Agricultural Manual of Requirements and Guidelines - Ag MORAG

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Legal Background

1.   INTRODUCTION

The gross value of Australia’s annual farm production now exceeds $30 billion. The majority of primary producers rely on the supply of pesticides and veterinary medicines to protect their crops and livestock from pests and disease.

Because of the potential risks from the incorrect use of pesticides and veterinary medicines, Australian governments have, for many years, had a key role in the regulation of pesticides and veterinary medicines to ensure they work as claimed and are safe to humans, targeted animals and plants, and the general environment.

Regulatory controls over pesticides and veterinary medicines currently require:

  • all active constituents for agricultural and veterinary chemical products to be approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA)
    • the particular source identity of the manufacturing plant used to make an active constituent for an agricultural or veterinary chemical product is an essential part of this approval;
  • all agricultural and veterinary chemical products to be registered by the APVMA prior to their distribution, sale or use in Australia;
  • all agricultural and veterinary chemical products being sold in Australia to have a label approved by the APVMA attached to their containers; and
  • manufacturers of veterinary chemical products in Australia to be licensed by the APVMA.

The APVMA may also issue a permit to individuals, organisations or corporations allowing them (or others) to use a particular agricultural or veterinary chemical product in a limited way (such as for minor uses, emergency uses and experimental purposes) when that product is either not registered or the proposed use of a registered product is contrary to the use instructions and directions on the approved label of the product.

With the assistance of the States and Territories, the APVMA additionally has a role to monitor and enforce compliance with the regulatory controls governing the supply of agricultural and veterinary chemicals in Australia.

This chapter outlines the legislative provisions under which the APVMA performs its functions and exercises its powers in regard to the regulation of pesticides and veterinary medicines.

2.   WHY AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS REQUIRE REGISTRATION

There are now over 7,000 different pesticide and veterinary medicine products in the Australian marketplace. With such a wide choice of chemical products available, Australian producers need to know that the products they use will not only work as they should, but will not be harmful.

Under the existing national controls for agricultural and veterinary chemicals it is a serious offence for any person to import an agricultural or veterinary chemical product into Australia or to distribute or sell a chemical product in any State or Territory in Australia, if that product has not been registered by the APVMA for that State/Territory. It is also a serious offence for any person to sell a chemical product which does not have a label, approved by the APVMA, attached to its container.

In order to avoid the severe penalties for breaching these provisions, chemical manufacturers and/or distributors wishing to supply an agricultural or veterinary chemical product in any State or Territory in Australia should apply to the APVMA for registration of that chemical product and for approval of the proposed label for the product.

If the APVMA decides to grant the application for registration, and for approval of the proposed label, it must register the product by entering certain information about that product in the Register of Agricultural and Veterinary Chemical Products, and approve the label for the product. Upon registering a chemical product, the APVMA will issue a notice of registration and label approval to the applicant.

Once a product has been registered and its label approved, it can then be legally distributed, sold and used in all Australian States and Territories in which the product has been registered for use and which are described on the product label.

If a registrant subsequently wants to vary any of the ‘particulars’ of registration as entered in the Register or to make any variation to the approved label for the chemical product – including additional claims made about the product – then he or she would again be in breach of the regulatory controls over agricultural and veterinary chemical products unless he or she further applies to the APVMA seeking approval for the variation to the registration or a variation to the approved label for the chemical product. Note however that Permit 6868 allows certain variations to be made to labels without the need for application to the APVMA. Permit 6868 may be seen on the permits section of the APVMA website.

Registration ensures that users have access to products that are correctly packaged and labelled with all necessary limitations, precautions and directions for use. Registration of agricultural or veterinary chemical products also provides a stamp of security that those products have been scientifically assessed to ensure that, when used as directed by the label, they pose no unacceptable risk to human health, worker safety the environment or trade and that the products work effectively.

Registration also helps to ensure that unacceptable residues from the chemicals used in agriculture do not appear in food for human or animal consumption in Australia or in Australia’s export markets.

3.   THE NATIONAL REGISTRATION SCHEME FOR AGRICULTURAL AND VETERINARY CHEMICALS

In 1991, the Commonwealth, States and Territories of Australia agreed to establish a National Registration Scheme for agricultural and veterinary chemicals (NRS) setting out a new regulatory framework for the management of pesticides and veterinary medicines in Australia to replace Australia’s fragmented regulatory structure. The Scheme was designed to provide for the uniform regulation and control of the manufacture and supply of pesticides and veterinary medicines and to streamline the process of registering agricultural and veterinary chemical products.

