the Australian registration regime for pesticides and veterinary medicines

Australia’s annual primary agricultural production is worth A$48 billion, with an export value of over A$32 billion (for a fiscal year 2010/11). Pesticides and veterinary medicines are commonly used by Australian farmers to protect crops and livestock from pests and diseases, with total sale exceeding A$2.4 billion a year. Since 1993, a centralised Commonwealth (federal) government agency has been responsible for the registration of agricultural and veterinary (agvet) chemicals, with each Australian state and territory controlling the use of agvet products from the point of retail sale. Since 2004, this agency has been known as the APVMA, the Australian Pesticide and Veterinary Medicines Authority. The APVMA operates on a full cost recovery basis, with annually collected levies on the sale of agvet chemicals being the main source of revenue. To increase efficiency and effectiveness of the current regulations of agvet chemicals, the Australian Government introduced new legislation which will amend the Agricultural and Veterinary Chemicals Code Act 1994, known as the AgVet Code.

The AgVet Code describes 25 different Categories that can be used for approval of active constituent, registration of product, getting a permit, or making variations to approved active constituent or registered product. Each application sent to the APVMA undergoes a preliminary assessment (screening) within 1 month. If it fully complies with the APVMA requirements, it can proceed to the evaluation stage. Evaluation timeframes and fees applied to each particular Category reflect the amount of work required to assess the risks associated with the application (the most popular Categories are listed in Table 1). However, under the current AgVet Code, the APVMA has to inform the applicant about any deficiency of the application, and applicant has the right to correct deficiencies, provide additional information and apply for extension of time to provide response. By executing all those rights the applicant can in fact extend both screening and evaluation time quite significantly. For instance, it is not unheard of for the applications to be still at the preliminary assessment stage 2 years after sending to the APVMA, instead of being rejected at the outset due to a very poor quality.

The Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 will:

- change the process of assessing applications,
- change the application fees and levies structure,
- introduce re-approval of actives and re-registration of products,
- improve the ability of the APVMA to enforce compliance with the regulations.

Under the new arrangements the APVMA will have one month to complete a preliminary (technical) assessment of the application, and if application does not meet all the requirements it must be refused, which is a significant change to the current approval/registration procedure.  Similar changes will be introduced during the evaluation stage, which will be slightly longer for each Category to reflect more complex risk assessment approaches used (see Table 2). If application is incomplete or does not satisfy all the requirements, the APVMA may require additional information from the applicant. Under the new regulations this information must be provided within a specified timeframe, and if at the end of the extended statutory timeframe   (see Table 2) the application still has some outstanding or unaddressed data requirements it must be refused.

Based on the Cost Recovery Impact Statement (CRIS) published on 29 November 2012 and subject to the passage of the Bill, the APVMA will amend application fees and annual levies to return application fees to 40 per cent cost recovery level within 2 years (see Table 3). No change will be made to the existing annual product registration fee (A$430), but within 2 years levies will change to 0.63% (annual product sales up to A$1million), 0.35% (annual product sales between A$1million and A$5million), and 0.25% (annual product sales greater than A$5million). No levy will be collected for annual product sales up to A$5000.

Another significant change to the current regulatory regime will be the introduction of new requirements for the approval/registration holder to apply for re-approval/re-registration of actives/products after a certain period of time. A matrix approach will be used to classify active constituents and products based on health and environment criteria at three different priority levels (low, medium, high). Longer periods of approval will be provided for active constituents that satisfy the low priority criteria, and the re-registration of chemical products will be based on the active constituents present in the formulation. The period between re-approval/re registration applications for a chemical is to be not less than 7 and not greater than 15 years (see Table 4).

The Bill will provide the APVMA with a graduated range of compliance and enforcement powers in responding to non-compliant activities. They will include requiring claims to be substantiated, issuing formal warnings, enforcing undertakings, issuing penalty infringement notices, and seeking civil penalty orders for a body corporate, an executive officer of a body corporate, or an individual, within six years of an alleged contravention.

The Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 was introduced to the Parliament of Australia and read a first time in the House of Representatives on 28 November 2012.

After first reading in the Parliament, the Bill was referred to the House of Representatives  Standing Committee for Agriculture, Resources, Fisheries and Forestry for inquiry and report. That report was published on 28 February 2013 and the Committee recommended that the House of Representatives pass the Bill without amendment. However the Coalition (opposition) members declined to support the majority recommendation, and recommended to remove the re-registration process from the Bill.

The Bill was also referred to the Senate Rural and Regional Affairs and Transport Legislation Committee for inquiry and report. That report was published on 27 February 2013 and the Committee recommended that the Senate pass the Bill. However, both the Coalition Senators and the Australian Greens Senator provided dissenting reports, recommending that the Bill should not be passed in its current form.

Second reading of the Bill, and relevant debate, took place on 18 March 2013. Now the Bill is before the House of Representatives.



About AGROconsulting:
With their unique scientific, chemistry and regulatory expertise, AGROconsulting (http://agroconsulting.com.au) can assist in successful registration of the agrochemical products and active constituents in Australia. They advise on required data, prepare relevant documentation, fill appropriate forms, collate all relevant data in the format required, send the application to the APVMA and transfer appropriate application fee, liaise with the regulatory authorities, and report on the progress of the registration process. When Chemistry and Manufacture data package is required for the application they evaluate relevant information and provide a detailed assessment report to the client. Therefore, the applicant has a chance to address all deficiencies and correct the application well before it is sent to the APVMA.