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Category 23 Application

[1] Application for a research permit.
[2] Application for other permit type.

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 23 application as:

Application for a permit in respect of a chemical product or an active constituent if the application is not of a kind described in items 19 to 21.

A Category 23 application is an application for a permit relating to an agricultural chemical product or active constituent, which is not a permit for export, minor use, emergency use, or renewal or extension of a previously-issued permit. Permits issued under Category 23 are research permits or other (miscellaneous) permits.

Category 23 is a modular category. Data must be provided when a technical assessment is required. Data requirements, the fee payable and timeframe depend on which of the modules are required for assessment of a particular permit application. The modules are described in Module levels for modular categories in Volume 3 and also in the guidelines and examples later in this chapter.

1.1.   Research permit criteria

Research uses may involve either:

• the unapproved (‘off-label’) use of an existing registered agricultural chemical product; or
• the use of an unregistered agricultural chemical product.

For the purposes of an application for a research permit under Category 23, the APVMA defines research to be technical work of an investigative nature which occurs during development of new agricultural chemicals. It includes scientific research or investigation relevant to generating data required by the APVMA for registration or approval and includes:

• screening of potential new active constituents or products
• generating data required by the APVMA 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 active constituent or product is crucial to the conduct of the experiment
• other work determined by the APVMA to be genuine research.

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

• market testing
• supply and use of an unregistered product in order to gain early market access.

Application to the APVMA for a permit to conduct small-scale trials is not required provided that the research use complies with all of the conditions of small-scale trial permit 7250 (including the requirement that no produce resulting from the trial will be made available for human consumption). Permit 7250 may be viewed on the APVMA web site at: http://permits.apvma.gov.au/PER7250.PDF

1.2.   Miscellaneous permits

Category 23 includes an application for a permit that would nullify offences under sections 74, 75, 76, 77, 78, 79, 79A, 79B, 80, 81, 84, 85, 87, 87A, or 91 of the Agvet Code. These sections relate to the possession and supply of active constituents, chemical substances and chemical products, and offences relating to labels and claims.

The most common other (miscellaneous) permit applications under Category 23 include:

• supply of a particular batch or batches of a registered product where the batch does not comply with product specifications
• overstickering of information on the approved label of a registered product.

2.   REQUIREMENTS FOR a RESEARCH PERMIT

When making a Category 23 application for a research permit, applicants must provide all of the following:

• one unbound copy of the combined Permit Application Form and Overview (refer to paragraph 2.1)
• 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. A single unbound copy of the combined document must be provided to the APVMA.

The Application Form is required information and must be completed.

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.

• Application for a Research Permit for an Agricultural Chemical Product - KP25F13
• Application for a Permit for Supply a Batch of Product / Label Oversticker - KP25F14

2.2.   Data

Category 23 applications for research 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.

All Category 23 applications for a research permit 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 following data Parts may be required. The Parts refer to Volume 3: Data requirements and guidelines.

Table 1.  Data Parts and corresponding modules

Data parts	Modules
Part 2     Chemistry and Manufacture	2.2 – 2.4
Part 3     Toxicology	3.1 – 3.3 ± 4
Part 4     Metabolism and Kinetics
Part 5     Residues and Trade	5.1 or 5.3 or 5.5
Part 6     Occupational Health and Safety (OHS)	6.2 or 6.3
Part 7     Environmental Safety	7.1 – 7.3
Part 8     Efficacy and Host Animal Safety	8.1 – 8.3
Part 9     Non-food Trade	9
Part 10   Special Data	10.1 – 10.3

Note: Module 4 is for uses or products which may require poisons scheduling. Poisons scheduling will generally only be applicable to Category 23 applications for unrestricted use of an unapproved active constituent.

2.2.1.   How to determine modules

The data modules required to support an application 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 that 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).

For further guidance on likely data requirements for a range of Category 23 applications for a research permit, see paragraph 4 (registered products) and paragraph 5 (unregistered products).

2.2.2.   Data exemptions

The purpose of a research permit is commonly to screen and/or generate data to support a future regulatory submission. For this reason the APVMA may not require applicants to submit data relating to Part 2 (Chemistry and Manufacture) and Part 8 (Efficacy and Crop Safety). These exemptions will depend on the scale of the proposed research.

For example, large-scale product evaluation trials may require some proof of efficacy and crop safety, to the extent that the proposed use would be likely to be effective and unlikely to result in crop damage (Part 8) and that the formulation would remain stable for the duration of the research (Part 2).

2.3.   Label

2.3.1.   Registered products

For registered products where the research to be conducted is off-label, a leaflet may be produced which contains only information relevant to the off-label use and information required to comply with the requirements of the research permit. This may be limited to the name of the product, an active constituent statement, a directions for use table and any additional instructions pertinent to that use.