The NRS is a partnership between the Commonwealth and the State/Territory governments.

The APVMA is an independent statutory authority of the Australian Government that was established in 1993 to undertake the Commonwealth’s regulatory responsibilities under the NRS. The APVMA is responsible for the regulation of the manufacture of agricultural and veterinary chemicals throughout Australia and for their control up to and including the point of retail sale. This includes responsibilities for the registration of pesticides and veterinary medicines and for quality assurance and compliance of them during their manufacture, distribution and sale. The APVMA also manages a number of programs that monitor the ongoing safety and performance of registered pesticides and veterinary medicines

The States and Territories have retained responsibility for control over the use of agricultural and veterinary chemicals after their retail sale.

4.   THE ROLE OF THE APVMA

The APVMA operates in accordance with its governing legislation – principally the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994. There are also regulations under the Agvet Code Act and the Administration Act which are known as the Agricultural and Veterinary Chemicals Code Regulations 1995 (the ‘Agvet Regulations’) and the Agricultural and Veterinary Chemicals (Administration) Regulations 1995. Furthermore, because the APVMA has to fully recover its costs, there is also a separate suite of legislation covering these cost recovery arrangements.

The Administration Act establishes the APVMA1 and confers powers and functions on it, including to facilitate a consistent national approach to the assessment and control of chemicals and the assessment of the suitability for sale of active constituents for chemical products, chemical products and labels for chemical products.

The Agvet Code details the operational provisions under which the APVMA functions. Under the Agvet Code the APVMA has responsibility to ensure that agvet chemical products registered for use in Australia are suitably formulated and properly labelled and, when used according to instructions are:

  • safe to the host, the user, consumers and the environment;
  • efficacious (that is, the product does the job it claims it shall do); and
  • not unduly prejudicial to trade.

5.   OTHER GOVERNMENT AGENCIES INVOLVED IN THE REGISTRATION PROCESS

In considering whether to grant an application for registration of an agricultural or veterinary chemical product, the APVMA must be satisfied that the product will be safe and effective and that its label is suitable. As part of making this broad assessment in relation to a chemical product, the APVMA conducts a number of separate evaluations, including chemistry and manufacture; toxicology, metabolism and kinetics; residues and trade; occupational health and safety; and environment.

The APVMA uses the services of a number of Australian and State government agencies as advisers to help with some of these evaluations of applications for registration of agricultural and veterinary chemical products. These include:

  • the Office of Chemical Safety (OCS) of the Commonwealth Department of Health and Ageing which:
    • evaluates and reports on toxicology and metabolism studies; proposes first aid and safety directions; determines poison schedule classifications2; and establishes acceptable daily intakes (ADIs) and acute reference doses (ARfD); and
    • evaluates the occupational health and safety aspects of an application and recommends safety directions and occupational controls on use and advises on a Material Safety Data Sheet (MSDS);
  • the Commonwealth Department of the Environment and Water Resources (DEW) which evaluates environmental data and recommends appropriate use controls and instructions for the product that will protect the environment; and
  • State and Territory departments responsible for agricultural and primary industries which evaluate and reports on efficacy and target crop or animal safety data for new agricultural chemicals and new uses of registered products. In some cases the APVMA contracts this work out to other agencies such as universities, the CSIRO or to other experts.

6.   OTHER MATTERS IN THE AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION

It is not possible in this Manual to provide a detailed summary of every matter in the Agvet Code or Agvet Regulations or in the Administration Act or Administration Regulations that may be of relevance to a particular application for registration of a pesticide or veterinary medicine or approval of a product label. However, the following represents a brief outline of some of the more important matters in the legislation pertaining to applications for registration or approval of labels.

6.1.   Definition of an agricultural chemical product

Section 4 of the Agvet Code provides an exhaustive definition of an agricultural chemical product. In addition to substances included in the definition of an agricultural chemical product, the definition specifically provides that an agricultural chemical product includes certain other substances as prescribed in the Agvet Regulations and excludes certain other substances as prescribed.

