Category 21 application
Application for a minor use permit

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 21 application as:

Application for a permit where the proposed use is a minor use.

Applications under Category 21 for a minor use permit can include one of the following:

• the use of an existing registered product ‘off-label’
• the use of an unregistered product.

The great majority of Category 21 applications for a minor use permit are for off-label use of an existing registered product.

1.1.   Minor use criteria

A minor use is defined in the Agvet Code as:

…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).

Minor uses generally encompass low acreage crops or situations (minor crops) or the limited or infrequent use of a chemical in a major crop or situation. A definition of major crops may be found in Definition of terms used in MORAG in Volume 2.

For minor crops, use patterns approved by the issue of a minor use permit need not necessarily appear on the label of a registered product (ie off-label use) or can include products not currently registered in Australia.

Applications for uses of products in major crops must normally be made by the registrant via Categories 1–14, and the use pattern should appear on the label of the registered product. However, the APVMA will consider applications for minor use permits for major crops where it can be demonstrated that the proposed use is minor.

Further details regarding these criteria including a list of major crops are explained in the APVMA Guidelines for Determining Minor Uses. Category 21 applications for a minor use permit must demonstrate that they satisfy the requirements of this guideline.

2.   REQUIREMENTS

When making a Category 21 application for a minor use permit, applicants must provide all of the following:

• one unbound copy of the combined Permit Application Form and Overview (refer to paragraph 2.1)
• where data are provided with the application, one bound copy of each of the relevant data Parts (refer to paragraph 2.2)
• a draft label if relevant (refer to paragraph 2.3)
• the relevant fee (refer to paragraph 2.4).

2.1.   Combined Permit Application Form and Overview

The Permit Application Form and Application Overview have been combined into a single document (KP25F21) which is available on the APVMA website. A single unbound copy of the combined document must be provided to the APVMA.

The Application Form requires information which is relevant to a Category 21 permit application.

The Application Overview section of the combined document is in the form of a template. Applicants may use this template, or may submit their own Application Overview although this must conform to the instructions and format provided in Part 1 – Application overview in Volume 3.

2.2.   Data

Category 21 applications for minor use permits must satisfy the criteria of s.112 of the Agvet Code that the proposed use:

1. would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
2. would not be likely to have an effect that is harmful to human beings; and
3. would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
4. would not unduly prejudice trade or commerce between Australia and places outside Australia; and
5. would be effective for the intended purpose.

Category 21 is a modular category, therefore data studies and timeframe are determined by the module levels required for permit assessment, which themselves are determined by the type of product and the situations in which the product will be used.

All Category 21 applications require submission of data. The data modules are directly relevant to the level of assessment required and are determined by:

• the product and its active constituent
• the proposed use
• the presence and relevance of existing regulatory standards already established for that product or active constituent in Australia
• the similarity of the proposed use to currently approved uses of the product/active constituent in Australia.

Any combination of the data Parts and modules in Table 1 may be required. The data Parts refer to Volume 3: Data requirements and guidelines.

Table 1:  Data Parts and corresponding modules

Note: Module 4 exists for uses or products which may require poisons scheduling. Poisons scheduling will generally only apply to Category 21 applications for a minor use permit for use of an unregistered product.

2.2.1.   How to determine modules

The data modules will depend on the product, its active constituent, the proposed use, and the presence and relevance in Australia of existing regulatory standards already established for that product or active constituent.

Details and guidance on data Parts and modules are provided in Volume 3: Data requirements and guidelines.

Applicants should note that applications for a minor use permit are always subject to two non-technical modules: Screening (Module 1) and Finalisation (Module 11.1, 11.3 or 11.4).

Applications which require three or more modular assessments (for example Residues, OHS and Environment) will be subject to Module 11.1 (timeframe three months). Applications which require one or two modules (for example Residues and Efficacy/Host Safety) will be subject to Module 11.3 (timeframe two months). Applications which require only a minor chemistry assessment will be subject to Module 11.4 (timeframe two months).

