Permits

1. What is this guideline about?

1. This guideline is made pursuant to subsection 6A (1) of the Agricultural and Veterinary Chemicals Code, as set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code).
2. The purpose of this guideline is to set out our principles and processes in relation to performing our functions and exercising our powers relating to permits under Part 7 of the Agvet Code.
3. It covers applying for permits and determining permits applications, including what we take into account in determining permits applications. It also covers the imposition of conditions on permits and the duration and extension of permits.
4. The provisions of the Agvet Code and the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations) covered by this guideline are outlined in the annexure to this guideline.
5. This guideline commences on 18 September 2018.

2. Overview

1. Part 7 of the Agvet Code provides that we may issue permits, allowing a person to do something or omit to do something in respect of an active constituent for a proposed or existing chemical product, or in respect of a chemical product, that would otherwise be:
   1. an offence against certain provisions of the Agvet Code
   2. an offence against the provisions of a law of a jurisdiction declared by a law of that jurisdiction to be an eligible law for the purposes of the Agvet Code 
   3. a contravention against certain civil penalty provisions of the Agvet Code.
2. A person may apply to us for a permit, on behalf of that person, a class of persons or persons generally. The use of the active constituent or chemical product, as proposed in the application for the issue of a permit, must be:
   1. a minor use
   2. an emergency use, or
   3. for the purposes of research.

Alternatively, we may issue a permit to a person on our own initiative in particular circumstances.

3. What does applying for a permit involve?

3.1. Preliminary assessment – where can I get more information?

1. Applicants must ensure that applications for a permit contain or are accompanied by all relevant information such that the application 'meets the application requirements'.

   Note: Section 8A of the Agvet Code defines ‘meets the application requirements’.

2. We will undertake a preliminary assessment of applications for a permit in accordance with Section 6A guideline – preliminary assessment.
3. For the purposes of section 110A(5) of the Agvet Code, we may alter an application, after it has passed preliminary assessment, and with the written consent of the applicant, in accordance with Section 6A guideline – altering applications.

3.2. When will coordinators be consulted?

1. We must give the designated coordinator of a jurisdiction (usually a person designated by a minister of the relevant state or territory) a copy of the permit application and any accompanying documents unless we think it is inappropriate to do so (subsection 111(1)(a) of the Agvet Code).
2. One circumstance in which we think it inappropriate to do so is where we have agreed with the relevant state or territory that we do not need to consult with the designated coordinator in relation to an application for a permit of a particular type or class, and the application is for a permit within that type or class.

3.3. When will the applicant need to give us more information because of a request by a coordinator?

1. If a coordinator requests additional information for the purposes of enabling them to make a recommendation to us about the application, we will give written notice to the applicant requiring the applicant to give us that additional information, unless we have reasonable grounds for refusing the request (subsection 111(1)(b) of the Agvet Code).
2. We will have reasonable grounds for refusing the request if:
   1. the request does not relate to the application or the matters we have to take into account in assessing the application, or
   2. we are able to adequately respond to the request without seeking additional information from the applicant.

4. How do we determine an application for a permit?

1. We must be satisfied of the relevant matters in section 112 of the Agvet Code before we can issue a permit. Some of these matters are set out below.

4.1. What is ‘a minor use’?

1. We must issue a permit for the ‘use’ of an active constituent or a chemical product if, among other things, the ‘use’ proposed in the application is a ‘minor use’ (see subsection 112(2)(e) of the Agvet Code and regulation 57(2)(a) of the Agvet Code Regulations).
2. ‘Minor use’:
   1. in relation to a chemical product or an active constituent, is 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).

   2. in relation to a chemical product, is a use of the product where the following apply:
      (a)  instructions for that use are in the Register in relation to one or more registered chemical products;
      (b)  none of those registered chemical products is available for sale anywhere in Australia.

