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Amendments to legislative instruments for fees and timeframes
Atrazine Review Update
Amendments to legislative instruments for fees and timeframes
The APVMA has made some amendments to the instruments under the Agvet Codes relating to fees and timeframes and created a new principal instrument to deal with additional information submitted by applicants voluntarily.
On 9 January 2008, the following four instruments relating to fees and timeframes were registered on the Federal Register of Legislative Instruments:
Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 2008;
Agricultural and Veterinary Chemicals Code Amendment Instrument No. 2 (Multiple Applications) 2008;
Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008; and
Agricultural and Veterinary Chemicals Code Instrument No. 3 (Assessment Periods for Applications where Additional Information is Submitted Voluntarily) 2008.
All four instruments commenced on registration and are available on ComLaw: www.comlaw.gov.au.
The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 2008 amends the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 to allow residue assessments of trial protocols for agricultural and veterinary chemical products.
The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 2 (Multiple Applications) 2008 amends the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005 to allow multiple applications to be submitted under category 14 for the purpose of varying particulars or conditions of registration or label approval, provided the variation involves minor label changes in relation to two or more chemical products, the application is made by the same applicant and the variation is the same for each label change.
The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008 amends the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 by providing a new modular fee and timeframe for multiple applications. The proposed new modular fee for multiple applications allows applications to be "bundled" so that the module 1 screening fee (currently $460) applies once irrespective of how many separate products are included in the multiple application. In addition, the module 11.4 finalisation fee (currently $145) applies for each product up to five products and then once for each subsequent "bundle" of up to five products. If any technical assessment is required, the multiple application fee includes the ordinary modular fee for the technical assessment multiplied by the rate or actual number of times that the technical assessment is required.
The Agricultural and Veterinary Chemicals Code Instrument No. 3 (Assessment Periods for Applications where Additional Information is Submitted Voluntarily) 2008 is a new principal instrument, which provides additional time for the APVMA to consider additional information submitted by applicants voluntarily.
New compilations of the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005 and the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 are available on ComLaw: www.comlaw.gov.au and the APVMA website: www.apvma.gov.au/about_us/legislat.shtml.
Atrazine Review Update
See also Atrazine Review pages
As a result of refinements to the atrazine risk assessment published in 2004, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is considering whether it can continue to support the use of atrazine post emergence on raised bed crops. This proposed revised finding primarily affects growers of triazine tolerant canola in high rainfall areas in southern Australia.
On 13 November 2007 the APVMA, and the Department of the Environment and Water Resources (DEW) met with representatives from Southern Farming Systems (SFS), a Victorian-based grower group, agricultural consultants, Nufarm Australia Limited and the Victorian Farmers Federation, to discuss the atrazine review. The meeting followed written advice from the APVMA to affected registrants, grower groups and the States/Territories, detailing the basis for concern about this use of atrazine.
The APVMA believes there could be a problem with the ongoing use of atrazine post emergence on raised beds because runoff from treated areas may contain atrazine at levels which may potentially be harmful to the environment.
At the meeting SFS indicated that the proposed label restriction that the APVMA is considering is likely to have a significant adverse effect on raised bed croppers, as TT canola is currently a vital ‘weed breaker’ crop.
The APVMA was made aware of the implications of any regulatory restrictions for TT canola growers and was advised that SFS intended to provide additional information to the APVMA about the use of atrazine on raised bed crops.
The APVMA indicated that it would be prepared to consider further information that may enable it to adjust its proposed findings, but that such information is required as soon as possible, as the APVMA is moving towards finalising the atrazine review.
Any submission will need to detail either evidence contradicting the existing information considered by the APVMA and DEW, or provide a workable solution to the concern regarding runoff, in order to enable the APVMA to continue to support ongoing use. Should a substantive submission be provided within the next few weeks, it will be assessed on its merits.
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