2.3.   Label

For unregistered products, a copy of all parts of the label which will be attached to the container must be provided with the application. This may be:

• a copy of the existing label for the product if it is registered overseas
• a draft label that will be affixed to the container if the product does not have an associated label or if the label is not in English.

As part of its assessment, the APVMA will consider the appropriate labelling for use of the unregistered product under permit. Generally, the label must conform to the Ag Labelling Code.

2.4.   Fee and timeframe

The fee for a Category 21 application is $320.

Category 21 is a modular category, therefore the timeframe depends on which of the modules are required for assessment of the application. To calculate the timeframe assigned to an application once it has passed screening, an applicant must add the longest assessment period for a specific data module to the relevant finalisation module (11.1, 11.3 or 11.4).

To calculate the timeframe assigned to an application once it has passed screening, an applicant must add the longest assessment period for a specific data module to the relevant finalisation module (either 11.1, 11.3 or 11.4).

2.4.1.    There is no permit application fee for Australian, State or Territory governments, in support of their core business

If the Australian, State or Territory governments apply for a permit in support of their core business, there is no fee.

Core business

Core business includes activities which are undertaken by officers of a government agency which are directly related to a control strategy being developed, implemented and communicated by that government agency. This includes activities relating to the management of exotic pests and diseases, or market access. There is no fee for permit applications relevant to such activities.

If a government officer applies for a permit on behalf of an industry group, and if that industry group would otherwise be required to pay a fee for the permit, the application made by the government officer is not fee exempt. Whilst certain departments and their officers provide advice on management of pests and diseases, the actual management of those pests and diseases is NOT core business of those agencies and it is rarely undertaken. Government officers may lodge such applications on behalf of primary industry groups, but payment of the appropriate fee is required.

Commercial benefit

Activities for which there is no fee for permit applications include commercial state forestry operations and those which attract a profit from investment and/or the service provided. This includes activities such as commercial research activities undertaken by departments/agencies. It encompasses development of new technologies either through contract research or in-house, and activities which produce intellectual property which may later be sold for profit, or are conducted on a fee-for-service basis.

2.5.   Other requirements

The APVMA has always maintained a policy that it will not issue a minor use permit if a suitable registered product is already available for the purpose requested in the permit application. Therefore, applications that seek a minor use permit where other products are already registered or permitted for that purpose must demonstrate that a genuine need exists for an alternative. This may include demonstrating that the products currently approved are ineffective or unsuitable, or that use of the proposed product offers advantages with respect to integrated pest management (IPM) or integrated resistance management (IRM) strategies.

The APVMA does not consider cost or an applicant’s desire to use a product which the applicant believes poses a lower hazard as justification for the issue of a minor use permit.

3.   GUIDELINES

3.1.   What constitutes an application (single or multiple applications)?

Applications under Category 21 for a minor use permit for a product or active constituent may involve multiple crops, pests/diseases and use regimes.

The APVMA will not generally accept a single application for multiple products involving different active constituents, unless those products depend directly on one another as described above. This is because different active constituents will be subject to different data requirements and assessments and individual applications must be submitted and assessed by the APVMA.

However, the APVMA may agree to undertake an assessment if the applicant can demonstrate that all the following apply:

• close similarities exist between related active constituents (ie in chemistry and mode of action)
• the corresponding assessments will be closely similar
• the assessment is likely to involve an exchange of data between those related active constituents
• subsequent approval may be granted under a single permit.

4.   SPECIFIC DATA REQUIREMENTS

4.1.   Registered products

4.1.1.   Definition of a registered product

A registered product is one which is currently registered by the APVMA, has an approved product label and is available for use in Australia.

4.1.2.   Determining data requirements

Data modules will vary depending upon the nature of the proposed use, how similar or dissimilar the proposed use is to currently approved use patterns, and the relevance of existing regulatory standards. This allows certain data Parts to be exempted (refer to paragraph 4.1.3).

The proposed use of a registered product under a minor use permit will not require the submission of the same level of data as would be required to support the use of an unregistered product, or a new major use for a registered product.

The level and type of data required to support the use of a registered product under a minor use permit are largely determined by the extent of the proposed use and how similar or dissimilar the proposed use is to the registered product’s current approved uses.

