NRA Gazette 2, 4 February 2003 page 48

NOTICE

Guidelines for Determining Emergency Uses or Research Purposes

According to the Agricultural and Veterinary Chemicals Code Regulations (Agvet Code Regs), in the case of an application for a permit, the use of the product as proposed in the application must be:

i. a minor use; or
ii. an emergency use; or
iii. for research purposes.

Guidelines for Determining Minor Uses were published in the NRA Gazette, No.NRA 3,
5th March 2002 (pp39-43) and included in the NRA's website (/gazette/gazette0203p39.pdf.)

This notice outlines NRA guidelines for determining when a use is an "emergency use" or which uses constitute "research purposes".

Emergency Uses

Permit applications for an emergency use are not subject to a fee, irrespective of the applicant. The NRA attempts to assess and finalise a permit application for an emergency use as soon as possible, therefore, it is important that these uses are genuine emergencies.

The Agvet Code Regs defines an emergency use, in relation to a chemical product or an active constituent, as:

"a use of the product or constituent arising from an emergency in which there is a genuinely believed need for the use of the product or constituent".

Situations where the proposed use is generally unforeseen, such as the outbreak of an exotic pest or disease or where unusual weather patterns have caused higher or more frequent pest or disease incursions are considered to be an emergency. Any written submissions from relevant State Coordinator or government authority to the effect that there is a genuine emergency for which the use of a particular product or constituent is needed will be considered as strong evidence of that fact.

Situations that the NRA will not generally accept as an emergency include, but are not limited to where:

· the situation has arisen because the applicant has not submitted a permit application in sufficient time (with regard to allowing the NRA to properly consider the application before the required treatment); or
· the pest, weed or disease has been allowed to proliferate (contrary to sound agricultural or veterinary practice) to the stage where urgent control or treatment is then required; or
· the pest or disease generally recurs on a seasonal, annual or other regular basis; or
· resistance to registered products has occurred and where the resistance has built up and been evident over a period of time.

Research Purposes

With regards to permits, the term 'research' is considered to be technical work of an investigative nature which occurs at all stages of development of new agvet chemicals, agvet products, processes, equipment and uses. It includes scientific research or investigation relevant to:

· screening of potential new agvet chemicals;
· generating data required by the NRA for registration or approval;
· testing a particular set of label instructions, new packaging or application technology;
· undertaking a scientific study where the use of an agvet chemical or product is crucial to the conduct of the experiment; or
· other such situations determined by the NRA to be genuine 'research'.

Situations that will generally not be considered to be 'research' include:

· testing as to whether a product will be adopted by a particular market;
· supply and use of an unregistered product in order to gain early market access..

Supporting Material

Persons who apply for a permit on the grounds of an emergency use or for research purposes should submit detailed submissions addressing the relevant matters in this guideline. Submissions should include information demonstrating that the use is a genuine emergency or for research purposes, as the situation requires. Each case will be assessed by the NRA on its merits.

These guidelines will come into effect from 1st March 2003.

For further information, please contact:

Peter Prammer
Ph: (02) 6272-3216