Leaflets must also contain the following statement in a prominent position:

FOR RESEARCH USE ONLY THIS USE PATTERN IS NOT REGISTERED

2.3.2.   Unregistered products

For unregistered products, applicants must provide a draft product label that will be attached to the container. This label must be in a format that is consistent with the Ag Labelling Code (see Volume 5: Labelling), as if the product were to be supplied as a registered product.

The label and leaflet must also include the following statement in a prominent position on the main panel of the label:

FOR RESEARCH USE ONLY   THIS PRODUCT IS NOT REGISTERED

If unregistered products are to be used solely by company personnel employed by the permit holder, the APVMA may allow reduced labelling directions if the applicant will provide other material to staff undertaking the use, such as leaflets or a copy of the permit itself.

Full labelling of an unregistered product is required if the applicant will supply the product to collaborators who are not employed by the permit holder, including growers.

2.4.   Fee and timeframe

Category 23 is a modular category, therefore the fee payable and timeframe depend on which of the modules are required for assessment of the application.

The fee for a Category 23 permit application will always include the fees for Module 1 (Screening), plus the relevant Finalisation module (11.1, 11.2, or 11.4).

A fee must accompany a Category 23 application. Applicants may provide the complete fee when submitting the application, or may choose to provide $505 (Screening module fee) when submitting the application and provide the remainder of the fee when requested by the APVMA, after the application passes screening.

To calculate the timeframe assigned to an application, the longest assessment period for the specific data modules should be added to the timeframe for the relevant finalisation module.

The fee and timeframe for each application may be calculated by reference to Module levels for modular categories in Volume 3.

2.4.1.   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.   Consent to import an unapproved active constituent or unregistered chemical product

Active constituents and/or products which are not approved or registered and which will be imported into Australia for manufacture into products for export or for which Australia may be used as a distribution point, 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.

3.   GUIDELINES FOR a RESEARCH PERMIT

3.1.   What constitutes a single application?

For the purposes of Category 23 research permit applications, one application may only involve one of the following:

• one active constituent in a formulated product/s
• product/s formulated containing combined active constituents
• multiple active constituents present in different products where those products depend directly upon one another (ie either used in combination or in succession) to achieve the required level of efficacy against the target pest/disease.

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.

Applications for a product or active constituent described above may, involve multiple crops, pests/diseases and use regimes (but not vice-versa).

4.   RESEARCH PERMIT FOR A REGISTERED PRODUCT

4.1.   Determining data requirements

Data modules will depend 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 provides a capacity in some instances for certain data Parts to be exempted (see below).

4.1.1.   Data exemptions

Category 23 applications for research permits involving a registered product may not require the submission of all data Parts. Exemptions from submission of data may be considered in the following circumstances:

• chemistry and manufacture (Part 2), toxicology (Part 3) or metabolism and kinetics (Part 4) where these data have already been provided to and assessed by the APVMA for registration of the product
• occupational health and safety (Part 6) and/or environment (Part 7) where the proposed research is similar to existing registered uses for that product in terms of use regime (ie application rate, frequency, method and environment) and has already been assessed by the APVMA for use under similar situations and use regimes
• occupational health and safety (Part 6) and/or environment (Part 7) where it can be demonstrated that the risks associated with the proposed research are low, acceptable and/or manageable. Safety measures may include restrictions in the area to be treated, duration of use, method of application and persons conducting the research
• efficacy and crop safety (Part 8) where the purpose of the research is to generate such data. However, the APVMA may require some proof of efficacy and crop safety, to the extent that the proposed use would be likely to be effective and unlikely to result in crop damage should the proposed scale of research be considered significantly large to warrant such assessment.

Therefore, the proposed use of a registered product under a research permit may not require the submission of as much data as would be required to support research with an unregistered product. The type and level of data required to support the use of a registered product under a research permit are largely determined by existing regulatory standards, the scale and duration of the proposed research, persons undertaking the research and how similar or dissimilar the proposed use is to the product’s currently approved uses.

While toxicology data may not be required in a majority of cases, exemption will still depend upon established toxicological standards relevant to the proposed use. For example, research proposals which involve a movement from non-food to food-producing situations and where an acceptable daily intake (ADI) has not been established will require a toxicological assessment (see paragraph 4.4, example 5).

Table 2 shows the data Parts and modules that are typically required for various proposed uses based upon similarities of the proposed research to existing (label) use patterns. For the range of situations described in Table 2, certain data Parts have been omitted (exempted) where these would typically not be required. Should further data exemptions be sought for reasons similar to those described above (ie for OHS and environment), an applicant must provide valid reasons to support those exemptions.