The definition is as follows:

  1. This section defines what is meant by an agricultural chemical product for the purposes of this Code.
  2. Subject to subsections (3) and (4), an agricultural chemical product is a substance or mixture of substances that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:
    1. destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing; or
    2. destroying a plant; or
    3. modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity; or
    4. modifying an effect of another agricultural chemical product; or
    5. attracting a pest for the purpose of destroying it.
  3. An agricultural chemical product includes a substance or mixture of substances declared by the regulations to be an agricultural chemical product.
  4. An agricultural chemical product does not include:
    1. a veterinary chemical product; or
    2. a substance or mixture of substances declared by the regulations not to be an agricultural chemical product.

6.1.1.   Inclusions

Regulation 7 of the Agvet Regulations provides that this definition of an agricultural chemical product additionally includes:

  • dairy cleansers for on-farm use;
  • any substance used in conjunction with an agricultural chemical product to identify areas treated with that product; and
  • insect repellents for use on humans.

6.1.2.   Exclusions

The following substances specified in Schedule 3 of the Agvet Code Regulations are excluded from the definition of an agricultural chemical by being declared by subregulation 7(2) not to be agricultural chemical products:

Any mould inhibitor for use in the manufacture of paper, glue, plywood, carpets, or any surface coating (including paint), if:

  1. the mould inhibitor is incorporated into the product during manufacture as part of the manufacturing process; and
  2. the manufactured product is not claimed to have any effect as a pesticide

Any fungicide, bactericide or deodorant for use in footwear and clothing

Any soil ameliorant, conditioner or fertiliser if the product is not claimed to have any effect as a regulator of plant growth

Any invertebrate pest management lure based on food and not containing any active constituent, and any vertebrate pest management lure

Any disinfectant, mould inhibitor, air freshener or sanitiser sold by retailers, or presented or promoted primarily through retailers, to consumers for domestic use, except any sanitiser for use in swimming pools or spa water

Cyanuric acid for use in swimming pools as a chlorine stabiliser

Any cut flower preservative

Any hay inoculant, silage inoculant or legume inoculant, if the product is based on bacteria or enzymes, or both

Any predatory insect, predatory mite or macroscopic parasite

The nematode Deladenus siricidicola for the control of Sirex species wood wasps in pine plantations

Any industrial biocide used in the manufacture of paper pulp

Any head lice or body lice treatment for human beings

6.2.   Definition of a veterinary chemical product

Similar to the approach taken in the Agvet Code for defining an agricultural chemical product, Section 5 of the Agvet Code provides an exhaustive definition of an veterinary chemical product. In addition to substances included in the definition of a veterinary chemical product, the definition specifically provides that a veterinary chemical product includes certain other substances as prescribed in the Agvet Regulations and excludes certain other substances as prescribed.

The definition is as follows:

  1. This section defines what is meant by a veterinary chemical product for the purposes of this Code.
  2. Subject to subsections (3) and (4), a veterinary chemical product is a substance or mixture of substances that is represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:
    1. preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or
    2. curing or alleviating an injury suffered by the animal; or
    3. modifying the physiology of the animal:
      1. so as to alter its natural development, productivity, quality or reproductive capacity; or
      2. so as to make it more manageable; or
    4. modifying the effect of another veterinary chemical product.
  3. A veterinary chemical product includes:
    1. a vitamin, a mineral substance, or an additive, if, and only if, the vitamin, substance or additive is used for a purpose mentioned in paragraph (2)(a), (b), (c) or (d); and
    2. a substance or mixture of substances declared by the regulations to be a veterinary chemical product.
  4. A veterinary chemical product does not include:
    1. a substance or mixture of substances that is:
      1. prepared by a pharmacist in accordance with the instructions of a veterinary surgeon; or
      2. prepared by a veterinary surgeon in the course of the practice, by the person preparing the substance or mixture of substances, of his or her profession as permitted by or under a law of this jurisdiction; or
    2. a substance or mixture of substances declared by the regulations not to be a veterinary chemical product.

6.2.1.   Inclusions

Regulation 8 of the Agvet Regulations provides that this definition of a veterinary chemical product additionally includes:

  • allergenic substances supplied or used for administration to an animal by any means, or for consumption by an animal;
  • medicated blocks or licks;
  • enzymes supplied or used for administration to an animal by any means, or for consumption by an animal;
  • stockfood non-active constituents except stockfood non-active constituents excluded from this class by an order under section 7 of the Act;
  • direct-fed microbial products;
  • sheep branding substances.