3. The following are examples of what we might consider to be a minor use (that is, examples of uses that may not produce a sufficient economic return, as described in paragraph 4.1(b) above):
   1. Use of a product on a speciality crop or animal grown on a small scale
   2. Infrequent use of a product on a major crop for the control of a minor pest or disease
   3. Use of a product on a major crop for the control of a minor pest or disease, where the use is restricted to a small proportion of that crop
   4. Change in use of a registered product (that would normally require an application for variation) to account for unusual seasonal conditions (for example, changes to the method or rate of application of the product)
   5. Use of a product on a newly emerging crop or livestock species
4. Ordinarily, we will not issue a ‘minor use’ permit in relation to an approved active constituent or a registered chemical product, to permit use not covered by the approval or registration, to:
   1. the holder of the approval or registration, or
   2. a person principally responsible for the development, manufacture, marketing, distribution or commercialisation of the active constituent or chemical product the subject of the approval or registration.
5. In these circumstances, and where the holder or other relevant person obtains a commercial benefit from the supply of the approved active constituent or registered chemical product, the holder or person should apply for a new registration or approval, or to vary the relevant particulars or conditions of the registered chemical product or approved active constituent, as the case may be.

4.2. What is an ‘emergency use’?

1. We must issue a permit for the ‘use’ of an active constituent or a chemical product if, among other things, the ‘use’ proposed in the application is an ‘emergency use’ (see section 112(2)(e) of the Agvet Code and regulation 57(2)(b) of the Agvet Code Regulations).
2. ‘Emergency use’, in relation to a chemical product or an active constituent, means a use of the product or constituent in the genuine belief that the use is required because of an emergency or impending emergency (regulation 3 of the Agvet Code Regulations).
3. An example of an emergency use of a chemical product is the use of the product to control a pest or disease the outbreak of which was unforeseen, and which requires immediate or urgent attention, and for which no suitable alternative is available. The outbreak or the effects of the outbreak must be demonstrably unforeseen. Where it has arisen due to a lack of planning in controlling the pest or disease or in allowing it to proliferate, it is unlikely to be regarded as an emergency.
4. If an ‘emergency use’ is also a demonstrable ‘minor use’, a ‘minor use’ permit, rather than an ‘emergency use’ permit, should be applied for.

4.3. What is a contingency permit?

1. One example of an ‘emergency use’ permit we issue from time to time is known as a ‘contingency use’ permit. It is a permit we issue to various government agencies to allow them to respond to an exotic pest or disease incursion if it were to occur.
2. Contingency permits are not issued in response to an immediate need but rather are issued to allow the government agency to respond in a timely manner to an impending emergency. 

4.4. When is use ‘for the purpose of research’?

1. We must issue a permit for the ‘use’ of an active constituent or a chemical product if, among other things, the ‘use’ proposed in the application is ‘for the purpose of research’ (see section 112(2)(e) of the Agvet Code and regulation 57(2)(c) of the Agvet Code Regulations).
2. We consider that use of a new chemical product for the purpose of screening or testing it and its uses, and to generate data necessary to support the product’s registration, will likely be use ‘for the purpose of research’.
3. We can issue research permits for screening or scoping trials, small scale field trials, and larger scale product evaluation trials.
4. We usually issue research permits for field trials to allow the holder to conduct field trials in relation to either a registered or unregistered product for the purposes of gathering data to support a new registration or variation application. The data gathered will relate to efficacy or crop safety, environment or residues.
5. We usually issue research permits for product evaluation trials in relation to either registered or unregistered products. Such permits are only issued where the toxicological properties of the product have been evaluated with first aid and safety directions having been recommended. These trials are usually conducted to allow the holder to ascertain how the product will perform when used in commercial equipment and to determine the product’s fit within established spray programs. 