4.1.3.   Data exemptions

Applications for minor use permits involving a registered product do not usually require the submission of data with respect to Chemistry and Manufacture (Part 2), Toxicology (Part 3) or Metabolism and Kinetics (Part 4) as these data will have already been provided to the APVMA for registration of the product.

Furthermore, should the proposed minor use be similar to existing registered uses for that product in terms of use regime (ie dose/application rate, frequency, method and environment) data on Occupational Health and Safety (Part 6) and Environment (Part 7) are not usually required because these data will normally have already been assessed by the APVMA for the existing approved use.

Table 2 provides an indication of the data Parts and modules which may be required for various proposed uses, based upon the degree of similarity of the proposed minor use to existing use patterns. For these proposed uses, certain data Parts have been omitted. Should an applicant seek further data exemptions, the applicant must provide scientific reasons to support the exemption of that data Part.

4.1.4.   Module levels

Below is a guide to modules which would be likely to apply to certain Category 21 applications for a minor use permit for use of existing registered products. For further information see Module levels for modular categories in Volume 3.

Part 5  Residues and Trade — Module 5.3 (6 months) or Module 5.5 (3 months)

• Module 5.3 will apply to all new minor use permit applications involving a food crop and where the use requires a maximum residue limit (MRL) to be established (or exemption granted).
• Module 5.5 will apply to minor use permit applications where the use may be covered by an existing MRL or involves the assessment of confirmatory data generated under permit.

Part 6  Occupational Health and Safety — Module 6.3 (4 months)

• Module 6.3 will apply to applications for a minor use that involves a new host (crop or situation), application method, rate, frequency or environment (eg new crop uses in enclosed spaces). However, the module will NOT apply where the use pattern/regime is similar to, or poses a lower risk than existing approved (registered or permit) use patterns in similar crops and/or situations.
• Module 6.1 and 6.2 do NOT apply to applications involving the use of a registered product.

Part 7  Environment — Module 7.3 (4 months)

• Module 7.3 will apply to all applications for a minor use that involve a new host (crop or situation) or application method, rate, frequency or environment (eg irrigated cropping) for an existing registered product. The module will NOT apply where the use pattern/regime is similar to or poses a lower risk than existing approved (registered or permit) use patterns in similar crops and/or situations.
• Module 7.1 and 7.2 do NOT apply to applications involving the minor use of a registered product.

Part 8  Efficacy and Host Crop Safety — Module 8.3 (3 months)

• Module 8.3 will apply to all applications for a minor use that involve a new host (crop or situation), new pest and/or application method, rate, frequency or environment (eg use in enclosed spaces) for an existing registered product.
• Module 8.1 and 8.2 do NOT apply to applications involving the minor use of a registered product.

Screening — Module 1 and Finalisation — Module 11.1 (3 months) or Module 11.3 (2 months)

• Applicants must note that all applications for a minor use permit are also subject to two additional non-technical modules, Screening (Module 1) and Finalisation (Module 11.1 or 11.3).
• Applications that require three or more modular assessments will be subject to Module 11.1, whereas applications requiring one or two modules will be subject to Module 11.3.
• The Screening module does not have a set timeframe.

Notes to Table 2:

The total timeframe is calculated by adding the longest timeframe for Modules 1 to 10 to the finalisation timeframe (Module 11).

Applications for different methods of application such as using different equipment will not be accepted and considered if those uses are not genuine minor uses and where those new methods would not otherwise form part of the product label directions for use due to changed agronomic practices and/or advances in technology.

Table 2:  Registered products: Guide to likely data requirements and timeframes for minor use permits

• Hosts = crops or situations
• Pests = insects, weeds, diseases or other purposes
• Rates = application rate, frequency, method and/or environment

4.2.   Unregistered products

4.2.1.   Definition of an unregistered product

An unregistered product is a product that is NOT currently registered by the APVMA and is NOT available for use in Australia.

Category 21 applications for a minor use permit involving unregistered products will require the submission of significantly more data and be subject to greater assessment than Category 21 applications for a minor use permit for registered products, because regulatory standards and assessments for unregistered products are likely to be either non-existent or limited.