The order referred to in the fourth dot point above is set out in the Veterinary Chemical Products (Excluded Stockfood Non-Active Constituents) Order.  Note that stockfeed non-active constituents are veterinary chemical products unless those non-active constituents are included in an Order (‘The Stockfood Non-active Constituents Order’) in the Regulations to the Agvet Code.

Note also:

    • even if a stockfeed constituent is listed in the above Order, it cannot be regarded as a non-active constituent if it is included at a level that has biological or other effects; in these cases the constituent is an active constituent and the product is a veterinary chemical product.
    • Several permits are in place which allow supply and use without registration of stockfeed non-active constituents that are veterinary chemical products (that is, they are not included in the above Order).  These include (as at October 2010) permits 10987, 11051 and 10753 (zeolites).

6.2.2.   Exclusions

Several substances are excluded from the definition of a veterinary chemical by being declared by subregulation 8(2) not to be veterinary chemical products. These substances include certain stockfoods, medicated stockfoods and stockfood supplements; certain premixes and medicated premixes; certain blocks and licks; and colour intensifiers for aviary birds.

For a full description of the particular stockfoods, medicated stockfoods and stockfood supplements; premixes and medicated premixes; and blocks and licks excluded from the definition of a veterinary chemical by subregulation 8(2) see subregulations 8(3), (4), (5), (6) and (7) of the Agvet Regulations.

6.3.   Legislation covering active constituents

Approval from the APVMA is required for every active constituent used in the formulation of agricultural or veterinary chemical products intended for distribution, sale or use in Australia. This applies regardless of whether the product is formulated in Australia or overseas.

It is an offence (under section 69B of the Administration Act) to import into Australia, an active constituent that is not approved without prior written consent from the APVMA.

6.3.1.   Agricultural active constituents

All manufacturing sources of active constituents for use in agricultural chemical products must be approved by the APVMA. New sources of approved active constituents must be equivalent to, and are assessed against, the first approval of that active constituent.

6.3.2.   Veterinary active constituents

All active constituents for use in veterinary chemical products must be approved by the APVMA. If the active constituent is subject to a monograph in the British Pharmacopoeia, British Pharmacopoeia (Vet), European Pharmacopoeia or United States Pharmacopeia, that standard will be applied. Where such a standard does not exist manufacturer’s specifications may be applied.

6.4.   Conditions of approval and registration

In approving an active constituent for a chemical product, or in registering a chemical product, or in approving a label for containers for a chemical product the APVMA may impose conditions as it thinks are appropriate: section 23 of the Agvet Code.

One condition of registration that the APVMA may impose on an agricultural or veterinary chemical product is that the chemical product is supplied only in a container of a kind prescribed in the Agvet Regulations. For this purpose, regulation 18 of the Agvet Regulations provides that a container for a chemical product must

  1. be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service;
  2. have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions;
  3. if it is intended to be opened more than once - be able to be securely and readily closed and reclosed;
  4. have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage; and
  5. enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot
    1. harm any person; or
    2. have an unintended effect that is harmful to the environment

It is now usual for the APVMA to impose a condition of registration on an agricultural or veterinary chemical product to the effect that the chemical product can be supplied only in a container of a kind prescribed in regulation 18 of the Agvet Regulations.

Section 36 of the Agvet Code further provides that a breach of a condition is grounds upon which the APVMA may suspend or cancel the approval or registration.

6.5.   Notification of new information to the APVMA

Section 160A of the Agvet Code requires applicants for active constituent approval, product registration (or listed registration), a permit, or a manufacturing licence to notify the APVMA, as soon as practicable, if they become aware of any ‘relevant information’ in relation to the active constituent or chemical product after their application has been lodged with the APVMA.

‘Relevant information’ is a defined term that includes any information that contradicts the information given to the APVMA in the application, or shows that the use of the active constituent or chemical product would be unsafe or ineffective, or would have had to be given to the APVMA in connection with the application if the applicant was aware of the information when the application was made.

An applicant that is an Australian corporation is taken to be “aware” of information if the overseas parent of that Australian corporation is aware of that information.