4.5. What are ‘reasonable grounds’?

1. If an application has not been made for approval of an active constituent or registration of a chemical product, or if such application has not been determined, we must issue a permit for the constituent or product if, among other things, there are ‘reasonable grounds’ for the application not having been made or for issuing the permit pending determination of the application (see section 112(2)(f) of the Agvet Code).
2. Ordinarily, there will be reasonable grounds for the application not having been made if the permit is for:
   1. a ‘minor use’, subject to paragraphs 4.5(d) and 4.5(e) below
   2. an ‘emergency use’, subject to paragraphs 4.5(d) and 4.5(e) below, or
   3. ‘the purpose of research’.
3. Ordinarily, there will not be reasonable grounds for issuing the permit pending determination of an application for registration, or variation to the relevant particulars or conditions of registration, of the same or a similar product if the permit is for a ‘minor use’ that is covered by the proposed registration or proposed variation. However, there will ordinarily be reasonable grounds for issuing the permit pending determination of the application if the permit is for:
   1. an ‘emergency use’, subject to paragraphs 4.5(d) and 4.5(e) below, or
   2. ‘the purpose of research’.
4. Ordinarily, there will not be reasonable grounds if there are suitable and effective alternative registered chemical products or approved active constituents available with the same purpose as the product or constituent the subject of a proposed ‘minor use’ or ‘emergency use’ permit (the possibility that the product or constituent the subject of the proposed permit might be less expensive than the registered chemical product or approved active constituent is irrelevant). However, there may be reasonable grounds for issuing a ‘minor use’ or ‘emergency use’ permit in these circumstances:
   1. Where  a registered chemical product or approved active constituent has been demonstrated or confirmed to lack efficacy (for example, due to the development of resistance to it)
   2. Where the product or active constituent the subject of the permit would be used interchangeably with other registered chemical products or approved active constituents as part of a pest management or resistance management strategy
   3. Where the registered chemical products or approved active constituents cannot be supplied due to demonstrated manufacturing or supply issues
   4. Where commodities are required to be treated with the product or constituent to meet particular market access requirements
5. There may be reasonable grounds for issuing a ‘minor use’ or ‘emergency use’ permit in circumstances where an applicant has demonstrated that the option of pursuing a permit for the use of a registered chemical product or approved active constituent is not feasible for the reasons similar to those set out in paragraph 4.5(d) above.

4.6. What are ‘exceptional circumstances’?

1. We must issue a permit to allow a person to do or omit to do anything which would, apart from the permit, be an offence against section 121(4A) or (5A) of the Agvet Code, or a contravention of a civil penalty provision set out in, section 121(4) or 121(5) of the Agvet Code (which relate to manufacture and licences) if, among other things, there are ‘exceptional circumstances’ that justify issuing the permit (see section 112(2)(g) of the Agvet Code).
2. The following may be regarded as examples of ‘exceptional circumstances’:
   1. Multiple restructures or changes in control of the company that holds the licence or carries out the manufacturing business (for example, where a licence holder is acquired by another entity and, prior to the Australian Pesticides and Veterinary Medicines Authority (APVMA) being notified of the transfer of business and issuing a new licence, a second change in ownership occurs)
   2. Where manufacture is unable to take place at the licensed premises (for example, so that renovations can be undertaken to remove asbestos, or due to a natural disaster), but only where manufacture can take place at another premises in compliance with the manufacturing principles as defined in section 3 of the Agvet Code
   3. To allow changes to the label for a chemical product or a replacement label to be attached in circumstances where an incorrect label has been attached and where the product has already been transported from the place of manufacture (but only if it is unreasonable for the product to be taken back to the place of manufacture)
   4. Where there is no other manufacturer capable of manufacturing a particular chemical product and the product needs to be manufactured to deal with an emergency, but only if we are satisfied that the manufacturer will comply with the manufacturing principles

4.7. What are ‘special circumstances’?

1. We must refuse an application for a permit if we are satisfied of any of the matters set out in section 112(4) of the Agvet Code (generally relating to a contravention of an agvet law or the like), unless, in our opinion, ‘special circumstances’ make it appropriate to issue the permit (section 112(6) of the Agvet Code).
2. The following may be regarded as ‘special circumstances’:
   1. Where there has been a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, was convicted of an offence referred to in sections 112(4)(b)(iv) to 112(4)(b)(vi)
   2. Where there has been a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, was ordered to pay a pecuniary penalty referred to in sections 112(4)(b)(vii) to 112(4)(b)(ix)
   3. Where there has been a significant change in the ownership, governance or control of an applicant body corporate since it, or a person who participated in making decisions that affect the whole or a substantial part of it, held a permit that was cancelled under the provisions referred to in section 112(4)(b)(x)
   4. Where there is no other person capable of being the permit holder in relation to a particular chemical product and the product is required to deal with an emergency