There are two types of unregistered agricultural chemical products:

1. Unregistered products which contain an active constituent which has not undergone previous assessment in Australia
   
   These include active constituents that do not have any regulatory standards established in Australia, are not approved active constituents, have not been previously assessed by the APVMA and/or are not present in an existing registered product in Australia.
   
   

   Only applications that can demonstrate a genuine need for the import and use of an unregistered product will be considered for issue of a Category 21 minor use permit. Applicants must demonstrate that alternative active constituents/products registered by the APVMA (for other purposes) are either unsuitable or ineffective. Therefore, applicants are encouraged to examine products already registered in Australia and seek consideration for minor use permits for those products in the first instance.

2. Unregistered products which contain an active constituent which has undergone previous assessment in Australia
   
   These include active constituents likely to have some regulatory standards established in Australia. They may include an approved active constituent or an active constituent that has previously been assessed by the APVMA and/or may be present in an existing registered product in Australia.
   
   Only applications that can demonstrate a genuine need for the importation and use of an unregistered product will be considered for issue of a Category 21 minor use permit. Such applications must demonstrate that the existing registered products in Australia are either no longer available or are unsuitable for the proposed use. For example, the formulation of a registered product may be unsuitable for the proposed use and method of application and an alternative (unregistered) formulation may be genuinely required.

An applicant must provide information which clearly demonstrates that the proposed product can satisfy the requirements of a minor use as provided in the Guidelines for Determining Minor Uses. The APVMA may consider the potential for requests for the use of that product in crops/situations other than those requested in the application.

The APVMA may determine that the unregistered product does not satisfy the principles of the Guidelines for Determining Minor Uses. If a permit is granted and requests for the use of that product under permit increase, its minor use status may be reconsidered.

4.2.2.   Determining data requirements

As outlined in paragraph 2.2, the APVMA must be satisfied that an application meets the criteria of s.112 of the Agvet Code before it can grant a minor use permit.

Regulatory standards for unregistered products are likely to be either non-existent or limited and the APVMA will therefore require the submission and assessment of more data than for a registered product. In most cases, all or a majority of the data Parts are likely to be required, because either the active constituent and/or product are unlikely to have undergone previous assessment by the APVMA.

However, the APVMA may consider requests for exemption or reductions in the amount of data and level of assessment required (see below).

4.2.3.   Data exemptions

Exemptions or reduced data requirements may apply to unregistered products in some circumstances, depending mainly on the active constituent and its proposed uses.

Toxicological exemptions or reduced data requirements may apply to:

• unregistered products that contain active constituents that have previously been considered by the APVMA and where existing regulatory standards are established (eg poisons schedule, acceptable daily intake (ADI), acute reference dose (ARfD))
• biological chemical products
• products or active constituents supported by an overseas toxicological report.

Environmental exemptions or reduced data requirements may apply to uses in situations such as:

• buildings not used in animal production (eg warehouses, offices, glasshouses)
• treatment of stored produce or goods
• post-harvest applications.

Reduced assessments may also apply to other data Parts such as Residues (Part 5), OHS (Part 6) and Efficacy and Crop Safety (Part 8) where the product, although unregistered, contains an active constituent that has previously been assessed by the APVMA and where that assessment is deemed relevant to the proposed use.

It must also be determined what modules will apply. Commencing at paragraph 4.2.5 is a brief guide to modules that would be likely to apply to certain minor use permit application types for unregistered products. For a definitive determination applicants must refer to Module levels for modular categories in Volume 3.

Table 3 provides an indication of the data Parts and modules that are likely to be required for the four typical types of unregistered products. Should an applicant seek further data exemptions, the applicant must provide supporting scientific reasons.

4.2.4.   Import of unregistered products

Products and/or active constituents which are not registered or approved, and which will be imported into Australia , require a Consent to import unapproved active constituents or unregistered agricultural or veterinary chemical products.

Details on obtaining a consent may be found on the APVMA website at http://www.apvma.gov.au/qa/consent.shtml.