Table 2.   Registered products: Guide to likely data requirements and timeframes for research permits

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

Identical to label	Different from label	Data Parts required	Modules required	Total timeframe
Hosts & rates	Different rate (eg higher or more frequent applications)	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months
Hosts & pests	Different method of application (eg change from ground to aerial application or foliar to post-harvest)	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months
Hosts & pests	Different method of application (eg change from ground to aerial application or foliar to post-harvest)	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months
Pests	Hosts (non-food)	OHS (Part 6) Environment (Part 7)	6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	7 months
Pests	Hosts (food)	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months
Rates	Hosts & Pests	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months
Rates	Hosts, Pests & Rates	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months
Rates	Hosts & pests	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7) Efficacy & Safety (Part 8)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 8.3 (3 months) 1 (0 months) 11.1 (3 months)	9 or 7 months
No identical use to label	Hosts, pests & rates	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7) Efficacy & Safety (Part 8)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 8.3 (3 months) 1 (0 months) 11.1 (3 months)	9 or 7 months

Note: Applications for different methods of application such as using different equipment will not be 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.

4.2.   Modules and module levels

Below is a brief guide to modules that are likely to apply to certain Category 23 applications for a research permit for use of existing registered products. Further information is provided in 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 research 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 research 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 research permit that involves a new host (crop or situation), application method, rate, frequency or environment (ie 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.
• Modules 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 research permit 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.
• Modules 7.1 and 7.2 do NOT apply to applications involving a research permit for a registered product.

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

• Module 8.3 will apply to all applications for a research permit 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.
• Modules 8.1 and 8.2 do NOT apply to applications involving a research permit for a registered 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 applications for a research permit are also 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 will be subject to Module 11.1, whereas applications requiring one or two modules will be subject to Module 11.3. Applications that require only a minor chemistry assessment will be subject to Module 11.4.

4.3.   Examples

 

Example 1: Application is made for a research permit for the use of a registered product, Joe Bloggs Insecticide, on a new crop (bananas) against thrips at an application rate of 2–3L product per hectare. The proposed scale of the trial is a total of 12 sites across two States (NSW and Queensland) where each trial site will not exceed two hectares (24 hectares total). Application will be undertaken by a mix of growers and company personnel.

Joe Bloggs Insecticide has approved label uses 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 100L water, or 1–2L product per hectare.

Step 1

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

Identical to label	Different from label	Data Parts required	Modules required	Total timeframe
No identical use to label	Hosts, pests & rates	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7) Efficacy & Safety (Part 8)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 8.3 (3 months) 1.0 (0 months) 11.1 (3 months)	9 or 7 months

Step 2

Determine which data Parts may not apply (see paragraph 4.1.1, Data exemptions).

Given that the proposed use regime (2–3L/ha) is above the limits of use regimes already registered (1–2L/ha), the risks posed to OHS (Part 6) and Environment (Part 7) are likely to be greater than for uses already approved and are likely to require assessment. A Residues and Trade (Part 5) assessment will be necessary as the use is for a new food crop.

Therefore for this example, applicants must address Residues and Trade (Part 5), OHS (Part 6) and Environment (Part 7).

An applicant seeking exemptions from OHS and environment requirements in this example must provide evidence to show that the proposed higher application rate would not pose an unacceptable risk to users or the environment.

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) crop 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:

Module	Description	Timeframe	Fee
Module 1	Screening	N/A	$505
Module 5.3	Residues – Level 3	6 months	$2,490
Module 6.3	OHS – Level 3	4 months	$1,435
Module 7.3	Environment – Level 3	4 months	$620
Module 11.1	Finalisation – Type 1	3 months	$2,230
	Total timeframe & fee	9 months	$6,620

 

Example 2: Application is made for a research permit for the use of a registered product, Joe Bloggs Fungicide, on a new crop, barley, against rust at an application rate of 2L product per hectare. The proposed scale of the trial is for a total of 18 sites across three States, where each site would not exceed 20 hectares (360 hectares).

Joe Bloggs Fungicide has approved label uses for the control of rust in wheat at the same application rates of 2L product per hectare. An MRL only exists for this use on wheat at 1.0 mg/kg.

Step 1

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

Identical to label	Different from label	Data Parts required	Modules required	Total timeframe
Pests	Hosts (food)	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months

Step 2

Determine which Parts may not apply due to similarity of the proposed use regime to existing registered uses (see paragraph 4.1.1, Data exemptions).

Given that the proposed use regime (2L/ha) is the same as for wheat, the proposed use will not require an OHS (Part 6) or Environment (Part 7) assessment. A Residues and Trade (Part 5) assessment will be necessary because the use is for a new food crop.

Therefore for this example the applicant must address only 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 new crop 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:

Module	Description	Timeframe	Fee
Module 1	Screening	N/A	$505
Module 5.3	Residues – Level 3	6 months	$2,490
Module 11.3	Finalisation – Type 3	2 months	$620
	Total timeframe	8 months	$3,290

 

Example 3: Application is made for a research permit for the use of a registered product, Joe Bloggs Herbicide, on new oilseed crops linola, linseed, safflower and sunflower for pre-emergent weed control at an application rate of 800mL product per hectare. The proposed scale of the trial is a total of 32 sites across four States (NSW, Victoria, SA and Queensland ) where each trial site will not exceed 25 hectares (800 hectares total). Application will be undertaken by growers and company personnel.

