Latest update on the changes to the pesticide registration in Australia

On May 15th, one day after presenting very disappointing federal budget with a A$19.4 billion deficit, which only cemented voters' decision to remove current government of Julia Gillard from office in the coming  elections, the Labor Party proceeded with their 2010 election commitments. 'Second reading' and 'consideration in detail' debates about the Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 took place in the House of Representatives of the Parliament of Australia. With 69 votes for and 70 against the amendments proposed by the Opposition, and with 70 votes for and 69 against forty two amendments introduced by the Government, the Bill passed the House. It was transmitted to the Senate seeking its concurrence, and after introducing and reading a first time on May 16th, the second reading of the Bill was adjourned to 17 June 2013.

The most contentious issue during the debates was the re-registration and re-approval regime for the agricultural and veterinary (AgVet) chemicals proposed in the new legislation. The members of the opposition Liberal Party echoed concerns raised by the industry and farmers when the Bill was referred to the parliamentary committees back in November 2012, and articulated during public hearings in February 2013, that the new scheme will introduce unnecessary burden on the registrants and increase costs of maintaining registration, which in turn will be passed on to farmers (by increasing costs of food production) and finally to consumers (by rising food prices).

Sid Sidebottom, the Parliamentary Secretary for Agriculture, Fisheries and Forestry who presented the Bill to the Parliament, defended re-registration by saying that this scheme brings Australian regulator (Australian Pesticide and Veterinary Medicines Authority, APVMA) into line with other comparable international bodies, and was designed to improve farmer safety and to better protect human and animal health, as well as environment, by providing greater certainty that the AgVet chemicals used in Australia are safe.

He explained that every year the APVMA receives around 3000 applications for new registrations/approvals,  permits and variations to the existing records, and only few of them are made for products/actives which are  genuinely new or innovative. Furthermore, more than 90% of products registered in Australia contain active constituents which were inherited from the previous system in 1993/94, when the current registration scheme was created, and therefore their chemistry has not been reviewed against contemporary standards. “There is currently no systematic approach to considering whether it is appropriate for a chemical currently on the market to stay on the market. This is unacceptable. It is clear that the community expects a rigorous scientific approach to AgVet chemical assessments” - he said. “But it also expects that these assessments will occur on a regular basis so they remain up to date.”

Mr Sidebottom reassured that companies will not be required to generate new data for re-registration but will only need to provide information they already have access to: “The Bill specifically provides that the Authority cannot - and I reinforce that, cannot - require information from an applicant that the applicant cannot reasonably be expected to have. The Government accepts that a long history of safe use counts in favour of keeping a tried and true chemical on the market. After looking at the simple application, where there are no reasonable grounds to believe a chemical is not safe the chemical will be re-registered without further obligations on the chemical company.”

According to the proposals, the re‐approval/re‐registration application fee will be A$700 (with additional fee of A$500 for late re‐approval/re‐registration). There will be three possible outcomes:

-if no grounds for concern are identified, actives/products will be re-approved/re-registered for a defined period (from 7 to 15 years)
-in some cases, active/product will be eligible for re‐approval/re‐registration with some changes to particulars or conditions of approval/registration
-if scientifically valid reasons for concern are identified, active/product will be referred to Chemical Review.

The outcome of the re-registration process for the product will almost entirely depend on whether the active constituent present in that product is determined as still being safe to use. All products with the same active will be considered together. The APVMA will not look so much at the individual product as at the chemistry behind all the products (active). Re‐registration of the products containing any of 780 currently approved active constituents will be made progressively within 15 years, with the order determined based on the risk assessment. Mr Sidebottom confirmed that “Products will remain on the market during this time and will continue to be on the market until a decision is made. If the decision is that a more detailed review is required, this will be scheduled and unless there is an immediate safety issue the product will remain on the market until a full scientific review of the issues identified in re-registration can be considered.”

Taking into account recommendations of the parliamentary committees and the Greens Senators, as well as concerns of the industry, farmers and other stakeholders, the Government introduced additional amendments to the Bill. As a consequence, introduction of the reforms proposed in the Bill (and described in my previous article Changes to the Australian registration regime for pesticides and veterinary medicines) will be delayed one year, until 1 July 2014, to give sufficient time for the APVMA to properly implement new regulations and to communicate appropriately with the stakeholders about those implementations. Furthermore, when assessing the safety of a chemical, the APVMA will have to consider toxicity of its metabolites and degradation products. The amendments will also provide a possibility for a person to apply to the APVMA for copies of any information in the register, which that person is entitled to.

With 31 Labor Senators and 9 Greens in the 76 seat upper house of the Parliament, it is almost certain that the Bill will pass the Senate and will be signed by the Governor-General within the next 2 months. It is also highly probable that after September elections, the Coalition with Tony Abbott as Prime Minister will be too occupied (with governing and cleaning a messy, if not chaotic, fiscal situation of the country) to indulge in any significant changes to the pesticide registration regime. Therefore, further amendments are not expected to be on the agenda of the new Coalition government, at least during the first few years of returning to power, probably for the next two-three 3 year terms, or longer. That will provide a very welcomed stability and time required by the industry and farmers to accommodate to the new regulations introduced by the Bill, and will give companies a chance to modify existing and develop new registration and re-registration plans and strategies for their AgVet chemicals.



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.