Similarly, section 161 requires active constituent approval holders, product registrants, or permit holders to notify the APVMA, as soon as practicable, if they become of any ‘relevant information’ in relation to the active constituent or chemical product after the active constituent approval is given, the product is registered or the permit is issued.

6.6.   Confidential commercial information

Section 162 of the Agvet Code prohibits the APVMA (or any member of its staff) from disclosing ‘confidential commercial information’. ‘Confidential commercial information’ in relation to an active constituent or a chemical product is exhaustively defined in the Agvet Code but essentially it includes a trade secret relating to the active constituent or chemical product or other information about them that is of value that would be destroyed or diminished if disclosed; or information that if disclosed could unreasonably affect the owner of the information in an adverse manner.

Although it needs to be considered on a case-by-case basis, the APVMA accepts that most information and data sent to the APVMA as part of an application for approval of an active constituent, the registration of a chemical product, the approval of a product label, a permit, or for a manufacturing licence would be confidential commercial information that may not be disclosed.

The actual documents that are sent to the APVMA as apart of an application do, by section 169 of the Agvet Code, become the property of the APVMA.

Quite separate to the concept of information being confidential commercial information some information associated with applications to the APVMA attracts data protection – see Section 7 of this Part of the Manual.

6.7.   Reconsideration and review of certain decisions of the APVMA

The Agvet Code provides that, in relation to an application made to the APVMA for approval of an active constituent, registration of a chemical product or approval of a label, for a permit, or for a manufacturing licence (or for a variation of any of these things) the applicant can seek to have certain decisions of the APVMA reconsidered. A full description of the type of decisions for which a reconsideration can be sought is detailed in section 167 of the Agvet Code but, in general terms, they include a decision to reject an application under section 11A or a decision to refuse an application or to impose conditions of approval or registration.

In reconsidering an earlier decision the APVMA is legally obliged to reconsider its original decision and either confirm, vary or set aside that decision and make a new decision in substitution.

A reconsideration is taken to be a fresh decision on the relevant matter and thus must be made by a person in the APVMA other than the person who made the original decision. At the present time, only the Chief Executive Officer of the APVMA has been delegated the authority to reconsider an earlier decision of the APVMA.

Applications for a reconsideration must be made in writing to the General Counsel of the APVMA.

An applicant who is not satisfied with the APVMA’s original or reconsidered decisions also has a right to have some decisions of the APVMA independently reviewed by the Administrative Appeals Tribunal (AAT) subject to the Administrative Appeals Tribunal Act 1975. The AAT is a completely independent body which can review certain APVMA decisions on their merits and, where the Tribunal decides it is necessary, substitute its own decision. An application for review by the AAT must be in writing, accompanied by the required filing fee, addressed to the AAT at GPO Box 9955 in any capital city and should be lodged within 28 days of receiving the notice of the decision by the APVMA.

6.8.   Legislation covering the manufacture of veterinary chemical products

The effect of Section 121 of the Agvet Code is to require manufacturers of veterinary chemical products in Australia to be licensed by the APVMA.

Australian manufacturers must show that they comply with the APVMA’s Manufacturing Principles and the Australian Code of Good Manufacturing Practice (GMP) for Veterinary Preparations and/or Australian Code of Good Manufacturing Practice for Homemixed Feeds, Feed-Milling Industry and Stock-Food Premixes as may be appropriate before the APVMA will license them.

Applicants who wish to register veterinary chemical products manufactured overseas must provide acceptable evidence that the manufacturer complies with GMP standards comparable to those applying in Australia. Acceptable evidence consists of:

  • documentation from a recognised regulatory authority that supports compliance with an equivalent level of GMP to the relevant Australian Code; or
  • audit of the overseas plant by an APVMA-authorised auditor or by an auditor acceptable to the APVMA.

There is no requirement for manufacturers of agricultural chemical products to be licensed.

6.9.   Public consultation

The Agvet Code (sections 12 and 13) requires the APVMA to publish a general notice in the APVMA Gazette about new active constituents being considered for approval and chemical products containing new active constituents being considered for registration. In the notice the APVMA is to invite written comment from the public on specific grounds on whether the application for approval of the active constituent or registration of the chemical product should be granted.

Additionally, if the product is to be used on a food-producing species, a Public Release Summary (PRS) of the information provided in the application for registration is prepared and the public and relevant industry bodies are notified that the PRS is available on request.

