Category 11 application
Extension of use to include a new major food crop

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 11 application as:

Application to vary particulars or conditions of registration or label approval where the variation is to extend the use of the chemical product to a new major food crop.

A Category 11 application is to extend the use of a chemical product from use in one or more major food crops, to use in a new major food crop.

Applications to extend the use of a chemical product from a non-food-producing situation to a food-producing situation for the first time for the active constituent, are ineligible for assessment under Category 11 and will be assessed under modular Category 14.

1.1.   Major food crop

The APVMA has defined those crops (including pasture) which are grown for the purpose of producing food for human or livestock consumption, and which are major food crops. The definition is on the APVMA website at Guidelines for determining minor uses. Table 1 lists the major food crops.

Table 1:  Major food crops

2.   REQUIREMENTS

When making a Category 11 application for variation to the particulars or conditions of registration of a product and label approval, applicants must provide:

• one unbound copy of the combined Application Form and Overview (refer to paragraph 2.1)
• one bound copy of each of the relevant data Parts (refer to paragraph 2.2)
• the product label (refer to paragraph 2.3)
• the relevant fee (refer to paragraph 2.4)
• a data list (refer to paragraph 2.6).

2.1.   Combined Application Form and Overview

The Application Form and Overview have been combined into a single document (KP25F08) 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 10 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.

Sub-parts 1.1–1.10 of the Application Overview must all be completed.

Any Category 11 application may also include Category 12 or 13 variations, or variations permitted without an application under Permit 6868. In such cases the registrant must declare those changes in the Application Overview and must meet all draft label requirements for Category 12 or 13 applications.

2.2.   Data

Data requirements for Category 11 applications are as follows:

* Category 11 is a fixed category for which the fee and timeframe are predetermined. Although Category 11 is not a modular category, the required data studies correspond with those described in Module levels for modular categories in Volume 3.

Applicants may choose to submit scientific argument not to submit certain studies. An example is where the product is of biological origin and of low toxicological significance such that a maximum residue limit (MRL) is not required to be set and therefore residue trial data are not necessary for assessment. If the APVMA accepts that the argument is valid, those studies need not be submitted. However the application will remain in Category 11 and the fee will remain the same.

Applications to extend the use of a product from a non-food-producing situation to use in a food crop for the first time for the active constituent are ineligible for assessment under Category 11. This is because a toxicology assessment is likely to be required to establish an acceptable daily intake (ADI). Such applications require submission of toxicology data and will be assessed under modular Category 14.

A single Category 11 application may include more than one variation, for example extension to multiple crops and a technical label change involving application methods. However, this is only allowable where the data modules described above encompass these variations. If there are deficiencies or data requirements relating to only one of these assessments, the APVMA cannot grant any of the variations contained in that application until all deficiencies or requirements have been addressed satisfactorily, or the deficient use is removed from the label to be approved.

If data deficiencies can only be satisfied by the generation of new data (eg by conducting new trials), applicants must make a separate new modular application (which will include screening, finalisation and relevant data modules and fees), in order to seek approval for the use that is subject to deficiencies or requirements. Argument and clarification using existing data are acceptable under the original application.

2.3.   Label

Applicants must provide a label with the Application Form and Overview. The APVMA recommends that the label be in draft form so that it can be amended if necessary, however applicants may choose to submit the marketed product label (MPL).

Applicants may provide the draft label as either:

• two copies of the text label (TXL) printed on paper; or
• an e-label on CD. The CD must be attached to the Application Form and Overview and not submitted separately or by email.

The draft label must include all label components ie primary pack, immediate container and leaflet, as relevant.

All parts of the draft label must be in accordance with the latest editions of the:

• Labelling Code; and
• Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); and
• Handbook of First Aid Instructions and Safety Directions (FAISD Handbook).

After the APVMA has assessed the draft label and is satisfied that the label is acceptable, the APVMA will ask the applicant to provide an e-label of the MPL for approval. If the MPL is acceptable and all other matters relevant to the application are acceptable, the APVMA will approve the label and grant the application.

Refer to Label Approval Process in Volume 5 for further information.

2.4.   Fee and timeframe

The fee for a Category 11 application is $14,260.

The timeframe is eight months.

2.5.   Public consultation

Prior to granting the application for variation, the APVMA will conduct a round of public consultation. This is normally by means of publication of a Gazette Notice called a Public Release Summary (PRS) which invites comment on the APVMA’s intention to approve the variation.

Category 11 applications involve products intended for use in crops that may result in residues in food or animal commodities. Therefore the APVMA will publish a Trade Advice Notice (TAN) inviting comment.

2.6.   Data protection

Data protection applies for all applications which are assessed under Category 11 where the applicant is providing data to the APVMA that are eligible for protection. Publicly available data are ineligible for protection.

Applicants must provide a data list, including an entry for all information that meets the definition given on the APVMA website data protection page at http://www.apvma.gov.au/registration/data_protection.shtml . This requirement applies irrespective of whether an application is eligible for data protection.

3.   examples

Example 1: Application is made for variation to a fungicide currently registered for use in apples and pears. The application is to extend the use to stone fruit for control of a fungal pathogen.

Data expected to be provided for this application are residues and efficacy trial data. Residues data are required to demonstrate likely residues when the proposed product is used according to the maximum label rate, in order to determine an MRL for the active constituent in the new food commodity. Efficacy data are required to demonstrate that the product will be effective for the new use in Australia when used in accordance with label directions.

New data may not be required for OHS or environmental assessment, because data already held by the APVMA from previous applications (eg the pome fruit uses) may be sufficient to allow the OHS or environment assessments to be undertaken. However, the applicant should provide suitable argument in the Application Overview using the current information as to why the new use pattern will not pose unacceptable risks to workers or the environment.

Example 2: Application is made for variation to a pre-emergent herbicide for use in cotton, cereals and vegetables. The application is to extend the use to sugarcane at different rates of application.

Due to the environmental sensitivities associated with sugarcane production (ie impact on the Great Barrier Reef), additional data on environmental fate and/or ecotoxicity, as well as extrapolation and argument may be required. New data may not be required for the OHS assessment unless different application techniques warrant the need for worker exposure data.

Example 3: Application is made for variation to an insecticide currently registered for use in a limited non-crop situation (eg commercial and industrial areas). The application is to extend the use to include cotton. Use of the active constituent in a food-crop has not previously been approved and there is no relevant ADI.

This is a very significant extension of use from non-food use to food use.

Toxicological data are required in order to establish an ADI. This application is ineligible for assessment under Category 11 and will be assessed under modular Category 14.

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