Joe Bloggs Herbicide has approved label uses for pre-emergent weed control in cotton, canola and soybeans. An existing group MRL is established for the active constituent in oilseeds at *0.05mg/kg. The proposed use regime is identical to that already registered for use in the other oilseed crops.

Step 1

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

Identical to label	Different from label	Data Parts required	Modules required	Total timeframe
Pests	Hosts (food)	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months

Step 2

Determine which Parts may not apply due to similarity of the proposed use regime to existing registered uses (see paragraph 4.1.1, Data exemptions).

Given that the proposed use regime (800mL/ha) is the same as for other oilseeds the proposed use will not require an Occupational Health & Safety (Part 6) or Environment (Part 7) assessment. A Residues and Trade (Part 5) assessment will be necessary as the use involves new food crops.

Therefore for this example the applicant need only address Residues and Trade (Part 5).

Step 3

Determine which Residues and Trade module (5.3 or 5.5) will apply.

In this example whilst the application is for use in new oilseed crops a relevant MRL is likely to exist, 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:

Module	Description	Timeframe	Fee
Module 1	Screening	N/A	$505
Module 5.5	Residues – Level 5	3 months	$1,175
Module 11.3	Finalisation – Type 3	2 months	$620
	Total timeframe	5 months	$2,095

 

Example 4: Application is made for a research permit for the use of a registered product, Dippers Insecticide, on brassica vegetables for diamond back moth at an application rate of 250–400mL product per hectare. The proposed scale of the trial is a total of 24 sites across four States (NSW, Tasmania, SA and WA) where each trial site will not exceed five hectares (120 hectares total). Product will be applied by growers and company personnel.

Dippers Insecticide has approved label uses for the post-harvest treatment of citrus and mangoes.

Step 1

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

Identical to label	Different from label	Data Parts required	Modules required	Total timeframe
No identical use to label	Hosts, pests & rates	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7) Efficacy & Safety (Part 8)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 8.3 (3 months) 1 (0 months) 11.1 (3 months)	9 or 7 months

Step 2

Determine which Parts may not apply due to similarity of the proposed use regime to existing registered uses (see paragraph 4.1.1, Data exemptions).

Given that the proposed use regime is for field use and the product has only previously been considered by the APVMA for use as a post-harvest dip, no similarities exist between the proposed and existing approved use pattern. Occupational Health and Safety (Part 6) and Environment (Part 7) assessments will be required. A Residues and Trade (Part 5) assessment will be necessary because the use involves new food crops.

Therefore for this example the applicant must address Parts 5, 6 and 7.

Step 3

Determine which Residues and Trade module (5.3 or 5.5) will apply.

In this example the application is for use in new crops 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:

Module	Description	Timeframe	Fee
Module 1	Screening	N/A	$505
Module 5.3	Residues – Level 3	6 months	$2,490
Module 6.3	OHS – Level 3	4 months	$1,435
Module 7.3	Environment – Level 3	4 months	$620
Module 11.1	Finalisation – Type 1	3 months	$2,230
	Total timeframe & fee	9 months	$6,620

 

Example 5: Application is made for a research permit for the use of a registered product, Ratters Rodent Buster, in cereals, oilseeds, pulses, vegetables and orchard crops for the control of rodents. The product is broadcast at 1.5kg bait product per hectare. The proposed scale of the trial is a total of 25 sites across three States (NSW, SA & Queensland) where each trial site will not exceed 15 hectares (375 hectares total). Growers and company personnel will apply the product.

Ratters Rodent Buster has approved label uses for the control of rodents in and around agricultural buildings and the home, for use in bait stations only.

Previous toxicological assessments for this product, for use in non-food-producing situations, have not included the establishment of an ADI.

Step 1

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

Identical to label	Different from label	Data Parts required	Modules required	Total timeframe
Rates	Hosts and Pests	Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	5.3 or 5.5 (6 or 3 months) 6.3 (4 months) 7.3 (4 months) 1 (0 months) 11.1 (3 months)	9 or 7 months

Step 2

Determine which Parts may not apply due to similarity of the proposed use regime to existing registered uses (see paragraph 4.1.1, Data exemptions).

Given that the proposed use regime is for broadcast field use and the product has only previously been considered by the APVMA for use in bait stations, no close similarities exist between the proposed and existing approved use patterns. Occupational Health & Safety (Part 6) and Environment (Part 7) assessments will be required. A Residues and Trade (Part 5) assessment will be necessary because the application involves use in new food crops.

