Parliament of Australia accepted changes to the pesticide registration regime

After a very short second reading debate, which was limited to 30 minutes by the Labor Party trying to pass as much legislation as possible before the coming federal elections, the “Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012” passed the Senate on 28 June 2013, the last sitting day of what supposed to be the last sitting week of the 43rd Parliament.

Only two Senators had the opportunity to speak on the legislation, and the debate took place only because of the Labor government putting a motion to extend sitting hours of Senate and to schedule one additional sitting day for that very Friday. When introduced four days before, that motion was questioned by Senator Eric Abetz who accused Labor of collaborating with Greens to avoid proper scrutiny by “allowing the situation to arise where 55 important bills are to be guillotined through the Senate in just 57½ hours of sittings”. It was also heavily criticised by Senator Mitch Fifield who asked whether Senate sees itself as a house of review or “does this chamber see itself as a sausage factory? Does it see itself as a rubber stamp? Does it see itself as a mere convenience for the governing alliance of the day?”

The debate on the Bill took place on the second day after removing Julia Gillard from the leadership of the Labor Party, and a day after Kevin Rudd was reinstalled as Prime Minister and Joe Ludwig resigned as Minister for Agriculture, Fisheries and Forestry. Therefore, in his speech, Senator Richard Colbeck focused as much on the new legislation as on the current political situation, accusing Mr Ludwig and his predecessor Tony Burke of running the Green agenda and devastating Australian agriculture. In respect of the Bill, he warned that it “will add red tape and cost to industry - an estimated $2 to $8 million a year” and it will give environmental activists the platform to add additional costs by organising campaigns to get rid of agricultural chemicals through the re-registration/ re-approval process. “The capacity under this piece of legislation for campaigns to escalate from what the Government tries to assure us is going to be a low-level cost for the re-registration cycle of chemicals to become something that is much, much more expensive, and that requires full documentation, is of real concern to the Coalition” - he said. In response, and in part validating concerns of the opposition, Greens Senator Rachel Siewert stated that “The Greens believe that Australians should have access to the safest and smartest methods and chemicals available for pest management in their homes and gardens and, in particular, for the production of the nation's food. However, the Australian Pesticides and Veterinary Medicines Authority has never had the proper legislative triggers it needs to systematically review and quickly remove highly hazardous and unmanageable pesticides from the market, making way for safer pesticides.” With 35 votes for and 29 against, the Bill was accepted.

Other and less contentious changes introduced by the new legislation have been described before (see my previous articles). The one that was not mentioned, but is worth discussing in more details, relates to the new terminology used to describe different parties interacting with the APVMA during the registration process. Previously the legislation (AgVet Code) referred to the approved person, the interested person, the applicant and the approval/registration holder, in a way that for some stakeholders was a bit confusing, causing problems with clear identification of the roles and responsibilities of each particular party. In the previous as well as in the new regulations, an “applicant” is a person who makes application to the APVMA to register a product, or to get approval of an active or a label. A “holder” is the person entered in the APVMA register/records as holder of a registration or approval. However, an “approved person” is replaced in the new regulations by a “nominated agent”. A nominated agent acts on behalf of the applicant or holder in relation to the product registration or approval of active constituent in Australia. The nominated agent acts as a contact person between the APVMA and the applicant or holder, receiving notices and responding to the notices on behalf of the applicant or holder. “The holder may, at any time, apply to the APVMA for the person nominated in the application to be the nominated agent for the approval or registration.” The nominated agent must be a resident of Australia or carry on a business in Australia. Australian companies or individuals can have but are not obliged to have a nominated agent when dealing with the APVMA, but “if the holder is not a resident of, and does not carry on business in, Australia, it is a condition of the approval or registration that there is a nominated agent for the approval or registration”. At any time “the holder may apply to the APVMA to change the nominated agent” and “the nominated agent may, by signed writing given to the APVMA, request to withdraw from being the nominated agent”.

It was proposed back in September 2012 that new application category will be introduced for applying to change the nominated agent (and the registration/approval holder). It was suggested that a fee of A$50 and a timeframe of one month will apply. However, when asked to provide details of the new arrangements, and to explain how replacing an “approved person” by a “nominated agent” in the AgVet Code will affect current application forms, the APVMA responded by stating that all those amendments are still being finalised by the Department of Agriculture, Fisheries and Forestry (DAFF). It remains to be seen if new implementations will be finalised under a new leadership of Joel Fitzgibbon, or only after the federal elections, which are still to be announced by Kevin Rudd, a newly reinstalled Prime Minister who reserved himself the right to not follow  decision made by his predecessor. The only thing certain right now is that they need to be ready before the new regulations commence on 1 July 2014.



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.