4.2.5.   Module levels

Chemistry (Part 2) - Module 2.2 (8 months) or Module 2.4 (3 months)

• Module 2.2 will apply to minor use permit applications involving a new active constituent, typically in unregistered products which contain an active constituent that has not undergone previous assessment in Australia.
• Module 2.4 will apply to minor use permit applications involving an existing approved active constituent, typically in unregistered products which contain an active constituent that has undergone previous assessment in Australia. For Module 2.4 to apply, the active constituent must be an approved active constituent and/or have current and relevant toxicological standards established (such as poisons scheduling, ADI, ARfD).
• Modules 2.1 and 2.3 do NOT apply to minor use permit applications involving an unregistered product.

Toxicology (Part 3) - Module 3.1 (12 months), Module 3.2 (8 months) or Module 3.3 (4 months)

• Module 3.1 will apply to minor use permit applications involving a new active constituent for use in a food-producing situation, typically in an unregistered product which contains an active constituent that has not undergone previous assessment in Australia.
• Module 3.2 will apply to minor use permit applications involving a new active constituent for use in a non-food-producing situation, typically in an unregistered product which contains an active constituent that has not undergone previous assessment in Australia.
• Module 3.3 will apply to minor use permit applications involving a new active constituent where an overseas report has been supplied; a new active constituent which is a biological chemical product; or an existing active constituent in a new formulation type.

Poisons Scheduling - Module 4 (12 months)

• Poisons scheduling will be required for any active constituent present in an unregistered product where that active constituent does not have a current and relevant poisons schedule classification.

Residues (Part 5) - Module 5.1 (12 months), Module 5.3 (6 months) or Module 5.5 (3 months)

• Module 5.1 will apply to all minor use permit applications involving a new active constituent.
• Module 5.3 will apply to minor use permit applications involving an existing active constituent where the use requires a maximum residue limit (MRL) to be established (or exemption granted).
• Module 5.5 will apply to minor use permit applications where the use may be covered by an existing MRL or involves the assessment of confirmatory data generated under permit.
• Modules 5.2 and 5.4 do NOT apply to minor use permit applications involving the use of an unregistered product.

Occupational Health and Safety (Part 6) - Module 6.2 (6 months) or Module 6.3 (4 months)

• Module 6.2 will apply to all new minor use permit applications involving a new active constituent.
• Module 6.3 will apply to minor use permit applications involving an unregistered product containing an existing active constituent.
• Module 6.1 does NOT apply to minor use permit applications involving the use of an unregistered product.

Environment (Part 7) - Module 7.2 (6 months) or Module 7.3 (4 months)

• Module 7.2 will apply to minor use permit applications involving a new active constituent (Note: also refer to Module 7.3 for certain situations that may qualify for limited assessment).
• Module 7.3 will apply to minor use permit applications involving an unregistered product containing an existing active constituent, or a new active constituent for use in enclosed spaces, on stored produce or for post-harvest treatments.
• Module 7.1 does NOT apply to minor use permit applications involving an unregistered product.

Efficacy and Host Crop Safety (Part 8) - Module 8.1 (5 months) or Module 8.3 (3 months)

• Module 8.1 will apply to all minor use permit applications involving a new active constituent.
• Module 8.3 will apply to minor use permit applications involving an existing active constituent.
• Module 8.2 does NOT apply to minor use permit applications involving an unregistered product.

Screening - Module 1 and Finalisation - Module 11.1 (3 months) or Module 11.3 (2 months) or Module 11.4 (2 months)

Applicants must note that all minor use permit applications are also subject to two additional (non-technical) modules: Screening (Module 1) and Finalisation (Module 11.1, 11.3 or 11.4). Applications that require three or more modular assessments (for example Residues, OHS and Environment) will be subject to Module 11.1. Applications that require one or two modules (for example Residues and Efficacy/Host Safety) will be subject to Module 11.3. Applications that require only a minor chemistry assessment will be subject to Module 11.4. The Screening module does not have a set timeframe.