Where trade issues have to be assessed in the registration of a new chemical product the APVMA publishes a Trade Advice Notice (TAN) in the Gazette seeking public comment, on trade grounds only, as to whether the application for registration of the product should be granted.

This public consultation process allows members of the public and relevant industry bodies to have an opportunity to raise matters of concern about human and environmental safety and, where relevant, trade. The APVMA must take into account any submissions received in response to public consultation notices before it makes a decision as to whether or not to grant an application for approval of an active constituent or an application for registration of a chemical product.

7.   DATA PROTECTION PROVISIONS OF THE AGVET CODE

Amendments to the Agvet Code which came into force on 1 January 2005 regulate the way in which the APVMA uses scientific information provided as part of applications.

The amendments introduced three major changes to the manner in which the APVMA uses the information provided with certain applications:

  • Data protection: New limitations on how the APVMA can use information in making certain decisions
  • Early disclosure: Publishing application summaries once an application has been accepted for assessment
  • Summaries of advice: Publishing the advice provided by other government departments and agencies, and other specialists the APVMA consults, in relation to applications which are approved.

7.1.   Data protection

The provisions relate only to information provided with applications for active constituents, products and labels. They do not have any impact on information provided for chemical reviews undertaken by the APVMA.

Where applicants provide information with an application, the APVMAwill be restricted from using it for certain decisions without the permission of the ‘authorising party’. Essentially, the data protection provisions apply to the following four situations:

  • screening
  • evaluation
  • after-application approval (ie new active constituent, product or label in the market)
  • s.161 data.

7.1.1.   Some qualifications

Pre-approval protection (screening and evaluation)

While an application for an active constituent or product is in screening or is being evaluated, the APVMA will be restricted from using that information for another application relating to an active constituent or product (but not to a permit) as well as any chemical reviews currently in progress.

After-application approval (or market protection)

Once an application has been granted, all information that the APVMA relied on to approve the application will become protected data. This protection means that the APVMA will be limited from using that information to make a decision on another application (except for a permit) or a chemical review without the consent of the authorising party (or when one of the other exceptions apply, see paragraph 7.1.2 below).

The length of protection depends on the purpose of the application. Appendix A provides details of the protection periods for application data and extending the period of protection.

7.1.2.   Exceptions allowing use of protected data

The APVMA can use protected data when making a decision on an application or chemical review if one of the following conditions is met (see Figure 1 for graphic representation).

Consent for use

The APVMA can use protected data when a consent for use has been provided by the authorising party for those data. The consent remains valid even if it is withdrawn or was fraudulently provided. Any disputes as to the validity of a consent will be a matter for the parties. However, it is a criminal offence to make a false statement to the APVMA.

Public interest

The APVMA can use protected data when it is in the public interest to do so. Public interest can include a range of things but will include when the data indicates an undue risk to human health or the environment. The APVMA currently has similar powers in relation to chemical reviews. Data owners will receive a notice indicating the APVMA’s intention to use the information in the public interest and the data owner has the right to seek a review of that decision in the Administrative Appeals Tribunal (AAT). There is no right of review where the APVMA considers it is necessary to use the data due to an imminent risk to health or the environment.

Unfavourable to another application

The APVMA can use protected data when considering another application involving an active constituent, product or label where the APVMA considers that the data demonstrates the second application is unable to meet requirements with respect to safety to people or the environment, or the product is ineffective.

Identical information

The APVMA can use protected data when there is identical information available that are not protected (ie publicly available information). Information that are declared to be publicly available will not receive protection. There are, however, penalties for making a false declaration to the APVMA.

Ineligible applications

The APVMA is not limited from using data provided with one of the following types of application, as they are ineligible for data protection:

  • an application for an active constituent which at some time in the past had been approved (either by the APVMA or a State/Territory government) or had been an active constituent in a registered product (either by the APVMA or a State/Territory government). If the active constituent had already existed previously in Australia then it cannot be considered a new active constituent (and gain protection), but is a ‘previously endorsed active constituent’
  • an application to vary the particulars of an active constituent approval. Information provided with an application to vary the particulars or conditions of an approval does not gain protection
  • an application for registration of a companion animal product where that product does not contain a new active constituent (ie includes a previously endorsed active constituent). Companion animal products are products for use on, or to be administered to, non-food-producing animals and any food-producing animals defined by the Agvet Code Regulations. Horses are companion animals
  • an application to vary the registration of a companion animal product
  • an application to approve a label of a companion animal product where that product does not contain a new active constituent
  • an application to vary a label of a companion animal product.

