Criteria for determining the suitability of Permit Holders. October 2002

CRITERIA FOR DETERMINING THE
SUITABILITY OF PERMIT HOLDERS

According to section 112(2)(a) of the Agricultural and Veterinary Chemicals Code Act, 1994 (the Code), prior to issuing a permit, the APVMA must be satisfied that, having regard to criteria determined by it, the applicant is a suitable person to hold the permit applied for.

This information sheet outlines the criteria the APVMA will use to determine whether applicants would be suitable permit holders for the requested Off-Label Permits (OLPs), Supply/Use Permits (SUPs), Export Permits (XPs), Emergency Permits (EPs) and Research Permits (RPs).

Applicants and 'permit holders'

Any person or corporate body may apply to theAPVMA for a permit under s.110 of the Code. The applicant may be any person or organisation, including individual growers or farmers, grower associations, government departments, government institutions, veterinary surgeons and manufacturers or suppliers of agvet products. Once the APVMA has granted an application and issued a permit in response to an application, the applicant for the permit becomes the holder of the permit, or what is generally termed, the 'permit holder'.

Permit holders and permit users

In some situations, the applicant (whether an individual or body corporate) and the person(s) or class of persons who are to be approved to do the thing specified in the permit, are one and the same. This situation can range from an individual applying for their own use to a company or government department seeking a permit that enables their employees and/or contractors to undertake specified actions. Grower associations or peak grower bodies may also wish to apply on behalf of their members.

Conversely, other applications include the situation where the applicant and the persons who will use the product are different. For example, a company, government department or peak grower body may apply on behalf of all growers of a particular commodity. An individual grower could also apply for a contractor to undertake a use on the applicant's property.

The consideration of the suitability of an applicant to be a permit holder is a different and separate matter to the consideration of whether a person, or class of persons, is suitable to be able to undertake the proposed actions specified in the permit. The criteria that the APVMA utilises to determine whether an applicant is suitable to become a permit holder must take into account whether the permit holder and potential user(s) are one and the same or are different.

General responsibilities of permit holders

The determination of whether an applicant would be a suitable permit holder is more or less dictated by the responsibilities that ensue. The responsibility begins at the application stage and continues through to granting of an application and issuing of a permit plus any follow-up activities required for that permit.

An applicant is generally responsible for:

i. supplying necessary information to the APVMA including relevant technical information about the chemical product or active constituent which is the subject of the permit; and
ii. supplying any information requested in writing by a relevant State Co-ordinator; and
iii. complying with any lawful direction of an inspector (operating under the Code); and
iv. accurately representing the requirements of the person(s), or the class of persons, who will be undertaking the intended use.

When the permit holder will also be the person who will use the product under permit, they must also comply with the responsibilities required of users. When an applicant is representing the requirements of other person(s), or a class of persons, who will undertake the proposed use, then the permit holder must also accept additional responsibilities. The permit holder is required to:

i. ensure that any information provided by them to other persons in relation to the permit is accurate, complete and totally in accordance with the permit; and
ii. inform the APVMA of any relevant information which they become aware of concerning the uses dealt with by the permit, which if the APVM had been aware of prior to issuing the permit, they may have not issued the permit or may have issued the permit with different instructions and/or conditions.

In the majority of cases, unless specified in the permit or in relation to the permit type, a permit holder is not responsible for:

1. ensuring the compliance of persons undertaking the proposed use; or

ii. 'advertising' the existence of a permit to all potential users; or
iii. providing a copy of a permit, or equivalent information, to all potential users; or
iv. supply of the product.

Whilst the permit holder is generally not responsible for 'advertising' the existence of the permit or supplying a copy of the permit to all potential users they are responsible for ensuring a certain level of information sharing. For example, if an organisation holds a permit and their employees or members can undertake the permitted use, then the organisation should take reasonable steps and use appropriate communication means to inform their employees and/or members of the existence of the permit. They should also provide accurate and complete details of the permit including all conditions or indicate from where a copy of the permit can be obtained.

Criteria for determining suitability of permit holders

For all permits, the APVM will generally consider:

i. whether the applicant has been convicted of an offence against the Agvet Code of this or another jurisdiction, or an offence against another law of this or another jurisdiction relating to chemical products or to active constituents for proposed or existing chemical products; and
ii. any criminal proceedings that the applicant is the subject of and that the APVM considers relevant to the application.

For all permits, the APVM will generally consider whether the applicant is in a position to:

iii. accurately represent the requirements of the person(s), or the class of persons, who will be undertaking the proposed use; and
iv. provide accurate and complete permit information to persons who are covered by the permit and who may undertake the permitted use; and
v. be aware of or be informed of any adverse reactions that may result from the permitted use and forward this information to the APVM.

For permits involving supply and/or use of an unregistered product, the NRA will generally consider whether the applicant is in a position to:

vi. supply, or have supplied, all relevant technical information in regards to the unregistered product including complete formulation details as the case requires; and
vii. provide feedback to the NRA, if requested, on the performance and suitability of the product for the permitted use.

For permits involving supply of an unregistered product, the APVM will generally consider whether the applicant is in a position to:

viii. exercise a degree of stewardship over supply and use of the product as the case requires (similar responsibilities to a registrant and the registered product), including the supply of an MSDS or any other information necessary for the safe and proper use of the product for the permitted use.