Additionally, as previous toxicological assessments have not established an ADI for the active constituent, a toxicological assessment (Part 3) will be required.

Therefore for this example data will be required to address Toxicology (Part 3), Residues and Trade (Part 5), OHS (Part 6) and Environment (Part 7).

Step 3

Determine which Toxicology (Part 3) and Residues and Trade (Part 5) modules will apply.

In this example the application is for use in new crops and no relevant MRL exists, therefore Module 5.3 will apply.

In accordance with Module levels for modular categories in Volume 3, the product involves an existing active constituent for extension from non-food to a food-producing situation, therefore Module 3.2 will apply.

Step 4

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

Module	Description	Timeframe	Fee
Module 1	Screening	N/A	$505
Module 3.2	Toxicology – Level 2	8 months	$14,620
Module 5.3	Residues – Level 3	6 months	$2,490
Module 6.3	OHS – Level 3	4 months	$1,435
Module 7.3	Environment – Level 3	4 months	$620
Module 11.1	Finalisation – Type 1	3 months	$2,230
	Total timeframe & fee	11 months	$19,910

Note: Overseas toxicological report. In this example, should an overseas toxicological report be available (containing appropriate data in order to establish an ADI) an applicant may request a reduced toxicological assessment under Module 3.3, with a four-month assessment timeframe and fee of $2,900. This would alter the total timeframe to nine months with a fee of $8,985.

5.   RESEARCH PERMIT FOR AN UNREGISTERED PRODUCT

Applications for research permits involving unregistered products will require the submission of significantly more data and be subject to greater assessment than research permit applications for registered products since 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 that 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.
2. Unregistered products which contain an active constituent that 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.

5.1.   Determining data requirements

An application must satisfy certain legislative criteria prior to a research permit being granted and in doing so data in accordance with some or all of Parts 1–10 (see Table 1) must be provided to the APVMA.

5.1.1.   Data exemptions

Data requirements will vary according to application types.

Unregistered products will generally require the submission of all data Parts (Parts 1–10). Exemptions may apply to certain applications, such as where the research involves only company personnel, the scale and duration of the trial are very limited and/or the use is non-food-producing (including destruction of treated produce).

Applicants seeking an exemption from any data Part for an active constituent that has not undergone previous assessment in Australia must provide valid reasons to support the exemption. Each case will be assessed on its merits and applicants seeking data exemptions should discuss these with the APVMA prior to application.

In summary, the type and level of data required to support the use of an unregistered product under a Category 23 research permit are largely determined by existing regulatory standards, the scale and duration of the proposed research, the qualifications and experience of persons undertaking the research and how similar or dissimilar the formulated product and its proposed uses are to registered products containing that active constituent.

Whilst toxicology data (Part 3) may not be required in a majority of cases for unregistered products containing an approved active constituent, this will still depend on established toxicological standards relevant to the proposed research. For example, research proposals which involve extension of an active constituent’s use from non-food to food-producing situations and where an ADI has not been established will require a toxicological assessment.

To provide guidance to applicants on likely data requirements, Table 3 provides an indication of the data Parts and modules that are typically required for various research proposals based upon similarities of the proposed research to existing (label) use patterns.

5.2.   Modules and module levels

In addition to determining the data Parts that apply to a Category 23 application, an applicant must determine what modules will apply to the corresponding data Part.

A brief guide to modules that would be likely to apply to certain research permit application types for unregistered products is provided below. For further information, see Module levels for modular categories in Volume 3.

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

Module 2.2 will apply to research permit applications involving a new active constituent, typically for unregistered products which contain an active constituent that has not undergone previous assessment in Australia.

Module 2.4 will apply to research permit applications involving an existing active constituent, typically for unregistered products which contain an active constituent that has undergone previous assessment in Australia.

To be eligible for assessment under Module 2.4 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 research 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 research permit applications involving a new active constituent for use in a food-producing situation, typically for unregistered products which contain an active constituent that has not undergone previous assessment in Australia.

Module 3.2 will apply to research permit applications involving a new active constituent contained in an unregistered product that has not undergone previous assessment in Australia, where the use is for one of the following:

• a non-food-producing situation
• a food-producing situation involving restricted and limited use (eg single season/single use/specified research personnel only).

Module 3.3 will apply to research permit applications involving one of the following:

• a new active constituent where an overseas report has been supplied
• a new active constituent that is a biological chemical product
• an existing active constituent in a new formulation type.

Toxicology (Part 4) – Scheduling (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 and Trade (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 research permit applications involving a new active constituent for use in a food-producing situation.

Module 5.3 will apply to research permit applications involving an existing active constituent where the use requires an MRL to be established (or exemption granted).

Module 5.5 will apply to research 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 research 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 research permit applications involving a new active constituent.