Figure 1. Situations where the APVMA is not limited from using protected information

Figure 1 - Situation 1: Consent for use

Figure 1 - Situation 2: Public interest

Figure 1 - Situation 3: Unfavourable to another application

Figure 1 - Situation 4: Identical information

Figure 1 - Situation 5: Ineligible applications

7.1.3.   What is required in applications for data protection?

Application requirements relating to data protection fall into two types:

  • requirements when providing data
  • requirements when referencing data.

The following is a general description of what is required. For further details please see the APVMA website Data Protection Application Requirements (PDF, 46kb).

Requirements when providing information

When providing new data with an application, applicants are required to complete a data list, setting out all data provided. The APVMA has created two templates for applicants’ use (with instructions on how to complete them). Please see the APVMA website Data Protection Application Requirements page for full details.

Both hardcopy and electronic versions are required.

The APVMA will use this information to generate application summaries and to produce the required documentation for assessment.

New requirements when referencing information

For applications that need to reference information held by the APVMA in order to satisfy the APVMA’s full data requirements, applicants will need to consider:

  • Do my reference products/active constituents have associated protected data?
  • If so, do I have the necessary consent for use from the authorising party?

To assist applicants, the APVMA intends to provide (via the website):

  • a means of discerning what active constituents and products have associated protected data, what that data is and who the authorising party is
  • a ‘consent for use’ letter template to ensure appropriate consent is provided.

7.2.   Early disclosure

For most applications, the APVMA is required to publish a ‘summary of application’ shortly after the application has been accepted for assessment. Early disclosure increases the transparency of the process. It also eliminates the previous requirement that the APVMA must not publicly acknowledge whether a certain application has been made.

One benefit to applicants of this change is that other government authorities with which the APVMA deals, such as Food Standards Australia New Zealand (FSANZ) and the Office of the Gene Technology Regulator (OGTR), will be able to disclose the existence of the application, thus allowing other related regulatory actions to occur at the same time.

The type of applications to which early disclosure applies include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change to the use, supply or disposal of the product.

The summary will include details specified in the Agvet Code Regulations. The Regulations require different application summaries depending on the type of application. They will include different combinations of the following details:

  • applicant name
  • application number
  • active constituent name and number
  • product name and number
  • application purpose and description of active constituent or product use
  • a list of data provided with the application and required by the APVMA (as discussed in data protection requirements above)
  • the relevant reference active constituent and/or product names and numbers.

What will be required of applicants in regard to early disclosure?

To allow the APVMA to publish application summaries for early disclosure as efficiently as possible, applicants will be required to provide the information in the specified format.

7.3.   Summaries of advice

Where the APVMA has granted an application involving an active constituent, product or label and the APVMA has relied on advice provided by another government body or a person contracted by the APVMA, the APVMA must publish a summary of that advice.

The summary will include details specified by the Agvet Code Regulations. The Regulations require the same details as for application summaries, plus:

  • a summary of the assessment undertaken to provide the advice
  • a list of the information relied on in providing the advice.

Confidential Commercial Information (CCI) will not be included in the summary of advice.

What will be required of applicants in regard to summaries of advice?

To allow the APVMA to publish summaries of advice as efficiently as possible, applicants will be required to declare what data they consider to be CCI.

In addition to application summaries, advice reports, minus any CCI, will also be publicly available. Although reports and summaries will be written in accordance with the CCI guideline and will not contain any agreed CCI, applicants should check the advice reports and summaries to satisfy themselves.

7.4.   Miscellaneous provisions

The amendments to the Agvet Code in the US Free Trade Agreement Implementation Act 2004 include additional matters relevant to the APVMA that are of importance to industry. For the sake of restricting this manual to matters that the APVMA is likely to encounter, these additional matters have not been discussed in any detail. The APVMA will, however, ensure that the requirements of the US Free Trade Agreement Act are met and will discuss them with industry as required. They involve matters such as:

  • other rules regarding the public interest exception
  • APVMA requirements on disclosure of protected information
  • liability of persons to bring suit if disclosed information is subsequently used by the APVMA for an unauthorised purpose
  • decisions that are appealable to the AAT.