Table 3:  Unregistered products: Guide to likely data requirements and timeframes for an application for a minor use permit

5.   EXAMPLES

5.1.   Application for a minor use permit for a registered product

Example 1: Application is made for a minor use permit for the off-label use of a registered product, ‘Joe Bloggs Insecticide', on a minor use crop (spring onions) against thrips. The proposed application rate is 100–150 mL product per 100 L water.

‘Joe Bloggs Insecticide’ is a registered product for the control of various thrip species in field and orchard crops such as lettuce, potatoes, brassicas, pome and stone fruit. Approved (label) application rates in these crops range from 100–200 mL product per 100 L water, or 1–2 L product per hectare.

Step 1

Use Table 2 to determine the data Parts and modules required.

Step 2

Determine which data Parts may not apply due to similarity in the proposed use regime to existing registered uses.

Given that the proposed use regime (100–150mL/100L) is within the limits of use regimes already registered (100–200mL/100L), the risks posed to OHS (Part 6) and environment (Part 7) are likely to be no greater than for those uses already approved and therefore would not require assessment. Reasons and justification must be provided in an application seeking the omission of data Parts as included in Table 1 above.

Therefore for this example, the only data requirements will be residues and trade (Part 5) and efficacy and safety (Part 8).

Step 3

Determine which residues and trade module (5.3 or 5.5) will apply.

In this example the application is a new (first-time) application for this use pattern and no relevant MRL exists, therefore Module 5.3 will apply.

Step 4

Calculate the modules and corresponding assessment timeframes that will apply, including the required screening and finalisation modules.

Example 2: Application is made for a minor use permit for the off-label use of a registered product, ‘Joe Bloggs Fungicide’, on a minor crop (rambutans), against Alternaria leaf spot (purple blotch),a fungal disease that is known to affect rambutans. The usage rate will be 1.5L product per hectare.

‘Joe Bloggs Fungicide’ is a registered product and has an approved label claim for the control of various fungal diseases in broad-acre and field crops such as lettuce, brassicas and wheat. Label application rates in these crops range from 500mL to 1L product per hectare.

The product does not have approved label claims in any crop against Alternaria leaf spot.

Step 1

Use Table 2 to determine the data Parts and modules required.

Step 2

Determine which data Parts may not apply due to similarity in the proposed use regime to existing registered uses.

If all the following apply, the application is likely to require assessments of OHS (Part 6) and environment (Part 7):

• The proposed use regime (1.5L/ha) is higher than use regimes already approved (500mL to 1L/ha).
• The product is not approved for use in orchard-type crops.
• Using existing orchard application equipment to apply the product may not have previously been considered.
• The risks from the proposed use may be greater than from those uses already approved.

In this example, significant reasons and justification would be required for these modules to be omitted due to the differences between the proposed and existing approved use patterns. Therefore for this example it is likely that all data Parts will be required.

Step 3

Determine which residues and trade module (5.3 or 5.5) will apply.

In this example the application is a new (first-time) application for this use pattern and no relevant MRL exists, therefore Module 5.3 will apply.

Step 4

Calculate which assessment timeframe will apply, including the screening and finalisation modules:

Example 3: Joe Bloggs Herbicide is a registered product. A minor use permit has previously been issued for the control of broadleaf weeds in linola.

The previous assessment for this minor use permit was subject to the generation of confirmatory residue data. The original permit was issued with only a temporary MRL.

This application is for a minor use permit to ‘renew’ the existing minor use permit.

Step 1

Table 2 cannot be utilised to determine the data Parts and modules required because a previous minor use permit assessment remains valid. In this application, only the Part applicable to the confirmatory data requirement applies, ie residues and trade (Part 5).

Step 2

Determine which data Parts may not apply due to similarity in the proposed use regime to existing registered uses.

As with Step 1, because a previous minor use permit assessment remains valid, only the Part applicable to the confirmatory data requirement applies, ie residues and trade (Part 5).

Therefore for this example, the only data requirements are for residues and trade (Part 5).

Step 3

Determine which residues and trade module (5.3 or 5.5) will apply.

In this example the application is a second-time application for this use pattern with confirmatory data requirements and a relevant (although temporary) MRL in place, therefore Module 5.5 will apply.