Module 6.3 will apply to research permit applications involving an unregistered product containing an existing active constituent. However, Module 6.3 will NOT apply where the use pattern/regime is similar to or posing a lower risk than existing approved (registered or permit) use patterns in similar crops and/or situations with an existing formulation type.

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

Module 7.2 will apply to research permit applications involving a new active constituent (Note: also refer to Module 7.3 for certain situations that may qualify for a limited assessment).

Module 7.3 will apply to research permit applications involving an unregistered product containing one of the following:

• an existing active constituent
• a new active constituent for use in enclosed spaces, on stored produce or for post-harvest treatments.

Module 7.1 does NOT apply to research permit applications involving an unregistered product.

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

The APVMA will generally not require the submission of Part 8 data because one of the primary objectives of conducting research is to generate efficacy and crop safety data. The APVMA may require some evidence of efficacy and crop safety, to the extent that the proposed use would be likely to be effective and unlikely to result in crop damage, should the proposed scale of research be considered large enough to warrant such assessment. In these instances only Module 8.3 will apply.

Module 8.1 and Module 8.2 do NOT apply to research 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 should note that all research 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, whereas applications requiring one or two modules (for example Residues and Environment) will be subject to Module 11.3. Applications that require only a minor chemistry assessment will be subject to Module 11.4.

5.3.   Likely data requirements

The types of research permits and applicable data Parts, modules and fees required can vary considerably. The following tables provide a guide to the likely data requirements and fees that will apply to certain types of applications.

Applications under Category 23 for research permits fall into four principal groups:

• new active constituent used in a food-producing crop
• new active constituent used in a non-food-producing crop
• existing active constituent in a food-producing crop
• existing active constituent in a non-food-producing crop.

Table 3 shows the maximum data requirements that would apply to these application groups.

Table 3.  Unregistered products: Guide to likely data requirements and timeframes for research permits

Product (unregistered)	Data Parts required to support the application	Data modules	Fee	Time-frame
New active constituent, food-producing crop   For further examples including reduced data requirements that may apply, refer to Table 3.1	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.1 (12 mths)   5.1 (12 mths) 6.2 (6 mths) 7.2 (6 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $19,490   $5,595 $2,900 $3,255   $505 $3,720 $2,230 $36,290	15 months
New active constituent, non-food-producing crop   For further examples including reduced data requirements that may apply refer to Table 3.2	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.2 (8 mths)   6.2 (6 mths) 7.2 (6 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $14,620   $2,900 $3,255   $505 $3,720 $2,230 $26,775	15 months
Existing active constituent, food-producing crop   For further examples including reduced data requirements that may apply refer to Table 3.3	Chemistry (Part 2) Residues & Trade (Part 5) OHS (Part 6)   Environment (Part 7)	2.4 (3 mths) 5.3 (6 mths) 6.3 (4 mths) 7.3 (4 mths) + 1 11.1 (3 mt hs) TOTAL	$200 $2,490 $1,435 $620   $505 $2,230 $6,800	9 months
Existing active constituent, non-food-producing crop   For further examples including reduced data requirements that may apply refer to Table 3.4	Chemistry (Part 2) OHS (Part 6)      Environment (Part 7)	2.4 (3 mths) 6.3 (4 mths) 7.3 (4 mths) + 1 11.3 (2 mths) TOTAL	$200 $1,435 $620   $505 $620 $3,075	6 months

Table 3.1:  New active constituent for use in a food-producing crop: reduced assessment based upon different permit types/situations

	Data Parts required to support the application	Data modules	Fee	Timeframe
Full assessment – as provided in Table 3 above use by persons generally	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7) Screening (Module 1) Scheduling (Part 4) Finalisation (Module 11)	2.2 (8 mths) 3.1 (12 mths) 5.1 (12 mths) 6.2 (6 mths) 7.2 (6 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $19,490 $5,595 $2,900 $3,255 $505 $3,720 $2,230 $36,290	15 months
Reduced assessment use by company personnel only AND involves single season/single use	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) Environment (Part 7)	2.2 (8 mths) 3.2 (8 mths) 5.1 (12 mths) 7.2 (6 mths) + 1 11.1 (3 mths) TOTAL	$2,230 $14,620 $5,595 $3,255 $505 $2,230 $25,845	15 months
Reduced assessment: use by company personnel only AND includes either overseas toxicological report supplied OR a biological chemical product	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) Environment (Part 7)	2.2 (8 mths) 3.3 (4 mths) 5.1 (12 mths) 7.2 (6 mths) + 1 11.1 (3 mths) TOTAL	$2,230 $2,900 $5,595 $3,255 $505 $2,230 $15,190	15 months
Reduced assessment: use by persons generally AND includes either overseas toxicological report supplied OR a biological chemical product	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.3 (4 mths) 5.1 (12 mths) 6.2 (6 mths) 7.2 (6 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $2,900 $5,595 $2,900 $3,255 $505 $3,720 $2,230 $21,205	15 months
Reduced assessment: use by persons generally AND includes either use as a treatment for stored produce or goods OR use as a post-harvest application	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.1 (12 mths) 5.1 (12 mths) 6.2 (6 mths) 7.3 (4 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $19,490 $5,595 $2,900 $620 $505 $3,720 $2,230 $33,895	15 months
Reduced assessment: use by company personnel only AND includes either use as a treatment for stored produce or goods OR use as a post-harvest application AND includes either overseas toxicological report supplied OR a biological chemical product	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) Environment (Part 7)	2.2 (8 mths) 3.3 (4 mths) 5.1 (12 mths) 7.3 (4 mths) + 1 11.1 (3 mths) TOTAL	$2,230 $2,900 $5,595 $620 $505 $2,230 $12,795	15 months