5. What information do we take into account in determining an application?

1. Section 8C of the Agvet Code sets out the information that we must, may and must not take into account in determining an application.
2. Section 8C of the Agvet Code requires us, in determining an application, to have regard to any submission made in response to an invitation given by us in relation to the application. We will only invite a person to make a submission in relation to an application where we are required by the Agvet Code or the Agvet Code Regulations to invite submissions (see, for example, section 8S of the Agvet Code).

6. What kinds of conditions will we impose on permits?

1. Section 114(3) of the Agvet Code provides that a permit may be unconditional or subject to any conditions that we think appropriate.
2. We consider that generally, it will be appropriate to impose conditions on a permit so that we can be satisfied that all applicable statutory requirements are met.
3. Conditions relating to the following matters may be appropriate:
   1. Supply (including in relation to labelling and the amount of chemical product or active constituent to be supplied)
   2. Possession
   3. Record keeping
   4. Monitoring
   5. Reporting
   6. Testing
   7. The scale of treatment (such as the area to be treated or the quantity of produce to be treated)
   8. The fate of treated produce
   9. Advertising
   10. Packaging
4. Any conditions that we impose on a permit will be:
   1. consistent with the Agvet Code and the Agvet Code Regulations, and otherwise lawful
   2. consistent with our regulatory approach
   3. capable of being monitored and measured.

7. How long will a permit be in force for?

1. We have the power to issue a permit of unlimited duration, in which case the permit will remain in force until it is surrendered or cancelled (section 115(1) of the Agvet Code) or of limited duration, in which case the permit will remain in force for the period stated in the permit (section 115(2)).
2. Ordinarily, we will only issue a permit for a limited duration. The duration of such permits will usually vary according to the type of permit issued (see below).

7.1. Minor use permits

1. The duration of a ‘minor use’ permit will usually be in one of the following ranges:
   1. Less than one year
   2. 2 to 3 years, or
   3. 5 to 10 years
2. A minor use permit of less than one year duration may be issued where the chemical product is for a specific use and is to be applied for a single season only, and where  further use of the product (beyond that single season) is not anticipated.
3. A minor use permit of 2 to 4 years duration may be issued where:
   1. there is an application for registration of the product on foot
   2. further confirmatory data is required to be submitted for re-assessment prior to the permit being considered for extension (subsection 115(3) of the Agvet Code).
4. A minor use permit of 5 to 10 years duration may be issued where there are no outstanding data requirements (for example residue data). 