Step 4

Calculate the modules and corresponding assessment timeframes that will apply, including the required screening and finalisation modules.

5.2.   Application for a minor use permit for an unregistered product

Example 1: An application is made for a minor use permit for the use of an unregistered product that does not have any associated regulatory standards established in Australia.

The product is Bloggs US Insecticide and it is proposed for use on spring onions (a minor crop) against thrips. The proposed application rate is 100–150 mL product per 100L water.

Bloggs US Insecticide is NOT registered with the APVMA for use in Australia and contains an active constituent NOT previously assessed for use in Australia . No regulatory standards are currently established in Australia for the product or active constituent. The product is, however, registered for use in an overseas country (ie United States).

Step 1

Use Table 3 to determine the data Parts and modules required.

Step 2

Determine whether modules at a lower level than those in Table 3 may apply. For example:

• A reduced toxicological assessment under Module 3.2 may apply if the use is non-food-producing, or Module 3.3 may apply if the application is supported by an overseas report, or involves a biological product.
• A reduced environmental assessment under Module 7.3 may apply if the application is for one of the following:
  • use in a building not used in animal production
  • treatment of stored produce or goods
  • use as a post-harvest application.

In this example the application is for a new active constituent not previously assessed in Australia. It is a synthetic pesticide for use on a food crop and a supporting overseas toxicological report is not provided. Therefore no reduced modules apply to this application.

Example 2: Application is made for a minor use permit for the use of an unregistered product where the active constituent does have some regulatory standards established in Australia.

The requested product is Bloggs UK Fungicide and it is proposed for use on rambutans (a minor crop) against purple blotch. The proposed application rate is 1.5L product per hectare.

Bloggs UK Fungicide is NOT registered for use in Australia although it contains an active constituent that is present in an existing registered product, a furrow spray used in cereals. Therefore, the active constituent has previously been assessed by the APVMA and some regulatory standards are currently established in Australia for the active constituent, including poisons scheduling and an acceptable daily intake.

The product is registered for use in an overseas country (United Kingdom). The reasons provided in support of the permit application are that whilst a product containing the active constituent is registered in Australia (as a furrow spray used in cereals) its formulation is unsuitable for use on rambutans.

Step 1

Use Table 3 to determine the data Parts and modules required.

Step 2

Determine whether modules lower than those in Table 3 may apply. In this example the lowest modules possible already apply for each data Part and no further reductions in module levels are possible.

Example 3: Application is made for a minor use permit for the use of an unregistered product where the active constituent does not have any associated regulatory standards established in Australia, although a supporting overseas report is provided.

The requested product is Bloggs UK Herbicide and it is proposed for use on a minor crop, parsnips, against various annual grasses at 3L product per hectare.

Bloggs UK Herbicide is NOT registered with the APVMA for use in Australia and contains an active constituent NOT previously assessed for use in Australia. No regulatory standards are currently established in Australia for the product or active constituent. The product is registered for use in an overseas country (United Kingdom) and a supporting overseas report has been provided.

Step 1

Use Table 3 to determine the data Parts and modules required.

Step 2

Determine whether modules lower than those listed under Step 1 may apply. For example:

• A reduced toxicological assessment under Module 3.2 (eight months) may apply if the use is for a non-food-producing situation, or Module 3.3 (four months) may apply if the application is supported by an overseas report, or involves a biological product.
• A reduced environmental assessment under Module 7.3 (four months) may apply if the application involves use in a building not used in animal production; treatment of stored produce or goods; or use as a post-harvest application.

In this example the application is for a new active constituent not previously assessed in Australia, it is a synthetically produced pesticide for use on a food crop and a supporting overseas toxicological report is provided. Therefore a reduced toxicological assessment under Module 3.3 will apply to this application.

Footnotes

1. [Table 3] - Reduced toxicological assessment (Module 3.3 – 4 months) may apply where the proposed use involves either an overseas technical report OR a biological chemical product.
2. [Table 3] - Reduced environmental assessment (Module 7.3 – 4 months) may apply where the proposed use involves either use as a treatment for stored produce or goods OR use as a post-harvest application.

Revision history