Table 3.2:  New active constituent for use in a non-food-producing crop: reduced assessment based upon different permit types/situations

Product (unregistered)	Data Parts required to support the application	Data modules	Fee	Timeframe
Full assessment – as provided in Table 3 above use by persons generally	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.2 (8 mths) 6.2 (6 mths) 7.2 (6 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $14,620 $2,900 $3,255 $505 $3,720 $2,230 $26,775	15 months
Reduced assessment use by company personnel only AND includes either single season/single use OR overseas toxicological report supplied OR biological chemical product	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Environment (Part 7)	2.2 (8 mths) 3.3 (4 mths) 7.2 (6 mths) + 1 11.1 (3 mths) TOTAL	$2,230 $2,900 $3,255 $505 $2,230 $10,105	11 months
Reduced assessment: use by persons generally AND includes either overseas toxicological report supplied OR biological chemical product	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.3 (4 mths) 6.2 (6 mths) 7.2 (6 mths) + 1 4.0 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $2,900 $2,900 $3,255 $505 $3,720 $2,230 $16,120	15 months
Reduced assessment: use by company personnel only AND includes either use as a treatment for stored produce or goods OR use as a post-harvest application AND includes overseas toxicological report supplied OR involves a biological chemical product	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Environment (Part 7)	2.2 (8 mths) 3.3 (4 mths) 7.3 (4 mths) + 1 11.1 (3 mths) TOTAL	$2,230 $2,900 $620 $505 $2,230 $7,710	11 months

Table 3.3:  Existing active constituent for use in a food-producing crop: reduced assessment based upon different permit types/scenarios

	Data Parts required to support the application	Data modules	Fee	Timeframe
Full assessment: use by persons generally	Chemistry (Part 2) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	2.4 (3 mths) 5.3 (6 mths) 6.3 (4 mths) 7.3 (4 mths) + 1 11.1 (3 mths) TOTAL	$200 $2,490 $1,435 $620 $505 $2,230 $6,800	9 months
Reduced assessment: use by company personnel only	Chemistry (Part 2) Residues & Trade (Part 5) Environment (Part 7)	2.4 (3 mths) 5.3 (6 mths) 7.3 (4 mths) + 1 11.3 (2 mths) TOTAL	$200 $2,490 $620 $505 $620 $4,035	8 months
Reduced assessment: use by company personnel only AND where the use does not require an environmental assessment	Chemistry (Part 2) Residues & Trade (Part 5)	2.4 (3 mths) 5.3 (6 mths) + 1 11.3 (2 mths) TOTAL	$200 $2,490 $505 $620 $3,470	8 months
Reduced assessment: use by company personnel only AND the use does not require an environmental assessment AND an existing MRL is established for the commodity	Chemistry (Part 2) Residues & Trade (Part 5)	2.4 (3 mths) 5.5 (3 mths) + 1 11.3 (2 mths) TOTAL	$200 $1,175 $505 $620 $2,275	5 months
Reduced assessment: use by persons generally AND the product formulation has established First Aid & Safety Directions AND the use does not require an environmental assessment	Chemistry (Part 2) Residues & Trade (Part 5)	2.4 (3 mths) 5.3 (6 mths) + 1 11.3 (2 mths) TOTAL	$200 $2,490 $505 $620 $3,470	8 months
Reduced assessment: use by persons generally AND the product formulation has established First Aid & Safety Directions AND the use does not require an environmental assessment AND an existing MRL is established for the commodity	Chemistry (Part 2) Residues & Trade (Part 5)	2.4 (3 mths) 5.5 (3 mths) + 1 11.3 (2 mths) TOTAL	$200 $1,175 $505 $620 $2,275	5 months

Table 3.4:  Existing active constituent for use in a non-food-producing crop: reduced assessment based upon different permit types/situations

