This content is current only at the time of printing. This document was printed on 19 December 2021. A current copy is located at http://www.ipagescanada.com/node/10931
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Guide for determining a minor use
The Agricultural and Veterinary Code Regulations 1995 state that a minor use:
In relation to a chemical product or an active constituent, means a use of the product or constituent that would not produce sufficient economic return to an applicant for registration of the product to meet the cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).
It is recognised that a minor use can include:
- use on a minor crop, animal or non-crop situation, or
- limited use on a major crop, animal or non-crop situation.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) recognises that whilst the current legislative definition is still relevant, it is nonetheless somewhat difficult to operate within because the issue of 'sufficient economic return'?is a very subjective concept. One of the recommendations from the APVMA Review of the National Permit System was to develop guidelines to assist in determining whether a particular use can be defined as a ‘minor use’.
This notice includes APVMA guidelines to assist in determining whether a use is defined as a minor use for the purpose of making an application for a permit or product registration.
Please note: The following are guidelines only. The final decision on which uses are determined to be a minor use rests with the APVMA.
1. Based on the list in Schedule 1, is the crop, animal or situation a minor crop, animal or situation?
- YES –?then use is a minor use
- NO –?go to 2
2.?Does the use meet the criteria specified in Schedule 2 for a limited use within a major crop, animal or situation?
- YES –?then use is a?minor use
- NO –?then go to 3
3. Would registration produce 'sufficient economic return*'?
- YES –?cannot be considered a minor use
- NO –?then provide evidence as outlined in Schedule 3.
*?'Sufficient economic return'?means in relation to the costs of obtaining registration for a specific use pattern compared to the returns to the manufacturer (registrant) from making the use available. This criterion is generally only available to registrants who are able to furnish the necessary information as outlined in Schedule 3.
Schedule 1 – Minor crop, animal or non-crop situation
These are based on current statistics in regard to:
- volume of commodity production
- area under cultivation (ha) or numbers of trees or animals
- dietary consumption (g/kg BW/day)
- value of crop or animal
- export quantities.
The following are deemed to be 'major'. All crops, animals or non-crop situations that are not included in the following list are deemed to be 'minor'.?
Major crops/situations (agricultural chemicals)
Grasses (cereal grains and sugarcane)
Berries and other small fruit
- Grapes (wine and table)
Assorted tropical and sub-tropical fruit – inedible peel
Assorted tropical and sub-tropical fruit – edible peel
- No commodities
Fruiting vegetables – cucurbits
- Melons (except watermelons)
Fruiting vegetables – other than cucurbits
- Peppers (capsicums)
Legume vegetables and pulses
- Beans (French and runner)
- Field peas
- Green peas
Root and tuber vegetables
Stalk and stem vegetables
- Agricultural non-crop areas (includes land associated with farmland but not used for regular cultivation and/or grazing)
- Commercial forests (includes plantations grown specifically for timber production)
- Fallow land
- Commercial and industrial areas (includes factories, factory land, industrial sites, parking lots, fuel tank farms, outside chemical storages)
- Domestic and public service areas (includes houses, residential subdivisions, schools, hospitals, restaurants, hotels, motels, cafes, rubbish tips and playground and recreational areas such as golf courses, municipal parks and gardens, etc.)
- Non-crop areas (includes areas of lands not being used or intended to be used for cropping or grazing)
These areas include industrial sites, timber yards, areas around farm buildings, along fences and roadsides, rights-of-way, storage areas, wastelands, vacant lots, cemeteries, etc.
- Ornamentals (when used as a group)
- Bushland/native forests (includes natural forest areas used for recreational/scenic purposes, national parks, etc.)
- Turf areas (includes commercial turf farms, sports ovals, bowling greens, general lawn areas, etc.)
- Pastures (herbage grown specifically for the purpose of being grazed by, or fed to livestock. Pastures includes lucerne, medics, clovers and grasses, whether for grazing or seed crops. The word 'herbage'?excludes crops such as cereals, oilseeds, vegetables and cole crops)
- Aquatic areas (includes irrigation channels, streams, lakes, dams, drainage ditches)
Major animal species (veterinary chemicals)
Food (meat and milk) animals
Non-food animals (companion animals)
Schedule 2 – Limited use within a major crop, animal or non-crop situation
A minor use can also occur from limited use within a 'major'?crop, animal or situation. 'Limited use'?means the use does not occur across the whole industry but is only confined to limited segments or it is only used infrequently or sporadically.
An applicant must demonstrate that a use will remain limited to segments of the major industry, otherwise, it will be determined to occur across the whole industry and hence be a major use. For example, it is inappropriate to claim a use on a major crop as being minor because only one location or one state is being treated yet there is no evidence to demonstrate that the pest/disease would not spread to other locations or states where the crop is grown.
Limited use within a major crop, animal or non-crop situation (that will determine whether the use is minor) must not exceed:
- 10%?of the total**?area of crop, number of animals, or area of situation, or
- 10,000 hectares
(whichever results in the least amount) per annum.
**total refers to the national total area for that crop, numbers of animals or area of situation.
Limited use within a major crop such as barley, for example, would be limited to 10,000 ha which is less than 10% of the total national crop (i.e. 10,000ha < 10%?of 3,163,000 ha). On the other hand, minor use in lettuce would be limited to 380ha (i.e. 10%?of 3,800 ha < 10,000ha).
The 'per annum'?criteria is for limited uses in major crops/animals based on time rather than area. It is to allow infrequent or sporadic applications. For example, a limited use includes treating a major crop/animal/situation in the following extent:
- 10% (or 10,000 ha – whichever is the least) every year, or
- 20%?(or 20,000 ha – whichever is the least) every 2?years, or
- 30%?(or 30,000 ha – whichever is the least) every 3?years.
Generally, the determination of the frequency that a pest or disease occurs and the percentage of the crop/animal/situation that may require treatment can only be effectively determined by reliance upon previous records or an estimation based on sound scientific principles.
Applicants must supply full costs and projected incomes associated with a particular use covering a period of no less than 3?years.
Information required includes:
- investment costs (includes but not limited to):
- costs associated with data generation
- costs of data analysis
- internal costs including costs of label changes
- registration fees
- total costs
- return on investment (includes but not limited to):
- product cost/yr/ha
- sales margin (per cent)
- projected area (ha) of product usage
- percentage (per cent) adoption by farmers
- total income.
The applicant must demonstrate that based on the data in relation to the above that there is insufficient economic return to consider registration of the product and/or use.