For research permits (RPs), the APVM will generally consider whether the applicant:
ix. is directly responsible for the research and development, registration, marketing and stewardship of the product being tested, as the case requires; or
x. is an individual or an organisation that would be expected to be capable of undertaking research with chemical products as part of their general operations.

Guide for potential applicants

Based on the above criteria, an attached table gives an overview of potential applicants and the likely permits that they may hold. Note: This table is only a guide and each case must be assessed on its merits. Please refer to the section on Further supporting claims of suitability.

Use of agents

If the application is made by an individual residing in Australia or a body corporate incorporated in Australia, it must be signed by that person or the person representing the body corporate. It is not acceptable that consultants engaged to assist with the permit application sign applications on behalf of applicants.

An application made by a non-Australian resident of body corporate must be signed by an Australian resident or a representative of the body corporate incorporated in Australia, who is authorised in writing by the applicant to act on their behalf in all permit matters, including making the application and being responsible for paying the permit fee and other fees (where applicable).

Being authorised in writing by the overseas principal for permit matters makes the Australian signatory an agent of the overseas principal. However, the APVM must have a letter from the overseas applicant stating that the required authorisation has been given. It is not acceptable that the Australian agent claims that they have been properly authorised by the overseas principal.

Notifying the NRA of additional information

All permit holders must inform the APVM of any relevant information they become aware of concerning the uses dealt with by the permit that, if the NRA had been aware of prior to issuing the permit, they may have not issued the permit or may have issued the permit with different instructions and/or conditions. Whilst permit holders are not responsible for ensuring compliance with the permit by all users (which is the role of State and Federal Governments), it is expected that they will inform theAPVM should they become aware of any non-compliant action(s) of any user(s) in regards to the permitted use(s).

Further supporting claims for suitability

Persons or organisations who do not comply with the above criteria, but still wish to apply for and hold a particular type of permit, will need to submit appropriate supporting information that would convince the APVM that they are a suitable permit holder. Each case will be assessed on its merits.

Guide for potential applicants and the types of permits that they may hold. This is only a guide and each case must be assessed on its merits.
[Note: The information in this table must be read in conjunction with the criteria specified above].

Type of Applicant

Maximum scope (scale) of permit that may be held

Guide as to the type of permit that an applicant may hold

		OLP	EP	SUP	XP	RP
Individual grower / user	· a user is the applicant or a limited number of identified persons acting under the permit holder's direct supervision; · use on a property owned / controlled by the applicant; · involves generally one or a few identified registered products or use of unregistered products (does not involve supply)	YES	YES	YES	NO	YES
Spray contractors (including licensed PCOs, licensed fumigators, aerial applicators, etc.)	· users are appropriately licensed and employed or contracted to applicant; · use is generally limited to a specific location within a state; · involves generally one or a few identified registered products or use of unregistered products (does not involve supply)	YES	YES	YES	NO	YES
Registrants / manufacturers	· users can be 'persons generally'; · use can be in all states;· generally only involves their own products (registered and unregistered) or supply of unregistered products	YES	YES	YES	YES	YES
State or area-based grower associations (or equivalent) (appropriate national grower association exists)	· users can be either members of the association or 'persons generally'; · the use is usually restricted to the industry in a particular area or a state; · may include all relevant registered products or may include supply and/or use of an unregistered product(s) under special circumstances.	YES	YES	YES	NO	YES
State or area-based grower associations (or equivalent) (appropriate national grower association does not exist)	· users can be either members of the association or 'persons generally'; · the use can be in all states; · may include all relevant registered products or may include supply and/or use of an unregistered product(s) under special circumstances.	YES	YES	YES	NO	YES
Local councils or utilities	· users can be employees of the council or utility; · use can only be in the area controlled by the applicant;· involves generally one or a few identified registered products or use of unregistered products (does not involve supply).	YES	YES	YES	NO	YES
State government departments(eg agriculture, national parks, natural resources, etc..)	· users can be 'persons generally'; · use can be in the relevant state; · may include all relevant registered products or may include supply and/or use of an unregistered product under special circumstances.	YES	YES	YES	NO	YES
National primary industry associations or peak grower bodies	· users can be 'persons generally'; · use can be in all states; · may include all relevant registered products or may include supply and/or use of an unregistered product under special circumstances.	YES	YES	YES	NO	YES
Federal government departments and authorities	· users can be 'persons generally'; · use can be in all states;· may include all relevant registered products or may include supply and/or use of an unregistered product under special circumstances.	YES	YES	YES	NO	YES
Other recognised national grower representative organisations	· users can be 'persons generally'; · use can be in all states; · may include all relevant registered products or may include supply and/or use of an unregistered product under special circumstances.	YES	YES	YES	NO	YES
Recognised research institutions and/or facilities	· users can be employees of the institution or facility;· use can be in the area controlled by the applicant;· involves generally one or a few identified registered products or use of unregistered products (does not involve supply).	YES	YES	YES	NO	YES
Registered veterinary surgeons	· users are the applicant or a limited number of identified persons under their direct supervision; · use on animals via genuine vet/client relationship; · may include one or a few identified registered products or may include supply and/or use of an unregistered product(s) under special circumstances.	YES	YES	YES	NO	YES
Dealers / distributors of agvet chemicals	· users can be persons generally · use can be in the relevant state in which the dealer operates; · involves generally one or a few identified registered products (usually products that they supply at a retail level)	YES	YES	NO	NO	NO