	Data Parts required to support the application	Data modules	Fee	Timeframe
Full assessment use by persons generally	Chemistry (Part 2) OHS (Part 6) Environment (Part 7)	2.4 (3 mths) 6.3 (4 mths) 7.3 (4 mths) + 1 11.3 (2 mths) TOTAL	$200 $1,435 $620 $505 $620 $3,075	6 months
Reduced assessment: use by company personnel only	Chemistry (Part 2) Environment (Part 7)	2.4 (3 mths) 7.3 (4 mths) + 1 11.3 (2 mths) TOTAL	$200 $620 $505 $620 $1,770	6 months
Reduced assessment: use by persons generally AND the product formulation has established First Aid & Safety Directions AND the use does not require an environmental assessment	Chemistry (Part 2)	2.4 (3 mths) + 1 11.4 (2 mths) TOTAL	$200 $505 $160 $785	5 months

5.4.   Examples

 

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

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

Bloggs US Insecticide is NOT registered for use in Australia and contains an active constituent NOT previously assessed for use in Australia and no regulatory standards are currently established in Australia for the product or active constituent. The product is registered for use in the United States.

Step 1

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

Product (unregistered)	Data Parts required to support the application	Data modules	Fee	Timeframe
New active constituent, food-producing crop	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.1 (12 mths) 5.1 (12 mths) 6.2 (6 mths) 7.2 (6 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $19,490 $5,595 $2,900 $3,255 $505 $3,720 $2,230 $36,290	15 months

Step 2

Determine whether modules lower than those required above 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 not provided. Therefore no reduced assessments/modules apply to this application.

 

Example 2: Application is made for a research 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 a minor crop, custard apples, against purple blotch at an application rate of 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 product registered in Australia and has previously been assessed by the APVMA. Some regulatory standards are currently established in Australia for the active constituent, including poisons scheduling and an ADI.

The product is registered for use in the United Kingdom.

The reasons provided in support of the application are that whilst a product containing the active constituent is registered in Australia (as an in-furrow spray in cereals) that product’s formulation is unsuitable for use on custard apples as proposed.

Step 1

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

Product (unregistered)	Data Parts required to support the application	Data modules	Fee	Timeframe
Existing active constituent, food-producing crop	Chemistry (Part 2) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	2.4 (3 mths) 5.3 (6 mths) 6.3 (4 mths) 7.3 (4 mths) + 1 11.1 (3 mths) TOTAL	$200 $2,490 $1,435 $620 $505 $2,230 $6,800	9 months

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 research 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 an application rate of 3L product per hectare.

Bloggs UK Herbicide is NOT registered for use in Australia and contains an active constituent NOT previously assessed for use in Australia and no regulatory standards are currently established in Australia for the product or active constituent.

The product is registered for use in the United Kingdom and a supporting overseas report has been provided.

Step 1

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

Product (unregistered)	Data Parts required to support the application	Data modules	Fee	Timeframe
New active constituent, food-producing crop	Chemistry (Part 2) Toxicology (Part 3) Metabolism (Part 4) Residues & Trade (Part 5) OHS (Part 6) Environment (Part 7)	2.2 (8 mths) 3.1 (12 mths) 5.1 (12 mths) 6.2 (6 mths) 7.2 (6 mths) + 1 4 (12 mths) 11.1 (3 mths) TOTAL	$2,230 $19,490 $5,595 $2,900 $3,255 $505 $3,720 $2,230 $36,290	15 months

Step 2

Determine whether modules lower than those required above 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 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 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.

6.   OTHER (MISCELLANEOUS) PERMITS

Category 23 includes an application for a permit that would nullify offences under sections 74, 75, 76, 77, 78, 79, 79A, 79B, 80, 81, 84, 85, 87, 87A, or 91 of the Agvet Code. These sections relate to the possession and supply of active constituents, chemical substances and chemical products, and offences relating to labels and claims.

The most common other (miscellaneous) permit applications under Category 23 include:

• supply of a particular batch or batches of a registered product where the batch does not comply with product specifications
• overstickering of information on the approved label of a registered product.

Applications for a permit under Category 23 may include compliance permits relating to the possession and supply of active constituents, chemical substances and chemical products, and other situations relating to labels and claims where an offence would be committed against the Agvet Code unless the APVMA has issued a permit. The relevant modules will apply if assessment of associated data is required. If no technical assessment is required, or if the application can be assessed at screening, only screening (Module 1) and finalisation (Module 11.4) modules will apply.

When making an application under Category 23 for a permit of this nature, applicants must provide:

• a covering letter that includes the purpose and justification for the permit application
• one bound copy of each of the relevant data Parts (refer to paragraph 2.3)
• the relevant fee (refer to paragraph 2.5).

All applications for a permit relating to a particular batch of a registered product will be assessed on their merits. The relevant modules will apply if assessment of associated data is required. If no technical assessment is required, or if the application can be assessed at screening, only screening (Module 1) and finalisation (Module 11.4) modules will apply.

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