APPENDIX A:   Protection periods for application data


  Data provided with this type of application… …will receive this number of years protection*

1

Application to approve a new active constituent (ie one never previously approved or present as an active constituent in a registered product)

8

2

Application to register a product containing a new active constituent as described in item 1 above, where the application for the product had passed screening (ie been accepted for evaluation) before the active constituent in item 1 had been approved

8

3

Application to register an agricultural chemical product other than as described in 2 above

5

4

Application to register a veterinary chemical product other than as described in 2 above (food/fibre-producing animals only)

3

5

Application to vary an agricultural chemical product and/or label

5

6

Application to vary a veterinary chemical product and/or label

3

* The protection period starts from the day the application is granted.

Extending the protection period – distinct uses

It is possible to extend the protection period for certain data when the following conditions are met. For data that receive eight years protection (ie items 1 and 2 of the above table), the protection period will be extended by one year for each five distinct uses that meet the following requirements:

  • the distinct use is on an approved label of a product as described in item 2 of the table
  • the application to include the distinct use on a label for the extension product was accepted for evaluation before the end of the sixth year of protection of the data associated with the new active constituent
  • all five distinct uses are specified in the relevant Agvet Code Regulation by the time the application including the fifth use is granted. Regulation 22A of the Agvet Code Regulations determines what is a distinct use by requiring that:
    • the use is a non-major use as listed in the table attached to the Regulations (essentially minor crops and minor animal species); and
    • data have been provided specifically on that non-major use (ie the applicant is not extrapolating from data provided on other uses to satisfy APVMA requirements for the distinct use); and
    • the data were required for the type of application involved and were relied on by the APVMA to grant the application including the distinct use on the label; and
    • the use is specified on the label. Note that if the use is a food or non-food crop, then the use can be specified on the label via either the crop or the associated crop group as specified in the Regulations.

Importantly, the period of protection cannot exceed 11 years.

Section 161 data (notification of new information to the APVMA)

Section 161 of the Agvet Code requires that when a registrant, approval holder or a person acting on their behalf becomes aware of any new information that is relevant to the approved active constituent or registered product, and the information is also new to the APVMA, they must give that information to the APVMA.

If s.161 information is provided for a product (whose application for registration was made after 1 January 2005), the APVMA is limited from using the information for the purpose of making a decision on another person’s application involving an active constituent, product or label or a decision in a review for:

  • a period of five years if the product is an agricultural chemical product
  • a period of three years if the product is a veterinary chemical product.

The protection period starts from the day the information was received.

FOOTNOTES

  1. The Administration Act originally established the national regulator with the name of the National Registration Authority for Agricultural and Veterinary Chemicals (NRA). In changing the name of the NRA to the APVMA in June 2004, the Administration Act (section 6) formally continued the NRA in existence but with its new name. In so doing, all the previous approvals and registrations issued, or other decisions made, by the NRA thereby remain valid.

    The Agvet Code also authorises the APVMA, with assistance from the States and Territories, to undertake a national program of compliance and surveillance of agricultural and veterinary chemicals during their manufacture, distribution and retail sale. The Agvet Code provides for severe penalties against any person who distributes or sells an unregistered agvet chemical product, or manufacturers or sells a chemical product which fails to meet registered specifications, or sells a chemical product that does not have an approved label attached to its container.

    Another function that the APVMA is authorised to perform is to issue export or ‘free sale’ certificates under section 69D of the Administration Act to registrants or distributors to facilitate the export from Australia of registered agricultural and veterinary chemical products (or unregistered ‘export only’ products manufactured in Australia) to countries that require such certificates. Further information on export certificates may be found at http://www.apvma.gov.au/supply/export/apply.php
  2. The determination of poison schedule classification for an agricultural or veterinary chemical product by OCS is authorised separately under the Therapeutic Goods Act 1989 administered by the Therapeutics Goods Administration (TGA) of the Commonwealth Department of Health and Ageing. In making its assessment of a chemical product, the APVMA is required to consider the poison schedule classification determined by a separate law of the relevant jurisdiction.

REVISION HISTORY

Revision Date Description of Revision

1 July 2005

First edition

1 October 2005

Second edition

  • extensive revision of complete document.

1 April 2006

Third edition

  • updated link to Agvet Code Regulations.

1 July 2007

Fourth edition

  • minor text edits.