7.2. Emergency use permits 

1. Emergency use permits are issued to address a particular need associated with an emergency. Accordingly, the duration of an emergency use permit we issue in respect of a particular emergency, at least initially, will correspond with the time we consider is required to meet the need associated with the emergency. The duration of an emergency use permit will vary depending on the emergency.
2. If we issue an emergency use permit for an initial period, and the emergency is or likely to be ongoing, the holder of the permit should take steps to register the chemical product for the particular emergency use (or vary the relevant particulars or conditions of registration), if appropriate (see below).
3. Where an emergency permit has been issued and the emergency is ongoing (for example, where unusual climatic conditions are causing variable disease or insect pressures in relation to a particular crop or situation), we may extend the permit beyond the initial period (for potentially up to a period of several seasons or years).
4. In doing this, we recognise that, in the first year of an emergency, the primary objective is usually to control the pest or disease involved, and extending the period may allow the permit holder:
   1. time to react to the needs of industry and determine if it will be commercially viable to pursue registration of the product for the particular emergency use (or variation of the relevant particulars or conditions of a registration)   
   2. time to gather data to support registration of the product for the particular emergency use (or variation of the relevant particulars or conditions of a registration) – for example, to establish trials and finalise data sets (it is usually the case that data needs to be gathered over at least 2 seasons to obtain efficacy, crop safety and residue data)
   3. (and industry) time to determine if a disease or pest is likely to become established (that is, time may be needed to determine if the use by the permit is for a one-off eradication campaign or an ongoing control program).
5. However, the longer the circumstances that give rise to an emergency persist, the more likely we are to find that those circumstances no longer constitute an emergency. For this reason, where an emergency permit has been issued for an initial period, and the emergency is likely to be ongoing, it is important that the holder, in seeking an extension, demonstrate:
   1. progress towards registering the product for the particular emergency use (or varying the relevant particulars or conditions of a registration), where appropriate – this can be done by providing us with updates on progress in generating the data necessary for registration (or variation), and
   2. that the emergency use is not also a minor use (if it is, a minor use permit should be applied for).
6. Where an emergency is ongoing, it is not unusual for emergency use permits, after being issued for an initial period, to be extended for periods of up to one to 5 years. This is determined on a case-by-case basis . 
7. For more information on extending permits, see paragraph 7 below.

7.3. Contingency permits

1. A contingency permit may be issued to a government agency in relation to an impending emergency for a period of up to 10 years.

7.4. Research permits

1. Research permits are issued for the period of time we consider reasonable for the particular research project or trial the subject of the permit to be conducted – that is, the time we consider reasonable for aims of the project or trial to be met.
2. Generally, most research projects or trials last for 2 to 3 years. This is reflected in our assessment of a reasonable duration for a research permit.
3. Screening or scoping trials are usually very small scale and, as a result, they are usually issued for a period of one year only. If further trial work is required beyond the one year period, the holder should apply to extend the permit.
4. Research permits for field trials are usually issued for a period of 2 years. This reflects our requirement that the data set provided in support of a registration application be generated from at least 2 seasons. If further time is required beyond the 2 year period, the holder should apply to extend the permit (and in doing so notify us of the further data required to be collected).
5. Research permits for product evaluation trials are usually issued for a period of no more than one year. If the holder seeks to carry out additional trials, the applicant should apply to extend the permit (and in doing so provide us with reasons as to why further data are required to be generated).
6. For more information on extending permits, see paragraph 8 below.

8. When will we extend a permit?

1. The holder of a permit of limited duration may apply to us in writing for an extension (or extensions) of the permit (section 115(3) of the Agvet Code). We may extend the permit for a further period that we think appropriate if we are satisfied that the application meets the application requirements and the requirements in regulation 57B of the Agvet Code Regulations (section 115(3A)).
2. The guidelines set out above in relation to section 112 of the Agvet Code apply to the operation of regulation 57B of the Agvet Code Regulations to the extent regulation 57B refers to the requirements set out in section 112.
3. In deciding whether to extend a permit for a further period, our original assessment of the matters set out in sections 112(2)(c) or 112(2)(d) of the Agvet Code may be no longer valid, and we may be required to be satisfied anew of those matters (see regulations 57B(b) and 57B(c)). This is likely to occur where:
   1. We have obtained new information in relation to those matters since issuing the permit (including data or other information that may have been provided to us as part of a previous application for extension), or
   2. If the permit was issued pending determination of an application for approval or registration, our continuing assessment of the application has since indicated that we may not be satisfied of those matters.
4. In deciding whether to extend a permit for a further period, we must be satisfied that the holder will continue to be able to comply with the conditions of the permit, unless we are satisfied that special circumstances make the extension appropriate despite this requirement not being met (regulation 57B(d)). Examples of special circumstances may include where:
   1. the holder is unable to comply with the condition or conditions because of circumstances beyond their control (for example, because of a natural disaster)
   2. a permit is issued for research purposes, the holder is unable to comply with a condition to generate and give to us a report or some other information within a specified timeframe, and failure to extend the permit would detrimentally affect the research program.

9. Annexure – relevant legal provisions